TRIPS and international exhaustion of patents - Dr Nicola Davies

Producing drugs is an expensive business, and to help ensure the sustainability of such a business, drugmakers are granted patent s that protect product innovations, writes Dr Nicola Davies in her monthly exclusive for The Pharma Letter.

In reality, many large companies enjoy public policies and monopolistic powers that make access to, and affordability of, medicine challenging for a large portion of the global market. Consequently, humanitarian arguments are often invoked in discussions on drug patents.

The Trade Related Aspects of Intellectual Property Rights (TRIPS) Agreement, established in 1995, is a multilateral framework for the protection of pharmaceutical patents of companies located within World Trade Organization (WTO) member countries. The original provisions for patent protection were mostly in favor of the developed countries in which many of the patent holders resided. This created a dividing line between developed and developing nations.

To create a sense of compromise for international trade of patented medicines, flexibilities to the TRIPS Agreement were negotiated in 2001 in what is called the Doha Declaration. According to Sisule Musungu and Cecilia Oh (2005) of the World Health Organization, local governments in developing countries are now given the autonomy to amend their domestic implementation of the agreement’s intellectual property (IP) rights to allow them “sufficient room” to accommodate their own patent, IP systems and developmental needs.