Brussels, 02/09/2002 (Agence Europe) - The European Commission has relaunched discussion over the transparency of medicine pricing, in line with the G10 recommendations for criteria for accessing Member States' markets and has convened a meeting of the Transparency Committee set up under a 1988 directive on the transparency of human medicines pricing and their inclusion in the scope of national sickness insurance schemes. The Committee, made up of Member States' representatives, monitors the implementation of the directive. It met on 27 August in the presence of Paul Weissenberg, Director with responsibility of internal market legislation at the European Commission (Enterprise Directorate-General).
According to close Commission sources, the meeting looked at progress in the implementation of the 1988 directive by the Member States. The Commission took advantage of the opportunity to stress that there has been an ever increasing number of complaints. Several Member States have been criticised by industry for failing to respect the transparency objectives set out in the directive for pricing and decisions on the refunding of medicines. Criteria vary widely from one Member States to the next, are often vague and procedures usually take more than 200 days to complete, thereby considerably slowing down the process of actually getting medicines that have been authorised onto the market. Research has revealed that the countries with the highest performance are Ireland (where it only takes 70 days to conclude negotiations to set prices/reimbursement levels), Denmark and Sweden (around 120 days) and Spain and the Netherlands (less than 180 days). The procedure takes almost 300 days in Italy and France, 400 days in Austria, Greece, Finland and Portugal, and 700 days even in Belgium. Austria was found guilty in November 2001 of failing to comply with the 1988 directive. The Commission is currently in the process of implementing infringement proceedings against four countries and some sources suggest that two of the cases might be taken to the Court of Justice.
Against this backdrop, the Commission also called on Member States to get involved in the process of considering the two G10 recommendations on the time it actually takes for medicines to get to the market and the criteria used to assess the cost effectiveness of the medicines. In the perspective of the Communication it is planning to draft (to be published in the first six months of 2003), the Commission is suggesting that Member States consider the option of setting common criteria without challenging the way their national health services function. It is proposing that Member States that so desire participate in the drafting of a reflection document that could form the basis of discussions at an upcoming Transparency Committee meeting (expected in December). Europe understands that the UK representative immediately confirmed that the UK would like to be involved in this working group. Other country's representatives explained that they were waiting for the go-ahead from their governments. Austria called for the 1988 directive to be revised.