In response to escalating global geopolitical challenges and efforts to streamline EU legislation, Medicines for Europe is advocating for enhanced support of the off-patent medicines sector. Representing a significant portion of Europe’s pharmaceutical landscape, the association’s members dispense 70% of medicines and contribute to over 90% of the EU’s Critical Medicines List. Their resilience has been evident through crises like the COVID-19 pandemic, the conflict in Ukraine, and various natural and humanitarian emergencies.
Reforming the EU Pharmaceutical Framework
Medicines for Europe views the ongoing revision of the EU pharmaceutical regulations as a pivotal chance to modernize the regulatory system, ensuring it aligns with the demands of the digital era. As trilogue negotiations commence, the organization urges lawmakers to finalize a balanced pact that includes regulatory and market incentives. This would enhance patient access to medications and innovations across all member states. Key proposals include extending the repurposing clause to maintain investments in public health priorities such as antimicrobial resistance and cardiovascular diseases, harmonizing the Bolar exemption to foster active pharmaceutical ingredient development, and implementing global regulatory measures to boost competitiveness and improve accessibility for millions of Europeans.
Advancing Health Security through the Critical Medicines Act
The introduction of the EU Critical Medicines Act marks a significant advancement for health security, with Medicines for Europe calling on the European Parliament to focus on strengthening supply security. Recommendations include integrating MEAT criteria and multi-winner tendering in procurement processes, forming investment partnerships to bolster medicine and API production, and enhancing EU solidarity through strategic reserves and national stockpiling mandates. Additionally, the association urges a pause on the Urban Waste Water Treatment Directive at the national level to prevent shortages of essential medicines.
• Medicines for Europe emphasizes the necessity of regulatory harmonization to accelerate generic and biosimilar market entry.
• The association highlights the need for dedicated funding to support manufacturing innovation within the EU.
• Ensuring patient access takes precedence during medicine shortages is a top priority for health security.
As the sector strives to remain competitive, Medicines for Europe addresses the flawed impact assessment underpinning the UWWTD, advocating for adjustments to safeguard medicine availability. The organization’s president, Markus Sieger, underscored the critical opportunity presented by the legislative reforms, stressing the importance of a resilient and access-friendly regulatory framework. Meanwhile, EU Commissioner Olivér Várhelyi affirmed the government’s commitment to securing a robust European manufacturing base through strategic initiatives under the Critical Medicines Act.
The proactive stance of Medicines for Europe not only seeks to enhance public health and security but also aims to drive innovation and efficiency within the pharmaceutical industry. By advocating for strategic investments and regulatory clarity, the association aims to ensure that Europe remains self-sufficient and responsive to future healthcare challenges. Stakeholders and policymakers are encouraged to collaborate closely to realize these objectives, ultimately benefiting millions of European patients and fortifying the continent’s health infrastructure.
Membership in Medicines for Europe spans across key manufacturing and R&D sites, with the association championing sustainable access to high-quality medicines. Through continuous investment in research and development, member companies are pivotal in providing affordable generics, pioneering biosimilars, and delivering value-added medicines that enhance patient care and healthcare system sustainability across Europe.
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