ROME (ITALPRESS) – Procurement reform, new rules on state aid and financial measures dedicated to strategic projects for the production of critical medicines in the EU, solidarity on strategic stockpiles of medicines: these are the main ingredients of the recipe drafted by the EU Commission in the Critical Medicines Act proposal adopted by fulfilling Ursula von der Leyen’s formulated commitment to take action on the matter in the first 100 days of her second term.
The Critical Medicines Act adds to the overhaul of European pharmaceutical legislation by addressing the economic and industrial causes of drug shortages in line with recent Commission studies and the strategic report of the Critical Medicines Alliance, the participatory consultation platform of national authorities, the pharmaceutical industry, civil society, and the scientific community launched by Hera (Health Emergency Preparedness and Response) in 2024 to suggest possible strategies. Specifically, the document calls for: a real reform of drug bidding rules by including MEAT (most economically advantageous offer) criteria and multi-award bidding along with proposals for reforming national markets to make sure that security of supply is rewarded in pricing and purchasing policies; greater flexibility of state aid and IPCEI rules to support member states’ investments in the production of medicines and active pharmaceutical ingredients (APIs).
Also envisioned is an EU fund dedicated to the production of critical medicines, a link to the future Multiannual Financial Framework (EU budget), and more flexible regional aid funding to support investment in the sector; unbureaucratization of approvals and permits for new production sites and targeted investments; EU solidarity on strategic stockpiles to ensure that in the event of a medicine shortage patient access to medicines takes precedence over national stockpiling; increased possibilities for the Commission, in crisis situations, to carry out joint procurement at the request of member states; a reference to the need for new international partnerships with third countries for security of supply of medicines. This should be clarified as part of the new EU trade policy that is currently evolving due to the geopolitical situation.
“The adoption of this measure represents a first concrete response to the problems that began to manifest themselves clearly during the pandemic and that have been gradually worsening,” commented Stefano Collatina, president of Egualia (the Italian association of manufacturers of equivalents biosimilars and value-added medicines) on the eve of the association’s private Annual Meeting to be held tomorrow, March 12, in Milan, with the participation of Guido Bertolaso, councillor for welfare of the Lombardy Region, the main national industrial and scientific hub for the pharmaceutical sector – We hope for the maximum commitment from the European Parliament and the Council in supporting a reform that is essential for the health of all European citizens. The Critical Medicines Act promotes the revitalization and re-location of pharmaceutical production within the EU, so as to reduce non-EU dependence and strengthen security of supply in all countries along with, however, concrete reforms on pricing and purchasing policies for essential medicines. Now we need to hurry up and get the plan operational before it is too late. That’s why we call on our government to, in line with the non – paper signed by Italy along with 10 other European states, support and improve the EU plan and give an answer to what our industry has been asking for 5 years: coordination of economic, industrial and health policies to ensure our patients all critical and necessary medicines for public health.”
– IPA Agency photo –
(ITALPRESS).
