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The Deputy Chairman of Committees (Lord Bates) (Con)
My Lords, welcome to this first Hybrid Grand Committee, which will now begin. Some Members are here in person, respecting social distancing, while others are participating remotely, but all Members will be treated equally. I must ask Members in the room to wear a face covering except when seated at their desk, to speak sitting down and to wipe down their desk, chair and any other touch points before and after use. If the capacity of the Committee Room is exceeded or other safety requirements are breached, I will adjourn the Committee immediately. If there is a Division in the House, the Committee will adjourn for five minutes.
The time limit for the debate on the Industrial Training Levy (Engineering Construction Industry Training Board) Order 2020 is one hour.
Industrial Training Levy (Engineering Construction Industry Training Board) Order 2020
(3 years, 7 months ago)
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Baroness Berridge
That the Grand Committee do consider the Industrial Training Levy (Engineering Construction Industry Training Board) Order 2020.
The Parliamentary Under-Secretary of State, Department for Education and Department for International Trade (Baroness Berridge) (Con)
My Lords, engineering construction as a label is not easily understood, but as the country responds to and recovers from the impact of Covid-19, there can be no doubt about how reliant we are on a skilled engineering workforce.
I ask your Lordships’ House to consider how different our lives would have been in recent months without the electricity, oil, gas and nuclear industries being able to cope with the shifts in demand on power supply; without access to clean, healthy water systems; or without the right infrastructure to enable the food industry to meet an unprecedented demand from the public—and, critically, to consider how much our hopes lie with the pharmaceutical industry being able to identify and roll out a vaccine to this terrible virus. All this is enabled by the engineering construction sector.
As noble Lords know, this House passed legislation only last year to ensure that Britain meets the Committee on Climate Change’s ambitious target to reduce emissions to net zero by 2050. These challenges, whether brought about by Covid, climate change or clean growth, mean that investment in skills and training and supporting young people into jobs in engineering construction are now more important than ever. This goes to the heart of the Engineering Construction Industry Training Board, known as the ECITB. The order before your Lordships will enable the ECITB to continue to play its role in securing and maintaining a sufficient supply of highly skilled labour in the engineering construction industry.
Established in 1964, the ECITB—then named the Engineering Industry Training Board—is industry led and is there to ensure that the engineering construction industry has a highly skilled workforce. It provides targeted training grants to employers to enable workers to access and operate safely on engineering construction sites, drive up skill levels and incentivise training that would otherwise not take place. It also supports strategic initiatives to maintain vital skills in the industry and create a pipeline of skilled workers.
The ECITB is responsive to the needs of the engineering construction industry. During lockdown, it swiftly introduced a package of support measures including a scheme to retain apprentices and graduates and a new scholarship to support new entrants. Over the coming three-year levy period, the ECITB expects to raise around £80 million, to be invested in skills training. The latest available figures show that in 2018, 99.4% of the levy raised went directly into supporting training.
Turning to the detail, I wish to thank the Secondary Legislation Scrutiny Committee for considering this draft order. The key change from the previous 2017 levy order is an increase in the levy rate for offsite employees. These offsite workers are defined by the geographical location of their work, which is mainly at a distance from an engineering construction site such as a chemical works or power station.
The offsite rate is increasing to reflect the substantial growth in demand for training grants for offsite workers in recent years. Last year, offsite training took out almost 25% of total grant expenditure, yet paid in only 13% of the total raised. The ECITB considers that the demand for offsite training is likely to increase further still as companies harness opportunities from new technologies and more work is conducted remotely. This increase from 0.14% to 0.33% of an employer’s annual payments to workers for services is being phased in over the three-year period of this levy order to minimise its impact on employers. Noble Lords will be reassured to learn that the sector affected gave overwhelming support for the increase. The rationale for a fairer split between who contributes to the pot and who can take from it is clear.
This order also recognises that SMEs are a critical part of the engineering industry but at the same time are less likely to have an in-house training budget. As such, it retains the exemption thresholds from the 2017 levy order, which ensure that smaller engineering construction firms can access the support that the ECITB provides without having to contribute financially. The ECITB expects that around 25% of all establishments within the scope of the levy will be exempted from payment.
The ECITB has consulted industry on the levy proposals via its consensus process. Consensus consists of two tests: both the majority who pay the levy and those who pay more than half the levy raised must agree to the proposals. I assure noble Lords that both tests have been overwhelmingly met. To summarise, 75% of all companies in scope of paying the levy, who together are likely to pay 87% of the value of the levy, voted in favour of the proposals before us. This is testament to the value in which the ECITB is held by industry and the recognition that there is a long-term skills challenge, which can be addressed only through collective action.
This order will enable the ECITB to continue to carry out its vital training responsibilities. As the country responds to the Covid-19 pandemic, this is now more important than ever. I beg to move.
Lord Addington (LD)
My Lords, when we look at something that deals with training across such a wide field, the obvious question that comes to mind is: how have the groups the Government are supporting been set? We need a bit more of an idea about the exact criteria for where you get the support from. That would help us in future.
Also, if you are going across these sectors, when will we decide how to encourage the necessary people in? The noble Baroness has already expanded my knowledge of this slightly by suggesting that we interact with both apprenticeships and graduates. There cannot be many other bodies doing that degree of consultation and trying to bring people into the construction sector. It is quite reassuring to hear that, and to hear that we are not only training people but encouraging them to work in the field and telling them how to access training.
Another steady subject of mine when it comes to these issues is, what about people with special educational needs or other disabilities? How are we encouraging them to get involved? The range of skills that has been suggested here is mind-blowing, going from the most basic forms of apprenticeship to postgraduate qualification and bringing them together. Presumably, that includes people training in colleges. A huge number of people can take on the training, provided they get over the initial hurdle.
I declare my interest—I did not do so earlier—as the president of the British Dyslexia Association, as someone who is dyslexic and as someone who uses technology to enable them to write more easily; I certainly use it all the time. How are we working these things to make sure that we get the right people through? We have a skills shortage in these places. What is the current outreach capacity? There are other groups that you will want to look at, but are you looking at the people who have a problem not with the initiation or even considering it but with taking the exam?
Here, a wide-ranging body has a very good opportunity to set an example by saying, “This is what you can do practically to go on and do this, using the flexibility of examination boards and institutions.” We often have a problem with one small aspect of this training: the English language. I remember somebody in apprenticeships training saying, “Oh, don’t worry about that, I wouldn’t pass the English language test”—and they were doing the training. There are certain arbitrary barriers. What are we doing to make sure that we get the right people into these positions? Here, the levy is supporting an organisation that is perfectly placed to undertake some of this work. It would be interesting to know whether this is being considered.
The Deputy Chairman of Committees (Lord Bates) (Con)
I now call the next speaker, the noble Lord, Lord Bourne of Aberystwyth.
The Deputy Chairman of Committees (Lord Bates) (Con)
Can you unmute, Lord Bourne?
Lord Bourne of Aberystwyth (Con) [V]
I think that is it. I apologise; I thought I was going to be unmuted.
My Lords, I first thank the Minister for setting out the background of the draft industrial training levy order. I am certainly not, in principle, against employers contributing via a levy, but I have several concerns about the background to the order.
The first matter that strikes me is that this really seems to come from a different, pre-Covid world. For example, the consultation exercise was carried out by the Engineering Construction Industry Training Board between July and October last year. The situation facing the country and industry now is massively and dauntingly different from then.
The questions I wish to ask are not on the micro-aspects of the order itself but on what I believe is the massive leap of imagination needed by the Government, and awesome extension of ambition, in relation to apprenticeships in general. We face a position now where many apprentices have not, for understandable reasons, been getting the work experience that they normally would have received and which they, and we, expected. Many people have of course been furloughed, and many more, alas, will lose their jobs. Against this background, we really need to address the situation we are facing in relation to apprenticeships, rather than looking at a bit of a mouse of a measure of what is really needed.
I believe that we need an apprenticeship guarantee scheme. This has been echoed in the other place by Robert Halfon, the chair of the Education Committee and the right honourable Member for Harlow. The Prime Minister has committed to look at this; he has said that this is something we should be doing, and I agree. I would like to hear from the Minister how far down this road we now are, because that was said in June. What progress are we making on this?
As a nation, we had made some progress on apprenticeships over the last few years, though that had stalled a little bit, even pre-Covid. We need to ensure that we do something for some of the disadvantaged youngsters who will fall behind because of the education stutters—rather more than stutters, to be honest—that we have experienced. What are we doing in relation to that? That has got to be done against the backdrop of an apprenticeship guarantee scheme, to help the people who will suffer because of the economic consequences of the pandemic. The Chancellor has moved very nimbly on the furlough scheme, but we need to address the education gap and the apprenticeship problems that we face.
The apprenticeship scheme will need to be backed up with infrastructure projects—particularly green projects—on a nationwide basis, to give support to the apprenticeships guarantee that we would bring in. I am sure that the noble Lord, Lord Hain, will have something to say on this in relation to, for example, the Severn barrage tidal lagoon project. These are the things which will be needed to provide training for our youngsters for the future, so that we can address our productivity gap and some of the real problems and challenges that we face. This will certainly involve the public sector playing its part. Some rebalancing of the levy may be needed to ensure that we are getting the appropriate help for the more disadvantaged youngsters who have suffered; they really will suffer through this crisis if we do not make some real efforts to address these problems.
These are the issues I wish to raise against the backdrop of the order. As I say, I have no particular problem with the order, but it does not begin to address the scale of the problem that we have, as I am sure the Minister will acknowledge. I will not be opposing the order, but I certainly think we need to come up with some bolder solutions. It would be good to hear from the Minister how she sees that going forward.
The Deputy Chairman of Committees (Lord Bates) (Con)
Before calling the next speaker, the noble Lord, Lord Hain, I would like to clarify that all speakers will have seven minutes, not six minutes as was indicated earlier, apart from the Minister, who will have 10 minutes at the end. I now call the noble Lord, Lord Hain.
Lord Hain (Lab) [V]
My Lords, I very much agree with the points made by the noble Lord, Lord Bourne, especially on the vital necessity for new skills on green projects. Wales, of course, has many to offer, not least the Severn barrage, which is capable of harnessing the enormous power of the Severn estuary, but also the tidal lagoons and other forms of tidal power and marine energy. Anglesey has developed a marvellous strategy as an energy island. I hope that the skills needed for that will be supported by the Government in the UK, by providing the funding to the Welsh Government. I also welcome the Minister’s acknowledgement at the outset of the vital role of key engineering workers in keeping going the essential infrastructure of the country during the Covid lockdown.
Although the Explanatory Memorandum is candid about the policy background to the order, it is hardly comprehensive in its coverage and it is short on significant detail. It is indeed true that industrial training boards have operated in the UK since 1964—since March 1964, in fact, because industrial training boards were originally set up in the dog days of Alec Douglas-Home’s Conservative Government.
Today’s Tories seem shy about acknowledging one of their party’s more important initiatives aimed at tackling UK skills shortages. We know why: the noble Lord, Lord Tebbit, put 16 of the 23 industrial training boards to the sword nearly 40 years ago. The Engineering Construction Industry Training Board was one of the few that survived his cull. It also survived a more recent review, in 2017, by shrinking its board and taking the nonsensical step of cutting its training levy.
There are several reasons why the Engineering Construction Industry Training Board has lived on where others have been sacrificed; some are identified in the Explanatory Memorandum, and others are acknowledged in the board’s 2019 annual report. The overwhelming reason is market failure, which Ministers never seem willing to acknowledge. There are few incentives for individual employers to train, since the work is often short-term and the labour force highly mobile. This means that long-term skills needs get overlooked, and these are vital, in engineering especially. The board is right to claim that it helps to make the labour market in engineering construction more efficient and more effective.
The board’s chair, Lynda Armstrong, is also right that it faces an emerging skills shortfall as an ageing workforce retires. The 137% rise in the number of recruits starting apprenticeships in 2018—to 1,171—is a positive development, and I welcome the priority that the board is attaching to promoting the recruitment of a more diverse workforce.
I also welcome the fact that the board has an advisory council that includes trade unions and not just employers, trade associations and other stakeholders. However, I note that this falls a long way short of the provision made in the Industrial Training Act 1964 for equal numbers of representatives of employers and employees. Perhaps the Minister will say something about that.
The Engineering Construction Industry Training Board is an example of successful intervention that the Government are reluctant to build upon in other industries. It is a love-child that the Government are too embarrassed to acknowledge openly. Its very success highlights the discomfort that the Tory party feels when its free market ideology comes up against the practical consequences of free market failure. I hope—although I fear my expectations are very low indeed—that the Government will take heed of this story and begin to invest properly in the vital skills we need for the future. They have not done so for more than 10 years.
With not only the green projects of which the noble Lord, Lord Bourne, spoke, but with robotics and artificial intelligence coming up fast, surely the Minister must agree that the Government should start investing massively in skills now, or see Britain continuing to fall behind badly on productivity and the new jobs of the future.
Baroness Garden of Frognal (LD)
My Lords, this order is not contentious, but it is worthy of some discussion. The construction industry is alone in continuing a training levy, as the noble Lord, Lord Hain, just set out. Some years ago, industry training boards were transformed from statutory to non-statutory bodies, and as the Minister stated, the Construction Industry Training Board, or CITB, and the Engineering Construction Industry Training Board, or ECITB, retained their statutory status and powers. They make annual proposals for the levy for their respective industries. The Secretary of State, having been satisfied that the proposed levies meet the statutory criteria, lays orders before Parliament to give effect to the proposals. This is the routine order we are now considering. The ECITB training levy is specific to the engineering construction industry. The ECITB determines how the money is invested in training and other projects for the benefit of the sector and is a registered charity. There might be advantages in other industries having such well-regulated training requirements.
However, issues now arise with the introduction of the apprenticeship levy. I agree with what the noble Lord, Lord Bourne, said. Employers with a pay bill of more than £3 million per fiscal year relating to employed labour have been required to pay the apprenticeship levy since April 2017. This payment is made to HMRC through the PAYE process and is in addition to any industrial training levy charged by the ECITB. The apprenticeship levy is ring-fenced to support apprenticeships in England across all sectors and occupations. However, we know there have been many issues with this levy, with it being applied to programmes of learning which could in no way be described as apprenticeships, such as master’s degrees and other advanced learning. In my book, an apprentice is somebody who is starting out on their career. Employers have long asked to be able to use the levy for a wide range of training, not just apprenticeships. Does the Minister have any update for us on whether that change might happen?
As we have said before, the apprenticeship levy system means that the electrical and construction industries have a double bill of training levies. Can the Minister say whether this is contentious in the industry? What discussions are held to ensure that those in the engineering and construction industries are happy to pay twice for training in this way? We know that the ECITB consults widely and we hope that it would pick up such concerns.
We know that the construction industry’s workforce is around only 2% female, yet women who are practitioners can earn an excellent living and enjoy their work. What efforts are the Government making to attract more women and girls into construction? How, for instance, does careers advice and guidance in primary schools, as well as in secondary schools, portray this industry as attractive and accessible to all? The image of construction is of burly men with hods in muddy fields, and of engineers with spanners and greasy overalls. The reality is so very different. My daughter was an oil engineer for a number of years, yet she never had greasy overalls. Early in her career, she was the most senior woman at Esso’s refinery, which said less about her meteoric career and more about how very few women there were at the refinery—yet most of the jobs there could equally have been done by men or women.
The Prime Minister has expressed his intention to “build, build, build”, but without qualified builders, this is a hollow promise. Vocational, practical, technical education should be right at the heart of the political agenda, yet this Government have driven a coach and horses through long-standing, well-understood, highly-respected vocational qualifications by bringing in the untried, untested and flawed T-levels. I declare an interest as a vice-president of City & Guilds, an organisation for which I worked for 20 years. I am very well aware of the value of and respect for City & Guilds qualifications, and indeed of BTECs, which are highly regarded but are sidelined by curious, non-expert decisions with this new qualification. How do the Government hope to encourage and train construction workers when they are set on destroying the very training and qualifications which have been the bedrock for generations?
A further aspect of the apprenticeship levy is that Liberal Democrats would seek to expand its scope to a wider skills and training levy and to add flexibility that works for employers and trainees. While keeping the contribution at 0.5%, we would use the cash raised not just for apprenticeships but for a wider training programme, and ensure that 25% of the funds raised would go into a social mobility fund, which we would use to feed into the regions and the cold spots and to make sure that we have diverse apprenticeships in the parts of the country and the sectors where they are most needed.
The electrical and construction industries are vital to our economic revival. As we agree this order—because we have no other option—can we keep in mind the vital importance of explaining and selling these exciting industries to children and adults? If we continue the obsession with academic qualifications and achievement, we shall never be able to restore the economy as the country needs.
Lord Watson of Invergowrie (Lab)
My Lords, I thank the Minister for the clear and concise manner in which she laid out this statutory instrument and what it seeks to achieve. The Opposition welcome the introduction of the latest version of the Engineering Construction Industry Training Board levy.
The levy has gained the status of a most venerable instrument. As my noble friend Lord Hain, an esteemed historian, said, it was first introduced in 1964, at a time when the UK was ending 13 years of Tory misrule by welcoming the Government of Harold Wilson and the white-hot heat of the technological revolution. The levy that we are considering today has certainly stood the test of time, although, as my noble friend Lord Hain also highlighted, the representation on the board unfortunately has not.
In a previous life, I was a trade union official involved in negotiations in the manufacturing sector. That involved regular dealings with some of the various industrial training boards then in existence. From memory, there were in excess of 20, until being significantly reduced in number by the Industrial Training Act 1982 —the legislation under which this order is issued. Today, there are just three boards, each of which is a non-departmental public body sponsored by the Department for Education, and thus accountable to Parliament.
The ECITB website reveals, to my surprise, the importance of the sector. It directly supports around 190,000 jobs and accounts for more than one-fifth of the total UK economy. The board raises its funds through training levies, and we learn from the Explanatory Memorandum to this order that, in 2019, the ECITB made grants of just under £20 million to subsidise employers’ training costs. Inevitably, that figure will be substantially lower this year, and it would be helpful if the Minister could indicate what estimate the ECITB has made to her officials about what it expects it to be.
Given the effects of the pandemic, does the Minister know whether the ECITB intends to return or retain levies paid this year that are currently unable to be used for training purposes? If the latter, does it intend to reduce the amount taken from employers in levy payments in 2021 as a consequence?
The annual priorities letter sent to the board by the predecessor of the noble Baroness in January this year—it now seems a lifetime away—states:
“The ECITB has a vital role in ensuring that our country has the technical skills needed to deliver critical infrastructure and energy projects.”
The letter set out the Government’s six priorities for the ECITB for the current year. While all are important—even more so because of the pandemic—the one that stood out for me was this:
“Help the industry to tackle current and future skills issues, with a primary focus on supporting employers to recruit a diverse and inclusive workforce, engage with the apprenticeships programme and to develop the training that best meets their needs, supporting the implementation of the new engineering and manufacturing T levels and the provision of industry placements.”
I emphasise that priority because it links to the need to ensure that more young people, particularly females, understand the importance of the engineering construction sector and the fact that it offers sustainable and well-paid employment, and embrace the STEM subjects at school to enable them to follow that path. There remains a serious and distinct market failure in the development of skills in the construction industry as a whole, something that stems in part from the fact that trading conditions, incentives and culture do not, it seems, lead to a sufficient level of investment in skills by employers. That is not by any means a failing restricted to the construction sector, but the ECITB also has a vital role in providing support in reskilling and upskilling, a factor that will increase in importance after the break with the European Union.
The introduction of the apprenticeship levy in 2017 was a clear sign that the Government accepted that employers would not in sufficient numbers invest in skills of their own volition but required a firm hand on their shoulder to encourage them to do so. As other noble Lords have said, that levy has not yet been as successful as many had hoped, but I believe that no purpose is served by criticising an initiative that is a positive step and ultimately will raise significantly the number of apprenticeships undertaken. The question now is how long that will take, with so much of industry in difficulty.
There is no mention in the Explanatory Memorandum of how the ECITB levy interacts with the apprenticeship levy. There are many apprentices in the engineering construction sector whose employers are being asked to pay two training levies, albeit that they are differently focused. Given that in general many apprenticeships are taken up by people aged 25 and above, it is perhaps surprising that greater resistance from employers in engineering construction is not evident. The Explanatory Memorandum tells us that 25% of employers registered their opposition to the levy in the ECITB’s consultation but gives no hint as to the reasons for that sizeable minority position. On a point touched on by the noble Baroness, Lady Garden, can the Minister say whether being asked to pay two levies was an issue in the sector?
The so-called consensus process to which the Minister referred—it is the name given to the way in which the board seeks the industry’s approval for its proposed levy rates—gained acceptance for the existing levy rate being maintained for onsite employees but being raised on a phased basis over three years for offsite employees. I was going to ask the Minister about this, so I was glad that she explained in her opening remarks why such differential rates are deemed appropriate.
The consultation demonstrates that engineering construction employers strongly support the levy, clearly valuing the payback from their contributions. I wish both the organisation and the industry that it represents well and I look forward to hearing of progress in the development of the skills that are required when Parliament comes to consider the effectiveness of the levy from this year until 2022.
If I may, I should like to finish by paying tribute to my noble friend Lord O’Neill of Clackmannan, who very sadly passed away last week. I feel it appropriate to do so here because my noble friend campaigned long and hard against the construction industry’s failure to pay subcontractors on time, too often causing the bankruptcy of small companies. The noble Lord, Lord O’Neill, argued for the establishment of a retention fund to avoid such events, but to no avail. Such a scheme would give subcontractors a measure of security and provide more security in the industry and I hope that it will soon be established, forming, as it would, a fitting tribute to a fine man and a good friend to so many.
Baroness Berridge (Con)
My Lords, I thank noble Lords for their contributions to this debate today and will endeavour to answer many of the questions that have been raised. First, I join the noble Lord in his tribute to the noble Lord, Lord O’Neill, recognising his contribution to the sector. I extend my sympathies.
The noble Lord, Lord Addington, asked how we are encouraging people into this industry, specifically those with special educational needs. I thank the noble Lord for the question. The industry training boards exist in specific industries and are mainly funded by statutory levies on employers in their sectors. Employment in the engineering construction sector is linked to the project life cycle, which means that there is a high number of temporary workers and a lot of movement between employers. As a result, the need for high-level skills is not necessarily met in the training on a particular job, so the cost can be high for employers. Many of the core engineering skills are transferrable in the sector. I will unfortunately have to repeat this to the noble Lord, Lord Addington, as he will be in receipt of a second letter this afternoon from the chair of the ECITB on these specific issues. The ECITB is bound by the equality duties, so it is under an obligation to ensure that a diversity of people is recruited into the sector.
My noble friend Lord Bourne asked whether the ECITB is of another world. It is not. It has shown itself to be valuable, as was demonstrated when it was reviewed in 2017, when the decision was made to retain it. Other options were looked at, but it was seen that the payment of the levy was still supported and was dealing with an issue across the sector. The Covid pandemic poses particular challenges for employers and learners across the sector, so we would argue that the levy is more important than ever in ensuring resilience and the entry into and retainment of people in the sector. We know that the ECITB is firmly committed to doing all that it can to ensure that vital skills are retained in the sector, despite the ups and downs of particular projects.
On apprenticeships, I assure my noble friend Lord Bourne that a redundancy service has been launched, as we recognise that the Covid pandemic has affected them. He will be aware that specific funding of £1,500 per apprenticeship and £2,000 for any apprenticeship for people under 24 has been announced by the Government to try to ensure that new entrants are coming into the sector. As the Minister responsible for school capital, I am sure that he will also be aware of the build, build, build process, in which engineering construction will be vital.
I saved the concession for the noble Lord, Lord Hain. There is a recognition that there has been a market failure. It is addressed by a collective action, ensuring that across the sector there are appropriate training opportunities for people. That is part of the reason for the collective role of the board, which is distinctive. Apprenticeships are often employer-based, so this is a particular issue. The levy supports the industry well and has industry support. It is developing with working practices—hence we see the change in the percentage being asked for for offsite workers. As we have all seen in the Covid pandemic, there has been a recognition in many sectors other than engineering construction of the ability to work remotely—for example, if you are working on a nuclear plant or in a chemical works. The board and the levy are showing themselves fit for the developing world we live in, particularly post this epidemic.
Noble Lords will be aware that the Secretary of State for Education has talked about further education, further education, further education. The lack of parity sometimes between higher education and further education has meant a lack of investment in the skills that industries such as this need. We will soon be announcing details of the £2 million kickstart scheme for young people.
I want to move on to the points raised by the noble Baroness, Lady Garden of Frognal, about the apprenticeship levy and the potential difficulties for those who now pay both levies. She also commented on construction training qualifications. First, let me be clear that the ECITB levy and the apprenticeship levy fund different activities. Funding from the apprenticeship levy supports apprentices across all sectors and occupations, whereas the ECITB is specifically for the engineering construction industry, using levy funds to provide direct grants to employers to train staff or to develop the skills of their existing workforce. As I said, it is collective rather than employer based. It funds more than apprenticeships, although I recognise that apprenticeships are offered at various different levels. That sector-specific support may and does support apprentices within engineering construction in addition to the apprenticeship levy support. It is true that some organisations are in the scope of both levies. Even so, the sector has shown strong support for the ECITB levy. I reiterate that 75% of all levy payers, who between them are likely to pay 87% of the levy, voted in favour of the proposal that your Lordships’ House is discussing today.
I take this opportunity to emphasise that the levy order under debate is for the ECITB. Engineering construction is a specialised industry that underpins delivery, maintenance and decommissioning of the UK’s critical infrastructure. It is different from an industrial training board supporting skills in the broader construction sector, which is not for discussion today.
Regardless of the specific sector, I reassure noble Lords that training and qualifications are at the forefront of the Government’s plans for recovery. We are scaling up the National Careers Service and investing more money in offering 30,000 traineeships, as well as providing the additional funding for apprenticeships that I have outlined.
The ECITB recognises the need for diversity. I also have the pleasure of being the Minister for Women; I hosted a remote round table when it was International Women in Engineering Day, where I believe I had before me the only female BAME structural engineer working on the big sewage tunnel under London. I look forward to the day when I will be able to visit her on site. Therefore, there is a focus on that, and the industry recognises—the Government have various initiatives on this as well—that we need to increase the number of women studying STEM subjects, which is often a precursor to entering engineering and construction. However, there will be a focus on and the launch of the new T-levels. Although the Government support and recognise the value of vocational qualifications, there is too much complexity within them. There has been a review to ensure that good qualifications are maintained and offered clearly to young people—as clearly as the routes to higher education are outlined.
I thank the noble Lord, Lord Watson, for his questions. First, on whether the ECITB intends to return or retain levies paid this year or reduce levy payments in 2021, it does not have the legal power to issue levy rebates. It derives its powers to collect a levy through the Industrial Training Act 1982, the 2017 levy order and, once it is made, this order. This legislation would need to be amended to allow the ECITB to give rebates. Therefore, it does not intend to reduce levy payments in 2021. Given the impact of Covid-19, it is more important than ever that the ECITB is able to support employers to retain workers both immediately and in the longer term.
In response to the challenges created by Covid, the ECITB has introduced a package of measures to help industry, including: a Train to Retain scheme to help employers retain apprentices and graduates, which I outlined; a new scholarship scheme to support trainees embarking on engineering construction careers; and increased investment in digital training and assessment tools. Furthermore, the ECITB uses levy funds to strengthen the industry in the long term. By supporting employers to make sustainable investment in training to maintain vital skills and to create a pipeline of skilled workers, this helps to future-proof the industry. Without that investment, there would be a shortage of skilled workers to deliver infrastructure projects that will form part of this country’s recovery.
On the noble Lord’s question about the reasons for employers opposing the levy, the ECITB does not ask employers to document their reasons. However, I point out that of the 25% that the noble Lord outlined in his speech, 10% of levy-paying employers did not support the proposal, and 15% just did not respond.
The noble Lord also asked me to explain the reason for the phased increase in the levy rate for offsite employees over the three-year levy period. The offsite workforce consists of everyone who is working at a geographical distance from the site, and, as we can anticipate, the size of that offsite workforce is increasing; currently it represents 53% of the overall industry workforce. I should point out that while the offsite levy rate is increasing, it will remain significantly lower than the site levy rate. In the first year during which the levy will have an impact, it will increase by only 0.06%. Of the 129 employers who pay the offsite levy and were eligible to vote, 78% voted in favour of the levy.
Noble Lords will be aware from previous debates that the ECITB exists because of the support it receives from employers and employer interest groups in the engineering construction sector. It continues to be the collective view of industry that training should be funded through a statutory levy system to secure a sufficient pool of skilled labour and the future of the sector. There is a firm belief that without the levy, there would be a serious deterioration in the quality and quantity of training in this sector that would create particular challenges in the current economic climate, as such training is vital for meeting various infrastructure projects, including those relating to the environmental challenge of reducing the UK’s carbon emissions to zero. I commend the order to the Committee.
The Deputy Chairman of Committees (Lord Bates) (Con)
I remind Members to sanitise their desks and chairs before leaving the Room. The Committee stands adjourned until 3.45 pm.
Arrangement of Business
(3 years, 7 months ago)
Grand CommitteeRead Full debate Read Hansard Text
The Deputy Chairman of Committees (Lord Bates) (Con)
My Lords, Hybrid Grand Committee will now resume. Some Members are here in person, respecting social distancing, others are participating remotely, but all Members will be treated equally. I must ask Members in the room to wear a face covering, except when seated at their desk, to speak sitting down and to wipe down their desk, chair and other touch points before and after use. If the capacity of the Committee Room is exceeded or other safety requirements are breached, I will immediately adjourn the Committee. If there is a Division in the House the Committee will adjourn for five minutes.
Equivalence Determinations for Financial Services (Amendment etc.) (EU Exit) Regulations 2020
(3 years, 7 months ago)
Grand CommitteeRead Full debate Read Hansard Text Read Debate Ministerial Extracts
Lord Agnew of Oulton
That the Grand Committee do consider the Equivalence Determinations for Financial Services (Amendment etc.) (EU Exit) Regulations 2020
Relevant document: 21st Report from the Secondary Legislation Scrutiny Committee
The Minister of State, Cabinet Office and the Treasury (Lord Agnew of Oulton) (Con)
My Lords, the Treasury has been undertaking a programme of legislation to ensure that after the end of the transition period there continues to be a functioning legal and regulatory regime for financial services in the UK. The Treasury is laying SIs under the European Union (Withdrawal) Act 2018 to deliver this legislative programme and the majority of these SIs have already been approved in this place and in the House of Commons.
As part of this financial services legislative programme before exit day the Treasury laid the Equivalence Determinations for Financial Services and Miscellaneous Provisions (Amendment etc) (EU Exit) Regulations 2019, commonly known as the Equivalence Regulations 2019. Those regulations were designed to ensure that if the UK left the EU without a transition period, the UK would have a fully functioning equivalence framework from exit day. The additional time afforded by the transition period has provided us with the opportunity to put in place supplementary measures in the Equivalence Regulations 2019 to ensure that the UK continues to have a robust and functioning equivalence framework for financial services, both during and after the end of the transition period.
The measures in the instrument being debated today complement the Equivalence Regulations 2019 by creating additional stand-alone powers in this instrument for the UK-relevant financial services regulators—the Bank of England and the Financial Conduct Authority in this case—which are appropriate for those regulators in the transition period. They also make minor amendments to the earlier 2019 regulations, again as appropriate for the transition period. This SI will, finally, make minor amendments to add to the powers available to the regulators after the end of the transition period and to correct errors in earlier financial services EU exit legislation.
I am grateful that this SI was raised as an instrument of interest by the Lords Secondary Legislation Scrutiny Committee in its July report and for the question that the committee raised. I intend to address the question now and in the course of the debate.
The instrument being debated concerns the UK’s future regime for equivalence, a process to determine that another country’s regulatory and supervisory regime is equivalent to the UK’s corresponding regulatory framework. Recognising the regulatory equivalence of third countries is a key component of financial services regulation. Equivalence of determinations can help to reduce regulatory burdens on firms and can facilitate cross-border market access. This may lead to increased competition that can benefit both UK firms and consumers by engendering healthy market incentives to lower prices and offer innovative products.
At present, equivalence functions are performed by the European Commission and the European supervisory authorities. At the end of the transition period, these functions will be transferred to HM Treasury and the UK regulators as provisions in retained EU law. During the transition period, equivalence determinations can be made for EEA states via powers within the 2019 equivalence regulations. This instrument provides a UK equivalence framework that is appropriate for use during the transition period in relation to the EU’s existing framework. It allows the UK financial services regulators to complete the associated actions that mean that HM Treasury equivalence determinations taken during the transition period can take full effect at the end of that period.
This is a technical SI that provides for the UK’s transition to its new position outside the EU. I will turn now to the main categories of fixes that are being introduced here. The first three changes provide UK regulators with the appropriate powers to complete the associated actions to ensure that HM Treasury equivalence determinations can take effect fully at the end of the transition period. Currently, the 2019 equivalence regulations allow HM Treasury to make equivalence determinations by direction during the transition period for EEA states where these directions would not enter into force until the end of the transition period. As part of the equivalence process, almost all equivalence provisions in retained EU law will require UK financial services regulators to conclude co-operation agreements with the relevant regulatory authority or authorities for that EEA state before the determination can take effect.
There is currently no mechanism to allow regulators to undertake this during the transition period. Where the Treasury has made an equivalence determination by direction, this SI will make transitional provision for UK financial services regulators to have the power to enter into relevant co-operation agreements with the appropriate EEA regulatory authorities before the end of the transition period. These co-operation agreements would come into effect at the end of the transition period for the necessary provisions in retained EU law.
In addition, as part of the direction-making process, almost all equivalence provisions require regulators to issue recognition or registration decisions for non-UK firms. Where the Treasury has made an equivalence determination by direction during the transition period, this instrument puts in place a regime for firms to make an application to the appropriate regulator, and for that application to be processed. It will therefore ensure that regulators have the power to process applications and issue recognition and registration decisions during the transition period to come into effect at the end of that period for the necessary provisions in retained EU law.
This SI will also give regulators the power to request fees from applicants for such regulatory decisions. I appreciate that the House of Lords Secondary Legislation Scrutiny Committee questioned whether there is enough time for UK regulators to establish co-operation agreements with EEA regulators once an equivalence determination is made and then process applications made by EEA firms. I am pleased to say that regulators have a period of one year to process applications from EEA firms once the required co-operation agreements have been established. Both the Treasury and the regulators consider this to be ample time for the regulators to decide any applications.
Secondly, this SI will amend the Credit Rating Agencies (Amendment etc.) (EU Exit) Regulations 2019, which in turn make provision for the onshoring of the EU credit rating agencies regulation. The amendments will onshore powers to enter into co-operation arrangements currently held by the European Securities and Markets Authority, such that in the future they will be held by the FCA. The amendments also make provision for existing EU equivalence determinations that will form part of retained EU law by operation of Section 3 of the European Union (Withdrawal) Act 2018.
Finally, two minor but necessary amendments are made to the Central Securities Depositories (Amendment) (EU Exit) Regulations 2018. The first relates to a provision which stipulates that equivalence may be granted only to states that have a regime for the recognition of central securities depositories authorised in other states. The amendment ensures that the UK is one of these states. The second amendment ensures that the Bank of England has the appropriate timescales to make recognition decisions for central securities depositories.
In summary, the Government believe that the proposed instrument is necessary to ensure that there is an appropriate equivalence framework for financial services during the transition period and to complement that already put in place by the 2019 equivalence regulations. I hope that colleagues will join me in supporting these regulations, and I commend them to the Committee.
Lord Ashton of Hyde (Con)
My Lords, we have no room for manoeuvre on time for this debate, so I would be grateful if Peers could keep to time and ideally go slightly short.
Baroness Bowles of Berkhamsted (LD) [V]
My Lords, I refer to my interest set out in the register as a director of the London Stock Exchange.
I thank the Minister for introducing the regulations, but I admit that I got off to a bad start when looking at them. Helpful though it is to have tables in the schedule, I found it very awkward to have the regulations themselves drafted as an adjunct to a table that requires simultaneous viewing on different pages. I thought that I was in a puzzle book and having to take a cheat peek at the answers at the back.
First, I must consult the Schedule 1 list in the 2019 SI, and then I must cross-reference to table 1 in Schedule 1 of this SI—although it is unclear from reading Regulation 3 whether this refers to Schedule 1 of the 2019 instrument, as has just been referenced, or, as happens to be the case, Schedule 1 of this SI. I can find that out by discovering that Schedule 1 of the 2019 SI does not have a table. I must then repeatedly consult the table and look at each column to find out which paragraph of Schedules 2 and 3 and Schedule 1 of the 2019 SI are relevant. All of these instructions distract greatly from the clarity of Schedules 2 and 3, which really did not need all this obfuscation.
Aside from the structure, the SI seems to do what is necessary—although I reckon that it should have been part of the 2019 regulations to give regulators clarity. Unfortunately, this is all part of a patchwork that replicates, and makes even more confusing, the already tangled web of EU equivalence provisions that has evolved over time.
I hope that one day soon an overarching policy will be outlined on how the UK will balance openness, competitiveness, security and public interest in our future equivalence regime. This must reflect the needs not just of financial service companies in large countries but also the real economy companies that they serve, and encompass issues such as enabling trade at reasonable cost for the less developed countries. There can be a lot more to equivalence than first meets the eye, as was eventually realised with EMIR. At times, the benefits of equivalence may be needed within the country giving equivalence rather than the country gaining equivalence.
A similar point can be found in one of the fixes in today’s SI, which creates equivalence-determining powers so that where EU legislation says a third country has to have a recognition regime, we have one that qualifies. For us, this is fine, but the subtext of the EU requirement is a reciprocity requirement, and it is the sort of provision that needs care before imposing in any generic way, should that idea arise in the future.
It has been discussed previously, and in the context of authorisations, that regulators have been busy making various co-operation arrangements with third-country regulators where they did not already exist. It would be good to have an update on the progress of those agreements and how complete they are, including the business volume covered and the countries or instances where requirements are being waived.
Finally, a lot of energy and time has been expended researching, debating and hoping for a broad equivalence deal with the EU on financial services. Maybe that kept some in the City sweet and had to be heard and tried, but it has always been my informed view that that was unrealistic. Taken collectively, and in practice, equivalence for the EU is not really a matter of co-operation; it is yielded only when essential or aimed at promoting EU regulatory prevalence. Both those tendencies meant that resisting giving the UK equivalence was always going to be tested to destruction. It is what rises from the destruction that will be interesting, but it is not a sit-and-wait game.
Viscount Trenchard (Con)
My Lords, I thank my noble friend the Minister for introducing the debate today. It is good news to know that the Government are taking the necessary steps to ensure that a coherent and functioning financial services equivalence framework continues in the UK after the end of the transition period.
The position is complicated by the fact that the EU’s single market in financial services is only partly developed. It is therefore necessary for the Treasury to determine whether or not each member state has an equivalent regulatory regime for a particular firm or product to that which applies in the UK.
There are several problems with this approach. First, does it mean that arrangements similar to the EU passport system for particular individual firms are to be continued? Secondly, the products referred to in the SI seem to conform to the categories of products—or, rather, services—covered in individual European regulations. Would it not be simpler for the UK to set out its own regulatory regime based on equivalence of outcomes, and to allow all regulated service providers in a particular category to operate in the UK subject to satisfactory co-operation arrangements being established between the relevant member state or EEA country regulator and the FCA or the Bank of England?
Presumably, ESMA also needs to be involved, because it has taken over many powers from the member state regulators and will doubtless continue to expand its area of control. It may not be just ESMA: perhaps the EBA or EIOPA is the relevant European regulator for the firm or product concerned.
The SI does its job in avoiding a cliff edge and providing stability and continuity for financial companies and markets in the UK after the end of the implementation period. However, is it sensible to continue to grant equivalence on the basis of single European regulations? Going forward, do we want a regulatory system that is a clone of the EU system? How are we going to make equivalence decisions in respect of financial firms from third countries such as the United States, Japan and Australia, and others whose regulatory systems are not based on prescriptive EU-style legislation?
Many smaller British firms have been forced out of business or to merge by the cumbersome rules and excessive costs forced on them by European directives such as the AIFMD and MiFID II. To ensure that the City of London will preserve and further consolidate its position as the world’s leading and most competitive financial centre, does it not need to move away from the cumbersome European system and adopt a simpler, rules-based proportionate system which would allow innovative new products and markets to develop?
Does my noble friend the Minister not agree that the Government cannot legislate only for continuity EU-UK arrangements but must do more to set out their stall and attract financial services companies from third countries as we again take responsibility for our own regulatory policy and framework, and as we start to play a bigger part, commensurate with the size of our markets and the skills of our practitioners, in the development of common international regulations through IOSCO and other bodies?
Baroness Wheatcroft (Non-Afl) [V]
My Lords, I refer to my role as a director of a financial services company, as listed in the register.
We all know the importance of financial services to our economy: it is the highest exporting sector that we have. However, as this legislation indicates, we risk jeopardising its success. There is no denying the need for this legislation, but we are already into September: if a comprehensive deal is not agreed soon with the EU—and the omens do not look good—then the financial services industry risks being badly damaged.
I listened to the noble Viscount, Lord Trenchard, talk about how much we could innovate and so on if we were free of EU regulations. But innovation in financial services is rarely a benefit; in fact, I am hard-pressed to think of an innovation since the invention of the hole-in-the-wall that has actually been beneficial.
Equivalence in regulation is imperative for trade with the EU to continue, and recognition of that equivalence has to be in place for transactions to continue. The Minister sounded confident that that will be the case within the required timescale. Can he explain why he is so confident that equivalence will be granted in the EU?
The political declaration sounded optimistic about the prospects for equivalence, with the implicit intention that cross-border service provision would continue. But can we now be assured that this is a view shared by both parties? The direction that the negotiations have been taking appears to be diverging somewhat drastically, and certainly progress is not being made.
More specifically, do the UK regulators have the capacity required to make the decisions on equivalence that they will be asked to make? Has a decision been taken on the level of charges that they can implement and whether this will be sufficient to cover the extra costs involved?
Finally, I point out that one of the major assets of the UK financial services sector will not be impacted at all by any success on the equivalence front: the supply of talented Europeans who have played such an important part in making a success of the financial services industry in the UK. They have already been leaving in large numbers, and it is highly unlikely that they will return once freedom of movement has been turned off. The UK has been a star in the global financial services market; we are now deliberately risking dimming that star.
Baroness Altmann (Con)
My Lords, I thank my noble friend for moving this necessary SI and I support the measures it contains. However, I have a number of questions—I will try to be brief, as requested.
Clearly, there is an assumption that a 12-month transition period is sufficient to reach the agreement necessary, but can my noble friend tell me what provision might be made should it not prove sufficient, as many of us are concerned about? Perhaps 12 months seemed to be enough at the time, but will it be?
I also ask my noble friend—I declare my interests as set out in the register—what impact there might be on defined benefit pension schemes in a no-deal scenario, regardless of these measures, which I assume and hope we will approve today, with respect to financial derivatives and remittance of payments, including assessment of the risk that clearing or margin requirements could be triggered, and what provisions the Government may be able to make in changes to derivatives documentation entered into by those funds.
Another important area is the third-country requirements for the purposes of EMIR and whether this might mean that counterparty risks from EU banks may no longer rely on the exemptions under EMIR when entering into derivatives with UK entities such as defined benefit pension schemes. I note that the FCA, the Bank of England and the PRA are involved and would be grateful to know whether there have been any discussions with the Pensions Regulator in this regard. That is particularly relevant here for UK pension schemes if their bank counterparty in the EU is relying on exemptions available to pension schemes under EMIR’s mandatory clearing obligation.
Finally, when the UK’s asset management industry enters into intragroup transactions with EU group companies, should it consider whether those EU companies will continue to be able to rely on the exemptions under EMIR and what impact this SI or other government plans may have on those entities?
Lord Bruce of Bennachie (LD) [V]
My Lords, this instrument raises many more questions than it answers, as is increasingly the case with government business.
First, what does paragraph 7.2 of the Explanatory Memorandum mean when it states:
“The UK has now left the EU with a deal”?
Is that not at best disingenuous, if not downright deceitful? We have an agreement to leave; we do not have a deal.
At the end of June, M Barnier said that the political declaration committed us to use best endeavours to finalise our respective assessments by the end of June. The Commission sent 28 questionnaires to the UK covering the areas where equivalence is possible. At that time, only four had been returned. Where are we now? Are we not empowering ourselves to set out our terms for equivalence to third parties? This is of course necessary to enable us to deal with the world and to negotiate with the EU, but when will the industry get any clarity as to what equivalence will be agreed with the EU? Is there any prospect—which always seemed unlikely, and is much less so given the current mood music—that the EU will agree to any longer time for ending equivalence unilaterally than its current 30-day rule?
I turn to the impact of the changes in Scotland, which is the UK’s largest financial centre outside London. It is estimated that financial and related professional services account for 9.4% of the Scottish economy, something the Scottish National Party sometimes seems unaware of. According to Scottish Enterprise, there are 28,865 companies in the sector in Scotland, employing 247,000 people directly or indirectly and generating around £16.7 billion. UK in a Changing Europe also highlights the importance of financial services to Scotland. In Edinburgh, a conservative estimate of employment in financial services stands at 10.7% of the workforce. Indeed, Edinburgh employs a larger proportion of people in financial services than anywhere in the UK outside the square mile and Tower Hamlets, and significant numbers also work in financial services in Glasgow and West Dunbartonshire. Edinburgh has now risen 12 places in the 2020 global financial centres index to be ranked as the 17th most important financial centre in the world. It is home to the global headquarters of the Royal Bank of Scotland and Scottish Widows, and CYBG, which owns the Clydesdale Bank, Virgin Money and Yorkshire Bank, has its European headquarters in Glasgow.
Financial services are Scotland’s largest service export, with the EU being a significant component of our exports. The EU single market is an important export market for Scotland’s financial services. Some 18% of Edinburgh’s total services exports are financial services to the EU, which is higher than the comparable figure for London, at 15%. This suggests that, proportionately, Scotland’s financial services are slightly more dependent on the EU. There are now signs that Scottish financial firms, as elsewhere in the UK, are planning a future outside the UK. For example, Scottish Widows transferred its European portfolio to a new legal entity in March 2019, Standard Life Aberdeen has opened a portfolio management and distribution service in Dublin to service the EU 27 and Royal Bank Of Scotland began operating a banking entity in the Netherlands in March 2019 to serve non-UK EEA customers.
In the financial crash, the impact of the changes was more severe outside London, so it is important to monitor how the changes we face impact on the Scottish economy in terms of jobs and access to finance, and on other areas of the UK outside London.
Big companies will do whatever it takes to develop their business, and that may not be in the interests of the UK. They will put their business before the UK national interest. There are a lot of small businesses in financial services. They might not find it so easy. Valid as this legislation is, what is lacking is any sense of political direction or certainty on which such businesses can be planned.
Baroness McIntosh of Pickering (Con) [V]
My Lords, I am grateful to my noble friend the Minister for setting out so clearly the ramifications of these technical regulations, as he describes them. I have just a couple of questions, which are not dissimilar to those raised by other noble Lords. On page 1 of the Explanatory Memorandum, paragraph 2.3 states:
“At present equivalence functions are performed by the European Commission and the European Securities and Markets Authority ... At the end of the Transition Period these functions will be transferred to HM Treasury and the UK regulators as provisions in retained EU law.”
Clearly, they will be the regulators and will apply the equivalence regime but, in the event of an alleged breach being raised by a financial services company in the UK, which body will provide a remedy? My understanding is that currently, the EU Commission is the watchdog and recourse can be had to the European Court of Justice. Which body do the Government imagine will provide an appeal and a remedy in the event of the regulations being breached?
My second question relates to my noble friend’s clear statement that the regulation before us today deals with retained EU law. As other noble Lords, not least the noble Lord, Lord Bruce, have said, the current regime is a matter of ongoing interest in the EU Commission. Concerns were raised in the Financial Times in the middle of August that it may take longer for firms based in London to gain access after Brexit. My final question to the Minister is: what will be the position on 1 January 2021 for any future changes to the equivalence regime in Brussels? Will firms based in the UK—any part of the UK, either Edinburgh or London—have blanket access to the whole of the European Union or will the Commission insist that negotiations take place on a country-by-country basis? The noble Lord, Lord Bruce, accurately stated that only a small number of questionnaires have been returned. They will obviously take some time to complete fully and accurately.
Finally, I say on a note of disappointment that, while it is excellent that we have the equivalence regime under retained EU law, it will not provide anything like the prosperity and excellence that has made the City of London the most successful global financial centre.
Baroness Kramer (LD) [V]
My Lords, this statutory instrument is clearly necessary to enable an equivalence regime for financial services to be in place following the transition period.
We all know that financial services are critical to this country’s GDP and tax base. Historically, the sector has provided more than 2 million jobs in the UK and more than £76 billion a year in tax revenue but, in the past, one-third of the sector has relied on EU clients, nearly half of whose business has been lost due to Brexit. I note with concern that, reflecting this shift, London, according to the think tank Z/Yen, which manages the index, has lost its position as the global number one financial centre to New York.
Even more concerning, both New York and London have been losing position, although London is losing it faster than New York. The rising locations are in Asia and the EU 27. One expert described these centres, especially the EU ones, as small black holes, growing rapidly as they sweep in new and transferred operations. We cannot afford to lose any more business. Equivalence matters. My party therefore supports the passage of this SI. We note that, like all the SIs dealing with equivalence, this one represents unilateral action by the UK, without which EEA firms could not continue to access the London markets. However, to deny that access would be extreme self-harm as we would be the losers. Essentially, this SI attempts to retain some parts of the status quo.
However, I want to confirm that the arrangements in Schedule 3, which relate to benchmarks, allow Libor to be replaced by risk-free reference rates set by the eurozone and non-eurozone EEA countries. The UK equivalent will be SONIA, the sterling overnight index average. Your Lordships will know that Libor has been a disgraced benchmark since American journalists exposed that it had been corrupted and manipulated for decades under the noses of the UK Government and regulators, who were blinded by their philosophy of light-touch regulation.
I also want to use this opportunity to ask the Minister to give the Committee an update on the status of the equivalence negotiations with the EU. Can the Government confirm that they are no longer seeking mutual recognition? Quite a number of members of the Tory party—we heard some of this again today—and the regulators have indicated that they expect and want divergence to be a significant feature of future financial services regulation. Is that correct? What will be the underpinning philosophy of divergence, since I assume that light-touch regulation remains disgraced? Are the Government making any progress on finding a mutually agreed mechanism with the EU to resolve any dispute on divergence and equivalence? Is there any progress on getting a notice period for cancellation longer than the current norm of 30 days? Without a notice period of at least two years for equivalence cancellation, firms that use London will be living with disturbing uncertainty.
How are other issues that could lead to the cancellation of equivalence to be resolved? Perhaps the most obvious issue is that of financial stability related to the supervision in the UK of central counterparties clearing trillions of euros in derivatives. Actions to protect the UK economy in a crisis could cause havoc for the euro and the EU without some mechanism for co-operation and mutual support.
The expectation of the financial services industry is not that London will collapse as a global financial centre the day after the end of the transition period but that it will be in the EU’s interest to pull business into the 27 salami slice by salami slice as capacity expands, which is at least a 10-year strategy. New York has been reasserting its dominance in dollar-based financial business. China and India, as rising economic stars, have made it clear that they have no intention of ceding control of their key financial markets to any foreign country. The UK remains a major global player only so long as it dominates European financial services. How this Government deal with equivalence will essentially determine the future of this key sector of our economy.
Lord Tunnicliffe (Lab) [V]
My Lords, I thank the Minister for presenting this SI. As he knows, the Opposition will not oppose it as it would create a constitutional crisis. Nevertheless, it is the duty of Her Majesty’s loyal Opposition to scrutinise the instrument.
As we have discussed on previous occasions, the volume of and interplay between the Treasury’s EU exit SIs makes keeping track of the changes somewhat difficult. The intricacies of this instrument, which simultaneously amends and supplements a 2019 measure, is a case in point. I thank Vanessa McKay, the designated Treasury contact, for helping me to achieve a limited understanding of the regulation and the equivalence framework in which it fits.
I conclude that the instrument is technical in nature and complements the actions taken under the authority of the equivalence regulations of 2019 and 2020. The instrument provides for subsequent co-operation arrangements and regulatory decisions. I do not believe that it introduces any significant new policy. I would value an assurance from the Minister on that point.
Nevertheless, having previously met the Commons Minister on this issue, I am dissatisfied with the level of understanding that I was able to achieve on first reading the supporting documentation. It may be inevitable that the instrument is written in impenetrable language but surely the Explanatory Memorandum is supposed to overcome this barrier. In January 2020, the Secondary Legislation Scrutiny Committee published guidance for departments on statutory instruments. I quote from paragraph 4 of Part 2:
“The purpose of an EM is to provide the Houses and the public with a plain English, free-standing, explanation of the effect of an instrument and how it is intended to operate. It is not meant for lawyers. Legal explanations of the changes are given in the Explanatory Note that forms part of an SI and should not be duplicated.”
This Explanatory Memorandum clearly fails this test. Perhaps it is what comes of reading such documents during Recess, but I fear that if somebody like myself who has dealt with 50 of these instruments has difficulties in following the commentary, an interested citizen without prior knowledge stands no chance. For example, paragraph 2.2 of the Explanatory Memorandum contains a circa 100-word, nine-line sentence. I understand that there are more Treasury SIs to come. I hope that Her Majesty’s Treasury will prioritise EMs that are easier to read, set the SI in context and require less prior knowledge. I would be happy to discuss this matter with the Minister and his officials if they feel this would be of use.
The essence of today’s debate is equivalence for financial services. The guidance in this area is provided in paragraphs 35, 36 and 37 of the political declaration. It envisages concluding,
“these assessments before the end of June 2020.”
I understand that that deadline was missed. What are the implications of this in terms of the trade negotiations and the preparedness of financial services firms? Does the Minister have an estimate of when the process will be completed?
John Glen, Economic Secretary to the Treasury, said in a letter of 27 May 2020 to the noble Lord, Lord Sharkey, chair of the EU Financial Affairs Sub-Committee:
“Successfully concluding equivalence assessment and delivering comprehensive positive findings will be in the UK and EU’s mutual interest and we can see no reason why the UK and EU will not be able to find each other equivalent across all existing equivalence regimes. As you will be aware, equivalence assessments are unilateral processes and thus not part of the ongoing negotiations on the future EU/UK partnership.”
Further, the concluding sentence of paragraph 2.1 of the EM says:
“This statutory instrument … is not linked to the ongoing UK-EU negotiations on a free trade agreement.”
These statements imply that the determination of equivalence is independent of the free trade negotiations. Does this not display heroic optimism and naivety in the light of the Swiss experience? Switzerland lost its equivalence recognition over a lack of progress in an unrelated negotiation.
Further, what is the Minister’s view of the recent statement by Mr Dombrovskis, an executive vice-president of the European Commission? The Financial Times reports him as saying that Brussels would not be ready in the coming months to assess whether Britain qualifies for some pan-EU access rights, known as equivalence provisions, because the bloc’s own regulations are in flux.
If an equivalence ruling is not given, or at least not in a timely manner, what is the Minister’s assessment of the impact on cross-border financial services trade between the UK and the EU? Is he concerned about a financial stability impact if access is withdrawn suddenly after 31 December? What assessment has he made of London’s attractiveness as a place from which financial services firms operate if their ability to sell services into the EU on the basis of equivalence is withdrawn?
Lord Agnew of Oulton (Con)
My Lords, I thank noble Lords for their questions and for the important points raised in this debate. I will try to answer as many as I can in the time available, and, where I am not able to, I will ensure that we write to noble Lords.
The noble Baroness, Lady Bowles, asked about progress on co-operation agreements. That is an ongoing process, and we will of course keep this House updated on that process of engagement over the next few months. My noble friend Lord Trenchard asked whether we should continue with a policy of holding to equivalence with the EU regime. That is certainly our policy at the moment, because that is how the City has worked over the past 40 or so years. However, by being in control of our own regulatory policy, we will have the opportunity in the coming years to keep reviewing that. The noble Baroness, Lady Kramer, made the important point that the growth is now in Asia. By having our own regulatory regime, we will have the flexibility to consider those opportunities.
My noble friend Lady Wheatcroft raised a number of questions. Possibly the most important one was whether the EU will grant equivalence. We are of course at the tail end of these negotiations, a time at which things will be most fraught. It would certainly be absolutely in the interests of the EU to grant equivalence, but I cannot prejudge the outcome of the discussions over the next few weeks.
On the capacity of our regulators to take on these decisions, we have engaged in depth on this issue and we are assured that they have this resource. Fees will be a matter for individual regulators in order to recover their costs in processing any applications.
My noble friend Lady Altmann asked what provision should be made beyond the 12-month period to process these applications. Certainly, that was the period of time that was considered reasonable. My noble friend made a perfectly reasonable point that the transition period has seemed tight, but we have had the worst pandemic in nearly at 100 years in the middle of it, so I am confident that we can deliver on that. She raised one or two other technical questions on defined benefits, and I will write to her in an attempt to answer them.
The noble Lord, Lord Bruce, made one or two points on paragraph 7.2 which states,
“The UK has now left the EU with a deal.”
While decisions on equivalence are autonomous and unilateral in many areas of financial services, it is essential to understand the approach of the other party when deciding how to approach an area of cross-border activity. While the UK has undertaken an assessment of the EU, we will not be making equivalence decisions at this stage; we will make decisions where and when we determine that it is in the UK’s interest. Our ambition is to achieve a reciprocal equivalence, supported by the effective regulatory co-operation of an ambitious FTA, and we continue to work towards that goal. We continue to believe that comprehensive mutual findings of equivalence between the UK and the EU are in the best interests of both countries. However, as I said in relation to earlier questions, it will be a very rough few months. We must be perfectly realistic about that.
My noble friend Lady McIntosh asked about the handling of a breach. The normal rules of public law will apply, and, after the transition period, equivalence will be covered by provisions in retained EU law, as amended under the European Union (Withdrawal) Act 2018.
The noble Baroness, Lady Kramer, asked about the status of the negotiations. We have completed round 7. We have been clear in discussions throughout that this intensified process continues to be constructive, but there are still significant differences. Our preference is to leave with an FTA as long as it guarantees our political and economic independence, and these are tricky issues.
On plans for divergence, as I mentioned on an earlier question, we are committed to regulatory autonomy but at this stage to providing as much equivalence as we can. We are committed to the highest standards of regulation and the appropriate levels of supervisory oversight. In many areas we already go beyond what the EU rules require. Where we make changes, they will be for good reasons, but our starting point will be what is right for the UK, our economy and to ensure financial stability.
The noble Lord, Lord Tunnicliffe, raised a number of questions. He was worried about the quality of the guidance documents and felt that they were not in a spirit of providing clarity. That is a fair criticism, and I will certainly encourage officials to try to provide a more accessible guidance for future SIs, which I expect we will have over the next few weeks and months.
The noble Lord asked whether the instrument, which provides for subsequent co-operation agreements and regulatory decisions, introduces any significant new policy. I can confirm that that is correct; the provisions in this SI complement existing provisions and make minor amendments to earlier EU exit instruments and retained EU law but do not alter the policy of the earlier instruments or introduce any new policy.
The noble Lords, Lord Tunnicliffe and Lord Bruce, asked about the progress on the questionnaires, which have a deadline of the end of June of this year, and about the implications of not having met that deadline. We returned all 17 questionnaires received from the EU as part of its assessment process. The returns totalled some 2,500 pages. We received the first questionnaire only in late March, and the last 250 pages of questions reached us only at the end of May. The equivalence assessments are a technical process which each side is carrying out separately and are not linked to the UK-EU trade negotiations. Many, if not most, of the questions relate to explaining the details of the rules and regulations in the UK and the rules and regulations that we share with the EU. We have made sure that the EU has the information it requires to make a positive decision for the UK for all regimes, and we have always been clear that as the UK and EU start from a position of having very similar financial services regulations, that should be a straightforward process. We continue firmly to believe that comprehensive mutual findings of equivalence between the UK and the EU are in the best interests of both parties.
The noble Lord, Lord Tunnicliffe, asked about statements from my colleague the Economic Secretary, which he believes are optimistic. Equivalence is a unilateral autonomous process that is distinct from the FTA negotiations, and the politicisation of the financial services sector is not in anyone’s interest. The financial stability that underpins our economy and the EU’s economy depends on trust and predictability in relation to regulatory matters. A thriving financial services sector is clearly important to our economy but also to the EU’s economy. The UK is a global financial hub. Among other things, it channels investment into Europe cost effectively and manages the assets of millions of EU firms and consumers. Fragmentation of that market would be costly and disruptive and, given the shock of the pandemic over the past few months, it would be an odd decision for the EU to make that more difficult for its member states.
The noble Lord asked what is my assessment of the impact on cross-border financial services trade between the EU and the UK if the equivalent ruling is not given, or at least not in a timely manner. We continue firmly to believe that comprehensive mutual filings of equivalence between the UK and the EU are in the interests of both parties. We remain open and committed to continuing the dialogue with the EU about its intentions on this. The financial stability that underpins our economy and that of the EU depends on trust and predictability in relation to regulatory matters.
This SI is needed to ensure that the UK continues to have a robust and functioning equivalence framework for financial services in the UK during and after the end of the transition period. The SI will also make minor amendments to modify the errors in onshore legislation. I hope that the Committee has found this afternoon’s sitting informative. I will write on technical questions that I have not been able to answer. I hope that noble Lords will join me in supporting these regulations.
Arrangement of Business
(3 years, 7 months ago)
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The Deputy Chairman of Committees (Lord Russell of Liverpool) (CB)
My Lords, Hybrid Grand Committee will now resume. Some Members are here in person, respecting social distancing, others are participating remotely, but all Members will be treated equally. I must ask Members in the room to wear a face covering, except when seated at their desk, to speak sitting down and to wipe down their desk, chair and any other touch points before and after use. If the capacity of the Committee Room is exceeded or other safety requirements are breached, I will immediately adjourn the Committee. If there is a Division in the House, the Committee will adjourn for five minutes.
Immigration (Persons Designated under Sanctions Regulations) (EU Exit) Regulations 2020
(3 years, 7 months ago)
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Baroness Williams of Trafford
That the Grand Committee do consider the Immigration (Persons Designated under Sanctions Regulations) (EU Exit) Regulations 2020
The Minister of State, Home Office (Baroness Williams of Trafford) (Con)
My Lords, this instrument is a technical one; unusually it does not create any new powers, but simply relates to the immigration consequences for someone who is designated or sanctioned for immigration purposes under the Sanctions and Anti-Money Laundering Act 2018, which I will refer to as SAMLA from now on.
I will first set out some background to international sanctions, particularly travel bans, with which these regulations are concerned. Under current arrangements, travel bans can be imposed by a resolution of the UN Security Council or by a decision of the Council of the European Union. In the vast majority of cases, they are imposed on individuals who are outside the UK and who have no connection with the UK. However, in the unlikely event that a travel ban is imposed on a person who is in the UK, then this would, as a matter of domestic law, have consequences for their immigration status in the UK as they will lose the right to remain here and will be subject to removal.
A person who is affected in this way may argue that removal would be an interference with their rights under the European Convention on Human Rights, or that it would be contrary to our obligations under the refugee convention. As a result, they may make a human rights or humanitarian protection claim to prevent their removal. These claims can give rise to a right of appeal before the Immigration and Asylum Chamber of the First-tier Tribunal, where a well-developed machinery has grown up to ensure that it is both fair and effective and that it complies with our international obligations.
Now that the UK is leaving the European Union and we have the ability to create autonomous domestic sanctions regimes, a similar situation may arise. A human rights or protection claim may be made against the immigration consequences of a travel ban imposed under SAMLA. Again, this is most likely to arise where an individual is in the UK and would lose their right to remain here as a result of being sanctioned.
I turn to the purpose of the regulations. Noble Lords will recall the issue of interface between challenges to sanctions and challenges to the immigration effect of sanctions being raised during the passage of SAMLA through this House. SAMLA has established an administrative assessment process for sanctions and a court review process in the High Court, or, in Scotland, the Court of Session. This is new; no such mechanism has been needed until now because challenges to UN or EU sanctions are made to them directly.
Now that the UK is creating its own domestic sanctions regimes, we could have a situation where someone wishes to challenge their travel ban in the civil courts, but at the same time also lodges an appeal to the Immigration and Asylum Chamber against the immigration effect of the travel ban—that is to say, the refusal of their human rights or protection claim against removal from the UK. Cases of this kind are likely to be extremely limited in number, but the Government consider it important to ensure that such claims are handled appropriately.
We do not want domestic sanctions to unjustifiably interfere with fundamental rights or run contrary to our obligations under the Refugee Convention. However, at the same time it is also important that the effectiveness of our domestic sanctions regime is not compromised by becoming muddled with immigration claims. The Government have therefore considered how to address this and have concluded that, as a starting point, we should seek to maintain the status quo, so that the Immigration and Asylum Chamber should remain the appropriate decision maker for appeals against the refusal of a human rights or protection claim. Both the Home Office and the tribunal are vastly experienced in this area, having disposing of 53,179 appeals in 2019.
I am sure noble Lords will agree that it is right for this to continue, but we need to manage situations where there would otherwise be the possibility of the High Court and the tribunal considering the same issue. To illustrate the point, whereas the tribunal would be best placed to determine an appeal of an immigration decision, determining the lawfulness of a ban on entry to the UK is a decision that is better suited to the High Court. These regulations ensure that each jurisdiction does not consider matters which are properly the remit of the other, that we continue to comply with our international obligations and that the effectiveness of our domestic sanctions regime is not compromised. I commend these regulations to the Committee. I beg to move.
The Deputy Chairman of Committees (Lord Russell of Liverpool) (CB)
Before I call the first speaker, all speakers should note that the speaking time for everybody is eight minutes, not six minutes, just so there is no confusion.
Lord Cormack (Con)
My Lords, I begin by saying that I do not think that I shall need eight minutes.
I congratulate my noble friend on the way she introduced this non-controversial statutory instrument, but I am concerned about the aftermath of leaving the European Union in one particular context. It is something I raised when I was a member of the Home Affairs Sub-Committee of the European Union Committee of your Lordships’ House and that I have raised on the Floor of the House as well.
I deeply regret the fact that, unless there has been some dramatic change in negotiations, we are not going to be able to take advantage of the European arrest warrant, nor are we going to be a member of Europol. As we are essentially dealing with potentially dangerous people who could, economically or in other ways, be a profound danger to our country, our society and our way of life, it is crucial that we maintain the closest possible co-operation with our friends and neighbours in the European Union as we leave Europol and move out of the European arrest warrant. I would be grateful if the Minister will reassure me on that point when she winds up. I know that it is an issue that troubles a number of people, and it is one that certainly troubles me.
Lord Singh of Wimbledon (CB) [V]
My Lords, I wholly concur with the sentiment that the human rights of individuals should be no less at the end of transition than they were under the European Convention on Human Rights and the refugee convention. It is said that there are some 2,000 individuals and entities involved. Given the sad state of human rights in the world, the number itself is not surprising.
Do the regulations also include those involved in international cybercrime designed to thwart the democratic process? All cases should be speedily investigated and the right of residence of those clearly involved should be speedily terminated. Equally, the right of residence of those found to be without fault should be fully protected.
My main concern is about the effectiveness and morality of targeted sanctions; that is sanctions against individuals and entities, rather than against countries that are sponsoring or supporting them in illegal activities that involve the abuse of human rights. The Magnitsky case, in which a Russian accountant exposed massive government fraud and died in a Moscow prison, illustrates my concern. Those who sent him to prison bear a greater share of the blame for his death than the prison authorities.
In the same way, those that order state-sponsored torture and murder are more guilty than those they hire to carry it out. We are told that those involved in the brutal murder and dismemberment of the Saudi journalist Khashoggi are subject to such restrictions. My question is: what about those who ordered his brutal murder? Will MBS—Mohammed bin Salman—be included in the sanctions?
Targeting hired assassins or a couple of generals from countries guilty of gross human rights abuses can easily become tokenism, giving a false impression of action and commitment simply designed to protect trade with rogue countries. My fears are underlined by the recent statement of a Conservative Minister, who said that when we talk trade with China, we should not mention human rights. I have never been a great fan of Brexit, but we can take it as an opportunity to give the world a new direction on human rights.
The Deputy Speaker (Lord Russell of Liverpool) (CB)
I call the next speaker, the noble Lord, Lord Randall of Uxbridge. Lord Randall?
Lord Randall of Uxbridge (Con) [V]
Yes, I am here. I was not able to hear the Minister or my noble friend Lord Cormack very clearly, so if I repeat anything that they have asked or said, I apologise.
I have just a few questions about this. I echo a lot of what the noble Lord, Lord Singh, has just said. I would like to know whether, as a result of this instrument, the UK will have the power to sanction different persons or entities—or possibly states, although this may not be within this particular instrument—than those already on the UN or EU lists. Will we have to automatically sanction those that are on lists from the UN or the EU?
I also hope that this instrument will make sure that there is no possibility of loopholes and that those who are sanctioned elsewhere will not find succour and refuge in the United Kingdom. Those are the only comments that I have, and I look forward to hearing my noble friend’s answers.
Baroness Hamwee (LD) [V]
I thank the Minister for her explanation of the instrument. I was able to hear her, though I regret I was not able to hear the noble Lord, Lord Cormack.
We on the Liberal Democrat Benches are certainly not opposing the regulations. Sanctions are an important tool to protect both security and human rights; the noble Lord, Lord Singh, in particular has focused on this. UN sanctions seem in the main to relate to security, though I would argue that human rights are both intrinsically important and very closely bound up with security issues. Liberal Democrats are far from alone in having called for more sanctions against those responsible for human rights abuses in Hong Kong—which we must not allow to go off the agenda—and abuses against the Uighurs, which take the meaning of the term “abuse” to an extreme.
Immigration sanctions are not the only sanctions which can be applied against individuals. Financial sanctions can be very telling, though in both cases the impact on people in this country, and on the families of those people, can be very considerable—something that we might come back to in the Counter-Terrorism and Sentencing Bill. Judicial oversight is a necessity, and I will come back to that this afternoon.
Can the Minister explain whether the travel bans under these regulations will have corresponding financial sanctions, or are the two entirely different but possibly parallel streams? One would be very keen to know that we can make more difficulty for some people, not only over shopping trips to Harrods but regarding the acquisition of residential properties whose vacancy is, at best, offensive.
These travel bans carry with them the right to large human rights law protection claims. I trust that the lawyers who undertake that work will not be attacked as “activist lawyers” by the Home Office, though I have to say for myself that I would be proud to be an activist lawyer. Indeed, I hope that all parliamentarians find it possible from time to time to be activists in the law-making process. Where would Parliament be, having made the laws, without lawyers enabling people to exercise rights under them?
I am going to take the opportunity to make the point about the importance of the European Convention on Human Rights and its place in our domestic law. I pay tribute to Lord Lester, my noble friend who died very recently, for his work on human rights and the creation of the Human Rights Act.
I emphasise the importance of judicial review. It may be called on more often and more extensively than was the case some years ago, which is not actually surprising when individual rights are threatened by the state. Judicial review is often portrayed as something pursued by tedious lefty lawyers, but I see it as having a very important function.
I have some more specific questions for the Minister. Will the claimant be able to make a human rights claim and appeal against a refusal of the claim in-country, or will he be required to apply from abroad? I suspect, in the light of Section 92 of SAMLA, that it is mostly going to be the latter, something to which we have often expressed opposition.
The instrument extends beyond the UK to jurisdictions that we are told in the Explanatory Memorandum have not been consulted. The fact that a territory has no competence does not mean it is not affected, and it may well have something to say on the issue. Most specifically, presumably the Channel Islands, the Isle of Man and the British Overseas Territories are going to have to enforce the bans. Is that the case, or is enforcement a matter for the UK courts? Can the Minister explain how that is going to work?
I confess I am stumped by paragraph 7 of the regulations. Nothing in subsection (4) of the section that it refers to permits the tribunal to consider the validity of a decision to make or vary, or to refuse to revoke or vary, the immigration designation of an appellant. Can the Minister help us by approaching it the other way around and telling us what it can do?
I assume that the term “notification” does not necessarily mean that the notice has actually been received. I guess that would be something for other provisions.
Paragraph 3 applies the instrument to a person lawfully within the UK. What if that person is here unlawfully? Does one just go straight to immigration enforcement? What if the person has made an asylum claim that has not yet been determined? I should say that I do not regard that as being here unlawfully, but which claim will be determined first?
I think the Minister said that the Home Office intends to start with this arrangement, which suggests that there will be a review. Can she tell us when that is likely to take place and anything more about the review?
Lord Kennedy of Southwark (Lab Co-op)
My Lords, I thank the Minister for setting out clearly the purpose of the regulations. As other noble Lords have said, this matter is technical but important. I do not intend to speak for very long.
It is important that we recognise that the current process for considering a human rights or protection claim is retained for those new individuals who are subject to these travel bans, and that it is not conflated with the review and challenge mechanism for the sanctions. It is important that we delineate and set out the boundaries clearly so that we keep separate the routes for appeal, the immigration consequences of the sanction and the challenge to the sanction.
My only question concerns powers and how the Government intend to ensure that the system works as it devised to work. I know that the idea is to keep the system as it is at present, but this would not be the first time that things have gone wrong, that there have been unintended consequences or that people have unintentionally been treated unfairly or unlawfully—or, on the other hand, are able to avail themselves of something incorrectly. I very much agree with the comments that the noble Lord, Lord Cormack, made in connection with our friends and colleagues in the European Union. We need to ensure that, although we are outside the European Union, we still work closely with it. Should we not keep people safe?
I see this as two sides of the same coin. It is about treating people fairly and justly while at the same time dealing effectively with those who are alleged to have committed serious offences in terms of their movements being restricted and action being taken against them. I am looking for assurance from the Minister that this has been thought about and will continue to be thought about as we move forward.
The noble Lord, Lord Randall, talked about loopholes. It is important that we focus on them. They are not the subject of these regulations but I am of course reminded of them; indeed, we are regularly reminded of them in the Chamber. One appeal mentioned property. We often talk about the fact that, allegedly, a lot of property in London and elsewhere in the UK is owned by questionable people or organisations with no problem whatever; there is no issue at all. It is almost as if illegal or dodgy money is put into a safe jurisdiction because the criminals want to keep their money safe—and they come here. That is bad. I know that they are not part of these regulations as such, but that issue is of concern. We are lucky to live in a safe jurisdiction but equally, it should not be safe for criminals and people who want to act badly. It would be useful if the Minister could address that point to ensure that, where people have done wrong, they are dealt with and restricted properly while at the same time ensuring that people who have not are treated fairly and properly.
I will leave it there. Noble Lords have asked a number of questions. I look forward to the Minister’s response.
Baroness Williams of Trafford (Con)
I thank noble Lords for their contributions.
The noble Baroness, Lady Hamwee, asked about the different types of sanctions that might be imposed. First, they can be used to fulfil a range of purposes, including supporting foreign policy and national security objectives, maintaining international peace and security and preventing terrorism. They do not operate or succeed in a vacuum. The noble Lords, Lord Singh and Lord Randall, alluded to the fact that this is not just about people. It can be about states and how those who are sanctioned elsewhere—we can think of some very obvious cases—can find succour in the UK. That is absolutely right. Think about the extradition process: a judge will look into whether any extradition request has been made maliciously or whether there would be a threat to a person’s life if they were extradited to a country where they would certainly face torture and, in some cases, death.
I will go through some recent asset freezes and travel bans to illustrate the point. Some 25 Russian nationals involved in the mistreatment and subsequent death of Sergei Magnitsky were subject to them, as were 20 Saudi nationals involved in the murder of Jamal Khashoggi. So were two high-ranking Myanmar military generals involved in the systematic and brutal violence against the Rohingya population and other minorities by the Myanmar armed forces, and two organisations involved in forced labour, torture and murder in North Korea’s gulags. Those are just some examples of the types of organisations and people that we have imposed asset freezes and travels bans on.
Several noble Lords, including the noble Lord, Lord Kennedy, and, I think, the noble Lord, Lord Cormack —although I cannot be sure—talked about the almost hiding in plain sight of assets that sit in our capital city, which may or may not be the product of dirty money, for want of a better expression. Of course, they will also have shared the experience of taking through legislation the year before last on how we can get hold of assets that people have attempted to hide and how we ensure that proceeds of crime are uncovered.
The noble Lord, Lord Singh, asked if these sorts of sanctions would cover cybercrime. Yes, they very well could do given some of the effects that cybercrime can have. The noble Baroness, Lady Hamwee, asked whether someone can appeal from abroad. The answer is yes. What if someone is here unlawfully? Obviously, there are two things to untangle: first, someone’s immigration application or, indeed, asylum appeal, and then a sanction, if indeed one is necessary.
On Crown dependencies, a revised Explanatory Memorandum was laid today and the Crown dependencies confirm that they do not need regulations extended to their jurisdiction. However, we do not ignore our international obligations. Those who claim fear of persecution or a breach of their fundamental rights still have a statutory right of appeal against a decision to refuse those claims.
I reiterate that these regulations do not change the status quo and, on that note, I ask that the Motion be approved.
The Deputy Chairman of Committees (Lord Lexden) (Con)
I remind Members to wipe their desks and chairs before leaving the Room. The Committee stands adjourned until 6.15 pm.
Arrangement of Business
(3 years, 7 months ago)
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The Deputy Chairman of Committees (Lord Lexden) (Con)
My Lords, Hybrid Grand Committee will now resume. Some Members are here in person, respecting social distancing, others are participating remotely, but all Members will be treated equally. I must ask Members in the room to wear a face covering, except when seated at their desk, to speak sitting down, and to wipe down their desk, chair and any other surfaces they have touched. If the capacity of the Committee Room is exceeded or other safety requirements are breached, I will immediately adjourn the Committee.
Investigatory Powers (Communications Data) (Relevant Public Authorities and Designated Senior Officers) Regulations 2020
(3 years, 7 months ago)
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Baroness Williams of Trafford
That the Grand Committee do consider the Investigatory Powers (Communications Data) (Relevant Public Authorities and Designated Senior Officers) Regulations 2020
Relevant document: Special attention drawn to the instrument by the Secondary Legislation Scrutiny Committee, 13th Report
The Minister of State, Home Office (Baroness Williams of Trafford) (Con)
My Lords, these regulations, and the Functions of the Investigatory Powers Commissioner (Oversight of the Data Access Agreement between the United Kingdom and the United States of America and of functions exercisable under the Crime (Overseas Production Orders) Act 2019) Regulations 2020, are both made under the Investigatory Powers Act 2016. That legislation brought together powers available to our public authorities to obtain communications and data about communications, powers that are vitally important to their efforts to tackle crime and protect our citizens. It also created extensive and world-leading safeguards, including a powerful new Investigatory Powers Commissioner who provides independent oversight and authorisation of the use of these powers.
As the operational requirements of our public authorities continually evolve, it is vital that the use of the investigatory powers can adapt in response, within the strict parameters that Parliament agreed during the passing of the Investigatory Powers Act. When we do adapt the use of the investigatory powers, it is equally important that the appropriate safeguards can be applied. The regulations we are debating today collectively represent this adaptation in action.
I turn first to the Functions of the Investigatory Powers Commissioner (Oversight of the Data Access Agreement between the United Kingdom and the United States of America and of functions exercisable under the Crime (Overseas Production Orders) Act 2019) Regulations 2020. As I have previously informed the House, the agreement will allow UK public authorities, with the appropriate legal authorisation, to obtain data directly from US-based telecommunications operators for the purposes of preventing, detecting, investigating and prosecuting serious crime.
It is a requirement of the agreement to ensure an appropriate level of audit and oversight of its use. Given that the agreement has been designated under the Investigatory Powers Act 2016 and that almost all the authorities using the agreement fall under the Investigatory Powers Commissioner’s remit for aspects of their work already, it was decided that the commissioner and his team should oversee the UK’s use of the agreement.
The commissioner will, in accordance with the agreement, keep under review the compliance of UK public authorities with its terms. This will include the ex post facto review, by a judicial commissioner, of communications data authorisations and certain modifications to targeted interception warrants that would not otherwise be specifically subject to a commissioner’s review. This ex post facto review must be conducted as soon as is reasonably practicable, and no later than three months from when the authorisation is given.
In addition to the Investigatory Powers Act 2016, the agreement has been designated under the Crime (Overseas Production Orders) Act 2019. These regulations therefore amend the Investigatory Powers Act to provide the statutory basis for the commissioner to perform his role in relation to the agreement and to oversee the use of overseas production orders under the agreement. The commissioner is supportive of this and his team have recruited additional resources in preparation for the agreement coming into use. Although, as I have described, these regulations require the commissioner to perform his review of public authorities’ compliance in accordance with the agreement, the commissioner, as an independent officeholder, will continue to discharge his functions of inspection, investigation and audit as he sees fit.
The Government remain resolutely committed to the independence of the Investigatory Powers Commissioner. The Investigatory Powers Communications Data (Relevant Public Authorities and Designated Senior Officers) Regulations 2020 amend Schedule 4 to the Investigatory Powers Act to add five public authorities to the list of bodies which can legally obtain communications data, and they make minor amendments to bring certain role titles and organisation names into line with the current terminology.
Communications data includes the “who, when, where and how” of a communication but not the content: the “what” was said or written. It includes the method and way in which one person or thing communicates with another person or thing. Access to this data is a crucial investigative tool for a variety of law enforcement bodies and has a range of operational uses.
The five public authorities that we propose to add to Schedule 4 by these regulations have each demonstrated through extensive consultation with the Home Office and the Investigatory Powers Commissioner’s Office that access to the data is now necessary and proportionate to their operational requirements and statutory duties. The authorities are the Civil Nuclear Constabulary, which requires these powers to investigate threats to the most sensitive nuclear sites in the UK; the Environment Agency, in order to tackle serious organised waste crime; the Insolvency Service, in order to investigate and prosecute criminal wrongdoing connected to personal and company insolvencies; the National Authority for Counter Eavesdropping, in order to protect the Government from technical espionage attack from hostile state actors; and the Pensions Regulator, in order to investigate serious crimes associated with workplace pension schemes, including fraud and money laundering.
In short, without communications data access, these public authorities often cannot carry out their role of investigating crime effectively. By adding them to Schedule 4, they will be subject to the stringent safeguards that already govern the use of communications data. These include the independent authorisation of most requests by the Office for Communications Data Authorisations, a serious crime threshold for requiring certain types of communications data and inspections conducted by the Investigatory Powers Commissioner’s Office. The oversight, together with the communications data code of practice, ensures that requests for communications data are necessary and proportionate. Where it is no longer necessary and proportionate for a public authority to acquire communications data, the entry in Schedule 4 will be removed. Noble Lords will see that in the recent removal of the fire and rescue service.
In summary, the regulations we are debating relate to provisions already set out in the Investigatory Powers Act 2016. They will allow the use of investigatory powers by our public authorities to adapt to changes in their operational requirements as they respond to an evolving threat picture, while ensuring that the appropriate safeguards can continue to apply. I beg to move.
Lord Blunkett (Lab)
My Lords, the Minister is aware that I am very supportive of the updating of measures that, necessarily, take account of enormous and rapid change taking place around us and the need, therefore, to adapt and adopt processes commensurate with that challenge. I particularly welcome the decision to change the formula so that we do not have to rely on mutual legal assistance, which was the most time-consuming and bureaucratic way of operating. The measures also deal with the relationship with the United States.
I am also very aware of mission creep from the original investigatory powers Act of 20 years ago. I came in as Home Secretary in 2001, inheriting the primary legislation but not having the orders laid. It has rent on my heart, because my second son, who had just qualified as a computer analyst, got in touch with me to say that the order that we laid under the Act was so wide-ranging on the agencies and institutions that had the ability to draw down and use the powers under RIPA that a storm was going on in what was then the embryo of social media. Having examined it, I discovered that they were right: we had allowed too many agencies and institutions access to the powers. A great deal has been learned over the 20 years about how to avoid that, and the Minister referred to the updated Investigatory Powers Act of five years ago.
I just want to test this out this evening. There is an agency with which I do not think that many people will be familiar—in fact, I will go as far as to say on public record that I was completely unaware of the necessary but obscure UK National Agency for Counter Eavesdropping. I should be grateful if the Minister could say a word or two about it when winding up. I am very strongly in favour of avoiding eavesdropping, whether it is by state actors on our Government and economy or on private enterprise, individuals and families. I have suffered myself in the past from gross intrusion on those around me, and I am very interested to know the extent of the powers of this counter-eavesdropping agency and the role of the commissioner in overseeing it, and in particular what powers it might possess.
I will not delay the Grand Committee any longer, because I think that, on the whole, we are all in favour of the two orders and the changes being made, but it is interesting what you find out by being in the House of Lords.
Lord Naseby (Con)
My Lords, I have read the papers in front of us this afternoon and should like to highlight a couple of things. I note from paragraph 7.2 that there has been a
“rapid escalation of organised crime”
in recent years of fly-tipping and so on. It seems to me, as one who has been using the tidy tip in Biggleswade in Bedfordshire by appointment, that there is no provision for small businesses or small builders to get rid of their bits and pieces of rubbish. Although it is not absolutely covered by the order, I wonder whether it is not time to look at the fly-tipping challenge that we are facing in this country.
My other point concerns paragraph 7.3 and the Department of Health and Social Care. Am I right in thinking that that is to do with the purchasing done by the department? If not, what else does it cover?
Moving on, I note that 10 departments are now involved. One asks who is co-ordinating those 10 to ensure that they are consistent in their approach to what they think is fraud.
I declare an interest as a trustee of the parliamentary pension fund. We all know that small businesses have, quite rightly, been brought into the national pension scheme since 2012. Why, at this point, eight years on, is it felt for the first time that the Pensions Regulator should be given powers? Previously, it was not given powers, because they were not up to scratch. Any of us who are involved in that world know that it is hugely complicated at the moment; it is not easy, particularly for the millions of small businesses, to keep up to date with the changes that are being made. I am sure that mistakes are made, but I do not think that, at this point in time, this particular edition of the Pensions Regulator is proportionate to the problems in that area.
Moving on to the second order, those of us who have worked with or alongside the United States will be well aware that there are six states, Delaware being the leading one, that do not co-operate with the US Government very much at all in declaring who has moved money in and out of a state. We have had instances in the past on the Public Accounts Committee where it was clear that that particular state—and five others, I think—just does not co-operate. This all sounds fine here, but what will happen in relation to those states that do not co-operate with the US Government as a whole?
Secondly, what is the position of our overseas territories? I declare an interest: I have family in the Cayman Islands. In my judgment and, I think, in that of Her Majesty’s Government, those islands have been highly co-operative in trying to find a modus vivendi in the illegal movement of funds. Other parts of the overseas territories have not been quite so co-operative. It is not clear to me whether this agreement with the US is limited to just the UK and, as far as the States is concerned, probably does not touch those six states—I have mentioned only the leading one. I am not sure whether this measure covers the overseas territories. I do not think that it does, but I would be grateful for elucidation on that point.
Are we in a position to say okay, we have got the States, but there are other countries that we believe we should have a similar agreement with? If that is private and confidential, I do not expect it to be indicated this evening, but it would be helpful for the Committee to know the key parties—that is, countries—that we would like to have agreements with.
Paragraph 7.5 of the Explanatory Memorandum says that
“the Parties shall engage in a review of each Party’s compliance with the terms of this Agreement”.
One wonders how often. I happened to notice that tomorrow we will deal with a separate SI in which reviews will occur every three years. In other places, it is eight years. There does not seem to be too much consistency in government.
Paragraph 7.6 states:
“The IPA is included in this list, but the COPO Act is not, because it did not exist when the IPA was drafted. Consequently, the IPC is currently unable to keep under review any Agreement-related activity exercisable by virtue of the COPO Act, such as the use of OPOs.”
Is this not a loophole? Since we are doing this now—this measure must have been prepared some time ago—what are we doing to close that loophole?
The Deputy Chairman of Committees (Lord Lexden) (Con)
I call the noble and learned Lord, Lord Morris of Aberavon, Lord Morris? I think we have to move on, so I call the noble Baroness, Lady Jones of Moulsecoomb.
Baroness Jones of Moulsecoomb (GP)
My Lords, the Investigatory Powers Act was a landmark piece of repressive legislation passed by this Parliament, granting unprecedented powers to gather information on the public at large. It is so bad that even the Chinese Communist Party has pointed to the UK’s law to justify its own intrusive surveillance of the Chinese people. Many of us who are concerned about state surveillance and government overreach raised the alarm at the time, but Parliament continued regardless.
However, I am happy to see that the Investigatory Powers Act that exists today is a very different beast from the one passed by Parliament only four years ago. The European Court of Justice did not take long to rule that some of the worst parts of the Act, including the Orwellian hoovering up of information about everyone’s internet usage, was plain illegal. A second court case saw the High Court rule, again, that parts of the Act were unlawful and must be replaced. That forced the Government into retreat, with powers now being deployed only against serious crime.
At a time when the Government are seeking to curtail judicial review, we should remember that the courts have acted as a beacon of our freedoms and liberties when Parliament has failed properly to scrutinise the Investigatory Powers Act. That is one example of so many reasons why we must fight against the Government’s attack on the constitutional role of the judiciary to hold the executive power to account. This is an important context which I am happy to have the opportunity to set out, with an unusually long speaking time by recent standards. This context colours the two regulations before your Lordship’s Grand Committee today.
These two regulations are relatively benign precisely because campaigners beat the Government in the court 2-0. The regulations are restricted in their scope and power, applying only to serious crime and with judicial safeguards in place. They are a world apart from the draconian, dystopian legislation dreamed up by the then Home Secretary Theresa May.
I have a specific query for the Minister, and the noble Lord, Lord Naseby, has referred to some of this. The functions of the investigatory powers order implements part of the agreement between the UK and the USA on access to electronic data for the purpose of countering serious crime. Article 12 of that agreement requires a review within 12 months of the agreement coming into force of
“each Party’s compliance with the terms”
of the agreement, and
“a review of … handling of data acquired”
under the agreement. Can the Minister say whether that review has taken place? Am I to understand from her opening remarks that it has not happened yet? When will it take place, and will your Lordships’ House have a copy of that review so that we can see it and discuss it? In particular, I seek assurances that President Trump is not using powers in this agreement against his political enemies in the USA, who seem to be growing in number. He is ruling over what looks like a totalitarian state apparatus purely for his own personal interests, and I very much hope that our Government do not go the same way.
The Deputy Chairman of Committees (Lord Lexden) (Con)
I call again the noble and learned Lord, Lord Morris of Aberavon, and ask him to unmute so that we will be able to hear him. There is still no response, so I call the noble Lord, Lord Foulkes of Cumnock.
Lord Foulkes of Cumnock (Lab Co-op)
My Lords, may I say that it is a great pleasure to be here in person? For one thing, you do not have the problems that my noble and learned friend Lord Morris is experiencing. However, it was said on the way in that I would not be able to cause as much mischief as I normally do in Grand Committee as we are a bit like battery hens in here. I hope that it does not affect our behaviour in that way.
This is a very important issue. I was a member of the Intelligence and Security Committee for three years between 2007 and 2010, so I have a little inside information about what some of the countries that are not our best friends get up to. This is very important in relation to that, and I will come back to it in a minute.
First, the report of the Secondary Legislation Scrutiny Committee quite rightly points out that the Civil Nuclear Constabulary, the Environment Agency and the Pensions Regulator were removed and now they are being put back in again. There is a sort of explanation under paragraph 5, but it is not really a very satisfactory one.
I suspect—the noble Lord, Lord Paddick, is shaking his head; perhaps he can answer on this—that they were taken out by the coalition because of pressure from the Liberal Democrats and the Conservatives, now that they are ruling on their own, have put them back in again. For once, I agree that they should be in and that that is right—let us find out—but it represents yet another U-turn. We have had lots of them in the last few weeks, have we not? Let us add this one to the list—if anyone is keeping one.
Going back to the Intelligence and Security Committee, there was an astonishing U-turn there, mind you. Chris Grayling was so enthusiastic that he wanted to chair the committee; now he finds that he does not have enough time or enough interest even to be a member. Very strange things are going on there, but I do not think that the Minister, however good she is—and she is a good Minister—would be able to answer on that. Once Chris Grayling had dipped his toe in the water, it was not just right for him, as I think Goldilocks said.
The memorandum for the regulations relating to communications data and relevant public authorities states that the regulations
“have been subject to a successful 12-week consultation period with the Investigatory Powers Commissioner and the public authorities to which the modifications relate as required by … the IPA.”
However, given the role that the ISC had—as I know very well—in scrutinising the original Investigatory Powers Bill before it became law in 2016 and the critical recommendations it made in the 2016 report, can the Minister tell us whether the ISC itself was consulted on these regulations? If so, what did it say? If not, why not?
Similarly, I would be interested to know what scrutiny, involvement or consultation the ISC has had in the overseas production order regulations relating to UK and US communications data sharing.
Finally, these regulations come after the introduction of temporary powers—so many of them were brought into effect by the Coronavirus Act 2020—enabling the Secretary of State to grant the Investigatory Powers Commissioner powers to appoint temporary commissioners with powers to sign warrants to allow authorities to access communications data. That was in anticipation of staff shortages due to coronavirus. The time limit on seeking retrospective warrants was also expanded. As with all temporary regulations put in place because of the epidemic, can the Minister say how long she intends to keep these temporary powers in place?
I have just two or three questions to which I would like answers. Otherwise, although it might not seem it from some of my demeanour, I support the Motion.
Lord Paddick (LD)
My Lords, I thank the Minister for outlining these draft statutory instruments to the Committee. I find it a little disconcerting being back in London, having been away for such a long time.
Bearing in mind the comments of the noble Lords who have spoken before me, I was beginning to wonder whether I had read the wrong statutory instruments; perhaps that is all to do with my disorientation. However, the noble Lord, Lord Foulkes of Cumnock, was reassuringly in line with some of my concerns. I am also grateful to the Secondary Legislation Scrutiny Committee for drawing to the special attention of the Committee the first of the statutory instruments in its 13th report. If the Minister will bear with me, I will take the statutory instruments in the order in which they are on the Order Paper rather than in the order that she spoke to them.
As noble Lords will remember, the Investigatory Powers Act was controversial—not going quite as far as the noble Baroness, Lady Jones of Moulsecoomb—when it passed through your Lordships’ House. One of the few reassuring aspects of the legislation was the fact that a number of public authorities, most notably local authorities, had their power to access communications data revoked. It is therefore somewhat concerning that three public authorities that had their authority to access communications data removed under the 2016 Act have now had that power reinstated. My understanding is that was at the time that these public authorities had their authority removed, rather than anything to do with the coalition; I think it was post coalition.
Even more concerning is the fact that the Home Office have agreed to add these and other public authorities on the basis of new business cases, changes in circumstances and work with local police forces that the Home Office has evaluated and that it has decided to grant the powers to. I accept that the Home Office has provided a memorandum explaining the purpose and effect of the regulations, but there is only one brief paragraph on each provision. Again, the Minister was very brief in explaining why there had been a U-turn on three of these public authorities and the basis for granting the powers to the others, including this eavesdropping body—nobody has heard of it, although when I Google searched it, there it was.
These regulations are laid under the enhanced affirmative procedure of Section 268 of the 2016 Act, and yet the detailed reasoning for adding these public authorities, including the three that were previously moved, has not been made available to us. How is Parliament to properly assess whether these public authorities have made a sufficient case, so that the grant of these powers is “necessary and proportionate”? Where is the parliamentary oversight?
Can the Minister explain how many public authorities in total have sought these powers under the Investigatory Powers Act? What proportion of requests made to the Home Office have actually been granted, and how many of them have been turned down? Can the Minister explain the process for evaluating such requests, and what consultation takes place with the Investigatory Powers Commissioner before such requests are agreed to?
I understand that the complexity of crimes these public authorities investigate may have increased, and that their specific expertise and experience often make them a better place to investigate crimes in the first instance, before handing over to local police forces. However, what is to stop joint investigations with local police forces applying for the communications data required, rather than separately authorising these organisations? These are significant powers to access sensitive personal information, and the case for each public authority to access them should be made out in more than a few-line summary.
The second statutory instrument relates to the Crime (Overseas Production Orders) Act 2019—another controversial piece of legislation—and the controversial data access agreement between the United Kingdom and the United States of America. I will not rehearse the concerns expressed in your Lordships’ House about data being provided by UK communications service providers to US law enforcement agencies, under this agreement, which could result in the accused being convicted in a US court and sentenced to death.
However, can the Minister remind the Committee what the effect of Article 8(4) of the agreement is in practice? It looks to me like a case-by-case provision rather than a death penalty assurance. Are the Government reviewing this part of the agreement in light of recent Supreme Court cases?
I am reassured that the Investigatory Powers Commissioner has been involved in the drafting of this statutory instrument, but what additional resources are being given to the Investigatory Powers Commissioner to ensure proper compliance with the agreement and the periodic review of each party’s compliance with the terms of the agreement, as set out in Article 12(1)? I look forward to the Minister’s response.
Lord Rosser (Lab) [V]
We are not opposed to either of these two draft orders. The first of the two draft orders we are debating adds a further five additional public authorities to the list that are now deemed to have a “necessary and proportionate” requirement to obtain communications data, which is, of course, information about communications rather than what was said or written.
This power to obtain communications data is, according to an extra government factsheet memorandum explaining the purpose and effect of the draft instrument, on the basis that these five public authorities
“are increasingly unable to rely on local police forces to investigate crimes on their behalf”.
The five additional public authorities are the Civil Nuclear Constabulary, the Environment Agency, the Insolvency Service, the UK National Authority for Counter Eavesdropping and the Pensions Regulator. Can the Minister explain why it is that, in the light of cuts in police numbers since 2010, each of these five additional public authorities
“are increasingly unable to rely on local police forces to investigate crimes on their behalf”?
Could the Minister say whether this inability to investigate these crimes applies across all local police forces or only to some police forces, and if the latter, which ones?
We will support measures that cut crime and deal effectively and meaningfully with offenders. Can the Minister explain why the remedy is not to increase the capacity of local police forces so that they can investigate these crimes, rather than give powers to obtain communications data to civilians within these five public authorities? On the latter point about civilians, can the Government give a categorical assurance that this draft instrument does not lower the rank or seniority of designated officers and that there is no widening of the authority to exercise the powers here within the organisations covered by this or by previous orders?
The Explanatory Memorandum states that in deciding whether to grant these powers to the public authorities concerned, the Government consider the seriousness of the offences they investigate and the number of requests for data the public authorities each estimate they will make. Can these powers be used only in respect of serious offences or can they be used in respect of any offence? Can the Minister also say how many such requests for communications data each of the five additional authorities have estimated they will make and how that compares with the number being made currently by local police forces investigating crimes on their behalf? How do the estimates of the number of requests each of the five public authorities have said they will make compare with the number of requests being made by broadly comparable public authorities that already have these powers?
Currently, the public authorities that can obtain communications data under the provisions of the 2016 IP Act include, among others, intelligence agencies, law enforcement agencies, the Food Standards Agency, the Gambling Commission, the Prison and Probation Service, and the NHS Counter Fraud Authority. Can the Minister give details of which public authorities have already been given powers in relation to investigating crimes because increasingly they too cannot rely on local police forces being able to investigate crimes on their behalf? Can she also say if any public authorities for whom powers to obtain communications data have been sought have had that request declined by the Government? This point was raised by the noble Lord, Lord Paddick.
The IP Act sets out the circumstances in which various investigatory powers may be used and the safeguards that apply in relation to ensuring that any interference with privacy is strictly necessary, proportionate, authorised and accountable. Since the Government are not required to report on the operation of the Act until five and a half years from Royal Assent, what assurances can the Government provide now that the statutory safeguards in relation to interference with privacy are proving to be effective and are delivering in line with the intentions of Parliament? What views did the Investigatory Powers Commissioner express about the addition to the list of these five further public authorities, and did the commissioner have any reservations or other comments?
The second draft instrument provides the statutory basis for the Investigatory Powers Commissioner to have the required oversight of compliance by UK public authorities on access to electronic data in relation to serious crime, as provided for in the 2019 international agreement between the UK and USA and exercisable under the Crime (Overseas Production Orders) Act 2019 and the IP Act 2016. According to the Explanatory Memorandum, this arrangement, which presumably relates to the IPC providing independent oversight of UK activity under the agreement with the USA, has been agreed with the US Department of Justice. However, to avoid any misunderstanding, can the Minister place on record in her response exactly what it is that has been agreed with the US Department of Justice? Can she also place on record in her response what arrangements the US Department of Justice has agreed with the UK in relation to independent oversight of USA activity under the agreement, since presumably there is reciprocity when it comes to agreeing each other’s arrangements?
Can the Minister also say if any UK public authorities have yet sought to obtain data directly from US-based telecommunications operators under the terms of the 2019 COPOA Act using an overseas production order? If so, on how many occasions? Likewise, have any US public authorities sought to obtain data from UK-based service providers under the same, or similar, arrangements? If so, on how many occasions? Have assurances been given in relation to the non-use of the death penalty, and has protection been given to journalistic sources and material? Finally, is the Investigatory Powers Commissioner likely to be using statutory oversight and compliance powers in relation to agreements between the UK and any other countries apart from the US?
Baroness Williams of Trafford (Con)
I thank all noble Lords who have taken part in the debate and the noble Lord, Lord Morris of Aberavon, for his brief appearance. I could not keep up with the questions from the noble Lord, Lord Rosser, so I have missed some bits out. I hope to pick them up in the answers to other questions, but I will write to him if not.
I was very pleased to hear the opening remarks from the noble Lord, Lord Blunkett; I thought he would be supportive. He admitted to never having heard of the UK National Authority for Counter Eavesdropping. I join him in that: neither have I. It is the national authority for technical security and counter-eavesdropping. It helps the Government on technical espionage attacks by hostile state actors. Its capabilities and purpose are distinct and focus on countering close-access technical operations that could ultimately damage national security.
As he will know only too well, hostile state actors currently have the desire and the means to gain access to or otherwise compromise the integrity of highly classified communications systems and secure facilities. They are known to be able to carry out close-attack technical attacks, as demonstrated by the attack on the Organisation for the Prohibition of Chemical Weapons in The Hague by the Russian intelligence services in 2018. In that case, the Dutch authorities were able to detect and apprehend the agents involved, along with a car full of equipment.
We assessed that Russia and other hostile state actors, particularly China, will continue to attempt to disrupt, attack and commit espionage in the UK. I do not think any noble Lords in the Committee would disagree with that. The Intelligence and Security Committee’s recent report into the interference by Russia in UK democracy demonstrates intent, capability and, indeed, tenacity.
There is also the insider threat to consider, whereby an individual in an organisation may place a device for eavesdropping purposes. Insider threats can be from corrupt, compromised, disgruntled staff or from contractors. They can be among the hardest threats to identify. In order to fulfil its role, the UK National Authority for Counter Eavesdropping needs to be able to identify illicit and covert eavesdropping devices that may be present in sensitive and classified areas and then identify the user behind the device using communications data. We are now all experts in that particular agency.
There were a number of questions, particularly from the noble Lords, Lord Paddick and Lord Foulkes, about agencies being added and taken away, about why that happens and about the purposes of the various agencies that have been added. For clarity, the authorities we are talking about are the Pensions Regulator, the Civil Nuclear Constabulary, the Environment Agency and the Insolvency Service. It was right that those powers were removed in 2015, just as it is right for them to be reinstated now. We cannot foresee how operational requirements will evolve in response to the crimes that public authorities are investigating. We need to have the option to add and remove authorities depending on the necessity of the powers; the noble Lord, Lord Paddick, was right that it is nothing to do with the coalition. This is precisely why the IPA included the power to add and remove bodies from Schedule 4.
These authorities have all demonstrated a strong necessity and proportionality case against similar criteria that the Home Office applied when removing powers in 2015. Those criteria were: the statutory responsibilities of the authorities with access; the seriousness of the offences that they investigate; and the number of requests that they made. As is demonstrated by the case of the Civil Nuclear Constabulary in particular, which does not expect to use the powers often, assessing the volume of applications made is perhaps not the most effective of criteria for deciding which bodies should be listed in Schedule 4. The risk here is just too high to ignore. A public authority can make infrequent use of powers, yet still lead on investigations where communications data is critical.
I congratulate my noble friend Lord Naseby on celebrating his diamond wedding anniversary today.
Baroness Williams of Trafford (Con)
In fact, I think I ought to congratulate his wife more than him on enduring 60 years of marital bliss with my noble friend.
My noble friend talked about local fly-tipping. That is precisely the type of thing for which the Environment Agency might wish to use its communications data powers to protect the natural environment. Its statutory duties include the protection of the environment, natural resources and, of course, human health, which fly-tipping affects. It prosecutes offences that create serious risks of harm to people and the environment, such as illegal landfills and hazardous waste disposal—that might come under my noble friend’s question—and treatment and shipments. Its remit encompasses more than 400 different offences and it encounters some 40,000 suspected offences each year. Of course, we know that waste crime costs the economy in excess of £600 million a year.
Back in 2018, the Secretary of State for the Environment announced an independent review into waste crime, which published the report Independent Review into Serious and Organised Crime in the Waste Sector. That report recommended that the Home Office grant communications data powers under Part 3 of the Investigatory Powers Act. We have a duty to respond to that recommendation.
My noble friend asked about the DHSC. Its inclusion has nothing to do with financial matters; it is purely because its name has changed. He also talked about the Pensions Regulator. It is sad to say so, but criminality in pensions is not only a present threat but a growing one. It is recognised as a risk by the Pensions Regulator and its supporting regulatory partners, including the Serious Fraud Office, the National Crime Agency and HMRC. Having previously referred cases to law enforcement partners to prosecute, the Pensions Regulator now actively leads on these types of investigations and the prosecution of offenders. As my noble friend will appreciate, communications data will be a vital tool in assisting these investigations.
The Pensions Regulator took ownership of Project Bloom from the NCA in 2016. Bloom is a multiagency approach to pension scams and fraud. The Pensions Regulator can evidence £500 million-worth of scams in its regulatory remit, which is quite significant. It estimates that the ongoing threat runs into several billion pounds. Through Project Bloom, the Pensions Regulator has been running a communications campaign with the FCA featuring national television advertising campaigns, which noble Lords may well have seen.
The noble Lord also asked about states, such as Delaware, that do not co-operate. It is to companies rather than states that these requests will be made. That is an important point. Overseas territories do not use it.
The noble Baroness, Lady Jones of Moulsecoomb, asked about the review. It has not yet appeared because the agreement is not yet in force. I am sure that when it is the review will be forthcoming.
The noble Lord, Lord Foulkes of Cumnock, asked about temporary powers. Those statutory powers will last for one year. He asked about the IPCO’s role in all this. It will cover its role in the agreement and in the annual report, which is publicly available.
The noble Lord, Lord Paddick, rightly asked about the business cases, which I did not go into at great length because they are sensitive and extremely lengthy. Reflecting on that thought, I am very happy to organise a private session to go through the business cases for interested noble Lords. The noble Lord also asked about the consultation period under the Investigatory Powers Act. A 12-week period is required for consultation with relevant public authorities and the IPCO on Schedule 4 changes.
The noble Lords, Lord Paddick and Lord Rosser, asked how many organisations have applied and been turned down. I do not know the answer to that question, but I can find out. They also covered the death penalty assurances, which they know are being sought. It was interesting that we have received assurances from the US that should the UK accede to the 2015 MLA request by transferring evidence, the death penalty will not be sought or imposed in any prosecution in the recent case of Kotey and Elsheikh. I hope noble Lords will understand—I know they will—that it would not be appropriate to comment any further while legal challenges are ongoing in that case.
The noble Lords, Lord Rosser and Lord Paddick, talked about additional resources. They are well-versed in our ambitions for 20,000 police officers. The noble Lord, Lord Rosser, also asked about lowering the rank. Quite simply, no lowering of the rank is required. On the ISC, it is not a requirement in the legislation already using the enhanced procedure—laid for 40 days and debated in both Houses—but I fundamentally agree with the noble Lords that engagement with the ISC is an important factor.
The final question to which I have an answer is about safeguards, raised by the noble Lord, Lord Rosser. I am sure the IPCO will lay out any concerns the commissioner has in his annual report, particularly on any safeguarding issues around the whole regime.
I will leave it there for now. I will attempt to answer any questions I have not answered in writing.
Motion agreed.
Functions of the Investigatory Powers Commissioner (Oversight of the Data Access Agreement between the United Kingdom and the United States of America and of functions exercisable under the Crime (Overseas Production Orders) Act 2019) Regulations 2020
(3 years, 7 months ago)
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Baroness Williams of Trafford
That the Grand Committee do consider the Functions of the Investigatory Powers Commissioner (Oversight of the Data Access Agreement between the United Kingdom and the United States of America and of functions exercisable under the Crime (Overseas Production Orders) Act 2019) Regulations 2020.
Relevant documents: 23rd Report from the Secondary Legislation Scrutiny Committee
The Deputy Chairman of Committees (Lord Lexden) (Con)
My Lords, that completes the business before the Grand Committee today. I remind Members to wipe their desks and chairs before leaving the room.
House of Lords
(3 years, 7 months ago)
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Arrangement of Business
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The Lord Speaker (Lord Fowler)
My Lords, the Hybrid Sitting of the House will now begin. I welcome noble Lords back and bid you all good afternoon. Some Members are here in the Chamber, respecting social distancing, others are participating remotely, but all Members will be treated equally.
Death of a Member: Lord O’Neill of Clackmannan
(3 years, 7 months ago)
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The Lord Speaker (Lord Fowler)
My Lords, I regret to inform the House of the death of the noble Lord, Lord O’Neill of Clackmannan, on 26 August. On behalf of the House, I extend our very sincere condolences to the noble Lord’s family and friends.
Retirements of Members
(3 years, 7 months ago)
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The Lord Speaker (Lord Fowler)
My Lords, I should next like to notify the House of the retirement, with effect from 31 August, of the noble and right reverend Lord, Lord Williams of Oystermouth, and the noble Lord, Lord Jones of Birmingham, and, with effect from today, of the noble Lord, Lord Kirkwood of Kirkhope, pursuant to Section 1 of the House of Lords Reform Act 2014. On behalf of the House, I should like to thank all the noble Lords for their much-valued service to the House over the years.
Oral Questions will now begin. Please will those asking supplementary questions keep them short and confined to two points? I ask that Ministers’ answers are also brief.
EU: Non-financial Services
(3 years, 7 months ago)
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The Earl of Clancarty
To ask Her Majesty’s Government what progress they have made on a trade deal between the United Kingdom and the European Union in respect of non-financial services.
The Minister of State, Cabinet Office (Lord True) (Con)
My Lords, we have discussed non-financial services in all seven negotiating rounds to date and have identified large areas of common ground. However, in some areas the EU has been unable to match our ambition. In the interests of compromise, we have agreed to use the EU’s services proposal as the starting point for a text-based negotiation, although the Commission’s insistence on parallel progress in other areas is currently impeding our efforts to agree a consolidated text.
The Earl of Clancarty (CB)
My Lords, a no deal for services would be disastrous for a sector already under immense strain from Covid. Does the Minister agree that, out of the range of concerns voiced by industries, including IT and creative services, it is essential that a suitable mobility framework is in place by the end of the year? For the music industry, will the Government negotiate a two-year, multi-entry visa, or ensure that the commitments in mode 4 are extended to include touring under the free-trade agreement? An appropriate solution for all services would be beneficial to both the EU and the UK.
Lord True (Con)
My Lords, I fully agree with the noble Earl on the importance of the creative industries, particularly music, for which he is such a doughty champion. Some of the points he raises today have been raised with my colleagues in DCMS, and there are difficulties. Monsieur Barnier has labelled some of our proposals, which I referred to in my Answer, as “freedom of movement for service suppliers”—which I hope shows that we are trying our level best to do the best. We are seeking to lock in, on a reciprocal basis, only arrangements that the UK already has with third countries.
Lord Dobbs (Con) [V]
Has my noble friend noticed that over the summer months our trade negotiators have been making excellent progress in trade talks with Japan, the United States and others, yet the EU seems to be the odd one out? Is the confusion in the EU due to the fact that its Trade Commissioner had to resign and it did not get round to appointing a replacement, even at such a crucial time—or might it be because the EU is still trying to cherry-pick the negotiating agenda, insisting that we give it what it wants on fishing rights in British waters and on jurisdiction before it deals with other matters? Why is the EU alone in surrounding itself with despondency and difficulty?
Lord True (Con)
My Lords, I am not quite as adept as my noble friend, but I try never to bring too much despondency to the House. The Government’s position is that we still very much hope that we will get a fruitful and excellent agreement, but my noble friend is right to say that major difficulties remain and that the EU’s insistence on progress on state aid and fisheries is an obstacle to making progress overall.
Lord Whitty (Lab) [V]
My Lords, nearly three years ago I chaired an inquiry into non-financial services. As far as I can see, and from what the Minister says, virtually none of the concerns of those sectors has yet resulted in an actual agreement, even in draft. It would of course be helpful if the Minister could undertake to get his department to reply to each of the recommendations in that report but, for today, perhaps he could respond on just two sectors. On the creative industries—music, film, broadcasting and theatre in particular—what progress has been made for reciprocal provisions on intellectual property, free movement, particularly mode 4, and even such basic things as transportation of musical instruments and theatrical scenery, for example? On transport, specifically aviation—I declare my vice-presidency of BALPA in the first sector—and road haulage, aside from any short-term contingency provisions—
Lord Whitty (Lab)
Progress has to be made on obtaining long-term reciprocal EU-UK arrangements for those sectors.
The Lord Speaker (Lord Fowler)
Before the Minister replies, I remind Members that we have now gone for four and a half minutes and have had only two questions. If people could keep their questions short, it would be much appreciated by the House.
Lord True (Con)
My Lords, I cannot answer all the questions that the noble Lord has asked, for the reasons discussed, but I will seek out the answer to his question on his report. So far as reciprocal arrangements are concerned, I repeat what I said earlier: namely, that the Government are seeking to make progress but there are technical delays in the negotiations as a result of the EU’s position.
Baroness Ludford (LD) [V]
My Lords, historically the UK led in the push for freedom to provide services across the EU, but now the Government’s determination to leave the single market and to privilege regulatory autonomy over market access and, even worse, their cavalier attitude to no deal risk sacrificing our trade in services, which represents over 80% of our economy and 30 million jobs, and nearly half our exports with a trade surplus with the EU. Any action can only mitigate the damage. Lawyers, musicians and other creative artists, IT consultants and truck drivers all depend on the ability to move freely to work. Many services are also bundled into the production of goods. These sectors are already reeling from the Covid shutdown. What real hope can the Government, who are rejoicing in ending free movement, genuinely offer these professionals regarding their ability to continue to earn a living from the mobility of working in the EU?
Lord True (Con)
My Lords, the people of the United Kingdom voted to leave the single market. The Government have tabled proposals in a number of the areas that the noble Baroness referred to, and I have commented on the reasons for some of the current difficulties in making progress.
Lord Stevenson of Balmacara (Lab) [V]
My Lords, further to the question from my noble friend Lord Whitty, what assessment have the Government made of the concerns raised by the chair of the DCMS Select Committee about the impact on any adequacy agreement on personal data if the mooted free trade agreement with the US includes Section 230 of the US Communications Decency Act?
Lord True (Con)
My Lords, in the interests of time, I will write, if I may, to the noble Lord with a detailed response on that point.
Baroness Neville-Rolfe (Con)
My noble friend will be aware that the withdrawal agreement does not protect the rights of representation of UK trademark and design professionals in the European Union Intellectual Property Office, while it does protect the rights of EEA professionals to work in the UK for an extended period, when there will be a great deal of new work at the UK IPO. What plans do HMG have to make these arrangements reciprocal?
Lord True (Con)
My Lords, the Government are committed to protecting IP to a very high level and are proposing a chapter in the free trade agreement based on precedence to reflect this. Both the EU and the United Kingdom are IP-intensive economies and we need to make progress. My noble friend is right in relation to rights of representation that flow from the single market, and I assure her that these issues are currently very much in the mind of the Government.
Baroness Wheatcroft (Non-Afl) [V]
My Lords, what revenue does the Treasury receive from non-financial services and, in the event of no deal, how does it propose to replace that revenue?
Lord True (Con)
My Lords, I do not have in my brief the precise figure that the noble Baroness has asked for, so, as I promised earlier in relation to another question, I will write to her with that. The Government’s overall objective is to sustain, develop and increase the viability of our magnificent non-financial services and creative services.
Lord Purvis of Tweed (LD)
My Lords, information on the Department for International Trade website that I accessed this morning shows that we have made agreements with countries representing only 8% of UK trade in goods and services. If we ended the year on that basis, it would be catastrophic for the British economy, as I am sure the Minister would agree. What is the Government’s target for the amount of trade that we will be doing with the world under free trade agreements—if indeed the Government have a target at all?
Lord True (Con)
My Lords, the Government’s target is to seek friendly agreements with the widest possible range of nations, including the European Union, and I am confident that the figure that the noble Lord cites will be greatly exceeded by the end of the year.
Lord Bowness (Con) [V]
There are 120 days until 31 December. We know what has not been agreed, because that is in the newspapers, and we know what the Government have chosen not to pursue in the agreement—namely, security and defence—but we do not know what has been raised and what has been agreed, subject of course to “Nothing is agreed until everything is agreed”. Will my noble friend undertake to provide a Statement to Parliament setting out exactly what has been agreed, which aspirations we have put forward and which have been completely rejected? This is not interfering with the negotiations; it is informing Parliament and the public.
Lord True (Con)
My Lords, the Government are not giving a running commentary on the negotiations. We remain in close contact with our EU counterparts. There were discussions yesterday and we look forward to the next round of talks in London next week. I can promise my noble friend that we will publish the agenda for that next round towards the end of the week as usual.
The Lord Speaker (Lord Fowler)
My Lords, the time allowed for this Question has elapsed. I apologise to the two Members who have been excluded.
Green Investment Fund
(3 years, 7 months ago)
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Baroness Jones of Moulsecoomb
To ask Her Majesty’s Government what is the total amount of public investment in carbon intensive sectors, including air travel, car manufacturing and road building; and what comparison they have made between that level of investment and the amounts available to the Green Investment Fund.
Baroness Penn (Con)
My Lords, the Government are committed to a green recovery with concern for our environment at its heart. This summer we announced £2 billion for the green homes grant to help people to reduce energy bills and cut carbon, and £2 billion over the course of this Parliament to increase walking and cycling.
Baroness Jones of Moulsecoomb (GP)
I thank the Minister for her reply. What I was trying to ferret out with this Question was the discrepancy between the Government’s support for environmentally damaging sectors of the economy and the tiny amounts of money given to green sectors. We are in a climate emergency. The Green Party has a fully costed manifesto, and I would be happy to sit down with the Minister to go through some policies that would pay dividends in recovering our environment.
Baroness Penn (Con)
My Lords, our economy is not yet in a net-zero status, so to support the economy during the time of coronavirus we have invested in sectors that might contribute carbon. However, I disagree with the noble Baroness about the level of investment that the Government have put into green recovery. In addition to the £4 billion that I just referred to, there is an extra £1 billion for ultra-low emission vehicles and £800 million for carbon capture and storage, in addition to the Clean Growth Fund and a new future homes standard, which will align with the fact that we are planning to build, build, build to get the clean homes that we need.
Baroness Bryan of Partick (Lab) [V]
The Cameron Conservative Government showed their lack of commitment to the Green Investment Bank when they took the short-sighted step of privatising it and then mishandling the sale. Could the Minister outline in what ways a second green investment bank will be more effective and, importantly, how its success will be evaluated?
Baroness Penn (Con)
My Lords, the reason for moving the Green Investment Bank into the private sector in 2017 was to allow it to raise equity from private finance sources to increase the amount of investment going into these sectors. In addition, the Government have launched the Clean Growth Fund, a venture capital fund that will match fund with a charity that invests in new businesses looking to accelerate the commercialisation of innovative new technologies.
Baroness Boycott (CB)
On 29 June this year there was a Question about reducing emissions and ensuring sustainable aviation. The Minister, the noble Baroness, Lady Vere of Norbiton, responded that the Jet Zero Council had recently been set up and would look at these issues. Could the Minister report to the House on the progress of those discussions and whether there is any further progress in investing in sustainable aviation, such as the electrification of short-haul flights and cleaner fuels?
Baroness Penn (Con)
I am afraid I have to tell the noble Baroness that I do not have the details of the progress of that particular initiative with me. I will write to her on that matter.
Baroness McIntosh of Pickering (Con) [V]
My Lords, will my noble friend take this opportunity to examine the damage to the economy, as well as the reduced impact on the environment, of the collapse of the aviation sector as a result of Covid-19? Will this be taken into consideration regarding future investment and assessment of the impact on the environment?
Baroness Penn (Con)
My Lords, the Government take into account both the economic and climate impacts of the aviation sector. As that sector seeks to rebuild after the virus, we need to invest in technologies to ensure that that can be done in a greener way.
Lord Oates (LD)
My Lords, does the Minister recognise that the anger of the Extinction Rebellion protesters outside Parliament relates directly to our failure inside Parliament, particularly the gaping chasm between the Government’s rhetoric on climate change and their actions? Will they at least begin to bridge that gap by instituting a comprehensive green investment plan, including investment in green hydrogen and clean battery production, so that the UK economy is not once again left catastrophically behind the curve?
Baroness Penn (Con)
I am afraid I have to disagree with the sentiments the noble Lord expressed in that question. We have announced, including in the summer economic update, billions of pounds for a green recovery to support our economy. The evidence from fiscal stimulus packages in response to the global financial crisis showed that green policies can support short-term jobs—indeed, more short-term jobs than traditional stimulus. That is why the Government are investing in a green recovery.
Lord Randall of Uxbridge (Con) [V]
I welcome the Government’s green homes grant scheme. How are they publicising this excellent scheme to ensure the widest possible uptake?
Baroness Penn (Con)
I reassure my noble friend that last week we launched an eligibility checker on the Simple Energy Advice website so that homeowners and landlords can find out what measures they are eligible for. Another important part of making this scheme work is for tradespeople to sign up for TrustMark status to deliver the scheme. We will be investing more in publicising the scheme to tradespeople and those who may benefit over the next few weeks and months.
Lord Stevenson of Balmacara (Lab) [V]
My Lords, the Minister mentioned the Clean Growth Fund, but I am right in saying that it is limited to £40 million at the moment, so there is a bit of a gap in the investment required. In July the Energy Minister said that the transition to a greener economy would require a huge amount of investment. Although it might be seen as another U-turn, is the answer not another green bank?
Baroness Penn (Con)
The Clean Growth Fund has £20 million of government investment, but that is matched pound for pound by CCLA, one of the UK’s largest charity fund managers. As I referred to in response to previous questions, that is not the limit of the Government’s investment in clean growth, which runs to billions of pounds.
Lord Bradshaw (LD) [V]
My Lords, are the Government fully committed to the undertakings that they made in the Paris Agreement in 2015? If so, when do they expect emissions to fall in line with that agreement?
Baroness Penn (Con)
The Government remain completely committed to the commitments they made in Paris. Emissions are falling and the Government set out in their carbon budgets their plan to meet their targets in each period that those carbon budgets cover.
Lord Browne of Ladyton (Lab) [V]
My Lords, success for the £800 million of public investment in carbon capture and storage that the Minister referred to depends on a credible business model; the previous two competitions failed because of the absence of one. When will the Government publish their response to the eight-week consultation on CCUS business models that ended a year ago?
Baroness Penn (Con)
I am afraid I do not have a date for the noble Lord for the response to that consultation, but I can say that at Spring Budget 2020 the Government announced at least £800 million to support this sector in two industrial clusters. We aim to have the first one up and running by the mid-2020s.
Lord Berkeley (Lab) [V]
My Lords, will the Minister use this opportunity to commit the Government to phasing out any further support for the aviation and motor sectors by the end of this financial year unless they obtain legally binding commitments from the companies concerned that are firmly and transparently tied to achieving our zero-carbon targets? If she will not do that, can she explain why not?
Baroness Penn (Con)
Of course the Government want to support business and industry during this difficult time. We do not see a tension between getting our economy back on its feet now and meeting our longer-term targets on climate change action.
Baroness Randerson (LD)
My Lords, the Government are urging us to abandon home-working and to return to our offices with the old daily commute, but travelling to work creates harmful emissions. What assessment have the Government made of the impact of the return to the daily commute on both climate change and the health of the population?
Baroness Penn (Con)
As we can see from a slightly busier House today than before Recess, some noble Lords have returned to a bit of a commute. I do not think there has to be a contribution to climate change from commuting. That is why we have invested £2 billion in walking and cycling, which can contribute to people’s well-being. One of the things that we have seen during the pandemic is more flexible working structures that may allow people to get away from just peak travel. That can reduce congestion and reduce the impact on climate change.
The Lord Speaker (Lord Fowler)
My Lords, the time allowed for this Question has elapsed. I congratulate those who took part.
Childhood Obesity
(3 years, 7 months ago)
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The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell) (Con)
My Lords, we published Tackling Obesity: Empowering Adults and Children to Live Healthier Lives on 27 July. The strategy demonstrates an overarching campaign to reduce obesity, takes forward actions from previous chapters of the childhood obesity plan and sets out measures to get the nation fit and healthy, protect against Covid-19 and protect the NHS.
Lord Dubs (Lab) [V]
My Lords, if the Government persist in abolishing Public Health England, who will be responsible for policies to tackle obesity? Secondly, does the Minister agree that tackling obesity, especially childhood obesity, requires more than a few policy headlines but rather a whole-government approach that includes healthcare, education, local government, transport, finance, the built environment, sports provision, advertising—especially social media—and scientific research, plus a focus on preschool children, disadvantaged groups and involving young people themselves?
Lord Bethell (Con)
My Lords, I pay tribute to those at Public Health England who brought together the obesity strategy announced in July and who will continue to work on the obesity strategy. We are consulting on where the ultimate home for that team should be. I emphasise that the obesity strategy launched in July was the most holistic and joined-up piece of policy on obesity in recent times. I emphasise that the money that has come from the sugar tax is now going to pay for sports in schools.
Baroness Bennett of Manor Castle (GP) [V]
My Lords, the noble Lord, Lord Dubs, referred to the need for what the IPPR—in a report from last week that I am sure the Minister is aware of—called a “whole society” approach. The current strategy focuses on a few aspects of consumption. Will the Government consider the issue of production and the fact that large multinational companies are making huge profits from unhealthy products, particularly in the beverage sector? What will the Government do to make sure that they make a larger contribution to solving the problem they have created?
Lord Bethell (Con)
My Lords, I welcome the IPPR report, but it is not true that the Government do not have a whole-society approach. Our approach to obesity involves physical education, supporting underprivileged families, addressing issues with marketing and a whole range of different issues. As for the noble Baroness’s points on profit, this Government are not against profit, but we are for healthy outcomes for young people.
Baroness Chisholm of Owlpen (Con)
My Lords, clearly prevention is better than cure and there is no panacea. However, there seems to be some evidence that, where families are brought together in family programmes to help them bring about behavioural change, there is more likelihood of them sticking to a healthier lifestyle. I ask my noble friend the Minister whether these programmes are ongoing and, if not, whether they can be started again and rolled out countrywide? It seems that, if families are brought together to help them think about behavioural change, this could be one way of tackling the obesity crisis.
Lord Bethell (Con)
My Lords, I pay tribute to the noble Baroness, Lady Chisholm, for her expertise in this matter. She is entirely right that decisions made by families together are more powerful than those made by individuals. The obesity campaign launched in July seeks to achieve exactly that by having a campaign on better health targeted at the whole population. I also emphasise the Healthy Start vouchers, a scheme to provide a nutritional safety net to hundreds of thousands of pregnant women and families with children aged under four, which is one way of bringing families together around healthy food.
Baroness Watkins of Tavistock (CB)
School nurses play important roles in dietary education for new parents and school pupils. With the anticipated changes to Public Health England, how will the Government ensure, without structured plans, that these services are strengthened to promote healthy eating and exercise to prevent early childhood obesity?
Lord Bethell (Con)
The noble Baroness is entirely right that these nurses play an absolutely pivotal role. The reorganisation around PHE is due to start in April. We are seeking the best possible advice on where that work could be best sited. The National Institute for Health Protection is one potential home, but I reassure the Chamber that a safe and important home for those nurses is a priority for the Government.
Baroness Massey of Darwen (Lab) [V]
My Lords, obesity is overwhelmingly a problem of deprived communities. Therefore, does the Minister agree that initiatives on child obesity need to be tackled by communities themselves, supported, of course, by adequate government funding. How are the Government encouraging such activity—for example, by harnessing the power of food banks, parents, schools, clubs and children themselves—to develop local solutions?
Lord Bethell (Con)
The noble Baroness has a point on the importance of targeting the right populations and there are certainly some demographics that incur higher incidences of obesity and for which the health disbenefits of obesity are higher. For these, we have special programmes to support them in schools with vouchers and medical interventions. However, obesity is a national problem that affects all parts of society. In Britain we have got it wrong and we need to address this issue as a nation.
Baroness Tyler of Enfield (LD) [V]
My Lords, the noble Baroness, Lady Massey, rightly emphasised the link between deprivation and childhood obesity. Therefore, while welcoming the announcement of the Government’s obesity strategy, I ask the Minister: what specific steps are the Government taking to address the links between deprivation and obesity; how will this be funded; and what plans do they have to introduce policies with a more explicit focus on early years to reduce childhood obesity rates?
Lord Bethell (Con)
My Lords, there are individual programmes specifically targeting those from deprived backgrounds. I emphasise the childhood obesity trailblazer programme, which has funding for several councils to pioneer forward-thinking ideas to address childhood obesity among those target populations.
The other area that I emphasise is exercise in school. Of course, obesity is linked to intake, not exercise, but exercise helps to get the disciplines right around looking after one’s mind and body. The £320 million going into school sports facilities is a massive bonus in this area.
Baroness Wyld (Con)
My Lords, could my noble friend say, a little more specifically, what training and support will be available to health visitors for the very earliest intervention? Would not the one-year and two-year checks that the majority of children go along to be an ideal opportunity to inform parents about the nutritional needs of very young children so that they can make those informed choices?
Lord Bethell (Con)
Health checks in the early years of childhood are an incredibly valuable opportunity to intervene in a number of health inputs. Diet and exercise are two of those. Training is in place for health visitors to provide dietary advice but, when back at the department, I will ask whether we are working on any new initiatives at the moment and write back to my noble friend.
Baroness Thornton (Lab)
I have two questions for the Minister. Could he explain to the House why Professor Dame Sally Davies’ 2019 report on childhood obesity, which made 49 recommendations, seems to have been lost? Given that Public Health England plays a crucial role in addressing obesity, as my noble friend Lord Dubs said, and the obesity team seems to be homeless at present, how will the Government ensure that its expertise, accountability and leadership is retained and relevant bodies are sufficiently funded?
Lord Bethell (Con)
My Lords, the report from Professor Sally Davies has not been lost; the July obesity strategy leans extremely heavily on the insight and advice of Sally Davies, who continues to have a strong presence in the department and informs all our decisions, as does the public health team at PHE. Professor John Newton had an extremely high profile during the launch of the obesity strategy in July and continues to have an important voice at all levels of the department.
Lord Harries of Pentregarth (CB) [V]
In her 2019 report, the Chief Medical Officer pointed out that, when we leave the European Union, it will be open to the Government to alter VAT rates. She recommended that healthy foods should remain without VAT, as they are at the moment, but that there should be a tiered approach to unhealthy foods and drinks as far as VAT is concerned. What is the Government’s response to this recommendation?
Lord Bethell (Con)
My Lords, the Government are not planning a review of VAT at present.
The Lord Speaker (Lord Fowler)
My Lords, the time allowed for this Question has elapsed.
Covid-19: Self-isolation Payment Scheme
(3 years, 7 months ago)
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Baroness Sherlock
To ask Her Majesty’s Government what are the eligibility criteria for the new payment scheme for people self-isolating and unable to work from home in areas with a high incidence of COVID-19.
The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell) (Con)
My Lords, to be eligible for this payment, individuals must live in Blackburn with Darwen, Oldham or Pendle and have been asked to self-isolate by Test and Trace, be employed or self-employed, stand to lose income because they are unable to work from home while self-isolating, and receive at least one of the following benefits: universal credit, working tax credit, income-related employment and support allowance, income-based jobseeker’s allowance, income support or pension credit or housing benefit.
Baroness Sherlock (Lab) [V]
My Lords, I am grateful. People are told to quarantine as soon as they have symptoms and wherever they live. Can I ask the Minister two questions? First, why is the payment only for those who have had a positive test or been told to isolate by NHS test and trace? Secondly, the Government’s description of the scheme says that it is intended only for those in high-infection areas, but if there is an outbreak elsewhere, in a care home or a factory, do those workers not need support? If they cannot afford to stay at home, does that not risk creating a new high-infection area?
Lord Bethell (Con)
My Lords, the reality of the epidemic is that it targets some communities in specific areas with laser-like focus. The feedback from some of those communities, local authorities and community leaders is that support is needed in some areas where there has been a local lockdown. We have responded to those suggestions and put this financial support in place for specific communities in specific areas. In that, we are responding to local suggestions.
Baroness Lister of Burtersett (Lab) [V]
My Lords, can the Minister explain the evidence base for the decision that £13 a day would be sufficient to persuade low-paid workers to forgo their earnings and self-isolate?
Lord Bethell (Con)
My Lords, I am not sure that I heard all the question. Can I just explain that those who are isolated for 10 days will receive £130? Other eligible members of their household who have been self-isolating will also be entitled to a payment. Eligible non-household contacts instructed to stay at home and to self-isolate will also be entitled to a payment of up to £182.
Lord Scriven (LD)
My Lords, what is the difference in the Government agreeing to pay only certain low-paid people £13 a day to do their civic duty to stop the spread of a deadly virus, but up to £70 a day for anyone to serve on a jury?
Lord Bethell (Con)
My Lords, I do not see that there is a parallel between the two.
Baroness Warsi (Con) [V]
My Lords, what current criteria are the Government using to determine local lockdowns? In the light of reports from Manchester today, what improvements, if any, have been made in the area of local consultation and the imposition of a local lockdown since the decisions of 30 June in Leicester?
Lord Bethell (Con)
My Lords, a huge amount of data, both national and local, gets put into the local lockdown process during the gold meetings of the JBC. The liaison between gold and local authorities and local MPs has been improved and upgraded massively in the last few weeks. I cannot share any update from the JBC meetings today.
Lord Loomba (CB) [V]
My Lords, there are many situations where citizens are being mandated to self-isolate or quarantine, such as specific workplaces or specific countries or, as we have seen at the weekend, with the flight from Zante. However, those people may not live in areas with high incidence of Covid-19. In these circumstances, how will such people be covered by any benefits so that the choice is not between feeding themselves or health protection for anyone affected?
Lord Bethell (Con)
My Lords, under the current scheme, benefits are provided to those who live in Blackburn with Darwen, Oldham or Pendle. It does not extend to other areas. We will assess the impact of this scheme and review whether it should or could be extended in any way.
Lord McKenzie of Luton (Lab) [V]
My Lords, support for the most vulnerable in undertaking self-isolation should not just, as suggested, be a matter of financial support, important though that is. It should include emotional and mental health support to the household. Does the Minister agree? What provision is being made for this sort of support? In so far as it is provided by local authorities, will adequate funding be made available to them?
Lord Bethell (Con)
The noble Lord is entirely right. The decision to isolate is extremely tough for a great many people, both economically and psychologically. The importance of isolation is absolutely critical in our battle against Covid. We have to think of ways of supporting people in every way we can. That is the responsibility of local authorities, and we have provided them with £300 million of funding to support their isolation, test and trace programme. I would like to pay tribute to local authorities that are doing a fantastic job of putting support in place for those who are isolating in expectation of the winter.
Lord Greaves (LD) [V]
My Lords, I speak from Pendle, and declare my interests, where council staff and the council leadership are working heroically in the front line of the Covid battle. This is a welcome although very small step. Is the Minister aware, though, that our determination to test, test, test and find positive cases is greatly hindered by the inefficient and failing national tracking, contact and isolate system and by the complex, obscure and bureaucratic way in which decisions on local restrictions and support are being made? Will the Government give much more authority and resources to local people with the skills and local knowledge that are needed, particularly in tracking down local contacts and persuading them to co-operate? Give us the tools and we will get on with the job.
Lord Bethell (Con)
The noble Lord gives fascinating testimony, and I pay tribute to the council in Pendle, which is well known for its energetic approach in dealing with the epidemic. I honestly say a massive thank you to all those in Pendle who are working so hard. Despite what the noble Lord has just said, they are being successful. The strategy is working and they are fighting the disease and breaking the chains of transmission, and we are all hopeful that Pendle will be restored to normal life as soon as possible. Our approach is to give those on the ground the tools they need, exactly as the noble Lord asks. I am hopeful that that is happening. I hear reports that it is, and that is very much the emphasis of our approach.
Lord Wigley (PC) [V]
My Lords, will the Minister confirm that if local spikes appear around the United Kingdom, this scheme will be available to them? Will it be available in Glasgow, for example? Can he confirm that enough flexibility will be allowed to those administrating the scheme to ensure that those who need the scheme, whose circumstances will vary greatly, will be able to get it quickly and expeditiously?
Lord Bethell (Con)
The noble Lord asks a wide-ranging set of questions. We are looking at the effectiveness of the scheme. We are working with DAs to see whether the scheme could or should be extended in Scotland, Wales and Northern Ireland. Once that review is done and we have assessed its impact, we will be able to make decisions of the kind he describes.
Lord Polak (Con)
The headline figure of £13 can be, and has been, taken out of context. Can my noble friend the Minister reconfirm that the payment will not impact existing benefit entitlements?
Lord Bethell (Con)
My Lords, the payment itself will not affect existing benefits in any way. Payments through the scheme will, though, be subject to income tax and some form of national insurance contribution, in line with other support payments such as through the Coronavirus Job Retention Scheme.
Baroness Primarolo (Lab) [V]
My Lords, I return to the question asked by my noble friend Lady Lister. What was the evidence base for the decision that £13 a day would be sufficient to persuade low-paid workers to forgo their earnings and therefore self-isolate? The Minister did not answer the question the first time round; perhaps he could answer it now. What were the criteria?
Lord Bethell (Con)
The evidence base and criteria were our discussions with local authorities and community leaders on what an effective amount would be that would tip the balance in a personal decision to isolate. As I said earlier, those personal decisions are extremely tough. It was agreed with local infection teams and authorities that this was the kind of sum that would make a difference.
The Lord Speaker (Lord Fowler)
My Lords, the time allowed for this Question has elapsed, and that concludes Question Time.
Arrangement of Business
(3 years, 7 months ago)
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The Deputy Speaker (Lord Lexden) (Con)
My Lords, hybrid proceedings will now resume. Some Members are here in the Chamber, respecting social distancing; others are participating remotely, but all Members will be treated equally. If the capacity of the Chamber is exceeded, I will immediately adjourn the House.
Aid Spending
(3 years, 7 months ago)
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Baroness Sheehan
To ask Her Majesty’s Government, further to the establishment of the Foreign, Commonwealth and Development Office, what plans they have to maintain the requirement to spend 0.7 per cent of Gross National Income on aid.
The Parliamentary Under-Secretary of State, Foreign, Commonwealth & Development Office (Baroness Sugg) (Con)
My Lords, the commitment to spending 0.7% of our national income on aid is a manifesto commitment and is enshrined in law. As the PM has made clear, the new Foreign, Commonwealth and Development Office will maximise the impact of our aid budget to help the world’s poorest, while making sure that we get the best value for money for the UK taxpayer.
Baroness Sheehan (LD)
My Lords, in an article in this week’s Sunday Times on the Chancellor’s possible tax rises was this line:
“Treasury officials are also examining ways of siphoning cash from the foreign aid budget.”
Given that £2.9 billion has already been cut from UK aid this year, going further would mean repealing legislation. From the same article was this quote:
“A source said: ‘Foreign aid is being looked at as well’.”
Quite simply, can the Minister say whether such media reports over the last few days are wishful thinking within elements of her party, or is it a precursor to yet another government U-turn, this time on a Conservative manifesto commitment?
Baroness Sugg (Con)
My Lords, rather than focusing on unattributable media reports, I point the noble Baroness to No. 10’s confirmation yesterday that there is no change to the Government’s commitment to maintaining a 0.7% aid target. Also, the Foreign and Development Secretary today confirmed that we will continue to spend 0.7%. That is written into the law. The Prime Minister has said that we want aid capacity and development expertise; that is what we want to be the beating heart of the new department.
Baroness Symons of Vernham Dean (Lab)
My Lords, I have two questions. When will the first accounts for the new joint department be signed off, as they must be, by the FCO permanent secretary, and published? Secondly, on 19 June, 191 NGOs, think tanks and charities, all working on humanitarian assistance—including of course the current Covid problem—wrote to the Prime Minister protesting about this new arrangement. The doctors wrote, similarly, a couple of days later. All made the point that DfID is one of the most successful and respected aid departments anywhere in the world, and is recognised as such by everywhere else in the world. Has the Prime Minister answered those letters from the 191 NGOs and the doctors? They were written 10 weeks ago. If not, after almost 10 weeks, when will he reply?
Baroness Sugg (Con)
My Lords, departmental accounts will be published in the usual way. I reassure the noble Baroness and, indeed, the NGOs to which she referred, that of course we are listening very closely to what they say to ensure that the new department is greater than the sum of its parts, and what we want it to be. We aim to use all the tools of our influence and expertise to continue our work and development. We are a world leader in international development, as the noble Baroness says, helping to end extreme poverty in developing countries around the world. We are absolutely committed to putting UK aid at the heart of what we do in the new department. We will continue with our 0.7% and will ensure that we continue the good work that we have seen from DfID in the new FCDO.
Baroness Northover (LD) [V]
Development is global and long term, which is usually different from the aims of other government departments. Given the headlines about raiding the development budget, including from the Treasury, exactly how will her department guard against this?
Baroness Sugg (Con)
My Lords, as I hope I have made clear, we will continue our commitment to 0.7% in the new department, as was said in the Conservative Party manifesto on which we were elected, and we will proudly maintain that commitment. We must ensure that both our diplomacy and development work continues, as it has done in the two separate departments, within the new department. In our new department, we aim to pursue our national interests and project the UK as a force for good in the world, which includes safeguarding UK security, defending our values, reducing poverty and tackling the huge global challenges that we face.
Baroness Hayman (CB)
My Lords, our overseas aid programme is under a triple threat: the questioning of the commitment to 0.7%; the reduced value of the 0.7% because of the post-Covid recession; and the subverting of aid spending into quite different areas, such as defence. Does the Minister accept that an effective aid programme is, in fact, firmly in the UK’s national interest and enhances our reputation globally? Will she reassure me that spending in areas where we are acknowledged world leaders, such as malaria—I declare my interest—which was also specifically mentioned in the Conservative Party manifesto, will be safeguarded going forward?
Baroness Sugg (Con)
I completely agree with the noble Baroness that our work in international development is firmly in the national interest and absolutely enhances our global reputation abroad. We have been a world leader in many things, including malaria. We need to focus, rightly, on the Covid-19 response, but we must not forget or reverse the significant gains that have been made over the years. We have many proud achievements on malaria, and the UK will continue to lead the way on eradicating malaria as part of our work on ending preventable deaths.
Baroness Nicholson of Winterbourne (Con)
I welcome the Minister’s comprehensive replies and have a simple question for her. On the back of my views that the merger will add greatly to UK influence in global leadership, given that public health is central to all our thinking at the moment internationally, can the Minister reassure me that, from now on, we will use our contribution to the World Health Organization, where we are in fact the largest and most powerful contributor, to the greatest possible extent? That means perhaps not just contributing, but ensuring that the WHO has reorganisation in the centre, or whatever is needed, because it has lagged a little bit, which is why we have lost the United States. Will the Minister reassure me that she will do everything she can to make Britain more powerful in the World Health Organization dimension?
Baroness Sugg (Con)
As my noble friend says, we are a leading donor to the WHO. We have already pledged £75 million to help it to lead international efforts to stop the spread of the virus and then the pandemic. The UK has long been an advocate for reform in the WHO. We want to see the WHO continue to learn lessons on how to improve its response to global health emergencies. The new department will help us in this aim, bringing together our diplomatic engagement with the WHO and other bilateral donors, and also our development funding, for the first time.
The Lord Bishop of Bristol
My Lords, I have personally seen through the Anglican Communion’s worldwide partnerships the positive impact that the UK’s overseas aid has made to alleviating poverty. I share the concerns of other Peers about the reports of the Government’s intent to overturn the legal commitment to spend 0.7% of gross national income on aid. At the risk of tedium, I hope that the Minister will continue to give this House assurances that the Government have no such plans, which would reduce the UK’s impact under the UN sustainable development goals.
Baroness Sugg (Con)
I thank the right reverend Prelate for her question. Like her, I have seen at first hand the incredible work that church and faith groups do around the world. I assure her that we will continue to be guided by our responsibilities under the International Development Act, which of course includes a commitment to poverty reduction.
Lord Collins of Highbury (Lab)
My Lords, as we have heard, there has already been a substantial reduction in real aid spending due to the contraction of our own economy. Where is the strategy? Which country programmes have been identified for closure and cuts? Does the Minister agree with the Prime Minister that we should be diverting aid from partners in countries such as Zambia and Tanzania? If so, why?
Baroness Sugg (Con)
As the noble Lord said, given the expected fall in gross national income this year, our commitments to aid spending have been reviewed across all departments. The strategy behind that was to ensure that there is continued support for the five priorities for overseas development assistance: the Bottom Billion support, poverty reduction, climate change, girls’ education and, of course, Covid-19. We want to ensure that Britain continues to play its role as a force for good in the world. That implementation is happening as we speak, and we are discussing that with suppliers. As usual, there will continue to be adjustments in year to individual departmental overspend to meet the 0.7% target, but we are absolutely focused on making sure that we continue to fund the priorities that I have outlined.
Lord Campbell of Pittenweem (LD)
My Lords, is not the problem for the Minister that whatever she says in good faith is being undermined by persistent and detailed leaking, not least in today’s edition of the Times? The aid budget is a jewel in a very jaded foreign policy. Why should it be put at risk?
Baroness Sugg (Con)
My Lords, I agree with the noble Lord that it should not be put at risk. It is not at risk. I point to the comments from No. 10, from the Foreign Secretary today and, indeed, from the Prime Minister when he made his announcement to Parliament on the merger. We should be incredibly proud of the changes that 0.7% has made and continues to make in people’s lives around the world, from girls’ education to eradicating wild polio in Africa. We continue to be proud of that and to be absolutely committed to carrying on the good work of 0.7% in the new FCDO.
Lord Berkeley of Knighton (CB) (V)
My Lords, nothing, I suspect, could prick our collective conscience a moment more than the terrible suffering in Yemen. Can the Minister tell me how we are managing to extend some sort of help to the agencies working in that area?
Baroness Sugg (Con)
My Lords, we continue to be incredibly concerned about the situation in Yemen. In fact, we have an announcement today, given the impact of Covid-19 heightening the risk of famine in countries from Sudan through to Yemen. We are providing an extra £190 million of famine relief. At the same time, in order to leverage our diplomatic network and bring countries together, we have appointed a new envoy for famine relief and we will continue to ensure that we are giving the support to the people of Yemen that they need.
Baroness Chalker of Wallasey (Con)
Can the Minister give us more assistance in developing public health training, because it is the lack of public health training in many of the countries concerned with Covid-19 that is putting them at even greater risk than they are already? Will she also discuss with the Foreign and Development Secretary the whole question of training officials from the two participating departments, perhaps with some help from those of us who have experienced working in both departments? That way we can show the diplomats exactly why foreign aid is so critical to what they do, and help the development specialists to understand the problems faced by the diplomats.
Baroness Sugg (Con)
As my noble friend said, it is incredibly important that we think carefully about how we spend our 0.7% budget. Of course, Covid-19 has changed our perception of what we should be doing. I agree with her that we need to invest more in health training and health systems in the developing world to make sure that they are strong enough to cope with this pandemic and any others that might come in the future. I also agree with my noble friend about the importance of sharing the expertise from DfID and the FCO with the new department. There will, of course, be learnings for everybody, and I would very much like to take her up on her offer of help on that, because I know that she has many years of experience in this. I am sure that the new department would benefit from that.
Lord McConnell of Glenscorrodale (Lab)
My Lords, I welcome the Government’s reassurance on the matter of 0.7% and I should mention my entry in the register of interests. However, I do not think that the announcement at the end of July of the cuts in the budget as a result of the contraction in the economy was a good start for transparency in the new department. To announce £2.9 billion of cuts without any detail or criteria was a significant problem, so I would like the Minister to give us some assurance, first, that there will be a detailed announcement about these cuts and, secondly, that the criteria used to make the cuts will be properly announced to Parliament in due course.
Baroness Sugg (Con)
My Lords, the Foreign Secretary explained in letters to the Select Committees and placed in the Libraries of both Houses the priorities on how these decisions were made. We remain firmly committed to transparency in our aid spending. I hope noble Lords will welcome the announcement that we will continue in the Independent Commission for Aid Impact.
On the prioritisation decisions, at a minimum our DevTracker website is being updated at the end of every month. If, by the end of August, amended programmes and projects have been uploaded on to that, provisional international development statistics will be published in the usual way. Then, of course, the final international development statistics in autumn next year will include country-level data.
We do not know what the current GNI figure is, so this is an iterative process as we go, but we are absolutely determined to ensure that we are using the aid money that we have to deal with the many issues that the world faces.
The Deputy Speaker (Lord Lexden) (Con)
My Lords, the time allowed for this Private Notice Question has now elapsed.
Immigration and Social Security Co-ordination (EU Withdrawal) Bill
(3 years, 7 months ago)
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Lord Parkinson of Whitley Bay
That it be an instruction to the Committee of the Whole House to which the Immigration and Social Security Co-ordination (EU Withdrawal) Bill has been committed that they consider the bill in the following order:
Clause 1, Schedule 1, Clauses 2 to 5, Schedules 2 and 3, Clauses 6 to 9, Title.
Parliamentary Constituencies Bill
(3 years, 7 months ago)
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Arrangement of Business
(3 years, 7 months ago)
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The Deputy Speaker (Lord Lexden) (Con)
My Lords, the Hybrid Sitting of the House will now resume. Some Members are here in the Chamber, respecting social distancing, others are participating virtually, but all Members are treated equally. If the capacity of the Chamber is exceeded, I will immediately adjourn the House.
Schools and Colleges: Qualification Results and Full Opening
(3 years, 7 months ago)
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Lord Watson of Invergowrie (Lab)
My Lords, my apologies: I thought that the noble Baroness the Minister was going to repeat the Statement.
I start by congratulating young people across the country on their GCSE and A-level results, which have caused them much more anxiety than necessary. Labour is absolutely clear: we want children back in school and we want them to stay there safely. As the shadow Secretary of State said yesterday, we will always work constructively with the Secretary of State to achieve that, and the questions that I put to the Minister should be taken in that spirit.
The vast majority of schools will reopen fully over the next few days. We welcome that, but many issues of concern remain. For example, schools were denied the necessary information to prepare for reopening, with the Government’s guidance for head teachers to plan for tier 2 restrictions only being published last Friday.
Over the past month, we have been presented with the extraordinary saga of the 2020 examinations. Ministers’ fixation on avoiding grade inflation led to the adoption of a statistical approach that was never going to survive contact with real live students. Mr Gove’s reforms to exams meant that there was no back-up to call on. It beggars belief that the Secretary of State was warned of the debacle and yet allowed such flawed results to reach publication before the inevitable retreat, thereby causing not just distress to so many students but chaos in the university sector. It seems that we have a Government that resolutely refuse to recognise problems that are so obviously coming down the road, proclaiming absolute confidence in their ostrich-like convictions until the moment of the screeching U-turn.
With regard to this summer’s exam results, can the Minister say when the Secretary of State first knew of the potential problems with the flawed standardisation approach, and what action he took as a result? The evidence given by Ofqual to the Education Committee today has raised serious questions about the Secretary of State’s role in the fiasco. We welcome the apology in the Statement but not his repeated attempts to blame Ofqual and officials for the exams crisis. It is now clear that he was responsible. The head of Ofqual has gone and the head of DfE is going. As we say in Scotland, Mr Williamson’s jaiket is on a shoogly nail.
In a helpful letter to all noble Lords last week, the noble Baroness the Minister stated:
“The relevant awarding organisations have assured the DfE that students will receive their results by this Friday.”
That was 28 August. Can the Minister say how many BTEC students have still not received their results?
On the national tutoring programme, can the noble Baroness say when it will take effect? Yesterday, the Secretary of State merely referred to “this academic year”, which is, to say the least, open-ended. Is she also aware that there is scope for the independent sector to demonstrate public benefit under its charitable status by becoming registered tutors under the programme? Not all the work should be handed to private tuition agencies, but whoever is involved it must start soon.
Finally on the return of schools, can the Minister say why early years and post-16 providers remain ineligible for the catch-up premium, and what extra support will be available for children with SEND?
Turning to the 2021 examinations, the tinkering around the edges proposed by Ofqual does not begin to address the scale of the problem that Years 11 and 13 have faced this year and will face next year. The call by teaching unions to change the exams more fundamentally is right: we need to address how we can “build back better”.
Two immediate principles should underpin exams in 2021. First, as the noble Baroness may recall, I argued—in response to the Statement of 8 July—that a plan was needed when schools returned, not in desperation as June 2021 approaches, to cope with the disruption that has already happened, and, just as importantly, for what may happen next year. A robust system does that, and it is surely a condemnation of the Government’s approach that there was no such plan this year. Failing to announce a plan that would have gone some way to reassuring students that they will not be penalised because of the possible future impact of the pandemic amounts, essentially, to a head-in-the-sand assumption that the next academic year will run smoothly and exams and progression in 2021 will operate as if nothing much has really happened. That is surely wishful thinking.
Schools, colleges and universities need time to plan. What discussions are Ministers having with the sector and UCAS to ensure that workable arrangements are in place? Can the Minister guarantee that a contingency plan will be put in place this month in case exams are disrupted again? Removing the cap on admissions by individual universities without a strategy for dealing with the fallout from that decision merely pushes the problem into next year.
Children and their families should have been the Government’s top priority over the summer, but their interests have been placed below those of the Government and Ministers. That must now change, for the good of all young people--for their education and their futures.
Lord Storey (LD)
My Lords, I was slightly confused because I thought the Minister would start by reading the Statement—I do not quite know what happened, but I have obviously got that wrong.
We welcome the fact that children and young people are returning to school, and we have to do all in our power to make this work successfully—and to make it safe. Naturally, the Government have produced reams of guidance for schools. Head teachers have told me that some of it is quite contradictory. I shall give one example. The guidance says:
“No-one should be excluded from education on the grounds that they are not wearing a face covering.”
Yet it also says that when children are walking down corridors or are in open-access areas in schools they should wear a face covering. However, the guidance says that, no, you should not be excluded or told that you had to wear one. That guidance has to be there—I understand that—but head teachers, schools and teachers are looking for simplified, easy-to-follow advice that they can adhere to.
During this period of school closures, children have fallen further and further behind, particularly disadvantaged pupils and those from BAME communities. Schools should be doing everything in their power to ensure that those children are able to catch up on those lost months of learning. I have seen it floated that the Government are considering doing some formative or summative testing to find out what the gap is and what the loss of learning is and how that can be supported. I welcome that—it is an important initiative that should happen.
I am concerned about three areas. One is that, during the period of school closures, children and young people who were excluded from school—they were not on any register because they were excluded—and those young people in alternative provision were the most vulnerable pupils in our system, and they need extra support and help. I do not know what the Government view on that should be, but alternative providers are concerned that those young people could easily get into further trouble.
Then there is the question of the 60,000 home-educated children. I strongly believe, as I suspect the Minister does, that now is the right time to introduce a policy to ensure that home-educated pupils are registered so that we know what is going on in their learning. However, I was concerned to see that external, home-schooled students have not received an A-level or GCSE grade. Could the Minister shed light on this? I am told that 20,000 students have been informed by their institutions that they will not receive a GCSE grade this year.
Let me give noble Lords the case of a young man from Oxford—I apologise to the Minister for throwing this out now and I will give her the correspondence afterwards. Due to personal reasons, he had to be home educated and do his own learning for biology, chemistry and physics at GCSE and A-level. He had a place at a university, but he has been told—I presume that this is true of other young people too—that he will not get a grade because he was an external candidate, not through a school. That is incredibly worrying. Could the Minister look at this issue?
Finally, I go back to mainstream schools. If, God forbid, a pupil is tested as Covid positive, who tells the school? Who tells the head teacher? Is it left to the parents to inform the school? Who is it left to? I am told by head teachers that there are no processes whereby the testing regime should automatically inform the head teacher. That is crucial for the well-being of schools and pupils, and to making the return to full-time education successful.
The Parliamentary Under-Secretary of State, Department for Education and Department for International Trade (Baroness Berridge) (Con)
My Lords, I join the noble Lord, Lord Watson, in thanking young people for their resilience during a crisis this summer that no-one intended them to have to go through. I repeat to your Lordships’ House the apology made by the Secretary of State and in my letter to noble Lords. I thank the noble Lord for his wish to work constructively on these matters.
On schools reopening, the main guidance to put in place the hierarchy of controls, on the need for bubbles or for year groups to be kept separate in secondary schools was issued on 2 July—well in advance of the end of summer term—and enabled schools to prepare. However, for the thankfully very small number of situations where there are additional restrictions, the guidance was issued only recently.
On the noble Lord’s questions about exams, it is important to remember the principle that Ofqual was a body created by Parliament. It was created by statute and is answerable to Parliament. There are good reasons in principle why the regulation of public examinations in this country is not subject to direct government interference. It was Ofqual’s responsibility to have the data to develop the algorithm and then send that algorithm to the various examination boards. There was a reaction at the stages at which the department was made aware of additional concerns and Ofqual met regularly with the department even from before the announcement was made for exams to be cancelled. The department reacted, but Ofqual is the independent regulator.
On sharing data, in the week running up to the A-level results the system was as per any normal year. On the Monday or Tuesday some headline data is given to the department. On the Wednesday that data is shared with schools and is then published on Thursday. To respect the normal division of responsibilities between the department and Ofqual, that long-standing practice was abided by and Ministers did not see the detail of results for individual students or the schools that would have been affected.
Only a tiny fraction of BTEC examination results remains to be communicated to students. That is where further information is needed. Each year there are normally, unfortunately, a small number of results outstanding. Pearson has assured us that it is working to issue these remaining results as soon as possible.
It is envisaged that the first services from the national tutoring programme, which is being delivered by the EEF and Teach First, will be delivered in the second half of the autumn term.
On the specific questions on early years catch-up, of the £350 million tutoring programme, £8 million has been awarded to Nuffield for early language development and there was an announcement that there will be small-group tuition for disadvantaged 16 to 19 year-olds. They are now included in the catch-up.
On the issue around special educational needs students, as noble Lords will be aware, the Oak Academy’s provision of online lessons has of course included some for those with special educational needs. The guidance and the links to the various resources on the Department for Education’s website include links to these. We have been working closely with the sector. Over the next year an additional £730 million will go into the high-needs budget, meaning that it will have grown by £1.5 billion, or 24%, in just two years. We are responding on special educational needs. The £650 million of main catch-up funding going out to schools has been weighted per pupil for specialist schools, because we recognise the higher per pupil costs in those settings.
There will be a contingency plan for examinations next year. There has already been guidance on the curriculum so that schools knew what they were doing from the moment they came back. For instance, in English literature they know that pupils will potentially be examined on only three of the four set texts and there have been changes to field work in geography, et cetera. The question of whether there will be a delay was part of Ofqual’s consultation on the 2021 series, and that will be confirmed as soon as possible.
There is now a higher education task force, chaired by Michelle Donelan, the Minister for Universities, which meets regularly with Universities UK and other stakeholders to work with the sector on the implications of the change in the awarding of grades for A-levels.
Turning to the questions raised by the noble Lord, Lord Storey, I specifically checked and, while it is my personal preference to read the Statement, I was told that in this hybrid situation I do not repeat it. However, I put my view that I want to read it to noble Lords because it helps.
A lot of specific guidance has had to be set out for the sector. Officials and the sector have worked very closely to try to get the right boundary in not being able to be prescriptive, because we have over 20,000 schools in about 70,000 buildings. There must be the framework and the principles for head teachers and other school leaders to make their risk assessments and the changes to their buildings.
Masks are recommended only where we have something such as a tier 2, where there is a local lockdown, but schools can advise their students on that. I hope that the guidance is not contradictory on that matter.
Disadvantaged pupils are of course a concern for noble Lords and for the department. That is why there is the £1 billion catch-up fund. On excluded pupils, many of whom will have been in alternative provision, all schools reopening includes AP schools. At the end of the summer term we announced additional funds for those leaving AP to make sure that they had additional support and did not end up not in education, employment or training. We are working to ensure that they do not fall within the gaps.
On home education specifically, yes, we are particularly concerned. Going back to the cancellation of exams and the work the exam centres did, obviously some home-educated students then register at a school and sit their examinations in that school. As far as possible, we asked those schools to evaluate the performance of that student if they had any data on which to do so, but of course there were situations in which it just was not possible. That is also about the integrity of head teachers and teachers who did not feel they could give a grade. That is why the autumn series of resits in all subjects will be so important, particularly for home-educated students.
There was a recent consultation from the department on whether to have a register with local authorities and whether to pay exam fees for home-educated students, because we are concerned about the rise in the number of home-educated students. The reasons are not, as perhaps they were 10 or 20 years ago, well-meaning parents. Some who are in home education are potentially not getting the education they deserve, but we do not have the data. I will update the House as soon as I can on what is happening with that consultation.
Finally, I thank noble Lords for their support. I hope we can work constructively, going forward.
The Deputy Speaker (Lord Lexden) (Con)
My Lords, we now come to the 20 minutes allocated for Back-Bench questions. I ask that questions and answers be brief, so that I can call the maximum number of speakers.
Baroness Bull (CB)
My Lords, the combined impact of schools’ closure during lockdown and the discriminatory effect of the grading algorithm has further widened the education and attainment gap between pupils from less-advantaged backgrounds and those privileged to attend better-resourced, fee-paying schools. Can the Minister say what discussions are taking place with the independent school sector about its potential contribution to the national effort to help disadvantaged pupils catch up? For example, donating tutoring capacity or access to high-quality outdoor facilities such as sports grounds would not only help the children most in need but would justify the charitable status these schools enjoy.
Baroness Berridge (Con)
My Lords, forgive me; the noble Lord, Lord Storey, also asked about the attainment gap. At the moment the department is seeking as quickly as possible an assessment of what education has been lost and the effect on the attainment gap. We appreciate the EEF’s work, and there have been other reports. There is a procurement out at the moment so that we can assess not all pupils, obviously, but get a better base as to what has actually happened, allowing the next few weeks for things to settle down in schools. Teachers will be assessing that at the moment.
Independent schools are very keen to engage. I personally have been engaging with them through the Independent Schools Council and the Boarding Schools’ Association. They offered some summer clubs over the school holidays, but in my next meeting with them I will take to them how we can structure more their desire to help.
Lord Caine (Con)
My Lords, given that examinations are by their very nature socially distanced and that most schools broke just before the exam period, some of us wonder whether the wholesale cancellation of all exams was absolutely necessary. On postponing next year, the Schools Minister yesterday highlighted the need to consult the devolved Administrations. What formal structures are being considered to ensure that in future there is a properly co-ordinated approach to these matters across the whole of our United Kingdom?
Baroness Berridge (Con)
My Lords, on the cancellation of exams, I think we need to cast our minds back. At the time exams were due to start, no secondary school pupils had been back in the building and the confidence was not there among parents. I hate to think of the trauma we could have caused by children going straight from lockdown into an invigilated situation. It just was not possible, and the department was commended on a decisive decision at that moment that exams were cancelled. So, with the best will in the world, that was the right decision and we stand by it.
On communication with the four nations, only yesterday officials were in a four-nations meeting. There is regular dialogue at both ministerial and official level with the four nations. For instance, the direction letters sent by the Secretary of State to Ofqual were copied to each of his three counterparts in the nations. We are working closely. It is unfortunate for all young people that none of the four nations managed to deliver the standardisation that we had intended to deliver and believed was best for children.
Baroness Morris of Yardley (Lab)
It makes sense to have a back-up plan for the examinations next summer, and the Minister mentioned contingency plans. I am not clear whether the Government are considering anything other than a delay of four or so many weeks. There is gathering support for the idea of moderated assessments throughout the school year. Is something like that being considered by the Government? If so, why have details not already been announced? Term has started and teachers need to know how their children might be assessed before they start the academic year.
Baroness Berridge (Con)
My Lords, yes, there will be a 2021 contingency plan. As I have mentioned, Ofqual has already consulted in relation to 2021, and one of the suggestions in that consultation was a short delay to the sitting of exams. I cannot remember offhand whether moderated assessments were part of that consultation, but this highlights again the issue of what form the examinations will take. There is the direction of government policy, but then it is for Ofqual to run that. I will make sure that the idea of moderated assessments is put forward. As the noble Baroness will probably be aware, Ofqual has delegated to a sub-committee of its board chaired by Amanda Spielman, who will take forward what the system will be for examinations next year. We recognise that decisions need to be made as soon as possible.
Baroness Smith of Newnham (LD) [V]
My Lords, I refer to the register of interests; I am a Cambridge academic. The Statement the Minister did not have the opportunity to read to the House states:
“To ensure that students can progress to higher education, we intend to remove the temporary student-number controls that had been introduced for the coming academic year.”
There is then also a discussion about deferring places for students who got their grades this summer. What impact do the Government expect these changes to have on students just entering year 13? They have had their year 12 education damaged or impeded and will potentially face a challenge for places next year.
Baroness Berridge (Con)
My Lords, until students enrol at the end of this month—clearing is still going on at the moment—we will not know the enrolment for this year and the implications for higher education institutions. Obviously, the process is beginning for next year’s students, and I know that some schools used the one-on-one contact with students at the end of last term to talk to them about that process and their personal development statements. Of course, there are offers of deferral to next year for this year’s students, as an option when courses are full and they do not want to be on a substitute course this year. Further details of the impact on next year and the decisions that need to be made will be given as soon as possible.
Lord Birt (CB) [V]
My Lords, I ask the Minister to define conceptually for education—and indeed for other Whitehall departments—where power, responsibility and accountability begin and end, both for the now-misnamed Permanent Secretaries and for Secretaries of State.
Baroness Berridge (Con)
My Lords, in this sector I have outlined where the responsibilities of Ofqual and the department are in relation to this matter. I myself am bound by ministerial responsibility. On this matter, the Prime Minister made clear that it was time for new leadership at official level, and sadly the Permanent Secretary agreed to stand down.
The Senior Deputy Speaker (Lord McFall of Alcluith)
I call the noble Baroness, Lady Verma. No? I call the noble Lord, Lord Knight of Weymouth.
Lord Knight of Weymouth (Lab) [V]
My Lords, I remind noble Lords of my educational interests. The Education Select Committee warned Ministers in May that the model used for exam gradings may be biased against young people from disadvantaged backgrounds. The former director-general for schools, Sir Jon Coles, warned them again in July, and so did Tim Oates from one of the exam boards, also in July. What happened in Scotland with Highers previewed the chaos in England. The Minister of State for Schools has Ofqual in his list of responsibilities. Did he ask questions of Ofqual following those warnings? When did he know that the model was not going to work?
Baroness Berridge (Con)
My Lords, in relation to the situations the noble Lord outlined, yes, there were meetings between Ofqual and the department. We always knew that there were limitations within the system, but the department was reassured that those limitations could be dealt with by an appeals system. As evidence that there were discussions, shortly after the situation arose in Scotland, we introduced the ability for students to appeal on the basis of mocks. When it became apparent after the issuing of the A-level results that the anomalies between grades were such that it was more just to award on the basis of assessments by teachers, the scales tipped and the grades were awarded on that basis. But at every stage, when those warnings were issued, the department reacted, responded and was reassured.
Lord Addington (LD)
My Lords, when it comes to the taking of exams—the gong that has clanged loudest over this—some with special educational needs take exams slightly differently, such as those who have to dictate to an amanuensis. Are we establishing a process where we know what will be required of that person? Many people—for instance, someone with severe dyslexia or even a damaged hand—will dictate their exam to some other person. That means sitting close to them in a confined room. Are we looking into how this will be done? Is there a testing process? Or, are we going to take the revolutionary step of saying that you can use assisted technology in public examinations on a mass scale? I wonder whether the Government have any idea about this for the autumn.
Baroness Berridge (Con)
My Lords, I always try to come very well prepared, particularly on special educational needs and disabilities, but on that issue, which I think may be within the province of Ofqual, I do not have a detailed answer for the noble Lord. But I will write to him, since it is important, with social distancing, to enable all students to sit examinations in the autumn.
Baroness Meacher (CB) [V]
My Lords, I, too, welcome children’s return to school. But I rise to express my considerable concern about parents with severe underlying conditions, who received letters from the department earlier this year warning them not to leave their homes because they were at such risk from Covid-19. These parents are now risking their lives to send their children back to school. The Minister mentioned that there will be a small number of home test kits for anyone who develops symptoms. What plans do the Government have to provide home test kits to enable daily testing of children of the most vulnerable parents? These kits would need a rapid return of results—ideally, within about 10 minutes. Only then could these families hope to continue to lead normal lives. I think this is urgent.
Baroness Berridge (Con)
My Lords, it is my understanding that, although people received those letters earlier in the year, shielding ended on 1 August. In relation to the test kits, there are initially 10 per school for school leaders to distribute to families or support staff who might have difficulty accessing a test either by post or by attending one of the mobile centres. Test results should be received within 24 hours and unfortunately not within the 10 minutes the noble Baroness suggested.
Baroness Bennett of Manor Castle (GP) [V]
My Lords, I welcome the assurance from the Minister in response to the question from the noble Baroness, Lady Morris of Yardley, that moderated assessment will be considered for next year. But is this not an opportunity—given that in our age of shocks, there could be a more resilient and secure method of testing—to allow students to show what they can understand and think critically about in coursework, rather than relying on the 20th-century, old-fashioned idea of testing what people can regurgitate in exams?
Baroness Berridge (Con)
My Lords, although I agree to take back the suggestion to see whether it was in train or any one of the processes, the Government stand by their view that, as this year has shown, the fairest way to assess student attainment is by public examinations, and that is what we expect to do next summer.
Lord Lucas (Con) [V]
My Lords, I declare my interest as editor of the Good Schools Guide. We review tutoring companies, and private tutoring has been one of the great successes of independent education in the last 10 years, with an enormous increase in both quantity and quality. I congratulate the Government, therefore, on the introduction of the National Tutoring Programme, which I believe will be a great support to those children who can access it. But I am surprised to be told that many of the most successful tutoring companies with the highest reputations are to be excluded from competing for part of that contract. Can my noble friend tell me what is going on?
Baroness Berridge (Con)
My Lords, it is an integral part of catching up for disadvantaged students to have access to small-group tuition. We hope that this will be one of the changes that Covid-19 brings about, through the use of remote education, for example. In relation to the programme, Teach First is providing it where there must be a person physically in the building—certain schools will need one person to devote themselves to their cohort—but other tutoring will be delivered remotely. That is being delivered through the grant to the Education Endowment Foundation. If the noble Lord could send me details of those companies, the foundation is seeking to make sure that the best tutoring out there is made available to disadvantaged students.
Baroness Blackstone (Ind Lab)
I want to press the Minister on the question asked by the noble Lord, Lord Birt, because, regrettably, I do not think her answer was satisfactory. Was it not the Secretary of State who decided not to follow the example of the Scottish Government to bring back teacher assessments instead of Ofqual’s algorithms, which were leading to gross injustices to many students? In these circumstances, why did the Secretary of State not resign, when the Permanent Secretary was shown the door? Surely, this is an abrogation of our constitutional principle that Ministers take responsibility in the end.
Baroness Berridge (Con)
My Lords, I have outlined to noble Lords that once issues were raised about the Scottish results, there were concerns that they should not be repeated in England. That was the moment at which that could be compensated for by the introduction of an additional appeal based on a valid mock. There was a response; it is not that nothing was done once we were aware. When issues were brought to our attention, matters were dealt with.
Baroness Garden of Frognal (LD)
My Lords, this summer’s debacle threw up a massive disadvantage gap between state and independent schools. The latter continued with online teaching and learning to far greater effect than the former. Following the question from the noble Baroness, Lady Bull, and the Minister’s answer, independent schools are always ready to play their part, so can the Minister say why the National Tutoring Programme has a minimum of 500 students to access, when most independent schools have only about 390? They would be asked to tutor more pupils than they actually teach.
Baroness Berridge (Con)
My Lords, the National Tutoring Programme is to deliver small-group tutoring, envisaged to be for groups of about four or five pupils. I will have to write to the noble Baroness about the details of the disparity and the numbers she outlines.
Baroness Altmann (Con)
My Lords, given the scientific evidence that schools are extremely low-risk environments for the spread of Covid-19, and the harm already suffered by children from not being in school, I am delighted that the Government are now getting on with seeing children back into school. I will ask my noble friend two questions, if I may. First, could she reassure the House—she may have just done so—that the Government intend that exams will be sat by years 11 and 13 next year, given that that is so important? We do not want to see another cohort disrupted like this year’s. Secondly, could she help us understand the criteria the Government want to use to decide which children receive the special remedial help for disadvantaged children, and by whom these decisions will be made?
Baroness Berridge (Con)
My Lords, it is wonderful that we are all in agreement that it is great to know that, as we stand here, so many children are back in school today, where they belong. It is the expectation that exams will be taken in 2021. In relation to the delivery of catch-up support, the majority of the £1 billion has gone out through the normal system of core funding for schools, because it is the schools on the front line that know which of their students have fallen furthest behind during the lockdown period. They have been given information from the Education Endowment Foundation on how best to use that money to support students. We trust the professionals to make those judgments and we are aiding them to do that.
Tutoring support will be offered with about a 25% cost reduction. We have given guidance that some of the £650 million will be spent on buying in the tutoring that we are providing at this heavily subsidised cost. We have confidence in the head teachers who, today and tomorrow, will know how their pupils have fared—some of whom they, sadly, will not had any contact with for many months.
Lord Holmes of Richmond (Non-Afl) [V]
My Lords, I declare my interests as set out in the register. Does the Minister agree that education is one of the few means by which we can go beyond our circumstances and achieve our potential? To this end, is the department considering an equality impact assessment into what happened this summer, not least the impact on white working-class young men and indeed all other protected characteristics?
Baroness Berridge (Con)
My Lords, I am sure I am not alone in saying that education has enabled me to go way beyond my circumstances. It is vitally important that we know the impact that policies have on different communities. Ofqual published an equality impact assessment when it launched its consultation on the 2020 exams and it will publish a similar document in relation to the examinations next year.
Lord Wood of Anfield (Lab)
My Lords, I want to take the Minister back, I am afraid, to the process leading up to the announcement of A-level results, because the process that she described is really quite extraordinary. It is not that there was no consultation between the Minister and Ofqual, it is that there was consistent regular dialogue, with questions asked and answers given, and yet the fiasco that we now know about still unfolded. It does not say much for the competence of the Minister that, despite intense scrutiny, conversation and demands for answers, we still ended up with the scale of the discriminatory fiasco that emerged. I ask again: how can it possibly be justified that the accountability and responsibility principles applying to the Permanent Secretary and the Ofqual head do not also apply to a Minister who was so embroiled in the process for weeks and months in the run-up?
Baroness Berridge (Con)
My Lords, as I have outlined, during that process, reassurances were given that the limitations of this system could be dealt with through an appeals process. Noble Lords will have seen the incremental changes in that appeals process. I have outlined the introduction of mocks after the Scottish results. When the balance changed, the most just of the two systems became the use of only teacher assessments. That is when the decision in relation to using only teacher assessments was taken, but that decision was for Ofqual, in agreement with the Secretary of State.
Medicines and Medical Devices Bill
Wednesday 2nd September 2020
(3 years, 7 months ago)
Lords ChamberRead Full debate Medicines and Medical Devices Act 2021 View all Medicines and Medical Devices Act 2021 Debates Read Hansard Text Read Debate Ministerial Extracts Amendment Paper: Consideration of Bill Amendments as at 23 June 2020 - (23 Jun 2020)
Lord Bethell
Relevant documents: 19th Report from the Delegated Powers Committee. 10th Report from the Constitution Committee.
The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell) (Con)
My Lords, the Medicines and Medical Devices Bill is crucial to the development of a modern, safe, medical regulation regime. Its focus is the development of important innovations that will improve and save lives for the next generation, and the protection of patients in an area which has, historically, been slow to move and which, in a few months, passes from European to domestic legal oversight. When we look at our plans for the health of the nation, having the agility to revise our key regulatory regimes is not a “nice to have”; it is absolutely essential to protect the lives of patients and empower the innovations that will extend their length and quality.
I begin with safety. The first and most critical consideration of any Bill on medicines and medical devices must be the safety of patients. We also consider the safety of providers, the environment and, in Part 2 of the Bill, animals, but the safety of patients is paramount. We have all reflected on the detailed and thorough report of my noble friend Lady Cumberlege. I have listened to the testimony of some of the patients and families who have campaigned on patient safety, and shared, in a small way, their pain and suffering. They brought to life how critical this Bill is. We owe them a huge debt of thanks, as we would not be here today without their determination.
There is no disagreement among us on the importance of the safety of patients. The Bill puts safety at the heart of regulatory decision-making, facilitating the sharing of information to support public health concerns and creating mechanisms to track the use of medical devices or medicines against a patient record. The thoughtful, thorough, modern use of data is how we know that something is going wrong and how to put it right. That is the view of the Government, which my noble friend Lady Cumberlege and her team brought vividly to life in the Bill’s passage in another place. That is why I am delighted with Clause 16, introduced as an amendment, which ensures that data provisions in the Bill are central to its effectiveness. By introducing a medical devices information system—or database—we have radically improved that effectiveness.
We once faced a situation where patients could not be traced, and a conversation could not be had between a patient and their clinician because we did not know which specific device had been implanted into a person or by whom. When I found this out, I was dumbstruck. This must not happen in the future. The Bill will support the tracking and tracing of medical devices and will enable a future system of clinical registries, such as the National Joint Registry, to ensure that UK patients are better supported.
When there is a problem, it is important not only that we know that something has happened, but that we take forceful action. Part 3 of the Bill therefore sets out a consolidated suite of powers available to the regulator, including the ability to step in and recall a device if the manufacturer fails to do so where necessary. Chapter 4 of Part 3 of the Bill clarifies the powers of disclosure around devices, allowing the Secretary of State to warn members of the public about safety concerns. We must ensure that avoidable harm is avoided by acting expeditiously to protect patients. Let me be clear: the regulator can and does work in close partnership with industry to deliver on behalf of patients, but it has, and will continue to have, teeth when industry fails to protect patients.
We live in a world where big data, artificial intelligence and genetics have become enormously powerful engines of innovation, and where engineering and computer science have combined with medicine to create an unexpected synthesis. These drivers of development are generating exciting new medical innovations that are aiding patients who were previously beyond help, bringing down the costs of treatment and driving growth in Britain’s thriving life sciences industry. I have seen the power of innovation at first hand in the last few months, during the Covid-19 crisis. Our National Health Service is the first around the world to have determined the importance of an effective therapeutic drug, dexamethasone, through the recovery clinical trials programme. Our medical manufacturing industry worked closely with the regulator to move swiftly and safely and put 14,000 ventilators into the health system. In the area of diagnostics—my specialist subject—innovation is driving the accuracy, cost, speed and scale of devices beyond our initial hopes.
We need this pace of innovation in day-to-day, back-to-business delivery too. That is why we are investing in the partnership between the NHS, with its unique pool of patients, and the life sciences sector, which can make treatments happen. I pay tribute to the noble Lord, Lord Darzi, who is chair of the excellent Accelerated Access Collaborative, which gets the best new treatments and technologies into the hands of patients and clinicians faster than ever before. We face a new horizon of tailored treatments and diagnostics that we never could have envisaged five or even three years ago: biotechnology, artificial intelligence, robotics. We are at an inflection point where innovation can make a huge difference. I am pleased and proud to be a Minister championing the role of innovation in the healthcare system at this incredible time. Supporting innovation through this Bill ensures that UK patients benefit from the thriving life sciences sector by bringing investment, jobs and prioritisation to Britain’s medical needs, balanced by the need to manage risk.
Availability and attractiveness are the twin pillars of the Government’s strategy on medicines and medical devices, and the key themes of this Bill. Availability means the reliability of medicines and medical devices and their availability to UK patients. Attractiveness means doing everything reasonable to be the first place where new treatments are rolled out and adopted, where investment in life science takes place and where the enrolment of patients in clinical trials is supported.
Recent months have proved how the availability of medicine relies on fast, accurate, responsive regulation. It is the work of the regulator, hand in hand with the industry, that has ensured that therapeutics, including those used in intensive care, have been in safe supply and that devices, including the important vaccines, get into the right hands to bring this crisis to an end. Clauses 2, 6, 8, 12 and 15 all deal with how we ensure the essential and safe flow of medicines and medical devices. Clauses 2, 8 and 12 allow for regulations to be made that could, for example, affect how medicines or devices are distributed. Clauses 6 and 15 allow us to make pre-emptive regulations to reflect the realities of an emergency, such as a pandemic, and to prepare early.
It is right that we do more to get regulated medicines into patients’ hands and do not keep people waiting long for innovative treatments. I pay tribute to a number of noble Lords who I know tirelessly make the case for certain therapeutics or treatments to be accelerated through the health system. The attractiveness of the UK is fundamental to getting new breakthroughs to patients here quickly.
Let me say a word about regulating for the future, and the work of the Delegated Powers and Regulatory Reform Committee and the Constitution Committee. I pay tribute to learned colleagues on these committees: I know they approach their work diligently and seriously, with significant legal expertise, and I anticipate discussion of their conclusions. I know a number of noble and noble and learned Lords will wish to speak to those reports today, and I will pay serious attention to the points raised.
This is, as it must be, a framework Bill. I recognise that concerns have been expressed about the breadth of the powers and a number of suggestions have been made as to how the Bill might be improved. I am listening, but it is important to note the challenges of taking a different approach to that outlined here.
These delegated powers are necessarily broad, given the hundreds of pages of the Human Medicines Regulations alone. These regulations can span many different matters and it is vital that the ability to make a change for the benefit of patients, where even a really minor point can be important, is not lost. We live in a world where it was only 12 years ago that the iPhone was released, yet today we are trying to figure out how to regulate an AI-supported cancer-screening gadget from KardiaMobile that plugs in to your smartphone and delivers a medical-quality ECG in about 30 seconds. We live in a world where 3D bionic arms, such as the Hero Arm from Open Bionics, have multigrip functionality, and where the national lung matrix trial at the University of Birmingham is exploring how patients with non-small cell cancers respond to tailored treatments.
Primary legislation cannot be relied on to be passed quickly when there are matters of concern for the safety of medicines and medical devices. For example, when concerns were raised across the EU about the scrutiny of notified bodies, and safety concerns arose from certain implants, it took years to update legislation. My noble friend Lady Cumberlege has made clear what happens when change is slow: it has an impact on patients. I know this from another area and I will give an example. When the Communications Act 2003 was passed, the internet was hardly mentioned. Some will say we could not have predicted the immense role that video sharing and social media platforms would now play in our lives, but I remember at the time that legislators were urged to take internet innovations seriously and put in place frameworks to anticipate technical change. Now we have widespread fake news, cyberbullying, the intimidation of public figures and a pornography boom, but without the legislative powers that perhaps we would like to stop or regulate them, because there was no framework to make new regulations to cover these innovations. I am here to listen, so I would like to listen to the advice of the Chamber on how to handle this complex challenge.
In conclusion, I remind noble Lords that because of its importance for patients, we need to get the Bill done and to secure the ability to protect patients quickly if the need arises. We need powers to deliver and to trace and track medical devices as soon as possible. I know it is important that we discuss these issues properly, but the Bill is not just exciting, ambitious and direction-setting; it is essential that it makes it to the statute book by the end of the year. I look forward to listening to the contributions ahead; we are receptive to how we might make the Bill better, as we did in the other place. My door is open, and in that spirit of co-operation and consensus building, I beg to move.
Lord Hunt of Kings Heath (Lab)
My Lords, I thank the Minister and declare my interests as a member of the GMC board and as president of GS1, the barcoding organisation responsible for the Scan4Safety programme. The Bill is of great importance for patient safety, but also for the health of the life sciences sector, yet it is striking for its brevity and, as the Minister acknowledged, for the extensive powers given to Ministers without the exceptional justification required for the skeleton approach taken. The Minister said he was listening, but he will know that both the Delegated Powers Committee and the Constitution Committee were highly critical, and I believe there is a strong argument for the Bill’s powers in relation to medicine and medical devices regulation to be subject to sunset clauses.
Leaving the EU’s regulatory regime brings significant risks that companies will choose somewhere other than the UK to trial and launch medicines. At the moment we are nowhere near knowing whether our new regulatory system is to be aligned with the rest of Europe—the policy statement published yesterday by MHRA on devices and clinical trials regulation from 1 January 2021 is silent on this. I have to say to the Minister that I am not impressed that his department thinks it is acceptable for such a publication to be produced hours before our Second Reading debate. There is certainly no room for complacency. The European Medicines Agency covers 25% of global pharmaceutical sales; the UK on its own makes up just 3%. The odds are that companies will want to submit applications for new drugs to the EMA before the MHRA, meaning that the UK will lose its advantage and UK patients will risk getting slower access to the latest medicines.
As Sarepta pointed out to me, for many companies the attractiveness referred to in the Bill equates to speed of decision-making at every stage. That means being able to approve clinical trials faster than in the EU, maintaining swift decision-making on medicines approvals and getting approved medicines to patients faster. Yet the Minister will know that the NHS record in uptake of new medicines is very poor indeed, and I would like to hear from him what is going to be done to improve access for NHS patients to these new medicines.
On patient safety, Ministers are silent on whether they will accept many of the recommendations of the Cumberlege review. In particular, will the Minister support the appointment of a commissioner for patient safety, which the noble Baroness, Lady Cumberlege, argued for very persuasively in her report?
Finally, I turn to the abhorrent practice of forced organ harvesting taking place in China today, and to the importance of ensuring that the UK is not in any way complicit in these crimes. In a letter to me last night, the Minister referred to the World Health Organization’s view that China is implementing an ethical voluntary organ transplant system. That is simply not credible, and in fact it is based on a self-assessment by China itself. A much more objective assessment comes from the China Tribunal, which concluded:
“Forced organ harvesting has been committed for years throughout China on a significant scale.”
At the moment, human tissue and organs can be imported into the UK from countries such as China without traceability, documentation or consent. Marie Rimmer MP tabled an amendment in the Commons to deal with this. A similar amendment will be tabled here and I very much hope that the Government will agree to it.
Baroness Barker (LD)
My Lords, Brexit poses many threats to the economy and well-being of UK citizens. Perhaps the greatest is the threat to our life sciences and pharmaceutical industries which, based on our scientific resources in universities and companies that have easy access to international talent and resources, have been truly world-leading. The impact of moving away from the existing collaborative approach between the UK and the EU will be substantial. The European market accounts for 25% of all world sales of medicines and has timely access to new medicines and devices. The UK, in comparison, accounts for only 3% of the total world market. It is against that backdrop that we have to consider this legislation, which is intended to mitigate threats to our industry.
We all agree that we need legislation, but not this thoroughly unsatisfactory Bill. It is a Bill that should not be accepted unless it is thoroughly revised, for three main reasons. The first is that alluded to by the Minister: it is built on the flawed assumption that the Secretary of State or an “appropriate authority” must take equal account of the safety of human medicines and medical devices, the availability of human medicines and medical devices, and the “attractiveness” of the relevant part of the UK as a place in which to conduct clinical trials, supply human medicines or develop medical devices.
The last two considerations depend on the paramountcy of the first. If we do not accept that in legislation, none of the rest will apply; we will simply be signalling to the world a willingness to move away from international standards. One of the most interesting and detailed points made in the briefings that we were given came from the Association of the British Pharmaceutical Industry, which pointed out that it wanted to encourage the UK to apply for full membership of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use and the International Organization for Standardization. They are global organisations that produce harmonised regulatory guidance across nations. It was pointed out that previously the UK had represented the EU at meetings of those bodies and contributed to committees and regulatory thinking. Since 1 February 2020, we have had no direct recognised status as either a member or an observer. If we are willing to move away so swiftly from the international standard-setting bodies, we cannot do so on the basis of this unsatisfactory legislation.
The second reason for rejecting this Bill is that it is a Toom Tabard Bill, as we would say in Scotland; it is an empty cloak. The Minister put the best gloss possible on the reports from the Delegated Powers Committee and the Constitution Committee, whose comments were detailed, comprehensive and scathing—I have rarely seen reports of that nature.
On the delegated powers, Clauses 1, 8 and 12 allow Ministers by regulations to amend or supplement the whole regulatory regime for human medicines and clinical trials under important legislation such as the Human Medicines Regulations 2012. Those regulations alone contain 350 criminal offences which a Secretary of State could unilaterally or without any scrutiny change completely. It is something when the Constitution Committee says, as it has done:
“The delegated powers to create and adjust criminal offences in this Bill are constitutionally unacceptable.”
That is a very powerful reason.
Both the Delegated Powers Committee and the Constitution Committee were deeply critical of the way in which the Government have used this legislation, coming as it does at the time of the current pandemic, to confer emergency powers on Ministers to disapply existing health medicines regulations. They point out that there are no formal requirements to set out the form, publication or dissemination of protocols; Ministers can do that simply by publishing a document on a website. That is not taking back control; it is taking the mickey. It is time for us as a Parliament to stand up and say that this is not an acceptable way forward.
The third reason for rejecting this Bill is its potential to do harm. Many professionals in the pharmaceutical and medical devices industries have expressed the fear that by slightly and incrementally moving away from existing regulation from the EU we could very quickly put ourselves into sudden isolation. We should be fearful of that, not just because it could harm our ability to market into the European Union but because many other countries—African countries, for example— use EU approval as a short-cut mechanism for approving medicines which they do not have the capacity to trial themselves.
The report of the noble Baroness, Lady Cumberlege, is sobering. If we were to take just one thing from it, it would be the need for us to set up as soon as possible and as a matter of urgency not just databases but registries of medical devices. Those of your Lordships who have read the report will understand the difference that makes to traceability.
The Government are in trouble with the timescale that they have set for Brexit. This Bill demands detailed and lengthy scrutiny. For the health not just of our fellow citizens but of future generations, some forensic surgery needs to be done on it. It should not pass without receiving detailed attention from your Lordships’ House.
Lord Patel (CB) [V]
My time limit curtails me from commenting on the Minister’s or other speeches, so I shall get on.
I know that the Government feel that this is a simple Bill that is needed to implement EU laws in UK legislation in relation to medicines and medical devices, but the implications of it go far beyond that. The Cumberlege report has added the need to strengthen the Bill in relation to patient safety.
In Part 1, the Government set out their ambition to have a world-class regulatory authority for medicines and medical devices that puts patient safety at the forefront and promotes innovation by making the UK “attractive” to investors. I cannot complain about that.
The Government have stated their ambition to make the UK a science superpower in which life sciences and the development of new medicines will play a crucial part. This Bill offers the Government an opportunity to say how they plan to do this but fails to do so. As the Science and Technology Committee report on life sciences indicated, the UK leads in life sciences research, but it is not very successful at taking research to innovation and commercialisation. The stated aim in the Bill to make the UK attractive is presumably to address this deficit, but it gives no definition of “attractiveness”, although the Minister referred to it in his speech. I hope that he will clarify it in more detail in Committee and even define “attractiveness”.
The Bill falls short of identifying how it will achieve its objectives, except that the Secretary of State will take wide powers to do it. Let me highlight the areas of my concern which I wish to explore in Committee. The Bill gives broad delegated powers to the Secretary of State to amend or supplement regulations. As the Delegated Powers Committee and the Constitution Committee—already referred to several times—recognise, some delegated powers may be necessary, but the Bill grants powers far wider.
Furthermore, the Bill adds to the complex regulatory regime rather than simplifies it. Clarification is needed as to how it intends to prioritise patient safety, even when there might be conflicting interests, such as “attractiveness” for investors. The findings of the Cumberlege review, that patients’ concerns were ignored, need to be addressed in the Bill. While the creation of a registry of devices is welcome, their safety and efficacy need to be addressed. I hope that my noble friend Lord Kakkar takes up this cause. If he does, I shall certainly support him.
Why will the MHRA be the regulator that licenses devices and maintains the register, but any new information systems are to be held by NHS Digital, referred to in the Bill as the information centre? What pre-market processing will there be for devices prior to approval for usage?
Clarification is needed from the Minister on the powers that the Secretary of State will have in emergency situations and on the removal of the duty of confidentiality and privacy afforded to patients. I want to explore how the Government plan to make the United Kingdom a prime destination to conduct clinical trials, an area of considerable concern for a wide sector of pharma. The Minister may well remember the debate at the time of the withdrawal Bill on clinical trials and making the UK a prime destination to conduct trials. The key point in being able to do this was the ability for the MHRA to have a close relationship with the EMA. What discussions are going on currently to enable this to happen? Regulations for medicines is a devolved issue for Northern Ireland, a potential area of divergence in the future from the rest of the UK. The implications of this need to be clarified in the Bill.
In conclusion, I am able to support much of the Government’s ambitions through this Bill to make UK regulations in medicine world-leading. Having said that, I will support amendments that allow for greater scrutiny of the powers of the Secretary of State, place greater emphasis on patient safety and give a clear commitment to allow the MHRA to make strong partnerships with other regulators. I look forward to Committee.
Lord Lansley (Con)
My Lords, I welcome the Bill. As my noble friend rightly said in a very positive opening speech, it is not only a necessary Bill but one which presents us with opportunities. I hope that, during the passage of the Bill, we will look to realise those opportunities, and I want to refer to one or two.
My noble friend talked about the Delegated Powers Committee’s remarks, which made the very compelling point that, in reproducing the regulation-making powers, we are moving from the power to make regulations to meet EU legal requirements to the ability of Ministers to set down their own legal requirements; these are very different things. What we need to do in the latter case is not to move from where we are now, as my noble friend might have suggested, to something that sets out in primary legislation the detail of these regulations—nobody is intending that—but to something that moves us from a skeleton Bill to a framework Bill. What is the difference? The difference, in my mind, is a very straightforward one. The framework Bill is purposive. It sets out why regulations are being made and gives an ability to look at the primary legislation and ask, “Do these secondary instruments fulfil the purposes of the primary legislation?” During the passage of the Bill, we must look very carefully to meet that test.
I want to make three quick points. First, I think we are already among the best places in the world for medicines innovation. We may be 3% of the pharmaceuticals market but we are 10% of medicines innovation. I want to continue that. One thing the industry has told us, including me, over past years is that it wants to see our NHS take up new medicines and make them available to patients—a point that my noble friend reiterated. There is a commitment in our manifesto that says:
“We will extend the successful Cancer Drugs Fund into an Innovative Medicines Fund”.
I think the time has come for that and I hope that the Bill will make provision for that to happen.
Secondly, the MHRA is a world leader—for example, in the assessment of medical devices—but we have a problem, as the noble Lord, Lord Hunt of Kings Heath, said. We will be accepting CE markings through to 2023. I am pretty sure, unless somebody tells me otherwise, that the EU is not going to accept UK conformity assessments any time soon. So we are in an asymmetric relationship, and we have to think very hard about how we can sustain the MHRA. In the course of that, what the noble Baroness, Lady Barker, said is absolutely right: we must not be pulled between American FDA standards and EMA standards. We should be trying to move everybody to international standards, and that is something we will have to look at hard.
As we put more registries in place, I hope that they will include patient-reported outcomes: that is important. For medical devices, I hope that we will show how we are going to take them up in the NHS as well. On the consultation that ended last year on the medtech funding mandate, the time has come to do it. Ministers have not said that it will be brought into place this year or next. I think that the Bill should bring forward the medtech funding mandate, as the medicines mandate is in place. Finally, on clinical trials, the EU has not implemented its clinical trials information system and is not at present expected to do so until the end of 2021. We need to be in it. The legislation says “corresponding or similar to” but I do not know what “or similar to” means. We are either in it or not in it, and I hope we will be in it.
Lord O'Shaughnessy (Con)
My Lords, I declare my interests as set out in the register, in particular as an adviser to Intuitive Surgical, to Healthy.io and, until the end of August, to the Department of Health and Social Care.
I congratulate my noble friend on bringing this Bill to the House; I know how hard he has worked to do that. For those of us concerned to make sure that British patients get access to the best drugs and devices—and, frankly, after the past six months, who is not concerned with that?—this is the most important piece of legislation we have in front of us.
My belief is that the Bill gives the UK the chance to create the most rigorous, innovative and safety-conscious regulatory scheme in the world. While there are many downsides to leaving our current system in the EU, as noble Lords have pointed out, there are many benefits, too. Just look at the way that the US FDA has embraced digital and algorithmic therapeutics, while the EMA has lagged behind. To make the most of these new freedoms, we need a regulatory system that can evolve in response to new discoveries and advances in medicine.
Considerable concern has already been expressed in the House today, and no doubt will continue to be throughout the afternoon, about the use of delegated powers in the Bill to provide this kind of flexibility. Having been in my noble friend’s shoes, and having been not so gently admonished by the DPRRC in the past, I can only say that this is not a hill that I wish to die on again. But it seems to me that we are exchanging one system of delegated powers for another, with the added benefit that the authority that will be using these powers has the virtue of being elected by the people it seeks to regulate. At the very least, this is surely an improvement on the status quo ante.
There are two substantive issues that I would particularly like to focus on, already raised by my noble friend: innovation and patient safety. On innovation, we currently benefit from being in one of the top two markets in the world for medicines and devices, and our regulator is rightfully regarded as one of the best in the world. As other noble Lords have said, leaving the European system could bring challenges when it comes to patients accessing innovative therapies, but these can be more than mitigated by a new joined-up approach to research, regulation and uptake. This would require the creation of a world-beating, digitally powered clinical trials infrastructure to test ground-breaking medicines and devices; a rapid but rigorous regulatory process for the most promising technologies; as my noble friend Lord Lansley has pointed out, the creation of an innovative medicines fund to bring those to market; and harnessing the collective might of the NHS to adopt and scale those therapies.
My noble friend the Minister pointed out that during the Covid crisis this is precisely what we have done for therapeutics, vaccines and other technologies that can help. The pandemic has shown British science and medicine at its best. Does he agree that we now need this kind of regulatory regime for all medicines and devices in the future? If so, will he tell the House when comprehensive plans for creating such a regime will be published?
Even as we go about producing the most pro-innovation regulatory regime in the world, we must never forget, as my noble friend Lady Cumberlege put it in her excellent report, that our obligation is first to do no harm. Too many people—often, it seems, women—have borne the brunt of an approach to post-licensing surveillance that, historically, has been too analogue and too unresponsive to patients’ needs. The sad consequences of this are movingly documented in my noble friend’s report. I wholeheartedly endorse her recommendations, and I am delighted that the government amendments in the other place will improve the use of data for patient safety.
But let us be clear: there is much more to do, so I ask my noble friend the Minister, when will the Government respond to the Cumberlege report’s thoughtful and sensible proposals? Does my noble friend agree that we should use the next few weeks to make progress on implementing its recommendations? Otherwise, as I am sure he is aware, he might find that the House does that work for him.
I have every confidence that my noble friend will work with noble Lords to produce a pro-innovation, safety-conscious regulatory system for the UK. He has my support for those efforts, and I am happy to welcome and support his Bill.
Lord Collins of Highbury (Lab)
My Lords, my noble friend Lord Hunt of Kings Heath mentioned the China Tribunal’s final report and its conclusions about forced organ harvesting in China. Despite the overwhelming evidence, China denies the claims, relying on the fact that the WHO cleared it of wrongdoing.
In June this year, I reminded the Minister the noble Lord, Lord Ahmad, that 12 months earlier he had shared my concern that the evidence on which the WHO had cleared China was based on self-assessment by the Chinese authorities. At that time, I asked about the Government’s response to the China Tribunal and what the result had been of representations to the WHO and the Chinese authorities. The Minister replied that the Government’s position remained that the practice of systematic state-sponsored organ harvesting would constitute a serious violation of human rights. He assured this House that the UK regularly raised these concerns with China. He also confirmed that the UK had consulted the WHO, which had restated its view that China’s system was ethical. The WHO does not have an independent expert compliance assessment mechanism; it merely has a reporting requirement. So why has the UK not argued for change within the WHO? We should all, including the UK, be ensuring that there is independent verification.
UK legislation requires prior consent and traceability for human tissue for medical research and use in medicines when sourced from the UK, but if human tissue has been imported then the consent requirements do not apply. We have seen exhibitions in New York and Birmingham, in 2008 and 2018 respectively, both of which used plastinated bodies from Dalian Hoffen Bio-Technique in Dalian in China. They were classified as unclaimed bodies with no relatives to identify them. In 2008, the New York state attorney-general required a disclaimer that included the words that the organisers
“cannot independently verify that the human remains you are viewing are not those of persons who were incarcerated in Chinese prisons.”
The UK has arguably some of the most ethical and comprehensive consent requirements for human tissue in the world, yet imported human tissue slips through the net. It has also been reported that two UK companies supply organ-preserving devices to mainland China, which could explain how they are being transported around China.
I hope the Minister will heed the words of my noble friend Lord Hunt of Kings Heath and other noble Lords and ensure that the Government have the means to ensure that the UK is no longer complicit in the harvesting of human organs from living victims.
Baroness Northover (LD) [V]
My Lords, I want to address two areas. The first is the future of life sciences research and the pharmaceutical industry and the other, as mentioned by the noble Lords, Lord Collins and Lord Hunt, is the use of human tissue.
As we have seen so clearly during the pandemic, life sciences in our universities, working closely with the pharmaceutical industry—for example, the Jenner Institute with AstraZeneca—have been a key UK strength. However, our life sciences are already threatened by the Government’s decision to leave the single market and end the free movement of people, as well as by their losing access to EU funding. The pharmaceutical industry is affected by our pulling out of EU regulation, damaging its ability to access that market. Our standards must therefore be at least as high as those in the EU, and I ask for the Minister’s reassurance on that.
As my noble friend Lady Barker noted, the ABPI cogently argues that the UK should apply for full membership of the ICH and the ISO. Previously, as she said, the UK represented the EU at meetings, but since Brexit the EU has had no status here at all. We must urgently rectify that. We were global leaders because of the NHS and our history in the development of clinical trials and comprehensive data registries, such as that which demonstrated the link between smoking and cancer. As the noble Lord, Lord Patel, has flagged, we are risking that. We must not damage our life sciences sector further.
Consistent with the need to maintain standards, I come to my second area, where I fully endorse what the noble Lords, Lord Hunt and Lord Collins, have said about imported human tissue and biological medicines. We simply cannot allow human tissue from victims of forced organ harvesting to enter the UK. We have become more aware in recent times of the treatment in China of the Falun Gong and the Uighurs. The China Tribunal, chaired by Sir Geoffrey Nice, released its full report in March. Has the Minister read the report? Forwarding the letter from the WHO to the noble Lord, Lord Hunt, when he must know the current constraints on the WHO, is, frankly, astonishing. If the Minister has read the report, he will know the tribunal concludes that crimes against humanity have been committed against these groups beyond reasonable doubt.
As the noble Lord, Lord Hunt, noted:
“Forced organ harvesting has been committed for years throughout China on a significant scale and that Falun Gong practitioners have been one – and probably the main – source of organ supply.”
With regard to the Uighurs, the tribunal says it has
“evidence of medical testing on a scale that could allow them, amongst other uses, to become an ‘organ bank’.”
We now hear that they are being used for unapproved Covid vaccines.
The Human Tissue Act 2004 has strict requirements for tissue sourced within the UK, but it does not restrict imported tissue in this way. That gap must now be filled if we are to maintain that the UK has the highest standards in this area. The Minister will be hearing the signs of cross-party support, and I trust that the forthcoming amendment will be immediately accepted by the Government. That is clearly right, but it is also vital if the UK is to remain a leader in the life sciences field. There are many challenges that this field now faces.
Lord Alton of Liverpool (CB)
My Lords, I declare an interest as vice-chair of the All-Party Parliamentary Group on Hormone Pregnancy Tests. I want to raise two issues: Primodos, which is part of the investigation conducted by the noble Baroness, Lady Cumberlege; and the violation of human rights in the trading and misuse of organs and human tissue, referred to earlier by the noble Lords, Lord Hunt of Kings Heath and Lord Collins, and the noble Baroness, Lady Northover.
The Minister knows how much I admire the noble Baroness, Lady Cumberlege, but I reiterate my whole hearted support for her report and recommendations, and I place again on record my admiration for the sensitive way in which she collected evidence, dealt with the many people who were affected by these scandals and brought forward these admirable recommendations. Parliament must now ensure that the report does not gather dust. The Royal College of Surgeons rightly draws attention to the review’s recommendation of a patient safety commissioner, as referred to earlier, and I look forward to hearing from the Minister what we are going to do about that.
It is over 10 years since I first questioned Ministers about Primodos after a man called Karl Murphy came to my university office and showed me the disabilities with which he has had to live all his life. Following the recent Sky TV documentary, he emailed me last week saying:
“the lies and deceit I have seen regarding this drug is an utter disgrace … I really do hope that the Government and Bayer have some respect and understanding of what these families are going through.”
The redoubtable Marie Lyon has refused over all these years to let this scandal be swept under the carpet, and I am glad that the Minister heard from her first-hand only yesterday. She made a telling point to me that in appointing Stephen Lightfoot, an ex-director of Bayer, as the new chair of the MHRA, they have clearly learned absolutely nothing about conflicts of interest and public perception and confidence. In the light of such appointments and reports of five scientists walking out of a task force for back pain after finding out that a briefing paper was funded by the drug company Grünenthal, perhaps the Minister will say what the Government will be doing to police conflicts of interest and the suppression or manipulation of data.
If Primodos teaches us anything, it is the importance of the independent assessment and scrutiny of all clinical trials. But, like others, I would like to see the Bill tackle the misuse of human tissue and organs. In the letter sent yesterday by the Minister, he says the
“government takes these allegations seriously and we continue to monitor all available evidence”,
but monitoring is simply not enough.
Two years ago, in August 2018, along with Professor Jo Martin, the president of the Royal College of Pathologists, I wrote to the Times after the NEC in Birmingham hosted the exhibition referred to by the noble Lord, Lord Collins. It was called “Real Bodies” and from the company Imagine Exhibitions. The exhibition consisted of human corpses and body parts. It advertised those exhibits as
“real human specimens that have been respectfully preserved”.
They were categorised as “unclaimed bodies”, with no relatives to identify them. As we heard, in advance of the American equivalent of that exhibition it was stated in a disclaimer —after a settlement with the New York State Attorney-General—that these human remains could be those of persons who were incarcerated in Chinese prisons. Imagine Exhibitions admitted that there was no documentation to prove the identities of the cadavers, yet they were permitted to enter the UK to be put on public display for commercial gain. Human tissue from abroad has no consent or traceability requirements to enter the UK, nor do we prohibit commercial gain. However, we should do and this Bill gives us the opportunity to do it.
Baroness Cumberlege (Con)
My Lords, I stand before you as a person who was shaken by the experience of personally listening to over 700 women and their families, who have been damaged by the healthcare system. Their testimonies actually haunt me. Their bravery impels me to right their wrongs.
In our report, First Do No Harm, we examined and researched two medications. First, Primodos, already very well explained by the noble Lord, Lord Alton, was a hormone pregnancy test taken between the 1950s and 1970s and associated with terrible damage to some newborn babies. Those newborn babies now need care and support as adults while their surviving mothers, now elderly, have lived a life wracked by guilt. Secondly, there is sodium valproate, an effective medication to control epilepsy. When taken in pregnancy, there is a 50% chance of a severely damaged child being born. Even today, that medication is still being given to women who are unaware of the consequences. Then there is pelvic mesh: a plastic net which can migrate, disintegrate and wrap itself around vital organs, severing some and causing appalling suffering and pain.
The root cause was the failure of the healthcare system as a whole, and by some in the medical profession who ignored the concerns of women and their families. These women knew what was wrong but they were dismissed. They were told it was all in their heads—just a woman’s problem, not to be taken seriously. This made me furious. As Sir Cyril Chantler, the review’s vice-chairman, reminded us, for whom is the healthcare system run? We pay for it; it is ours. It is run for us, the people and patients. Your Lordships all know, as I do, that when we are ill or in pain most doctors will listen. But if they sense that a mistake has been made, they clam up, become defensive and act irrationally.
Now for the good news. The report has raised a clarion call for action and I thank all parliamentarians who have been so supportive—particularly your Lordships, but you are not alone. There are the 15 patient groups, the Royal College of Surgeons, the Royal College of Obstetricians and Gynaecologists, the Royal College of Physicians, the Royal College of General Practitioners and the British Society of Urogynaecology—all with their medical membership—along with the BMJ, in its stunning editorial last week. All these and so many more want to see our recommendations implemented and we can start right now, with the safety Bill.
I intend to put down an amendment to appoint a patient safety commissioner—a voice for, and listener to, patients. If a product raises concern, that commissioner must say “Stop—this is a worry. We need to investigate and research to ensure safety”. It is better to have a few false alarms than the tragedies we have witnessed, which have cost lives, caused suffering and family break-ups, and damaged children. These are personal costs beyond price, with millions of pounds to be paid from the public purse.
We parliamentarians are establishing a parliamentary group called “First Do No Harm”. Its purpose is to ensure that all our recommendations are implemented. The only cloud on the horizon is the Department of Health and Social Care, which simply does not get it. Asking everyone, as it does now, to work together better in the future simply will not work, any more than it has in the past. We need someone and something new: a patient safety commissioner. Yesterday, we heard that the First Minister of Scotland, Nicola Sturgeon, has announced that Scotland is to have a patient safety commissioner on our lines. But in England, rumours are absolutely rife of a ritual burial and answers to the PQs are evasive. I say to my noble friend the Minister: this is his opportunity to give an assurance that this report will be implemented with a taskforce and timetable, as set out in our Recommendation 9. Please can the families who have been hit so tragically hard have that assurance?
Baroness Andrews (Lab)
My Lords, it is a privilege to follow the noble Baroness and to pledge our support—I feel sure of that in this House—for what she is trying to achieve, in the light of what she has achieved so far. We all look forward to what the Minister will say in response to her plea.
This is a Bill that we can and should welcome, in many respects. For example, I share many of the ambitions mentioned by the noble Lord, Lord O’Shaughnessy, when he spoke. It sets out a necessary regulatory framework; my concern is that it comes with unnecessary risks as well. It spans the range of human and veterinary medicine. It includes clinical trials and the ability to prescribe. It addresses some of the abuses raised by the noble Baroness in her report, and it raises fundamental questions about capacity and professional standards. That means it is important, not least for the reasons which the noble Baroness has just explained in her example, that the balance between powers and accountability—between patient safety and risk—is got absolutely right. We will obviously probe this in detail as the Bill goes through the House.
I have two concerns. One is how patient safety can be protected within the context of creating an attractive environment, whatever that means. The other is the speed, direction and potential impact of the cumulative divergence from the stability and standards of inherited EU law. The Bill is designed to achieve just that and to accelerate it. Our task in this House is how to anticipate impacts and correct for perverse consequences. That is why I feel that the better purposes of the Bill are undermined by the fact that it is a skeleton Bill. We are not surprised, of course; this is what we have come to expect. Skeleton Bills have become not the exceptional position, as urged by the Constitution Committee, but the default position of this Government, who are so committed to accelerating deregulation and for whom, frankly, Brexit provides the obvious opportunity.
The first 15 clauses of the Bill consist entirely of powers to make provisions by regulations about human and veterinary medicine and medical devices. I hope that the House will challenge in particular the provocative powers of delegation in Clauses 1, 8 and 12, not least given the chaotic conditions that we seem to be approaching with no deal at the end of this year. However, it is the fundamental disregard for Parliament which explains the exasperation expressed by the Constitution Committee and the DPRRC in its report on the Bill, the latter in particular towards the flimsy and, frankly, disingenuous justifications that were offered for the use of powers.
Noble Lords will also find if they read the whole report that there is more than a disregard for the job of Parliament. In some cases, the suggestion is that the new powers offer the same restraints as the existing ones. They do not. This is why the Bill presents such a risk. The anticipated divergence is away from a stable regulatory framework into an unknown environment in ways that cannot be tested in this House because the design, as well as the delivery, is in secondary legislation. The Bill is divergence by delegation.
The Secretary of State has made no bones about this. At Second Reading in the other place he spoke of the Bill giving
“the means to depart from EU rules and regulations in future, moving at a faster pace … it ensures that we can easily amend regulation through secondary legislation without having to bring a new Bill”.—[Official Report, Commons, 2/3/20; col. 659.]
The DPRRC has replied that the Secretary of State has taken upon himself
“very wide powers to almost completely re-write the existing regulatory regimes for human and veterinary medicines and medical devices.”
In the strongest language that I can remember, it describes the powers taken to allow regulations for making the disapplication of legislation subject to conditions set out in a protocol—whatever that might mean—as
“yet another example of ‘camouflaging legislation’.”
This is Parliament; this is our job: to expose legislation, not camouflage it. Will the Minister assure us that he will listen and respond positively to the call for restraints and the removal of those powers in the Bill that have been so insufficiently explained by the Government so far? He will save himself a lot of grief if he does.
Baroness Walmsley (LD) [V]
My Lords, I very much agree with the noble Baroness, Lady Andrews. The Bill covers a multitude of issues, but apart from giving massive powers to Ministers it provides very little detail. It is an empty bucket. Henry VIII would have been proud of it.
Like others, I have read the Delegated Powers Committee’s report on the Bill. I have rarely read a report from this respected committee that is so trenchant in its criticism of a Bill and of the government memorandum, which failed miserably to justify those elements that the DPRRC finds to be “inappropriate”. The powers given to Ministers are not just for transferring EU regulations into UK law; they are extensive—almost unfettered—powers to amend, extend or disapply regulations, breaking many of which would be a criminal offence carrying a two-year prison sentence.
Many of these regulations would be laid by the negative procedure, with the excuse that they might be urgent. Even those that carry the affirmative procedure do not allow Parliament to scrutinise them or amend them in the same way as we would if they were done by primary legislation. Ministers claim that there is no alternative other than putting all the detail of all the regulatory changes into primary legislation. This is nonsense and the Government know it.
I have to agree that it is not always possible or even desirable to use primary legislation for technical changes, but there is no detail at all in the Bill about what changes the Government intend about human and veterinary medicine and very little about medical devices regulations. The Government even plan to disapply some regulations simply by introducing a protocol, thereby completely bypassing any parliamentary scrutiny at all. It is rightly described by the DPRRC as “camouflaging legislation”. Its overall conclusion is that the Bill transfers powers from the European Union directly to Ministers, completely bypassing Parliament.
If this is what the Government mean by taking back control, it is exactly what remainers feared when the EU referendum was put to the people. Control is going to Ministers, not Parliament. In a parliamentary democracy, that is unacceptable. Under the Bill, Ministers could completely rewrite the regulatory frameworks for medicines and medical devices, so it is not surprising that noble Lords have received so many very concerned briefings from the field.
Having in mind the fact that patient safety must be at the heart of the legislation, what constraints do we find on Ministers in the Bill? In making regulations, Ministers must have in mind three issues: patient safety; the availability of medicines and medical devices; and the attractiveness of the UK for clinical trials and the supply of medicines and medical devices. I was surprised when I first read the Bill to find the word “attractiveness”. I have never seen it in a health Bill before—a trade Bill, yes, but not a health Bill. My primary question to the Minister is: is this a hierarchy of issues and is patient safety paramount? I would not want rigorous regulation of the safety of medicines to be subservient in any way to the ability to attract producers or researchers to come to the UK to take advantage of a more lenient regulatory regime.
Frankly, if the Government want to attract people here to do research and clinical trials, I can think of no better way than to remain as closely aligned as possible to the EMA and set up the safest, fairest, most rigorous and transparent regulatory regime in the world. This Bill does not do that. I ask for detail, transparency, appropriate parliamentary oversight and the whole package of recommendations from the report by the noble Baroness, Lady Cumberlege.
Lord Ramsbotham (CB) [V]
My Lords, I declare an interest as co-chair of the All-Party Group on Speech and Language Difficulties.
On 6 May, the chief executives of the British Dietetic Association, the Royal College of Occupational Therapists, the Society of Radiographers, and the Royal College of Speech and Language Therapists, and the chair of the British and Irish Orthoptic Society collectively wrote a letter to Jo Churchill, the Minister responsible for taking the Bill through the other place, in which they appealed for extended prescribing rights, in view of the range of benefits that they would provide to patient care and the potential savings to the NHS that would result. In particular, they pointed out that such rights would result in better support and more timely care for the patients they worked with, and improved patient safety, because allied health professionals, with appropriate expertise, were often best placed to make safe medical decisions. This is particularly apposite during the problems posed by Covid-19, because patients in the community may have to wait for weeks or months for assessment or continuance of treatment.
On 10 June, I and my co-chair of the APG, Geraint Davies MP, also wrote to the Minster, welcoming her response during the processing of the Bill in the Commons, in which she said that it would give the Government powers to extend prescribing responsibilities to professional groups where it was safe and appropriate to do so. In this connection, I note the comments on delegated powers in the damning report of the Delegated Powers and Regulatory Reform Committee, published on 22 July, to which other noble Lords have already referred.
The Minister responded to our letter on 12 August, saying that the Bill will allow the Government to continue to update the professions that can prescribe medicines where it is safe and appropriate to do so, without, however, specifying which professions. To date, the professional organisations that wrote to the Minister in May have not received a reply.
All requests by professional organisations for the grant of prescribing rights will need to be subject to intense consultation before they are granted and any resulting recommendations subject to parliamentary scrutiny, as the Delegated Powers Committee points out. Will the Minister say whether that is HMG’s intention and to which professions they plan to give prescribing rights?
Lord Ribeiro (Con) [V]
My Lords, I will focus my contribution on the safety of medical devices, post-marketing surveillance and organ donation. The noble Baroness, Lady Cumberlege, did us all a service with her review, highlighting the trauma and damage suffered by women who have had implantable devices, such as surgical mesh, inserted in the pelvis to treat urinary incontinence.
This Bill could become an important vehicle for implementing the Cumberlege review. It recommends that, in the event of an issue with a device, the Medicines and Healthcare products Regulatory Agency—the MHRA—must have the power to remove a device from the register. This can occur only if all devices, not just some, are included. The report, in recommendation 7, calls for a central patient-identifiable database for all implantable medical devices.
Post-marketing surveillance often relies on professional organisations such as the royal colleges and the specialist associations to undertake outcome studies to assess complications after surgery. The Royal College of Surgeons believes that provisions included in Clauses 13 and 16 should be strengthened to ensure expert oversight of medical devices registers. The National Joint Registry is an excellent example of a long-established registry overseen by a steering committee of experts. Recommendation 7 is key, stating that the database can be
“linked to specifically created registers to research and audit the outcomes both in terms of the device safety and patient reported outcomes measures.”
The poly implant prosthesis, or PIP, breast implant is another example of a product that causes harm and misery to many women. The utilisation of systems for tracking devices, such as the Scan4Safety programme, which involves patients wearing barcoded wristbands that can be scanned and tracked against patients’ records, is to be recommended. Although new Clause 16 is welcome, we need to be clear whether the intention is to mandate the tracking of all medical devices or just a select few.
The Healthcare Safety Investigation Branch, or HSIB, has published several reports on safety problems arising from the design, usability, regulation, procurement and marketing of medical devices. For example, it has carried out an investigation into flaws in the design and usage of smart infusion pumps and several investigations into problems with poorly designed devices and equipment which might be manageable by those familiar with them but become a problem when used by those such as staff redeployed in the Covid crisis. The HSIB can highlight these issues but needs legislation to be able to enforce the withdrawal of defective equipment.
Finally, on organ donation—we have heard much of this from the noble Lord, Lord Hunt, the noble Baroness, Lady Northover, and others—in a study published in BMJ Open, ethical issues were raised over the estimated 85,477 organ transplants in China. Ninety-nine per cent of the 445 studies failed to report whether the organ donors had given consent to transplantation. The paper concluded:
“The transplant community has failed to implement ethical standards banning publication of research using material from executed prisoners. As a result, a large body of unethical published research … exists, raising questions of complicity to the extent that the transplant community uses and benefits from the results of this research.”
The noble Lords, Lord Alton and Lord Hunt, and the noble Baroness, Lady Finlay, will be bringing forward an amendment on this issue which I plan to support.
Lord Turnberg (Lab) [V]
My Lords, I, like most other noble Lords, have been inundated with briefings from a range of interested parties. Of course, everyone sees the Bill as important and absolutely essential as we leave the EU, but there is a widespread fear that, as it stands, it leaves far too many uncertainties.
The main issue at stake is that the Bill has too little detail and leaves too many actions to the regulations that the Secretary of State may or may not wish to put in place at some unspecified date. It gives the impression that the Bill has been written in haste. The fact that the Explanatory Notes are longer than the Bill speaks volumes. Here are a few of the areas where we should seek greater clarity in the Bill and not in some uncertain future secondary legislation.
The first is the clinical trials directive. It is absolutely essential that we get this, or the successor to the EU regulations, right when those regulations are no longer available to us. Heaven knows we in the UK spent enough time trying to get the directive fit for purpose. I remember spending much frustrating time in Brussels arguing the case for the workable scheme that eventually emerged, and now it seems that we will have to start again with a UK version. The research community and the pharmaceutical industry are deeply concerned that, in undertaking the clinical trials essential both for patient safety and for the timely availability of new drugs, we do not place new barriers in their way.
Can the Minister reassure us that, whatever regulations we put in place, we can interrogate them and that they are entirely compatible with the EU schemes so that we can avoid all that time-wasting frustration of submitting applications to more than one body? There is a fear that anyone conducting trials in Europe will have to employ expensive lawyers in Brussels to sort out the problems. Can he also ensure that the MHRA is given a clear remit for what is likely to be its enhanced role and that it is given the resources necessary to take on the extra work?
While I am on about clinical trials, it is clear that for many rare diseases there are just too few cases in the UK alone and that trials of new treatments have to be done with the much larger populations available across Europe. We can do this now, but can the Minister tell us whether and how it will be possible to do so in the future? For the very many rare diseases—there is a large number of them—will we be able to continue trials across Europe without all sorts of hurdles getting in the way, and will we get the full alignment so essential if we are to encourage industry investment and if our patients are to receive new treatments as rapidly as those in the rest of the world? There are opportunities to sort out some of the issues surrounding data protection and confidentiality in relation to clinical trials.
Then there is the whole question of the safety of medical devices, on which we have the important and very impressive report of the noble Baroness, Lady Cumberlege. How could anyone listening to her impassioned speech today resist her pleas? Her recommendations are clear and necessary. Will the Government take them up? Will they ensure that Britain remains at the forefront in developing safe and effective devices by making all new devices before and after development registrable and trackable so that all outcomes can be monitored? Does the Minister agree that the appointment of a patient safety commissioner, as the noble Baroness, Lady Cumberlege, proposes, would be a very positive move? Patients certainly need some sort of shepherd to take them through the myriad regulatory bodies. They, and we, need that.
There are many other concerns with the Bill where matters are skimmed over and left to be dealt with by regulations that bypass parliamentary scrutiny. I hope that the Minister will tell us when he expects those regulations to be available and that he will help us to fill in those huge gaps.
Lord Clement-Jones (LD)
My Lords, as we have heard loud and clear today, this Bill is fraught with many critical flaws that the Government must address. However, I will focus on the concerns that have been expressed by pharmacists about the wording of Clause 3, relating to the development of a successor UK system to prevent the supply of falsified medicines, which is symptomatic of the Government’s high-handed approach.
The clause refers to
“the use, retention and disclosure, for any purpose to do with human medicines”
of information collected by such a system, which considerably broadens the original data-collection provisions of the Falsified Medicines Directive. Yet the Explanatory Notes make no mention of this legislative creep and, indeed, the Health Minister, Jo Churchill, said in Committee in the Commons:
“The Bill, in the main, does not deliver any immediate change to the regulation of medicines and medical devices.”—[Official Report, Commons, 8/6/20; col. 7.]
In this context, data is sensitive, commercial currency. All parts of the medicines supply chain need access to broad patterns of medicines usage but, in the current scheme, access to pack information, which could highlight purchasing decisions and margins being made, is restricted to details such as the name, batch, expiry, serial number and active/inactive status, with some exceptions for investigating incidents and the national competent authority, MHRA, used for various purposes.
Because of the issue of the commercial sensitivity of data, Article 54a, regarding the protection of personal information or information of a commercially confidential nature generated by the use of the safety features, was inserted into the preamble of the Falsified Medicines Directive and the principle of “whoever generates the data owns the data” was enshrined in Article 38 of the associated delegated regulation of 2016, which followed the Falsified Medicines Directive.
The Department of Health and Social Care already has access to a very wide range of data on medicines sales and use in the UK under the Health Services Products (Provision and Disclosure of Information) Regulations. Ministers can request more detailed information if required. Given both this access and the known sensitivities around falsified medicines data, it is unclear why the department wants to extend the purposes for which data is collected under a future UK system and why this has not been discussed with stakeholders in the existing Falsified Medicines Directive scheme. Pharmacists have concerns not just that the department might accidentally release commercially sensitive data but that it might use such data to gain an unfair advantage, given its monopoly position as the main purchaser of medicines in the UK.
Of course, the details of a new scheme will need to be set out in regulation, but the regulation-making powers under Clause 1 are, as the Delegated Powers and Regulatory Reform Committee pointed out in very clear terms in its damning report—which many noble Lords have referred to—considerable, and they provide no guarantee at all that the use of falsified medicine data will follow the previously agreed pattern.
It is clearly important to ensure that primary legislation provides the necessary protection. I hope the Minister, on mature consideration, will agree to ensure that the Bill is amended to enshrine a duty of full consultation and agreement in the Bill over this data use as we go forward.
Baroness Butler-Sloss (CB) [V]
My Lords, I will raise two issues, the first being organ harvesting. I propose to support the amendment of the noble Lord, Lord Hunt of Kings Heath, and the noble Baroness, Lady Finlay of Llandaff. Like other noble Lords, I am very concerned by the activities in China. There are other countries where organs, particularly kidneys, are also sold, and we should not be allowing them to be used in this country.
Secondly, I support the constitutional concerns of the Delegated Powers and Regulatory Reform Committee, especially with regard to the proposed use of negative rather than affirmative procedures. I am also very concerned about the creating and adjusting of criminal offences by regulation and I would strongly support sunset clauses.
Baroness Bennett of Manor Castle (GP) [V]
My Lords, many noble Lords, including the noble Baronesses, Lady Andrews and Lady Walmsley, have made reference to the extremely strong—you might almost say scathing—report of the Delegated Powers and Regulatory Reform Committee. It is worth going back to its conclusions, in which it states that Ministers are
“given very wide powers to almost completely rewrite the existing regulatory regimes for human and veterinary medicines and medical devices”.
This Bill sees the Government seize control, rejecting the oversight and scrutiny of the elected Members in the other place and the technical experts here. In the best Trumpian style, it declares that the rules will be whatever they want them to be. Forget checks and balances, forget consultation and careful consideration; let Ministers rip. Indeed, that is what the Minister suggested he wanted in his opening remarks, focusing on speed of action, which would happen with scant parliamentary scrutiny. What he is suggesting is something new and radical.
Yet, as the Delegated Powers and Regulatory Reform Committee points out, the Government claim elsewhere that this is like-for-like replacement of existing powers. The Government cannot have this both ways: it is either new and radical or just more of the same. However, the Minister is clearly right: this is new and radical, because what exists now is
“a mechanism for transposing into UK law EU rules on medicines and medical devices ... The new powers are subject to no such constraint”.
The answer here is not to concentrate power in the hands of the Government. The current system is clearly not good enough, but the answer is not to take away controls and oversight but rather to strengthen them through democracy, openness, a focus on the patient experience and independent expertise. As the Cumberlege report suggests, a commissioner for patient safety is crucial, and I am pleased to offer the Green group’s support for the noble Baroness’s proposed amendment, which she just outlined. We need a more democratic, listening approach, as the noble Baroness, Lady Cumberlege, demonstrated so effectively, not a centralised, unchecked one, in which few have input.
Let us consider what the UK regulation might look like if the Bill goes through. We will have a Minister who will be bombarded by well-funded industry lobbyists on what the new rules should look like. A pharmaceutical company or a device manufacturer has not taken the Hippocratic oath. Their job—their legal obligation, in fact—is to maximise profits, and their profits are very large. As the former editor of the New England Journal of Medicine suggested, an appropriate metaphor for the pharmaceutical industry is an 800-pound gorilla. “What does that do?” he asked rhetorically. Whatever it likes. Your Lordships’ House might like to contemplate the image of Matt Hancock up against that gorilla.
We have already seen drug companies flexing their muscle in the notable case of Selexipag—also known as Uptravi—using a patient representative group as cover for a massive lobbying effort. We know that pharmaceutical companies are lining up for a post-Brexit bonanza, increasing the price that the NHS pays for drugs. As the noble Lord, Lord Alton of Liverpool, made clear in his excellent speech, there is a huge problem in our system with conflict of interest, which is only likely to grow.
I am most often talking about the disastrous model of US healthcare in the context of the rush to privatise our NHS, but a significant contributor to its disastrous and highly expensive outcomes is the political power of the pharmaceutical companies. This Bill is not “take back control”. This is “abandon control” and, when you are talking about medicines and medical devices from the industry that gave us thalidomide, the US opioid epidemic, Primodos and pelvic mesh, that is a frightening development.
Lord Balfe (Con)
My Lords, I too extend my congratulations to the Minister on introducing the Bill. I suspect it will be a somewhat different Bill by the time we have finished with it.
This exposes the whole nonsense of “taking back control”. We are 3% of the world drugs market; the European Medicines Agency is 25%. The way for us to gain control is to work with our colleagues in large organisations where we can have considerable impact, not to start setting up our own organisations. The impact of moving away from the European Medicines Agency is going to be a considerable extension of a centralised process of regulation and it is also going to add to the unaccountable powers of Ministers, because the EMA does have a certain amount of accountability attached to it, which I do not think will happen. Indeed, it will not be the Ministers who will be making these decisions; it will be civil servants some way down the pecking order—and many of them will in the end have to take account of what the medicines agency has to say.
One danger we face is what the British Medical Association has called the butterfly effect: we have a slight derogation from a slight position of an EMA rule, then it multiplies, because one leads to another and then to another. You have to ask yourself whether this divergence can be kept under constant evaluation, because it needs to be. I put it to the Minister—he may not like it—that in the end we are going to have to negotiate a formal agreement for continued participation in EMA assessments, because we need a common assessment. We face otherwise the danger of delay—that manufacturers will say, “Let’s be logical: 22% of the market is in Europe, 3% is in Britain, so let’s get the European agreement first, because that’s where things are based.”
As a side-effect, we will then need an agreement with Euratom for isotopes, which has not yet been mentioned but is crucial to the health service, and that will have to be a separate agreement. We will also need to maintain access to EU funding programmes; we need these joint programmes to develop to do the best job for the citizens of this country—and, of course, we need alignment with the clinical trials regulations. We cannot have a different clinical trial regulation in Britain from what is in practice in the rest of Europe. We need all those things, and we need a professional structure in Britain for advising the Minister and drawing on the advice available.
I support the idea of a commissioner for patient safety. I hope that the Minister will go away and work out how it is to be done before he gets defeated on the Floor of the House. I also believe that the proposal on the harvesting of organs will not get through this House, and there will be an amendment on that. I say to the Minister: please do your homework and bring us something that we can agree with. Otherwise, the Government are going to get defeated.
Lord Bradley (Lab) [V]
My Lords, I shall raise just one issue—that of prescribing rights, already highlighted by the noble Lord, Lord Ramsbotham. Clause 2(1)(n) deals with amendments made to provisions that govern who can supply or prescribe human medicines. As the Minister, Jo Churchill, recognised in Committee in the other place on 8 June, the provisions referred to are set out in Clause 2(2). The power gives the Government the ability to amend the rules around who can supply, administer and prescribe medicine in line with healthcare needs when it is safe and appropriate to do so. The most recent changes to prescribing responsibilities were in 2018, when legislation was amended to allow trained paramedics to act as independent prescribers.
The Minister informed the Committee that the Government had published an illustrative SI, showing how the provision could be made to permit dental hygienists to supply and administer certain medical products in the course of their professional duties. That is important, because the Government could use the opportunity presented in this Bill to extend supplementary prescribing rights training for occupational therapists and extend independent prescribing rights training to other allied health professionals, including dieticians, orthoptists, diagnostic radiographers and speech and language therapists. As the noble Lord, Lord Ramsbotham, has made clear, this could help to deliver better support and more timely care for patients; reduce pressure on other health professionals; increase system efficiency; and maximise the ability to respond to the Covid-19 pandemic now and in the predicted post-pandemic surge on services. The extension would also build on the groundwork already undertaken by NHS England’s scoping exercise over the last few years on extending prescribing rights. However, having had full consultation with professional bodies, any SIs laid must be subject to affirmative resolution in this House—and, of course, such SIs must be underpinned by efficient, robust and coherent regulation.
I support the views of the allied health professionals that there could be considerable benefits to extending these prescribing rights, including better support and more timely care for the patients they work with, enabling them to have more equitable access to treatment and reduced pressure on other stretched professionals, especially GPs. As an example of those benefits, I highlight the work of speech and language therapists. Without independent prescribing rights, speech and language therapists have to hand over a prescription to a different prescriber, such as the GP. If the prescriber is on another site, that can sometimes result in considerable delays. In addition, for those patients with eating and drinking difficulties, the current situation could increase the risk to their safety, including adverse effects such as aspirational pneumonia or reflux, with the possible increased likelihood of hospital admissions.
As noble Lords will be aware, speech and language therapists provide life-changing treatment, supporting care for children and adults who may have difficulties with communication or with eating, drinking and swallowing. They are also involved in key clinical and health pathways, including cancer, particularly head and neck cancers, learning disabilities, brain injuries, stroke and progressive neurological conditions such as dementia. Expending prescribing rights to them and allied health professionals could enable safer and more efficient patient care, and I hope that the Minister will confirm that he will support this issue as this legislation progresses though this House.
Baroness Burt of Solihull (LD)
A lady local to me wrote to me about the excellent Cumberlege report. She said: “Mesh has ruined my life. I have lost my colon, appendix, cervix, uterus and parts of my vagina to mesh. I have been violated with at least two unconsented mesh procedures in my rectum and bladder—the scans don’t lie—and if I want removal, I may lose those parts of me as well. I have lost my sex life, my continence and my well-being. I have lost four jobs and I will shortly be losing my home since I cannot work.”
I shall call this lady Jane, which is my middle name, but it could be any woman in this Chamber or this country. Indeed, the online support group for women victims of mesh alone has over 8,000 members. Jane, like many others, has been brushed off, patronised and accused of imagining symptoms or being hysterical, while the perpetrators closed ranks, covered up their mistakes and made her suffer.
Vaginal mesh implants have caused women extreme pain, “like having razor blades inside them.” The noble Baroness, Lady Cumberlege, found in her report inadequately tested and poorly regulated meshes to be the cause of so much pain and misery. But the treatment of women over mesh, and the two drugs in her report, seem symptomatic of a culture of exasperation, impatience and disbelief on the part of many medical professionals when women tell them what they are going through. Barbara Ellen of the Guardian speculates about what would happen if the boot were on the other foot, and men had penis implants that felt like slashing razors. Would they be written off as “hysterics” and “whingers”?
Although I normally steer well clear of all matters medical, I cannot allow this Bill to pass without doing my utmost to ensure that women such as Jane, and all the Janes to come, will be properly protected from the inadequate testing of products, the failure to react and recognise when things are going wrong, and the cover-ups of life-ruining mistakes which have gone on without being called to account.
I am entirely in accord with the recommendations of the noble Baroness’s report and those of the Royal College of Surgeons. What we need in this Bill is proper traceability for all medical devices; a redress agency and revision of the MHRA; registries to monitor patient outcomes and spot early on if things are going wrong; and the setting up of a patient safety commissioner. Above all, we need to recognise the importance of giving primary regard to the safety of medicines and medical devices. This medical misogyny has to end.
Baroness O’Loan (CB) [V]
My Lords, I would like to thank the noble Baroness, Lady Cumberlege, for her excellent work on the report that she has presented to the House. I would like to support her recommendations, and most particularly her recommendation for a patient safety commissioner.
This is an important Bill, and there is an opportunity presented by it to improve the regulation of human organ harvesting across the world. Organ transplantation is one field of medicine that offers great hope to the recipient. Organs are taken from deceased donors in particular circumstances and for years living donations have been possible. A person can donate a kidney, part of a liver and so on, and live perfectly well afterwards. I have seen it. It can make the difference between life and death. It is a rapidly growing field of medicine in which demand exceeds supply.
Here in the UK, we have stringent regulation of the process of organ donation to ensure that those who donate are protected and that donation is only allowed from those who are fit and are willing to donate without any payment but to help someone else. That is how it should be and at its best this is a wonderful development. Similarly, organ transplantation after death can, in the right circumstances, bring untold blessing to those who receive an organ.
However, the very fact that demand for organs for transplant exceeds supply means that there is a market in organ harvesting, both from the living and the dead. For decades, people have been forced through poverty to sell their own organs. This is unethical and wrong. There should be no support for such practices, and we must ensure control over any contribution made by British companies that enable such activity.
We know, too, that there is transplant tourism, where people travel to countries where they may be able to get a transplant, in some cases with few questions asked about where the organ donated to be transplanted came from. We know, too, that organs can be shipped and transplanted into recipients across the world without proper procedures. There continues to be a major problem in the lack of global control over organ harvesting. There has been a reference to the work of the China Tribunal and to reports of a state-run programme of forced organ harvesting in China, the organised butchery of living people to sell body parts, which the China Tribunal compared to the
“worst atrocities committed in conflicts of the 20th century.”
We know that Uighurs, Falun Gong practitioners and others are being killed and subjected to forced organ harvesting.
When an organ is taken, whether from a living or a dead body, it needs to be preserved and transported to its destination. Just as we now require that imported products, whether they be clothes or anything else, should be manufactured in ethical conditions, we need to ask ourselves whether British manufacturers are selling to China the devices, medicines and technology which will enable China to sell organs which have been harvested from people in China’s detention camps or otherwise wrongly obtained. There could be many spin-offs from such activity, including the use of such organs—that can be imported here without any evidence of consent or traceability—for medical research, a market in immunosuppressant drugs for the recipient, and a market in harvested organs which might even be imported and used here in the absence of full regulation.
China is not self-sufficient; it is highly reliant on the West for the equipment and medicines which it needs to help its organ transplant and harvesting industry. The extent of British engagement is not immediately accessible in the context of the Chinese organ transplantation process. The report The Economics of Organ Harvesting in China indicates that there are British companies with interests in this area—in research and in producing and selling organ-preservation solutions to China.
It is right to support and develop ethical, regulated organ transplantation. It is profoundly important that this Bill provides for proper regulation. We can provide regulation to prevent companies being empowered and enriched by the mass crimes that may be facilitated elsewhere. This will show the People’s Republic of China and the Chinese Communist Party that the balance between human rights and commerce will change.
We need to think very carefully about how this Bill will proceed, so that it does that which it seeks to do and protects the health and safety of those who may be forced organ donors.
Lord Brennan (Non-Afl)
My Lords, this Bill, the scope of your Lordships’ debate and the report from the noble Baroness, Lady Cumberlege, emphasise the importance of government supervision of the supply, distribution and safety of medicines and medical devices.
The noble Baroness’s report is entitled a “Safety Review”. In the Commons debates, the junior Minister for the Government, Jo Churchill, described patient safety as paramount. The conduct of the affected families, described in the report, is exemplary: the way they try to cope with their suffering; their attempts to change things, to be listened to and to make reasoned submissions; and they deserve the assistance of this House and the Government.
The report refers to three conditions arising from two drug-related circumstances and one involving a medical device. The report identifies six other separate conditions that have not been investigated. History reveals to us thalidomide, the haemophiliacs given infected plasma that caused them to have AIDS, CJD or mad-cow disease, and one or two more. There has been over a dozen major, medical events affecting the safety of our people over two generations. This is a problem that is always to be dealt with—preferably before the problem happens.
The noble Baroness’s report therefore recommends that the Government should act. First, it should create a redress agency. Doctors and staff are taught “First, do no harm”. The necessary consequence of that is, if harm is done then there should be a remedy for it. That can best be done through a no-fault fairly based redress agency, which does not take away social care, special educational provision or additional provision but gives help in addition. Some of these children will never be able to manage their own affairs.
Who should pay for it? It should include manufacturers of drugs and medical devices. The industry’s capitalised market value in this country is several hundred billion pounds. The French company Sanofi, which makes sodium valproate, have a capitalised value of over €100 billion. Such companies can afford to contribute to the downside that comes from their place in the market.
Secondly, a patient safety commissioner should be created. Legislation has three principal tests: purpose, structure and effectiveness. Let us not become hypnotised by structure. What is the purpose? How can we make it effective and safe? Those questions guide us to the structure. He or she could co-operate with the MHRA and any other relevant authorities.
Lastly, as to what is to be done, the Government should set up a task force now that is government-based, with independents involved, to find out how, at what time, in what manner and at what cost this report’s recommendations can be implemented. Let us not be told that it is too complicated. Within days of becoming Prime Minister, after years of litigation in which I was involved on behalf of the haemophiliac AIDS victims, John Major’s Government publicly accepted all the terms. I thank noble Lords for their patience.
Baroness Whitaker (Lab) [V]
My Lords, this potentially useful Bill raises many questions. I declare my interests as patron of the British Stammering Association—I am a stammerer myself—and vice-chair of the All-Party Group on Speech and Language Difficulties. In particular, it will be important to use the Bill to establish the post of patient safety commissioner, which was so powerfully advocated by the noble Baroness, Lady Cumberlege, and supported by many speakers today.
Like the noble Lord, Lord Ramsbotham, I echo the concerns of the Royal College of Speech and Language Therapists, which wants to work with the commissioner to safeguard people with communication needs, especially those with additional health inequalities, to ensure that their needs are identified and tackled, and their voices heard. There is a deficit here.
In addition, I add my voice to the call to extend powers to undertake supplementary training and to prescribe to occupational therapists, radiographers, dietitians and members of the British and Irish Orthoptic Society. This would greatly improve the efficacy of these services while reducing pressure on other professionals. I look forward to the Minister’s answer.
Lord Sharkey (LD)
My Lords, I declare my interests as chair of the Association of Medical Research Charities, whose members contributed £1.9 billion to medical research last year, and of the Specialised Healthcare Alliance, which campaigns for those with rare conditions and those needing specialised care.
I will make three broad points. The first is to do with the Bill’s structure. I welcome the Bill, in that it could create opportunities for improved regulatory regimes. We cannot, however, tell whether it will. It is a skeleton Bill with a whole array of delegated powers and no detail of how the powers will actually be used. This makes effective, proper scrutiny very difficult, if not entirely impossible. The DPRRC report is especially damning on this point, as many noble Lords have noted. It is worth quoting its conclusion:
“We are deeply concerned not only by the Government’s failure to provide sufficient justification for the adoption of a ‘skeleton bill’ approach—which would give Ministers sweeping powers to almost completely re-write the existing regulatory regimes for medicines and medical devices—but also by their failure to acknowledge the breadth of the powers that the Bill would confer.”
The Minister wrote to me on 2 August, saying:
“You expressed some concern that this way of regulating the sector meant that Parliament would not be able to scrutinise the powers in the Bill if we did not provide further clarity about the policy changes we intended to make through the delegated powers. I have asked my officials to think further about the extent to which we can provide Parliament greater information to aid its scrutiny.”
That was a month ago. Can the Minister say what progress has been made in his thinking and whether we will see the fruits of it before Committee? For our part, in Committee we will want to explore means to improve scrutiny mechanisms, including the use of the made affirmative procedure mentioned by the DPRRC, and the use of a sunset provision, as discussed in the Commons.
My second point is to do with clinical trials, which are an absolutely critical part of UK life sciences and of what makes the UK a global leader in medical research. Anything that reduces the number of clinical trials will weaken that leadership and could delay access to new drugs and treatments. The Government understand this, which is why I was surprised by the weakness of their approach. The Bill simply requires the Minister, in making regulation, to “have regard to” the attractiveness of the UK as a place to carry out these trials or to supply human medicines. “Attractiveness” is not defined, and in any case this is a very weak and perhaps meaningless obligation that also entirely omits to mention manufacturing. We will want to return to all that in Committee.
We will also want to ask again which aspects of the CTR the Government believe to be in the best interests of UK patients, industry and non-commercial researchers, and which they will regulate for. We will also ask how the Government will assess these best interests and what they may be.
My final point is about consultation. We welcome the commitment to consultation and to a possible early start for it. Such consultation is necessary, but is not, as the DPRRC points out, a substitute for parliamentary scrutiny. The Bill and the Explanatory Memorandum contain no detail about the form of consultation, who is to be consulted and when, or when the consultation results will be available to Parliament. Will the Minister provide answers to these questions ahead of Committee, and could he confirm that patient groups, medical research charities and academic researchers will be among the consultees?
Lord Woolf (CB) [V]
My Lords, I begin by referring to the entries in the register regarding my legal career.
When I first read the Bill, I appreciated immediately that its powers of delegation to legislate by regulation were extraordinarily broad. I do not think anyone has disputed that. The Government have done no more than say how its breadth will assist them. They have not yet dealt with the concerns that are naturally being expressed by committees of this House, and by others, about the lack of anything more than a skeletal framework for the Bill.
In that connection, I noted with interest that the noble Lord, Lord Lansley, made the point that what was needed was to make the Bill a framework Bill, which it currently is not. If his plea were accepted by Ministers, as I believe it should be, there would be a power to make sure that the regulatory power, though undesirable—especially on criminal matters—is at least capable of being controlled. What the Government actually then do in exercising the delegated powers can be tested against the framework—indeed, it can be tested by the courts. This would enable the proper disciplining of any misuse of the regulatory powers provided by the delegated legislation.
If the Minister is in listening mode, as he said, I ask him to bear the wise remarks of the noble Lord, Lord Lansley, very much in mind. It may be thought that giving powers like this is harmless. It is not. We do not know who will exercise the powers, why, and with what result, because that cannot be supervised in the way that a Bill could be. However, at least it helps.
I suggest that another thing that would help would be a sensible sunset clause. It has been suggested that the difficulty with a sunset clause is the timespan that would inevitably be involved before it would come into operation. I suggest that that matters not. The advantage of a sunset clause in this case is that those who are exercising the delegated powers will know that what they have done will come under scrutiny again within a set limit. It would be really helpful to the effectiveness of the Bill if a sunset clause of that sort were there.
Having said that, there are many things that have been said in the course of the debate today that I agree with. The first, of course, is what the noble Baroness, Lady Cumberlege, had to say in her report. I strongly endorse the support that she has already received. There are particular difficulties with harvesting paths, referred to by my noble and learned friend Lady Butler-Sloss and others. Again, I exercise my support. We must make this Bill better than it is now.
Lord Sheikh (Con) [V]
My Lords, I support this Bill as it will enable us to put together and implement the various regulations governing human medicines, veterinary medicines and medical devices. We live in a world that is changing and the medical and veterinary sciences are constantly evolving. The Bill will enable us to innovate and ensure that all medicines and medical devices will be safe to be used by the public when needed. The Bill will enable us to amend the regulations periodically and we will be able to act and react swiftly through secondary legislation and be a world leader in the pharmaceutical industry.
In formulating the regulations, we must ensure complete patient safety. In the regulations, we need to ensure that all the important issues are full covered. I note that Parts 1, 2 and 3 of the Bill stipulate that the appropriate authorities must have regard to the safety, availability and conducting of clinical trials of medicines and medical devices. I fully agree with and support Part 4 of the Bill, as it states that the regulations under Parts 1, 2 and 3 will be subject to the draft affirmative process. The proposed legislation would be required to be fully scrutinised and approved by both Houses.
Furthermore, I note that under Clause 41, the relevant authority would be asked to approach such persons as the authority considered appropriate. This consultation will be essential. I note that under Chapter 3, the enforcement authority will issue notices in respect of compliance, suspension, safety and information. The right to issue these notices will be essential to consolidate the enforcement regime.
I noted the remedies under Clause 24, which include criminal convictions. Will the Minister say whether it is in order to do so under this Act? I welcome the proposals in Clause 27 and Schedule 1 to apply civil sanctions rather than impose criminal proceedings in relation to offences connected with medical devices.
I will talk briefly about Clause 5, which refers to fees, offences and powers of inspection. Under Clause 5(1)(b), it is stated that the regulations may create a criminal offence
“for failure to comply with a provision made in the regulations”,
which may be punishable by a prison sentence of no more than two years. Will the Minister tell us whether the creation of the criminal offence is in order under the regulations?
I will now discuss the provisions of Clause 35, which relates to the disclosure and sharing of information. My slight concern is the protection of data, particularly relating to the patient. We must ensure that there is complete protection in regard to this. Will the Minister comment on the issue of protection? Will the recommendations in the Cumberlege report be fully implemented, including the appointment of a patient safety commissioner?
Finally, I have three more questions for my noble friend to address. First, under Part 1 of the Bill, will there be provisions to regulate alternative medicines, as some of these can cause serious problems? Secondly, what measures are being taken to prevent the importation of medicines from countries where human organs have been removed for medical testing? Falun Gong and Muslim Uighurs are subjected to these horrible practices in China. I am also concerned about tackling antimicrobial resistance. Can the Minister assure us that this issue will be looked into as a matter of priority?
Lord Brooke of Alverthorpe (Lab)
My Lords, I came in earlier today to listen to the Minister respond to the Question asked by my noble friend Lord Dubs on child obesity. I was pleased with what the Government announced in July—I thought it was a step forward—but then I was disappointed when I heard that Public Health England was to be dismembered. I had hoped that when the Minister responded earlier today he would have given a more positive response than he did. I was disappointed to hear that he was simply going out on consultation again to see what would follow and who would supervise the implementation of the policy. It is this kind of change of direction when we are making progress that disturbs people. That is why there have been so many criticisms made of what is happening in this area.
The Bill is needed; we are out of Europe, we need regulation and we are dealing with a technological, fast-changing world. The Minister, in presenting his case, talked about the difficulties we face in handling AI and with biotechnology, how we stay abreast of it and keep pace with it. He went on to give the example of mobile phones: how life has changed so dramatically in such a short space of time and how we have also run into difficulties. He spoke of how, having run into difficulties, the Government have learned that we need to have proper regulation of what is happening with online matters, particularly those relating to children and harm. They are now moving on that, but it has taken some years to get to that point. The Minister said that he was in a listening mood and asked how we should deal with these complex changes. Well, we try to learn from history. The history there is that we should have had a regulator in place earlier. We would then have avoided many of the problems that we currently have.
The noble Baroness, Lady Cumberlege, has come up with a range of recommendations in her warmly welcomed report that are so deserved by people who have suffered as a consequence of medical devices and treatment in the past in a way that they should never have suffered. So I suggest to the Minister that he answer the question himself. We need confidence in dealing with this; I am not going to deal with the technicalities relating to the report, particularly the regulatory report that many others here are well able to dissect and determine what is needed in terms of the law. In general political terms, the Government need to add something that will give people confidence in this piece of legislation. If the Minister is in a listening mood, he will have heard from almost every speaker that the Cumberlege report must be addressed. I ask him to answer one simple question, as there is a limit to the number of recommendations that the Government would be prepared to embrace. Is he prepared to think again about the possibility of having a patient safety commissioner to go along with this piece of legislation? If he were willing to take that step, it would be a big move in the direction that so many people in this Chamber want.
Lord Rennard (LD) [V]
My Lords, the Bill is necessitated by Brexit but, as many noble Lords have said, it does not provide the detail required to address the concerns about protecting patient safety, promoting innovation and helping British businesses at such a difficult time.
Soon after the Brexit vote, I attended a meeting convened by the MHRA involving many of the trade associations representing businesses in the healthcare sector. There was a strong feeling that the best way of addressing some of these issues would be for transitional arrangements to continue for quite some time, if not indefinitely. This case has been strengthened by the Covid crisis.
The UK has been a powerful player within the licensing framework for European medicines and medical devices for many years. The crucial role played by our scientists has been greatly appreciated across the EU and has benefited everyone, so the principle of dividing scientific expertise into two camps, one covering the UK and one covering 27 EU member states, is not a good one.
The case for the UK becoming an independent regulator of medicines and medical devices has never really been made convincingly and we have yet to see any real evidence that the risks and difficulties are likely to be outweighed by any benefits. Patients in the UK may find themselves accessing the latest innovations significantly later than patients in the EU. Businesses are told that they may benefit from different licensing arrangements in future, but if they are different, approval may well still be needed for export to the EU or to other countries which have learned to rely on EU standards. Likewise, patients who might benefit from new products licensed by the EU may not be able to get them until the UK has also approved them.
Two sets of licensing processes will mean two sets of applications, two sets of costs and two potential sets of delays, with the consequence that businesses may be less inclined to invest in innovation than they are under present arrangements. In future, we really need closer alignment in regulation between the UK, the EU and other international standards bodies.
The government case is that the UK will now be able to give more of a lead and to deal with approval processes more expeditiously, but the Bill lacks any detail showing how this could be the case. We might hope that in future greater emphasis will be placed on regulating areas of emerging and cutting-edge science where the UK has significant expertise, such as cell and gene therapies. We may aim for the UK to be seen more widely as a destination for the regulation and trialling of innovative and advanced medicines.
We should want the UK to be an attractive place for companies to undertake research and launch new products and therapies, but we have no real evidence yet that the UK will be able to achieve any of these things alone, and everything appears to be left to government Ministers to decide how things will be done at a time when confidence in some Ministers is very low. Greater detail and greater provision for parliamentary scrutiny may provide greater hope of progress on some of the worthy aspirations that have been outlined.
Lord Kakkar (CB)
My Lords, I thank the Minister for introducing this Bill. In so doing, I remind noble Lords of my registered interests, particularly as professor of surgery at University College London and chairman of UCLPartners.
The Bill is important, as has been emphasised on so many occasions during this debate, because at its heart its purpose is to secure patient safety. Beyond that, it has the objective of ensuring a regulatory environment in which our life sciences industry can thrive. That is important because, beyond financial services, the life sciences are the second-largest contributor to our economy. However, patient safety comes first.
A number of issues in the Bill should have enjoyed detailed debate at Second Reading, but the way we are forced to conduct Second Readings at this time and the limited time we have to explore these issues make that impossible. However, I will identify and bring to your Lordships’ attention two specific issues that will need to be explored in Committee.
The first is the question of clinical trials. Twice in your Lordships’ House, Her Majesty’s Government have given very clear assurances that the clinical trials regulation that will at some point be adopted and implemented in the European Union would have its provisions reflected in UK legislation. It is regrettable that the new clinical trials regulation will not be in place by the time we leave the European Union and therefore not automatically become part of EU retained law.
The important issue here is that the trials regulation replaces the current clinical trials directive, which is defective. It seems unfortunate and unacceptable that, having lobbied so strongly in Europe to replace the current directive with the new regulation, our country, our patients and our researchers will be left with the defective current directive on the statute book. Why do Her Majesty’s Government not wish to use the current opportunity of this Bill to undertake implementation of the key improving provisions of the clinical trials regulation so that our research community and patients can benefit from an enhanced and much more effective clinical trials regulatory environment as we move forward?
The second issue is regulation of medical devices. We have heard much discussion about this problem during this debate. It is quite right that Clause 16 of the amended Bill, having completed its passage in the other place, provides for the opportunity to create registries to look at marketed device products to ensure that they can be traced and patients identified, but it does not deal with the important question of what level of evidence for the safety and efficacy of a device should be necessary before marketing authorisation is provided in the United Kingdom. This is vital.
There are trial methodologies beyond clinical, randomised trials which could be instituted that provide the opportunity for limited authorisation of new devices with patients included in prospective registries with very careful follow-up. The comparison of data from those patients with broader patients with similar diseases and conditions would allow for a proper safety evaluation of newly marketed devices and, ultimately, broader marketing once those initial data were made available. That would be the appropriate approach to patient safety. I hope Her Majesty’s Government will consider using the Bill to provide that kind of certainty.
Baroness Redfern (Con) [V]
I congratulate the Minister on introducing this important Bill and the review team, led by my noble friend Lady Cumberlege, on its commitment to patient safety.
This Bill delivers an extensive programme for the regulation of medicines, veterinary medicines and medical devices in the UK, and provides for a high standard of safety. To capture the fast pace of innovation in these areas within a regulatory legal framework, it is important to share vital information and be responsive and flexible, while being less complex and unwieldy, with data central to effectiveness. Can the Minister say how the duty to consult on regulations about human medicines will be carried out and which stakeholders will be involved?
I am pleased to see the Bill upholding and enhancing of the attractiveness of UK life sciences, as mentioned by previous noble Lords, while not hindering its ability to continue to provide for these important innovations for patients. It demonstrates a wish to make clear the importance of commitment to the life sciences sector, which is worth over £75 billion to our economy. We all know and acknowledge that enhancing continued collaboration of technical and scientific expertise is of significant importance to the UK going forward, but it should not be put before patient and user safety.
There is also a government commitment to a world- leading regulatory system, enhancing us as an attractive destination for clinical trials; to allowing strong collaboration, not just across the EU but maintaining alignment with global standards on the different routes to accessing innovation; to supporting patients’ access to innovation, creating more opportunities as we leave the EU; to maintaining and strengthening our position as a global player in the world of R&D; to allowing the removal of barriers to hub and spoke dispensing, giving smaller community pharmacies the same opportunities as large pharmacies; and to extending low-risk drug prescribing to other healthcare professionals.
An area of concern in the dispensing of medicines is oversupply, particularly in repeat prescriptions. Unused medicines have an environmental impact, so I would like to know how that can be responded to. How, too, can regulations be made to provide for a database of information on medical devices, to be established and managed by the Health and Social Care Information Centre?
As with human medicines regulations, the framework in the Veterinary Medicines Regulations 2013 upholds the safety of veterinary medicines by having a robust system for their availability, development and supply. Changes making prescribing professionals for veterinary medicines as accessible as possible, without compromising animal safety and while ensuring that the person administering the medicine is protected, are to be welcomed.
The Bill is an important piece of legislation for the regulatory system for medicines and medical devices, and for enabling new developments, but it must always display safety front and centre. The Government have stipulated that they do not intend to make any bold policy changes without full consultation, and that is to be welcomed.
The Deputy Speaker (Baroness Garden of Frognal) (LD)
The noble Lord, Lord Gadhia, has withdrawn from the debate, so I now call the noble Baroness, Lady Sheehan.
Baroness Sheehan (LD)
My Lords, I will raise an issue that was not raised in the other place; I cannot hope to do it justice in four minutes. However, it is topical and urgent and, as confirmed by the Public Bill Office, within scope.
A safe and effective vaccine for Covid-19 is critical if we are to return to life as we knew it just a few short months ago. One does not yet exist. There are promising candidates out there, but we know from our experience in setting up an efficient testing regime that it is not easy to get from concept to delivery, however much of a world-beater a candidate may be. Bearing that in mind, thought and planning are necessary to help us beat this disease. Moreover—this point lies at the crux of my contribution today—we must act in unison with all countries of the world to ensure equitable access for all to any successful vaccines and treatments, because until everyone is safe, no one is safe.
Our experience here also shows that a small number of local cases can very soon become an outbreak and stringent restrictions have to be reimposed, Glasgow being the most recent example. It does not need a great leap of imagination to extrapolate this to the global stage. We really do all have to work together and co-ordinate action. Pharmaceutical companies have to play their part too.
Let us suppose that a safe and effective vaccine is found. The volumes of production required to inoculate the entire global population will be staggering and vastly outstrip the manufacturing capacity of individual companies. Holding exclusive licences over Covid-19 health technologies will not only affect pricing and hinder further research but prevent countries producing the volumes needed. Given that the UK, US, Japan and the EU countries have already secured over 1.8 billion of CEPI’s estimated 2 billion to 4 billion dose volume available until the end of 2021, the sharing of IP and know-how will be key to scaling up manufacturing capacity to meet global demand, in particular to ensure that low and middle-income countries can access a Covid-19 vaccine. To control the spread of Covid-19, it is crucial for all countries to be able to vaccinate the minimum 20% of their population necessary to protect key workers and vital health systems that, once lost, will take much time and money to reinstate.
Together with partners such as Gavi and CEPI, the WHO has been working to co-ordinate global action, resulting in myriad acronyms—the ACT accelerator, the AMC COVAX facility and CTAP, among many others. It is good that the Government have supported these initiatives, but—this is the huge part—they lack safeguards to ensure that vaccines and treatments, often resulting from huge investment from public purses, will be made available for all at a fair price.
I will give just a couple of examples of why these safeguards are so necessary. Gilead’s Remdesivir has been proven to reduce the need for mechanical ventilation for Covid-19 patients in hospital. However, with monopoly protection, Gilead was able to charge the US $2,340 per five-day treatment course of the drug, despite the substantial amount of public funding to develop the drug and researchers at the University of Liverpool calculating that the drug can be made for $9 at a reasonable profit. AstraZeneca has said it will supply the vaccine at cost to the UK Government during the pandemic phase, but what price will the NHS have to pay post pandemic? What happens to the money paid in advance if the vaccine is not approved? The contract between the UK Government and AstraZeneca has still not been published.
The Bill represents a timely opportunity to ensure that intellectual property rights support public health imperatives, as per the 2001 Doha declaration on trade-related aspects of intellectual property rights, TRIPS. The Government also have another tool in the issuance of Crown-use licences, similar to steps taken by countries such as Australia, Canada and Germany. In conclusion, will the Government take up the International Trade Select Committee’s recommendation to evaluate the case for measures to allow compulsory licensing, so that Covid-19 technologies are available as quickly, cheaply and widely as possible?
Lord McColl of Dulwich (Con) [V]
My Lords, I congratulate my noble friend Lady Cumberlege and her committee on producing such a thorough and important report.
I draw attention to a practice that many of us clinicians used for years. It detected clinical problems in treatment, equipment and management early on. We had weekly meetings for an hour or so to discuss any complications that had occurred in the previous week. It was attended by consultants, junior staff, medical students, nurses and a manager or two. It was always an interesting and very instructive meeting, and it brought problems to light early on. People were very honest about their mistakes; it became rather like the general confession. Of course, it was essential to have as a chairman of these meetings somebody who was friendly and encouraged people to adopt the attitude of “There but for the grace of God go I”. It was a very inexpensive and successful kind of quality assurance.
I have a few questions to put to the Minister. First, do the Government plan to mandate the tracking of all medical devices used in the UK and not just those selected at random? Secondly, will the use of medical device registries be extended to patient outcomes? Thirdly, will the Government go ahead and establish the post of a patient safety commissioner, as strongly recommended by my noble friend Lady Cumberlege and many of your Lordships? Some years ago, I used to carry out transplant operations and became very familiar with the problems involved.
I emphasise that in Committee I shall fully support the amendments in the names of the noble Lord, Lord Hunt of Kings Heath, and the noble Baroness, Lady Finlay of Llandaff, dealing with forced organ harvesting. As mentioned before, Sir Geoffrey Nice QC stated in his report that forced organ harvesting has been committed for years throughout China. [Inaudible.]
Baroness Penn (Con)
I am afraid that we can no longer hear my noble friend. If he would make his concluding point, that would be wonderful.
Lord McColl of Dulwich (Con) [V]
Perhaps those who spend so much time attacking the Government about this and that might like to turn their attacks on the Chinese Government, whose morally corrupt behaviour demonstrates to the world what is going on in China.
Finally, I again congratulate my noble friend on her outstanding report.
Baroness Uddin (Non-Afl)
My Lords, I express at the outset my gratitude to many organisations, including the BHF, PSA, Birmingham University and of course our own House of Lords Library for their insightful briefings. The Bill seeks to keep high standards and safeguard patient safety as paramount considerations and to propel the UK as a standard bearer of new innovations. Like other noble Lords, I am uncomfortable about the extensive range of delegated powers afforded to the Government over medicines and medical devices and I would have liked, given time, to have elaborated further on the implications of Clauses 2, 4, 15 and 16 on the regulatory requirements during public health emergencies. I can only hope and pray that the other place and this House will ensure continuous scrutiny, with an agreed timeframe for a review of this legislation.
While I appreciate the legislative context of the Bill and the need for it, I wish to make some general points and do so as a grass-roots advocate who has campaigned for more than four decades for accountability and equity within healthcare and social services. I spent years working in this field and recall supporting many women who had experienced untold misery as result of medical intervention; I therefore welcome the sensitive way in which the Minister in the other place, Nadine Dorries, acknowledged that women’s voices and informed choices continue to be discarded and not believed, as has gone on for decades. This recognition is critical, as the noble Baroness, Lady Cumberlege, so powerfully and lovingly spoke of: women cried out for help to alleviate the massive damage caused to them by the medicines and medical devices deemed safe for years by health institutions and professionals. Women have endured countless years of unnecessary pain and injury, leaving many with insurmountable psychological, physical and financial scars. Even the most outspoken champions for their needs found it difficult to be heard, while women awaited justice.
The report from the noble Baroness, Lady Cumberlege, First Do No Harm, must be at the forefront of the Government’s mind as we look to safeguard and embed patient safety with this Bill. We have an opportunity to ensure that this legislative framework is watertight against any such injustice and costly negligence occurring again.
I support the creation of patient safety commissioners to improve patient safety and represent patient interests. In this Bill, glaring fragmentation remains; no clear pathways are indicated in the regulatory system to where patient safety is located. The Paterson inquiry referred to these anomalies as a “jigsaw of organisations” to keep patients safe without sufficient clarity. In this context, I would have wished for clarity on further safeguarding of informed consent.
Can the Minister say how the Government intend to complete this obligation for consultation with patients and the wider healthcare sector, as called for in the most recent proposals, including the Cumberlege Report, in order to rebuild trust and confidence that another set of disasters is not in the making as we proceed rapidly to create a new vaccine in the face of this horrendous pandemic?
Of equal significance, but which appears to be absent, is reference to safeguarding informed consent. I therefore welcome the Minister’s willingness to listen. Would the Minister consider that the proposed commissioner be supported by a diverse group of experts to ensure that women, as well as minority groups, have full confidence that their voices and needs are not overridden by the Government’s rush for central decision-making? Prioritising patient safety must not be compromised. The noble Baroness, Lady Cumberlege, has reminded us of the thin wedge where the medical profession and women patients, in particular, interact. There is urgent need for a robust regulatory framework for medicine and medical devices with the principal aims of serving and protecting patients and users of our service.
Baroness Masham of Ilton (CB) [V]
My Lords, I have a personal interest in this most important Bill, as medicines have saved my life on several occasions, and I use several medical devices. But most important to me is the safety of our country in this difficult time of coronavirus and leaving the EU.
The Secretary of State has an immense responsibility in providing safe functions relating to medicines for humans and animals and to medical devices. Leaving the EU means that we will not have the advantage of voting at the European Medicines Agency, where we were among the leaders, and it puts extra stresses and strains on our MHRA. The MHRA works so well with the European Medicines Agency, which has now moved from London to Amsterdam. I ask the Minister: will the MHRA be given more support and funds to carry out its extra and vital work? What will happen with clinical trials in the UK, which are based on the EU clinical trials directive and operate through the MHRA? It is not expected to apply in the EU until after the end of the transition period. This means it will not be part of the EU law, so what will the UK do about this important matter? My noble friend Lord Kakkar also stressed this.
Thousands of clinical trials seeking new treatments for diseases, including cancer, heart disease and many rare conditions, have been suspended or abandoned in the wake of the Covid-19 pandemic. Charities that raise money to provide funds have lost millions of pounds in revenue that would go a long way to helping to research new medicines and therapies that are desperately needed. Coronavirus has cast a shadow across the world. We should work together to fight this disease. But the emphasis on the attractiveness of the UK to conduct clinical trials or develop medical devices must not be put before patient and user safety.
The Bill covers so many aspects of safety. I have been involved with the disaster of sodium valproate, the drug given to pregnant women with epilepsy; their children were born with autism. I hope that the recommendations of the Cumberlege report will be accepted, especially the creation of the post of patient commissioner. I am pleased that the Bill addresses the dangers of falsified medicines. However, the Company Chemists’ Association would like to avoid the unintended consequences of data being used for purposes other than to ensure that medicines are safe. It is asking for “any purpose” to be amended to “in agreed framework”.
Everyone to whom I have spoken agrees that we should maintain the highest possible standards of patient and animal safety. I hope that we can work globally and not become isolated.
Lord Willis of Knaresborough (LD) [V]
My Lords, I suspect that much of my contribution will echo that of other noble Lords as this vital piece of legislation makes its way through our House. I say “vital” not simply because the overall market in pharma-medical devices and medical products is worth some £74 billion a year, but because without this legislation the chaos that derived from a no-deal Brexit would be catastrophic for patients and their families.
Let us be clear: this Bill is short on detail and accountability and places far too much power in the hands of the Secretary of State. The one overriding consequence is to deliver a system of regulation that is inferior to and more expensive than the one that currently exists. That is quite a triumph.
That said, there are elements of the Bill I welcome, particularly the registry of medical devices, and the greater enforcement powers over rogue operators, which are so clearly needed, following the excellent report by the noble Baroness, Lady Cumberlege—a report, incidentally, whose recommendations are embarrassingly absent from the Bill.
I welcome a more realistic approach to prescribing and extending the ability to prescribe to more healthcare professionals. What is not clear is how this is to be achieved. Will the Human Medicines Regulations 2012 be amended by a new clause in the Bill? Will a common framework for competency, based on the Royal Pharmaceutical Society’s competency framework, be included as a requirement for any new professional prescribing group? If not, where will its standards come from? Do the Government intend to address the issue of competency for those who do not prescribe but who administer drugs to patients? A safe administering practice is crucial, particularly in community settings, where often prescribing colleagues are in short supply.
Like many Peers, I am deeply concerned about aligning future regulatory systems. I welcome assurances given by Ministers, but we have to anticipate a situation where divergence of regulation may lead to the non-compliance of either our products or those of the EU and the US, our two major suppliers. Currently, the UK is a key player in the global regulation of medicines. Despite having only 3% of the global market, compared to the rest of Europe with 25%, we are able, through the MHRA, to punch well above our weight, as the noble Baroness, Lady Masham, so clearly stated. Three years ago, the UK was a rapporteur, assistant rapporteur or scientific advice co-ordinator for one in five EMA regulatory decisions—decisions that were accepted across the globe. The UK is a global player because of our excellent science but also because it has access, through the EMA, to the EU. Should we not retain the closest possible alignment with the EU, when the regulatory cost and impact burden might see huge problems for the UK medicines industry, with a rapid decline of market authorisations?
Finally, given the surge in personalised medicine which will drive so many novel treatments, I hope that the Bill can be amended to make it a requirement that, should a health professional offer a patient treatment using a fast-track drug, therapy or device with which they have had or will have a pecuniary interest, it must be declared. That is not the case today and it certainly should be. The report by the noble Baroness, Lady Cumberlege, looked particularly at areas such as fertilisation treatment, where there are some very important differences to be made. I look forward to further examination of the Bill in Committee but regret the fact that we have to have this at all.
Lord Mancroft (Con)
My Lords, the purpose of the Bill before us today is set out very clearly in the Long Title and few could disagree with the Government’s objectives. Indeed, the Bill had a relatively untroubled passage through the other place. However, I am slightly confused. At least part of the motivation for improving the law and regulation in this area was the subject of the review of the safety of medicines and medical devices by my noble friend Lady Cumberlege—a first-class if somewhat harrowing report. I am therefore unclear how the Government can be entirely confident that the Bill achieves what it purports to, as it was drafted before my noble friend’s report was published.
I would like to take this opportunity to make a few comments about my noble friend’s review, because I became concerned and, frankly, pretty horrified by its findings, particularly in relation to the use and misuse of surgical mesh. We have become accustomed over the last few months to applauding outside our homes the sterling work of front-line NHS staff during the pandemic at a time when large numbers of people became very ill and required significant interventions and care in a particularly challenging environment. We were right as a nation to acknowledge the work that they selflessly undertook on our behalf.
However, my noble friend’s review sets out a description of another side of our National Health Service that we need to be equally willing to acknowledge, although it is less palatable and some people may not be willing to admit it. Everybody makes mistakes, and large, nationally delivered services are no exception. So it is important to keep things in perspective, which is not easy when we are talking about the lives of people we know, or our loved ones.
One thing that sticks out to me in the review is the extraordinary lack of data, which has been mentioned before in this debate. I can tell your Lordships that 336,000 people have been infected with coronavirus in the UK this year and that 41,000 have died—precise and tragic statistics. But I cannot tell your Lordships how many women have had their lives ruined by the insertion of medical mesh, because the National Health Service does not have those figures. It does not know how many people had those operations or how many have suffered adverse effects, although the number is probably in the tens of thousands, and certainly more than those who have died of Covid.
Doesn’t know, or doesn’t care? It is very hard to tell from the review or from talking to those who have suffered. But the language of the review bears repeating and should go on the record. I am obviously not going to quote all 267 harrowing pages, but perhaps I can take a few quotes from page 4, which cites
“lack of awareness of who to complain to and how … the struggle to be heard … not being believed … dismissive and unhelpful attitudes on the part of some clinicians … a sense of abandonment … life-changing consequences … breakdown of family life … loss of jobs … loss of identity and self-worth”.
Lastly, “inaccurate or altered patient records” is a particularly shocking remark to me. I will not go on, noble Lords have heard enough. This is not a service that we should be applauding on our doorsteps. This is a service that in this area should be hanging its head in shame.
I have two questions for my noble friend. Can he assure the House that the Bill will go a long way—a very long way—to ensuring that something like this can never happen again? Can he explain exactly how the Bill will contribute to that, because it is far from clear to me from his remarks on opening this debate. It is far from clear to me because, as many noble Lords have pointed out, it is only a skeleton Bill or a framework Bill—I am not sure what the difference between the two is.
Secondly, can he explain what steps the Government are taking now, today, to make redress to those women who have been harmed and how exactly they are doing that? I have read what my noble friend’s review recommends but have not yet heard the Government’s response, and this Bill does not cover that most important point.
Lastly, if my noble friend Lady Cumberlege moves an amendment to set up a patient safety commissioner, I shall be delighted to support her in the Lobbies.
Lord Bhatia (Non-Afl) [V]
My Lords, this Bill is being debated against the background of the UK exiting the EU by the end of this year and the Covid-19 pandemic, which has paralysed this country and virtually the whole world. It covers a multitude of subjects, from medical devices and medicines, to research and consultation with the medical community and the general public. I will comment on Part 1, entitled “Human Medicines.”
This vast Bill ultimately will affect every citizen in this country. Many of us have illnesses and depend on our NHS. Our GPs are our first contact; they assess our health conditions and decide on the next step of treatment. The enormous responsibility that GPs carry is truly awesome. Their work decides our fate, whether medication is needed and whether to send us to a consultant or to an NHS hospital. Few of us realise that our GP practices have budgetary problems.
Next in line are the pharmacists, who deliver the medications prescribed by GPs. In the lockdown era, they must deliver those medications to our homes. We are rightly recognising and applauding the work of our NHS hospitals, doctors, surgeons, nurses and other staff, but few of us recognise the work of the pharmacies. They work long hours. In most cities and towns a pharmacy is open 24 hours a day. They too have budgetary problems. Before the pandemic they could run profitably, since customers collected their medications and, while doing so, could buy other, non-medical items, ranging from toothbrushes to perfumes and soaps. Because of the lockdown, that extra trade has disappeared and none of us realises that pharmacies may now be running at a loss. Supermarkets have their own pharmacies and competing products. There should be better recognition of the work of pharmacies and some level of subsidy provided following the lockdown.
Baroness Finlay of Llandaff (CB) [V]
My Lords, I declare my registered medical and university interests, and that my son is developing cardiac medical devices.
The Bill could either cripple UK medical devices development or enable the UK to become a major player in advancing new devices and medicines for the world market. There must be safety—the report First Do No Harm is aptly titled. Its recommendations must be fast tracked. I will address the proposed information centre, the need for a provisional licensing system for medical devices development, and our duty to uphold international standards.
The information centre that will be formed to collect data on medical devices must establish a level playing field, as a four-nation institution, with representatives from each nation on the board to ensure governance oversight and strategic direction, equal access to data analysis and data sharing, and reporting to all four Health Ministers. The model exists in the joint biosecurity centre, yet the lop-sided power base currently proposed will bleed the devolved Administrations of funds and information. Parity of funding and powers is essential. Clause 41 needs strengthening to require consultation with UK devolved Governments and health bodies impacted by the medical device information system.
Others have stated how EU-UK clinical trials for medicine must continue, with regulation that is compatible worldwide and rapid reciprocity in licensing. The UK must be attractive to medicine and device development by ensuring efficient streamlined systems that provide economic benefit to international investors.
We must catalyse medical device development pathways in the UK, as happened in Galway in Ireland. The UK—a small part of the world market—must grasp the opportunity to become a medical devices development and production hub by being worldwide-compatible and attractive to start-ups. Currently start-ups have the initial brilliant idea and do the safety studies required by the MHRA, but often cannot fund the utility studies in the second phase of licensing. The start-up is then bought out by overseas manufacturers, which market the device back to the NHS at great profit. A provisional MHRA licence would allow the start-up to sell to the NHS when safety studies have been completed as the utility data is gathered. A provisional licence would allow marketing to the NHS with post-marketing surveillance. I think that that reflects the proposals made by my noble friend Lord Kakkar. Patients would benefit more rapidly, with high monitoring standards in place, and it would stimulate the manufacturing infrastructure if the second stage of development happened in the UK.
Regarding China’s organ harvesting and experimentation on detained citizens, the Minister wrote to me last night, citing the WHO’s view as reassuring. It is not, as many noble Lords have already pointed out. Consent documentation for tissues from outside the UK is required only on an advisory basis. It must be statutory. There are now reports of Covid vaccine experiments in China being carried out on prisoners without consent. The UK cannot ignore increasing evidence of abuses, so I will co-sign an amendment to close the glaring gap. The Government can then prove that they really take this extremely seriously.
Lord Blencathra (Con) [V]
My Lords, I wholeheartedly agree with the noble Baroness, Lady Finlay of Llandaff, that Britain can and must become a world leader in medical innovation. I strongly supported the Saatchi Bill on medical innovation. I am currently trying out a couple of MS drugs and will volunteer for everything. Personally, I am not too worried about safety, but that is a unique viewpoint.
I begin by paying a warm tribute to my noble friend the Minister. He is one of the finest Ministers I have encountered in this House: intelligent, knowledgeable, on top of his brief, courteous and very hard-working. I am delighted that he is going to listen to the criticisms on delegated powers today. Thus it grieves me to say that the structure of the Bill is absolutely atrocious and an affront to parliamentary democracy. Of course, it is not unique; it is just one more Bill stuffed full of Henry VIII clauses but devoid of substantive content. It is the barest skeleton, all to be filled in with negative secondary legislation.
I am speaking in my capacity as chair of the Delegated Powers Committee. We considered the key clauses—Clauses 1, 8 and 12—and concluded that they contain inappropriate delegations of power. We say that
“the Government have failed to provide sufficient justification for … the Bill adopting a ‘skeleton bill’ approach, with Ministers given very wide powers to almost completely re-write the existing regulatory regimes”.
But of even greater concern are the powers in these clauses allowing Ministers to create completely new criminal offences by statutory instrument: see paragraphs 29, 30 and 31 of our report.
Then we come to the negative/affirmative procedure ploy. We say:
“We are wholly dissatisfied by departments repeatedly arguing for powers … to be subject to the negative procedure where there is a need to act quickly, and seeking to justify this without acknowledging the existence of the made affirmative procedure. Departments are very well aware of that procedure and we can only conclude that their failure to mention it is a device to try to minimise Parliamentary scrutiny. In future … we will expect them to explain why the made affirmative procedure should not apply.”
That is pretty hard-hitting, and I am sorry that my noble friend the Minister is bearing the brunt of this criticism when it applies equally to dozens of Bills across all government departments. It is simply that my committee is fed up with Bill after Bill drafted with the negative procedure, on the excuse that the only alternative is the affirmative procedure. This is simply not true. The Office of the Parliamentary Counsel and the Cabinet Office are perpetuating a falsehood in their official guidance on drafting legislation, which completely, and I say deliberately, ignores the “made affirmative” procedure.
Then we come to the wonderful new term “protocols”, another ploy invented by draftsmen to avoid parliamentary scrutiny. We say:
“Allowing regulations to make … legislation subject to conditions set out in a ‘protocol’ is yet another example of ‘camouflaging legislation’ … those powers … should be set out in the regulations themselves and not in a ‘protocol’ which is not subject to Parliamentary scrutiny”.
The memorandum states on Clause 2 that the negative regulations will be made
“following extensive consideration and scrutiny by the relevant professional bodies”.
Jolly good for them—everyone is to be consulted except this Parliament.
Finally, we say in our conclusion:
“We are deeply concerned not only by the Government’s failure to provide sufficient justification for the adoption of a ‘skeleton bill’ approach—which would give Ministers sweeping powers to almost completely re-write the existing regulatory regimes … but also by their failure to acknowledge the breadth of the powers that the Bill would confer. In future, we will expect a more transparent approach in which a department acknowledges the breadth of the powers and seeks to fully justify it.”
Of course, Ministers must take responsibility for their legislation, but the root cause of this abuse of Parliament can be found in the Cabinet Office guidelines to departments on preparing legislation. The Office of the Parliamentary Counsel boasts on its website:
“We are committed to promoting good law—law that is: necessary, clear, coherent, effective, accessible.”
If the lawyers drafting our laws think this Bill is good law, God help us. Do they think good law includes skeleton bills, Henry VIII clauses, negative procedure everywhere, regulations masquerading as guidance and protocols, and criminal offences created with no parliamentary scrutiny at all? Parliament is effectively bypassed; that is a sick joke of good law.
I will return to this theme at a later date. I apologise again to my noble friend the Minister that he is on the receiving end of criticism that applies across the board.
Baroness Watkins of Tavistock (CB)
My Lords, I feel that I have drawn the short straw, speaking at this point.
Like other noble Lords, I broadly welcome and support this relatively short, important and necessary Bill. To promote patient safety, the meaning of
“the attractiveness of the … United Kingdom”
environment for medical research in future, particularly in relation to clinical trials, requires clarification. We see the global race to produce safe vaccines for Covid-19 that must, despite their urgency to protect populations, be tested for safety as well as efficacy. The UK currently adheres to the EU protocols that apply to ensure the safety of such products before licences are given for mass use. Can the Minister explain if there are any plans to relax our adherence to current EU legislation on clinical trials?
The Bill refers to regulations relating to medical devices and the fact that Ministers will be given delegated powers in relation to their approval. Do the Government intend to adopt the EU regulation on medical devices 2017/745, which is not due to come into force until after the end of the transition period? Will the Government ensure that, as well as approving new devices in future, any maintenance of devices necessary to keep them safe in operating terms will also be included in the provision of granting such licences? We know that patients have occasionally been put at risk due to inadequate and/or irregular maintenance of devices—for example, with smart infusion pumps used to deliver medication. What onus will the Government put on purchasers of approved devices not only for safe maintenance but for adequate training for people to use the new devices to protect patients? This does not seem to be mentioned at all in the legislation as drafted.
I too fully support the excellent report and recommendations produced by the noble Baroness, Lady Cumberlege, and the way it uses plain English to describe the horror that some patients and their families have suffered. I am reminded of trying to find out, when I was training as a nurse, what “iatrogenic complications” meant. I think it is stark that the noble Baroness uses modern language that we can all understand. That is so important.
Will the Bill be used to incorporate some of the principles of the Health Service Safety Investigations Bill, which reached a Second Reading in this House, or is it the intention that that Bill will not be timetabled for completion and therefore the medical devices Bill will need to take up many of those issues at the same time?
Without doubt, I fully support the concept of a patient safety commissioner being appointed.
Baroness Ritchie of Downpatrick (Non-Afl) [V]
My Lords, like many noble Lords who have spoken today, I agree that the provision of high-quality healthcare in which its citizens can all have confidence defines any nation. That is why this Bill, with all its warts, is so important.
We must always ensure that our ethical practices are of the highest standard. Any medical product available in the UK, or indeed anywhere, must be rigorously tested, safe and effective. That is also particularly true of any future vaccine for Covid-19.
However, I want to focus today on one aspect of this Bill, that relating to medical devices. I have long campaigned on the issue of winning justice for pelvic mesh sufferers, who have been left with internal damage and intense, chronic pain. They were failed by an appalling culture of mismanagement, ignorance and apathy within the health system. These victims deserve justice, and we must ensure that this sort of systemic failure never happens again.
The recent report by the noble Baroness, Lady Cumberlege, entitled First Do No Harm, on surgical mesh and other medical interventions was scathing in its assessment of the failures of a disjointed and defensive health system to listen to and address patient concerns. Much of the suffering, it concluded, was entirely avoidable. As someone who met victims of this appalling mismanagement when I was a Member in the other place and learned at first hand of the pain they had been forced to endure and its effect on their quality of life, I am pleased that this review was commissioned and am happy to support the noble Baroness in her proposals. I am pleased, too, that it was able to be so honest in its findings.
I am further pleased that the Minister, the noble Lord, Lord Bethell, provided an apology in your Lordships’ House on the 9 July to all the people who have suffered as a result not only of pelvic mesh issues but of certain medications. I am now going to ask the Minister a direct question. Will the recommendations of the noble Baroness, Lady Cumberlege, be reflected in this Bill through government amendments in Committee? I refer in particular to the implementation task force, which must be set up without delay to oversee progress. Like other noble Lords, I believe that that recommendation should be given statutory effect if the Government and Parliament are to take this report seriously. That goes also for the recommendation that a commissioner for patient safety be created.
In relation to Northern Ireland, there is also the issue of potential regulatory divergence. As medicines are a devolved power but medical devices are not, the Bill in its current form raises the possibility of future regulatory divergence between Northern Ireland and the rest of the UK. That matter requires clarification in relation to the report of the noble Baroness, Lady Cumberlege, and this Bill. Can the Minister provide that? There is no doubt that such assurances are very necessary, but they should not and will not close the door on the past.
Baroness Hollins (CB) [V]
My Lords, I refer to my interests in the register and congratulate the noble Baroness, Lady Cumberlege, on her review, which, as we have heard, was asked to look at three interventions in particular detail: hormone pregnancy tests, the use of sodium valproate in pregnancy, and pelvic mesh implants. The connection between these was not lost on the review, which noted that each of them are
“taken or used by women and, in the cases of valproate and hormone pregnancy tests, usage is during pregnancy.”
The review found a litany of failures in the system to monitor harmful effects and heard about: patients not being provided enough information to make informed choices; a lack of awareness as to how to raise complaints; struggles to be heard; not being believed; dismissive attitudes by clinicians; and life-changing consequences due to the harms that ensued.
For women, there seemed to be a confounding factor, which the report described as
“the widespread and wholly unacceptable labelling of so many symptoms as ‘normal’ and attributable to ‘women’s problems’.”
In my field, we call this diagnostic overshadowing. The review described the stories of adversity and harm it heard as being “harrowing”. This is what happens when a group is not believed and when systematic prejudices diminishes a speaker’s credibility. This stark example of epistemic injustice should serve as a reminder to all of us of the harms of ignoring the voices of the disfranchised. Of course, there are many groups whose voices are not heard and have, for too long, proved to be too easy to ignore. These include, for example, the voices of some patients detained under mental health legislation.
As we have heard, the Bill we are debating today grants wide-ranging powers to the Government—and, indeed, the Minister—in relation to medicines and medical devices, with a large number of putative regulations subject only to the negative procedure. Will Her Majesty’s Government commit to using this timely opportunity to implement the recommendations of the noble Baroness, Lady Cumberlege, in the framework of the present Bill?
There were nine recommendations, which included appointing a “patient safety commissioner” and the formation of an independent “redress agency”. Another was, quite simply, for the Government to apologise to all the women who have suffered lasting harm. I hope the Minister will inform the House of Her Majesty’s Government’s specific intentions with respect to patient safety.
The report suggests that the MHRA’s yellow card safety-monitoring scheme is poorly sensitive to adverse treatment outcomes and that the MHRA needs “substantial revision”. Will the Government commit, in this Bill, to a far greater emphasis on post-market surveillance of medicines and medical devices? In Clause 1(2), the Bill places market considerations on an equal footing with patient safety and distributive justice—namely, the availability of human medicines.
While the economic implications of the pharmaceutical and medical devices market are, of course, important, there is no implicit or explicit hierarchy in the current drafting of the Bill that would enable defence of the appropriate authority’s decision-making being based primarily on safety, or safety and availability. Will Her Majesty’s Government amend the Bill to ensure that the hierarchy of these principles is recognised in statute? I am considering such an amendment myself.
The Bill gives the Government power to extend prescribing responsibilities to new professional groups where it is safe and appropriate to do so. Can Her Majesty’s Government comment as to which professional groups they propose to extend prescribing responsibilities to and, if they do not intend to do so at the present time, when they would consider addressing this issue? What safeguards would they consider to be necessary?
Baroness Blackwood of North Oxford (Con)
My Lords, I refer to my interests as declared in the register.
I pay tribute to all those who have worked tirelessly to deliver lightning-fast and globally important Covid trials, including RECOVERY, REACT and the Genomics England genomic host sequencing study. These have been a clear demonstration of the strength of the MHRA and UK life sciences. However, surely none of us can read my noble friend Lady Cumberlege’s heartrending report or watch the race to a Covid vaccine without knowing that we have more to do. Therefore, although this Bill has been triggered by Brexit, it is in fact timely regardless of Brexit.
A great deal has been said regarding the delegated powers—I note my noble friend Lord Lansley’s comment regarding framework Bills—and we will have time in Committee to cover all this, but I add that while current frameworks governing MMD will be retained, the loss of the ECA Section 2(2) power causes specific challenges for operating a safe and responsive regulatory regime. By its nature, MMD regulation requires frequent, prompt updating. The Human Medicines Regulations 2012 have been updated 11 times using Section 2(2). Over and above this, as has been mentioned, we have significant decisions to come on MDR, CTR, in vitro diagnostics and much that is as yet unknown.
Passing this Bill will mean that we will be able to shape our MMD regulatory environment in a far more tailored way. We may well choose to mirror upcoming EU regulations. The MHRA has been clear that we want a seamless process for multisite clinical trials not just across Europe but globally. However, there are other areas, such as genomics and cell and gene therapies, where innovative regulation may be highly desirable for novel trial design or surrogate end points, for example.
From Genomics England to Wellcome Sanger and Biobank, we have a unique concentration of institutions, skills and industry that puts us at the forefront of this field. This is a position that we must maintain. Furthermore, genomics drives two of our most highly skilled and high-growth sectors: life sciences and data science. These are critical to our economic recovery. However, primarily, these technologies should be assured and accelerated due to their promise for patients: more accurate diagnostics, personalised medicines, and screening tools that may even help prevent certain diseases altogether. The value of knowing that you carry a faulty BRCA1 gene and therefore have an increased risk of ovarian or breast cancer is well known. However, combining this genotyping with emerging tech such as polygenic risk scoring can sharpen that risk profile and prevent inappropriate interventions. The same is true of familial hypercholesterolaemia, promising to improve care of the highest-risk CVD patients.
We know that gene editing tools are producing entirely new casts of medicine, including cell and gene therapies such as the blood cancer drug Kymriah. It was the UK that struck the first full-access deal in Europe for this breakthrough CAR-T therapy, and there is promise of much more, with 12% of global ATMP trials happening here. The benefit of cell and gene therapies is patient-specific treatment with curative potential. The challenges include cost, complex manufacturing and short shelf lives. This Bill would help, enabling approved therapies to be processed at the bedside, and much more.
Genomics and other such tech generate vast swathes of data, and none of us needs to be reminded of the challenge and urgency of regulating the intersection of novel medicines, medical devices and health data. This Bill would help us develop a future-proof health data regulatory framework that could unlock the potential of ML in healthcare while maintaining the highest ethical and data standards. But align or innovate, it will be our decision. Clause 41 makes it clear that these decisions will be fully consulted on and largely subject to the affirmative procedure, but it would be helpful for the Minister to clarify the points raised by the noble Lord, Lord Sharkey.
The balance to be struck is articulated in all three sections, which call for Ministers to consider safety, access and attractiveness of UK life sciences. Of course, patient safety is paramount, but a sick patient is not safe if they cannot access the treatment they need, and they will not be able to do that if the UK becomes an unattractive environment to trial and launch the best treatments. This requires rigour and prompt intervention to ensure the highest standards of patient safety, yes, and I fully support the patient safety commissioner and an effective devices register, but it also requires addressing barriers to access and uptake and creating certainty and right-touch regulation that limits bureaucracy and takes a proportional approach to fostering innovation in life sciences. That way, not only will UK patients get the best and safest care but we will ensure our life sciences sector remains one of the most productive in the country and one of the most innovative in the world.
Baroness Morgan of Drefelin (CB) [V]
My Lords, I declare an interest as chief executive of the research and care charity Breast Cancer Now and as chair of the National Cancer Research Institute.
I would like to start by congratulating the noble Baroness, Lady Cumberlege, and her colleagues on her committee, for her report and her compelling contribution today; it was incredibly moving. I, too, will be supporting steps to see this Bill serve as a vehicle for the implementation of her recommendations, most notably, as so many Peers have commented today, the establishment of a patient safety commissioner.
This Bill covers two areas of particular concern to cancer patients that I wish to emphasise today, which others have touched on, too. These are access to clinical trials and speed of access to newly licensed medicines. For the estimated 35,000 women living with incurable secondary breast cancer in the UK, clinical trials can provide early access to potential new treatments which might extend the time before their disease progresses, which might extend their lives and which can improve quality of life. These women often have few treatment options available to them, and clinical trials really do offer people with incurable secondary breast cancer and other cancers hope for the future. I do not want us to underestimate the value of that in these debates.
Research is, as we have heard, underpinned by pan-European and international collaboration. As an example, over 4,800 EU clinical trials involved the UK between 2004 and 2016. That is a significant number of important trials. The new EU clinical trials regulation, which we have already heard about today, will improve patient safety and streamline the process for setting up new trials, and this is vital. The Government made an extremely welcome commitment in 2018 to align as closely as possible with the new regulation, and it is essential that this commitment is restated and honoured. Today is an opportunity for that. However, without access to the infrastructure that clinical trials require, such as the portal and the database to support the regulation system, it will become much more difficult to run clinical trials across borders; that has already been talked about today.
Where trials show that medicines are safe and effective, it is vital that they are licensed and made available to patients as quickly as possible. We have heard today that the EMEA area represents 25% of global pharmaceutical sales and the UK just 3%. These are important numbers to bear in mind. If the pharmaceutical companies have to make a separate application to the MHRA, and incur additional costs, to license their medicines, delays are likely in those medicines becoming available in the UK. This is a threat to timely access for patients to new medicines, and its importance should not be underestimated.
We are also particularly concerned about access to medicines developed by small pharmaceutical companies. Can the Minister give some reassurance to patients with secondary breast cancer and other incurable cancers that access to clinical trials and newly licensed medicines will not be adversely impacted by the effects of this Bill? I look forward to hearing from the Minister.
The Deputy Speaker (Baroness Garden of Frognal) (LD)
The noble Lord, Lord Darzi, has withdrawn, so I now call the noble Lord, Lord Freyberg.
Lord Freyberg (CB)
My Lords, I have spoken at length about the value of harnessing healthcare data in the UK, and the Bill reads across to that topic. The Bill is needed to regulate medicines and the estimated 500,000 medical devices licensed for manufacture world- wide as we transition from membership of the European Union. However, it is heavily reliant on definitions set out in the Medical Devices Regulations 2002, and the use of technology has advanced significantly since then.
Simply stated, the Bill would benefit from up-to-date definitions of medical devices, or what are commonly referred to as decision support tools, that more readily reflect recently developed and near-future technologies. Many are deployed by professionals in clinical settings, while others are designed for use by members of the public. The Bill should guarantee patient safety and the efficacy of tools, including, for example, algorithm-based smartphone apps that help people assess the extent to which they may be at risk of skin cancer. A recent study found that the regulatory process for awarding the CE kitemarking to algorithm-based apps does not currently provide the public with adequate protection.
The onus is currently on the professional or individual to make appropriate use of such devices, rather than on the developers and regulators to take clearly defined steps to guarantee patient safety. Ideally, the Bill should offer at least the same level of protection afforded to patients in the EU and the US, where legal provisions make use of contemporary definitions associated with data-driven devices.
Medical devices are being developed in novel ways, and the regulation of software that makes use of algorithms to process vast quantities of data raises different issues to the regulation of software that has traditionally controlled, for example, pacemakers. These newer products are also developed, realised and updated in a very different way. By their very nature, many change, or learn over time, as they are informed by, or amass, new data. Without the means to monitor such updates, it is impossible to assess how many patients might be adversely affected by them at any point in time.
The Government have made plain their ambition to invest in science and innovation while boosting digital trade post Brexit, and the Bill is in part designed with that in mind. However, Ministers must negotiate new trade agreements with countries that subscribe to an increasingly protectionist approach to intellectual property. I am concerned that the effect of some provisions in agreements could be to reduce access to and understanding of the algorithms which underpin data-driven medical devices, in particular where developed countries seek restrictions on forced disclosure of digital technology, treating source code and algorithms as trade secrets.
I will therefore ask the Minister three questions about the Bill. First, do the Government intend to make provision for decision-support tools and the use of algorithms in medical devices now or in the future, and, if so, when? Secondly, does the Minister perceive merit in building on pertinent provisions introduced to safeguard systems of the European Union or under development in the US, and, if not, why? Finally, if there is an opportunity to learn from other countries, can the Minister highlight which nations the UK is looking towards and outline what he thinks he can usefully learn from them?
Lord Mackay of Clashfern (Con) [V]
My Lords, first, I thank the Minister for the excellent way in which he introduced this Bill. Secondly, I want to say a word or two about the distinction made by the noble Lord, Lord Lansley, and the noble and learned Lord, Lord Woolf, between a skeleton Bill and a framework Bill. I understand that a framework Bill would be one in which the powers given under the Bill would have to be used for purposes specified in the Bill. Accordingly, if we are to make this a framework Bill, we will have to produce realistic purposes for which the powers must be used.
My second point is in relation to tissue. I strongly support all that has been said about that already.
My third point is that I am very concerned about the question of trials. It is very important that clinical trials are ready to be used over quite a large area of population, particularly, as has been mentioned, in specialist diseases.
My last point is about my noble friend Lady Cumberlege’s report. I fully support it in every aspect. I worked with my noble friend Lady Cumberlege long ago and I know how valuable her work is. The thing that worries me somewhat is how long this might take to implement. There is certainly the possibility of a task force, which was recommended in the report and mentioned today by the noble Lord, Lord Brennan. That strikes me as a signal that nothing much will happen for some time. I regard the present situation with regard to the people mentioned who have suffered so greatly as a very pressing situation, to be dealt with immediately. I would like this to be stopped as soon as possible.
The Bill requires Royal Assent by the end of the year and therefore there is a limited amount of time available. I suggest that a possible way to deal with this would be to set up a patient safety commissioner whose job is to hear from the public and treat that information as important and give it to the people who are responsible for the authorisation and use of various medicines and devices.
I think it would be possible to frame very quickly an amendment that could be used now to set up such a commissioner, with the responsibility to hear from the public and then bring the information that he gets from the public appropriately before the authorities responsible for carrying out the safety assessments in authorisation and use. That could be done now; then a task force would be able to look with slightly more leisure at what else could be added. That could be a Bill separate from, but associated with, what I am proposing.
The Earl of Devon (CB) [V]
My Lords, I am not a medicines or medical devices expert, but I have enjoyed this debate and have benefited hugely from the breadth and depth of your Lordships’ expertise. I am an IP litigator qualified in the UK and the US and I have experience of representing pharma and medical device companies in both jurisdictions.
Many thanks to the Minister for his hard work on this Bill and throughout the current pandemic response. Never in our lifetime have our medical expertise and ability to foster cross-border innovation research and reliable clinical trials been more important. This is why the Government’s approach to this issue is such a disappointment. During the four years before I joined your Lordships’ House, I worked in the London office of a large US law firm, advising companies on the management of IP portfolios in Europe. Of particular interest to US pharma and medical devices companies was the unitary patent and the Unified Patent Court. As currently stated on the GOV.UK website, the UPC would give such companies,
“the choice of protecting your invention in up to 25 EU countries with a single unitary patent. This will streamline the system … You will be able to challenge and defend unitary patents in a single court action through the Unified Patent Court.”
The ability to use the UK’s academic and research expertise as a stepping stone for EU-wide IP protection was key to international investment in the industry and the professional services that support it in this country. In recognition of the UK’s pre-eminence in the field of medicines and medical devices, the UK was able to secure London as the seat of the UPC’s specialist central division to hear appellate cases relating to chemistry, including pharmaceuticals and the life sciences. In other words, London was to be Europe’s specialist centre for pharma and life-science intellectual property development and litigation.
Post Brexit, the previous Conservative Government agreed to proceed with ratification of the UPC, showing that it would be possible to leave Europe but retain the UK’s leadership in this field. But the current Government abandoned that sensible middle ground; in February, they withdrew our ratification of the UPC without consultation or debate. With that simple decision, London lost the UPC central division and the UK lost the opportunity to be at the forefront of the development of medicines and medical devices for a generation.
I raised this important issue with the Minister before the Summer Recess, noting how withdrawal from the UPC was simply not consistent with the Government’s aim, as stated by Matt Hancock, that they wanted the UK to be
“the best place in the world to design and trial the latest medical innovations.”—[Official Report, Commons, 2/3/2020; col. 662.]
Lord Bethell responded to me by saying that the Government did not believe that withdrawal from the UPC would make the development of medical devices, medicines and clinical trials harder and more expensive. However, in support, the Minister cited only the fact that this Bill provides for a consideration of the attractiveness of the UK as a place to develop medicines as part of the process of making regulations. This is Alice in Wonderland stuff. The Government cannot in February choose to withdraw the UK from the UPC and terminate its leadership position, and then hope to replace that leadership position with some warm words in a framework Bill. That is simply not enough.
The UK is currently negotiating free-trade agreements with Europe, the US and a host of other countries. Will the Minister enlighten us as to what the Government’s goals are in those negotiations with respect to intellectual property? How will the Government use those opportunities to make the UK once more
“the best place in the world to design and trial the latest medical innovations”?
Baroness Jolly (LD)
My Lords, I am sorry that my noble friend Lady Brinton is unwell and not able to lead today. I hope that she is better and back in her place soon.
The Bill creates extensive delegated powers in the fields of human medicines, veterinary medicines and medical devices—but, I note, not veterinary devices. They enable the existing regulatory frameworks in those fields to be updated following the UK’s departure from the EU. The Bill creates a delegated power to establish one or more information systems in relation to medical devices, consolidates enforcement provisions for medical devices, introduces sanctions and provides an information gateway to enable the sharing of information held by the Secretary of State about medical devices. Your Lordships’ Delegated Powers and Regulatory Reform Committee published a report on the Bill in July. I was going to have a go at the Government about how poor the Bill was, but the noble Lord, Lord Blencathra, did it so much better.
Medical devices legislation currently relates only to medical devices for the field of human healthcare. Thanks to the health and cost benefits, these devices have also found their way into veterinary medicine. Somewhat surprisingly, however, the regulation of these products is missing altogether, unlike in some other European countries. Veterinary practice makes use of all kinds of medical devices, including products designed for use on humans, regardless of their regulatory status and control. With rapid growth in the animal health monitoring field, there should be opportunities to regulate such devices with regard to their safety and efficacy. Given the complexity and potential hazards of certain veterinary devices, the current unregulated state of affairs may lead to health and safety risks, both for animals and the clinical personnel involved. Perhaps the Minister would like to comment and think again.
Claims of medical relevance of new diagnostic tools should be considered because of the potential impact on animal welfare. Although ultimate responsibility for diagnosis should always rest with vets, reliance on these devices will increase, as will the need for regulation of performance standards. Although I recognise that Part 3 of the Bill, entitled “Medical Devices”, currently relates only to medical devices for the field of human healthcare, remote animal health and welfare services and remote health monitoring is a field of rapid growth. Opportunities to regulate such devices with regard to safety and efficacy, and to set standards for production, should be considered.
I move on to people. The timing of this debate, only two months after the publication of the Cumberlege report, is opportune. Many aspects of the report have not been debated, and I am sure that other noble Lords will have areas from the report that suggest amendments to the Bill. It will give us an opportunity in Committee to debate some of the recommendations.
For as long as I have been actively involved in either health governance or policy—some 20 years—the NHS has said that it wants to put the patient at the centre; there are various ways of framing it, but that is what it has said. The recommendations in the Cumberlege report do just that, absolutely and without any equivocation. We should legislate for a patient safety commissioner, tasked with focus on the patient, and for a redress agency, based on looking at systemic failure, not individual blame; I think there has been quite a lot of agreement in the House this afternoon on that.
The MHRA needs to highlight its public protection roles and ensure that it actively engages with the patient body. This is another theme running through the Cumberlege report. There will be a searchable register of who has had an implant and when; details about its type; the clinician carrying out the procedure; and, I would hope, any financial or other interests of that clinician.
While I recognise the need for the UK to remain competitive, patient and user safety must be paramount. There is a real need for strong regulatory oversight. Recent scandals, such as those concerning DePuy metal-on-metal hips, as well as those already discussed today relating to Primodos, sodium valproate and pelvic mesh, highlight the importance of safety.
The final recommendation of the Cumberlege report is that the Government should set up a task force to implement its recommendations. Public confidence needs to be restored, and with a matter of urgency, so will the Minister tell the House when he expects the task force to start its work and how its members will be selected?
The Bill confers on the Secretary of State an extensive range of powers to make regulations pertaining to medicines, clinical trials and medical devices. This is necessary in the short term to facilitate alignment with those parts of EU law which are to be implemented post transition—notably, the EU clinical trials regulation and the medical devices and in vitro devices regulations. However, the ongoing use of delegated powers in this area should be time-limited. Will the Minister tell the House whether this was debated in the department when the Bill was being drafted and why time-limiting was rejected?
On trade, the UK has a strong industry base in both medicines and devices, but we will not be able to be self-reliant. How does the Minister expect that we will be able to trade with the rest of the world in the future? What conversations has the department had with the EU, and what strategy is in place to work with non-EU countries? Time is against us. Negotiations with the EU are ongoing but if we have to set up treaties with various countries, it will be some time before all this is pulled together.
Our pharmacies not only dispense medicines, and some devices, but act as a local high-street source of information and advice; that is welcome to those who think that they do not need a doctor but want an expert’s opinion. The Bill enables community pharmacy contractors to use innovative new systems to support dispensing and is welcomed by members of the profession.
There is much that I have not had time to outline and I suspect that we all have a long list of points that we were not able to shoehorn into our speeches, but I look forward to the detailed work in Committee. I hope that the Minister will acknowledge that this Bill is important but needs detailed examination.
Baroness Thornton (Lab)
My Lords, I thank the Minister for introducing the Bill, all noble Lords for their contributions and all the organisations, including the Library, that have sent us briefings. I particularly thank the Delegated Powers and Regulatory Reform Committee and the Select Committee on the Constitution for their reports, produced in a timely fashion at the beginning of the recess, thus giving us all time to digest and reflect upon the issues concerning powers contained in the Bill.
We on these Benches recognise that this is an important Bill; indeed, the issues that it addresses are vital. I will concentrate on two or three, or maybe four, issues, most of which have been mentioned in the debate.
As the noble Lord, Lord Blencathra, said in his stirring contribution earlier, it seems that most of the Brexit Bills between now and Christmas will contain the same or similar constitutional challenges, so I think that we can anticipate some serious learned and constitutional debates throughout the autumn.
I am not sure whether I want to describe the Bill as a Trojan horse—something that has a seemingly innocent and benign exterior hiding huge and serious dangers within. Perhaps it is yet another example of the Prime Minister’s cavalier disregard for both timeliness and accountability, combined with our own Health Minister’s self-confessed aptitude for hustling, or perhaps it is all those things combined. However, it is worth recalling the words of one of our most distinguished Cross-Bench colleagues, the noble Lord, Lord Wilson, during the passage of the international healthcare arrangements Bill in February and March last year. On 19 February, he recounted his time as a junior civil servant when he went to discuss a Bill with our very much respected parliamentary counsel. He said:
“My assistant secretary was asked why we needed a particular power, and he rather flippantly replied, ‘Because I thought it might be useful’. Parliamentary counsel gave him a withering look and said, ‘I am not going to draft a clause for you simply because it might be useful. You have to know what you want it for’. He did not know, and we did not get that power.”—[Official Report, 19/2/19; col. 2185.]
It feels as if it is the same with this Bill. Powers have been thrown in just in case they might be useful. The Minister called it “agility”. We agree that agility can be useful, but if it is not linked to policy and what you want to do with it, it is a power that can be abused.
Do the Government know what they want, or are they are putting these powers in simply because they might be useful later? I suggest that they do know what they want: they want the power to do exactly as they decide, whenever they decide it, without scrutiny, accountability or due consideration. For our NHS and care services the important matters are whether medicines are available and how much they cost, the future of scientific research, fake medicines, proper safeguards for medical devices and putting patients at the heart of this. They deserve our full scrutiny and the best constructed Bill possible.
As my noble friend Lord Hunt said—this risk was amply illustrated in the stark narrative of the noble Earl, Lord Devon—leaving the EU’s medicines regulatory regime poses a significant risk to the UK. The Bill is crucial for maintaining the attractiveness of the UK’s life sciences sector and ensuring that patients continue to benefit from the excellent clinical research that takes place in the UK. Therefore, it is vital that we fully understand what constitutes “attractiveness” on the global stage.
Will the Minister reflect on the rumour that leaving the EU is likely to see the UK drop down the list of markets that companies will choose to trial and launch medicines in if mitigating steps are not taken? It is crucial that this legislation carefully defines what the Government mean when they talk about the UK’s attractiveness as a place to conduct clinical trials or supply human medicines. Does “attractiveness” equate to the speed of decision-making at every stage of the medicine pathway? How will patient safety be assured? Will the Minister set out what the Government mean when they talk about attractiveness, how they will apply this to medicines access and what he is doing to ensure that patients in the UK can access new therapies on the NHS as soon as countries such as France can?
The British Medical Association asked about the potential divergence in standards and suggested that this must be kept under constant evaluation to ensure that such changes do not negatively impact the timely supply of safe medicines to UK patients, as my noble friend Lord Turnberg said. The new EU regulation on medical devices is an example of a change coming through from the EU that the UK should seek to capture in the future regulatory framework around medical devices, as facilitated by the Bill. Expected to come into force in 2021, the revised rules were drafted in the aftermath of the metal-on-metal hip and PIP implant scandals. They will introduce stricter requirements on the bodies authorising medical devices and ensure greater post-market surveillance. Will UK patients benefit from changes such as these, which were orchestrated at EU level, when we are no longer part of the EU’s processes? How will that happen?
The impact of moving away from the existing collaborative approach between the UK and the EU could be substantial. The centralised processes that we are currently part of reduce the burden on the regulatory authority in each member state, create a larger European market for the pharmaceutical industry and medical device manufacturers, and thereby facilitate timely access to new therapies and technologies to patients across the EU and EEA. As many noble Lords have said, the EMA accounts for 25% of world sales of medicines, second only to the United States. By comparison, the UK accounts for only 3%.
On medical research, negotiating a formal agreement to maintain access to EU funding programmes, ensure alignment with clinical trials regulations and secure the participation of the MHRA in clinical trials that cross the EU and the UK to maximise collaboration between researchers in both is particularly important if UK researchers are to benefit from the EU’s new clinical trials regulation, which is due to be introduced in 2022 and is expected to significantly improve the current research climate via the introduction of a single clinical trial database and a centralised clinical trial portal. I have been talking to your Lordships’ House about this portal ever since the Brexit vote. It looks like we will not be part of it. I would like the Minister’s comments on that and an explanation of the disadvantage that this will bring to UK patients.
As many noble Lords have said, the Bill presents an opportunity to address the issues raised in the excellent report First Do No Harm, launched and led by the noble Baroness, Lady Cumberlege, whose remarks were very moving indeed in addressing the terrible sufferings of women at the hands of the NHS and the regulatory regimes that failed them so comprehensively. Surely we need to take this opportunity to provide for its recommendations. As other noble Lords have said, we need to consider amendments that will fall within the scope of the Bill and cater for the nine recommendations in the report. At the heart of the Bill lies the issue of patient safety in terms of medicine and medical devices, so it must be an appropriate vehicle with which to implement the report’s recommendations. Will the Minister bring forward amendments to remedy these omissions?
It is rumoured that there are mutterings, possibly among officials, about burying the proposed patient safety commissioner. I would really appreciate it if the Minister could take this opportunity to refute such rumours and commit to working with colleagues across the House—I include these Benches—to make sure that the necessary amendments happen.
I briefly turn to other issues. We are very supportive of extending the prescribing rights to additional healthcare professionals, as the noble Lord, Lord Ramsbotham, and my noble friend Lord Bradley outlined. It is time that this issue was resolved. We intend to support or table amendments in Committee requiring proposals and a timetable for additional prescribing rights.
We will seek clarification about Northern Ireland and regulatory divergence. We will probe the changes to the hub-and-spoke proposals. We will look closely at the work of the proposed patient safety commissioner, the medical devices register and, of course, the impacts of the Bill on animal medicine and veterinary regulation.
Although only 46 clauses, the Bill is a veritable cornucopia of medical and other proposals. We hope to work with the Minister, the Bill team and other noble Lords to improve it and make it worthy of the importance attached to it.
Lord Bethell (Con)
My Lords, what a debate. This is without doubt the House of Lords at its best, with thoughtful and powerful points covering medical regulation, legal propriety, patient safety, the European transition, animal welfare, foreign relations and much more. We have listened to powerful points made by 50 speakers. There was a great deal to take in. Our time together in Committee and on Report promises to be rich with important material. I fear I will therefore be unable to address every single point from every noble Lord who has spoken today, but I will give it my best shot.
Noble Lords addressed five broad themes in their contributions: my noble friend Lady Cumberlege’s review, improving regulation for medicines and medical devices, the Delegated Powers and Regulatory Reform Committee report, organs and tissues, and the UK’s future relations with the EU. I will take them in turn.
I am exceptionally grateful to my noble friend Lady Cumberlege for her report and her contribution today. Noble Lords have sent a clear message to the Government and the public that patient safety must be paramount in how we regulate medicines and medical devices. My noble friend is right that patients should be believed. She is also right that it is counterproductive to create an environment in which health professionals clam up or go into hiding. I note her intention to table an amendment on a patient safety commissioner and the large number of noble Lords who expressed their support.
The noble Lord, Lord Alton, gave poignant testimony from his own long-standing campaign on these important causes, including on Primodos. The noble Baroness, Lady Hollins, spoke of the epistemic injustices towards the disfranchised, and the noble Baroness, Lady Burt, spoke movingly about mesh, giving testimony of what she called “medical misogyny” that was hugely uncomfortable. There is a limit to how much I, as a man, can really understand all these cases, but as a husband and a father of two daughters I understand the claim that our healthcare system has not treated women fairly. This Government and this Minister are committed to doing what we can to address this.
I have heard the clear commitment from many Peers, including the noble Lords, Lord Brooke and Lord Patel, the noble Baronesses, Lady Ritchie, Lady Uddin and Lady Watkins, and my noble friend Lord Sheikh to see the report of my noble friend Lady Cumberlege implemented. I said that I would listen, and I have heard very clearly the support for a patient safety commissioner. The nine strategic recommendations in the review need to be considered carefully and we will respond in due course.
I reassure the noble Baroness, Lady Barker, who asked that registries of devices as well as databases should be our expressed direction of travel: we have set this out in the government guidance published alongside the amendment. I would be happy to write to set this out clearly. Many have spoken of the importance of Clause 16 and the underpinning of data. I assure Members that we are able to capture all devices where it is considered necessary to track their use. My noble friend Lord Mancroft is quite right that it is unacceptable in the 21st century, and makes no sense, that our National Health Service cannot keep track of who puts what in whom, and we are determined to change that.
The noble Baronesses, Lady Barker, Lady Walmsley and Lady Andrews, and the noble Lords, Lord Patel and Lord Brennan, raised patient safety. That must be a first consideration. I concur completely with the Minister in the other place that patient safety is paramount—under no circumstances will we seek to make changes that increase risk to patients in the UK. It is absolutely right that we ensure the delicate balance between supporting innovation and maintaining the UK’s position as an attractive place to develop new medicines and devices, but patient safety remains paramount. Innovation and patient safety are not mutually exclusive, and we want to continue to ensure that our regulatory framework facilitates the furtherance of both.
Several noble Lords mentioned the importance of consultation with patient safety groups on regulation that directly affects patients. I reassure all noble Lords that the consultation clause is worded such that where matters affect a particular group or groups, it will be entirely appropriate for them to be consulted.
I turn to the improved regulation of medicines and medical devices. The noble Lord, Lord Patel, expertly described the need to ensure the safety of medical devices. This is something I have indicated that we are wholeheartedly committed to, as indicated by the inclusion of Clause 16. The Government are determined to deliver regulatory change to the current UK system for medical devices to increase patient safety and drive pre-market scrutiny, and we will continue to assess opportunities to improve the wider regulatory system at the end of the transition period. The Bill is vital as it provides the necessary powers that will allow us to make regulatory changes in the interests of patient safety and confidence. The Government are committed to ensuring that patients continue to have rapid access to new medicines, and we have increased access through the early access to medicines scheme. We recognise the importance of innovation and clinical trials for patients and are absolutely committed to building on the UK as a centre of excellence for trials after the end of the transition period. We will ensure that no patients are disadvantaged.
I reassure my noble friend Lord Balfe that the UK already has substantial capacity and expertise to regulate and evaluate the safety of our medicines and medical devices. The Bill ensures that the legal frameworks around medical devices, human medicines, veterinary medicines and clinical trials can be updated to protect patient safety and reflect innovative practices. This is vital as negotiations on the UK’s future global relations continue, as several noble Lords alluded to.
I agree with the noble Baronesses, Lady Redfern and Lady Whitaker, and the noble Lords, Lord Ramsbotham, Lord Bhatia, Lord Willis and Lord Bradley, that it is right that patients are treated by the healthcare professional best qualified to care for them, including prescribing for them where that is safe and appropriate. However, putting individual professions on the face of primary legislation is not the right platform for any potential amendments to medicine supply or prescribing responsibilities. Over time the roles of staff within the health service will evolve and, using this proposed power, professional groups can be given new or additional powers to supply or prescribe medicine, subject to consultation, by amending human medicines regulations. NHS England and NHS Improvement are considering across all non-medical groups, influenced by learning from the Covid-19 pandemic, where there is a need to consider undertaking formal consultation on potential amendments to prescribing responsibilities for several professional groups.
The noble Lord, Lord Hunt, spoke of his frustration that the NHS is slow to adopt new technologies. He is right. Uptake of new medicines is still too slow, and we are working to address that. We recognise the importance of aligning regulatory and health technology assessment processes to ensure timely access to effective medicines.
My noble friend Lord Lansley is right that 10% of global medical innovations in the UK is good—but it is not good enough. I welcome his persuasive points on a new innovation fund and confirm that the Government have made a commitment to support innovative medicines by extending the successful Cancer Drugs Fund into an innovative medicines fund. The Cancer Drugs Fund shows the impact that this approach can have for patients, with 81 drugs treating 167 cancer indications funded by the CDF since July 2016.
I reassure the noble Baroness, Lady Bennett, that there is no contradiction between an intention to change very little in the immediate future and a commitment to evolving our domestic regime to protect patients, to meet the opportunities of technical revolution and to make Britain a destination for life sciences investment, clinical trials and better health services for patients.
My noble friend Lord O’Shaughnessy spoke wisely about the regulatory arms race, the impact of the FDA’s competitiveness and the opportunity of leaving the EMA. I welcome my noble friend Lady Blackwood’s point about the fact that the Bill is incredibly timely, irrespective of EU exit. I am proud of the energy and flexibility that the MHRA has shown during the response to Covid. I agree wholeheartedly with my noble friend Lord O’Shaughnessy that this is an opportunity that must be taken.
The noble Lord, Lord Clement-Jones, speaks knowledgeably about falsified medicines and the importance of commercial data. I reassure him that our objective is to fully consult with industry, patient groups, pharmacists and all interested parties on any regulatory changes before they are implemented.
To the noble Baroness, Lady Sheehan, I say respectfully that I reject the idea that we need to move away from the intellectual property rights regime that has provided incentives to create new inventions and accelerate the development of health technologies, such as Covid vaccines, over more than a generation.
By way of conclusion of this point, I echo my noble friend Lady Blackwood, who set out the opportunity well: there are key areas of regulation where we must choose to develop new regulatory regimes, including gene therapies, genetics, AI and big data. The Bill will help us to produce future-proof, proportionate regulations and standards in full consultation and largely with affirmative regulations that will have full parliamentary scrutiny.
On the question of parliamentary scrutiny, I turn to the DPRRC report. I reassure noble Lords that the majority of the delegated powers in the Bill are not new. They are absolutely necessary if we are to have the appropriate powers to make changes to the critical regulatory frameworks after the end of the transition period. We can currently make changes to those frameworks under Section 2(2) of the European Communities Act 1972, but that power will not be available once we have left the EU and we cannot allow those regulations to stagnate. While oversight of the delegated powers in the Bill will be different from that which currently occurs, we have taken deliberate steps to ensure that the oversight will involve greater parliamentary scrutiny and secure greater involvement by patients, industry and other experts. We will carefully consider the specific and detailed recommendations of the DPRRC as to how we might go further.
As reiterated by my noble friend Lady Blackwood, the majority of regulations are subject to the draft affirmative procedure—a high level of scrutiny that has usually been applied when we have used Section 2(2) of the European Communities Act 1972. As noble Lords know, by its nature this procedure requires parliamentary approval before those regulations may be made and come into force.
I am grateful to my noble friend Lord Blencathra for early sight of his speech, which was a model of courtesy and delicacy. I have heard his message loud and clear. I would welcome his counsel on the central challenge of how to legislate for a fast-moving industry in which there is so much opportunity and so much danger, but also so much uncertainty.
The noble Lord, Lord Hunt, and the noble and learned Lord, Lord Woolf, called for sunset clauses. Here I must express some scepticism. Sunset clauses would emasculate a Bill that is meant to give regulators the powers to be effective and to future-proof medical regulations in a fast-changing industry for many years to come. We must understand the impact on an industry that needs regulatory certainty or else, as many noble Lords have noted, will move elsewhere.
I firmly agree with my noble friend Lord O’Shaughnessy that the Bill gives us the ability to respond flexibly in future to regulate, for example to support the transformation of community pharmacy, to respond to innovations in the market and to improve standards of scrutiny of medical devices. Without the powers in the Bill to update the existing comprehensive regimes, we will be in danger of having static rules that could jeopardise patient safety. We must not allow ourselves to end up in this position.
The noble Baroness, Lady Barker, suggested that there is no scrutiny of the regulations generated under this Bill, but in fact the regulations come back to Parliament and cannot be enacted without scrutiny. I assure the noble Baronesses, Lady Andrews and Lady Walmsley, that we are certainly listening carefully. We are open to ideas for improving the Bill.
I welcome the constructive remarks by my noble friend Lord Lansley, my noble and learned friend Lord Mackay and the noble and learned Lord, Lord Woolf, on the building of a clear framework for the Bill. I have sought to outline such a framework in my remarks on patient safety, availability and attractiveness. I anticipate that these thoughts will be developed ahead of Committee and I look forward to further discussions on these points.
On China and organs, I have heard clearly the points of the noble Lords, Lord Hunt, Lord Collins, Lord Sheikh and Lord Alton, the noble and learned Baroness, Lady Butler-Sloss, the noble Baronesses, Lady O’Loan and Lady Northover, and my noble friends Lord McColl and Lord Ribeiro on imported human tissue, the suggested role of British firms in enabling this trade, the plight of the Falun Gong and the Uighurs, and potential forced organ donors. As the noble Lord, Lord Alton, put very clearly, the idea that British companies are profiting from these trades is abhorrent.
The noble Lord, Lord Collins, is right that we have one of the most ethical regimes for human tissue use in the world, and I share his concerns that we should in no way enable a horrible trade. I recognise that noble Lords are concerned about reliance on overseas reassurances, as outlined in the Human Tissue Act, and I hear these arguments clearly. I note that the noble Lord, Lord Alton, and the noble Baroness, Lady Finlay, will bring an amendment with the support of other noble Lords, including the noble Lord, Lord Balfe, and my noble friend Lord McColl. I reiterate my offer to the noble Lords, Lord Alton and Lord Hunt, and the noble Baroness, Lady Finlay: I would be happy to meet them to discuss this in further detail and will take this up with my noble friend Lord Ahmad, Minister for South Asia and the Commonwealth.
On EU exit, I am committed to ensuring that the UK has one of the best regulatory regimes that ensures patient safety and that patients benefit from innovative products. My noble friend Lord Lansley and the noble Lords, Lord Turnberg, Lord Kakkar and Lord Sharkey, raised the EU clinical trial regulations, which are currently expected to take effect during 2022. I am committed to ensuring that the UK’s regulatory framework for clinical trials is geared towards providing the best possible environment that takes into account the needs of patients, industry, non-commercial researchers and hospitals. That is why this Bill is so critical. The powers will ensure that we have the flexibility to adapt our regulatory framework and that the UK retains a thriving clinical trials environment, so that those engaged in clinical trials can continue to develop innovative and cost-effective treatments that both benefit patients and boost growth.
To the noble Baroness, Lady Morgan, I say that I am totally committed to improving the clinical trials regime. I assure the noble Baroness, Lady Masham, who touched us all with her account of the life-saving efficacy of modern medicines, that we are looking to give the MHRA the resources it needs to provide the best regulations and to give horizon-scanning intelligence and industry insight to help innovation.
The noble Lords, Lord Clement-Jones and Lord Freyberg, highlighted the importance of data. We are considering how to improve the regulation of software-driven devices, including AI and algorithms, and will consult on this. The Bill provides a power to make regulations about the use of data collected for the purpose of preventing the supply of falsified medicines.
Currently, the EU scheme information held on the system can also be used for the purpose of reimbursement, pharmacovigilance and pharmacoepidemiology. Determining the best model for the UK will be subject to consultation and parliamentary scrutiny of the proposed regulations. I will be happy to follow up with further detail in writing.
To my noble friend Lord Balfe, whose knowledge of European democratic structures is extensive, I say that we should embrace the opportunity we have now to discuss our own future and regulatory system here in this place. However, we should continue to work with our international partners.
A number of noble Lords referred to the importance of co-operation with the EU and EMA. As outlined in our approach to negotiations with the EU, we want to agree with the EU an annexe on medicinal products to facilitate trade and support high levels of patient safety.
The noble Lords, Lord Hunt and Lord Rennard, referred to the guidance published yesterday on standstill arrangements. We recognise the importance of continued access to medicine and medical devices. Therefore, to ensure continuity of supply of medicines and medical devices from 1 January 2021, the UK will unilaterally recognise certain EU regulatory processes for a time-limited period. By communicating this well in advance of the end of the transition period, we are providing industry with clarity on the preparations that need to be taken for the 1 January and beyond to ensure the supply of vital goods to UK patients. I would be happy to meet the noble Earl, Lord Devon, to discuss his concerns.
The noble Baroness, Lady Ritchie, referred to arrangements in Northern Ireland and I want to underscore that the implementation of the Northern Ireland Protocol is a top priority for the Government.
There is much more that could be said about the debate tonight. It is a testament to the interest in these issues and the importance of getting this right. I welcome the scrutiny of noble Lords in seeking to make the Bill better, as we so diligently try to do when it reaches us.