ArticleJournal of pharmaceutical policy and practice2025
Crossing silos: how changes in EU chemicals policy and legislation are reflected in its pharmaceutical policy and legislation.
Article in Journal of pharmaceutical policy and practice, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Background: The European Union (EU) has introduced several changes to its chemicals policy and legislation with an ambition to transform society greener. This study examined selected changes introduced in EU chemicals policy and legislation and how they may affect the pharmaceutical sector. The objective was to find out whether structural changes in one political sphere (chemicals) influence the other political sphere (health). Methods: First, concrete changes to EU chemicals legislation or its implementation were identified. Then, qualitative content analysis was used to analyse how these changes are reflected in EU pharmaceutical policy, legislation and related guidance documents. Data was analysed using both deductive and inductive approaches. The concrete changes identified were used as codes for the deductive classification of quotations. The analysis continued inductively by examining these quotations for the topics they raise in EU pharmaceutical policy, legislation and related guidance. Results: The results imply that structural changes in EU political sphere of chemicals may have a range of implications for the pharmaceutical sector. The need for derogations in certain cases regarding medicinal products was recognised, but in general, the pharmaceutical sector will not be exempted from the application of the new provisions. However, changes to EU chemicals legislation were rarely referred to in pharmaceutical policy, legislation and guidance. An inductive analysis of the quotations revealed that some changes (such as substances with endocrine-disrupting properties and changes to EU water legislation) have got more prominence in the pharmaceutical sector than others. Conclusion: The analysis indicated that the pharmaceutical sector is taking a defensive approach to changes in EU chemicals legislation. This may be partly because many changes occur simultaneously, creating uncertainty about their combined and cumulative impacts. Closer cooperation between the Environment and Health Directorates-General is needed to steer more coherent transformation governance across different policy sectors in the EU.
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