Industrial associations comment the Commission’s Communication on shortages and strategic autonomy
EFPIA, on behalf of the innovator pharma industry, particularly welcomed the structural measures contained in the Communication to address the industrial dimension of medicines shortages in the medium and long term. In particular, the Critical Medicines Alliance “should provide a genuine platform for national authorities, industry, civil society, the Commission and EU agencies to develop coordinated action against shortages and provide structural solutions rather than treating symptoms”. Critics refer to the exclusion of the information stored in the European Medicines Verification System (EMVS) from tools to manage shortages.
Use of EMVS data has been indicated also by Medicines for Europe, representing the generic and biosimilar industry. Further developments towards a Critical Medicines Act should include also legal guidance on medicines public procurement and security of supply, a strategic EU reserve of essential medicines, EU funds and State aid projects to incentivise investments in greener and safer manufacturing processes for essential medicines and APIs. Regulatory flexibility to harmonise pack sizes and presentations and digitalisation of the regulatory systems are other suggested points of attention.
The biotech industry represented by EuropaBio mentioned the need EU actions “are not limited to essential medicines but aim to address Europe’s growing dependency on third countries for innovation medicines”. To this instance, the European institutions are called to make mid- to long-term EU actions on shortages part of a true European industrial strategy. EuropaBio also recalled how the intricate processes involved in the manufacturing biological medicines, APIs, and intermediates require cutting-edge technologies that Europe can lead on.
Source: EFPIA; Medicines for Europe; EuropaBio