Several reforms to EU chemicals policy and legislation have been introduced in recent years, with the aim of promoting the green transformation. Many of these reforms also affect the pharmaceutical sector and its stakeholders. A study conducted at the University of Eastern Finland found that changes to EU chemicals legislation create both opportunities and challenges for the green transformation in the pharmaceutical sector.
The interview study explored pharmaceutical sector stakeholders’ views on how changes to EU chemicals legislation affect the green transformation in the sector, as well as their practices for supporting it. The interviewees came from seven European countries and worked in the pharmaceutical industry, industry associations, non-governmental organisations, public authorities and academia. The study was carried out as part of the PharGTrans project, funded by the Research Council of Finland.
Views among pharmaceutical sector stakeholders varied on how legislation affects the green transformation
“Many stakeholders in the pharmaceutical sector viewed the various legislative changes, such as the proposed restriction of PFASs under the REACH Regulation, and the Regulation on Packaging and Packaging Waste, as supporting the green transformation,” says Doctoral Researcher Sanja Riikonen of the University of Eastern Finland.
Pharmaceutical sector stakeholders found that these regulations encourage the development of environmentally less harmful compounds that could, in the future, replace substances of concern used in pharmaceutical production processes and increase the use of recycled materials in packaging. Changes aimed at improving information sharing and transparency, such as the regulation establishing a common data platform on chemicals, were likewise seen as supporting the green transformation in the pharmaceutical sector.
On the other hand, the stakeholders interviewed for the study felt that several of the changes also posed major challenges for the sector and questioned their contribution to advancing the green transformation.
“The restriction of PFASs under the REACH Regulation, together with the recast Urban Wastewater Treatment Directive and its extended producer responsibility scheme, prompted considerable discussion, particularly among interviewees from pharmaceutical companies and industry associations,” Riikonen notes.
Although the proposed restriction of PFASs does not apply to active pharmaceutical ingredients the pharmaceutical industry uses many PFAS-containing materials in its production processes. The interviewees viewed a rapid transition to alternative materials as challenging. The extended producer responsibility scheme under the Urban Wastewater Treatment Directive has direct implications for the pharmaceutical industry, as it requires the pharmaceutical and cosmetics industries to cover a large proportion of the costs associated with upgrading wastewater treatment processes in EU Member States. The interviewees found that requiring industry to bear these costs could divert companies’ resources and attention away from other measures that promote sustainability.
Greater collaboration is needed across sectors and among stakeholders
According to the study, closer collaboration between different policy sectors and stakeholder groups is needed in 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.
“The effects of regulation supporting the green transformation on different stakeholders should also be taken into account more effectively. This could help to avoid unintended consequences of regulation that may even slow down the green transformation it is intended to advance,” Riikonen concludes.
PharGTrans project website
Research article:
Riikonen, S., Timonen, J., Sivén, M., Miettinen, M. Stakeholder views on recent changes to EU chemicals legislation – are they promoting green transformation or posing challenges for the pharmaceutical sector? Sustainable Chemistry and Pharmacy 2026; 53:102552. https://doi.org/10.1016/j.scp.2026.102552