REGIONAL COMMITTEE
Provisional Agenda item 4.7.4
Sixty-sixth Session SEARO, New Delhi, India 10–13 September 2013
SEA/RC66/16 30 July 2013
Progress reports on selected Regional Committee resolutions: Consultative Expert Working Group on Research and Development: Financing and Coordination (SEA/RC65/R3) Resolution SEA/RC65/R3 has outlined detailed recommendations and action points for Member States and WHO on the follow-up of the Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG). The background to the resolution is as follows: the CEWG presented its report to the Sixty-fifth World Health Assembly in May 2012. This report made a number of proposals for new and innovative sources of financing to stimulate research and development (R&D) related to Type II and Type III diseases, and the specific R&D needs of developing countries in relation to Type I diseases. By resolution WHA65.22, Member States resolved to hold consultations at the national level among all relevant stakeholders, as well as in each of the six WHO regional committee meetings scheduled for 2012. They also resolved to hold an open-ended meeting of Member States at WHO headquarters, Geneva to develop consensus. Pursuant to this, Member States of the WHO South-East Asia Region held consultations at national levels and participated in a Regional Technical Consultation from 15 to 17 August 2012 in Bangkok, Thailand, organized by the Regional Office for South-East Asia to develop a regional perspective on the CEWG report. This regional position was reflected in resolution SEA/RC65/R3 at the WHO Regional Committee for South-East Asia held in Yogyakarta, Indonesia, from 5 to 7 September 2012. This resolution also provided the basis for the draft resolution during the open-ended meeting of all WHO Member States, held from 26 to 28 November 2012 in Geneva which led to resolution WHA66.22 this year. The regional resolution and WHA66.22, inter alia, urge Member States and WHO to strengthen health R&D capacities and investments for diseases that disproportionately affect developing countries. The resolutions also request WHO to establish a global health R&D observatory to monitor and analyse relevant information on health R&D as well as to promote advisory mechanisms. Resolution WHA66.22 calls for specific actions through a
strategic workplan to improve monitoring and coordination, and to ensure sustainable funding for health R&D (in line with WHA61.21, Global strategy and plan of action on public health, innovation and intellectual property) and identify projects as a step towards achieving the goal of development and the delivery of affordable, effective, safe and highquality health products. To take SEA/RC65/R3 and WHA66.22 forward, the Regional Office organized a "Regional consultation for developing a strategic workplan as a follow-up of the Consultative Expert Working Group on Research and Development: Financing and Coordination” from 25 to 26 July 2013 in Bangkok, Thailand. This meeting enabled discussions on the next steps on both these resolutions and for prioritizing activities for the Region (executive summary is included as an Annex). The High-Level Preparatory (HLP) Meeting held in the Regional Office in New Delhi, India, from 1 to 3 July 2013 reviewed the attached working paper and made the following recommendations: Actions by Member States (1) To engage in developing a strategic workplan for the Region as a follow-up of the Consultative Expert Working Group on Research and Development: Financing and Coordination. To explore mechanisms for promoting and strengthening health research and development, including coordination, monitoring and capacity building.
(2)
Actions by WHO-SEARO (1) (2) (3) (4) To assist countries in promoting and in exploring mechanisms for strengthening health research and development including coordination, monitoring and capacity building. To include in the working paper for presentation to the Sixty-sixth Regional Committee the outcomes of the Regional Technical Consultation (July 2013). To assist in prioritizing projects, as part of the strategic workplan, through regional consultations and broad engagement of relevant stakeholders. To explore information sharing mechanisms in respect of health R&D to enable identification of gaps in countries, including employing the global health R&D observatory for this purpose.
The working paper and the HLP recommendations, along with an executive summary of the "Regional consultation for developing a strategic workplan as a follow-up of the Consultative Expert Working Group on Research and Development: Financing and Coordination" are submitted to the Sixty-sixth Session of the Regional Committee for its consideration.
SEA/RC66/16
Introduction 1. The Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG) set up by the Sixty-fifth World Health Assembly submitted its report in May 2012. The CEWG was established by resolution WHA63.28 to take forward and deepen the analysis of the work of an earlier expert working group. 2. The events leading to the formation of the CEWG are related to the independent Commission on Intellectual Property Rights, Innovation and Public Health (CIPIH), set up in pursuance of WHA56.27. The CIPIH report made important observations on the status of innovation, intellectual property rights and the pharmaceutical industry. In 2006, based on the recommendations of the CIPIH, resolution WHA59.24 established … “an intergovernmental working group (IGWG) … to draw up a global strategy and plan of action (GSPA)”. The GSPA (WHA61.21) identified several deliverables on public health, innovation and intellectual property to promote innovation, transfer of technology and access to medicines for public health. Across eight elements, 25 sub-elements and 108 specific actions, the GSPA developed an action plan. The CEWG was established under element seven to promote sustainable financing mechanisms to stimulate R&D needed by developing countries for health products for Type I, II and III diseases.1
Recommendations of CEWG 3. The CEWG recommended a coordination function under the auspices of WHO that would include: (1) a global health R&D observatory – this would need to collect and analyse data, including the areas of financial flows to R&D and the R&D pipeline; and (2) advisory mechanisms – a network of research institutions and funders that may include specialized sections according to the subject of research (e.g. type of disease), based on an electronic platform supported by WHO, and which may provide inputs to an advisory committee that could be based on the current Advisory Committee on Health Research mechanism.
1
Type I diseases are incident in both rich and poor countries, with large numbers of vulnerable populations in each. Examples of communicable diseases include measles, hepatitis B, and haemophilus influenzae type b, and examples of noncommunicable diseases abound (e.g. diabetes, cardiovascular diseases and tobacco-related illnesses). Many vaccines for Type I diseases have been developed in the past 20 years but have not been widely introduced into the poor countries because of cost. Type II diseases are incident in both rich and poor countries, but with a substantial proportion of the cases in the poor countries. HIV/AIDS and tuberculosis are examples: both diseases are present in both rich and poor countries, but more than 90% of cases are in the poor countries. Type III diseases are those that are overwhelmingly or exclusively incident in the developing countries, such as African sleeping sickness (trypanosomiasis) and African river blindness (onchocerciasis). Such diseases receive extremely little R&D, and essentially no commercially-based R&D in the rich countries. When new technologies are developed, they are usually serendipitous, as when a veterinary medicine developed by Merck (ivermectin) proved to be effective in control of onchocerciasis in humans. Type II diseases are often termed neglected diseases and Type III diseases very neglected diseases (CIPIH p. 13).
SEA/RC66/16 Page 2
4. The CEWG suggested a framework for negotiation of an R&D convention with the objectives of, inter alia:
promoting R&D to develop new health technologies for developing countries and securing access through delinking R&D costs and the prices of the products; securing sustainable funding to address R&D priorities in developing countries; improving the coordination of public and private R&D, enhancing the innovative capacity in developing countries and technology transfer to these countries.
5. The CEWG outlined the need for securing sustainable financing and recommended that all countries commit a certain percentage of gross domestic product (GDP) to government-funded R&D.
Action taken by Member States 6. In May 2012, by resolution WHA65.22, Member States resolved: to hold consultations at national level among all relevant stakeholders; to discuss the CEWG report in each of the six WHO regional committee meetings scheduled in 2012 (in the light of GSPA, of which the CEWG is a part); and to hold an open-ended meeting of Member States at WHO headquarters to develop consensus. 7. Pursuant to this, Member States of the South-East Asia Region held consultations at national level and participated in a Regional Technical Consultation in Bangkok, Thailand, from 15 to 17 August 2012, organized by the WHO Regional Office for South-East Asia to develop regional perspectives on the CEWG report. This regional position was reflected in the WHO Regional Committee for South-East Asia held in Yogyakarta, Indonesia from 5 to 7 September 2012. Resolution SEA/RC65/R3 was adopted, with detailed recommendations and action points for Member States and WHO. These include, inter alia: promoting and strengthening R&D capacities; promoting coordination of R&D; establishing or strengthening health R&D observatories; and promoting partnerships and exploring funding for health R&D. It may also be noted that the Sixty-fifth Session of the Regional Committee for South-East Asia preceded the regional committee meetings of the other WHO regions; as a result, the South-East Asia Regional Resolution on CEWG was discussed in each of the five other WHO regional committee meetings. The resolution also provided the basis for preparing a draft resolution during the openended meeting of Member States, held from 26 to 28 November 2012 in Geneva. 8. While CEWG recommended a binding convention for health R&D under Article 19 of the WHO Constitution and identified the need to secure sustainable financing through a commitment by all countries for a certain percentage of GDP to government-funded R&D, the discussions in the open-ended meeting of Member States fell short of making these commitments.
SEA/RC66/16 Page 3
Outcome on CEWG at the Sixty-sixth World Health Assembly 9. In May 2013, Member States agreed to a coordination function under the auspices of WHO that would include: (1) a global health R&D observatory to collect and analyse data, including the areas of financial flows to R&D; and (2) advisory mechanisms: a network of research institutions and funders that may include specialized sections according to the subject of research. The resolution stressed the need for capacity building and technology transfer to developing countries, the need to promote partnerships and collaborations, and the need for priority setting related to developing country health needs and national plans for essential health research. The resolution calls for specific actions by Member States and WHO and the implementation of a few health R&D demonstration projects to address research gaps that disproportionately affect developing countries. It calls for a strategic workplan to improve monitoring and coordination, and to ensure sustainable funding for health R&D (in line with the GSPA), as a step to achieve the goal of development and delivery of affordable, effective, safe and high-quality health products. The World Health Assembly also decided to convene a technical consultative meeting in 2013 to assist in the identification of demonstration projects.
Action for WHO Regional Office for South-East Asia 10. For the South-East Asia Region, the next steps relate to SEA/RC65/R3 and WHA66.22. It may be noted that since all aspects of the Regional Committee resolution are part of the World Health Assembly resolution, the Regional Office is proceeding accordingly. To take the CEWG process forward, the Regional Office organized a "Regional consultation for developing a strategic workplan as a follow-up of the Consultative Expert Working Group on Research and Development: Financing and Coordination” in Bangkok, Thailand from 25 to 26 July 2013. This meeting has proposed the next steps on these resolutions and suggested priority activities for the Region. The meeting has also suggested global norms and standard setting appropriate for health R&D in the CEWG process. 11. As desired by the High-Level Preparatory Meeting, an executive summary of the regional consultation is submitted to the Sixty-sixth Session of the Regional Committee for its consideration (Annex).
SEA/RC66/16 Page 4
Annex Regional consultation for developing a strategic workplan as a follow-up of the Consultative Expert Working Group on Research and Development: Financing and Coordination Executive summary The WHO Regional Office for South-East Asia organized a Regional consultation for developing a strategic workplan as a follow-up of the Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG) from 25 to 26 July 2013 in Bangkok, Thailand. The regional consultation discussed the next steps for Regional Committee resolution (SEA/RC65/R3, September 2012) and World Health Assembly resolution (WHA66.22, May 2013) on the CEWG. The CEWG was established by WHA63.28 to take forward and deepen the analysis of the work of an earlier expert working group on the global strategy and plan of action on public health, innovation and intellectual property (WHA61.21). The CEWG dealt with the increase in investments in health research and development (R&D) related to Type II and Type III diseases and the specific R&D needs of developing countries in relation to Type I diseases. It may be recalled that the CEWG submitted its report to the Health Assembly in May 2012. Thirty-two participants representing Member States of the WHO South-East Asia Region (excepting the Democratic People’s Republic of Korea) attended the consultation. The regional consultation was chaired by Dr Sopida Chavanichkul, Director, Bureau of International Health, Ministry of Public Health, Thailand. The meeting was co-chaired by Mr Md Neazuddin Miah Secretary, Ministry of Health and Family Welfare from Bangladesh. Drg Agus Suprapto, Head of Center of Humanities, Health Policies and Community, Empowerment National Institute for Health Research and Development, Ministry of Health from Indonesia acted as Rapporteur for the meeting. The consultation brought together both senior health policy officials and experts in the area of public health. The meeting was also attended by a number of observers from the scientific community and nongovernmental organizations, as well as participants from the WHO Regional Office for the Western Pacific. The participants reiterated the need for enhancing investments in health R&D related to Type II and Type III diseases and the specific R&D needs of developing countries in relation to Type I diseases. The participants also stressed the need to “explore and, where appropriate, promote a range of incentive schemes for R&D including addressing, where appropriate, the de-linkage of the costs of R&D and the price of health products with the objective of addressing diseases which disproportionately affect developing countries”.
SEA/RC66/16 Page 5
The consultation examined norms and standards for classification of health R&D including a number of international classifications in vogue on the subject and their relevance to Member States of the Region. Regional priorities for the strategic workplan under WHA66.22 were examined. In addition, the current situation of R&D for health products for developing countries was discussed, with specific reference to Bangladesh, India, Indonesia, Sri Lanka and Thailand. For development of norms and standards for classification of health R&D (WHA66.22), the consultation suggested a template for pilot testing the present available data (Appendix 1). This template could serve as a model for the setting up of norms and standards and would be invaluable for classification of health R&D for the purposes of the proposed R&D observatory. The consultation also identified seven priority areas based on public health needs of the Member States of the Region and for which demonstration projects could be initiated to deliver health products. In order to arrive at demonstration projects, the countries decided to work informally in groups. A lead country was identified for each of the seven priority areas for implementation of R&D demonstration projects (Appendix 2) and for which other countries and nongovernmental organizations could participate. The participants to the technical consultation made the following recommendations.
Recommendations for Member States For development of norms and standards for classification of health R&D towards setting up of R&D observatories: (1) A national R&D observatory may be set up to collect, analyse, coordinate, prioritize and monitor R&D resource flows from the public and private sector. Member States may develop modalities and identify institutional entities to develop, establish, maintain and manage health R&D observatories. (2) The scope of the observatory may include data on R&D infrastructure, human resources and financial flows, intellectual property and technology transfer projects. (3) Member States may pilot test the proposed classification grid for norms and standards for R&D (Appendix 1) in terms of diseases, product development and policy. Those Member States that have collected data as part of the preparation for this consultation may revisit the data to test this classification system and suggest improvements, if any, to the proposed classification system. (4) A technical national meeting/review may be organized to validate these outcomes, before these are recommended for consideration by WHO. For identification and implementation of R&D demonstration projects: (1) Priority may be given to the R&D demonstration projects that address regional health conditions/diseases. (2) Seven potential priority areas for R&D demonstration projects have been identified and ranked, in the following order:
SEA/RC66/16 Page 6
combating tuberculosis in the Region (development of diagnostics, vaccines, and
new anti-TB drugs); combating global diabetes by development of new diagnostics and new anti-
diabetes drugs (both traditional and modern medicines); new point-of-care diagnostics for fever of unknown origin in field settings; R&D in new drugs and diagnostics for cancer (type of cancer to be identified
referring to disease burden); dengue vaccine; pan-serotype pneumococcal vaccine; development of active pharmaceutical ingredients for medicines.
(3) Member States need to develop detailed project proposals within the timeline implied by WHA66.22 specifying the current status of research in the above identified projects, expected timeline, costs, organization structures/partnerships/consortiums/networks and processes to develop and implement specific project proposals and the respective products. (4) Some of the overarching principles for any demonstration project must include mechanisms to ensure the access and affordability of the products planned under demonstration projects to all countries in the Region, including legal and patent issues and open access platform for diagnostics. (5) Demonstration projects should lead to capacity building and technology transfer to developing countries, where appropriate.
Recommendations for WHO For development of norms and standards for classification of health R&D towards setting up of global health R&D observatory: (1) WHO may provide or mobilize technical assistance to assist Member States as appropriate, to facilitate development of R&D classification systems and R&D observatories. The Regional Office will present a report on this consultation to the Sixty-sixth Session of the Regional Committee, to be held from 10 to 13 September 2013.
(2)
For identification and implementation of R&D demonstration projects: (1) WHO may provide technical assistance to Member States for project development and formation of implementation teams to take these recommendations forward.
SEA/RC66/16 Page 7
Appendix 1 Proposed classification grid for norms and standards for health R&D
Disease
Measuring Understanding Development Implementation Evaluation the the Cause of a Solution of Impact Problem
Type I
Type II
Type III
Other diseases
The CEWG was established under element seven of GSPA (WHA61.21) for promoting sustainable financing mechanisms for stimulating R&D needed by developing countries for health products for Type I, II and III diseases. Defining disease Types I, II and III Type I diseases are incident in both rich and poor countries, with large numbers of vulnerable populations in each. Examples of communicable diseases include measles, hepatitis B, and haemophilus influenzae type b, and examples of noncommunicable diseases abound (e.g. diabetes, cardiovascular diseases and tobacco-related illnesses). Many vaccines for Type I diseases have been developed in the past 20 years but have not been widely introduced into the poor countries because of cost. Type II diseases are incident in both rich and poor countries, but with a substantial proportion of the cases in the poor countries. HIV/AIDS and tuberculosis are examples: both diseases are present in both rich and poor countries, but more than 90% of cases are in the poor countries. Type III diseases are those that are overwhelmingly or exclusively incident in the developing countries, such as African sleeping sickness (trypanosomiasis) and African river blindness (onchocerciasis). Such diseases receive extremely little R&D, and essentially no commerciallybased R&D in the rich countries. When new technologies are developed, they are usually serendipitous, as when a veterinary medicine developed by Merck (ivermectin) proved to be effective in control of onchocerciasis in humans. Type II diseases are often termed neglected diseases and Type III diseases very neglected diseases (CIPIH p. 13).
SEA/RC66/16 Page 8
Appendix 2 Proposed informal collaborations for demonstration projects among Member States* Priority areas 1 Combating tuberculosis in the Region (development of diagnostics, vaccines, and new anti-TB drugs) Combating global diabetes by development of new diagnostics and new anti-diabetes drugs (both traditional and modern medicines) New point-of-care diagnostics for fever of unknown origin in field settings R&D in new drugs and diagnostics for cancer (type of cancer to be identified referring to disease burden) Dengue vaccine Pan-serotype pneumococcal vaccine Development of active pharmaceutical ingredients for medicines Lead country India Participating countries Indonesia, Timor-Leste
2
Sri Lanka
Bangladesh, Thailand
3
India
4
Indonesia
Bangladesh, Thailand
5 6 7
Thailand India Bangladesh
India, Maldives
* The lead country would encourage participation of countries.