TWN Info Service on Intellectual Property Issues (Nov07/03)

16 November 2007


WHO WORKING GROUP ON IPR AND INNOVATION FINISHES WEEK OF WORK, TO MEET AGAIN IN APRIL 2008
Published in SUNS #6364 dated 13 November 2007
Reproduction requires permission of SUNS (sunstwn@bluewin.ch)
By Riaz K. Tayob (TWN), Geneva, 11 Nov 2007

Member governments of the World Health Organization ended Saturday a week of intensive negotiations on a global strategy and plan of action to improve access to health care in developing countries, in particular, health research and development on diseases disproportionately affecting developing countries.

The negotiations at the WHO Intergovernmental Working Group (IGWG) on Public Health, Innovation and Intellectual Property Rights, chaired by Peter Oldham of Canada, were suspended on 10 November evening to resume again at a meeting tentatively set for 28 April to 3 May 2008. The dates are to be confirmed by the bureau of the IGWG.

At the six-day talks, the negotiators are reported to have made some progress in a few areas, but with considerable and difficult negotiations ahead to agree and draw up "a global strategy and plan of action" to provide a medium framework based on the recommendations of the WHO Commission on Public Health, Innovation and Intellectual Property Rights. The strategy and plan of action are to aim at among others an enhanced and sustainable basis for essential health research and development on diseases that disproportionately affect developing countries. Clear objectives and priorities for research and development in this area are to be set, and funding needs estimated.

The draft being negotiated includes texts on aim, focus and principles; and on elements to prioritize and promote R&D, building innovative capacity, transfer of technology, management of IP, improving delivery and access, financing mechanisms, and monitoring and reporting systems. The Plan of Action, based on the Global Strategy, includes specific actions, stakeholders and indicators.

The negotiations were conducted in two drafting groups, the first Group A chaired by Dr. Viroj Tangcharoensanthien of Thailand, and Group B, chaired by Mr. N. Dayal of India.

On Saturday, Oldham proposed to the Committee of the Whole, that the working group session be suspended to resume before the meeting of the World Health Assembly next year. The tentative dates for the working group are set at 28 April to 3 May. The IGWG has been mandated to provide a draft Global Strategy and Plan of Action to the 2008 WHA.

The secretariat, in consultation with the bureau, is to prepare a progress report for the Executive Board (21-26 January 2008). The secretariat is to prepare and issue (for the next meeting of the IGWG) a document on the work so far - clearly indicating language that is agreed, bracketed texts (parts discussed but where no agreement has been reached as yet), and the parts of the texts yet to be discussed. Members will have time till end January to comment on the parts not yet discussed, and the secretariat will issue a paper with these comments. There will also be an open-ended meeting of the sub-drafting group on elements one and two of the Plan of Action (prioritizing R&D, and promoting R&D), immediately after the January meeting of the Executive Board.

While member states are invited to make comments before end January on texts not yet discussed, no comments are to be made on texts discussed, but without reaching consensus. At the next meeting, the texts not yet agreed are to be discussed, but no new texts can be introduced on them.

A Conference Paper issued on 10 November (to be finalised and revised by the secretariat, taking account of the discussions on 11 November) shows that Members have been unable to agree upon the aims of the Global Strategy. Though members had not proposed any limitations, the secretariat document of 31 July, limited the focus to 14 diseases. This part is marked (but not agreed yet) for deletion, pending consensus.

There is consensus on the aim and strategy to promote R&D, focussing on type II and type III diseases, and specific needs of developing countries in respect of type I diseases - those that are incident in rich and poor countries, and with large numbers of vulnerable populations in each, Type II diseases are those in both rich and poor countries, but with a majority of cases in poor countries - often termed neglected diseases, like tuberculosis. Type III are those diseases overwhelmingly or exclusively incident in developing countries, and termed very neglected diseases. (See SUNS #6360 dated 7 November 2007.)

There is lack of consensus on supporting the application and management of intellectual property that maximises health-related innovation, protects public health and promotes access to "health products" or "medicines." Divergences exist on the use of the terms "health products" or "medicines." There are also divergences on support to explore and implement "innovative" or "alternative" incentive schemes for R&D "to complement the existing ones." The US is reportedly against suggestions that the current incentive system is inappropriate.

Similarly, there is consensus except from the US, regarding the development of proposals for health-needs driven R&D to include a range of incentive mechanisms and a method for tailoring the "optimal mix of incentives" to a particular condition or product for addressing diseases that disproportionately affect developing countries.

Under Principles, there is consensus that, intellectual property rights are an important incentive in the development of new health care products. However, this incentive alone does not meet the need for the development of new products where the potential market for the sale of the products is small or uncertain.

Two alternate principles are also pending further discussion. The Rio Text Group (a group of 14 Latin American countries) has proposed that "right to health takes precedence over commercial interests"; this is posed as an alternative to the "objectives of public health and the interests of trade should be appropriately balanced and coordinated."

Under element one, prioritising research and development needs, there is consensus to map and identify gaps in research and development on diseases that disproportionately affect developing countries. Developing countries are also to set research priorities on traditional medicine.

Under element two, promoting research and development, there is no consensus on whether developed countries "shall allocate a progressive percentage of its budget" or an "appropriate proportion" of their health R&D to the health needs of developing countries. There is also contention on whether there should be facilitation of upstream research; the identification of intellectual property provisions that might negatively affect increased research on public health; the creation of open databases and compound libraries; and consideration and assistance of the use of research exemptions in legislations of developing countries to address public health needs.

There is consensus that there should be support for national health research programmes in developing countries through political action and "where feasible and appropriate, long term funding." There is also encouragement for further exploratory discussions on the utility of possible instruments or mechanisms for essential health and biomedical R&D including an essential health and biomedical R&D treaty.

Regarding element three, building and improving innovative capacity, there is no consensus to urge member states to mitigate the adverse impact of the loss of health personnel through migration; strengthen clinical trials and regulatory infrastructure in developing countries particularly in sub-Saharan Africa; promote protection and documentation of traditional knowledge and natural genetic resources in an international sui generis framework; and, encourage and promote national and international policies on traditional medicine to facilitate prior art for patent regimes and disclosure and benefit sharing. There is consensus to strengthen health surveillance and information systems, ethical reviews in R&D, and regulatory capacity in developing countries.

Under element four, transfer of technology, there is no consensus to devise a list of essential technologies related to research and local production; encourage/promote the dissemination of health-related technology information contained in patents, patent applications and information related to patent status, oppositions, revocations and nullifications; make arrangement to support technology transfer from the North to the South; and, consider additional or voluntary and complementary or alternative mechanisms to promote innovation. There is consensus to encourage North-South and South-South cooperation and to continue to promote technology transfer to least developed countries consistent with Article 66.2 of the WTO TRIPS agreement.

Under element five, Management of Intellectual Property, there is agreement that incentive schemes for R&D into type II and type III diseases need to be explored, and where appropriate type I. However, there is no consensus on many of the elements discussed thus far including support for the application and management of intellectual property that maximises health-related innovation to meet the R&D needs of developing countries, and, the compilation and maintenance of global databases on the status of health patents.

Discussions are to continue in the reconvened session. The proposal to promote and support national and regional institutional frameworks and international cooperation to build and strengthen capacity to manage and apply intellectual property in a manner orientated to public health needs and priorities of developing countries, is pending consensus from the US.

Regarding element 7, promoting sustainable financing mechanisms, there is no consensus on the establishment of a task force to examine current financing, coordination and prioritisation of R&D; devising and setting up sustainable sources of funding; or, the establishment of a global R&D fund. Element 8, on monitoring and reporting systems envisages the establishment of systems to monitor performance and progress of the implementation of each element of the Global Strategy and Plan of Action and to report periodically to the WHO governing bodies. A progress report will be submitted every two years and a comprehensive evaluation of the strategy will be undertaken after four years.

At the closing session, WHO Director General, Margaret Chan, expressed WHO's and her personal commitment to move forward in areas where "we have mandates and the organisation is gearing to do more."

Kenya, for the 46 member states of the AFRO region, said that current systems have failed to meet the needs of the poor and that type II and III diseases are not given attention. It expressed the hope that no one will put brackets around this.

The current proprietary regimes results in major problems in Africa and the Working Group must provide leadership, Kenya said. Avoiding the real problems will not bring a solution. To achieve results, "we must have a clear funding mechanism; this is the cement that will hold the structure together."

Kenya assured the constructive role of Africa and urged others to negotiations with a view to provide a solution through the spirit of flexibilities to save lives and reduce suffering. It requested that AFRO members receive the documentation for Working Group meetings well in advance. In addition, Kenya looked to the Secretariat to provide for the participation of African delegations so that it is not disorganised, particularly, as relates to travel arrangements.

Honduras, on behalf of the Group of Latin American and Caribbean Countries, reiterated what Brazil had said regarding the follow-up process. Honduras emphasised that the further discussions must take into account the (health) situation of countries and their level of development.

Libya, for the EMRO region, stressed that the main objective was to find solutions and hoped there would be solid cooperation through transfer of technology and exchange of experiences in order to produce medicines that are available to all.

Oldham, in some personal comments, hoped that there would be no reversal at the next meeting of the progress achieved so far.

Brazil said after the meeting that it takes a great amount of effort to change a culture of monopoly and the concentration of power. Progress has been painfully slow but WHO has shown itself to be more engaged. It said the shortcomings of the intellectual property system go to the heart of delivery and that the in-depth discussion would enrich the WHO.

The United States, backed by the EU, expressed concern that some parts of the Conference paper, that have been merged and marked as consensus, was not acceptable to the US, and wanted a review to accurately reflect the discussions.