My Lords, I shall speak also to Amendments 25, 41, 80 and 91, which are also in my name.
My intentions in participating in this Committee and engaging on this Bill were originally modest. As a feminist and someone concerned about the impact of the profit motive on healthcare, I wanted to back up the work of the brilliant, ground-breaking and terribly important report prepared by the noble Baroness, Lady Cumberlege. However, when I looked at the Bill, I saw some gaping holes, which I have done my best to fill with assistance—which I wish explicitly to credit—from the British Society for Antimicrobial Chemotherapy; Dr Felicity Thomas, co-director of the WHO Collaborating Centre for Culture and Health at the University of Exeter; and, on the medical devices side, Team Consulting, which has provided me with a great deal of pro bono assistance. I am informed also by participants in the Westminster Health Forum event on sustainability in healthcare that I chaired recently.
The context in which this Bill comes before us is an ageing demographic, the rise of chronic health conditions in our deeply unhealthy society, and the advent of “lifestyle” drugs, all of which have been key drivers in increasing use of pharmaceutical medicines and, although I do not have any statistics on it, I would also believe in medical devices. Prescriptions for just one type of statin used to reduce cholesterol rose from 12.8 million items to 18.2 million items over one year alone. One in six 18 to 64 year-olds was prescribed antidepressants at some point in 2017, rising to one in five of those aged 65 and over.
Critics of the pharmaceutical industry have highlighted how a “culture of optimism” generates new drugs, which increases the demand for such treatments while exaggerating their benefits and not counting their flow-on costs, including the environmental. Medicines and medical devices already have significant environmental impacts which, in the context that I have outlined above, are likely to grow rapidly. As we tackle many other causes of environmental damage, the proportionate impact of medicines and medical devices will grow unless we act.
The point that I am about to make is crucial. I note that the veterinary medicines section of the Bill states that
“the appropriate authority must have regard to … the safety of veterinary medicines in relation to animals, humans and the environment.”
I ask the Government why “the environment” appears only in the veterinary medicines section, when, as I will set out, human medicines and medical devices have significant environmental effects.
There are well-known concerns about veterinary medicines—I note in particular the impact of anthelmintics on insect life—but these issues are not contained to them. Why is there no parallel provision in the medicines and medical devices parts of the Bill? I ask the Government to consider parallel provisions from the veterinary part in the human medicine and medical devices part, which is what my amendments aim to achieve.
I am well aware that people will say that human health is different and has to be the top priority, and I agree with many of the issues about safety and health that we talked about in earlier groups of amendments. But this is not a case of saying that we have to weigh health benefits against environmental ones; it is not either/or. As Covid is reminding us, public health is very dependent on the state of the environment, whether that is in the rising danger of zoonoses; the spread of antimicrobial resistance; the well-documented impact of air pollution on health; or the as yet little understood but extraordinarily pervasive existence of microplastics in the air, soil and water in our lives. This is systems thinking—the sustainable development goals approach to which the Government are signed up.
If we look for an overarching way to think about this, the phrase “green pharmacy” recognises 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 their packaging. It is clear to me that the expectation of this approach should be built into this legislation.
There are some examples of this happening. A project under the EU’s innovative medicines initiative aims to develop tools to screen environmental properties earlier in drug development. I hope to see that transferred into automatic practice in the UK through this legislation. In Sweden, Stockholm county council grades medicines on their environmental effects and doctors can choose to prescribe a less harmful drug where the option exists. If the Government want to be world-leading, that is the standard to be ahead of. The organisation Health Care Without Harm has elaborated 15 recommendations to the European Union for sustainable healthcare. I hope the Government are already well aware of those.
With the exception of Amendments 41 and 91, the amendments do not spell out in detail, in keeping with the Bill’s status as a framework Bill, what kind of provision should be made, although I suggest that they should be included in regulation. They set out the environment as a key issue in the development of medicines and medical devices, and their manufacture, distribution and use. I suggest that that is essential.
Amendments 18 and 25 both look at environmental impacts, with Amendment 25 explicitly about the disposal of unused medicines and the impact of medicines that otherwise reach the environment. That often, although not always, means talking about how medicines reach waterways and get into our drinking water. A 2014 report by UK Water Industry Research found that, in most of 160 sewage treatment works studied, several common drugs were present in the final effluent in concentrations high enough to potentially affect ecosystems. With current trends, the amount of pharmaceutical effluence
leaching into waterways could increase by two-thirds before mid-century, according to a 2018 study by the Delft Institute for Water Education.
There are three ways in which drugs can enter into our waterways: by passing through the body, through being disposed of in waste, or during or after manufacturing. It is worth noting that, globally, over half of all medicines are prescribed, dispensed or sold inappropriately, and that half of all patients fail to take them as directed. Unused and waste medicines are also a problem, when they stay within the healthcare system. In the UK, the estimated cost of dealing with medicine waste in the NHS ranges from £100 million to £300 million a year. Research undertaken in Germany found that up to 16,000 tonnes of pharmaceuticals were disposed of annually from human medical care, with 60% to 80% of these drugs flushed down the toilet or placed in normal household waste.
I am aware that, in this context, there are often disproving statements of, “Patients are not disposing of the drugs properly”, but there is often very little information on drug packets or in information given to patients. I have heard anecdotal reports of people taking drugs back to their GP for appropriate disposal and being told, “Why are you doing that? Just throw it in the bin.”
6.30 pm
It is also worth noting that the 2018 study by the US Geological Survey found that drug manufacturing facilities were an important source of environmental pollution. It is clear that improved sewage treatment, which is very much an issue for the UK and for our water companies, could reduce the amount of pharmaceutical residue reaching ground and surface waters. But that would be dealing with the problem after it had been generated. It should only be a back-up for essential medicines, not something to rely on as an alternative to good practice elsewhere.
Amendments 18 and 80 refer to social impacts. I should at this point acknowledge the assistance of the Public Bill Office in preparing these amendments. I had some discussion with it about whether “social” was the right word, but I shall expand on my intention, and I would appreciate assistance from other noble Lords—and also, I hope, from the Minister—in thinking about the wording.
Let us consider a medical device made from a mineral obtained by “artisan mining” in the Congo, to the great detriment of the health and well-being of child labourers and others there, or a drug made from a rare plant, which is then effectively denied to an indigenous community that has relied on it for its own use. As many global health leaders have reminded us in the context of Ebola and Covid-19, no one is safe until everyone is safe. These are not just moral questions: ultimately, a safe world is crucial to the health of every individual.
With Amendments 18 and 80, I come to the issue of greenhouse gas emissions. The World Bank estimates that the healthcare sector is responsible for about 5% of global carbon emissions. The NHS sustainable development unit estimates that 30% of NHS emissions come from pharmaceuticals and medical devices. Clinical waste is also a problem, as it is predominantly managed through incineration, which creates more emissions
and air pollution, or sent to landfill. A large proportion of clinical waste is made up of single-use devices or packaging, often made of plastics.
Let us look at where we need to go—the direction of travel that the Bill needs to provide. Novo Nordisk is a global healthcare company based in Denmark, specialising particularly in diabetes care. It has an environmental strategy, “Circular for Zero”, which aims to move from a linear economy of “take, make, dispose” to a circular economy, which means designing out waste and pollution, keeping products and materials in use, and regenerating natural systems. This is clearly what we have to do with all design, production and management of medicines and medical devices.
Amendment 80 deals with medical devices. Once we understand how to assess the environmental impact, there is a long list of measures that can be taken, which the Bill should be encouraging. For example, we should: design for multiple use and long life; avoid single-use devices where possible; design robust devices for extended use life; design for end of life; design for reuse; design for recyclability; design for energy recovery; and manufacture with sustainable materials, using recycled content. A number of standards already exist, particularly for packaging, but are often observed only voluntarily. I will not read out a long list here, but I hope the department is already well aware of them. Experts tell me that the simple inclusion of an amendment along the lines of Amendment 80 could direct us to this as a standard for research, development, manufacture, use and disposal of medicines and medical devices.
Finally—and I apologise for having spoken for quite some time—I come to Amendments 41 and 91, both of which are highly technical, and were tabled at the request of a senior NHS consultant. Amendment 41 includes a requirement for all commercially led or sponsored antimicrobial trials to report on the emergence of
“antimicrobial resistance in the microbiota of subjects during receipt of the drug in clinical trials and during the follow-up period.”
That means that, as part of the requirement to report on adverse events, investigators should report on such issues. I would have thought that that should be standard, but apparently it is not. In our debates last week, the Minister referred to antimicrobial resistance. An estimated 25,000 people die each year in Europe from antibiotic-resistant bacteria.
Amendment 91 represents a reaction to the concerns of the NHS consultant who expressed frustration with the problems in the current system, and with the failure to ensure that apparently reusable devices come with appropriate decontamination information. I will not detain the Committee with details, but I hope that the Minister can provide information in his answer, or perhaps later in writing, that could help to assure me—and, more importantly, concerned NHS staff—that the Bill will ensure that this problem is removed.