Covid-19: Vaccine
Lord Patel Excerpts(3 years, 6 months ago)
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Lord Bethell (Con)
My Lords, we are taking a four nations approach to the deployment of the vaccine. The Scottish NHS has been involved in all the arrangements we have been putting together and in both the Vaccine Taskforce, to procure the vaccines, and the Joint Committee on Vaccination and Immunisation, which has been discussing prioritisation. Furthermore, it has a voice at the DHSC, which is responsible for deployment.
Lord Patel (CB) [V]
My Lords, the announcement of the effectiveness of the Pfizer BioNTech vaccine being not only the first vaccine against Covid-19 but the world’s first vaccine against infection developed using messenger RNA is a huge scientific advance. There are challenges in delivering an effective national vaccination programme. As Professor Melinda Mills, in a report from the Royal Society and British Academy, pointed out, not the least is honest, transparent public communication free from hyperbole. Does the Minister agree? If so, who does he think would be best placed to lead the public communication of the programme?
Lord Bethell (Con)
The noble Lord is entirely right that we have to approach the prospect of a vaccine in a measured way. There remain considerable imponderables about the effectiveness, longevity, impact and side-effects of a vaccine. These are things that we do not know yet, and we have to keep our eyes open to the limits of what the vaccine may or may not be able to do. That said, the initial data from Pfizer is incredibly encouraging. We have taken a measured approach in our communications to date. Jonathan Van-Tam, the Deputy Chief Medical Officer, is the face of the vaccine, as it were; he is the member of the Vaccine Taskforce who has brought the clinical perspective to its work, and he will remain an important voice in all this.
Medicines and Medical Devices Bill
Lord Patel ExcerptsWednesday 4th November 2020
(3 years, 6 months ago)
Grand CommitteeRead Full debate Medicines and Medical Devices Act 2021 View all Medicines and Medical Devices Act 2021 Debates Read Hansard Text Read Debate Ministerial Extracts Amendment Paper: HL Bill 116-IV(a) Amendment for Grand Committee (for Fifth Marshalled List) - (3 Nov 2020)
Baroness Penn (Con)
To reassure the noble Baroness, I can tell her that the Opposition’s position on the government amendments is well noted. We will take away and reconsider the use of the term “person”, but there is a view that the safeguards that the noble Baroness is talking about are built in elsewhere, in how the clause would take effect. That does not mean, however, that we would not be happy to go away and look at those exact concerns, and see whether we can provide further reassurance. I am not a lawyer drafting the Bill, but that would be about looking at the terminology as well.
Lord Patel (CB) [V]
My Lords, I thank the Minister most sincerely for her full and comprehensive—I might even say persuasive—response. She is right to say that it has been a week since we debated this group, and even I had forgotten some things. Certainly, the venom certainly seems to have gone out of our debate.
The Minister reminded us what our anxieties were. She is right to point out that I referred to the word “person” in the government amendment, and also to the GDPR. I am pleased to hear that, on reflection, she, too, had realised why we were concerned about the use of data that might not be protected through the GDPR. Some questions remain.
The noble Baroness, Lady Thornton, has raised some important points, and I am glad that we may debate this subject again. It would be useful to have a discussion beforehand, if possible, because the word “person” is too amorphous—unless the definition could be confined as to what kind of person is meant. In her response, the Minister mostly covered organisations that might be involved in the regulation of medicines or in recommendations regarding medicines and devices, but the proposal as drafted goes much wider than that and would go beyond that. I will not say any more about that now.
The meeting that the noble Lord, Lord Bethell, arranged with the MHRA was useful, and it would have been better if we had had some of the information earlier. The information that I gave with regard to my Amendment 27 I had acquired from the industry. Of course, we got the same information from the chief executive of the MHRA. It would have been better if we had had that earlier—but that is water under the bridge. We know that there will be new ways of keeping us informed, and that will be good. At this point, I thank the Minister sincerely for her response, and I beg leave to withdraw the amendment.
Lord Patel
“Innovative Medicines Fund
In section 261 of the National Health Service Act 2006, after subsection (9) insert—“(9A) The Secretary of State must make a scheme to promote the availability of innovative medicines for human use within the National Health Service and must provide monies paid to him or her under subsection (9) for the benefit of that scheme to be known as the “Innovative Medicines Fund”.”Member’s explanatory statement
This amendment would require the Secretary of State to establish the Innovative Medicines Fund, as foreshadowed in the Conservative 2019 Manifesto; and provides that it is funded from rebates paid to the Government under the terms of the Pharmaceutical Price Regulation Scheme.
Lord Patel (CB) [V]
My Lords, this amendment was tabled by the noble Lord, Lord Lansley, who unfortunately is not able to attend today. My name is on the amendment and I am very pleased to move it in his name.
This is an amendment that normally one would have thought the Government would have no difficulty in accepting, because it was in the Conservative manifesto at the time of the election. So if you are going to choose an amendment, choose the one that they cannot turn down. I am in the good position of making two speeches, one in the name of the noble Lord, Lord Lansley, and one in my own name. It will be interesting to see which one the Minister accepts, because I am not going to tell her which one is which—I may as well enjoy this while I can.
Patients in the UK often face delays in accessing breakthrough innovations due to the NICE technology appraisal process. This is particularly true of treatments for smaller patient populations, such as patients with rare diseases, where there is greater uncertainty around effectiveness due to the challenges of collecting sufficient data to satisfy NICE’s requirements. To overcome similar challenges and enable access to the latest cancer treatments, in 2016 changes were made to the Cancer Drugs Fund, to increase NICE’s flexibility in decision-making. Between July 2016 and November 2019, approximately 41,000 patients were registered to access 79 drugs, used to treat 160 different cancer conditions. Despite the clear benefits to patients, similar flexibilities have not been extended to other areas such as gene therapy and gene silencing—treatments for rare diseases where there is not much treatment available.
Amendment 28, in the name of the noble Lord, Lord Lansley, would add a clause to the Bill that would require the Secretary of State to establish the innovative medicines fund. This fund was promised in the 2019 Conservative manifesto. Like the Cancer Drugs Fund, its purpose would be to bring innovative medicines into use in the NHS. It would give NHS patients in England access to the latest new medicines, as advised by clinicians, and would give the NHS and NICE valuable data on their effectiveness, often adding information about drugs being used in clinical practice which is not normally available through clinical trials alone. There is an increasing need to extend these access schemes to disease groups beyond cancer, including neurodegenerative conditions such as motor neurone disease and Parkinson’s, as well as haemophilia, cystic fibrosis and sickle cell disease. These are diseases with a high unmet need for treatment, but also with real hopes for new treatment options, including gene therapy and gene silencing, as I have already mentioned.
This amendment would amend Section 261 of the NHS Act, which provides powers for the pharmaceutical voluntary price and access schemes, often known as VPAS, as amended by the Health Service Medical Supplies (Costs) Act 2017. An essential part of VPAS is to improve access to innovative medicines. The new fund would help to deliver this, alongside the MHRA Early Access to Medicines Scheme that we have already heard about. The predecessor to VPAS was the Pharmaceutical Pricing Regulation System. However, over the years, lack of access to innovative medicines has been a source of angst in the industry about the scheme and, for many of us, is part of a system that fails patients. It was not only industry that did not like the scheme; it was denying treatments to patients. We should not have a stand-off between the NHS and drugs companies, with patients losing out in the process. We should have a scheme that adequately rewards the value that is inherent in medicines and also ensures that the NHS is able to provide the treatments that patients need.
The current VPAS sets a budget limit on the NHS drugs bill. If it is exceeded, the industry will provide a rebate. In the past, the NHS has seen rising drug costs but has not seen the rebate—so the NHS took the rebate but did not reinvest it in other innovative medicines. By way of the Innovative Medicines Fund, the NHS, the life sciences sector and patients would all see the benefit of the rebate. The proposed new clause would require the rebate to be made available to the fund, and it is that rebate which will provide the money for the fund. I hope—and I hope that the noble Lord, Lord Lansley, will agree—that it will be open to Ministers to take advantage of these powers to provide additional resources to the fund, according to its needs. The clause will provide the means by which the Government can deliver on their manifesto pledge and, in doing so, deliver to patients, some of whom are in great need.
I do not see how the Government can resist Amendment 28; they can only improve on it. I beg to move.
Lord Hunt of Kings Heath (Lab) [V]
My Lords, I am glad to support the noble Lord, Lord Patel, and I have a great deal of sympathy with this amendment. Of course, I speak as one of a long line of former Ministers who have wrestled with the tension between a cash-restrained NHS and the imperative to invest in new medicines and devices. I have come to the conclusion that we are not going to see the investment we want to see in these new medicines without a radical change of approach.
When we debated access in Grand Committee a couple of meetings ago, the Minister used words to the effect that he would not go anywhere near reimbursement. That is at one with the way the NHS regards drug costs: as a price and a cost to be pared down rather than as an investment in patient care. The unwillingness of Ministers to tackle the issue of reimbursement to the industry in a way that incentivises the use of new medicines is, I think, very disappointing. I do not think that there is any way around this, unless we top-slice some of the resource for the NHS and distribute it separately for investment in new medicines.
The noble Lord, Lord Patel, referred to current and previous agreements with the industry. I want to go back to the 2014 PPRS agreement, which does I think provide a model for us. It provided assurance on almost all of the branded medicines bill for the NHS, so the bill stayed flat for the first two years of the scheme and grew slowly after that. The industry made quarterly payments to the Department of Health when NHS spending on branded medicines exceeded the allowed growth rate. The quarterly payments that the industry made could have been used to fund new medicines—but, as the noble Lord, Lord O’Shaughnessy, mentioned last week, it is very hard to explain what exactly happened. With a cap in place and with reimbursements being made by the industry, the NHS proceeded to try to ration drug costs at local level. So, instead of having a virtuous circle where essentially the industry guaranteed the cap on drug costs in order to allow for investment in new medicines, we had a double whammy. The industry price was pared down and the NHS continued in its bad old ways of trying to prevent new medicines being accessed by patients.
Baroness Penn (Con)
I am reminded that my noble friend Lord Lansley referred to the collective noun for former Health Ministers as a “frustration” of former Health Ministers. I can tell my noble friend that the engagement exercise will involve the pharmaceutical industry, the NHS and associated bodies and patient groups. That is the level of detail that I can give to him today. I was very pleased with being able to say “quarter 1” next year; it felt to me like a very specific timeframe for when that engagement exercise would be undertaken.
Lord Patel (CB) [V]
Thank you, my Lords. I apologise to the Chair for jumping in. I forget that, in the new world, I do not speak unless instructed to do so.
I thank the Minister enormously for her response. She mentioned the frustrations of the former Ministers. If she thinks that former Ministers get frustrated, think about us lesser mortals who have suffered the former Ministers when they have not listened to our arguments. Maybe that should be taken into account, too.
I thank all noble Lords who have taken part. They have spoken with passion and commitment. This has been referred to by several people, but I do so again. The noble Lord, Lord Hunt of Kings Heath, has been pursuing this passionately and eloquently for a very long time. He has made an important point: if the medicines are available and people are suffering, why do we keep arguing about health and drug budgets and how to deliver it? The principle should be how we can get those drugs to the patients who might be suffering. He is right. If a rebate is available, where did the money go? The rebate was a drug fund rebate to be reinvested, you would have thought, in people getting the medicines.
No doubt the Minister is aware that there seems to be complete consensus around this amendment. I hope that it does not need to go to Report but, if it does, Ministers will be aware that there will be complete consensus. I hope that the Minister makes rapid progress with sorting this out. In the meantime, I thank all noble Lords and the Minister most sincerely for taking part. In begging leave to withdraw the amendment, I hope that the noble Lord, Lord Lansley, will feel that we gave it enough airtime and passion.
Lord Patel
“(f) about requirements to consider babies, children and young people in research about new medicines, in a manner similar to the EU Paediatric Regulation.”Member’s explanatory statement
This amendment is to ensure that in the development of new medicines and clinical trials, data related to children is taken into consideration.
Lord Patel (CB) [V]
My Lords, I shall curtail my remarks, as time is limited and this is very much a probing amendment. It draws attention to the need to ensure that paediatric regulation-specific measures that preside over the licensing of medicines to better protect the health of children, are reflected in future legislation regarding clinical trials in the United Kingdom.
New medicines licensed in the EU are currently subject to an EU Parliament directive that requires research about new medicines to consider babies, children and young people. The directive means that standardised procedures are in place for sponsors to plan and conduct studies. To get new medicines intended for use by children licensed for marketing in the EU, sponsors must have in place a paediatric investigation plan that aims to ensure that the necessary data are obtained through studies in children. In short, new medicines applying to be licensed for use by children must be trialled by them. It is often the case that medicines trialled in adults are then given in lower doses to children.
New medicines trialled in the United Kingdom are currently subject to this regulation. Moving on, there are clear clinical reasons why it is important for babies, children and young people, as they may show differences from adults in their response to and tolerance of medicines. To ensure that new medicines are safe for their use, they must be involved in clinical trials. That is the important point of my modest amendment.
Furthermore, there is a commitment and a key pledge in the NHS long-term plan to raise to 50% by 2025 the involvement of children and young adults in clinical trials. If there is no regulation requiring that data be collected in clinical trials with children, we will not achieve this. So all I seek is an assurance from the Minister that the Government and the MHRA are well aware of this and that the paediatric regulation will be considered whenever the clinical trials regulations are drawn up by the MHRA. I beg to move.
The Deputy Chairman of Committees (Baroness Garden of Frognal) (LD)
My understanding is that the noble Lord, Lord Lansley, has withdrawn, so I call the noble Baroness, Lady Jolly.
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.
Lord Patel (CB) [V]
My Lords, I support these amendments. They touch on the issues and arguments returned to in respect of amendments to Clauses 15 and 42, which set out the procedures to be followed in exercising these powers, as was mentioned by the noble Lord, Lord Hunt of Kings Heath, its unjustified use of negative procedure and this case of protocols. Clauses 6 and 15 provide that the Secretary of State can disapply certain provisions of the medicines and medical devices regulations
“in circumstances which give rise to a need to protect the public from a risk of serious harm to health.”
Such provisions may be within the Human Medicines Regulations 2012, the Medicines for Human Use (Clinical Trials) Regulations 2004, and the Medical Devices Regulations 2002. However, they also may refer to those provisions that are still to be drafted at the current time and are thus unknown and not yet subject to scrutiny.
I recognise that it is necessary to be flexible in the face of an emergency situation as in the current pandemic. However, in its present form this is another example of broad-reaching powers falling outside of that which is reasonable and proportionate. While the disapplication of certain provisions using this power can be exercised to regulations under the affirmative procedure, they may also be passed in certain circumstances by the negative procedure, and, as in these amendments, by protocol. The use of a protocol, in particular, bypasses Parliament, and therefore is unnecessary. I support these amendments.
The Deputy Chairman of Committees (Baroness Garden of Frognal) (LD)
The noble Lord, Lord Blunkett, has withdrawn, so I call the noble Baroness, Lady Jolly.
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.
Medicines and Medical Devices Bill
Lord Patel ExcerptsWednesday 28th October 2020
(3 years, 6 months ago)
Grand CommitteeRead Full debate Medicines and Medical Devices Act 2021 View all Medicines and Medical Devices Act 2021 Debates Read Hansard Text Read Debate Ministerial Extracts Amendment Paper: HL Bill 116-III(Rev) Revised third marshalled list for Grand Committee - (26 Oct 2020)
Lord Patel (CB) [V]
Thank you, Chairman. It is a pleasure to resume where the Committee left off last Monday. I will speak to Amendment 19, in the name of the noble Baroness, Lady Sheehan. I congratulate the noble Baroness, who spoke with eloquence and passion. On Zoom, you can see faces more clearly and you could tell by looking at her while she was giving her speech that she really feels for the cause. I will speak briefly to support the noble Baroness in her efforts to use human rights legislation to get medical therapies available to patients, particularly in developing countries.
I am no expert in human rights law, but I have seen at first hand what lack of everyday medicines, which we in developed countries have easy access to, does to patients in need in developing countries. In my own medical speciality of obstetrics, I have come across situations where mothers die, or end up with lifelong disability, for lack of availability of cheap medications that would have saved them from dying of childbirth-related haemorrhage. Medicine that costs less than £2 would have saved those mothers’ lives in a very short time.
Despite progress, over 2 billion people worldwide face obstacles in getting the medicines that they need. The current research and development model is mostly market driven and is ill equipped to deliver medicines for neglected tropical diseases and emerging infectious diseases that only affect those in developing countries. Only 1% of the total number of new medicines coming to market are licensed for treating tropical and rare diseases in poorer countries. Another big barrier is the pricing mechanism that makes what we may regard as cheap medicines unavailable in poorer countries because of cost. A human rights model, proposed by the WHO and the United Nations, for making more treatments available in poorer countries, faces serious obstacles because of world trade and patent regulations. The monopoly market power of patent rights plays against the availability of medicines for poorer countries.
All that being said, a soft-power model can sometimes be effective. The Bill & Melinda Gates Foundation has had considerable success in its efforts to create an access-to-medicine index for pharma to demonstrate its commitment to getting medicines to the developing world. One example is the generic medicine for treatment of hepatitis C, but some pharma companies prevent early recourse to generic versions of medicines through extending patent laws by using tactics such as data exclusivity. I heard an announcement today that, if the Sanofi and GSK vaccine works, they will provide 200 million doses of it free to the developing world. That is good news, but it is far away from the billions of doses that we will require.
If there is a serious desire for the world to make treatments available to patients in poorer countries, at a price that they can afford, laws will be needed to change the market-driven model to a more rigidly applied human-rights-driven one. The noble Baroness is right to highlight the problem. The Government can help by working with other Governments to create opportunities for easier access to medicines for developing countries. There has to be a way to get around the model of profit versus patients.
Lord Stunell (LD) [V]
My Lords, I endorse what the noble Lord, Lord Patel, has said about the excellent speech of my noble friend Lady Sheehan. I support her arguments and those of all the previous speakers. I could never hope to bring the level of expertise that the noble Lord, Lord Patel, does to this subject.
I want to focus, very simply, on what happens next—and what happens next is based on what has happened so far. Proposed new subsection (2)(d) in Amendment 19 is an affirmation of the International Covenant on Economic, Social and Cultural Rights, which was first passed in 1966 and the United Kingdom Government ratified 10 years later in 1976. My first question, therefore, is to ask the Minister: do the UK Government still stand by that covenant, or is it another piece of international legislation that can be broken in certain limited and specific circumstances? I think that noble Lords will want to hear the Minister say very clearly that the Government are still committed to the full meaning of that covenant. If he does, I hope he will also acknowledge that the key feature of that covenant is that it requires access to medical care and treatment to be affordable and available to all. That is exactly what the second part of Amendment 19 is talking about. It aims to give teeth and real substance to that covenant and to make sure that medicines and treatment are indeed affordable and available to all.
What is the risk that we are guarding against? Why do we need to do this? The noble Lord, Lord Patel, also focused on those questions. Although there are many risks, the leading risk which this amendment deals with is greedy pharmaceutical companies. The story of Gilead selling its drug in the United States for £2,300, when it can be manufactured with a profit for £9, was drawn to our attention by the noble Lord, Lord Alton, on Monday. That is just one of many examples of companies unscrupulously using their monopoly to reap profits at the expense of those who need the treatment. Sadly, there have been many other examples of it. In the current worldwide search for a vaccine, the pressure on companies to deliver a treatment, and the pressure from communities throughout the world to receive it, means that the risk of profiteering and gouging are very much higher.
Of course pharmaceutical companies are fully entitled to recover their costs, and that should include the costs of their research, including for the research on products which they cannot bring to market for one reason or another; and of course they should be entitled to make a profit as well. But in the case of Covid-19 vaccines, nearly all the money has been pumped into the research from the public via Governments around the world. Hundreds of millions of pounds from the United Kingdom Government have gone to these firms. The Government therefore have some really powerful levers to pull to make sure that there is fair and equitable pricing by those companies and fair and equitable sales around the world.
Of course, the truth of the matter is that we have a WTO TRIPS agreement that protects pharmaceutical companies’ monopoly purchasing. But attached to that is the Doha declaration of 2001, which gives Governments the right to step in to prevent that profiteering and price gouging. Under the declaration, the United Kingdom has in principle the right to grant compulsory licences so that other manufacturers can make the product in an alternative way at an alternative price. We need to hear from the Minister today that the UK Government will use the powers available to them in the Doha declaration to prioritise the safeguarding of access to medicines for all right round the world. “All” has to mean all, not just within the United Kingdom but worldwide, as my noble friend Lady Sheehan made so clear, especially in low and middle-income countries.
The role of the United Kingdom in ensuring that an effective worldwide response to Covid actually happens may well require compulsory licensing using the basis provided by the Doha declaration. Certainly, having that basis, and having this amendment passed, gives the Government a credible threat that they will indeed make sure that medicines are available for all. I look forward to hearing the Minister agree that, if not Amendment 19 itself, at least a loud and clear commitment from the Government to implement their powers under the Doha declaration is very much a part of their armoury in tackling the current situation.
Lord Patel (CB) [V]
My Lords, it is always very difficult to follow the noble Lord, Lord Alton of Liverpool, because his speeches are always so powerful, convincing and well researched, so I do so with some hesitation. I absolutely agree with him that it is abhorrent that the plastinated bodies of human beings are used for commercial purposes in exhibitions. It is certainly not science, and I do not think it is art either. It should be banned, and I was surprised that the exhibition took place.
Tissue and organs were taken from children at the Alder Hey Hospital. I was involved in the subsequent inquiry and heard the harrowing stories of parents whose children’s organs—there were thousands of them—were taken and stored without their consent.
I was touched by and support the powerful speeches of all the preceding speakers. The noble Lord, Lord Hunt, raised an important issue and I agree that his amendment is a modest provision asking the Government to look at the issue and to amend the Human Tissue Act if necessary. In the past, I chaired for four years the Medical Research Council’s ethics committee, and for more than four years I have chaired the UK Stem Cell Bank. I am also familiar with the research ethics committee—at one time I was its chairman—of the National Patient Safety Agency, which the noble Lord, Lord Hunt of Kings Heath, chaired before me, when it introduced a nationwide regime for examining consent through that ethics committee, which is now a statutory committee. Noble Lords have rightly said that the regulation of consent in the use of tissue and organs is strict in the United Kingdom. There is strict monitoring in the use of tissues for any purpose. The noble Lord, Lord Hunt, alluded to the fact that the law on the importation of tissues is lax. If that is true, it needs to be examined. I have looked into the current law and at various websites covering human tissue importation and, in particular, the issue of consent. The noble Lord, Lord Alton of Liverpool, asked how we can be certain of the validity of the consent that was given. I agree it is an important point, and the Government should seriously consider Amendment 24.
On the issue of research, I will tell a story about HeLa cells. I do so not to immortalise HeLa cells, although they are immortal, but to immortalise the person from whom the tissue sample was taken on 8 February 1951: Henrietta Lacks—which is why they are called HeLa cells. She was a black American mother of five who developed extremely aggressive cervical cancer. She attended Johns Hopkins Hospital, in Baltimore, and a tissue for diagnostic purposes was taken from her cancer. The tissue was then passed on to a laboratory that was trying to culture cell lines. Ever since then, HeLa cells have been used all over the world to develop treatments in all kinds of therapies. For instance, Salk used them to develop the Salk polio vaccine. They were used to develop treatments for cancers, such as breast cancers. They were used for xenografts, again to develop cancer treatments. They are also being used to study aging processes. As our cells age they eventually become senescent and inflamed, which produces some of the chronic diseases that humans suffer from. That does not seem to happen with HeLa cells as regards telomerase, which controls the size of telomeres, which is part of the aging process. HeLa cells have been used for all kinds of purposes.
I have another concern about the commercialisation of tissue use. In advertisements on the internet—noble Lords can see them there if they wish—many commercial companies say: “We will supply tissues to industry for the testing of drugs”. What consent was given for the use of that tissue? Does the HTA have to give permission to import this tissue or ask where it came from? When the Government examine this issue I would only ask them to distinguish between tissues, organs and cell lines and ask why they should be treated differently. I do not say that regulation is not required; I am simply saying that, when it comes to importation, we need to have a clear understanding of why cell lines should be treated differently from tissues and organs. I support the amendment.
The Deputy Chairman of Committees (Lord Lexden) (Con)
The noble Baroness, Lady Stroud, who is next on the list, has withdrawn so I call the noble Lord, Lord Sheikh.
Lord Patel (CB) [V]
My Lords, I will speak to Amendment 97 in the name of my noble friend Lord Kakkar, to which I have added my name. Before I do so, I have a comment in response to an important question asked by the noble Baroness, Lady Cumberlege, which my noble friend Lord Kakkar answered. How do you test the effectiveness of a device which is an implant, and is likely to remain in the body permanently? This is opposed to implants such as pacemakers—as I alluded to on Monday—where, in one example, a device was unsatisfactory after having gone through testing, but was then implanted in 1,400 patients before its faults were clearly recognised. In that case, it was possible to remove the device, and put in one which functioned better. The testing of an implant which is likely to be permanent must be more rigorous, in terms of its tissue reactivity, in the training it will require, and in the possible harm it can do. This is particularly true for things like mesh that are likely to be embedded into the tissue. People claimed that that mesh was safe because it had been used by surgeons for years for hernia repairs. As I said on Monday, I have never used mesh for any of the surgery I did, so I do not know its performance. The question of the noble Baroness is quite right: it does not mean that we do not have to progress with finding new medical devices which would be effective; it means that we need to ask significant questions, depending on the device we are talking about. I may not have answered her question, but I have tried to identify ways we might do that.
My noble friend Lord Kakkar has made a very important point about the need for medical devices to be tested for their effectiveness in the functions they are supposed to provide prior to their being granted full market approval. Generally, the design of a medical device is regulated by its essential principles of safety and performance with respect to its design and construction. Less attention is paid to its clinical effectiveness throughout its expected life, whatever that might be. Medical devices play an important role in enhancing patient quality of life, but there is a need for improved methodology to obtain evidence for their safety, performance and efficacy. The UK, with its strong research base, and with the NHS at its core, is well placed to generate the high-quality evidence needed. Guidance is needed to generate, implement and produce the evidence required to foster innovation. Adopting engineering principles of continuous monitoring, reporting of accidents or near misses—similar to post-market surveillance of medical devices—is important. In developing medical devices, dialogue between clinicians, manufacturers, and end users—the patients—to identify which devices need to be developed is valuable, but not often followed.
While not as robust as a randomised control trial, observational studies are important in identifying rare, catastrophic and delayed harm. Furthermore, medical devices are less amenable to controlled trials, being part of a complex system of care, involving people in other systems. The UK has an opportunity to develop specialised medical device trial centres and clinical networks to oversee early to late-phase trials. That initiative would benefit patients and put the UK in a lead position to develop safe and effective medical devices.
The Royal Academy of Engineering and the Academy of Medical Sciences, of which I am a fellow, have much to offer in such an initiative. With his amendment, which rightly promotes the requirement that medical devices should demonstrate their clinical effectiveness prior to a full market authorisation licence, my noble friend Lord Kakkar has also provided an opportunity for the UK to develop leading-edge medical device regulation, and be a place for developing safe and effective medical devices.
Baroness Jolly (LD) [V]
My Lords, the noble Baroness, Lady Cumberlege, made some telling remarks and asked some searching questions. We support the amendments in this group relating to the granting of licences and the processes of clinical trials. They aim to improve patient safety, as the granting of provisional licences will allow more information to be available on devices and medicines.
Amendment 84 is intended to probe the various thresholds for medical device trials. At present, new devices deemed to be “substantially equivalent” to something already on the market are certified as safe via a notified body and can go on to be used quite straightforwardly. In contrast to standards for introducing new pharmaceutical products, data from robust clinical trials are not required. Delays in the introduction of innovative treatments and medical devices should be avoidable. We should, and could, become a key player in the world market.
Safety is always paramount and the amendment in the name of the noble Baroness, Lady Finlay, to develop rapid, two-year, provisional MHRA licences is a good innovation. Start-ups would welcome these moves.
The noble Lord, Lord O’Shaughnessy, spoke about hip replacements. He made some helpful remarks about registries. I was a trustee of an organisation called Orthopaedic Research UK, which was left a considerable amount of money by a wealthy orthopaedic surgeon with a view to fostering innovation in orthopaedics. Research scientists, doctors and start-ups are able to bid for funding on projects to aid orthopaedic research, with a view to taking a development to market. The amendments in this group will help researchers working on these projects, as will the granting of two-year licences on these devices.
Devices certified through this process are not tested to establish whether they deliver significant patient benefit. Rather, the system only establishes that a device is not unsafe and that it fulfils its intended function. Meanwhile, even when clinical trials are required, because a device is deemed sufficiently different from what is on the market to merit that, the rules around how that research is constructed are looser than for medicines. These are practical, useful measures.
Lord Patel
“( ) Regulations under section 1(1) must make provision to enable the Medicines and Healthcare products Regulatory Agency to work with other regulators to minimise delay for the United Kingdom to get early access to new medicines.”
Lord Patel (CB) [V]
My Lords, I speak to Amendment 27, and I am immensely grateful to the noble Lord, Lord Hunt of Kings Heath, for adding his name to it. He adds not only his name, but his weight and expertise, which I look forward to hearing.
I beg the indulgence of the Committee, as I may be long, as I will also speak to the government amendments with my own, as I am allowed to speak only once. My amendment is a short and simple probing one to explore how the Government will mitigate against delays for UK patients getting early access to medicines, particularly innovative treatments such as gene therapy, gene silencing, other treatments for rare diseases, and cancer drugs. Part of the problem, as mentioned on our previous day in Committee, is that we are not able to speak to the MHRA and other regulators to know what their plans are. Yet, to my surprise, I was sent something yesterday evening, which I will refer to in a minute.
I understand that the MHRA are developing plans, but it is not clear whether that includes working with other regulators, NICE and NHS England for patient access to treatment. I understand that a new medicines designation will be created, alongside an integrated framework across healthcare agencies to enable innovative treatments to be approved more quickly. As gene therapy and other gene-based treatments, such as gene silencing, are one-time treatments, they require a different approach to the evaluation of efficacy. While the UK has a rigorous process of regulating and reimbursement, it is known to be lengthy, delaying access to treatments. When it comes to getting cancer treatments to patients quicker, clinicians are asking for complex innovative design trials to be implemented instead of the usual clinical trials. As mentioned previously, patients with rare diseases are concerned that if a UK regulator does not work with the EMA or the FDA, a lack of access to patient numbers and data will mean that UK patients miss out on treatments.
I turn now to the information that I have received. During Covid, the MHRA have been exemplary in rapidly allowing clinical trials to be conducted and therapies to be brought to patients very quickly. A process that would normally take two years was completed in six months for some medicines. Looking to the past, as was mentioned on Monday by the noble Lords, Lord Blunkett and Lord O’Shaughnessy, NHS England was very committed to ensuring that the UK was the first country in Europe to provide access to the two latest chimeric antigen receptor T-cell drugs, commonly known as CAR-T therapies, an immunotherapy for cancer. It was a very positive case study of what could be done, but this has not been the experience for all treatments. We need to ensure that the new NICE framework is fit for the future for the high number of innovative treatments coming through. There are potentially 27 cell and gene therapies that will need to be appraised by NICE within the next three years.
I understand that the MHRA has published a guidance note on new assessment routes from the end of the Brexit transition period, to which NICE needs to be more aligned. In addition to continuing to accept EMA decisions for two years, the MHRA has also announced its intention to design new approaches to market: from 1 January 2021, it will introduce an accelerated assessment procedure and then reach its opinion on approvals within 150 days of submission of a valid application. Applicants interested in seeking accelerated assessment are told to contact the MHRA in advance of the intended date of submission.
Rolling review is a new route for marketing authorisation applications which offers ongoing regulatory input and feedback. It is a good idea if the regulator wants to get involved at a very early stage in the development of clinical trials and hence get treatments to patients early. As to overlapping an integrated pathway for new medicine, the MHRA is, I gather, working with partners across the system, including NICE, to develop a streamlined route to market for new medicines. This will include a new medicines designation and an integrated pathway with multiple entry points. That is all good news, and I hope it will all come to fruition very quickly so that patients can get the medicines they need, particularly for rare diseases.
I turn to the government amendments in this group. As I said earlier, I seek the Committee’s indulgence as I will need to deal with these amendments at some length, particularly their amendment on information sharing. The Minister said in a letter that the provision was to protect public health. He said that information is currently shared between the MHRA and the Veterinary Medicines Directorate and international partners to support their work in ensuring that medicines and medical devices are safe. Information sharing currently falls within the purview of the EU, and the Minister implied that this government amendment is intended to ensure the capacity of the MHRA and the VMD to continue to collaborate internationally to ensure public safety. In principle, this amendment appeals to common sense. The MHRA and the VMD need to share information with international partners to ensure the safety of devices and medical products. However, the issue is the breadth of the amendment’s wording and the vague terms used in drafting the power.
The amendment inserts new clauses after the current Clauses 6, 10 and 35, which set out that the relevant authority may disclose information it holds in connection with human medicines, veterinary medicines and medical devices
“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, veterinary medicines and medical devices. That immediately raises several points. First, the provision refers to
“information which a relevant authority holds”.
That is a broad construction and could potentially cover all information in patient records relating to medicines and medical devices. The term “in connection with” is broad and vague. Does it mean any information tangentially related to medicines, veterinary medicines and medical devices? Could it include any information in medical records relating to the use of medicines for patients? No definition of
“person outside the United Kingdom”
is given, which leaves it open to broad interpretation and places no limits on the category of persons to whom information may be disclosed.
The purposes of information disclosure are also broad and could relate to the fulfilment of requirements of potentially any international agreement. That is particularly highlighted by the use of “or” in reference to arrangements “relating to the regulation” of medicines and medical devices. It means that international agreements that require disclosure of information do not need to relate strictly to the regulation. In fact, despite the arguments detailed in the letter of the noble Lord, Lord Bethell, relating to information disclosure for purposes of promoting public safety, there is no mention of public safety in the purposes of information disclosure in the amendment. The purposes are left to be determined by any international agreement, and this power is exceptionally broad.
Medicines and Medical Devices Bill
Lord Patel ExcerptsMonday 26th October 2020
(3 years, 6 months ago)
Grand CommitteeRead Full debate Medicines and Medical Devices Act 2021 View all Medicines and Medical Devices Act 2021 Debates Read Hansard Text Read Debate Ministerial Extracts Amendment Paper: HL Bill 116-III(Rev) Revised third marshalled list for Grand Committee - (26 Oct 2020)
Baroness Burt of Solihull (LD) [V]
My Lords, I speak to Amendments 10, 12 and 74, to which I have added my name. Although I support all the amendments in this group, they pretty much do the same or a similar kind of job, but I added my name to those amendments specifically because they speak to safety being paramount for new drugs and devices. I say that because the excellent Cumberlege report tells the graphic and heart-rending story of what happens when it is not.
We have heard about the effects of the drugs Primodos and sodium valproate from the noble Baroness, and other noble Lords will cover those areas. My interest relates to mesh and what happens when insufficient care is taken in the implementation and tracking of the well-being of women who have had it inserted. When it goes wrong, it really can ruin the life of the woman affected. Noble Lords may recall the case that I mentioned on Second Reading of how Jane’s life has been ruined by mesh—not just physically but emotionally and economically. The noble Baroness described such things as well. Yet the surgeons who did this to her seem to exhibit no remorse and have closed ranks, denying the very existence of some of the pieces of mesh inside her.
It makes my blood boil to hear those harrowing stories, and the noble Baroness had to listen to such testimony from victims for two years. As she says in her report, this took its toll on her and the other members of the panel, but how much worse must it have been for the victims themselves? Yet we see phrases in the Bill such as,
“the appropriate authority must have due regard to ... the attractiveness of the relevant part of the United Kingdom as a place in which to conduct clinical trials or supply human medicines”.
Attractiveness? What does that even mean? My noble friend Lady Jolly spoke on the third group of amendments about the multiple interpretations that the term could have. Are we trialling drugs and devices on human beings so that we can subsequently flog them abroad? I am sure that the Minister will deny that and give us a proper definition of the word.
Attractiveness and availability must be a low priority compared with safety and that is why I strongly commend the amendments. If the Minister believes that safety must be the overriding consideration, I trust that he will have no difficulty in accepting them.
Lord Patel (CB) [V]
My Lords, as I was not able to get in following the comments made by the noble Earl, Lord Howe, I say that, as a Cross-Bencher, I was irritated that we were not involved in the communication, I am glad that the statement has been made and I concur with most of the comments of the noble Baroness, Lady Thornton. I hope that from now on the procedure will be better. I had threatened to negative the amendments, but I will not do so now.
I speak in strong support of Amendments 10, 12, 74 and 75 tabled by the noble Baroness, Lady Cumberlege, to which I have added my name. I concur with all that she and other speakers have said. So far as her findings were concerned, I will repeat what I said when we debated her report. The profession needs to hide its head in shame that such trauma was inflicted on women and that such harm to unborn children was caused by disregard for guidance. As an obstetrician, I have never used mesh; I am one of those old-fashioned surgeons who did not use any artificial devices, but then I was not regarded as an avant-garde or fancy surgeon in that respect. Her report is a salutary lesson about the importance of patient safety. I will confine my remarks to medicines and medical devices, and the importance of embedding patient safety.
The noble Baroness’s report is entitled First Do No Harm. I say with humility that the motto on my coat of arms is “Primum non nocere”. I am privileged that the shield that bears it will hang for ever in the chapel of St Giles’ Cathedral in Edinburgh. I took that motto not because of the medical oath, which of course is correct, but because I was at the time chairman of the National Patient Safety Agency of England, an organisation that the noble Lord, Lord Hunt of Kings Heath, had chaired before me. It no longer exists, but its aim was to establish the whole concept and methodology of patient safety in the NHS in England. The NPSA, as it was then known, had developed a confidential reporting system for incidents relating to patient safety for healthcare staff and patients. Nearly 40% of the large number of reports—we used to get as many as 200 confidential reports a day—were related to medicines, medicines delivery and devices.
The concept of the safety of medicines is not new, and the experience of over a century has framed laws, regulations and amendments to make medicines safe and effective. In 1937, more than 100 deaths were reported in relation to sulfanilamide. They were due not to the medicine itself but to the solvent, diethylene glycol, which was added to the active ingredient. This led to regulations requiring testing of medicines in non-clinical and clinical settings prior to their being licensed for therapeutic purposes. Is it not ironic, especially in the context of the report of the noble Baroness, Lady Cumberlege, on Primodos, that the drug thalidomide, used as an antiemetic in early pregnancy, was not licensed in the USA due to animal studies that had shown some deformities in animal embryos? The USA therefore avoided the harm that the medicine caused to unborn children and a condition called phocomelia. It was accepted in a large part of the world, including the United Kingdom, and resulted in tens of thousands of children being born with such deformity.
There are patient groups to whom regulators need to pay special attention when approving medications, such as pregnant women, children and older people. We will come to amendments later on alluding to this. There are many examples of medications that are withdrawn from the market because of patient harm, emphasising the importance of a secure system of post-licensing surveillance. Some 1.1 billion prescriptions are supplied every year in primary care. Furthermore, a mid-sized hospital supplies about 50,000 doses a day. A study in 2018 showed that 237 million medication errors occurred every year in England, of which 68 million caused some degree of harm. While the harm may appear in one part of the system, the solution often lies across it. Much can be learned from a well-run and monitored national reporting and learning system, particularly as to which medicines are commonly involved in errors and hence patient harm. A single change that would make a big difference is a system that recognises and establishes the greater involvement of patients in their own care.
A healthcare system that wants to achieve a significant reduction in patient harm from medications will need a national programme in which different parts of the system work together. The amendment in the name of the noble Baroness, Lady Cumberlege, may be a start to that, and I commend her for it.
Unlike with medicines and the EMA, even at EU level, there is no agency for the safety of medical devices. Regulation relating to medical devices or standards is often a voluntary process and is not governed by national or international standards unless recognised by a regulator as mandatory. The list of what constitutes a medical device is long and ranges from machines and in vitro reagents to software. As the UK leaves the EU, it has an opportunity to devise a system of regulation focused on safety. In 2017, there were more than 16,000 device-related reports of harm. Following the publication by investigative journalists of a series of reports on medical devices known as “The Implant Files”, there has been a demand from doctors and others for greater transparency from manufacturers of devices, particularly regarding safety. The same stringent regulatory process, including disclosure of data related to adverse events, should be part of a market approval process.
I know that several amendments coming up are related to safety and licensing, which currently does not exist in the UK for medical devices. The amendment in the name of the noble Baroness, Lady Cumberlege, in relation to patient safety, including medical devices, will go further than current requirements for market approval. Information and data related to safety, both short-term and long-term, may well be a requirement for market approval. Why is it necessary to have full safety data to license a cardiac drug but not for an implanted pacemaker? As an example, a device called Nanostim was withdrawn from the market three years after safety approval due to the alarming number of patients to whom it was causing harm, by which time 1,400 patients had had it implanted. The noble Baroness is right to highlight the need for more effective regulation for safety of medical devices and medication overall. I am pleased to support her amendment.
Baroness Hollins (CB) [V]
My Lords, it is a pleasure to follow my noble friend Lord Patel. I commend his work on patient safety over many years. I strongly support the amendments in this group, which are intended to improve patient safety—in particular, Amendments 10 and 12 tabled by the noble Baroness, Lady Cumberlege. I withdrew my own, very similar amendment and added my name to that of the noble Baroness.
In the present drafting, as the noble Baroness has explained, there is no explicit hierarchy of the three stated principles: safety, availability and attractiveness of parts of the UK as a place to conduct clinical trials or supply medicines, yet this Bill could be so much more effective if it was more explicitly about patient safety. These amendments put patient safety first, as so clearly called for in the noble Baroness’s shocking recent report First Do No Harm. I quote from that report’s foreword:
“The system is not good enough at spotting trends in practice and outcomes that give rise to safety concerns.”
I simply stress that safety must apply across all aspects of the development and provision of human medicines with respect to both mental and physical illness. Noble Lords may be unfamiliar with the national STOMP programme, launched in 2016—STOMP stands for stopping over-medication of people with a learning disability, autism or both. Public Health England says that, every day, between 30,000 and 35,000 adults with a learning disability take psychotropic medications when they do not have the health conditions the medicines are for—they are also prescribed to children and young people—yet such medicines may have serious side effects, including adverse effects on their mental and physical health.
I do not wish to speak at length about this or other aspects of these amendments other than to stress that patient safety must be the foremost consideration in this Bill.
The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)
I call the next speaker, the noble Lord, Lord Patel. Lord Patel? Oh dear, we are not having a great afternoon. If we cannot establish contact with the noble Lord I will move on to the next speaker. Lord Patel, are you with us?
The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)
I am sorry. We could not hear you and we still cannot see you.
The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)
Ah! You are with us in all your glory. Please continue.
Lord Patel (CB) [V]
Not much glory, but thank you very much.
Before I talk about the amendments I intended to speak to, I want to comment on the amendment tabled by the noble Lord, Lord Lansley, and the comments that the noble Lord, Lord Hunt of Kings Heath, just made, which I absolutely agree with.
The noble Lord, Lord Lansley, is right about innovation. It should be part of the Bill, together with clinical trials. As he rightly said, we are a nation that excels, and has done for more than 20 years, in discovery science, particularly in biology and molecular biology. He mentioned Nobel prizes: the United Kingdom has won 29 Nobel prizes in medicine and physiology, and 29 in chemistry, two subjects often linked with discoveries in biology.
However, as the noble Lord, Lord Hunt, said, we are poor at taking the biology forward into innovations and drug development. We have some fantastic universities for drug development, but for that they require a strong allegiance with the NHS. The science base needs to be integrated with our NHS and its data, including patient data, to develop drugs. That is what we lack. He is absolutely right. I hope that we will have another opportunity to address this matter. Are our policies on how drugs are procured and assessed holding us back? That is a good debate to have, and it is a pity we are not having it today.
I have already said that I support Amendment 16, in the name of the noble Lord, Lord Lansley; I also support Amendment 20, in the name of the noble Baroness, Lady Thornton, to which I have added my name. I shall also speak to my own amendments—Amendments 21, 61 and 82—which are supported by the noble and learned Lord, Lord Mackay of Clashfern, who could not be with us because he is in the Chamber.
With regard to government Amendment 14, I have said before, and I repeat now, that the construction is open to the interpretation that the attractiveness of the UK is to be treated as part of what promotes public safety. If so, the amendment would not address—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. The consideration of attractiveness can undermine the consideration of safety. This is in line with the Government’s repeated assertion that attractiveness is never in conflict with safety.
Lord Blunkett (Lab)
My Lords, although I was the shadow Health Secretary for two years in the 1990s, I speak with some temerity because the three contributors that we have just heard have expertise on this issue that I do not. I rarely say that when I decide to speak in Committee or on the Floor of the House.
I want to make three points. One was made by my noble friend Lord Hunt but reinforces the points made by the noble Lords, Lord Lansley and Lord O’Shaughnessy. It is about innovation and the way in which the acceleration of known therapies—in this case, gene therapy—can make such a difference. My much-missed and much-loved friend, the late Baroness Jowell, pioneered the idea of rapid, speedy throughput of potential new therapies, including gene therapy, and ideas to fruition. As a Minister at the time, the noble Lord, Lord O’Shaughnessy, was extremely helpful and supportive. I will always be grateful to him for attending Tessa’s funeral and being really committed to seeing her ideas go forward. I am glad that he was able to contribute this afternoon. I hope that the Minister will bear in mind the reality of what happens to individuals in practice and not forget the continuing campaign and support of Tessa’s family, particularly her daughter and her son.
I want to touch on two tangential issues. One is the real problem we have with substituting for procedures that are withdrawn because overseas manufacturers decide that they will not sell to us, including how we can initiate alternatives within the research available to us. Eighteen months ago, I had a procedure on my hand. I was told by the consultant that this procedure avoided having to have surgery; your Lordships and those who are taking any notice of this debate will be aware that hands are rather critical to me in a whole range of ways, so it was a very attractive alternative. However, she told me that I was one of the last patients to benefit from it because it had been withdrawn by an American supplier.
The very opposite happened in my old constituency, where Swann-Morton, a mutual that has existed for more than 80 years, produces a large number of cutting-edge facilities, from old-fashioned scalpels to the most modern and up-to-date tools for doing the job. I want to know what we will be able to do post Brexit to protect the likes of Swann-Morton, which is a big employer in the locality—it is a mutual in every sense, including the decisions taken by the employees themselves —from being excluded from markets that they previously had obvious access to, which reduces their competitiveness and ability to proceed. They have also been hit by Covid, of course; the fewer the procedures undertaken through the NHS, the more this hits the budgets of those who rely on a continuing flow of orders.
I could not find another niche in this particular group of amendments to make my point, so I have used my ingenuity. I am grateful for not having been heckled.
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.
Covid-19: South Yorkshire
Lord Patel Excerpts(3 years, 6 months ago)
Lords ChamberRead Full debate Read Hansard Text Read Debate Ministerial Extracts
Lord Patel (CB) [V]
My Lords, as the infection rates and admissions to hospital rise, as seen in tier 3 areas, what are the Government doing to accelerate clinical trials to bring more treatments that could help patients with Covid infections? We have got to the market two treatments: dexamethsasone and remdesivir. Recent anecdotal and observational studies suggest that vitamin D, for instance, is related to mortality ratios in Covid infections. What are the Government doing to accelerate clinical trials of other treatments, including vitamin D, to improve the outcome for Covid patients?
Medicines and Medical Devices Bill
Lord Patel ExcerptsMonday 19th October 2020
(3 years, 6 months ago)
Grand CommitteeRead Full debate Medicines and Medical Devices Act 2021 View all Medicines and Medical Devices Act 2021 Debates Read Hansard Text Read Debate Ministerial Extracts Amendment Paper: HL Bill 116-I Corrected Marshalled list for Grand Committee - (15 Oct 2020)
Baroness Thornton (Lab)
My Lords, at last we begin the scrutiny of this important Bill.
Although we have been keen to make progress with the MMD Bill, if I might call it that, it is not at the expense of proper debate, and I am afraid we feel that some of the amendments before us today will not benefit from the contributions they deserve because of the clash with the Second Reading of the Internal Market Bill and the rules of the hybrid House, which seem to mean we lose the contributions of at least four, five or possibly six noble Lords who have either put their names to amendments or are keen to take part in our discussions today.
The procedure, if the House were sitting normally, is that noble Lords would “Box and Cox” between the Chamber and the Grand Committee. As it is, they are not allowed to do so and I put on record that either scheduling or rules need to ensure this does not happen again. I would be very grateful if the Minister and his colleagues ensured that the usual channels are aware of this. This clash will not deter those who are absent, I am sure, from making their contribution either later in Committee or on Report.
The group of amendments right at the beginning of this Bill concerns sunset provision, a time limit on delegated powers and draft consolidated legislation. As my honourable friend Alex Norris MP said at the beginning of the Committee session in the Commons,
“we should not just wave … off to secondary legislation without understanding what that might mean and whether there might be a better way to do it … The proposed arrangements allow the Secretary of State and his successors to make hundreds or more individual decisions to change our current regulatory regime into a markedly different one, one statutory instrument at a time, which I do not think is desirable.”—[Official Report, Commons, Medicines and Medical Devices Bill Committee, 8/6/20; col. 4.]
I agree with my honourable friend.
This is a skeleton Bill. Its aim is to provide the Government with powers to regulate on critical, life-and-death matters involving medicines, devices, humans and animals. It is at risk of inadequate scrutiny; it has an overreliance on delegated powers; it gives rise to potential regulatory divergence in Northern Ireland; it has a need for streamlined primary legislation, not statutory instruments; and it gives rise to concerns regarding patient and user safety.
It has to be said that the Delegated Powers and Regulatory Reform Committee and the Constitution Committee agreed with my honourable friend and us at Second Reading, and were particularly unimpressed by the delegated powers memorandum the department produced. It said:
“This is a skeleton bill containing extensive delegated powers, covering a range of significant policy matters, with few constraints on the extent of the regulatory changes that could be made using the powers. The Government has not provided the exceptional justification required for this skeleton approach. We accept that regulatory regimes in policy areas such as these require frequent adjustment, and so need to be flexible, but the Government has not made a persuasive case for conferring largely unrestricted delegated powers that can be used to rewrite the existing regulatory framework. We recognise that the existing powers to amend these complex regulatory regimes will cease to have effect on 31 December 2020 and that alternative arrangements are required. If the Government is unable to specify the principles according to which it intends to amend and supplement the existing law, the delegated powers in the Bill should be subject to sunset clauses. This would allow Parliament to scrutinise a new bill which provides sufficient detail on the policy it is being asked to approve.”
This Bill gives Ministers very broad powers indeed. We acknowledge this and are seeking full justification for them. Those are just the opening remarks from both those committees, which agreed that Clauses 1, 8 and 12 contain inappropriate delegations of power and that the Government have failed to provide sufficient justification for this part of the Bill, adopting a skeleton Bill approach, with Ministers given very wide powers indeed.
Instead of seeking to justify such powers, the Government have downplayed them by suggesting that they are like-for-like replacements for the existing powers in Section 2(2) of the 1972 Act. The delegated legislation committee found this not to be the case. The Section 2(2) power is subject to a very significant built-in constraint; it is a mechanism for transposing into UK law EU rules on medicines and medical devices that the UK is required to follow. The new powers are subject to no such constraint; they would give Ministers free rein to legislate in those areas. The Government claim that the new powers are constrained in significant ways, but the reasons found for those constraints were described as “more apparent than real”.
I suggest that over the next few weeks we need to make those constraints real, democratic and accountable, and at the same time support medicine and devices safety and supply, and promote and protect innovation and research. Given the threatening no-deal scenario which seems to be looming, it becomes even more urgent that the issues dealt with in this legislation are clear and that the routes to ensuring medicine supply, safety, research and innovation are also clear and protected, in the interests of the NHS and patients, through parliamentary accountability.
This suite of amendments aims to open that discussion. Amendment 1 in my name and that of my noble friend Lord Hunt provides a sunset clause for Part 1 of the Bill, requiring the Government to return with primary legislation. We need this to happen because it is not satisfactory or democratic to run such an important part of public policy through regulation alone. We feel that three years is a generous, sensible and reasonable amount of time. It allows for a settling in of the new regime following Brexit and time for new legislation to be framed.
Our Amendment 140 follows the advice of the two committees and ensures that there is a time limit on delegated powers.
My Amendment 116 inserts a new clause which requires the Secretary of State to publish draft consolidated legislation within two years to streamline the existing regulatory framework. It offers the Secretary of State two years of that considerable power, but asks him—it might be “her” at some point—to return in two years’ time with a comprehensive set of regulations across medicines for humans and animals, medical devices and, critically, the proposed new regime surrounding the Medicines and Healthcare products Regulatory Agency.
This would provide a chance for proper consultation across the sector, including with patient groups, industry bodies and interested companies, as well as more parliamentary scrutiny to set up the regime that we all want—a safe one, an effective one and a world-class one. It would also give us two years of life outside the European Union and would really help us to land in that place and find out how different we intend to be, certainly in this sector. I beg to move.
Lord Patel (CB) [V]
My Lords, as I had four minutes to speak on Second Reading, it is inevitable that it will take me longer to speak to my amendments in Committee. I refer to Amendments 50, 67 and 115 in my name, and am grateful to the noble Lord, Lord Kakkar, for his support.
Amendment 50 requires consolidated legislation for medicines, veterinary medicines and medical devices. Together with Amendments 67 and 115, it creates the same obligation in respect of veterinary medicine and medical devices and intends to complement a later amendment calling for the powers of this Bill to be time-limited to three years. The Bill confers an extensive range of delegated powers in relation to medicines, veterinary medicines and medical devices. The Government state that they intend the Bill to be the primary legislation in this area while providing no substantive content to the law.
The powers granted in this Bill go far beyond what is necessary or prudent. The existing regulatory regime for medicines is complex and unwieldy, running to more than four pieces of primary and secondary legislation implementing several EU directives in preparing for Brexit. This complexity is mirrored in respect of medical devices as the Bill merely grants powers to create future regulation through such statutory instruments. It does not provide a clear picture of the future shape of regulations that can be scrutinised. This adds to the existing regulatory complexity.
The lack of detail in the Bill in its current form could lead to uncertainty among stakeholders as to their obligations. There is a need for clarity, for regulatory bodies, manufacturers, patients and other end-users, which makes the case for more streamlined primary legislation. The lack of detail in the current Bill, the broad delegation of powers with no indication of the substantive content of future regulation created by them provides no clear or certain path ahead for medicines and medical devices that can be scrutinised or relied on by stakeholders. For this reason, this amendment, together with similar amendments for veterinary medicines and medical devices, requires that the Government return with consolidated legislation in due course.
I refer briefly to Amendment 115, which relates to medical devices. As with medicines, the regulation relating to medical devices is complex and unwieldy. Currently, it consists of the Medical Devices Regulations 2002, which implement three different EU directives and the Medical Devices (Amendment etc) (EU Exit) Regulations) 2019, which came into force at the end of the EU exit implementation period and runs to over 200 pages of detailed amendments. The 2019 regulations were intended to ensure that the existing medical devices regulations continue to operate correctly, once we had left the EU, but they also mirror and implement key aspects of EU regulation on medical devices, Regulation (EU) 2017/745 MDR.
The regulations were due to be implemented this year, but following the European Union withdrawal agreement, they will come into effect at the end of the transition period. The MDR was also due to be implemented during the transition period. Had it done so, it would have automatically become part of UK law. However, due to the disruptions of Covid-19, the implementation date of MDR was postponed by a year. The situation is complicated further by the ambiguous operation of the 2019 regulations in light of the postponement until the end of the transition period, much like the MDR. The 2019 regulations contain clauses which set specific dates and periods of transition between the implementation of different provisions and considerations.
I hope I have made the point that there is a need to have consolidated legislation. The current Bill will simply add to the existing body of regulations without consolidating or clarifying any of these issues. This demonstrates the need to time-limit these delegated powers and ensure that consolidation primary legislation is introduced to Parliament after three years, in order to subject any policy changes to adequate scrutiny.
Lord Patel (CB) [V]
My Lords, I am grateful to the Minister for his response and, to a degree, his assurance that he is at least prepared to look at ways to consolidate the legislation. I do not accept his point about time. We are not asking that this Bill be held up; we are asking that the Government consider over the next three years bringing in legislation to consolidate the current legislation.
I am also grateful to the noble Lords, Lord Lansley and Lord O’Shaughnessy—both of whom are experienced in dealing with matters related to medicine in their own right—for their comments and support. I hope that, in the debate on the next group of amendments, the Minister will confirm in a more tangible way how he will address this issue because when we discuss those amendments, we will have an opportunity to come back to what he has said about the government amendments.
Lord Bethell (Con)
My Lords, I hear the noble Lord, Lord Patel, very clearly. The arguments that he made during our conversations and engagement earlier were powerful. The comments made by my noble friends Lord Lansley and Lord O’Shaughnessy, one of whom is my predecessor and one of whom is a former Health Secretary, were also extremely persuasive.
The Government do not think that putting consolidation in the Bill is wise, but we hear the points made by the noble Lord, Lord Patel, loud and clear. We would definitely consider this matter at a future date if the arguments made were persuasive and agreeable.
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.
Lord Kakkar (CB) [V]
My Lords, I shall speak in support of the amendment in the name of the noble Lord, Lord Lansley, to which I have added my name. Important arguments have been made with regard to the need to ensure that we can move away from the clinical trials directive which is currently the basis for such legislation in our country, and to adopt the clinical trials regulation to which our regulatory authorities have made such an important contribution over recent years.
On previous occasions Her Majesty’s Government, with specific regard to the 2018 EU withdrawal agreement Bill and the 2018 Trade Bill, made clear commitments that we should implement the clinical trials regulation in full as part of a negotiated agreement incorporating its legislative and non-legislative provisions; or, in the event that no agreement can be reached, that an element of the regulation would be adopted to the greatest extent possible on a unilateral basis in domestic legislation. We have received further reassurances in terms of the withdrawal agreement Act that the Government would give priority to taking the necessary steps to bring into UK law without delay all the relevant parts of the EU clinical trials regulation that were within the control of the United Kingdom. With regard to the Trade Bill, in September 2018, the House was reassured in the strongest possible terms by Her Majesty’s Government that a commitment was being made to implementing the regulation. However, when the Bill before us was considered in the other place, no such commitment was made and therefore, this probing amendment is vital.
I know that arguments have been made that not all the elements of the regulation are within the power of Her Majesty’s Government to implement, but as we have heard from the noble Lord, Lord Lansley, there is the opportunity to deal with the clinical trials portal and information system in a different way and to design, as other amendments propose, a system that might be agreeable. Arguments have also been made that the clinical trials regulation itself, although a substantial improvement on the current directive, is not perfect, and that the GCP and ICH guidance to which the clinical trials regulation makes reference need themselves to be advanced. Work is being undertaken in that regard.
The European clinical trials regulation provides for referring to guidance on the operational delivery of clinical trials or other guidance, so that should not be seen as an impediment. The real concern here is that while, unfortunately, impediments and hurdles to the adoption of the clinical trials regulation may be identified, that would be the wrong thing to do. The regulation is important. The current clinical research legislation under which we labour in our country is not ideal, which is why we have this regulation. On many occasions, Her Majesty’s Government have committed to the adoption of the regulation, so can the Minister indicate why the opportunity provided by this Bill should not be taken to fulfil those undertakings and thus provide us with the greatest possible certainty regarding the conduct of clinical research in our country? This is vitally important to patients, to the economy and to sustaining a viable life sciences ecosystem.
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.
The Deputy Chairman of Committees (Lord Bates) (Con)
I have received a request to speak after the Minister from the noble Lord, Lord Patel.
Lord Patel (CB) [V]
My Lords, the Minister referred to the large number of trials that are started in the United Kingdom. Can he say how many phase 3 trials have been started here? He also referred to the platform that the MHRA has developed with regard to Covid that accelerated the delivery of drugs, which is correct. However, that is not the same as a platform for rare diseases.
I agree that the licensing that was done at speed, within six months, would normally have taken two years: for instance, the licensing of the use of Remdesivir, produced by Gilead Sciences for the treatment of Covid-19. However, that is not the same as the noble Lord’s implication that it could be used for rare diseases. Those require a larger database, which Covid had, because there is no shortage of Covid data. Furthermore, he said that the EU portal means that individual countries have to approve. That is correct, but the approval is a speedier process because it has gone through the portal, unlike before.
Lord Bethell (Con)
My Lords, I will be happy to write to the noble Lord with the precise figures for phase 3 trials. However, he is right that they are incredibly important. The Bill must defend our position on phase 3 trials, which are very much the sharp end of the clinical trials process.
The learning from RECOVERY is that it is not a direct read-across to rare diseases. The noble Lord is right that in rare disease trials, we are often trying to drill down into very small communities, whereas 113,000 signed up for RECOVERY, and tens of thousands took some of the drugs that went through the trial process. However, it is the general capability of being able to run significant platforms, manage ethics at speed, get regulatory sign-off for these trials, and have a clinical trials regime which suits many different purposes. That is our objective, that is why we are putting through these reforms, and that is why we believe that the Bill can support a modernisation of our clinical trials regime.
On the European trials process, the noble Lord is entirely right that the portal contributes to speedy processes. However, it is not the only way of having a speedy sign-off of trials through Europe; we believe there are other ways of doing that.
Lord Hunt of Kings Heath (Lab)
I have added my name to Amendments 4, 52 and 69, which would remove the provision for criminal offences to be created by delegated legislation.
The Government are developing a reputation for riding roughshod over the law, personal liberties and the role of lawyers. Indeed, the Internal Market Bill, debate on which is taking place in the Chamber today, is a reflection of that.
I am afraid that this Bill continues that trend, as indicated by the Delegated Powers and Regulatory Reform Committee in its very direct criticism of the criminal offence provisions. The committee drew attention to provisions in the Bill which give Ministers powers to create and modify imprisonable offences by statutory instrument. Thus regulations under Clauses 1 and 8 may create a criminal offence of failing to comply with provision made in such regulations that is punishable by imprisonment up to two years. Regulations under Clauses 1 and 8 may also amend the dozens of offence-creating provisions in the existing regulations. Regulations under Clause 12 may create new criminal offences relating to medical devices that are punishable by imprisonment for up to one year. Schedule 2 inserts a new regulation 60A and a new schedule into the 2002 regulations which make it a criminal offence, punishable by imprisonment for up to one year, to breach any of the provisions in the 2002 regulations that are listed in the new schedule. It goes on: Clause 14(1)(d) provides that regulations under Clause 12 may amend the new Schedule 30.
The powers conferred in all these provisions give rise to two concerns. As the Select Committee reported, it has previously expressed the view that it expects a compelling justification for the ingredients of a criminal offence to be set by delegated legislation. The powers in Clauses 1, 8 and 12 would allow Ministers to create completely new criminal offences and make changes to the ingredients of existing offences, yet the memorandum does not appear to contain any justification at all for this. The committee also points out that it has also said that where the penalty for a criminal offence may be set by delegated legislation, it would expect the maximum penalty to be included in the Bill, save in exceptional circumstances.
While the Bill limits the maximum penalty for offences created by regulations under Clauses 1 and 8, it is unclear whether this limit also applies to the many existing medicines offences which could be modified by regulations under Clause 1 or Clause 8. Again, the memorandum does not appear to shed any light on this. The Minister in his Amendments 43, 44, 64 and 65 has attempted to soften the pill by ensuring that regulations under Clause 1 (1) and Clause 8 (1) may not provide for an offence to be punishable with a sentence of more than two years. That is obviously welcome, but I do not think it goes far enough. From my reading of the amendments—no doubt we will hear about them later—they do not deal with the other substantial concern of the committee that the powers in Clauses 1, 8 and 12 would allow Ministers to create completely new criminal offences and make changes to the ingredients of existing offences. Given that, I do not think we can allow these delegated powers to be retained in the Bill. I beg to move.
Lord Patel (CB) [V]
My Lords, I shall speak to Amendments 42 and 63, in the name of the noble Baroness, Lady Thornton, to which I added my name and to which the noble Lord, Lord Hunt of Kings Heath, has just alluded. I also have my name to Amendment 92 in the name of the noble Lord, Lord Pannick, and the noble and learned Lords, Lord Mackay of Clashfern and Lord Judge. Noble Lords can immediately tell that I must be the tenth reserve speaking on this important amendment, but the noble Lord, Lord Hunt of Kings Heath, has laid out very clearly the problems with the government amendments that were brought in and the powers they seek.
I shall be brief on this as the Constitution Committee report spelled it out in its last line:
“The delegated powers to create and adjust criminal offences in this Bill are constitutionally unacceptable.”
It was making a constitutional point.
As the noble Lord, Lord Pannick, who is a member of the Constitution Committee, cannot be here, I shall speak on his behalf. Paragraph 21 of the Constitution Committee’s report states:
“We have concluded previously that ‘the creation of criminal offences through delegated powers is constitutionally unacceptable’, save for exceptional circumstances. The delegated powers to create and adjust criminal offences in this Bill are constitutionally unacceptable.”
The noble Lord, Lord Pannick, went on to say that the response of the Minister, the noble Lord, Lord Bethel, that regulations cannot be used to provide for an offence to be punishable with a sentence of imprisonment of more than two years is not satisfactory. A sentence of imprisonment of up to two years is a very serious matter. Parliament, not Ministers, should decide when such a potential sentence should be available to the courts.
Lord Kakkar (CB) [V]
My Lords, I support the noble Lord, Lord Sharkey, and everything he has said in moving Amendment 6. These are clear matters of principle, and although one must accept that government Amendment 133 is an attempt to provide concessions on them, the noble Lord has set out clearly why adoption of even the affirmative procedure will not provide sufficient scope for appropriate scrutiny of what may turn out to be exceedingly important regulations.
The argument for adoption of the super-affirmative procedure has been well made, and I shall not repeat all the noble Lord’s arguments, save to say that in moving his amendment he also dealt with all the potential arguments that could be put against what is proposed in the amendments. In those circumstances, bearing in mind the importance of the issues that the legislation will cover, and the deep anxieties already expressed in Committee about the nature of the Bill, both in practical terms and in terms of its constitutional implications, Her Majesty’s Government should seriously consider accepting these important amendments.
Lord Patel (CB) [V]
My Lords, Amendments 137 and 138 in this group are in my name. They have partly been answered by government Amendment 133, and I shall speak about all three. My amendments are probing amendments, which would prevent regulation exercise in respect of Clauses 6 and 15 in relation to the disapplication of certain provisions in the medicines and medical devices regulations where there is a serious risk to public health. The reasons for this are the same as those set out earlier on the amendment tabled by the noble Baroness, Lady Thornton, and the noble Lord, Lord Hunt of Kings Heath.
The Government do not require the negative procedure to intervene swiftly in emergency scenarios, as the affirmative procedure is available, and safeguards parliamentary scrutiny. That is what the amendment is about. The Government have tried to respond to it, to some extent, through their Amendment 133, which removes subsections (3) to (9) of Clause 42 and inserts instead many new subsections, including a table detailing which specific provisions will be subject to the negative procedure, the “made affirmative” procedure and the draft affirmative procedure.
The Deputy Chairman of Committees (Lord Bates) (Con)
My Lords, I have received one request to speak after the Minister. I call the noble Lord, Lord Patel.
Lord Patel (CB) [V]
I thank the Minister most sincerely for her extensive response. I understand some of the points she made. I am also grateful that she is going to write to me and other noble Lords about the definitions that I questioned in my speech.
I accept that at times the Government will need to have powers in emergencies, but some of the examples the Minister gave were not really emergencies. I made the point that in such situations government Amendment 133 and the table do not allow for parliamentary scrutiny. The fact that there is no sunset clause means that the Government will have power to make regulations under both the negative and the affirmative procedure for evermore. That cannot be right. Yes, there will be a learning process, but there should be more ability for Parliament to scrutinise.
The Deputy Chairman of Committees (Lord Bates) (Con)
I call the Minister to respond to the point made by the noble Lord, Lord Patel.
Coronavirus Act 2020: Temporary Provisions
Lord Patel Excerpts(3 years, 7 months ago)
Lords ChamberRead Full debate Read Hansard Text Read Debate Ministerial Extracts
Lord Patel (CB) [V]
My Lords, from the outset of the pandemic there has been a lack of transparency, openness and scrutiny of the policies in relation to pandemic management. This has been a pity. At the start of the pandemic, the Government stated that their policy in relation to managing the pandemic was to “follow” the science and be guided by it. Yet the membership of SAGE and the advice it got from it was confidential, and therefore the veracity of science advice underpinning the government decisions could not be challenged.
The purpose of the emergency powers was to enable the Government to plan an effective response to the pandemic. The effectiveness of the various pieces of legislation and guidance in doing so can be measured in many ways. The simplest way would be to look at some key outcomes. The noble and learned Lord, Lord Judge, mentioned the need to balance health and wealth. In terms of health, the UK ranks number five in the world for deaths directly related to Covid-19, at 41,936 deaths. Compare that to Germany, which is ranked at number 19, which has had 9,519 deaths. Comparing deaths per million population, the UK has had 618 deaths per million citizens, compared with Germany’s 119 deaths per million population. Similarly, we have higher infection rates. Are the differences related to quality of decision-making? Policy related to testing for infection was key to better management. Germany got it right, resulting in better outcomes for health and wealth. Several of our distinguished scientists pleaded for a similar strategy at the beginning of the pandemic; I believe one of our Nobel laureates wrote to the Prime Minister suggesting that.
Since April, the Science and Technology Committee of the House of Lords, which I chair, has been taking evidence on the science behind the control of the pandemic to help guide policy decisions, particularly its ongoing management. At the end of July, having taken evidence from some of our most distinguished scientists and epidemiologists, I, as chair of the committee, wrote to the Prime Minister, outlining the key areas of pandemic management that needed urgent attention to avoid a second wave, and pointing out that we had two months in which to do this. The areas of concern highlighted in the letter were: to reduce levels of infection by October; to make sure that testing capacity can meet the needs; a clear plan of national and local public health leadership to help control any emerging infections; and, above all, the need for transparency, openness and scrutiny of decisions taken to inform clear public messaging. I understand that my counterpart in the House of Commons had also written to the Prime Minister following their evidence sessions.
October is nearly here, and we face increasing levels of infection. That leads to my concerns about our opportunity to scrutinise the evidence used by government and its likely impact on management of the pandemic. The House has significant expertise in all areas of science, economy, law and social behaviour to help make better decisions. I hope the Government accept that some of the policy decisions might have benefited from wider input to protect the health and economic welfare of our citizens. I most sincerely hope that government finds ways to enable Parliament to have more involvement in decision-making before decisions are made. The usual 30-second question to the Minister at the end of a Statement is hardly holding government to account or helping to make better decisions.
My question to the Minister is simple: how do the Government plan to get Parliament more involved?
Covid-19 Update
Lord Patel Excerpts(3 years, 7 months ago)
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Lord Patel (CB) [V]
My Lords, I want to pick up on what the noble Baroness, Lady Thornton, said about the clarity of messages. Enough has been said about test, track and isolate, and I will not go there, but I want to pick up on the comment made by the Chief Medical Officer in the presentation this morning about how people’s changing behaviour may help reduce or suppress the transmission of the virus significantly. The Government’s slogan “Hands, Face, Space” is apt. The Government were quite clear at the beginning of the pandemic about handwashing but less clear about face masks or face coverings and space. In future, as we are facing a serious problem, what message does the Minister wish to give to citizens when it comes to the use of face masks and space?
Lord Bethell (Con)
Our message remains clear and the same as when we started this epidemic. There is no other better alternative than the three principles articulated by the noble Lord, Lord Patel: clean hands, clean face, and social distancing. That mixture of hygiene and social distancing is the only thing that can beat this virus; that is our first line of defence. Test, trace, and isolate is our second line of defence. Face masks—in situations where social distancing is a challenge—can provide some secondary back-up, but they are not our primary form of defence.
Covid-19 Update
Lord Patel Excerpts(3 years, 7 months ago)
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Lord Bethell (Con)
I thank my noble friend for his comments, but my perspective is slightly different. The fact is that this disease is incredibly aggressive and nimble; we sometimes have to turn decisions around literally within hours. I cannot think of another situation, other than war, where the decision-making has to be quite so quick. I would love to be able to bring regulations to this House for full debate in advance of their implementation, but no human institution can move at that kind of speed—it is just not possible. In answer to his question, we have no plans to switch horses at the moment. We are working as hard as we can to bring regulations here as quickly as we can, and I pay tribute to the House authorities for doing everything they can to put regulations in front of the House as quickly as they can.
Lord Patel (CB) [V]
My Lords, the Office for National Statistics records over 52,000 deaths of people whose death certificates have Covid-19 as a contributory cause. More than 42,000 of these deaths were of people over the age of 65. As the numbers of infections increase, which they are, more older and vulnerable people will be infected—as has happened in France—leading to a rise in hospital admissions and deaths. What plans do the Government have as the rate of infection increases in our country to protect the elderly and more vulnerable?
Lord Bethell (Con)
My Lords, we are discussing, among other things, the very regulations we are putting in place to protect the elderly and vulnerable. The rule of six, although not part of this provision, is an emphatic commitment to protect the people whom the noble Lord cites. I add that we are concerned about not only the elderly and vulnerable; we are increasingly concerned about the phenomenon of long Covid, which hits the young. It is one of our objectives to rid this country of Covid altogether and to protect all demographics.
Covid-19 Update
Lord Patel Excerpts(3 years, 8 months ago)
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Lord Bethell (Con)
My Lords, it is not a mutant algorithm that is sending people to hospital in France, Spain, Belgium and other countries up and down Europe, and it is not a desire to introduce a police state that is seeing prevalence leading to hospitalisation and death in many countries in Europe. It is our fear that Britain is going that way that leads us, regretfully, to put these measures in place; it is not any desire to exert state influence.
Lord Patel (CB) [V]
My Lords, I am sorry that the Minister keeps having a hard time, but that is partly because he is having to defend the indefensible. I had a completely different question to ask, but I have changed my mind and, instead, will follow on from the question asked by the noble Lord, Lord Lansley, and the Minister’s response to it. In terms of transmission of the disease indoors as opposed to outdoors, which bit of science is confusing?
Lord Bethell (Con)
I answered the question as clearly as I possibly could. This is about communication and clarity and making sure that people understand the instructions; it is not about science. If that is not effective then the guidelines are pointless.