On Monday, 1 September, MEP Tomislav Sokol (EPP/HR) presented the Critical Medicines Act Draft Report. MEPs from various political groups had the opportunity to voice their views and concerns on the Act. They shared different opinions as avoiding unnecessary duplicities, ensuring equitable access to medicines, and supporting collaborative procurement.
A brief rundown of the political groups is as follows:
S&D: Tiemo Wolken (S&D/DE) shared that there is support for multi-owner contracts and coordinated contingency stock. He warned against unnecessary duplication between national and EU stocks, as well as cautioning on regulatory fast-tracking. In addition, he called for stakeholder involvement and advocated for EU manufacturing and more investments in the EU.
Patriots: Viktoria Ferenz (PfE/HU) highlighted the opportunity to secure vital medicines and reduce dependency. She shared that the framework must be clear and precise – defining which products are critical and clarifying procurement rules beyond cost. In addition, she stated that duplication and contradictions with other frameworks, such as the GPL, must be avoided and that financial support, flexibility, and long-term resilience are essential.
ECR: Aurelijus Veryga (ECR/LT) emphasised the need to bring production of active substances back to Europe and avoid overlapping production across countries. He showed support for joint procurement to protect smaller Member States and highlighted that environmental requirements must be considered alongside pharma.
Renew: Vlad Vasile-Voiceulescu (Renew/RO) welcomed the creation of a union coordination mechanism and inclusion of stakeholders. He also supports the extension of the deadline for amendments.
Greens: Tilly Metz (Greens/LU) shared that equitable access is a priority, as well as coordination and a common EU approach. Public health and environmental standards must come hand in hand, and strategic projects should be targeted towards the highest dependency.
Shadow for Opinion, ITRE: Oliver Schenk (EPP/DE) suggested that the proposal does not go far enough and that the whole pharmaceutical sector must be strengthened. He added that financing innovation and new technologies, as well as securing stable partnerships for supply chains, is vital.
Shadow for Opinion, IMCO: Marion Walsmann (EPP/DE) shared that collaborative procurement is strong but must have clear rules and avoid inconsistencies. Additionally, she shared that patients should not suffer delays due to procedural barriers and instruments must align with WTO and attract investment.
The added value of a fully established SANT Committee is evident in the handling of the Critical Medicines Act, as the draft report already shows significant improvements compared to the Commission’s original proposal from March. A broad consensus has emerged among MEPs in favour of reshoring pharmaceutical manufacturing to the EU, though the practical feasibility of such measures remains uncertain. Suggested amendments for the draft report are due on 19 September.
In terms of timeline, Rapporteur MEP Sokol is aiming to finalise work on the act before the end of the year, but this is not a realistic scenario. After MEPs table their amendments on 19 September, shadow meetings will begin to consolidate these amendments together with the opinions of ITRE, ENVI, and IMCO into a single compromise text. This draft will then need to be voted on in the SANT Committee before trilogue negotiations can start.
In parallel, the Council must prepare its own position, which requires approval in COREPER ahead of the trilogues. Only once both Parliament and Council are ready can negotiations between the two institutions, with the participation of the European Commission, formally begin. These discussions are likely to take several months. Afterward, the final compromise text will need to be endorsed again by the Council and then approved in plenary by the European Parliament.
Even if policymakers push to move as quickly as possible, it is clear that all of these steps cannot realistically be completed before the end of the year.
