Amendment 7

Medicines and Medical Devices Bill - Report (1st Day) – in the House of Lords at 6:00 pm on 12th January 2021.

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Baroness Bennett of Manor Castle:

Moved by Baroness Bennett of Manor Castle

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

Photo of Baroness Bennett of Manor Castle Baroness Bennett of Manor Castle Green

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.”—[GC 62.]">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.

Photo of Baroness Masham of Ilton Baroness Masham of Ilton Crossbench

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.

There is also an environmental problem of contamination of the river courses by industrial waste, leachate, pesticides and fertilisers, which can cause fish to die. Contamination of fresh water by rats’ urine poses an environmental public health risk as it causes Weil’s disease, also known as leptospirosis, which can be fatal. Rats and mice can also contaminate food. Increased asthma and respiratory disease due to poor air quality is another environmental problem. There should be an effective, well-funded public health system, which works in conjunction with the environment and agricultural organisations. Prevention of disease and the safety of the environment are of extreme importance.

Photo of Baroness Jolly Baroness Jolly Liberal Democrat 6:15 pm, 12th January 2021

My Lords, this amendment would require the appropriate authority to have regard to the protection of the environment when making regulations about human medicines. We have left the EU and need to be sure that our replacement regulations are fit for purpose. Many of us have spent a lot of time checking that these replacements are in such a fit state; but, while the health and safety of patients remain paramount, it is reasonable and, indeed, important, given the climate crisis, to consider the environmental implications of any policy stemming from these regulations.

The manufacture of human and veterinary medicines, and medical devices, does not happen in an environmental vacuum. Manufacturers have a duty to protect their environment—and manufacturers of medicines will need to be open about how they deal with chemical and other waste. I live in Cornwall where oestrogen has found its way into local rivers, ecosystems and oysters. Wastewater from pharmaceutical manufacturers could also find its way into local waterways. Will the Minister outline how this is dealt with by regulators, and how it is covered by the Bill?

Much waste from pharmaceutical plants is toxic and dealt with appropriately by manufacturers but, in a Brexit world, the regulation regime will have different regulations from the very strict ones that applied when we had to follow EU regulations. We can buy our medicines and medical devices from all over the world; we know that not everyone has the same high environmental standards governing manufacture that we have. What criteria are appropriate in the commissioning and purchasing of medicines from the rest of the world? Can the Minister please outline for us the nature of discussions with regulators about these issues?

Photo of Lord Hunt of Kings Heath Lord Hunt of Kings Heath Labour

My Lords, this debate follows a very interesting one in Committee, in which the noble Baroness, Lady Bennett, posed some searching questions about the potential for designing new drugs that are less harmful for the environment, whether in their composition, their impact when they escape into the environment, or in their packaging. Today, she also argues that the expectation of this approach should be built into legislation.

In Committee, the noble Baroness gave some very interesting examples. I was particularly interested to hear that in Sweden—

Photo of Lord McNicol of West Kilbride Lord McNicol of West Kilbride Deputy Chairman of Committees

We appear to have lost connection with the noble Lord, Lord Hunt. We will give it a few seconds. We have now reconnected but we missed about 30 seconds of his speech; perhaps the noble Lord could take us back about 30 seconds.

Photo of Lord Hunt of Kings Heath Lord Hunt of Kings Heath Labour

I thank the noble Lord; that is a temptation to be eagerly accepted. I was referring back to what the noble Baroness, Lady Bennett, said in Committee and the example in Sweden of Stockholm county council, which grades medicines on their environmental effects. Doctors can choose to prescribe a drug that is less harmful in relation to the environment where that option exists.

We have also had the 2014 report by UK Water Industry Research, which found that in most of the 160 sewage treatment works studied, several common drugs were present in the final effluent in concentrations high enough to potentially affect ecosystems. The noble Baroness, Lady Jolly, referred just now to the amount of pharmaceutical effluence entering waterways, and according to a 2018 study by the Delft Institute for Water Education, that could increase by two-thirds before mid-century.

In Committee, my noble friend Lady Wheeler referred to the Environment Agency also having found examples of contaminated hospital waste being illegally exported to developing countries such as Malaysia for disposal. What steps are we taking to prevent the illegal export of such waste and ensure that we dispose of our own waste in this country? There are also concerns about the use of incinerators for hospital waste and the health impacts on those living nearby. We must ask whether the Government are doing enough to ensure that chemists and GPs’ surgeries provide a secure depository for unused medicines, so that they do not contaminate the water supply by being washed down the sink or ending up in landfill.

The noble Baroness, Lady Bennett, said today that the Government’s approach has been to say that legislation is already on the statute book regarding the impact on the environment more broadly, including legislation to address the impact of producing and disposing of manufactured goods such as medical devices. But there is a persuasive argument that we should go further and that it is appropriate that in this Bill on medicines and medical devices there should be a way of ensuring that the environmental impact is not a damaging one. I hope that the Minister can respond with a positive reflection that this is an area that needs further exploration.

Photo of Baroness Penn Baroness Penn Baroness in Waiting (HM Household) (Whip)

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.

Photo of Baroness Bennett of Manor Castle Baroness Bennett of Manor Castle Green

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.

Photo of Baroness Penn Baroness Penn Baroness in Waiting (HM Household) (Whip)

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.

Photo of Baroness Bennett of Manor Castle Baroness Bennett of Manor Castle Green

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.

Ayes 42, Noes 278.

Division number 3 Medicines and Medical Devices Bill - Report (1st Day) — Amendment 7

Aye: 42 Members of the House of Lords

No: 278 Members of the House of Lords

Ayes: A-Z by last name

Nos: A-Z by last name

Division conducted remotely on Amendment 7

Amendment 7 disagreed.