Health Minister Riina Sikkut remarked, "This reform aligns perfectly with our intention to create a regulatory environment that meets the needs of patients and is in line with the European principles of solidarity. It is important that smaller markets in the EU, like Estonia, should have equal and rapid access to the pharmaceuticals when comparing to other countries."
The European Commission proposed a reform of the EU pharmaceutical legislation in April this year, with the aim to update a legal framework that is more than two decades old. This reform addresses the most pressing issues in the EU pharmaceutical sector –availability, affordability, supply security, and innovation.
Core aspects of the reform:
- Fueling innovation: The reform targets areas of significant unmet medical needs, specifically focusing on drugs for rare diseases, pediatric use, and combating antimicrobial resistance.
- Drug supply security: A robust framework is introduced to ensure continuous availability and tackle challenges in the supply chain across Europe.
- Boosting market entry: Measures to facilitate the introduction of generic and biosimilar drugs to the market.
- Environmental stewardship: The reform strengthens the environmental risk assessment as part of the marketing authoration procedure for medicinal products and ensures that healthcare professionals and patients are well-informed about environmental implications (for example the disposal of medicines).
- Modulation of regulatory data protection: The data protection periods for new medicines placed on the market will be adapted to public health needs. This means that manufacturers can benefit from an additional extended protection period if they either address unmet medical needs or make their product available in all EU countries, in which the marketing authorisation is valid.
The revision of the EU legislative framework will also contribute to the achievement of Estonian National Medicines policy 2030 goals. A wide spectrum of stakeholders from the pharmaceutical sector provided insights to the process of formulating the Government’s position on the package.
The overarching principles of the EU pharmaceutical legislation remain, however, intact, especially around maintaining rigorous standards for the safety, quality and efficacy of medicinal products. There are only minor adjustments in areas like pharmacovigilance, advertising, wholesale and sales at a distance.