AESGP Annual Report 2023 - Non-Prescription Medicines

Supporting a regulatory framework fit for the self-care needs of EU citizens

We were pleased to confirm that some of our demands were reflected in the proposal. However, some additional challenging aspects that may impact non-prescription medicines were also introduced. AESGP therefore analysed both proposals and identified key priorities for our work and engagement in the legislative process going forward. Supported by the AESGP Committees and Pharma Strategy Expert Groups, AESGP drafted a position paper which was finalised in July and published on the AESGP website together with a dedicated press release. Based on the position paper, the amendments that have been used in the advocacy work towards both co-legislators, namely the European Parliament and Council of EU, have also been developed.

In our position paper on the revision of the general pharmaceutical legislation, AESGP values that the legislation aims to tackle affordability, promote innovation, and enhance supply security while increasing regulatory flexibility. However, we are concerned about a potential unintended impact on non-prescription, which could negatively affect medicine availability, patient accessibility, and the sustainability of healthcare systems.

The following key issues were highlighted:

On prescription status, AESGP is concerned about the broad definition of antimicrobials in the proposal. We consider that restricting the use of these products without scientific reason would lead to delayed treatment and spreading, thereby 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 be limited to antibiotics with confirmed antimicrobial resistance risks and be removed for environmental hazards.
AESGP recognizes the importance of environmental risk assessments (ERAs) for human medicines. However, the legislative proposal has some shortcomings. We underline issues such as repetitive studies, inconsistent conclusions, and inequitable testing burdens. We recommend extending ERA (eERA) to the entire life cycle of the medicinal product as a 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 non-prescription medicines, with notifications made two months prior to the occurrence.

We continue to criticize the lack of adequate measures to incentivize innovation and investment within the EU for the switch 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 current one-year data protection is insufficient, as the EU lags behind other markets (US and Japan grant three-year data protection).

Regarding product information, we call for a smooth transition to digital product information due to its benefits.

On regulatory agility, we appreciate that marketing authorization procedures remain unchanged, and that procedure timings are shortened. As AESGP, we propose maintaining the well-established use application route to foster innovation in the self-care sector and avoid unnecessary clinical trials.
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.
Last, requirements outside the scope of the pharmaceutical law review (traditional herbal and homeopathic medicinal products and advertising) should remain untouched as they have not been impact-assessed.
Following the start of discussions in the European Parliament and with the support of our members, AESGP extensively engaged in the advocacy work towards Members of the European Parliament (MEPs.)

Revision of the variation system

On 26 September, AESGP sent the European Commission its response to the EC call for evidence on the revision of the Commission Regulation 1234/2008, known as the Variation Regulation. The previous AESGP work and position paper on this topic informed the answer. AESGP welcomed the revision of the variation system to modernise it. It called for leveraging digital technology to enable direct upload of simple administrative changes into the OMPS/PMS database. It also called for a more risk-based approach and the possibility to down-grade variation classification, a more level playing field between chemical and herbal APIs, and the extension of grouping and work-sharing, amongst others. AESGP and its members presented their concerns to the authorities on a number of occasions.