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.

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.

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”.

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.

Covid-19: Charitably Funded Hospices

Lord Hunt of Kings Heath Excerpts

Wednesday 28th October 2020 Lords Chamber

[Lord Bethell (Con)]

The noble Lord is entirely right. Some £1.54 billion is spent on hospices each year. Of that, £1.2 billion is charitable; I pay tribute to those from the hospice movement who were recognised in the recent Birthday Honours List for supporting that fundraising. Let me assure the noble Lord that the challenge he describes is recognised in the department. The Minister responsible will meet key hospice stakeholders, including from Marie Curie, Sue Ryder, Hospice UK and Together for Short Lives, on 4 November when the challenge that he describes will be discussed.

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

My Lords, I am a long-standing supporter of Birmingham St Mary’s Hospice. If the current restrictions stay the same as now, the hospice estimates that, by the year’s end, fundraising and retail income will be down by more £1.5 million—and by more if we have a more severe lockdown rule. This is a massive amount for a small charity to make up. The Minister has referred to the support received from the Government via Hospice UK. That was hugely welcome, but the hospice movement needs an immediate second injection of funding, and it needs to know when that will happen. Hospices cannot wait much longer.

[Lord Bethell (Con)]

My Lords, I completely recognise the note of urgency in the noble Lord’s comments. I also recognise that, as we go into a Covid winter, the hospice movement, which has contributed so much to our response to Covid and brought valuable capacity to the care of the elderly and the vulnerable during the first wave, needs answers. I recognise the funding gap that he describes, in particular the collapse in retail income that many depend on, but I assure the noble Lord that the meeting on 4 November will have these issues on the agenda. The movement should look forward to that meeting as an opportunity to discuss the issues he describes.

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.

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[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.

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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.

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[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.

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[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.

Medicines and Medical Devices Bill

Lord Hunt of Kings Heath Excerpts

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

[Lord Hunt of Kings Heath (Lab)]

My Lords, although I am a member of the GMC board, I am not speaking on behalf of the GMC on this group of amendments.

I speak on behalf of my noble friend Lady Thornton’s Amendment 8, which seeks to beef up the duty of the Secretary of State to make regulations under Clause 1(1) in relation to the safety and availability of human medicines and the attractiveness of the relevant part of the UK as a place to conduct clinical trials or supply human medicines. Amendment 73 does essentially the same for medical devices. As she said, the concept of attractiveness is rather vague and open to misunderstanding, which makes a statutory definition so important. I have also put my name to Amendments 74 and 75 tabled by the noble Baroness, Lady Cumberlege, and will speak in support of her Amendment 12.

Apart from teasing out from the Government what attractiveness means, this is essentially an opportunity to draw out from the Minister their response to the noble Baroness’s report, First Do No Harm. The report is a stark and moving account of how thousands of patients were let down in a serious and life-changing way. I have met many of the campaigners involved and their stories were heart-rending, as she has said. I am particularly grateful to the organisation known as Sling the Mesh, whose representatives I had the pleasure of meeting. Noting that the noble Lord, Lord O’Shaughnessy, is speaking later, I say that I remember, after I asked an Oral Question about mesh, that he met campaigners and talked to them for some considerable time. That was very helpful in getting across to the Government and Ministers just what damage had been done by a procedure that for many women proved to be positive and life-affirming. The awful thing is that the women who had terrible outcomes were ignored, because it was inconvenient and the operation was so successful for quite a large percentage. The system completely pooh-poohed them. Even now, under the counter, there is a lot of resistance to the noble Baroness’s recommendations.

The noble Baroness found that the healthcare system—in which she included the NHS, private providers, regulators and professional bodies, pharmaceutical and device manufacturers—was disjointed, siloed, unresponsive and defensive. That is why her core recommendation is the appointment of an independent patient safety commissioner, a person of standing who sits outside the healthcare system, accountable to Parliament through the Health and Social Care Select Committee. Obviously we are debating this later, but it would be helpful to get some sense of the Government’s response. No doubt the Minister might point to the work of Aidan Fowler, the NHS national director of patient safety, and the strategy produced under the auspices of NHS England and NHS Improvement last year. That is fine so far as it goes; it makes the point that patient safety is about maximising the things that go right and minimising the things that go wrong for people experiencing healthcare.

I commend Aidan Fowler for his efforts and commitment. Does the strategy go far enough? Does it represent a systems approach to safety where that becomes the No. 1 objective of the NHS? Does it mean that all equipment and buildings in future will be designed with safety as the first consideration? Will boards of NHS trusts treat safety as their No. 1 responsibility? Will that lead to a wholly different approach by the CQC, because I do not think that safety is a priority so far as it is concerned in its inspections? The big question is: will NHS England and NHS Improvement change their approach and make it clear that safety is an important priority for them? Unless they do, I do not think that any change will take place. The strategy—an NHS England strategy, of course—feels like a collection of good practices, but not something that will change the system, which clearly needs to happen.

To get some sense of this, I looked back to the report by Don Berwick, whom I regard as the guru on patient safety internationally, entitled A Promise to Learn and produced in 2013 in the wake of the Mid Staffs inquiry. Berwick was clear that the quality of patient care, especially patient safety, should be placed above all other aims. He said:

“Patient safety problems exist throughout the NHS as with every other health care system in the world. NHS staff are not to blame—in the vast majority of cases it is the systems, procedures, conditions, environment and constraints they face that lead to patient safety problems. Incorrect priorities do damage: other goals are important, but the central focus must always be on”


patient safety.

What Berwick said in 2013 holds good today. The NHS has made progress since then—I readily accept that—but on no count has safety been embedded as the No. 1 concern. That is what makes the report by the noble Baroness, Lady Cumberlege, so important and why she wants an external champion of patient safety, because it clearly ain’t going to come from inside. It is too diffuse. No one is responsible for patient safety. If Aidan Fowler were directly accountable to the Secretary of State and resided in the Department of Health and Social Care, I would begin to believe that that was a serious attempt, but because the Government have decided that all the national clinical directors should be placed under an NHS management system, direction and accountability at the top of the office have been lost. Therefore, the report by the noble Baroness, Lady Cumberlege, makes sense and will have to be listened to positively.

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[The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)]

My Lords, I have received one request to speak after the Minister, from the noble Lord, Lord Hunt of Kings Heath. Once we have heard from the noble Lord, I will try one more time to establish contact with the noble Baroness, Lady Jolly. However, I have to tell the Committee that so far we have not been successful.

[Lord Hunt of Kings Heath (Lab)]

My Lords, I thank the Minister for his response. Could he say a little more about the Government’s overall patient safety strategy? He is saying essentially that the Bill is confined to medicines and medical devices regulation, yet underlying the concerns of the noble Baroness, Lady Cumberlege, is the fact that patient safety has not been gripped. In a sense, he has given a technical response. We will come to more specific amendments relating to, say, a patient safety commissioner, but at some point it would be interesting to get an insight into government thinking about patient safety more generally.

[Lord Bethell (Con)]

I will be candid with the noble Lord. The Cumberlege report has put patient safety absolutely at the top of the agenda. If it was not for Covid, it would be the primary issue of today in health matters and would lead all our thinking for the year ahead. The report is incredibly important and it has made its mark in a big way. However, it was delivered at the end of July and, if you take out August, that is only six or seven weeks ago. It takes a bit of time to respond to these reports. I know that the noble Baroness is chafing at the bit and wants a response—of course she does—but it has not been very long in report terms.

I cannot avoid the obvious, which is that we are in the middle of an epidemic. The Department of Health is completely overrun. We have nearly doubled in size in the past four weeks, but even so the capacity for response, in ministerial time and official time, simply is not there. I completely understand the keenness of noble Lords in this Room to get a clear response, but the sequencing is that this is a Bill on medicines and medical devices. We seek to take on board the lessons of the Cumberlege report and, where possible, specific items, but the Bill is not designed to be a vehicle for the implementation of the report recommendations. We will acknowledge and, where possible, accommodate the report’s insight, but the report needs a formal response from the Minister for Patient Safety and I am not that Minister and there has not been time for that response to arrive yet.

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[The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)]

My Lords, before I call the next speaker, I should just inform the Committee that we now know that the noble Baroness, Lady Jolly, is unwell, and will therefore be unable to take part in the remainder of today’s proceedings. In due course, no doubt, we will know who will take her place in subsequent groups. I call the next speaker, the noble Lord, Lord Hunt of Kings Heath.

[Lord Hunt of Kings Heath (Lab)]

Can I just follow the noble Lord, Lord Lansley? Clearly, we are going to continue teasing out “attractiveness”. I have no doubt that I want the UK to be attractive in terms of the development of medicines and medical devices, and I think the noble Lord, Lord Lansley, was absolutely right when he paid testimony to the underlying strength of our medical innovation and discovery, and indeed the life science sector as a whole. I think one of the questions we are going to consistently talk about is that we do have a problem with the attitude of the National Health Service to those very medical innovations that take place in this country. As I will touch a bit on procurement, I should declare an interest as president of the Health Care Supply Association, because clearly it is involved in procurement decisions.

As I think was discussed in the first day of Committee, the ABPI has reported that for every 100 European patients who can access new medicines in the first year, just 15 UK patients have the same access. It is a major problem that we are so slow to take advantage of developments in new medicines and devices, both in our country and globally. We are seeing in the NHS essentially an unprecedented level of rationing, both locally and nationally. My own view is that NICE has developed into more of a rationer than it was ever intended to be. Locally, clinical commissioning groups are making almost perverse decisions, ranging from cutting out health promotion programmes to being very restrictive on some operations or, again, on access to innovative drugs.

Of course I understand that the drugs budget cannot be open-ended, and the NHS must achieve value for money. But the fact is that we are at great risk of losing our place at the top table when it comes to medicines and medical devices innovation, despite the excellence of the people we have, which the noble Lord, Lord Lansley, referred to. At the moment, I think we have developed around 14% of the top 100 global medicines, but 20 years ago it was 25%, and the risk, of course, is that we go lower and lower.

Similarly, in relation to access to devices, we have a very innovative devices sector, but again it is utterly frustrated by the NHS’s record in adopting innovation. Its suppliers are forced to battle against a fragmented marketplace—they lack a clear route to market—budget silos that impact on buyers’ ability to release savings directly, and a short-term focus on cash-releasing savings at the expense of longer-term benefits. As an example, I was approached by the Urology Trade Association, which represents the suppliers of the majority of urology projects to the NHS, which pointed out that, in normal times, urinary tract infections are the greatest single cause of unplanned hospital admissions, so it has a big impact on quality and duration of life and on use of NHS resources. If we were prepared to invest in improved devices, it could have a major benefit. But essentially, whatever the Government say about procurement and value-based procurement, they always go for the lowest price, and I am afraid that we often buy the lowest-quality products.

The ABHI has told me of one company in the dialysis sector which now sees the UK as a second or third-tier sector, due to the prices it commands here. I know that on the first day of Committee the noble Lord said he cannot talk about reimbursement; the problem is that Ministers will never talk about reimbursement. It is interesting that, in general, if we are increasing staff—the numbers of doctors and nurses—I think Ministers tend to proclaim that as a good thing. However, increased budgets in devices and medicines is a shock, because the whole philosophy of his department and the NHS is to hold down the budget.

The problem is that, essentially, we do not invest in the great things that are happening. It is naive to think otherwise. There are a lot of things we can do to encourage the kinds of things that are happening in Cambridge—through tax incentives, for example, and schemes for faster access—but they relate only to a few selected medicines and devices. Overall, we are at great risk. I am afraid that the NHS has to face up to some responsibility for that, both in terms of the industry, and in terms of patients. Why should we in this country have to wait so long for medicines that in other European countries are available much sooner? This is a major issue which we need to tackle.

[The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)]

I call the next speaker, the noble Lord, Lord Patel. Lord Patel? Oh dear, we are not having a great afternoon. If we cannot establish contact with the noble Lord I will move on to the next speaker. Lord Patel, are you with us?

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[Lord Lansley (Con)]

The amendment is in my name and that of the noble and learned Lord, Lord Woolf. This group includes four amendments, three of which are mine. I am glad to see in it too Amendment 124, in the name of the noble Lord, Lord Hunt, because it goes to similar issues. I hope that he will find some common ground between us.

Amendments 17 and 79 would add to the considerations to which the Secretary of State should have regard when making medicines regulations and medical devices regulations respectively—Amendment 17 referring to the former and Amendment 79 to the latter. They would bring the same factors into play.

The first factor is the effect of the regulations on the ability of the National Health Service to meet the needs of patients. There could be two interpretations of how this might be seen. The first is that the medicines regulations could give rise to the authorisation of medicines that the NHS was not in a position at that point to fund. I do not think that it is about that. If the NHS has difficulty in paying for such medicines, it has a power under the National Health Service Act to vary the funding mandate that would otherwise be applicable under NICE. The NICE funding mandate for medicines is in that Act and not in the regulations for medicines. What I think this is about is the NHS being increasingly keen to secure the benefits of innovation. We have had a decade or more of reports telling the NHS that while there is a great deal of innovation there is poor diffusion of its benefits through its adoption in the National Health Service. This is about the ability of the medicines regulations to help the NHS to meet unmet medical need, to bring forward innovations and to deploy them. One might say, “Well, the medicines regulator just authorises medicines”, but let me give a couple of examples.

The first is the early access to medicines scheme, which is precisely about giving the NHS the opportunity to bring forward innovative new medicines that meet unmet medical need and to do so more quickly and in ways that often require collaboration between the NHS, MHRA and NICE. The second example is the Accelerated Access Collaborative, which also looks at other schemes such as the small business research initiative. Its purpose is to bring products through to authorisation and approval, which is quite often in relation to medical devices.

The amendments would require the Secretary of State when making the regulations to have regard to the potential for innovative medicines and medical devices respectively, so that they might be accelerated through processes of authorisation in order to realise their benefits more quickly and hence help the National Health Service to meet its objectives.

The second factor to which the amendments would require the Secretary of State to have regard is consultation. Clause 41 places a requirement on the Secretary of State to consult when making the regulations. A later amendment, Amendment 131, requires the Secretary of State to make a report on any such consultation—I think that my noble friend the Minister referred to it earlier—but there is nothing that links back the consultation to the making of regulations. The amendments say not only must the Secretary of State conduct consultation but he must have regard to the outcome of it—these are specifically “have regard to” factors; they are not factors that should be placed above any other factors in the hierarchy that we are talking about or conflict with them.

Amendment 85 is a bit different. I freely admit, before my noble friend the Minister explains it to me, that trying gently to insert it into Clause 13 is probably quite difficult in terms of the legal structure, because that is a place where requirements are to be laid on those who bring products forward for marketing and supply, whereas the amendment would place a requirement on those who are effectively buying medical devices—that is, the NHS in particular. However, I want to ask my noble friend to consider that we are trying to stimulate innovation in medical devices and bring them through into practice. We know that there are significant potential benefits to the National Health Service in such innovations, which improve outcomes for patients and can reduce costs—it can be a win-win. However, there is no funding mandate for medical devices which mirrors that for medicines, so that when NICE produces a positive evaluation the NHS after a period of delay has an obligation to bring forward the funding for those devices.

In January 2019, the NHS Long Term Plan said that the NHS wanted to accelerate proven affordable innovations into use in the NHS. In November 2019, a consultation was launched to look specifically at what is known as the medtech funding mandate—that is, to give that funding mandate to medical technology devices, not just medicines. By March this year, the Accelerated Access Collaborative was meeting and agreeing—this was one of its objectives—that, in the financial year beginning in April 2020, three such products would be brought forward. Those three products were placental growth factor-based testing, whose title more or less explains what it is; SecurAcath, which, as the title again implies, makes catheters more secure, reducing infection; and HeartFlow, which piloted at the Royal United Hospitals Bath NHS Trust and is a 3D model mechanism for imaging coronary arteries in ways that reduce intensive testing and enable clinicians to work with a highly developed form of imaging in their practice.

Those three products were to come forward in 2021. The intention, as reported to the board of the Accelerated Access Collaborative, was to do more in future years. As I understand it, NHS England intended to establish this as a medtech funding mandate—perhaps with slightly different characteristics and requirements than that of medicines but, none the less, to give medical device manufacturers the same sense of assurance that, if they bring this forward in the United Kingdom, the NHS, with a positive evaluation, will bring them into practice. However, that has stopped. I have seen nothing since April; it seems to have fallen by the wayside. I seek from my noble friend the Minister an assurance that NHS England wants to do it, that the Accelerated Access Collaborative will help to push it forward and that we will see action on this—if not this day, then this year. I beg to move.

[Lord Hunt of Kings Heath (Lab)]

My Lords, my Amendment 124 concerns NICE’s current review of its methods and processes as part of the agreement of the voluntary scheme for branded medicines pricing and access—commonly known as the VPAS. I will also speak to Amendment 85 in the name of the noble Lord, Lord Lansley, because he made some important points in his opening remarks.

I have a particular interest in NICE. Under Frank Dobson, I was the first Minister and worked closely with it for the first few years. It was established because of concern that effective new treatments, including medicines and devices, were not getting to NHS patients. This is a continuing problem. At the beginning, we put an additional sum into baseline budgets to cover the estimated cost of technology appraisals.

I have to say that pharmaceutical companies were obviously reluctant to embrace NICE, but so was the NHS. As early as December 2001, I was responsible for a funding direction to the NHS—the original one, referred to by the noble Lord, Lord Lansley—which required NHS bodies to implement their technology appraisals, because research showed that they were not doing so. They had been given the money, although it was not identified but put into baseline budgets, which is an interesting point.

The funding directions have been modified a few times since then and, to an extent, have reduced the impact. But the fact is that the NHS remains a reluctant partner—and you can add that to the unprecedented level of rationing taking place locally. There is a tendency, even when NICE has approved drugs or a technology appraisal, and even when the funding direction applies, for local mechanisms to be used to restrict access by patients. I have already referred to clinical commissioning groups: they are informed by regional medicines optimisation committees. Essentially, these are rationing committees designed to legitimise decisions by CCGs to ration treatments. I come back to this point: why do we tolerate NHS patients missing out on medicines and devices that are available to most patients in most European countries?

We come to the NICE review. I am a great admirer of NICE, which has done a fantastic job and has some brilliant people. It works with some fantastic universities, and we are world leaders in this field. However, I hope that the methods review will lead to tangible change and that we will get a fair and effective assessment of the true value of innovative medicines.

We are clearly at a crossroads: exiting the EU represents a significant threat to the attractiveness of the UK for pharma and devices companies. What factors do companies take into account? Clearly, the strength of our life sciences sector is one of them. Secondly, there is the regulatory system, which we are discussing in Grand Committee. Thirdly, there is the ability to launch medicines and technologies quickly into a market, getting medicines to patients who need them quickly. These are clearly part of the equation for any company, and pharmaceutical companies tend to be global, to all intents and purposes. The risk is that we will start to lose our reputation as a leader at the cutting edge of medical science. My hope is that NICE’s approach to appraising value must take into account the strategic benefits of the NHS remaining at the forefront of medical innovation.

I shall give an example of where NICE’s current rules rule against this. Gene therapy is a prime example of a medical technology that the UK should embrace, but a procedure called discount rate, used by NICE to adjust for future costs and health benefits when valuing treatments, discriminates against one-time therapies that offer potential long-term health benefits over many years, such as gene therapies. NICE almost always uses the 3.5% rate but can apply a lower 1.5% rate for therapies that offer longer-term health benefits. I understand that it chooses to do that only on exceptionally rare occasions. Post the new 2019 voluntary scheme, negotiated to deliver a triple win for patients, government and industry, we now see NHS England doing bespoke commercial agreements, which of course significantly undervalue innovation.

There is always a tension, but the tension is that the main interest of NHS England is to pare down drug costs. The impact that that has is that, for all the brave words about innovation, it simply does not play out in the field. I was very interested in what the noble Lord, Lord Lansley, had to say. There is a HealthTech Connect portal, but I am told that not a single innovation submitted via that portal was adopted by NHS Supply Chain during the first year of operation, March 2019 to April 2020. Are we to assume that none of the submissions meets the criteria in terms of evidence, efficiency or satisfying unmet needs, or are they simply being thwarted by a process that raises the bar to unrealistic levels?

Health Protection (Coronavirus, Restrictions) (Self-Isolation) (England) Regulations 2020

Lord Hunt of Kings Heath Excerpts

Thursday 22nd October 2020 Lords Chamber

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

My Lords, we have just two minutes each to debate these important regulations, which create large fines and come at the same time as the agreement reached with the police for the handing over of the personal information of individuals notified to isolate. This is a travesty of parliamentary scrutiny. I simply do not understand why we could not have debated these regulations before they came into force.

On clarity, as the Minister said, I am extremely sympathetic to the argument of Big Brother Watch, and of my noble friend Lord Rooker, that the sheer complexity of the regulations means that the period of time that a person must isolate for is not immediately evident and requires very careful reading of the regulations —not a good basis for public trust.

Added to this is the concern expressed by the Secondary Legislation Scrutiny Committee that those without the app, who may be poorer or more elderly, could be more likely to be contacted by traditional track and trace, and therefore more liable to be fined. Can the Minister comment on this?

Finally, a fascinating report, recently published by the Nuffield Council on Bioethics, asked some searching questions about the values which inform the most recent decisions on Covid-19 restrictions, and the challenging trade-offs between different rights and interests. It asked what support is to be given to those in the parts of society asked to bear the greatest burden in the Covid-19 response, arguing that the state has a duty to ensure that they are supported to do so. I hope that the Minister might be prepared to look at its work.