Critical Medicines Act wants to secure medicines manufacturing
The publication of an EU Critical Medicines Act is a major milestone for increased strategic autonomy in Europe. Alongside EU Member States and the European Parliament, our industry has been calling for this Act to secure access to high-quality, safe, effective and affordable off-patent medicines and we appreciate the high priority given to the Act by the recently appointed Commission
The Critical Medicines Act adds to the pharmaceutical legislation review by tackling the economic and industrial root causes of medicines shortages in line with recent Commission studies1 and the Critical Medicines Alliance strategic report. The most essential components of the Act for legislators should be to support: • Real procurement reform by including MEAT (most economically advantageous tender) criteria and multi-winner tendering in tandem with national market reforms, so that security of supply is rewarded in pricing and purchasing policies. • An investment partnership between the EU, Member States and our industry to invest in EU competitiveness for medicine and active pharmaceutical ingredients (API) production. This requires a new approach to EU state aid and IPCEI rules to allow investments in manufacturing innovation and production, a dedicated EU critical medicines manufacturing fund the future Multiannual Financial Framework (EU Budget) and more flexible regional aid funding to support EU-wide investments in production. • More EU solidarity on strategic EU reserves and national stockpiling mandates to ensure that patient access to medicines takes precedence over hoarding in the event of a medicine shortage.
Speaking on the adoption of the Commission’s proposal for a Critical Medicines Act, Medicines for Europe’s Director General Adrian van den Hoven said “We have lived experience from COVID-19 and a myriad of European and national level studies have underlined the need for this Critical Medicines Act. Today’s geopolitical reality is uncertain, and the EU must now take bold steps to secure its medicines supply and manufacturing. The Commission has prioritised the Critical Medicines Act as its first major legislation, and we call on the Parliament and Council to advance much-needed reforms to make security of supply a central component of medicines policy across the EU.”