Medicines and Medical Devices Bill

Baroness Penn Excerpts

2nd reading & 2nd reading (Hansard) & 2nd reading (Hansard): House of Lords
Wednesday 2nd September 2020 Lords Chamber

[Lord McColl of Dulwich (Con) [V]]

My Lords, I congratulate my noble friend Lady Cumberlege and her committee on producing such a thorough and important report.

I draw attention to a practice that many of us clinicians used for years. It detected clinical problems in treatment, equipment and management early on. We had weekly meetings for an hour or so to discuss any complications that had occurred in the previous week. It was attended by consultants, junior staff, medical students, nurses and a manager or two. It was always an interesting and very instructive meeting, and it brought problems to light early on. People were very honest about their mistakes; it became rather like the general confession. Of course, it was essential to have as a chairman of these meetings somebody who was friendly and encouraged people to adopt the attitude of “There but for the grace of God go I”. It was a very inexpensive and successful kind of quality assurance.

I have a few questions to put to the Minister. First, do the Government plan to mandate the tracking of all medical devices used in the UK and not just those selected at random? Secondly, will the use of medical device registries be extended to patient outcomes? Thirdly, will the Government go ahead and establish the post of a patient safety commissioner, as strongly recommended by my noble friend Lady Cumberlege and many of your Lordships? Some years ago, I used to carry out transplant operations and became very familiar with the problems involved.

I emphasise that in Committee I shall fully support the amendments in the names of the noble Lord, Lord Hunt of Kings Heath, and the noble Baroness, Lady Finlay of Llandaff, dealing with forced organ harvesting. As mentioned before, Sir Geoffrey Nice QC stated in his report that forced organ harvesting has been committed for years throughout China. [Inaudible.]

[Baroness Penn (Con)]

I am afraid that we can no longer hear my noble friend. If he would make his concluding point, that would be wonderful.

[Lord McColl of Dulwich (Con) [V]]

Perhaps those who spend so much time attacking the Government about this and that might like to turn their attacks on the Chinese Government, whose morally corrupt behaviour demonstrates to the world what is going on in China.

Finally, I again congratulate my noble friend on her outstanding report.

Medicines and Medical Devices Bill

Baroness Penn Excerpts

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

[Baroness Thornton (Lab)]

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

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

[Baroness Penn (Con)]

My Lords, it is perhaps appropriate if I begin by speaking to the government amendments—Amendments 43, 44, 64 and 65 in the name of my noble friend Lord Bethell —in this group. In doing so, I thank my noble friend Lord Blencathra for his committee’s report. As previously noted, we have listened to that report, and the changes that we propose through these amendments are intended to address the specific concern in that report regarding penalties for existing criminal offences.

As drafted, Clause 5(1)(b) already provides a restriction limiting the maximum penalty to imprisonment for two years when creating a criminal offence. The DPRRC asked us to explain whether the penalties for existing offences could be amended when there was no maximum specified in the Bill. I want to be clear that we do not intend to increase the penalties for existing offences.

Amendments 43 and 44 would work together to amend Clause 5. They make it clear that, under Clause 1, we may not make regulations that provide for a criminal offence to be punishable by more than two years’ imprisonment. This will apply to both new and existing criminal offences. For veterinary medicines, Amendments 64 and 65 seek to achieve the same by amending Clause 10.

The government amendments will, I hope, remove any concern that powers in Clauses 1 or 8 could be used to make regulations extending sentences for existing offences beyond two years’ imprisonment.

I now turn to Amendment 4 and the other amendments in this group to which noble Lords have spoken. The ability to enforce breaches of the regime governing medicines is a power originally conferred on the Secretary of State in the interest of protecting public health. This was introduced by the Medicines Act 1968 and provisions around offences are found throughout the Human Medicines Regulations 2012. They are also contained in the Veterinary Medicines Regulations 2013.

Offences deter potentially harmful activity and make it possible to take punitive measures against those whose actions put people, animals and the environment at risk. As we make necessary updates to the regulatory requirements, we must be able to remain consistent with the current enforcement regime, which already imposes criminal sanctions. It would not be right that a person may face a criminal sanction for breaching current requirements but not for breaching new regulatory requirements, for example relating to novel technologies and medicines. As with other changes to provisions, making changes to offences will be subject to the draft affirmative procedure, and we will make offences proportionate and necessary. It is imperative that we are able to balance novel regulation with enforcement of that regulation.

It cannot be ignored that crime involving medicines is increasing. Furthermore, criminal activities adapt to new environments and technology. In recent months we have seen opportunistic criminals selling online unauthorised and unapproved medicines and devices for the treatment, prevention or diagnosis of Covid-19, including antimalarials, self-testing kits, “miracle cures” and “antiviral misting sprays”, which could cause harm and unnecessary stress to patients. Enforcement capabilities must be able to keep pace with criminal exploitation. Delegated powers afford us our continued ability to enforce the regulatory requirements for medicines and devices for public protection. To be effective, they must be enforceable.

The Veterinary Medicines Regulations 2013 contain numerous criminal offences for breaches of the regulations; again, this is for the purposes of enforcement. The Veterinary Medicines Directorate’s enforcement strategy is risk-based; it focuses on proportionality, consistency, transparency and targeting. The VMD works with businesses and individuals to assist them in complying with the legislation through the provision of advice and guidance. However, where necessary the VMD will use more formal means of enforcement to secure compliance. It is critical that we have the delegated powers to enforce this.

We have always been clear that we are trying to provide greater clarity on how to enforce the regulations on medical devices. The regulator’s ability to have teeth when we are looking to raise medical device safety standards in future is essential. The report from my noble friend Lady Cumberlege tells us that.

The Bill is also clear on the maximum time limit for imprisonment, which applies to any new criminal offence introduced. This limit matches the current system for devices, where criminal offences for medical devices are already punishable for up to six months. The devices regulations are in place to protect public health; breaches of those regulations put people at risk and can cause significant harm. It is only appropriate that there is a clear consequence for any such actions, including potential criminal prosecutions. We will of course have regulations subject to the duty to consult at Clause 41, which will mean the public have the opportunity to comment on the necessity and proportionality of the approach.

I hope the necessity of enforcing the new regulations, and the safeguards the government amendments have provided, persuade the noble Lord to withdraw his Amendment 4 and others not to move theirs.

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

I have received no requests to speak after the Minister, so I call the noble Lord, Lord Hunt of Kings Heath, to respond to the debate on his amendment.

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[Baroness Thornton (Lab)]

My Lords, I thank the noble Lord, Lord Sharkey, for his comprehensive introduction to this group of amendments, particularly those that he is supporting.

We are minus at least four noble Lords from this debate because of the clash with the other Bill. I have certainly made my view known to the usual channels in the next booth that we cannot continue to discuss this Bill in those circumstances because we will be missing too many people who have a stake in the Bill and amendments down. I cannot imagine what the noble Lord, Lord Forsyth, is saying to his own Benches about this—actually, I probably can, and it will not be polite, I suspect. He put his name down to this amendment and, presumably, found out that he was not allowed to speak in both the Second Reading debate and in this Committee at the same time. I can see why that rule is there, but we are finding that this really does not work.

While the affirmative procedure offers nothing like the scrutiny given to a Bill, which typically goes through several substantive stages in each House and can be amended, we agree wholeheartedly with the DPRRC’s view that Clauses 1, 8 and 12 contain inappropriate delegations of power. We are where we are, and we therefore take the view that the affirmative procedure should apply. Amendment 134 provides for all regulations to be made subject to the draft affirmative procedure rather than the negative procedure and for urgent regulations to be subject to the made affirmative procedure rather than negative procedure.

Both the DPRR Committee and the Constitution Committee have expressed considerable concern at the inappropriate use of the negative procedure in this Bill. For example, Clause 2(1)(n) provides that regulations under Clause 1 may make provision about prohibitions relating to the supply of human medicines. Clause 42(9) provides for such regulations to be subject to the negative procedure. The explanation given for this in the memorandum, which I think I referred to in the very first debate in this Committee, is as follows:

“proposals to make changes to existing provisions, or to introduce new provisions enabling the supply, administration or prescribing of medicines are made to reflect shifts in best practice following extensive consideration and scrutiny by the relevant professional bodies.”

The DPRRC found this an unconvincing explanation. I probably do as well. It noted:

“It isn’t clear why consultation with relevant professional bodies lessens the requirement for scrutiny in Parliament. Indeed, if proposed changes are sufficiently important for there to be extensive consideration and scrutiny by professional bodies, this supports requiring the higher level of scrutiny in Parliament that the affirmative procedure affords. Furthermore, the prohibitions to which clause 2(1)(n) applies are sufficiently important that breach of them is a criminal offence (punishable, in the case of 4 of the 5 prohibitions, by imprisonment for up to two years). Even accepting the appropriateness of the delegation of powers in clause 1, we take the view that the affirmative procedure should apply. The consultation requirement imposed by clause 41 of the Bill is to be welcomed but we are concerned at consultation being presented as a substitute for Parliamentary scrutiny. On the contrary, if the exercise of the power is of sufficient importance to merit extensive consultation, it is of sufficient importance to warrant the higher level of Parliamentary scrutiny which the affirmative procedure affords.”


The committee also highlighted and raised concerns about Clause 9(1)(f), which provides that regulations under Clause 8 may make provision about the categories of person who may apply for veterinary medicines. The EM states:

“any proposals to make changes to existing powers or to introduce new powers for veterinary professionals to supply, administer or prescribe medicines will be subject to extensive consideration and scrutiny by professional bodies”.

Again, the committee found this unconvincing for the same reason, and took the view that the affirmative procedure still applies. I must say, I wholeheartedly agree with its assessment. As it says,

“if the exercise of the power is of sufficient importance to merit extensive consultation, it is of sufficient importance to warrant the higher level of Parliamentary scrutiny which the affirmative procedure affords.”

My amendment also addressed the egregious provisions of Clause 42 that provide that where any such regulation needs to be made urgently to protect the public from imminent risk of serious harm to health, the negative procedure applies instead. The Government’s justification for departing from the affirmative procedure was that:

“It is appropriate for regulations made in these circumstances to be subject to the negative resolution so that they can come into force immediately and provide an efficient means of addressing an imminent serious public health risk. We expect that such regulations would only need to be in place for a very short period of time, potentially shorter than it would take to schedule and hold debates”.


This is wholly inadequate.

The DPRRC stated:

“We are wholly dissatisfied by departments repeatedly arguing for powers otherwise subject to the affirmative procedure to be subject to the negative procedure where there is a need to act quickly, and seeking to justify this without acknowledging the existence of the made affirmative procedure … Even accepting the appropriateness of the delegation of powers in clauses 1 and 12, if the affirmative procedure provides the appropriate level of Parliamentary scrutiny for regulations made in reliance on clauses 6 or 15 in non-urgent cases then, in the absence of cogent reasons for the negative procedure to apply in urgent cases, we take the view that the made affirmative procedure should apply in urgent cases.”


The Constitution Committee concurred, recommending that

“the emergency powers in this Bill are subject to the made affirmative procedure, rather than the negative procedure, such that Parliament is required actively to approve them.”

The Minister will be well aware that regulations under the “made affirmative” procedure can be made and laid as expeditiously as can regulations subject to the negative procedure. They can also be laid during a parliamentary recess, unlike draft affirmative instruments. Quite frankly, it is insulting that the Government have the gall to argue for emergency powers to be subject to less scrutiny under the negative procedure, especially in the current climate when hundreds of emergency regulations have been introduced with considerable haste using the “made affirmative” procedure. Can the Minister say how this dereliction ever made it into the Bill, never mind through the Commons? I imagine that the Minister might be quite embarrassed to put her name to the Bill, which is perhaps why the Government have introduced Amendment 133 at the 11th hour.

I also speak in support of the super-affirmative amendments in the name of the Lord, Lord Sharkey. They are supported by Members across the House—including my noble friend Lady Andrews who is not here to give her support although she is extremely enthusiastic about this amendment.

Given that this is a skeleton Bill, the use of the super-affirmative procedure seems a sensible and proportionate mechanism. In this case, it would allow relevant parliamentary committees, in consultation with stakeholders, opportunities to comment on proposals for secondary legislation and to recommend amendments before orders for affirmative approval are brought forward in their final form. It has been used effectively by Governments of all colours, who recognise that it allows them flexibility when they need to bring forward regulations, while consultation and scrutiny happen before any amendments come to the House by affirmative resolution.

That is particularly important given that many areas in which we expect regulations to be laid, ranging from life sciences and clinical trials to hub and spoke pharmaceutical models, could make the contents of the SIs—and, in the absence of policy details in the Bill, even examples of draft regulation that have been published in respect of other Brexit legislation—controversial. I hope that the Minister recognises the merit of this proposal.

[Baroness Penn (Con)]

My Lords, I will begin by speaking to government Amendment 133 on behalf of my noble friend Lord Bethell. It provides significant changes that I know many will welcome. We have listened to the concerns raised about parliamentary scrutiny on emergency powers. I assure noble Lords that we have carefully considered their views and the different amendments that have been put forward on this topic.

As a result, government Amendment 133 would change applicable parliamentary procedure for reactive emergency regulations to the “made affirmative” procedure. It also provides that regulations about prescribing, advertising, packaging and labelling in relation to human and veterinary medicines will no longer be subject to the negative resolution procedure, but instead to the draft affirmative procedure. Using the “made affirmative” procedure when making regulations reactively in emergency situations affords the Government the required speed and flexibility to react to emergencies while providing that Parliament can scrutinise what has been done and why. When we make the regulations proactively, we must demonstrate the need to protect the public from the risk of serious harm; these regulations will be subject to the draft affirmative procedure.

It is important to acknowledge that the emergency powers are not intended to be used. However, as the noble Baroness, Lady Thornton, said, we are in a situation where we are currently using emergency powers, so she is correct that the “made affirmative” procedure has been put to good effect during the current pandemic. None the less, these powers are a measure of last resort to protect the public from the risk of serious harm to health.

We want to avoid using the powers reactively where possible. It is already a condition in the regulations that the situation must be accompanied by a declaration of the urgent need to protect against the imminent risk of serious harm to health. I note the questions asked by the noble Lord, Lord Patel, about the definition of that statement. I will write to him further on that matter.

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

I call the Minister to respond to the point made by the noble Lord, Lord Patel.

[Baroness Penn (Con)]

My Lords, I believe that the noble Lord’s comments reflect the themes that we are discussing throughout our scrutiny of the Bill. I certainly take them on board with regard to this group of amendments, I believe that we have discussed them before and will discuss them again on other groups of amendments.

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

Finally, I call the noble Lord, Lord Sharkey, to respond to the debate on his amendment.

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

Weighty matters of this nature are dealt with by the usual channels; the Government Whip will respond.

[Baroness Penn (Con)]

My Lords, I understand that the need to rise at a set time is part of the needs of the hybrid House. With other Grand Committees that have taken place in this circumstance, we have made progress on groups and had to adjourn mid-group. That is incredibly important in order to make progress on legislation when we are operating to time-constrained sessions.

[Baroness Thornton (Lab)]

I have to register my objection to that. If we want a proper debate, this is not just about people making timed speeches; it is about a debate. A debate should be a coherent whole, not one or two speeches and then continuing after maybe a week’s break. Would I be allowed to make my opening speech again when we go back on the second day of Committee?

[Baroness Penn (Con)]

My Lords, we would not have a second opening speech. If the noble Baroness has strong objections, we can adjourn.

[Baroness Thornton (Lab)]

I think we should. This is an important debate and we need it as a whole debate. I would be very grateful if that could be considered. I promise to make a small speech when we restart.

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.

Medicines and Medical Devices Bill

Baroness Penn Excerpts

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

I agree with the noble Lord, Lord Hunt of Kings Heath: many people use their pharmacies to ask about basic health issues, to get a flu jab or the regular off-the-shelf medicines. As the noble Lord, Lord Lansley, remarked, an effective local pharmacy takes huge pressure off GP practices. If the Minister is unable to accept Amendment 29, can she confirm what the Government would propose by way of legislation? Can she guarantee a proper consultation? I am sure that noble Lords would instinctively prefer primary to secondary legislation and be happy to accept this amendment.

[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.

--- Later in debate ---

[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.

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[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.

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[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.

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[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.

Motion agreed.

Medicines and Medical Devices Bill

Baroness Penn Excerpts

Committee stage & Committee: 4th sitting (Hansard) & Committee: 4th sitting (Hansard): House of Lords
Wednesday 4th November 2020 Grand Committee

Debate on Amendment 27 resumed.

[Baroness Penn (Con)]

My Lords, I thank noble Lords for their patience in waiting a full week to hear the response to what was a very useful and detailed debate. By way of compensation, I hope my response today reassures them that my time has been put to good effect: I am sure they will let me know if that is not the case.

Amendment 27 was tabled by the noble Lords, Lord Patel and Lord Hunt of Kings Heath. I reassure both noble Lords that the Government and the MHRA remain committed to ongoing international collaboration for the benefit of patients and the life sciences sector in the UK. The noble Lord, Lord Patel, set out some of the work the MHRA is doing to deliver on this commitment after the end of the transition period in his opening remarks on this group. I am pleased that noble Lords had the opportunity to hear from and question the MHRA directly on this and other issues this week. The Government heard the request from noble Lords to ensure that this is part of an ongoing dialogue with the regulator and parliamentarians.

In response to the noble Lord, Lord Hunt, I am reluctant to revisit the debate on alignment with the EU, which we have already had in this Committee, as well as in many previous debates. However, I reassure him that the UK is seeking mutual recognition with the EU on a number of areas, including batch testing, good manufacturing practice and continuing co-operation on pharmacovigilance. Certain aspects of medicine regulations are also harmonised at an international level and we are committed to those international standards in all areas. Indeed, to further support the aim of continued international collaboration, we have tabled Amendment 48, which I will come to shortly.

Turning to Amendment 118, tabled by the noble Baroness, Lady Thornton, I reassure her that this amendment is unnecessary. The MHRA and the VMD are both recognised globally as leading regulators and will retain their regulatory sovereignty regardless of any trade deals agreed. This will include the MHRA’s duty to consider the safety and efficacy of human medicines placed on the UK market. We will ensure that our new FTAs provide flexibility for the Government to protect legitimate domestic priorities; we have made this clear in our published approach to trade negotiations with specific trading partners.

On the price the NHS pays for medicines, the Government have made clear that this is not on the table for negotiations. The prices of branded medicines will continue to be controlled through the 2019 voluntary scheme for branded medicines pricing and access—VPAS. To be absolutely clear, the powers in the Bill do not enable regulations to be made that relate to the pricing of medicines or medical devices. In relation to data, the UK has a strong system to protect health and care data, as set out in the Data Protection Act 2018 and covered by the common law duty of confidentiality. Our objectives for trade negotiations are explicit that we will maintain the UK’s high standards of data protection. Again, to be absolutely clear, it would not be within the scope of the powers in the Bill under Clauses 1, 8 and 12 to create exceptions to or modify the provisions of our data protection legislation.

I heard in last week’s debate that questions of safeguards and data protection were at the heart of noble Lords’ concerns about the government amendments in the name of my noble friend Lord Bethell, to which I will now turn. These amendments would allow us to share information regarding these areas with international regulators or networks where this is required to give effect to international agreements or arrangements. I reassure the noble Lord, Lord Clement-Jones, and others about the motivation behind these amendments, which have been identified as necessary as part of the work to support the future relationship with the European Union, and to protect and preserve existing work that the MHRA does. On his question about source codes and algorithms in medical devices, I make two points. The UK-Japan trade deal, as with the EU-Japan trade deal that came before it, provides for safeguards against IP infringement on the question of source code and algorithms. However, to protect patient safety, and for effective regulation, there remains provision for a regulator or conformity assessment body to request source code and algorithms as part of their regulatory responsibilities.

The MHRA and the VMD presently share and receive intelligence from their counterparts through our membership of the European Union, which will come to an end. The MHRA and the VMD will be the UK’s independent, standalone regulators and require appropriate legal powers for their own reciprocal information-sharing arrangements with other nations and forums. Without this, the UK may not be able to comply with its information-sharing obligations under international agreements; nor would it be able to participate in international arrangements facilitating the mutual exchange of intelligence regarding medicines and medical devices. These exchanges of information are of vital interest to UK patient safety. For example, intelligence sourced from international regulators through the EU has ensured access to life-saving medical devices for UK patients during Covid and has enabled the MHRA to trace suppliers of non-compliant testing kits. This is vital and will continue to be so going forward.

Future reciprocal information-sharing agreements with international regulators will help the MHRA and VMD to take swift regulatory action on medicines and medical devices that pose a risk, removing them from the marketplace if necessary. I reassure noble Lords that this data is limited to the data that the MHRA holds. The MHRA will always anonymise patient data before it is shared internationally, under the powers in the Bill. For the purpose of pharmacovigilance, for example, the MHRA might need to share information received through adverse incident reports. However, the information would always be anonymised and is usually kept at a high level—for example, description of the safety signal, or a trend report to identify whether another country has also identified an issue with a particular product or manufacturer.

I appreciate that there has been some concern over the use of the word “person” in the drafting of the amendment. We used that word, rather than specifying particular organisations, because we anticipate that international agreements will require the UK to share information not only with overseas regulators but with other bodies, such as overseas Governments, international organisations such as the World Health Organization, and international networks such as the International Medical Device Regulators Forum.

The wording is necessary because it provides the breadth, for example, to share data with international networks that might not be formalised. If we were to list all the organisations, networks and relationships that might be involved, it would simply not be possible to keep that list live on the face of legislation. Debate has been categorical that the MHRA needs to be a front-footed international regulator, and to limit it to the relationships it has now, rather than being flexible with regard to new regulatory forums or relationships, would restrict that aim.

The noble Lord, Lord Patel, asked pertinent questions about the data protection provisions in the new clauses. I have to admit to noble Lords that I had the same reaction about their potentially circular nature when I first read them, and I hope that I shall be able to unpack their effect here. The GDPR sets out seven key principles for processing personal data, the first of which involves “lawfulness, fairness and transparency”. We are providing a lawful basis for processing personal data by inserting these powers. That does not remove the other protections under the Data Protection Act that apply to the sharing of information under these clauses.

Where personal data are sensitive personal data, which are now called special category data, the GDPR requires further conditions, under Article 9, to be met for the processing to be lawful. Patient health data are a type of special category data. Relevant conditions under the GDPR, of which there are 10 that could be relied on to disclose patient data under the clause, would include “explicit consent”, reasons of “substantial public interest”, health or social care reasons, or public health reasons.

The GDPR also sets out further requirements where personal data are to be shared internationally. There must be an adequacy decision in place confirming that the third country or international organisation ensures an adequate level of data protection. In the absence of an adequacy decision, appropriate safeguards must be put in place that provide enforceable data subject rights and effective legal remedies, which can take the form of a legally binding agreement or contracts between parties. In the absence of an appropriate safeguard, data could be transferred only if it were

“necessary in order to protect the vital interests of the data subject or another natural person where the data subject is … incapable of giving consent.”



Equivalent safeguards for personal data and commercially sensitive information are already in place in Clause 35 for information relating to medical devices. This is solely to facilitate the appropriate sharing of information to give effect to international agreements and arrangements. They are critical to ensuring we can regulate effectively and uphold high standards of patient safety and access.

Amendment 45, in the name of the noble Baroness, Lady Thornton, seeks to achieve what is already standard and long-standing practice. Existing arrangements already ensure that timeliness, openness and transparency are key to the fees regime, and they are published online and available on GOV.UK. We will ensure that the industry and any other interested stakeholders know about any future fee changes in good time. We have laid statutory instruments to implement changes at the end of the transition period, as the cost of providing some regulatory services has fallen, so the fees charged will need to be reduced.

On the basis of the reassurances I have provided on Amendments 27, 45 and 118, I hope the noble Lord, Lord Patel, feels able to withdraw Amendment 27, and that the noble Baroness, Lady Thornton, is similarly assured and will not move her amendment.

[The Deputy Chairman of Committees (Baroness Watkins of Tavistock (CB)]

I have received a request to speak after the Minister from the noble Baroness, Lady Thornton.

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[Baroness Penn (Con)]

To reassure the noble Baroness, I can tell her that the Opposition’s position on the government amendments is well noted. We will take away and reconsider the use of the term “person”, but there is a view that the safeguards that the noble Baroness is talking about are built in elsewhere, in how the clause would take effect. That does not mean, however, that we would not be happy to go away and look at those exact concerns, and see whether we can provide further reassurance. I am not a lawyer drafting the Bill, but that would be about looking at the terminology as well.

[Lord Patel (CB) [V]]

My Lords, I thank the Minister most sincerely for her full and comprehensive—I might even say persuasive—response. She is right to say that it has been a week since we debated this group, and even I had forgotten some things. Certainly, the venom certainly seems to have gone out of our debate.

The Minister reminded us what our anxieties were. She is right to point out that I referred to the word “person” in the government amendment, and also to the GDPR. I am pleased to hear that, on reflection, she, too, had realised why we were concerned about the use of data that might not be protected through the GDPR. Some questions remain.

The noble Baroness, Lady Thornton, has raised some important points, and I am glad that we may debate this subject again. It would be useful to have a discussion beforehand, if possible, because the word “person” is too amorphous—unless the definition could be confined as to what kind of person is meant. In her response, the Minister mostly covered organisations that might be involved in the regulation of medicines or in recommendations regarding medicines and devices, but the proposal as drafted goes much wider than that and would go beyond that. I will not say any more about that now.

The meeting that the noble Lord, Lord Bethell, arranged with the MHRA was useful, and it would have been better if we had had some of the information earlier. The information that I gave with regard to my Amendment 27 I had acquired from the industry. Of course, we got the same information from the chief executive of the MHRA. It would have been better if we had had that earlier—but that is water under the bridge. We know that there will be new ways of keeping us informed, and that will be good. At this point, I thank the Minister sincerely for her response, and I beg leave to withdraw the amendment.

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[Baroness Finlay of Llandaff (CB) [V]]

I thank the Committee for allowing me to come in a bit late; I apologise for that.

Noble Lords have made the main points that I would have made but I simply add this. A large number of molecules are held by pharma, often with a good scientific rationale, for use in a rare condition, and we have drugs that are licensed for other uses that could be reused or repurposed. If we can speed up all these processes, and provide an incentive for medicines development, those with rare conditions—who are often absolutely desperate to try something new and very keen to be part of a monitored development—could access medicines. That would put the UK in a stronger position in the long term.

In addition, the concept of this seems so sensible that I have also put down an amendment, later in the Bill, to try to replicate it for innovative devices. We have complex situations where medical engineers may come with up a device, but we will deal with that the next time round.

In the meantime, I am most grateful to all noble Lords for the important points they have made. I await the Minister’s reply with interest.

[Baroness Penn (Con)]

My Lords, this debate has once again focused the Committee’s mind on the importance of innovation and the way in which it can have a transformative impact on patients’ lives.

As noble Lords have spoken of, the success of the Cancer Drugs Fund in providing interim funding means faster access to cancer drugs, saving valuable time—up to eight months in some cases—for patients accessing those drugs. Patients are now able to access cancer drugs that have received a draft NICE recommendation from the point of marketing authorisation. As noble Lords have noted, this provides the template for the innovative medicines fund.

The success over the lifetime of the Cancer Drugs Fund to date did not need legislation. It was a response to the immediate need to target access to cancer drugs. In expanding the fund to become the innovative medicines fund, I do not think legislation would advance the fund’s purpose, capacity or delivery in any material way. It will be a managed access scheme delivered by NHSEI and NICE to expand the range of medicines that could be supported by that funding.

I understand that my noble friend Lord O’Shaughnessy and other noble Lords would like this debate to cover an update on progress towards delivering that fund. I assure noble Lords that proposals for the innovative medicines fund are in development as we speak. We know that patients will be keen to understand the impact on them, as well as pharmaceutical companies and the NHS. It is our intention that NHSEI and NICE will lead an engagement exercise in the first quarter of 2021 to get the fund established.

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[Lord Hunt of Kings Heath (Lab) [V]]

My Lords, before the noble Lord winds up, I want to thank the Minister. Clearly, the fund is welcome, but it will cover only a limited number of medicines. The debate goes wider than that.

I want to ask the Minister about the financial contribution that her department receives under the current voluntary agreement with pharma for sales of branded health service medicines. Does she not agree that it is a strange position we have reached where, if the cost to the NHS of those branded medicines goes above the agreed rate, her department receives a rebate? That is excellent, but why then does the NHS continue to treat drug costs almost as a pariah and hold down its investment in new medicines? Why cannot that rebate be used as a way to incentivise a switch by the NHS to new medicine?

I have debated this with the noble Lord, Lord O’Shaughnessy, and his predecessor. It is a real issue. The NHS itself believes drug costs to be a major problem, but the department has essentially solved the problem at a national level through the rebate scheme. Somehow, instead of a virtuous circle, we have got the very opposite.

[Baroness Penn (Con)]

The noble Lord speaks with great passion. He is right that the debate goes wider than the innovative medicines fund, but it might also go somewhat wider than the scope of the Bill. I am, however, happy to write to him on the points that he raises.

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[Lord O'Shaughnessy (Con)]

I apologise for my email ineptitude.

I am grateful to my noble friend for her response. I was not planning to do so, but I have to again underline the points made by the noble Lord, Lord Hunt. We have trapped ourselves in a vicious, rather than a virtuous, circle that could well be undone. That may not be a discussion for now, but I want to underline its importance.

I want to ask my noble friend a very practical question. What did she mean by engagement? That could mean anything; it could mean pre-consultation discussion or a formal consultation. She will have garnered the strength of feeling on the topic, even in this small debate, and I am sure that will not dissipate as move forward to Report. The more detail and specificity she can give us on that process, the better.

[Baroness Penn (Con)]

I am reminded that my noble friend Lord Lansley referred to the collective noun for former Health Ministers as a “frustration” of former Health Ministers. I can tell my noble friend that the engagement exercise will involve the pharmaceutical industry, the NHS and associated bodies and patient groups. That is the level of detail that I can give to him today. I was very pleased with being able to say “quarter 1” next year; it felt to me like a very specific timeframe for when that engagement exercise would be undertaken.

[Lord Patel (CB) [V]]

Thank you, my Lords. I apologise to the Chair for jumping in. I forget that, in the new world, I do not speak unless instructed to do so.

I thank the Minister enormously for her response. She mentioned the frustrations of the former Ministers. If she thinks that former Ministers get frustrated, think about us lesser mortals who have suffered the former Ministers when they have not listened to our arguments. Maybe that should be taken into account, too.

I thank all noble Lords who have taken part. They have spoken with passion and commitment. This has been referred to by several people, but I do so again. The noble Lord, Lord Hunt of Kings Heath, has been pursuing this passionately and eloquently for a very long time. He has made an important point: if the medicines are available and people are suffering, why do we keep arguing about health and drug budgets and how to deliver it? The principle should be how we can get those drugs to the patients who might be suffering. He is right. If a rebate is available, where did the money go? The rebate was a drug fund rebate to be reinvested, you would have thought, in people getting the medicines.

No doubt the Minister is aware that there seems to be complete consensus around this amendment. I hope that it does not need to go to Report but, if it does, Ministers will be aware that there will be complete consensus. I hope that the Minister makes rapid progress with sorting this out. In the meantime, I thank all noble Lords and the Minister most sincerely for taking part. In begging leave to withdraw the amendment, I hope that the noble Lord, Lord Lansley, will feel that we gave it enough airtime and passion.

Medicines and Medical Devices Bill

Baroness Penn Excerpts

Committee stage & Committee: 5th sitting (Hansard) & Committee: 5th sitting (Hansard): House of Lords
Wednesday 11th November 2020 Grand Committee

[Baroness Jolly (LD) [V]]

My Lords, I support Amendment 49 in the names of the noble Baroness, Lady Thornton, and the noble Lords, Lord Hunt of Kings Heath, Lord Ramsbotham and Lord Bradley. It mandates the Secretary of State to publish proposals and a timetable for additional healthcare professionals to be given appropriately restricted prescribing rights. As other noble Lords have said, for well over 20 years, some appropriately trained nurses have been prescribing from a restricted list. I see no reason why, as the noble Baroness, Lady Thornton, described, appropriately trained allied health professionals and others, working from a list of approved medicines commensurate with their profession, should not do the same.

This is entirely appropriate at the moment, when it is not always easy to access a GP. We have seen how successful giving prescribing rights to both community and practice nurses has proven to be. Patients are becoming more willing to have appointments with AHPs and nurses, rather than GPs, which frees doctors to concentrate on patients requiring more experience, such as those with unusual or complex conditions. This is a win-win amendment and I heartily commend it.

[Baroness Penn (Con)]

My Lords, I recognise that there is keen interest in how we may use powers in Clause 2(1)(n) of the Bill, relying on Clause 1(1), to continue to update the prescribing and supply responsibilities of healthcare professionals. However, I hope to persuade noble Lords that Amendment 49, in the name of the noble Baroness, Lady Thornton, is unnecessary.

I am very pleased to say to noble Lords that NHS England and NHS Improvement are already leading work to scope the current and potential future use of medicines supply, administration and prescribing mechanisms by a range of non-medical healthcare professionals. On 15 October, they started consulting on a range of proposals to extend medicines administration and supply responsibilities, and to update the medicines that some existing independent prescribers may prescribe.

The consultations cover the use of patient group directions by biomedical and clinical scientists and operating department practitioners, exemptions enabling dental therapists and hygienists to supply some medicines, and changes to the controlled drugs that can be prescribed by physiotherapists, podiatrists and paramedic independent prescribers. If progressed, these proposals would allow patients to get timely and safe access to medicines from the most appropriate healthcare professionals, without the need for extra appointments from other prescribers, such as a GP. The current consultation will run until 10 December and is of course a public consultation. It will be informed by the views of key patient and professional groups, with engagement starting shortly through a series of online events.

I reassure noble Lords that we are committed to updating the prescribing and supply responsibilities of professional groups, where it is safe and appropriate to do so. In keeping with the rest of the Bill, any such changes will be made in a way that serves the best interests of patients. The powers allow us to ensure that professional responsibilities can be updated to reflect developments in professional practice, new approaches to care, changing scientific understanding and growing technical abilities. This ensures that we can continue to make full use of the skills available to us among NHS professionals, and support patients to receive the best possible care and support from NHS staff.

I know that a number of NHS professional groups are keen to see their members taking on responsibility for supplying or prescribing medicines. We have recently seen papers put forward by the British Dietetic Association, the Royal College of Occupational Therapists, the British and Irish Orthoptic Society, the Society of Radiographers and the Royal College of Speech and Language Therapists. I am very grateful to the professional groups for the careful consideration that they have given to these issues.

I reassure noble Lords that NHSE/I already has extensive joint working and engagement under way with these and other professional groups to consider whether any other changes would help keep patients safe and well. This will build on the historic work with various professional bodies and the devolved Administrations, over the last few years, which resulted in a number of changes, including allowing paramedics and therapeutic radiographers to be independent prescribers. As well as this, a wider scoping project is being led by NHS England and NHS Improvement, with the devolved Administrations and professional bodies, on the current and potential future use of medicines supply, administration and prescribing mechanisms by a range of non-medical healthcare professionals.

I also reassure the noble Baroness, Lady Thornton, the noble Lord, Lord Hunt, and other noble Lords who raised this that NHS England and NHS Improvement’s work on prescribing and supply will of course account for lessons learned from the Covid-19 response. For instance, NHSE/I wishes to learn from professional bodies and, in its scoping work, is asking them how the use of medicines mechanisms contributed and how they can play a role in increasing capacity to respond to future challenges. On that basis, I hope that the noble Baroness, Lady Thornton, feels able to withdraw her amendment.

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

I have received no requests to speak after—

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[Baroness Thornton (Lab)]

I am sorry; it was possibly delayed. It was really just to ask the noble Baroness: when is the earliest she thinks there will be change? Are we looking at three months, six months or a year?

[Baroness Penn (Con)]

I might need to pick this up with the noble Baroness in writing afterwards. The consultation will close in December and, obviously, work has to be done after that—but it is probably safest to write, if that is okay.

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[Baroness Penn (Con)]

My Lords, I am grateful to the noble Baroness, Lady Wheeler, for raising the important issue of the prescribing cascade, as put forward in Amendment 62. I recognise the desire to ensure that the use of the cascade continues to be regulated. It is an important tool for veterinary surgeons, as they can access a wider range of medicines to treat animals under their care and avoid unacceptable suffering. However, I reassure the noble Baroness that this amendment is not necessary. The Bill already confers discretionary powers that will allow the appropriate authority to decide, following public consultation, if and how the existing cascade provisions in the Veterinary Medicines Regulations 2013 should be amended.

The existing provisions for the prescribing cascade are well used and well understood by veterinary surgeons who are responsible for their prescribing decisions. The provisions were so well described by the noble Baroness that I shall not repeat them here.

The noble Baroness, Lady Wheeler, is right that the second option under the cascade is the use of human medicine authorisation in the UK or a veterinary medicine authorised in an EU member state. She and the noble Baroness, Lady Jolly, asked what will happen after the end of the transition period. On 1 January, the second option will be extended to encompass the importing of veterinary medicines from any other country, rather than only EU member states. This is being provided for through secondary legislation taken through last year, I believe.

The Veterinary Medicines Regulations 2013 also set out additional conditions that need to be met when a product is prescribed under the cascade for use in food-producing species. These conditions help protect the safety of consumers of produce from treated animals. The conditions state that the pharmacologically active substances contained in the medicines must have a maximum residue limit, an appropriate withdrawal period must be specified, and specified records must be kept. These conditions help protect the safety of consumers of produce from treated animals. We do not plan to significantly diverge from the current prescribing cascade for veterinary medicines.

The new EU regulation 2019/6 on veterinary medicinal products will apply in the EU from January 2022. This regulation introduces changes to the cascade, such as separate cascade structures for food producing and non-food producing animals. It includes provisions on the use of antimicrobial medicines under the cascade. For example, the European Commission may, by means of implementing Acts yet to be adopted by the EU, establish a list of antimicrobials which shall not be used under the cascade and a list of antimicrobials which shall be used, subject to certain conditions for cascade use. If it is in the best interests of the UK, we can make provision corresponding or similar to those in EU regulation under the powers in the Bill.

The UK Government and animal sectors have already shown their commitment to tackling antimicrobial resistance and the sectors have substantially reduced their use of antimicrobials in food-producing species—a 53% reduction in sales between 2014 and 2018. The Government will consult on proposed changes to the VMR, including changes implementing our priorities on antimicrobial resistance.

The amendment that the noble Baroness has proposed would obligate the Secretary of State to make changes to the regulations on the use of the cascade. I hope I have reassured her that the cascade remains of vital importance, and it is right that we have the option to amend the regulations when it is appropriate and necessary, subject to consultation, rather than being obliged to do so.

I will write to the noble Baroness, Lady Jolly, on her question about trade deals.

In the light of that response, I ask the noble Baroness, Lady Wheeler, to withdraw her amendment.

[Baroness Wheeler (Lab)]

I thank the noble Baroness, Lady Jolly, for her support and the Minister for her response. As I said, I have learned a great deal about this valuable procedure. I am grateful for the Minister’s reassurance on the Government’s continued support for and commitment to the cascade. I will certainly read her comments carefully. I did not hear any reference to the VICH, but if she would write to me on that that would be very helpful. With that, I withdraw the amendment.

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[Baroness Thornton (Lab)]

My Lords, the noble Lords, Lord Freyberg and Lord Clement-Jones, have done the Committee a great service today. I was fascinated by the speech from the noble Lord, Lord Freyberg, which set the tone for this discussion. I welcome his main points and his knowledge. He knows that I am a supporter of his work in this area, particularly on the protection of patient data.

It is a constant source of concern that either through carelessness, lack of expertise, unscrupulousness or policy fragmentation, our NHS will not benefit from AI and the use of patient data. I see this amendment as part of that discussion and that effort to decide what happens. The noble Lord, Lord Freyberg, has asked some very pertinent questions about algorithms, how they change and how they develop. Our job, surely, during the course of this Bill, is to find legislation that is ahead of the technology for once, not behind it. I was particularly struck by what the noble Lord, Lord Freyberg, has to say about GOQii and the MHRA, and the definition for medical devices and algorithms. The use of AI and algorithms is not impartial. We know that, particularly given our recent experience with A-levels, which was mentioned by the noble Lord, Lord Clement-Jones.

The Minister has to find a way of ensuring that this Bill reflects the modern situation and does not stop innovation. I really hope that she is not going to say that those of us who are asking these questions are opposed to innovation, because that is absolutely not the case. These are very important questions indeed for the future, as we find ourselves between the FDA and the European Union, and we make our way in this particular world.

[Baroness Penn (Con)]

My Lords, all the amendments in this group deal with the important matter of forward-thinking regulation—regulation that evolves as technology evolves. I say to the noble Baroness, Lady Thornton, that all the questions raised in this debate are very pertinent and are pro-innovation, not anti-innovation questions, concerned with ensuring that we can regulate this area properly.

As my noble friend the Minister said in previous communication to the noble Lord, Lord Freyberg, artificial intelligence is already in use in medical device technology and is already regulated—for example, Babylon’s mobile application Healthcheck is software that provides a general health assessment to users. That application is registered as class 1 medical device by the MHRA. We are also working on equipping our regulator for these products. The MHRA secured £740,000 from the Regulators’ Pioneer Fund to work with NHS Digital on developing a pilot in order to test and validate algorithms and other AI used in medical devices. There are other works in train to get the benefit of artificial intelligence in the health service. The Artificial Intelligence Award is run by the Accelerated Access Collaborative in partnership with NHSX and the National Institute for Health Research. It is making £140 million available to accelerate the testing and evaluation of the most promising AI technologies that meet the strategic aims set out in the NHS Long Term Plan.

I recognise that the intention of Amendments 83, 112 and 113 is to address the potential to cause harm to patients without appropriate regulation of these technologies. I can reassure noble Lords that software used for the application of medical devices falls within the definition of a medical device under the EU medical device directive, transposed into UK law through the Medical Devices Regulations 2002. Artificial intelligence and algorithms are encompassed within the term “software” where they have a medical purpose, and I can reassure the noble Lord, Lord Freyberg, that this covers static and dynamic algorithms.

In addition, within 12 months of this Bill gaining Royal Assent, we will start to develop new medical device regulations. The development of these regulations will include a full consultation on any changes proposed. I can commit here that the consultation will conclude within 12 months and will include the definition of a medical device, with particular reference to algorithms and methodologies used for the interpretation of data and associated technical architecture used within medical devices. This process will allow members of the public, patients and industry bodies—as well as perhaps noble Lords in this Committee—to help shape the future of regulation in the UK and the terminology that we use to describe what is captured by those regulations.

The amendments are accordingly unnecessary, as the outcome sought will be achieved under the umbrella of the wider-scale review of medical devices regulation in the UK, which will take place during a similar window as that sought by the amendment and will address the specific questions that it raises. So I hope that I have reassured the noble Lord, Lord Freyberg, that the existing definition covering both dynamic and static algorithms is sufficient and, if I have not, that he will take satisfaction from the Government’s commitment that, within 12 months, we will have concluded a consultation—to which I hope the noble Lord will contribute—that will include the definition of a medical device and specific reference to algorithms and methodologies used for interpretation of data.

This is an incredibly important debate. This is an emerging area of technology and, while we are reassured that the current regulations capture what they need to, we also need to look to the future, which is what the consultation can do. I hope that the noble Lord will feel able to withdraw his amendment.

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

I have received a request to speak after the Minister from the noble Baroness, Lady Thornton. I now call the noble Baroness.

[Baroness Thornton (Lab)]

I thank the noble Baroness the Minister. This is such an important issue, with the potential for huge benefits and huge harms. I regard it slightly like the sort of issues we dealt with in relation to the Human Fertilisation and Embryology Authority and the Human Tissue Authority—this is very important and runs very deep into our humanity. So the question I need to ask the Minister is: when the consultation is over, will we be looking at primary legislation, because I am not sure that regulation will quite do?

[Baroness Penn (Con)]

My Lords, the consultation will look at the specific issue of medical device regulation that takes place through secondary legislation. However, the noble Baroness is right in that this is not the only aspect of this issue that we are looking at and working on. There is work across government on a number of areas where this technology comes up, and we have established a number of bodies to help us in our work, such as the Centre for Data Ethics and Innovation. So, although the specific issue about the definition of a medical device and medical device regulations will take place under this Bill—subject to public consultation —there is a broader landscape that we will also address across the board and across government.

[Lord Freyberg (CB)]

My Lords, I first thank the Minister for her attentiveness during my very long and quite tortuous speech, and for the very detailed responses I have had, back and forth, from the Minister’s officials, which have been exceptionally helpful. They have been doing that over many days and many weeks. I also thank the other noble Lords who supported my amendment: the noble Baronesses, Lady Jolly and Lady Bennett, and the noble Lord, Lord Clement-Jones. It was hugely welcome and I thank them for the contributions that they made.

I was fascinated by the fact that the Minister thought that it was both dynamic and static. That is not what I had understood from the letters, but I would like to look at that again. I will obviously follow her remarks in Hansard quite closely. Perhaps I could have further dialogue with her or the noble Lord, Lord Bethell, about that, because I am not entirely sure that that is how I have interpreted it—so I would like to come back on that, if I may.

Like the noble Baroness, Lady Thornton, I recall what the noble Baroness, Lady Cumberlege, said about the ongoing situation that faces those affected by sodium valproate and mesh. We do not want to be in a situation in years to come of not having something that adequately protects the public, and I worry that we are not getting to the root of this. So, while I am happy that the Minister has offered this review in 12 months’ time, I would like more information about that. In the meantime, I beg leave to withdraw my amendment.

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[Baroness Penn (Con)]

My Lords, Amendment 94A in the name of the noble Lord, Lord Field of Birkenhead, deals with a topic of great difficulty. As the noble Lord has personally testified, patients and families deal courageously with challenging conditions, and I know that the issue of medicinal cannabis is one that has had much debate.

As other noble Lords have pointed out, it is almost two years to the day that the Government changed the law to allow the supply of medicinal cannabis under misuse of drugs legislation. These regulations provide that medicinal products containing cannabis can be prescribed or supplied when certain conditions are met. These conditions are that the relevant cannabis product is a special medicinal product, an investigational medicinal product for use in a clinical trial or a medicinal product with a marketing authorisation.

I do not have specific figures for the noble Baroness, Lady Thornton, on the number of people who may have accessed cannabis drugs since then. I understand that the collection of data on certain private prescriptions was suspended because of Covid-19, but we can go away and look for the latest data and, when it becomes available, update the House. I believe I heard the noble Lord, Lord Field, say that there may have been 204 prescriptions. While I cannot endorse that figure, and noble Lords may feel it is low, it is considerably higher than the figure that the noble Baroness quoted for one year after the approval of medicinal cannabis. Therefore, if it is correct, progress is being made in the right direction.

Noble Lords are right that cannabis remains a controlled drug. I appreciate that the noble Baroness, Lady Meacher, already expressed views on this in our discussions with the MHRA on whether it ought to be a controlled drug at all. The noble Lord, Lord Field, also made that point. However, the changes to its restrictions are set out in the Misuse of Drugs Act 1971, the Misuse of Drugs Regulations 2001, for England, Scotland and Wales, and the Misuse of Drugs Regulations (Northern Ireland) 2002. Those regulations are not within the scope of the Bill.

What is within scope is when those medicinal products are regulated as a human medicine. The noble Lord is asking for regulations to provide for a specific licensing regime for medicinal cannabis. However, I stress that medicinal cannabis products already have a route to market. They fall within the scope of the Human Medicines Regulations 2012 and the Medicines for Human Use (Clinical Trials) Regulations 2004. It is entirely appropriate that they are subject to the same standards and requirements of evidence as any other medicine. The MHRA’s licensing process takes into account evidence of clinical efficacy. This includes consideration of all evidence supplied by the manufacturer. The regulators also inspect the factory where the medicine is to be made to make sure that supplies will be of a uniformly and consistently high standard. Companies can and do submit evidence of use from other countries, so there is no need to set an explicit requirement to consider efficacy internationally. If a company wishes to make a product available, it can within this regime.

Medicinal devices that administer medicinal products, including medicinal products containing cannabis, would also need to comply with the relevant provisions of the Medical Devices Regulations 2002. But a medicinal product in the UK must be safe. We have talked throughout the Committee about the critical importance of safety and the need to uphold standards. There is a paucity of evidence to support the quality, safety and efficacy of these products, meaning that very few hold marketing authorisations. To address this, the industry needs to further the evidence base and support the use of their products. Government is supporting this with a programme of two randomised control trials commissioned by the National Institute for Health Research. I hope that reassures the noble Lord, Lord Patel, as the National Institute for Health Research is engaged in assessing the evidence in this matter. These trials will be critical in ensuring that evidence for cannabis-based medicinal products can be developed to plan future NHS commissioning decisions for the many patients who may benefit from these innovative medicines.

Just to pick up on the question of how many drugs may already hold licensing, I can say that there are three such licensed products, including Sativex for MS and Epidyolex for rare epilepsies. These drugs are proof that cannabis-based products can meet the high standards of quality, safety and efficacy that we rightly expect in the UK. I say to the noble Baroness, Lady Jolly, that the drugs that have been licensed by the MHRA also have NICE approval for use in the NHS in certain appropriate conditions. As we heard in our meeting with the MHRA on Monday, it is able and willing to provide advice to researchers and companies that wish to conduct clinical trials and go through the licensing process for their products.

Cannabis-based products for medicinal use can also be supplied as unlicensed “special” medicines, as noble Lords have noted. A special medicinal product is a product that is manufactured or assembled according to the specifications of a specialist medical practitioner to meet the needs of a specific patient, in accordance with the stringent “specials” regime provided for in the Human Medicines Regulations 2012. Those unlicensed products have not been assessed by the National Institute for Health and Care Excellence for clinical or cost effectiveness. These are the foundations of NHS decisions about routine funding for medicines.

I appreciate that families with ill children, or patients themselves, would dearly love to have greater products available to them for more purposes, but this is not about creating new licensing routes. It is about companies coming forward and undertaking clinical trials and tests and it is about having the appropriate level of assessment and understanding of the impact. We are taking steps to improve the body of evidence available. When marketing authorisations are sought, they will be dealt with by the regulator, as they would for any other medicine. That may not be as quickly as some would like, but it is necessary to protect patients. On that basis, I hope that the noble Lord, Lord Field, is content to withdraw his amendment.

[The Deputy Chairman of Committees (Baroness Watkins of Tavistock) (CB)]

I have received requests from three noble Lords to speak: the noble Baronesses, Lady Finlay, Lady Walmsley and Lady Thornton. I call the noble Baroness, Lady Finlay.

[Baroness Finlay of Llandaff (CB) [V]]

My Lords, I am most grateful to be able to come in at the end of this important short debate. I particularly commend the noble Lord, Lord Field of Birkenhead, for his outstanding and long history as a parliamentarian and, yet again, for his clarity and ethical approach to every subject that he addresses.

I am glad that the Minister has referred to the two studies from the NIHR and simply support the idea that we need to wait for those, although I draw attention to the fact that, in 2018, there was a Cochrane database review, which looked at the 16 double-blind randomised control trials that it could find. It found some support, but it was not terribly strong. One of the difficulties here is that pain is a symptom that occurs in an enormous range of disorders, but the fundamental cause of the pain will be very different in different people. To get a matched population where you can compare one with another is extremely difficult. I hope that the change that NICE is looking to in the evidence that it seeks, where it will also look at evidence in practice, will support the evidence coming through from large patient cohorts who can then be put into broader groups.

The other point about pain is that, as people get multiple pathologies, they often take several other medications as well, which can interfere with the ability to assess them. They are also often elderly. The evidence certainly needs to be accrued. I would say as a clinician that one worry was always whether there would be a leak of cannabis on to the streets. However, in practice, I think that the leakage has gone other way so that it comes from the streets into people’s homes. Clinicians have had to look at this with Nelson’s eye because they do not want to support clinical activity. In a study that I did, while we did not ask patients to tell us specifically where they were getting some things from, when we put together all the different types of alternative therapies being used by a group of people who were cancer patients, the numbers were huge. This supports many of the comments that have already been made. I am glad that the Government are looking at it and I expect that it will not be too long before we find that the ability to get the medication that is needed is made easier. I worry that it may be too late for some patients, but we are getting there.

[Baroness Penn (Con)]

I thank the noble Baroness for her comments about the importance of evidence. The Government and the MHRA recognise some of the difficulties around these trials. That is part of the reason that NIHR is supporting two trials and is asking people to come forward. The MHRA has also indicated that it is willing to work with those who have these products in order to support them in the process for licensing.

That has reminded me of one other point. The noble Baroness, Lady Walmsley, asked me about the NHS commissioning through evaluation programme. I undertake to write to her with a response, perhaps when I update the noble Baroness, Lady Thornton, on prescription numbers.

[Baroness Walmsley (LD) [V]]

My Lords, I thank the Minister for that. With regard to her earlier response, if it were as easy as that, there would have been tens of thousands of NHS prescriptions in the past two years, but clearly that has not been the case. The noble Baronesses, Lady Finlay and Lady Meacher, have both made it clear why it is very difficult to conduct randomised double-blind clinical trials for these products. That is why I have suggested that, while we wait for many more than two trials, the commissioning through evaluation system could be used. I am grateful to the Minister for promising to write to me about that.

[Baroness Penn (Con)]

I thank the noble Baroness for her comments. I emphasise that there has been a great deal of discussion in the debate about the use of evidence. That is what will guide the Government and the MHRA in this, and that is why we are supportive of these RCTs taking place.

[Baroness Thornton (Lab)]

I have two brief questions. I agree with the noble Baroness, Lady Walmsley, in what she said about 200 being two a week. That is really pathetic in terms of what the need is likely to be. I wondered if the problem was because early on, there was a certain nervousness among GPs and clinicians in terms of the legal issues as regards prescribing cannabis products. Is that still an issue? The other thing I want to ask the Minister about is whether the MHRA is drawing on international experience because some countries are much further ahead on these issues than we are.

[Baroness Penn (Con)]

The MHRA is very clear about its desire to be an international regulator and engage with other regulators across the world on all issues regarding the regulation of medicines and medical devices, so I am sure that it is working in this area. On the point the noble Baroness has made about the nervousness of clinicians on the legal status, this is not something that I am aware is still an issue, but I am happy to take the point away and look at it again.

[Lord Patel (CB) [V]]

My Lords, I wish to concur with some of the points made; I do not speak against anything said by the noble Baroness, Lady Finlay. We are in complete agreement and I do not counteract anything that she says anyway. Having said that, most people look at medicines as things that cure disease. Most medicines do not cure disease. Symptoms are what patients experience, and we have to treat those symptoms. As an obstetrician, I have spent most of my life treating the symptoms of pain, prescribing morphine and heroin as painkillers to mothers who are suffering from labour pains. I could not measure their pain in any way except by what they told me about it.

The problem with database evaluation is that it looks for the size of the randomised trials. I suggest that observational studies that look at the experience of patients are a good enough database to evaluate whether the substance used is effective in alleviating their suffering. That is the sort of evidence that I hope NIHR will seek to establish a proper database. I am pleased to hear the Minister say that NIHR is looking at ways of dealing with this.

[Baroness Penn (Con)]

My Lords, the only thing that I will add is that the noble Lord, Lord Field of Birkenhead, said that this was about equality. My point is that MHRA’s approach to medicinal cannabis is the approach it takes to licensing all other medicines. So whatever approach we take to evidence, or how we look at the appropriate gathering of that evidence, will be based on the approach we take to all medicines. The way in which cannabis is treated is not as a different or exceptional case, and we will want to ensure that that is the case going forwards.

[Lord Field of Birkenhead (CB)]

My Lords, it may be because I am a new Member that I do not quite understand the nuances of language in the House of Lords. I thank most sincerely my fellow Peers who have participated in the debate, and I agree with the Minister’s wish that at this stage I should withdraw the amendment, but in doing so, I would like to say that we will return to this issue. I would particularly like to return to the issue that my noble friend Lady Thornton raised, about equal access.

Only 10 NHS prescriptions have been offered under the new provisions that Parliament made. When I got what had to be a private prescription and took it to Boots, the pharmacist came back with it as though I had left some terrible mess, dropped the prescription back on the counter and said, “We do not dispense that drug.” So all the talk that somehow, if only we could get a prescription, we would get a supply, is also a myth.

I am disappointed with the Minister’s reply. I thought it was pretty thin gruel to offer us. Although I beg leave to withdraw the amendment, I hope that those of us who are interested in this topic will return to it at the most suitable date.

Medicines and Medical Devices Bill

Baroness Penn Excerpts

Committee stage & Committee: 6th sitting (Hansard) & Committee: 6th sitting (Hansard): House of Lords
Tuesday 17th November 2020 Grand Committee

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

Thank you, Madam Deputy Chairman; I resisted the urge to leap in. My contribution, anyway, will be brief. I want to build on my remarks in the previous group and, in particular, to address Amendment 108 in the name of the noble Lord, Lord Patel. I referred then to the article in the British Medical Journal about the medical-political complex. We have seen over the decades, again and again, in respect of medicines, pesticides and herbicides, situations where there has been growing concern about a particular chemical. Critics have come under tremendous pressure, including critics often from Governments—critics in official positions—from very large, powerful commercial interests to remain silent.

The noble and learned Lord, Lord Mackay of Clashfern, asked how anyone could not speak out in a situation where they saw that there was a danger or a serious cause for concern. We have seen again and again, however, situations where people, including Ministers in Governments, have come under tremendous pressure. Does the Minister not think that an amendment such as that proposed by the noble Lord, Lord Patel, would protect the Government, the individual and the public if she or one of her successors were in a situation where there was grave cause for concern but also very powerful multinational company forces at play?

[Baroness Penn (Con)]

My Lords, I thank the noble Lord, Lord Patel, for his amendment, designed to ensure that the public are always warned about concerns relating to a medical device where there is a clear threat to public safety. The Government agree that sharing information with the public—as well as the healthcare system—is important. Safety information is provided already to relevant special interest groups and through social media channels to ensure that messages are accessible and reach those affected who need to be aware or take action. This can include patients, healthcare professionals and members of the public. For example, MHRA recently urged users of Safe and Sound Infrared Ear Thermometers to check their product code and lot number due to a voluntary recall of specific lots because of a two-degree temperature overreading fault. This is a safety concern for members of the public who are monitoring their temperature, particularly in view of the pandemic. However, noble Lords are correct that it is critical that we do more to improve transparency and share more safety information to support patient safety. This has been made even more apparent in the findings of the report by my noble friend Lady Cumberlege.

Clause 35, along with Clause 13(1)(h)(iii), is designed to ensure that in future we can share information with key parts of the healthcare system, academia and the public in a considered and effective way. Under the current medical device legislation, MHRA does not have a clear legal basis to report all incidents involving medical devices occurring in the UK. By contrast, this has been common practice in the USA, via the FDA’s MAUDE database, and in Australia, via its DAEN database. Medicines legislation already enables MHRA to provide its interactive drug analysis prints, or iDAPs. It is therefore right that, via the information-sharing powers in this Bill, we are able to disclose in an appropriate manner all medical-device serious incidents. This will provide greatly improved transparency about the safety of medical devices in the UK.

Amendment 108 would place a legal requirement on the MHRA to disclose information to the public to warn them about concerns relating to a medical device where a clear threat to public safety had been determined. The amendment is unnecessary, as the MHRA would always share safety information with the public where it was necessary to do so. However, issuing warnings and safety information to the public needs careful management, a good understanding of the situation, full verification of the data and consideration of wider complexities. There is a high risk that mandating the disclosure of clear threats to public safety would commit MHRA to regular disproportionate direct communication to the public about safety issues that the public cannot act on.

The great majority of MHRA’s medical device safety alerts require healthcare workers, not members of the public, to take action to remove a public health threat. For example, MHRA’s national patient safety alert of 23 September 2020, addressing a clear threat to public health, instructed all hospital trusts and other healthcare providers on actions to be taken to avoid potential unexpected shutdown, leading to a complete loss of ventilation, when using the Philips Respironics V60 ventilator. Such messages should not be targeted and promoted to the public but should be made available passively to the public; for example, via access to a website. Otherwise, this would likely create unwarranted anxiety in the public about safety issues that they themselves could address because they required the intervention and clinical support of healthcare professionals.

--- Later in debate ---

[Baroness Thornton (Lab)]

My Lords, I thank the Minister for her explanation in response to Amendment 114. My desire to explore the issue slightly more is partly a result of what the noble Baroness, Lady Cumberlege, and others have said. It is also partly a result of the very helpful discussions this morning about the time that it is going to take to get the protection on devices in place. If we have another mesh situation, will that be able to emerge in this period of time? If so, who will be responsible for saying that it is not a safe device?

[Baroness Penn (Con)]

I believe that responsibility will continue to lie with the MHRA. We have existing systems, such as the yellow card reporting system. The report by my noble friend Lady Cumberlege will have made an important difference; as we discussed earlier and in other sittings, not just the systems but the culture will need to change. That culture change has begun already.

We must get the systems right so that they operate as intended and deliver the results that we all want, but the noble Baroness, Lady Thornton, is right: in the space that there will be while we implement these changes, we need to be extra vigilant about these potential issues.

As I have already said, adverse incidents involving medical devices are published on the MHRA website. The job is to take all that information and make sure that it is not just dispersed but that people can build the bigger picture. That is what we are working towards.

--- Later in debate ---

[Baroness Ritchie of Downpatrick (Non-Afl) [V]]

My Lords, I am delighted to follow the noble Baroness, Lady Wheeler, and the noble Lord, Lord Patel, on these amendments dealing with regulatory divergence and Northern Ireland. I am a signatory to Amendment 119 in the name of the noble Baroness, Lady Thornton.

During Second Reading, I stated that there is the issue of potential regulatory divergence in relation to Northern Ireland, as medicines are a devolved power but medical devices are not. The Bill raises the possibility of future regulatory divergence between Northern Ireland and the rest of the UK, and that matter requires clarification, hence my support for Amendment 119. Both amendments seek to ensure greater accountability and transparency, to which the noble Lord, Lord Patel, referred, in that Parliament should receive reports on regulatory divergence as a means of oversight and accountability—with which I totally agree.

In some areas, this also relates back to the Northern Ireland protocol. There is no doubt that we must ensure the highest level of standards in relation to veterinary medicines, human medicines and medical devices. In his response at Second Reading, the Minister indicated to me that the Government intended to implement the Northern Ireland protocol, but I ask how that squares with the UK internal market Bill, this Bill and the need to ensure that we have the highest standards for medicines, medical devices and veterinary medicines—how does this all square?

I note that the NHS Confederation will continue to follow developments, analyse the implications for the health sector in the UK and push for as much clarity as possible on the implementation of the Northern Ireland protocol from 1 January 2021. It has also been stated that Northern Ireland will remain part of the UK customs arrangements constitutionally, so HMRC—not EU officials—and the UK’s Medicines and Healthcare products Regulatory Agency should administer the necessary controls. The MHRA remains responsible for placing the goods on the market and monitoring products once sold, but they will have to be approved through the European procedures because Northern Ireland will be treated as a member state in terms of regulatory decisions.

There is also concern that there will be delays in the import and export of medicines and medical devices, which need to continue to reach patients as quickly as possible, and we must ensure that any such delays are minimised, particularly during a pandemic. Avoiding delays caused by tariffs and regulatory barriers requires the UK and the EU to reach agreement on shared standards, such as manufacturing and inspections, so that goods can be licensed for rapid release into the UK market, or vice versa. With potential new checks and the lack of clarity on how the regulatory framework will apply, this could create unnecessary delays and impact on individual patients but also on medical practitioners.

There is also a need, as the Northern Ireland Affairs Committee said, for the Government to commit to covering all costs to businesses for complying with the protocol, which includes the whole area of medicines. I ask the Minister, the noble Baroness, Lady Penn, what discussions she and the noble Lord, Lord Bethell, have had with Minister Swann in the Northern Ireland Executive, as the Minister responsible for the Department of Health, about these issues, particularly in relation to the measures to minimise and mitigate the impact of divergence and how that will be achieved. We want to ensure the least impact from regulatory divergence on the availability and accessibility of medical devices and any other forms of medicine, whether for humans or for animals.

[Baroness Penn (Con)]

My Lords, we have unfortunately come to the end of our allotted time for this Grand Committee. I am afraid that I will need to adjourn our debate for today.

[The Deputy Chairman of Committees (Lord Russell of Liverpool) (CB)]

That concludes the work of the Committee this afternoon. I remind Members to sanitise their desks and chairs before leaving the Room.

Medicines and Medical Devices Bill

Baroness Penn Excerpts

Committee stage & Committee: 7th sitting (Hansard) & Committee: 7th sitting (Hansard): House of Lords
Thursday 19th November 2020 Grand Committee

[The Deputy Chairman of Committees (Lord Brougham and Vaux) (Con)]

I call the noble and learned Lord, Lord Mackay of Clashfern. He is not there. The noble Baroness, Lady Jolly, is not with us either so I call the noble Baroness, Lady Penn.

[Baroness Penn (Con)]

My Lords, before I speak to the helpful debate we had on this group of amendments, I should like to make a correction to my response to an earlier grouping. At the time, I said that all adverse incidents with medical devices are available online on the MHRA’s website. I would like to correct this: adverse incidents with medical devices will be published online on the MHRA’s website as part of the plans to deliver increased transparency and in line with developing future legislation enabled by the powers in the Bill. However, it is not presently the case.

Turning to our present debate, I thought it might be helpful first to address the current arrangements for the regulation of medicines, veterinary medicines and medical devices in Northern Ireland. Responsibility for medical device regulation is reserved in respect of the whole of the UK. However, Part 1 of the Bill, relating to human medicines, and Part 2, on veterinary medicines, deal with transferred matters in relation to Northern Ireland. Clauses 1 and 8 set out that regulations in relation to Northern Ireland can be made either by the Secretary of State acting jointly with the Northern Ireland department or by the Northern Ireland department. This has always been the case; however, the MHRA and the VMD regulate these areas UK-wide on a day-to-day basis. After the end of the transition period, with regard to both human and veterinary medicines, as well as medical devices, under the terms of the Northern Ireland protocol, Northern Ireland will continue to follow the acquis.

Amendment 119 in the name of the noble Baronesses, Lady Thornton and Lady Ritchie of Downpatrick, seeks to ensure that, in making regulations under the Bill, the Government must minimise and mitigate the potential for regulatory divergence between Great Britain and Northern Ireland. Along with Amendment 120 in the names of the noble Lord, Lord Patel, and my noble and learned friend Lord Mackay of Clashfern, Amendment 119 seeks to establish a requirement for the Secretary of State to report to Parliament on areas of divergence between Great Britain and Northern Ireland.

I completely understand that these probing amendments seek to ensure that Parliament has proper sight of how medicines and medical device regulation develops in the future, particularly in relation to any differences between Great Britain and Northern Ireland. That is right and proper. Noble Lords will be aware, however, that the amendment in the name of my noble friend the Minister, on reporting obligations, means that the Government must already provide Parliament with a report every two years. This sits alongside the separate amendment to Clause 41 in my noble friend’s name, which requires a public consultation on any regulatory change to be made under the Bill.

That new reporting obligation on the operation of regulations made by the Secretary of State under Clauses 1(1), 8(1) and 12(1) is both forward and backward-looking. It must include any concerns raised or proposals for change made by anyone consulted by the Secretary of State in the preparation of the report, and the response to these. That may include advance notice of further regulatory change that the Secretary of State is proposing to make.

These reports, along with the public consultation on regulations under the Bill, would be the right place to deal with any issues of possible regulatory divergence raised. It would therefore be duplicative to require the Secretary of State to lay additional reports specifically on regulatory divergence for medicines and medical devices.

Noble Lords also asked a number of practical questions on how regulation will operate in Great Britain and Northern Ireland after the end of the transition period, which I will also address. The noble Baroness, Lady Wheeler, asked who would be responsible for any possible divergence between the Great Britain and Northern Ireland regulatory systems. I can reassure her that the MHRA and the VMD, reporting to their respective Secretaries of State, will continue to regulate human and veterinary medicines and medical devices for the whole of the UK, and will continue to ensure that patients and animals in Northern Ireland, just as in Great Britain, receive the safe and effective medicines and devices they need.

The noble Baroness, Lady Ritchie, asked specifically about the interaction between the UK Government and the Northern Ireland Executive on issues relating to future regulation of medicines and medical devices. I can reassure the noble Baroness that officials in the Department of Health and Social Care meet officials in the Northern Ireland Executive every two weeks to discuss the Bill and regulation of medicines and devices, and that a strong working relationship exists.

Robin Swann MLA has also given consent for the medicines day one-readiness statutory instrument, laid on 20 October, to be made by the Secretary of State for Northern Ireland as well as for Great Britain. We will continue to engage with the Northern Ireland Executive as plans for the future regulatory environment for devices and medicines develop.

The noble Lord, Lord Patel, also raised the approach to the day one readiness after the end of the transition period on which the MHRA has based its guidance to industry. I can reassure the noble Lord that, as I have just said, those regulations have been laid before Parliament, and we expect to debate them in early December.

Those regulations also require that from 1 January 2021, marketing authorisation holders must transmit all global serious reports of adverse drug reactions directly to the MHRA, to ensure that the agency has access to the totality of the information, to assess safety issues. This links to the noble Lord’s point on pharmacovigilance. I can reassure him that, following the end of the transition period, the MHRA will continue to be responsible for pharmacovigilance across the whole of the UK, and will use common processes for the assessment of safety issues in Northern Ireland and Great Britain.

--- Later in debate ---

[Lord Patel (CB) [V]]

My Lords, I sent in a request to speak after the Minister. I am grateful to her for her lengthy response, but in a way it just shows that there will be considerable areas of divergence once we exit Europe, even after we exit Europe and the agreement with the EU has expired. What the Minister said is correct—that maybe the emergency power regulations will allow us to ask questions—but those are only emergency powers, and this is longer-term.

My amendment asks for an indication, on at least a yearly basis, of where divergences are occurring. It is interesting that the Minister said that the statutory instrument is now available and will be debated in due course. Of course it is available now—although I do not know when it was made available—and we will have an opportunity to debate it. However, the MHRA was already giving guidance on the basis of that instrument before we had seen it or debated it. The Minister’s reply did not therefore satisfy the intention behind my amendment—although I will, of course, not move it today—in terms of the necessity for the Government to produce a report of where divergences are occurring and why.

[Baroness Penn (Con)]

To address the noble Lord’s question about when the statutory instrument was laid, I believe it was on 20 October. I think the statutory instrument laid on 20 October, which we shall debate, is not the Government’s approach to an answer on how we deal with the future issues of regulating medicines, medical devices and vet meds in Northern Ireland and Great Britain. What I was trying to express to the noble Lord is that we have a mechanism that means the Minister will report to Parliament every two years, both looking forward to prospective changes and back at any changes that may have been made. Of course, where new regulations are proposed there will be public consultation on those, but there will also be reports to Parliament ahead of that about the intentions, and those reports will provide a mechanism, which I think the noble Lord wants, to ensure that these issues are discussed properly in Parliament in future.

[Baroness Wheeler (Lab)]

I thank the Minister for her response. Due to the break in the group since Tuesday, we have all had the advantage of being able to have a closer look in Hansard at the speeches made by the noble Lord, Lord Patel, and the noble Baroness, Lady Ritchie. If we had managed to squeeze in the Minister’s response, that would have been perfect; I could then have responded having read it all very closely.

Anyway, I thank the noble Lord, Lord Patel, both for his support of our amendment and his very detailed considerations and questions on the MHRA guidance on Northern Ireland-Great Britain regulatory diversion on medicines and medical devices. His speech was very much a tour de force on the whole situation, understating how confusing the situation is in relation to the distinction the MHRA guidance makes between the EU market, the GB market and the market for Northern Ireland. We will need to read Hansard carefully but, despite the Minister’s best endeavours, I cannot see that she has managed to clear up for us exactly how the whole confused system will work in the future.

Moreover, as the Minister and the noble Lord, Lord Patel, mentioned, we do have the draft regulations. My attention has been drawn to them only this week. I thought they were published on 13 November, not in October, but that may be just me not reading them properly. Both regulations deal with Northern Ireland and Great Britain regulatory diversion issues, so this debate will be paused until we have considered those regulations and come back to the main Bill, and while we see what outcome there will be on the adoption of the Northern Ireland protocol.

The noble Baroness, Lady Ritchie, underlined the need for monitoring, oversight and accountability on this issue, and the importance of reporting to Parliament, and we obviously strongly agree with that. I did not specifically hear a response to her question on what internal discussions there have been between the noble Lord, Lord Bethell, and the Minister in the Northern Ireland Executive with responsibility for the NI Department of Health. If the Minister could write to her and put a copy in the Library, so that we can see what progress the discussions have made so far, that would be really helpful.

On the issue of reporting to Parliament annually—as in the amendment in the name of the noble Lord, Lord Patel—and not every two years, as the amended legislation provides for, I think the annual report called for by the noble Lord will be very much needed as all the problems and issues underlined by him and others in this debate are being worked through.

The issue is vital, and many issues are still to be identified, considered, worked through and resolved, which will mitigate and minimise the potential for regulatory divergence in human medicines and medical devices between Northern Ireland and Great Britain. In that expectation, I beg leave to withdraw the amendment.

Medicines and Medical Devices Bill

Baroness Penn Excerpts

Report stage & Report stage (Hansard): House of Lords & Report: 1st sitting & Report: 1st sitting: House of Lords
Tuesday 12th January 2021 Lords Chamber

[Lord Hunt of Kings Heath (Lab) [V]]

I thank the noble Lord; that is a temptation to be eagerly accepted. I was referring back to what the noble Baroness, Lady Bennett, said in Committee and the example in Sweden of Stockholm county council, which grades medicines on their environmental effects. Doctors can choose to prescribe a drug that is less harmful in relation to the environment where that option exists.

We have also had the 2014 report by UK Water Industry Research, which found that in most of the 160 sewage treatment works studied, several common drugs were present in the final effluent in concentrations high enough to potentially affect ecosystems. The noble Baroness, Lady Jolly, referred just now to the amount of pharmaceutical effluence entering waterways, and according to a 2018 study by the Delft Institute for Water Education, that could increase by two-thirds before mid-century.

In Committee, my noble friend Lady Wheeler referred to the Environment Agency also having found examples of contaminated hospital waste being illegally exported to developing countries such as Malaysia for disposal. What steps are we taking to prevent the illegal export of such waste and ensure that we dispose of our own waste in this country? There are also concerns about the use of incinerators for hospital waste and the health impacts on those living nearby. We must ask whether the Government are doing enough to ensure that chemists and GPs’ surgeries provide a secure depository for unused medicines, so that they do not contaminate the water supply by being washed down the sink or ending up in landfill.

The noble Baroness, Lady Bennett, said today that the Government’s approach has been to say that legislation is already on the statute book regarding the impact on the environment more broadly, including legislation to address the impact of producing and disposing of manufactured goods such as medical devices. But there is a persuasive argument that we should go further and that it is appropriate that in this Bill on medicines and medical devices there should be a way of ensuring that the environmental impact is not a damaging one. I hope that the Minister can respond with a positive reflection that this is an area that needs further exploration.

[Baroness Penn (Con)]

My Lords, when considering Amendment 7, tabled by the noble Baroness, Lady Bennett of Manor Castle, I draw the attention of noble Lords to our earlier discussion on the government amendments to this clause, introducing the requirement that safeguarding public health is the overarching objective when making regulations. The clause sets out a number of important factors that the appropriate authority must have regard to, and it is important to note that this is by no means a closed list of factors to be taken into account when making regulatory changes. I recognise that the intention is to put this important issue at the forefront of our minds, and that the factors involved in environmental protection, while broader than the remit of this Bill, may indeed be relevant as something to have regard to—and in those situations, this will happen. Let me explain.

In Committee, the noble Baroness raised important points about tackling the causes of environmental damage and listening to relevant stakeholders. As she knows, the Bill now includes Clause 43, which states that a public consultation must be carried out before regulations are made. This would provide an appropriate platform for relevant stakeholders in the production, distribution and consumption of human medicines, including manufacturers, healthcare practitioners and patients—and the noble Baroness will surely think also of campaigners—to raise their concerns and provide suggestions regarding regulations, which may include factors involving environmental protection. We would all agree that considering the environmental impact of what we do is important, but the power in Clause 1 is restricted to amending and supplementing the law relating to human medicines.

However, as I have reassured the noble Baroness previously, that law does not stand in isolation. The regulations made under this Bill must be considered within the wider context of other existing legislation that makes provision for environmental protection and access to medicines and healthcare services. The collective picture of legislation across the statute book ensures that environmental concerns are taken seriously. It includes provisions around packaging, safe management of medicines waste and medicines disposal. An example is the Environmental Protection Act 1990, which makes provision for the safe management of waste. This Act, which must be complied with by community pharmacies, 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.

I also reassure the noble Lord, Lord Hunt, on that point with regard to the management of waste and the noble Baroness, Lady Jolly, on the fact that the Government have made a clear commitment that, post Brexit, our environmental standards will not be reduced. As the noble Baroness, Lady Bennett of Manor Castle, pointed out, the upcoming environment Bill will be a further opportunity to debate many of those matters in detail.

On the question put by the noble Baroness, Lady Bennett, of why the environmental impact of veterinary medicines has been included in the Bill, whereas the environmental impact of human medicines is not specifically provided for, the situation with veterinary medicines is slightly different. The environmental safety aspects of the regulatory framework on veterinary medicines relate to their potential impact on the terrestrial and aquatic ecosystems and their flora and fauna—soil, micro-organisms, fungi, algae, plants, invertebrates, fish, et cetera—so veterinary medicines occupy a slightly different space in our regulatory framework. I also point out to her that animals receiving veterinary medicines form part of the human food supply chain, so that is also taken into account.

I hope that the noble Baroness has heard sufficient from me to be persuaded that, while the issue of environmental protection is of course vital, the law in this area is already well established and, in the light of this, that she will feel able to withdraw her amendment.

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

I thank the Minister for her answer and the noble Baroness, Lady Masham of Ilton, for her support for the amendment and her full reflections on the importance of antimicrobial resistance—something that we will be talking about a great deal in the coming years. The contribution of the noble Baroness, Lady Jolly, was also hugely valuable, in that she complemented by looking at aspects that I had not taken up. She mentioned manufacturing not happening in an environmental vacuum, and in particular the issue of hormones such as oestrogen, and also focused on imported medicines and medical devices and their global impact—something that I talked about in Committee but had not talked about tonight.

I thank the noble Lord, Lord Hunt, for his interest in and attention to what I said in Committee, and for his patience with the technology. I will take what he said as something of an expression of support for the intention behind this amendment.

I have two specific questions to press the Minister on further. She spoke about the processes of overseeing production and distribution, but she did not refer to, and was apparently not thinking about, issues around how research is regulated and how manufacturers are expected to look at the environmental impact of drugs when they are researching and making choices about which drugs to pursue. Secondly, the Minister said on veterinary medicines versus human medicines that it is there for veterinary medicines because of the impact on the terrestrial and aquatic ecosystems, the soils, et cetera. I go back to what the noble Baroness, Lady Masham, said about the impact of sewage. Human waste impacts very much on the ecosystems that the Minister acknowledged that veterinary medicines need to take into account.

[Baroness Penn (Con)]

On the first point—considering environmental impacts in terms of research—obviously safety is one of the things primarily considered when looking at research on medicines. There is then separate provision in legislation for the safe disposal of any medicines that are not used. So we look at the safety of their use in humans and, through separate legislation, address the safe disposal of any medicines via that route.

That is also relevant to the second point on how human medicines can enter the ecosystem. I will write to the noble Baroness with further detail on that, but veterinary medicines are in a slightly different position, since we look at veterinary medicines for their impacts on animals but also have to think about their wider impact on the environment in terms of their position in the food chain. The safety standards on human medicines are much higher, because we look at their impact on patients taking them directly.

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

I thank the Minister for her answer. I am aware this may not be entirely popular in the House, but I really feel this is an important issue the Government have not got to grips with. I am aware we have a long evening ahead of us, but none the less, I would like to test the opinion of the House.

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Moved by

[Baroness Penn]

8: Clause 1, page 1, line 16, leave out “an attractive or” and insert “a”
Member’s explanatory statement
This amendment omits the word “attractive” from Clause 1(3)(c).

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[Baroness Wheeler (Lab)]

My Lords, I too congratulate the noble Baroness, Lady Sheehan, on another important speech on this key issue and the dogged way she has pursued her arguments and key questions to the Minister. I thank her for sharing her response letter of 7 January to the Minister, which clearly sets out the issues she is still pressing the Minister to address, and I am looking forward to the response from the noble Baroness, Lady Penn, on these matters. I also welcome the very expert and thoughtful contributions from other noble Lords both today and in Committee on this issue, drawing on their extensive professional and international experience and knowledge.

As my noble friend Lady Thornton made clear in Committee, we support this amendment. The reassurance from the Minister during Committee about the Government’s commitment to collaborating with public and private partners in the UK and globally to promote affordable access to vaccines and medicines for all is welcome. Also, we are grateful for their continued commitment to the UK’s obligations on the WHO TRIPS agreement and the DOHA declaration, which provide important flexibilities that support access to medicines and are especially vital during public health emergencies such as the Covid-19 pandemic that is so engulfing us today.

Noble Lords are right to underline the deep concerns of patient groups on the issue of fair and free access to medicines. I remind the House that the Royal College of Physicians, the Faculty of Pharmaceutical Medicine, the British Association of Dermatologists and other key stakeholders have called for a review of the processes for issuing sole manufacturing licences and consideration of the use of price control mechanisms in relation to costs of production to increase access to medicines at fair prices. The Government’s assertion that non-exclusive voluntary licensing provides incentives for developing new medicines and health technologies is not borne out by recent evidence on newly patented drugs, as the noble Baroness, Lady Sheehan, has pointed out.

On vaccines, and our participation as a country in the global sharing and effort, access to the Covid-19 tools accelerator COVAX advance market commitment needs continuing support from the UK and wealthier nations. The promise was for matched funding if the £1 billion target was reached by the end of last year. Can the Minister update the House on this, and what will be the UK’s contribution? Is there any further information on the role the UK will play in the WHO’s proposed Technology Access Pool, C-TAP?

Finally, on funding of research and development, a number of noble Lords raised the issue of the absence of analysis of, and data on, how much public and private money goes into the development of new vaccines and medicines. The Minister referred to the VPAS voluntary pricing scheme negotiated with the industry, which runs alongside the statutory pricing scheme, the NICE appraisal process and the commercial NHSI arrangements. The scheme is designed to support patient access to innovative medicines and expires next year, so these coming months will provide a crucial opportunity to commence a detailed review on how the research and development of medicines are actually funded. This would not only strengthen the Government’s negotiating position but lead to greater transparency in the UK’s future relationship with the pharmaceutical industry, which we all want to see.

[Baroness Penn (Con)]

My Lords, first, I would like to address the issue of patient and clinician access to affordable medicines in the UK. Patient and clinician access to affordable medicines is at the core of the NHS and this country’s healthcare policy. This Bill will not diminish that. Indeed, a safe and innovative regulatory regime for medicines and devices will support that outcome, although patient access is not dealt with directly in this Bill. The Government have recourse to a number of mechanisms to ensure that patient and clinician access to affordable medicines is upheld. For example, the price of branded medicines is controlled by the 2019 voluntary scheme for branded medicines pricing and access. The National Institute for Health and Care Excellence also continues to ensure cost-effectiveness for medicines purchased by the NHS.

As the noble Baroness, Lady Sheehan, has noted, in line with the flexibilities in the TRIPS agreement, the Government also retain the right to order Crown use of patented medicines under Section 55(1)(a) of the Patents Act, where collaborative approaches are not successful or we determine that it is in the public interest. I should emphasise that this would be used only in very narrow circumstances, such as an emergency. The UK has an internationally renowned IP system, which cultivates an innovative pharmaceutical sector, attracts generics manufacturers, and ensures that the NHS has access to the most cost-effective options. We will continue to work with these stakeholders to provide cost-effective access to Covid-19 therapies and vaccines, in the UK and globally, on a voluntary basis.

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Moved by

[Baroness Penn]

11: Clause 1, page 1, line 17, at end insert—
“(3A) Where regulations under subsection (1) may have an impact on the safety of human medicines, the appropriate authority may make the regulations only if the authority considers that the benefits of doing so outweigh the risks.”Member’s explanatory statement
This amendment provides that the appropriate authority may make regulations that may have an impact on the safety of human medicines only if the authority considers that the benefits of doing so outweigh the risks.

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[Lord Collins of Highbury (Lab)]

My Lords, I too thank all noble Lords who put their names to this amendment. It truly reflects the cross-party concern on this issue. I pay particular thanks to my noble friend Lord Hunt and the noble Lord, Lord Alton, who have been absolutely persistent in raising this at every level. We have debated this not only on this Bill but in other debates in this House.

I thank the noble Lord the Minister and particularly the noble Baroness, Lady Penn, for the regular meetings she has had with noble Lords to listen to our concerns. The fact that they have both listened and acted is a reflection of the good work this House can do in not acting in a partisan way. We have put the issue first and delivered on it. I am also grateful to the noble Baroness for the way she has gone to the limit of this Bill’s scope. I recognise that the Bill’s scope has placed limitations on us, but it does not stop us speaking about and delivering on the political issue that my noble friend and the noble Lord, Lord Alton, have raised. I am particularly pleased to thank everyone concerned.

I will pick up a couple of points. One of the big political issues that started my noble friend’s concern was the exhibitions we saw. The idea that consent could be given by dead or dying prisoners in China is absolutely ridiculous. We should never accept it and should continue to ensure that we strengthen regulation in that regard. It will be ongoing work.

I also pick up a point that both my noble friend Lord Hunt and the noble Lord, Lord Alton, raised in Committee; in fact, we raised it at Second Reading. We named two companies involved in supplying organ-preserving devices to mainland China. This could explain how organs are being transported around China, supporting this obnoxious practice of harvesting organs.

I was pleased to read the statement made by Dominic Raab in his announcement that the Government will conduct an urgent review of export controls, specifically as they apply to the situation in the Xinjiang Province, to, as he said,

“make sure that we are doing everything that we can to prevent the export of any goods that could directly or indirectly contribute to human rights violations in that region.”

We have heard in our debates in this House that that is potentially going on, and I hope that the Minister will be able to respond that she will work with both the FCDO and the International Trade Department to ensure that the concerns raised today will be reflected the review that Dominic Raab has promised. I hope she will take that up and, as raised by both the noble Baroness, Lady Northover and my noble friend Lord Hunt, the China tribunal’s conclusions about the nature of the practice that has been going on and the fact that the Uighurs and Falun Gong practitioners are its main victims.

As we have said in many debates, the Communist Party of China and the Government of the People’s Republic have denied all claims about this, despite the evidence of the tribunal, and have relied on the WHO clearing them of wrongdoing. Of course, we know that that is because the WHO does not have an independent expert compliance assessment mechanism: it relies on the Government of China and the Chinese Communist Party simply saying that it does not happen. I know that the noble Lord, Lord Ahmad, has been consistent and persistent in raising this issue and it has been raised with the WHO, but I hope the Minister will be able to respond today that we will continue to raise it through the organ of the WHO.

In conclusion, I repeat what has been said by all noble Lords. The importance of this amendment is not simply the specific points of law that it will address. The most important thing the amendment and this debate tonight does is send a very clear message that we will not tolerate such appalling acts against humanity and will deliver for the people of China, not for the Communist Party of China.

[Baroness Penn (Con)]

My Lords, I begin by thanking all noble Lords for their valuable and ongoing engagement on the matters raised by Amendment 13. Throughout the Bill’s passage, we have heard numerous passionate and heartfelt speeches on the allegations of organ harvesting in China and how the UK seeks to guard against complicity in any such practices. Anyone listening to speeches made by noble Lords in Grand Committee or this debate cannot have failed to understand the considerable strength of feeling behind those concerns. My noble friend Lord Bethell and I have greatly welcomed the thoughtful and constructive discussions on these issues.

Earlier today, the Foreign Secretary made an announcement setting out an ambitious package of measures that will help to ensure that no British organisations, whether public or private, are contributing inadvertently to human rights violations in Xinjiang. This demonstrates that we will not stand by as violations there continue. We will never hesitate to stand up for human rights as a force for good in the world.

The Government’s position is clear: if true, the practice of systemic, state-sponsored organ harvesting would constitute a serious violation of human rights. The China Tribunal report has been carefully considered by the FCDO and adds to a growing body of evidence about the disturbing situation that Falun Gong practitioners, Uighurs and other minorities face in China.

Given the considerable interest in these and related concerns over human rights violations in China, my noble friend Lord Ahmad, Minister for South Asia and the Commonwealth, has met repeatedly a number of noble Lords with particular interest in these matters over recent months. I trust that these discussions have provided some assurance of the Government’s absolute commitment to strong UK action. The Minister, is, I know, committed to ongoing engagement in coming weeks.

During Grand Committee, the noble Lords, Lord Hunt and Lord Alton, made clear their view that the WHO should be further engaged to take more robust action and to provide greater transparency on organ transplant practices in China. I am pleased to tell noble Lords that continued efforts by FCDO Ministers to engage the WHO on these matters have led to a valuable meeting between senior officials at the UK Mission in Geneva and Jane Ellison, executive director for external relations at the WHO. These discussions have opened up dialogue with key international partners on organ harvesting allegations, which we are committed to continuing.

Crucially, noble Lords may know that my noble friend Lord Ahmad has committed to meeting Sir Geoffrey Nice QC in the coming months to discuss further the findings of his report. The FCDO is, I know, absolutely committed to considering carefully all and any evidence presented on allegations of organ harvesting in China. I want to take the opportunity on behalf of the Minister for South Asia and the Commonwealth to thank my noble friend Lord Ribeiro and the noble Baroness, Lady Northover, for their role in engaging international medical organisations on these matters.

I now turn to the specifics of the amendment tabled in the name of the noble Lord, Lord Hunt, to which I am pleased that my noble friend Lord Bethell has put his name. The amendment provides absolute clarity that the powers in Clause 2 of the Bill can be used to make regulatory changes about the use of human tissues or cells in legislation relating to human medicines.

While it is important to be absolutely clear that the use of imported tissue in any medicines on the UK market is extremely limited—there is only one licensed medicinal product in the UK that uses donor-derived tissues, and that tissue is sourced from within the EU—we are all in agreement that we would not want the UK medicines industry compromised by the use of human tissue or cells sourced through human rights violations. The amendment will ensure that we have the power to take action to amend or supplement provisions governing the use of human tissues in medicinal products in the Human Medicines Regulations 2012 or the Medicines for Human Use (Clinical Trials) Regulations 2004 to help assure the integrity of tissues and cells used in UK medicines if necessary.

The drafting, an iteration of the wording of a similar amendment tabled by the noble Lord, Lord Hunt, in Grand Committee, delivers important clarity on a number of points. In particular, the specific reference to both tissues and cells provides certainty on the scope of materials captured. The reference to definitions of those terms under the Human Tissues (Quality and Safety for Human Application) Regulations 2007 ensures consistency with wider UK legislation.

I am also assured that this drafting allows for provisions to encapsulate the full stream of activities in the regulation of medicines that could relate to the use of tissues and cells. Of course, as with any such provisions brought forward under Clause 1 of the Bill, this would be informed by public consultation, a critical step in ensuring the full consideration of an appropriate approach and mitigating against any unintended consequences—for instance, for the supply or development of medicines in the UK.

Finally, I recognise that noble Lords have raised a number of other important, related questions on how we safeguard domestic practices from being at risk of compromise by human rights violations overseas. In these discussions, we have sought to be completely clear with noble Lords on the limitations of what can be done under this Bill. However, let me reassure noble Lords that concerns have not gone unheard.

First and foremost, on the consent standards applied to tissues imported for the purposes of public display, I am pleased to announce that we will take forward work to strengthen the Human Tissue Authority’s code of practice on public display for imported tissues. Although such imports are rare, we are committed to ensuring that when tissues are imported from outside the UK for the purposes of display, the consent standards applied are clear, firm and enforceable.

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[Lord Hunt of Kings Heath (Lab) [V]]

My Lords, it is a great pleasure to support the noble Lord, Lord Clement -Jones, and my noble friend Lady Thornton. I urge the Minister to respond, as the noble Lord asked, on how Clause 3 will actually be used. It did not help that the Explanatory Notes made no mention of what the noble Lord described tonight and at Second Reading as “legislative creep”.

We have had submissions from a number of organisations that make the point that the wording goes beyond the current EU legislation, which was carefully implemented after extensive consultation with the relevant bodies. That is from the Company Chemists’ Association. The ABPI said that the falsified medicines directive was introduced as a barrier to counterfeit and falsified medicines entering the supply chain, thus reducing the potential risk of harm to patients, that the ABPI and its members have worked to fund and implement the falsified medicines directive, and that any future considerations under this clause must include full consultation with industry.

So there is general concern in the industry about how the clause will be used. We know that the department already has access to a wide range of data on medicines sales and use in the UK under the Health Service Products (Provision and Disclosure of Information) Regulations. Given this and the known sensitivities around falsified medicines data, I am still unclear why the department wants to extend the purposes for which data is collected under a future UK system. I know that we were very privileged—

[Baroness Penn (Con)]

My Lords, unfortunately the noble Lord cut out again briefly. If he could rewind about 30 seconds, that would be appreciated.

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[Baroness Penn (Con)]

My Lords, Amendment 15 in the name of the noble Lord, Lord Field of Birkenhead, deals with a topic that has been discussed at length in both Houses. The noble Lord spoke eloquently in Committee, sharing his experience of medicinal cannabis and the benefits he obtains from it.

I will first address a separate but related matter that a number of noble Lords raised concerning the supply of certain cannabis-based medicines from the Netherlands. I know that the noble Baroness, Lady Walmsley, and others in the House have received distressing calls from patients and families who have relied on these imported medicines. The Parliamentary Under-Secretary of State for Prevention, Public Health and Primary Care, Jo Churchill, met Alfie Dingley’s family and the patient group End Our Pain on Saturday to provide reassurance and an update on the action that we are taking.

I reassure noble Lords that we are working urgently with the Dutch Government to find a solution that will enable patients to access the medications they need. I cannot discuss the details of the proposals today, but I commit to provide noble Lords with a further update when I can.

Returning to the matter at hand, I reassure noble Lords that the issues raised by the noble Lord, Lord Field, in his amendment sit firmly with the Department of Health and Social Care, not the Home Office. While I am pleased that the noble Lord finds some relief with this medicine, the fact remains that the vast majority of cannabis-based medicines have not been assessed by the MHRA for safety, quality and efficacy, nor by the National Institute for Health and Care Excellence for clinical and cost effectiveness. I believe that that is the nut that the noble Lord is trying to crack with his amendment. We are also trying to crack it as a Government, but from a slightly different approach.

As the noble Baroness, Lady Meacher, noted, the Government changed the law on 1 November 2018, to reschedule cannabis-based products for medicinal use in humans. This moved these products from Schedule 1 to the Misuse of Drugs Regulations 2001—no legitimate use—to Schedule 2, to permit the lawful prescribing and supply of cannabis-based medicines when certain criteria are met. In particular, cannabis-based medicinal products can be prescribed by one of three routes: as a “special medicinal product”, subject to the “specials regime” contained in the Human Medicines Regulations 2012, prescribed by a specialist medical practitioner; as an investigational medicinal product for use in a clinical trial; or as a medicinal product with a marketing authorisation.

Given that there is insufficient evidence on the safety, quality and efficacy of these unlicensed medicines, it is entirely appropriate that these products are subject to these stringent conditions. It would be inappropriate to establish parallel arrangements or to subject medicinal cannabis to any less stringent assessment than is the case for other medicines used for serious or chronic conditions. To do so would undermine the integrity of our medicines regulation in the UK. Also, it would run counter to the noble Lord’s objective to see the placing on the market of high-quality, standardised cannabis-based medicinal products that are safe and effective.

As noble Lords heard in Committee, we have removed some of the barriers to how these products are imported into the UK and we now see a wider range of products available to prescribers. I reassure noble Lords that we are also taking steps to improve the body of evidence available. NHS England and NHS Improvement have made good progress to establish a national patient registry for patients receiving medicinal cannabis. This has been developed with clinicians and aims to cover all clinical indications and all licensed and unlicensed medicinal cannabis products prescribed on the NHS and privately. The registry will be an important step forward in the collection of uniform data to support monitoring and evaluation of prescribing activity, patient safety and clinical outcome data. This data, and that produced from clinical trials, will help inform future NHS commissioning decisions. The registry is currently being piloted, with a view to further rollout next year.

On clinical trials, the National Institute for Health Research and NHS England are working together to set up a programme of two randomised controlled clinical trials. These trials will be critical in ensuring that evidence for cannabis-based medicinal products can be developed to inform future NHS commissioning decisions for the many hundreds of patients in the UK with refractory epilepsy. This is a pioneering area of research and we hope the trials will start as soon as possible. However, I must emphasise that industry also needs to step up and invest in robust clinical trials to improve understanding of how patients might benefit from these products.

I must say to noble Lords that it is not the job of the independent regulator to generate evidence. To do so would undermine the independence and objectivity of medicines regulation in this country, including the pharmacovigilance of medicines. The safety of the public will always come first, and the producers of medicinal cannabis must be prepared to subject their products to scrutiny by the MHRA and by NICE.

When marketing authorisations are sought, they will be dealt with by the regulator, as with any other medicine, taking into account their herbal origin. The MHRA offers, and has given, regulatory and scientific advice to companies and researchers to support their research and development of these products. I reassure noble Lords that the MHRA is committed to using the latest techniques and takes a patient-centric approach to medical regulations.

Regarding further discussion of this with the MHRA, I will take that request away. I think we all welcomed June Raine’s approach in the meeting with Peers last year on this Bill. I am also conscious at this exact moment in time of the pressures on the MHRA to support our national effort on vaccination rollout. I am sure we will get a positive response, but there might be a small issue around timing that we will have to take away and address.

As we have seen with the Pfizer and BioNTech Covid vaccine, and, indeed, with the other Covid vaccines that have come online, the MHRA upholds the highest standards and will authorise the use of medicines only following the most rigorous scientific assessment. This is essential to ensure that the public can have trust in the regulator and the medicines they use. Licensed products, such as Sativex for multiple sclerosis and Epidyolex for rare epilepsies, have gone through this process and are proof that cannabis-based products can meet the high standards of quality, safety and efficacy that we rightly expect in the UK.

On that basis, and on the basis of the Government’s ongoing efforts to ensure that we have a strong evidence base to provide further access to these medicines, I ask the noble Lord, Lord Field, to withdraw Amendment 15.

[Lord Field of Birkenhead (CB)]

My Lords, I can willingly agree to that last request. I think if we put it to a Division we might not win, so what is the point of closing doors when the Minister was busy opening them? I am immensely grateful to her for that.

As the House can see, many people can do two things at once—both speak and keep their masks in place. I fail that test. But I want to thank those who have participated—the noble Baronesses, Lady Meacher, Lady Walmsley, Lady Thornton, Lady Masham, Lady Jolly, Lady Bennett and Lady Penn, and the noble Lord, Lord Hunt—for their contributions in taking this debate further.

If I may, I will end on a cheerful note. Let us suppose that, in the next few days, the Prime Minister finds the time to look at this issue and decides that the Government’s line will be different. We know that the people who have had to defend the line tonight would then put another case to us, and I hope that that case will be put very shortly.

Safety is, of course, crucial. However, we have just experienced the introduction of the Oxford vaccine and other vaccines. Presumably they went through randomised controlled trials, so those can be accomplished very quickly. I hope that, when the Prime Minister changes his mind, we will move to testing the safety of these products as quickly as we have the vaccines. Just as the vaccines offer us hope of life after Covid, I hope that we will see a quick response for those millions of people who are not free to obtain their cannabis on the NHS but who, like me, are lucky enough to be able to buy it. I hope that we will move very quickly and resolutely. One way of levelling up is to make these products—once their safety has been established—free for everybody on the NHS.

Medicines and Medical Devices Bill

Baroness Penn Excerpts

Report stage & Report: 2nd sitting (Hansard) & Report: 2nd sitting (Hansard): House of Lords
Thursday 14th January 2021 Lords Chamber

[Baroness Penn (Con)]

My Lords, we appear to have lost the connection to the noble Baroness, Lady Thornton, so I suggest that we adjourn for five minutes.

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[Baroness Thornton (Lab) [V]]

I thought these amendments were part of the group that was passed on Tuesday?

[Baroness Penn (Con)]

The noble Baroness is correct that Amendment 27 is consequential to an amendment agreed on day 1 of Report, so she may wish to move it.

[Baroness Thornton (Lab) [V]]

I think Amendment 26 is similar, possibly. We may need some guidance from the clerk. Was Amendment 26 also related to the group of amendments that were agreed on Tuesday? I apologise; it is always difficult to do these things when you are not actually in the Chamber.

[Baroness Penn (Con)]

My understanding is that Amendment 26 is also consequential to amendments passed on day 1 of Report, so we may wish to ask the noble Lord, Lord Patel, whether he wishes to move his amendment, which is consequential to previous amendments agreed.

[Baroness Thornton (Lab) [V]]

That is what I thought

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[Baroness Penn (Con)]

The noble Lord may wish to know that the amendment is consequential on an amendment passed earlier on Report, so he or a fellow signatory may wish to move it.

Amendment 63

Moved by

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[Baroness Thornton (Lab) [V]]

The noble Baroness, Lady Jolly, is quite right: two of our health big thinkers have laid out the issues here. My noble friend Lord Hunt gave a wonderful introduction to Amendment 66, which covered the reasons why it is important and what it will do. The noble Lord, Lord Lansley, took us on a journey through how health inequalities can be addressed. The point, and the reason the amendment is on the Marshalled List today, is that it does not always work like that. Implementation is key. As the noble Baroness, Lady Jolly, said, requiring NICE to support NHS access to new medicines and medical devices seems kind of obvious. The challenge for the Minister here is how to use this legislation and this discussion to make what we think is obvious work better.

[Baroness Penn (Con)]

My Lords, I know the noble Lord, Lord Hunt of Kings Heath has a long-term interest in and commitment to the work of NICE and, as such, will know that NICE’s remit is set out in other legislation. I do not intend to rehearse the arguments on why we do not see that as strictly for this Bill. Instead, I hope to provide some reassurance on the issues he raises with his amendment.

The noble Lord will be aware that NICE’s methods and processes for assessing the cost-effectiveness of medical technologies are internationally respected and have been developed over almost 20 years through periodic review, including extensive engagement with stakeholders, and the latest iteration of that process of periodic review of its methods is ongoing. NICE finished the first phase of its consultation on the case for change to its methods on 18 December 2020. There will be a second consultation on the case for change to its processes in the spring. The result of those will inform the final consultation on the updated methods manual in summer 2021. I hope that the noble Lord is reassured by the consultative nature of that process in considering the issues he raised.

Subsection (1)(a) of the new clause proposed in his amendment would require NICE to address the implications of health inequalities when assessing the cost effectiveness of medicines and medical devices. Subsection (1)(b) would require NICE to accept a greater degree of uncertainty and risk in recommending their use. I reassure the noble Lord that NICE is already considering both of those as part of its review, and they were both consulted on as part of the consultation on the case for change that ran from 6 November to 18 December 2020.

In that consultation, NICE noted that there may be a case for a modifier that considers health inequalities. However, further work is needed to explore how this could be defined and implemented in a health technology evaluation, and under which circumstances. This will be done in NICE’s second consultation running from February to March. Such a modifier could consider the types and sources of inequality, as well as how a modifier should be applied—qualitative or quantitative. It could also consider whether such a modifier covers technologies that directly reduce inequalities—for example, by specifically targeting or providing additional benefits for a disadvantaged group; or whether indirect effects might also be considered—for example, if a technology has uniform benefits across groups, but the condition disproportionally affects a disadvantaged group. At this stage, it is not clear that there is sufficient evidence for a health inequalities modifier, but it is being explored, and will be explored further in the second stage.

I hope that level of detail on the consideration that NICE is undertaking helps to reassure the noble Lord, but of course it would not be appropriate to pre-empt that review, and we want to encourage all stakeholders to respond to it.

In addition, I remind the noble Lord that a requirement to have regard to reducing health inequalities is already imposed on NICE under Section 1C of the National Health Service Act 2006. This applies to NICE as a non-departmental public body of the Department of Health and Social Care.

Proposed new subsection 1(c) would require NICE to have regard to the need

“to ensure patients with rare diseases have access to medicines and medical devices”.

The noble Baroness, Lady Wheeler, noted some concern during Grand Committee as to why NICE did not propose a rarity modifier in its methods review. A rarity modifier was considered by NICE prior to publication of the consultation document. However, stakeholders noted that rare diseases would be covered by the proposed severity modifier, which more accurately reflects society’s values. Although there is of course overlap between severity and rarity, not all rare conditions are severe and some severe conditions are more common. Of course, the consultation was an opportunity for all stakeholders to express their views on this point. As noted previously, NICE is also consulting on changes, such as a more accepting attitude towards uncertainty in some situations, which should benefit medicines for rare diseases.

Where there is uncertain evidence relating to a medical technology—I appreciate this can be a challenge for rare diseases—NICE and NHSE&I have developed managed access agreements. NICE has already recommended six topics for use subject to a managed access agreement outside of cancer. NHSE&I continues to use its sophisticated commercial capabilities to negotiate deals with industry that enable patients to access the most innovative new medicines and ensure that the NHS gets good value.

Proposed new subsection 1(d) would require NICE to have regard to supporting

“the use of curative therapies involving medicines and medical devices.”

The word “curative” should be used with caution, as there is no standard definition of what might be meant by it. For example, in some cases it may mean a significant amelioration in symptoms, in others that the treatment pathway is different or more tolerable.

While I appreciate that recently launched advanced therapy medicinal products hold great promise by targeting the specific cell or genetic defect, the data on long-term effectiveness is often immature at the time of marketing approval. Further, we need flexibility to respond quickly and effectively to developments in life sciences. We want to avert a situation whereby an effective therapy is not guaranteed funding because it did not meet the legal definition of a “curative therapy”. However, I think that the noble Lord was more trying to get at our support for some of these innovative approaches. Again, this is being looked at in the review of NICE’s methods.

NICE’s working group has explored whether there is a case for changing the approach to discounting, which the noble Lord asked about, in particular the impact on technologies with long-term benefits such as one-time gene therapies. This is a complex area that needs to take into account the policy-level need to support particular types of technologies or circumstances, the limitations of the current criteria for non-reference case discounting, and the effects and any accompanying policy and affordability challenges of any change. This will be covered by the second stage of the NICE methods review. Again, while we would not want to pre-empt that review, all stakeholders are encouraged to respond to it.

Briefly, proposed new subsection (2) would require the Secretary of State to lay a report and impact assessment before both Houses of Parliament, setting out how NICE has implemented its duty under proposed new subsection (1). As I said in Grand Committee, NICE will publish its revised methods and process manual, including its impact assessment, on its website for all to access, including parliamentarians, once the process has been completed. That is the correct forum.

I will briefly address Amendment 46 in the name of the noble Baroness, Lady Finlay, which touches on similar issues—the importance of access to medical technologies, the future medical devices regulatory regime, and the critical nature of medical device safety. I pay tribute to the noble Baroness’s work through her engagement with Ministers and our officials in developing government Amendment 45, which provides greater clarity on the types of activity we would intend to encourage through appropriate regulation. That includes, in respect of medical devices, carrying out research, developing medical devices, or manufacturing and supplying medical devices.

The Government support the agenda for early access to medical devices for NHS patients, as demonstrated through other mechanisms such as the rapid uptake products programme, managed by Accelerated Access Collaborative, and the medtech funding mandate, due to launch in April.

The second stated purpose of the noble Baroness’s amendment—to allow monitoring of the safety and efficacy of medical devices in real-time use—is already achieved by regulations that may be made under Clause 15(1)(i) and (j), so the mechanism to deliver this is already in place. In addition, Clause 18 empowers the Secretary of State to make regulations for the establishment of a medical device information system by NHS Digital, which will support the monitoring of patient outcomes and patient safety.

The noble Baroness also asked about the timeframe for future devices regulation made under the Bill. I assure her we will consult on this issue this year.

I hope the reassurances I have provided, here and during Committee, are of comfort to noble Lords and that the noble Lord, Lord Hunt of Kings Heath, feels able to withdraw his amendment.

[Lord Hunt of Kings Heath (Lab) [V]]

My Lords, I wanted to stimulate a debate on the NICE review and it certainly succeeded, because we had a very high-quality debate. I am very grateful to the Minister for what was a comprehensive and encouraging response, in a number of ways.

I will start with the noble Baroness, Lady Finlay, because she made a powerful speech and argued very convincingly for the speeding up of approval processes, alongside speeding up the introduction to the National Health Service of proven, innovative new medicines and treatments. The noble Baroness, Lady McIntosh, asked about patient safety, but my amendment and, I believe, that of the noble Baroness, Lady Finlay, would do nothing to undermine patient safety. In the first place, the Minister has already tabled an amendment to Clause 1, which we debated on the first day of Report, which gives priority to considerations of patient safety. It is clear from the explanation given for Amendment 46 from the noble Baroness, Lady Finlay, that her proposals for a preliminary licence would allow for monitoring of safety and efficacy in real time. That could be a real bonus indeed.

I thought that the noble Baroness, Lady Masham, asked the fundamental question: why are we so slow to introduce new medicines and devices? Why are we behind so many other developed countries?

The noble Lord, Lord Lansley, gave a very thoughtful contribution. He is absolutely right to argue that we need more support for innovative medicine. The tragedy is this. We have the excellent VPAS agreement whereby, essentially, industry accepts that if the cost of medicines goes above a certain agreed level it will pay a rebate back to the Government, or ideally the National Health Service. If this worked properly the resource going back would be used for innovation, but for reasons that I have never quite understood the money does not seem to go back directly in an identifiable form to the NHS. We have the bizarre situation where, locally, the NHS worries about its drug costs. When it goes above a certain level there is a rebate, but unfortunately that rebate does not seem to find its way back in a tangible, transparent form, to the NHS. We have not created out of the agreement the kind of win-win situation that surely was envisaged when the previous voluntary agreement was first developed.

The noble Lord, Lord Lansley, mentioned one of the big issues: the need for NICE and NHS England to work together. I do not get the impression that they do work together that well, because NHS England regards most innovation as costly and therefore tries to dampen it down. I agree with the noble Lord, Lord Lansley: we need a much better partnership where we build in value for innovation and dealing with inequalities—one where NHS England would actually be on board.

The noble Baroness, Lady Jolly, and my noble friend Lady Thornton talked about this being a big-picture debate. Of course, this is not something that can be solved by an amendment to a medicines Bill, but Parliament ought to debate these important issues and, at the very least, raise some issues that the review should undertake to address.

--- Later in debate ---

[Baroness Jolly (LD) [V]]

My Lords, the amendments in this group relate to reporting requirements and consultation. The noble Lord, Lord Hunt of Kings Heath, has just put the political case very clearly; the noble Lord, Lord Patel, looked at the technical and regulatory issues; I will look at the practical issues around health services on the island of Ireland.

Amendment 69 from the noble Baroness, Lady Thornton, would require the Secretary of State to report on regulatory divergence between Northern Ireland and the rest of the UK. Can the Minister tell us when the first report would be published, whether the Republic would be part of this consultation, and if not, why not? The noble Baroness, Lady Thornton, and I tabled this amendment to require the relevant authority to consult with patients and healthcare and industry stakeholders when preparing a report under Clause 44.

Divergence is inevitable. The situation for healthcare on the island of Ireland could become extremely complicated. In the past, patients have travelled north or south to receive treatment wherever the appropriate treatment is available. Will citizens from Northern Ireland and the Republic have to use the new GHIC, or do the Government have an agreement with the Republic so that business as usual will be the new norm—no change?

Government Amendments 75 to 77 and 79 to 85 extend the reporting requirements under Clause 44 so that they apply to regulations made by a Northern Ireland department and in respect of regulations under Clause 18. However, we cannot ignore the Republic when we talk about health in Ireland.

[Baroness Penn (Con)]

My Lords, we now turn to the way in which reports are prepared and made on the exercise of the regulatory-making powers in the Bill.

Amendment 69 in the name of the noble Baroness, Lady Thornton, would make changes to the existing requirement to report, introduced in Grand Committee. It proposes that an additional report be made by the Secretary of State to Parliament, this time on regulatory divergence with Northern Ireland introduced as a consequence of future regulations. I understand the noble Baroness’s intent. I heard the concerns raised in Grand Committee about the potential impact of regulatory divergence. The Government take that seriously. However, I will explain why this amendment is not necessary to address it.

As a reminder, the amendments made in Grand Committee provided for a reporting obligation on the operation of regulations made by the Secretary of State under Clauses 1(1), 9(1) and 14(1)—one that was both forward- and backward-looking. Those reports must include any concerns raised or proposals for change made by anyone consulted by the Secretary of State in the preparation of the report, and the response to these. It will necessarily draw Parliament’s attention to regulations that have been made.

Parts 1 and 2 of the Bill relating to human and veterinary medicines are matters transferred to Northern Ireland. As such, legislative consent was secured for the Bill earlier in its passage, but as amendments were made during Grand Committee, further legislative consent was sought. At Northern Ireland’s request, government Amendments 75, 76, 79, 80, 81, 82 and 85 in this group replicate the existing reporting obligation for Northern Ireland. This means there will be a report laid in Parliament every two years on what new regulations have been made and any plans to make further related regulations. A separate report will be laid before Northern Ireland. Between our report and the report laid before the Northern Ireland Assembly, any areas of regulatory divergence between the UK and Northern Ireland regulatory regimes will be made clear. Therefore, it would be duplicative to require the Secretary of State to lay additional reports specifically on regulatory divergence for human and veterinary medicines and medical devices.

In addition, where there are concerns about the implementation of the protocol and its impact on patients and animals in Northern Ireland, there are formal channels in place. Officials meet regularly in the Ireland/Northern Ireland Specialised Committee. The Specialised Committee reports to the Withdrawal Agreement Joint Committee and provides advice on decisions to be taken by the Joint Committee under the protocol.

Before the end of the transition period, we raised with the EU through its specialised committee the issue of the falsified medicines directive and regulatory importation requirements for medicines moving from Great Britain to Northern Ireland after 1 January. We agreed with the EU a pragmatic one-year, time-limited approach to implementing these regulations that ensures no disruption to the flow of medicines to Northern Ireland. I say this to reassure noble Lords as to the effectiveness of those mechanisms under the protocol.

Noble Lords made a number of comments on the issue of regulatory divergence and I thought I would dwell on it briefly. The noble Lord, Lord Patel, gave a good description of future provisions regulating devices between Northern Ireland and Great Britain. He is wrong to say that the Bill lays out Northern Ireland separately because of this. It does so because medicines and veterinary medicines in Northern Ireland are the responsibility of the Northern Ireland Assembly and are therefore devolved. However, divergence may be an issue for the future, not least because the EU may change its own regulatory regime under the protocol that Northern Ireland will follow, and the UK may make changes here as well.

To reassure noble Lords, we have agreed a standstill period of two years for medicines and veterinary medicines and two and a half years for devices, during which we will continue to recognise EU regulations in these areas. This means that there is time for adequate consultation on regulations made under this Bill, for consultation on any future changes and for these mechanisms to operate properly. Divergence may be a matter for the future, but we have reporting to Parliament and public consultations on any regulations made under this Bill to address those questions.

The noble Lord, Lord Hunt, asked how we ended up here. I think that question is slightly wider than the purview of this Bill. I have quite a lot of lived experience of how we ended up here and I do not intend to recount that now.

I hope the amendments I have referred to in the name of my noble friend Lord Bethell, coupled with these other, existing arrangements, make the amendment tabled by the noble Baroness unnecessary.

Government Amendments 77, 83 and 84, also in the name of my noble friend, are made in the same light of expanding reporting obligations. In the interests of transparency and scrutiny, amendments have been made to extend the obligation to include regulations made under Clause 18—the regulation-making power in relation to the medical devices information system. We have made this change to make clear our absolute commitment to transparency, to giving Parliament continued visibility, to understanding the assessment made of any proposals or concerns raised as to how the regulations have been working, and to ensure that the regulation-making powers specifically containing provisions that may ensure or affect device safety and post-market surveillance are treated equally.

The noble Baroness, Lady Thornton, again seeks to test us on the preparation of the reports with Amendment 78, which would add a list of stakeholders to be consulted under the obligation. Again, this is unnecessary. If her concern is that the stakeholders listed may be ignored, I reassure her that the reports must summarise concerns raised, or proposals for change made, in relation to regulations enforced during the reporting period. That information will come from engagement with relevant stakeholders. Therefore, I do not think it necessary or proportionate to add a list of specific stakeholders to be consulted for each report, which will be a summary of public consultation that will already have been responded to.

I must say to the noble Baronesses, Lady Jolly and Lady Wheeler, that the Government will not return to this issue at Third Reading, so if they wish to press it, now is the moment. However, with the number of avenues already available, I hope that they are reassured that their amendment is not needed and will not wish to press it.

[Baroness Wheeler (Lab)]

I thank the Minister for her response. I shall not go into details now, but we know that there will be significant issues of regulatory divergence, as the noble Lord, Lord Patel, my noble friend Lord Hunt and the noble Baroness, Lady Jolly, have stressed. We know that it is an issue about which we will have to be very watchful. In the circumstances we currently face, an annual report would have aided the process of working through the issues and encouraged understanding of the plans to address them and the progress being made.

On Amendment 78, the Minister is obviously not going to oblige me with a tidying-up amendment at Third Reading to underline the importance of the patient voice. I think that is a mistake; it would have been helpful. However, I beg leave to withdraw Amendment 69.