WTO Members Still Battling Over TRIPS And Health

20 December 2002

As BRIDGES Weekly went to press, negotiations were still going on in the WTO Council for Trade-related Aspects of Intellectual Property Rights (TRIPs) over paragraph 6 of the Doha Declaration on the TRIPs Agreement and Public Health. While most WTO Members had expressed their willingness to approve the Chair's most recent draft Decision, released on 16 December, on the condition that it was not re-opened, the US rejected the draft, disagreeing in particular with the disease coverage.

According to paragraph 6 of the Doha Declaration on the TRIPs Agreement and Public Health, the TRIPs Council must find an expeditious solution by the end of 2002 to the problems countries may face in making use of compulsory licensing (i.e. allowing the use of a patent without the consent of the patent-holder under certain conditions) if they have insufficient or no pharmaceutical manufacturing capacity. The perceived need to address this issue arose from concerns related to Art. 31(f) of the TRIPs Agreement, which requires that production under compulsory licensing must be primarily for the supply of the domestic market.

US pushing for restricted disease coverage

The 16 December draft Decision retains the disease coverage of previous drafts, referring to paragraph 1 of the TRIPs and Health Declaration, i.e. "public health problems afflicting many developing and least- developed countries, especially those resulting from HIV/AIDS, tuberculosis, malaria and other epidemics". The draft also covers active ingredients used in the manufacture of medicines as well as diagnostic kits needed for their use, as proposed in particular by the Africa Group. The US, however, is fighting hard to restrict disease coverage to HIV/AIDS, malaria, tuberculosis and similar infectious diseases, arguing that the current scope of the decision could fundamentally undermine patent rights for a broad array of pharmaceutical products. While Switzerland, traditionally a supporter of the US position on this issue, described the text as an "improvement", they believe that Members can still find a solution on disease coverage that would suit everyone.

Other outstanding issues

Most countries, including the US, appear willing to accept the Chair's proposal regarding the other five outstanding issues that the Chair had previously identified (see BRIDGES Weekly, 12 December 2002).

Regarding eligibility of importing and exporting countries, references to "developed countries not in transition" have been removed, thereby responding to concerns by Members from economies in transition and high- income developing countries that had objected to the inclusion of any categories of countries that were not officially recognised by the WTO. Instead, the draft Decision now includes a list of countries -- i.e. the US, New Zealand, Australia, Switzerland and EU member states -- that have signalled their willingness to not use the system. The decision also notes that other Members have said that, if they used the system, "it would be in no more than situations of national emergency or other circumstances of extreme urgency".

With respect to the legal mechanism for the solution, the waiver-plus- amendment solution remains unchanged. Work on the preparation of such an amendment would start by the end of 2003 with a view to its adoption within six months.

Similarly, requirements for Members to implement measures to prevent flow-back of generic medicines into developed country markets remain largely unchanged. In response to developing country concerns that such measures could be too burdensome, the most recent draft includes references to technical and financial cooperation by developed country Members to those importing countries experiencing difficulty in implementing these measures.

The paragraph addressing the African Group's request that "domestic market" in 31(f) should also refer to customs unions or free trade areas has been completely reformulated. Thus, the draft Decision allows for the "domestic market" requirement in Article 31(f) to be waived for regional trade agreements (RTA), it sets out clearly which RTAs this rules would apply to, including a requirement that at least half of the membership of the RTA is made up of least-developed countries.

Recent developments

The informal TRIPs Council was reconvened at 10 am on 20 December, but was suspended almost immediately to allow for further informal consultations. During the morning's brief meeting, Korea had presented a proposal to include 15 diseases in the paragraph 6 solution. The informal TRIPs Council was reconvened at 8 pm for further negotiations ahead of the General Council meeting. 20 December is the last working day of the WTO.

The draft Decision is available at http://ictsd.iisd.org/ministerial/cancun/docs/TRIPs_para6_16-12-02.pdf  

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