A364 - MERCK - ACTIVE INGREDIENTS (CONCLUSION OF INVESTIGATION)
PRESS RELEASE
PRESS RELEASE
PHARMACEUTICALS: ANTITRUST AUTHORITY RULES MERCK MUST GRANT FREE LICENCES FOR THE ACTIVE INGREDIENT FINASTERIDE
The Authority accepts and renders obligatory a commitment presented by the companies Merck & Co. Inc. and Merck Sharp & Dohme (Italia) in order to conclude the investigation launched in February 2005 into possible abuse of a dominant position. Expected price reductions for the drug to benefit consumers and the National Health System.
The Merck group will be obliged to grant free licences to allow the manufacture and sale in Italy of the active ingredient Finasteride and related generic drugs two years before the 2009 expiration of the Complementary Protection Certificate. This was decided by the Italian Competition Authority when, at its meeting on 21 March 2007, it accepted and made obligatory the commitment presented by the multinational itself, thus bringing to a close without penalty the proceeding relating to abuse of a dominant position.
The corporation's commitment to remove an obstacle to the production in Italy of Finasteride and a generic version of related pharmaceuticals, among the most important drugs used in the treatment of hypertrophy of the prostate, will encourage greater competition in this market and may lead to significant reductions in retail prices and in costs for the National Health System in Italy and in other European countries.
This ruling needs to be seen in the wider context of the Authority's efforts to encourage businesses to adopt commitments aimed at improving market conditions, competition and consumer choice. In the pharmaceuticals sector in particular the Antitrust Authority's initiative is aimed at encouraging more widespread use of generic products, taking advantage of notifications from the Italian Office of Patents and Trademarks within the Ministry of Economic Development which are based on regulations governing patents in this sector. In February 2006, the Antitrust Authority had already obtained the opening up of licensing from another multinational, Glaxo, which paved the way for the manufacture of generic forms of a powerful migraine medicine, sumatriptan succinate. In this recently concluded investigation, the Authority had also obliged the Merck group, by way of an injunction, to grant licences for the manufacture of the active ingredient imipenem cilastatina which is used in the treatment of serious hospital infections.
These were cases in which the Authority had to assess the abusive nature of unjustified refusals to grant licences that were indispensable for the production of active ingredients in quantities sufficient to allow wide distribution of generic drugs, to the benefit of competition and consequently of consumers.
Rome, 26 March 2007