|
Background
Despite enormous progress in the prevention, diagnosis and treatment of diseases, developing countries still remain largely excluded from the benefits of modern science. Caught in a cycle of poverty and disease, people in the hardest-hit countries are facing shorter life expectancies and economic decline. The issue of better access to healthcare products for poor populations has been the subject of many World Health Assembly resolutions. In May 2006, Member States asked the WHO to establish an Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG).
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 Secretariat for Public Health, Innovation and Intellectual Property was established in September 2006 to facilitate the functioning of the IGWG. The Working Group, composed of WHO Member States, held its first session on December 4-8, 2006, in Geneva. The Working group has so far completed two sittings. During the previous meetings, countries had submitted their versions of the draft text, which have been assimilated into the present text for further discussion. The IGWG is going to meet in again April.
In this context, Centad held an informal consultation on the Draft Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property that was adopted on December 14, 2007, by the Intergovernmental Working Group (IGWG) on Public Health, Innovation and Intellectual Property of the WHO. The meeting had representation from individuals who were part of the Indian delegation at IGWG, WHO (India) and WHO SEARO as well as from public health groups. The objective of the consultation was to help in aiding the Government of India to build a consensus on the Indian position on the IGWG Draft of December 14, 2007.
The draft text of the Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property lays down the strategy agreed upon by States to achieve the objectives of the IGWG. This strategy comprises the following 8 elements for promoting innovation, building capacity, improving access and mobilising resources for the same:
- Prioritising R&D needs
- Promoting R&D
- Building and improving innovative capacity
- Transfer of technology
- Application and management of IPRs to contribute to innovation and promote public health
- Improving delivery and access
- Promoting sustainable financing mechanisms
- Establishing monitoring and reporting systems
Presentation of Current State of Play
The discussion was led by an update from a member of the Indian delegation on IGWG on the current state of play in IGWG. It was pointed out that the present text has more or less incorporated the recommendations given by the Commission on Intellectual Property Rights, Innovation and Public Health (CIPIH). During the previous meeting, the Brazilian delegation had made a voluminous submission and insisted that all its terms be negotiated.
It was pointed out that a primary issue of concern for the developing countries with regard to the IGWG draft text relates to access to medicines. Among the other contentious issues from the perspective of the developing countries is the inclusion of the concept of intellectual property management in element 5 of the draft text. While the developing countries do not want to include the concept of IP management within in the text, they have highlighted the importance of including all TRIPS flexibilities in this element.
With regard to transfer of technology (element 4) it was pointed out that among the upstream and downstream technologies present, the developing countries are yet to decide on the nature of technology that will be beneficial to them. The developed countries, on the other hand, are willing to agree on the transfer of downstream technology rather than of upstream technology. Therefore, the terms of transfer of technology to the developing countries are crucial.
It was pointed out that with respect to element 1, the standards to be adopted for prioritising R&D in traditional medicines are very important for developing countries and the same must be explored further.
The draft text categorises diseases into Type I, Type II and Type III diseases. Type I diseases are those that are increasingly prevalent in developing countries (eg, diabetes, cardiovascular diseases and cancer). Type II diseases are prevalent in both rich and poor countries with a substantial proportion in poor countries (HIV/AIDS, TB). And Type III diseases are those that are overwhelmingly or exclusively incident in developing countries (9 diseases including malaria, dengue, leprosy, etc). The developed countries were silent on this issue. The developing countries were, however, divided with the Asian and African countries on one side and the Latin American countries on the other, as the latter felt that the list neglected the diseases that were of concern to them.
Major thrust from the developing countries was on access rather than innovation. The text spoke more about the innovation relating to drugs rather than on access to medicine. However, the Latin American countries had submitted that in Type I diseases, the concern is on access, and in Type II & III, the concern is of both access and innovation. It was pointed out that India has suggested to have an open-ended list of diseases to which each country can make additions as per their need.
It was agreed that access to medicines can be addressed through the operationalisation of Type I & II. The concern of the Asian and the African countries is that if all the diseases were in Type I or II then the proposed fund may be misused for small innovations alone.
Discussion
In the discussion that followed the presentation on State of Play, the following points were highlighted:
• Some drugs will not be designed to meet the needs of the developing countries. It was stated that the proposed price fund (element 7) can be used to focus on development of standards for the developing countries.
• It is to be kept in mind that most of the medicines are old and new strains of many diseases have developed a resistance to them. This calls for research to be made in these areas and inclusion of diseases has to be left to the country interest while keeping it open-ended.
• It was asked whether under the proposed R&D treaty, research would have to be centralised. It was pointed out, there is no need to ratify this text as a treaty since the US is not going to invest on research for diseases like malaria as they are not of concern to them. This is going to be the stand taken by others as there would be no money invested for research in them. The WHO has to work out how to resolve this. Regarding the price fund it was mentioned that every country in the region has to pool in money and the group has to use that money for research and for providing infrastructure. This needs to be done as we cannot match the infrastructure available in R&D as compared to the MNCs.
• Opinion was raised that in the present text, IPR is not merely an issue confined to element 5 but is spread all through the text. Intellectual property includes not only medicine but health products. The Latin American, Asia Pacific countries also adopted these languages in the present text. It was also pointed out that the text has relied on the CIPIH language for data protection.
• The proposal in element 7 to set up a price fund (global R&D Fund) was also viewed with some concern in terms of how it will be operationalised. It was suggested that a range of alternative mechanisms should be identified to regulate the fund, such as, advance purchase commitments, ASEAN technology on open source research, non-exclusive licensing, public-private partnership, etc. With regard the proposal to use the price fund for buying out-patents, it was pointed out that buying out patents in themselves will not necessarily lead to drug development and also there will be the problem of identifying which patents should be bought off.
It was agreed by the discussants that the IGWG text that is finally adopted should be based on the CIPIH recommendations and the final text should not make developing countries like India concede more than what has been conceded under the patent system.
The house also proposed that in the lead up to the next IGWG meeting, the draft text should be disseminated to obtain comments from experts in India which may help further clarify and strengthen India's position on the IGWG text.
|
