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?

Covid-19: South Yorkshire

Lord Hunt of Kings Heath Excerpts

Thursday 22nd October 2020 Lords Chamber

[Lord Bethell (Con)]

The noble Lord is right that the situation at airports is distressing and has caused huge damage to travel, the airline business and hotels. However, foreign travel represents a massive threat in forward transmission of the virus. Testing at airports catches only a tiny proportion of those infected, and quarantine arrangements are not wholly reliable. For that reason, we are running a pilot in the UK to see what can be done but we will tread cautiously.

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

My Lords, the Minister has said that he will not publish the criteria under which a local area can move in and out of a tier. Does he agree that publishing some indication would give local people a clearer understanding of what needs to happen to move out of a tier? Perhaps I may refer to the proceedings of the Secondary Legislation Scrutiny Committee earlier today, which, looking at the tiered approach, said, “For public trust to be maintained, the Government have to be much more transparent in explaining the basis of their decision-making, including setting out how they balance the competing health, social and economic interests and the data to support the decision.” Will the Minister look at this?

[Lord Bethell (Con)]

My Lords, I hear the point loud and clear from both the noble Lord and others who have raised it. The question of the exit strategy is a priority and it is inevitable that people will be asking exactly that. We have sought hard over recent months to make the regulations clearer, simpler and more understandable for the public; the rule of six, the tier strategy and other measures are efforts to do that. However, his point about exit strategies is extremely well made and I would be glad to take it back to the department and to push as hard as I can on it.

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.

Covid-19: Information Sharing with Police Forces

Lord Hunt of Kings Heath Excerpts

Tuesday 20th October 2020 Lords Chamber

Asked by

[Lord Hunt of Kings Heath]

To ask Her Majesty’s Government what is the legal basis for their Memorandum of Understanding with the National Police Chiefs’ Council which allows police forces to access information that tells such forces if a specific individual has been told to self-isolate due to the COVID-19 pandemic.

[The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell) (Con)]

My Lords, the Health Protection (Coronavirus, Restrictions) (Self-Isolation) (England) Regulations 2020 authorised the police, local authorities and NHS Test and Trace to share information where necessary for the purposes of enforcement. The Department of Health and Social Care and the National Police Chiefs’ Council have agreed a memorandum of understanding so that, when given a report that someone is failing to self-isolate, the police can check with NHS Test and Trace whether the person in question has been formally notified to self-isolate.

[Lord Hunt of Kings Heath (Lab)]

My Lords, I am grateful to the Minister but does he agree that sharing what is essentially health information with the police is a highly sensitive matter? This should not have been sneaked out on a Friday night without any parliamentary reference whatsoever. Was NHS experts’ advice taken regarding the impact this might have on people prepared to take the test? Is the Minister aware of the advice given by the BMA and other health service organisations, particularly in relation to harder-to-reach communities, that this may dampen down the numbers of people coming forward for tests? Was that taken into account?

Health Protection (Coronavirus, Restrictions) (No. 2) (England) (Amendment) (No. 5) Regulations 2020

Lord Hunt of Kings Heath Excerpts

Tuesday 20th October 2020 Lords Chamber

[Lord Hunt of Kings Heath (Lab)]

My Lords, it is a great pleasure to follow the noble Baroness, Lady Jolly, because she has put some pertinent questions to the Minister—not least about the evidence behind the 10 pm curfew. He made a few comments in his introductory remarks, but I am still at a loss to understand the scientific rationale behind it.

I would also say to the Minister that the implications on the hospitality sector are absolutely devastating. Now that Greater Manchester is to have the imposition of tier 3 on it, without agreement with the mayor, the devastation of the hospitality industry in Greater Manchester will be profound. Surely, at the end of the day, we deserve some form of explanation about the scientific evidence behind the decision that has been made.

I shall turn to the West Midlands, which is the subject of the second order before us. The noble Lord will know that the Conservative elected Mayor of the West Midlands and the leader of Birmingham City Council, Ian Ward, are concerned about the implications of tier 2 because the big impact again will be on the hospitality trade, which is a massive employer in the region. From the figures, the number of infections caused from that quarter is very small when compared with family contacts. Given that the level of trust in government is—shall we say and to put it at its mildest—fragile, it is very important that we understand the rationale for these measures.

I will come back to the point that the Government turned down the SAGE advice for a sharp circuit-breaker. Yesterday, Mr Gove suggested that the Government have rejected circuit-breakers for all time. Can the Minister confirm whether that is now government policy?

Covid-19

Lord Hunt of Kings Heath Excerpts

Tuesday 20th October 2020 Lords Chamber

[Lord Bethell (Con)]

The noble Baroness is right to raise questions about the way in which the disease is transmitted. We have put a huge amount of effort into studying it. I pay tribute to the epidemiologists who have crafted sophisticated models and have sought to test them in practical ways in order to establish, for good, the really important questions of how one person’s conversation, breathing and spoken word might transmit the disease to another person either through the air or on surfaces. Understanding that is absolutely essential in order for us to put in place the right kinds of Covid safety measures. However, at this stage it is an imprecise science. For instance, there is some evidence that transmission from hygiene and surfaces can play a very important role, perhaps meaning that we have to invest more thought and commitment in cleaning measures. The guidelines we have for workplace and school testing reflect the very best provable standards according to scientific evidence. We continue to invest in these important epidemiological insights, and I welcome very much the contribution of the scientists on SAGE and all those who continue to try to gain a better understanding of this issue.

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

My Lords, in the first Statement that we are debating, the Secretary of State spoke about the strategy being to suppress the virus and support the economy and the NHS. He did not specifically mention the vaccine programme, although clearly it is an important part of our approach. Although the Government have secured early access to, I think, over 300 million doses, there will not be enough for the entire population to receive them immediately. The Joint Committee on Vaccination and Immunisation has published interim advice on a prioritisation programme. Will the Government follow that advice, and can the Minister say more about what work is being undertaken to encourage a high uptake?

[Lord Bethell (Con)]

I thank the noble Lord for his interest. The JCVI is, as he described, the agency responsible for giving advice on the prioritisation plan. Our policy is to follow that advice, and I pay tribute to those on the panel for the hard work they are putting into that. The interim advice is extremely thoughtful and follows the best values and standards of this country. We are putting a lot of work into trying to raise adoption rates of the vaccine. We face a challenge from those who would like to query the science or have some form of national or commercial vested interest in undermining confidence in the vaccine. We are putting a lot of work into mitigating that risk. That is not work that I would like to discuss at the Dispatch Box but I would be very glad to share some of it privately at a later date.

Medicines and Medical Devices Bill

Lord Hunt of Kings Heath Excerpts

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

[Baroness Jolly (LD) [V]]

My Lords, given that we are in Committee, I will not be making lengthy speeches, but I will raise what I think are the key issues in each of the groups. The amendments to the Bill relate to some of the constitutional issues. As a general rule, noble Lords do not much care for delegated powers because it is not considered good practice or procedure to give a Secretary of State carte blanche in any area. There are some areas in this Bill where the Secretary of State is being given powers that we would rather that he or she did not have.

As the Bill is skeletal and consists mostly of delegated powers, it is important and a good idea to ensure that appropriate steps are taken to set an end date on these, so sunset powers are being proposed. The noble Lords, Lord Lansley and Lord Kakkar, and the noble Baroness, Lady Thornton, have requested the Secretary of State to publish draft legislation to consolidate the legislation relating to human and veterinary medicine within three years of the Bill being enacted.

My noble friend Lord Sharkey and I have put our names to several amendments in this group. My noble friend calls for the super-affirmative procedure so that all powers given in the Bill will elapse after three years. I confess that this is the first time that I have seen that being used. The super-affirmative procedure involves an additional stage of scrutiny where Parliament considers a proposal for a statutory instrument before it is formally laid. This procedure is used for those instruments that are considered to need a particularly high level of scrutiny, which I think is certainly the case with this Bill.

Some of the amendments call for consolidation within three years, but in general what we are saying to the Minister is that there are not enough checks and balances. Please use the time between now and Report stage to look again, speak to Members of the Committee and bring forward government amendments—otherwise, I suspect that we may be voting on Report.

[Lord Hunt of Kings Heath (Lab)]

My Lords, I have added my name to Amendments 1 and 140 tabled in the name of my noble friend Lady Thornton. As we are at the start of the Committee stage, perhaps I may remind the House of my membership of the board of the General Medical Council and my role as president of GS1 and the Health Care Supply Association.

I agree with my noble friend Lady Thornton about the clash between the first day of the Committee stage of this Bill and the Second Reading of the United Kingdom Internal Market Bill in the main Chamber. Today we are dealing with some of the most important debates in the whole Bill and when we come back on Report there will be a need to give more time to allow those people who could not be present today to make a full contribution to these debates. I hope that the usual channels will take that away. I am not quite sure about the procedure in these unusual circumstances, but in normal times I would have asked that the Committee stage procedure be used for these introductory debates on Report in order to allow for interventions. However, since interventions are now limited, that may not run well, although I think that noble Lords will understand what I am getting at.

This is an important Bill on patient safety and the health of our life sciences sector. It is striking in its brevity and in the extensive powers to be given to Ministers. The noble Lord, Lord Patel, has spelled out the wide range of delegated powers contained in the Bill, while a pungent analysis by my local university, the University of Birmingham, points out that, while delegated powers may be needed to ensure responsiveness in the EU exit transition period and to meet the challenges of technological change, they should not be used indefinitely or relied on to implement matters of policy. I am not going to repeat what the Delegated Powers Committee or the House of Lords Select Committee on the Constitution have said, but it is rare for two Select Committees to comment at the same time and in such a critical way about the skeletal nature of a Bill. It is to be hoped that the Government will listen carefully to what is being said.

At Second Reading, the Minister suggested that the sunset clause as proposed by my noble friend would emasculate legislation

“meant to give regulators the powers to be effective and to future-proof medical regulation in a fast-changing industry for many years to come. We must understand the impact on an industry that needs regulatory certainty or else, as many noble Lords have noted, will move elsewhere.”—[Official Report, 2/9/20; col. 433.]

I have to say to the Minister that most of the regulatory uncertainty has been caused by the Government’s failure to be clear about what regulatory regime they want for medicines and medical devices. They have now had four years to think about this and we are still nowhere near knowing what regulatory system they want to put in place. Are they going to go for alignment with the European Medicines Agency or do they want to strike out on their own? Do they want to ally with the US FDA? What on earth are the Government’s aims? The industry is at risk because of this huge uncertainty. The idea that we should allow the Government willy-nilly to get this Bill through and make whatever changes they want without the House treating it as primary legislation simply will not wash. I am absolutely convinced that the long-term regulatory system must be subject to detailed primary legislation. As far as I can see, the amendment to bring in a sunset clause is probably the most appropriate vehicle to ensure that that happens.

[Lord Kakkar (CB) [V]]

My Lords, in contributing to the first day in Committee on this Bill, I draw the attention of noble Lords to my registered interests, in particular to those as a professor of surgery at University College London and as the chairman of UCLPartners.

I support Amendments 50, 67 and 115 tabled in the name of my noble friend Lord Patel, to which I have added my name. The point has been well made by my noble friend that the ecosystem for the delivery of healthcare in our country and therefore the use of medicinal products, medical devices and veterinary medicines is a complex one that is attended by substantial legislation, much of which has been brought into force as a result of the European Communities Act 1972. It is therefore absolutely right, to echo a point made previously by the Minister, that there is a need for this Bill to ensure that such regulation can continue, so that we can continue to have a safe and effective healthcare system and take advantage of the essential requirement to avail ourselves of medicinal products and medical devices.

There is surely also an absolute obligation to ensure that regulation should avoid adding to the complexity that already exists. For those who have to labour under these regulations and ensure that they can present innovation and advances to benefit our fellow citizens within the context of the regulations, we should always be working to simplify them.

In this regard, we are all conscious of the fact that many different types of regulations touch on the healthcare system. There are those that pertain to ethics, and those that deal with the function and delivery of ethics committees and the evaluation of intervention at a local and national level. We have regulations that deal with the adoption and evaluation of innovation within the context of the MHRA, and with the evaluation of intervention and innovation pertaining to NICE. We have heard from the noble Lord, Lord Patel, about the medical device regulations enacted in 2002, which codify and implement various EU directives in this matter, and the substantial amendment attending medical device regulations in terms of the legislation passed as part of EU exit regulations in 2019.

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[Lord Woolf (CB) [V]]

I am most grateful to the noble Lord, Lord Lansley, for setting out the position we are in with such clarity. I will add just a few words to explain my involvement. It has already been pointed out that not many of my legal friends who I would expect to be concerned about this are present in Committee today. I am sure that the ones who one thinks of are busily engaged in the Chamber over a different piece of legislation which is causing them greater concern than the proposal here, although I believe that they would not disagree with my comments.

In this House, we naturally think as parliamentarians and are concerned about our process of scrutinising legislation, but bad legislation all too frequently ends up not being disputed in this House. That is not the end of the matter, however: the difficulties it creates then have subsequently to be sorted out, which is frequently done by judicial review in the courts. What the noble Lord, Lord Lansley, has said so well is very relevant to judicial review, and that is an area where I feel that, just as the doctors can comment about this Bill with a certain background of knowledge, I should refer to my entries in the register, which, at least with regard to judicial review, are quite important.

If the courts are to provide scrutiny at a later stage, they must know the purpose of the legislation. That is why what the noble Lord, Lord Lansley, has already said is so important. With blank cheques, the danger is that they can be used for all sorts of purposes. I have been trying, under the leadership of the noble Lord, to ensure that the blank cheques given by this legislation are as restricted as they can practically be, bearing in mind the situation in which we find ourselves.

I agree with what the noble Lord said about the amendments with regard to the present proposals. On the one hand, there is the proposal put forward by the Government; on the other is the proposal that the noble Lord, Lord Lansley, and I have suggested might be appropriate. My view, for the reason he indicated, is that our proposal is better, but, above all, I am attracted by the fact that what the Government are proposing is much better than what was there before. On that basis, with a degree of reluctance, I would be capable of being persuaded that we should accept what the Government offer, whereas I am quite satisfied that we should not have accepted what was there before.

Leaving the matter in that way, I hope that the further discussion which will no doubt take place will enable agreement to be reached on an amendment which achieves what is needed for the purposes I have indicated.

[Lord Hunt of Kings Heath (Lab)]

My Lords, I am glad that the Minister said that he was listening, and his amendments are important, particularly the one that makes the principle of the health and safety of the public the key consideration when making regulations under the parts of the Bill relating to human medicines and medical devices. He will be aware that concern was expressed by patient groups, in particular, about the Bill as originally drafted and the implication of the attractiveness provision. That concern takes us back to our first debate on “whither regulation in future”.

If we are not going to be aligned to the European Medicines Agency and are to plough it alone, the UK pharma industry will be at a huge disadvantage unless the Government offer an incentive. It may be a bung—the debate about state aid is very relevant to that—or much faster regulation. Otherwise, it is very difficult to see why the industry would continue to invest in R&D in this country. Its position could be as vulnerable as is the motor car industry as a result of the bumbling ineptitude of the Government in their Brexit so-called negotiation.

It is not far-fetched, it is a legitimate question to ask what on earth the Government really want from medicines and medical devices regulation. They may have issued all sorts of draft regulations, but we are clueless about what they are actually seeking to do. The MHRA is clearly not allowed to talk to anybody about this. I remember when the MHRA would talk to politicians and debate these things. It has clearly been given an instruction not to talk to anyone. We are absolutely clueless about the future direction of regulation. None the less, the amendments are clearly helpful, and no doubt we will consider them between Committee and Report.

I would, however, like to ask the Minister about Amendment 2 and its relevance to Northern Ireland. I understand that, exceptionally, it will be moved in Grand Committee because legislative consent takes three months to get through, which impacts on the Bill’s process. I understand that, but, as Parts 1 and 2 of the Bill affect Northern Ireland, does that similarly affect any amendment to Part 1 or 2 passed on Report? What is then the impact on Northern Ireland legislation?

Overall, however, most of the amendments are a constructive improvement, but we will obviously consider them further between now and Report.

[Baroness Barker (LD)]

My Lords, we must consider the whole Bill as building the foundations for the future of the medicines and pharmaceutical industry in this country. We do so in the knowledge that we have had a perhaps pre-eminent role in the world in pharmaceutical development because of the coming together of a number of factors—the European medicines regulations and all the conventions to which we are party, plus the existence of the NHS and the potential it offers for clinical research and our long tradition of working in the life sciences and biosciences sector.

The Minister definitely listened at Second Reading to the many voices of concern that perceived the Bill as it came to us as a weakening of the many factors that underpin our success in this area. He understood entirely, I think, that if we were to take away the pre-eminence of the health and safety of the industry, we would fatally undermine the whole basis of the construction of this very important sector for our economy.

The Minister has listened but not quite hard enough. I agree with the noble Lord, Lord Lansley, that Amendment 2 is an improvement, but it still leaves the decision-making on whether something promotes health and safety to the Secretary of State. I much prefer the construction in Amendment 5, to which my noble friend Lady Jolly has added her name.

My main concern in this group is with Amendment 51 on regulation for veterinary medicines. In his introduction, the Minister pointed to the fact that medicines for animals can work back into the food chain and to humans. I understand the interplay between taking into account things that are done to improve human well-being, animal well-being and the environment, but he will understand that, when people see the amendments, it will not be immediately apparent to them that human welfare is pre-eminent in the list. It says that the regulations must promote “one or more” of the three. I agree that the Minister has moved on the first set of amendments, but he has not gone anywhere near far enough on the regulations on veterinary medicines, so we may well need to come back to that at a later stage.

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The stakes are very high. Innovation will demonstrate the UK’s leadership role. The MHRA is a world-leading national regulatory body. While it will no longer have a seat at the table within the EU after the end of the transition period, introducing innovative ways of working to enhance our existing risk-based approach to trials regulation will allow the MHRA to continue to be influential in the development of regulatory policy around the world. Maintaining alignment with pharmacovigilance standards will also help the UK to maintain influence at an international level. I beg to move.

[Lord Hunt of Kings Heath (Lab)]

My Lords, I support the two amendments in the name of my noble friend Lady Thornton. I have also put my name to Amendment 22 from the noble Baroness, Lady Finlay—she is currently in the internal markets Bill Second Reading debate—which links this to a definition of attractiveness, and to Amendment 39 in the name of the noble Lord, Lord Patel, which focuses on clinical trials for rare diseases and the importance of alignment with the European Medicines Agency.

At the end of this debate, I hope we will have a better idea of the Government’s approach to the regulation of medicines and medical devices. I do not want to repeat myself, but, as my noble friend said, the big question seems to be that at the moment the EMA covers 25% of global pharmaceutical sales and the UK on its own makes up 3%. We know that the NHS is a very poor customer in terms of adopting new medicines. The UK market is pretty hopeless for pharma. If we are not going to be aligned to the EMA, what will this mean for UK pharma in terms of future investment? My guess is that it will snap off that investment.

This is the big issue, which we do not yet understand. What is the Government’s aim? Is it the idea that a no-deal Brexit is a good thing and UK pharma will survive with a hopeless home market and all the problems of dealing with Europe? Countries will clearly not come to the UK first when they have the EMA next door, unless we offer fast-track licensing, which brings us back to patient safety, which is why the two link so much together.

I hope that this time the Minister will give us some idea of what the Government are aiming for. The same applies to medical devices, although there are some specific opportunities, because at the moment the MHRA has no involvement in the pre-market phase of medical device development. Is the intention that the UK develops a proactive regulatory role for devices that is more akin to the licensing of medicines? If so, what will be the implications for industry and patient safety? Clearly, there have been many issues about medical devices in the past which have not gone through such a robust regulatory regime. Is it the intention that the UK goes through a more extensive regime in the future under its own steam? What will the general implications be?

Again, we know that Covid-19 is having an impact on clinical trials, a significant number of which have been paused. It is my understanding that only 45% of studies are currently open to recruitment and only 36% of them have successfully recruited patients since 1 June. The ABHI has highlighted the need for a sustainable plan and aims to return clinical research to pre-pandemic levels by spring next year.

This is important because, despite the size and growth of the global market for clinical research, the UK’s share of clinical trial applications and patient recruits has fallen since 2016. The UK is now falling behind the US, Germany and Spain for phase 3 commercial clinical trials. What is to be done about that? What is the Government’s approach? Again, how does this relate to the future regulation of clinical trials?

I hope that the Government’s intention is to stimulate the UK’s clinical research environment, but part of that must be enabling multi-state UK-EU trials to continue. The idea that we can have multi-state trials that do not involve some agreement with the EU seems fanciful in the extreme. Again, at this stage, we are entitled to know from the Government exactly what they intend.

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

I call the noble Lord, Lord Sharkey.

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4: Page 1, line 6, at end insert—
“( ) The power under subsection (1) may not be exercised to—
(a) create a criminal offence of failing to comply with a provision made in regulations; or
(b) modify penalties for existing criminal offences.”
Member’s explanatory statement
This probing amendment would remove provisions for criminal offences to be created by delegated legislation. The DPRRC considered this an inappropriate delegation of power.

[Lord Hunt of Kings Heath (Lab)]

I have added my name to Amendments 4, 52 and 69, which would remove the provision for criminal offences to be created by delegated legislation.

The Government are developing a reputation for riding roughshod over the law, personal liberties and the role of lawyers. Indeed, the Internal Market Bill, debate on which is taking place in the Chamber today, is a reflection of that.

I am afraid that this Bill continues that trend, as indicated by the Delegated Powers and Regulatory Reform Committee in its very direct criticism of the criminal offence provisions. The committee drew attention to provisions in the Bill which give Ministers powers to create and modify imprisonable offences by statutory instrument. Thus regulations under Clauses 1 and 8 may create a criminal offence of failing to comply with provision made in such regulations that is punishable by imprisonment up to two years. Regulations under Clauses 1 and 8 may also amend the dozens of offence-creating provisions in the existing regulations. Regulations under Clause 12 may create new criminal offences relating to medical devices that are punishable by imprisonment for up to one year. Schedule 2 inserts a new regulation 60A and a new schedule into the 2002 regulations which make it a criminal offence, punishable by imprisonment for up to one year, to breach any of the provisions in the 2002 regulations that are listed in the new schedule. It goes on: Clause 14(1)(d) provides that regulations under Clause 12 may amend the new Schedule 30.

The powers conferred in all these provisions give rise to two concerns. As the Select Committee reported, it has previously expressed the view that it expects a compelling justification for the ingredients of a criminal offence to be set by delegated legislation. The powers in Clauses 1, 8 and 12 would allow Ministers to create completely new criminal offences and make changes to the ingredients of existing offences, yet the memorandum does not appear to contain any justification at all for this. The committee also points out that it has also said that where the penalty for a criminal offence may be set by delegated legislation, it would expect the maximum penalty to be included in the Bill, save in exceptional circumstances.

While the Bill limits the maximum penalty for offences created by regulations under Clauses 1 and 8, it is unclear whether this limit also applies to the many existing medicines offences which could be modified by regulations under Clause 1 or Clause 8. Again, the memorandum does not appear to shed any light on this. The Minister in his Amendments 43, 44, 64 and 65 has attempted to soften the pill by ensuring that regulations under Clause 1 (1) and Clause 8 (1) may not provide for an offence to be punishable with a sentence of more than two years. That is obviously welcome, but I do not think it goes far enough. From my reading of the amendments—no doubt we will hear about them later—they do not deal with the other substantial concern of the committee that the powers in Clauses 1, 8 and 12 would allow Ministers to create completely new criminal offences and make changes to the ingredients of existing offences. Given that, I do not think we can allow these delegated powers to be retained in the Bill. I beg to move.

[Lord Patel (CB) [V]]

My Lords, I shall speak to Amendments 42 and 63, in the name of the noble Baroness, Lady Thornton, to which I added my name and to which the noble Lord, Lord Hunt of Kings Heath, has just alluded. I also have my name to Amendment 92 in the name of the noble Lord, Lord Pannick, and the noble and learned Lords, Lord Mackay of Clashfern and Lord Judge. Noble Lords can immediately tell that I must be the tenth reserve speaking on this important amendment, but the noble Lord, Lord Hunt of Kings Heath, has laid out very clearly the problems with the government amendments that were brought in and the powers they seek.

I shall be brief on this as the Constitution Committee report spelled it out in its last line:

“The delegated powers to create and adjust criminal offences in this Bill are constitutionally unacceptable.”


It was making a constitutional point.

As the noble Lord, Lord Pannick, who is a member of the Constitution Committee, cannot be here, I shall speak on his behalf. Paragraph 21 of the Constitution Committee’s report states:

“We have concluded previously that ‘the creation of criminal offences through delegated powers is constitutionally unacceptable’, save for exceptional circumstances. The delegated powers to create and adjust criminal offences in this Bill are constitutionally unacceptable.”


The noble Lord, Lord Pannick, went on to say that the response of the Minister, the noble Lord, Lord Bethel, that regulations cannot be used to provide for an offence to be punishable with a sentence of imprisonment of more than two years is not satisfactory. A sentence of imprisonment of up to two years is a very serious matter. Parliament, not Ministers, should decide when such a potential sentence should be available to the courts.

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

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

[Lord Hunt of Kings Heath (Lab)]

I first thank my noble friend Lady Thornton for her words in support of the amendment and the noble Lord, Lord Patel, who was hoping to field an impressive cast list in this debate. I thought he did very well; I have always thought he would make a first-class lawyer—he should take that as a compliment.

At the heart of it, as he and the noble Lord, Lord Sharkey, said, this is a constitutional point: the advice we have had from a House of Lords Select Committee is that what the Government are proposing is constitutionally unacceptable. While the Minister’s amendments are always welcome, the fact remains that the Bill, after the Government’s amendments, would allow Ministers to create completely new criminal offences and make changes to existing offences. The Minister kindly explained this, but here we get to the heart of this Bill and the problem that many of us have with it. She talked about novel regulation and the need to keep pace with developments. I understand that.

Health Protection (Coronavirus, Local COVID-19 Alert Level) (High) (England) Regulations 2020

Lord Hunt of Kings Heath Excerpts

Wednesday 14th October 2020 Lords Chamber

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

My Lords, I am grateful to the Minister but I am afraid that, just as in the spring, it is a case of action taken by the Government being too little, too late.

I will return to the SAGE meeting of 21 September and the comment that the more rapidly interventions are put in place and the more stringent they are, the faster the reduction in incidence and prevalence and

“the greater the reduction in Covid-related deaths.”

Clearly, the Government have decided that they will not go down that course. I am afraid that the outcome will be more ill health and more deaths.

Why is the Minister so confident that this approach will work? We know that in 19 of the 20 areas that have been under local restrictions for over two months, infection rates have gone up, not down. It looks as if, caught between opposing forces in government, the Prime Minister has dithered once again and gone for this unsatisfactory compromise.

I would like again to ask the Minister about the Government’s relationship with local authorities. The Prime Minister said that he wants to reset it. Yet last night, the Government were again briefing the media that parts of the north-west are to be moved into the very high priority tier—again, without discussion with local leaders. How on earth is that a recasting of the relationship?

Given the Government’s decision to go down this route, there are inevitable inconsistences regarding where local authorities are placed in the system and the financial support they receive. Is the Minister aware of the criticism made by Andy Street, the Conservative West Midlands Mayor, and Ian Ward, the Labour Birmingham City Council leader, of the impact of closing down the hospitality sector in the West Midlands? This decision has been made for the greater good, but the impact is devastating on that sector, which supports more than 135,000 jobs across the West Midlands. Surely, adequate financial support needs to be provided to protect jobs and livelihoods.

We need a combination of tough restrictions in the light of the SAGE discussions and decisions of 21 September, but we also have to support our businesses to ensure that they survive for the long term.

Health Protection (Coronavirus, Restrictions) (North East of England) Regulations 2020

Lord Hunt of Kings Heath Excerpts

Monday 12th October 2020 Lords Chamber

[Lord Hunt of Kings Heath (Lab)]

My Lords, thank you. Surely, the Minister was right to open by emphasising the gravity of the situation, but here we are again debating regulations that have already been superseded, which serves to underline the unsatisfactory nature of how we are dealing with local Covid lockdown regulations. I do not want to go over the grounds of my PNQ on Friday, but, when Mr Speaker called for the most significant of these regulations to be debated in Parliament at the earliest possible point, I think he spoke for the great majority of parliamentarians.

As the Minister has said, the Government propose to introduce a new tiered system of restrictions for local lockdowns, and, whatever the justifications for them—the noble Lord is right about the evidence that we are facing—they involve a serious reduction of people’s liberties and, of course, put many businesses in jeopardy. I am in no doubt that this House should be asked to approve them before they come into force, just as the Commons is likely to do. My understanding is that that is now likely, and, if so, this is very welcome.

Of course, the relationship between government and local authorities is highly relevant to this and the regulations the noble Lord spoke to today. Right from the start—going back to March—the Government seemed to exclude local bodies from the key part that they could have played in helping to combat and manage the virus. Public health directors were ignored, NHS and university lab capacity was overlooked and, as the Institute for Government has pointed out in its analysis of government decision-making:

“The decisions on lockdown and school closures were taken and introduced swiftly, and with little consultation and planning for how they would work in practice.”


I was very struck by a comment made by the Newcastle City Council leader Nick Forbes a few days ago. He said that confusion over the latest restrictions was deeply unhelpful and that they were very difficult to enforce and had left dangerous conspiracy theories to fill the void. We know that a frequent complaint of many leaders is that local authorities were often given little notice of when local regulations were to be made.

In parallel to the new regulations that we will debate later this week, it has been reported that the Prime Minister wants local leaders to help shape the package of local lockdown measures. Clearly, as a principle, that is welcome. Does the Minister agree that, generally, evidence shows that, globally, countries that rely on a central approach are not as effective as those that use trusted local bodies? Does he also accept that local authority test and trace services seem to have a much higher rate of contact, both for complex and non-complex cases, than the national scheme, which faces so many problems? Can he also expect to see the ending of decisions on lockdowns being leaked in advance of local leaders being told what is in them?

It is clearly important that the rules are complied with. Will the noble Lord say something about compliance rates? I do not know whether he has studied the recent report of the C19 National Foresight Group, which has been looking at the communications the Government have with the public over these restrictions. It concluded:

“National Integrity and Trust is Being Eroded”


because of the

“style, pace and timings of communications”.

It says:

“This mostly focussed around rhetoric, over-promising and timing (where late night national announcements created negative impacts on the relationship with the public). Apparent conflicting activities (where two announcements seem to contradict) and stating ambitious targets that are then not achieved were aligned to eroding trust with the public.”


Regarding local bodies, the C19 group went on to say:

“The lack of trust in the local structures from ministers and government departments… also impacts on their ability to feel included as part of a greater UK wide management”


of the pandemic. Does the Minister recognise this, and will this be considered as part of the recasting of the relationship between the Government and local authorities?

[The Deputy Speaker (Lord Lexden) (Con)]

My Lords, I apologise again, particularly to the noble Lord, Lord Hunt, and the noble Baroness, Lady Thornton. I was looking at the list for the next debate. I call the next speaker for this debate, the noble Lord, Lord Greaves.