Medicines and Medical Devices Bill

Baroness Masham of Ilton Excerpts

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

[Lord Lansley (Con) [V]]

My Lords, I am pleased to follow the noble Baroness, Lady Ritchie of Downpatrick, who asked some good questions. Indeed, many noble Lords have asked good questions about the functioning of a patient safety commissioner. All are agreed that we have come very far, very quickly, and the Minister and my noble friend Lady Cumberlege are to be congratulated on having brought this proposal from her excellent report to primary legislation so rapidly. Knowing how difficult it is, I commend the Minister and his team for securing collective agreement to such a significant policy innovation so rapidly, to the point that we can put it into the Bill on Report.

I want to make two points. First, as I know from the past, independence can be instrumental to the functioning of an organisation, but the NHS can, if one is not careful, see independence as something outside the system. It is somewhat discounted because of that. We must always think of the patient safety commissioner in two important respects. First, it should be not only independent but influential. A number of noble Lords have spoken about how that might best be achieved. That influence is terrifically important.

Secondly, patient safety is central across the NHS and is regarded as such. As the Minister and the noble Lord, Lord Patel, evidenced, we have come a long way with safety in the NHS—for example, in the reduction in healthcare-acquired infections. I was responsible for introducing never events and a range of other factors. Mainstreaming safety to become a central concern of commissioners and providers across the NHS has been a recurring feature of the work of this Government and their predecessors, and of my successors, Jeremy Hunt in particular.

I stress that that work on safety inside the NHS is clinically led and data-driven. The patient safety commissioner has a remit focused on hearing from, understanding and working with patients. That distinction is tremendously important and must be made clear to all those working across the health and care systems, from the outset. There is something new and distinctive about the patient safety commissioner, and it is not simply another accretion to the many organisations that those who work in the health system feel impede their lives. On the contrary, this is a representative of patients who, by virtue of that, attracts special attention from their point of view and brings a distinctive and unique voice into the NHS systems. I am pleased to have had this opportunity to say those few things and to support the government amendment in the name of the Minister.

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

My Lords, I agree with the noble Lord, Lord Lansley. It is very good news that there is to be a patient safety commissioner. I congratulate everyone who has worked so hard to create this amendment, especially the noble Baroness, Lady Cumberlege. It is so good that the Government have listened. Patient safety is vital, especially now when the NHS is under so much stress and demand. Over the years, some tragic incidents could have been avoided if patients had been listened to and there had not been cover-ups.

The noble Baroness feels that the words

“so far as reasonably practicable”

should be removed. She may feel that they would weaken the amendment; is this the case? This is important, because patients need clear information about how they are to communicate with the patient commissioner, so that they trust the system.

[Baroness Watkins of Tavistock (CB) [V]]

My Lords, I am delighted to follow my noble friend Lady Masham of Ilton. I reiterate my support given in Grand Committee for the appointment of a patient safety commissioner, and I thank both the Minister and the noble Baroness, Lady Cumberlege, for the work they have done together to get to this point.

To reflect on the speed since the report of the noble Baroness, Lady Cumberlege, I remind noble Lords of the report, in the early 1970s, called Sans Everything, about the terrible atrocities and lack of safety in some in-patient mental health services. It took nearly a decade for that to be taken seriously, so we warmly welcome the speed with which we are dealing with this situation now.

I am delighted that Amendment 54, which will be moved by the noble Lord, Lord Bethell, on behalf of the Government, will identify the principles relating to core duties, involvement of patients and amendment to primary legislation, together with regulations for appointment and operation of the office for the commissioner. I too have concerns about paragraph 3(3) of the proposed new Schedule A1, concerning the statement:

“A relevant person must, so far as reasonably practicable, comply with a request by the Commissioner”.


This means that a reluctant organisation—we need to remember that some very small organisations deliver healthcare on behalf of the NHS—or individual is potentially provided with an excuse not to co-operate with the commissioner on a reasonable request. I ask the Minister: could the words

“so far as reasonably practicable”

be removed?

Clarity over roles and responsibilities will be key to maximising patient safety, as will the independence of such a commissioner. It may well be that, as we work forward, we can be clear about the level of independence to ensure that, as they revise the principles of better patient safety, they consider not only patients in hospitals and mainstream community care but patients further afield, particularly in areas provided by the independent and charitable sector.

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A failure to do this would be a lost opportunity. There is strong support for this Bill and a recognition that it must be passed in its current fashion as rapidly as possible. However, there is also a strong recognition that many of the issues are tied up in long-standing regulation created over a period of time, without the clarity and benefit of understanding the opportunities and risks offered by modern medical practice and innovation in healthcare. Not to consolidate would put our country behind rather than at the forefront of the opportunities that are afforded by being leaders in this area.

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

My Lords, I support these amendments. It seems totally sensible to consolidate legislation so that it is not fragmented and some medicines do not get missed. Medicines and medical devices are vital to some people. We depend on many of our medicines and devices coming from abroad, so bringing legislation together for human and animal medicines will help prevent mistakes. We are an island and crossing the borders has already caused problems with filling in the forms. With much-needed medicines there should not be a risk of not receiving them.

[Lord Lansley (Con) [V]]

My Lords, I am very pleased to follow the noble Baroness, Lady Masham, who rightly emphasises the importance of accessible and understandable legislation in this area. There are two issues. As my noble and learned friend Lord Mackay of Clashfern said, there is the question of the sunset clause and the question of the preparation of consolidated legislation.

On Amendment 2 and a sunset clause, I believe that we should reserve the imposition of sunset clauses for legislation where we anticipate that those powers may not be needed in future. This is not the case with this legislation. With the end of the transition period we require our own domestic legislation for medicines, veterinary medicines and medical devices, so these regulations and these powers will be required.

The points made by the noble Baroness, Lady Thornton, quite legitimately, about the framework—the rather skeletal nature of the Bill as introduced to this House—must be dealt with in other ways, and in the group led by Amendment 4, we have substantive changes which make it a framework rather than simply a skeleton, and give us greater assurance about how the powers are structured in the Bill. I hope that if she reflects on it the noble Baroness will realise that shutting down these powers three years after Royal Assent would be a very taxing imposition. It would probably mean that in less than a year and a half, Ministers would be thinking about the reintroduction of legislation. We would risk the powers in this Bill being shut down in order for a Bill very like it to be introduced in a couple of years’ time. I see no intrinsic purpose in that, so I cannot support Amendment 2.

I do however want to specifically refer to the other issue of consolidation and Amendments 26, 39 and 63, in the name of the noble Lord, Lord Patel. There is a general proposition that people agree that, notwithstanding that additional regulations are going to have to be made in the weeks and months ahead using these powers, they will continue for the time being to be a complex mix of powers. Some will use this legislation, some will be in retained EU law and some will be in existing and other statutes and regulations.

What we want, as my noble and learned friend Lord Mackay of Clashfern quite rightly emphasised, is legislation in this important area that is understandable and accessible. These are not regulations for the benefit of lawyers; they are regulations for the benefit of practitioners, so they need to be very clear. The noble Lord, Lord Kakkar, helpfully and kindly referred to the points I made in Committee about the role of the Law Commission. As I understand it, indeed, I think it is well to remember two things about this. First, Law Commission members are the experts in the process of codification and simplification. Consolidation of legislation is valuable, but it is even better for it to be codified and simplified so that the end result is far more accessible and understandable to practitioners.

So I would very much recommend that we proceed by asking the Government to put the areas of human medicines and medical device regulation, and perhaps veterinary medicine as well, into the work programme of the Law Commission. As I understand it, the 14th programme of work for the Law Commission will be the subject of discussion between the Government and the Law Commission up to the spring of 2022. The work programme of course will happen subsequently. So I do not think any rigid timetable should be imposed. I hope that the noble Lord, Lord Patel, would not insist upon a three-year limit or his amendment for this purpose because I hope that, at the end of this process with the Law Commission, we will end up with something much better that is brought forward as a Law Commission Bill—which can have an expedited process of scrutiny and passage through both Houses. As a former Leader of the House of Commons, and therefore responsible for the Government’s legislative programme, I say that all the evidence tells me that, if a requirement to insert a Bill into the Government’s legislative programme can be avoided, it should be.

We have been there with a Law Commission Bill on the regulation of clinical professions and professions allied to medicine, which is still waiting for legislation, because it included not only codification and simplification but substantive changes to the policy—so I am afraid that it is still waiting. So let us not go down that route; let us do the very sensible thing rightly initiated by the noble Lord, Lord Patel, which is call for consolidation, making sure that it is not about changing policy but about making the legislation work effectively for the benefit of the various practitioners and those who depend on them. And let us work through the Law Commission. I hope that, if the Minister were to tell the House that he and the Government were willing to proceed in that direction, without a timetable in place, the noble Lord, Lord Patel, would not press his amendment when the time comes.

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[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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I hope the Minister is able to tell us in response what appropriate system the Government are prepared to put in place as an alternative to clinical trials, so that UK patients can have the benefits that patients in the Netherlands, Canada, the United States and many other countries have had for years.

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

My Lords, I thank the noble Lord, Lord Field of Birkenhead, who moved this amendment so movingly. This debate has gone on for many years.

It has been found by parents that medical cannabis can help some children who have multiple seizures due to epilepsy. I need to know: has NICE approved it? If it is waiting for more research, there will have to be more people using medical cannabis so that the information can be collected. If it is helping, doctors who understand the problems need to be the people who prescribe it. It should be carefully monitored. If it gives better quality of life, why should it not be prescribed? I hope the Minister will do his best to see that it is.

[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.