MEPs tabled over 1,000 amendments to the proposed regulation on critical medicinal products, revealing both convergence and divergence on several key points, including public procurement and stockholding obligations (see EUROPE 13699/9). The draft report on this dossier was drawn up by Tomislav Sokol (EPP, Croatian).
With regard to public procurement, several groups (EPP, S&D, Renew Europe, Greens/EFA and The Left) broadly support the idea of multi-winner tenders and the integration of non-financial criteria such as sustainability, safety or quality. For the Greens/EFA, these criteria should account for between 50 and 70% of the final decision.
The Commission is proposing ‘collaborative purchasing’ mechanisms at three levels (cross-border, joint or coordinated by the Commission). Tiemo Wölken (S&D, German) suggests joint procurement of antimicrobials. The Renew Europe group is proposing that the minimum threshold be raised from nine to three Member States interested in purchases made by the Commission (lowered to a minimum of three for joint purchases).
On the issue of stockpiling, the EPP, Renew Europe, S&D and Greens/EFA groups are proposing measures to harmonise national policies, including the introduction of a European mechanism and reporting obligations to guarantee the availability of critical medicinal products.
On the question of medicines of common interest, the Commission defines these as medicines that are not available in sufficient quantities in at least three Member States. The EPP proposes including orphan drugs, antimicrobials and new active ingredients, while other groups sometimes suggest extending the definition to certain costly or innovative treatments.
With regard to strategic projects, the S&D group considers that these could include initiatives to modernise production capacity, with priority given to medicinal products that have been the subject of a vulnerability analysis.
The EPP rapporteur also wants medicines of common interest to be able to benefit from these projects. Tilly Metz (Greens/EFA, Luxembourg) believes that strategic projects should be limited to creating and increasing production capacity for critical medicinal products, defined as those whose production depends more than 60% on a third country.
Environmental assessments are also at the heart of the debate. Right-wing and far-right groups are calling for environmental constraints to be eased in order to facilitate production and investment.
Link to the amendments: https://aeur.eu/f/iv9 (Original version in French by Lionel Changeur)