Brussels, 26 April 2023 – The self-care sector, represented by AESGP, has issued an industry statement in response to the proposed revision of the EU pharmaceutical legislation. While welcoming the publication of this long-awaited and much-needed revision, AESGP expresses some concerns and other considerations impacting non-prescription medicines, and ultimately people and health systems in the EU.
The self-care industry, represented by AESGP, welcomes the publication of the European Commission’s proposal for a revision of the EU pharmaceutical legislation. This legislation review has been long awaited by AESGP members who are particularly implicated in this regulatory framework, namely the sector of self-care pharmaceutical products (non-prescription medicines). It represents an opportunity to ensure that legislation fully benefits people and health systems, while also embracing scientific and technological evolution as well as learnings from recent crises.
Jurate Svarcaite, AESGP Director General, said: “Responsible self-care is an integral part of comprehensive health promotion and disease prevention strategy. We believe that self-care products, including non-prescription medicines, should be given greater recognition for their role in the sustainability of health systems. The review of the EU pharmaceutical legislation is an opportunity to recognize and promote this role in the future.”
Address today’s challenges with science-based, risk-balanced and proportionate measures
In line with its mission to support access to safe, effective and sustainable self-care for all in Europe, AESGP supports a pragmatic and risk-based regulatory framework that reinforces the role of self-care and prevention.
In its industry statement, AESGP highlights – based on its initial assessment of the published text – key provisions for the self-care sector:
- Welcomes regulatory agility and diversity of market access procedures: provisions help strengthening access
- Recommends improvements to product information provisions
- Promotes a wide definition of real-world data and evidence to allow use in regulatory processes and decision-making
- Advocates for proportionate and risk-based shortage countermeasures
- Calls for greater incentives for switches (i.e., legal status change from prescription to non-prescription status) which remain lowest amongst comparable jurisdictions
- Warns about the unintended impact of disproportionate environmental risk-mitigation measures that may hinder access to medicines.
Jurate Svarcaite, AESGP Director General, said: “AESGP supports the revision of the EU pharmaceutical legislation in principle. While we welcome the regulatory simplifications introduced by the revision, we are voicing some concerns on behalf of non-prescription medicines manufacturers that may have unintended negative consequences. We are committed to actively contributing to the dialogue with co-legislators and stakeholders so that the final text is fit for the rapidly changing world we live in, embraces the evolution of science and, ultimately, responds to the needs of people while ensuring the highest level of public health protection.”