Medicines and Medical Devices Bill
Wednesday 28th October 2020
(4 years ago)
Grand CommitteeMedicines 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 Sharkey (LD) [V]
My Lords, it is a pleasure to follow my noble friend Lord Stunell. As my noble friend Lady Sheehan so clearly and compellingly explained on Monday, this amendment deals with the key question of access to medicines and is particularly relevant as we find ourselves swept along by wave 2 of the global pandemic. It is clear that, at least initially and perhaps for much longer, supply of any Covid-19 vaccines will fall behind demand. This raises the urgent question of who should receive priority access to these vaccines. Who should get them first, here and internationally? How should equitable access be decided?
The Government appear to be adopting two contrasting approaches to this question. On the one hand, we have Gavin Williamson saying:
“It’s the right thing to be doing to be at the absolute front of the queue to make sure we’re in a position to get those vaccines first when they become available”—
and that does seem to be what we are doing. As of August, the United Kingdom was the world’s highest per caput buyer, as the noble Lord, Lord Alton, mentioned on Monday. The vaccine taskforce has placed orders for six unproven vaccines, taking its potential stockpile to 340 million doses. Of course, we do not yet know to what extent, if at all, these vaccines might work, so some duplication is obviously prudent. But on the other hand, and while securing our place at the front of the queue as Mr Williamson recommends, we are also involved in trying to work out, under the auspices of the WHO, an equitable access scheme. The rationale for that is pretty obvious. Unless we have such a scheme, rich countries will end up vaccinated well in front of poor countries. In the face of a global pandemic, that approach carries obvious risk. It also carries moral risk.
The Government have committed £60 million to the WHO COVAX facility—the Covid-19 Vaccine Global Access Facility mentioned by my noble friend Lady Sheehan on Monday. COVAX seeks to enable global collaboration and equitable access to vaccines. It views this model of pooled procurement as preferable to rich countries doing bilateral deals. We have also joined 150 countries in expressing an interest in participating in COVAX for our own vaccine purchases. But there is clearly a risk that the bilateral purchasing of vaccines by the United Kingdom and other rich nations could undermine the work of COVAX. Could I ask the Minister how we balance our Williamson approach with our COVAX approach? How are these approaches prioritised? How much should we try to secure for ourselves and how much should we share? What criteria will be used to decide what access means in practice? We know something of what people in the UK think about the issue. Some 96% of the UK public supported the idea that national Governments should work together to ensure that treatments and vaccines can be manufactured in as many countries as possible and distributed globally to everyone who needs them.
My noble friend’s amendment also raises the issue of Crown use licences. We have previously used or threatened to use these licences in our negotiations with pharma. Can the Government confirm their willingness to use these licences if price negotiations on Covid-19 vaccines fail to reach a satisfactory conclusion?
I urge the Minister to give very serious consideration to the issues raised by this amendment. I will listen to his reply with great interest.
Baroness Barker (LD)
I thank my noble friend Lady Sheehan for her introduction to this amendment and the noble Lord, Lord Alton, for the detail that he added to that.
My interest in this matter stems back to 2013, when I was part of the All-Party Parliamentary Group on HIV and AIDS, which produced a report called Access Denied. It was about barriers to access to antiretroviral drugs for HIV and AIDS in low and middle-income countries. In the course of our research work for that report, we held a number of hearings with all sorts of representatives from a number of international research groups based in the United Kingdom but which worked across Africa and Asia. We met user and patient groups and also included representatives from the pharmaceutical companies.
I vividly remember sitting in a room in Portcullis House during one of our question and answer sessions and putting a question to a representative of a pharmaceutical company that has cropped up in our discussions in the last couple of days. I asked him a simple question—whether there was a direct correlation between the R&D costs of a drug and the price. With disarming candour, he said, “No”. Once people’s jaws had ceased to drop, we had the revelation that actually there is no transparency about pricing in the pharmaceutical industry or about the extent to which public and private funding goes into the development of new medicines—and, in effect, an admission that the overstatement by pharmaceutical companies of the need to charge excessive prices in some markets to maintain their viability is not substantiated.
I am not an anti-pharma campaigner. I believe that human and animal welfare rests very much on the development of pharmaceutical knowledge and science, and I am all in favour of extension of research and development of new drugs. However, for far too long Governments of all sorts have been held over a barrel by pharmaceutical companies, and that should stop.
I say this as someone who has had a long-standing interest in HIV. To see some patient groups in some parts of the world continue to become infected and, perhaps, have threats to their lives that would not occur if they had simply been born in another country is devastating. For example, in the world of HIV, very little work is being done on development of antiretroviral drugs for paediatrics because there is very little call for that in western developed nations, whereas there is a very big need for it in sub-Saharan Africa. Our involvement in these matters has a direct bearing on the lives of people across the world and on our standing not only as one of the major governmental funders through the different international funds but as a country in which research into new and emerging transmissible diseases is second to none because of our long-standing history.
For all those reasons, I very much support my noble friend Lady Sheehan, and I await with interest the answer to the question that my noble friend Lord Stunell put, which was the one I was going to ask, about proposed new paragraph (d) in my noble friend’s amendment.
Baroness Thornton (Lab)
The Committee owes the noble Baroness, Lady Sheehan, a debt of gratitude for bringing forward this amendment. I very much enjoyed her opening speech—and, indeed, those of the noble Lords, Lord Alton and Lord Crisp, both of whom are so well qualified to speak about international health responsibilities.
What this debate does is to remind us of how privileged we are to live in a country with free access to new medicines and innovations. However, we are now entering choppier international waters. We have been sheltered, as it were, over 40-odd years or so by the European Union’s heft and regulatory framework. So we need to take notice of the need for greater co-operation, as has been outlined by the noble Lord, Lord Patel.
I was very struck by the mention of things like price gouging by the noble Baroness, Lady Sheehan, and their dangers for those less fortunate than ourselves. On the immediate responsibilities and dangers around the Covid vaccination, which we so desperately need, the World Health Organization says that it is working on a plan to ensure equitable distribution of vaccines, but how that would be enforced in practice is not clear. Professor Mariana Mazzucato, who heads the University College London’s Institute for Innovation and Public Purpose, says:
“In a pandemic, the last thing we want is for vaccines to be exclusively accessed by countries that make them and not be universally available.”
That is absolutely right.
However, as the noble Lord, Lord Crisp, said, we need to pay attention to what is happening in the UK and what the effect of Brexit might be—and, goodness me, we are all on tenterhooks as to whether we get a deal or not. Rick Greville, the director with responsibility for supply chain at the Association of the British Pharmaceutical Industry said, in the run-up to a no-deal Brexit—the last time this happened—that there could be currency fluctuations, including a fall in the value of the pound. He said:
“You can imagine in that situation that exporting medicines into Europe would become even more profitable. It may be that”
drugs
“that currently aren’t being exported suddenly become attractive to export, driven entirely by profit”.
The UK is not invulnerable to what might happen next, and I would like the Minister’s observations on that.
Launched earlier this year, COVAX wants wealthy nations to pool funds that together can be used to develop and scale up vaccine production. In return, rich countries would have a guaranteed supply for about 10% and 15% of their population. I would also like the Minister’s answer to that, because several noble Lords have raised that question.
This is one of those debates in which one feels that so many people are better qualified to speak than oneself. I finish by quoting the noble Lord, Lord Crisp, and what he said on Monday. He said:
“This amendment is absolutely right in asserting that the UK should reaffirm its position and its rights to protect the health of its population. We should adopt it. The future will be difficult, as will the negotiations on this issue, but no one should be in any doubt about the UK’s firm position. We should support not just the UK’s position for the population of the UK directly but a global effort to deal with these important matters.”—[Official Report, 26/10/2020; col. GC 71.]
I could not have put it better myself.
The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell) (Con)
My Lords, there can be absolutely no doubt about the importance of patient access to medicines. This is very much at the heart of the NHS constitution, and it is absolutely fundamental to how we regulate human medicines.
I completely agree with the noble Baroness, Lady Thornton, that the noble Baroness, Lady Sheehan, has done us a great service with an incredibly impressive speech, which was thoughtful and powerful and a privilege to listen to on Monday. The speeches of the noble Lords, Lord Alton and Lord Crisp, who I do not think is present, drew on many years and huge experience of international affairs and comparisons. We are very grateful for the challenge that those speeches have given us on this extremely important subject. But I reassure all speakers to this amendment that this Bill will absolutely not change the importance of patient access to medicines and how we regulate that.
The Deputy Chairman of Committees (Baroness Henig) (Lab)
I have received a request to speak after the Minister from the noble Lord, Lord Alton.
Lord Alton of Liverpool (CB)
My Lords, I thank the noble Lord, Lord Bethell, for the response he has given to the debate, but I have two questions I want to put to him. Like the noble Lord, Lord Stunell, and others, I accept that pharmaceutical companies will always want to and are entitled to reclaim research and development costs. On Monday, I referred to the phenomenal difference in the cost of remdesivir when purchased in the US at over $2,000 for a five-day treatment and Liverpool University’s estimate of $9 as the basic production cost. I asked how much public money went into developing that drug. If the Minister is unable to answer that question today, I would really appreciate it if he could undertake to write to us to let us know how much public money went into the development of that drug.
My second question is about Crown use licences, a question posed to the Minister by the noble Lord, Lord Sharkey. Are the Government considering using the Crown use licence, should the circumstances require that? It was used in the 1960s, and more recently the use of it was threatened in the case of an innovative new treatment for cystic fibrosis. The Government used the power, and that had the desired effect of bringing down the cost of that drug. Are the Government giving serious consideration to how they will use Crown use licences, should that become necessary?
Lord Bethell (Con)
I thank the noble Lord, Lord Alton, for his questions. On remdesivir, I will be glad to find out whether any UK funds were used in its development and will write to him. I will also be glad to write to him about Crown use licences.
Baroness Sheehan (LD) [V]
My Lords, this has been a quite passionate debate and I am profoundly grateful to all noble Lords who have taken part in it. The debate goes to the heart of how we see ourselves. We are a kind, caring compassionate country that also abides by the rule of law, whether that is national or international law. That is why I thought it was right to include our ratification of the ICESCR—the International Covenant on Economic, Social and Cultural Rights. The noble Lords, Lord Crisp and Lord Stunell, both invoked that treaty as being an important and fundamental part of Britain’s reputation abroad. The amendment reminds us quite forcefully that a ratified international treaty is national law. That is quite a topical point as we debate this Bill in step with United Kingdom Internal Market Bill.
I am grateful to the noble Lord, Lord Alton, for his contribution, which was a real tour de force. It was informed by many years as a human rights activist and by his membership of the International Relations and Defence Committee, chaired by the noble Baroness, Lady Anelay. He reminded us that the African continent imports 94% of its pharmaceutical requirements. That figure struck me quite profoundly because the next figure that the noble Lord quoted was 96%. That was the finding of the YouGov poll of the proportion of the country that supports what we are trying to achieve here—equitable and fair access across the world for essential medicines. That is a very important reference point for the Government to bear in mind.
At all costs, we must avoid the unseemly debacle that we saw across the world in the early days of Covid-19 as countries scrabbled to get hold of scarce PPE. We must think ahead, put logistics planning in place and up front and support the global effort that seeks to do that.
The noble Lord, Lord Crisp, and my noble friend Lady Walmsley reminded us that public health safeguards were built into the TRIPS agreement because, as my noble friend Lady Barker noted, countries in the least developed parts of the world are right at the back of the queue when it comes to the development of medicines that are desperately needed.
My noble friend Lady Walmsley also highlighted that the insertion of the amendment in Clause 1(2) would mean that the Government would need to have regard to the provisions of the amendment. That is an important point. In his reply, the noble Lord, Lord Bethell, said that we have such a right already—of course we do—but the issue is that existing price control mechanisms are not used effectively enough at the moment; otherwise, we would not see the recurring incidence, which many noble Lords referred to, where the NHS is regularly held to ransom in trying to negotiate prices. While those negotiations go on, with all the delay involved, patients suffer and some patients die.
I thank the noble Lord, Lord Patel, who from his deep health expertise spoke passionately about the ways in which pharmaceutical companies bend the rules and how patients suffer as a consequence. I repeat the request made by the noble Lord, Lord Alton, and by my noble friend Lord Stunell. Why is it that Gilead can get away with charging £2,350 per dose, when the Liverpool University work shows that £9 per dose would reap sufficient profit?
I also thank the noble Baroness, Lady Thornton, for her support. I agree that we ought to listen to Professor Mazzucato on how to approach global challenges, because she understands global economics and can explain it in a way that I find very compelling. My noble friend Lord Sharkey gave a superb summary of the issues at stake. He highlighted, yet again, the moral imperative: it is so true that no one is safe until everyone is safe and, if nothing else, enlightened self-interest must compel us to act more collaboratively on the global stage.
On the issue of C-TAP, the waiver requested by South Africa and India at the TRIPS council meeting speaks to the need to have some way of overcoming the issues in respect of sharing IP rights, data, know-how and the expertise that is lacking at the moment. They would not be asking for that and would not be pushing for it unless it was necessary. Without that, we will not immediately be able to ramp up manufacture of the vaccine when we need it, which will be immediately.
In conclusion, this is a reputational issue for Britain, because it speaks to who we are as a country. I am with the 96%. If we truly want global Britain to be seen as a force for good, we must take this opportunity to join others, to lead from the front and to throw our heft—our quite considerable heft—and expertise behind the global collaborative effort to keep control of Covid-19. And when we are good, we are very, very good.
The Deputy Chairman of Committees (Baroness Henig) (Lab)
We now come to the group beginning with Amendment 23. I remind noble Lords that anyone wishing to speak after the Minister should email the clerk during the debate.
Clause 2: Manufacture, marketing and supply
Amendment 23
Baroness Wheeler
Member’s explanatory statement
This is a probing amendment that would omit the Secretary of State’s power to make changes to wholesale dealing, including hub and spoke models.
Baroness Wheeler (Lab)
My Lords, I am pleased to move Amendment 23, in the name of my noble friend Lady Thornton, and to support Amendment 29, in the name of the noble Lord, Lord Clement-Jones.
Our amendment is a probing amendment, which has two aims. First, it provides us with the opportunity to hear from the Minister why the Government consider that the extensive delegated powers on the hub and spoke model for pharmacies are needed at this present time under the Bill, rather than ensuring that any such proposals are instead contained in future planned and well-thought-out primary legislation—properly consulted on and worked through—that amends existing legislation and regulations.
Secondly, we understand that there has been some discussion with key stakeholders in the pharmacy industry since the Government’s intentions were revealed in the nine short paragraphs on dispensing medicines in the impact assessment for the Bill—as we know, hub and spoke dispensing centres are not referred to on the face of the Bill. Today is an opportunity for the Minister to update us on the Government’s response to the concerns and issues raised by MPs in the Commons and by noble Lords during the Bill’s Second Reading, and in representations from leading industry organisations, including the National Pharmacy Association and the Pharmaceutical Services Negotiating Committee.
We need far greater clarity on what exactly is proposed, how the Government intend to take all this forward and how the very limited proposals that we have heard so far fit into the NHS long-term plan vision for the transformation of community pharmacy as an integral part of local primary care. How will pharmacists’ enhanced role in the future limit the number of people who will not have to see their GPs, in the way that the Government envisage?
Amendment 23 would amend Clause 2, on the “Manufacture, marketing and supply” of human medicines, and would delete the Secretary of State’s power to make provision for the distribution of human medicines by wholesale dealing, as is proposed for hub and spoke dispensing in the delegated powers proposed in the Bill. I have deep concern about the extensive range of delegated powers proposed under the Bill, and I support the decisive views of both the Delegated Powers Committee and the Constitution Committee on this matter, which have been made crystal clear by my noble friend Lady Thornton at all stages of the Bill. Major changes such as those envisaged for the community pharmacy sector through the extension of hub and spoke dispensing should be on the face of the Bill, with appropriate safeguards on their development, including a full public consultation.
The impact assessment tells us that
“dispensing needs to become more efficient to free up pharmacists’ time for other activities”
and that this will be achieved if all pharmacies have access to more efficient hub and spoke dispensing. We strongly support the aim of freeing up pharmacists’ time, better use of the skill mix in pharmacies, extending prescribing duties for pharmacists and a greater role in clinical service delivery. We also fully acknowledge the work, expertise and development of the hub and spoke models, including automated prescription assembly facilities—PAS facilities—operated by the large pharmacists, such as Lloyds Pharmacy, within their community retail pharmacy operations.
The impact assessment acknowledges the scale, substantial up-front and running costs and slow timetables of setting up and then operating hub and spokes efficiently and effectively, which are in reality way beyond local groups of pharmacies not part of nationwide businesses to fund and operate. In a moment of understated frankness, the IA admits:
“The costs and benefits remain uncertain, as do some details around the policy design, and the changes would be provided for by regulations made under the Bill.”
The Minister will know that the NPA has serious doubts about the suggested economic efficiency of the hub and spoke model, particularly in light of the impact assessment’s uncertainty. Under the five-year community pharmacy contractual framework agreement, the PSNC is tasked with the role of agreeing hub and spoke models which will allow the sector to benefit fairly. Can the Minister explain to the Committee how it is envisaged that hub and spoke models will be able to operate to ensure that the arrangements are fair to all pharmacies?
The NPA has stressed that, without a level playing field, competition and choice in the pharmaceutical wholesale market could be reduced by the pressure to set up or join hub and spoke arrangements. The resilience of the medicines supply system could be impacted, and medicine prices could rise as a result. As the NPA says, huge barriers will need to be overcome to make any model fair and appropriate for independents, including the risk of introducing new process errors, lack of clarity on the ownership of problems between the hub and spoke, longer lead-in times and impact on procurement margins—essentially, a reduction in system resilience and problems caused by restrictive distribution arrangements.
The impact assessment stresses that the proposed regulatory change is intended to be entirely permissive, with pharmacy businesses developing hub and spoke arrangements only where they deemed it would be
“beneficial for them to do so”.
Paragraph 255 sets out three types of hub and spoke arrangement that could be entered into, underlying the complexity of the range of models and reinforcing the need for greater consideration and thought to be given as to how further hub and spoke models could be introduced.
The Company Chemists’ Association, the trade body for large community pharmacy operations, which include Boots, Lloyds, Asda, Morrisons, Tesco and Superdrug, has expressed particular concern at hub and spoke models being introduced through secondary legislation and stressed the importance of extensive consultation with the industry—in fact, the consultation on the future of the industry began in 2016 but has yet to be concluded. When and how will consultation on this vital matter, which sees the most significant changes to pharmacy in decades, commence?
The Minister has rightly praised the contribution of independent pharmacies, particularly during the Covid pandemic. However, we know that, before Covid, more than half reported operating at a loss, a situation greatly exacerbated by Covid and extra costs, which led to their income decreasing while their role in the community became more important than ever, working long hours with often reduced staffing numbers, providing advice and support and supplying medicines. In rural areas, such pharmacies have always played a key role as often the only source of information and advice as well as of prescriptions and medical equipment. During Covid, in many areas they were and are the only primary healthcare professionals that patients can still see in person. What progress has been made in the discussions with the sector about additional funding on Covid costs? The £370 million provided in July was an advance payment to an already struggling industry rather than new money. Can the Minister place on record how much additional funding has been provided? My noble friend Lord Hunt will expand on this issue of funding community pharmacies and the wider pharmaceutical industry in relation to the price regulation scheme.
I want briefly to express support for Amendment 29 in the name of the noble Lord, Lord Clement-Jones, which would place a duty on the Secretary of State to consult the pharmaceutical, wholesale and pharmacy sectors and their regulators on an agreed framework for the safe transfer of patient data, prescription information and dispensed products between separate hubs and spokes. This and other provisions in the amendment would provide some vital safeguards if hub and spoke models are developed in future secondary legislation. We strongly support the noble Lord’s approach.
As I stressed earlier, the nine paragraphs of the impact assessment do not represent a strong or coherent case for moving forward at this time under the secondary legislation enabled by the Bill. Instead, they demonstrate the need for more thought, analysis and development of proposals for the future delivery and transformation of pharmacy services, with full involvement of and consultation with the industry, including on extending hub and spoke models. That would ensure a fair and level playing field and the survival of the independent local community pharmacies so valued by patients and their families and carers. I beg to move.
Lord Clement-Jones (LD)
My Lords, I want to speak to Amendment 29 in my name and those of the noble Lord, Lord Hunt, and my noble friend Lady Jolly. I thank the noble Baroness, Lady Wheeler, for her support and comprehensive exposition of the issues involved with regulation in respect of hub and spoke.
Like the noble Baroness’s amendment, mine is an attempt to flesh out concerns about the lack of detail in the regulation-making powers under Clause 2(1)(c) as regards authorising hub and spoke arrangements and the process by which new regulations will be agreed. For the record, I should say that “hub and spoke” describes how prescriptions are sent from a community pharmacy “spoke” to a central premise, or “hub”, for assembly, often using automated technology. The assembled medicines are then distributed back to the community pharmacy “spokes” for collection by patients. By removing elements of the existing workload in pharmacies, centralised automated assembly can give the pharmacist and their team more time to deliver healthcare services and advice and to support patients who have urgent and acute needs. This is not the same as an online-only pharmacy or a delivery system. It is not a means to enable home delivery of prescription items. There are significant costs of both setting up and running hub and spoke facilities, but it frees up capacity.
It is not blindingly clear on the face of it but, as a result of powers given under the Medicines and Medical Devices Bill, the Government intend to enable medicines assembly through hub and spoke models across legal entities, which is not allowed under current legislation. It is important that this technology is harnessed for the benefit of patients and the NHS within an agreed framework.
Over the past decade, many pharmacists have invested significantly in hub and spoke technology and use it to release capacity in their community pharmacy branches. It is hoped that, if wider use of the hub and spoke model can be permitted, this capacity can be used to enable community pharmacy teams to provide more clinical services to patients.
Noble Lords participating in Committee will be only too aware that community pharmacy is already helping the NHS in providing services and wants to deliver more. At a recent meeting with pharmacists I heard how, through freeing up capacity, hub and spoke arrangements support the delivery of essential and more advanced pharmacy services such as medicines use reviews, diabetes control, support during taking new medicines, minor ailments and vaccinations. NHS England, likewise, wants to open up the market to new technologies and enable greater efficiencies to be found in medicines supply, but the major pharmacy players believe that this can happen only if other barriers to automation are addressed through the community pharmacy contractual framework at the same time.
The noble Baroness, Lady Wheeler, mentioned the impact assessment and the need for much greater clarity on how the Government will deal with the barriers on the way to realising the efficiency benefits of hub and spoke. These barriers, over and above those mentioned by the noble Baroness, include, first, original pack dispensing. Very often, the quantities prescribed by doctors do not match the amount of medicines in the packs produced by the manufacturers. Pharmacy teams in England and Wales manually “snip” the plastic strips of pills to either add or take away from the manufactured quantity. Snipping is a time-consuming and expensive manual intervention that cannot be automated or delivered at scale.
A second barrier is the need for government support for infrastructure investment. Despite its potential, less than 10% of prescription items are currently dispensed using hub and spoke technology. The industry has already invested tens of millions of pounds in this technology. Government capital investment is needed for it to expand further.
A further barrier relates to fair community pharmacy funding, mentioned by the noble Baroness. The level of remuneration for pharmacy has been a challenge for some time. It needs to be addressed to help the sector to deliver the urgent care and services that the NHS badly needs, especially in the current Covid environment. This is even more important if pharmacy capacity is increased and there is a real prospect of enhancing pharmacy services to fill it.
The noble Baroness has explained the concerns over secondary legislation. I hope that the Minister will address some of these issues in her response and explain how she sees the extension of the hub and spoke dispensing model taking place and how consultation and agreement on a framework will take place.
Lord Hunt of Kings Heath (Lab) [V]
My Lords, I am glad to add my name to Amendments 23 and 29. I am a strong supporter of community pharmacies. Over the past few months, they have done magnificent work. They stayed open, took pressure off the rest of the NHS, and are a central part of community resilience. We cannot take them for granted. They face a number of extra costs at the moment: increased prescription numbers, extra staff costs from the increased demands for advice and medicines, covering for sickness and the rise in locum rates, and one-off costs such as decontaminating pharmacies when someone infected has visited. Before Covid-19, the community pharmacy network was already pretty vulnerable.
I am glad that, at the end of March, the Government agreed to inject £300 million-worth of advance payments into community pharmacy. A further £50 million was paid in May, followed by £20 million in June. That £370 million cash advance was of course very welcome, but it will not relieve the ongoing financial pressures because it is set against future income. Instead of this being treated as a loan to be repaid, there should be a recognition of the extra costs that community pharmacies have had to carry since Covid-19. Will the Minister consider that? I also ask her to consider what further financial support needs to be given to the sector over the next few potentially very difficult months.
That is the background to the debate about hub and spoke. As the noble Lord, Lord Clement-Jones, pointed out in previous debates, we have to go to the impact assessment to find any reference at all to hub and spoke. Clearly, it could offer many advantages. Mobile deliverers will be able to partner with dispensing pharmacies to deliver their prescriptions; he spelled out the key advantages. Equally, there are fears that it could undermine the whole community pharmacy network. My concern is about the impact on smaller pharmacy groups and individual companies and shops.
The Minister in the other place, on Third Reading, said that she intended
“to give smaller community pharmacies the same opportunity that large pharmacy businesses already enjoy.”—[Official Report, Commons, 23/6/20; col. 1239]
That is a good statement, but I say to our Minister that Governments often make statements about the importance of small businesses and, when it comes to the actual arrangements, those business often struggle to compete. I hope that this is not being done to try to rationalise the community pharmacy network, because it is a great strength that we have so many pharmacies on our high streets, where people can walk in and get immediate access to health advice and help.
The amendment is very reasonable. It simply asks that the Government consult the sector again on their plans. A previous consultation, started in 2016—two Parliaments ago—has never been concluded. Given the impact on the sector and on patients, surely the Government should undertake a proper consultation, to make sure that any legislation follows that rather than the anticipatory approach referred to by my noble friend Lady Wheeler. I hope that the Government will signal their support for the community pharmacy sector as a whole.
Lord Lansley (Con)
I thank the noble Baroness, Lady Wheeler, and the noble Lord, Lord Clement-Jones, for tabling their amendments, which allow us to have a useful debate; we might not otherwise reach into what some implications of the use of these powers might be. I particularly thank them for the way in which the amendments were introduced, which set out clearly and fairly the context and facts with which we need to work.
I recognise that Amendment 23 is a probing amendment. I am sure that the noble Baroness knows that, if she actually wanted to remove the capacity for legislating to introduce hub and spoke models, Clause 2(1)(g) would have to go as well as paragraph (c) to make that effective, but I do not think she wants to do that; I do not either. We all want to express our support for the pharmacy sector. In my view, the Government’s proposals in the Bill will allow that support to be given additional expression; they seem a positive step to have taken.
As someone who was shielded earlier in the year, about the only place I ever visited in April and May was the local pharmacy—not that often, but the fact that it was there and working, and the way in which it worked, was immensely impressive. Over the years, I have had a great deal to do with the pharmacy industry. In some cases, I am not sure that it was altogether happy about that. The noble Lord, Lord Hunt of Kings Heath, may remember that I worked with the National Audit Office in about 2008, when I was shadow Secretary of State, to establish the extent to which the pharmacy sector benefited through the category M reimbursement system by hundreds of millions of pounds more than it was supposed to. Those large-scale additional funds that were going into the sector had to be clawed back, as happened in the early part of the decade that we have just gone through.
That led to considerable turbulence in pharmacy incomes and values. They were overinflated and the incomes were higher between about 2015 and 2018, and the considerable clawback had a negative impact. Most recently, it is telling that the value of pharmacies—and the price increase—has gone down. It is also interesting to read the commentaries that say that pharmacy in Scotland attracts greater value because the flow of resources into it there is regarded as more stable than in England.
That is a great pity, because we have reached a point where there should be more stability and funding for pharmacies, and I want to pick up a point made by the noble Lord, Lord Hunt of Kings Heath. He suggested that the Government consider turning the advance payment into not a loan but a grant. It is a large sum of money, so it is not as easy as that. However, whereas earlier this year the global fund for pharmacies was set at about £2.6 billion and was going to be retained at that level in cash terms over five years, we have to think hard about whether that is reasonable under the circumstances. There is a good case for recognising additional costs met by pharmacies this year, and potentially into next year, and for reimbursing them perhaps through a change to the establishment fee before it disappears, with a considerable sum to recognise that.
We must also recognise that pharmacies will need real-terms increases in their resources—much as other parts of the NHS-related system are seeing real-terms increases in resources—and not to stand still in cash terms. Over the next four years, that might be something like £130 million extra.
All the way through, we have never achieved as much as we should in terms of pharmacies delivering additional services, particularly clinical services. It is partly because clinical commissioning groups have never quite recognised the flexibility they have in budget terms to use pharmacies. The noble Lord, Lord Clement-Jones, referred, quite rightly, to medicines use reviews—which are being phased out—new medicine services, nicotine-replacement services, sexual health services, minor illness services and so on. A wide range of additional services can be provided by pharmacies. If they can do it, frankly, the GPs, as those at the heart of the clinical commissioning groups, will find that it benefits them directly in reduced demand on their surgeries, which is of course one of their principal stresses at the moment. I hope that the Government will think about all that.
In this context, with these powers in the Bill, the Government do not need to know whether a large number of independent pharmacies will take advantage of the hub and spoke model. It is entirely permissive; they can choose to do so or not. The fact that they cannot at the moment is a significant potential constraint on the ability of independent pharmacies to access the benefits of automation in their sector. I am absolutely clear that we ought to give them access to this potential benefit. I do not know how many would take advantage of it or to what extent the large company chains would make their hub and spoke model available to allow independent pharmacies to get the benefits of that automation. It seems to me that they should, because there are many parts of the country that they do not reach and where they are not in competition. It is perfectly reasonable for them to allow them to access to it, particularly in some of those more remote parts of the country where dispensing is more difficult.
Many of the concerns raised about this in the debate seem to come down to the separate question that I can remember debating on legislation 15 or more years ago about whether we retain the role of the responsible pharmacist. This does not change that. The responsible pharmacist will remain as is; I do not see any plan to change that part of the pharmacy regulation. The change to hub and spoke seems potentially desirable.
While Amendment 29 does not need to be in the Bill, it makes a very good point, which is that there should be consultation and an agreed framework with the industry, and we should ensure that the framework is one that is seen to link resources and changes in the regulations, to enable it to compete more effectively. To that extent, I hope the Minister will take on board and support the intentions of Amendment 29.
Baroness Jolly (LD) [V]
My Lords, I thank noble Lords for their kind words and messages. I now have a tentative diagnosis and when I get my medication I hope to be functioning at 100% soon.
These amendments are on hub and spoke dispensing, where a hub pharmacy dispenses medicines on a large scale, often by making use of automation, preparing and assembling the medicines for regular spoke pharmacies that supply the medicines to the patient. My noble friend Lord Clement-Jones has given a detailed account of how hub and spoke works.
When the five-year funding contract for pharmacy in England was announced, the Government also pledged to change legislation so that independent pharmacies could operate this hub and spoke dispensing model. My noble friend tabled Amendment 29, which would ensure that the Government consult stakeholders on how hub and spoke is used and agree a framework with the support of the relevant sectors. This will ensure that the expected savings and efficiencies, and new healthcare services via pharmacies, can be delivered.
Baroness Penn (Con)
My Lords, as we have heard, hub and spoke is an issue on which there was debate in the Commons and we return to it now.
I first want to explain the intention of the inclusion of Clause 2(1)(c) on wholesale dealing and why it is vital that it remains. Wholesale dealers, involved in moving products from manufacturers to the person supplying the product to the patient, are an essential part of the supply chain, ensuring patient access to medicines. More than one wholesale dealer may be involved in the supply chain for a particular medicine, but anyone who intends to sell or supply medicines to someone other than the patient using the medicine must obtain a wholesale dealer’s licence.
Clause 2(1)(c) allows amendments to be made to the law governing the distribution of medicinal products by way of wholesale dealing. This could include matters around providing and maintaining the equipment and facilities needed for the handling, storage and distribution of the medicinal products under a wholesale dealer’s licence. This is vital, particularly in light of emerging safety concerns, or innovative new techniques and technologies. Omission of this power would limit our ability to maintain the integrity of the supply chain. For example, some vaccines require storage and transport at ultra-low temperatures to ensure that they remain effective. Courier companies delivering medicines are exempt from certain licensing requirements.
If we could no longer make changes under Clause 2(1)(c), we could not amend the definition of wholesale dealing to support the transport of temperature -sensitive pharmaceuticals in different ways, if needed. Recent exemptions to wholesale dealer licensing during Covid have allowed for the swift and safe transfer of flu vaccines and other medicines for treatment of pandemic disease between NHS organisations. Through this flexibility, we have been able to quickly respond to patient need. The noble Baroness, Lady Wheeler, has indicated that, in addition to the question around the need for this power in particular, there is a question around its intention for use in delivery of the hub and spoke model. That is part of the intention behind Amendment 23.
As we have heard, enabling hub and spoke dispensing arrangements where both the hub and spoke pharmacies are not part of the same pharmacy chain is one such example of how powers in Clause 2 could be used, including under Clause 2(1)(c), as we may need to amend the definition of wholesale dealing to support hub and spoke dispensing models. Under current regulatory provisions, only a subset of pharmacy businesses are realising the benefits of hub and spoke. For hub and spoke dispensing, our intention is to give all community pharmacies the same flexibility to explore efficiencies of scale and use of automation that some larger pharmacies already enjoy. Removing this barrier would level the playing field for all community pharmacies and enable them to make use of this type of dispensing model.
However, we have heard from the noble Lord, Lord Clement-Jones, in speaking to his amendment, the noble Baroness, Lady Wheeler, and all other noble Lords in this discussion the concern around how these matters were consulted on in 2016 and what the Government’s intention is for consultation on changes to this model. I reassure noble Lords that there is a difference between then and now. The proposed use of hub and spoke and changes to support it have the support of the Pharmaceutical Services Negotiating Committee, and the five-year deal under the community pharmacy contractual framework for 2019-20 to 2023-24 included a commitment to pursue legislative change so that all pharmacies may benefit from these efficiencies.
We have of course also in recent months had the changes Covid has brought. The pharmacy landscape has changed and adapted in this environment. I pay tribute to the work of community pharmacists and their teams in responding to the challenges of the pandemic. They have been on the front line supporting patients throughout this very challenging time.
The Government agree with the spirit of all noble Lords’ comments, particularly in relation to the amendment from the noble Lord, Lord Clement-Jones, on the need for proper consultation before any changes are brought in, and on the importance of the sector’s engagement to deliver hub and spoke. That is exactly what we intend to achieve. I assure noble Lords that it is absolutely the case that hub and spoke would be taken forward only on the basis of a fresh consultation, based on the current state of play in community pharmacy. Our approach to hub and spoke dispensing models is to consult and make use of productive stakeholder engagement to develop the policy, then to set out in detailed secondary legislation the new regulatory provisions. We are keen to ensure that strong engagement with stakeholders is fed into the development of this policy.
We recognise that there are some important considerations to make use of this type of dispensing model safely and to enable efficiencies. We want to consult specifically on the right approach to hub and spoke, including any patient data safeguards that may be needed, to ensure that our proposals are safe and in the public interest before legislating. To meet the requirement of the government amendment tabled later in the Bill, this would of course be a public consultation.
On the specific points in the amendment from the noble Lord, Lord Clement-Jones, it is critical that we consider how patient data will be safeguarded, as he said at Second Reading. I of course recognise that patients’ healthcare information is confidential and must be handled in accordance with data protection regulation. Handling patient information appropriately and confidentially is of course a routine part of a pharmacy’s business. As part of their professional standards, pharmacists must respect and maintain a person’s confidentiality and privacy, and owners of pharmacy businesses must make sure that they comply with all legal requirements, including data protection legislation.
The noble Lord is right that in considering changes to pharmacies’ operating models we must consider the security of patients’ data and the integrity of the supply chain carefully, drawing on the input from stakeholders. I am happy to put on record that that will be part of the forthcoming consultation on hub and spoke.
My reservation with the noble Lord’s amendment is that placing a timeframe in the Bill, as he proposes, will force the Government to consult in haste. Rather than an arbitrary deadline, which could lead to ill-considered policy development, we want to be able to consult with stakeholders fully and thoroughly on proposals. It is important that we take the time needed to get this right—noble Lords have made that very clear in the debate—first by engaging with stakeholders, as well as with formal consultation. We want to take forward this work as soon as possible, subject to the Bill’s passage.
Noble Lords raised a couple of other points relating to community pharmacy. I agree with all noble Lords on the integral role of community pharmacy in the delivery of health services. Hub and spoke is one way the Government envisage the potential for pharmacists’ skills to be better deployed in patient-facing care.
On financial support to the sector, we are consulting the PSNC on this and other matters as part of the year 3 community pharmacy contractual framework discussions. We also intend to continue discussions with the PSNC on the additional costs that Covid has placed on community pharmacies.
The Government absolutely value and support the work of community pharmacies. I hope noble Lords have heard enough by way of reassurance and that the noble Lord and the noble Baroness feel able not to press their amendments.
The Deputy Chairman of Committees (Baroness Henig) (Lab)
There are no requests to speak after the Minister, so I now call the noble Baroness, Lady Wheeler. Oh, apologies, I call the noble Lord, Lord Clement-Jones.
Lord Clement-Jones (LD)
I was very struck by the support for pharmacists and pharmacy services throughout this debate. It is not often we get a really good opportunity to talk about pharmacists’ potential. I chaired the London School of Pharmacy, which then merged into UCL. I used to see bright, bushy-tailed MPharms depart the School of Pharmacy, all expecting the bright future for pharmacy promised by plan after plan from Government after Government. To use their clinical skills in particular was the great goal.
Sadly, we are still not in the right place with community pharmacy. I was very struck by what the noble Lord, Lord Lansley, said: we have never achieved as much as we should. That is absolutely apposite in the case of pharmacy. We have all these highly skilled people, many of them very young, who are capable of taking on all kinds of clinical work in the community, with consultation and so on. We seem to ebb and flow in the services we think we can make available in pharmacy.
I am very grateful for what the Minister said about the need for proper consultation being a given and that there will be consultation to develop the policy and so on. She of course talked about the five-year plan, but many people are worried that the plan will run out and there will not be resources for hub and spoke to develop further. She talked about the fact the amendment would limit the time available but, as the noble Lord, Lord Hunt, pointed out, pharmacists have been talking about this since 2016. It is not as if we are imposing too harsh a timetable.
Underlying all this is the question: where is the plan to use that additional capacity? That is really what pharmacists are after. On the basis that automation is augmentative and will help community pharmacists free up capacity, they want to deliver more clinical services in particular. Where is the plan? That is what we all want: to use their expertise in and knowledge of the community, and the trust they have. We have talked about the access people have to the local pharmacy. I wish there was a better relationship between many general practitioners and the pharmacy profession. There is still that rather standoffish attitude to pharmacists. Be that as it may, this is a really important aspect that could deliver much greater capacity, but I do not feel that the Government have yet really picked up the ball and started running with it.
Baroness Penn (Con)
I will pick up on the noble Lord’s point about timing. The Government acknowledge that this has been committed to for a long time. However, I also pick up on the point that when this process started in 2016 it might not have been as consultative as it could have been. Therefore, there is a balance to be struck between making progress and making sure that progress happens through engagement with stakeholders and proper consultation.
On the immediate timeframe in the noble Lord’s amendment, while I would be incredibly supportive of swift progress, we need to recognise, as some noble Lords have, the pressures that Covid has placed on the sector and other parts of the healthcare system. While we are committed to making progress on this, such a firm deadline could mean that the process again did not run as well as it might, given that the Covid pressures still exist and we are not sure when that situation will change exactly. We are enthusiastic about making progress, but we need to ensure it is done properly. A deadline placed in the way it would be by the amendment might not be supportive of that.
The Deputy Chairman of Committees (Baroness Henig) (Lab)
The noble Lord, Lord Hunt, would also like to come in at this point.
Lord Hunt of Kings Heath (Lab) [V]
I just wanted to come back to the consultation. I am grateful to the Minister for her full and encouraging response, but can she say a little more about how the public and patient groups are to be involved in this consultation? In terms of the work, given what the Minister in the Commons said about the small pharmacies, will part of the consultation look at the actual economics of how those small businesses can compete and take advantage of hub and spoke?
Baroness Penn (Con)
My Lords, the commitment on the consultation is that it would be a public one, in line with the government amendment on what type of consultation we need to undertake for regulations made under the Bill. That would therefore include patient groups. On the content of the consultation, I understand that when it first took place it was very open, to hear from the sector how it would want to make use of the powers. My understanding is that we have heard the need to have a more structured conversation on the framework for how these powers could deliver the benefits which people think they could. Maybe I could undertake to write to the noble Lord with some more detail on that.
Baroness Wheeler (Lab)
Some of the points I was going to come back on have been raised pertinently by the noble Lord, Lord Clement-Jones, and my noble friend Lord Hunt. I too thank the Minister for her full and comprehensive response, and I thank all noble Lords for their contributions. Between us, we have covered a pretty comprehensive range of the issues and concerns around this. However, the Minister has not really made the case that warrants the use of the delegated powers contained in the Bill, nor met the criteria of the DPRR Committee—in particular, that the use of secondary legislation needs to be justified. The words of the DPRR were that the department should “acknowledge the breadth” and depth of the powers proposed and justify them. I do not think that has yet been done.
My noble friend Lord Hunt raised the complex issues on funding, as have other noble Lords. There is much to be achieved in putting funding on a stable footing for community pharmacists. The Minister was unable to answer the specific questions on the £370 million that my noble friend raised, but there needs to be recognition of extra costs. That point has been made forcefully in the House, in questions to the Minister, and I hope that the Government will make that response.
Overall, the Minister has not fully answered the key question of how these proposals fit into the longer-term NHS plan for transforming pharmacy as an integral part of primary care. There are a number of issues around that, which is why we particularly wanted to see a comprehensive plan going forward. Where is the overall strategy and plan for this?
The noble Lord, Lord Clement-Jones, raised a number of issues about how we want to take the development of pharmacists forward. The prescribing powers set out in the Bill are obviously the road to that, but I still do not have a comprehensive picture of how all this fits together. It comes back to the fairness of hub and spoke. Yes, of course the legislation is permissive, and community pharmacies will not have to join hub and spoke arrangements if they do not want to, but the complexity of some of the models proposed and the power of the large-scale providers really make the level playing-field so important—and important to the survival of community pharmacists—that we need to be much clearer about how it is going to work out.
I certainly welcome the commitment on consultation. That is so vital and, as everybody has said, the 2016 consultation was never really completed. As the Minister explained, there was neither the time nor the follow-through for it. I hope that this one will be comprehensive. I would have liked to have heard some kind of timescale but that is obviously yet to come. Much remains unanswered, which we may need to come back to on Report. We will look carefully at Hansard, but meanwhile, I beg leave to withdraw my amendment.
The Deputy Chairman of Committees (Lord Lexden) (Con)
We now come to Amendment 24. I remind noble Lords that anyone wishing to speak after the Minister should email the clerk during the debate.
Amendment 24
Lord Hunt of Kings Heath
“(o) the origin and treatment of human tissue used in the process of developing and manufacturing medicines.”Member’s explanatory statement
This amendment adds the origin and treatment of human tissue, including organs, to the list of matters about which regulations may be made by the appropriate authority, in the context that informed, valid, uncoerced and demonstrably documented consent may not have been given for the harvesting of such human tissue and organs.
Lord Hunt of Kings Heath (Lab) [V]
My Lords, the world is increasingly aware of China’s forced organ harvesting from prisoners of conscience. This horrific crime of forcibly removing the organs from living victims—the process leading to inevitable murder—has recently been found by the China Tribunal to be happening extensively. The organ recipient may have had their life saved, but at the expense of another innocent life. It is now a multimillion-pound commercial business in China, with wealthy Chinese officials, Chinese nationals and organ tourists receiving treatment in high-end recovery centres.
Evidence of forced organ harvesting has grown and whistleblowers have emerged. Millions of Chinese citizens are currently detained in labour camps. UN experts estimate that at least 1 million Uighurs are being held in camps in the region of Xinjiang. Elsewhere throughout China, other ethnic and religious minorities such as Tibetan Buddhists, Falun Gong practitioners and Christians are also being held in labour camps. Companies from the West are complicit in this. Adidas, Nike, Zara and Amazon are among the western brands which, according to a coalition of civil society groups, currently benefit from the forced labour of Uighurs in Xinjiang. In July this year, a 13-ton shipment of hair products from Xinjiang, worth more than $800,000, was seized by US Customs and Border Protection. This shipment included wigs made from human hair, which is hugely concerning considering the many reports and personal testimonies of female Uighur Muslims having their heads forcibly shaved in the camps.
Last year, the China Tribunal, chaired by Sir Geoffrey Nice QC, concluded:
“forced organ harvesting has been committed for years throughout China on a significant scale and that Falun Gong practitioners have been one—and probably the main—source of organ supply.”
and that:
“In regard to the Uyghurs the Tribunal had evidence of medical testing on a scale that could allow them, amongst other uses, to become an ‘organ bank’.”
I point out to the Grand Committee the vast body of evidence of forced organ harvesting in China. Such evidence includes: detailed statistical analysis of transplantations and donations; numerous recorded undercover telephone conversations, including with well-known Chinese officials admitting to the practice of forced organ harvesting; legal and policy statements and practice of the CCP; advertisements and admissions of university and military personnel; incredibly short waiting times; and a large number of personal testimonies. The China Tribunal spent 12 months assessing all available evidence. Additionally, its international panel of highly respected individuals interviewed over 50 witnesses, experts and investigators, and formally invited representatives of the People’s Republic of China to respond. I do not believe it is sufficient for the UK Government to ignore this any longer.
Although Ministers have been personally sympathetic, so far the Government have relied on the World Health Organization’s view that China is implementing an ethical, voluntary organ transplant system. I am afraid this is simply not credible; the fact is that it is based on a self-assessment by China, as became clear during my noble friend Lord Collins’s PQ on 29 June 2020. The WHO has not carried out its own expert assessment of China’s organ transplant system, so I am afraid that the WHO cannot be considered reliable in this area. For me, the China Tribunal is persuasive on this point.
This Bill provides an opportunity to prevent British complicity in such crimes and to send an important signal to other countries. Currently, the Human Tissue Act does not require appropriate consent for imported human tissue. In addition, imported human tissue for use in medical research does not require traceability. The Minister has written to me to state that whether sourced from within or outside of the UK, there is comprehensive domestic legislation to ensure the ethical and appropriate use of human tissues. Yet while this is all true for human tissue sourced from within the UK, this does not address the gap in legislation for imported human tissue. On the concern about the use of human tissues in the development of medicines, which I do understand, the Minister commented that the use of imported tissue in any medicines on the UK market is very limited. However, while it may be limited, there is a gap in the legislation which could be exploited in the future.
I am grateful to the noble Lord, Lord Ahmad, for his awareness of the passion which many of us feel about the allegations of forced organ harvesting in China and for ensuring that the UK is not complicit in any way. I hope that he will acknowledge that my amendment—which has been signed by a number of very distinguished colleagues— is not prescriptive and essentially gives Ministers regulation-making powers to deal with the issue if and when they decide to do so.
Up to now, we know that many countries have pulled their punches when talking to China about these practices. Of course, as The Economist has pointed out, China’s economic power has helped it to avoid censure regarding its abuse of the Uighurs. Many companies in the West appear reluctant to use any leverage they may have to put pressure on China, and that is not helped by the reluctance of so many countries to upset that country. The UK, of course, faces dilemmas too, and we have seen them already in the issues over 5G and potential Chinese investment in new nuclear energy. I am not naive; I understand some of the pressures which are on the Government, but there must be a time when we make a stand.
I was encouraged by the reported words of Dominic Raab to the Foreign Affairs Select Committee on 6 October, when he referred to evidence of “gross human rights violations” against the Uighur Muslim minority in Xinjiang province. I pay tribute to the Government for being prepared to say that. I simply want them to go one step further, and agree to a very modest amendment. It seeks to give Ministers the powers to take action when they deem it right to do so. Accepting it would be a very important signal of this country’s attitude to gross human rights violations, and I have great pleasure in moving my amendment.
Baroness Finlay of Llandaff (CB) [V]
My Lords, it is a great privilege to follow the powerful speech of the noble Lord, Lord Hunt of Kings Heath.
While the Human Tissue Act 2004 is thorough and comprehensive with regard to human tissue sourced from within the UK, this does not hold true for imported human tissue. Human tissue can be imported into the UK without any consent or traceability. Notably, if it is for use in medicines, traceability is required through the Human Tissue (Quality and Safety for Human Application) Regulations 2007, but for use in medical research neither consent nor traceability is required. They are merely considered good practice. This means that human tissue sourced from China—where people are imprisoned and tortured, and where organs are extracted and sold for profit, a process which kills the donor—can legally enter the UK and be used in medical research.
Baroness Jolly (LD) [V]
My Lords, the amendment in the name of the noble Lord, Lord Hunt, and signed by my noble friend Lady Northover, allows the Secretary of State to make regulations about human tissue. I repeat the noble Lord’s explanation of the amendment:
“This amendment adds the origin and treatment of human tissue, including organs, to the list of matters about which regulations may be made by the appropriate authority, in the context that informed, valid, uncoerced and demonstrably documented consent may not have been given for the harvesting of such human tissue and organs.”
I find it hard to imagine when any state has power over its citizens that few other states share. I find it even harder to imagine how desperate and selfish people must be to buy these organs, knowing that their donors’ lives will certainly be blighted, or even lost, to feed such a market, which is the dark side of consumerism.
Human tissue and organs can currently be imported into the UK from countries such as China without traceability, documentation or consent, and there is widespread concern that forced organ harvesting is taking place. It is appalling that Falun Gong Christians are targeted as donors, although I hate to use the word “donor”, which suggests that the organ is freely and willingly given, whereas the evidence to the contrary is total. This amendment would urge the Government to introduce legislation to ensure that the UK is not complicit in this. I support my noble friend Lady Northover, the noble Lord, Lord Hunt of Kings Heath, the noble Baroness, Lady Finlay of Llandaff, and the noble Lord, Lord Ribeiro, who put his name to the amendment. If the Government do not support this amendment, will the Minister confirm that she will be prepared to look at bringing forward, on Report, a government amendment to stop this abhorrent practice?
Lord Ribeiro (Con) [V]
My Lords, I was delighted to add my name to the amendment, so ably introduced by the noble Lord, Lord Hunt, and the noble Baroness, Lady Finlay. The Human Tissue Authority code of practice refers to the EU tissues and cells directive, which requires importers of donated material to have a
“detailed description of the criteria used for donor identification and evaluation, information provided to the donor or donor family, how consent is obtained … and whether the donation was voluntary and unpaid or not.”
During my career as a surgeon and a urologist, I supported transplant teams to harvest organs from patients who had requested that their organs be used in the event of their death. In every case, informed consent was obtained, and relatives were in agreement and consented to the procedure. One cannot be confident that such arrangements pertain in relation to donor parts used in transplantation in China and elsewhere, particularly where the donors are likely to be prisoners.
Advice that I have received from the Royal College of Surgeons notes that, sadly, the issue of UK patients travelling overseas for transplant surgery is not confined to China and is known to occur also in Pakistan and India. A considerable number of UK patients have undergone kidney transplantation from living donors in this way. For the report mentioned by the noble Baroness, Lady Finlay, Sir Geoffrey Nice met with the Royal College of Surgeons to discuss the allegations relating to China. It found the allegations alarming and the evidence concerning. We know that, in China, patients can receive organs within a matter of weeks. Heart transplant surgery can be bought in advance and, according to data collected by the China Liver Transplant Registry, the percentage of emergency, compared to non-emergency, liver transplants is far higher than one would expect. During his investigation, the BBC journalist Matthew Hill was offered a liver for $100,000 by a Chinese hospital, at very short notice. Patients in the UK would struggle to achieve this with a waiting time of several months.
According to experts, an estimated 60,000 to 90,000 organ transplants are happening in China each year, yet China’s voluntary donation system was only established in 2013. Quite recent data, from June 2020, shows that 2,127,955 people have registered as organ donors in China. That is a significant increase on the figure in 2014, which was 22,660. Is it a coincidence that the UK signed the Council of Europe Convention against Trafficking in Human Organs in 2015 and that, in the same year, the Chinese Government introduced legislation that rendered illegal the use of executed prisoners as organ donors? Contacts in the transplant society in the UK believe that this legislation was introduced in good faith and that any such practices that continue are illegal and without official sanction. I hope that that is the case, but the perception is that these practices have not ceased completely. It is the view of some UK transplant surgeons who have visited China, as I have, for transplant-related meetings, that large, prestigious hospitals practise within the law. However, illegal practices do occur and we should use this amendment to send a clear message to the Chinese Government that they must make greater efforts to stamp out the illegal practices that tarnish the reputation of their country.
We have a moral and ethical obligation to investigate UK patients who receive transplants in China, as identified by the noble Baroness, Lady Finlay, and to clearly identify the source of the transplant organs. That is doubly important because, if complications occur, it will be the NHS that has to pick up the pieces.
Finally, it would appear that, although the UK has signed the Council of Europe convention on organ trafficking, we have yet to ratify it. Will my noble friend undertake to explain why this has not been done?
Lord Alton of Liverpool (CB)
My Lords, it is a great pleasure to be able to follow the noble Lord, Lord Ribeiro, and to support the noble Lord, Lord Hunt of Kings Heath, my noble friend Lady Finlay and other noble Lords who have spoken to the amendment. In doing so, I return to an issue that I raised at Second Reading and declare my interests as set out in the register.
On 2 August 2018, the Times published a letter signed by me, Professor Jo Martin, President of the Royal College of Pathologists, and 55 others, including Dr Adnan Sharif, a consultant nephrologist in Birmingham, who is the secretary of Doctors Against Forced Organ Harvesting. We began the letter by recalling the Liverpool Alder Hey Children’s Hospital scandal, which had involved the retention of human organs and tissue, without consent, and which led to the Human Tissue Act 2004.
With my antecedents as a Liverpool Member of Parliament and a one-time grateful parent, deeply appreciative of the skills of Alder Hey doctors, I was appalled that such an ill-judged breach of ethics had inflicted such damage on a wonderful hospital. Fourteen years later, and notwithstanding that scandal and that important Act of Parliament in 2004, I was incredulous that in 2018 an exhibition, entitled “Real Bodies”, of Chinese corpses and body parts preserved with silicon in a process called plastination, was being staged for commercial gain at the National Exhibition Centre in Birmingham—denigrating ethics, science, and human rights, and far worse than even the scandal of Alder Hey.
The Deputy Chairman of Committees (Lord Lexden) (Con)
The noble and learned Lord, Lord Mackay of Clashfern, has withdrawn, so I call the noble Lord, Lord Patel.
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 Sheikh (Con) [V]
My Lords, I fully support Amendment 24. The issue of organ harvesting was raised in the other place and at Second Reading by me and other noble Lords. The ability to use human tissue in medicines and transplants saves many lives and is a great achievement of modern science. However, we need to make sure that the way human tissue is obtained and used is completely ethical. At the moment, we do not have legislation that properly stops organs that have been obtained forcibly or without proper consent from entering the UK. That is completely unacceptable.
We should be greatly concerned about the treatment of Muslim Uighurs and Falun Gong in China. The detention and persecution of these innocent people is a crime against humanity. Millions are suffering in inhumane conditions. They are tortured and a great many have been murdered. Last year, the China Tribunal, chaired by Sir Geoffrey Nice QC, concluded that forced organ harvesting in China had been practised for a substantial time, involving a substantial number of victims. The tribunal also found that Muslim Uighurs were used as an organ bank.
The British Medical Journal found that 99% of studies that looked at organ transplants in China did not report whether the organs used were donated with consent. This is unacceptable and a disturbing violation of human rights. It is also illegal. Furthermore, The Economics of Organ Harvesting in China report found that large profits had been made from organ harvesting.
I appreciate that although the companies, including British ones, may not be directly involved with organ harvesting, they could be part of a wider system that provides devices, drugs, materials and know-how for transplantation. Sir Geoffrey Nice QC also stated that anyone interacting with the People’s Republic of China was interacting with a criminal state. If we do not have proper checks on human tissue entering the UK, we risk being complicit in this crime.
Organ harvesting is not limited to China. There are gangs and traffickers all over the world that exploit vulnerable people to obtain organs without any proper aftercare. This coercion is also illegal and must be stopped. Through this amendment we can prevent this happening and close the gaps in our existing legislation. For instance, the Human Tissue Act 2004 has strict consent and documentation requirements for tissue in the UK, but does not enforce the same standards for imported tissue. Instead, it advises only that the same standards should be applied. Although the human tissue regulations 2007 ensure that there is proper documentation and tracking from donor to recipient, they request details on how consent was obtained and look into whether the donation was voluntary or unpaid or not with consent at all. This means that there is no legislation against importing organs that have been obtained involuntarily and without consent.
We must accept this amendment so we can make better regulations that uphold human rights and values. By including the ability to make provisions about the origin and treatment of human tissue used in developing and manufacturing medicines, this amendment means that we can make regulations if there are any concerns as to whether consent has been given. This amendment would require that informed, unforced and properly documented consent must be given for all tissue entering the United Kingdom. At present we do not have appropriate safeguards against forced organ harvesting or human tissue. Innocent people are tortured and killed while businesses and some Governments have made a profit.
This amendment is an opportunity to take a proper stand against organ harvesting and to have a statutory commitment. Through this amendment we can ensure that all human tissue imports are ethical. During Second Reading, my noble friend Lord Bethell stated that the idea that any British companies profit from these trades is abhorrent. This is an abhorrent practice. We must put a stop to it and therefore we need to pass this amendment. I emphasise that it is our moral duty to do so.
Baroness Northover (LD) [V]
I am very pleased to have added my name to Amendment 24. The noble Lord, Lord Hunt of Kings Heath, is to be commended for his determination on this issue. Given his previous service as a Health Minister as well as his career-long engagement at different levels of the NHS, no one can say that he does not have a good grasp of all the implications of his amendments. As he made clear, this amendment gives the power to the Government to take action in this area. It closes a gap between what is expected in terms of the origins and uses of human tissue in the UK and that which may be brought in from overseas.
As we have heard, the Human Bodies exhibitions were able to slip through this gap. It cannot be said that no problem can be envisaged. The noble Lord, Lord Alton, laid out the potentially horrendous origins of those bodies. Like the noble Lord, Lord Hunt, the noble Lord, Lord Alton, has been determined and assiduous in pursuing such cases and he is remarkable in his ability to never pass by on the other side. He made a powerful and passionate contribution here as usual.
Lord Collins of Highbury (Lab)
My Lords, I begin by thanking all noble Lords who put their name to this amendment, because it truly reflects the cross-party concern on this issue. I also echo the comments by the noble Baroness, Lady Northover, regarding my noble friend Lord Hunt, who has been absolutely committed to continuing to raise this important issue.
As the noble Lord, Lord Patel, said, this is a modest amendment, designed to empower the Government to act and to create regulations to help protect the United Kingdom from being complicit in the abhorrent crimes evidenced by the China Tribunal chaired by Sir Geoffrey Nice QC. But, as my noble friend Lord Hunt said, it is also an opportunity for the Government to send a clear message that we will not stand by, and we will not tolerate such gross abuses of human rights.
I thank both the noble Baroness the Minister and the noble Lord the Minister for meeting me and other noble Lords interested in this issue and for arranging the FCDO Minister, the noble Lord, Lord Ahmad, to be present, so that we could all hear exactly what is being done across departments on this issue.
In its final report, the China Tribunal concluded that:
“Forced organ harvesting has been committed for years throughout China on a significant scale”,
with Falun Gong practitioners and the Uighurs being the main victims. As my noble friend Lord Hunt said, Sir Geoffrey Nice and the tribunal spent 12 months assessing all the available evidence. Additionally, the tribunal’s international panel of highly respected individuals interviewed over 50 witnesses, experts and investigators, and formally invited representatives of the People’s Republic of China to respond. Of course, Sir Geoffrey himself has an incredible reputation as the former lead prosecutor of Slobodan Milošević at the International Criminal Tribunal for the former Yugoslavia.
Some of the other evidence I want to draw attention to is a study by the medical journal BMJ Open, and reported on by the Guardian, which raised ethical issues on over 400 studies conducted in China using an estimated 85,477 organ transplants. Of those studies, 99% failed to report whether organ donors had given consent for transplantation. The paper concluded that:
“The transplant community has failed to implement ethical standards banning publication of research using material from executed prisoners. As a result, a large body of unethical published research now exists, raising questions of complicity to the extent that the transplant community uses and benefits from the results of this research.”
As we have heard in the debate, the Government of the People’s Republic of China deny all such claims, relying on the fact that the WHO cleared them of wrongdoing. In June, I reminded the Minister, the noble Lord, Lord Ahmad, that 12 months earlier he had
“shared my concern that the evidence on which the WHO cleared China was based on self-assessment”
by the Chinese authorities. At that time, the noble Lord, Lord Ahmad, stated:
“The Government’s position remains that the practice of systematic state-sponsored organ harvesting would constitute a serious violation of human rights”.—[Official Report, 29/6/20; col. 472.]
He assured the House that the UK regularly raised these concerns with China. At the recent meeting with other noble Lords with an interest in this amendment that I referred to, the noble Lord, Lord Ahmad, confirmed that the UK had sent the full report of the China Tribunal to the WHO, asking it to respond to the evidence.
The fact remains that the WHO does not have an independent expert compliance assessment mechanism; it has merely a reporting requirement. I hope that the UK, the Government and the noble Lord, Lord Ahmad, will continue to press the WHO for a clear response to the report and argue for a proper independent assessment by the WHO to guarantee compliance.
However, today is not about whether the WHO acts; it is about this country saying quite clearly that it will not be complicit in these abhorrent acts. Absolutely nothing I have heard from noble Lords much better qualified than me suggests that by passing the amendment we would hinder medical research or progress. As the noble Baroness, Lady Finlay, pointed out, the UK has arguably some of the most ethical and comprehensive consent requirements for human tissue in the world, yet imported human tissue slips through the net. This is an opportunity that I am sure we will not forget or miss. I hope the Minister will respond positively.
As we have heard in the debate, other issues have been reported. I raised this at Second Reading. Two UK companies supply organ preserving devices to mainland China, which could explain how organs are being transported around China.
We all agree that we need to ensure ethics in the origin and treatment of human tissue and organs in the process of developing and manufacturing medicines. As I said before, this amendment would give the Government the means to ensure that human body tissue and organs that are being forcibly harvested are not allowed to enter the UK for medicines or medical testing. However, as I said, just as important as that is the message we can send to the world, in particular to the People’s Republic of China, that we will not stand by. This is an opportunity that we should not miss. I hope the Minister will be able to respond positively to the noble Lords’ amendment.
Baroness Penn (Con)
Let me begin by thanking noble Lords for their time last week when they spoke to me and my noble friend about the issues raised in relation to Amendment 24. We have listened carefully to the concerns raised both in meetings and at Second Reading, and again today.
First and foremost, I want to reiterate the Government’s position that, if true, the practice of systematic, state-sponsored organ harvesting would constitute a serious violation of human rights. I know that my noble friend Lord Ahmad, Minister for South Asia and the Commonwealth, takes seriously the concerns expressed by noble Lords and he continues to monitor the issue very closely. As noble Lords may know, my noble friend Lord Ahmad wrote to the WHO encouraging it to give careful consideration to the findings of the 1 March report by the International Coalition to End Transplant Abuse in China. We hope to have a response to this shortly. As my noble friend indicated, he is happy to meet noble Lords again to discuss this further.
Noble Lords have spoken powerfully on a number of issues that go beyond the scope of this Bill, and I hope they will forgive me if I focus on the specifics of Amendment 24. As I said when we met last week, I think that we are largely agreed on the outcome that we wish to achieve, and this is about getting the mechanism right. None of us wants our UK medicines industry to be compromised by unethically sourced human tissues.
However, it is important to be clear that the vast majority of tissue-based medicinal products in the UK do not use material sourced from a donor at all; they use patients’ own tissues. As we have outlined previously, there is only one licensed medicine on the UK market that uses donor tissue. This material is procured within the EU. The product uses human adult stem cells extracted from fat tissues, and those cell donations are taken in Spain during the process of liposuction. The starting material is procured from authorised EU centres in accordance with the EU tissues and cells directive. Noble Lords will also know that there are schemes where UK sites may be licensed to manufacture tissue-based or cell-based products without a marketing authorisation, but even among those only one site uses donor tissue. That tissue is sourced within the UK.
That is not to say that I do not have sympathy with the amendment. Noble Lords have made it clear that they want to ensure that the Bill allows for changes to be made as necessary to the regulation of human medicines which could tighten requirements around the use of tissues in the development of medicines. I reassure noble Lords that the Bill already provides powers to allow us to make regulatory changes to tighten requirements, such as strengthening requirements on evidence of consent that would be provided as part of the marketing authorisation process. Nevertheless, I also understand noble Lords’ desire to make this explicit and to send a message.
However, there are some important drafting deficiencies in the amendment as it stands. It refers specifically to
“the origin and treatment of human tissue used in the process of developing and manufacturing medicines”.
My concern is that “developing … medicines” causes too much ambiguity. There is no single, established point in the pre-clinical stages of research where the development of a new medicinal product begins. How far back into research studies does the development of medicines start? Does it, for instance, capture academic research on a substance which then finds the product to be of medicinal value? Equally, medicinal products are often developed with international partners, and the early medicines development is inevitably outside of UK jurisdiction. How would new consent requirements be applied in that context?
These are important drafting questions. It is important to ensure that any enabling power is drafted with the appropriate level of precision. As noble Lords know, the drafting has a material impact on the potential subject matter of any regulations made under the power. We would not want wording in the Bill to create a risk of unintended consequences when making regulations. For instance, if regulations were made to apply significant, broad consent requirements when testing medicines, this might capture medicines tested on cell lines which date back more than 50 years, and for which seeking and evidencing consent would be impossible. As the noble Lord, Lord Patel, referred to, we would want to think carefully about the scope of any regulation and the approach that we should take.
We have heard many noble Lords talk throughout debate on the Bill about the importance of supporting future availability of innovative new medicines in the UK. They are right. The same is true for the ongoing supply of established medicines to the UK market. While I am, as I have said, sympathetic to the amendment in the name of the noble Lord, Lord Hunt, I am concerned that the current drafting would create a risk of unintended consequences when making regulations.
There is also an important point on consistency. Within the Bill, “law relating to human medicines” is defined in Clause 7 to include comprehensive legislation such as the Human Medicines Regulations 2012 and the Medicines for Human Use (Clinical Trials) Regulations 2004. With that in mind, when it comes to human medicines, the powers in this Bill are concerned with clinical trials. To add the concept of development would create confusion and inconsistency with drafting elsewhere in the Bill, in particular Clause 1(2)(c).
I thank all noble Lords for the considerable thought and engagement which they have given to this issue. I would really welcome further discussion involving officials, myself and my noble friend the Minister in coming weeks to discuss the issues that noble Lords have raised and the drafting issues that I have mentioned today. The noble Lord, Lord Ribeiro, asked a specific question about the Council of Europe and ratification of a treaty there. I will ask the FCDO to write to him on that.
I therefore hope that the noble Lord, Lord Hunt, feels able to withdraw his amendment today. I look forward to further discussions on this matter between Committee and Report.
The Deputy Chairman of Committees (Lord Lexden) (Con)
My Lords, I have received a request to speak after the Minister from the noble Baroness, Lady Northover, whom I now call.
Baroness Northover (LD) [V]
Can the Minister tell me whether she has read the China Tribunal report in preparation for this amendment, as I asked when I was speaking to it? If she has not, will she agree to do so before Report, especially to help inform her since she may come forward with her own amendment, as I hope she is indicating?
Baroness Penn (Con)
My apologies to the noble Baroness, Lady Northover. I have read the findings of the report and will agree to read the full report ahead of any further meetings that we have.
Lord Hunt of Kings Heath (Lab) [V]
My Lords, this has been a very powerful debate. Each contribution has been measured and the product of expertise, human value and internationalism. I am grateful to the noble Baronesses, Lady Finlay, Lady Jolly and Lady Northover, the noble Lords, Lord Ribeiro, Lord Alton, Lord Patel and Lord Sheikh, and my noble friend Lord Collins. I am also grateful to the Minister, who I thought provided a very constructive response at the end.
When the noble Lord, Lord Alton, talked about Alder Hey, he probably did not realise that that is really where my interest in this subject stemmed from. I was the Minister responsible for the north-west at the time that scandal emerged. I appointed the chair of the inquiry and met the parents involved on a number of occasions. I listened to the harrowing tales from parents; some of them took part in three funerals for parts of their child’s body. What happened was shocking, and I learned from that how crucial it is that, when we deal with human tissues and organs, the integrity of the process is vital.
I was also fortunate to be able to take the Organ Donation (Deemed Consent) Bill through your Lordships’ House a couple of years ago; it is now law. I hope that it changes the basis of organ consent and will lead to more organ donations in this country—the noble Baroness, Lady Finlay, referred to this eloquently. Again, when you move to presumed consent, you have to have absolute trust in the integrity of all the people involved. Just as it is important in this country, so it is globally, which is why we must take action in relation to the activities of China—and other countries, as we heard during this debate.
I listened carefully to what the Minister had to say. She made the point that the use of imported human tissues is very limited. None the less, we have identified a gap in the legislation. She made two points: first, she said that the Bill already provides for the kind of authority we wish to give to Ministers; then she went into detail on the drafting challenges that she thought our amendment faced. However, she used her words in a constructive way and I am very grateful to her. I reassure her that I and my colleagues will be very willing to work with her officials to see whether we can come up with an amendment that meet our needs but does not lead to the kind of perverse incentives that she referred to.
This has been a wonderful debate. We have had a constructive response from the Government. I am convinced that we are going to make progress and, at the end of the day, in this legislation we will make a mark—important in this country but also internationally —saying that we will do everything we can to stop this appalling process. Having said that, I beg leave to withdraw my amendment.
The Deputy Chairman of Committees (Baroness Fookes) (Con)
My Lords, the Grand Committee is resuming its deliberations. We now come to the group beginning with Amendment 26. I remind noble Lords that anyone wishing to speak after the Minister should email the clerk during the debate. The noble Baroness, Lady Finlay, is no longer able to move Amendment 26, so the noble Lord, Lord Hunt, will do so on her behalf.
Amendment 26
Lord Hunt of Kings Heath
“(o) developing rapid provisional two-year licences.”
Lord Hunt of Kings Heath (Lab) [V]
I should explain that the noble Baroness, Lady Finlay, is required in the main Chamber to speak in a debate on the Bill there. I have put my name to her amendments. Amendment 26 and others in this group would ensure the development of a rapid provisional two-year licensing procedure, so that patients might more quickly access potentially life-saving medicines and medical devices, and that device trial results were consistently registered and published.
In earlier amendments, several noble Lords commented on the avoidable delays in innovation, and the tardy response of the NHS to new and improved medical devices. The current licensing procedure in the UK can be lengthy. Safety and efficacy of course are paramount, but in our debate on Monday, my noble friend Lord Blunkett referred to my late noble friend Lady Jowell and her powerful call for fast-tracking. Many patients wanting to trial novel therapies say, “It may not help me, but it may help others.”
As the Minister said at Second Reading, and all speakers on the second group of amendments last Monday, particularly the noble Lord, Lord Sharkey, we must remain an attractive place to develop new medicines and devices. Amendment 26 supports that aim through the development of a licensing procedure that would speed up making new medicines accessible to the NHS when clinical trials have shown them beneficial and safe for people with the relevant conditions.
Baroness Cumberlege (Con) [V]
My Lords, I will speak briefly in support of Amendment 84 in the name of the noble Baroness, Lady Finlay. I also wish to raise a question on Amendment 97 in the names of noble Lords, Lord Kakkar and Lord Patel, and to ask the Minister a question on equivalence, of which I have given him notice.
During my review, we heard much that greatly concerned us about the way that medical devices reach the market. Our focus was on pelvic mesh, but similar concerns apply to devices more generally. When mesh for stress incontinence and pelvic organ prolapse first came into use, the safety data available was woefully inadequate. It relied on very short-term studies, often funded by manufacturers with vested interests, with limited follow-up. Mesh is a product that is designed to remain inside the body, which presents a problem, because it is designed not to be removed. Removal can be done, on rare occasions, but it is very difficult and dangerous. Implanting a device such as this into so many patients with such a lack of safety data is, as we said in our report, foolhardy.
I recognise that some risks of new treatment options may become apparent only when they have been in use for some time. I agree with the noble Lord, Lord Hunt, that surgeons need to be able to offer new, innovative treatments. That is how medicine has made such tremendous progress in our lifetimes. We must not stifle innovation, but we must do all we can to improve patient safety and to prevent avoidable harm. We had a full discussion of this on our previous day in Committee.
In clinical trials of medicines all adverse events are reported, whatever their cause, and that is good. In the case of mesh, if selected cohorts of patients had undergone enhanced reporting, it is most likely that the adverse impacts we heard about would have been detected sooner. Thousands of ruined lives, in this country alone, could have been avoided.
In the field of medical devices, better, more thorough trials with long-term follow-up are vital, but they are not the whole answer. We also need transparency. It is one thing for trials to be conducted, but quite another to ensure that the findings they produce, and the concerns they may give rise to, are made available to the public and to potential patients. Patients have the right to know about trial outcomes and safety concerns that arise in trials. They have the right to know who is conducting the trial and who is funding it. Without that knowledge, there cannot be an informed decision about an individual’s treatment options.
Many common themes arose during our review, but one that is particularly powerful, and relevant to today’s discussions, is the phrase that so many women with terrible mesh complications used. They said to us: “If only I had known”. If only they had known the risks, perhaps they would never have had the procedure and their lives—and those of their families—would not have been ruined.
This amendment would ensure that medical device trials are entered on a publicly available database and would bring devices into line with medicines. This is much needed, which is why I support the amendment.
I turn to Amendment 97, proposed by the noble Lords, Lord Kakkar and Lord Patel. One of the issues that we encountered during our review was that the full safety implications of an implantable medical device may become obvious only once the device is inserted. Some women told us that they sensed immediately that something had gone wrong; for others it was not until years later. Trials need to be sufficiently long term to detect safety concerns some years after the device is implanted.
Lord Kakkar (CB) [V]
My Lords, I shall speak to Amendment 97 in my name and that of my noble friend Lord Patel. In so doing, I of course recognise the important points the noble Baroness, Lady Cumberlege, made. I will answer some of her questions in a moment.
The particular purpose of Amendment 97 is to extend the reach of Clause 16, which already gives powers to establish information systems for assessing
“the safety and performance … of medical devices that are placed on the market”,
to include provision for the establishment of an information system for the safety and performance of medical devices before they are placed on the market via a form of provisional licence. It would provide for the Secretary of State to require, under certain circumstances, that new devices would in the first instance be given a limited approval based on clinical evidence and clinical trials. However, it recognises that further information would be required and that a provisional licence, or formal marketing authorisation, would therefore be given only for information gathering purposes. This would ensure that the level of evidence provided prior to broad unfettered use of a device would be much greater than is currently available.
This approach is both important and practical. It is important, as we have seen in the report from the noble Baroness, Lady Cumberlege, because implanted devices can have serious, harmful effects for patients. Not all devices have the capacity to be harmful, but where there is concern, where there are limited data or where the argument is based on equivalence using the kinds of arguments that the noble Baroness has made, the introduction of a device into routine clinical practice would be limited by a provisional licence, with the need for careful, pre-specified monitoring and evaluation, both for efficacy and for safety. This will protect the patient. It will protect innovation and it will ensure that we continue to facilitate innovation but in a responsible way.
Arguments are made about the practicality of such an approach. During this debate, we have heard that there are differences between the standards required for the authorisation for marketing a medicinal product compared with a medical device. The reality is that medical devices have profound implications for the management of patients. Implantable devices, in particular, also have profound implications for patient safety. The approach is practical because successive Governments have emphasised and prioritised the ability of the National Health Service to collect data and to develop its digital capacity.
We have seen the benefit of these investments and this emphasis during the Covid-19 national research effort. The regulator working, for example, with NHS Digital could devise integrated data-acquisition platforms and clinical research methodologies, potentially applied in specialist clinical centres. Data might then be collected prospectively to a high level and a high quality on the devices selected for such a provisional licensing process. These devices would also be used under appropriate and informed clinical supervision by experts before widespread adoption across the entire health system was allowed.
Rather than stifling innovation, which is a concern, I believe such an approach would ensure that our country could secure a position of leadership in the increasingly important field of medical devices development. These are going to play an increasingly important role in the delivery of healthcare. We would provide a fully facilitated environment for the appropriate clinical evaluation of medical devices, both their efficacy and their safety. In much the same way that the establishment of NICE and the Scottish Medicines Consortium, of which my noble friend Lord Patel was a founding leader, helped establish our country at the forefront of the evaluation of medicine and the responsible adoption of innovative medicines, the proposals included in this group of amendments and the proposal for provisional licensing outlined in Amendment 97 would allow us to develop unique leadership in the development, evaluation and responsible advocacy for the use of medical devices in a way that is clearly not available currently.
The noble Baroness, Lady Cumberlege, made an important point about devices that are designed for implantation in a patient and whose removal is dangerous or practically impossible. What must be demanded here is a much higher level of evaluation in development and research—she made the clear point that equivalence is not an appropriate approach in those or any circumstances. Moreover, offering the opportunity after appropriate clinical evaluation for such devices to be introduced in a limited fashion—still in routine clinical practice but with careful, pre-specified evaluation and monitoring—ensures, as she said, that if there are early reports of adverse events, those might be identified quickly prior to any opportunity for such devices to be provided across the entire healthcare system, where reporting on their implantation and follow-up may be less rigorous. In a provisional system, data acquisition and reporting would be pre-specified, using platforms provided by the regulator and the NHS. With the remarkable capacity we now have for data acquisition and analysis in the NHS, such methodologies, applied in a routine fashion in appropriate circumstances, would provide the greatest opportunity to protect patient safety while driving forward innovation and making use of all the opportunities that the NHS provides in this regard.
Lord O'Shaughnessy (Con) [V]
My Lords, it is a pleasure to follow that excellent exposition of his and other amendments by the noble Lord, Lord Kakkar. I want particularly to speak in support of amendments aimed at putting post-marketing reporting requirements for medical devices on a par with those for medicines.
My noble friend Lady Cumberlege has again given a powerful and moving testimony of the reports that she uncovered in her review of the dangers for some patients of pelvic mesh, but severe problems have emerged in other medical devices, be that metal-on-metal hip replacements, PIP breast implants or elsewhere. They have shown how potentially dangerous medical devices, particularly, as other noble Lords have pointed out, those implanted into body tissue, are simply not regulated enough.
The regulatory regime for licensing medical devices distinguishes between different categories of risk. Higher-risk devices of course have to clear a higher bar, and the UK’s notified bodies are renowned for taking on such work—prior to Brexit, they carried out more higher-risk assessments than any other notified body in the EMA family. We therefore have potential strength in this area. However, these tragedies demonstrate that even this strong regulatory regime does not go far enough. We need a broader definition of risk which takes account of the nature of the device, the therapeutic ways in which it can be used and the places in a patient in which it can be put, as well as much better post-market surveillance and wider use of registries, including coverage of the independent sector, which is where some of the most acute problems arose.
It goes without saying that these are recommendations from my noble friend Lady Cumberlege’s report. Like other noble Lords, I strongly urge my noble friend the Minister and the Government more broadly to adopt them and reduce the unacceptable gap between the safety regimes for medicines and medical devices.
Having expressed my concerns the other day about access to experimental medicines, I applaud the intention behind the idea of provisional two-year licences, but we obviously have a job of work to do to reconcile these two sometimes competing imperatives—the noble Lord, Lord Kakkar, explained how he thinks that can be achieved. It may be stealing the thunder of a future group of amendments that we hope to deal with tonight, but I wonder whether a better answer would be the expansion promised in the Conservative manifesto of the Cancer Drugs Fund into an innovative medicines fund more broadly, as well as continuing and early access to compassionate-use schemes for medicines post Brexit.
Both the noble Lords, Lord Hunt and Lord Kakkar, raised the idea of these conditional licences being applied to devices, and my noble friend Lady Cumberlege mentioned safety concerns which might apply. I wonder whether the right approach would be to open the innovative medicines fund up to devices, digital and diagnostics. It would mean a name change, but that presumably would not be a problem. They could then qualify as well as medicines, so the kind of early access possible under these two-year conditional licences could take place in that specific, heavily monitored and controlled environment that has already demonstrated huge value when looking at transformative cancer drugs before they have achieved their full licence. Within these ideas is the right approach to balancing these two risks, and in fact merging them and getting something stronger as a result. I look forward to hearing from the Minister how the Government intend to move forward on these issues.
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.
Baroness Thornton (Lab)
This has been a wholly positive and helpful debate, and I hope that it will lead to improving the Bill and the future of this issue. I shall speak briefly to the amendment in my name and that of the noble Baroness, Lady Watkins. It would allow the Secretary of State to make regulations about notification and reporting requirements for medical device clinical investigations, as is currently the case for medicines. It is about the equality of treatment between medicines and medical devices, so it is very straightforward.
I thank my noble friend Lord Hunt, who I suspect made a double speech, his own and that of the noble Baroness, Lady Finlay, and it is all to the good that he did. I again register the protest that we are losing experts and speakers because of the clash of timetabling.
All the amendments in this group are positive amendments about how medicines and medical devices reach the market, how the UK can build and maintain a leading position, and the regulatory framework required to support that. Amendment 97, in the names of the noble Lords, Lord Kakkar and Lord Patel, does that, and I thought that the noble Lord, Lord Kakkar, made some very interesting points about how it might best be achieved. The noble Lord, Lord O’Shaughnessy, and the noble Baroness, Lady Cumberlege, were quite right about putting patient safety at the heart of this and having higher levels of evaluation—the term used by the noble Lord, Lord Kakkar. The noble Lord, Lord Patel, got straight to the heart of the issue, which is that we need to get together to work out how best to take this issue forward at the next stage of the Bill. I look forward to what I hope will be a positive response from the Minister and then to the Government taking some action.
Lord Bethell (Con)
My Lords, I start by endorsing the comments of the noble Baroness, Lady Thornton, and saying that I am extremely grateful for this debate, both the spirit in which it is being conducted and the objective of trying to improve the legislation. I think it will make a big difference to the legislation.
The issue of the safety of medical devices and medicines is, of course, critical. We have been greatly moved by the report of my noble friend Lady Cumberlege, who spoke earlier to this group of amendments. It is an extensive and important report, which highlights the impact on patients when they have not been heard, when they report problems or concerns with a medicine or a medical device. It is particularly focused on pelvic mesh but could have addressed other subjects. The Government will address its detailed recommendations when the time is right.
I understand that safety is the driving concern behind Amendments 26 and 90, tabled by the noble Baroness, Lady Finlay. She offers up an alternative way in which to regulate medicines and medical devices, with the creation of a rapid, provisional two-year licence. Medicines and medical devices are regulated very differently between the two of them. That is in part because we have anticipated regulatory change for medical devices at an EU level for some years, and it is in part down to the practical realities of how they are developed.
I shall touch on the process and distinction. However, what I would say is that, intent aside, the amendments of the noble Baroness, Lady Finlay, are not necessary. Amendment 26 would introduce a rapid two-year provisional licence for medicines. The Bill as drafted already provides the necessary powers under Clauses 1 and 2(1)(d) to make changes relating to marketing authorisations. It is similarly already possible to introduce a rapid, provisional two-year licencing process as she suggests in Amendment 90 at Clause 13(1)(b) of the Bill.
By tabling parallel amendments with the same suggestion of a two-year, rapid provisional licence for medicines and medical devices, the noble Baroness suggests, perhaps, paralleling similar requirements of a pre-market assessment. The noble Lord, Lord Kakkar, suggests using the information system in the government amendment in Clause 16 in combination with a limited marketing authorisation system as a way of assessing devices before licencing them, as in his Amendment 97. We believe that Clause 13(1)(b) is sufficiently flexible to deliver the purpose of his explanatory statement. We believe that it is not needed as an amendment to Clause 16.
However, this debate is not, I think, about what the Bill could provide for; it is about what the Government will actually do. For human medicines, we have made changes in the statutory instrument that sets out the situation on 1 January. That update provides for a national “conditional marketing authorisation”, valid for one year. It can be renewed annually. It is a procedure to expedite the assessment of medicines that fulfil an unmet medical need but, importantly, maintain the robust evaluation of supporting evidence. It is less than the five years an ordinary marketing authorisation is granted for, but none the less we believe it serves the purpose. I hope the existence of that process is what the noble Baroness is driving at.
The Deputy Chairman of Committees (Baroness Fookes) (Con)
I have received a request to speak after the Minister. I call the noble Baroness, Lady Cumberlege.
Baroness Cumberlege (Con) [V]
My Lords, it has been a really interesting debate. One of the things that I have found so wonderful in this House is all the professors. I did not go to university and, when I listen to the professors and the way they care for their students—and in this case I am something of a student—I really value it. I thank the noble Lord, Lord Patel, for pointing out the dilemmas that we face. They are very difficult. I am sure that the Minister also feels that: it is how you balance what we are trying to achieve as a successful United Kingdom in innovation, marketing and all the rest of it, and the dilemma of safety as well.
I thank the noble Lord, Lord Kakkar, very much. I need to read very carefully in Hansard what he said and then come to some conclusions. I am not sure that we have quite cracked it, but I believe we are working towards it. The noble Lord, Lord O’Shaughnessy, had some really interesting ideas about how we can take this forward, and we need more work to be done on it.
I want to say one thing. In the review, we were so horrified by the stories that we heard that we said we had to do something to prevent further surgeries taking place in women who were suffering so deeply. We called it the pause; we went to NHS England and the department and very quickly they agreed to our pause, with six safety conditions that had to be introduced if it was to be lifted—and, of course, they still have not been introduced. That was in July 2018.
The interesting thing about the pause is that, because surgeons were prevented from using what they would see as the normal solutions to stress urinary incontinence, with pelvic mesh, they started to think of different ways in which to do things and help women, ensuring that the discomfort that they had through these conditions was ameliorated. We are getting innovation in a very interesting way. I am convinced that such innovation would not have taken place if we had not introduced the pause. But it should not have been us, the review team, who introduced it. It should have been the healthcare system, which had put forward some measures and thoughts about it years before, but nothing happened. Of course, that was one of the burdens that I carried throughout the review—that promises were made and nothing happened. We called the healthcare system glacial; it just did not move. There are some hugely bright people in this country and throughout the healthcare system and beyond, in universities and everything else. Surely, if we could only utilise the wonderful brains that we have in this country, we could do much better.
I thank my noble friend for the very full summing-up today. The categories of risk relevant to devices have been so badly used in the past in terms of how pressure has been put on to change the risk when people knew that harm was being committed. We have a meeting with the MHRA, and I am sure that a lot of these issues will be discussed.
I thank the noble Lord, Lord Hunt, for introducing the amendment. It is very difficult to pick up somebody else’s work, but he did it with his usual tremendous skill.
Lord Bethell (Con)
I completely endorse the words of the noble Baroness, Lady Cumberlege, about the failings around some of the medical device regulatory regimes, which failed to pick up many of the problems with mesh. I am grateful for the interventions from the review team on that matter.
I remind noble Lords that the Bill seeks not to lay down the policy on what precise regime will suit the future of medical device regulation but to set up the framework in which those regulations are put together. The Bill meets the need on that matter. I cannot urge enough how important it is that we get the Bill on the statute book as soon as possible.
Lord Hunt of Kings Heath (Lab) [V]
My Lords, I know what the noble Baroness, Lady Cumberlege, means when we have the privilege of hearing, as we have in this debate, so much expertise on very challenging issues. Much of the debate has been about devices, but of course my noble friend Lady Finlay’s first amendment related to medicines. To reiterate, she sought to create a rapid two-year provisional licence without reducing safeguards on new medicines. She thought this would enable us to make best use of innovative new medicines without compromising safety at all.
It is understandable that much of our debate was on devices, because it was informed by the report from the noble Baroness, Lady Cumberlege. She has identified a number of issues around the regulation of devices—it is clearly a less vigilant approach than for medicines, with a lack of data and transparency, the equivalence issue and the challenges she raised. The noble Lords, Lord Kakkar and Lord Patel, went into further detail on some of the challenges around devices, particularly those that have a capacity to cause damage. The argument they put was that provisional licences would allow much more effective safety monitoring and early identification of problems and would protect innovation.
The noble Lord, Lord O’Shaughnessy, raised the interesting idea of extending the innovation fund that we are shortly to debate to devices. That deserves a great deal of consideration, although he will of course know that the innovation fund will essentially be funded by payments from the pharmaceutical industry. Seeing how money from the devices industry would come about is a much more challenging issue.
The Minister essentially said two things. The first was that what my noble friend wants to achieve in relation to medicines can be done already, that it is in the Bill and that, in any case, there is a new process to expedite medicines where it is deemed appropriate. I think my noble friend will want to look very carefully at that.
The Minister is right on devices. I think he spoke of 500,000 devices. It is a massive challenge; there is no question about that. There are reasons why devices regulation is different from medicines regulation, but when it is clear that there are defects in the current system, we must at least take advantage of the fact that we are now in a position, post-Brexit, to develop our own regulations.
The Minister went through the processes that are currently in place, including the role of notified bodies, but he said that the system can be strengthened and that regulations can be reviewed. At this stage, I urge that this be as open as possible so that we have a really good debate about medical device regulation, informed by the report from the noble Baroness, Lady Cumberlege, and by experience elsewhere. We want to do two things: to ensure that our innovative devices sector is given all encouragement, but also to ensure safety in a way that it has not been ensured before. That is a challenge, but it is one worth accepting. In begging leave to withdraw the amendment, I say that this has been a very good debate and I hope it will inform government thinking.
The Deputy Chairman of Committees (Baroness Fookes) (Con)
We now come to the group beginning with Amendment 27. I again remind noble Lords that anyone wishing to speak after the Minister should email the Clerk during the debate.
Amendment 27
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.
Lord Hunt of Kings Heath (Lab) [V]
My Lords, that was a very interesting opening speech from the noble Lord, Lord Patel, and I am very glad to have put my name to his amendment—although, of course, he went wider and commented on the government amendments. I very much agree with his desire to minimise delay for the UK to get access to new medicines. That has been a constant theme of our debates.
There are a number of elements in this, including the attractiveness of the UK to pharma companies, for our life sciences, our approach to access to early phase trials, the regulatory system for licensing medicines and the NHS’s willingness to take up those medicines, including the role of NICE. We have debated all of those.
The Minister on the first day in Committee responded to a number of those issues and said that the Government wanted to
“build on our established strengths so that the UK has the opportunity to anchor international drug development in this country and grow that capability. I am committed to international standards, international partnerships and multi-country clinical trials … The UK works closely with many other regulators; those relationships are underpinned by many shared international standards. The EU bases its regulations on exactly those standards”.—[Official Report, 19/10/2020; cols. GC 357-8.]
The issue is, that being said, will we in the end be aligned with Europe so that companies do not have to go through separate processes in which, because the market that we offer in this country is so small compared to the EU market, we will not be a country of first choice for developing new medicines and seeking a licence?
I refer the Minister to a comment that I picked up in the last few days from Britain’s pharmaceutical industry: it has appealed to the Prime Minister to strike a swift side deal with Brussels to avoid delays and shortages of medicines if we leave at the end of the year with a no-deal Brexit. We have heard continuously from the Prime Minister that he was preparing for—indeed, he would embrace—no deal on 31 December. The Government’s departure from any rationality or seeming concern for Britain’s industry and their posturing have left industry without the agreement on mutual recognition of standards that is needed to avoid hugely costly duplication of red tape to maintain the flow of trade in vital drugs. The one phrase that the Minister has not articulated in our debate so far is “mutual recognition of standards”. The fact is, if we are seriously going into a new world where we do not believe that mutual recognition between ourselves and the EU is a sensible or serious proposition, I am afraid that all the talk about this country being an attractive place for pharma will fall on rather stony ground.
The noble Lord, Lord Patel, has done a great service in bringing this matter back with a slightly different approach. I hope we can look for a positive response from the Government.
Lord O'Shaughnessy (Con) [V]
My Lords, I speak in support of the intention of Amendment 27 in the names of the noble Lords, Lord Patel and Lord Hunt of Kings Heath. As noble Lords know, I made my views on the Brexit approach of working with other regulators clear on the first day in Committee and I do not intend to rehearse them—I am sure that noble Lords will be relieved—but I was struck by how this might work in practice. While listening to the noble Lord, Lord Patel, who gave an excellent exposition, I reflected on his story about CAR-T therapies and how that provides a good example of what we need to guard against as we move out of the EMA post Brexit.
In September 2017, I went on a visit to Pennsylvania and had the opportunity to go to Penn Medicine, which is where CAR-T was developed, in a lab sponsored by Novartis. I remember sitting down afterwards and being told about the amazing progress they had made, how this was rolling out to patients and indeed how they were thinking about the next iteration of this medicine, how useful it would be and how much demand there would be for it to be given to American dogs—that is right, dogs. I was sitting there at a time when UK patients did not have access to CAR-T therapies, but American dogs were about to get access. This in a way exemplifies a problem that we have today as part of the EMA but are likely to have tomorrow: our unwillingness to accept the decisions of other stringent regulators who make good decisions and whose processes we trust.
The idea of how we could work with other regulators as expressed in this amendment is incredibly important and could be carried out in two ways. The first is, as I said, in accepting decisions from other stringent regulators, including the FDA, the EMA, of course, and others. There has been resistance—there certainly was in my time as a Minister—about so-called rubber-stamping of other decisions and the implications for legal liability if things go wrong, but I am absolutely confident that these can be overcome. Our regulator should be prepared to accept the paperwork submitted to other regulators and the decisions of other stringent regulators where we have confidence in their processes. Ideally, as the noble Lord, Lord Hunt, said, this would be in the form of mutual recognition, but it is perfectly possible for us to do that unilaterally as well. That would go a long way to assuaging the concerns of industry.
The second way, and they are not mutually exclusive, is that the UK could lead the creation of a third global market to go alongside the FDA and EMA by working with independent regulators in Switzerland, Australia, Singapore, Canada and so on. As I say, these are approaches that we could follow in tandem as part of, I hope, a global move towards a single approach.
I am confident that we can follow these routes without causing any harm to patient safety while improving patient access. I am not convinced that they require legislation. I can understand why the noble Lord has tabled the amendment and I support its intention; I do not know that we need to change the law. What I would like to hear, and I hope other noble Lords would like the same, is a commitment from my noble friend the Minister that the Government intend to take this kind of approach. We look forward to speaking to the director of the MHRA on precisely this issue, as she has kindly agreed to meet us next week.
Lord Clement-Jones (LD)
My Lords, I am very glad that I put my name down to speak on this group of amendments. I had designed my contribution to be about the government amendments. Having heard the noble Lord, Lord Patel, I am reassured that I am not tilting at windmills. I hope that when the Minister winds up on this group she will be much more explicit about the purpose behind Amendments 48 and 109 and the limitations on their use. There are very thin explanatory statements accompanying the amendments. I heard the helpful paraphrase from the noble Lord, Lord Patel, but, regrettably, I did not receive the Minister’s letter although I have spoken on health data issues in the Trade Bill at some length. I share the noble Lord’s concerns.
I have a series of questions to put to the Minister in relation to those amendments. Can the Minister confirm that they do not, as such, permit the sharing of NHS patient data, whether related to medicines or medical devices and whether anonymised or not? The new UK-Japan trade agreement permits either party, in its Article 8.73, to share source codes and algorithms for regulatory purposes. This is directly relevant to modern medical devices. Is this why the Government are seeking the provision inserted by Amendment 109? In agreeing the trade deal, did the Government realise that they did not have a clear power to do so? How widely do the Government interpret these two amendments? What is their essential purpose and subject matter? I am raising this and the noble Lord, Lord Patel, raised it. What are the constraints as the Government see them?
Of course, there is an important patient safety issue in terms of the operation of medical devices. I entirely take the point raised by the Lord, Lord Patel, that there is no specificity in the article about that but does that mean that UK medical device manufacturers will, as a matter of routine, need to reveal their source codes and algorithms? Is this to be a standard provision in trade agreements, permitted by these provisions? What safeguards will there be against IP infringement and know-how theft in these circumstances?
I am sorry to throw these questions at the Minister in this fashion, but it comes as a result of me not having any brief from the Minister in the first place. We have all commented on the fact that the government amendments, tabled as they have been, need a fair bit of explanation. I hope the Minister can answer some of these questions and I look forward to her reply, but it may be that she prefers to write after Committee.
The Deputy Chairman of Committees (Baroness Fookes) (Con)
I understand that the noble Lord, Lord Lansley, has withdrawn so I call the next speaker on the list, the noble Baroness, Lady Jolly.
Baroness Jolly (LD) [V]
My Lords, the noble Lord, Lord Patel, set the tone for this debate. I share the concerns of the noble Lord, Lord Hunt of Kings Heath; his concerns should concern us all. We are entering new territory. We have worked across an EU framework for a long time and are now going to be on our own. We need to work out policies and procedures to deal with this new landscape, which of course is what we are doing today. However, we will still have to work with Europe, if not within it.
I understand that we are to leave on 31 December, but we really must not bury our heads in the ground. Regulation will be key; mutual recognition is important. I think the Minister has referred to mutual recognition in the past. I wonder if he or the noble Baroness, Lady Penn—I am not sure who will be summing up—could clarify that issue. We need easy and ready access to new medicines, early-phase trials and the willingness of the NHS to take them up. There is also the role of NICE. We have not looked at mutual recognition of standards, but we need to share information with international partners. My noble friend Lord Clement-Jones asked a lot of pertinent questions. If the Minister does not have these issues in her brief, perhaps we might have either a letter or a meeting, because these are really meaty issues that we are discussing.
Amendment 27 would make provision to enable the Medicines and Healthcare products Regulatory Agency to work with other regulators to minimise delay so that the UK can get early access to new medicines. Amendment 45 would require the Secretary of State to publish their proposed regime for a list of fees in respect of human medicines. What is the timescale on that? It would be interesting to see this fees regime alongside the old regime that we will be leaving.
Government Amendments 48 and 66 relate to the disclosure of information in accordance with international agreements. My noble friend Lord Clement-Jones had something to say about that. Interestingly, although I am not absolutely clear, Labour’s Amendment 118 aims to protect medicines and medical devices regulations from any form of control from outside the UK in the event of a trade deal. This goes back to legislation that we dealt with, which I think we ended up renaming the international health Bill. We need to be clear, coming up to the end of the year, about what a trade deal might actually look like and what things would look like without a trade deal. Those are my reflections on the amendments.
Baroness Thornton (Lab)
This is a slightly strange time to be making this speech, because it seems likely that we will not hear the Minister’s speech until we reconvene in a week’s time. If that is the case, I would like to register that I will probably want to ask a question after the Minister speaks, if that is where we finally end up.
I am very grateful to the noble Lord, Lord Patel, and my noble friend Lord Hunt for the way in which they spoke at the beginning of this debate. The noble Lord, Lord Patel, went into a level of detail about the effects of the government amendments that was absolutely right and accurate. It also lies at the heart of my remarks. I need to make it clear from the outset that we on these Benches regard the government amendments to this part of the Bill as dangerous, sloppy and possibly sinister. The Minister must be aware, because we have discussed it with the Bill manager, that we regard the use of “a person” in Amendment 48 as something that should set alarm bells ringing right across the House.
I am getting a feeling of déjà vu. The Bill mentioned by the noble Baroness, Lady Jolly, started its life as the international healthcare arrangements Bill and ended it as the European Union and Swiss healthcare arrangements Bill, because it cast its net so wide. One of the giveaways is what the Government say in their description of their amendments:
“This new Clause makes clear that information held by the Secretary of State or the Department of Health in Northern Ireland in connection with human medicines can be disclosed, subject to certain restrictions, to persons outside the United Kingdom in order to give effect to a relevant international agreement or arrangement.”
The same explanatory statement follows the other government amendments in this group and tells us what the purpose of these amendments is. This underlines why we on these Benches will ask the Delegated Powers Committee to have another look at the Bill. These amendments fundamentally change the purpose of the Bill. It is not the same Bill that it looked at when it did its first report in July.
One of the reasons why this discussion—I am afraid I do not use the word “debate” about these proceedings—is so important is the read-across to the Trade Bill, to which I moved an amendment in Grand Committee a few weeks ago. It is about scrutiny and accountability. Amendment 45 is about fees: accountability and transparency and setting the level of fees. I would like the Minister to address that issue, which is fairly straightforward.
Amendment 118 in my name concerns international agreements. In terms of its policy content, it is probably the opposite of government Amendment 48. There is a policy clash here and I need to be clear that I am very unhappy about the fact that we have to agree to amendments that are unacceptable to us because of the time problems that the Government face on the Bill. We will be looking very carefully indeed at these sections of the Bill and will be seeking to amend them at the next stage.
The read-across we need to look at is to do with the trade negotiations with the United States, the EU and elsewhere, where we have to have systems of transparency and scrutiny about trade deals. The House of Lords passed an amendment to a previous Trade Bill on parliamentary scrutiny, but the Government have not made good their promises to give Parliament a say in new trade deals. I am concerned about the threat to our NHS and public health from these amendments, and about the misuse of information. We are concerned that, at present, Parliament does not have adequate powers to guide and scrutinise either the trade negotiations or the issues that will arise out of the Bill. We will need to look at this very carefully when it moves to the next stage.
Baroness Penn (Con)
My Lords, I am responding as a Whip, rather than as a Minister. I understand that this is not the ideal moment to break, but I believe that noble Lords would wish to hear a full response to the issues raised. I therefore beg to move that the debate on this amendment be adjourned.
The Deputy Chairman of Committees (Baroness Fookes) (Con)
My Lords, that concludes the work of the Committee this afternoon. The Committee stands adjourned. I remind Members to sanitise their desks and chairs before leaving the Room.