Several changes have been made to EU chemicals policy and legislation with the aim of making society greener. These changes may affect the pharmaceutical sector in many ways, but they are rarely reflected in pharmaceutical policy, legislation and guidance, a new study from the University of Eastern Finland shows.
The study analysed how a set of concrete changes, introduced in EU chemicals policy and legislation through the European Green Deal were reflected in EU pharmaceutical policy, legislation and related guidance. The study was carried out as part of the PharGTrans project, funded by the Research Council of Finland.
Reporting requirements increase in the pharmaceutical sector
The changes to EU chemicals legislation cover several topics, ranging from amendments to core EU regulations REACH and CLP to EU water and industrial emissions legislation as well as new requirements for packaging and sustainability reporting.
“The changes address, for example, endocrine disruptors, microplastics and per- and polyfluoroalkyl substances (PFAS), and though human and veterinary medicinal products are often exempt from these provisions, many of these new provisions apply to medical devices,” Academy Research Fellow Mirella Miettinen points out.
“The derogation for human and veterinary medicinal products usually includes new reporting requirements, and increased reporting is also required, for example, in relation to the extended producer responsibility scheme in the new Urban Wastewater Treatment Directive,” Miettinen adds.
According to Miettinen, it is noteworthy that the pharmaceutical sector has not been completely exempted from the application of these new provisions, though the need for derogations has been recognised in certain cases for human and veterinary medicinal products.
“This can be seen as a step towards transformation governance, where structural changes, such as new rules or regulations, are made with the aim of influencing a larger system,” Miettinen says.
Many concurrent changes are difficult to follow and predict their cumulative impacts
The results revealed that some changes, such as those pertaining to endocrine disruptors and changes to EU water legislation, have received more attention in the pharmaceutical sector than others. The analysis also indicates that many simultaneous changes are causing uncertainty among actors regarding their combined and cumulative effects. As the concrete changes address the objectives of the European Green Deal on achieving a toxic-free environment, enhancing cooperation between EU agencies, accelerating the circular economy, and improving the sustainability of value chains, the result is a network that is difficult to follow.
Miettinen further explains that there may be conflicts between the desired outcomes in different sectors. If the structural changes in the EU chemicals sector threaten to undermine the desired outcomes in the pharmaceutical sector (i.e. to ensure human health and access to medicines), the responses in the pharmaceutical sector to these changes may not necessarily facilitate the green transformation but may even hinder it.
“It is important to consider this social complexity in transformation governance,” Miettinen underlines.
Crossing silos to reduce fragmented responses
One explanation for the scarcity of reflections on the changes to EU chemicals legislation in the pharmaceutical sector is the prevalence of institutional silos between different sectors in EU regulatory system. The findings of this study propose that a more integrated approach to chemicals in EU legislation is needed, requiring closer cooperation between the Environment and Health Directorates-General.
Miettinen argues that a paradigm shift is needed in the pharmaceutical sector so that environmental considerations are acknowledged as significant and truly incorporated into pharmaceutical legislation and guidelines.