Policy field(s)

Enterprise

Target group(s)

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.

Reference documents

• 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]

Contact details

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• Protection of personal data
• Specific privacy statement (14 kB)