Accessibility, resilience and effectiveness: European doctors' proposed amendments to EU pharmaceutical reform
European doctors have proposed amendments guided by three principles: accessibility, resilience and effectiveness.
We welcome the strong focus on addressing medicine shortages and strengthening security of supply in the revision, especially by proposing earlier notifications, clear definitions of shortages and an obligation of having in place shortage prevention plans. We think this could be further improved by introducing communication about shortages and alternatives for prescribers, as well as by establishing safety stocks of medicines.
Second, access to medicines for patients should not be determined by where they live. Therefore, we strongly call for an obligation to file for pricing and reimbursement in all Member States where medicines are approved.
Third, when it comes to supporting meaningful innovation, CPME welcomes the proposal of modulated incentives that in our opinion would provide tailored and proportionate rewards for relevant innovation. European doctors also call for a definition of “innovative medicines” and for including quality of life in the definition of unmet medical need.
Finally, safety and effectiveness of medicines is vital for healthcare practitioners. Increasing number of medicines enter the market with limited information on safety issues and effectiveness. We need to strengthen our regulatory framework to ensure evidence provided before and after authorisation is robust and based on randomised clinical trials.