On Friday 26 September, the EU Council Working Party examined a compromise proposal put forward by the Danish Presidency of the EU Council on legislation concerning critical medicines (see EUROPE 13711/9).
The delegations focused on two main areas: the rules on public procurement and security stocks (articles 18 to 24) and the provisions on strategic projects (articles 5, 6, 15 and 16). Analysis of the text should continue at the next meeting of the working party, scheduled for 7 October.
Public procurement. On the issue of public procurement, several delegations reportedly stressed the importance of guaranteeing security, clarifying quality criteria and improving vulnerability assessments. Many insisted on the need to preserve national room for manoeuvre and reduce the administrative burden.
There was general support for the principle of solidarity for emergency stocks, but concerns remain about planning, information sharing and the potential impact on the internal market. In addition, the deadlines, which were deemed too short (15 days), the voluntary nature of participation and the Commission’s responsibility when negotiating on behalf of the Member States were the subject of heated debate.
Article 23 on joint procurement remains controversial. The Danish Presidency of the Council is said to have proposed its abolition: almost twenty Member States are in favour, while just under ten would like to see it retained. The question of the legal basis would remain open, particularly if the scheme were to include donations to third countries.
Strategic projects. Discussions also focused on the recognition and funding of strategic projects. The criteria for designation and the need to preserve existing production was at the heart of the discussions.
Member States welcomed the creation of a national one-stop shop to reduce administrative complexity, but some questioned the assessment timescales.
In addition, questions of State aid, project duration and consistency with the pharmaceutical package were raised, without however calling into question the current wording of the text.
Link to the compromise text: https://aeur.eu/f/io0 (Original version in French by Lionel Changeur, with Anne Damiani)