EU Pharma Strategy
AESGP has actively followed and participated in the implementation of the EU Pharmaceutical Strategy, in particular the upcoming revision of the general pharmaceutical legislation. On several occasions, we have expressed our concerns and demands when interacting with the European Commission and European Medicines Authorities, expressing our support for a pragmatic and risk-based regulatory framework that promotes a greater role for self-care and prevention.
Supporting a regulatory framework fit for the self-care needs of EU citizens
In the AESGP Reply to the European Commission’s Combined Evaluation Roadmap / Inception Impact Assessment on the Evaluation and revision of the general pharmaceutical legislation, we highlighted that the current legal framework is broadly suited to its purpose, although some problems may arise from differing interpretations, non-harmonised application and the addition of gold-plating or administrative elements, and we supported the Commission’s targeted approach to the revision.
AESGP also contributed to the open public consultations and the targeted consultation which will inform the revision of the general pharmaceutical legislation, calling for:
- incentives to promote self-care and reclassification from prescription to non-prescription status (switch) (in particular, data protection for switch should be expanded to 3 years and should apply to all types of studies).
- streamlining lifecycle management, including variations.
- a broader definition of real-world data (RWD) and applications.
Reducing the regulatory burden and optimising access procedures
Regulatory flexibility, which has proven useful during the COVID-19 crisis, should also be applied in other cases or maintained in a post-pandemic scenario to reduce the regulatory burden and optimise procedures. Specific measures, which have been introduced regarding, for example, the acceptance of digital versions of documents, remote inspections and variations, could be considered for permanent establishment.
For non-prescription medicines, all regulatory market access procedures operate in a complementary manner with clear criteria. Therefore, we continue to argue that the centralised procedure remains an option to switch. The current optional scope of the centralised procedure allows immediate access of non-prescription medicines to the entire EU market and therefore gives fast and fair access to non-prescription medicines for all EU citizens. A number of non-prescription medicines have been authorised through the centralised procedure since 2009 (6 in total and 2 in 2020 alone). The sector welcomed a widened scope for the centralised procedure as it ensures full harmonisation across the EU and increased availability of non-prescription medicines.
EU structured dialogue on the security of medicines supply
The strategic importance of the ‘resilient supply chains’ was identified as a priority early in the EU’s Pharmaceutical Strategy process and further evidenced by the start of an EU structured dialogue on the security of medicines supply launched in February 2021. The structured dialogue steered by the European Commission brought together actors in the pharmaceuticals manufacturing value chain, public authorities, research community, health professionals and patient organisations.
AESGP has contributed to the Structured Dialogue by actively participating in the 4 workstreams (WS1: Robust supply chain; WS2: Critical medicinal products; WS3: Vulnerabilities; WS4: Innovation).
Throughout the dialogue, AESGP has encouraged the European Commission to continue its engagement and constructive dialogue with the stakeholders involved in the decision-making process to ensure that solutions are targeted, effective and proportionate. Overall, AESGP’s points have been well reflected in the overall picture of the situation drawn by the Commission at the end of this first phase:
- Pharmaceutical supply chains are highly complex and increasingly specialised.
- Heterogeneity of the sector – strategies to address challenges need to acknowledge this; no one size fits all solutions.
- Reliability of the supply chain is a critical factor; ensuring responsiveness, particularly in times of crisis.
- Globalisation of the supply chain is acknowledged.
- EU has a strong manufacturing footprint of technology-intensive niche products, including innovative APIs and finished dosage form and generic APIs.