Medicines and Medical Devices Bill

Lord Hunt of Kings Heath Excerpts

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

[Lord Mackay of Clashfern (Con) [V]]

My Lords, I join my noble friend Lady McIntosh of Pickering in apologising for having my name to amendments here while I have found myself in proceedings on another Bill which was fairly encompassing in the sense that it required a good deal of attention to understand what was going on. We were not able to achieve the result that the noble Baroness, Lady Finlay, managed of being in both places at once. However, I am glad to be here on this occasion and I am particularly interested in Amendment 117, which we may reach later.

In this group, I particularly support Amendment 127, which the noble Lord, Lord Patel, has carefully referred to already. I generally support all that has been said by others before me on this group of amendments, especially the reference of the noble Lord, Lord Sharkey, to the need to keep in mind the medical charities. I think particularly of Cancer Research, but it applies equally, as he said, to all of them.

I wondered whether the government amendment made unnecessary some of our amendments, but I really wonder about that, because a public consultation is not specifically targeted, and I think the groups that we have represented—particularly in relation to Amendment 127—require to be consulted more directly. I do not know how your Lordships feel about consultations, but I often find that I did not know that there was a consultation at all until the time allowed for it was well passed. That is no doubt due to my lack of efficiency, but I suspect that a lot of patients will not know that a public consultation is happening unless it is drawn specifically to their attention. It is important that the consultation, public as it is, has direction as well. Therefore, I think that Amendment 127 and the other specific amendments are well worth considering in relation to the new government amendment.

I am also extremely anxious that the devolved Administrations should be properly consulted. Of course, devolution and independence are different things, and we are talking about devolved institutions at present. This group of amendments is important, and I agree with most of what has been said about them. Therefore, I do not need to say any more on this occasion.

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

My Lords, it is a great pleasure to follow the noble and learned Lord. I have added my name to that of my noble friend Lady Thornton to Amendment 128, which was introduced by my noble friend Lady Wheeler. This regards the organisations to be consulted—other noble Lords have already referred to this—and concerns the provisions of Clause 41 for consultation on Parts 1, 2 and 3 of the Bill. As noble Lords have said, at the moment, it is entirely up to the Secretary of State who is consulted, other than the clarification the Government have brought in relation to the devolved Administrations.

The context of this amendment is the extensive power given to Ministers under the Bill. We have debated this before, but it is worth reminding the Committee that the Delegated Powers Committee in its report on the Bill was highly critical of Ministers for failing to provide sufficient justification for parts of the Bill adopting a skeletal approach. As the committee said, the Bill gives Ministers wide powers to almost completely rewrite the existing regulatory regime for medicines and medical devices.

It is also worth reminding the Committee that the Constitution Committee described the Bill as

“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 using the powers.”

It went on to say:

“The Government has not provided the exceptional justification required for this skeleton approach.”


The case for a sunset clause is readily apparent, but in its absence, the way in which consultations are done assumes more importance than normal. It is very surprising that the duty to consult is open-ended and simply leaves it to Ministers to decide who to consult. The Minister may say that he does not like lists of organisations to be consulted, but legislation is littered with lists of organisations because it is important to reflect the range of bodies that ought to be consulted. Discretion is always given to Ministers to add to those lists of organisations.

I hope that the Minister will be prepared to take this back because in the end, certainly in the absence of a sunset clause, we have to beef up the provisions on consultation.

[Baroness McIntosh of Pickering (Con) [V]]

My Lords, I support in particular Amendments 105 and 127 in this group, but I shall speak briefly to Amendment 105 and thank the noble Baroness, Lady Wheeler, for introducing this short debate on it. In the context of the proposal for a requirement to consult the devolved Assemblies, I share the concern expressed by my noble and learned friend Lord Mackay of Clashfern: it is essential that we keep all the devolved Assemblies in tune with Westminster thinking as the Bill and the regulations under it progress.

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[The Deputy Chairman of Committees (Baroness Fookes) (Con)]

I have received a request to speak after the Minister from the noble Lord, Lord Hunt of Kings Heath. I am not clear whether the noble Lord, Lord Patel, also wishes to do so. Perhaps that could be clarified.

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

I thank the Minister for his extensive response. Essentially, he has relied on the well-known departmental argument that, by listing certain categories of organisation, you exclude others. However, legislation that has been passed in the last few years has often contained extensive lists of organisations to be consulted. Amendment 128, which I support, would give Ministers the power to consult any other persons that the authority considered appropriate. I wonder whether the Minister will just answer this. He would surely accept that this Bill is highly unusual in giving a huge amount of powers to Ministers essentially to change primary legislation through regulation and extensively to alter the regulatory framework for medicines and medical devices. Given that, we should be careful about similarly open-ended regulations on consultation. The amendment would provide reassurance to the key sectors that they will be consulted, but it would also give discretionary power to Ministers to add to that on the occasions when greater flexibility was needed.

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

My Lords, it is a great pleasure to follow the noble Lord, Lord Patel. No doubt we will have further debates about the role of politics in the National Health Service. I would just say to him that I think the failure of NHS England is, in many ways, an example of how we end up with a quango that seems unaccountable to Parliament but Ministers wash their hands of many of the decisions that they make. The problem is that you can end up with the worst of all worlds.

That perhaps reflects some of the issues relating to patient safety because, thanks to the Minister, we all enjoyed meeting the person responsible for patient safety in NHS England. The problem is that NHS England has many other responsibilities, including financial and target responsibilities. Patient safety does not really seem to be that body’s top concern.

This seems to be the very point that the noble Baroness, Lady Cumberlege, makes. Her report’s conclusion is really rather shocking in many ways. She made a general conclusion from the three areas that she investigated. She said that the healthcare system

“is disjointed, siloed, unresponsive and defensive. It does not adequately recognise that patients are its raison d’etre. It has failed to listen to their concerns and when, belatedly, it has decided to act it has too often moved glacially.”

That is a devastating critique, particularly in relation to patient safety.

I forgot to declare an interest as a member of the GMC board, but I must make it clear that I am not speaking on behalf of the GMC.

The noble Baroness’s recommendation of a patient safety commission is so powerful because she proposes that somebody sits outside the current system, accountable to Parliament and not to Ministers or the devolved NHS management system. She argues for the commissioner to have the necessary authority and standing to talk about, report on, influence and cajole where necessary without fear or favour on matters related to patient safety.

In pointing to the Children’s Commissioner, the noble Baroness, Lady Cumberlege, has really put her finger on it. This gives us an idea of the sort of person we need—someone who, like the Children’s Commissioner, challenges the positions of Governments, schools, unions and local authorities. As the noble Baroness said, I am certain that it was the Children’s Commissioner’s comments that led to the reopening of schools. I do not believe that somebody in a government department or a quango could have done that. She did it because, personally, she is a very admirable person, but structurally, because she is wholly independent.

The noble Baroness made some very telling points when she anticipated a potential criticism of her report. The core of it is that many organisations already have some responsibility for patient safety in their remit. That is true, and they all do good work, but she is right because none of them really has patient safety as a systematic approach to the NHS as their sole remit. Until we have some independent agency or person with patient safety as their sole remit, I am afraid that I do not think that we will make progress. We must accept that, if patient safety is one of many objectives of an organisation, compromises inevitably have to be made.

There is a tension between funding, throughput, targets and patient safety—not always, but sometimes. Here, I turn back to my experience as a foundation trust chair. The trust boards hold a huge amount of tension within them. Of course they are concerned with patient safety and quality, but they are also under the cosh from NHS England and the regulator, NHS Improvement, for their overall performance, whether financial or in throughput. I certainly accept the argument that many of the best organisations where everything runs well include patient safety, but to deny that there is a tension between these other objectives and patient safety is disingenuous.

That is why we look forward to the Minister making a strong statement. If he simply says that this is outside the Bill’s scope, as we have been told consistently, it will not cut the mustard, because we could easily start expanding and extending the Bill as we get other legislation and when the Government finally respond to the report of the noble Baroness, Lady Cumberlege. In my view, the Bill will not leave this House unamended unless the Government can make it clear that they are determined to implement the noble Baroness’s central recommendation.

[The Deputy Chairman of Committees (Baroness Fookes) (Con)]

My Lords, I suggest that the Committee adjourn for 15 minutes.

Department of Health and Social Care: Unpaid Advisers

Lord Hunt of Kings Heath Excerpts

Tuesday 17th November 2020 Lords Chamber

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

My Lords, yesterday former Conservative Attorney-General Dominic Grieve described the Johnson Government as presiding over

“the disappearance of any standards of conduct at the heart of government”,

and said that the cronyism of administrative decisions had communicated to young people in particular a sense of government as corrupt. Given that, can the Minister be surprised that there was concern over the conduct of Mr Pascoe-Watson after he had ceased to be an adviser?

[Lord Bethell (Con)]

I always take the words and advice of former Attorney-General Dominic Grieve extremely seriously, and I value his opinion greatly.

Covid-19 Update

Lord Hunt of Kings Heath Excerpts

Thursday 12th November 2020 Lords Chamber

[Lord Bethell (Con)]

My noble friend is right that the advice to business is extremely important, and we are ambitious to try to unlock the economy to enable people to return to as normal a life as they possibly can and to prepare the country for Christmas. However, it is too early to tell exactly what the state of the pandemic will be on 2 December. There is a review of the tiering system, and we will learn the lessons of the last round. The Prime Minister has made it very clear that he is committed to returning to a regional tiering system, but the exact dimensions and specifications of that system are under review, and communication to business of how, and to which regions, it will apply will be forthcoming once the analysis of the contagion has been completed.

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

I declare my interest as a member of the GMC board. I return to the Statement made by the Secretary of State, in which he said, referring to NHS staff:

“The deployment of the vaccine will involve working long days and weekends, and that comes on top of all the NHS has already done”.—[Official Report, Commons, 10/11/20; cols. 746.]


The noble Lord will be aware that the GMC granted temporary registration to around 27,000 doctors in order to help out with the pandemic crisis. My question is: has the department considered using these doctors, not many of whom have actually been used by the NHS so far, for the vaccine programme? Will he look into that?

[Lord Bethell (Con)]

My Lords, the noble Lord raises a very good point. We pay tribute to all those who stepped forward, whether they were young doctors at the end of their training or older doctors who were returning to the profession. It was a really important and touching moment when those doctors stepped forward. He is right that not all of them were needed or used during the pandemic. My understanding, from the deployment team, is that they are looking at all avenues to have the largest army of people possible in order to use the vaccine. I am not exactly sure of the exact status of the 27,000 doctors he alluded to, but I would be glad to write to him with details.

Medicines and Medical Devices Bill

Lord Hunt of Kings Heath Excerpts

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

[Baroness Thornton (Lab)]

My Lords, I said at Second Reading that we on these Benches are supportive of the extension of prescribing rights to additional health- care professionals, including radiographers, dietitians, orthoptists and speech and language therapists. It is time that this issue was resolved and that is our intention in tabling this amendment. The new clause would require the Secretary of State to publish proposals and a timetable for additional healthcare professionals to be given appropriately restricted prescribing rights. I thank my noble friends Lord Bradley and Lord Hunt, and the noble Lord, Lord Ramsbotham, for their support and I look forward to hearing their remarks.

The background to this issue is that, in February 2020, in response to a Parliamentary Question tabled by my honourable friend Geraint Davies MP, the Government said:

“Subject to Parliamentary approval, the Medicines and Medical Devices Bill currently before Parliament will give the Government powers to extend prescribing responsibilities to new professional groups where it is safe and appropriate to do so.”


We support that extension and our proposed amendment to the Bill will expedite that, resulting in better outcomes for patients and the system as we face a surge in demand on health services both now and in the future due to the Covid-19 pandemic.

The extension will build on the groundwork already undertaken by the NHS England scoping exercise over the past few years on extending prescribing rights to members and professionals. Extending prescribing rights would help to deliver better support and more timely care for patients. It would improve patient safety, as allied health professionals with appropriate expertise would be able to make decisions rather than relying on junior clinicians signing off clinical management plans. It would decrease the number of patient group directions needed, thus reducing the time spent on development, use and training, and it would bring prescribing expertise closer to the patient. It would reduce the pressure on other stretched professionals, including GPs, and it would improve system efficiency by reducing the duplication of work among health professionals, with a potential result of significant time and resource savings. The extension of prescribing rights to these professionals and others would make a significant and positive difference to those professionals and to the ability of the wider health system to respond as swiftly and efficiently as possible to the post-Covid-19 surge in demand on health services, including the rehabilitation and recovery of post-Covid-19 patients.

It is important to recognise the impact of Covid-19 and how it has emphasised the urgency of taking action. When we discussed these issues before the Bill came before the House, representatives expressed their frustration at how long it seemed to be taking to get approvals to work their way through the system. Given that we have managed to shortcut various systems because it has been necessary to do so with Covid-19, it seems that this is one that presents itself and needs a positive response. It will benefit the NHS, patients and expert health groups. I beg to move.

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

My Lords, I support my noble friend’s amendment and the potential for increasing prescribing responsibilities. The noble Baroness, Lady Cumberlege, was a huge champion of prescribing rights for nurses. I was able to extend that to community pharmacists and I want to see us now build on that by extending it to other professions in healthcare. Dietitians, occupational health therapists, orthoptists, radiographers and speech and language therapists all have a hugely important role to play and giving them prescribing responsibilities would help to deliver safer, better and timelier patient care.

We have seen already how dietitians have hugely expanded their role in the treatment of diabetes, gastroenterology, bariatrics, metabolic conditions and oncology. Orthoptics has seen its roles expand in stroke management and neuro-rehabilitation and neuro-ophthalmology, in particular among children with SEN and for paediatric ophthalmology. Diagnostic radiographers are increasingly performing routine interventional procedures under imaging control, while speech and language therapist roles have developed in respiratory care, ear, nose and throat services, critical care and end-of-life care. Occupational therapists have increased their advanced practitioner roles and are demonstrating a hugely beneficial impact across all areas of the NHS.

There is a problem. It has been reported that the current ability of these professions to administer medicines to support patients through patient group directions and/or patient-specific directions is apparently becoming increasingly difficult. They are either taking longer to secure or they are being more restrictive, to the detriment of patient care and safety. I ask the Minister why this is. I refer to his interesting comment on Second Reading, when he said:

“NHS England and NHS Improvement are considering across all non-medical groups, influenced by learning from the Covid-19 pandemic, where there is a need to consider undertaking formal consultation on potential amendments to prescribing responsibilities for several professional groups.”—[Official Report, 2/9/20; col. 432.]


This is very welcome—and, of course, implied in that statement is a recognition that during the past six months we have had to rely on professional and other staff adding to their responsibilities and going beyond the extra mile. By extending prescribing rights, we would be recognising that fact and recognising that many of our professionals can do more, if they are given the ability to do it.

Provided that this happens within safe bounds—and so far, prescribing for non-medics seems to have worked very successfully—we have a total win-win situation, in which patients will benefit and the professional development and satisfaction of many of our staff groups will increase. I believe that my noble friend’s intention is to give the Minister all support for charging on with the extension of prescribing rights, and I hope that she will embrace that support and get a move on.

[Lord Ramsbotham (CB) [V]]

My Lords, I must declare two interests in explaining why I have put my name to the amendment—first, as co-chair of the All-Party Parliamentary Group on Speech and Language Difficulties, and secondly, as an honorary fellow of the Royal College of Speech and Language Therapists. As always, it is a great pleasure to follow the noble Baroness, Lady Thornton, and the noble Lord, Lord Hunt, both of whom know a great deal more about this subject than I do.

As I reported on Second Reading, on 12 August the Minister in the other place wrote that the Bill would allow the Government to update those professional organisations that can prescribe medicines when it was safe and appropriate to do so. This is in line with what the Minister said on Second Reading, which was quoted by the noble Lord, Lord Hunt. If the experience of dieticians, orthoptists, diagnostic radiographers and speech and language therapists is anything to go by, the role of such people has expanded considerably during the pandemic, during which there has been ever-increasing pressure on health professionals.

Prescribing responsibilities would enable allied professions to share the burden with their NHS colleagues and avoid unnecessary delay and duplication for patients. Their call for increased prescribing responsibilities is backed up by hard-pressed NHS trusts, which have identified a means of increasing their capacity. Therefore I hope that, on the basis of experience during the pandemic, the Minister will be able to announce proposals and a timetable for extending prescribing rights for certain carefully chosen health professional organisations within three months of the Bill being passed, as part of the NHS long-term improvement plan.

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[Lord Lansley (Con)]

My Lords, I am grateful to the noble Baroness, Lady Finlay of Llandaff, for tabling and moving this amendment for a number of reasons, the first of which is that it allows me to express my appreciation to the noble Lord, Lord Patel, for moving Amendment 28, in his name and mine, last week on the innovative medicines fund and to say how much I welcomed the debate on it, which I have read, and the Minister’s response.

I am also grateful to my noble friend the Minister for his subsequent letter about the innovative medicines fund. There is of course a direct parallel in that Amendment 91A would look for the innovative medical devices fund to be funded in a similar way. I just gently dispute one proposition with my noble friend: he said that the use of the rebate on the voluntary pharmaceuticals access scheme would not be appropriate for the innovative medicines fund because the amounts could vary sharply from one year to the next. This would be a problem only if there were a direct hypothecation for the amount, and that is not necessarily implied. The amount of the innovative medicines fund could be established as a fixed amount that would then be funded by the rebate or, in the absence of a rebate, by the Exchequer or though NHS England’s total budget. It would not necessarily rise or fall with the rebate. The same would of course be true for the innovative medical devices fund.

There is a central proposition that supports both an innovative medicines fund and a medical devices fund; it is not that we in the United Kingdom lack innovation, it is that we lack the adoption of innovation in the National Health Service. That was the starting point for the Cancer Drugs Fund, on which this proposition is based. The Cancer Drugs Fund arose, in policy terms, from an analysis by Professor Mike Richards, who was then the cancer tsar under the last Labour Government, that there was a significant lack of availability of the latest cancer medicines for cancer patients, compared with other, principally European, countries. At the time that was not true for some other disease groups and medicine available for other diseases. It was a problem particular to cancer.

Why does this happen? It is not simply about funding; there is a systematic issue here, separate from the amount of resource, which is that the United Kingdom has a single-payer system. A single-payer system necessarily makes decisions about the availability of medicines on the basis of the whole system moving together. I suspect the same is true for devices. Pretty much all of the other European systems are not single-payer systems, but insurance-based systems, where, essentially, clinicians advise, patients choose and insurers pay. That brings innovations into use much more rapidly. There is potentially a problem with the diffusion of innovation in the NHS, which we have seen before and we have to continually guard against.

I put this question to the Minister for when he responds to this debate: are patients in the NHS getting access to new, effective medical devices as quickly as patients in other countries? I do not know the answer to that. I am absolutely clear that there was a good case for the Cancer Drugs Fund. I am clear that there is a continuing need for the innovative medicines fund, because there is sometimes a continuing gap between the availability of the most effective new medicines here and in other countries. I do not know about devices.

To this extent I offer an apology to the noble Baroness, Lady Finlay of Llandaff, because a medical devices fund might be premature, in the sense that we do not know to what extent there is a gap in the adoption or diffusion of innovation where medical devices are concerned. We identified real potential in the previous debate on Amendment 85 about the funding mandate for medical devices. If that is rolled out, as I think is the intention, and extended to a faster and larger pipeline of medical devices going through the NICE evaluation process, then we may find there is not too much of a problem. There may well be a case for understanding to what extent medical devices are being adopted by the NHS, relative to other health economies. I hope the Minister will agree that is worth looking at.

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

My Lords, it is a great pleasure to speak to the amendment tabled by the noble Baroness, Lady Finlay, and to follow the noble Lord, Lord Lansley. Because this is about devices, I should remind the Committee that I am president of GS1 UK, the barcoding association, and chair of the advisory board of TenX Health.

I thought the noble Lord, Lord Lansley, posed a very interesting question about whether NHS patients have less access to innovative new medical devices than those in other European countries. My gut feeling is that they do, but I agree that the more information we can obtain the better so that we can debate whether the fund that the noble Baroness, Lady Finlay, proposed is a good way forward. On the face of it, I think it is. We have a situation in this country that is rather the case for medicines, where we have a very important health technology and medical devices sector. The ABHI informed me recently that the health technology industry employs over 127,000 people, generating a turnover of £24 billion. That is very substantial.

Covid-19: Dental Services

Lord Hunt of Kings Heath Excerpts

Tuesday 10th November 2020 Lords Chamber

[Lord Bethell (Con)]

My Lords, the concern about children is particularly acute. We are especially keen to encourage parents, to ensure that they are still bringing children forward. That is why we have the Help Us to Help You campaign to encourage public access to NHS services. She is entirely right that acute situations—involving, for instance, some form of anaesthetic—provide a particular challenge. We have a prioritisation process in place, and I understand that that is working well to ensure that those who have the greatest need are put at the front of the queue. However, as I said to the noble Baroness, Lady Uddin, I would welcome any feedback from those who think that the system is not working well enough.

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

My Lords, I declare my interest as president of the British Fluoridation Society. Just on that last point, in a number of parts of the country, no elective surgeries, except for those that might be totally prioritised, are being done at the moment. The prospect is of a few more months with a virtual lockdown of elective surgery. As far as children are concerned, will the Minister look into this matter urgently? Will the Government prioritise preventive schemes as we come out of the pandemic, such as fluoridation, supervised tooth-brushing programmes in schools and public service ads?

[Lord Bethell (Con)]

My Lords, I completely agree with the noble Lord that prevention is the key. In our document on the matter, Advancing Our Health: Prevention in the 2020s, we have committed to the consulting on and rolling out of supervised tooth-brushing schemes in more preschool and primary school settings in England. We have also set out our support for expanding water fluoridation, and we intend to announce further details of our water fluoridation plans shortly.

Medicines and Medical Devices Bill

Lord Hunt of Kings Heath Excerpts

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

[Lord Patel (CB) [V]]

My Lords, this amendment was tabled by the noble Lord, Lord Lansley, who unfortunately is not able to attend today. My name is on the amendment and I am very pleased to move it in his name.

This is an amendment that normally one would have thought the Government would have no difficulty in accepting, because it was in the Conservative manifesto at the time of the election. So if you are going to choose an amendment, choose the one that they cannot turn down. I am in the good position of making two speeches, one in the name of the noble Lord, Lord Lansley, and one in my own name. It will be interesting to see which one the Minister accepts, because I am not going to tell her which one is which—I may as well enjoy this while I can.

Patients in the UK often face delays in accessing breakthrough innovations due to the NICE technology appraisal process. This is particularly true of treatments for smaller patient populations, such as patients with rare diseases, where there is greater uncertainty around effectiveness due to the challenges of collecting sufficient data to satisfy NICE’s requirements. To overcome similar challenges and enable access to the latest cancer treatments, in 2016 changes were made to the Cancer Drugs Fund, to increase NICE’s flexibility in decision-making. Between July 2016 and November 2019, approximately 41,000 patients were registered to access 79 drugs, used to treat 160 different cancer conditions. Despite the clear benefits to patients, similar flexibilities have not been extended to other areas such as gene therapy and gene silencing—treatments for rare diseases where there is not much treatment available.

Amendment 28, in the name of the noble Lord, Lord Lansley, would add a clause to the Bill that would require the Secretary of State to establish the innovative medicines fund. This fund was promised in the 2019 Conservative manifesto. Like the Cancer Drugs Fund, its purpose would be to bring innovative medicines into use in the NHS. It would give NHS patients in England access to the latest new medicines, as advised by clinicians, and would give the NHS and NICE valuable data on their effectiveness, often adding information about drugs being used in clinical practice which is not normally available through clinical trials alone. There is an increasing need to extend these access schemes to disease groups beyond cancer, including neurodegenerative conditions such as motor neurone disease and Parkinson’s, as well as haemophilia, cystic fibrosis and sickle cell disease. These are diseases with a high unmet need for treatment, but also with real hopes for new treatment options, including gene therapy and gene silencing, as I have already mentioned.

This amendment would amend Section 261 of the NHS Act, which provides powers for the pharmaceutical voluntary price and access schemes, often known as VPAS, as amended by the Health Service Medical Supplies (Costs) Act 2017. An essential part of VPAS is to improve access to innovative medicines. The new fund would help to deliver this, alongside the MHRA Early Access to Medicines Scheme that we have already heard about. The predecessor to VPAS was the Pharmaceutical Pricing Regulation System. However, over the years, lack of access to innovative medicines has been a source of angst in the industry about the scheme and, for many of us, is part of a system that fails patients. It was not only industry that did not like the scheme; it was denying treatments to patients. We should not have a stand-off between the NHS and drugs companies, with patients losing out in the process. We should have a scheme that adequately rewards the value that is inherent in medicines and also ensures that the NHS is able to provide the treatments that patients need.

The current VPAS sets a budget limit on the NHS drugs bill. If it is exceeded, the industry will provide a rebate. In the past, the NHS has seen rising drug costs but has not seen the rebate—so the NHS took the rebate but did not reinvest it in other innovative medicines. By way of the Innovative Medicines Fund, the NHS, the life sciences sector and patients would all see the benefit of the rebate. The proposed new clause would require the rebate to be made available to the fund, and it is that rebate which will provide the money for the fund. I hope—and I hope that the noble Lord, Lord Lansley, will agree—that it will be open to Ministers to take advantage of these powers to provide additional resources to the fund, according to its needs. The clause will provide the means by which the Government can deliver on their manifesto pledge and, in doing so, deliver to patients, some of whom are in great need.

I do not see how the Government can resist Amendment 28; they can only improve on it. I beg to move.

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

My Lords, I am glad to support the noble Lord, Lord Patel, and I have a great deal of sympathy with this amendment. Of course, I speak as one of a long line of former Ministers who have wrestled with the tension between a cash-restrained NHS and the imperative to invest in new medicines and devices. I have come to the conclusion that we are not going to see the investment we want to see in these new medicines without a radical change of approach.

When we debated access in Grand Committee a couple of meetings ago, the Minister used words to the effect that he would not go anywhere near reimbursement. That is at one with the way the NHS regards drug costs: as a price and a cost to be pared down rather than as an investment in patient care. The unwillingness of Ministers to tackle the issue of reimbursement to the industry in a way that incentivises the use of new medicines is, I think, very disappointing. I do not think that there is any way around this, unless we top-slice some of the resource for the NHS and distribute it separately for investment in new medicines.

The noble Lord, Lord Patel, referred to current and previous agreements with the industry. I want to go back to the 2014 PPRS agreement, which does I think provide a model for us. It provided assurance on almost all of the branded medicines bill for the NHS, so the bill stayed flat for the first two years of the scheme and grew slowly after that. The industry made quarterly payments to the Department of Health when NHS spending on branded medicines exceeded the allowed growth rate. The quarterly payments that the industry made could have been used to fund new medicines—but, as the noble Lord, Lord O’Shaughnessy, mentioned last week, it is very hard to explain what exactly happened. With a cap in place and with reimbursements being made by the industry, the NHS proceeded to try to ration drug costs at local level. So, instead of having a virtuous circle where essentially the industry guaranteed the cap on drug costs in order to allow for investment in new medicines, we had a double whammy. The industry price was pared down and the NHS continued in its bad old ways of trying to prevent new medicines being accessed by patients.

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

I have received a request to speak after the Minister from the noble Lord, Lord Hunt.

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

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

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

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

[Baroness Penn (Con)]

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

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[Baroness Thornton (Lab)]

This clause deals with falsified medicines and is a very important clause, and it is important therefore that we get this right. Amendment 30 would tighten the provisions to avoid unintended consequences of data being used for purposes other than to ensure that medicines are safe, and Amendment 33 would place a duty on the Secretary of State to act with a view to, rather than having regard to, the importance of ensuring that information is retained securely when exercising powers. The amendments in the name of the noble Lord, Lord Clement-Jones, whom I thank for supporting mine, are similarly concerned with the safety of information and accountability.

The MHRA said that the Falsified Medicines Directive will cease to apply in the case of a no-deal Brexit, because UK pharmacies will no longer have access to the database that holds false medicines data under the FMD. The noble Lord, Lord Clement-Jones, during Second Reading described the measures as “legislative creep” with regard to how any data could be used. He said that the clause

“considerably broadens the original data-collection provisions of the Falsified Medicines Directive”.—[Official Report, 2/9/20; col. 391.]

That is the whole point of these amendments. Indeed, the noble Baroness, Lady Masham, also said at Second Reading that the Company Chemists’ Association had raised concerns around the clause. Malcolm Harrison, the chief executive of the CCA, said he had grave concerns about the wording of Clause 3(1)(b), which relates to the development of a UK system to prevent the supply of falsified medicines. Jerome Bertin, general manager of SecurMed UK, said

“it is hard to determine if this would broaden the rights of access to such data, but the use of ‘for any purpose’ might suggest wider access rights, though for which stakeholders or regulators is unclear”.

Clearly, there needs not to be any ambiguity in this Bill. The wording of the clause therefore needs to be adjusted to ensure that there is no confusion and that there is a clear direction that data should not be used for any other purpose than ensuring that medicines are safe. Jerome Bertin also said that the Bill

“does not go anywhere near the detail of the EU directives (2001/83/EC superseded by 2011/62/EU) so it is hard to assess whether the FMD style protections would be diluted in a UK-only falsified medicines regulation”.

That is a legitimate question that needs to be answered.

There is no mention of this clause or this issue in the Explanatory Notes or the impact assessment for the Bill. With such a big issue regarding extremely sensitive data, there should be a more clearly outlined direction and a better thought-out way of introducing this clause for falsified medicines that also protects the extremely sensitive data that comes with it.

These amendments aim to ensure that data is protected and will not be used for any other purpose other than to ensure that medicines are safe. It is crucial that we get this right to avoid any unintended consequences, which could have grave repercussions. I beg to move.

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

I very much support my noble friend in these amendments. As they have with her, a number of organisations have raised with me their concerns. The clause refers to the

“use, retention and disclosure, for any purpose to do with human medicines”,

which is very open-ended. In relation to information collected by such a system, it considerably broadens the original data-collection provisions of the Falsified Medicines Directive. Yet the Explanatory Notes make no mention of this. The noble Lord, Lord Clement-Jones, is not with us today but, when we debated it earlier, he referred to it as “legislative creep”—and, I must say, I agree with him.

In the Commons, the Health Minister Jo Churchill said in Committee:

“The Bill, in the main, does not deliver any immediate change to the regulation of medicines and medical devices.”—[Official Report, Commons, Medicines and Medical Devices Bill Committee, 8/6/20; col. 7.]


So it is very surprising to see this clause as currently drafted.

We have had briefings from the Company Chemists’ Association and ABPI, in addition to the ones that my noble friend mentioned. Because of the issue of commercially sensitive data, Article 54a, regarding the protection of personal information or information of a commercially confidential nature generated by the use of the safety features, was inserted into the preamble of the Falsified Medicines Directive. The principle of “whoever generates the data owns the data” was enshrined in Article 38 of the associated delegated regulation of 2016, which followed the Falsified Medicines Directive.

The Minister’s department already has access to a wide range of data on medicines’ sales and use in the UK under the Health Services Products (Provision and Disclosure of Information) Regulations, which we debated at some length a little while ago in your Lordships’ House. Of course, Ministers can request more detailed information if required. Given this access and the known sensitivities around falsified medicines data in general, it is unclear why the department wants to extend the purposes for which data is collected under a future UK system and why this has not been discussed with stakeholders in the existing Falsified Medicines Directive scheme. Why was such little reference made to it in the Explanatory Notes?

It is not unreasonable to ensure that the Bill is amended to enshrine at least a duty of full consultation with stakeholders before it goes through your Lordships’ House.

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

The noble Lords, Lord O’Shaughnessy and Lord Clement-Jones, have withdrawn. I therefore call the noble Baroness, Lady Jolly.

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[Baroness Wheeler (Lab)]

I am pleased to move Amendment 46 in the name of my noble friend Lady Thornton, which, alongside other amendments in this group, amends provisions in Clauses 6 and 15 and removes provisions for the disapplication of regulatory provisions in an emergency to be made subject to conditions set out in a protocol published by Ministers.

We understand why the Bill confers emergency powers on the Government to disapply existing health medicine regulations in circumstances which give rise to the need to protect the public from a serious risk to public health. However, we are concerned that the disapplication authorised in the regulations can be subject to conditions specified in the regulations, or conditions set out in a protocol published by the public authority. Furthermore, no formal requirements are set for the form, publication or dissemination of a protocol. It may simply be a document published on a website by the appropriate authority. This is completely inappropriate and unsatisfactory.

The Minister will be very aware that both the Delegated Powers and Regulatory Reform Committee and the Constitution Committee raised concerns about this provision. The Constitution Committee noted that:

“In other bills emergency powers are time-limited and there are often requirements for periodic reviews of their use”,


and yet

“No such constraints or safeguards exist in this Bill. These powers are subject only to the negative resolution procedure and can be adjusted by the amendment of a protocol which is not subject to parliamentary scrutiny”.


As the DPRRC commented at paragraphs 39 and 42:

“On a number of occasions, we have drawn the attention of the House to provision in Bills which enables Ministers to make what are, in effect, legally enforceable rules under the radar of the Parliamentary scrutiny that is afforded to primary and secondary legislation … Allowing regulations to make the disapplication of legislation subject to conditions set out in a ‘protocol’ is yet another example of ‘camouflaging legislation’ … we consider that, where those powers are to be used to provide for legislation to be disapplied in an emergency, any conditions to which disapplication is to be subject should be set out in the regulations themselves and not in a ‘protocol’ which is not subject to Parliamentary scrutiny.”


The Constitution Committee concurred and recommended that

“the use of these powers should be time bound, subject to periodic review and that any conditions on the disapplication of legal provisions should be set out in regulations.”

Although the Government have yet to publish their full response to those reports, as we know, the Minister has tabled, and indeed moved, a number of amendments in Grand Committee which are intended to address the concerns of the DPRRC and the Constitution Committee. This amendment provides an excellent opportunity for the Minister to explain to the Committee exactly why he has not therefore tabled an amendment ensuring that the disapplication of legal provisions is invariably set out in regulations, as recommended. I beg to move.

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

My Lords, I am very glad to support my noble friend Lady Wheeler. I will not repeat what she said, because I thought she put across the points very powerfully. She quoted extensively from the Delegated Powers Committee, which complains that no justification whatever has been given for what the Government seek to do.

It is worth saying that the committee has drawn the attention of the House to this kind of mechanism being adopted in a number of Bills over the past few years. I was very struck by the assurance it sought from the Government that they would not continue the practice of what it called “camouflaging legislation” as guidance. In response to the committee’s report on both the Ivory Bill and the Mental Health Units (Use of Force) Bill, the Leader of the House, the noble Baroness, Lady Evans, wrote:

“As you will be aware, it is Government policy that guidance should not be used to circumvent the usual way of regulating a matter. If the policy is to create rules that must be followed, the Government accepts that this should be achieved using regulations subject to parliamentary scrutiny and not guidance”.

Health Protection (Coronavirus) (Restrictions) (England) (No. 4) Regulations 2020

Lord Hunt of Kings Heath Excerpts

Wednesday 4th November 2020 Lords Chamber

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

My Lords, I have no doubt the latest lockdown will damage the economy, but you can have as many impact assessments as you like; the fact is that, unless we take action, the NHS will simply fall over.

In his opening remarks, the noble Lord, Lord Robathan, referred to capacity of the NHS to deal with non-Covid treatments. I would like to link that to criticism made by a number of Conservative MPs, who have argued that because hospital intensive care is currently no busier than normal for the majority of trusts, the national lockdown is not justified. I refer them to the statement made today by NHS providers, collating the views of NHS trust chief executives. They put forward three points. First, you cannot just measure the degree of pressure in a hospital just by looking at ICU capacity; you must look at pressures on acute and general beds, which is often greater, partly because many Covid patients are being treated with oxygen therapy on general wards.

Secondly, if NHS hospitals have too many Covid patients over the next two to three months, they will not be able to deal with winter pressures and carry on recovering elective surgery backlogs. Those cases are usually all treated in general and acute wards. Many hospitals are having to turn those wards into Covid beds. This in turn, is threatening elective surgery recovery rates and impacting on ability to cope with winter.

Thirdly, many hospitals are already seeing a frighteningly high level of general bed occupancy. If this pattern, now mainly in the north, is repeated elsewhere, it will coincide with winter, when the NHS is at its most stretched. None of this is reflected or effected by current national intensive care unit bed occupancy rates; in fact, they are irrelevant as far as risk is concerned. The argument for national lockdown therefore fully stands. That is the view of people at the front line of the health service; they need to be listened to.

The only question I have, which is one asked by my noble friends Lady Andrews and Lord Knight, is why the Government did not act in late September following the SAGE advice on 21 September? The more you read the two pages of advice, the more you see it was abundantly clear the circuit breaker was required. I did not hear the Minister refer to that in his introductory remarks. I hope he will respond to that. The point is this; government is not easy at the moment, but they could have taken action six weeks ago. They should have done it.

Blood Safety and Quality (Amendment) (EU Exit) Regulations 2020

Lord Hunt of Kings Heath Excerpts

Monday 2nd November 2020 Grand Committee

[Lord Hunt of Kings Heath (Lab)]

My Lords, I thank the Minister for introducing and explaining so carefully the statutory instruments. Clearly, as he said, they are very important. The key statement he made, which is repeated in paragraph 7.7 of the Explanatory Memorandum, is:

“Neither the 2019 SIs, nor the 2020 SIs make changes to the safety and quality standards, which will remain the same across the UK from 1 January 2021.”


However, for Northern Ireland, these standards are expressed by reference to EU legislation, whereas for Great Britain they are not; although, at the moment, the substance is the same in both cases. So I ask the Minister: what are the implications of any future change made in EU directives or in UK law? Since we may not stay aligned with the EU, there must be some inevitability, at that stage, of that arising. Will that not then lead to a confusing situation in future where UK regulators are responsible for overseeing different laws in separate parts of the UK? If that is the case, and given that this is a hugely sensitive area, will this inhibit the movement of tissues and organs between Ireland and Great Britain? The Minister mentioned such movement, but will he clarify how much movement there is at the moment?

I would also like to ask the Minister about the six-month transition period from exit day to allow establishments time to put the necessary arrangements into place for importing and exporting tissues and cells with the EU? Is he confident that that is sufficient time for those establishments?

I refer to our recent debate on the Human Tissue Act during the passage of the Medicines and Medical Devices Bill. As the Minister knows from our debate, it is our view at least that the Human Tissue Act does not require appropriate consent for imported human tissue, and, in addition, imported human tissue for use in medical research does not require traceability. Of course, this is very relevant in the case of China and the shocking use of organs of prisoners and minority groups for commercial exportation. I readily acknowledge that we are currently in discussion with the Minister’s department about a suitable amendment to deal with this, but will any such amendment agreed in the Medicines and Medical Devices Bill apply also to Northern Ireland?

I am sure the noble Lord, Lord Alton, will speak in some detail on this, but, as I have the opportunity, I would like also to talk about human tissue. As the Minister will know, we have been concerned about the view of the WHO on the practices in China, as it is based upon a self-assessment by China itself. This has been the subject of correspondence between the Government and the World Health Organization. The Minister, the noble Lord, Lord Ahmad, has now turned down a freedom of information request from the noble Lord, Lord Alton, and I want to express my disappointment. This is so important that the Government really ought to publish the correspondence. Having said that, I am very grateful for the opportunity to debate these regulations.

Covid-19: Intensive Care Treatment

Lord Hunt of Kings Heath Excerpts

Thursday 29th October 2020 Lords Chamber

[Lord Bethell (Con)]

My noble friend is entirely right to chase me in this matter. I remember the commitment very well and I will endeavour to find out from my colleagues at the department how they are doing in getting those important papers into the Library.

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

My Lords, the Minister was very forthright today in rejecting the Sunday Times story. A month ago, he was very forthright in an answer to the noble Lord, Lord Balfe, about blanket DNR notices. Picking up on the question today from the noble Lord, Lord Balfe, does he think that there might be an issue of communication where staff are working on the front line, where impressions are given that are not in accord with official government policy? In the light of all this, has he given some thought to the way in which communications with NHS staff might be improved in order to deal with these very troubling issues?

[Lord Bethell (Con)]

I am not sure that I agree with the implication of the noble Lord’s question—that somehow there is a prejudice on the front line against older people and that staff take it into their own hands to make decisions that are in themselves inherently unfair. That is not my experience. Where the noble Lord absolutely has a point is that people are extremely sensitive about these kinds of issues, and, quite rightly, are deeply concerned that they are going to get the treatment and care that they deserve and will not be subject to any form of unfairness. It is imperative that the NHS builds trusts and conveys a strong communication on these issues. To push back against the noble Lord, it is not my impression that the staff at the NHS have lost sight of this important principle.

Medicines and Medical Devices Bill

Lord Hunt of Kings Heath Excerpts

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

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

My Lords, I am glad to add my name to Amendments 23 and 29. I am a strong supporter of community pharmacies. Over the past few months, they have done magnificent work. They stayed open, took pressure off the rest of the NHS, and are a central part of community resilience. We cannot take them for granted. They face a number of extra costs at the moment: increased prescription numbers, extra staff costs from the increased demands for advice and medicines, covering for sickness and the rise in locum rates, and one-off costs such as decontaminating pharmacies when someone infected has visited. Before Covid-19, the community pharmacy network was already pretty vulnerable.

I am glad that, at the end of March, the Government agreed to inject £300 million-worth of advance payments into community pharmacy. A further £50 million was paid in May, followed by £20 million in June. That £370 million cash advance was of course very welcome, but it will not relieve the ongoing financial pressures because it is set against future income. Instead of this being treated as a loan to be repaid, there should be a recognition of the extra costs that community pharmacies have had to carry since Covid-19. Will the Minister consider that? I also ask her to consider what further financial support needs to be given to the sector over the next few potentially very difficult months.

That is the background to the debate about hub and spoke. As the noble Lord, Lord Clement-Jones, pointed out in previous debates, we have to go to the impact assessment to find any reference at all to hub and spoke. Clearly, it could offer many advantages. Mobile deliverers will be able to partner with dispensing pharmacies to deliver their prescriptions; he spelled out the key advantages. Equally, there are fears that it could undermine the whole community pharmacy network. My concern is about the impact on smaller pharmacy groups and individual companies and shops.

The Minister in the other place, on Third Reading, said that she intended

“to give smaller community pharmacies the same opportunity that large pharmacy businesses already enjoy.”—[Official Report, Commons, 23/6/20; col. 1239]

That is a good statement, but I say to our Minister that Governments often make statements about the importance of small businesses and, when it comes to the actual arrangements, those business often struggle to compete. I hope that this is not being done to try to rationalise the community pharmacy network, because it is a great strength that we have so many pharmacies on our high streets, where people can walk in and get immediate access to health advice and help.

The amendment is very reasonable. It simply asks that the Government consult the sector again on their plans. A previous consultation, started in 2016—two Parliaments ago—has never been concluded. Given the impact on the sector and on patients, surely the Government should undertake a proper consultation, to make sure that any legislation follows that rather than the anticipatory approach referred to by my noble friend Lady Wheeler. I hope that the Government will signal their support for the community pharmacy sector as a whole.

[Lord Lansley (Con)]

I thank the noble Baroness, Lady Wheeler, and the noble Lord, Lord Clement-Jones, for tabling their amendments, which allow us to have a useful debate; we might not otherwise reach into what some implications of the use of these powers might be. I particularly thank them for the way in which the amendments were introduced, which set out clearly and fairly the context and facts with which we need to work.

I recognise that Amendment 23 is a probing amendment. I am sure that the noble Baroness knows that, if she actually wanted to remove the capacity for legislating to introduce hub and spoke models, Clause 2(1)(g) would have to go as well as paragraph (c) to make that effective, but I do not think she wants to do that; I do not either. We all want to express our support for the pharmacy sector. In my view, the Government’s proposals in the Bill will allow that support to be given additional expression; they seem a positive step to have taken.

As someone who was shielded earlier in the year, about the only place I ever visited in April and May was the local pharmacy—not that often, but the fact that it was there and working, and the way in which it worked, was immensely impressive. Over the years, I have had a great deal to do with the pharmacy industry. In some cases, I am not sure that it was altogether happy about that. The noble Lord, Lord Hunt of Kings Heath, may remember that I worked with the National Audit Office in about 2008, when I was shadow Secretary of State, to establish the extent to which the pharmacy sector benefited through the category M reimbursement system by hundreds of millions of pounds more than it was supposed to. Those large-scale additional funds that were going into the sector had to be clawed back, as happened in the early part of the decade that we have just gone through.

That led to considerable turbulence in pharmacy incomes and values. They were overinflated and the incomes were higher between about 2015 and 2018, and the considerable clawback had a negative impact. Most recently, it is telling that the value of pharmacies—and the price increase—has gone down. It is also interesting to read the commentaries that say that pharmacy in Scotland attracts greater value because the flow of resources into it there is regarded as more stable than in England.

That is a great pity, because we have reached a point where there should be more stability and funding for pharmacies, and I want to pick up a point made by the noble Lord, Lord Hunt of Kings Heath. He suggested that the Government consider turning the advance payment into not a loan but a grant. It is a large sum of money, so it is not as easy as that. However, whereas earlier this year the global fund for pharmacies was set at about £2.6 billion and was going to be retained at that level in cash terms over five years, we have to think hard about whether that is reasonable under the circumstances. There is a good case for recognising additional costs met by pharmacies this year, and potentially into next year, and for reimbursing them perhaps through a change to the establishment fee before it disappears, with a considerable sum to recognise that.

We must also recognise that pharmacies will need real-terms increases in their resources—much as other parts of the NHS-related system are seeing real-terms increases in resources—and not to stand still in cash terms. Over the next four years, that might be something like £130 million extra.

All the way through, we have never achieved as much as we should in terms of pharmacies delivering additional services, particularly clinical services. It is partly because clinical commissioning groups have never quite recognised the flexibility they have in budget terms to use pharmacies. The noble Lord, Lord Clement-Jones, referred, quite rightly, to medicines use reviews—which are being phased out—new medicine services, nicotine-replacement services, sexual health services, minor illness services and so on. A wide range of additional services can be provided by pharmacies. If they can do it, frankly, the GPs, as those at the heart of the clinical commissioning groups, will find that it benefits them directly in reduced demand on their surgeries, which is of course one of their principal stresses at the moment. I hope that the Government will think about all that.

In this context, with these powers in the Bill, the Government do not need to know whether a large number of independent pharmacies will take advantage of the hub and spoke model. It is entirely permissive; they can choose to do so or not. The fact that they cannot at the moment is a significant potential constraint on the ability of independent pharmacies to access the benefits of automation in their sector. I am absolutely clear that we ought to give them access to this potential benefit. I do not know how many would take advantage of it or to what extent the large company chains would make their hub and spoke model available to allow independent pharmacies to get the benefits of that automation. It seems to me that they should, because there are many parts of the country that they do not reach and where they are not in competition. It is perfectly reasonable for them to allow them to access to it, particularly in some of those more remote parts of the country where dispensing is more difficult.

Many of the concerns raised about this in the debate seem to come down to the separate question that I can remember debating on legislation 15 or more years ago about whether we retain the role of the responsible pharmacist. This does not change that. The responsible pharmacist will remain as is; I do not see any plan to change that part of the pharmacy regulation. The change to hub and spoke seems potentially desirable.

While Amendment 29 does not need to be in the Bill, it makes a very good point, which is that there should be consultation and an agreed framework with the industry, and we should ensure that the framework is one that is seen to link resources and changes in the regulations, to enable it to compete more effectively. To that extent, I hope the Minister will take on board and support the intentions of Amendment 29.

--- Later in debate ---

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

I just wanted to come back to the consultation. I am grateful to the Minister for her full and encouraging response, but can she say a little more about how the public and patient groups are to be involved in this consultation? In terms of the work, given what the Minister in the Commons said about the small pharmacies, will part of the consultation look at the actual economics of how those small businesses can compete and take advantage of hub and spoke?

[Baroness Penn (Con)]

My Lords, the commitment on the consultation is that it would be a public one, in line with the government amendment on what type of consultation we need to undertake for regulations made under the Bill. That would therefore include patient groups. On the content of the consultation, I understand that when it first took place it was very open, to hear from the sector how it would want to make use of the powers. My understanding is that we have heard the need to have a more structured conversation on the framework for how these powers could deliver the benefits which people think they could. Maybe I could undertake to write to the noble Lord with some more detail on that.

--- Later in debate ---

Moved by

[Lord Hunt of Kings Heath]

24: Clause 2, page 2, line 23, at end insert—
“(o) the origin and treatment of human tissue used in the process of developing and manufacturing medicines.”Member’s explanatory statement
This amendment adds the origin and treatment of human tissue, including organs, to the list of matters about which regulations may be made by the appropriate authority, in the context that informed, valid, uncoerced and demonstrably documented consent may not have been given for the harvesting of such human tissue and organs.

--- Later in debate ---

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

My Lords, 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—the process leading to inevitable murder—has recently been found by the China Tribunal to be happening extensively. The organ recipient may have had their life saved, but at the expense of another innocent life. It is now a multimillion-pound commercial business in China, with wealthy Chinese officials, Chinese nationals and organ tourists receiving treatment in high-end recovery centres.

Evidence of forced organ harvesting has grown and whistleblowers have emerged. 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 such as Tibetan Buddhists, Falun Gong practitioners and Christians are also being held in labour camps. Companies from the West are complicit in this. Adidas, Nike, Zara and Amazon are among the western brands which, according to a coalition of civil society groups, currently benefit from the forced labour of Uighurs in Xinjiang. In July this year, a 13-ton shipment of hair products from Xinjiang, worth more than $800,000, was seized by US Customs and Border Protection. This shipment included wigs made from human hair, which is hugely concerning considering the many reports and personal testimonies of female Uighur Muslims having their heads forcibly shaved in the camps.

Last year, the China Tribunal, chaired by Sir Geoffrey Nice QC, 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 point out to the Grand Committee the vast body of evidence of forced organ harvesting in China. Such evidence includes: detailed statistical analysis of transplantations and donations; numerous recorded undercover telephone conversations, including with well-known Chinese officials admitting to the practice of forced organ harvesting; legal and policy statements and practice of the CCP; advertisements and admissions of university and military personnel; incredibly short waiting times; and a large number of personal testimonies. The China Tribunal spent 12 months assessing all available evidence. Additionally, its international panel of highly respected individuals interviewed over 50 witnesses, experts and investigators, and formally invited representatives of the People’s Republic of China to respond. I do not believe it is sufficient for the UK Government to ignore this any longer.

Although Ministers have been personally sympathetic, so far the Government have relied on the World Health Organization’s view that China is implementing an ethical, voluntary organ transplant system. I am afraid this is simply not credible; the fact is that it is based on a self-assessment by China, as became clear during my noble friend Lord Collins’s PQ on 29 June 2020. The WHO has not carried out its own expert assessment of China’s organ transplant system, so I am afraid that the WHO cannot be considered reliable in this area. For me, the China Tribunal is persuasive on this point.

This Bill provides an opportunity to prevent British complicity in such crimes and to send an important signal to other countries. 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. The Minister has written to me to state that whether sourced from within or outside of the UK, there is comprehensive domestic legislation to ensure the ethical and appropriate use of human tissues. Yet while this is all true for human tissue sourced from within the UK, this does not address the gap in legislation for imported human tissue. On the concern about the use of human tissues in the development of medicines, which I do understand, the Minister commented that the use of imported tissue in any medicines on the UK market is very limited. However, while it may be limited, there is a gap in the legislation which could be exploited in the future.

I am grateful to the noble Lord, Lord Ahmad, for his awareness of the passion which many of us feel about the allegations of forced organ harvesting in China and for ensuring that the UK is not complicit in any way. I hope that he will acknowledge that my amendment—which has been signed by a number of very distinguished colleagues— is not prescriptive and essentially gives Ministers regulation-making powers to deal with the issue if and when they decide to do so.

Up to now, we know that many countries have pulled their punches when talking to China about these practices. Of course, as The Economist has pointed out, China’s economic power has helped it to avoid censure regarding its abuse of the Uighurs. Many companies in the West appear reluctant to use any leverage they may have to put pressure on China, and that is not helped by the reluctance of so many countries to upset that country. The UK, of course, faces dilemmas too, and we have seen them already in the issues over 5G and potential Chinese investment in new nuclear energy. I am not naive; I understand some of the pressures which are on the Government, but there must be a time when we make a stand.

I was encouraged by the reported words of Dominic Raab to the Foreign Affairs Select Committee on 6 October, when he referred to evidence of “gross human rights violations” against the Uighur Muslim minority in Xinjiang province. I pay tribute to the Government for being prepared to say that. I simply want them to go one step further, and agree to a very modest amendment. It seeks to give Ministers the powers to take action when they deem it right to do so. Accepting it would be a very important signal of this country’s attitude to gross human rights violations, and I have great pleasure in moving my amendment.

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

My Lords, it is a great privilege to follow the powerful speech of the noble Lord, Lord Hunt of Kings Heath.

While the Human Tissue Act 2004 is thorough and comprehensive with regard to human tissue sourced from within the UK, this does not hold true for imported human tissue. Human tissue can be imported into the UK without any consent or traceability. Notably, if it is for use in medicines, traceability is required through the Human Tissue (Quality and Safety for Human Application) Regulations 2007, but for use in medical research neither consent nor traceability is required. They are merely considered good practice. This means that human tissue sourced from China—where people are imprisoned and tortured, and where organs are extracted and sold for profit, a process which kills the donor—can legally enter the UK and be used in medical research.

--- Later in debate ---

[Baroness Penn (Con)]

My apologies to the noble Baroness, Lady Northover. I have read the findings of the report and will agree to read the full report ahead of any further meetings that we have.

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

My Lords, this has been a very powerful debate. Each contribution has been measured and the product of expertise, human value and internationalism. I am grateful to the noble Baronesses, Lady Finlay, Lady Jolly and Lady Northover, the noble Lords, Lord Ribeiro, Lord Alton, Lord Patel and Lord Sheikh, and my noble friend Lord Collins. I am also grateful to the Minister, who I thought provided a very constructive response at the end.

When the noble Lord, Lord Alton, talked about Alder Hey, he probably did not realise that that is really where my interest in this subject stemmed from. I was the Minister responsible for the north-west at the time that scandal emerged. I appointed the chair of the inquiry and met the parents involved on a number of occasions. I listened to the harrowing tales from parents; some of them took part in three funerals for parts of their child’s body. What happened was shocking, and I learned from that how crucial it is that, when we deal with human tissues and organs, the integrity of the process is vital.

I was also fortunate to be able to take the Organ Donation (Deemed Consent) Bill through your Lordships’ House a couple of years ago; it is now law. I hope that it changes the basis of organ consent and will lead to more organ donations in this country—the noble Baroness, Lady Finlay, referred to this eloquently. Again, when you move to presumed consent, you have to have absolute trust in the integrity of all the people involved. Just as it is important in this country, so it is globally, which is why we must take action in relation to the activities of China—and other countries, as we heard during this debate.

I listened carefully to what the Minister had to say. She made the point that the use of imported human tissues is very limited. None the less, we have identified a gap in the legislation. She made two points: first, she said that the Bill already provides for the kind of authority we wish to give to Ministers; then she went into detail on the drafting challenges that she thought our amendment faced. However, she used her words in a constructive way and I am very grateful to her. I reassure her that I and my colleagues will be very willing to work with her officials to see whether we can come up with an amendment that meet our needs but does not lead to the kind of perverse incentives that she referred to.

This has been a wonderful debate. We have had a constructive response from the Government. I am convinced that we are going to make progress and, at the end of the day, in this legislation we will make a mark—important in this country but also internationally —saying that we will do everything we can to stop this appalling process. Having said that, I beg leave to withdraw my amendment.

Amendment 24 withdrawn.

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Moved by

[Lord Hunt of Kings Heath]

26: Clause 2, page 2, line 23, at end insert—
“(o) developing rapid provisional two-year licences.”

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

I should explain that the noble Baroness, Lady Finlay, is required in the main Chamber to speak in a debate on the Bill there. I have put my name to her amendments. Amendment 26 and others in this group would ensure the development of a rapid provisional two-year licensing procedure, so that patients might more quickly access potentially life-saving medicines and medical devices, and that device trial results were consistently registered and published.

In earlier amendments, several noble Lords commented on the avoidable delays in innovation, and the tardy response of the NHS to new and improved medical devices. The current licensing procedure in the UK can be lengthy. Safety and efficacy of course are paramount, but in our debate on Monday, my noble friend Lord Blunkett referred to my late noble friend Lady Jowell and her powerful call for fast-tracking. Many patients wanting to trial novel therapies say, “It may not help me, but it may help others.”

As the Minister said at Second Reading, and all speakers on the second group of amendments last Monday, particularly the noble Lord, Lord Sharkey, we must remain an attractive place to develop new medicines and devices. Amendment 26 supports that aim through the development of a licensing procedure that would speed up making new medicines accessible to the NHS when clinical trials have shown them beneficial and safe for people with the relevant conditions.

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

My Lords, I know what the noble Baroness, Lady Cumberlege, means when we have the privilege of hearing, as we have in this debate, so much expertise on very challenging issues. Much of the debate has been about devices, but of course my noble friend Lady Finlay’s first amendment related to medicines. To reiterate, she sought to create a rapid two-year provisional licence without reducing safeguards on new medicines. She thought this would enable us to make best use of innovative new medicines without compromising safety at all.

It is understandable that much of our debate was on devices, because it was informed by the report from the noble Baroness, Lady Cumberlege. She has identified a number of issues around the regulation of devices—it is clearly a less vigilant approach than for medicines, with a lack of data and transparency, the equivalence issue and the challenges she raised. The noble Lords, Lord Kakkar and Lord Patel, went into further detail on some of the challenges around devices, particularly those that have a capacity to cause damage. The argument they put was that provisional licences would allow much more effective safety monitoring and early identification of problems and would protect innovation.

The noble Lord, Lord O’Shaughnessy, raised the interesting idea of extending the innovation fund that we are shortly to debate to devices. That deserves a great deal of consideration, although he will of course know that the innovation fund will essentially be funded by payments from the pharmaceutical industry. Seeing how money from the devices industry would come about is a much more challenging issue.

The Minister essentially said two things. The first was that what my noble friend wants to achieve in relation to medicines can be done already, that it is in the Bill and that, in any case, there is a new process to expedite medicines where it is deemed appropriate. I think my noble friend will want to look very carefully at that.

The Minister is right on devices. I think he spoke of 500,000 devices. It is a massive challenge; there is no question about that. There are reasons why devices regulation is different from medicines regulation, but when it is clear that there are defects in the current system, we must at least take advantage of the fact that we are now in a position, post-Brexit, to develop our own regulations.

The Minister went through the processes that are currently in place, including the role of notified bodies, but he said that the system can be strengthened and that regulations can be reviewed. At this stage, I urge that this be as open as possible so that we have a really good debate about medical device regulation, informed by the report from the noble Baroness, Lady Cumberlege, and by experience elsewhere. We want to do two things: to ensure that our innovative devices sector is given all encouragement, but also to ensure safety in a way that it has not been ensured before. That is a challenge, but it is one worth accepting. In begging leave to withdraw the amendment, I say that this has been a very good debate and I hope it will inform government thinking.

Amendment 26 withdrawn.

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These objections go to the heart of executive overreach, as I mentioned when discussing other amendments on the first day in Committee. Yet again, it is about conferring broad and vaguely delimited powers. Of most concern is that the Minister’s letter takes pain, at the end of the argument on the need for those particular powers, to align them with the promotion of safety, yet the purposes for which disclosure would be lawful under this new amendment are underdefined, to be decided by any international agreement conducted in future, and thus not open to scrutiny here. I beg to move.

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

My Lords, that was a very interesting opening speech from the noble Lord, Lord Patel, and I am very glad to have put my name to his amendment—although, of course, he went wider and commented on the government amendments. I very much agree with his desire to minimise delay for the UK to get access to new medicines. That has been a constant theme of our debates.

There are a number of elements in this, including the attractiveness of the UK to pharma companies, for our life sciences, our approach to access to early phase trials, the regulatory system for licensing medicines and the NHS’s willingness to take up those medicines, including the role of NICE. We have debated all of those.

The Minister on the first day in Committee responded to a number of those issues and said that the Government wanted to

“build on our established strengths so that the UK has the opportunity to anchor international drug development in this country and grow that capability. I am committed to international standards, international partnerships and multi-country clinical trials … The UK works closely with many other regulators; those relationships are underpinned by many shared international standards. The EU bases its regulations on exactly those standards”.—[Official Report, 19/10/2020; cols. GC 357-8.]

The issue is, that being said, will we in the end be aligned with Europe so that companies do not have to go through separate processes in which, because the market that we offer in this country is so small compared to the EU market, we will not be a country of first choice for developing new medicines and seeking a licence?

I refer the Minister to a comment that I picked up in the last few days from Britain’s pharmaceutical industry: it has appealed to the Prime Minister to strike a swift side deal with Brussels to avoid delays and shortages of medicines if we leave at the end of the year with a no-deal Brexit. We have heard continuously from the Prime Minister that he was preparing for—indeed, he would embrace—no deal on 31 December. The Government’s departure from any rationality or seeming concern for Britain’s industry and their posturing have left industry without the agreement on mutual recognition of standards that is needed to avoid hugely costly duplication of red tape to maintain the flow of trade in vital drugs. The one phrase that the Minister has not articulated in our debate so far is “mutual recognition of standards”. The fact is, if we are seriously going into a new world where we do not believe that mutual recognition between ourselves and the EU is a sensible or serious proposition, I am afraid that all the talk about this country being an attractive place for pharma will fall on rather stony ground.

The noble Lord, Lord Patel, has done a great service in bringing this matter back with a slightly different approach. I hope we can look for a positive response from the Government.

[Lord O'Shaughnessy (Con) [V]]

My Lords, I speak in support of the intention of Amendment 27 in the names of the noble Lords, Lord Patel and Lord Hunt of Kings Heath. As noble Lords know, I made my views on the Brexit approach of working with other regulators clear on the first day in Committee and I do not intend to rehearse them—I am sure that noble Lords will be relieved—but I was struck by how this might work in practice. While listening to the noble Lord, Lord Patel, who gave an excellent exposition, I reflected on his story about CAR-T therapies and how that provides a good example of what we need to guard against as we move out of the EMA post Brexit.

In September 2017, I went on a visit to Pennsylvania and had the opportunity to go to Penn Medicine, which is where CAR-T was developed, in a lab sponsored by Novartis. I remember sitting down afterwards and being told about the amazing progress they had made, how this was rolling out to patients and indeed how they were thinking about the next iteration of this medicine, how useful it would be and how much demand there would be for it to be given to American dogs—that is right, dogs. I was sitting there at a time when UK patients did not have access to CAR-T therapies, but American dogs were about to get access. This in a way exemplifies a problem that we have today as part of the EMA but are likely to have tomorrow: our unwillingness to accept the decisions of other stringent regulators who make good decisions and whose processes we trust.

The idea of how we could work with other regulators as expressed in this amendment is incredibly important and could be carried out in two ways. The first is, as I said, in accepting decisions from other stringent regulators, including the FDA, the EMA, of course, and others. There has been resistance—there certainly was in my time as a Minister—about so-called rubber-stamping of other decisions and the implications for legal liability if things go wrong, but I am absolutely confident that these can be overcome. Our regulator should be prepared to accept the paperwork submitted to other regulators and the decisions of other stringent regulators where we have confidence in their processes. Ideally, as the noble Lord, Lord Hunt, said, this would be in the form of mutual recognition, but it is perfectly possible for us to do that unilaterally as well. That would go a long way to assuaging the concerns of industry.

The second way, and they are not mutually exclusive, is that the UK could lead the creation of a third global market to go alongside the FDA and EMA by working with independent regulators in Switzerland, Australia, Singapore, Canada and so on. As I say, these are approaches that we could follow in tandem as part of, I hope, a global move towards a single approach.

I am confident that we can follow these routes without causing any harm to patient safety while improving patient access. I am not convinced that they require legislation. I can understand why the noble Lord has tabled the amendment and I support its intention; I do not know that we need to change the law. What I would like to hear, and I hope other noble Lords would like the same, is a commitment from my noble friend the Minister that the Government intend to take this kind of approach. We look forward to speaking to the director of the MHRA on precisely this issue, as she has kindly agreed to meet us next week.