Bulletin of the World Health Organization

Using TRIPS flexibilities to facilitate access to medicines

Dianne Nicol & Olasupo Owoeye

The problem of how to mitigate the impact of pharmaceutical patents on the delivery of essential medicines to the world’s poor is as far from being resolved as it has ever been. Extensive academic commentary and policy debate have achieved little in terms of practical outcomes. Although international instruments are now in place allowing countries to enact legislation that permits the generic manufacture of patented pharmaceuticals, many countries have not yet enacted appropriate legislation and most of those that have yet to make use of it. One major problem is that the requirements of international instruments and implementing legislation are seen as being so stringent as to be unworkable. This paper calls for fresh attempts to enact workable legislation that fits within the prescribed requirements of international law without going beyond them. It argues that high-income nations should refocus on their moral obligation to enact appropriate legislative mechanisms and provide appropriate incentives for their use. Draft legislation currently being considered in Australia is used to illustrate how workable legislative frameworks can be developed.