Internal Market, Industry, Entrepreneurship and SMEs

Transparency Directive

Transparency Directive

The EU’s so-called Transparency Directive (Council Directive 89/105/EEC) aims to ensure the transparency of measures established by EU countries to control the pricing and reimbursement of medicinal products. It defines a series of procedural requirements designed to verify that national pricing and reimbursement decisions do not create obstacles to the pharmaceutical trade within the EU’s Internal Market.

The Directive is a peculiar instrument under EU law because it lies at the interface between EU responsibilities for the Internal Market and national competences in the area of Public Health in accordance with Article 168(7) of the Treaty on the Functioning of the European Union (TFEU). Its provisions do not affect national policies on the setting of prices and the organisation of social security schemes, except as far as necessary to achieve transparency.

Key requirements

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 EU countries and is chaired by the European Commission. It is responsible for discussing issues relating to the implementation of the Directive.

EU case law

The European Court of Justice has issued the following judgments on 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

Judgments in the language of your choice can be found on the European Court of Justice website.

Proposal for a new Directive

After having conducted a review, the Commission proposed a new Directive to replace the longstanding Transparency Directive. The aim is to streamline and reduce the duration of national decisions on pricing and the reimbursement of medicines.

The new Directive represents an important simplification measure and will replace the longstanding Directive from 1989 as it no longer reflects the increased complexity of pricing and reimbursement procedures in EU countries.

Documents related to the proposals:

Withdrawal of the renewal proposal

The Commission, by following a line of political discontinuity, proposed the withdrawal of the revising proposal. This is covered in the "List of proposals for withdrawal" at point no 49 on page 10 of Annex 2 of the European Commission Work Plan 2015 as published on 16 December 2014.

The withdrawal was justified by the fact that, after 16 meetings of the Pharmaceuticals and Medical Devices Council Working Group, no agreement was foreseeable in the Council, where objections were made by a number of EU Member States.

The Commission's list of proposals for withdrawal, which covered a significant number of pending legislative initiatives, also aimed to avoid allocating further resources to proposals which had, from the Commission's point of view, no chance to be adopted or that, after negotiations, would not have delivered the expected results on the ground.

The formal withdrawal of the proposal was published on 7 March 2015 (OJ C80, p.17).

The Commission is now exercising alternative ways of achieving the proposal's objectives and to ensure the transparency of pricing and reimbursement measures for medicinal products adopted by EU Member States:

  • by receiving feedback from stakeholders about the functioning and the problems related to the implementation of the current Directive 89/105/EEC, which remains in force;
  • via the Transparency Committee with EU Member States; meetings will regularly be convened to discuss actual questions of implementation as well as to inform the Committee about recent and forthcoming case-law;
  • by launching investigations and infringement proceedings whenever appropriate to make sure that the current rules are fully complied with and that the existing problems related to the regulatory framework in place on pricing and reimbursement are appropriately addressed.