Submission: South Centre
This submission explains how a binding international instrument/convention/treaty on medical product R&D to be negotiated under the auspices of the UN, can address the misalignment between the pharmaceuticals R&D model under the present trade rules and public health, in order to promote more effective and less costly innovation and increase access to medicines.
A fundamental public health challenge that must be addressed to achieve the health related sustainable development goals and targets is that the current incentive model for pharmaceutical research and development (R&D) has failed to incentivize R&D for new medicines to treat a number of diseases that do not offer substantially profitable markets. Several reports and studies, as well as the WHO Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property (GSPOA) adopted by WHO Members States (2003-2008) have acknowledged this problem. On one hand, there is little investment in R&D in relation to diseases that are prevalent in developing countries, since major pharmaceutical companies concentrate on the development of products to satisfy the demand of wealthy markets. On the other hand, products that are subject to patents and other forms of exclusive rights are normally sold at prices that are out of reach for large sectors of the population.
The failure of the current incentive model to provide needed medicines, especially in southern countries, calls for urgent action. Today, in the 21st century, communicable diseases still kill more than 10 million people every year, 90% of whom live in developing countries. One-third of the global population does not have regular access to needed medicines. This situation is worsened in Least Developed Countries (LDCs) where up to 50% of the population does not have access to necessary medicines. At the same time, the context for tackling the problem of access to pharmaceutical products is changing. Developing countries – including India, the largest provider of generic medicines – are now implementing the WTO’s agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) with respect to the patentability of pharmaceutical products. As a result, the proportion of drugs that is being protected by patents is on the increase and it is expected that this will imply higher prices.
Ten years ago, the report of the Commission on Intellectual Property Rights, Innovation and Public Health (known as the CIPIH Report), 2006, submitted to the WHO, recognized that intellectual property rights incentives were not meeting the needs for the development of new products to fight diseases in countries where “the potential paying market is small or uncertain”. The CIPIH Report also recognized “the need for an international mechanism to increase global coordination and financing of R&D medications”, and recommended that work toward the adoption of an R&D treaty should continue “in order to develop these ideas, in a way that governments and other people in charge of the formulation of policies can make a decision based on it”.
In April 2012, the WHO Consultative Expert Working Group (CEWG) on R&D Financing and Coordination recommended the WHO member States to start negotiations on a binding international instrument on health R&D under article 19 of the WHO Constitution, as the best way to create an appropriate framework to ensure priority setting, coordination, and sustainable financing of affordable medicines for developing countries. The CEWG stated that “… a binding instrument on R&D is necessary to secure appropriate funding and coordination to promote R&D that is needed to address the diseases that disproportionately affect developing countries.” The CEWG recommendation was made after considering a number of proposals that recommended the conclusion of a binding R&D treaty, including a proposal by Bangladesh, Barbados, Bolivia and Suriname for WHO discussions on a biomedical R&D treaty.
However, this recommendation of the CEWG has still not been adequately considered by the WHO member States owing to political opposition from developed countries to the idea of an alternative R&D mechanism. The work in the WHO has been limited to undertaking some specific R&D demonstration projects which have failed to generate sustainable financial resources.
The problems that are faced in this field cannot be resolved only by means of improvements on or adaptations to the existing incentive-based model. IP does not produce the innovation necessary to address the public health needs in developing countries, and the CIPIH Report recognized that this problem can, in fact, affect developed countries, as is now the case for the new medications for Hepatitis C:
“This is an important issue, because even in developed countries, the rapidly rising cost of health care, including drug delivery, is of great public concern. In developing countries, and even in some developed countries, the cost of drugs, which often cannot be acquired through the public health care systems, can be a matter of life or death.”
Therefore, new mechanisms are needed in order to simultaneously and effectively promote innovation and access to medicines, particularly for diseases that mainly affect developing countries.
After the call for a global pharmaceutical R&D (GSPOA and CEWG), there have been numerous initiatives and policy processes related to global health innovation. In addition, there are ongoing efforts through product development partnerships (PDP’s) to step up R&D for neglected diseases. There is a major risk that the multiplication of such proposed R&D frameworks could lead to further duplication and fragmentation and lack of consistent application of the CEWG principles that R&D mechanisms must be based on – affordability, effectiveness, efficiency and equity.
Elements of a binding international instrument on R&D for medical products
A binding international instrument or international treaty on R&D can be negotiated under the auspices of the UN to provide an adequate framework to define medical R&D priorities and ensure the coordination and sustainable financing of R&D on drugs that could be made available at affordable prices.
The conclusion of a binding R&D instrument under the UN will contribute to the realization of the Sustainable Development Goals (SDGs), and particularly the health related SDG Goal 3 and Targets 3.8 and 3.b which states:
SDG Target 3.8 - Achieve universal health coverage, including financial risk protection, access to quality essential health-care services and access to safe, effective, quality and affordable essential medicines and vaccines for all.
SDG Target 3.b - Support the research and development of vaccines and medicines for the communicable and non-communicable diseases that primarily affect developing countries, provide access to affordable essential medicines and vaccines, in accordance with the Doha Declaration on the TRIPS Agreement and Public Health, which affirms the right of developing countries to use to the full the provisions in the Agreement on Trade-Related Aspects of Intellectual Property Rights regarding flexibilities to protect public health, and, in particular, provide access to medicines for all.
A binding international R&D instrument under the UN would provide a global framework for financing R&D in a way that delinks costs from prices for new medical products, and for improved coordination to avoid the fragmentation of medical R&D efforts.
A global instrument on R&D of medical products negotiated at the UN could have the following specific objectives:
(i) To promote R&D for all diseases, conditions and problems (including non-communicable diseases), while prioritizing those for which there is little R&D investment such as neglected diseases that disproportionately affect developing countries;
(ii) To set priorities for R&D on the basis of the global disease burden;
(iii) To provide alternative incentives to the intellectual property systems for the engagement of private and public actors involved in R&D based on public health needs rather than market expectations
(iv) To develop sustainable financing mechanisms including pooled financing to increase available resources for R&D;
(v) To promote coordination of R&D and make better use of existing R&D capacities of the private and the public sector in both developing and developed countries;
(vi) To build R&D capacity in developing countries
(vii) To promote greater transparency in the costs of R&D and sharing of data and information, particularly in early research and clinical trial stages.
(viii) To establish ethical criteria and financial mechanisms for conducting clinical trials with full disclosure of test data
(ix) To promote that the results of R & D are in the public domain or otherwise accessible to all populations.
Though the proposed binding international legal instrument on biomedical R&D pursues public health objectives, the establishment of an alternative mechanism for medical R&D will have to necessarily involve multiple government agencies besides ministries of health, such as finance, trade, science and technology, and industry. As this proposed instrument would address a diverse range of government agencies and also a number of the SDGs, it is submitted that it will fall within the ambit of the UN to negotiate a binding international legal framework or convention on biomedical R&D.
Therefore, it is submitted that the High Level Panel should recommend that negotiations be undertaken for a UN Convention on Coordination and Financing of Biomedical Research and Development.
Bibliography and Refernces
Velásquez G et Seuba X “Rethinking global health: A binding convention for R&D for pharmaceutical products” Research papers 42 ; South Center ; Dec. 2011
WHO and HAI “Measuring medicine prices, availability, affordability and price components” second edition (2008).
Gehl Sampath P. “India's product patent protection regime: less or more of ‘pills for the poor’?” The Journal of World Intellectual Property 2006 ; 9 (6): 694 – 726.
WHO, Report of the Consultative Expert Working Group on Research and Development: Financing and Coordination, 2012, http://www.who.int/phi/CEWG_Report_5_April_2012.pdf?ua=1
WHO, CIPIH Report, 2006
United Nations treaty collection, https://treaties.un.org/Pages/overview.aspx?path=overview/definition/page1_en.xml#introduction
World Health Organization “Global strategy and plan of action on public health, innovation and intellectual-property” WHA Resolution 61.21 (May 24, 2008).
List of submissions made to the WHO CEWG, http://www.who.int/phi/news/cewg_submissions/en/