Pharmaceutical package: Véronique Trillet-Lenoir is appointed rapporteur for the Renew Europe Group on the Medicines Directive

On April 26, 2023, the European Commission finally presented its proposal for the revision of the pharmaceutical legislation twenty years after its initial adoption. This long-awaited revision, which comes at a time when severe drug shortages are affecting Europe, finally puts the patient at the core of the virtuous circle of medicine.

On May 5, 2023, Véronique Trillet-Lenoir MEP was appointed rapporteur for the Renew Europe Group on the Directive on the Community code relating to medicinal products for human use.

The package revises the European pharmaceutical legislation by consolidating it into two major texts: a regulation on community procedures for authorization and monitoring of human drugs, and a directive establishing a community code on human medicines. These two legislative proposals are accompanied by a Council recommendation project on strengthening EU actions to fight antimicrobial resistance with a "One Health" approach.  

With this ambitious reform of the European market of medicines, the European Commission finally places the interests of patients and those of the industry on an equal footing.

Learning from the health crisis, the Commission responds to the concerns of citizens and patients by proposing strong measures aimed at:

• Ensuring equitable access to medicines across the European Union, through incentive measures for pharmaceutical companies;
• Ensuring faster access to medicines by simplifying the governance of the European Medicines Agency, and expanding the European authorisation procedure for marketing, limiting the practice of 27 parallel national evaluations and promoting the access to generics;
• Better prevent and manage medicines shortages;
• Promote the development and the marketing of pediatric and orphan drugs;
• Improve transparency in public funding for research and innovation;
• Strengthen the environmental risk conditions of medicines.

In addition to these significant measures, the European Commission proposes a balanced position by reducing intellectual property rights exclusivity by one or two years while increasing the number of exemptions, allowing manufacturers to retain the protection acquired under previous legislation. This compromise should help promote equal access to treatments for all 27 Member States and encourage SMEs or non-profit organizations to enter the European market of medicines.

However, the French MEP highlights that antimicrobial resistance should instead be addressed through innovative solutions, reduced prescriptions, the dissemination of good practices, and a strengthening of the role of HERA (Health Preparedness and Response Authority) in the search for new antibiotics, rather than through a system of "vouchers" designed to incentivise manufacturers to develop "priority antimicrobials." Indeed, Véronique Trillet-Lenoir believes that this proposal would only increase the risk of manufacturer using this voucher on any medicine in their catalogue, thus reducing access to it.

"This colossal and long-awaited revision is heading in the right direction. However, there are still many areas for improvement. During the examination of this text in the European Parliament, we will be committed to defending ambitious measures concerning transparency of drug prices, promotion of joint medicines purchases outside of crises, obligation for industry to constitute stocks of essential medicines, and the creation of a European public database indicating tensions and shortages of drugs authorized by the EMA. It is time to develop and strengthen a true European market of medicines that can guarantee all European citizens access to available, innovative and affordable medicines."

_{Press contact: claudie.gilot@europarl.europa.eu}