Manual on good practices in public-health-sensitive policy measures and patent laws.

The effect of patents on the prices of, and access to, medicines has become one of the major controversies of tour time. Attention on this issue has intensified since the coming into force of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) in the world Trade Organization (WTO) in 1995. In various international and national for, both developing-country governments and civil society groups have raised grave concerns over the high and escalating prices of medicines for the treatment of HIV/AIDS and other diseases. They identified the need to effectively address the adverse effected of patent protection (further exacerbated by implementation of the TRIPS Agreement) on the publics access to life-saving medicines. In the WTO, developing-country Members initiated a process in early 2001 to clarify that the TRIPS Agreement should not prevent governments from takings measures in favour of public health. This process culminated in the Doha Declaration on the TRIPS Agreement and Public Health at the WTO Ministerial Conference in November 2001. It is now widely recognized that the TRIPS Agreement does contain a degree of flexibility that permits governments the ability to consider a range of options when formulating laws and policies in relation to patents and public health. This flexibility was re-affirmed and further clarified by the Doha Declaration. It is thus important for developing countries to fully understand the legal and policy options available to them so that they can select and decide on those options at national level that are most appropriate to the health needs of their people. Formulation of appropriate national laws and policies is critical because the implementation of the TRIPS Agreement is undertaken at the national level. The Agreement requires WTO Member governments to enact (or amend) national laws conforming to the minimum standards of intellectual property protection required by the provisions of the Agreement.