If you think about the ecological footprint of the health sector, which is the single most important factor regarding greenhouse gas emissions, material extraction, waste generation, and water and land use? The answer is: pharmaceuticals and other chemical products. Therefore, when we started working with lawyers at the Bucerius Law School in Hamburg to identify the most important legal levers for ecological sustainability in the German health care system, we zoomed in pretty quickly on the elephant in the room – the pharma sector. Regulation along the life cycle of medicines must reduce their environmental impact, otherwise the health and wellbeing of people and ecosystems will be at risk in both producing and consuming countries. As we explained in our recent policy brief, there is currently a lack of transparent data and effective consideration of ecological impacts in authorisation (of medicinal products for human use); tendering (of medicinal products); and professional education processes. Let’s take a closer look at those aspects.

Whilst you can find claims about sustainability and moving towards climate neutrality on many pharmaceutical companies’ websites, until now there were few mandatory regulations that effectively reduced the climate and environmental impact of medicines for human use. Even the introduction of the environmental risk assessment (ERA) by the EU in 2005 had little impact on the authorisation of a drug for human use. The EU Commission’s brand new Pharma Strategy  will give the ERA more teeth – if it’s implemented in its current version, at least. Under the proposed legislation, market authorisation could be suspended or revoked if serious environmental concerns (including emissions and discharge at the production, use and disposal states of a medicine) are not sufficiently addressed. An ERA can also be imposed for medicines authorised before 2005 by the responsible agency if a potential environmental risk is identified, which would somewhat address the lack of transparent data for these older drugs. From an ecological perspective, this development is long overdue. We have to recognise, however, that some producers of generic medicines might decide that it is more economical to take a drug with very low profit margins off the market than pay for the ERA. It’s important to find solutions for those cases so that the availability of necessary drugs is not endangered. For new drugs, the ERA as well as risk mitigation measures for environmental risks should be a mandatory element of the risk-benefit assessment to be carried out for authorisation.

The most sustainable drug is of course the drug that’s never been produced. Overconsumption is a difficult but important topic to address in this context – not just for environmental but also patient safety reasons. Think for example about certain over-the-counter drugs with little to no evidence of substantial health improvements (such as many weight-loss products and dietary supplements) and the potential of prevention and health promotion to reduce the need for many drugs. Maybe we need to look at expectations of alleged ‘easy-fix’ solutions to health concerns, maybe at advertisement, maybe at how other policy areas need to make the healthy choice the easy choice. Probably all of the above.

This is where health professionals come in. Pharmacists have a responsibility to advise customers on the use and disposal of medicines but right now they only have an income if they sell drugs, so there is no financial incentive to advise a customer NOT to buy an over-the-counter drug. In Germany, pharmacists have also almost completely stopped to take back used medicines and medical products to dispose of appropriately. Regarding prescription drugs, several factors need to be addressed to reduce overuse: financial incentives, education of physicians, clear guidelines and definitions of ‘inappropriate’ or low-value treatment options, better monitoring and addressing expectations on the patient/physician interaction to name but a few.

Finally, a few words about the role of production of generic drugs in countries with decent working conditions and environmental protection laws that are properly enforced. As we have seen in the context of the recent drug shortages, European countries have become dependent on China and India for a number of antibiotics, painkillers and other essential drugs. Both German and EU policy-makers are now trying to promote more production in Europe but it will take time, resources and different incentives to enable this, given the higher production costs and different regulatory regimes in the EU. Perhaps the corporate sustainability due diligence directive proposed by the EU Commission last year could play a role in favouring more ethical production.

Several other levers are available to address pharmaceuticals’ footprint such as chemical and water pollution regulation. It is encouraging to see that the EU Commission is increasingly tackling the ecological impact of the pharma sector but a lot will now depend on the agreement and implementation of the Member States, their own initiatives in this regard and how proactively the pharmaceutical sector itself will reduce its eco-footprint.