On 2 December, European Parliament’s Committee on Public Health is due to adopt the draft report amending the proposed regulation on critical medicinal products.
Over 1,300 amendments have been tabled by MEPs (see EUROPE 13727/21). “I’m delighted to see that many amendments proposed by the political groups reflect our common priorities and shared objectives. This gives us a solid basis to continue working together constructively towards balanced compromises”, said the rapporteur, Tomislav Sokol (EPP, Croatian).
He reiterated his main priorities, such as defining medicines of common interest, which includes orphan medicines and new antimicrobials. In his view, it is also essential to identify strategic dependencies, with a list of third-country products that have no equivalent in the EU.
Furthermore, ‘strategic projects’ must avoid duplicating existing or planned capacity, unless justified by real demand. Any company receiving public financial support must comply with clear obligations, including prioritising supply to the European market and honouring agreed commitments, under penalty of sanctions for non-compliance. The rapporteur also proposes strengthening financial support at EU level by ensuring that all EU programmes can contribute to strategic projects.
In addition, the rules for awarding contracts need to evolve. Public procurement cannot be based on price alone. Member States should provide for multi-tendering and include qualitative criteria to ensure both stability of supply and fair competition, according to the rapporteur. Requirements should favour suppliers who produce a significant proportion of critical medicinal products within the EU. It is essential to protect European industry so that in ten years’ time we are not totally dependent on imports from countries such as the United States, China or India, stressed Mr Sokol.
With regard to stock planning and coordination, he proposes a more transparent and efficient system. A distinction must be made between emergency stocks, managed by operators, and national stocks, held by governments. He also calls for an EU-wide coordination mechanism so that medicines can be moved quickly to the areas where they’re most needed, while ensuring that Member States maintain their minimum reserves and are fairly reimbursed.
Lastly, he suggests amendments to specify the conditions for collaborative purchasing between Member States and the Commission in order to strengthen coordination and avoid conflicting negotiations.
Vlad Vasile-Voiculescu (Renew Europe, Romanian) felt that the threshold for launching collaborative procurement should be lowered from 9 to 3 EU countries. He advocated harmonised practices for emergency stocks across the EU, as well as a coordination mechanism to ensure fair redistribution between member countries in the event of critical medicinal product shortages.
Tilly Metz (Greens/EFA, Luxemburgish) felt that it was necessary to focus on certain priorities, given the limited resources in the health sector. She advocated for a coordination mechanism within the EU, well-controlled emergency stocks and measures in case of pharmaceutical pollution. (Original version in French by Lionel Changeur)