Draft Doha texts fail to reflect developing-country concerns on TRIPS
Developing countries are bitterly disappointed that the concerns they have voiced on TRIPS during the preparatory process for the Fourth Ministerial Conference have not been accurately reflected in the draft WTO texts for the Doha meeting.
by Cecilia Oh
THE second drafts of the Ministerial Declaration texts were issued late 27 October 2001. Five documents were sent to the WTO Members: 1) Draft Ministerial Declaration; 2) Draft Decision on Implementation-Related Issues and Concerns; 3) Draft Declaration on Intellectual Property and [Access to Medicines] [Public Health]; 4) Compilation of Outstanding Implementation Issues Raised by Members; and 5) Proposed Procedures for Extensions under Article 27.4 for Certain Developing Country Members.
Three documents had initially been expected, i.e., the Ministerial Declaration, the Decision on Implementation Issues, and the Declaration on Intellectual Property and Access to Medicines/Public Health. It is understood that the two extra documents were the results of last-minute consultations.
The Compilation of Outstanding Implementation Issues (hereafter the Compilation) is intended to be a listing of all other implementation issues (identified by developing countries in the draft Seattle Ministerial Declaration text of 19 October 1999 and beyond) which are not included in the Implementation Decision. A large number of developing countries had expressed dissatisfaction with the narrow coverage of the implementation issues in the first draft of the Implementation Decision, in which only the minimum and least controversial of the implementation issues had been included. The compilation of outstanding issues is seen as an attempt to appease the developing countries. However, it is not clear how these outstanding issues will be dealt with at the Doha Ministerial Conference, or how these relate to the Implementation Decision itself. The concern is that these outstanding issues will not be addressed and that the document is only a window-dressing exercise which will, in the end, be left out of the real negotiations at Doha.
Insofar as TRIPS issues are concerned, a number of the concerns and proposals of the developing countries have been relegated to the Compilation, including concrete proposals from the relating to the review of Article 27.3(b) and extension of transition periods for developing countries.
Below is a brief commentary on some of the sections relating to TRIPS issues as they appear in the texts.
Draft Ministerial Declaration
The draft Ministerial Declaration now has three paragraphs on TRIPS instead of four: one on the public health and access to medicines aspect; the second, on the multilateral system for geographical indications for wines and spirits; and the third, on the TRIPS Council’s work programme in relation to the reviews under Articles 27.3(b) and 71.1.
TRIPS and public health
The draft of the main Ministerial Declaration makes reference to the separate Ministerial Declaration on TRIPS and public health, as has been called for by developing countries. However, the developing countries have demanded that the reference to the issue of TRIPS and public health in the Ministerial Declaration should set out the common understanding that ‘nothing in the TRIPS Agreement shall prevent WTO Members from taking measures to protect public health’, followed by an endorsement of the clarification and interpretation of the TRIPS Agreement which was to be contained in the separate declaration. This has not been reflected in the Ministerial Declaration. The Africa Group and the Like-Minded Group (LMG) of countries in the WTO have proposed the following formulation:
‘We affirm our understanding that nothing in the TRIPS Agreement prevents Members from taking measures to protect public health. In line with this understanding, we endorse a clarification and interpretation of the TRIPS Agreement, as contained in the Ministerial Declaration on TRIPS and Public Health, that will allow and encourage Members, particularly developing country and least-developed country Members, to avail themselves of the widest range of policy options for the protection and promotion of public health.’
The separate declaration on Intellectual Property and [Access to Medicines] [Public Health] is discussed below.
Review of Article 27.3(b)
References to Articles 27.3(b) and 71.1 reviews are contained in paragraph 19 of the draft Ministerial Declaration. This paragraph is very similar, in terms of its lack of political intent and direction, to the corresponding paragraph in the first draft of the declaration. What is new is the explicit references to the mandated reviews under Articles 27.3(b) and 71.1. The new paragraph instructs the TRIPS Council, in pursuing its work programme (which includes the Article 27.3(b) and 71.1 reviews), to examine the relationship between the TRIPS Agreement and the Convention on Biological Diversity, protection of traditional knowledge and folklore, and other relevant new developments raised by Members pursuant to Article 71.1.
It does not, however, reflect the concerns of developing countries over the implications of Article 27.3(b). It also fails to provide much-needed guidance and direction to push forward the review process, which has been effectively stalled for the past two years. The oft-cited proposal of the Africa Group prior to the Seattle Ministerial Conference appears to have been relegated or downgraded onto the Compilation document.
The revised paragraph also ignores the most recent proposals of the Africa Group and the LMG, which set out the modalities for the conduct of the review under Article 27.3(b). The Africa Group proposal submitted to the General Council Chairman and circulated to the WTO Members on 7 October 2001 is as follows:
'We note with concern the lack of progress in the review of Article 27.3(b). We instruct the TRIPS Council to complete the review process by 2002. In the review process, Article 27.3(b) shall be clarified to eliminate the artificial distinctions made between plants and animals, and micro-organisms; and between essentially biological processes, and microbiological processes. The review process shall therefore clarify that plants and animals, as well as micro-organisms and all other living organisms and their parts, cannot be patented, and that natural processes that produce plants, animals and other living organisms shall also not be patentable. With regard to the protection of plant varieties, the TRIPS Council shall clarify that Members have the right to determine the appropriate sui generis system for the protection of plant varieties that is best suited to their interests. The implementation of this provision shall not prevent developing country Members from implementing sui generis sytems that accord due recognition to farmers and local communities for their traditional knowledge, ensure food security and safeguard farmers’ livelihoods. Such sui generis systems shall also not undermine traditional farming practices, including the right of farmers to save, use, exchange and sell seeds, as well as to sell their harvest. We further agree that the transition period for the implementation of Article 27.3(b) shall be extended for a further five years from the date its review is satisfactorily completed.’
The least developed countries (LDCs) had also made proposals with regard to the review of Article 27.3(b) to the effect that the review process should clarify that ‘all living organisms, including plants, animals, and parts of plants and animals, including gene sequences, and biological and other natural processes for the production of plants, animals and their parts shall not be granted patents’. Yet again, this was not reflected in the text of the Ministerial Declaration, but mentioned in the Compilation document.
Review under Article 71.1
While there is an explicit mention of Article 71.1 (absent in the first draft), the declaration again does not make mention of the detailed proposals submitted by the Africa Group and the LMG. The Africa Group and the LMG submitted the same proposal relating to the review process under Article 71.1. The proposal instructs the TRIPS Council to identify amendments to TRIPS so as to allow its objectives and principles to be met, including amendments to exclude certain medicines from patentability, as follows:
‘In view of serious concerns expressed by Members and the general public regarding the imbalances of the TRIPS Agreement, we agree that, in the review of the TRIPS Agreement under Article 71.1, it shall be appropriate for the TRIPS Council to take into account new developments that warrant modification and amendment of the Agreement. In so doing, the TRIPS Council shall work out the necessary amendments that ensure the ability of developing country Members to fully meet the objectives and principles of the TRIPS Agreement, as contained in Articles 7 & 8. This includes amendments to enable developing country Members to balance public policy objectives with the interests of rights holders, as appropriate to their national needs and conditions, and to allow developing country Members maximum flexibility in their implementation of the TRIPS Agreement. Among others, the TRIPS Council shall examine the effects of the TRIPS Agreement on public health, with particular emphasis on access to medicines, and research and development on medicines for the prevention and treatment of diseases predominantly affecting people in developing and least developed countries, with a view to excluding such medicines from patentability in order to ensure their accessibility and affordability.'
It would appear that this detailed proposal submitted by over 40 countries has been ignored.
Draft Declaration on Intellectual Property and [Access to Medicines] [Public Health]
This draft declaration is based on a document issued by the Chairman of the General Council on 21 October 2001 entitled ‘Elements for a Draft Declaration on Intellectual Property and [Access to Medicines] [Public Health]’.
Of note is the inclusion in the draft of two options for language relating to TRIPS and governments’ ability to take measures to protect public health. This has been the major sticking point in the negotiations thus far. The first option starts off with the developing country proposition that: ‘Nothing in the TRIPS Agreement shall prevent Members from taking measures to protect public health’. It goes on: ‘Accordingly, while reiterating our commitment to the TRIPS Agreement, we reaffirm that the Agreement shall be interpreted and implemented in a manner supportive of WTO Members’ right to protect public health, and in particular, to ensure access to medicines for all. In this connection, we reaffirm the right of WTO Members to use, to the full, the provisions in the TRIPS Agreement which provide flexibility for this purpose’.
Option 2 appears to reflect the position of countries like the US and Switzerland, which would like to see a declaration that is limited in scope (to access to medicines for HIV/AIDS and other pandemics). It states: ‘We affirm a Member’s ability to use, to the full, the provisions in the TRIPS Agreement which provide flexibility to address public health crises such as HIV/AIDS and other pandemics, and to that end, that a Member is able to take measures necessary to address these public health crises, in particular to secure affordable access to medicines. Further, we agree that this Declaration does not add to or diminish the rights and obligations of Members provided in the TRIPS Agreement. ...’
Whilst there are square brackets around the two options, indicating disagreement, it is disconcerting to see that the US proposals on transition period and moratorium have been incorporated into the declaration without square brackets Ð as if they had already been accepted by the Members. This is not the case. [The US had proposed: (i) a 10-year extension, till 2016, of the transition period for LDCs to implement the TRIPS provisions on patents and protection of undisclosed information with regard to pharmaceutical products; and (ii) a 5-year moratorium on dispute actions against ‘any non-discriminatory intellectual property law, regulation or other measure’ by non-LDC sub-Saharan African countries to improve access to patented pharmaceutical products used in the treatment of HIV/AIDS and other pandemics.] Indeed, the proposal from the US is seen by developing country negotiators as a means of enticing the LDCs and African countries into accepting the proposal in exchange for a weakened declaration, and of breaking up the developing country coalition.
Another new paragraph (which had been left blank in the ‘Elements’ document) is that which deals with the issue of countries with limited domestic manufacturing capacity in the pharmaceutical sector. Discussions and consultations prior to the declaration being issued had been focused on how such countries could be allowed to issue compulsory licences to foreign manufacturers, since they do not have local manufacturers. By such means, a country without local manufacturing capacity would be able to effectively make use of compulsory licensing under the TRIPS Agreement.
In the joint proposal for the Declaration on TRIPS and Public Health submitted by 52 developing countries, developing countries had proposed that compulsory licences issued by a Member should be given effect by another Member, so that the manufacturers in the other Member could produce and export medicines to the Member granting the licence.
The declaration recognises that 'WTO Members with insufficient or no manufacturing capacities in the pharmaceutical sector could face difficulties in making effective use of compulsory licensing ...’, but it merely instructs the TRIPS Council ‘to find an expeditious solution to this problem, and to report to the General Council before the end of 2002’. It does not make reference to the developing country proposal. And it is also understood that the US and Switzerland had objected to the proposal.
As far as the treatment of TRIPS issues is concerned, the second versions of the Ministerial texts are no real improvement over the first drafts. The criticism of developing countries directed at the first draft - that there did not appear to be a serious attempt to address issues of concern to developing countries Ð is still applicable. The issue of process and procedure is also of concern. With the second drafts being issued so close to the Ministerial Conference, the worry is that negotiators will not have sufficient time to consult the drafts and to make amendments. This is particularly serious, especially when proposals of developing countries have been blatantly ignored, as has been the case with the proposals of the Africa Group, the LMG and the LDCs. Yet, the draft Ministerial texts (with the exception of the two options in the declaration on access to medicines/public health) are presented as ‘clean’ texts, i.e., texts on which there is agreement. But this is far from the truth.
Cecilia Oh is a legal advisor and researcher with the Third World Network.