Medicines and Medical Devices Bill

Baroness Penn Excerpts

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

[Baroness Wheeler (Lab)]

My Lords, we are grateful to the noble Lord, Lord Lansley, and my noble friend Lord Hunt for amendments that would ensure that the future role and funding of NICE are placed firmly in the Bill. Amendments 17 and 79 to Clauses 1 and 13 —in the name of the noble Lord, Lord Lansley—underline for both human medicines and devices the importance for the appropriate authority making regulations under the Bill to consider the ability of the NHS to meet the needs of patients and ensure consultation in accordance with Clause 41.

Amendment 85 to Clause 13, in the name of the noble Lord, Lord Lansley, and Amendment 124 in the name of my noble friend Lord Hunt, which proposes to insert a new clause after Clause 38, deal with the funding mandate to the NHS, the availability of human medicines and medical devices, timescales, and ensuring effective monitoring and reporting arrangements by the Secretary of State to both Houses of Parliament.

Noble Lords speaking to this group, particularly those with experience as former Ministers, have made powerful arguments based on their expertise. Those speeches have been very illuminating. I hope, therefore, that the Minister will respond in a positive way that reflects these concerns and these amendments’ intentions.

My noble friend Lord Hunt’s amendment, in particular, places a duty on NICE to take account of the availability of innovative medicines and medical devices for human use on the NHS. It also requires the Secretary of State to report to Parliament on the anticipated impact of new medicines and devices on inward investment and the attractiveness of the UK life sciences sector, whose vital importance to patients and the UK economy we all recognise fully.

As we have heard, my noble friend’s Amendment 24 is very much embedded in the current review of the methods and processes of NICE, amid widespread concerns that despite its recognition as a world-class institution, there is still a major problem with the take-up of new medicines by the NHS, with many CCGs financially or structurally unable to deliver the innovation that NHS patients deserve and must have. The recent report from the cancer charities showing how UK patients are missing out on new innovative treatments that are readily available in any other comparable country shows that stark reality. The NHS’s record on implementation of technical appraisals of new drugs by NICE says it all.

We must therefore ensure that the review of NICE’s methods, which is under consultation until the end of the year, and the consultation on changes to NICE’s processes, which is due to follow early next year, deliver real and effective change, and are open and transparent. The Bill should set out clear responsibilities for both NICE and the Secretary of State on their role in funding; they will be more important than ever in getting that change and innovation.

My noble friend expressed a genuine fear, which is shared across the NHS, about the de facto rationing of innovative medicines and the role that NICE often ends up playing in this without having the clear funding mandate from the NHS that these amendments would provide. His amendment is important because it would inject some parliamentary oversight into the review of NICE’s methods and process, which many consider as having been progressing very much under wraps for a while.

I declare an interest as vice-chair of the cross-party Specialised Healthcare Alliance. We have heard worrying noises about the rarity modifier consideration on rare diseases being removed. I have heard real concerns from rare disease charities among our 100-plus members that the review could be taking a worrying turn in terms of impeding access to treatments for rare diseases. This remains to be seen but it would certainly be a retrograde step; I hope that the Minister will provide me and rare disease charities with some reassurance on it today. I hope that the Minister will at least commit to more parliamentary scrutiny of the review’s work as it reaches its conclusions over the coming months. It is crucial for NICE to be obliged to improve, rather than frustrate, access and for Parliament to be given a view on these matters.

Amendment 85 in the name of the noble Lord, Lord Lansley, would ensure that the NHS has to implement NICE’s recommendations on medical devices as swiftly as for medicines. It is squarely in line with the Government’s stated aims, in so far as the Government have promised a medtech funding mandate of the kind referred to by the noble Lord himself and the noble Lord, Lord O’Shaughnessy.

However, the reality of the Government’s limited proposals—which are now delayed until next year at the earliest—is rather different. Many of the SHCA’s charities represent patients who have already had to shield this year, and now have to do so again, and the newest medtech innovations stand to help them care for themselves at home better. Does the Minister acknowledge that the Government’s medtech funding plans need to be expanded and accelerated rather than delayed? I hope that the Minister will commit to this important issue.

Finally, the threat to the UK life sciences industry from leaving the EU, and the steps that must be taken by the Government to ensure that the NHS does not start to lose its reputation as a global leader in medical science and innovation, have been fully explored. They are a constant theme from these Benches and across the House on the Brexit legislation that we have considered so far. A statutory duty on NICE to take account of the need for improved availability of innovative medicines and medical devices for NHS patients, with a duty on it and the Secretary of State to work together to ensure that the latest medicines are able to provide the care and treatment that patients need and deserve, will be a key part of supporting a world-leading life sciences sector in future.

[Baroness Penn (Con)]

My Lords, if the noble Lord, Lord Blunkett, speaks with temerity given the other speakers on this group, I ask noble Lords to consider how it feels to be the Minister responding.

I assure the noble Lord, Lord Patel, that Health Ministers may not be completely transformed on leaving government, but discussions that may have taken place in private can become much more public once they are on the other side of the fence.

I turn to Amendment 17, with which it may be convenient to take Amendments 79, 85 and 124 in the names of my noble friend Lord Lansley and the noble Lord, Lord Hunt. On the first half of Amendments 17 and 79, my noble friend conceded that the Bill likely already delivers what is within its scope to deliver. The consideration of the availability of medicines and medical devices when making regulations is relevant. This is what sits behind the ability of the NHS to meet the needs of patients, where it relates to regulation. The Bill simply does not deal with matters related to the NHS supply chain. It supports it by ensuring that medicines and medical devices that are safe are available on the UK market. As my noble friend knows, and has referred to, these matters are set out in other pieces of legislation. NICE was established as a statutory body by the Act that he took through as Secretary of State. I know that his Amendment 85 also probes on issues to do with the NHS supply chain.

I was interested to hear my noble friend Lord Lansley’s fuller explanation of the intention behind the amendment: to enable access to innovative medicines in the NHS. I know that he has done a huge amount to improve such access in the NHS. Although the Government do not think that this amendment is necessary to achieve his goal, I hope that when we come to debate later groups of amendments, including on the Innovative Medicines Fund, I can provide him with further reassurance on this matter.

On the second parts of Amendments 17 and 79, which deal with the results of the consultation on subsequent regulations that flow from the Bill, my noble friend Lord Lansley may have noted government Amendment 126, which we shall reach in a later group. This would add to the consultation requirements in the Bill. On the result of any consultation, I assure him that there is already case law requiring that consultation responses are taken into account. This is reflected in the Cabinet Office consultation principles, which require the Government to explain the responses that have been received from consultees and how these have informed the policy. A public consultation must be formally responded to. Not only that, the Explanatory Memorandum that must accompany a statutory instrument must explain the consultation outcome. Between these various documents, the Government must not only take into account the consultation but set out what has changed as a consequence of that consultation. I therefore think that the amendment may render these changes unnecessary, as the requirement to respond and explain is already there.

My noble friend Lord Lansley also tabled Amendment 85. While I understand his interest in ensuring that we have the appropriate funding and frameworks in place so that NICE-approved devices are made available to patients—an issue already touched on in the previous discussion on attractiveness—he may have anticipated my saying to him, once again, that the Bill is not necessarily the appropriate vehicle.

None the less, my noble friend and other noble Lords have raised an incredibly important issue. I reassure him and others that the NHS medtech funding mandate will be launched in April 2021. It will get selected NICE-approved, cost-saving devices, diagnostics and digital products to patients more quickly and ensure that specified innovations are funded locally. In advance of the mandate’s launch and to support adoption of relevant technologies, the NHS standard contract has been updated to include reference to the medtech funding mandate. I hope that that provides my noble friend with the reassurances that he seeks from me. We are on the way. This Bill is not the means to the end, and I hope he feels sufficiently assured to refrain from pressing his amendment to a Division, when we reach it.

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We also know that investment in research into AMR has to be much greater. This is not just about funding to deliver ground-breaking research. The UK does a good job training PhD students but loses a lot of talented people because the post-doctoral period is so unstable. We need continued support for interdisciplinary networks to strengthen research and development capacity. The key question is whether the strategy is addressing this issue as robustly as the emergency situation that we face requires.

[Baroness Penn (Con)]

My Lords, the noble Baroness, Lady Bennett of Manor Castle, is a tireless champion of matters environmental and I am at one with her in wanting to consider sustainability in all that we do. However, I do not think these amendments are necessary and they are not strictly within the realms of regulating medicines and medical devices, which is what the Bill seeks to deal with.

Legislation is already on the statute book regarding the impact on the environment more broadly. In fact, I suggest that the Bill is part of a wider legislative canvas that delivers what the noble Baroness seeks reassurance on. Within that wider canvas is legislation on packaging waste, which is enforced by the Environment Agency in England. That imposes obligations on packaging producers to seek to reduce the amount of packaging produced, reduce the amount of waste going to landfill and increase the amount of packaging waste that is recycled. I will pick up her point on the production of medical devices being within this principle of producers being responsible for manufacturing waste and write to her on it.

Turning to elsewhere on the canvas, I say that there is also legislation on the statute book to address the environmental impact of producing and disposing of manufactured goods such as medical devices. This includes the Waste Electrical and Electronic Equipment Regulations 2013, which require the recycling of certain types of electrical equipment, including some types of medical devices. I hope that provides the noble Baroness with reassurance that these regulations are part of a wider whole.

The noble Baroness, and the noble Baroness, Lady Wheeler, also raised the importance of the appropriate use of reusable medical devices, which is essential to the provision of health services, with many medical devices being reusable in some form. I think we all agree that it is vital to ensure that decontamination of those devices is possible and, where it is, that it is efficient, effective and safe for patients to reuse. I assure the noble Baronesses that, under Clause 13, we would have the power to make provisions specifying that reusable medical devices must be designed and manufactured in such a way as to facilitate decontamination.

Amendment 25 deals with the important issue of medicines waste and medicine disposal, also touched on by the noble Baronesses, Lady Barker and Lady Wheeler. The environmental impacts of these are taken seriously, but dealt with by other legislation. For example, the Environmental Protection Act 1990 makes provision for the safe management of waste. The Act imposes a duty of care on any person who disposes of controlled waste to take all reasonable steps to ensure that it is not disposed of in a manner likely to cause pollution of the environment or harm to human health. Community pharmacies must comply with this legislation, and the NHS community pharmacy contractual framework makes specific provision for pharmacies in England to act as collection points for the public’s unwanted medicines. These returned medicines are then stored securely by pharmacies until they are collected for safe disposal.

I understand that the noble Baroness and others may also want to know what we are doing to reduce waste medicines in the first place. Medicines optimisation is a key workstream within NHS England’s medicines value programme; it aims to ensure that the right patients get the right choice of medicine at the right time. Through focusing on patients and their experiences, the goal is to help patients to improve their outcomes, take their medicines as intended, avoid taking unnecessary medicines, reduce wastage of medicines, and improve medicines safety.

The Secretary of State for Health and Social Care has asked Dr Keith Ridge, the chief pharmaceutical officer for England, to carry out a review of overprescribing in the NHS. Following a pause due to the Covid-19 pandemic, the review is due to report later this year. This work is looking at reducing inappropriate prescribing with a particular focus on the role of digital technologies, research, culture change and social prescribing, repeat prescribing, and transfer of care. The report will provide recommendations to reduce overprescribing, which will help to reduce medicines wastage.

Amendment 41, proposed by the noble Baroness, Lady Bennett, highlights the serious and growing global problem of antimicrobial resistance, or AMR. It has been placed on the National Risk Register of Civil Emergencies as a “longer term trend” likely to change the overall risk landscape for the UK over the coming decades. Already it is estimated to cause more than 700,000 deaths each year globally. That figure is predicted to rise to 10 million, alongside a cumulative cost of $100 trillion by 2050 if no action is taken. She will be aware that in January last year the Government set out the UK’s vision to contain and control AMR by 2040. This vision is supported by a five-year national action plan that includes comprehensive One Health action across the spectrum of human and animal health, agriculture, the environment and food.

While recognising the serious threat of AMR, I respectfully suggest that this amendment, specifically in the context of a clinical trial, is not necessary. Clinical trials of medicines, including those of antimicrobials or antibiotics, have strict requirements for reporting adverse events and for continuous monitoring of the benefits of the medicine under investigation versus the risks, as set out in the Medicines for Human Use (Clinical Trials) Regulations 2004 and associated good clinical practice guidance. Development of AMR during a clinical trial may manifest as an adverse event or as a lack of efficacy to the medicine being investigated. In either case, the investigators and trial sponsor have obligations to take action to protect the safety of the trial participant. This action might include taking an urgent safety measure, amending the trial protocol or terminating the trial early. These actions would require notification to the medicines regulator—the MHRA—and a research ethics committee. Development of AMR during a trial would also be expected to be transparent via the publication of the results of that trial.

The Health Protection (Notification) Regulations 2010 places a legal duty on the operator of a diagnostic laboratory to notify Public Health England of the identification of specified causative agents in a human sample within seven days. On 1 October, those regulations were updated to require diagnostic laboratories to report the results of any antimicrobial susceptibility test results and any resistance mechanism identified in respect of a sample. I hope that provides reassurance of the Government’s focus, not just to maintain high levels of surveillance of rates of AMR but to successfully contain and control its spread for future years. Given the existing provisions and ongoing work in the department, I hope I have reassured the noble Baroness that additional powers in this regard are unnecessary and she now feels able to withdraw her amendment.

[Baroness Bennett of Manor Castle (GP) [V]]

My Lords, I thank the noble Baroness, Lady Barker, for adding to the outline that I provided on the importance of the greenhouse gas emissions of the NHS and bringing in the issue of the use of water, which is becoming an increasingly rare resource in the UK. I thank her for providing her personal account of the frustrations of individuals who want not to waste NHS resources, based on her own experience.

I thank the noble Baroness, Lady Wheeler, for focusing on plastic waste. I shall restrain myself from commenting on the broader points of this issue, but thank her for highlighting the particular importance of illegal exports of medical waste and the big issues around Covid-19 and the waste unavoidably being generated at this point, as she said.

Coming to the Minister’s response, at the start there was a suggestion that this was a provision to go somewhere else—that all these issues could be in the Environment Bill or packaging regulations, et cetera. I do not accept that. If we take a systems-thinking sustainable development goals approach, then we have to make sure that all these issues are in every piece of legislation. Everything has to be considered as a whole. Rather than saying “We’ll deal with it somewhere else”, given the issues of legislation being delayed—we do not know when the legislation that we have not yet seen will arrive—it needs to be built into every element of our thinking on this fragile, much-abused planet.

Coming to some specifics, the Minister commented on current arrangements for recycling of devices. I note that there was a disturbing report out this morning through the waste industry about the number of fires occurring in waste management facilities as a result of the inappropriate disposal of batteries. I do not know how many of those involved medical devices, but I would think it highly likely that, in some cases, they would be. There is clearly a real problem with our current disposal systems. The Minister referred to Clause 13 dealing with the contamination issues. I will take that back to my technical advisers. I was pleased with her comments about the efforts on medicines optimisation. If we think about this in the context of a waste period more broadly, we know that “reduce” is always the best option.

I am also pleased with the overall tenor of this debate and the focus that we have seen on antimicrobial resistance. If we think back—gosh, it is two Prime Ministers back now—David Cameron gave a major speech on antimicrobial resistance and we have seen growing awareness of this issue. I am pleased that this debate has been an opportunity to highlight it and focus on the need for more action. For the moment, I beg leave to withdraw my amendment, but I reserve the possibility of further consultation, and potentially bringing it and my other amendments back in this or a different form.

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[Baroness Walmsley (LD) [V]]

My Lords, the Government take an enormous number of powers to make regulations in the Bill.

In the light of the paucity of parliamentary powers to check these, particularly prior to them coming into effect—as demonstrated by the recent Covid-19 regulations —the only way in which Parliament can influence these regulations before they are even drafted is by inserting into the Bill those things to which Ministers must have regard. That is why my noble friend Lady Sheehan seeks via Amendment 19 to insert two important elements into the Bill after the priorities of safety, availability and so-called attractiveness. I support her amendment and look forward to the Minister’s answers to her questions.

Proposed new paragraph (d) would ensure that the Government have regard to the International Covenant on Economic, Social and Cultural Rights of 1996, which the UK ratified 10 years later. This affirms a citizen’s basic human right to access medicines without discrimination, which means that they must be both affordable and available. We have committed ourselves to that.

Proposed new paragraph (e) reaffirms the international protections conferred by the WTO’s TRIPS Agreement. It recognises that these intellectual property rights protections have been misused and abused by big pharma; that resulted in the WTO’s Doha declaration of 2001, which reaffirmed public health safeguards for citizens of all nations. The details are in the amendment.

The amendment is absolutely crucial as the world awaits new tests, treatments and vaccines for Covid-19, as other noble Lords have mentioned. In particular, the pandemic demonstrates the importance of paragraph (e)(ii): the right to determine what constitutes a national emergency. The Government have used that.

However, the track record of big pharma does not bode well for equitable distribution of medicines, and this demonstrates the importance of the right to issue a Crown use licence. Drugs to treat cancers, HIV/AIDS, hepatitis C, cystic fibrosis and toxoplasmosis have all been withheld from citizens while Governments were held to ransom during negotiations with pharmaceutical companies. The NHS has had to ration necessary drugs because of price gouging. The threat of using a Crown use licence, and the actual issuing of one, has been helpful in such negotiations, and several countries have used the powers to great effect.

The issue of compensation, however, needs to be clarified. This section of the law has not been tested in court. Will the Minister commit the Government, therefore, to review Section 57A of the Patents Act to ensure that it does not block the use of the crown use licence provision? Countries such as Australia, Canada and Germany have revised their patents laws for this purpose, and other countries have taken action. Will the UK Government do the same? This power could be needed to ensure access to Covid vaccines and treatments, so time is of the essence. Will the Government act now and not just stick to business as usual?

[Baroness Penn (Con)]

My Lords, I suggest that this is an appropriate moment at which to pause our debate for today. I beg to move that the debate on this amendment be adjourned.

Motion agreed.