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

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.