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REPORT OF South East Asia Regional Organization (SEARO) Meeting on Consultative Expert Working Group (CEWG) on R&D Financing and
Coordination, WHO‐SEARO, New Delhi, India
7 October 2011 I. INTRODUCTION 1. A one‐day regional consultation meeting was held on 7 October 2011 at WHO‐SEARO, New Delhi, India to examine the appropriateness of different research and development (R&D) financing approaches under review by the Consultative Expert Working Group on R&D Financing and Coordination (CEWG) and to examine the feasibility of the implementation of these approaches in the WHO South‐East Asia Region (SEA Region). 2. The meeting was attended by representatives from the following Member States: Bangladesh, Bhutan, India, Indonesia, Maldives, Myanmar, Nepal, Sri Lanka and Thailand. It was noted that despite the short notice, all Member States except DPR Korea and Timor‐Lest were represented at the meeting. Two expert members of the CEWG from the WHO SEA Region attended the meeting. Dr Mirza and Ms Miriam Clados from WHO Headquarters were also present and a representative from the Council for Scientific and Industrial Research (CSIR), India attended the meeting as observer. 3. Dr Poonam Khetrapal Singh, Deputy Regional Director to WHO‐SEARO opened the regional meeting by welcoming all participants. She informed them that this regional meeting was held to further the work related to World Health Assembly (WHA) resolution 63.28 (2010) on the establishment of the CEWG. The work of the CEWG was taken up under Element Seven of the WHO Global Strategy and Plan of Action on Public Health, Innovation and Intellectual property (GSPA‐PHI) which was contained in the Annex of resolution WHA61.21. The GSPA‐PHI comprised eight elements, which were designed to promote innovation, build capacity, improve access and mobilize resources. 4. Dr Singh informed that for WHA61.21, SEARO had earlier convened a Regional Consultation from 5 to 6 April 2011 for the Development of a Regional Framework. The Report of this Consultation that deliberated on all Eight Elements of the Strategy for SEA Regional and National contexts was made available to the participants. She highlighted the fact that various international trade agreements and commerce had brought to the fore new challenges in the management of public health. A key issue was that markets for diagnostics, vaccines and medicines that disproportionately affected developing countries was small and uncertain. As a result, the incentive effect of intellectual property rights in these circumstances may be limited. The complexity posed by data exclusivity and intellectual property provisions in trade agreements amplified the concerns for public health for developing countries.
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5. Dr Singh emphasized that there was a need to examine innovative approaches to ensure enhanced financing for R&D to address treatments for diseases that principally affect developing countries and that promote synergy between different partners in public health. It was important to take up the task of transforming the GSPA‐PHI into a workable set of policies and actions that made a difference. She hoped that as a result of this meeting the participants from Member States would enhance their understanding and provide a regional perspective to the CEWG. This meeting would also give an opportunity to the CEWG members from this Region to share their work and for them to obtain national and regional input to the proposals under consideration of the CEWG. 6. Dr Praveen Mishra Secretary, Ministry of Health and Population, from Nepal was elected as Chair and Professor Quazi Tarikul Islam, Professor of Medicine and Controller of Bangladesh College of Physicians & Surgeons, Bangladesh was elected co‐Chair. Prof. Laksono Trisnantoro, Director, Post Graduate Program in Health Policy and Management, Gadjah Mada University, Yogyakarta, who is also a member on the CEWG, was Rapporteur for the meeting. II. AGENDA 7. Seven presentations were made in order to set the context of the meeting, to introduce and embed the work undertaken by the CEWG and to link the group's work with the WHO SEA Region. 8. Dr Mirza, Coordinator of the Department of Public Health, Innovation and Intellectual Property Rights introduced the work of the CEWG by delivering a presentation on the mandate of the CEWG in the context of the GSPA. 9. Dr Shridhar, Technical Officer, Intellectual Property and Trade, WHO SEA Region gave an account of the work done under the GSPA in SEARO. In particular, attention was drawn to the regional workshop held on 5‐6 April at WHO‐SEARO for “Development of a Regional Framework on Public Health, Innovation and Intellectual Property”. The participants in this workshop identified national and regional priorities for the Eight main Elements and 25 sub‐elements of the GSPA and delineated a set of recommendations for WHO‐SEARO and Member States of the Region. 10. Dr Setiadi, Regional Advisor, Research Policy and Cooperation, highlighted the important R&D efforts being undertaken in the SEA Region. He gave a presentation on the R&D financing and coordination activities, resource allocation and future plans in the WHO SEA Region in the context of the WHO Research Strategy.
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11. Ms Clados, Technical Officer WHO, explained the templates and methodology used by the CEWG to evaluate different financing and coordination approaches. 12. Mr L.C. Goyal, CEWG member from India, gave a detailed account of the 16 groups of R&D financing and coordination proposals under consideration by the CEWG and of the CEWG's preliminary assessment of these groups of proposals. He reiterated that the aim of this consultation was to receive feedback on the CEWG's initial assessments of proposals from the Member States in the Region. 13. Prof. Trisnantoro, CEWG member from Indonesia, gave a presentation on the importance of regulatory harmonization proposal for SEA Region (See below under regulatory harmonization). 14. Mr Zakir Thomas, observer for the meeting highlighted the salient features of the Open Source Drug and Discovery (OSDD) model of Council for Scientific and Industrial Research (CSIR) in India (See below under precompetitive platforms). 15. All R&D financing and coordination mechanism proposals under consideration of the CEWG were then discussed in three Groups based on their similarities and assessed by the attendees of the meeting. The 16 proposals were grouped as follows: a. Group I i. Essential health and biomedical research treaty (Proposal 1) ii. Milestone prizes and End prizes (Proposal 5) iii. Direct grants to Companies (Proposal 6) iv. Pooled Funds (Proposal 7) v. Health Impact fund (Proposal 12) vi. Tax Breaks for Companies (Proposal 14) b. Group II i. Pre‐competitive Research and Development and open source (Proposal 2) ii. Open Access and Equitable Licensing (Proposal 3) iii. Patent Pools (Proposal 4) iv. Priority Review Voucher (Proposal 8) v. Transferable Intellectual Property Rights (Proposal 9) vi. Green Intellectual Property (Proposal 11) c. Group III i. Orphan drug Regulation (Proposal 10) ii. Changes to Data Exclusivity Rules (Proposal 13) iii. Purchase or Procurement Agreements (Proposal 15) iv. Regulatory Harmonization (Proposal 16) The conclusions of the discussions are given below.
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III. SUMMARY OF OUTCOMES WITH REGARDS TO INDIVIDUAL R&D FINANCING AND COORDINATION PROPOSALS DISCUSSED Group I 16. Essential health and biomedical research treaty: • There was an unequivocal and strong support for this proposal. All countries
supported the idea of an R&D treaty which could function as an "umbrella mechanism" that had the potential to bring together elements from many other proposals. The representatives from Member States emphasized the importance of the R&D Treaty and that this would be a special treaty in WHO. As of this date, there was only one similar treaty, the Framework Convention on Tobacco Control.
• Participants noted that the R&D treaty would take up an R&D framework at the global level; it was not an R&D treaty for SEA Region only but for all countries. The R&D treaty would be a long term intervention on R&D Financing and Coordination while for the medium and short term other proposals under consideration of the CEWG would be important.
• A concern was raised that providing new resources and increasing R&D financing for diseases could potentially entail further obligations on tax payers. On the other hand, it was noted that governments usually already invested in R&D and that the allocations made thereby could be used to offset their obligations under the treaty although the detailed mechanisms have to be negotiated among the member states.
• Participants agreed that for the R&D treaty to succeed it would be necessary to have strong commitments by governments in place, in particular in order to create a fund that could then allocate funds to the R&D of neglected diseases. Yet it was not clear how this fund was to be governed and whether all WHO Member States would be willing to commit to an obligation to contribute to this R&D fund.
• Conclusion: All Member States present fully endorsed this proposal in principle. 17. Milestone prizes and End prizes: • Well‐functioning examples of Milestone prizes and End prizes existed in many
countries in the SEA region. The Indonesian representative, for example, explained that Indonesia had a reward structure in place which gave support to junior researchers. Bangladesh also had a similar scheme in place though not for discovery; under the scheme a researcher was rewarded when his research was published in a peer reviewed journal.
• Overall, participants agreed that Milestone prizes and End prizes could be designed in a manner which furthered increased access and affordability of drugs while these schemes could also allow for a management of the intellectual property rights system in a way that promoted health. This was, for example, the
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case when prizes were given on the basis that the product financed by the prize would not be protected by intellectual property rights.
• Conclusion: All participants favorably considered the idea of Milestone prizes and End prizes and agreed with the assessment of the CEWG.
18. Direct grants to Companies: • Examples of national grant schemes existed in several countries in the region.
India, for example had a system in place to encourage R&D by Small and Medium Enterprises (SMEs).
• Overall, direct grants to companies were considered to be a proposal worthy of support, yet it was felt that further capacity needed to be built in the area of monitoring and administration of grants in order for companies in developing countries to receive and administer funds properly.
• Participants also agreed that it may be more desirable to finance, in particular, the R&D efforts of private companies that worked with government/public R&D units, i.e. operated as part of Public and Private Partnerships.
• The production of Active Pharmaceutical Ingredients (APIs) and its support through grants was proposed as a much needed initiative in the region.
• In South‐East Asia, the National Science Technology and Innovation Policy Office, Thailand, could be considered as a model for how grants are administered. It was agreed that the CEWG should further investigate this scheme.
• Conclusion: Participants agreed with the assessment of the CEWG. 19. Pooled Funds: • Participants felt that pooled funds could form part of a global R&D treaty as
pooled funds served to raise funds that would then be allocated to PDPs or other research institutes by an administrative body. Pooled funds were therefore considered to be an important proposal, especially until a global R&D treaty came into existence.
• A concern was raised regarding the sustainability of funding of pooled funds. • It was also stated that development banks in developing countries may have the
capacity to manage such funds and that this possibility should be further explored. The Global Fund to Fight AIDS, Tuberculosis and Malaria, for example, already included a non‐disease specific agenda in its project portfolio by generally supporting health system strengthening.
• Conclusion: Participants agreed with the assessment of the CEWG. 20. Health Impact fund (HIF): • A concern was raised as to whether companies would in fact opt for the reward
system of the HIF instead of relying on traditional IP protection. • It was further felt that if it was, in fact, possible to assess and monitor the impact
of certain drugs under the HIF then this idea had a great potential. Participants stated that the proposal could function as an alternative to the intellectual
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property protection in pharmaceutical companies. Medicine and health technology development would be rewarded not based on profit but based on the health impact of a product.
• Some participants expressed concern as to the source of financing for such a fund. It was also unclear how the fund would ensure that quality drugs were developed and under what governance and management structures the fund would operate. Overall it was felt that there was a need to pilot the HIF and that there was a need to determine which diseases could be targeted in a pilot case.
• Conclusion: It was generally felt that the HIF was an interesting idea but would need further development. Participants supported the assessment of the CEWG.
21. Tax Breaks to Companies: • Participants endorsed tax breaks for companies and held that this could
constitute a valuable incentive for companies to increase their R&D into neglected diseases.
• Certain countries, like the Maldives, stated that this proposal was not applicable to them.
• Conclusion: In general the participants agreed with the assessment of the CEWG. Group II 22. Pre‐competitive Research and Development and Open Source: • Mr Zakir Thomas gave a presentation to the group, highlighting the salient
features of the Open Source Drug Discovery (OSDD) model of the Council for Scientific and Industrial Research (CSIR) in India. He explained that OSDD was a CSIR Team India Consortium with Global Partnership with a vision to provide affordable healthcare to the developing world by providing a global platform where minds can collaborate and collectively endeavor to solve some of the complex problems associated with discovering novel therapies for neglected tropical diseases like Malaria, Tuberculosis, Leshmaniasis, etc. He further explained in response to several questions raised with regard to the scope of OSDD's work that
CSIR would take successful molecules to phase II and III stages of drug development and then take it to the market as it was only by taking a drug through to the market that its low price would be ensured.
CSIR would attempt to collaborate with public hospitals for them to host clinical trials so that it could be ensured that the latter were not expensive.
• It was mentioned that so far there was a lack of enthusiasm by pharmaceutical companies to participate in precompetitive platforms. At present, the OSDD was only collaborating with one pharmaceutical company.
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• Conclusion: All participants favorably considered the idea of Pre‐competitive Research and Development and Open Source and agreed with the assessment of the CEWG.
23. Open Access and Equitable Licensing: • The discussions on this proposal formed part of the discussion of the previous
proposal on pre‐competitive research and development and Open Source. • Conclusion: Participants agreed with the analysis and conclusions of the CEWG. 24. Patent Pools: • Because of its innovative use of intellectual property, this proposal was held to
be extremely relevant for countries of SEA region. Patents could be pooled together and made available to manufacturers of drugs at minimum royalty payments. This proposal was therefore supported by all Member States.
• It was suggested that in parallel to the UNITAID model where currently 6 countries impose air travel taxes to support the work and expenses of UNITAID, similar taxes could be levied on for example bus or train travel in the SEA Region. However, such a model would need to be balanced against people's ability to pay.
• Conclusion: All participants favorably considered the idea of Patent Pools and agreed with the assessment of the CEWG.
25. Priority Review Voucher (PRV): • Participants discussed that the PRV was not necessarily beneficial to developing
countries as the PRV scheme did not ensure that drugs would be made available in developing countries at an affordable price. Also, it did nothing to ensure faster generic drug production.
• The PRV so far had been used only once by Novartis. There was thus limited experience with regard to the effectiveness and efficiency of the PRV.
• Conclusion: Participants agreed with the assessment of the CEWG. 26. Transferable Intellectual Property Rights (TIPR): • Participants were concerned that since TIPR schemes benefited companies by
prolonging the intellectual property protection for certain drugs TIPR may not be beneficial to developing countries.
• It was also not clear to participants how long the product to which the patent protection was extended would then be protected. Moreover, the prolongation of patent rights could result in that a drug became more expensive and thereby raised overall health expenditures in countries.
• Conclusion: Participants agreed with the assessment of the CEWG.
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27. Green Intellectual Property: • Participants agreed that this proposal could result in increased costs of patents
and that companies might pass on the higher costs to the end user. • Conclusion: Participants agreed with the assessment of the CEWG Group III 28. Orphan drug Regulation: • After clarifying that this legislation only existed in certain jurisdictions of
developed countries participants agreed with the analysis and conclusion of the CEWG. In its present form Orphan Drug Legislation was thought to have little relevance to developing countries.
• Conclusion: Participants agreed with the assessment of the CEWG. 29. Changes to Data Exclusivity Rules: • Most of the discussion on this proposal was clarifying in nature. It was clarified
that the TRIPS agreement did not mandate the introduction of Data Exclusivity but only requested that Member States shall protect relevant data "against unfair commercial use". There was no evidence that Data Exclusivity contributed to R&D and innovation for diseases in developing countries. Implementation of Data Exclusivity could in fact adversely affect access to medicines in developing countries and removal of data exclusivity would be more appropriate.
• Conclusion: There was no support for the introduction of Data Exclusivity laws in developing countries. On the other hand participants generally agreed that changes in existing data exclusivity laws could have an impact on the availability and affordability of drugs. There was a general agreement with the analysis and conclusion of the CEWG on this proposal.
30. Purchase or Procurement Agreements: • The Advanced Market Commitment model was seen to have resulted in
improved access to new vaccines. It was discussed that this mechanism could also be considered for medicines.
• The question of sustainability was raised as it was not clear whether procurement agreements could keep prices of drugs consistently low. There was also a need for further evidence that proved this proposal's value. Issues of transparency, developing monopolies and conflict of interest could become issues of concern in this regard.
• Conclusion: Participants agreed with the analysis and conclusions of the CEWG. 31. Regulatory Harmonization: • While it was acknowledged that each member state had the right to endorse its
national laws and regulations it was also felt that regulatory harmonization could benefit the whole region in the long term. Regulatory harmonization, thereby,
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was more than standards and specifications. It was about procedures which often were unnecessarily cumbersome and differed in operation between regulatory authorities, thereby resulting in long and avoidable delays in market authorization.
• A concern was raised that potential cost savings through regulatory harmonization may not be passed on to patients.
• Participants also felt that there was a need to strengthen capacity building and develop human resources in this area.
• Conclusion: After an initial assessment, participants were not convinced that regulatory harmonization met all the criteria set by the CEWG.
32. Coordination: • All the participants agreed on the need for having better coordination
mechanisms in place. • Conclusion: The issue of coordination needs to be addressed by WHO and
partners as suggested by the CEWG. OUTCOMES OF THE MEETING • There was a general feeling among participants that further investments needed to
be made in the development of innovative capacity in countries in SEA Region. • Participants stressed the need to properly address the issue of potential sources of
funding and sustainability of R&D on many occasions and also during the discussions on individual proposals.
• While discussing individual proposals it was mentioned that there are conceptual overlaps and interconnectedness among many proposals which is why the discussions on the proposals were taken up in three groups. The Biomedical R&D Treaty was felt to constitute one overarching proposal that could benefit from many good and viable ideas available in other proposals.
• There was generally a strong support for the idea of a biomedical R&D treaty. • Participants stressed the need for strengthening and supporting the research
institutions in developing countries. • Several participants felt that there was a greater need to develop proposals of
greater specific relevance to SEA Region. In the same vein, it was stated that several of the proposals under review by the CEWG lacked relevance to the region.
• The discussion revolved on the Public Health context and access to medicines particularly on the issue of availability of generic medicines. Tangible inter‐governmental efforts were needed to promote sustainable financing mechanisms for needs driven R&D.
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CONCLUSIONS • Detailed discussions on all proposals currently under review by the CEWG took place
and substantive value was added to these by the examination of their feasibility and implementability from a SEA Region perspective. The important input received through the SEA Region meeting will help inform the future work of the CEWG.
• The report on the SEA Region meeting will be presented to the CEWG for its consideration during its 3rd meeting in November 2011. The CEWG will take into account the outcome of this meeting and will take the points raised into consideration when further assessing the R&D financing and coordination proposals before it.
• The report of the consultation meeting and the presentations delivered at the consultations will be made available at the webpage of the CEWG, at: http://www.who.int/phi/news/cewg_2011/en/index.html.
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ANNEX 1
Meeting on Consultative Expert Working Group (CEWG) on R&D Financing and Coordination
7 October 2011, SEARO, New Delhi
List of Participants BANGLADESH Prof Quazi Tarikul Islam Professor of Medicine and Controller of Bangladesh College of Physicians & Surgeons BCPS Bhavan NIPSOM Road, Mohakhali Health Complex Dhaka Email: prof.tarik@gmail.com Bhutan Ms Sonam Yangchen Assistant Program Officer Planning and Policy Division Ministry of Health Thimphu Email: sonamyangchen@health.gov.bt INDIA Mr L. C. Goyal Addiitional Secretary and Director General Ministry of Health and Family Welfare Nirman Bhavan New Delhi Email: lc.goyal@nic.in
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INDONESIA Dr Emiliana Tjitra Senior Researcher National Institute of Health Research and Development (NIHRD) Ministry of Health Jakarta Dr Laksono Trisnantoro Director Post Graduate Program in Health Policy and Management Gadjah Mada University Yogyakarta Email: trisnantoro@yahoo.com MALDIVES Mr Ibrahim Waheed Minister of State for Health and Family Ministry of Health and Family Male Email: waheed@nspa.gov.mv MYANMAR Dr Khin Lin Director Department of Medical Research Upper Myanmar Email: drkhinlin@gmail.com
NEPAL Dr Praveen Mishra Secretary Ministry of Health and Population Kathmandu Email: praveen.mishra73@yahoo.com
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SRI LANKA Mrs K A A Gunathilaka Director / Finance Ministry of Health Colombo 10 Email: ajanthagunathilaka@yahoo.com Thailand Mrs. Kanchana Pankhoyngam Deputy Secretary‐General National Research Council of Thailand 196 Phaholyothin Road Chatuchak, Bangkok Email: k_pankhoyngam@yahoo.com WHO/HQ Dr Zafar Ullah Mirza Coordinator Department of Public Health, Innovation and Intellectual Property Email: mirzaz@who.int Ms Miriam Clados TechnicalOfficer Department of Public Health, Innovation and Intellectual Property Email: cladosm@who.int SECRETARIAT Dr Poonam Khetrapal Singh Deputy Regional Director Dr Athula Kahandaliyanage Director Health Systems and Development Dr Sudhansh Malhotra, Regional Adviser Primary and Community Health care
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Dr Manisha Shridhar Technical Officer Intellectual Property and Trade Dr Gunawan Setiadi Regional Advisor Research Policy and Cooperation Dr Kathleen Holloway Regional Advisor Essential Drugs and Medicines OBSERVER Mr Zakir Thomas Project Director, OSDD Council of Scientific and Industrial Research New Delhi
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