Covid-19: Vaccinations

Baroness Bennett of Manor Castle Excerpts

Wednesday 13th January 2021 Lords Chamber

[Lord Bethell (Con)]

I pay tribute to the role of dispensing GPs, who will play an incredibly important role in the rollout. However, I reject the suggestion that any spike in care homes is in any way related to decisions on the second dose. The new variant has spread throughout society, including care homes, and that is the explanation for the spike.

[Baroness Bennett of Manor Castle (GP) [V]]

Can the Minister assure the House that the Government have a co-ordinated plan involving not just vaccination but improved test, trace, self-isolate and support, and flexing controls on commercial and social activity to reduce and control the levels of the virus over the coming weeks and months? Can he tell us when the Government plan to publish such a plan? Obviously, events will have an impact, but now that we have had a year of learning about the virus, surely the Government have an overall vision of how we as a nation will emerge from the pandemic, and it would help us all if that was shared with the nation.

[Lord Bethell (Con)]

The noble Baroness is right that we have the vaccine today but that does not mean that we will not need to be testing, distancing and washing tomorrow. In fact, there will be a very large number of people—tens of millions—who will not be vaccinated through the summer but who could still catch the disease. We have to make provisions for our public health to protect those people in the workplace, in society and in their homes. The plan is very clear—it is the plan that we have already. However, the noble Baroness is right that we have to be focused on it and ensure it is kept up to date and deployed with energy and enthusiasm.

Medicines and Medical Devices Bill

Baroness Bennett of Manor Castle Excerpts

Report stage & Report stage (Hansard): House of Lords & Report: 1st sitting & Report: 1st sitting: House of Lords
Tuesday 12th January 2021 Lords Chamber

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

My Lords, I, too, add my congratulations to my noble friend the Minister and pay particular tribute to the tireless work of my noble friend Lady Cumberlege in bringing us this far. I welcome government Amendments 1 and 54.

I want to take this opportunity to mention two specific issues that we focused on in Committee and seek confirmation on where we are in this regard. I want in particular to look at the right of patients to report directly on their own experience, rather than waiting for the patient safety commissioner to investigate. I would welcome hearing that my noble friend the Minister imagines that the commissioner should have this power. If not, would he consider introducing such a measure at the first available opportunity? It is so important that the voice of patients is heard. I remember the accounts that my noble friend Lady Cumberlege gave in Committee of her work and that of her team in producing the report, First Do No Harm; that will be a lasting legacy. Allowing patients the right to report directly, without necessarily waiting to be asked, would cut through many of the difficulties with medicines and medical devices, and would enable the patient safety commissioner to report directly to the Government in this regard.

The only other point that I wish to make at this stage is that of the regulations that my noble friend envisages in the government amendments in this group. Can he confirm that these will be discussed and agreed with the devolved Administrations at the earliest possible stage? Can my noble friend assure us that if the devolved Administrations raise any significant issues or highlight any problems that they have with the draft regulations, these will be acted on before the regulations are adopted and sent to each House of Parliament?

We are in a very good place. I congratulate my noble friend Lady Cumberlege and her team on bringing us here, and I pay special tribute to my noble friend the Minister for listening to the concerns of so many people, over so many years, to bring us to where we are today. I wish the amendments godspeed.

[Baroness Bennett of Manor Castle (GP) [V]]

My Lords, I join the universal commendations for the Government for accepting the recommendation to introduce a patient safety commissioner. It demonstrates that campaigning can work for everybody, from school pupils to Premiership footballers to Members of the House of Lords—in this case supported by patients, many of them suffering from continuing illness and disability.

I want briefly to pick up three points made by the noble Baroness, Lady Cumberlege. The first is the importance of the commissioner being a person of standing. As the noble Baroness’s report clearly explains, there is a strong gender aspect to the fact that far too many patients have not been listened to, have been ignored and have been mistreated by the system. It is really important that the patient safety commissioner is well equipped to understand that and make themself accessible to all patients. As the noble Baroness said, it is clear that the patient safety commissioner should be a person of standing and the kind of person who should shape the role that they will ultimately fulfil.

That brings me to my second point, which the noble Baroness and many others have stressed: the urgency of this appointment. As has already been pointed out, the Domestic Abuse Commissioner has been appointed before we have even passed the Domestic Abuse Bill. That is very much a model. I have a direct question for the Minister. It should not be beyond the capacity of the department to advertise this role within, say, one month. If he does not think that this timetable is reasonable, can he suggest what he thinks a reasonable timetable is? The noble Lord, Lord O’Shaughnessy, also asked this. I also echo the point made by the noble Lord, Lord Hunt of Kings Heath, that it is crucial that this appointment has Select Committee scrutiny.

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[Baroness Bennett of Manor Castle (GP) [V]]

My Lords, I will save up some of my time for my next amendment, Amendment 7, so I will be very brief. I will chiefly speak to the non-government amendments in this group. It is encouraging that the Government have taken onboard so many of the contributions from Committee, but that shows what an unbaked condition the Bill came to us in.

To address the somewhat related Amendments 12, 34 and 48, all in the name of the noble Baroness, Lady Thornton, we are talking about publication of the data, information and assessment of benefits versus risks. We heard powerfully from the noble and learned Lord, Lord Judge, and many others in the previous group of amendments how great a concern there is about a lack of scrutiny of this whole procedure in the House. Public scrutiny is surely the best scrutiny of all. I commend all those amendments to the House.

Amendment 5 is very interesting. My innate reflex is to go towards public health as a systems-thinking, sustainable development goal kind of approach to looking at the whole. But to build on the remarks the noble Baroness, Lady Thornton, made in introducing the amendment, which is also back by the noble Baroness, Lady Jolly, when we talk about the immensely financially powerful and often very opaque pharmaceutical industry, with its very large multinational companies, we have to worry about what lawyers call equality of arms and the degree to which economic and financial arguments might be deployed in potentially damaging ways. I am interested in the Minister’s response to Amendment 5, but I can certainly see the strength of the argument of the noble Baroness, Lady Thornton.

[Baroness Cumberlege (Con) [V]]

My Lords, I will speak to government Amendments 11 and 47, and those that follow on from them, Amendments 12 and 48 from the noble Baroness, Lady Thornton. The first lot refer to medicines and the second to devices. But first I thank the Minister for his strong emphasis on safety in all the amendments. He certainly has listened to noble Lords. In Committee we stressed the objective of making sure that the Bill is a safety Bill. I believe that safety now permeates throughout the Bill, which is so encouraging, and I thank him and his colleagues for that.

Although I welcome the government amendments, I really do not envy a Secretary of State’s task in weighing up the risks versus the benefits. This will require the wisdom of Solomon. At least once the Bill is enacted we will have the data, which is all-important and has just been referred to. Our review’s report shone the light on our frustration of not knowing what was happening to whom, by whom, when and where. This will, of course, become apparent, which will be very useful once we have these processes in place.

But we are still left with weighing up the benefits versus the risks. Surely this depends on where the threshold is set concerning any medicine or medical device. For instance, if 99 people benefit from one of these products but one dies, what weight do we give to the 99—or, perhaps more importantly, to the one who died? Does the Minister see thresholds as important? If so, does he envisage the application of a threshold for an individual medicine or device, or would there be a threshold to cover a similar range of products, or indeed a more overriding policy? I am not quite sure how this will be tackled.

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Moved by

[Baroness Bennett of Manor Castle]

7: Clause 1, page 1, line 14, at end insert—
“(ba) the protection of the environment;”

[Baroness Bennett of Manor Castle (GP) [V]]

My Lords, I thank the noble Baroness, Lady Jolly, for her support. This is the survivor of a suite of amendments that I moved in Committee. About half an hour ago I tweeted out the Hansard link to that for anyone who is interested, and a link to an article I wrote at that time in the Ecologist. The amendments were all about the environmental impacts of medicines and medical devices, including the impacts of packaging.

Responding for the Government, the noble Baroness, Lady Penn, suggested that the environmental issues of packaging, and the issues around medical devices, would be covered elsewhere, notably in the Environment Bill. She did, however, acknowledge the importance of these issues. Some of those amendments related particularly to anti-microbial resistance, and the noble Baroness, Lady Penn, noted that this

“has been placed on the National Risk Register of Civil Emergencies as a ‘longer term trend’ likely to change the overall risk landscape for the UK over the coming decades.”—[Official Report, 26/10/20; col. GC 62.]

I think that is an acknowledgement by the Government of the importance of these issues around anti-microbial resistance. But we are starting to see much bigger issues: we have heard and seen the Government acknowledge in other contexts the cocktail effects of drugs and chemically active compounds in the natural environment.

I am not convinced by the argument presented by the noble Baroness, Lady Penn, about the other amendments. Since this is Report, I decided to focus on this one single amendment, for which I think the Government have—unintentionally—made their own case very strongly, by ways which I will come to at the end of my comments.

To briefly set out the case for why the Environment Bill and general environmental legislation will not cover medicines, the fact is that human medicines are highly biologically active substances, that are in the human body and pass through it. The medics will tell you that they need to be at still very high concentrations when they pass out of the human body to ensure that they have medical effectiveness. They are also metabolised in the human body in the natural world, in both anaerobic and aerobic environments. It is highly unlikely that normal legislation about waste—normal environmental legislation—will be able to deal with that, let alone its impact on the human microbiomes, and the microbiome all around us.

If we think of bringing this back to the practical: the manufacturer of baked beans might be regulated about the impacts of the tin or the impacts of consumption on human health, but in normal food safety or environmental health impact assessments, the broader impact of that consumption of baked beans is probably not going to be taken into account.

I am aware that your Lordships’ House might find me often citing some fairly technical science, and I am afraid I am going to do it again. Just as one example, I am going to cite a 2018 article from Frontiers in Microbiology. The title of the article is “Antibiotic Effects on Microbial Communities Responsible for Denitrification and N2O Production in Grassland Soils.” Your Lordships’ House might note that I have been spending lots of time at the Oxford Real Farming Conference recently.

To quote from that article, it says that

“the acute effects of tetracycline on soil microbial community composition and production of nitrous oxide … and dinitrogen … as the end-products of denitrification”

are

“an increase in the fungi:bacteria ratio and a significant decrease in the abundance”

of bacteria carrying a certain gene. Those who follow these issues will know that that has significant climate change impacts, but it also has very serious soil impacts.

Before I make my next comments, I should perhaps declare my membership of the APPG on Human Microbiome. The human microbiome that we have on our skin, in our lungs and in our gut also has impacts on the microbiome all around us, and the medicines that we take have an impact on both of those—that is, the microbiome of everything from bees to bats. Perhaps Covid-19 will help us understand the complexity of the systems that we are dealing with.

The fact is that past generations have left us with a poisoned planet. Historically, various diseases were treated were mercury. Many poisons have also been used as medicines, and of course many chemicals were used and are now widespread in the environment and are having enormous impacts. A story came out this morning about the fertility of male porpoises living off the UK being affected by polychlorinated biphenyls—PCBs—which were phased out decades ago but are still having impacts today. We are talking here about systems thinking.

I believe that the Government are, unintentionally, making their own argument for this amendment. I point noble Lords to page 6 of the Bill and Part 2, Chapter 1, covering veterinary medicines. Clause 9(2)(c) refers to

“the protection of the environment.”

Here, we are talking about the authority that makes the regulations on veterinary medicines having to be sure that it promotes the protection of the environment.

On page 1, we find the almost matching subsection under Chapter 1 on human medicines. The first two paragraphs of Clauses 1(3) and 9(3) are the same, then Clause 1(3)(c) goes on to talk about the UK being

“an attractive … place in which to conduct clinical trials or supply human medicines.”

But there is something missing—words about protecting the environment.

Therefore, with this amendment I have chosen simply to take the Government’s own words, as used in the part of the Bill on veterinary medicines, and say that we have to apply the same oversight and approach to human medicines as to veterinary medicines.

I come back, as this debate so often has done, to the brilliant report of the noble Baroness, Lady Cumberlege, First Do No Harm. I would say that the Government have accepted that principle in putting the clause on environmental impacts in the veterinary medicines section of the Bill. I really cannot see how they can justify not doing the same for human medicines.

I have previously called only one vote in your Lordships’ House—on what one might call the “grand matter of principle”, which was about freedom of movement—but at the moment I am feeling very inclined also to call a vote on this amendment. We are in a situation where our planet is at its limits—right at its edge. We are all on the edge: our life is on the edge. We cannot keep saying about the environment, “Oh, we’ll include that in a nice little silo in the Environment Bill.” We have to look at the impacts of everything that we do. The impact of human medicines on the environment is significant, as is the impact of veterinary medicines.

I will listen very carefully to what other speakers and the Minister have to say, and I shall be very interested in hearing the Minister’s explanation for the veterinary medicines and human medicines sections of the Bill being different. However, at the moment, I am certainly inclined to test the opinion of the House on this amendment. I beg to move.

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

My Lords, I thank the noble Baroness, Lady Bennett of Manor Castle, for tabling this very important amendment. For a long time, I have been interested in the growing resistance to antibiotics. The residue of many of them, used for both humans and animals, pass into the environment by different routes. One route is through sewage, which is then processed and goes back into the land where animals graze, and then enters the food chain. Flooding causes contamination and can cause infections through escaping sewage, and this can give rise to environmental and public health matters that need addressing.

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[Baroness Penn (Con)]

My Lords, when considering Amendment 7, tabled by the noble Baroness, Lady Bennett of Manor Castle, I draw the attention of noble Lords to our earlier discussion on the government amendments to this clause, introducing the requirement that safeguarding public health is the overarching objective when making regulations. The clause sets out a number of important factors that the appropriate authority must have regard to, and it is important to note that this is by no means a closed list of factors to be taken into account when making regulatory changes. I recognise that the intention is to put this important issue at the forefront of our minds, and that the factors involved in environmental protection, while broader than the remit of this Bill, may indeed be relevant as something to have regard to—and in those situations, this will happen. Let me explain.

In Committee, the noble Baroness raised important points about tackling the causes of environmental damage and listening to relevant stakeholders. As she knows, the Bill now includes Clause 43, which states that a public consultation must be carried out before regulations are made. This would provide an appropriate platform for relevant stakeholders in the production, distribution and consumption of human medicines, including manufacturers, healthcare practitioners and patients—and the noble Baroness will surely think also of campaigners—to raise their concerns and provide suggestions regarding regulations, which may include factors involving environmental protection. We would all agree that considering the environmental impact of what we do is important, but the power in Clause 1 is restricted to amending and supplementing the law relating to human medicines.

However, as I have reassured the noble Baroness previously, that law does not stand in isolation. The regulations made under this Bill must be considered within the wider context of other existing legislation that makes provision for environmental protection and access to medicines and healthcare services. The collective picture of legislation across the statute book ensures that environmental concerns are taken seriously. It includes provisions around packaging, safe management of medicines waste and medicines disposal. An example is the Environmental Protection Act 1990, which makes provision for the safe management of waste. This Act, which must be complied with by community pharmacies, imposes a duty of care on any person who disposes of controlled waste to take all reasonable steps to ensure that it is not disposed of in a manner likely to cause pollution of the environment or harm to human health.

I also reassure the noble Lord, Lord Hunt, on that point with regard to the management of waste and the noble Baroness, Lady Jolly, on the fact that the Government have made a clear commitment that, post Brexit, our environmental standards will not be reduced. As the noble Baroness, Lady Bennett of Manor Castle, pointed out, the upcoming environment Bill will be a further opportunity to debate many of those matters in detail.

On the question put by the noble Baroness, Lady Bennett, of why the environmental impact of veterinary medicines has been included in the Bill, whereas the environmental impact of human medicines is not specifically provided for, the situation with veterinary medicines is slightly different. The environmental safety aspects of the regulatory framework on veterinary medicines relate to their potential impact on the terrestrial and aquatic ecosystems and their flora and fauna—soil, micro-organisms, fungi, algae, plants, invertebrates, fish, et cetera—so veterinary medicines occupy a slightly different space in our regulatory framework. I also point out to her that animals receiving veterinary medicines form part of the human food supply chain, so that is also taken into account.

I hope that the noble Baroness has heard sufficient from me to be persuaded that, while the issue of environmental protection is of course vital, the law in this area is already well established and, in the light of this, that she will feel able to withdraw her amendment.

[Baroness Bennett of Manor Castle (GP) [V]]

I thank the Minister for her answer and the noble Baroness, Lady Masham of Ilton, for her support for the amendment and her full reflections on the importance of antimicrobial resistance—something that we will be talking about a great deal in the coming years. The contribution of the noble Baroness, Lady Jolly, was also hugely valuable, in that she complemented by looking at aspects that I had not taken up. She mentioned manufacturing not happening in an environmental vacuum, and in particular the issue of hormones such as oestrogen, and also focused on imported medicines and medical devices and their global impact—something that I talked about in Committee but had not talked about tonight.

I thank the noble Lord, Lord Hunt, for his interest in and attention to what I said in Committee, and for his patience with the technology. I will take what he said as something of an expression of support for the intention behind this amendment.

I have two specific questions to press the Minister on further. She spoke about the processes of overseeing production and distribution, but she did not refer to, and was apparently not thinking about, issues around how research is regulated and how manufacturers are expected to look at the environmental impact of drugs when they are researching and making choices about which drugs to pursue. Secondly, the Minister said on veterinary medicines versus human medicines that it is there for veterinary medicines because of the impact on the terrestrial and aquatic ecosystems, the soils, et cetera. I go back to what the noble Baroness, Lady Masham, said about the impact of sewage. Human waste impacts very much on the ecosystems that the Minister acknowledged that veterinary medicines need to take into account.

[Baroness Penn (Con)]

On the first point—considering environmental impacts in terms of research—obviously safety is one of the things primarily considered when looking at research on medicines. There is then separate provision in legislation for the safe disposal of any medicines that are not used. So we look at the safety of their use in humans and, through separate legislation, address the safe disposal of any medicines via that route.

That is also relevant to the second point on how human medicines can enter the ecosystem. I will write to the noble Baroness with further detail on that, but veterinary medicines are in a slightly different position, since we look at veterinary medicines for their impacts on animals but also have to think about their wider impact on the environment in terms of their position in the food chain. The safety standards on human medicines are much higher, because we look at their impact on patients taking them directly.

[Baroness Bennett of Manor Castle (GP) [V]]

I thank the Minister for her answer. I am aware this may not be entirely popular in the House, but I really feel this is an important issue the Government have not got to grips with. I am aware we have a long evening ahead of us, but none the less, I would like to test the opinion of the House.

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[Baroness Bennett of Manor Castle (GP) [V]]

My Lords, it is a great pleasure to follow the noble Baroness, Lady Sheehan, and to join the noble Lords, Lord Alton of Liverpool and Lord Crisp, in backing her important amendment. The introduction the noble Baroness provided was powerful and comprehensive, so I will not speak at length. I endorse the two asks she put to the Minister; it is important that we hear very clear, direct answers to them.

As the noble Baroness powerfully put it, there is a contest between public need and private profit, and we know that the reality of how our current system works is that private profit comes first. That means that human rights and public health trail behind. We know that so much of our healthcare system has been dragged in the direction of the disastrous US model, the most extreme example on the planet of a private, profit-driven healthcare system that has disastrous outcomes for massive costs. We also know that there are healthcare systems around the world that spend even less than we do but have a very fair and reasonable distribution of resources and money.

We often talk about these issues in moral terms; we must make sure that everyone has these medicines, and I endorse that moral approach, but in the context of the Covid-19 pandemic, nationally and globally, we must come back to the phrase, “No one is safe until everyone is safe.” It is in everyone’s interest that everybody in the UK and around the world has access to the best possible medicines and medical devices and that the research effort and all that wonderful power of human ingenuity are put into the best possible causes and results for public health, for the good of us all.

[Lord Alton of Liverpool (CB) [V]]

My Lords, I spoke at some length on this issue in Committee and am delighted that the noble Baroness, Lady Sheehan, has given us the opportunity to explore it again. She has done so with her usual thoroughness and thought. I am also pleased to follow the noble Baroness, Lady Bennett, who spoke so well. The noble Lord, Lord Bethell, has exchanged letters, as the noble Baroness, Lady Sheehan, referred to; that has been extremely helpful, as she intimated, and I think will avoid the need for a Division, but it is right we explore this issue thoroughly.

I will not repeat all the detailed arguments made in Committee, but, in headline terms, Amendment 10 is being considered in the context of exclusive intellectual property rights which can in some circumstances create monopolies, leading to high prices and supply issues for medicines and medical devices. We are seeing those issues come to the fore in the Covid-19 response.

In an Oral Question that I asked on the Floor of your Lordships’ House on 30 November to the Trade Minister, the noble Lord, Lord Grimstone, I argued that in the context of hundreds of millions of Covid vaccines being held in the United Kingdom and the significant sums of public money invested in developing new drugs and treatments, notwithstanding the need to generate funds to enable future research and development, when companies such as Gilead repurpose drugs such as remdesivir and charge $2,340 for a Covid treatment that Liverpool University estimates can be done for $9, the Government should invoke their powers in such circumstances to use Crown licences to prevent patent monopolies impeding access to medicine, to ensure equitable access, prevent exploitative profiteering and recognise that affordable drugs and their fair distribution are a public good that this country should be at the forefront in providing.

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

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

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

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

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

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


That simply has not happened.

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

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

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


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

[Baroness Bennett of Manor Castle (GP) [V]]

My Lords, we started this debate today with widespread plaudits to the Government for listening to very strong campaigns to have a patient safety commissioner. Indeed, the noble Baroness, Lady Cumberlege, who has been so instrumental in this, commented on the importance of that person listening to patients. We have to draw the parallels here because we have heard—as a community, as a society, and as a Parliament—from the parents of children who desperately need these medicines but are unable to access them. Those patients are not being listened to. We really do have to ask ourselves the question of why that is happening and what kind of political block or ideological barrier exists so that we are not seeing action in this area when it is so clearly, urgently needed.

When we were talking about a patient safety commissioner, I commented on how effective campaigning has been in that area. There is also a very effective campaign called End Our Pain, which has been working with families trying to access this medicine. It has been doing a great job, but the Government have not been doing their job in delivering on the campaign. I give credit to the noble Lord, Lord Field of Birkenhead, and all the other people who have signed this amendment, which is very much cross-party and across the House. As the noble Lord said, we have a division here—a human rights issue, referred to in the amendment tabled earlier by the noble Baroness, Lady Sheehan. People, or families, who can afford it, are able to access this medicine; those who need NHS support for it cannot. We should not be tolerating that situation in Britain at any time, particularly in 2021.

I have a direct question for the Minister. I have been looking at what assessment the Government might have made of the impact of current policies and the lack of financial support for vulnerable families. I should be happy to be corrected and perhaps told that an assessment is under way, but the most recent information that I was able to find was from September last year, when Liz Saville Roberts MP asked a Written Question in the other place about whether such an assessment had been made—and the answer was no. I will be brief, because the issues have been well set out by the noble Lord, Lord Field, and others. However, I ask the Government what assessment they have made of the impact of their current policies.

[Baroness Jolly (LD) [V]]

My Lords, today’s final amendment, tabled by the noble Lord, Lord Field of Birkenhead, and signed by my noble friend Lady Walmsley and the noble Baroness, Lady Meacher—all long-term campaigners on this issue—would require regulations to be introduced to allow doctors to prescribe medicinal cannabis products. I know that the movers of the amendment have been campaigning for ever—probably as long as I have been in the House—and can be excused their despair at the inactivity of GP prescribers.

The Home Office changed the status of medicinal cannabis two years ago, after a long campaign, but it has not been widely prescribed. The need for clarity on this matter was brought to the forefront by the news that nine year-old Alfie Dingley, whose use of medicinal cannabis has greatly improved his health, is no longer able to access his medication from the Netherlands due to Brexit. The Lib Dems have long been advocates of making medical cannabis accessible to those whose health would greatly benefit from it, and we support this amendment.

Will the Minister tell us what she can do to persuade the medical profession that cannabis has real medicinal value? Why are doctors deaf to children such as Alfie, and why are children such as Alfie and his parents left in the lurch? I hope that the Minister will be able to accept the invitation from the noble Baroness, Lady Meacher, to join her in a meeting with Dr June Raine, the chief executive officer of the MHRA.

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

Baroness Bennett of Manor Castle Excerpts

Thursday 7th January 2021 Lords Chamber

[Baroness Bennett of Manor Castle (GP) [V]]

My Lords, I make two points—the first on transmission. As the Minister made clear in his introduction, the SARS-CoV-2 virus is hideously out of control. As scientific knowledge has increased, the importance of aerosol transmission and the key place of the need for ventilation in prevention, and not sharing inside spaces, has becoming increasingly obvious, as the noble Baroness, Lady Finlay of Llandaff, highlighted.

It may not be the Government’s intention but the slogan “hands, face, space” places this crucial issue last on the list and appears to make it of lesser importance. There are people, some of whom I have encountered, who think they are safe if they wear a mask, even in a confined space with a stranger, when the science makes it clear that that is not the case.

Are the Government considering an enhanced, expanded education and publicity campaign to stress the importance of ventilation and not sharing space, perhaps utilising something like the excellent graphics produced by the Spanish newspaper El Pais, which clearly illustrates how the risk of the virus being transmitted in confined spaces is increased, and ways of reducing that risk?

Are the Government also considering rethinking the use of the term “Covid-safe”, particularly when applied to workplaces? Given aerosol transmission, risk can be reduced but not eliminated. Broader understanding of that can make us all safer.

Secondly, I ask about the Government’s long-term plans to provide maximum safety in the period when significant numbers have been vaccinated. Current evidence suggests that the vaccines we now have will not provide sterilising immunity and, therefore, vaccinated individuals will still present an infection risk. What plans are the Government making to redesign spaces and practices, look at ventilation, crowding and practical arrangements in schools, hospitals, prisons and other institutions, and in guidance provided to private companies, to minimise prevalence of the virus? They need to prepare and have a plan that would also make us safer from other infectious agents that we know present a continuing danger in this world scarred by the climate emergency and nature crisis.

Covid-19 Update

Baroness Bennett of Manor Castle Excerpts

Tuesday 15th December 2020 Lords Chamber

[Lord Bethell (Con) [V]]

My noble friend Lord Balfe is entirely right to say that the symptoms in young people are zero in many cases. There are issues of both saliency and believability among many young people who think that this is a disease that simply does not touch their lives. It is understandable that they may think it implausible that they could be carrying the disease. However, the statistics are crystal clear. When looking at the heat maps, you can see easily how infections grow among the young and then graduate through the demographics until they hit older people, and then hospital admissions rise. I am extremely sympathetic to young people and why they find this idea a challenge to believe in, but we have to hit home with this message—otherwise, we will not be able to contain the disease.

[Baroness Bennett of Manor Castle (GP)]

My Lords, my question follows that asked earlier by the noble Lord, Lord Young of Cookham, to the noble Baroness, Lady Stedman-Scott. It referred to how some local authorities have run out of funds to give the £500 payment for people to self-isolate, when they would not otherwise be able to financially. In response, the noble Baroness said that there is only a fixed envelope of money, suggesting that no more would be provided to those local authorities. As Health Minister, would the noble Lord agree with me that, whatever tier people are living in, they have to be able to self-isolate and feed themselves, pay their rent, et cetera? Do people not need that £500 in every part of the country, without there being a postcode lottery?

[Lord Bethell (Con) [V]]

My Lords, the noble Baroness is entirely right: the whole purpose of the isolation payments and the idea behind them is the recognition that people who are being asked to self-isolate, particularly if they come from a low-income household, to which the isolation payment is targeted, need financial support to fulfil their civic obligations. That is why we put the scheme in place. It is true that it has been tremendously successful in some areas. We continue to review whether that fund needs to be topped up.

Ockenden Review

Baroness Bennett of Manor Castle Excerpts

Monday 14th December 2020 Lords Chamber

[Lord Bethell (Con) [V]]

My Lords, policy officials at the DHSC are working with both the CQC and NHS England on improving our surveillance and the publication of data, as the noble Baroness rightly points out. A key development in this area is the work by HSIB to investigate each and every death and major incident in maternity suites. That provides an absolutely invaluable resource to understand where and when things go wrong. We will continue to publish those reports as they happen and will learn lessons from their insights.

[Baroness Bennett of Manor Castle (GP)]

My Lords, much of this debate has already focused on the issue of staffing shortages in our NHS, particularly among midwives. I am sure that the Minister is aware of the survey last month from the Royal College of Midwives, which showed that 83% of midwives did not believe that their trust or board had enough staff to provide a safe service and 42% said that half or more of their shifts were understaffed. The Minister referred to recruitment campaigns and investment in future training, but the Ockenden review calls for an immediate focus on relationship building, training and things that will take a great deal of time and resources to deliver, where there are problems. I cannot see any alternative if we are to fill some of those gaps immediately. Training will take many years, but an overseas recruitment of midwives will bring in the staff we need to create the space to allow people to have that training—that time and reflection.

[Lord Bethell (Con) [V]]

My Lords, I respectfully disagree with the noble Baroness’s insight—the Ockenden review does not point the finger at staffing levels in relation to the problems; it points the finger at a number of items, particularly the cultural problems that emerge when differences of opinion between clinicians and midwives arise and where a culture of respect breaks down. Those cultural differences can be improved by what we would politely call education; it is essential that we invest in the right kind of education in order to bring midwives, obstetricians and gynaecologists closer together and to break down the hierarchical differences and the ideological differences about the best way to have a baby.

Health and Social Care Act 2008 (Regulated Activities) (Amendment) (Coronavirus) (No. 2) Regulations 2020

Baroness Bennett of Manor Castle Excerpts

Thursday 10th December 2020 Grand Committee

[Baroness Bennett of Manor Castle (GP) [V]]

My Lords, it is a pleasure to associate myself with the comments just made by the noble Baroness about the risks of deregulation and self-regulation. We have seen a great deal of concerning and tragic events flowing from that in the building industry. However, my first question, of which I have given prior notice, addresses what follows from testing: self-isolation. The Minister himself is self-isolating today, and I wish him and his family all the best. It is very difficult for many people to do, for financial reasons, because of care responsibilities, or for other reasons. In recognition of that fact, the Government have brought in a £500 payment for people ordered to self-isolate, with the money paid through local authorities. I credit Martin Lewis’s MoneySavingExpert website for what I understand is its original research, published yesterday, in doing spot checks and identifying at least five local authorities where the allocation of money has run out. It is reported that therefore people are being told they cannot get a payment. Can the Minister confirm that? If so, do the Government plan to fix this as a matter of urgency?

On my second point, I appreciate the fact that the Minister took time to explain in his introduction how he saw the idea of a market operating in Covid-19 testing. I have problems with the whole idea of a market in healthcare, but at least it was outlined clearly. In that outline, he said that everyone should have access to affordable tests. The explosion in the use of food banks started before Covid-19 but has certainly increased. People are unable to afford to buy even food. It is clear that lots of people would not be able to afford the price of a Covid test that they might have very good reason to want. Will the Minister consider perhaps approaching the suppliers of these tests and seeing if they could supply some to each food bank in the land, so that they would be genuinely available to everyone who might have good cause to need them?

Secondly on the issue of markets, the purpose of trading in a market is generally to make a profit on the good or service provided. Given the clear high demand and need for Covid tests, how are the Government ensuring that windfall profits are not made? Indeed, I ask the Minister directly: what percentage profit does he consider it would be reasonable to make on a Covid test?

Finally, given that this statutory instrument is essentially a deregulatory one, how are the Government ensuring that the use and promotion of lateral flow testing, which has been reported in the real world to have up to a 50% false negative rate, is used appropriately? Clearly it can be useful at population level to identify asymptomatic infections, but does the Minister agree that it would be deeply dangerous if it was used to give people an all-clear to mix and mingle, with or without precautions?

[The Deputy Chairman of Committees (Baroness Pitkeathley) (Lab)]

The noble Lord, Lord Randall, has withdrawn, so I call the noble Lord, Lord Bourne of Aberystwyth.

Human Medicines (Amendment etc.) (EU Exit) Regulations 2020

Baroness Bennett of Manor Castle Excerpts

Wednesday 2nd December 2020 Lords Chamber

[Baroness Bennett of Manor Castle (GP) [V]]

My Lords, it is a pleasure to follow the noble Lords, Lord Blunkett and Lord Goddard, with another northern perspective. The noble Lord, Lord Blunkett, made a good choice of location today, being in your Lordships’ House rather than in Sheffield, because here the emergency services are dealing with an unexploded World War II bomb just up the road from me. I thank those emergency services workers. This is a reminder that all our essential services and workers have so many things to deal with at the moment, including all the medical professionals dealing with the complexities that we are discussing today.

I agree with the noble Lord, Lord Blunkett, about the importance of acknowledging international collaboration. Whether we are talking about vaccines or medical research, the nature of science today is innately collaborative, and we need to keep that in focus.

I also agree with the noble Lord that the Minister has been highly informative and helpful to your Lordships’ House right through the pandemic. That has built trust, which is so crucial. I hope that the Government will ensure that the information they provide is always accurate and trustworthy—as other representatives, I am afraid, have not been today, in their claims that exiting the EU made it possible to approve the vaccine so quickly.

Turning to the detail of these complex and detailed instruments, I decided to engage in the debate because I have also been heavily involved with the Medicines and Medical Devices Bill. As the Minister said in his introduction, it is clear that these instruments and the Bill are closely interrelated. It is also clear from our debates on the Bill, and from the report by the noble Baroness, Lady Cumberlege, that we need a great deal of improvement in our regulation and oversight of medicines and medical devices.

These statutory instruments also address the issue of falsified medicines. With fake medicines estimated to cost the pharmaceutical sector about €10 billion, and considerable evidence that the Covid-19 pandemic has accelerated that problem, this is truly a key issue.

I shall address four key points. The first is the Northern Ireland complexities, with which the SIs are heavily involved. The second is the extra costs for the NHS, and potentially for private patients, for medicines and medical devices. The third is falsified medicines, which I have already mentioned, and the fourth is the risk of shortages in the immediate post-transition period and the later post-transition period.

In relation to the first point, about Northern Ireland, the Explanatory Memorandum says, at paragraph 7.10:

“To ensure unfettered access only benefits NI businesses, these regulations require that:


a) only an NI business should be able to apply for a licence from MHRA … and


b) the market authorisation holder … will need to be located in NI.”


It will have to provide information and data, and take

“legal responsibility for the medicine once on the GB market, including access to a suitably qualified person for UK regulators to interact with on ongoing safety monitoring … related to those medicines”

and medical devices. My first question for the Minister is: are there enough qualified, appropriately registered, people in Northern Ireland for those roles? Secondly, are small independent businesses, such as small pharmacies in rural areas, ready for this situation?

As of early November, a phased process for implementing medicines regulation in Northern Ireland up to 31 December 2021 has been agreed, which means that the current batch testing, importation, and falsified medicines directive requirements will remain in place for another 12 months. December 2021 is not very far away. Are these regulations future-proofed? Will they still cover the situation in 12 months’ time?

The Explanatory Memorandum also notes all the extra costs—for example, £18,000 for a new active substance, £10,000 for a complex abridged application, and so on. Can the Minister provide any information on what extra costs the end of the Brexit transition period will bring, for drugs both for the NHS and for people with private prescriptions?

On the third point, about falsified medicines, in October the Royal Pharmaceutical Society wrote to the Health Secretary, Matt Hancock, asking for “robust plans” to be put in place

“to help authenticate the legitimacy of medicines”.

The RPS also said:

“We are concerned that removal of these safeguards could leave the UK vulnerable to an influx of counterfeit medicines, impacting on patient care in the UK and across the EU”.


Can the Minister provide assurances on that point?

Finally, I want to ask about shortages. In August the Government recommended that pharmacies and hospitals build up a six-week stockpile before 31 December. Is the Minister confident that that is in place, given all the many other pressures from Covid-19, normal winter illnesses and the general pressure on our medical systems? In the shorter long term, at the end of those six weeks, will the supply be secured? Can we be confident that we will have the medicines we need?

HIV: Pre-exposure Prophylaxis

Baroness Bennett of Manor Castle Excerpts

Tuesday 1st December 2020 Lords Chamber

[Lord Bethell (Con)]

The noble Lord will be aware that there is a detailed conversation with local authorities about ensuring that we get exactly the right balance for funding. As the noble Baroness rightly pointed out, we need to make sure that the supply of PrEP is conducted in a way where there is good consultation and where those who are applying for the therapy are given good advice. That is best done with help from local authorities, and we are trying to hammer out a deal to ensure that that is done thoughtfully. That deal has been delayed by Covid, but we are looking forward to announcing a resolution of that before the next funding round finishes.

[Baroness Bennett of Manor Castle (GP) [V]]

My Lords, can the Minister confirm that the Government are collecting information on who is accessing PrEP in England? It is obviously crucial to ensure that there is equity among the groups given the currently limited supply, unlike the situation in Scotland and Wales, to which the noble Lord, Lord Scriven, has just referred. Will the Government commit to publishing the data on who is accessing PrEP?

[Lord Bethell (Con)]

I am not sure that I can give the reassurances that the noble Baroness is looking for. These are very delicate and private matters. I am not sure if it is right that the details of who is accessing PrEP are necessarily for are public domain, but I would welcome any suggestion that she might have in correspondence about what exactly she is looking for.

Personal Protective Equipment: Procurement

Baroness Bennett of Manor Castle Excerpts

Thursday 19th November 2020 Lords Chamber

[Lord Bethell (Con)]

I am extremely grateful to my noble friend for giving me advance notice of his question. I am aware of the changes in procurement practices in the NHS, which I welcome. They will have a huge impact and protect us in the case of future pandemics. I am also aware of the phenomenal effort by British manufacturers, which have stepped up to the challenge of producing PPE and have, in my view, gone a lot further than anyone expected, producing around 50% of the NHS’s PPE. There have clearly been unintended consequences if this company, Wearwell, has somehow fallen off the procurement list. I would be happy to take a letter from my noble friend and look into the matter.

[Baroness Bennett of Manor Castle (GP) [V]]

My Lords, public trust has clearly been lost over PPE procurement and the NAO report. What do the Government plan to do to restore it?

[Lord Bethell (Con)]

My Lords, I simply do not accept the assumption of that question. I think that the public see a Government who stepped up to an enormous challenge and did their best under very difficult circumstances. Many of the public individually stood up as volunteers and many professionals returned to former jobs to help out. Many businesspeople turned over their capacity, their staff or their focus to help out in the pandemic, and the Government took on a huge amount of support from members of the public. These sweeping assumptions that somehow everything was done in a negative way are very unhelpful and in fact do not chime with the mood of the public at all.

Medicines and Medical Devices Bill

Baroness Bennett of Manor Castle Excerpts

Committee stage & Committee: 7th sitting (Hansard) & Committee: 7th sitting (Hansard): House of Lords
Thursday 19th November 2020 Grand Committee

[Baroness Bennett of Manor Castle (GP) [V]]

My Lords, I will speak briefly in favour of this amendment in the name of the noble Baroness, Lady Cumberlege. Like the preceding speaker, I am aiming to add extra angles and approaches rather than to repeat what has already been said—but I associate myself, essentially, with everything that has already been said.

As I was thinking about this amendment, I was reflecting on a session in the House—I believe it was this week, although it all blurs slightly if one looks at a screen for long enough—when the Minister, the noble Lord, Lord Bethell, was being questioned by one of his noble friends about why a whole series of Written Questions about Covid had not been answered. The fact is, of course, that all aspects of our health system are currently under enormous pressure. The proposition that I put—as I was arguing in another amendment to the Bill earlier this week—is that this is actually an amendment that makes the Government’s job easier. It carves off a recognisable, obvious piece of work that does not have to be done by already horribly overworked, stretched systems. It means that something can be done: something can be ticked off and said to be under control, managed and done, in a way that does not draw too heavily on that existing overstretched system. That is the first point I wanted to make.

The second point I want to make—and I feel that I need to apologise to the noble Baroness, Lady Cumberlege, for bringing this up—is that, as a former newspaper editor, when I was thinking about reports and what happens to reports, I had to go back to the Leveson inquiry, conducted by Lord Justice Leveson. I remember, when I first read that report, I thought about how it had been carefully structured to put aside some of the more difficult areas, particularly the issue of media ownership concentration. In the report Lord Justice Leveson had tried very hard to create something that was implementable and manageable, and that had some chance of being delivered. I think we all know that that is not what happened, so I can understand that anyone asked to take on a huge job of work, as the noble Baroness, Lady Cumberlege, did with this, must ask themselves the question, “If I devote so much time, energy and effort to this work, will it actually be delivered?”

I said before that the patient safety commissioner amendment was possibly the most important one. In some ways, this certainly vies with it. This is about delivery. We know that there are three reasons to call an inquiry. One might be to find information, one might be to reassure the public, and another might be to create a plan of action. Those are the three often-stated reasons, but sometimes there is a fourth reason—perhaps “sometimes” is not the right word; perhaps “often” might be a better word—to kick something into the long grass. It is crucial that the issues uncovered by the noble Baroness are not kicked into the long grass, and that the very clear, obvious and important recommendations are not lost. So I support this amendment and, should it need to go further, I will continue to support it.

[Lord Sharkey (LD) [V]]

My Lords, Amendment 121 is another recommendation, as we have heard, from the Cumberlege review. We would, within three months of the Bill being passed, set up a task force to implement the recommendations of the Independent Medicines and Medical Devices Safety Review. This particular recommendation, like the others in the review, received very widespread support at Second Reading, and a key element of the recommendation contained in this amendment is the appointment of an independent chair of the task force. It is absolutely critical that this independence is real, and perceived as being real. It should be clear to all that the chair is not an establishment place-person, and is an obviously safe pair of hands. It is vital that public confidence in the safety of medical devices be restored, and we very strongly support this amendment. This amendment is the means—and perhaps the only means currently available to us—of making the Cumberlege recommendations a reality. If the Minister is not inclined to accept this amendment, I hope that the noble Baroness, Lady Cumberlege, will bring it back on Report, so that we can test the opinion of the House.

--- Later in debate ---

[Baroness Cumberlege (Con) [V]]

My Lords, it is hard to follow the very well-researched contribution to this whole issue from the noble Lord, Lord Hunt. It was interesting to hear about Sir Liam Donaldson’s report, which got on to the statute book but was not implemented. Is that not a disgrace? It is really dreadful.

Very near to where I live is the centre for Chailey Heritage, now the Chailey Heritage Foundation, for children who suffered through their mothers having taken the drug thalidomide. I chaired its governing body for years. It is interesting that that redress system still continues; it is supported by a trust, which inherited the disaster of the medication, and it has honoured that and receives government support. So we have examples where this is working.

The redress agency that we recommend is really about the future. My amendment is about the present. We know that so many patients and their families have suffered such harm, and we need a system that is more compassionate and a much more certain route for obtaining redress to compensate them. We are talking not about compensation as such, but about redress. You have to go to the courts to achieve compensation, and it is a very miserable experience—we have heard that from patients. It also takes a very long time and, as the noble Lord, Lord Hunt, said, very often the people who benefit most are the lawyers.

We are talking about Primodos, sodium valproate and pelvic mesh—the three interventions through which people have suffered avoidable harm. The suffering they endure now is terrible. All three have caused and are causing avoidable psychological and, of course, physical and neurological harm. These families really need a little help with the conditions they are living with. Indeed, some are looking after some very disabled children. We do not believe that their needs are adequately met by the healthcare, social care or benefits systems. Some of these people are actually very elderly—the parents of the children who took Primodos. It would be a scandal if those people were to live their lives unable to access the redress they need and the outcome they deserve. After all, the harm was caused not by them, but by the state.

In the case of these three interventions, there is a moral and ethical responsibility to provide ex gratia payments in respect of the avoidable damage that occurred. That responsibility falls on the state and the manufacturers of the products in question. The schemes that would be established through this proposed new clause would provide discretionary payments, and each of the three schemes would have tailored eligibility criteria.

The payments the schemes make would not be intended to cover the cost of services that are already available free of charge, such as healthcare and social security payments. They would be for other needs—for example, the cost of travel to medical appointments. We have met and talked to many of those people, and they have said that it is a significant cost burden. The payments might be for respite breaks or emergency payments where a parent has had to stop work to cover care. These redress schemes would not be in place of litigation, nor will they be to deliver compensation. People should retain the right to take legal action if they wish to obtain compensation—of course they should; that is in our law. The schemes I am talking about should be set up in such a way that they can be incorporated into the wider redress agency that the noble Lord, Lord Hunt, spoke about, once it is established.

These people have suffered for decades. They have tried to obtain compensation through the courts. That action has failed in the case of valproate and Primodos, although I am aware that a new Primodos action is under way. I have been told by solicitors that, in fact, the report does not in any way affect that action. There have been some awards and settlements in the case of mesh, but legal action takes time, as the noble Lord, Lord Hunt, said. It creates added stress and much more personal cost can be involved.

I believe that a measure of a decent society is how well it looks after those who have suffered harm, especially when that harm was avoidable. From having met many hundreds of people who have suffered and heard from many more, I am clear that help is needed and deserved. People should not be made to wait any longer. I hope my noble friend the Minister will agree with that.

[Baroness Bennett of Manor Castle (GP) [V]]

My Lords, I shall speak to Amendments 122 and 123, to which I attached my name. The first is in the name of the noble Lord, Lord Hunt of Kings Heath, and the second in the name of the noble Baroness, Lady Cumberlege. They have both introduced these very clearly, so I will make only three points to add some extra, different perspectives.

The first point I wish to make is that there is what I can describe only as a heart-rending report in the Guardian today about Windrush compensation two years on. The headline talks about

“long waits and ‘abysmal’ payouts”.

The story mentions an agency that talks about five people waiting more than 18 months for compensation. If this—as high-profile a scandal as we can possibly imagine, which attracted far more attention than the issues covered by the report from the noble Baroness, Lady Cumberlege—is going so badly, surely we have to address this issue, which in many ways is smaller, more limited and perhaps much less complicated, to create a situation via Amendment 123 to deal with these three issues. Amendment 122 would create a situation to deal with all cases, so that we would have a system and framework that, I hope, would do better than the Home Office is doing. I hope that such an agency in the health framework would not suffer from the same hostile environment in the Home Office that the Windrush compensation scheme has to act within.