Renew Europe delivered a strong outcome in last night's final trilogue on the EU Pharmaceutical Package – the first major revision of EU pharma legislation in 20 years. This landmark agreement represents a historic step forward for patient access across Europe and strengthens Europe’s competitiveness in pharmaceutical innovation at a time of intense geopolitical competition.
The agreement builds on Renew Europe’s dedicated work to deliver on the Draghi Report, reinforces the EU Health Union, secures reforms that advance patient access, tackles medicine shortages, and enhances Europe’s strategic autonomy in public health and pharmaceuticals. With this package, Europe is well positioned to lead globally in health innovation while ensuring that no patient is left behind.
The reform strengthens the EU pharmaceutical ecosystem and will impact millions of lives across Europe. The agreement:
· Ensures faster and fairer access and availability of medicines for patients across all EU Member States, and addresses persistent shortages;
· Creates stronger incentives for innovation in rare diseases, benefiting the 36 million Europeans living with a rare condition, many of whom will gain access to life-saving medicines for the first time;
· Makes Europe the first region in the world to put in place market incentives for the development of new antibiotics, a powerful response to the silent pandemic of antimicrobial resistance (AMR);
· Reinforces a patient-centric, competitive and sustainable pharmaceutical ecosystem, ensuring Europe remains an attractive region for research, development, and production of innovative medicines.
“This historic reform marks a decisive step forward for patients across Europe,” said MEP Stine Bosse (Moderaterne, DK), Vice Chair of the Committee on Public Health and Renew shadow on the Regulation.
“It ensures faster and fairer access to medicines as well as strengthens innovation. With this agreement, Europe can continue to lead globally in pharmaceutical innovation while delivering tangible benefits to all patients across the EU.”
Stine BosseRenew Europe MEP, Denmark, Moderaterne
MEP Vlad Voiculescu (Uniunea Salvați România, RO), Renew coordinator of the Committee on Public Health and shadow on the Directive added:
“The revised pharmaceutical package strengthens equity and public health across the continent. By tackling medicine shortages and supporting innovative treatments for rare diseases, it ensures that patients in all Member States have timely access to safe and affordable therapies.”
Vlad Vasile-VoiculescuRenew Europe MEP, Romania, Uniunea Salvați România
The agreement strikes a careful balance between patient needs and the industry’s ability to innovate, maintain patents, and supply medicines across Europe by establishing new binding obligations on pharmaceutical companies to prevent shortages while supporting the sector’s competitiveness.