South’s No to Restrictive, Public Health Doha Declaration

by Chakravarthi Raghavan

Geneva, 21 Sep 2001 - - India and several other developing countries, that have put forward a ‘non-paper’ for a Ministerial Declaration on TRIPS and Public Health, served notice Friday that they would not accept any declaration that under the guise of clarifying TRIPS provisions would in fact restrict the flexibilities available to them under the existing provisions.

The Counsellor of the Indian delegation to WTO, Mr. Mohan Kumar was reacting to some of the ‘non-papers’ on a ministerial declaration from a US-led hard core of rich nations and to a secretariat ‘non-paper’ summarising the issues raised in the debates, and points of possible convergence and others where positions were not yet clear or differences had been indicated.

The Indian delegate said he was instructions from his capital to make clear that India would not agree to a Ministerial Declaration on the issue that would reduce the flexibilities which were available to India under the TRIPS nor agree to a Declaration which merely repeated TRIPS provisions without any value added.

India also made clear that India or any other country could not sign away through the TRIPS or any other agreement the sovereign right (and responsibility) of the government of a country to safeguard and protect public health of its citizens.

The Philippines, Brazil, Peru, Kenya, Zimbabwe for Africa group, were among the developing countries who had presented a ‘non-paper’ on Wednesday on a draft Ministerial Declaration. Argentina also supported the Indian position and statement.

Switzerland, which has been a pointman for the hard-core group (the US, Canada, Czech Republic, Japan and New Zealand and Switzerland that have given a ‘non-paper’ of operative parts for a declaration with the restrictive interpretations of flexibility, national emergencies and parallel imports) in quickly responding to India insisted that no ‘added value’ could be obtained by the declaration of clarification or interpretations, but only an amendment of TRIPS itself.

The EC had also circulated yesterday a ‘non-paper’ claimed to be slightly middle-ground, would appear to have indicated Friday that it had not been cleared by all the EU members. After the meeting there were reports that the EC was ‘withdrawing’ its non-paper.

‘Non-papers’ in the GATT/WTO terminology are informal negotiating texts put forward by a country or group of countries that could be a basis for discussions and negotiations, with countries open to change both on the content and the phraseology or wording.

The US-led hard-core (with Australia as an additional cosponsor) paper Wednesday had set out only the preambular portions of a declaration which indicated the declaration was to deal with access to medicines in relation to HIV/AIDS and other pandemics of communicable diseases.

The paper introduced Friday with operative paragraphs sought to qualify the provisions of Art.6 about each country being free to set its own regime for exhaustion of rights (and thus able to allow parallel imports) by in effect linking it the Art 28 TRIPS provisions (about rights conferred), and further creating an obligation about the exhaustion regime to require countries receiving drugs under differential pricing to ensure it does not ‘leak out’ to other countries.

The US-led group non-paper also sought to restrict the scope of flexibility available for compulsory licensing under Art 31 (which only stipulates non-exhaustively some procedures and conditions to be followed) to the provisions of Art. 27.1 about patentability and patent rights without discrimination, thus seeking to reduce the scope of Art. 31.

The non-paper of the US-led group also appears to provide that the declaration

should state that

        each provision of TRIPS should be read in accordance with customary rules of interpretation of public international law as reflected in the Vienna Law of


        the Art 31 provision of TRIPS for compulsory licensing left Members freedom to determine grounds for granting compulsory licenses so long as other provisions of the TRIPS are respected, and each compulsory licence being considered on its merits,

        the declaration of national emergencies or conditions of ‘extreme urgency’ (under which compulsory licenses could be granted without going through lengthy procedures) to declarations of pandemics of life-threatening communicable diseases such HIV/AIDS, malaria and tuberculosis,

        linking the Art 6 (exhaustion of rights regimes that countries could determine) to Art 28.1 (about exclusive importation rights of a patentee) and by bringing in Art. 3 and 4 of TRIPS (about national treatment and MFN treatment for IPR holders), and further linking an exhaustion regime to goods put on a market by the rights holder or with his/her consent, and

        Members defining their own exhaustion regimes and allowing parallel imports to take steps to prevent pharmaceutical goods provided to the poorest populations under discounted or differential pricing to be diverted to markets for which they were not intended.

The secretariat non-paper lists as points of apparent convergence for recognition in preambular language as issues: health crises affecting many developing and LDCs and need to respond; importance of protection of public health for sustainable development, welfare and social cohesion; challenge in ensuring access to medicines in many developing and LDCs; affordability as one factor in access, and recognition of other factors as also involved; recognition that protection of IPRS encourage development new medicines and thus promotion of public health; reaffirmation of flexibility available under TRIPS and right of members to implement an IPR regime supportive of public health objectives/ensure medicines for treatment of HIV/AIDS and other pandemics; reaffirmation that IPR protection should lead to transfer of technology.

As points for preambular language where convergence yet to emerge or differences exist, the secretariat non-paper also seems to include:

affirmation of - national sovereignty for protection and promotion of public health; fundamental human right to life and to enjoyment of highest available standard of physical and mental health; commitment to implement TRIPS;

recognition of - IPR protection as factor affecting prices of medicines; protection of IPRs should promote development and maintenance of sustainable domestic manufacturing capacities; important and complementary roles of research-based and generic pharmaceutical industries; problems of countries with small domestic markets in making effective use of Art.31; civil society concerns and importance of participation of public health officials; concern about insufficiency of R%D into diseases predominantly affecting developing and LDCs;

WTO/TRIPS provisions on avoidance of barriers to legitimate trade and special needs of LDCs; vulnerability of developing and LDCs to bilateral pressures and chilling effects of challenges at the WTO; desirability of tiered pricing; commitment, in the context of a global fund, to work with private sector; technical assistance on implementation to developing and LDCs taking into account health concerns; recognition of fundamental importance of objectives and principles of TRIPS.

Under operational issues of apparent convergence, the non-paper of the secretariat talks of:

        relevance of rules of interpretation in Vienna Law of Treaties, including the requirements about provisions to be read in light of object and purpose,

        freedom to determine grounds for adoption of measures under Art. 31 provided conditions set out in the TRIPS are met,

        reaffirmation of right to apply for and issue compulsory licences without seeking voluntary licence in situations of ‘national emergency’ or ‘other circumstances of extreme urgency’, including those resulting from HIV/AIDS and other pandemics, and

        right of each country to establish its own regime for exhaustion of IPRs, subject to respect for provisions of Art. 3 & 4.

The non-paper mentions a number of other points of non-convergence including among them problems of countries without sufficient domestic capacity in issuing compulsory licences, production and export of medicines to meet public health needs in others, non-aapplicability of Art 31(b) and (f) provisions to remedy practices determined to be anti-competitive, establishing marketing procedures for generic products, disclosure of undisclosed information for public interest, provisions of Art.39.3 not weakening other rights as under 31.b, definition of exhaustion, measures to prevent diversion of drugs provided under discounted or differentially pricing schemes, restraint in raising dispute settlement procedures, extension of transition periods and post-Doha work programme.

In a sharp oral reaction India, supported by other developing countries, made clear it could not accept under the guise of a declaration where existing flexibility as understood by it will be reduced. It could not also accept a declaration that limits the sovereign right of countries to declare national emergencies, by qualifying its use only for pandemics of life-threatening communicable diseases. It would not also agree to any declaration that in fact attempts to dilute the right of countries to set regimes about exhaustion of rights and allowing parallel imports and which as now could not be challenged under the DSU. In particular India made clear that its view of Art.31 and Art 6 was that products put on a market, without consent of IPR holder, in cases of compulsory licensing could be covered by a regime of exhaustion of rights, as also generic products brought on a market.

India also criticised the secretariat non-paper, in its narration of elements lacking convergence, adopting language that in effect whittled down the actual point made in each of the operative paragraphs, including the view of developing countries that nothing in TRIPS could take away the right of countries to protect public health.

India also complained against a mere reference to the Vienna law of treaties for interpretation (which was axiomatic, and did not need a ministerial declaration) without reference to the Art 7 and 8 of TRIPS being overriding provisions for interpreting all TRIPS as provided in the developing country paper. “What is the value added in merely mentioned the Vienna Law of Treaties” India asked.

India also had problems with the mention of IPR protection as contributing to creation of medicines without simultaneously mentioning that developing countries had accepted these patent system as needed for creation of new medicines conditional on access to medicines and elements impeding it.

“We have had a bitter experience of the Uruguay Round and we cannot be expected to adopt any ministerial declaration, for example, modifying the right to define an exhaustion of regime.”

Some trade diplomats later reported that one of the ‘non-papers’ circulated inside the room, but hastily taken back after delegations had seen and read it, creating a flutter of sorts, seemed to bring out some partisan approaches emanating from sections of the secretariat and attempts to denigrate opposition to the WTO instruments emanating from other parts of the UN system or civil society.

However, the contents were not readily available.

Some delegations said that adding to the complexities and problems of the Doha Ministerial and overall outlook, uncertainties of security depending on nature of the US retaliatory strikes and military-build ups in the region, and differences on agenda of launching of a new round are the hard stands on a range of public interest about benefits of the WTO and liberalisation calls from outside, agitating developing countries and civil societies everywhere, and now the stand of the hard-core industrial nations and others on TRIPS and Public Health.

These are additional to the extraneous elements using the worldwide support for an undefined campaign against terrorism and how and where to respond, including the US and EC trade ministers wanting to use the US global war on terrorism and the public sympathy for the US over the New York terrorist attacks to launch a new round to benefit their corporations - with the US Fed Chairman Alan Greenspan joining the fray for using the situation to push for further trade liberalisation, through a new round. – SUNS4972

The above article first appeared in the South-North Development Monitor (SUNS) of which Chakravarthi Raghavan is the Chief Editor.

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