2022-10-19 22:00:00
During its meeting this morning, the European Affairs Committee of the Senate gave its opinion on the pharmaceutical strategy for Europe presented by the European Commission. Under the chairmanship of Jean-Francois Rapinit adopted the information report of the senators Pascale Gruny et Laurence Harribey which puts forward proposals to combat drug shortages, ensure access to innovative drugs for all and better direct research, all in the interest of patients, a major priority in the eyes of the senators.
With regard to the fight once morest drug shortages, the Committee on European Affairs proposes define an EU-wide list of critical medicines considering both their clinical criticality and their industrial criticality. It also proposes the establishment of a notification system enabling the competent authorities of the Member States and companies in the pharmaceutical industry to report potential or actual supply disruptions of these critical medicines and a obligation de stocks that companies in the pharmaceutical industry will have to set up, an obligation accompanied by financial support from the Union. Finally, the Committee on European Affairs proposes the use of electronic notices for critical medicinal products in the event of a shortage, in order to allow exchanges of medicinal products between Member States.
To ensure the Union’s health sovereignty, the Committee on European Affairs is proposing financial and fiscal incentive measures to enable the maintenance or relocation of production sites in Europe, particularly targeting critical drugs. President Jean-François Rapin had already supported this imperative of European strategic autonomy within the framework of the Conference on the future of Europe, which moreover retained it in its conclusions. According to him, “ensuring the health sovereignty of the European Union implies guaranteeing the supply of essential but also innovative medicines, and considering the creation of a common strategic stock on its territory”. For critical drugs, the European Affairs Committee also wants a public production might be envisaged within the framework of public-private partnerships.
To promote access to medicines for all patients in the Union, the Committee on European Affairs proposes to facilitate the purchase of innovative medicines intended to meet an unmet medical need, on the one hand by creating a support fund which would be managed by the European Commission and the Member States to come to the aid of the less endowed States, and, on the other hand, by providing for thecompulsory licensing to a generic drug manufacturer or a public body under fair and reasonable conditions and as a last resort, when the price offered by the manufacturer of the originator drug will not be considered fair and equitable, a concept to be defined by the European Commission.
The Committee on European Affairs has decided to send the European Commission a political opinion summarizing the observations and proposals of the report (summary of rapport) that it has adopted, an opinion to which the European Commission must respond within three months.
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