The debate on the draft reports amending the proposals on medicinal products for human use confirmed, on Tuesday 7 November, the differences between the MEPs of the European Parliament’s Committee on the Environment, particularly on Transferable Exclusivity Vouchers and the need for a ‘regulatory sandbox’.
Tiemo Wölken (S&D, German), rapporteur on the proposal for a regulation laying down EU procedures for the authorisation and supervision of medicinal products, said that Transferable Exclusivity Vouchers to develop new priority antimicrobials are not very transparent and have a budgetary impact on health systems (see EUROPE 13265/13). Mr Wölken pointed out that 15 EU countries are opposed to these ‘vouchers’. The Greens/EFA and The Left groups supported the S&D group in its fight against Transferable Exclusivity Vouchers, while the EPP group defended the Commission’s idea.
The rapporteur’s idea of creating a ‘European Medicines Facility’ (an independent agency) was supported in particular by the Greens/EFA group, but was contested on the right of the hemicycle.
The rapporteur also opposes the proposal to create ‘regulatory sandboxes’ to enable regulators to acquire better regulatory knowledge and find the best ways of regulating innovations on the basis of real evidence.
Tomislav Sokol (EPP, Croatian) criticised the “controversial” elements of the draft report, including the deletion of the provisions on regulatory sandboxes and transferable exclusivity data. Mr Sokol is also unconvinced by the idea of a ‘European Medicines Facility’, an approach he considers too hierarchical. He also called for the gaps in the proposal on paediatric diseases (incentive measures) to be filled.
Catherine Amalric (Renew Europe, French) welcomed the rapporteur’s ideas on creating a system of progressive incentives to develop new classes of antimicrobials and combat antibiotic resistance. However, the Renew Europe group is opposed to “a series of proposals that run counter to making new treatments for rare diseases available more quickly in Europe”. Ms Amalric criticised the rapporteur’s suggestions to abolish the ‘regulatory sandbox’ project, to limit the progressive examination of applications for authorisation to periods of health emergency only, and to create an “artificial hierarchy” of patients’ needs.
Andrey Slabakov (ECR, Bulgarian) focused on stimulating competition for rare disease medicines.
Kateřina Konečná (The Left, Czech) argued for shorter data protection periods, measures to “break up monopolies”, and reiterated her opposition to transferable vouchers.
Link to Mr Wölken’s draft report: https://aeur.eu/f/9ef
Proposal for a directive. Pernille Weiss (EPP, Danish) presented her draft report on the proposed directive (see EUROPE 13264/14), which drew negative comments from Nicolás González Casares (S&D, Spanish). The rapporteur’s position “is far removed from that of the other groups”, he said. He criticised Ms Weiss for suggesting that current incentives should be increased, without getting anything in return.
In particular, Ms Amalric defended the status quo on current regulatory protection, and an additional year of protection for all the conditionalities proposed by the Commission.
Finally, the MEPs expressed their concern at the disappearance of a study by the European Parliament’s Panel for the Future of Science and Technology (STOA) on medicinal products for human use. We need to get to the bottom of what happened, said Nicolás González Casares (https://aeur.eu/f/9ei ).
Link to the draft report by Ms Weiss: https://aeur.eu/f/9ey
The deadline for tabling amendments to these draft reports is 14 November. The European Parliament committee vote on the ‘pharmaceutical package’ is scheduled for March 2024, followed by Parliament’s plenary vote in April. (Original version in French by Lionel Changeur)