Catherine Amalric presents her position on the revision of the pharmaceutical legislation

On Tuesday 14 November, MEP Catherine Amalric tabled her amendments to the revision of the European pharmaceutical legislation: the Medicinal products Directive - for which she is rapporteur for the Renew Europe group - and the Regulation.

Aware of the need to build a compromise at European Parliament level by April, the MEP and hospital pharmacist was keen to demonstrate pragmatism and balance in order to consolidate a more attractive, more equitable and more sustainable European medicines market.

Therefore, and following intensive consultation with the stakeholders involved in the revision of this legislation, Catherine Amalric has tabled a range of amendments to:

  • Guarantee fair access to medicines, by extending joint purchasing to treatments for chronic and rare diseases, by facilitating voluntary cooperation between Member States on the pricing of medicines, and also by lifting the possibility of banning or restricting contraceptives and abortifacients throughout Europe;
  • Prevent and fight shortages by drawing up a list of critical medicines and making greater use of the European Monitoring Platform, while promoting the setting up of a Critical Medicines Act and the establishment of a European Voluntary Solidarity Mechanism for medicines;
  • Build an attractive European medicines ecosystem, with centres of excellence, bioclusters and strong support for research programmes;
  • Maintain optimum drug safety by preparing for the transition towards a more reliable electronic package leaflet, and by promoting information on proper use of medicines and allowing caregivers to report side effects;
  • Improve the fight against antimicrobial resistance by encouraging single-use dispensing of antibiotics and better management of antimicrobial residues;
  • Continue building a more sustainable Europe for medicinal products, with the possibility of a gradual transition to unit packaging of medicinal products and better management of pharmaceutical residues.

Finally, as regards intellectual property rights protection, the MEP is keen to maintain the status quo by maintaining the duration of protection to the eight years mentioned in the directive in force, but will support incentives to extend protection by a further year for all the conditionalities proposed by the Commission. At the same time, she proposes more ambitious incentives linked to the establishment of a pharmaceutical ecosystem for research and innovation, the launch of clinical trials in the 27 Member States, the relocation in Europe of the production of active substances and compliance with environmental criteria throughout the life cycle of the medicinal product.

Press contact: