Medicines and Medical Devices Bill

Baroness Jolly Excerpts

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

[Baroness Jolly (LD) [V]]

My Lords, the amendments in this group relate to the introduction of a commissioner for patient safety. We have supported this proposal right from the publication of the review, First Do No Harm.

At Second Reading and in Committee we supported the amendments tabled by the noble Baroness, Lady Cumberlege, to put the patient safety commissioner on a statutory basis, as recommended in the report of the Independent Medicines and Medical Devices Safety Review. I was pleased to add my name to Amendment 65, tabled by the noble Baroness, Lady Cumberlege, that we are debating. Along with all the government amendments, it will enable the progress of the commissioner’s appointment. I join others in congratulating the noble Baroness, Lady Cumberlege, and the Minister, the noble Lord, Lord Bethell, for getting the patient safety commissioner accepted so quickly by the establishment.

The critical issue is to be independent, and to be seen to be independent by example. As the noble Baroness, Lady Finlay, mentioned, both the children’s and the victims’ commissioner have remained independent, and I am sure would be useful allies and candid friends in the world of commissioners—who, as the noble Baroness, Lady Cumberlege, underlined, are not regulators.

I look forward to the time when in every NHS healthcare setting there will be easily accessible information on the role of the patient safety commissioner, and the way to contact them. We welcome the department’s commitment to working at pace, and there are many parliamentarians here today who will be keen to ensure that it does just that.

As the noble Baroness, Lady Cumberlege, said, there is a time pressure to appoint the commissioner. I join the noble Lord, Lord O’Shaughnessy, the noble Baroness, Lady Bennett, and others, in their concern for the pace of the appointment. What body will have oversight of setting up the office of the patient commissioner? I wonder whether the Minister could tell the House when he would expect the office to be up and running—in a year, in two, or more?

[Baroness Thornton (Lab)]

My Lords, I can only join in with the congratulations that everybody has expressed in this debate today. I congratulate of course the noble Baroness, Lady Cumberlege, and support her—as we have from these Benches throughout. I also congratulate and thank the Minister, the noble Baroness, Lady Penn, and also somebody who I do not think has been mentioned but I do remember sitting giving his wisdom in the many discussions we have had, who is of course the noble Earl, Lord Howe. I think the team were very wise indeed to have him sitting with them.

I am not going to say very much because I think we are there with this. Most of the questions that needed to be asked have been asked: on speed, independence, resourcing and powers, and on the issue of “relevant person”, which several noble Lords mentioned. These are the key issues.

One issue that has not been mentioned—here I thank the PSA for its brief—is the need to ensure that there is no reduction in public protection in any other areas of government policy, and that the remit of the role should link closely with the work of the other bodies involved in patient safety.

Finally, I have to say that I agree with the noble and learned Lord, Lord Mackay of Clashfern, that there has to be a four-country element in this. As the role is intended to cover only England, there should be consideration of how the link with equivalent or complementary mechanisms will work in the other countries of the UK. Otherwise, we might find ourselves with a dissonance here, which will not be in patients’ interests.

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As for sunset clauses, I have never been in favour of them in what I would call the creative part of industry. It seems that they usually do not work because the nature of this industry is that some developments take years and years to come to fruition. The market changes. Gosh, we have just had a prime case history in Covid-19, to which the world has responded—and, in particular, our people have responded. But even now, we do not know the answer to all the different phases of it. So I hope my noble friend on the Front Bench will recognise, as I am sure he does, that we have an absolute watershed Bill here, creating a huge opportunity for our country. However, personally I would not put a sunset clause in. I would like to see some work done, particularly to have consultations with industry on which consolidated legislation would really work.

[Baroness Jolly (LD) [V]]

As the noble Lord, Lord Hunt of Kings Heath, and others have said, these amendments relate to sunset provisions and consolidated legislation. As we have already heard, the Bill is largely a skeleton Bill and allows the Secretary of State or a relevant authority to make legislation by statutory instrument on policy issues relating to human medicines, veterinary medicines and medical devices. Can the Minister confirm whether the SIs referred to will come before the House? Will he also confirm that the SIs we see will live up to the expectations of the noble Lord, Lord Blencathra, and his committee?

It is important that there is a limit on how long the delegated powers should last. The amendments in the name of the noble Baroness, Lady Thornton, would mean that, after the suggested three years have elapsed, the policy objectives of the Government would be clearer and they could return with primary legislation. The amendments in the name of the noble Lord, Lord Patel, would require the Government to publish the consolidated primary legislation in draft form. We support these measures but, for the intervening period, we believe that the powers should be subject to the additional scrutiny required by my noble friend Lord Sharkey’s amendments in the next group.

[Lord Bethell (Con)]

My Lords, I thank noble Lords for an extremely powerful session on these amendments. I confess that I completely share the aspiration voiced by many noble Lords about Britain having the best possible legislation on life sciences in the world. As the Life Sciences Minister, that is a natural ambition, but it is also a real possibility, and it is what we are working towards at the department, and through the Bill. But I have severe reservations about whether this approach is the right mechanism, and I would like to address those directly.

The noble Baroness, Lady Thornton, has tabled Amendment 2, which relates to the sunset clause, and with this amendment it would be convenient to speak to Amendments 26, 27, 39, 40 and 63. I will come to Amendment 2 shortly but, first, I cannot say that Amendment 26 is a big surprise. The noble Lord, Lord Patel, who authored it, indicated as much when he and other noble Lords discussed these matters after the excellent debate in Grand Committee. The intent of his amendment is to require the Government to publish draft legislation within three years—legislation that consolidates medicines and medical devices regulation. I understand the arguments made during Committee, and again here today, that the regulation could benefit from clarification and those arguments made on how secondary legislation could be used. The amendments in the name of the noble Baroness, Lady Thornton, go further. They would append a sunset clause after three years—I repeat, three years—requiring not draft legislation but passed legislation.

I start by addressing the timing put forward. The noble Lord, Lord Patel, asks for the Government to publish draft legislation within three years of Royal Assent. I assume that he intends this consolidation effort to include changes made under the delegated powers in the Bill, including policy that may be made to, for example, take forward a national falsified medicines scheme. The noble Baroness’s amendment would have the delegated powers lapse entirely, leaving us without the ability to amend or supplement the regulatory regimes at that point. In reality, three years between Royal Assent and draft legislation ready for publication that consolidates the existing legislation and includes any changes made under the Bill is just not long enough. Each change to the regulatory regimes will take time. Public consultation must be conducted and amending regulations must be laid, debated and so on. We do not intend—in fact, it would not be possible—to front-load policy changes into the first half of 2021, let alone 2021 at all.

Noble Lords have spoken to the importance of consultation. I say it would not just be the Government front-loading legislation; it would be about asking the affected sectors to engage with a lot of consultation very quickly and in parallel. That does not seem the right way to go about it at all. It inevitably means that the sorts of exciting policy changes that support our life sciences sector and protect patients will take an enormous amount of time to stand up. Developing and consulting on policy proposals that require legislative changes takes time, as does the drafting of any proposed legislation. Before getting to the point of drafting the legislation and so on, you need to have made an assessment of what it would be appropriate to consolidate —and that takes time.

The Human Medicines Regulations 2012 were the product of a consolidation exercise that required extensive consultation. Consultations were run while explanatory documents setting out changes so far, and so on, were all prepared before the regulations were made. Let me be clear on the timescale involved in that exercise. A concept paper was issued by the MHRA in 2009. There was an expectation that consolidating human medicines regulations, including looking at the Medicines Act 1968, would take around three years to complete. That concept paper was put out to consultation; a response was published and further consultation took place in 2010.

The first complete draft of the regulations was published in August 2010 and a number of specific consultations also run in that year. A further consultation, following the consultation on the draft regulations of August, was run between October 2011 and January 2012. Three years is the time it takes to do the comprehensive exercise that the noble Lord, Lord Patel, alludes to in his amendment, and that exercise did not involve making up new primary legislation in the first place: it resulted in the Human Medicines Regulations 2012. The noble Lord has extended his amendments to medical devices and veterinary medicines as well.

The noble Lord cannot mean us to start a review the day after this Act is given Royal Assent, with the intention of bringing forward proposals within three years. There would be no legislation made under the Act to assess. I cannot see an exercise of seeing what to consolidate and then preparing the drafting taking less than a year altogether. In fact, it would more likely take much longer if the consolidation is intended to be as far-reaching as the noble Lord and others have very powerfully indicated. Taken together, the noble Lord’s amendments would mean that the process would need to start by 2022, but not all the legislative change to be brought forward under the Bill’s powers would yet be made and in effect.

I anticipate that a consolidation exercise as proposed by the noble Lord would wish to consider the practical effects and operation of such a complex and comprehensive body of legislation. In order to do that, we would need time for the secondary legislation to be made to deliver policy. Industry then has to comply with revised regulatory changes and the MHRA needs to assess how it works. This does not, as the noble Lord may recognise, amount to a realistic exercise. We will not have all the pieces to assess before he asks us to conduct the assessment and also provide an alternative. Change takes time. The standstill period for medical devices, for example, lasts two and a half years, in recognition of this, so while some changes are likely to be made to the regulatory regimes within three years, some will not. When his proposal amounts to no more than a year of operable amending legislation to assess and consolidate—perhaps less—it is therefore impracticable.

This issue is compounded by the noble Baroness’s Amendments 2, 27 and 40, which would introduce a sunset clause to the regulation-making powers in Parts 1, 2 and 3 of the Bill, in effect creating a new cliff edge at the end of three years, after which the existing regulatory regimes cannot be updated. If what the noble Baroness seeks is similar to what the noble Lord, Lord Patel, seeks—an assessment of whether secondary legislation is the right place for the regulatory regimes—I say to her that the means simply do not fit the ends. Introducing a cliff edge in legislation is unhelpful. It forces legislation on to the timescale of a sunset clause. It does not allow for pandemics or for the consideration of new developments that arise and need to be addressed.

The noble Baroness’s amendments would further compress the timescale, stripping out another year. Working back from a sunset clause of three years’ time, we would need Royal Assent of a new Act by then. Let us be generous and provide for a year of parliamentary scrutiny. We began this Bill in February last year; it is January now and we must allow parliamentary drafters to do their job of translating policy intent into clauses. The noble Baroness and the noble Lord have both argued in favour of a very different drafting approach: let us give them, say, a year. While that may seem a long time, I suggest that many noble Lords have experienced the challenges of drafting amendments. There are questions about intent and about the choice of language, and these would apply to tens and possibly hundreds of clauses. Suddenly, that time is not very long at all. That then leaves us with a year from Royal Assent to begin the drafting process—not even the assessment process. All the problems I have already mentioned, including the inability to set up a regime to assess and not only pass legislation but implement that legislation, apply, but much more urgently.

We must also consider the impact on those who are being regulated. The arguments I advanced in Committee on the uncertainty that this would create for businesses, manufacturers and, importantly, patients apply very gravely but would become even more critical. In effect, we would be making regulation in 2021—potentially substantive, bold new regulation to protect patients from harm and ensure the highest standards of safety for medical devices—but we would also be saying that this would be immediately under review, and potentially completely rewritten within three years. The new policy to be delivered by these regulatory changes would not be able to come into force, be implemented and enforced before we would be back here again. I simply cannot think that this is good regulation.

I am sympathetic to the issue of how Parliament assesses our plans. There are, of course, avenues open to Parliament to consider whether it wishes to express a view to the Government on any particular topic. We have Select Committees to scrutinise government policy and we have provided for a reporting requirement in the Bill that gives Parliament the opportunity to reflect on the legislation we have made under the Bill in the first two years and any plans we have at that point to make further changes in response to concerns and proposals raised in relation to it. There are institutions such as the Law Commission that can be called upon to take a view on whether legislation is the right legislation, or too complex. However, if noble Lords want me to say, “In three years, we will have made changes under this Bill that are right to consolidate, and we will be in a position then to review and assess and produce something for Parliament to look at,” I simply cannot give them that assurance; nor can I say anything similar to the noble Baroness.

We need to make changes to the regulatory regimes and follow the full and thorough processes to do so, including public consultation and, most likely, draft affirmative amending regulations. We need to have them working, understood and operable by industry and the regulators. Getting that up and running is where I think we need to direct our resources, before we can think about reviews of how it works. To that end, I hope the noble Baroness understands why I am not able to concede here. I hope she feels able to withdraw her amendment and that the noble Lord will not feel compelled to press his.

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

My Lords, I must say that I very much disagree with the noble Lord’s remarks. If we want certainty, we need legislation that is well grounded and which has had thorough scrutiny in Parliament. The problem with this Bill is that it essentially gives a blank cheque to Ministers to change the regulatory regime for medicines and medical devices. If this was just to deal with the aftermath of Brexit, that, of course, would be understandable. But it was made clear in Committee and at Second Reading that the Government are wedded to this way of doing legislation. As the Minister said in Committee,

“this is a modern and fast-changing industry … we may still need to preserve our ability to amend and update regulations.”—[Official Report, 19/10/20; col. GC 328.]

The noble and learned Lord, Lord Judge, referred to two of our most distinguished Select Committees. We need to return to what our Constitution Committee said:

“This is a skeleton bill containing extensive delegated powers, covering a range of significant policy matters, with few constraints on the extent of the regulatory changes that could be made … The Government has not provided the exceptional justification required for this skeleton approach.”


As the noble and learned Lord, Lord Judge, has said, the Government have form. We are increasingly seeing the use of skeleton Bills and Henry VIII clauses. We really must come to a point where we say to the Government that we will not put up with this any longer.

I listened to the Minister in the last debate: what did he offer the House in respect of further scrutiny? It seemed to me he offered a debate or two, and that was it. The Government do not have an answer; they are refusing to budge on a principle which I believe is fundamentally wrong.

The noble Lord, Lord Naseby, talked with joy about the effectiveness of affirmative statutory instruments. This is nonsense. I think eight SIs have been defeated in your Lordships’ House in history; the last one led the Government to threaten to abolish the House of Lords. Unfortunately, the affirmative procedure is hardly any better than the negative procedure, and they do not allow this House to really exert any change on the orders going through.

We have to stand up on this matter. It is much more important and much wider than the issue of medicines regulation. I very much support the amendment moved so effectively by the noble Lord, Lord Sharkey.

[Baroness Jolly (LD) [V]]

My Lords, these amendments, led by my noble friend Lord Sharkey with eminent cross-party support, replace the affirmative procedure for delegated powers in the Bill with the super-affirmative procedure.

Because of the skeleton nature of the Bill, outlined in the previous group, it is key to ensure that Parliament is able to properly scrutinise regulations made under the Bill. The super-affirmative procedure, which affords a committee of either House the opportunity to comment on a draft of the regulations and make representations, is in our view the best way to do it.

The past year has made clearer than ever the need for outward-facing health policy with public health and safety at its heart. The regulations brought forward under this Bill are central to doing this, and the highest level of scrutiny is needed to ensure their success.

One of the first things I had to learn when joining the House was the sovereignty of the House. My 10 years in your Lordships’ House have taught me to spot Henry VIII powers and call them out. As the noble Baroness, Lady Andrews, said, these amendments are hardly revolutionary, so I urge the Minister to accept them.

We need well-grounded legislation, and this Bill gives the department carte blanche to do what it likes. The amendments tabled by my noble friend give Members of the House the opportunity to scrutinise in a proper way and that, after all, is what the public expect of us.

[Baroness Thornton (Lab)]

The noble Baroness, Lady Jolly, and I are not in a competition about who can speak most briefly, but we have promised the Minister that we will—I overshot my promised three minutes by a minute in an earlier speech.

I say from these Benches that we will support this amendment and we are very pleased to be doing so. I reread the debate and discussion in Grand Committee, and I was actually so impressed with my remarks that I am nearly tempted to read them out again, but I will not do so. I also have to say that the whole debate was very good and important.

As my noble friend Lord Hunt says, this is not just about this Bill; this is about how the Government intend to move forward in terms of legislation and policy and subject themselves to appropriate scrutiny. That is what this amendment is about, in our view, and that is why we will support it.

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[Baroness Jolly (LD) [V]]

My Lords, this has been a fascinating debate. We all want the UK to be a manufacturing centre for pharmaceuticals and valuable medical devices. The amendments in this group relate largely to the overarching objective of regulations made under the Bill.

It was argued in Committee that the Government needed to be clearer about the intent of the regulations and what the guiding principles would be. I am pleased that they have accepted this, and a number of amendments in this group provide that the appropriate authority’s overarching objective in making regulations must be safeguarding public health.

The noble Baroness, Lady Thornton, and I put down an amendment to change “public health” in the government amendment to

“the health and safety of the public”.

That was not an “angels dancing on the head of a pin” moment. Public health could have a very narrow definition in a health and social care context—we think of local government and Public Health England. However, our wording describes the issue that we are discussing. It is much broader than the “public health” definition, which is too narrow. Health and safety should be at the centre of what is used in treatment. The abuse of this was illustrated by the noble Baroness, Lady Cumberlege, who gave us perfect examples in her report. Mesh is technically a device and sodium valproate was the medicine. They were both abused, and their use was inappropriate. They hurt and damaged a lot of people, predominantly women, for a very long time—some people, for ever.

Now we have a workable framework in which to put both medicines and medical devices in the context of the health of the public, and that is extremely welcome.

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There is also an environmental problem of contamination of the river courses by industrial waste, leachate, pesticides and fertilisers, which can cause fish to die. Contamination of fresh water by rats’ urine poses an environmental public health risk as it causes Weil’s disease, also known as leptospirosis, which can be fatal. Rats and mice can also contaminate food. Increased asthma and respiratory disease due to poor air quality is another environmental problem. There should be an effective, well-funded public health system, which works in conjunction with the environment and agricultural organisations. Prevention of disease and the safety of the environment are of extreme importance.

[Baroness Jolly (LD) [V]]

My Lords, this amendment would require the appropriate authority to have regard to the protection of the environment when making regulations about human medicines. We have left the EU and need to be sure that our replacement regulations are fit for purpose. Many of us have spent a lot of time checking that these replacements are in such a fit state; but, while the health and safety of patients remain paramount, it is reasonable and, indeed, important, given the climate crisis, to consider the environmental implications of any policy stemming from these regulations.

The manufacture of human and veterinary medicines, and medical devices, does not happen in an environmental vacuum. Manufacturers have a duty to protect their environment—and manufacturers of medicines will need to be open about how they deal with chemical and other waste. I live in Cornwall where oestrogen has found its way into local rivers, ecosystems and oysters. Wastewater from pharmaceutical manufacturers could also find its way into local waterways. Will the Minister outline how this is dealt with by regulators, and how it is covered by the Bill?

Much waste from pharmaceutical plants is toxic and dealt with appropriately by manufacturers but, in a Brexit world, the regulation regime will have different regulations from the very strict ones that applied when we had to follow EU regulations. We can buy our medicines and medical devices from all over the world; we know that not everyone has the same high environmental standards governing manufacture that we have. What criteria are appropriate in the commissioning and purchasing of medicines from the rest of the world? Can the Minister please outline for us the nature of discussions with regulators about these issues?

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

My Lords, this debate follows a very interesting one in Committee, in which the noble Baroness, Lady Bennett, posed some searching questions about the potential for designing new drugs that are less harmful for the environment, whether in their composition, their impact when they escape into the environment, or in their packaging. Today, she also argues that the expectation of this approach should be built into legislation.

In Committee, the noble Baroness gave some very interesting examples. I was particularly interested to hear that in Sweden—

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[Lord Crisp (CB) [V]]

My Lords, I am very pleased to add my name to the amendment in the name of the noble Baroness, Lady Sheehan. I shall be brief and limit myself to one central point, because the arguments have been put so well by noble Lords who have already spoken. At its heart, this amendment is about achieving the right balance between the public interest and private interests. In this particular context, it is clear to me that the Government should commit themselves clearly to safeguarding the public interest and to taking action on—let me stress this—those rare occasions when it will be necessary.

This is particularly vital, as other noble Lords have said today and on earlier occasions, because, sadly, there is a history of price gouging and exploitation of the public. There has also been lack of transparency and, of course, one should also note that the development of many treatments and vaccines have benefitted from public investment. I hope the Minister will be able to make the commitments that the noble Baroness, Lady Sheehan, has requested.

[Baroness Jolly (LD) [V]]

My Lords, the purpose of this amendment, tabled by my noble friend Lady Sheehan, with cross-party support, is to ensure that fair and affordable access to medicines for all must be a consideration when regulations are made with respect to human medicines. This is key for two reasons. The first is to ensure that medicines, including on the NHS, are available at a fair price. We know that the NHS buys medicines at an industrial scale and is very able to be tough in its bargaining to get a good deal for the taxpayer. The second is that the British Government used to play a pivotal role, through DfID, in helping many across the world in the eradication of polio and other life-changing or life-threatening diseases. Will the Minister outline what criteria are used now that DfID has been subsumed by FCDO?

On Covid-19, collaboration on the production of vaccines is critical. What is being done by the Government to collaborate in this life-saving mission? Time is of the essence. Can the Minister tell us where we are now and outline what support is going to those who have neither the contacts nor the money to fund these vaccinations? Our economy has taken a serious hit, but we have a moral duty to support those with no industry, and so no income. I endorse all the comments from the noble Lord, Lord Crisp, who has many years’ experience of these issues—many more than I have. I would be grateful if the Minister could answer my questions.

[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.

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[Baroness Jolly (LD) [V]]

My Lords, this has been a detailed, depressing debate and I feel completely powerless. I pay tribute to the noble Lord, Lord Hunt of Kings Heath, for his phenomenal tenacity on this and to the noble Lord, Lord Alton, for his tireless work. I am sure others do just as much and I do not know about it.

Amendment 13, led by the noble Lord, Lord Hunt, and signed by my noble friend Lady Northover and the Minister, would enable regulations under Clause 1(1) to make provision about the use of human tissues or cells in relation to human medicines. The amendment pushes the Government to respond to the horrifying practice of forced organ harvesting that evidence suggests is taking place in China. The account of organ banks by the noble Baroness, Lady Finlay of Llandaff, was chilling. Liberal Democrats, among others, have been vocal about the appalling human rights violations faced by the Uighurs. The amendment would be an important step in the right direction, and we urge the Government to do all they can to put an end to this practice.

It is most unusual for a Minister on a Bill to be included as a signatory to an amendment. It should send a real signal that our Government do not support this appalling treatment of minorities, and I commend him on this stance. I would be grateful if the Minister, in summing up, could tell us whether there is anything we could practically do on this matter.

[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.

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[Baroness Jolly (LD) [V]]

My Lords, this amendment, led by my noble friend Lord Clement-Jones, would narrow the use of data in relation to falsified medicines to that which ensures patient safety. The use of patient data is a really delicate issue. As currently drafted, Clause 3 allows for regulations to be made about

“the use, retention and disclosure, for any purpose to do with human medicines, of information collected for the purpose of preventing the supply of falsified human medicines.”

The Minister has said that we want to explore creative uses of information. I am not quite sure what the general public would think of that statement. I am not quite sure what I think of that statement. As my noble friend Lord Clement-Jones has said, this is an incredibly wide remit granted to the Government. Restricting it to information that ensures patient safety, as in the amendment, will help protect patients’ information. In his summing up I would like the Minister to outline how this amendment will work in practice, and we will consider whether this might be brought back at Third Reading.

[Baroness Thornton (Lab)]

I am grateful to the noble Lord, Lord Clement-Jones, for his full and comprehensive explanation of the background thinking behind this amendment. It is clearly important that we understand and have clarity about the scope of Clause 3, and it is that clarity we seek from the Minister this evening. As my noble friend Lord Hunt said, we are urging the Minister to respond about how Clause 3 might be used. It is not good practice when you are law-making to put something in a Bill that might just come in useful at some point. The House probably needs a wider explanation and reassurance about this clause and how it will be used.

--- Later in debate ---

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

My Lords, we started this debate today with widespread plaudits to the Government for listening to very strong campaigns to have a patient safety commissioner. Indeed, the noble Baroness, Lady Cumberlege, who has been so instrumental in this, commented on the importance of that person listening to patients. We have to draw the parallels here because we have heard—as a community, as a society, and as a Parliament—from the parents of children who desperately need these medicines but are unable to access them. Those patients are not being listened to. We really do have to ask ourselves the question of why that is happening and what kind of political block or ideological barrier exists so that we are not seeing action in this area when it is so clearly, urgently needed.

When we were talking about a patient safety commissioner, I commented on how effective campaigning has been in that area. There is also a very effective campaign called End Our Pain, which has been working with families trying to access this medicine. It has been doing a great job, but the Government have not been doing their job in delivering on the campaign. I give credit to the noble Lord, Lord Field of Birkenhead, and all the other people who have signed this amendment, which is very much cross-party and across the House. As the noble Lord said, we have a division here—a human rights issue, referred to in the amendment tabled earlier by the noble Baroness, Lady Sheehan. People, or families, who can afford it, are able to access this medicine; those who need NHS support for it cannot. We should not be tolerating that situation in Britain at any time, particularly in 2021.

I have a direct question for the Minister. I have been looking at what assessment the Government might have made of the impact of current policies and the lack of financial support for vulnerable families. I should be happy to be corrected and perhaps told that an assessment is under way, but the most recent information that I was able to find was from September last year, when Liz Saville Roberts MP asked a Written Question in the other place about whether such an assessment had been made—and the answer was no. I will be brief, because the issues have been well set out by the noble Lord, Lord Field, and others. However, I ask the Government what assessment they have made of the impact of their current policies.

[Baroness Jolly (LD) [V]]

My Lords, today’s final amendment, tabled by the noble Lord, Lord Field of Birkenhead, and signed by my noble friend Lady Walmsley and the noble Baroness, Lady Meacher—all long-term campaigners on this issue—would require regulations to be introduced to allow doctors to prescribe medicinal cannabis products. I know that the movers of the amendment have been campaigning for ever—probably as long as I have been in the House—and can be excused their despair at the inactivity of GP prescribers.

The Home Office changed the status of medicinal cannabis two years ago, after a long campaign, but it has not been widely prescribed. The need for clarity on this matter was brought to the forefront by the news that nine year-old Alfie Dingley, whose use of medicinal cannabis has greatly improved his health, is no longer able to access his medication from the Netherlands due to Brexit. The Lib Dems have long been advocates of making medical cannabis accessible to those whose health would greatly benefit from it, and we support this amendment.

Will the Minister tell us what she can do to persuade the medical profession that cannabis has real medicinal value? Why are doctors deaf to children such as Alfie, and why are children such as Alfie and his parents left in the lurch? I hope that the Minister will be able to accept the invitation from the noble Baroness, Lady Meacher, to join her in a meeting with Dr June Raine, the chief executive officer of the MHRA.

[Baroness Thornton (Lab)]

The noble Lord, Lord Field, will know from this afternoon’s Question that I have huge sympathy on this issue, and I also completely recognise the frustration that exists around this subject. As I said earlier, “Come on, Prime Minister: if you can solve Brexit, in your own terms, I am sure that you will be able to solve this one, too.”

“Irresponsible” is not a word I would use to describe the noble Lord, Lord Field. He was very temperate in his introduction of the amendment. It is shameful, as the noble Baroness, Lady Meacher, said, that only three prescriptions have been issued properly by the NHS for free use. That means there is something is seriously wrong here. I thank my noble friend Lord Hunt, who is quite correct: this does require political muscle. The noble Baroness, Lady Bennett, is quite right, because this issue also completely exposes the inequalities we see in our society, whereby people who are fortunate enough to be able to afford to buy cannabis products can do so, while those who cannot, cannot, and then they suffer the consequences of that—literally. The noble Baroness, Lady Jolly, mentioned despair, and I agree with her.

So I do think that, as a result of this short but very potent debate, the Minister needs to commit at least to the meeting with the MHRA and the movers of the amendment.