Initial reactions from the sector’s European organisations are fairly positive about the 11 March proposal of a Critical Medicines Act, although they are calling for harmonisation of medicine stockpiling policies (see EUROPE 13597/18).
The European Federation of Pharmaceutical Industries and Associations(EFPIA) believes that the regulation needs to “go further” and “provide an effective response to fragmented national contingency stock requirements that disrupt the functionality of the single market”.
Medicines for Europe (generics and biosimilars) is now calling on the co-legislators for " more EU solidarity on EU strategic reserves and national stockpiling mandates ".
EU Member States will have to “present programmes and communicate them to the Commission and the other Member States” when they draw up “their own rules” in this area, the European Commissioner for Health, Olivér Várhelyi, told MEPs (see EUROPE 13597/4).
Collaborative public procurement. In addition,EFPIA welcomes efforts to introduce criteria beyond price for the public procurement of critical medicines (collaborative procurement options to improve the availability of medicines in certain circumstances). However, a systematic application of these collaborative public procurement contracts could create more harm than answers to the problems linked to access, according to this association. In its view, “clarity is required to identify those circumstances where collaborative procurement options would improve access beyond existing national pricing and reimbursement pathways”.
For Medicines for Europe, the publication of an EU Critical Medicines Act “is a major milestone for increased strategic autonomy in Europe”. In particular, the organisation welcomes "a real procurement reform by including MEAT (most economically advantageous tender) criteria and multi-winner tendering in tandem with national market reforms”.
EuropaBio supports the recognition of biomanufacturing in the Critical Medicines Act as a solution for strengthening the EU’s autonomy and security of supply of medicinal products. The organisation believes that the European institutions should “prioritise support for new technologies and access to raw materials, which are just as essential as manufacturing capacity ". (Original version in French by Lionel Changeur)