Documents that sustainability generates
Environmental content now reaches several documents medical writers prepare: the environmental risk assessment, the investigational medicinal product dossier, the risk management plan and grant applications, and it may in future reach value dossiers. A packaging or formulation change made for environmental reasons passes through the ordinary regulatory variation process, and the Declaration of Helsinki has carried wording on research that may affect the environment since 1975.
Documents that carry environmental content
Regulations and guidelines look at the environmental impact and life-cycle management of healthcare products, and certain documents medical writers develop for regulatory submissions cover these topics, including the risk management plan, the investigational medicinal product dossier and the environmental risk assessment. Medical writers are involved in preparing EMA marketing authorisation documents such as the investigational medicinal product dossier and the environmental risk assessment.
- Environmental risk assessment. As of 2020, the environmental risk assessment for healthcare products was a standalone document that had to be written. It may not be familiar to many medical writers.
- Investigational medicinal product dossier. In 2020, a workshop leader on investigational medicinal product dossier and IND writing expected it to involve a lot of writing on carbon dioxide and on product labelling and packaging.
- Documents on healthcare waste. In 2020, one practitioner was discussing the management of waste in the healthcare industry, such as radioactive and biohazard waste, with the regulator: whether regulations would come, whether documents would have to be written on it, and where those would fit into the Common Technical Document.
- Global value dossiers and value messages. These provide scientific information demonstrating the value of a new product, and in future they may include environmental or other sustainability information in addition to the product's effectiveness and safety, which writers may be called on to communicate. Writers therefore need to understand why such information is included in product development and use.
The EU Green Deal brings sustainability to the forefront of all economic sectors, including the healthcare industry. As of 2021, it formed the basis for all policies in the healthcare, pharmaceutical and medical technology sectors, so the need to address sustainability in certain regulatory documents and in grant applications was likely to increase and become more explicit. Writers need to be aware of how those policies will be reflected in changes to regulatory documents, such as the environmental risk assessment, and to European grant applications. Medical writers and communicators need to stay abreast of new developments and requirements for regulatory and nonregulatory documents so that they can prepare them adequately for their clients.
Regulatory procedure for a packaging or formulation change
As of 2024, a regulatory specialist did not think there was any specific pathway for a packaging change made after a sustainability assessment, and the standard process for regulatory variations still applies. That process looks at what is changing, such as whether it is the primary or the secondary packaging and whether the qualitative or quantitative composition changes, at the impact on stability, and at whether the product's quality, safety and efficacy remain unchanged. These regulations are in place because a change in packaging can sometimes have major repercussions on product quality that could damage patient safety.
Changing a product's packaging means going back to the regulator, so it is not a simple swap: it requires work and costs from the contract manufacturer as well as the sponsor. In 2024, one contract manufacturer was not necessarily seeing the regulators of FDA-, EMA- or similarly regulated products change the requirements for reauthorisation after a packaging change to make more sustainable options less of a hurdle, though its speaker did not know that it had asked them either, and the regulatory specialist agreed. The company takes into account what it perceives to be the regulators' views. One participant saw a real benefit in such a change despite potential safety concerns, and suggested that a higher authority might have to speak to the regulators directly but that lobbying from the writers' side might also help encourage it. The regulatory specialist encourages sponsors to explain to the health authorities the change they want to make and its benefit from a sustainability point of view, and to try to find a solution with them. She reports that in 2024 the authorities were quite open to discussion on propellant gases for medical devices.
In 2024, the contract manufacturer had agreements with some customers to remove non-recyclable plastic packaging from their products by a set date. Whether to move from plastic to glass depends on the usage, and its speaker thinks the manufacturer tends to focus more on getting rid of non-recyclable plastics. Its speaker agreed with a questioner that microplastics had become a health concern, but could not think of a case where they had come up for the company.
The complexity of a change differs between primary and secondary packaging: a thin plastic wrap around the secondary packaging is much easier to change than a blister pack in contact with the product. To risk-rank which change to start with, the contract manufacturer weighs how long the product will be on the market, how easy the change is and what volume it could affect. The difficulty is that there are a thousand things to do, and the question is which five will have the most impact. Its speaker holds that the biggest impact is on new products, by designing their packaging more sustainably from the start, and that reformulating propellants has to happen.
As of 2025, high-GWP gases, including hydrofluorocarbon gases such as the propellants used in pressurised metered-dose inhalers for respiratory diseases, are being phased out for environmental reasons in line with the EU Regulation on fluorinated greenhouse gases (EU Regulation 2024/573) and applicable legislation in other regulatory constituencies. The propellant of a metered-dose inhaler is a liquefied compressed gas that generates an aerosol cloud containing the small particles of active pharmaceutical ingredient that the patient inhales. Trixeo Aerosphere and its duplicate product Riltrava Aerosphere are metered-dose inhalers, administered as two inhalations twice daily for maintenance treatment in a subset of adults with moderate-to-severe chronic obstructive pulmonary disease, and their marketing authorisation holder investigated replacement options for their propellant, focusing on a lower-GWP propellant that could keep the same performance properties. In July 2025 the European Medicines Agency recommended a change in their composition to replace the existing gas propellant with a low global warming potential (GWP) alternative that has a 1,000-fold reduction in global warming potential and similar physical properties, making them the first inhaled medicines in the EU with a low-GWP gas propellant. The reformulated product, with the same active ingredients and dose, was characterised in line with the principles of the draft guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products for asthma and COPD, and it is therapeutically equivalent to the product on the market. Studies confirmed that its safety and efficacy are equivalent to those of the approved product. The opinion was then to be sent to the European Commission for the adoption of a decision on the variation to the marketing authorisation.
The Declaration of Helsinki on the environment
The Declaration of Helsinki covers not only the protection of human subjects but also the protection of the environment and of animals, and as of 2022 it had done so for almost 50 years. Its language has evolved, but the principles were in place before "sustainability" and "climate change" became common everyday terms.
- Versions of 1975, 1983, 1989 and 1996. Special caution must be exercised in the conduct of research which may affect the environment, and the welfare of animals used for research must be respected.
- Versions of 2000, 2002 and 2004, principle 12. Appropriate caution must be exercised in the conduct of research which may affect the environment, and the welfare of animals used for research must be respected.
- Version of 2008, principle 13. Appropriate caution must be exercised in the conduct of medical research that may harm the environment.
- Version of 2013, general principle 11. Medical research should be conducted in a manner that minimises possible harm to the environment.
Minimising the impact of pharmaceuticals on the environment is part of Good Clinical Practice and is stated in the 11th principle of the Declaration of Helsinki.
One writer held in 2024 that the Declaration was the first to highlight that medical research should minimise its impact on the environment, and that its new version, released that year, was not yet common knowledge. One practitioner sees the new version as another example of documents, treaties and ideologies around healthcare increasingly incorporating a sustainability lens, which means writers are more and more asked, formally and informally, to think about these things. In the same practitioner's view, the Declaration is a potential tool in ethics and funding applications for healthcare research, a tool to motivate regulatory change, and perhaps one in public opinion and professionals' ethical codes, to say that if a body like that says the environment matters in healthcare research, then it really does.