Meddelelse fra Kommisjonen til Europaparlamentet, Rådet, Den europeiske økonomiske og sosiale komite og Regionsutvalget. Reform av legemiddellovgivningen og tiltak mot antimikrobiell resistens
EU-strategi for reform av legemiddellovgivningen og tiltak mot antimikrobiell resistens
Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions. Reform of the pharmaceutical legislation and measures addressing antimicrobial resistance
Omtale publisert i Stortingets EU/EØS-nytt 2.5.2023.
Nærmere omtale
BAKGRUNN (fra Kommisjonens pressemelding 26.4.2023)
European Health Union: Commission proposes pharmaceuticals reform for more accessible, affordable and innovative medicines
Today, the Commission is proposing to revise the EU's pharmaceutical legislation - the largest reform in over 20 years - to make it more agile, flexible, and adapted to the needs of citizens and businesses across the EU. The revision will make medicines more available, accessible and affordable. It will support innovation and boost the competitiveness and attractiveness of the EU pharmaceutical industry, while promoting higher environmental standards. In addition to this reform, the Commission proposes a Council Recommendation to step up the fight against antimicrobial resistance (AMR).
The challenges this reform addresses are fundamental. Medicines authorised in the EU are still not reaching patients quickly enough and are not equally accessible in all Member States. There are significant gaps in addressing unmet medical needs, rare diseases and antimicrobial resistance (AMR). High prices for innovative treatments and shortages of medicines remain an important concern for patients and healthcare systems. In addition, to ensure that the EU remains an attractive place for investment and a world leader in the development of medicines, it needs to adapt its rules to the digital transformation and new technologies, whilst cutting red tape and simplifying procedures. Finally, the new rules need to address the environmental impact of medicine production in line with the objectives of the European Green Deal.