26 November 2020

ECL Access to Medicines Task Force welcomes the European Commission’s patient-centred Pharmaceutical Strategy for Europe published yesterday. Notably, the Strategy seeks to tackle the EU medicine shortages crisis, better alignment between R&D investment and patient needs and the everincreasing cost of new treatments.

The Strategy rightly identifies that the ‘’lack of transparency of research costs or return on investment can influence decisions that impact affordability and ultimately access for patients’’. ECL firmly believes the following initiatives are of particular concern to patients across Europe and should, therefore, be prioritised:

• Ensuring research priorities are aligned with the needs of patients and health systems by fostering collaboration between regulators, academia, healthcare professionals, patients and payers at the early stages of R&D;
• Revising the system of incentives, imposing obligations and conditionalities in the pharmaceutical legislation, taking into account public investment in R&D and the relationship with IP rights and access and the affordability of medicines across the EU;
• Revising the legislation on orphan and paediatric medicines to prioritise unmet medical needs ensuring incentives do not pose a threat to affordable access to new medicinal products; 
• Stepping up cooperation between Member States on the affordability and cost-effectiveness of medicines as well as cooperation between national pricing and reimbursement authorities and healthcare payers, including fostering transparency of price information;
• Revising the current pharmaceutical legislation to enhance security of supply and preventing as well as addressing existing shortages, including (i) stronger obligations for suppliers and supply-chain transparency, (ii) earlier notification of shortages and withdrawals, (iii) enhanced transparency of stocks and stronger EU coordination and (iv) mechanisms to monitor, manage and avoid shortages.

ECL invites the Commission, EU Member States, the European Parliament and the European Medicines Agency to prioritise the five points outlined above, as they truly lie at the heart of patients and society. In addition, ECL wishes to stress that while accelerated product access and a degree of regulatory flexibility might be needed, it should not contribute to the lowering of regulatory standards in product development and evaluation, and posing serious threats to patient safety.

ECL trusts that these priorities will be streamlined across other relevant EU policy initiatives and legislation, taking the patient and society-centric approach.