US pressures African capitals on TRIPS and public health

The US is pressuring sub-Saharan African nations to accept a limited solution to the problems they and other poor countries face in importing affordable generic drugs, one that would effectively negate many of the gains afforded by a declaration agreed by trade ministers in Doha last year.

by Chakravarthi Raghavan

GENEVA: The United States is applying considerable direct pressures at capitals of sub-Saharan African (SSA) countries asking them to instruct their trade delegations in Geneva to oppose several of the proposals (from the African Group and other developing countries) before the WTO’s TRIPS Council for implementing Paragraph 6 of the Doha Ministerial Declaration on the TRIPS Agreement and Public Health.

A letter to the capitals of the SSA countries from the Assistant US Trade Representative to Africa Rosa Whitaker, dated 25 October, on the TRIPS-and-public-health issue, is drafted in language reflecting the position of the big pharmaceutical corporations and their efforts to dilute and rewrite the Doha Declaration on this.

The US stance is aimed at developing countries, as well as the Europeans who have taken a slightly more accommodating position partly because of their own public interest civil society movements as well as the strong viewpoints expressed in the European Parliament.

Civil society groups closely monitoring the issue have obtained copies of the Asst. USTR’s letter, and are readying a campaign and widely denouncing the US pressures.

Apart from the issue of TRIPS and public health, the Whitaker letter also relates to the implementation issues, relating to the Agreement on Textiles and Clothing (ATC). Whitaker claims that proposals to ease the industrialized countries’ textiles and clothing quotas would harm the SSA countries and deprive them of the benefits provided through the US’ Africa Growth and Opportunity Act (AGOA).

On both these subjects, the US letter, through its embassies to the trade ministers and trade establishments of the SSA countries, and seeking their support for the US position and instructions to the Geneva negotiators, provides some misleading information aimed at confusing the capitals.

Narrowing the scope

On TRIPS and public health, the US attempt seems to be aimed at effectively rewriting Paragraph 6 of the Doha declaration. That paragraph mandates the TRIPS Council to “find an expeditious solution” by 31 December to the problem of WTO members “with insufficient or no manufacturing capacities” in the pharmaceutical sector who “could face difficulties in making effective use of compulsory licensing under the TRIPS Agreement.”

The US stance appears to be aimed at narrowing the public-health issues that the Doha declaration encompasses, the beneficiary importing countries and the supplying countries that could provide the generic medicines. It is seemingly geared towards making the supply and export of these drugs as complicated and time-consuming as possible so that the suppliers would not be too anxious to export and cut into the profits of Big Pharma.

The Doha declaration affirmed (Paragraph 4) that the TRIPS Agreement does not and should not prevent WTO members from taking measures to protect public health and promote access to medicines for all. In Paragraph 1, it recognized the “gravity of the public health problems” afflicting many developing countries and the least developed countries (LDCs), “especially those resulting from HIV/AIDS, tuberculosis, malaria and other epidemics.” It thus covers, and was intended to cover, all public health problems in developing countries, and not merely the specified diseases (HIV/AIDS, TB, malaria). It affirmed the flexibilities available under the TRIPS Agreement and the right of countries to take actions to secure them and meet “public health problems.”

In terms of Paragraph 6, the discussions at Geneva have focussed on the issues of product and disease coverage: products of the pharmaceutical sector, including active substances for the manufacture of medicines; and, on disease coverage, while HIV/AIDS, TB and malaria are mentioned in Paragraph 1, the use of “especially” in that paragraph, in terms of its ordinary dictionary meaning and international public interpretation law, means that other diseases too may fall in these categories.

Also, the discussions have centred on which are the “eligible” countries that could import the generic drugs and on which could be the supplier countries.

The US letter to the African countries covers some of these, and seeks African support for the position paper of the Mexican Chairperson of the TRIPS Council (Ambassador Eduardo Perez Motta) - which will have the effect of trying to limit the countries that can qualify as “eligible countries” to issue compulsory licences to import, and also the supplying countries.

Part of the US thrust is also probably aimed at preventing pharmaceutical firms and manufacturers in other developed countries from making use of these provisions to export to the eligible countries.

Interestingly, the European Parliament recently adopted a resolution asking the European Commission to amend its patent directive to enable issue of a compulsory licence to a European manufacturer to export the production to a developing country with “no or insufficient manufacturing capacity”.

Some civil society groups in the US and Europe view this as an important advance; others are more sceptical and cautious: the European Commission and the Council of Ministers would still need to agree to this and issue such an amendment, and even thereafter the Commission or a member government may or may not issue such a licence and/or stipulate conditions that may inhibit supplies.

The EU has both pharmaceutical interests to protect, and member countries where there are strong opinions about the cost of healthcare and prices of proprietary medicines.

One thing seems fairly clear, though: the US, the EC, Japan and others dare not end the talks at the WTO on this issue without reaching a solution satisfactory to the developing countries, in particular the African countries. Any failure here will result in a considerable backlash.

At the same time, unless the African countries take care, they may end up with a pyrrhic victory, where they may hope to settle for something but find that “that something” does not deliver: and they get neither the active substances for import and production of generic medicines inside their country, nor the medicines themselves; neither the cheap medicines needed nor investment and technology transfer.

Manufacture and distribution of pharmaceuticals at cheap prices for their populations needs of course production and technology, and capital and investment. But it needs something more too, in terms of infrastructures - a need clearly foreseen as early as the 1978-79 Alma Ata Declaration and the essential drugs programme that was enunciated at the World Health Organization (WHO) by its then Director-General Halfdan Mahler and adopted enthusiastically by the World Health Assembly, committing WHO members to adopt a range of national and international policies for implementing them.

These have been quietly forgotten and ‘buried’ by his successors, as well as the developing countries themselves which were committed to primary health care and essential drugs.

Also required within a country are a considerable amount of expertise and capacity to adequately test on a continuing basis the quality of the medicines produced inside the country, and a public machinery to get the information across to the medical practitioners and public healthcare institutions, rather than depending only on the pharmaceutical industry and its field medical representatives.


The US letter to the SSA countries refers to the mandate to the TRIPS Council and need to find “a practical solution” before the end of 2002, to meet the problems that African countries and others face in making effective use of compulsory licensing of pharmaceuticals. In effect this also tries to restrict the scope of the Doha declaration.

The US also commends the proposals of Amb. Motta, which several developing-country delegations involved in the TRIPS consultations have viewed as being aimed at bridging the gaps between the US and the EC and not between the North and the South.

The US has asked the SSA countries to instruct their Geneva representatives to respond favourably to Motta’s paper and to work in Geneva with the US, to support a solution that addresses Africa’s interests and particular circumstances.

The US proposals, the Whitaker letter says, support a solution that focuses on the serious epidemics faced by Africans - HIV/AIDS, malaria and tuberculosis. “Broadening the solution to cover any public health problem, as some are advocating,” the US claims, in an effort to rewrite Paragraph 1 of the Doha declaration and restrict its scope, “would divert attention and resources away from these epidemics, at Africa’s expense, and risks trivializing the gravity of these serious epidemics.”

The US also wants to restrict its scope to “low-cost essential medicines” and not expand it to products including “the full range of diagnostic products and other health-related items.”

The compulsory licensing provisions of the TRIPS Agreement (Article 31) are available to all members of the WTO. But the US is clearly trying to limit their scope, by arguing that the benefits of compulsory licensing be limited to those in greatest need.

It mentions in this regard the least developed and low-income developing countries that do not have the capacity to produce essential drugs domestically (including all sub-Saharan African countries).

“Allowing developed countries or advanced developing countries to import under compulsory licensing might encourage the solution to be abused for commercial purposes - exporters would likely focus their attention on more lucrative developed country markets rather than on the developing world.”

Towards this end, the US wants to limit the exporters under compulsory licensing to least developed and developing countries. Permitting developed countries to be exporters would hinder technology transfer and pharmaceutical-company investment in the developing world, it argues in very misleading terms.

It also insists that the mandate to the TRIPS Council  is to  solve a specific problem in the TRIPS Agreement, not to open or renegotiate this agreement. (SUNS5233)                                         

From Third World Economics No. 294 (1-15 December 2002)