Brussels, 06/04/2009 (Agence Europe) - In a ruling published on Thursday 2 April 2009 (Case C-352/07 et al), the European Court of Justice (ECJ) ruled that member states may reduce medicinal product prices more than once a year on the basis of predicted expenditure. In other words, member states are allowed to manage their social security systems and the use of medicines to ensure financial balance in their health insurance systems.
In 2005 and 2006, the Italian Medicines Agency (Agenzia Italiana del Farmaco, “the AIFA”), which is responsible for monitoring consumption of medicinal products and pharmaceutical expenditure borne by the Italian National Health Service (“the SSN”), adopted certain measures reducing the prices of medicinal products in order to ensure compliance with the upper limit of pharmaceutical expenditure borne by the SSN. Menarini and other companies which market medicinal products, the costs of which are wholly borne by the SSN, sued the Ministero Della Salute and the AIFA in respect of those measures before the Tribunale Amministrativo Regionale del Lazio (Regional Administrative Court for Lazio). The Court of Justice was asked whether the Italian system for pricing medicinal products complies with EU Directive 89/105 on the transparency of measures regulating the prices of medicines for humans.
In its ruling, the Court of Justice pointed out that EU law does not detract from member states' powers to organise their social security systems and to adopt measures to govern the consumption of pharmaceutical products in the interests of the financial stability of their health-care insurance schemes. The Court decided that a member state may adopt general measures reducing the prices of all or some categories of medicinal products, even if the adoption of those measures is not preceded by a freeze on those prices. In the event of a price freeze imposed on medicinal products by a member state, it must review, at least once a year, whether the macro-economic conditions justify that freeze being continued. Such reviews are, under Directive 89/105, a minimum requirement. According to the results of such review, a member state may decide to continue a freeze on the prices of medicinal products, or to adopt measures increasing or reducing those prices. The Court decided that, provided that such minimum requirement is met, “measures reducing prices may be adopted more than once a year and for several years.”
The Court also decided that the directive does not preclude measures controlling medicinal product prices from being adopted on the basis of predicted expenditure, provided that the predictions are based on “objective and verifiable data”. The ECJ argues that a contrary interpretation would constitute interference in the organisation by the member states of their domestic social security policies and affect their policies for pricing medicinal products to an extent going beyond what is necessary to ensure transparency for the directive's purposes. Further, in the absence of any indication, in the directive, as to the types of expenditure which member states may take into account in order to continue a price freeze or to increase or reduce medicinal product prices, the Court confirms that it is for the member states to determine the criteria on the basis of which they are to review the macro-economic conditions. They may therefore, in compliance always with the objective of transparency, take account of pharmaceutical expenditure alone, health expenditure overall or even other types of relevant expenditure.
Finally, if, in exceptional cases and for particular reasons, an undertaking, which is the holder of a marketing authorisation for a medicinal product and concerned by a measure freezing or reducing medicinal product prices, applies for a derogation from the price imposed pursuant to such measure, it must set out the particular reasons justifying its application. The Court notes that the directive imposes on member states the obligation to ensure that a reasoned decision is adopted on any such application. (O.L./transl.fl)