Public consultation on the possible revision of Directive 89/105/EEC on the transparency of measures regulating the pricing and reimbursement of medicines
Citizens and stakeholders are welcome to contribute to this consultation.
Contributions are particularly sought from economic operators, healthcare professions, public interest organisations and relevant national authorities.
Period of consultation
From 28.03.2011 to 30.05.2011
Objective of the consultation
The European Commission is initiating a process of review of the “Transparency Directive” (89/105/EEC). In this framework, it is seeking the views of interested parties to determine how the existing EU rules on the transparency of pricing and reimbursement procedures for medicines may be modernised.
Although the prices of medicines and their reimbursement status are decided by each Member State, the Transparency Directive was adopted in 1989 to facilitate the free movement of medicines in Europe. It has never been amended since its entry into force. Nevertheless, the pharmaceutical market and national policies to control pharmaceutical expenditure have considerably evolved in the last twenty years.
This consultation will help the Commission propose initiatives to ensure that the directive continues to achieve its objectives in the current context. At present, the Transparency Directive applies exclusively to medicinal products. The consultation also aims to assess its relevance to the medical devices sector.
- Transparency Directive 89/105/EEC of 21 December 1988 relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of national health insurance systems.
- Impact Assessment Roadmap [29 KB]
DG Enterprise and Industry, Unit F/4: Food and Healthcare Industries, Biotechnology
European Commission, BREY 10/220, B-1049 Brussels, Belgium
View the contributions
Results of the consultation and next steps