Title

Arthritic Flexibilities: Analysis of WTO Action Regarding Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health

Abstract

This paper explores the tortured history of developing countries’ pursuit of access to affordable generic medicines that they are unable to produce efficiently on their own. Having lost rights to treat medicines as essential commodities and as generalized exceptions to patent protections in the WTO TRIPS Agreement, developing countries and public health activists temporarily reasserted the primacy of health over profits in the Doha Declaration on the TRIPS Agreement and Public Health in November of 2001. However, since most developing countries lack meaningful pharmaceutical capacity to manufacture medicines efficiently on their own, they needed flexibility to import medicines from countries with robust generic industries, especially since important exporting countries like India will soon loss their right to routinely reverse-engineer and manufacture pharmaceutical products for export. Thus, Paragraph 6 of the Doha Declaration mandated that member states negotiate an efficient mechanism for producing medicines for export/import, a mandate that was honored in the breach by delayed adoption and by an overly restrictive and procedurally burdensome set of requirements imposed by the August 30, 2003, Paragraph 6 Implementation Agreement. This paper outlines the many mechanisms that developing countries have to secure generic medicines produced, under compulsory licenses and otherwise, and explores in detail the arthritic flexibilities of the August 30 Agreement.

In addition to analyzing largely theoretical sourcing options, the paper recommends pragmatic legislative reform in developing countries aimed at maximizing intellectual property flexibilities under the TRIPS Agreement, the Doha Declaration, and the Paragraph 6 Implementation Agreement. More controversially, the paper recommends that developing countries implement a more vigorous competition policy slanted towards the granting of compulsory licenses and the regulation of voluntary licenses. The paper contextualizes a developing country’s decision of whether to invest in and perhaps subsidize domestic production with the “lowest-cost” procurement requirements of the Global Fund to Fight AIDS, TB, and Malaria and with a brief analysis of economies-of-scale in pharmaceutical manufacture. Finally, the paper urges developing countries to resist efforts to expand drug companies’ intellectual property rights in bilateral and regional trade agreements and instead argues that countries should continue to pursue a short-term strategy of exporting life-saving medicines pursuant to the Article 30 limited exception rule in the TRIPS Agreement and a long-term strategy of rolling back patent protects and data exclusivity rules for pharmaceutical products. Too many lives are at stake, most obviously people living with HIV/AIDS, to let the U.S., the E.U., and Japan, and the pharmaceutical industries that they represent, succeed in extending pharmaceutical hegemony.

Disciplines

Antitrust and Trade Regulation | Health Law and Policy | Intellectual Property Law | International Law | International Trade Law

Date of this Version

December 2003