Medicines and Medical Devices Bill

Lord Hunt of Kings Heath 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]]

My Lords, I, too, welcome the Government’s amendment establishing the patient safety commissioner. This is highly significant and a great tribute to the noble Baroness, Lady Cumberlege, and her team. I should also declare an interest I must declare an interest as a member of the GMC board.

The noble Baroness’s report, First Do No Harm, is a stark and moving account of how thousands of patients were let down in a serious and life-changing way. I go back to her report because she found that the healthcare system, in which she included the NHS, private providers, regulators, professional bodies, and pharmaceutical and device manufacturers, was disjointed, siloed, unresponsive and defensive. It does not adequately recognise that patients are its raison d’être. Those are telling points, which led the noble Baroness to recommend the appointment of a patient safety commissioner, an independent and proactive public leader with a statutory responsibility to champion the value of listening to patients and promoting users’ perspectives in seeking improvements to patient safety. That is welcome and it will be essential that the person who is appointed is robust, fearless and commands wide respect. Their independence needs to be assured. I hope also that the appointment will be subject to Select Committee scrutiny and I should be glad if the Minister can comment on that.

Picking up on a point that the noble Baroness made, I should also be grateful if I could have a little more explanation about what is meant by relevant bodies, as defined in the schedule. It is clearly important that bodies with responsibilities in relation to patient safety are expected to respond to a report or recommendation made by the commissioner. Can the Minister give a broad indication of the relevant bodies? Also, in relation to the private health sector, my reading is that this is covered by the Bill and that the schedule provides for that. Can the Minister respond?

Overall, however, I commend the Minister on the Government’s response to this significant recommendation by the noble Baroness, Lady Cumberlege.

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

My Lords, these amendments are a testament to the incredibly hard work and perseverance of the noble Baroness, Lady Cumberlege, the Minister and the noble Baroness, Lady Penn. They have all worked hard to get to this point. The report, First Do No Harm, must be a turning point in driving up better outcomes.

I hope that in the response to these proposals it will be helpful to have reassurance that the new post will be adequately resourced, the timeframe for fulfilling the appointment is rapid, and, subsequently, regulatory requirements can be defined and relevant statutory instruments drawn up. The independence of the post-holder is crucial. The person must be able to work across all the different and varied organisations and structures that have responsibility for patients, directly or indirectly. That will require promotion to all organisations that they have a duty to co-operate and collaborate with the commissioner to ensure that early warning signals are picked up and heeded through processes that are light on bureaucracy yet rapidly responsive in order to pick up signals. We cannot have years of accumulation of distressed patients. When things start not to be right, those amber warning lights must start flashing.

I urge the Minister to ensure that the remit of the commissioner is as wide as possible. For example, the coroners’ reports that the noble Baroness, Lady Cumberlege, referred to have not had adequate enforcement by others sometimes. The reports made powerful recommendations but it was found that those responsible for enforcing them have been so slow to act that the proposals have effectively gathered dust.

In previous debates, I raised the need for the yellow card scheme to be updated—opened for easy use by patients themselves, who may wish to report adverse outcomes. The wording of the Bill that I found most helpful and welcome is the part stating that the role

“does not prevent the Commissioner considering individual cases and drawing conclusions about them for the purpose of, or in the context of, considering a general issue”.

Can the Minister make sure that the reporting mechanisms are open to patients and do not hit a hurdle when they try to report to a clinician who does not recognise the full import of they are saying?

To conclude, I reiterate my congratulations to all, particularly the noble Baroness, Lady Cumberlege, and her team, and look forward to the next phase of working with her and others as this important development moves forwards.

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[Lord Lansley (Con) [V]]

My Lords, I am very pleased to follow the noble Baroness, Lady Masham, who rightly emphasises the importance of accessible and understandable legislation in this area. There are two issues. As my noble and learned friend Lord Mackay of Clashfern said, there is the question of the sunset clause and the question of the preparation of consolidated legislation.

On Amendment 2 and a sunset clause, I believe that we should reserve the imposition of sunset clauses for legislation where we anticipate that those powers may not be needed in future. This is not the case with this legislation. With the end of the transition period we require our own domestic legislation for medicines, veterinary medicines and medical devices, so these regulations and these powers will be required.

The points made by the noble Baroness, Lady Thornton, quite legitimately, about the framework—the rather skeletal nature of the Bill as introduced to this House—must be dealt with in other ways, and in the group led by Amendment 4, we have substantive changes which make it a framework rather than simply a skeleton, and give us greater assurance about how the powers are structured in the Bill. I hope that if she reflects on it the noble Baroness will realise that shutting down these powers three years after Royal Assent would be a very taxing imposition. It would probably mean that in less than a year and a half, Ministers would be thinking about the reintroduction of legislation. We would risk the powers in this Bill being shut down in order for a Bill very like it to be introduced in a couple of years’ time. I see no intrinsic purpose in that, so I cannot support Amendment 2.

I do however want to specifically refer to the other issue of consolidation and Amendments 26, 39 and 63, in the name of the noble Lord, Lord Patel. There is a general proposition that people agree that, notwithstanding that additional regulations are going to have to be made in the weeks and months ahead using these powers, they will continue for the time being to be a complex mix of powers. Some will use this legislation, some will be in retained EU law and some will be in existing and other statutes and regulations.

What we want, as my noble and learned friend Lord Mackay of Clashfern quite rightly emphasised, is legislation in this important area that is understandable and accessible. These are not regulations for the benefit of lawyers; they are regulations for the benefit of practitioners, so they need to be very clear. The noble Lord, Lord Kakkar, helpfully and kindly referred to the points I made in Committee about the role of the Law Commission. As I understand it, indeed, I think it is well to remember two things about this. First, Law Commission members are the experts in the process of codification and simplification. Consolidation of legislation is valuable, but it is even better for it to be codified and simplified so that the end result is far more accessible and understandable to practitioners.

So I would very much recommend that we proceed by asking the Government to put the areas of human medicines and medical device regulation, and perhaps veterinary medicine as well, into the work programme of the Law Commission. As I understand it, the 14th programme of work for the Law Commission will be the subject of discussion between the Government and the Law Commission up to the spring of 2022. The work programme of course will happen subsequently. So I do not think any rigid timetable should be imposed. I hope that the noble Lord, Lord Patel, would not insist upon a three-year limit or his amendment for this purpose because I hope that, at the end of this process with the Law Commission, we will end up with something much better that is brought forward as a Law Commission Bill—which can have an expedited process of scrutiny and passage through both Houses. As a former Leader of the House of Commons, and therefore responsible for the Government’s legislative programme, I say that all the evidence tells me that, if a requirement to insert a Bill into the Government’s legislative programme can be avoided, it should be.

We have been there with a Law Commission Bill on the regulation of clinical professions and professions allied to medicine, which is still waiting for legislation, because it included not only codification and simplification but substantive changes to the policy—so I am afraid that it is still waiting. So let us not go down that route; let us do the very sensible thing rightly initiated by the noble Lord, Lord Patel, which is call for consolidation, making sure that it is not about changing policy but about making the legislation work effectively for the benefit of the various practitioners and those who depend on them. And let us work through the Law Commission. I hope that, if the Minister were to tell the House that he and the Government were willing to proceed in that direction, without a timetable in place, the noble Lord, Lord Patel, would not press his amendment when the time comes.

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

My Lords, rather like the noble Lord, Lord Lansley, I see this as a group of amendments in two parts. The argument for consolidated legislation from the noble Lord, Lord Patel, was very ably supported by the noble and learned Lord, Lord Mackay, and I very much support it. For those working in the health service or in industry, trying to wrestle with all the elements of legislation that cover health is very difficult indeed, and the case for consolidating legislation every so often is a very powerful one. I very much hope that the Government will take note of this, bearing in mind of course that there have been strong arguments from NHS England for a further NHS reorganisation Bill, which might be coming within a short space of time. On that issue in particular, the reorganisation of the NHS, the need to consolidate legislation following such a Bill becomes very persuasive indeed.

Where I do not really agree with the noble Lord, Lord Lansley, is on his remarks on Amendment 2 and his suggestion of a sunset clause. He argued that the problem with that is that you shut down the powers and therefore the Government need to produce another Bill, because we obviously need a regulatory regime. Sticking to the three years in my noble friend’s amendment would mean that work would have to start within 18 months. That does not argue against the principle of a sunset clause, although there can be debate about the length of time in which the new Bill needs to be enacted.

The fact is that this Bill conveys a huge number of delegated powers to Ministers. In a pungent analysis, the University of Birmingham points out that, while delegated powers may be needed to ensure responsiveness to the EU transition period and to meet the challenges of technology change, they should not be used indefinitely or relied on to implement matters of policy. This is the problem. If we take this Bill and we do not have some changes in the future, Ministers ever after will be able to ram changes to medicines and medical devices regulation through the House, and the amount of scrutiny in relation to secondary legislation is limited.

The Delegated Powers and Regulatory Reform Committee was very clear in criticising Ministers for failing to provide a sufficient justification for parts of the Bill adopting a skeletal approach. The recent report from the House of Lords Constitution Committee also said that it recognises

“that the existing powers to amend these complex regulatory regimes will cease to have effect on 31 December 2020 and that alternative arrangements are required. If the Government is unable to specify the principles according to which it intends to amend and supplement the existing law, the delegated powers in the Bill should be subject to sunset clauses.”

That surely must be right.

At Second Reading the Minister suggested that sunset clauses would emasculate the Bill, and in Committee he said that a sunset clause

“will not change the very good reasons why delegated powers are necessary.”—[Official Report, 19/10/12; col. GC 327.]

I think we come then to the fundamental argument: that many noble Lords disagree with the extent of delegation that is going to be given to Ministers for all time. The only proper defence against that is to agree to the kind of amendment my noble friend has proposed in relation to a sunset clause. For that reason, I very strongly support her.

[Lord Naseby (Con) [V]]

My Lords, in the past I have had the privilege of working with two pharmaceutical companies, a US pharmaceutical company Upjohn and Reckitt pharmaceuticals. I think that as a country we face a unique opportunity at this point caused by Brexit and a situation where we have a major industry which has all the potential to be a world leader. But this point in time is going to go away unless we act. This is a watershed Bill. It creates an opportunity to enhance the role of the UK Medicines and Healthcare products Regulatory Agency. The industry and all of us should want the UK to be an attractive market for investment in medicines, medical devices and therapies for all our UK patients. It creates an opportunity to make significant improvements in UK clinical research environments and, very importantly, it increases the commercial trial activity to make the UK the number one destination for life sciences supporting UK public health.

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[Lord Naseby (Con) [V]]

My Lords, I disagree with this amendment. I had the privilege of being the Chairman of Ways and Means and Senior Deputy Speaker in the other House from 1992 to 1997—possibly, legislatively, one of the most challenging periods. I certainly found that MPs were highly creative in their interpretation of the rules of debate and in holding the Government to account.

Noble Lords have only to read Erskine May to see that we have two procedures for SIs that are normal and have been with us for decades: the negative procedure, where no amendments can be taken in your Lordships’ House; and the affirmative resolution. The affirmative resolution is not just a weak tool that puts us on the side; it is a very powerful tool if used properly by Members of Parliament and those of your Lordships’ House who take an interest in these matters. They can ensure that the Government of the day have to listen.

Frankly, I find that the super-affirmative procedure does no more, really, than involve an additional stage of scrutiny where Parliament has considered a proposal for a statutory instrument before the statutory instrument is formally presented. Today this procedure is used for statutory instruments that are considered to need a particularly high level of scrutiny. Quite frankly, we have Select Committees, in the other House in particular, dedicated to particular departments, and there is a very active Select Committee on health matters.

In addition, yes, there are some specialised categories of statutory instruments that are used for those particular purposes, and they can be considered under the super-affirmative procedure. But these statutory instruments usually amend or repeal Acts of Parliament. Examples would include legislative reform orders, localism orders, public bodies orders, regulatory reform orders and remedial orders. It is not usual to have them as part of the primary legislative process.

It is time that we as politicians understood that this country will be successful only if we get on and understand the needs of British industry. It has to have some certainty that things are going to proceed at pace, not be delayed even further because some noble Lords feel that they want to have another bite of the cherry. We already had quite enough bites, in my judgment, on this Bill as we worked through it, and it is being done very thoroughly. It has been done in Committee and is being done on Report. But we have to understand that this all adds to delay and, even worse, possible confusion in the commercial world.

I think adequate procedures are already available. All this does is stretch the thing out for very little marginal benefit. I personally will vote against this proposal with enthusiasm.

[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.

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Transparency is, of course, critical to open government and it should be welcomed, but I understand this as being retrospective. Is that right? Is this included in regulations, perhaps, where there will be an important opportunity to debate signal detection to prevent harm, and whether these regulations would be prospective measures? Avoiding harm, rather than actually seeing what has happened in the past, seems much more preferable. Can that be part of this whole exercise of what we will discuss in regulations?

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

My Lords, it is a great pleasure to follow the noble Baroness, Lady Cumberlege. She posed a very tough question to the Minister. I could not help reflecting on her report and the issues around surgical mesh, where we clearly had a situation where for some women the surgical mesh operation was successful and seemed to be effective, but for others it had devastating consequences.

The question of a threshold is surely very important. I doubt very much that the medical device regulation we have is up to dealing with it. It would be good to know from the Minister how the Government will take forward discussions in this area, which of course involves ethical as much as safety considerations. Generally, though, I very much welcome the government amendments. I think that my noble friend’s amendments add to the debate.

I have always wanted the UK to be safe in terms of medicine and medical devices and outcomes, but I also want this country to be attractive to pharmaceutical and medical device companies to research, develop and launch their products in the UK. The UK’s record in the current crisis, in the development of both vaccines and treatments, is second to none. I hope that it will be a huge boost to our future attractiveness. But as I have raised on a number of occasions, one of the big problems we have in this country is the general slowness of the NHS to adopt new medicines and new treatments. If we really are to be attractive and have a favourable climate, we have to get around that. We have to be seen, particularly post Brexit, as not only a place that has fantastic scientists and clinicians, and a very good science base—in fact, a brilliant one—but where the NHS is itself innovative, forward thinking and keen to use new medicines and treatments. That is a huge challenge. It would be good to hear the Minister respond and spell out how he thinks we can make this country safe, but attractive too.

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[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—

[The Deputy Speaker (Lord McNicol of West Kilbride) (Lab)]

We appear to have lost connection with the noble Lord, Lord Hunt. We will give it a few seconds. We have now reconnected but we missed about 30 seconds of his speech; perhaps the noble Lord could take us back about 30 seconds.

[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.

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Moved by

[Lord Hunt of Kings Heath]

13: Clause 2, page 2, line 32, at end insert “, or
(o) the use of tissues or cells (within the meanings given by regulation 5(1) of the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (S.I. 2007/1523)) in relation to human medicines.”Member’s explanatory statement
This amendment would enable regulations under Clause 1(1) to make provision about the use of human tissues or cells in relation to human medicines.

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

My Lords, I am delighted to move my amendment, which follows constructive and very helpful discussions with the Government. I am particularly grateful to the noble Lords, Lord Bethell and Lord Ahmad, the noble Baroness, Lady Penn, and their officials for their help, and to my fellow sponsors, the noble Baronesses, Lady Finlay and Lady Northover, and the noble Lords, Lord Ribeiro and Lord Alton, for the huge support they have given. I should also mention the enormous help I have had from Victoria Ledwidge of the end transplant abuse in China campaign.

The world is increasingly aware of China’s forced organ harvesting from prisoners of conscience. This horrific crime of forcibly removing the organs from living victims—a process leading to inevitable murder— has recently been found by the China Tribunal to be happening extensively.

Millions of Chinese citizens are currently detained in labour camps. UN experts estimate that at least 1 million Uighurs are being held in camps in the region of Xinjiang. Elsewhere throughout China, other ethnic and religious minorities are also being held in labour camps, such as Tibetan Buddhists, Falun Gong practitioners and Christians. This modern-day slavery has been entering the UK supply chain, and there is no doubt that we are currently complicit. I must say that I welcomed the Statement made today by the Foreign Secretary.

Last year, the China Tribunal concluded:

“Forced organ harvesting has been committed for years throughout China on a significant scale and that Falun Gong practitioners have been one – and probably the main – source of organ supply”


and that:

“In regard to the Uyghurs the Tribunal had evidence of medical testing on a scale that could allow them, amongst other uses, to become an ‘organ bank’.”


I hope the Government will seek to put pressure on the World Health Organization to take this seriously.

Domestically, the Bill provides an opportunity to prevent British complicity in such crimes and to send an important message to other countries. My amendment is designed to deal with gaps in current UK human tissue legislation. Currently, the Human Tissue Act does not require appropriate consent for imported human tissue. In addition, imported human tissue for use in medical research does not require traceability. Currently, neither the Human Tissue (Quality and Safety for Human Application) Regulations nor the Human Tissue Act require appropriate consent for imported human tissues for use in medicines. My amendment gives powers to Ministers to put this right. I should explain that the words “tissues” and “cells” are terminology which encompass all the human material that is used for the purposes of medicines. This includes organs.

The amendment would not include the prohibition of the dreadful travelling circus of Real Bodies exhibitions, nor would it include medical equipment manufactured and exported from the UK for the purpose of extracting or preserving human organs if exported to China. The noble Lord, Lord Alton, will come back to that point, and I know he has had some very helpful discussions with the noble Baroness, Lady Penn.

None the less, the passing of my amendment would be a significant action. By giving Ministers the power to make regulations, this is a specific act by the UK in relation to the abhorrent practices in China that I have spoken of. Of course, we need to see those regulations introduced and passed through Parliament. But, internationally, the UK’s action will be seen as a marker and a real signal to other countries.

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

My Lords, this has been a short but incredibly important debate. In addition to the noble Lords that I have already thanked, I pay tribute to the noble Baroness, Lady Jolly, and my noble friend Lord Collins, for their sterling support throughout the passage of this Bill. It is much appreciated.

I stress that this amendment is not the definitive response to the horrific abuse taking place in China. It is enabling legislation, and there is much to do, as the noble Baroness, Lady Finlay, said. We need greater vigilance over exports. Transplant tourism is another area of real concern.

The noble Baroness, Lady Northover, and the noble Lord, Lord Alton, spoke about the HTA and its rather relaxed approach to the “Real Bodies” exhibitions. I find it extremely embarrassing that one of these exhibitions took place in Birmingham, but I am glad that the Commonwealth Games are coming to the city next year and that it has adopted a robust ethical policy which, if extended to the National Exhibition Centre in the future, would ensure that we would not see these exhibitions again.

The noble Lord, Lord Alton, has identified a number of other areas, to which the Minister responded to today, and the noble Lord, Lord Ribeiro, spoke very forcefully about the role of the World Health Organization. Again, I am very glad that the Government and the FCO in particular are talking closely to the WHO about it.

The noble Baroness, Lady Penn, sent a number of very important messages at the end: the revision and toughening up of the HTA’s code of practice and licensing procedures; and she talked about exports of medicines and devices. These are all welcome. However, we cannot be complacent. As my noble friend Lord Collins says, we cannot as a country show any tolerance towards these barbaric acts. This amendment is significant, particularly because it shows that the UK, with the support of government Ministers, is taking it seriously, and I am very grateful to all noble Lords who have helped to make this happen.

Amendment 13 agreed.

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[Lord Clement-Jones (LD) [V]]

My Lords, on 4 November in Grand Committee, the noble Baroness, Lady Thornton, and my noble friend Lady Jolly introduced amendments designed to limit the ambit of the information-gathering powers under Clause 3, which deals with falsified medicines. I raised the subject at Second Reading but was unable to be present for the debate in Grand Committee.

The Minister, the noble Lord, Lord Bethell, said in resisting the amendments:

“We also want to explore creative uses of information as long as they are for public interest purposes. Therefore, we do not want to constrain or limit options ahead of engagement with stakeholders.”


It was not at all clear what the Minister meant by “exploring creative uses of information”, and in fact it was quite concerning given that these have not been set out anywhere in any consultation document. However, he went on to say:

“I should make it very clear that the overarching principles of the Bill as set out in Clause 1 also apply to our powers here. The scope of the purposes mentioned is not unfettered. The appropriate authority must be satisfied that regulations dealing with anything under Clause 3—not just around how the information will be used—will promote the health and safety of the public. In making that assessment, the appropriate authority is required to have regard to the three considerations discussed previously in Committee.”—[Official Report, 4/11/20; col. GC 326.]


Of course, as the result of the very welcome government Amendment 4, the safeguarding of public health is the key objective, and by Amendment 6, Clause 1(3) has been tightened up too. However, having carefully considered these amendments and the Minister’s previous response, I must still question his interpretation of Clause 3 and how it interacts with Clause 1. Clause 3(1)(b) currently says that the regulations may make provision 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.”

At best there is a conflict between the two clauses, and at worst Clause 3 is open-ended and gives the Government far too much discretion in the scope of regulations under Clause 3.

In the discussions we have had with the Minister between Committee and Report—for which I am grateful—it became clearer that we need to ensure that this information regarding falsified medicines is used for limited purposes. The Minister cited a whole range of possible uses for the data, which came as a considerable surprise. As I said earlier, there has been no industry consultation, despite considerable ambition on the department’s behalf. That is why in this amendment we have tied the purpose to “ensuring patient safety”. What possible objection could there be to this limitation? Why would the Government want any wider scope, especially if the Minister believes that Clause 1 already provides a limitation?

I have now seen the brief announcement issued by the department on the consultation on the regulations to be carried out on a new national scheme. It says:

“We are committed to public consultation around the need and details of any national scheme, as well as a specific consultation on the use of data collected as part of any scheme.”


That lacks detail, to say the least.

Many noble Lords have been briefed by the Company Chemists’ Association about the commercial sensitivity of this data. As my noble friend Lady Jolly said in Grand Committee:

“The Department of Health and Social Care already has access to a very wide range of data on the sales of medicines, and their use in the UK, under the Health Service Products (Provision and Disclosure of Information) Regulations 2018. These require manufacturers, wholesalers and pharmacies to provide summaries of products sold and prices paid. Ministers can request more detailed information if required.”—[Official Report, 4/11/20; col. GC 324.]


Given this access and the known sensitivities about falsified medicines directive data, it is unclear why the department has included this sweeping provision in Clause 3(1)(b). I described this as “legislative creep” at Second Reading. It goes well beyond the EU falsified medicines directive of 2011 and the associated delegated regulation of 2016. Of course, this was not acknowledged in the Commons by the Minister, Jo Churchill. As a result of the efforts of several noble Lords, the changes proposed to the FMD provisions are now out in the open—but that does not make it any more acceptable.

This might seem rather a specialised part of the Bill, but clarity about the scope of Clause 3 is vital if we are to have confidence that a suitable scheme for falsified medicines data will be put in place that does not go well beyond the current scheme in terms of the sensitive data that is collected and used. I hope the Minister can do better than last time in giving greater assurance about the ambit of Clause 3 so that I do not need to divide the House. I beg to move.

[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.

--- Later in debate ---

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

I am sorry, I have had a very poor connection tonight. Can you hear me now? All I was going to say was this: we were privileged to have a discussion with the noble Lord, Lord Bethell, and his officials before Christmas. The impression I had was that this is regarded as a useful clause to be used at some point in the future when a clearer purpose has emerged. I do not think that this is the way we should go forward. Like the noble Lord, Lord Clement-Jones, I hope the Minister can give some assurances tonight about how this clause and the information stored will be used.

--- Later in debate ---

[Baroness Masham of Ilton (CB) [V]]

My Lords, I thank the noble Lord, Lord Field of Birkenhead, who moved this amendment so movingly. This debate has gone on for many years.

It has been found by parents that medical cannabis can help some children who have multiple seizures due to epilepsy. I need to know: has NICE approved it? If it is waiting for more research, there will have to be more people using medical cannabis so that the information can be collected. If it is helping, doctors who understand the problems need to be the people who prescribe it. It should be carefully monitored. If it gives better quality of life, why should it not be prescribed? I hope the Minister will do his best to see that it is.

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

My Lords, I am really grateful to the noble Lord, Lord Field, and the noble Baronesses, Lady Meacher and Lady Walmsley, for sponsoring this amendment and for the powerful speeches they have given.

Last week, I heard Hannah Deacon talk on the “Today” programme about her son Alfie and the devastating consequences of Brexit and the impact of the inability to import Bedrocan from Holland. I know the Government have been active, and I very much hope the Minister will be able to report progress tonight.

That is the immediate issue, but of course there is then the long-standing issue that, when Parliament agreed to the legalisation of medical cannabis under prescription, there was a distinct impression that NHS patients would receive medical cannabis where appropriate. It is very clear that the NHS is not prepared to do that. The small number of prescriptions and the approach of the various bodies that advise the health service on commissioning make it abundantly clear that, unless Ministers intervene, patients will simply not be able to get these products in a legal way.

I say to Ministers that, with the campaigns, it is obvious there will be increasing noise, increasing concern. They really will have to step in and find a way of getting access to these products for patients. It is inevitable that it will happen, and it is better than they do this now rather than wait for another three, four or five years. I remind them that, when the legislation went through, the Home Secretary at the time said:

“We have now delivered on our promises … we will work with the NHS to help support specialists in making the right prescribing decisions.”


That simply has not happened.

I suggest four approaches: first, the All-Party Parliamentary Group on Medical Cannabis under Prescription believes that the only way to help families at the moment, and to make sure the policy does not stall completely, is to set up a small fund called something like the medical cannabis access fund, which can be used to help those families, until the blockage on NHS prescription eases.

Secondly, we have to come to the issue of research. I know the Minister is frustrated—he repeated this today—because he thinks the companies producing these products should come forward and undertake clinical trials and tests. I am not an expert, but I have listened very carefully to noble Lords and to advice that I have received, which suggests that randomised control trials are very difficult in this area. In that case, surely the Government should revisit the NHS England report, Barriers to Accessing Cannabis-based Products for Medicinal Use on NHS Prescriptions. The report looked at the issue of research, and said that there should be randomised controlled trials but, alongside this:

“NHS England and NHS Improvement and NIHR in conjunction with the specialist network will work together to determine an appropriate alternative study design that will enable evidence generation for those patients who cannot be enrolled into a standard RCT.”


I gather that this has not happened. The Minister really should inquire into this. It would basically be an observational study; it would allow medical cannabis to be prescribed for large numbers of people and for proper research to be undertaken. I suggest to him that it would be a way forward, so that the current frustration of so many patients is responded to in a sympathetic but also practical way.

[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.