WHA establishes working group on IPRs and health R&D

After a negotiating process that lasted many days and that was closely watched by dozens of health and development NGOs, the World Health Assembly adopted a resolution on 27 May that established a working group to come up with a global strategy on intellectual property, health research and development, and new medicines for diseases that especially affect developing countries.

The resolution was seen by many as the biggest achievement of this year's WHA, and was hailed by many public interest groups that had supported the developing countries, led by Kenya and Brazil, that had first advocated the resolution.

The resolution follows up on the report of the WHO Commission on IPRs, Innovation and Public Health that had been completed in April. That report in turn was the result of growing public concern that the patent system had hindered access of patients to affordable medicines.

Many developing countries, NGOs and health professionals and researchers have also in recent years raised concerns that much of the research and innovation in health was being motivated by corporate objectives to obtain profits.

As a result, most of the new medicines and other health care products being produced was catering to patients in developed countries, while little research was being done towards new medicines to meet the needs of developing countries.

A movement developed to have the WHO look into new systems of incentives towards research and development for health care products needed by developing countries. Such systems could complement or be alternatives to the current patent system.

The two streams (those concerned about innovation for new medicines, and those concerned about access to medicines) merged into the movement for a global framework or strategy that would lead to R&D appropriate for health needs in developing countries, and access to the results of the products.

The WHA resolution on "Public health, innovation, essential health research and IPRs: towards a global strategy and plan of action" is the result of this movement.

In the operational (or action) part of the resolution, the WHA notes that the report of the Commission on IPRs, Innovation and Public Health requests that WHO should prepare a global plan of action to secure enhanced and sustainable funding for developing and making accessible products to address diseases that disproportionately affect developing countries.

The resolution welcomes the report and urges Member States:

-- to make global health and medicines a priority sector, to take determined action to emphasize priorities in research and development addressed to the needs of patients, especially those in resource-poor settings, and to harness collaborative research and development initiatives involving disease-endemic countries;

-- to consider the recommendations of the report and to contribute actively to the development of a global strategy and plan of action, and to take an active part in providing support for essential medical research and development;

-- to work to ensure that progress in basic science and bio-medicine is translated into improved, safe and affordable health products - drugs, vaccines and diagnostics - to respond to all patients' and clients' needs and to ensure that capacity is strengthened to support rapid delivery of essential medicines to people;

-- to encourage trade agreements to take into account the flexibilities contained in the TRIPS Agreement and recognized by the Doha Ministerial Declaration on the TRIPS Agreement and Public Health;

-- to ensure that the Commission's report is included on the agendas of WHO's regional committees in 2006.

The resolution decides:

-- to establish, in accordance with Rule 42 of the Rules of Procedure of the World Health Assembly, an intergovernmental working group open to all interested Member States to draw up a global strategy and plan of action in order to provide a medium-term framework based on the recommendations of the Commission. Such a strategy and plan of action aims at, inter alia, securing an enhanced and sustainable basis for needs-driven, essential health research and development relevant to diseases that disproportionately affect developing countries, proposing clear objectives and priorities for research and development, and estimating funding needs in this area.

-- That regional economic integration organisations constituted by sovereign States, Members of WHO, to which their Member States have transferred competence over matters governed by this resolution, including the competence to enter into international legally binding regulations, may participate, in the work of the working group.

-- that the working group shall report to the Sixtieth World Health Assembly through the Executive Board on the progress made, giving particular attention to needs-driven research and other potential areas for early implementation action.

-- that the working group shall submit the final global strategy and plan of action to the Sixty-first World Health Assembly through the Executive Board;

The resolution also requests the Director-General:

-- to convene immediately the intergovernmental working group and to allocate the necessary resources to it;

-- to invite, as observers at the sessions of the intergovernmental working group, representatives of non-Member States, of liberation movements referred to in resolution WHA27.37, of organizations of the United Nations system, of intergovernmental organizations with which WHO has established effective relations, and of non-governmental organizations in official relations with WHO, who shall attend the sessions of the working group in accordance with the relevant Rules of Procedure and resolutions of the Health Assembly;

-- to invite experts and a limited number of concerned public and private entities to attend the sessions of the intergovernmental working group and to provide advice and expertise, as necessary, upon request of the Chair, taking into account the need to avoid conflicts of interest;

-- to continue to issue public health-based research and development reports, identifying from a public health perspective, gaps and needs related to pharmaceuticals, and to report on them periodically;

-- to continue to monitor, from a public health perspective, in consultation as appropriate with other international organizations, the impact of intellectual property rights and other issues addressed in the Commission's report, on the development of, and access to, health care products, and report thereon to the Health Assembly.

In the preamble, the resolution noted the following, among others.

-- The growing burden of diseases and conditions disproportionately affecting developing countries, including an upsurge in noncommunicable diseases;

-- The need to continue to develop safe and affordable new products for such communicable diseases as AIDS, malaria and tuberculosis, and for other diseases or illnesses disproportionately affecting developing countries;

-- The opportunities opened up by advances in biomedical science, and the need to harness them more effectively to develop new products;

-- Considerable progress in funding initiatives to develop new products to fight diseases affecting developing countries, and to increase access to existing ones; but recognizing, however, that much more needs to be done in relation to the scale of avoidable suffering and mortality;

-- Concern about the need for appropriate, effective and safe health tools for patients living in resource-poor settings;

-- The urgency of developing new products to address emerging health threats such as multi-drug-resistant tuberculosis, and other infectious diseases of particular relevance to developing countries;

-- The need for additional funding for research and development for new vaccines, diagnostics and pharmaceuticals, including microbicides, for illnesses, including AIDS, that disproportionately affect developing countries;

-- The importance of public/private partnerships devoted to the development of new essential drugs and research tools, and the need for governments to set a needs-based priority agenda for health, and to provide political support and sustainable sources of funding for such initiatives;

-- The importance of public and private investment in the development of new medical technologies;

-- A number of developing countries have been strengthening their research and development capacity in new health technologies, and that their role will be increasingly critical, and recognizing the need for continued support for research in and by developing countries;

-- Intellectual property rights are an important incentive for the development of new health-care products; however, this incentive alone does not meet the need for the development of new products to fight diseases where the potential paying market is small or uncertain;

-- The Doha Ministerial Declaration on the TRIPS Agreement and Public Health confirms that the Agreement does not and should not prevent Members from taking measures to protect public health; The Declaration, while reiterating commitment to the TRIPS Agreement affirms that the Agreement can and should be interpreted and implemented in a manner supportive of the rights of WTO Members to protect public health and, in particular, to promote access to medicines for all;

-- The need to take into account Article 7 of the TRIPS agreement that states that "the protection and enforcement of intellectual property rights should contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations";

-- The Universal Declaration of Human Rights provides that "everyone has the right freely to participate in the cultural life of the community, to enjoy the arts and to share in scientific advancement and its benefits" and that "everyone has the right to the protection of the moral and material interests resulting from any scientific, literary or artistic production of which he is the author";

-- Concerns about the impact of high prices of medicines on access to treatment;

-- The need to promote new thinking on the mechanisms that support innovation;

-- The importance of strengthening capacity of local public institutions and businesses in developing countries to contribute to and participate in R&D efforts.