Pricing and reimbursement of Medicinal products
The division of competences within the European Union leaves to Member States the power to organise their own social security systems. According to Article 152 of the EC Treaty, "Community action in the field of public health must fully respect the responsibilities of the Member States for the organisation and delivery of health services and medical care".
In this context, the national authorities are free to set the prices of medicinal products and to designate the treatments that they wish to reimburse under their social security system. However, the European Union has defined a common procedural framework through the adoption of Council Directive 89/105/EEC, which is generally known as the "Transparency Directive". This instrument aims to ensure that national pricing and reimbursement decisions are made in a transparent manner and do not disrupt the operation of the Internal Market.
The Pharmaceutical Pricing and Reimbursement systems established by Member States are usually quite complex. Each country uses different schemes and policies, adapted to its own economic and health needs. These national systems are regularly reviewed or adapted in order to take account of political priorities, market evolutions and patients' needs.
Although Member States are primarily responsible for pricing and reimbursement policies, the European Union has a major role to play in this area. Pricing and reimbursement systems are closely linked to the realisation of European policy objectives, such as the internal market, pharmaceutical competitiveness, sustainable research and development or human health protection. The variety of healthcare and social security systems has an impact on many national and international actors, including the pharmaceutical industry, wholesalers, pharmacists, doctors, health insurers and, of course, patients.
The European Commission's initiatives in the field of pricing and reimbursement therefore seek to foster cooperation through the establishment of a structured dialogue between the competent national authorities and all relevant stakeholders. The core objective is not only to enhance the functioning of the Internal Market, but also to ensure that national systems achieve an adequate balance between cost-containment, pharmaceutical innovation and patients' access to medicines.