EU Chemicals Reforms Offer Pharma Sector Both Green Gains and Growing Pains

A sweeping wave of reform is moving through the European Union’s chemicals policy landscape, and few industries feel its ripples as keenly as pharmaceuticals. A new study from the University of Eastern Finland has mapped how stakeholders across the pharmaceutical sector perceive recent changes to EU chemicals legislation, and the picture that emerges is one of cautious optimism shadowed by real anxiety. The research, published in the journal Sustainable Chemistry and Pharmacy, found that the legislative changes designed to accelerate the green transformation are simultaneously opening doors for greener chemistry and closing off resources that companies say they need to pursue sustainability on their own terms.

The study was carried out as part of the PharGTrans project, funded by the Research Council of Finland, and took the form of an interview study rather than a survey or laboratory analysis. Researchers spoke with stakeholders drawn from seven European countries, capturing perspectives from inside pharmaceutical companies, industry associations, non-governmental organisations, public authorities and academia. This breadth matters, because chemicals legislation does not land on all actors equally. A regulator interpreting a directive, an NGO campaigning for stricter limits and a manufacturer re-engineering a production line all experience the same legal text in profoundly different ways, and the study set out to document precisely those divergent experiences.

Among the reforms attracting the most attention was the proposed restriction of per- and polyfluoroalkyl substances, better known as PFASs, under the REACH Regulation, the EU’s flagship framework for the registration, evaluation, authorisation and restriction of chemicals. PFASs are a vast family of synthetic compounds prized for their chemical and thermal stability, which is exactly what makes them so persistent in the environment and so difficult to replace in industrial processes. Many stakeholders interviewed for the study viewed the proposed restriction, alongside the Regulation on Packaging and Packaging Waste, as a genuine push in the right direction for the sector’s green transformation.

According to the researchers, these regulations are encouraging the development of environmentally less harmful compounds that could, in the future, replace substances of concern used in pharmaceutical production processes. They are also expected to increase the use of recycled materials in pharmaceutical packaging, an area where the industry has historically lagged behind consumer sectors. Changes aimed at improving information sharing and transparency, such as the regulation establishing a common data platform on chemicals, were likewise seen as supportive, since better data flows can help companies identify hazardous inputs earlier and plan substitutions more strategically.

Yet the same instruments that inspire hope in some corners of the sector provoke alarm in others. Doctoral Researcher Sanja Riikonen of the University of Eastern Finland, who led the interviews, noted that the PFAS restriction and the recast Urban Wastewater Treatment Directive prompted considerable discussion, particularly among interviewees from pharmaceutical companies and industry associations. The tension is not simply resistance to change; it reflects a technical reality about how deeply certain substances are woven into modern pharmaceutical manufacturing.

Although the proposed PFAS restriction does not apply to active pharmaceutical ingredients, the pharmaceutical industry relies on many PFAS-containing materials in its production processes. These compounds can appear in equipment linings, filters, tubing, gaskets and other critical components where their resistance to aggressive chemicals and high temperatures is difficult to replicate. The interviewees viewed a rapid transition to alternative materials as challenging, and their concern highlights a recurring dilemma in green chemistry policy: banning a problematic substance class is straightforward on paper, but qualifying and validating replacements in a sector governed by strict quality and safety requirements can take years of testing and regulatory approval.

The recast Urban Wastewater Treatment Directive introduces a different kind of pressure through its extended producer responsibility scheme. Under this scheme, the pharmaceutical and cosmetics industries are required to cover a large proportion of the costs associated with upgrading wastewater treatment processes in EU Member States. The logic is that manufacturers should bear some responsibility for the residues their products leave in water systems, where trace pharmaceutical compounds can affect aquatic ecosystems. But the interviewees found that requiring industry to bear these costs could divert companies’ resources and attention away from other measures that promote sustainability, effectively pitting one environmental goal against another within the same corporate budgets.

This tension between well-intentioned instruments is one of the study’s most significant findings. A company spending heavily on wastewater treatment levies may have less capacity to invest in greener synthesis routes, safer packaging or substitution programmes. Stakeholders questioned whether some of the legislative changes would genuinely advance the green transformation at all, suggesting that the cumulative burden of overlapping requirements could slow the very transition the legislation is meant to accelerate. The finding underscores a broader lesson in environmental governance: the aggregate effect of individually reasonable policies can be unbalanced if their interactions are not carefully assessed.

In response, the study points toward a clear remedy: closer collaboration between different policy sectors and stakeholder groups throughout the legislative drafting process. Several stakeholders highlighted challenges arising from shortcomings in communication and a limited understanding of the broader picture across sectors. According to the interviewees, more transparent preparatory processes, better information-sharing and more inclusive dialogue could reduce inconsistencies between regulations affecting the chemicals, environmental and pharmaceutical sectors and promote more coherent decision-making. In practice, this would mean regulators consulting more systematically with the industries and communities their rules affect, and vice versa, before texts are finalised rather than after implementation problems emerge.

Riikonen’s concluding message reaches beyond the pharmaceutical sector to anyone shaping environmental regulation. The effects of regulation supporting the green transformation on different stakeholders, she argues, should be taken into account more effectively, because doing so could help avoid unintended consequences that may even slow down the green transformation the rules are intended to advance. As the EU continues to revise its chemicals framework in pursuit of a non-toxic environment, the Finnish study offers a grounded reminder that the path to greener pharmaceuticals runs not through legislation alone, but through legislation designed with a clear-eyed understanding of the laboratories, factories and treatment plants where it will ultimately take effect.

Subject of Research: Stakeholder perceptions of EU chemicals legislation reforms and their effects on green transformation in the pharmaceutical sector

Article Title: Pharmaceutical sector stakeholders see changes to EU chemicals legislation as presenting both opportunities and challenges for the green transformation

Article References: Pharmaceutical sector stakeholders see changes to EU chemicals legislation as presenting both opportunities and challenges for the green transformation. (n.d.). Original publication

Image Credits: AI Generated

DOI: Not provided

Keywords: EU chemicals legislation, pharmaceutical sector, green transformation, REACH Regulation, PFAS restriction, Urban Wastewater Treatment Directive, extended producer responsibility, sustainable chemistry, pharmaceutical packaging, stakeholder interviews, environmental policy, University of Eastern Finland