Policy Making on Data Exclusivity in the European Union: From Industrial Interests to Legal Realities

Abstract

After lengthening the duration of patents to twenty years in 1984, the pharmaceutical industry has turned to data exclusivity as a major vehicle for extending market protection, even after patents expire. Such protections give companies the power to tax consumers for innovation by charging above-market prices. This article draws upon unique information to describe how key actors lengthened data exclusivity for patented drugs to postpone generic competition in the European Union (EU) just before ten new members joined it. We explore the political route and the interests of different actors to understand the process by which industrial interests are translated into legal realities in the world's largest harmonized market. Several factors influenced the outcome, including the role of the pharmaceutical unit of the Directorate General for Enterprise of the European Commission in promoting the interests of the innovative branch of the industry, the time pressure to find a viable compromise before EU enlargement, and the heterogeneous preferences of the other actors. The case illustrates the inherent tension between the desire of both health care administrators and patients for high-quality, low-cost medicines and the objective of the innovator pharmaceutical industry to find and approve new drugs that are price protected and sell them in a way that maximizes revenues.

Whatever happened to the Norwegian Medical Need Clause? Lessons for current debates in EU pharmaceutical regulation

“…Whilst the essential medicines approach targeted developing health systems, many of the social aspects of drug regulation which it responded to were and continue to be of importance in European and Western health systems – a review of the field is beyond the scope of this paper but consumer protection, independent regulation, access to medicines, rational use and sustainability are among the key examples (Adamini et al . , Fraser , Garattini and Bertele , Garattini et al . , Lexchin , Medawar , ‘t Hoen ).…”

“…In Europe, the generics market has faced challenges in light of the new ‘8 + 2 + 1’ data and market exclusivity rules, as well as the 15‐year patent provision, all of which provide innovator manufacturers with substantially longer periods of protection than previously existed (Adamini et al . ). Since Norway observes the outcomes of the centralised European authorisation procedures, some of the post‐MNC changes in the generics market may also be attributable to this legislation.…”

“…The MNC allowed some synonym products, so as to ensure price competition and security of supply, but this was limited to between two and four drugs and only applied if they offered price advantages (Jøldal 1985, Norris 1998. In Europe, the generics market has faced challenges in light of the new '8 + 2 + 1' data and market exclusivity rules, as well as the 15year patent provision, all of which provide innovator manufacturers with substantially longer periods of protection than previously existed (Adamini et al 2009). Since Norway observes the outcomes of the centralised European authorisation procedures, some of the post-MNC changes in the generics market may also be attributable to this legislation.…”

“…Such a provision made pre-1994 Norway a pioneering embodiment of the WHO's essential medicines initiative, ensuring that the drug market catered to specific national needs whilst promoting rational use and cost-containment on an equal footing (Jøldal 1986). Whilst the essential medicines approach targeted developing health systems, many of the social aspects of drug regulation which it responded to were and continue to be of importance in European and Western health systemsa review of the field is beyond the scope of this paper but consumer protection, independent regulation, access to medicines, rational use and sustainability are among the key examples (Adamini et al 2009, Fraser 1985, Garattini and Bertele 2001, Garattini et al 2008, Lexchin 1990, Medawar 1992, 't Hoen 2002.…”

International Coercion and the Diffusion of Regulatory Data Protection

“…But the originator pharmaceutical industry—that is, the research‐based pharmaceutical firms that stand to benefit from protection—is concentrated in the United States and Western Europe, and not in the developing countries that are now adopting regulatory data protection. Furthermore, regulatory data protection applies equally to domestic and foreign firms, and thus conveys no unique competitive advantage to domestic firms (Adamini et al ., ).…”