Brussels, 09/01/2003 (Agence Europe) - The European Federation of Pharmaceuticals Industries and Associations (EFPIA) followed closely on the heels of the American laboratories when, shortly before the end of last year, it filed a complaint against the Italian system of fixing prices and reimbursing medicines. The purpose of these two complaints is to have the European Commission open infringement proceedings against Italy for failure to comply with the 1989 Directive on transparency.
The Directive makes it an obligation for Member States to guarantee, through the application of objective criteria, the transparency of procedures resulting in the fixing of prices for medicinal products and the reimbursement of medicines guaranteed by national health insurance schemes. It also makes it compulsory to give reasons for negative decisions and provides for the possibility of appeal. Finally, it provides for time limits: 90 days for price fixing and 180 days for the fixing of prices and for reimbursement. Except for a handful of Member States, these time limits have remained a dead letter. Such is the case above all for Italy and France, where they reach 300 days although 700 days have been reached in Belgium (see also EUROPE of 3 September 2002). Given the many problems faced by Member States for ensuring control of health expenditure, new criteria have been used to the detriment of transparency. In November 2001, Austria was found guilty of infringing the Directive and the same is soon to apply to Finland. Other procedures are under way concerning Belgium and Germany.
For about two years, Italy has made many changes to its medicine pricing and reimbursement system. Measures adopted include: - linear price cuts (5% on 31 December 2002); - the introduction of new categories of medicines (which have changed on several occasions thus strengthening the legal uncertainty faced by laboratories), which often include very different products intended for the treatment of different illnesses but for which, when they are no longer under patent, a reference price is imposed corresponding to the cheapest medicine of the category; - an obligation to grant a 50% reduction for the sale of medicine under patent (other than those benefiting from European market authorisation -AMM - for which prices continue to depend on negotiation between the State and the laboratories) when these are intended for hospital services, with regions being given the possibility to proceed to extra-hospital distribution from hospital services; - and a measure to restrict legal protection granted by the complementary protection certificate. This system was modified again in 2002 and should be changed again in coming weeks. In its complaint, the EFPIA affirms that the system is not based on objective and verifiable criteria using the subjective grouping of medicines as an argument. It also considers that these texts: 1) deprive AMM holders of their right to market medicinal products; 2) set in place obstacles to the free movement of products; 3) impose unrealistic prices; and 4) are not compatible with rules for protecting intellectual property. This complaint has still to be analysed by the European Commission services but the latter is faced with a considerable problem when it comes to opening infringement proceedings due to the extremely unstable nature of Italian legislation. Italy may take refuge behind a change under way in order to block the whole procedure. In this context, the association which groups the American laboratories is expected in the near future to file an updated complaint depending on the latest changes made to the Italian legislation.
Last summer, the European Commission had launched discussions on transparency by convening, on 27 August, a transparency committee meeting as established by the Directive. A further meeting is scheduled for 14 January, aimed at defining a number of principles for the collection and exchange of information on criteria employed for price fixing and reimbursement. In time (two annual meetings are envisaged), it is a question of reaching a formula of common criteria, especially for the cost/effectiveness ratio, in order to really improve the transparency of procedures.