Blood Safety and Quality (Amendment) (EU Exit) Regulations 2020

Lord Bethell Excerpts

Tuesday 10th November 2020 Lords Chamber

Moved by

[Baroness Bloomfield of Hinton Waldrist]

That the draft Regulations laid before the House on 8 October be approved.

Considered in Grand Committee on 2 November.

[Baroness Bloomfield of Hinton Waldrist (Con)]

My Lords, on behalf of my noble friend Lord Bethell, and with the leave of the House, I beg to move the four Motions standing in his name on the Order Paper en bloc.

Covid-19 Regulations: Assisted Deaths Abroad

Lord Bethell Excerpts

Tuesday 10th November 2020 Lords Chamber

[Baroness Thornton (Lab)]

My Lords, I think it is to be welcomed that the response to the Urgent Question last week was that travelling for the purposes of an assisted death would be exempt from lockdown travel restrictions. However, there are concerns that this Statement did not go into detail about whether family members could accompany people. Legal constraints mean that it is not clear whether the exemption applies to them. Presumably, they would have to demonstrate their reasons for travel and might, in the course of doing so, incriminate themselves for assisting a suicide. So can the Minister clarify that family members accompanying someone travelling for an assisted death will not be vulnerable in this way? If the Minister does not know the answer in detail to this important question, please would he seek to find out from the Ministry of Justice, write to me, and put the letter in the Library?

[The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell) (Con)]

The noble Baroness is entirely right on the question of travelling abroad for the purpose of assisted dying. It would be regarded as a reasonable excuse, and therefore anyone who did would not be breaking the law. In answer to the noble Baroness’s question, under Section 2(1) of the Suicide Act 1961, a person does commit an offence if he or she

“does an act capable of encouraging or assisting the suicide or attempted suicide of another person”

and that act

“was intended to encourage or assist suicide or an attempt at suicide.”

The 1961 Act provides no exceptions to the prohibition on assisting suicide. The maximum penalty, as noble Lords may know, is 14 years, and there is nothing in the Coronavirus Act or any recent legislation that in any way changes that.

[Lord Purvis of Tweed (LD)]

My Lords, whilst the 1961 Act provides no exemptions, as the Minister said, the Director of Public Prosecutions has issued guidance with regard to the avoidance of prosecution in this area. Will the Government ask for that guidance to be looked at again, in the context of the sensitive words of the Secretary of State for Health, to avoid the very situation that has happened in the past where public authorities sought injunctions against family members who supported those who took the very difficult decision to travel abroad? I live in Scotland, where the Suicide Act 1961 has never applied. Will the Government work with the Scottish Government to start collecting data? It was welcome that the Health Secretary indicated the openness of the Government to do that, so we can get a proper understanding of how many people are making the very difficult decision to travel abroad.

[Lord Bethell (Con)]

The noble Lord is entirely correct; the Director of Public Prosecutions’ policy for prosecutors in respect of cases of encouraging or assisting suicide sets out factors which prosecutors in England and Wales will consider, in addition to those already outlined in the code for Crown Prosecutors when deciding whether it is in the public interest to prosecute in cases of encouraging or assisting suicide. Among the public interest factors tending against prosecution are that the victim had reached a voluntary, clear, settled and informed decision to commit suicide and that the suspect was “wholly motivated by compassion”. I completely take on board the noble Lord’s encouragement of this review. There is no review planned, but we all acknowledge the changing tone of this debate and I will take his suggestion back to the department. On the point about Scotland and data, I acknowledge different circumstances in Scotland and the remarks on the importance of collecting data from my noble friend in the other place. That is indeed our intention.

[Baroness Hayman (CB) [V]]

My Lords, the Minister’s response to the second question today was more reassuring than his response to the first. I am sure he would agree that these are desperately difficult situations for families, and to have the uncertainty about whether someone would have to undertake alone a journey that should never be undertaken alone because of a wish to protect their relatives from prosecution is frankly unthinkable. On the wider point, could he assure the House that some urgency will be given to this issue of collecting data and seeing in the round the problems that are being caused? We have had piecemeal changes such as the changes from the DPP, but we need to understand more comprehensively the exact implications of what is going on.

[Lord Bethell (Con)]

The noble Baroness is entirely right; Covid has, in a very sad way, thrown a spotlight on the circumstances of those dying alone. That is one of the harshest and most heart-breaking dimensions of this awful pandemic. It throws a spotlight in particular on the way in which the law is applied in this country. The collection of data is a very important component of our review of this important area and I will definitely ensure that the indication given by my right honourable friend in the other place is picked up back at the department.

[Baroness Jay of Paddington (Lab) [V]]

My Lords, I am generally encouraged and relieved by the Government’s responses on this Statement, particularly the point made in the Commons by the Secretary of State that assisted dying must be considered in the general discussion of good end of life care. I hear the Minister say that a formal review is not planned, but when the Government come to look at the concerns about death and dying that have been thrown up by the pandemic, will they ensure that the questions of proper personal choice at the end of life will be both included and emphasised?

[Lord Bethell (Con)]

Well, this is an extremely complex issue. As the noble Baroness alluded to, there is a wide variety of issues at stake, including values issues, questions of faith and, as she rightly said, questions of personal choice. There are the components here for an important national debate. I acknowledge the comments of several noble Lords already that we are approaching the moment when that debate seems more relevant than it has ever done. When that debate takes place, certainly personal choice will be an important part of it.

[Baroness Grey-Thompson (CB) [V]]

What advice did the Secretary of State, Matt Hancock, have from the Director of Public Prosecutions in relation to the official guidance? The response on travelling to Dignitas suggests assisting suicide is an urgent act and encourages the suicide of those with disabling conditions. Some 25 years on from the Disability Discrimination Act, and with the rise in post-Covid mental health problems, this is particularly inappropriate, as data from other countries shows that the major driver for seeking assisted suicide is the fear of being a burden, and other social factors.

[Lord Bethell (Con)]

In direct answer to the noble Baroness’s question, I am not sure whether any advice was given by the DPP, because there has been no change in the law. Nothing we have done here changes in any way either the 1961 Act or the advice of the DPP. So, from that point of view, the consultation is not necessary. What we have sought to do is clarify travel guidance in a way that does not change the application of the law in the country.

[Baroness Jenkin of Kennington (Con) [V]]

My Lords, the Secretary of State said in the other place that this conversation on assisted dying must happen

“in an evidence-based, sensible and compassionate way.”—[Official Report, Commons, 5/11/20; col. 480.]

What efforts will the Government be making to ensure that we as a House have all the evidence available to us when this important debate next reaches the Chamber?

[Lord Bethell (Con)]

My Lords, the debate has not been scheduled, but evidence that would be of interest includes evidence from clinicians themselves, many of whom have seen some movement in their attitudes on this subject. There is also an enormous amount of values-based and faith-based evidence from those who have a particular view on this subject. There is also the evidence of the personal choices of those approaching death themselves. There are extremely moving testimonies by individuals faced with very daunting and challenging circumstances. All of these views have relevance and value, and they should all be part of this important and delicate debate.

[Baroness Stuart of Edgbaston (Non-Afl)]

My Lords, in response to the noble Baroness, Lady Grey-Thompson, the Minister stressed that this was travel advice, but surely it goes further than just travel advice. At a time of Covid, when many people in care homes would seek the companionship of members of their families but forgo it in the wider community interest, is it really the right decision to create a presumption that people at the end of life only have the option to travel abroad and to facilitate that? Surely more palliative care and more focus on helping people to a good death are more important during this Covid crisis than facilitating people to travel abroad.

[Lord Bethell (Con)]

I entirely agree with the noble Baroness that the contribution of hospices and the role of those involved in palliative care has been an incredibly important part of the Covid crisis, and it has given huge succour, compassion and care for those at the end of their life. We have sought to help with the financing of the hospice community with a substantial £150 million payment in the first wave, and there are currently talks in place on funding for hospice care through the second wave. Hospices’ work is enormously valued, and anything in this debate does nothing to underplay the value of the role that they play at the end of people’s lives.

[The Deputy Speaker (Lord Haskel) (Lab)]

My Lords, the time allowed for this Question has now elapsed, so I move to the next item of business.

Covid-19: Transparency and Accuracy of Statistics

Lord Bethell Excerpts

Monday 9th November 2020 Lords Chamber

[The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell) (Con)]

My Lords, the Office for Statistics Regulation is 100% right: the best use of data and statistics is critical in this unprecedented time. All slides and data from press conferences are published on GOV.UK, normally at the time of the press conference. The Government are committed to transparency to build public trust throughout the pandemic; that is why we publish data, the modelling used and any revisions as part of this process.

[Lord Lilley (Con)]

I thank my noble friend. Does he realise that this rebuke from the statistics regulator is unprecedented, as is the unparalleled series of errors, dubious charts, outdated data and failed projections? It would be bad enough if those errors were random, but they all point in the same direction: alarmism justifying a lockdown. It is invariably a symptom of groupthink when sincere people—I have been there myself—become so wedded to a prediction or policy that they uncritically accept evidence that supports it and ignore facts that challenge it. Will he heed the warning of the great Professor Feynman: when you convert even the finest scientists into policy advocates, you risk ending up with what he called cargo cult science? Should we not leave advocacy to politicians and ask scientists for balanced advice?

[Lord Bethell (Con)]

My Lords, we are grateful to the Office for Statistics Regulation for its challenge; its points were perfectly reasonable and we take them on board completely. However, I reject the characterisation made by my noble friend and his suggestion that the modelling is either political or erroneous in some way. I remind him that, in January, the modelling showed that the epidemic in China was considerably larger than anything reported at the time. In February and March, we used data from the “Diamond Princess” and elsewhere to show how the threat of Covid was much larger than had previously been understood. In March, we showed that the epidemic in the UK was doubling every three to four days, allowing us to make the difficult decision to lock down. Throughout the spring, the modelling demonstrated that half the UK had not been infected, as previously thought.

In mid-September, the modelling showed that we were at the start of a second wave, despite those who said that there was no evidence of it. It also showed that the uptick in cases involving younger people would spread to older adults and, as a result, into healthcare. Most recently, the six-week projections of SPI-M that were produced throughout October, based on contemporary trends, have been remarkably accurate at assessing the trajectory of hospital admissions and deaths.

[Lord Desai (Lab) [V]]

My Lords, the fact is that the public have lost trust in scientists and science. They lost trust in government long ago. Is it not time for the Government to ask the Royal Society to carry out a thorough check and review of every statistic released by SAGE or any other government adviser so that we can be sure that the statistics are presented properly, are sound and are not exaggerated so as to mislead the public?

--- Later in debate ---

[Lord Bethell (Con)]

My Lords, I am grateful to the Royal Society for its involvement in much of the work that we are discussing; it is a key contributor to some of the scientific thinking and modelling. As for public support, I remind the noble Lord that there is enormous public support for the measures introduced by the Government: in fact, more people think that our measures have not gone far enough than support them.

[Baroness Jolly (LD) [V]]

My Lords, the same level of regional and cluster detail is needed for the Covid-19 status of residents in care homes as for those in the NHS. When do we expect to have this level of detail for care homes? Can the Minister tell the House how many people are currently resident in English care homes with Covid-19 and what level of confidence the Government have in official statistics on that subject?

[Lord Bethell (Con)]

My Lords, the noble Baroness is right that, statistically, care homes present a unique challenge. There are more than 15,000 care homes, many of which are not plugged into day-to-day statistical canvassing and, therefore, knowing exactly what happens in every care home every day is a particularly large challenge. However, we have thrown an enormous amount of resources at that problem, and our understanding of the care home situation in relation to Covid is much better than it was. The precise statistics she asks for today are not at my fingertips, but I would be glad to write to her with a number.

[Lord Lamont of Lerwick (Con)]

My Lords, would the Minister agree that it is an extremely serious matter when the statistics authority criticises government advisers’ use of statistics? If the public are to accept lockdown and all the restrictions involved, they need to have confidence in the statistics and that they are not speculative. Would the Minister agree that the graph with four scenarios for daily deaths from Covid, rising to 4,000 a day—a rate that exceeds that of Brazil, which has three times our population—should never have been shown at the Prime Minister’s press conference? If he does not agree with that, why was it subsequently modified?

[Lord Bethell (Con)]

My Lords, my noble friend is entirely right: statistics are critical and very important to public trust. No one takes them more seriously than this Government. However, I remind him that it was not the statistics that the Office for Statistics Regulation expressed concern about; it was about material being used in press conferences that has not been published at the press conferences as they happened. That was a function of the speed at which that press conference was turned around, but he is entirely right that that chart had a presentational error in it, which was corrected. It was published as a result of the publication of the data behind it. I reassure him that the data upon which decisions were made and the data that went into the central case of that chart was correct, and the fact that we have changed it demonstrates that we are committed to transparency in all these matters.

[Baroness Hollins (CB) [V]]

My Lords, my question is about when Her Majesty’s Government will make accessible communication a priority. The Prime Minister’s press conference was like a scientific symposium, except that the slides were presented too quickly, with too much information. It felt as if we were being blinded by science. Does the Minister agree that providing information that is accessible to all viewers would be a more effective public education strategy, and that that means using everyday language?

[Lord Bethell (Con)]

On the manner in which the information was delivered, I take the noble Baroness’s comments completely on board. While it is not my role to be in charge of the presentation of No. 10 presentations, I think a lot of people would agree with her that there were a lot of slides, which were very detailed and not all formatted for the TV screen. However, we are trying our hardest to share with the public as much of the insight and science as we possibly can, and we are trying to hit that balance between too little and too much information. We are trying to publish data as soon as it can be reasonably verified. There will be some scratchiness around the edges on that, and I take the noble Baroness’s points about last Saturday completely on board. However, the commitment to transparency and open debate on these issues is sincere.

[Baroness Thornton (Lab)]

When will the Government start sharing data and having meaningful discussions before decisions are taken? Given that public confidence in these decisions is crucial for them to work, will the Government start working with the opposition parties, which they expect to—and which have—supported the lockdowns and proposals, as Keir Starmer and others have been offering for months?

[Lord Bethell (Con)]

The noble Baroness is right to pinpoint the sharing of data as being very important, and we have been as open and transparent as we can be. We publish an enormous amount of data. Just before this debate, I tweeted three of the main portals to the data, which there is not only an unprecedented quantity of but which is more up to date than could reasonably have been expected a few months ago, when such data was not available. Some of these decisions are made extremely quickly because the data changes so quickly. Sometimes, one believes that we are on track for one thing, and then the virus changes course and we have to change our policies accordingly. That is simply a fact of the challenge of fighting this virus: speed is of the essence, and sometimes it has been extremely difficult to do the kinds of consultation that the noble Baroness quite reasonably describes.

[Viscount Ridley (Con) [V]]

My Lords, my noble friend the Minister just said that the data changes quickly. Does he accept that all three datasets published towards the end of last week on reliable information on the number of positive cases, which is to say those of the Office for National Statistics, the government dashboard and King's College London’s COVID symptom study, all point to the second wave having already peaked and being on the way down, unlike the faulty models used to justify lockdown last weekend? Does he accept that this gives the Government every reason to pause the decision to impose a national lockdown and reconsider it?

--- Later in debate ---

[Lord Bethell (Con)]

The noble Viscount and I have corresponded on this matter. I do not accept that they suggested that the number of admissions was on the way down. Undoubtedly, the rate of increase has decelerated, but a lengthening doubling time is not the same as a halving time. The doubling time for hospital admissions was eight days at the start of September, 14 at the start of October and 20 days at the end of October. That is a slowing down of the increase, but it is not the same as a decrease.

[Lord Alton of Liverpool (CB) [V]]

My Lords, can the Minister tell us what analysis the Government have made of the root cause and relationship to lockdowns of some 20,000 excess deaths unrelated to Covid-19 during the first wave of the pandemic, including suicide, bacterial sepsis, cardiovascular disease, cancer and other conditions? Should the Government not be publishing regular analyses of the overall harm and not just contested projections of 4,000 deaths each day or the other figures that the noble Lord, Lord Lilley, and the noble Viscount, Lord Ridley, have just mentioned?

[Lord Bethell (Con)]

The noble Lord makes a very good point. We do publish data on excess deaths, which is available on the PHE website, but he is entirely right: we are deeply concerned not just about the Covid deaths but the impact of Covid on others who may be seeking to access the healthcare system. That is why we made the very hard and tough decision to lock down before the NHS was put under too much pressure, and it is why we have made the commitment to keep the NHS open during this lockdown in order to manage down that excess deaths figure to which he refers.

[Lord Rooker (Lab) [V]]

My Lords, given the leak, there must have been an element of rush for the Saturday press conference: 4 pm became 7 pm; I suspect a degree of panic. The leaker—and Gove, Hancock and Cummings must be suspects—is the cause of this. The refusal to accept supplementary questions at the press conference also contributed, because no sources were given, and the small print showed that the information was from early October. Therefore, in future, please could we have a Spiegelhalter kitemark on graphs at press conferences?

[Lord Bethell (Con)]

We all respect the word of Professor Spiegelhalter, who is a great man, but we have instead the Office for National Statistics and the publication of the graphs and the data behind them. I would be glad to send to the noble Lord a link, both to the slides and the data behind them, so that he can check them out for himself.

[The Deputy Speaker (Baroness Garden of Frognal) (LD)]

The noble Lord, Lord Fairfax of Cameron, is unable to join us, so I call the noble Viscount, Lord Waverley.

--- Later in debate ---

[Lord Bethell (Con)]

I will take on board the comments of the noble Lord. We try to make our briefings as accessible as possible. The point he made is perfectly reasonable. Let me look into whether there is more we could be doing and talk to the stakeholders involved about whether we should be doing more.

[Lord Taylor of Warwick (Non-Afl)]

Data should always make trust greater. Covid-19 appears to have more of an effect on BAME communities than their white counterparts. What further research are the Government carrying out in relation to the data to find out the reasons why?

[Lord Bethell (Con)]

The noble Lord is entirely right. The concerns we have for disadvantaged groups and those of an ethnic background are deep and sincere. That is why we have a large programme of work, sponsored by the NIHR, looking into a variety of different research projects to understand the behaviour of the virus and why it hits certain groups particularly hard.

[Lord Howard of Rising (Con)]

Could the Minister clarify whether or not Professor Neil Ferguson, who has given such misleading forecasts, was involved in the preparation of the charts and graphs used on 31 October? Not only were they out of date, they were so inaccurate that the question arises whether those involved in the preparation of the material paused to consider if what they had produced might be badly misleading.

[Lord Bethell (Con)]

My Lords, I am afraid I do not know the precise roles of individual academics in the preparation of those charts. I am happy to go back to the department to see if I can find out, and will reply to the noble Lord.

Covid-19: Contracts and Mass Testing Programme

Lord Bethell Excerpts

Wednesday 4th November 2020 Lords Chamber

[Lord Harris of Haringey]

To ask Her Majesty's Government how many contracts they have placed for the purchase of (1) personal protective equipment, and (2) the mass Covid-19 testing programme, (a) with suppliers identified as “VIPs”, and (b) using fast-track procurement procedures since 1 March; what is the total value of any such contracts; and what steps they are taking to demonstrate that such contracts (a) represented value for money, and (b) involved no favouritism.

[The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell) (Con)]

My Lords, 289 contracts with an estimated value of £6.1 billion have been awarded by the DHSC to private sector suppliers to support test and trace, and 370 contracts worth an estimated £8.3 billion for the delivery of PPE. These figures are currently being validated with the National Audit Office. A direct award of a contract—an option available under the procurement regulations in cases of extreme urgency—has been used in the great majority of these cases. I reassure noble Lords that suppliers are evaluated by departmental officials and awarded contracts in line with the DHSC’s standard contract terms and conditions.

[Lord Harris of Haringey (Lab)]

My Lords, the noble Lord must realise that he is in danger of appearing complicit in the stench surrounding these procurements. On 6 April, he met with Meller Designs, which provides beauty products. It is owned by a man who was the finance chief of Michael Gove’s leadership campaign and a donor to the Conservative Party, while the noble Lord, Lord Feldman, who also sat in on that meeting, was chairman of the party. A few weeks later, the company was awarded a series of contracts amounting to £155 million for face masks and hand sanitisers. Those did not go through the normal procurement processes. What was discussed on 6 April? Will the Minister publish all documentation relating to every one of these VIP and fast-track procurements, including emails or messages suggesting specific contractors, and show how decisions were based on value for money rather than favouritism?

[Lord Bethell (Con)]

My Lords, the noble Lord will remember that at the beginning of this year the global supply of PPE, in particular, and other medical supplies completely collapsed. There was a global drought in the supply of key materials necessary for the protection of doctors, nurses and front-line healthcare staff. In those circumstances, we relied on a very large network of contacts and formal and informal arrangements in order, under extremely difficult circumstances, to reach the people who could manufacture these supplies, often moving their manufacturing from one product to another.

[A noble Lord]

Oh!

[Lord Bethell (Con)]

My Lords, please.

[The Lord Speaker (Lord Fowler)]

Would noble Lords please not interrupt the Minister.

[Lord Bethell (Con)]

We have published 80% of the contracts to date and are working on publishing the rest. I hope that that will meet noble Lords’ expectations.

[Lord Sikka (Lab) [V]]

KPMG, PricewaterhouseCoopers, Deloitte and Ernst & Young have been fined for audit failures and have regularly been chastised by the regulator, even though they have been doing audits for over a century. They have no experience of test and trace or of dealing with viruses but have received multimillion-pound Covid contracts. What due diligence checks were carried out by the Government and how? Will the Government inform Parliament and allow a public audit of all their checks on these firms?

[Lord Bethell (Con)]

My Lords, the circumstances of the pandemic were exceptional, and I am not sure that any large company had any experience of putting together a national test and trace programme. The firms to which the noble Lord refers have considerable consulting experience and the capacity to support the national rollout of a large organisation such as NHS Test and Trace. They have provided invaluable support to the country at a time of need. All our contracts are scrutinised extremely closely by the finance function in the DHSC, and we are supported in that by the government legal service and finance staff from the MoD and the Cabinet Office, for which we are enormously grateful.

[Baroness Barker (LD)]

My Lords, in July, a company called Topham Guerin was given a £3 million contract, without any tender process, to test public understanding of health messages relating to Covid. It did not have any experience in health messaging; those running the company appeared to be friends of Dominic Cummings and Michael Gove. Will the Government now publish the tender that has subsequently been issued, the research findings and the evaluation relating to this contract? As the country goes into lockdown, it is fair that taxpayers know whether we are paying money for old rope.

[Lord Bethell (Con)]

My Lords, the insight into how the public react to key messages associated with our healthcare and health advice has been absolutely critical. Behavioural change and asking the public to step up to extremely challenging requests from the Government require a huge amount of analysis and study. The support from our own communications team has been supplemented by agency support, which has both the capacity and the expertise to provide the necessary insight. That insight has been critical to the success of our messaging.

[Baroness Warsi (Con) [V]]

My Lords, there is little doubt that one of the main reasons we are re-entering lockdown this week is the failure of Serco’s track and trace system, which the Prime Minister promised would be world beating. I do not want to go into the detail of the connections between Serco and the party and key members of the Government. However, on a general level, can my noble friend justify renewing the Government’s contract with Serco when it has failed so badly, resulting in loss of life and livelihoods—a situation that SAGE has warned will decline further in the future?

[Lord Bethell (Con)]

My Lords, I do not accept the assumption that we are going into a second lockdown because of the failure of tracing. The tracing system has led to the isolation of more than 1 million individuals, which has done an enormous amount to break the chain of transmission. However, there is more that we could do. I completely acknowledge that the Government are focused on improving performance in tracing, and we will use the opportunity of the next month to ensure that that performance gets better.

[Baroness Finlay of Llandaff (CB) [V]]

My Lords, I declare my interests in medicine. Given that 55% of GPs, 35% of physicians and 11% of surgeons recently reported that they lack confidence in adequate PPE being available during the ongoing pandemic, when will the Government issue revised guidance to all NHS managers insisting on a duty of care to all front-line staff to ensure that staff are supplied with quality-certified appropriate PPE that is in date and fit tested under a risk assessment for the well-being of the clinical workforce? Have the Government commissioned research into reusable UK-manufactured PPE?

[Lord Bethell (Con)]

My Lords, we take the duty of care to our staff and patients extremely seriously, and that is already well documented by the NHS. I reassure the noble Baroness that purchase orders have been raised for 32 billion items of PPE in anticipation of a second wave; 18.6 billion items have already been delivered, 2.2 billion are with our delivery partners, and a further 16 billion are on their way. This is a massive investment in PPE and I reassure her that it will be made available to healthcare staff in abundance.

[Baroness Thornton (Lab)]

My Lords, it seems to me that, however urgent the requirement for PPE and other services, transparency becomes even more important in those circumstances. The Minister will be fully aware that the Ministerial Code says that Ministers are responsible for ensuring that no conflict exists, or appears to exist, between their personal interests and their public duty. As the former chair of a procurement committee for MyCCG, I received extensive NHS training on conflicts of interest, which are defined as

“a set of circumstances by which a reasonable person would consider that an individual’s ability to apply judgement or act, in the context of delivering, commissioning, or assuring taxpayer funded health and care services is, or could be, impaired or influenced by another interest they hold.”

Perception is as important as reality. Has the noble Lord declared the interests that arise out of the meetings that other noble Lords have mentioned today? Where are they recorded and published?

[Lord Bethell (Con)]

The noble Baroness is right that transparency is key. I take those principles extremely seriously, and that is why we are publishing the contracts. I encourage anyone who is interested in looking at them to look at my Twitter feed, where I published a link to the Contracts Finder service yesterday. I reassure her that, although some connections were made through networks, absolutely every contract had exactly the same technical assurance, exactly the same contract negotiation and exactly the same procurement scrutiny. Those were done by civil servants, and value for money for the taxpayer and the people was guaranteed by that process.

[Lord Scriven (LD)]

My Lords, the Minister seems to say that there is nothing to see here, whereas some of us think that there is a whiff of uncertainty and of some things being not quite right. Therefore, will he agree to appoint an independent forensic auditor to carry out an independent report that can be published publicly to show exactly what has happened with PPE procurement?

[Lord Bethell (Con)]

My Lords, I do not want to give the impression that absolutely everything is perfect. Those were desperate days and we had to do extraordinary things to protect our healthcare staff. I remind noble Lords that other countries were flying in their representatives with bags of cash on private jets in order to seal contracts and some of our supplies were literally taken from under our noses on the runway at Hong Kong airport. They were extremely difficult times and I do not pretend for a moment that everything was absolutely perfect, but I reassure noble Lords that the right procedures were put in place by officials, and I reassure the noble Lord that these figures are currently being validated with the National Audit Office.

[The Lord Speaker (Lord Fowler)]

My Lords, the time allowed for this Question has elapsed and it brings Question Time to an end.

Health Protection (Coronavirus) (Restrictions) (England) (No. 4) Regulations 2020

Lord Bethell Excerpts

Wednesday 4th November 2020 Lords Chamber

Moved by

[Lord Bethell]

That the Regulations laid before the House on 3 November be approved.

Relevant document: Instrument not yet reported by the Joint Committee on Statutory Instruments

[The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell) (Con)]

My Lords, we have come to a critical juncture. Incidence rates are growing, and the NHS is under increasing pressure. The ONS now estimates that approximately 568,100—one in 100 people—in England have Covid-19. That has risen from one in 2,000 in July, and one in 240 at the beginning of October.

The Prime Minister explained things very clearly in the other place. The R number is above one in every part of England, the virus is spreading even faster than the reasonable worst-case scenario, there are already more Covid patients in some hospitals than there were in the first wave, and, even in the south-west, current projections mean that we will start to run out of hospital capacity in a matter of weeks. The chief executive of NHS Providers, the membership organisation for NHS trusts, said:

“Looking forward, there is a clear and present danger that the NHS will not be able to treat all the patients it needs to in the best and most timely way.”


The modelling presented by our scientists suggests that, without action, we could see up to twice as many deaths over the winter as we saw in the first wave.

I recognise that some noble Lords are sceptical about whether the full range of measures in these SIs is needed right now, or whether they are needed at all. I acknowledge the concern that perhaps the cure does more damage than the disease itself, but that is not the belief of the Government. Without action, the NHS will be overwhelmed, which could put life-saving procedures, cancer therapies, emergency services and diagnostic investigations at risk.

It is true that we are much better prepared than before, with large stockpiles of PPE and ventilators, the Nightingales on standby and 13,000 more nurses than last time. However, the virus is growing exponentially, far faster and heading far further than we could ever conceivably add capacity for. Even if, by some incredible national effort, we doubled capacity, that gain would be consumed in one gulp of the virus doubling once.

Meanwhile, the scientific evidence shows us that the measures have worked and lives have been saved. The analysis of my department, the Office for National Statistics and the Government Actuary’s Department has shown that the mitigations we have put in place have prevented more than 500,000 deaths, and our previous sacrifices and efforts have therefore saved us all from untold personal heartache, civic pressure and economic disruption.

However, we recognise that these interventions are difficult for many people, and that is why we have evolved our approach from the first wave and the previous lockdown. I will say a few words about this. For the first lockdown we paused non-urgent care to stop the NHS being overwhelmed. This time, we are maintaining as many NHS services as possible. In response to arguments made forcefully by noble Lords in this Chamber, we are prioritising education—doing everything we can to keep open schools, colleges, universities, childcare and early years settings.

We have taken steps to mitigate the impact on the vulnerable: the new lockdown measures include allowing support and childcare bubbles, support groups and unlimited outdoor exercise, for instance, to continue. We have amended guidelines to suggest that the clinically vulnerable and the over-60s should minimise their contact with others, and the clinically extremely vulnerable should work only from home, rather than asking them and their households to shield themselves, as we did for the first lockdown. On funerals, we have changed the Covid-secure guidelines to allow up to 30 people to attend.

Lastly, we have improved how we work with local authorities to support them in responding to this crisis. My department has regional teams made up of PHE regional directors, Contain regional convenors and Joint Biosecurity Centre regional leads, who work continuously with local authority chief executives, the directors of public health and local resilience forums. I pay testimony to all those noble Lords who have brought this challenge to our attention. These groups attend local incident management meetings and outbreak boards as well as meeting more informally. They also organise meetings at a regional level to share good practice and help areas support each other through mutual aid.

In relation to those who are less privileged and in the area of financial support—another subject raised by noble Lords—we completely recognise that these measures are difficult for the general public and business, which is why we will provide support to protect jobs and get people through the crisis. This includes extending the furlough scheme until the end of November, helping with mortgages, helping the self-employed—as the Prime Minister outlined earlier this month, we are doubling our support from 40% to 80% of trading profits—extending the deadline for applications to the Covid loans schemes, cash grants of up to £3,000 per month for business premises closed as a result of the national lockdown, additional funding worth £20 per head to enable local authorities to support other business affected by the lockdown, and other measures.

My final points are on the steps out of this lockdown. I stress that these restrictions are time limited: after four weeks, on Wednesday 2 December, they will expire, and we will return to a tiered system on a local and regional basis according to the latest data and trends. As the Prime Minister set out in the other place, the best way to get R down now is to beat this autumn surge and use the breathing space to exploit the medical and technical advantages we are making to keep it low.

Our doctors and scientists have led the way in improving how we treat people with Covid, work continues to progress on developing a vaccine and we are working to continue to increase our testing capacity, most notably with cheap, reliable and rapid-turnaround tests with results in minutes. As the Prime Minister outlined, plans are already in place for the deployment of these quick-turnaround tests, which we will manufacture in this country and apply in an ever-growing number of situations to allow us to beat the disease.

By way of conclusion, I acknowledge that these measures are difficult for us all. There is not one of us who does not regard them with a heavy heart, but I know that the general public will continue to come together, as they always have done. Together, we can protect the NHS and the vulnerable, and save lives. We must place difficult but time-limited curbs on our freedom in the short term so that we ensure greater freedom and prosperity in the long term. If we act now to suppress the virus and support the economy, education and the NHS, we can restore those cherished freedoms more quickly and get closer to the lives that we all want to be living. We cannot do this with the virus growing exponentially so we must all make sacrifices now for the safety of all. It will not be easy, I know, but in a pandemic the effective steps are not always easy. We are called on to make fundamental changes to how we work, live and interact with each other, in pursuit of a common cause. I beg to move.

Amendment to the Motion

Moved by

--- Later in debate ---

[Lord Bethell (Con)]

My Lords, this has been a hard-hitting debate. I thank noble Lords for their clarity and candour. In honesty, I do not agree with everything that has been said, but I share the frustration expressed by noble Lords in the Chamber and I absolutely recognise the seriousness of the issues that have been raised.

Before going further, I reiterate noble Lords’ thanks to those NHS, social care and ancillary services for their ongoing work to tackle the virus, and to the public for the sacrifices that they have already made. I also thank the usual channels for allowing this debate to be scheduled before the regulations we are debating come into effect. I recognise that the delay in holding debates has been a concern for a number of Members, as has been raised many times in this Chamber, including by the noble Baroness, Lady Jolly. We have listened and will continue to value noble Lords’ scrutiny as we respond to the Covid crisis.

I completely hear the concerns of my noble friends Lord Robathan, Lord Forsyth and Lady Noakes and others that we have not published an impact statement. This is a temporary piece of legislation; there is no requirement to publish an impact statement. However, there has been a very large amount of published data, shared analysis and debate on these subjects. My noble friend Lord Mancroft put it very well with his characteristic colour. With NHS data, test and trace data, PHE data, SPI-M data and SAGE papers, a colossal amount of scientific data has been published into a vigorous debate. It is impossible to generate a scientific consensus; that is not what science is about. It is up to the politicians to make the decision. It has been the Government’s decision to go into these measures, and we stand by them, but in doing so we welcome the scrutiny of this Chamber and Parliament. I welcome the fact that we are debating these regulations today.

Noble Lords have raised a number of issues about the regulations. I would like to reference them, even if I do not have the time or capacity to offer answers to each and every one. A lot of them are about how we mitigate the lockdown measures. As I said in my opening words, we have already done a lot but there is more that we can do.

The noble Baroness, Lady Meacher, made a very good point about vape shops; I am happy to take that back to the department.

A number of Peers, including the noble Baroness, mentioned tennis and golf; that has been discussed and is the subject of a high-profile petition. I will take that back to the department as well.

The noble Baroness, Lady Bonham-Carter, and others mentioned rehearsals and live events, a subject that I care about enormously.

In terms of the relatives of those in care homes, particularly those visitors who provide an enormous amount of service and support for their loved ones, we are working really hard to get the testing capacity and systems in place to change the situation. The noble Baroness, Lady Walmsley, and the noble Lord, Lord Rooker, raised this.

The challenge faced by special needs children whose schools have been shut was well raised by the noble Baroness, Lady Walmsley. There will be challenges around riding schools for the disabled, but I am happy to take that back to the department. The noble Lord, Lord Knight, and the noble Baroness, Lady Jolly, mentioned children playing together, a situation that I am very aware of and one that I can definitely look into.

Private music teaching, raised by the noble Earl, Lord Clancarty, and the noble Lord, Lord Berkeley, swimming in pools, raised by the noble Baroness, Lady Altmann, and affordable food, raised by the noble Baroness, Lady Boycott, are all subjects that I am happy to take back to the department and write to noble Lords on.

Most powerful and emphatic was the point on freedom to worship, which my noble friends Lord Cormack and Lord Moylan, the right reverend Prelate the Bishop of Winchester and the noble Baroness, Lady Altmann, all raised. It is a very touching and important issue. I am happy to take it back to look into it further and, if possible, seek some sort of mitigation.

The noble Lord, Lord Desai, put it well when he described the “luxury” of six Motions on this SI; it is not something that I have come across before. I will try to enjoy the privilege in addressing them.

The concern of my noble friend Lord Lilley that the regulations were laid under the Public Health (Control of Disease) Act 1984 has been raised a number of times in the Chamber. I have answered it a few times before but will do so again. His point is that this Act does not give specific powers to Her Majesty’s Government to impose restrictions on uninfected persons. However, the Government’s view is that this legislation does provide those powers. I am happy to take up his points on the Civil Contingencies Act with him. It has been looked at by the Government, but our very strong advice is that it could not be used on this occasion.

In relation to the concerns of my noble friends Lord Shinkwin and Lord Cormack, I do not agree that we compare unfavourably with totalitarian regimes. This virus can infect everyone, and the only way to protect our loved ones is by taking the necessary steps to bring down the R number. Our measures have been applied largely through consent and enjoy enormous popular support.

I completely agree with the concerns of the noble Baroness, Lady Meyer, on the impact of the lockdown on mental illness and other long-term psychological harm. The Government share these concerns and we have taken a huge number of steps to reduce the risk, which include providing exemptions to stay-at-home guidance and supporting the charities concerned.

A number of noble Lords including the noble Lord, Lord Scriven, raised NHS Test and Trace and the challenge around tracing. I agree that the regulation provides breathing space for us to upgrade the tracing service and build the capacity of the testing service. Noble Lords mentioned the work we are doing on that in Liverpool; that will be an enormously impactful pilot and experiment which, if it proves successful, could have a transformative effect on the way in which we manage this pandemic.

The noble Lord, Lord Boateng, referred to the challenge faced by those from a BAME background. I reassure him that staff who are potentially at greater risk of serious illness from Covid have been protected. Over 95% of BAME staff in the NHS have received risk assessments and, where necessary, agreed to mitigating measures.

As I said before, no Government would want to take these measures. However, if we do not take them now, we will not make use of the hard work and sacrifices that we have all made. We do not seek to repeat the mistakes of the past, but to demonstrate that we have a plan and are serious about beating this virus. As the Prime Minister said in the other place, although scientists are bleak in their predictions in the short term, we are unanimously optimistic about the medium and long terms. The noble Baroness, Lady Thornton, asked about the exit strategy. The ongoing work on vaccines and test and trace will, I believe, allow us to beat this virus.

I will quite happily come back to the House when these regulations are near their expiry, if not before, to update your Lordships on our next steps. I believe that the case is proven, and that the necessity and urgency of these measures have been put forward by the Government. For that reason, I respectfully ask that my noble friends Lord Robathan, Lord Forsyth, Lady Noakes, Lord Shinkwin, Lady Meyer and Lord Lilley withdraw their amendments to the Motion. I hope that I have addressed noble Lords’ questions, and beg to move.

Medicines and Medical Devices Bill

Lord Bethell Excerpts

Committee stage & Committee: 4th sitting (Hansard) & Committee: 4th sitting (Hansard): House of Lords
Wednesday 4th November 2020 Grand Committee

[Baroness Jolly (LD) [V]]

I should apologise to noble Lords: my noble friend Lord Clement-Jones is unable to be part of today’s Committee, so I will be speaking on his behalf—at some length but without, I suspect, his bravura.

Amendment 30 seeks to tighten the provisions in Clause 3 to avoid the unintended consequences of data being used for purposes other than to ensure that medicines are safe. Amendment 31 also seeks to do this, by requiring a framework for data to be used as agreed in consultation with the pharmaceutical industry, and Amendment 33 places a duty on the Secretary of State to

“act with a view to”,

rather than

“have regard to the importance of”,

ensuring that information is retained securely when exercising powers.

There is no doubt that the noble Baroness, Lady Thornton, the noble Lord, Lord Hunt, and my noble friend Lord Clement-Jones are travelling down the same road, and I have very similar concerns. That is why we signed Amendment 30, and I am grateful to the noble Lord, Lord Hunt, for his support for the amendment tabled by my noble friend Lord Clement-Jones.

As explained at Second Reading, there are grave concerns about the wording of Clause 3(1)(b), relating to the development of a UK system to prevent the supply of falsified medicines. The clause refers to

“the use, retention and disclosure, for any purpose to do with human medicines, of information collected”

by such a system. This is an attempt to unreasonably broaden the original data-collection provisions of the Falsified Medicines Directive after the transition period.

The background to the current legislation is very clear. By the early 2000s, pharmaceutical companies were concerned about falsified, counterfeit products entering the legitimate medicines supply chain—especially high-value items such as Viagra. At that time, this was the only real way to distribute such products at scale. Schemes involving pack serialisation were proposed to reduce the risk of reputational and trading losses from counterfeit and falsified medicines entering the supply chain, and to reduce the potential risk of harm to patients.

A stakeholder model was established which is governed by the main groups in the supply chain and funded mainly by manufacturers—branded, generic and parallel trade—with smaller contributions to costs from wholesalers and pharmacies. These proposals became the EU Falsified Medicines Directive 2011/62/EU. In the meantime, the issue of falsified medicines had moved largely to the internet, where they are sold from trading platforms and/or unlicensed pharmacies.

So why is data use so important? As the Company Chemists’ Association has pointed out, data is a very sensitive commercial currency. All parts of the medicines supply chain need access to broad patterns of medicines usage for the purpose of planning or adjusting manufacturing, marketing, prescribing, buying and stock control. But access to pack information—who is handling which packs—could highlight purchasing decisions, the margins being made and those trading for import/export purposes.

So the principle of “Whoever generates the data owns the data” was enshrined in Article 38 of the associated delegated regulation of 2016. As a result, general access to FMD data is restricted to pack information—name, batch, expiry, serial number—and active/inactive status, with some exceptions for investigating incidents and national competent authority use for reports, reimbursement, and pharmacovigilance and pharmacoepidemiology research.

The Department of Health and Social Care already has access to a very wide range of data on the sales of medicines, and their use in the UK, under the Health Service Products (Provision and Disclosure of Information) Regulations 2018. These require manufacturers, wholesalers and pharmacies to provide summaries of products sold and prices paid. Ministers can request more detailed information if required.

Given both this access and the known sensitivities around FMD data, it is unclear why the department has included the sweeping provision of Clause 3(1)(b) on the use, retention and disclosure for any purpose of data collected under a falsified medicines system, and why this has not been discussed with stakeholders in the existing Falsified Medicines Directive scheme.

The pharmacy community has concerns not just that the department might accidentally release commercially sensitive data—this is covered by Clause 3(3)—but that it might use such data to gain unfair advantage by abusing its monopoly position as the main purchaser of medicines in the UK. Pharmacies wish to see data use under any future system being part of an agreement that has been subject to discussion with stakeholders and approved by Parliament. My noble friend understands that the department has said that the details of any proposed use under a new falsified medicines system would be contained in a statutory instrument by the affirmative procedure.

[The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell) (Con)]

My Lords, I understand that the intention of Amendment 30, in the name of the noble Baroness, Lady Thornton, is to prevent the use of data for any purpose other than preventing the supply of falsified human medicines. The noble Baroness raises an important question. Let me reassure her that we have thought very carefully about these powers. There is an important precedent already for using the data held in the current EU Falsified Medicines Directive “safety features” system for wider purposes. For instance, as well as using the data to investigate instances of falsified medicines, data on the EU system can be used for the purposes of reimbursement, pharmacovigilance and pharmacoepidemiology. The effect of this amendment would be a step backwards on what any potential falsified medicines scheme introduced under Clause 3 could deliver.

We know from implementation of the EU system that the checks involved could generate a rich source of data, and that there may be circumstances where we would want to be able to use that data to support the safe and effective use of medicines. For example, information in a future falsified medicines scheme could be useful in the event of a product recall to help quickly identify individually affected packs. I recognise that information about the supply of medicines through the supply chain can be commercially sensitive—the noble Baroness, Lady Jolly, made this point very well. That is why Clause 3 ensures that, in making regulations under this power, the appropriate authority must ensure that information is retained securely. Information will be subject to strict controls set out in regulations, including what purposes the data could be used for, who would have access to or use it, and under what conditions.

I turn to the noble Baroness’s second amendment in this group, Amendment 33. While I understand the desire of the noble Baroness, Lady Thornton, to ensure that we have robust requirements around the safeguarding of information, this amendment would cause difficulty for the appropriate authority making regulations under the provision in Clause 3. This is because it would require action to secure retention of data even where the regulations themselves may not concern data—for example, provisions related to who may set up the infrastructure.

Amendments 31 and 32, in the name of the noble Lord, Lord Clement-Jones, would operate together to place an obligation on the Secretary of State to seek to agree and lay a framework on the use of information collected for the purpose of preventing the supply of falsified medicines. This would be done within six months of the Act coming into force.

We can all agree with the noble Lord, Lord Hunt, and others that close collaboration through consultation with stakeholders, including with pharmacists, is essential to getting something like this right, not least given the importance of data security. However, Amendments 31 and 32 would not create the right mechanism for providing this. I can reassure the noble Lord that we have planned fulsome engagement and consultation with a wide range of stakeholders. This can be achieved without this additional obligation, but I would be glad to commit to an engagement session with noble Lords and officials if noble Lords would find this helpful.

The Government have committed to exploring all options in regard to a falsified medicines scheme to ensure that patients continue to be protected from the public health threat posed by falsified medicines. As part of this, we will explore with stakeholders what information needs to be collected as part of any national scheme. Only once we have established how any scheme could work can we fully consider how the information that it collects could be used to deliver the most benefits for the UK and for patients. However, this amendment would force us to consult on an agreed framework outlining the use of information within six months of Royal Assent, without necessarily having the full picture of how a national scheme could work.

We also want to explore creative uses of information as long as they are for public interest purposes. Therefore, we do not want to constrain or limit options ahead of engagement with stakeholders.

I should make it very clear that the overarching principles of the Bill as set out in Clause 1 also apply to our powers here. The scope of the purposes mentioned is not unfettered. The appropriate authority must be satisfied that regulations dealing with anything under Clause 3—not just around how the information will be used—will promote the health and safety of the public. In making that assessment, the appropriate authority is required to have regard to the three considerations discussed previously in Committee.

I remind noble Lords that Amendment 126 in my name ensures that this will be a public consultation, while Amendment 131, also in my name, places an obligation on the Secretary of State to review regulatory changes made under Clause 1(1). The consultation will consider how the information collected as part of the scheme could be used, and any regulations providing for the use of information would be subject to parliamentary scrutiny under the affirmative procedure. In light of these reassurances, I hope that the noble Baroness, Lady Thornton, will feel able to withdraw her amendment and the noble Lord, Lord Clement-Jones, will be content not to press his.

[Baroness Thornton (Lab)]

I thank the Minister for his detailed response. I just have to wonder why the consultation did not take place before the Bill was drafted. You have to ask why stakeholders were not involved in the discussions prior to this happening and why they then felt the need to get in touch with those of us involved in this Committee to express their concerns. So I have to say to the Minister that I will certainly be discussing with stakeholders their reaction to what the Minister has said and whether that allays their frustrations and anxieties.

The process that the Minister described, which I shall read in detail and think carefully about, looked circular. It looked like a process that involves consultation, powers in the Bill that we have already questioned, and the affirmative procedure. All those things may not be satisfactory, so we will probably need to return to discuss this at a later stage of the Bill—or, preferably, before. I beg leave to withdraw the amendment.

--- Later in debate ---

[Baroness Thornton (Lab)]

My Lords, I will not add much more, as I am very interested to hear what the Minister has to say. The noble Lord, Lord Patel, has done the Committee a great service by tabling the amendment and asking this question. I was not aware that there was an issue here, which there clearly might be, and I will be interested to hear the answer. If this is an area that is covered by European Union regulation, and we are therefore creating a new regulatory framework for children’s data in clinical trials, it is important that we know that and how it might happen. I am very interested to hear what the Minister has to say.

[Lord Bethell (Con)]

My Lords, in response to the point of the noble Baroness, Lady Thornton, the noble Lord, Lord Patel, is right: paediatric trials are very important, and they have sometimes been overlooked. However, that does not detract from the fact that the UK has a strong international reputation for paediatric medicine research. The MHRA authorised 177 new clinical trials that included children in 2019—more than any other country in the EU. The Bill, in Clauses 4(1)(d) and (e), already enables us to make regulations about requirements to be met before the clinical trial may be carried out and on the conduct of the clinical trial. That can provide for a number of different options, including paediatric clinical trials. I reassure the noble Lord that the Human Medicines Regulations 2012 will include provisions equivalent to those of the EU paediatric regulations when amendments come into force at the end of this year. These include requirements for the review and approval of paediatric investigation plans. These plans are aimed at ensuring that the necessary data is obtained through studies in children.

I recognise that the EU regulations played an important role in promoting the development of paediatric medicines, so that children are not forgotten when adult needs drive drug innovation. I am happy to commit to write to the noble Baroness, Lady Jolly, on her questions about EU statistics on that matter.

I understand that there is currently ongoing evaluation of the EU paediatric regulations and that this may bring about changes to the legislative landscape. This Bill will allow us to adapt the UK regulations based on patient needs and to keep pace with any changes in any other jurisdiction, including the EU. It gives us the opportunity to go even further to enhance the UK system and to encourage UK paediatric trials.

It is critical that the UK paediatric regulatory framework remains flexible, to adapt to emerging paediatric research challenges, and supports UK innovation, while also supporting global development plans. I reassure noble Lords that the MHRA has already published guidance on a new UK approach to paediatric investigation plans. This is part of the GOV.UK transition period guidance for businesses and citizens. The UK will simplify the PIP application process for applicants conducting paediatric research by offering an expedited assessment where possible and by mirroring the submission format and terminology of the EU PIP system. This approach ensures that the UK can continue to provide incentives and rewards to support innovation in paediatric drug development and to encourage manufacturers to bring medicines to the UK market.

The MHRA will aim to continue to participate in paediatric scientific discussion among the global regulators at an early stage and during the conduct of clinical trials. This will facilitate the exchanging of emerging information during the studies to minimise the exposure of children to medicines that do not work or are unsafe, and we will aim to maintain a national position of influence, so that the final paediatric development aligns with, and supports, global regulators’ requirements.

I hope that the noble Lord, Lord Patel, has had sufficient reassurance that the amendment is unnecessary and feels able to withdraw Amendment 40.

[Lord Patel (CB) [V]]

I thank the Minister for his response, as I thank all other noble Lords who have spoken. A small point was raised, with a good, short debate and the right response. I beg leave to withdraw my amendment.

--- Later in debate ---

Moved by

[Lord Bethell]

43: Clause 5, page 3, line 35, leave out from “regulations,” to “or” in line 36
Member’s explanatory statement
See the explanatory statement for the amendment in the Minister’s name inserting new subsection (1A) into Clause 5.

--- Later in debate ---

[Baroness Jolly (LD) [V]]

My Lords, we support these amendments, which relate to the disapplication of regulatory provisions in an emergency. As the Bill stands, the Secretary of State may make regulations about these provisions. This can be subject either to

“conditions set out in the regulations”

or in

“a protocol published by the appropriate authority.”

As the protocol is not subject to parliamentary scrutiny, the amendment in the names of the noble Baroness, Lady Thornton, and the noble Lords, Lord Hunt of Kings Heath and Lord Patel, would remove this provision from the Bill so that, as the noble Baroness, Lady Wheeler, said, conditions would have to be set by regulations alone.

[Lord Bethell (Con)]

My Lords, the lockdown debate later this afternoon brings home the significance of an emergency like Covid. It requires swift, dramatic change to protect public health. Clauses 6 and 15 are essential. They would allow us to make provisions about the disapplication of a medicine or medical devices provision where there is a need to protect the public from a serious risk to health. We would need regulations to do this, because to act in breach of an otherwise applicable provision would be an offence.

Medicines is a highly regulated area. Regulations apply from development of medicines to delivery, right the way down to the pharmacy. It is a complex and overlapping system, designed to protect the end-user, the patient. But there are times when we need to switch off a circuit of the system to respond to an emergency. This is most vividly apparent when we speak of a Covid vaccine. This is end to end, from port arrival, to the logistics of its delivery, to who may administer it. We need to be able to pick this circuit out of the whole and isolate it. Otherwise, to disapply regulation without being highly specific is to disapply regulation not just from the vaccine but from other medicines as well.

This is the point of conditions that go alongside the disapplication. Where we know what the conditions will be, of course it should be in the regulations. But often we cannot know what the specific conditions are. That is where the protocol comes in that the noble Baroness, Lady Thornton, with her Amendments 46, 47, 93 and 94, would like to remove. I acknowledge that the Delegated Powers and Regulatory Reform Committee objected to the use of a protocol. I note that its condemnation was not limited to this Bill but was a broader point about other legislation as well. I hope that I can explain why such a protocol is necessary here.

Protocols are a last resort in any emergency that provides critical flexibility in highly regulated areas. They would be time limited to provide flexibility and administrative detail, tailored to the professional audience that requires it and in language which they are familiar with. A protocol will be used only where it is not be possible to determine all the necessary conditions of disapplication at the pace needed to deal with an urgent threat. The protocol allows for the finer details to be sketched in, while giving Parliament the structure of the regulations to consider. We can debate the principle of disapplying certain provisions of the regulations, without always having the specific names of medicines or vaccines in front of us.

There are existing provisions in the Human Medicines Regulations 2012 that allow for the disapplication of regulatory provisions on how prescription, pharmacy and over-the-counter medicines may lawfully be supplied. These are limited to circumstances in the event or anticipation of a pandemic disease. This formed part of the response to the swine flu pandemic in 2009. Six protocols were issued in relation to specific antivirals for the treatment of swine flu, enabling them to be supplied by authorised staff who would not normally be able to supply prescription-only medicines. This involved separate protocols for different strengths of oseltamivir, a demonstration of just how specific we would expect the protocols to be.

We have made an SI this month introducing provision for the use of protocols in relation to coronavirus and influenza vaccinations. That SI seeks to anticipate the certain flexibilities that might be needed but it is not possible to cover all eventualities. It anticipates the need for rapid supply and the potential mass administration of medicines, since the anticipated vaccine may be delivered by injection.

However, until we are presented with a vaccine, we cannot know how many injections are required, for example. That is a finer point of detail that has implications for the scale of operation required. The SI makes clear that the disapplication of existing regulatory provisions about supply and administration of medicines will be subject to conditions set out in the protocol. These conditions of disapplication will include specifics around the class of persons permitted to administer the vaccines, and the protocol would specify the process by which a person in that class is designated as a person authorised to do so. It will provide for supervision and recording requirements that must be met when the vaccine is administered. These requirements will change depending on the necessities of the specific vaccine. Parliament can debate the regulation, but until we know the detail of that vaccine, we simply cannot establish how this operation will run.

The emergency powers allow us to go broader in terms of disapplications than what is currently available, a reflection of the type of emergency we face. In the illustrative SI published on introduction we have provided some clarity on our intent. It gives an example of what might be needed to ensure the disapplication could be relied upon in response to other circumstances, including a spread of toxins, pathogenic agents, and so on, that give rise to the risk of serious harm to health. This too would operate alongside a protocol.

Amendments 93 and 97 in the name of the noble Baroness, Lady Thornton, relate to emergencies involving medical devices. Provisions already exist in the Medical Devices Regulations 2002. These provisions allow particular devices to be put into service without being subject to CE marking, following a duly justified request if the Secretary of State considers this to be in the interests of the protection of health.

The ventilator challenge allowed us to fulfil the clinical need for ventilators through a combination of CE-marked devices, and devices which were granted an exemption from the requirement. They were required to conform to bespoke technical specifications as a condition of the exemption being granted, and the technical specifications evolved as they needed to. That ensured that the only devices in service without a CE mark were those that met the highest possible standards.

Online publication will also support dissemination to the required audience, to whom it will be targeted, such as operators in the supply chain, enabling conditions to be quickly understood by those who must use them, referring to concepts, processes and so on that they are familiar with from their field.

Protocols are a last-resort power. Where we can anticipate what the conditions of disapplication will be, we will put these into regulations, but I cannot say now how many injections will be required for a Covid vaccine or how many staff will be needed to deliver it. Parliament has our intent, our plans and our proactive preparations now, but not technical specifications—nor do we. I commend the noble Baroness, Lady Thornton, and her team for all they do to hold us to account. It is right that they look at how we can write good legislation, although we need legislation that allows for practicality in a crisis. Therefore, I hope I have provided enough assurances for her to feel able to withdraw her amendment.

[The Deputy Chairman of Committees (Baroness Garden of Frognal) (LD)]

My Lords, I have received a request to speak after the Minister from the noble Lord, Lord Patel.

[Lord Patel (CB) [V]]

My Lords, I say respectfully to my friend the Minister that he is putting up smokescreens. As he mentioned, he already has the power under the 2012 Act to do much of what he wants to do. Furthermore, the arguments used all relate to the Covid emergency. He alluded to this afternoon’s debate and the measures that are about to be taken, but he already has those powers, otherwise he would not be able to do it. We have emergency legislation related to Covid, which includes immunisation through vaccines. By the way, how many doses would be required? It is not necessary to have that in legislation: it is a clinical decision based on the effectiveness of a vaccine. I do not require legislation to tell me how many tablets I should prescribe to my patients for any disease, so I fear that these are smokescreens. He already has powers of disapplication in an emergency, and I continue to support the amendment.

[Lord Bethell (Con)]

I welcome the challenge from the noble Lord, but the examples we have given are also more recent, from the 2009 swine flu attack. The protocols were also used in the Salisbury Novichok attack. I know from my own experience that public health disasters can throw up extremely unexpected hurdles and barriers to action, in the form of legislative surprises. Therefore, these powers are not considered to be frequently used. In fact, they are never used—noble Lords will all breathe a sigh of relief—but public health challenges are likely to be a feature of the future, and it is prudent to put in place the protections we need in order to provide for them.

[Baroness Wheeler (Lab)]

I thank noble Lords for their contributions in supporting the amendment—the noble Lord, Lord Hunt, reinforced by the noble Lord, Lord Patel, and the noble Baroness, Lady Jolly. I was particularly interested to hear the quote from the Leader of the House on this matter, and I am glad that that has now gone on record. I certainly echo the comments by the noble Lord, Lord Patel, about what he calls smokescreens, and his underlining of the powers the Government already have for dealing with such situations.

I thank the Minister for the very detailed explanation he offered on this issue, and for telling us why the Government feel that they do not need to address the DPRR Committee’s concern and table amendments. He also talked about protocols being a last resort, and I was grateful for that—and also for the fact that they would be time limited. I note those two things. This is a complex issue, not least for me. I need to look carefully at the Minister’s response, and, if necessary, come back to this issue on Report. I beg leave to withdraw the amendment.

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Moved by

[Lord Bethell]

48: After Clause 6, insert the following new Clause—
“Disclosure of information in accordance with international agreements
(1) This section applies to information which a relevant authority holds in connection with human medicines.(2) The relevant authority may disclose information to a person outside the United Kingdom where required for the purpose of giving effect to an international agreement or arrangement concerning the regulation of human medicines. (3) The relevant authority may not disclose commercially sensitive information in reliance on subsection (2) unless the relevant authority—(a) considers that it is necessary to do so for the purpose mentioned in that subsection, and(b) is satisfied that the making of the disclosure is proportionate to what is sought to be achieved by it.(4) Except as provided by subsection (5), the disclosure of information in accordance with this section does not breach—(a) an obligation of confidence owed by the person making the disclosure, or(b) any other restriction on the disclosure of the information (however imposed).(5) Nothing in this section authorises a disclosure of information which—(a) contravenes the data protection legislation (but in determining whether a disclosure would do so, take into account the powers conferred by this section), or(b) is prohibited by any of Parts 1 to 7 or Chapter 1 of Part 9 of the Investigatory Powers Act 2016.(6) In this section—“commercially sensitive information” means commercial information whose disclosure the relevant authority thinks might significantly harm the legitimate business interests of the undertaking to which it relates;“relevant authority” means—(a) the Secretary of State, or(b) the Department of Health in Northern Ireland;“data protection legislation” has the meaning given by section 3(9) of the Data Protection Act 2018.”Member’s explanatory statement
This new Clause makes clear that information held by the Secretary of State or the Department of Health in Northern Ireland in connection with human medicines can be disclosed, subject to certain restrictions, to persons outside the United Kingdom in order to give effect to a relevant international agreement or arrangement.

Blood Safety and Quality (Amendment) (EU Exit) Regulations 2020

Lord Bethell Excerpts

Monday 2nd November 2020 Grand Committee

Moved by

[Lord Bethell]

That the Grand Committee do consider the Blood Safety and Quality (Amendment) (EU Exit) Regulations 2020.

[The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell) (Con)]

My Lords, these regulations are critical in giving effect to the Ireland/Northern Ireland protocol for the safety and quality of blood, organs, tissues and cells, including reproductive cells.

I will give a brief moment of context. In January, the European Union (Withdrawal Agreement) Act 2020 was agreed by this House. It brings into domestic law the withdrawal agreement between the UK and the EU. Included in the withdrawal agreement is the protocol on Ireland/Northern Ireland, commonly referred to as the Northern Ireland protocol.

On 20 May 2020, we set out our approach to implementing the Northern Ireland protocol as part of meeting our obligations under the withdrawal agreement. We are committed to meeting these obligations, all the while recognising the unique status of Northern Ireland within the UK and the importance of upholding the Belfast, or Good Friday, agreement.

These SIs covering donated blood, organs, tissues and cells support the vital role that these materials play in life-changing treatments for UK patients—whether it is blood transfusions to treat major blood loss, heart transplants to treat heart failure, stem cells to treat blood cancer, or eggs and sperm to treat infertility, patients rely on these treatments every day. Last year in the UK, there were 3,760 deceased organ transplants, approximately 1,100 people benefited from UK-donated stem cells and approximately 13% of IVF cycles used donor eggs or sperm. Many people would not be alive today if it were not for the generosity of donors.

The UK’s current high safety and quality standards for blood, organs, tissues and cells are derived from EU law. The application of these standards makes Britain one of the most progressive regulatory environments in the world.

Last year, in preparation for the UK leaving the EU, the Government made four statutory instruments to fix shortcomings in the current law caused by EU exit. These were made on a UK-wide basis and come into effect on 1 January 2021. These 2019 statutory instruments maintain the current safety and quality standards across the UK.

So let me explain for a moment what these regulations do. The Northern Ireland protocol requires Northern Ireland to remain aligned with the EU blood, organs and tissues and cells directives for as long as the protocol is in force, including any future changes to the directives. These four instruments will come into force on 1 January 2021 and will ensure that Northern Ireland continues to be aligned with the directives after the end of the transition period. There are five ways in which they do this.

First, the regulations ensure that the safety and quality standards will remain the same across the UK from 1 January 2021. These standards are currently aligned with EU directives. Secondly, the UK regulators for blood, organs, tissues, and cells will continue to act as the competent authorities for Northern Ireland in respect of the EU. This means that the Medicines and Healthcare products Regulatory Agency, the Human Tissue Authority and the Human Fertilisation and Embryology Authority will continue to meet the same EU obligations for Northern Ireland as they do now.

Thirdly, these instruments amend the definition of “third country” for imports into Northern Ireland to ensure that we meet the terms of the Northern Ireland protocol, but also meet our commitment to unfettered access. This means that from 1 January 2021, when establishments in Northern Ireland receive blood, organs, tissues and cells from Great Britain, they will need to treat them the same as those received from outside the EU. In accordance with our commitment to unfettered access for goods moving from Northern Ireland to Great Britain, there will be no changes to the requirements when sending blood, organs, tissues and cells from Northern Ireland to Great Britain. The movement of blood, organs, tissues and cells around the UK is critical for patient treatment, and we are committed to ensuring that this movement can continue from 1 January 2021.

Fourthly, these instruments will require tissue establishments in Northern Ireland to continue using the single European code for traceability purposes, as they do now. Fifthly, the 2019 statutory instruments introduced some limited regulation-making powers into UK law for each of the UK nations. The EU withdrawal agreement Act 2018 contains the powers needed to make changes in relation to the safety and quality of blood, organs, tissues and cells for Northern Ireland to ensure future alignment with any changes to the directives. Therefore, the powers in the 2019 statutory instruments are no longer needed for Northern Ireland, and consequently these regulations limit those regulation-making powers to Great Britain.

Let me be clear: the fact that Northern Ireland will remain subject to EU law in this area does not mean that the UK as a whole will be prevented from making changes to the safety and quality regime in this area. The EU directives in this area set minimum standards of safety and quality. They allow member states to go further if they wish. If the UK as a whole wished to move forward and change the safety and quality standards, this could be done. They are a floor, not a ceiling.

A lot of preparatory work has already taken place. The regulators for the relevant sectors are working with licensed establishments across the UK to help ensure they are ready for any changes that will arise from 1 January 2021. They are supporting establishments to put any necessary import licences and agreements in place, preventing any disruption in the supply of blood, organs, tissues and cells. These changes affect only a very small number of establishments in Northern Ireland: one blood establishment, one transplant centre, two licensed tissue establishments and four fertility clinics. There will be some minor administrative costs for establishments in Great Britain moving blood, organs, tissues and cells to Northern Ireland.

Regarding the DAs, legislative competence for the donation, processing and use in treatment of human reproductive cells remains reserved to Westminster. Competence in respect of all other human tissues and cells, blood and organs is devolved, and the relevant instruments are being made on a UK-wide basis with the consent of the devolved Administrations. Work is under way to put in place a common frame- work between the UK Government and the devolved Administrations, to support co-ordinated decision-making on the safety and quality of blood, organs, tissues and cells after the end of the transition period.

To conclude, these regulations are vital to the Government’s preparations for the end of the transition period. It is essential that they are made to allow the UK to fulfil its obligations under the Northern Ireland protocol. The UK already has high standards for the safety and quality of blood, organs, tissues and cells. These instruments ensure the UK will continue to work to these high standards after the transition period; that blood, organs, tissues and cells will continue to be able to be moved around the UK; and that we have a platform to build the regulatory regime even further. I beg to move.

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[Lord Bethell (Con)]

My Lords, I start by saying a profound thank you for a lively, insightful and patient debate, because I recognise that these issues have been visited before—and the debate only improves in the retelling. I shall try to trot through a number of points in quick order, because the debate has been wide-ranging and taken on a number of issues.

I want to start on the most important one, divergence, which was raised by a number of noble Lords, including the noble Lord, Lord Scriven, my noble friend Lord Lansley and the noble Baroness, Lady Thornton. On the question of divergence and one regulator overseeing different territories, I reassure noble Lords that we are moving towards developing a common UK framework for blood, organs, tissues and cells with the devolved Administrations precisely in order to avoid this problem. This is the mechanism whereby the four nations can work together to ensure that they are all aligned and that companies and individuals in each nation can feel confident that they are in one common legislative framework. Policy issues will continue to be considered on a four-country basis going forward. I reassure noble Lords that officials and Ministers in Northern Ireland will continue to be involved in policy development, as they have been to date.

After 31 January, blood, organs and tissues will keep moving from the UK to Northern Ireland and from Northern Ireland to the UK, and they will keep moving from the UK to the EU and from the EU to the UK.

There may be at an appropriate point in the future an opportunity for the department to review whether the UK’s exit from the EU offers us opportunities to reappraise current regulations to ensure that we continue to protect the nation’s health. When that moment arrives, we will consult, analyse and assess. The regulations put in place the opportunity to do that—but that is for a moment in the future and it is not envisaged in the near future. To reassure the noble Lord, Lord Alton, who asked about the devolved Administrations, Scotland, Wales and Northern Ireland have provided their consent to these statutory instruments and they continue to be closely involved in the development of policy.

The noble Lord, Lord Scriven, asked about the Medicines and Medical Devices Bill. I reassure him that the Bill as drafted would already allow us to strengthen the requirements governing the use of human tissues in the development of medicines, were it deemed necessary and appropriate to do so. For instance, powers under Clauses 1 and 2 would enable us to introduce new requirements to the Human Medicines Regulations 2012 for medicines manufactured using human tissues.

The noble Lord, Lord Scriven, and others asked about the movement of blood and blood components. This is a hugely important issue. Currently, the UK is largely self-sufficient in the supply of blood and blood components. It occasionally exports rare blood cells—fewer than 10 units per year—to the EU and to non-EU countries. However, as the noble Baroness, Lady Thornton, observed, blood components are frequently shared across the four nations, as needed to meet demand, and the regulations will ensure that that flow is not interrupted. The movement of blood, organs, tissues and cells around the UK is absolutely critical for patient treatment. That will continue as it is now. There will be some minor administrative changes for tissue establishments in Northern Ireland to receive tissues and cells from Great Britain, but there will be no change to the requirements for Northern Ireland establishments to send blood, organs and tissues to GB.

The noble Baroness, Lady Thornton, and my noble friend Lord Bourne asked about the United Kingdom Internal Market Bill. As they will know, the Bill has passed Second Reading. Amendments have been tabled to enable safety emergency exclusion functions as intended that can be applied, if required, to Northern Ireland qualifying goods. However, I absolutely reassure noble Lords that we are totally committed to upholding our long-standing track record of high standards on health and food, including in respect of the materials which are the subject of these statutory instruments. We have kept healthcare and social care services out of the scope of the services framework rules, ensuring that there is no disruption to the regulation of health and care services.

My noble friend Lord Lansley was right to point out that it is fast-changing world for blood plasma. This could not be more relevant than it is right now. Covid has shown the international constraints on supply and the potential for huge demand. I reassure him that this is uppermost in our minds and that we will put in place all the regulations necessary to ensure that British access to blood plasma from overseas remains as secure as it is today.

To the noble Lord, Lord Alton, I say personal thanks for the report which he sent me. It includes charges which we take very seriously. We are of course against organ tourism. I noted the powerful points that he made in Committee on the Medicines and Medical Devices Bill last month and look forward to further discussion on Report. I reassure him that my noble friend Lord Ahmad has written to the World Health Organization encouraging it to give careful consideration to the findings of the report of the International Coalition to End Transplant Abuse in China. The Government welcome any work that is rigorous and balanced, and that raises awareness of the human rights situation in China. We continue to monitor this issue closely and to consider carefully all the evidence presented to us.

I note the personal testimony of the noble Baroness, Lady Walmsley. My family has been the beneficiary of organ transplantation, so I completely endorse her concerns. Traffic between Great Britain and Northern Ireland will remain, as it will between GB and the EU. I am glad to confirm that Northern Ireland will align with the EU, but we will find a way to work with Northern Ireland within the UK common framework to ensure that this trade continues. I am reminded that between April 2019 and March 2020, the UK exported 13 organs to the EU and imported 13 organs from it. While these numbers may seem low, they are extremely important to those concerned and it is a priority to ensure that those movements continue. With those thoughts, I commend the regulations.

Motion agreed.

Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2020

Lord Bethell Excerpts

Monday 2nd November 2020 Grand Committee

Moved by

[Lord Bethell]

That the Grand Committee do consider the Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2020.

Motion agreed.

Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2020

Lord Bethell Excerpts

Monday 2nd November 2020 Grand Committee

Moved by

[Lord Bethell]

That the Grand Committee do consider the Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2020.

Motion agreed.

Quality and Safety of Organs Intended for Transplantation (Amendment) (EU Exit) Regulations 2020

Lord Bethell Excerpts

Monday 2nd November 2020 Grand Committee

Moved by

[Lord Bethell]

That the Grand Committee do consider the Quality and Safety of Organs Intended for Transplantation (Amendment) (EU Exit) Regulations 2020.

Motion agreed.