Source: European Parliament
1. As explained in the Pharmaceutical Strategy for Europe[1], companies are currently not under a legal obligation in the EU to market a medicine in all Member States. Access disparities, with smaller and less affluent countries especially affected, can be due to various factors. This includes national pricing and reimbursement policies, market size and the organisation of health systems. It can also be due to marketing decisions of individual companies.
2. The Commission is committed to addressing the issue of access to affordable medicines for all EU citizens while respecting national competences on pricing and reimbursement of medicines, in line with Article 168(7) of the Treaty on the Functioning of the European Union. The proposed reform of the general pharmaceutical legislation[2] includes stronger incentives to launch innovative medicines in all Member States; measures for earlier entry of generics and biosimilars and for faster and simpler authorisation procedures. The Commission also supports and encourages cooperation between Member States on pricing, reimbursement and procurement policies in the group of National Competent Authorities on Pricing and Reimbursement and Public Healthcare Payers (NCAPR), based on mutual learning and best-practice exchange, to improve the affordability and cost-effectiveness of medicines and health system’s sustainability.