Medicines and Medical Devices Bill

Lord Patel Excerpts

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

Debate on Amendment 19 resumed.

[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.

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[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.

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[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.

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Moved by

[Lord Patel]

27: Clause 2, page 2, line 35, at end insert—
“( ) 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.