TRIPS, the Doha declaration and paragraph 6 decision: what are the remaining steps for protecting access to medicines?

Background: The World Trade Organisation's Declaration on the TRIPS Agreement and Public Health (known as the Doha Declaration) of 2001, and subsequent Decision on the Interpretation of Paragraph 6 reached in 2003, affirmed the flexibilities available under the Agreement on Trade Related Property Rights (TRIPS) to member states seeking to protect public health. Despite these important clarifications, the actual implementation of these measures to improve access to medicines remains uncertain. There are also concerns that so-called TRIPS-plus measures within many regional and bilateral trade agreements are further undermining the capacity of the poor to access affordable medicines. Methods: The paper reviews policy debates among governments, nongovernmental organisations and international organisations from 1995, and notably since 2003, surrounding access to medicines and trade agreements. The provisions for protecting public health provided by the Doha Declaration and Paragraph 6 Decision are reviewed in terms of challenges for implementation, along with measures to protect intellectual property rights (IPRs) under selected regional and bilateral trade agreements. Results: While provisions, in principle, were affirmed for member states under the TRIPS agreement to protect public health, numerous challenges remain. Implementation of the flexibilities has been hindered by lack of capacity in many LMICs. More intransigent have been stark inequalities in power and influence among trading nations, leaving LMICs vulnerable to pressures to permit the globalization of IPRs in order to protect broader trade and economic interests. Such inequalities are apparent in proposals or adopted TRIPS-plus measures which re-establish the primacy of trade over public health goals. Conclusion: Despite being hailed as a "watershed in international trade", the Doha Declaration and Paragraph 6 decision have not resolved the problem of access to affordable medicines. The way forward must begin with a simplification of their content, to enable actual implementation. More fundamentally, once agreed, public health protections under TRIPS must be recognised as taking precedent over measures subsequently adopted under other trade agreements. This requires, above all, setting aside such protections as a basic need and shared goal from trade negotiations at all levels.