The European Commissioner for Health and Food Safety, Stella Kyriakides, was invited to a dialogue with members of the European Parliament’s Committee on Environment, Public Health and Food Safety (ENVI) on Wednesday 30 November.
Several coordinators and MEPs speaking during the ‘catch the eye’ procedure expressed their impatience to see the publication of the Commission’s proposal for the revision of the general European legislation on medicines for human use.
Stella Kyriakides said that a proposal could be expected in the first half of 2023 and that the Commission was working towards a strong, flexible legal framework that is resilient in times of crisis and will allow for innovation.
Several issues are on the table: access to medicines, sustaining innovation and supporting a world-leading industry in Europe, rare and childhood diseases, antimicrobial resistance, supply, bottlenecks and shortages, greening of production, the Health Union and the European Health Data Space.
To a question from Pernille Weiss (EPP, Danish), Ms Kyriakides replied that there would be no threshold used to define a rare disease in Europe.
The Commissioner affirmed her commitment to affordable prices for medicines. She said that if industry is supported and incentivised, the sector must also do its part and inequalities should disappear. Responding to Nicolás González Casares (S&D, Spanish), who also stressed his commitment to joint European procurement, the Commissioner said that reimbursement was the prerogative of Member States, but that some European initiatives could be envisaged to make medicines accessible: ensuring that generics arrived on the market earlier, facilitating exchanges of best practices, etc.
The Commissioner said that regulatory procedures needed to evolve to keep pace with technological progress, but that the Commission wanted to have a strong pharmaceutical sector, keep companies in Europe and not penalise the sector with the legislative proposal.
Stella Kyriakides also said that technical work was underway on the categorisation of diseases.
Other elements were discussed. Pieter Liese (EPP, German) described certain provisions on medical devices as “problematic”. He said that the rules needed to be changed, as some paediatric cardiac surgeons claiming that children would die. He is concerned that a proposal for revision will not be published this year and that, if it is published next year, the changes will be limited.
Emma Wiesner (Renew Europe, Swedish) pointed out that active ingredients were imported from India or China, where production methods were not controlled and sometimes unknown, and that there was a lot of resistance to control.
Tilly Metz (Greens/EFA, Luxembourger) asked in particular whether the Commission intended to ask pharmaceutical companies to be more transparent in order to improve the understanding of Member States in the procurement of medicines. (Original version in French by Émilie Vanderhulst)