The impact of FTAs on public health policies and TRIPS flexibilities
by Pedro Roffe (Senior Fellow ICTSD) and Christoph Spennemann (Technology Transfer and Intellectual Property, International Arrangements Section, Division on Investment, Technology and Enterprise Development, UNCTAD)
The impact of patents on public health policies, in particular with respect to access to medicines, has been one of the most debated WTO issues in recent years. With the adoption of the Doha Declaration on the TRIPS Agreement and Public Health1 and the General Council Decision for the implementation of paragraph 6 of that Declaration,2 the focus of the discussion has started to shift away from the multilateral level to the regional and bilateral arena, where a number of post-TRIPS Free Trade Agreements (FTAs) have been signed. As far as substance is concerned, these FTAs have added to traditional patent rights another form of protection that is relevant in the context of access to medicines: exclusive rights in pharmaceutical test data submitted to regulatory authorities in the course of marketing approval procedures.
Prominent actors have voiced the concern that provisions on intellectual property rights (IPRs) in FTAs that go beyond the TRIPS minimum standards (‘TRIPS-plus’) have a serious impact on countries’ public health policies. As expressed by Paul Hunt, UN Special Rapporteur on the Right to Health:
“I am deeply concerned that the US-Peru trade agreement will water-down internationally agreed health safeguards, leading to higher prices for essential drugs that millions of Peruvians will find unaffordable.” (Bridges Weekly Trade News Digest, 2004)
With respect to the FTA between the USA and Morocco, Nobel Prize laureate Joseph Stiglitz observed:
The new agreement, many Moroccans fear, will make generic drugs needed in the fight against AIDS even less accessible in their country than they are in the United States. (Stiglitz, 2004; Oxfam, 2004)
In a forceful manner, a report for US Rep. Henry A. Waxman has concluded:
In 2001, the United States joined the international community in adopting the Doha Declaration, which recognized that trade agreements should not impede the efforts of developing countries to obtain essential drugs at affordable prices. Since then, the Bush Administration has negotiated multiple trade agreements with developing countries, including the CAFTA agreement now pending before Congress. Contrary to the principles of the Doha Declaration, the Administration has used these trade agreements to restrict the access of developing countries to low-cost generic drugs. By delaying generic drug approvals, extending patent terms, limiting compulsory licensing, prohibiting parallel importation, and otherwise restricting countries’ efforts to improve access to affordable drugs, the trade agreements undermine the safeguards outlined in the Doha Declaration. These agreements may offer advantages to multinational pharmaceutical companies, but they do so at a serious cost to public health in the developing nations.” (United States House of Representatives, 2005, p.13)
FTAs risk losing the very flexibilities they are granted through the TRIPS Agreement, the Doha Declaration and its implementing decision. This paper, after providing a brief historical overview of the ways international agreements deal with public health-related IPRs, analyses the TRIPS-plus trend in FTAs and its impact on access-to-medicines policies. The Annexure provides a comparative overview of the main FTAs analysed in this paper.