As the UN meets to discuss non-communicable diseases, one area of controversy is the effort by White House trade officials and the European Commissioner for Trade to block any mention in a Political Declaration of the November 14, 2001 WTO Doha Declaration on TRIPS and Public Health.
This note explains why the Doha Declaration was important, and what USTR and DG-Trade are trying to do in the NCD resolution. I will start with a very quick history of the events that led to the 2001 WTO resolution.
The World Trade Organization (WTO) came into force in January 1, 1995, and with it a new Agreement on the Trade Related Aspects of Intellectual Property Rights (the TRIPS Agreement). Even before the agreement went into place, it was being described as something that would put an end to compulsory licensing of pharmaceutical patents. I met with Adrian Otten, then the head of IPR for the WTO, in Bariloche, Argentina in 1994, at a meeting organized by the Argentine domestic drug manufacturers. There, Otten explained how he thought the new provisions in the TRIPS would make it quite difficult to grant a compulsory license. One was the requirement that prior negotiation on “reasonable commercial terms and conditions” was normally required, another was that each license had be evaluated on its own merits, and the third, and probably most important, was that exports of products manufactured under a compulsory license would be limited to less than 50 percent of domestic production (Article 31.f). All of these conditions had been earlier introduced into NAFTA, and Canada had agreed to dramatically scale back its practice of compulsory licensing as a condition of the entering into the NAFTA negotiation.
Carlos Correa and I both discussed the areas where the TRIPS actually had existing flexibility (including issues relating to Articles 6, 30, 31.b, 31.k, 40 and 44 of the TRIPS) , with a rather skeptical Otten. However, it was clear that the WTO TRIPS did make it more problematic, and some important issues would be resolved by future WTO dispute resolution panels, were were effectively binding on the WTO members.
After the TRIPS came into force, several things happened which led eventually to the 2001 Doha Declaration, which profoundly changed the TRIPS landscape.
In 1996 Health Action International convened an important meeting of NGOs in Bielefeld Germany, and government officials from developing countries around the world meet in New Delhi, both to consider the impact of the newly implemented TRIPS Agreement on access to medicines. In 1997, the South Africa Parliament passed new controversial amendments to its medicine act, and were sued by the 42 pharmaceutical trade associations and companies in February 1998. Also in 1998, the World Health Organization, led by its African members, began to press for a new “Revised Drug Strategy” that would later call upon member states:
- (2) to ensure that public health interests are paramount in pharmaceutical and health policies;
- (3) to explore and review their options under relevant international agreements, including trade agreements, to safeguard access to essential drugs;
To advance the WHO negotiations, activists and government officials from around the world met in Washington DC. Later that year health activists in Thailand mounted a successful and influential campaign to eliminate the Pfizer monopoly on fluconazole, leading to a rapid drop the price, from 200 baht to 6.5 baht, and a radical change in access for AIDS patients with cryptococcal meningitis or thrush.
In 1999, health activists held a major meeting on the use of compulsory licensing on patents on essential medicines for AIDS and other diseases in Geneva, the World Health Assembly adopted WHA52.19, US AIDS activists shocked world with a campaign that disrupted Al Gore’s Presidential campaign, and a coalition of health groups presented the Amsterdam Statement at the 1999 World Trade Organization (WTO) Ministerial meeting in Seattle. At the highly contentious Seattle WTO meeting, President Clinton announced a new trade policy for the Untied States that was more open to public health concerns.
The impact of these earlier events continued to play out in a variety of fora and contexts over 2000, including at the Durban AIDS conference, but 2001 was a particularly important year.
In January 2001, as one of his last official acts in office, President Clinton filed a WTO case against Brazil over its compulsory licensing statute, and CPTech negotiated the CIPLA offer to MSF, for a 3 drug AIDS cocktail for $350 per year. The CIPLA offer shattered all previous notions of the feasibility of providing AIDS drugs in developing countries, and stimulated discussions, pushed by AIDS activists and led by Kofi Annan, to create the Global Fund for AIDS, TB and Malaria. The WHO held a high level meeting on tiered pricing in Hosbjor Norway, supported by Merck and other drug companies, and organized by Nils Daulaire on behalf of the WHO. The WHO tiered pricing meeting was essentially a failure. This was rapidly followed by two highly publicized sessions of the PMA court case in South Africa over its medicines act. The publicity over the South Africa trial was so massive and so negative for the companies, and their case was so thoroughly being demolished by the South Africa government lawyers, that the drug companies dropped the case during the second session of the trial.
During the early part of 2001, Martin Khor, then running the Third World Network, approached Boniface Chidyausiku, the Chairman of the WTO TRIPS Council from Zimbabwe, to put access to medicines on the agenda for the November 2001 WTO Ministerial meeting in Doha. That led to the intense negotiations throughout the summer and fall of 2001 over language about the TRIPS. The events of 9/11 changed the dynamics of the WTO negotiation. Not only did the Bush Administration then want greater global political support for its invasion of Afghanistan, but it faced its own access to medicine crisis, when there were escalating concerns over a possible Anthrax attack, and the US and Canadian governments threatened to use compulsory licensing to obtain lower prices for ciprofloxacin.
To make a very long story shorter, on November 14, 2001, the WTO adopted the Doha Declaration on the TRIPS Agreement and Public Health. The text was the product of a difficult negotiation, where DG-Trade and USTR tried to limited the scope of the declaration to AIDS, TB and Malaria, or some criteria that would narrow its application to emergencies. To this end, DG-Trade and USTR were able to get the following language in Paragraph 1:
1. We recognize the gravity of the public health problems afflicting many developing and least-developed countries, especially those resulting from HIV/AIDS, tuberculosis, malaria and other epidemics.
Additional language on the scope of disease was included in paragraph 5(c)
Each member has the right to determine what constitutes a national emergency or other circumstances of extreme urgency, it being understood that public health crises, including those relating to HIV/AIDS, tuberculosis, malaria and other epidemics, can represent a national emergency or other circumstances of extreme urgency.
The larger effort by DG-Trade and the USTR to limit the scope of diseases in the November 2001 document failed. However, over the course of the next several years, and particularly during a negotiation from 2002 to 2003 on paragraph 6 of the Doha Declaration, the USTR and DG-Trade continued to press claims that the Doha Declaration was “meant” to be used for a limited set of diseases and or emergencies only.
The November 14 2001 Doha Declaration changed several things immediately, and had one deferred benefit. The immediate changes included an extension of the deadline for least developed countries to adopt pharmaceutical product patents until 2016 (Paragraph 7), a set of substantive and useful clarifications of how compulsory licensing and parallel trade can be used (Paragraph 5), and a general provision in Paragraph 4 that:
“the Agreement can and should be interpreted and implemented in a manner supportive of WTO members’ right to protect public health and, in particular, to promote access to medicines for all.”
It was our view that the Paragraph 4 language was extremely important, and completely changed the odds of prevailing on all sorts of WTO disputes over specific TRIPS language. The standard “access to medicine for all” made it very easy for countries to justify more liberal interpretations of the various TRIPS flexibilities. The language in Paragraphs 5 and 7 would also be important. The outstanding issue was Paragraph 6, which concerned the important issue of exports of medicines manufactured under a compulsory license. Negotiations on Paragraph 6 then started, and concluded on August 30, 2003.
The August 30, 2003 agreement has been controversial for several reasons, including the complicated procedures used by some countries, like Canada, in its implementation — but it remains quite important. It waived the WTO limit on the export of medicines produced under a compulsory license — an issue of importance to almost all countries considering issuing a compulsory license to import medicines.
All efforts to attach a list of diseases to the August 30, 2003 agreement on Paragraph 6 of the TRIPS failed, but the August 30, 2003 decision did provide language that would be used to try to limit its scope, including the following language:
1. For the purposes of this Decision:
(a) “pharmaceutical product” means any patented product, or product manufactured through a patented process, of the pharmaceutical sector needed to address the public health problems as recognized in paragraph 1 of the Declaration. It is understood that active ingredients necessary for its manufacture and diagnostic kits needed for its use would be included; (1)
(b) “eligible importing Member” means any least-developed country Member, and any other Member that has made a notification (2) to the Council for TRIPS of its intention to use the system as an importer, it being understood that a Member may notify at any time that it will use the system in whole or in a limited way, for example only in the case of a national emergency or other circumstances of extreme urgency or in cases of public non-commercial use. It is noted that some Members will not use the system set out in this Decision as importing Members (3) and that some other Members have stated that, if they use the system, it would be in no more than situations of national emergency or other circumstances of extreme urgency;
DG-Trade and USTR subsequently pressured several countries to agree that they would never import drugs from a country using the export waiver, except in cases of “national emergency or other circumstances of extreme urgency.” These countries initially included developing countries such as Mexico, Turkey and China, as well as higher income countries like Korea, Israel, Singapore or Kuwait. Other countries, including all members of the European Union, the US and other high income countries, completely opted out as importers, even in cases of national emergencies.
Practical issues
As it currently stands, the 2001 Doha Declaration has dramatically increased the potential flexibility of the TRIPS agreement on all sorts of issues, ranging from the decisions to grant patents on pharmaceutical inventions that do not significantly improve the efficacy of products, on second uses of medicines, on parallel trade, and on probably a dozen different aspects of the uses of compulsory licensing of patents, as well as issues about TRIPS oblgiations for IPR on pharmaceutical test data, and even the relations between trademarks and copyrights and initiatives to promote use of generic drugs. Basically, post Doha TRIPS is much different than Pre-Doha TRIPS. So, when the NCD discussion began at the UN, the Obama White House and DG-Trade saw this as an opportunity to try, again, to make the case that the 2001 Doha agreement, and the 2003 TRIPS waiver for exports, do not apply to NCDs. Given the timing of the decision, this puts at risk the current understanding that the Doha Declaration applies to everything.
Krista Cox has more context on this issue in the following blog: Obama Administration Wants to Eliminate References to Doha Declaration in UN Political Declaration on Non-Communicable Diseases.