Transparency of decisions regulating the prices and reimbursement of medicinal products in European Union Member States

SUMMARY OF:

Directive 89/105/EEC on the transparency of measures regulating the prices of medicines for human use and their inclusion in the scope of national health insurance systems

WHAT IS THE AIM OF THE DIRECTIVE?

• It aims to ensure that any measures taken by European Union (EU) Member States to set the prices of and reimburse medicinal products are transparent.
• To achieve this, it sets out the procedures that Member States must follow so that their decisions and policies do not create obstacles to the EU pharmaceutical trade.

KEY POINTS

Once a medicine is authorised, Member States’ national authorities must:

• make a decision on the price charged and the level of reimbursement within 90 days of receiving an application, providing all the necessary information has been supplied;
• allow an applicant to sell the product at the price proposed, if they fail to take a decision within the 90-day deadline;
• provide reasons based on objective and verifiable criteria for any refusal to authorise the price of a medicine;
• follow largely the same procedures when considering applications:
  • for an increase in the price of a medicine,
  • for an exemption from a price freeze, or
  • for inclusion on the list of products covered by national health insurance systems;
• review at least once a year any price freezes which may be imposed on all medicines or certain categories of medicines to determine whether they are still justified by economic conditions;
• inform the European Commission of the terms of any direct or indirect controls they place on the profitability of pharmaceutical companies;
• allow decisions to be appealed before a national court and inform an applicant about the procedural requirements of those appeals.

A consultative committee, known as the Transparency Committee, consisting of national representatives and chaired by the Commission, is responsible for considering and discussing any problems relating to the implementation of the directive.

FROM WHEN DO THE RULES APPLY?

The directive had to be transposed into national law by 31 December 1989.

BACKGROUND

After conducting a review of the legislation, the Commission proposed a new directive in March 2012. This aimed to streamline procedures and reduce the time taken by national authorities in making decisions on the pricing and reimbursement of medicines. The legal proposal was aimed at simplifying procedures and improving legal clarity and certainty for all interested parties. The proposal was subsequently withdrawn by the Commission in March 2015.

The Court of Justice of the European Union has handed down several judgments on the interpretation and implementation of the transparency legislation.

For further information, see:

• Making medicines more affordable (European Commission).

MAIN DOCUMENT

Council 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 (OJ L 40, 11.2.1989, pp. 8–11).

last update 19.01.2024