Key directives: The EU Transparency Directive in the Pharmaceuticals sector

30 June 2009
by inadim -- last modified 09 July 2009

The EU Transparency Directive lays down harmonised provisions to ensure the transparency of measures adopted by national authorities to regulate the pricing and reimbursement of medicinal products.

Directive 89/105/EEC, commonly referred to as the "Transparency Directive", was adopted at the end of the 1980s out of a concern over potential distortions of intra-Community trade in medicinal products, caused by national measures to control public health expenditure.

The Directive aims to ensure the transparency of the procedures established by Member States to control the prices and reimbursements of medicinal products. It guarantees public access to information on pricing, profit control and reimbursement, in particular for participants in the medicinal product market. The Transparency Directive does not affect national policies on price setting and on the determination of social security schemes, except as far as it is necessary to attain transparency objectives.

 

The Directive spells out four main types of requirements with respect to pricing and reimbursement:
- Decisions must be adopted within a limited timeframe;
- Decisions must be based on objective and verifiable criteria;
- Decisions must be notified to the applicant and the rationale behind them must be published;
- Adequate judicial procedures must be in place to appeal the decisions.

 

2009 European Commission