Medicines and Medical Devices Bill

Baroness Barker Excerpts

Committee stage & Committee: 3rd sitting (Hansard) & Committee: 3rd sitting (Hansard): House of Lords
Wednesday 28th October 2020 Grand Committee

[Lord Sharkey (LD) [V]]

My Lords, it is a pleasure to follow my noble friend Lord Stunell. As my noble friend Lady Sheehan so clearly and compellingly explained on Monday, this amendment deals with the key question of access to medicines and is particularly relevant as we find ourselves swept along by wave 2 of the global pandemic. It is clear that, at least initially and perhaps for much longer, supply of any Covid-19 vaccines will fall behind demand. This raises the urgent question of who should receive priority access to these vaccines. Who should get them first, here and internationally? How should equitable access be decided?

The Government appear to be adopting two contrasting approaches to this question. On the one hand, we have Gavin Williamson saying:

“It’s the right thing to be doing to be at the absolute front of the queue to make sure we’re in a position to get those vaccines first when they become available”—


and that does seem to be what we are doing. As of August, the United Kingdom was the world’s highest per caput buyer, as the noble Lord, Lord Alton, mentioned on Monday. The vaccine taskforce has placed orders for six unproven vaccines, taking its potential stockpile to 340 million doses. Of course, we do not yet know to what extent, if at all, these vaccines might work, so some duplication is obviously prudent. But on the other hand, and while securing our place at the front of the queue as Mr Williamson recommends, we are also involved in trying to work out, under the auspices of the WHO, an equitable access scheme. The rationale for that is pretty obvious. Unless we have such a scheme, rich countries will end up vaccinated well in front of poor countries. In the face of a global pandemic, that approach carries obvious risk. It also carries moral risk.

The Government have committed £60 million to the WHO COVAX facility—the Covid-19 Vaccine Global Access Facility mentioned by my noble friend Lady Sheehan on Monday. COVAX seeks to enable global collaboration and equitable access to vaccines. It views this model of pooled procurement as preferable to rich countries doing bilateral deals. We have also joined 150 countries in expressing an interest in participating in COVAX for our own vaccine purchases. But there is clearly a risk that the bilateral purchasing of vaccines by the United Kingdom and other rich nations could undermine the work of COVAX. Could I ask the Minister how we balance our Williamson approach with our COVAX approach? How are these approaches prioritised? How much should we try to secure for ourselves and how much should we share? What criteria will be used to decide what access means in practice? We know something of what people in the UK think about the issue. Some 96% of the UK public supported the idea that national Governments should work together to ensure that treatments and vaccines can be manufactured in as many countries as possible and distributed globally to everyone who needs them.

My noble friend’s amendment also raises the issue of Crown use licences. We have previously used or threatened to use these licences in our negotiations with pharma. Can the Government confirm their willingness to use these licences if price negotiations on Covid-19 vaccines fail to reach a satisfactory conclusion?

I urge the Minister to give very serious consideration to the issues raised by this amendment. I will listen to his reply with great interest.

[Baroness Barker (LD)]

I thank my noble friend Lady Sheehan for her introduction to this amendment and the noble Lord, Lord Alton, for the detail that he added to that.

My interest in this matter stems back to 2013, when I was part of the All-Party Parliamentary Group on HIV and AIDS, which produced a report called Access Denied. It was about barriers to access to antiretroviral drugs for HIV and AIDS in low and middle-income countries. In the course of our research work for that report, we held a number of hearings with all sorts of representatives from a number of international research groups based in the United Kingdom but which worked across Africa and Asia. We met user and patient groups and also included representatives from the pharmaceutical companies.

I vividly remember sitting in a room in Portcullis House during one of our question and answer sessions and putting a question to a representative of a pharmaceutical company that has cropped up in our discussions in the last couple of days. I asked him a simple question—whether there was a direct correlation between the R&D costs of a drug and the price. With disarming candour, he said, “No”. Once people’s jaws had ceased to drop, we had the revelation that actually there is no transparency about pricing in the pharmaceutical industry or about the extent to which public and private funding goes into the development of new medicines—and, in effect, an admission that the overstatement by pharmaceutical companies of the need to charge excessive prices in some markets to maintain their viability is not substantiated.

I am not an anti-pharma campaigner. I believe that human and animal welfare rests very much on the development of pharmaceutical knowledge and science, and I am all in favour of extension of research and development of new drugs. However, for far too long Governments of all sorts have been held over a barrel by pharmaceutical companies, and that should stop.

I say this as someone who has had a long-standing interest in HIV. To see some patient groups in some parts of the world continue to become infected and, perhaps, have threats to their lives that would not occur if they had simply been born in another country is devastating. For example, in the world of HIV, very little work is being done on development of antiretroviral drugs for paediatrics because there is very little call for that in western developed nations, whereas there is a very big need for it in sub-Saharan Africa. Our involvement in these matters has a direct bearing on the lives of people across the world and on our standing not only as one of the major governmental funders through the different international funds but as a country in which research into new and emerging transmissible diseases is second to none because of our long-standing history.

For all those reasons, I very much support my noble friend Lady Sheehan, and I await with interest the answer to the question that my noble friend Lord Stunell put, which was the one I was going to ask, about proposed new paragraph (d) in my noble friend’s amendment.

[Baroness Thornton (Lab)]

The Committee owes the noble Baroness, Lady Sheehan, a debt of gratitude for bringing forward this amendment. I very much enjoyed her opening speech—and, indeed, those of the noble Lords, Lord Alton and Lord Crisp, both of whom are so well qualified to speak about international health responsibilities.

What this debate does is to remind us of how privileged we are to live in a country with free access to new medicines and innovations. However, we are now entering choppier international waters. We have been sheltered, as it were, over 40-odd years or so by the European Union’s heft and regulatory framework. So we need to take notice of the need for greater co-operation, as has been outlined by the noble Lord, Lord Patel.

I was very struck by the mention of things like price gouging by the noble Baroness, Lady Sheehan, and their dangers for those less fortunate than ourselves. On the immediate responsibilities and dangers around the Covid vaccination, which we so desperately need, the World Health Organization says that it is working on a plan to ensure equitable distribution of vaccines, but how that would be enforced in practice is not clear. Professor Mariana Mazzucato, who heads the University College London’s Institute for Innovation and Public Purpose, says:

“In a pandemic, the last thing we want is for vaccines to be exclusively accessed by countries that make them and not be universally available.”


That is absolutely right.

However, as the noble Lord, Lord Crisp, said, we need to pay attention to what is happening in the UK and what the effect of Brexit might be—and, goodness me, we are all on tenterhooks as to whether we get a deal or not. Rick Greville, the director with responsibility for supply chain at the Association of the British Pharmaceutical Industry said, in the run-up to a no-deal Brexit—the last time this happened—that there could be currency fluctuations, including a fall in the value of the pound. He said:

“You can imagine in that situation that exporting medicines into Europe would become even more profitable. It may be that”


drugs

“that currently aren’t being exported suddenly become attractive to export, driven entirely by profit”.

The UK is not invulnerable to what might happen next, and I would like the Minister’s observations on that.

Launched earlier this year, COVAX wants wealthy nations to pool funds that together can be used to develop and scale up vaccine production. In return, rich countries would have a guaranteed supply for about 10% and 15% of their population. I would also like the Minister’s answer to that, because several noble Lords have raised that question.

This is one of those debates in which one feels that so many people are better qualified to speak than oneself. I finish by quoting the noble Lord, Lord Crisp, and what he said on Monday. He said:

“This amendment is absolutely right in asserting that the UK should reaffirm its position and its rights to protect the health of its population. We should adopt it. The future will be difficult, as will the negotiations on this issue, but no one should be in any doubt about the UK’s firm position. We should support not just the UK’s position for the population of the UK directly but a global effort to deal with these important matters.”—[Official Report, 26/10/2020; col. GC 71.]


I could not have put it better myself.

Medicines and Medical Devices Bill

Baroness Barker Excerpts

Committee stage & Committee: 2nd sitting (Hansard) & Committee: 2nd sitting (Hansard): House of Lords
Monday 26th October 2020 Grand Committee

[Lord Patel (CB) [V]]

My Lords, there is no need for me to speak at length because I agree with much of what has been said. It has been fascinating to listen to how people who were Secretary of State and Minister of Health change, once they are not in that position, in fighting for resources and more innovation to be brought into the NHS quicker. I commend that, but I wish it had happened when they were in charge. I say this tongue in cheek to tease them, of course.

I support the amendments in the names of the noble Lord, Lord Lansley, and Amendment 124 in the name of the noble Lord, Lord Hunt of Kings Heath. What they both said is correct: the NHS is very slow to bring in innovation. Also, when innovations are available that will benefit patients, trying to use them is very difficult as a clinician because they are sometimes quite unique and not routinely used.

I will give noble Lords an example. Standard radiotherapy is used for cancer treatment, but occasionally the cancer does not respond, so the radiotherapist and medical oncologist would on very rare occasions want to use what is known as CyberKnife—focused radiotherapy that deals with the tumour but does not damage the surrounding tissue. I am told that to do this would require a request to be sent through the NHS trust system to the CCGs to get their approval, but this treatment is usually required now—today—not in about three weeks’ time, because the patient is in the advanced stages of cancer.

This is just one example; there are lots of others. What the noble Lord, Lord Hunt, said at the end of his speech was right: while this debate is maybe not directly linked to regulatory issues in medicines and devices, a much wider debate needs to be had on whether we have evolved processes that are counterproductive to bringing in or even developing innovations, as the noble Lord, Lord Lansley, referred to on a previous group of amendments. I am slightly hesitant to say that.

The original concept of NICE was to have an opportunity to bring modern innovations rapidly into the NHS. Yes, there was another side to it: that it should be effective and not increase costs unnecessarily. I know this because I was associated with it at the time of its formulation. I took a different route; I did not continue to be involved with NICE, but I became chairman of a similar organisation that the Scots established, at the time called the Clinical Standards Board for Scotland. I deliberately separated bringing innovations into the clinical area from the area of medicines by having the Scottish Medicines Consortium be quite different. However, the concept was the same in England and Scotland. Unfortunately, we need to get back to finding how we can bring in modern innovations more quickly and how we can use our science and the NHS as the core to make more innovation. However, I commend what the noble Lords, Lord Lansley and Lord Hunt, had to say.

[Baroness Barker (LD)]

My Lords, I thank your Lordships for allowing me to come off the substitutes’ bench to take part in place of my noble friend Lady Jolly. I did not have the opportunity to speak on the last group, but if I had I would have strongly echoed the words of the noble Baroness, Lady Thornton. I do not believe that the Government’s amendments go anywhere near strengthening, clarifying or taking away the reservations that many of us have that the definition of “attractiveness” is one that largely depends on the watering down of regulation and standards and the increasing of commercial competitiveness. That is very much germane to this set of amendments, because it is against this backdrop that the amendments from the noble Lord, Lord Lansley, sit.

--- Later in debate ---

[The Deputy Chairman of Committees (Lord Lexden) (Con)]

My Lords, the noble Baroness, Lady Sheehan, has withdrawn from the debate so I call the noble Baroness, Lady Barker, who will once again speak in place of the noble Baroness, Lady Jolly.

[Baroness Barker (LD)]

It is a great pleasure to follow the noble Baroness, Lady Bennett of Manor Castle, who introduced these amendments in her customarily thorough and diligent way; I thank her for taking the time to do that. I also thank her for bringing to the Committee information about the sources from which she brings forward these amendments. They not just represent the aspirations of politicians who wish to pursue their own green agenda; they present the thinking on the part of clinicians and people in the health services about the impact of medicines and medical devices and what they do.

It is no bad thing to remind ourselves that, in the NHS long-term plan, there is a specific commitment to the sustainability of the NHS. It is perhaps no wonder that, when the NHS Sustainable Development Unit reports that the NHS is responsible for 25% of public sector CO₂ emissions, there is a recognition that large entities such as the NHS and the British Army will be crucial if the Government are to reach our carbon reduction targets within the timetables set.

As the noble Baroness, Lady Bennett of Manor Castle, said, the NHS is an organisation that British people value very highly. It is an institution that British people do their best not to demand much of—indeed, to minimise their demands on it. It is an ongoing source of frustration for many people that it is difficult for patients to assist with recycling medicines and devices. I know that I am not alone in saying this: when I came to empty the house of my mother, who not only depended on medical devices—hearing aids—but had multiple conditions for which she took medication, I could not dispose of things such as batteries or medicines in an acceptable way. I could not take them to pharmacies and get them recycled for people who needed them. I know that many people have found themselves in that position; it is a source of great frustration for people who do not want to waste precious NHS resources and for whom being in that position is offensive.

I rather suspect, as the noble Baroness, Lady Bennett of Manor Castle, suggested, that the NHS is, at a corporate level, beginning to make some progress in looking at its use of single-use plastics, its disposal mechanisms and, in particular, its use of water. I also suspect that Covid has had a huge and damaging impact on all of that. I do not expect that we will see the NHS able to prioritise this subject for the whole of next year. That is all more the reason for us to do what the noble Baroness said we should do: make sure that this remains an aspiration towards which the NHS should work and should have an obligation to work. With that in mind, I would be very pleased to support the noble Baroness’s amendments.

[Baroness Wheeler (Lab)]

My Lords, I am very grateful to the noble Baroness, Lady Bennett, for tabling these amendments so that we can discuss these important issues in the context of the Bill. Many of the broader issues she addressed will of course be under detailed scrutiny in the forthcoming Environment Bill, but it is valuable to consider them in the context of the supply of human medicines and devices. I very much value the detailed information she provided on a range of issues of concern, here in the UK and globally.

To touch on a few of the points the noble Baroness raised, Labour strongly opposes the production of single-use plastics and agrees with the Government’s policy of producer responsibility when it comes to new plastics being manufactured, but they have been slow to introduce it. As we have stressed, waste, including plastic waste, pollutes our land and seas, kills wildlife and contaminates our food. We are committed to making producers responsible for the waste they create and for the full cost of recycling or disposal. Sustainable design and manufacturing are crucial to this. Can the Minister reassure the Committee that producer responsibility will extend to the manufacture of medical devices? What incentives are being provided for hospitals to use reusable metal equipment, which can be sterilised after each use?

The Environment Agency has found examples of contaminated hospital waste being illegally exported to developing countries, such as Malaysia, for disposal. What steps are the Government taking to prevent the illegal export of such waste and ensure that we dispose of our own waste in the UK? As we know, there are also major issues about the use of incinerators for hospital waste and concerns about health impacts on those living nearby. What alternative means of secure disposal are the Government planning which will protect the environment and cut the impact of carbon emissions?

Are the Government doing enough to ensure that chemists and GP surgeries provide a secure depository for unused medicines, so they do not contaminate the water supply by being washed down the sink or end up in landfill? Is the Department of Health working with the water companies to prevent the water supply being permanently contaminated by drugs that are flushed into sewers and cannot be refined out of the clean water system? There are concerns that the contraceptive pill might be affecting male fertility through the water supply, but high levels of cocaine are also being identified. What research is taking place on the effects of residual medicine in the water supply on human health?

We also know the deep concerns about the huge expansion of single-use PPE during the Covid pandemic. What arrangements are being made for the safe disposal of this equipment and what consideration is being given as to whether these materials can be sterilised and reused? There is strong concern about the widespread distribution of single-use masks to the general public, which are now causing a huge litter problem, as we have heard, as well as being washed away into our oceans. What are the Government doing to encourage the use of cotton masks, which can be washed and worn again?

On decontamination standards, as we have heard, decontamination and sterilisation are key topics for many medical device companies, particularly those involved in reusable surgical instruments and dental and endoscopy businesses. Key issues include prion removal, healthcare-acquired infections and the logistics of moving medical devices along the contamination chain. What engagement has the DHSC had with manufacturers, medical device decontamination and sterilisation providers and medical device users? Can the Minister tell the Committee what plans the Government have to review the decontamination guidance that is currently in place?

Finally, the important issue of antimicrobial resistance was pursued by Labour in Committee in the Commons by an amendment stressing the need to recognise its importance in the development of new medicines, and which would have laid a duty on the Secretary of State to produce an updated report to Parliament, setting out progress on a UK-wide strategy for tackling AMR. The Government’s 2019 five-year plan—which is part of the 20-year strategy, as we know—has been welcomed and has been the subject of considerable discussion in your Lordships’ House. The noble Baroness, Lady Bennett, is right to underline the awareness of AMR for those participating in clinical trials. The focus must be on developing new medicines to tackle AMR and curb the spread of bacterial diseases requiring antibiotics, and on the prevention and control of infection to contain the emergence and spread of resistance to antibiotics.

Covid-19: South Yorkshire

Baroness Barker Excerpts

Thursday 22nd October 2020 Lords Chamber

[The Deputy Speaker (Lord Lexden) (Con)]

Both the noble Lords, Lord Robathan and Lord Desai, who are next on the list, have withdrawn, so I call the noble Baroness, Lady Barker.

[Baroness Barker (LD)]

Will the Minister explain to the person in Sheffield who, having registered themselves as being positive for Covid, was contacted four times a day for four days on the trot, and managed to stop it only when they got the nurse to explain that they were so ill that they were in hospital, how their statistics will be recorded by Serco? Can he explain to the people of Sheffield why the Government continue to spend so much money on a system that is so bad?

[Lord Bethell (Con)]

The noble Baroness alludes to a glitch that the noble Baroness, Lady Thornton, raised yesterday, which I looked into overnight at her suggestion. It is true that if someone lives in a household with several other people who have been reported to have Covid, they are, at the moment, each receiving emails or calls, not on a household basis. We are looking at this and I hope to have it fixed in the next few days. I am grateful to the noble Baroness, Lady Thornton, for raising it.

Health Protection (Coronavirus, Restrictions) (No. 2) (England) (Amendment) (No. 5) Regulations 2020

Baroness Barker Excerpts

Tuesday 20th October 2020 Lords Chamber

[Baroness Barker (LD)]

My Lords, when introducing this measure in the Commons on 13 October, the Secretary of State, Matt Hancock, made a very important statement:

“The powers in SI 1029 are therefore revoked. In practice, the effect of SI 1029 is to deliver enforcement against individual places that have been flouting the rules, which is the one of the top demands of councils in their fight against coronavirus.”—[Official Report, Commons, 13/10/20; col. 199.]


Why has it taken six months for the Government to understand what it is that the people in charge of the local enforcement of these laws need both in local government and in public health?

I listened carefully to the way the Minister introduced this measure. The only data he has given us is about the increase in transmissions, and the only data we seem to have is about the Government’s failure. He talked about the fact that SAGE may regard this as being a way of controlling the virus and about the police saying that they think that 10 pm is an infection point. That is not a strong evidence base on which to curb the liberties of individuals and is not one in which the public can have faith that what is being done is the right thing.

Last week, the Minister talked about how we still do not know how infections are getting into households because the major route of transmission is within them. We will not know until our track and trace system is much better than it has been to date, for all the money that has been thrown at it, and until we are as vigorous in using the data and getting measurements that are much more granular and detailed, and then giving that information to the people who really know how to use it rather than sitting on it within the NHS Test and Trace, which clearly does not.

Medicines and Medical Devices Bill

Baroness Barker Excerpts

Committee stage & Committee: 1st sitting (Hansard) & Committee: 1st sitting (Hansard): House of Lords
Monday 19th October 2020 Grand Committee

[Lord Hunt of Kings Heath (Lab)]

My Lords, I am glad that the Minister said that he was listening, and his amendments are important, particularly the one that makes the principle of the health and safety of the public the key consideration when making regulations under the parts of the Bill relating to human medicines and medical devices. He will be aware that concern was expressed by patient groups, in particular, about the Bill as originally drafted and the implication of the attractiveness provision. That concern takes us back to our first debate on “whither regulation in future”.

If we are not going to be aligned to the European Medicines Agency and are to plough it alone, the UK pharma industry will be at a huge disadvantage unless the Government offer an incentive. It may be a bung—the debate about state aid is very relevant to that—or much faster regulation. Otherwise, it is very difficult to see why the industry would continue to invest in R&D in this country. Its position could be as vulnerable as is the motor car industry as a result of the bumbling ineptitude of the Government in their Brexit so-called negotiation.

It is not far-fetched, it is a legitimate question to ask what on earth the Government really want from medicines and medical devices regulation. They may have issued all sorts of draft regulations, but we are clueless about what they are actually seeking to do. The MHRA is clearly not allowed to talk to anybody about this. I remember when the MHRA would talk to politicians and debate these things. It has clearly been given an instruction not to talk to anyone. We are absolutely clueless about the future direction of regulation. None the less, the amendments are clearly helpful, and no doubt we will consider them between Committee and Report.

I would, however, like to ask the Minister about Amendment 2 and its relevance to Northern Ireland. I understand that, exceptionally, it will be moved in Grand Committee because legislative consent takes three months to get through, which impacts on the Bill’s process. I understand that, but, as Parts 1 and 2 of the Bill affect Northern Ireland, does that similarly affect any amendment to Part 1 or 2 passed on Report? What is then the impact on Northern Ireland legislation?

Overall, however, most of the amendments are a constructive improvement, but we will obviously consider them further between now and Report.

[Baroness Barker (LD)]

My Lords, we must consider the whole Bill as building the foundations for the future of the medicines and pharmaceutical industry in this country. We do so in the knowledge that we have had a perhaps pre-eminent role in the world in pharmaceutical development because of the coming together of a number of factors—the European medicines regulations and all the conventions to which we are party, plus the existence of the NHS and the potential it offers for clinical research and our long tradition of working in the life sciences and biosciences sector.

The Minister definitely listened at Second Reading to the many voices of concern that perceived the Bill as it came to us as a weakening of the many factors that underpin our success in this area. He understood entirely, I think, that if we were to take away the pre-eminence of the health and safety of the industry, we would fatally undermine the whole basis of the construction of this very important sector for our economy.

The Minister has listened but not quite hard enough. I agree with the noble Lord, Lord Lansley, that Amendment 2 is an improvement, but it still leaves the decision-making on whether something promotes health and safety to the Secretary of State. I much prefer the construction in Amendment 5, to which my noble friend Lady Jolly has added her name.

My main concern in this group is with Amendment 51 on regulation for veterinary medicines. In his introduction, the Minister pointed to the fact that medicines for animals can work back into the food chain and to humans. I understand the interplay between taking into account things that are done to improve human well-being, animal well-being and the environment, but he will understand that, when people see the amendments, it will not be immediately apparent to them that human welfare is pre-eminent in the list. It says that the regulations must promote “one or more” of the three. I agree that the Minister has moved on the first set of amendments, but he has not gone anywhere near far enough on the regulations on veterinary medicines, so we may well need to come back to that at a later stage.

[Lord Patel (CB) [V]]

My Lords, before I start, I should point out that someone is typing with their microphone on, which interferes with the sound, so would they mind turning it off?

The noble and learned Lord, Lord Woolf, said that other legal Members of your Lordships’ House were not able to be present today. That is a pity, because I thought that I had amassed a good legal team in the noble Lord, Lord Pannick, and the noble and learned Lords, Lord Mackay of Clashfern and Lord Judge, to support some of my amendments. I wonder what comments they might have made on what the noble and learned Lord, Lord Woolf, said.

I find myself in support of what the noble Lord, Lord Lansley, said. I would be interested to hear the Minister’s response to the question whether market approval of a device also means that it has therapeutic approval. I know that the noble Lord, Lord Kakkar, has an amendment on the therapeutic values of devices.

I do not find myself in total agreement with what the Government have produced and I do not think that Amendment 2 is satisfactory. Let me try to explain and we will see what the comments are. The amendments are about promoting public safety and insert into Clauses 1, 8 and 12 a new subsection (1A), so that the Secretary of State may only make regulations under those clauses where

“satisfied that they would promote the health and safety of the public.”

However, this is coupled with the insertion of the words “considering whether they would” to replace the start of subsection (2) in each clause. That means that, in the decision on whether the regulations would promote the health and safety of the public, the appropriate authority must have regard to the safety of medicines—or veterinary medicines or medical devices—their availability and the

“attractiveness of the relevant part of the UK as a place”

to conduct clinical trials or supply medicines, or develop or supply veterinary medicines or medical devices. That would be the effect of the amendments. That construction is open to the interpretation that the “attractiveness” of the UK is to be treated as part of what promotes public safety; the Minister might want to comment on that. If so, the amendment would not address the concern—indeed, it would appear to prevent the argument being made—that attractiveness and the safety of medicines and medical devices can sometimes be in conflict and that considerations of attractiveness undermine considerations of safety. This is in line with the Government’s repeated assertion that attractiveness cannot be in conflict with safety. In essence, the amendment appears to make little substantive change.

--- Later in debate ---

[Lord Patel (CB) [V]]

My Lords, I support Amendment 38, in the name of the noble Baroness, Lady Thornton, to which I have added my name. I shall also speak to Amendment 39. I am grateful to the noble Lord, Lord Hunt, who has already spoken, for lending his support. I have listened carefully, and I support what has been said about the issues raised, particularly about whether we remain aligned with the EU trials mechanism or whether we are to be part of that mechanism.

During the EU withdrawal debate this issue was discussed at length. In fact, there was an earlier opportunity for the amendment to be put—as noble Lords may remember, it was widely supported—but I withdrew it, because the then Minister, the noble Lord, Lord Callanan, said that at an appropriate time, when legislation was brought in, the Government would address the issue. By that I supposed he meant that they would address the issue of remaining part of the EU clinical trials regime—but this Bill does not do that.

What options are available to the United Kingdom? One of them, of course, is to remain and participate in the EU clinical trials regime, if that is possible. An alternative is silent participation, as in the EEA model. That would mean that we could not vote, we could not lead projects and we could not raise objections. The third option is to be independent and aligned. The noble Lord, Lord Lansley, referred to that, and I agree with him that the important part of the EU clinical trials regime is its portal—a portal that the UK played a major part in developing—through which companies can apply for clinical trials.

The fourth option is to be independent and divergent: the UK would create a new clinical trials system. There is no time to do that by the end of 2020, but over time the UK could create a new system and build alliances. However, the risks need to be clearly understood, and balanced. Where will the companies go? Will they go where they have a bigger market, and a bigger opportunity, with larger numbers of patients for the trials, or will they conduct their trials in the United Kingdom?

There might be novel ways to approach this, and I understand that the MRHA is discussing and trying to develop a novel way of conducting clinical trials, which might be more attractive to companies. But of course, as we do not know what those are and we are not being told what they are, we cannot comment on them.

Currently, what looks like the best option is to be part of the EU clinical trials mechanism. With clinical trials for rare diseases, it is even more important for the UK to remain aligned with, or to be part of, the EU processes for rare diseases in relation to trials, to the data that will be available, and to medicines—for example, treatments developed for muscular dystrophy and metabolic disorders.

About 3.5 million people in the UK suffer at some point from one of the 7,000 or so rare diseases. The number for which treatment is available is small; hence the great need for collaborative research, data collection and the development of medicines, because a larger population is needed for clinical trials. Companies such as Silence Therapeutics, which the noble Baroness, Lady Thornton, mentioned, use gene silencing technologies for developing novel therapies for rare diseases. Others, such as Sarepta, use gene therapy for developing medicines. Companies such as Gilead Sciences are developing CAR T therapy; it was the first to introduce CAR T therapy for cancers in the United Kingdom. All those companies have said that they would wish to remain in the United Kingdom to do their trials, if the environment was right.

The treatments that will utilise innovative techniques, such as gene silencing, are often used to treat rare diseases that affect a limited number of people, as I said. The number of patients with a rare disease in an individual country such as the UK is likely to be low by definition. However, for clinical trials to work, they require large numbers. Unified and streamlined international processes are essential to ensure that the application authorisation processes of these clinical trials can continue to work both effectively and at pace.

By implementing the clinical trials regulation, the UK can remain eligible for access to the central EU portals and processes for clinical trials, which ensure that clinical trials can recruit enough patients for rare diseases and include submissions, reporting and authorisation requirements and, particularly importantly, inclusion in patient registries. Those were developed as part of the EU-wide MHRA initiative to develop registries for rare diseases.

The UK should also seek to maintain alignment with patient safety and pharmacovigilance standards, as mentioned by the noble Baroness, Lady Thornton, to give patients and clinicians confidence in trials that are conducted in the UK and to support the UK’s ability to host trials that need to take place in multiple countries. Without this level of alignment, it is likely that clinical trials, particularly for innovative treatments such as gene silencing, will not be able to go ahead in the United Kingdom, denying UK patients access to new treatment options at an early stage.

I will end by saying a few words in support of Amendment 125 in the name of the noble Baroness, Lady Jolly. Given the global nature of the Human Medicines Regulations, the UK should be a member of the ICH—the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Having recently joined as an observer on Project Orbis and the Access Consortium, the UK can work towards providing a leadership role on global regulatory standards, and it is more likely to do that if it is part of the EU clinical trials mechanism.

[Baroness Barker (LD)]

My Lords, the noble Lord, Lord Hunt of Kings Heath, succinctly set out what we all know: post Brexit, the UK as a market will be significantly less attractive than it was as part of a single regulatory system for the development of medicines and clinical trials. The economics of that are inescapable. However, it is also true, as the noble Lord, Lord Lansley, said, that however much some of us may wish that we continued to be aligned with what will inevitably be a developing clinical trials basis in Europe, it may not be within our gift to do so. However, what we can do, and what all the amendments in this group attempt to do, is encourage the Government to come clean about the extent to which they will seek in future to maintain an ongoing alignment with those clinical trials regulations in Europe.

The noble Lord, Lord Patel, mentioned—as I intend to—the announcement last week of the UK participation in the Orbis trials, which are the new mechanism for fast-tracking cancer treatments, with players from the US, Canada and Australia. I still think that, given the history of this country as a leading player in the life sciences and biosciences fields, and given the amount of investment in research that we have traditionally had and which we must seek to maintain in the NHS and within our universities, if we do not signal at this stage a willingness to keep the regulations in place and ensure that we remain aligned with the European system, we stand to lose a great deal—not least involvement in the clinical trials information system. The Government would be well advised to take some, if not all, of these amendments, which all seek to do the same thing.

--- Later in debate ---

[Lord Kakkar (CB) [V]]

My Lords, I very much support what the noble Lord, Lord Sharkey, has just said. In so doing, I support Amendments 4, 42, 52, 63, 69 and 92 in this group.

It seems counterintuitive at the very least for a Government to come forward with proposals to give a Minister powers using a delegated provision to create new criminal offences and, when challenged, to justify the position by saying, “Well, we will limit the sanction to two years’ imprisonment.” This completely misses the point, as we heard from the noble Lord, Lord Sharkey. There is a clear principle at stake here, which has been well described by the Constitution Committee in its report on this legislation. Very simply, it offends liberty and the functioning of our democracy that a Government can propose to create criminal offences that would deny a citizen their liberty for one day, let alone a maximum of two years, and feel that there should not be proper parliamentary scrutiny in the accepted fashion for the creation of criminal offences. Her Majesty’s Government should think very carefully about what they propose to do here and bring their own amendments beyond the government amendments suggested in this group.

[Baroness Barker (LD)]

My Lords, I just want to add to what my noble friend Lord Sharkey said. This is a matter of principle; from the two reports by the two committees that have been cited and from the Second Reading debate, the Government can be in no doubt about the strength of feeling on it. In the light of those, the Government’s response in the government amendments in this group is, frankly, rather pathetic and not at all acceptable.

The Bill represents an enormous upheaval for one of the critical areas of our industry. The pharmaceutical industry is of immense importance to this country. Apart from anything else, to add criminal offences created through delegated powers by means of a Bill that is so spare and lacking in detail does a huge disservice to people who want to continue to pursue not just high-quality but ethical production of badly needed medicines in this country and within international frameworks. If the best the Government can do is to table the amendments in this group, they do the industry a great disservice.

[Baroness Thornton (Lab)]

I do not think that I need to say much in response to the remarks that were, I think, unanimous in their support for my amendment and the other amendments in the group. The cap on the sentence is not a good enough response by the Government. Earlier in our debates, I made a remark about amendments designed to circumvent; I am afraid that the government amendments before us are exactly that kind of amendment. They will not serve, I am afraid.

Unless the Government are prepared, as I hope they are, to table amendments that actually solve the problems and address the issues raised by the Constitution Committee and the Delegated Powers and Regulatory Reform Committee—they could not have been clearer on this issue: in this country, we do not set up criminal offences and their sentences by delegated legislation—there is nothing more for me to say, other than that I hope the Government will think again.

Health Protection (Coronavirus, Local COVID-19 Alert Level) (Very High) (England) Regulations 2020

Baroness Barker Excerpts

Wednesday 14th October 2020 Lords Chamber

[Baroness Barker (LD)]

My Lords, I welcome the noble Lord, Lord Moylan, to your Lordships’ House. For someone who has extensive experience in railways, he was pleasingly on time, something this House greatly appreciates. He is most welcome.

On these Benches, we have said for several months that assessments of the proportionality of measures must be up to date, based on the latest scientific evidence, and formulated as a result of a precautionary approach to minimising overall loss of life. The Government must be transparent in justifying their decision-making, including in explaining how they have balanced the competing interests and the evidence on which the balancing decision has been made. Today, yet again, they have not done so.

Six months ago, the Secretary of State said that test and trace was the “single most important thing” that we could do to conquer the virus. Then, on 22 September, the Prime Minister made a statement which was, at times, very odd. He said that test and trace had “little or nothing” to do with transmission of the virus. I wondered then what was going on. We now know that on 21 September the SAGE group had advised the Prime Minister that he needed to introduce harsher national restrictions on the spread of the virus. Instead, the Government, or Mr Johnson, decided to ignore that and opt for much lighter measures, such as the rule of six and the 10 pm closure of pubs. And here we are: infection rates are going up, lives are at stake and businesses are in trouble.

It is telling that the scientists who have been advising the Government have been damning about this “world-beating” test and trace system, which is having only a “marginal impact”. We said from the very beginning that the fundamental basis of the Government’s actions was wrong. They believed that they did not have to take into account the expertise in local government, public health and public services such as the police. They could build and introduce their own world-beating tech system. We now have more evidence than we will ever need of how wrong that is. They have just been winging it.

On top of that, we have had confused messaging for six months. Even today, noble Lords could go on to GOV.UK and read an explanation of the three different tiers that is utterly confusing. When will the Government publish the contracts given to companies run by friends of Dominic Cummings and Michael Gove to advise on messaging? Taxpayers appear to be paying a lot of money for old rope.

When the Government are in a corner, they always pray in aid the Joint Biosecurity Centre as the source of the intelligence on which their actions are based. We have now got to a point where they can no longer shield themselves behind that organisation. It is now time for them to release more of that intelligence, so that local directors of public health and environmental health—people who have detailed knowledge of their populations, who know what is about to happen in their areas that could have an impact on the transmission of the virus—have it to work with. Examples are the presence of students in Liverpool and the knowledge that the next three months are the run-up to a holiday season in which people will want to celebrate Christmas and Hanukkah and mark other religions. That is the sort of thing that people on the ground are used to doing and have a great deal of expertise in.

People want a break from gimmicks such as marshals, world-beating bluster, blunt instruments and lockdowns being inflicted on wider and wider areas and impacting on greater numbers of people. When will the Government build on the expertise of local civic leaders and public service professionals, and build resilient public health test, trace and isolate systems that can maintain people in isolation safely for the weeks that will be needed? Only then can we get to a point where we are not merely in another short lockdown, to contain a curve and prevent admission to hospitals, but can begin to build a level of community containment with which we can all live safely live.

It will be no surprise whatever to the noble Lord, Lord Robathan, that we will not be supporting his amendment. We sometimes end up in the same place, but for entirely different reasons. We do believe that there is a role for evidence-based, proportionate restrictions on businesses and individual movement in these dangerous times. If the noble Baroness, Lady Thornton, chooses to test the opinion the House, we will on this occasion support her.

However, all this is immaterial. We need to take some of the money away from this track and trace system which is not working and put those resources into the hands of local professionals, where they can make a real and lasting difference and where we really can begin to beat this virus on a sustainable basis.

Health Protection (Coronavirus, Restrictions) (North East of England) Regulations 2020

Baroness Barker Excerpts

Monday 12th October 2020 Lords Chamber

[Baroness Barker (LD)]

My Lords, hindsight is frequently knocked as the privilege of an Opposition, but provided it is used wisely, it is a very useful tool to bring about informed decision-making in the future. That is what I have felt all these last six months as we have stood up to talk about these different regulations which have come before us, often weeks after they have been implemented. I like to think that at least some of the changes that will come about later today are the result of weeks upon weeks of penetrating questioning in your Lordships’ House of some of the Government’s assumptions. It is worth saying that some of the things that we have said and will continue to say still stand. Herd immunity is a strategy for when a vaccine is available. It is not a strategy for an illness for which there is no vaccine, and that will not change. However, it is also true that back in March we said to the Government, “You must be led and informed in your decision-making by local people—in local authorities, the police and local public services. Those people know how to deal with these sorts of outbreaks, and if we do not learn from them, we will waste a lot of time, money and resources.” Well, here we are today.

I am not in the brigade which has seized on the Barrington declaration and misinterpreted what the WHO has said to try to reject lockdown. There will be an ongoing place for lockdown until such time as we have an effective vaccine. However, there is not a place for reliance on generalised lockdowns in perpetuity, because they are very crude and ineffective, serving only to suppress a virus within a population. However, what we can and should be doing in these repeated regulations is learning from what has happened in different parts of the country to inform things.

We should have listened to the leaders of the local authorities in the north-east who predicted that, after a summer in which young people had been allowed to go out, go abroad and so on, if thousands of them turned up in a university town, they would make a difference to the incidence of infection, even if not to its transmission. We should listen to the public health officials, who tell us that they can see from the rise of infections in the 18 to 25 year-old group a lag but none the less a correlation with people with infections in the over-60 group on whom this has a differential effect. That evidence is there.

We ought not at this stage to rely on such crude geographic interpretations of statistics. I would like to know whether the low number of people infected in Northumberland and County Durham work in Newcastle, and how many of them work in the universities in Newcastle and have contact with students there, so that we can begin to see the patterns of transmission of the infection. That is the important thing that we are not yet learning. We are learning about incidence but we are not being told about transmission. I would like us to have the information to be able to differentiate between different businesses. I guess that transmission of infection is more likely in pubs than in restaurants, at which people sit down—or hotels, for example—and we should be able to make a regulation which differentiates between those different types of venue.

As I say, I am no Florence Nightingale. As noble Lords will know, she was originally a statistician. She was not a nurse; she went to follow the pattern of infection and illness in the Crimea. I am also tempted to say that I am no Dido Harding. What are we doing to get information from households? They are the easiest groups of people to trace. We should be getting differential information per household from all across the country.

I make a plea to the noble Lord for when we are using this information to plan for things. We saw what happened back in March, April and May in care homes. We should now be talking to the civic leaders and care home providers in the north-east and the north-west to make sure that we have no repetition of the daft and dangerous situation in which we had three different systems for ordering PPE, none of which worked.

I want to go back to the councils in the north-west, which my noble friend Lord Greaves mentioned. A few weeks ago, they wrote to the Minister to say that the protocols for the NHS 111 system needed to be looked at and changed. The Minister has told us that NHS 111 will become the primary point of access to the NHS. If we are talking about the NHS in these areas not falling over in the next few months, and as it is the one source of information that the public trust when they have long since lost trust in the Secretary of State for Health, can he assure us that the resources, training and protocols for NHS 111 will be resilient enough to make sure that people all across these areas get access immediately to the services that they need?

Covid-19: Local Restrictions

Baroness Barker Excerpts

Friday 9th October 2020 Lords Chamber

[Lord Bethell (Con)]

Well, I very much welcome the noble Lord’s comments, but I reiterate what I said earlier. As my right honourable friend the Secretary of State for Health and Social Care said on 30 September, for significant national measures with effect for the whole of England or UK-wide we will consult Parliament—and, wherever possible, we will hold votes before such regulations come into force. Of course, we will balance that with ensuring that our response to the virus means that it is delivered with speed when required. We cannot hold up urgent regulations that are needed to control the virus and save lives.

[Baroness Barker (LD)]

What evidence do the Government have that introducing statutory instruments without notice rather than with parliamentary debate and approval is more effective than developing effective local Covid strategies which are understood and adhered to by the population?

Health Protection (Coronavirus, Collection of Contact Details etc and Related Requirements) Regulations 2020

Baroness Barker Excerpts

Wednesday 7th October 2020 Lords Chamber

[Baroness Barker (LD)]

My Lords, we return yet again to the subject of NHS track and trace. In view of our discussion yesterday, it is right for me to put on record with the Minister that we on this side of the House understand entirely the need for local and national action and for those to be complementary. However, they need to be informative of each other; it is not a matter of putting in place centralised top-down systems and not picking up on local data. Only by co-ordinating national and local action will we beat this thing.

We come to these regulations with no regulatory impact assessment. More than that, after three weeks, we have nothing but assertions on the Minister’s part that they are working well and are necessary. The Government are very short on evidence when they come back with repeated requests for regulatory powers. That cannot go on indefinitely. We on this side of the House are quite willing to support actions that are necessary and proportionate—we have been from the very beginning—but frankly, the Minister is trying the patience of the House when he repeatedly requests powers without any evidence to back them up.

I ask the Minister: how many people have not engaged with this process only because they have concerns about the privacy of their data—about it being shared beyond the NHS and local authorities? If people could be absolutely sure of that, there might be far greater uptake. I say that, but I have eaten out only once in the last six months. I happened to be with a group of four people, and I was not the contact person. Had I subsequently tested positive, I would not have known how to go about telling the establishment. If this is going to work to maximum benefit, we ought to look now at how it works in practice and could be made more effective.

On refusal of entry, what evidence do we have so far that that power is being used, how it is being used and who is enforcing it? What evidence is there that it is working? On what basis was the £500 fixed-penalty notice decided, how does it compare to other fees and penalties, and who is in charge of tracking the evidence that that works?

On fixed-penalty notices, Regulation 18(11)(a) states that they can be enforced by “authorised” persons such as

“a constable … a police community support officer”

and

“a person designated by the Secretary of State for the purposes of this regulation.”

Who would that be? Are they the infamous marshals we expect to come riding to our aid any day now, with undefined powers, no skills and no resources?

Finally, when will the Government share the data on the implementation of these regulations? It is great to have three weeks of positive signs, but for these powers, the Government need to tell us a bit more about what is coming. Before the Minister comes back to ask that these powers be extended, will he provide a full statement on their impact for the whole of England?

Health Protection (Coronavirus, Restrictions) (No. 2) (England) (Amendment) (No. 4) Regulations 2020

Baroness Barker Excerpts

Tuesday 6th October 2020 Lords Chamber

[Baroness Barker (LD)]

My Lords, on 21 September, the Joint Committee on Human Rights said:

“Assessments of the proportionality of measures must be up-to-date, based on the latest scientific evidence, and formulated as a result of a precautionary approach to minimising overall loss to life. Importantly, the Government must be transparent in justifying its decision-making, including in explaining how it has balanced competing interests and the evidence on which the balancing decision has been made.”


Twice, now, I have asked the Minister: What is the evidence base for this rule of six? I have had unsatisfactory answers.

On 14 September, the noble Lord said that the phenomenon they had noticed was that large groups of people, sometimes in pubs and other places, would seemingly say that they were from two households. It was

“proving to be extremely flexible in the minds of many people. Therefore, putting an integer into the formula makes it much clearer.”—[Official Report, 14/9/20; col. 1002.]

We now have regulations under which it is possible for a person to meet and socialise with 35 people from six households in the course of a week. The public has figured out that that, in public health terms, is an absurdity. It will not work. I am surprised that, during freshers’ week, more students have not got into trouble inadvertently due to the lack of clarity.

Between March and September, Dominic Cummings has, without competitive tendering, paid people and bodies such as Hanbury Strategy £946,000 to

“research public attitudes and behaviours in relation to”

the pandemic. That information is paid for by taxpayers’ money. It is not the property of the Government or the Conservative Party, so I ask the Minister: when will that and similar reports be published so that Members of Parliament can scrutinise the basis on which decisions such as these are being made? We are six months in, and the Prime Minister does not know what we are doing, local authorities do not know what we are doing and the general public are bamboozled by the lack of clarity and consistency. It is time for us to get real about this and stop putting people in danger.