Internal Market, Industry, Entrepreneurship and SMEs

Pricing and reimbursement of medicines: Commission consults on EU transparency rules

Pricing and reimbursement of medicines: Commission consults on EU transparency rules
Published on: 28/03/2011 Last update: 06/07/2015
Deadline: 30/05/2011

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

Contact details

Responsible service

DG Enterprise and Industry, Unit F/4: Food and Healthcare Industries, Biotechnology

postal address

European Commission, BREY 10/220, B-1049 Brussels, Belgium

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View the contributions (and summary report)