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Summaries of EU Legislation

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Transparency of decisions regulating the prices and the reimbursement of medicinal products in EU countries

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Transparency of decisions regulating the prices and the reimbursement of medicinal products in EU countries

 

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 EU countries to set the prices of and to reimburse medicinal products are transparent.
  • To achieve this, it sets out the procedures that EU countries must follow so that their decisions and policies do not create obstacles to the EU pharmaceutical trade.

KEY POINTS

  • EU countries’ national authorities, once a medicine is authorised, 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 freeze which may be imposed on all medicines or certain categories of medicines to determine whether it is 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 any discussing any problem related to the implementation of the directive.

FROM WHEN DOES THE DIRECTIVE APPLY?

It has applied since 27 December 1988. EU countries had to incorporate it 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 decisions on the pricing and reimbursement of medicines. The legal proposal aimed at simplification of procedures as well as at improving the 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 more information, see:

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 23.08.2016

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