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Background
The WHO Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG) was established as a result of a May 2006 request by the Member States of the WHO. The Working Group's mandate is to prepare a global strategy and plan of action on essential health research to address conditions affecting developing countries disproportionately. The resulting global plan of action will be presented to the World Health Assembly in mid-2008. The Working Group, composed of WHO Member States, held its first session on December 4-8 2006, in Geneva and has so far completed three sittings. The most recent sitting was completed between April 28 and May 3, 2008. This meeting resulted in a number of significant changes to the Draft Global Strategy and Plan of Action that is to be created as a result of these meetings. The IGWG will meet again on May 21, 2008.
Having witnessed some of the proceedings of the 2008 meeting of the IGWG, Centad felt that it was important to bring together key stakeholders across the areas of public health, intellectual property and innovation to reflect critically on the modifications in the Draft Global Strategy and Plan of Action adopted on May 3, 2008 by the IGWG and to seek negotiating inputs for the upcoming Fourth Session of the IGWG. The meeting was held on May 13, 2008 at the office of Centad and had representation from individuals who had attended the 2008 IGWG session, academics, scientists, public health advocates and members of civil society. The meeting updated all attendees on events that had occurred at the 2008 session and gave recommendations on important issues to be covered at the next round of IGWG negotiations.
Introduction
The meeting was opened by an introduction to the review session of the meeting of the IGWG held between April 28 and May 3, 2008 . The session was divided into two drafting groups. Discussions within Group A, which covered Element 5 (Intellectual Property Management) consumed most of the time, whereas discussions under Group B, which dealt with the remaining 6 elements was concluded in a shorter period. India's participation in the groups was divided into Ms. Aradhana Johri negotiating on behalf of India within Group A and Mr. Dayal chairing the discussions within Group B. The discussions under Group A also left a number of sections of text that would require further negotiation. These texts are marked in square brackets in the Draft Global Strategy and Plan of Action ("Global Strategy").
Important Developments
Alternative Incentive Schemes
Among the controversial issues highlighted, attention was drawn to paragraph 14 of the Global Strategy, addressing the need for alternative incentive schemes for R&D. Despite long periods of negotiation, countries could not agree to adopt the term 'alternative' in the context of incentive schemes for R&D, on the grounds that the term 'alternative' implied grounds for locating an alternative to the IPR system for R&D incentivization. Instead, the discussion groups preferred the adoption of the term 'possible', which was milder and more ambiguous in implication.
Favourable Results
It was noted that a lot of provisions on intellectual property had ended in favour of the developing countries, such as Element 5.2(a), which incorporated the second interpretation of the December 14 Draft Global Strategy, and at the same time incorporated references to the Doha Declaration and the August 2003 decision of the WTO. Similarly, it was agreed that Element 5.3(a), which dealt with alternative incentive schemes such as the Prize Fund, had passed through negotiations with the best possible interpretation, given the circumstances. It was also noted that progress on Element 6.2(g) had gone well, with a strong acknowledgement of the need for strong compliance with ethical principles in clinical trials and medical research involving human subjects.
Unfavourable Results
Disappointment was expressed, however, at the final deletion of Element 7.3, dealing with the R&D fund. It was noted that support for the R&D fund was relatively low, even among developing countries. Accordingly, it was agreed by the members of the IGWG to delete the provision relating to the fund. However, a proposal to explore alternatives to the fund was discussed. One suggestion that was discussed was to strive for the creation of an R&D treaty that would lay down the terms and conditions under which an R&D fund could be created. Until such a treaty was created, it would be possible to establish an R&D fund with rules to manage it. When the R&D treaty was brought into place, it would be possible to create a smooth transition of the fund into the treaty. However, the proposal was not accepted. It was noted that one of the outcomes that should have been different was Element 7 generally and the R&D fund specifically. The importance of Element 7 was emphasised, as an area where definable objectives could have been reached. It was noted that Element 7.1 was supposed to create an expert group on financing and R&D. However, the scope in the May Draft Global Strategy was limited to R&D. On the other hand, Element 7.2 on public-private partnerships was retained.
Suriname's Objections to Element 5.1(a)
Another area of interest that was highlighted was the bracketing of text within Element 5.1(a) and the introduction of "Consensus pending Suriname" into the text of the Global Strategy. It was noted that Suriname feared that IP management in Element 5.1(a) was focussed to closely on innovation and insufficiently on access to medicines. Their formulation (enclosed in square brackets) intends to strengthen the commitment to IP management in the context of access to medicine as well as R&D.
Traditional Knowledge Digital Library
On the subject of Traditional Knowledge, it was noted that the majority of discussions focussed on the Traditional Knowledge Digital Library (TKDL). The concept of the TKDL was actively opposed by the countries of Bolivia and Brazil due to the risks such as database may entail in further biopiracy. Ecuador opposed the concept of the TKDL on the grounds that it was against their Constitution. India also showed its flexibility on the position of the TKDL. It was agreed that there was a stronger need to create an international framework for traditional knowledge, rather than a TKDL.
TRIPS Plus Measures
On the subject of Element 5.2(b), concerning the avoidance of TRIPS plus measures, it was noted that the developed countries opposed its adoption, while most of the countries which had already adopted TRIPS plus measures, either unilaterally or through FTAs, were against the avoidance of such measures.
Positions on Important Paragraphs
Paragraph 14(b) - List of Diseases
The discussion around paragraph 14(b) focussed primarily on the footnote to that paragraph, with specific reference to the definitions of Type I, Type II and Type III diseases. There was some argument as to the manner in which the types of diseases should be treated. There were two prevailing opinions as to the manner of treatment of the lists. The first stated that it would be preferable to leave the names of specific diseases out of the definition, as this would lead to a restriction in the scope of diseases covered by the definition. The second stated that there was a need to provide a specific list of diseases as, otherwise, there would be protracted arguments about every disease and its inclusion into the definitions.
In favour of expansion, it was noted that the language utilised in this section of the text would have an impact on all areas of the text. It was also noted that in the event of restriction, the possibility of developed countries attempting to limit the scope of application of the Global Strategy to those diseases specified in the list would arise.
In favour of restriction, it was noted that the diseases referenced in this section were currently the ones most in need of research and access initiatives and that their inclusion would allow for more focussed initiatives for research and development.
It was also suggested that if names were included, the addition of qualifiers such as "including but not limited to" would address the problem of excessive restriction. One of the members also noted that in addressing these lists of diseases, and also in examining the rest of the Global Strategy, it was important to look at the larger role played by India in the negotiations and not merely with respect to domestic interest. India would be seen as a spokesperson for developing country interests and should, therefore, move beyond the narrow confines of national interest and look into interests that would serve all developing countries.
Element 6.2(e) - Counterfeit Drugs
The primary problem of Element 6.2(e) lay in the definition of counterfeit drugs, located in footnote 2 to the paragraph. The May Draft of the Global Strategy varies from the December Draft in that it introduces a definition of the term 'counterfeit'. There are currently 2 possible definitions of the term, with the latter definition expanding the scope of counterfeiting to exclude the need for any fraudulent or deliberate intention and by including standards that are not connected to the quality of access to the product, such as false representations as to identity, history or source. It was noted that at one point, the major pharmaceutical companies had called all generic medicines counterfeit. One strong objection to the latter definition was that a change in the label or trademark of a drug does not necessarily imply that the drug is of poor quality or ineffective or pose public health concerns. The only effect such a provision would have would be on the brand image of the originator company. It was also noted that the latter definition was created in the 3 rd day of negotiations, and that it was not an accepted WHO definition. India had made its position clear that the latter definition dealt with issues of violation of trademark and was not concerned with access. It was recommended that in further negotiations, attempts should be made to remove the phrase 'counterfeit' from the Global Strategy. Failing that, it would be important to ensure that the latter definition of counterfeit should not be included.
Element 6.3(f) and Element 5.3(e) - Competition Policy
Some doubts were raised as to the efficacy of including provisions for competition law in the Global Strategy as, given the current state of Competition law in India, such provisions may not be relevant in the immediate context. However, it was noted that if, in the future, competition law were to develop further, there would be a great amount of scope to utilise it in order to further the objectives of access to medicines and healthcare. It was noted that, as far as the draft was concerned, the focus solely on 'medicinal patents' was restrictive, and that the scope of the same should be expanded to address the pharmaceutical and health care industry more squarely. It may be preferable to use the competition law more generally than merely in the context of intellectual property. It was noted that a number of anticompetitive activities that would restrict access to medicines and healthcare may be associated with issues unconnected to intellectual property, such as restrictive agreements with retailers, collusive practices and price fixing. Accordingly, it would be wrong to limit the scope of competition policy in this provision to intellectual property and medicinal patents. It was also noted that Element 5.3(c) would be a more appropriate place to address issues of competition law and intellectual property. It was noted that one argument in favour of using measures that favour competition available under intellectual property law was that intellectual property laws themselves contained very specific and definitive prohibitions against intellectual property violations, whereas existing competition laws were very general and did not address issues of competition and intellectual property directly. It was finally recommended, in the context of Element 6.3(f), that the language be modified such that the phrase 'medical patents' be replaced with 'access to health' and the phrase 'under intellectual property law' be removed.
Element 5.3(c) was also observed, and it was noted that it would be important to distinguish the language between 5.3(c) and 6.3(f). It was also recommended that the language of Element 5.3(c) be modified so as to include its scope of application from health products to healthcare technologies, services etc.
Element 5.1(a) - IP Management to contribute to innovation
It was agreed that it would be important to support Suriname's stand on the issue of IP management in favour of access. It was agreed that Suriname's stand reflected the developing world's viewpoint that intellectual property should contain perspectives focussed on access as much as on innovation.
Element 5.2(b) - TRIPS Plus Measures
It was strongly felt that all efforts must be taken to ensure that some commitment be made towards the avoidance of TRIPS plus measures. It was also noted, however, that in order for such a measure to pass, the language of Element 5.2(b) should be made more subtle. However, it was countered that if the language was instead strengthened and made more forceful, it may then be possible to argue downwards towards language that would be more acceptable, yet, would include TRIPS-plus avoidance. It was noted that it would not be possible to force member states to avoid TRIPS-plus provisions in national legislation, and that the addition of 'without prejudice to member states' may be more acceptable. However, it was noted that this approach was attempted in the negotiations, to no effect.
Element 5.3(b) and 5.3(d)
It was agreed that efforts should be taken to ensure that the elements on the impact of data exclusivity and on guidelines for patent examiners should be retained.
Conclusion
It was agreed that though much progress had been made at the 2008 Session of the IGWG, some setbacks had also occurred and would need to be addressed. It was recommended that the Indian delegation remain adamant on issues of importance to public health and access to medicines, and that strategies be created for addressing the provisions of the Draft Global Strategy at the World Health Assembly as well.
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