BRUSSELS. The European Court of Justice has issued a ruling in Luxembourg, in which it establishes that it is legitimate for a Member State, and in this particular case for Italy, to reduce the prices imposed on medicines paid by the Service several times a year national health system, in order to ensure compliance with the public expenditure ceiling for the pharmaceutical sector. The Court's ruling concerns an appeal to the Lazio Regional Administrative Court by "Menarini Industrie Farmaceutiche" against the Ministry of Health and Aifa, the Italian Medicines Agency. In 2005 and 2006 AIFA, in charge of monitoring the consumption of medicinal products and the pharmaceutical expenditure charged to the Italian National Health Service, had adopted measures to reduce the prices of drugs to ensure compliance with the pharmaceutical expenditure ceiling. Menarini and other companies that market medicinal specialties whose costs are entirely borne by the NHS, had appealed to the Lazio Regional Administrative Court against the Ministry and Aifa, contesting the legitimacy of the measures. The European Court was therefore called upon to rule on the conformity of the Italian system for fixing the prices of medicinal products with Community law, and in particular with the directive concerning the transparency of the measures governing the fixing of the prices of medicinal products and their inclusion in the field of application of health insurance systems. In the ruling, as a preliminary point, the Court recalls that Community law does not affect the competence which the Member States have, in compliance with Community law, to set up their own social security systems and to adopt rules aimed at regulating the consumption of pharmaceuticals in the interest of the financial balance of their health systems. The Court clarifies, first of all, that a Member State can adopt measures to reduce the prices of all medicinal products, even if the adoption of similar measures is not preceded by a freeze on such prices. In the event of a price freeze, the EU directive prescribes as a condition that the Member State checks at least once a year whether the economic conditions justify the continuation of the freeze. Depending on the results of this verification, the State may decide to continue the price freeze. The Court states that reduction measures can be adopted even several times in a year and for several years. According to the Court, the directive does not preclude the adoption of price control measures for medicines based on cost estimates, provided they are based on objective and verifiable elements. An interpretation to the contrary, the judges observed, would constitute an interference in the organization by the Member States of their internal social security policies, and would affect their policies on the pricing of medicines, to an excessive extent compared to is what is necessary to ensure transparency under the Directive. Furthermore, the Court confirms that it is up to the Member States to determine the criteria on the basis of which to verify the macroeconomic conditions which justify maintaining, increasing or decreasing the prices of medicines.
Il Secolo XIX of 03/04/2009 ed. national p. 5
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