Brussels, 19 July 2023 – As part of the feedback procedure, AESGP submitted its feedback and a detailed position paper on the revision of the general pharmaceutical legislation to the European Commission.
AESGP expresses support for the Commission’s Proposal to revise the EU general pharmaceutical legislation. We believe this long-awaited revision will consolidate and streamline legislation which underwent multiple updates over the past 20 years. While AESGP members acknowledge the legislation’s goals, we raise concerns about unintended consequences for non-prescription medicines (NPMs).
AESGP argues that certain proposed changes may negatively impact medicine availability, patient access, and the sustainability of healthcare systems.
Regarding prescription status, we are concerned that the broad definition of antimicrobials in the proposal encompasses antivirals and antifungals, available as topical-use NPMs. We consider that restricting the use of these products without scientific reason could lead to delayed treatment, increased dosages, and longer-term usage, adversely affecting public health and burdening healthcare systems. The prescription status criteria applied for environmental reasons is also inadequate to reduce environmental exposure. We suggest prescription criteria to be limited to antibiotics with confirmed AMR risks and to be removed for environmental concerns.
AESGP is aware of the environmental risks associated with pharmaceuticals. While we recognize the importance of environmental risk assessments (ERAs) for human medicines, we found some shortcomings in the proposal. We underline issues like repetitive studies, inconsistent conclusions, or inequitable testing burdens. So, we recommend an extended ERA (eERA) as the primary regulatory tool for environmental assessment and stress the need for high-quality scientific data and alignment across agencies and legislative dossiers.
On medicine shortages, we emphasize the commitment of the pharmaceutical industry, including NPMs, to avoid shortages and mitigate their effects. We suggest that requirements for shortages prevention plans and notifications should be limited to critical NPMs, with notifications made 2 months prior to the occurrence. We would oppose granting specific powers to MSSG to mandate inventory management and supplier diversification, arguing that companies should be flexible to adopt the most appropriate shortage management strategies.
As AESGP, we criticize the lack of adequate measures to incentivize innovation and investment within the EU for the change of legal status from prescription to non-prescription. We highlight the need to weigh various types of evidence, like behavioural studies and RWE, when assessing the safety, effectiveness, and healthcare contribution of a switch. We also reason that the current 1-year data protection is insufficient, as the EU lags behind other markets (US and Japan grant 3-year data protection).
Regarding product information, we call for a smooth transition to digital product information due to its benefits. We recommend a stepwise approach, starting with the simplification of paper patient information leaflets and the introduction of detailed digital leaflets as a complement.
On regulatory agility, we appreciate that marketing authorization procedures remain unchanged and procedure timings are shortened. However, we suggest removing requirements related to member state notifications and opt-in provisions, as other mechanisms can improve access and availability.
As AESGP, we propose maintaining the well-established use application route to foster innovation in the self-care sector and avoid unnecessary clinical trials. We recognize the potential of RWD/RWE to inform authorities’ decisions on medicines, particularly on legal status, safety, and effectiveness. So, we call for broad definitions of RWD/RWE fit for NPMs.
As for pharmacovigilance, we suggest extending the generics exemption on submitting risk management plans (RMP) to medicines of well-established use without significant safety concerns. For other product categories, we support a risk-based approach to RMP, based on existing safety information and indications.