Transparency Directive 89/105/EEC
01/03/2012 - Commission proposes faster access to medicines for patients
Medicines should enter the market faster. With this intention the European Commission has proposed today to streamline and reduce the duration of national decisions on pricing and reimbursement of medicines.
In the future, such decisions should be taken within 120 days for innovative medicines, as a rule, and for generic medicinal products within only 30, instead of 180 days today.
Commission also proposes strong enforcement measures in case the decisions do not comply with the time limits, as these are often exceeded by Member States.
The new Directive represents an important simplification measure and shall repeal and replace the longstanding Directive from 1989, which no longer reflected the increased complexity of the pricing and reimbursement procedures in the Member States.
- Press release
- Proposal for a Directive of the European Parliament and of the Council relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of public health insurance systems [175 KB] repealing Council Directive 89/105/EEC
- Impact assessment
Council Directive 89/105/EEC lays down harmonised provisions to ensure the transparency of national provisions regulating the pricing and reimbursement of medicinal products. It is commonly referred to as the "Transparency Directive".
Directive 89/105/EEC of 21 December 1989 relating to the transparency of measures regulating the pricing of medicinal products for human use and their inclusion within the scope of national health insurance systems
The Transparency Directive was adopted at the end of the 1980s out of concerns over potential distortions of intra-Community trade in medicinal products which may be caused by national measures controlling public health expenditure.
It is a peculiar instrument under Community law because it lies at the interface between European Union responsibilities (Internal Market) and national competences in the area of Public Health (freedom of Member States to organise their social security systems).
The Directive aims to ensure the transparency of measures established by Member States in order to control the pricing and reimbursement of medicinal products. It defines a series of procedural requirements designed to enable interested parties to verify that national pricing and reimbursement decisions do not create obstacles to pharmaceutical trade within the European Union, in accordance with Article 28 of the EC Treaty. The provisions of the Directive do not affect national policies on the setting of prices and the organisation of social security schemes, except as far as it is necessary to achieve transparency.
The Transparency Directive lays down three major requirements with respect to individual pricing and reimbursement decisions:
- decisions must be made within a specific timeframe (90/180 days);
- decisions must be communicated to the applicant and contain a statement of reasons based on objective and verifiable criteria;
- decisions must be open to judicial appeal at national level.
Article 10 of the Directive establishes a consultative committee, called the "Transparency Committee". The Transparency Committee includes representatives of all Member States and is chaired by the European Commission. It is responsible for discussing issues relating to the implementation of the Directive.
Case-law of the European Court of Justice
The European Court of Justice has issued the following judgements with regard to the interpretation and implementation of the Transparency Directive:
- Case C-424/99 of 27 November 2001, Commission v. Austria
- Case C-229/00 of 12 June 2003, Commission v. Finland
- Case C-245/03 of 20 January 2005, Merck, Sharp & Dohme
- Case C-296/03 of 20 January 2005, GlaxoSmithKline
- Case C-317/05 of 26 October 2006, Pohl-Boskamp
- Case C-311/07 of 17 July 2008, Commission v. Austria
- Case C-352/07 of 2 April 2009, Menarini and joined cases C‑353/07 to C‑356/07, C‑365/07 to C‑367/07 and C‑400/07
Judgements in the language of your choice can be found on the European Court of Justice website.
Review of the directive
- The Commission Work Programme for 2011 announces a potential revision of Directive 89/105/EEC subject to the results of an impact assessment. Please consult the impact assessment roadmap.
- A public consultation on this topic was held by DG Enterprises and Industry from 28 March 2011 to 30 May 2011.
- An impact Assessment for the review of the Council Directive 89/105/EEC has been conducted.
- A proposal for a Directive of the European Parliament and of the Council relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of public health insurance systems [175 KB] repealing Council Directive 89/105/EEC was adopted by the Commission on the 1 March 2012.
- On 18 March 2013 the Commission adopted the Amended proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of public health insurance systems COM(2013) 168 final/2 [220 KB]