Skip to main content
Article thumbnail
Location of Repository

The Transition from Patented Drugs to Generics: TRIPS Constraints and Policy Options

By M. Patel

Abstract

The introduction of low-cost generic drugs upon patent expiry is an extremely contentious issue, with public health activists accusing pharmaceutical companies of profiteering at the expense of public health provisions, whereas pharmaceutical companies insist that stronger and lengthier protection for their intellectual property rights is necessary for them to sustain investments in research and development. This study is an overview of the transition from patent monopolies to free markets, studying the evolution of legislation and the mechanisms of introducing competition from generic pharmaceuticals once a patent expires. The TRIPS agreement, due to come into force in January 2005, has major implications for countries that have not yet introduced intellectual property legislation, as it will require them to introduce a minimum standard of patent and data protection legislation. This study looks at the possibilities available to such countries regarding the transition process, and the effects that different legislative measures could have on their economies. It also makes some recommendations regarding measures that will facilitate the fastest and cheapest possible introduction of generic drugs following the expiry of a patent

Topics: law, com
Publisher: Bournemouth University
Year: 2005
OAI identifier: oai:eprints.bournemouth.ac.uk:3709

Suggested articles

Citations

  1. (2001). 1) American Home Products Corp. v Novartis Pharmaceuticals UK Ltd.
  2. (1975). 19) Council Directive 75/318/EEC of 20
  3. (1986). amending Directive 65/65/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products 21) Council Regulation (EEC) doi
  4. (2003). Drug Patents: The Linkage Issue.
  5. (2002). Generic competition, price and access to medicines. Oxfam Briefing Papers,
  6. (2002). Hatch-Waxman Use or Abuse? Collusive Settlements Between Brand-Name and Generic Drug Manufacturers, Berkeley Tech.
  7. (2002). ICTSD-UNCTAD Dialogue on Ensuring Policy options for Affordable Access to Essential Medicines, Bellagio, Italy. Available from: www.iprsonline.org/unctadictsd/ bellagio/docs/Pugatch_Bellagio3.pdf 51) R. v Medicines Control Agency ex. p.
  8. (2000). Integrating Public Health Concerns into Patent Legislation in Developing Countries [online]. Geneva, The South Centre. Available from: http://www.southcentre.org/publications/publichealth/toc.htm 17
  9. (2004). Intellectual property and pharmaceutical data exclusivity in the context of innovation and market access.
  10. (1993). laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products doi
  11. (2002). Pharmaceutical Patent Term Extensions: A Brief Explanation. CRS Report for Congress,
  12. (2001). Protection of Innovative Medicinal Products and Registration of generic Products in the European Union: Is the Borderline Shifting? European Intellectual Property Review,
  13. (2003). Regulatory Data Protection if Medicinal Products in Europe. Bio-Science Law Review.
  14. (2004). The cost of protecting data. BusinessWorld India. Available at: http://www.businessworldindia.com/Jan2604/indepth01.asp 36

To submit an update or takedown request for this paper, please submit an Update/Correction/Removal Request.