Correspondence: Elke Grooten, Director of Pharmaceutical Policy, European Generic medicines Association, Rue d'Arlon 50 B-1000 Brussels, Belgium. E-mail: egrooten@egagenerics.com Web: www.egagenerics.com

¹is the official representative body of the European generic and biosimilar pharmaceutical industry, which is at the forefront of providing high-quality affordable medicines to millions of Europeans and stimulating competitiveness and innovation in the pharmaceutical sector. Formed in 1993, the EGA represents generic pharmaceuticals companies and their subsidiaries from throughout Europe, either directly or through national associations. Companies represented within the EGA provide over 130 000 jobs in Europe. Cost-effective generic medicines save EU patients and health-care systems over 25 billion each year, thus helping to ensure patient access to essential medicines and providing urgently needed budget headroom for the purchase of new and innovative treatments.

Received 13 February 2009; Revised 13 February 2009.

Abstract

In her speech launching DG Competition's preliminary report on the pharmaceutical sector inquiry on 28 November 2008, Commissioner Neelie Kroes clearly identified the Report's unspoken conclusion 'competition in this industry does not work as well as it should'. Among others, the Report rightly identifies delays to generic entry as an important failure of the competitive process in the pharmaceutical sector. The result is that national health-care systems (and patients) pay unnecessarily high prices for pharmaceuticals and, ultimately, that patients are unable to obtain the medicines they need. The behaviour of originator companies is correctly stated to be a significant factor in delays to the entry of generic medicines. As set out in the Report, originator companies have a 'tool box' of strategies that they deploy to frustrate the entry of generic medicines. In the opinion of the European Generic Medicines Association (EGA), a number of strategies is the most significant in creating hurdles to generic competition. In highlighting these strategies, the Report confirms the experiences of generic companies operating in Europe. The EGA's members regularly encounter use of each of these strategies when seeking to launch new generic products in EU markets, and will frequently encounter the use of multiple strategies by an originator company in relation to a single medicine and across a range of Member States.