Medicines and Medical Devices Bill

Baroness Walmsley Excerpts

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

The key issue, as I see it, is that Clause 16 is silent on the issue of which data should require the patient’s consent. My amendment would require that the types of data subject to consent should be clear when set out in regulations. I hope the Minister will agree that clarity for all concerned, not least for patients themselves, is essential. I look forward to his reply, as I have already given notice of my concerns and what I intended to say today.

[Baroness Walmsley (LD) [V]]

My Lords, I add my voice to those of the noble Baroness, Lady Finlay, and the noble Lord, Lord Ribeiro, on their Amendments 86, 88 and 102, about having unique identifiers for medical devices. In these days of barcodes, this should not be too difficult nor add much, if any, cost for the manufacturers. Indeed, it has been proved to work with medical devices, as the noble Baroness explained.

It is important that products found to be faulty are speedily traced. If my digital radio can be recalled speedily because it might burst into flames, surely a medical device implanted in someone’s body must also be able to be recalled speedily. Recall could also be useful when something better comes along; it could be vital for the future treatment of the patient.

There are occasions when an individual product develops a fault, although the majority of products of that model are perfectly okay. If we are to learn lessons and improve products, as the noble Baroness, Lady Cumberlege, has just pointed out, it would be essential to know where they are and how the receiving patient has reacted to them. A unique identifier could facilitate that, and also provide some protection for the patient concerned, especially in the case of a recall.

I look forward to the Minister’s answers to the questions that the noble Baroness, Lady Cumberlege, asked about patient consent. It is vital that patients have confidence in the system. Confidence in their own privacy is part of that, and patients can have that confidence only if they know what is being shared, and by whom.

[Baroness Redfern (Con) [V]]

My Lords, I am pleased to speak to this group of amendments, and to thank the noble Baroness, Lady Cumberlege, who has been so diligent in her review in proposing such needed changes, and making good for the recipient and building user confidence in the devices offered. It is a pleasure to follow the noble Baronesses, Lady Finlay and Lady Walmsley, and the noble Lord, Lord Ribeiro—as well, of course, as the noble Baroness, Lady Cumberlege.

I spoke on Second Reading in support of an extensive programme for medical devices, to provide for high standards of safety and to share vital information, with data central to effectiveness. The noble Baroness, Lady Cumberlege, in her review, regarded being able to track which treatments and implants people have had as being of particular importance. A barcoded wristband, with equipment used in treatment, including implantable medical devices, being scanned and tracked to a patient’s record, would save much precious time for product recalls, and reduce drug errors.

This means knowing who has had a device used in their treatment, so that they can be swiftly notified if there is a problem. Having unique device identification is therefore very important. The noble Lord, Lord Ribeiro, said—and I agree—that we must consider tracking all medical devices used in the UK, rather than a select few.

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[Baroness Walmsley (LD) [V]]

My Lords, I heartily support the noble Lord, Lord Field, and the noble Baroness, Lady Meacher. I thank the noble Lord for his important evidence, and congratulate the noble Baroness on her many years of energetic campaigning on this matter. Noble Lords may know that I too have campaigned long and hard for medicinal cannabis projects, that have been proved to be safe and effective, to be prescribed on the NHS for UK patients. When the Home Office changed the status of medicinal cannabis two years ago, many of us thought that, given the mass of evidence that there are many such safe and effective products in widespread use abroad, such medicines would become available free to UK patients. That has turned out not to be so. Although some expert clinicians are prescribing them for appropriate patients—including the noble Lord, Lord Field—in a private capacity at high cost, very few patients have received their medicine free on the NHS. Why is this? It seems that it is because NICE has not approved them because there have not been any random controlled double-blind trials. Therefore, several health trusts are forbidding consultants who want to prescribe these medicines to do so, on pain of losing their jobs.

There are children with intractable epilepsy in this country whose lives have been saved by the medicines, for which their parents have had to fundraise. The lives of some of those children have been put at risk because the coronavirus has prevented that fundraising, and they suffered serious preventable fits. Many of these children have been treated with approved pharmaceutical medicines that have never been approved for use with children and have serious side effects. That is why we need a proper regulatory framework based on the full cadre of available evidence, which this amendment proposes. It will not be difficult to establish the safety of these medicines, as required by subsection 3(a). If those making the regulations are allowed to take into account the health records of people who have already been taking these medicines, and also the vast amount of evidence from other developed countries which the noble Baroness, Lady Meacher, has listed, that will subsection 3(c). Subsection 3(b) requires that availability be considered when making the regulations. These medicines are readily available. Indeed, a lot of them are being made in this country and exported because they cannot be sold here. How mad is that? Nor are they expensive as medicines go, and the NHS can bulk buy at a discount anyway.

In order to satisfy those who do not trust evidence from other countries—although why is beyond me—we also need to collect data from UK patients who are managing to get cannabis medicines in order to provide the information required by NICE, but there is no system in place to do that. Will the Minister say why the NHS Commissioning through Evaluation system is not being used? It is a well-established and approved system that collects patient data and clinician observation on the use of novel medicines and treatments. It strikes me that, given that cannabis medicine’s illegal status made it impossible to collect much UK data before 2018, it would be an ideal candidate for this trusted method of evaluation. Finally, I would welcome the Minister’s response to this suggestion.

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

I call the noble Lord, Lord Norton of Louth. Lord Norton? We will move to call the noble Lord, Lord Patel, and come back to the noble Lord, Lord Norton if we have time. I call the noble Lord, Lord Patel.

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[Baroness Penn (Con)]

I thank the noble Baroness for her comments about the importance of evidence. The Government and the MHRA recognise some of the difficulties around these trials. That is part of the reason that NIHR is supporting two trials and is asking people to come forward. The MHRA has also indicated that it is willing to work with those who have these products in order to support them in the process for licensing.

That has reminded me of one other point. The noble Baroness, Lady Walmsley, asked me about the NHS commissioning through evaluation programme. I undertake to write to her with a response, perhaps when I update the noble Baroness, Lady Thornton, on prescription numbers.

[Baroness Walmsley (LD) [V]]

My Lords, I thank the Minister for that. With regard to her earlier response, if it were as easy as that, there would have been tens of thousands of NHS prescriptions in the past two years, but clearly that has not been the case. The noble Baronesses, Lady Finlay and Lady Meacher, have both made it clear why it is very difficult to conduct randomised double-blind clinical trials for these products. That is why I have suggested that, while we wait for many more than two trials, the commissioning through evaluation system could be used. I am grateful to the Minister for promising to write to me about that.

[Baroness Penn (Con)]

I thank the noble Baroness for her comments. I emphasise that there has been a great deal of discussion in the debate about the use of evidence. That is what will guide the Government and the MHRA in this, and that is why we are supportive of these RCTs taking place.

Covid-19: Dental Services

Baroness Walmsley Excerpts

Tuesday 10th November 2020 Lords Chamber

Asked by

[Baroness Walmsley]

To ask Her Majesty’s Government what measures they are taking to ensure the continued provision of dental services during the COVID-19 pandemic.

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

My Lords, the challenge presented to the dental profession by Covid is severe. We are grateful for the hard work of 10,000 NHS and private practices in introducing PPE and infection-control arrangements to keep patients and staff safe, and to the 600 urgent care centres that are providing services for the most severe cases. However, the impact on the nation’s health remains something that we are working hard to mitigate.

[Baroness Walmsley (LD) [V]]

My Lords, I thank the Minister for that reply, but 60% of dentists can now see only a quarter of their usual number of patients, particularly because of the measures needed for carrying out aerosol-generating procedures. There is a backlog of 15 million treatments, and many dentists are in danger of going out of business. They cannot afford ventilation equipment, which would enable them to see more patients in a day. Will the Government provide funding for this, so that the backlog of patients can be cleared?

[Lord Bethell (Con)]

My Lords, I completely acknowledge the challenge that the noble Baroness has described. Many dentists can see only 20% of their normal cases, and around half can see about 50%. The backlog is, as she describes it, severe, and the impact, particularly on private dentists, has been very hurtful for their businesses. I cannot make a commitment to fund ventilation arrangements, but we acknowledge the scale of this challenge and are looking at ways to mitigate it, including bringing in testing, which we hope would help provide a safe environment for both staff and patients.

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

Baroness Walmsley Excerpts

Wednesday 4th November 2020 Lords Chamber

[Baroness Walmsley (LD) [V]]

My Lords, I support the need for the lockdown and will not be supporting any of the amendments to the Motion that express regret. However, I regret the fact that the Government did not accept the advice of their scientific advisers and take the decision to do this sooner; if they had, the NHS might not have needed to move to the highest level of risk in its emergency preparedness framework this morning.

I agree with my noble friend Lord Scriven that the Government must use the lockdown to get test, trace and isolate right. There is no point in boasting about the capacity of 500,000 tests per day; people do not trust that figure because we know that it does not mean 500,000 people tested, so it undermines trust and affects compliance. Although the processing time of the tests has improved, it is still not good enough. Tests have been returned several days late or are sent back to the wrong care home, so they are of no use.

Isolating rates may be as low as 10% and the ability of police and local officials to enforce quarantine is low. We need to use the carrot rather than the stick and make more support available for those isolating. I heard an MP the other day say, “Just pay their wages”. After all, it is for only two weeks, but it would have a massive effect on people’s willingness to isolate, and that matters for getting the R rate right down. If we do not reduce the R rate well below one, it will cost the economy a lot more because the lockdown will have to be extended. Will the Government consider this?

The Government are now trialling the new mass testing system in Liverpool, and I wish it well. However, from residents’ comments I have heard, they do not seem to have the messaging right. People are questioning why they need to take a test if they feel well. That, of course, is the point—testing potentially asymptomatic people—but, clearly, the message has not got through. What does the Minister propose is done about that?

Now that the rapid test is available, could it please be given to relatives of care home residents so they can safely visit their loved ones whom they have not seen for many months? Finally, there are children with very rare diseases who need special treatments which schools cannot cope with and who therefore cannot go to school, and their parents are getting to the end of their tether. The prospect of another four weeks of lockdown fills them with dread. They also need more clarity about who should shield. Will the Minister look into this because these families have been left behind?

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

Baroness Walmsley Excerpts

Monday 2nd November 2020 Grand Committee

[Baroness Walmsley (LD) [V]]

My Lords, I intend to focus my remarks on the human tissue and organ transplant regulations and, in particular, on the issues of timeliness and trust.

I have a particular interest in both of these issues. Back in 1995, I gave my consent in Brussels for organs from my deceased husband to be removed for transplantation. I was happy to do so and received considerable comfort from the fact that, even after his death, he could do some good for other human beings somewhere in Europe. I mention this because, at the time, we and Belgium were both members of the European Union, and the administration and procedure were expedited smoothly and professionally. Since the 2016 referendum, I have been anxious that no barriers should be put in the way of the continued smooth running of this process.

As we have heard, in 2019 a set of regulations was approved to ensure that EU standards would continue during the implementation period, and today we have regulations that take account of the unusual position of Northern Ireland following our exit from the EU. The regulations ensure that, as long as Northern Ireland takes certain steps which have little or no cost, the same standards will apply and no barriers will be put in the way. I am reassured about that—in theory.

However, there are many practical considerations when you are dealing with human tissues that must be delivered in a timely way. The numbers we are dealing with are significant. Between April 2019 and March 2020, 32 organs from deceased donors moved from GB to Northern Ireland, and 126 organs moved in the other direction. As the Minister said, there are two tissue establishments in Northern Ireland, and they will continue to be able to receive tissues and cells from GB, but they will treat GB as a non-EU member state for this purpose.

I understand that Northern Ireland must continue to meet the requirements of EU directives for as long as the protocol is in force. But, as other noble Lords have said, changes to these instruments may be needed if there are changes to the directives. Can the Minister confirm that the Northern Ireland Administration intend to make these changes if they happen, and, if that is the case, what is the British Government’s intention?

My interest in the human tissue regulation is both personal and general. I have a family member who is currently awaiting a bone marrow transplant and, fortunately, matches have been found in other countries, possibly Northern Ireland. Time is of the essence, so my concern is whether organs and tissues from abroad will reach UK patients in a timely way after the end of the transition phase. If the ports are blocked, the Government have suggested that tissue and medicines—and indeed pharmaceuticals—will be flown in. But look what has happened to the aerospace industry during the pandemic. Will there be enough resource? Will the military be used if there are blockages?

I am also concerned about UK bioscience research. There are about 5,000 imports of tissues and cells from the EU alone in a typical year, so it is essential for UK life sciences that there are no barriers to this work. Can the Minister reassure me?

These SIs are to bring EU regulation into UK law, whether or not we get a deal. It is looking as if we will not. When the 2019 SIs were debated in Grand Committee on 9 January 2019, in Hansard col. 201 the Minister said that such materials would be “prioritised”. However, the problem is that everything will need to be prioritised.

In that debate my noble friend Lady Barker raised the issue of inspection of premises, pointing out that the UK and the EU will each inspect their own premises. But what happens if there is a serious incident on one side or the other? Will this not destroy the trust that is needed for this system to work? It is also essential that the public trust the regulations since, in many cases, such as transplantation, their permission is needed. How will the Minister reassure any member of the public listening to this debate that they can have the confidence to give that consent once we are independently responsible for our own standards? As the noble Lord, Lord Alton, said, confusion and inconsistency can destroy trust.

Medicines and Medical Devices Bill

Baroness Walmsley Excerpts

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

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

My Lords, I echo the point made by the noble Baroness, Lady Masham, about the noble Baroness, Lady Jolly. I am sure that we all send her our very best wishes.

I speak on the amendments tabled by my noble friend the Minister. However, on a quick clarification on something that the noble Baroness, Lady Thornton, said in the last debate, which is germane to this debate, I was not making the point that I believe that there can be trade-offs between safety and attractiveness as the Bill currently defines it. Rather it was around the effectiveness and efficacy of medicines and medical devices—points that were, thankfully, made much more clearly by my noble friend Lord Lansley than they were by me—and the impact on what that means for safety and its overridingness as a priority, even if it is always our most important consideration.

On the substance of the amendments, I am sure that my noble friend was not expecting complete consensus around his amendments and he certainly has not found it yet. However, I applaud him for his clarifications on the impact of the attractiveness subsection and also applaud him for moving so quickly in response to noble Lords’ concerns. None the less, there is an issue around this, which the noble Lord, Lord Hunt, brought out. It is an unfortunate truth that the NHS has a poor history of performance in scaling up innovative medicines and devices. I know that that is something that my noble friend is very concerned about.

I have a specific question in this area. In asking it, I draw attention to my entry in the register of interests, in particular as an adviser to Healthy.io. Do my noble friend’s plans for improving the attractiveness of the UK include improving the attractiveness of the UK as a place to develop, trial and scale data-driven health technologies? I know that we will come to that topic later, when the noble Lord, Lord Freyberg, has his amendments, but can my noble friend confirm that they are included in the definition of devices and explain his intentions in this regard?

[Baroness Walmsley (LD) [V]]

My Lords, this group begins with the Government’s minimal attempt to define the word “attractiveness” in Clause 1(2)(c). I am afraid that I preferred the version in Amendment 20 in the name of the noble Baroness, Lady Thornton, and others. I think that it became clear to the Minister in meetings before Second Reading and in the debate itself that many of us felt that a word such as “attractiveness”, which is very unusual in a piece of health legislation, requires a clear definition in the Bill.

“Attractiveness” is one thing, if properly defined, but “ambition” is another. That is what my noble friends Lord Sharkey and Lady Jolly—to whom I send my best wishes—seek to do in Amendment 15, for human medicines, Amendment 58 for veterinary medicines and Amendment 78 for medical devices. I am sure that my noble friend Lord Sharkey will say more about these in a few moments. But if Brexit must happen, which unfortunately it must, there is really no point if it does not allow us to do better than we have done before. That is why inserting the words “maintaining or improving” is so important. As others have said, the UK has hitherto been a very attractive place to conduct clinical trials, partly because of our massive access to patients through the NHS, partly because of our expertise and high standards and partly because of our alignment with the EU and its 400 million citizens.

This is particularly important for rare diseases, where the numbers of sufferers in the UK alone are too small for a trial of statistical significance. Alignment with the EU is, therefore, particularly important for maintaining our attractiveness, and this is dealt with by other amendments that the Committee will debate later. However, we should be wary of throwing away the advantage of that alignment; to do so would give us a much bigger mountain to climb if we are to improve our attractiveness. I hope that the Minister will bear that in mind when he replies.

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[Lord Crisp (CB) [V]]

My Lords, I support Amendment 19, which would have been important at any time, but is, of course, as we have already heard, particularly important at the moment. I will speak briefly, and I can do so thanks to the eloquent contributions by the noble Baroness, Lady Sheehan, in moving the amendment and by my noble friend Lord Alton.

There are points of principle here, and practical points. I start with the points of principle. First, the UK signed up to the International Covenant on Economic, Social and Cultural Rights in 1976, which guarantees access to medicines as part of the right to the highest attainable standard of health. This should be integral to all our medicines regulation.

Secondly, as we have heard, the World Trade Organization’s TRIPS Agreement explicitly included public health standards, giving countries the right to grant compulsory licences and to determine where there is a national emergency, and the freedom to establish a regime of exhaustion of intellectual property rights—in other words, taking control of access to medicines on behalf of their populations. Both these principles are underpinned by the basic responsibility that Governments have for maintaining, protecting and improving the health of their people, but also by the wider points that my noble friend Lord Alton just talked about on our interconnectedness and responsibilities to our fellow citizens of the world, in our own self-interest as well as from other motivations.

However, as the noble Lord and the noble Baroness said, in addition to principles there are very practical issues that should guide our thinking on this. The first is that there is good precedent. The UK and other Governments have used, and/or threatened to use, these rights on several occasions over the years with good effect for the benefit of their people. They are useful and viable measures, and should be at the front of our minds at this time, because—here the point is being made again—the response to Covid is bringing with it a frankly unprecedented number of new treatments and vaccines in a relatively short period of time. It is vital that these are made available as quickly, widely and cheaply as possible, not just in the UK.

I echo the questions from the noble Baroness, Lady Sheehan. I will be interested to hear the Minister’s response about our participation as a country in the global sharing and the global effort.

It was good to hear my noble friend Lord Alton’s description of the situation in Africa and of the imperative need for us to bear that in mind in our policy-making here in the UK, while also bearing in mind the great reputation that we have had over several years for doing so. On Friday, I got in touch with the World Health Organization in Africa. Some of the figures that the person I spoke to talked about, regarding the impact of the pandemic on wider health issues, were formidable indeed. I was told that we have lost the gains of 25 years in the past 25 weeks—an extremely depressing statement.

Just as depressing, as both noble Lords mentioned, is the fact that we are already seeing signs of the way in which some pharmaceutical companies will approach this extraordinary period of new vaccines and treatments in what is happening with remdesivir, with shortages and treatment rationing here in the UK, let alone anywhere else.

This amendment is absolutely right in asserting that the UK should reaffirm its position and its rights to protect the health of its population. We should adopt it. The future will be difficult, as will the negotiations on this issue, but no one should be in any doubt about the UK’s firm position. We should support not just the UK’s position for the population of the UK directly but a global effort to deal with these important matters.

[Baroness Walmsley (LD) [V]]

My Lords, the Government take an enormous number of powers to make regulations in the Bill.

In the light of the paucity of parliamentary powers to check these, particularly prior to them coming into effect—as demonstrated by the recent Covid-19 regulations —the only way in which Parliament can influence these regulations before they are even drafted is by inserting into the Bill those things to which Ministers must have regard. That is why my noble friend Lady Sheehan seeks via Amendment 19 to insert two important elements into the Bill after the priorities of safety, availability and so-called attractiveness. I support her amendment and look forward to the Minister’s answers to her questions.

Proposed new paragraph (d) would ensure that the Government have regard to the International Covenant on Economic, Social and Cultural Rights of 1996, which the UK ratified 10 years later. This affirms a citizen’s basic human right to access medicines without discrimination, which means that they must be both affordable and available. We have committed ourselves to that.

Proposed new paragraph (e) reaffirms the international protections conferred by the WTO’s TRIPS Agreement. It recognises that these intellectual property rights protections have been misused and abused by big pharma; that resulted in the WTO’s Doha declaration of 2001, which reaffirmed public health safeguards for citizens of all nations. The details are in the amendment.

The amendment is absolutely crucial as the world awaits new tests, treatments and vaccines for Covid-19, as other noble Lords have mentioned. In particular, the pandemic demonstrates the importance of paragraph (e)(ii): the right to determine what constitutes a national emergency. The Government have used that.

However, the track record of big pharma does not bode well for equitable distribution of medicines, and this demonstrates the importance of the right to issue a Crown use licence. Drugs to treat cancers, HIV/AIDS, hepatitis C, cystic fibrosis and toxoplasmosis have all been withheld from citizens while Governments were held to ransom during negotiations with pharmaceutical companies. The NHS has had to ration necessary drugs because of price gouging. The threat of using a Crown use licence, and the actual issuing of one, has been helpful in such negotiations, and several countries have used the powers to great effect.

The issue of compensation, however, needs to be clarified. This section of the law has not been tested in court. Will the Minister commit the Government, therefore, to review Section 57A of the Patents Act to ensure that it does not block the use of the crown use licence provision? Countries such as Australia, Canada and Germany have revised their patents laws for this purpose, and other countries have taken action. Will the UK Government do the same? This power could be needed to ensure access to Covid vaccines and treatments, so time is of the essence. Will the Government act now and not just stick to business as usual?

[Baroness Penn (Con)]

My Lords, I suggest that this is an appropriate moment at which to pause our debate for today. I beg to move that the debate on this amendment be adjourned.

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

Baroness Walmsley Excerpts

Thursday 22nd October 2020 Lords Chamber

[Baroness Walmsley (LD) [V]]

My Lords, I agree with the noble Lord, Lord Rooker, about the difficulty posed by the complexity of these regulations, and with the noble Lord, Lord Hunt. Poorer people, without a smartphone that supports the NHS app, are more likely to be fined if they fail to isolate than those who have the app. This is because, without the app, the only way that they can be asked to self-isolate is by test and trace or a council official. If those with the app who learn that they have had a contact are not subsequently contacted by test and trace and asked to self-isolate, nobody will be able to enforce the penalty if they do not.

Given the poor record of NHS Test and Trace in contacting those who have tested positive and their contacts, that would leave an awful lot of people not self-isolating and not liable for a penalty if they do not. I am concerned that these penalties may deter people from taking a test. Also, a person who tests positive may be quite reluctant to disclose any contact who they predict is not likely to be able to self-isolate, in case they expose them to the possibility of a big fine.

Like the noble Lord, Lord Hunt, I am also concerned about the disclosure that the police will be given the details of people who have been asked to self-isolate. The BMA and the Chief Medical Officer have expressed concerns that this could also deter people from getting a test, and this would apply in particular to those who feel that they cannot afford not to go to work. Why is it necessary to involve the police? This is a disclosure of health information and an invasion of privacy. If the police are informed, what guidance and training are they given about how to approach the person concerned? Will they initially explain why self-isolation is important and direct them to support before using the big hammer of a fine?

Medicines and Medical Devices Bill

Baroness Walmsley Excerpts

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

[Lord Lansley (Con)]

My Lords, I am grateful for the opportunity to speak on this group of amendments. May I, however, begin by seeking clarity about the grouping of the amendments? Amendment 116 is also to be found in the eighth group and is more appropriately to be found there. It is my amendment; I know where it should sit properly. It does not belong in this group and is not relevant to this subject. However, I think the Marshalled List should list Amendment 116 in the name of the noble Baroness, Lady Thornton, who raises what is effectively the sunset issue in that amendment. The noble Lord, Lord Patel, who I always think of as a friend, referred to his Amendment 141, which is not listed in the grouping but should be here; Amendment 142 is listed in group five and also should be here. With those two changes, I think that we are talking about the right group.

I could stop now, but I will be quick and refer to just two things. First, as a former Leader of the House of Commons, responsible for the legislative programme, I view with deep unhappiness the idea of attaching three-year sunset clauses to all the legislation we put through the House. If we start down that path, we will never introduce new legislation but will constantly be revisiting old legislation and trying to renew it. There is an argument about the nature of this Bill but it is an argument I am proposing to have when we debate the next group of amendments. It is skeletal, and there are things we can do to make the power not only clearer in its purposes but much more accountable if used. So, I am against the sunset clause.

My other point relates to Amendments 50, 67 and 115 in the names of the noble Lords, Lord Patel and Lord Kakkar. I have great sympathy with these. I think it was the noble Lord, Lord Patel, who referred to the consolidation of human medicines regulations in 2011 or 2012. There is a great deal to be said for the regular consolidation of legislation to make it more accessible. I do not regard consolidation as a purely technical legal exercise; it should always be used as an opportunity to simplify and clarify. It is not, in my view, sufficient to say, as I think Ministers might well reasonably do, “We consolidated human medicines legislation and we will continue to keep the regulations in as clear a form as we can”. From time to time, there is a purpose in coming back to primary legislation and looking for clarity and consolidation. That is often what we use the Law Commission to do, because it has particular expertise in this area. It may be inappropriate to do so at this stage for human medicines because of the necessity of making the regulations and of transposing former EU regulations and directives into UK law. It is perfectly reasonable for that to happen over some period of time, but I hope that Ministers will consider that.

Where medical devices are concerned, there may be a better argument. The noble Lord, Lord Patel, was quite right—navigating medical devices legislation is, if anything, harder than navigating human or veterinary medicines legislation. There is a lot to be said for finding the consolidation instrument for medical devices regulation, once we know what it looks like and we have brought it into force. My friends the noble Lords, Lord Patel and Kakkar, are on to something; I just do not think that new primary legislation within three years is the route. However, for Ministers to recognise the value of consolidating instruments including, from time to time, consolidating primary legislation is certainly desirable.

[Baroness Walmsley (LD) [V]]

My Lords, I support the attempts in this group to put a sunset clause into the Bill. I have a great deal of sympathy with the demands of the noble Lord, Lord Patel, for consolidation. It is vital that through these amendments and others to later clauses, we are able to review the use of the Bill’s powers by this failed Government, who have made so many mistakes. A Government who cannot even secure the free trade agreement that was supposed to be the easiest thing ever, who disastrously and expensively have not produced the promised world-beating test and trace system and who have presided over one of the worst rate of Covid-19 deaths in Europe due to their dithering and failure to put health first, must have their powers fettered. But, as has been said, this is a skeleton Bill and gives the Government extensive powers with little ability for Parliament to intervene.

A lot is changing. The Brexit transition phase is coming to an end in a couple of months. We have learned many lessons from Covid-19, which should be implemented. The NICE review is coming up, and every month new medicines and therapies are coming on to the market. It would be folly not to have a sunset clause in the Bill. I therefore support what was said by my noble friends Lady Jolly and Lady Thornton, and urge the Government to consider, in all humility, that in two or three years’ time they may not be in power, and the whole landscape will have changed. It is therefore essential that we have an opportunity to review how the powers in the Bill have been used to change things, especially if all has not gone well.

[Lord O'Shaughnessy (Con)]

My Lords, I point out to noble Lords my interests as set out in the register. On Second Reading, when taking a somewhat unfashionable stance in defence of the delegated powers, I said that I was not going to die on that hill again—but, to mix my metaphors, I have been drawn, like a moth to a flame, back into this argument.

I want to make two brief points. The first has been perfectly well made already by my noble friend Lord Lansley, and is about the sheer impracticality of sunsetting legislation. Committing to an arbitrary deadline of that kind is not something that any Government could responsibly do, particularly at this time, and given the uncertainty that has already been discussed.

The second point is that many of the criticisms raised by the Delegated Powers and Regulatory Reform Committee and by the Constitution Committee have been dealt with, to some extent, by changes that the Minister, my noble friend Lord Bethell, has proposed to the affirmative procedure, which we are not discussing today. It is therefore worth recognising the progress that the Government have already made to try to meet those concerns, which were set out so well by the noble Baroness, Lady Thornton, and others, about the powers being given to the Government.

Again echoing my noble friend Lord Lansley, I would say that if we were to go down that route, the amendments tabled by the noble Lord, Lord Patel, represent the right approach, which is to commit not to a sunset clause, with all the cliff edges that that would involve, but to providing draft consolidated legislation. There is a good case in its own right for doing that, particularly in the circumstances. Like my noble friend Lord Lansley, I encourage my noble friend the Minister to look seriously at that idea.

--- Later in debate ---

[Lord O'Shaughnessy (Con)]

My Lords, my only intention in speaking on this group is to ask a question. Given the flag raised by my noble friend Lord Lansley in his Amendment 76, I am glad that I am not the only one with the question, which is whether the concept of medical devices inherently includes their therapeutic usage. My understanding is that they are regulated as medical devices, not simply devices, and therefore the way in which we regulate and risk-stratify them as we regulate them inherently includes therapeutic use. The fact that my noble friend raised the question in his amendment made me slightly worried, so I seek the Minister’s reassurance on that point.

I have also become aware during this discussion of another issue worth considering. There has been some debate about the appropriateness of government amendments being approved in Committee. I concur with the view of my noble friend Lord Lansley that a Bill on which only half the Front Benchers agree is better than one on which none agree. I have been in my noble friend’s shoes and have been frustrated, as I know noble Lords opposite have been, by the need to stick to concession strategies, holding back concessions and amendments until Report. I do not agree with that approach. My noble friend has done absolutely the right thing in bringing forward amendments at the earliest possible opportunity, however imperfect they are. The problem with leaving everything to Report is that it is an all-or-nothing approach, as we do not tend to amend at Third Reading, whereas this potentially leaves open the iterative approach that I would like to see more of. Maybe my noble friend has even set a precedent, heaven forbid, in doing this. We would all welcome it as giving more than one opportunity to improve legislation, on Report. I hope that we can agree the government amendments because, as everyone has said, they are an improvement on where we were and we would have another opportunity, if the House felt it necessary, to improve them further on Report.

[Baroness Walmsley (LD) [V]]

My Lords, I support Amendment 5, which would insert the words

“objective of safeguarding public health by promoting the availability and supply of human medicines”.

While the purpose of the Bill is to bring some sort of order out of the chaos of Brexit, it is vital that we put those words up front. In the first words on page 1, before Clause 1, the purpose of the Bill is described as

“the protection of health and safety, in relation to medical devices”.

Why does it not say, “in relation to medicines and medical devices”? That is why we need Amendment 5.

Government Amendments 2 and 7 are weak, in my view. For example, the words “promote health and safety” in Amendment 2 and “considering whether they would” in Amendments 7 and 72 are well meaning and better than the original but, I dare to say, legally useless.

The word “promote” also appears in government Amendment 68. In contrast, the noble Lord, Lord Lansley, and the noble and learned Lord, Lord Woolf, use the much stronger word “safeguard” in their Amendment 70, which I support. I also support their probing amendment for clarification in Amendment 76 that therapeutic practice is also included. I will be interested to hear whether the Minister can explain whether this is needed or, perhaps, not.

[Lord Kakkar (CB) [V]]

My Lords, I support Amendments 5 and 70 in the names of the noble Lord, Lord Lansley, and the noble and learned Lord, Lord Woolf. I seek further clarification on the Government’s purpose regarding the amendments proposed by the Minister.

First, what is the rationale for moving away from the current basis on which regulations in this regard exist, which states the purpose of safeguarding public health? Why do the Government not think that appropriate as the basis for legislation for medicines and medical devices? It has been the basis on which regulations have previously existed in domestic legislation and it seems counterintuitive to move away from that purpose, as so clearly explained by the noble Lord, Lord Lansley.

Secondly, there is this question of whether there should be an objective or a subjective test attending the purpose of legislation, all parties having agreed that it is of benefit to move away from simply having a power to clearly defining a purpose. There has been considerable debate and discussion about what is considered the frequent use of judicial review now and how in some way it undermines the position of Parliament and is less than helpful more generally in our country. It seems therefore intuitive for a Government who have concerns about what is sometimes considered excessive use of judicial review to try to provide legislation that would make it less necessary and less frequently turned to.

The noble and learned Lord, Lord Woolf, made the point that clarity is essential. Surely an element of clarity would be to have in place an objective test—to safeguard public health—rather than, as currently, merely being “satisfied”. The need that the Secretary of State can make regulations if he is satisfied, as we have heard in this debate, is much more subjective and therefore must be open to much more frequent challenge.

--- Later in debate ---

[Lord O’Shaughnessy (Con)]

The noble Baroness, Lady Thornton, got to the heart of this when she said that these discussions are central to our debate on the Bill and its purpose.

I preface my comments on the amendments by drawing on my experience as a Minister with responsibility for preparing the health and social care sector for Brexit and for medicine regulation. During that time, I spent hours and hours—days and days—of time with pharma and medical device companies, patients and others. There was a consistent message from almost all of them about the desirability of remaining part of the EU family if possible and the importance of the MHRA and our notified bodies as regulators within that regime. I, together with others, worked extremely hard to make sure that that was recognised in the withdrawal agreement that was agreed at the time. We managed to create a special category of safety products. For those who remember back two or three years, there were chemicals, pharmaceuticals and medical devices in the withdrawal agreement and, indeed, the political declaration. I worked very hard to achieve that position and supported it.

It might also be worth reminding noble Lords that Parliament passed up the opportunity to agree that withdrawal agreement. It did not succeed. That has led to a different Government with a different agenda and with a majority, which might be something for us all to reflect on.

I make those points only so that noble Lords will understand that my concerns with the amendments on aligning with the EMA and European regulation in general are not ideological but practical. Actually, this is a very heterogenous group of amendments: it ranges from alignment through to collaboration to similarity where possible. When considering the issues around this, we need to tread very carefully as to what we commit ourselves to. The fact is that, as negotiations have progressed, it has become completely clear that the European Commission will not tolerate any meaningful associate membership: you are either in or you are out, and there is no possibility of the UK participating in making the rules that bind it. Clearly, being in is not compatible with leaving the European Union, so the question that falls to us is what we do when we are out. What should we do as a sovereign regulator that is not part of the EMA?

This is where I disagree with those amendments that seek to align us with the EMA. The truth is that we cannot have the best of both worlds; we cannot—as the Prime Minister might put it—have our cake and eat it. We cannot be in and take advantage of the opportunities that being out gives us. Tying ourselves in advance and in perpetuity to EU regulation over which we have no control or, critically, judgment of quality, would be a big mistake.

It is quite right that we should seek to mitigate the negative impacts of leaving the EMA family. I have never sought to sugar-coat those—I do not take a Panglossian view of the consequences—but tying ourselves in such a way is not the way to do it. Multiple stringent regulators in the world do just as good a job, if not better, as our MHRA—in Japan, Switzerland, Canada, Singapore and bits of the EFTA. We should as a nation be seeking to accept licensing applications and modelling our regulatory structures on all and any of those that we think are the best. That is the way to take advantage of our freedoms and give us the best possible opportunity of getting innovative medicines and products as they come on to market in any market in the world.

We do not need, as the noble Lord, Lord Hunt, and others, said, to create our own bespoke, novel, difficult regulatory system that puts up more barriers to innovation; nor should we tie ourselves to one other regulatory regime. I use just one example to exemplify why I think that is true. It is a well-worn example but is worth rehearsing: the introduction of the HPV vaccine. That was something that most regulators in the EMA family did not want to proceed with. The MHRA provided a very compelling case for us to do so. European countries did so. The effect of that in England alone has been to reduce HPV infections among 16 to 21 year-old women—the figures are a couple of years out of date but are probably still accurate—by 86%. Bear in mind that HPV causes 80% of cervical cancers among women. We might be tying ourselves to things that we regret and which cause harm; I know that that is not something that anyone would want to do.

I note from the ABPI’s briefing—obviously, I have worked closely with it—that it does not call for alignment with the EMA. It calls for making sure that

“the information or data required by the EU regulator is consistent with other leading regulators around the world and benchmarked against them for speed and approval.”

It also calls for the UK to apply for full membership of the ICH, as the amendment in the name of the noble Baroness, Lady Jolly, calls for—I quite agree with that—and generally to look to provide leadership on developing global regulatory standards in human medicines.

I utterly understand the impulse. The Government have partly got themselves into this difficult situation by creating a vacuum into which people are seeking to put policy. That is completely understandable but it would be a mistake to tie ourselves to one particular regulator. It may not be quite as true of clinical trials—I defer to the expertise of others—although I note that the ABPI briefing paper does not talk about the clinical trials directive; instead, it uses a much broader palette and says that future clinical trials and regulations in the UK should both support and enable international collaboration.

I know that that is not the only position and that people take a different view, but as we move forward, we will want to tread carefully over which regulators we seek to collaborate with, emulate and draw on, rather than tying ourselves to an in-perpetuity relationship that we may come to regret on occasion.

[Baroness Walmsley (LD) [V]]

My Lords, Amendment 3 makes clear the desirability of alignment with the EMA and the EU clinical trials regulations. It sets out early in the Bill the store for those of us who feel that the advantages we have gained from such alignment must not be sacrificed on the altar of some mistaken ideology of this failed Government. I point out to the noble Lord, Lord O’Shaughnessy, that we managed to introduce the HPV vaccine before we left the European Union.

Amendment 22 attempts to define the rather vague expression “attractiveness”. We have other definitions in later clauses; we certainly need to choose one of them but I will leave my preference for a later debate.

I support Amendments 34 to 39 to Clause 4 on clinical trials. As my noble friend Lord Sharkey pointed out, they tighten up the wording in the Bill to emphasise the benefits and avoid the damage of diversion from EU clinical trials regulations. British patients benefit from alignment, British bioscience research and development benefits, and the whole system is worth millions of pounds to the Exchequer. I and other noble Lords have received briefings from a number of organisations working on behalf of patients, such as the British Heart Foundation, emphasising that any diversion from these regulations will affect the rapid availability of new medicines and treatments to British patients. They are also concerned to protect the large amount of EU research funding that they currently receive. Diversion could also affect, to use the Government’s favourite word, the attractiveness of the UK as a place to conduct clinical trials. The problem is that the Government have not told us what they might want to change unilaterally in future, as a number of noble Lords have pointed out. I invite the Minister to tell us now.

Amendment 39 asks the Government to establish a clinical trials portal that aligns us with the EMA regulations for medicines for rare diseases. This is particularly important if we are independent from the EU as our population of 68 million is so much smaller than the EU population of more than 400 million, which would make it harder to find a big enough cohort of people with rare diseases for a clinical trial. The noble Lord, Lord Patel, pointed that out.

The EU clinical trials portal, which will come into play with the new and improved EU clinical trials regulations in 2022, was to a great extent designed by British participants. This shows how important it is considered to be by British scientists because it makes applications for clinical trials so much easier and less time-consuming. In its previous inquiry, the Science and Technology Committee heard from a number of witnesses about the issues with the current system, which wastes a lot of their time. So, like the noble Lord, Lord Lansley, I feel sad to know that we will be out of the system by the time the improvements are put in place.

Our current alignment also encourages British scientists to go abroad to broaden their expertise and EU scientists to come here and become part of our very successful research teams. I know the Government are in favour of that because I heard Amanda Solloway, the Science Minister in BEIS, say so last week to your Lordships’ Science and Technology Select Committee. I hope, therefore, the Minister will be minded to accept the amendment.

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

My Lords, I support this group of amendments, especially Amendment 22, but I first congratulate the Minister on his stamina and enthusiasm at this incredibly difficult time. I hope he will be able to answer some of our questions.

I spoke at Second Reading of the need to provide an attractive life science environment for researchers coming from abroad. If we are to recruit the brightest and the best to work in research and clinical trials with the highest standards, we must improve. How will this be achieved? Should they not feel welcome and needed?

Can the Minister assure your Lordships that there will be no barriers to access to medicines for UK citizens?

How can we still have a regulatory leadership role following the UK’s exit from the European Union and the European Medicines Agency? We must not become isolated. I hope we will still collaborate with the EMA and other international regulators. We desperately need new medicines for the very rare diseases. There is nothing more frustrating than other countries having medicines which are denied to people living in England.

I hope the Government will accept the need to incorporate these points, which have been expressed today, to make the Bill clearer and more positive and will put their own amendments down on Report to further improve it.

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

Baroness Walmsley Excerpts

Wednesday 14th October 2020 Lords Chamber

[Baroness Walmsley (LD) [V]]

My Lords, I am not one of those who want zero restrictions, but I want scientifically based timely restrictions with transparency. I am sure that Mr Johnson hoped that his three-tier system would bring clarity for people to follow; indeed, public compliance depends on it. I, too, hoped that replacing the multiple sets of rules would bring that about. Unfortunately, that is not the case and the complexity of these regulations proves it.

The Liberal Democrats believe that we should follow the science. The big question asked by many noble Lords is: why did the Government implement this week only one of the five recommendations made by the chief scientist three weeks ago? How on earth can the Government claim that they are following the science when the minutes of meetings make it clear that they are not? What is the science behind the 10 pm curfew? We have never been told and it has rapidly become clear that it may be having the opposite effect to that intended, as people stream out of socially distanced pubs and mingle out on crowded streets without appropriate space or masks.

As usual the Government made an announcement before they had all their ducks in a row. We hear that discussions with local leaders are ongoing about which tier their areas should be in. One cannot blame them for holding out for more financial support. If the Government had passed on to local authorities even half the money that they have been bunging into profitable contracts with their friends, councils could have used the money to do what they do best—tracing cases and supporting them to isolate, which is best done locally. Yet, the Government insist on allowing the national system to fail before sending many of the cases to local teams, thereby losing a valuable 24 hours. When time is of the essence, this is crazy.

You cannot blame local leaders for seeking to protect their local economy by resisting going into too high a tier. What percentage of cases or growth rates divides one tier from another? We and the local leaders are not told. We now know that many positive student cases are being wrongly assigned to their home area, because that is where they are registered with a GP, instead of at their university. That is skewing the figures. Will the Minister ensure that that factor, like many others, is taken into account when assigning a tier? It is that kind of issue that makes local government highly suspicious of the criteria being used. Councils and their residents also want to know what they have to achieve to have restrictions loosened.

We support the scientists’ alternative proposal of a circuit-breaker.

Social Care Workers

Baroness Walmsley Excerpts

Wednesday 7th October 2020 Lords Chamber

[Lord Bethell (Con)]

My Lords, I pay tribute to all those who contribute to the care of loved ones, neighbours and people in their community. The noble Baroness is entirely right to acknowledge the enormous contribution, born of civic duty and personal love, that people put into caring for those in need. I acknowledge the 10 extra hours that she mentioned; I have no doubt that many have had to put in extra work during the pandemic. That is why we have put in significant financial support for the charity sector, and these are the considerations that we will put into future social care reform.

[Baroness Walmsley (LD) [V]]

My Lords, health and care workers can now be reimbursed for the immigration health surcharge. While this is unlikely to fill the gap identified by the noble Lord, Lord Dubs, it is welcome. How are the Government ensuring that all care workers who do not work in large hospitals are aware of their right to the refund, and how are they monitoring what percentage of those eligible are making the claim and what sort of establishment they work in?

[Lord Bethell (Con)]

This is a very important piece of communication. We have sought to work through the colleges and through the CQC system in order to make sure that employers make knowledge of these funds available to those in social care. I will look at the department to see what we are monitoring and what the take-up rates have been, and if I have any further information I will be glad to write to the noble Baroness with that data.

Health Protection (Coronavirus, Restrictions) (No. 2) (England) (Amendment) (No. 4) Regulations 2020

Baroness Walmsley Excerpts

Tuesday 6th October 2020 Lords Chamber

[Baroness Walmsley (LD) [V]]

Mr Johnson presented the new regulations as a simplification and a strengthening of the coronavirus mitigation regime, based on consultation with the police and feedback from the public that the existing rules had become quite complicated and confusing. However, the Explanatory Memorandum recorded that a public consultation had not taken place, and nor had a regulatory impact assessment, which is why the noble Lord, Lord Lamont, has highlighted the public consultation issue. Perhaps if it had occurred, the public, or local authorities in particular, would have been able to highlight some of the illogicalities of the rules, because now they are even more confusing.

I, too, would like to ask why the rule of six in England includes children, even when they are upstairs in bed, when school-age children can go to school and work in their class or year bubble of dozens of children? This appears to be contradictory. Why are children under 12 excluded from the rule of six in Wales and in Scotland but not in England? Is there evidence in England that young children are more contagious than they are in Wales? If so, why can they go to school? I would really like to know on what scientific evidence the decision is based.

Secondly, I would like to ask about people with a learning disability or autism, for whom contact with family is vital in helping to maintain their well-being, especially during the pandemic. Current guidance on visitation is mainly aimed at care homes; other settings, such as supported living, have little guidance. There is no information, for example, about people with a learning disability visiting family in the community. Will the Minister ensure that this gap is filled? Will he ensure that people who may have difficulty social distancing or following other guidelines are considered when decisions are being made about the prioritisation of testing at a national and local level?