Thailand Country Study: Health R&D 1 1
Terms of Reference Suggest methodologies to develop norms and standards for classification of health R&D: Examine current norms and standards for classification in developed and developing countries Examine classification of R&D health and non-health Suggest possible methodologies Identify priorities for R&D for health products based on public health needs of developing countries Identify projects in order to develop and deliver health products 2 2
Guiding Principles Consultative Inclusive Focused Analytical Build on what is there 3 3
Methodology 3 phases of the country study Data collection Extensive desk/literature review Series of consultative meetings Key informant interviews Analysis Documentation & report writing 4 4
Extensive literature review Objectives : examine norms and standards for classification of health R&D in developed and developing countries examine norms and standards of health and non-health sectors of Thailand determine current status of research and development for health products in the country identify stakeholders Definition of health products: vaccines, diagnostics, medicines ( WHA 59.24, May 2006) 5 5
Literature review.(2) Sources of literature review: Peer-reviewed publications available online reports of government agencies, international organizations, academic institutions, NGOs, pharmaceutical industries, other bodies involved in health Websites of various institutions ( mission, profile, roles and responsibilities) Documents reviewed covered three levels: global, regional and national 6 6
Consultative meetings Objectives: to identify norms and standards for classification of health R&D utilized by different health and health-related organizations in Thailand; to list current R&D activities conducted for health products, in relation to the country s public health needs; to identify priorities for R&D for health products based on the country s public health needs; and to identify projects in order to develop and/or deliver health products 7 7
First Consultative Meeting Policy makers and planners Ministry of Public Health Food and Drug Administration National Vaccine Institute Department of Disease Control Department of Medical Sciences Bureau of Non-Communicable Diseases International Health Policy Program National Research Council of Thailand (NRCT), National Science and Technology Development Agency (NSTDA), National Science Technology and Innovation Policy Office Thailand Center of Excellence for Life Sciences (TCELS) Health intervention Assessment Program 8 8
Second Consultative Meeting Researchers and Academicians Mahidol University Faculties of Science, Tropical Medicine, Medicine and Pharmacy Chulabhorn Research Institute Armed Forces Research Institute of Medical Sciences (AFRIMS) Thai Red Cross AIDS Research Centre Medical Molecular Biology Research Unit (BIOTEC) Health Systems Research Institute Office of the National Research Council of Thailand 9 9
Third Consultative Meeting Pharmaceutical organizations and companies Pharmaceutical Research and Manufacturer s Association Government Pharmaceutical Organization Siam Bioscience Co. Ltd. Faculty of Pharmaceutical Sciences, Chulalongkorn University Food and Drug Administration 10 10
Mechanics of the Meeting Brief inputs given by the Project Team on the following: Background and Overview of the Project Norms and Standards Currently Used for Classifying Research and Development Activities Group Discussions Workshop 1: Identification of R&D norms, standards and priorities currently adopted, and activities currently undertaken Workshop 2: What ought to be done in terms of norms, standards, priorities, and activities to be conducted, to develop and deliver health products Plenary session for the presentation and discussion of group outputs Agreements Guide questions Worksheets 11 11
Objectives: Key Informant Interviews To get additional and more in-depth information on important data derived by the Project Team either during the literature review or the consultative meetings; To get first-hand information from institutions who were invited to but were not able to attend the consultative meetings; and To validate some of the information derived from the literature review and the consultative meetings, as part of the process of triangulating the data collected 12 12
Key Informants Interviews. Informants: Dr. Rungrueng Kitphati, Director, Bureau of Emerging Infectious Diseases Dr. Yongyuth Yuthavong, former Minister of Science and Technology and Advisor to the President of the National Science and Technology Development Agency (NSTDA) Dr. Yot Teerawatanon, Program Leader and Senior Researcher, Health Intervention and Technology Assessment Program (HITAP) Dr. Inthira Yamabhai, Researcher, Health Intervention and Technology Assessment Program (HITAP) Dr. Sansanee Chaiyaroj, Former Vice President for Research of Mahidol University; Executive Board Director, Office of the National Research Council of Thailand (NRCT) and Executive Board Director, Siam Bioscience Co. Ltd 13 13
Data Analysis Phase Steps Transcription of interviews and proceedings of meetings from tapes/field notes including translation Implementation of data quality control procedures Validation by members of the team present during each data collection activity Data triangulation Drawing of conclusions 14 14
FINDINGS 15 15
Norms and Standards for Classification of R&D Activities General Classification Systems OECD Frascati Manual Australian and New Zealand Standard Research Classification (ANZSRC) Malaysian Research and Development Classification System (MRDCS) 16 16
Norms Classification Systems for Health R&D RCDC (Research, Condition and Disease Categorization) system developed by the US National institutes of Health (NIH) MeSH (Medical Subject Headings) developed by the US National Library of Medicine CSO (Common Scientific Outline) developed and used by the US National Cancer Institute G Finder Survey funded by the Bill and Melinda Gates Foundation Health Research Classification System (HRCS) developed by UK Clinical Research Collaboration group 17 17
Findings. Policy directions in R&D several bodies/institutions involved in developing national policies on R&D in general and in health R&D weak coordination mechanism exist between and among these different bodies no single body that identifies the priority areas for health research for the entire country research efforts are based on the policies and plans of specific institutions; availability of internal and external funding; interests and expertise of the researchers Overlap of topics Majority of the areas covered in the current research efforts are relevant to the health needs of the country. 18 18
Norms and Standards for classification of health R&D no single/common system of norms and standards for the classification of health research and development there was a consensus among all three groups of stakeholders that a common system of norms and standards for the classification of health research and development activities be developed and utilized for Thailand there are initial efforts towards the development of a common system of norms and standards for classification of health research in the country HCRS with modification was recommended for use in Thailand in one study done and was presented to the policy-making bodies of health research One university is doing work on review of classification 19 19
Priority Areas for Health R&D Priority Areas Summary table of Priority Areas for health R&D Policy makers Research ers Pharm Literature Vaccine Development X X X X Ophan product development X X X Diagnostics/Screening kits X X Drug development using natural products/medicinal herbs X X 20 20
Recommendations Development/Adoption of a common norm and standard for classification of health research and development activities The National Research Council of Thailand can lead The following steps can be followed : Identification of resource persons to participate in determining the categories Consensus-building among resource persons on the dimension, categories and sub-categories to be used Pre-testing of initial set of categories: retrospective application & current application Modification of the initial draft 21 21
Norms Preparation of a User s Guide for the newly developed classification system Conduct of awareness building and training activities Application of the classification system for a couple of years as a pilot-testing phase, closely monitoring problems encountered Evaluation of the newly developed system System should be simple so that it will be user friendly; exhaustive to include all health R&D activities in the country; and flexible enough so as not to restrict its users 22 22
Global, Regional and National Health R&D Observatory Conduct of a series of Consultative Meetings among different health R&D stakeholders discuss the role of a health R&D observatory at the national, regional and global levels the most effective mechanism for its establishment, management, monitoring and evaluation Explore merits, acceptability and feasibility of the idea of the: - global health R&D Observatory acting merely as a Coordinator of a network of -regional and national observatories with - national level observatories taking a more major role covering different areas of health R&D countries having a greater sense of ownership of the data and in so doing, greatly improve data quality offers more opportunities for capability building on data processing, analysis and utilization at the country level 23 23
Collaborative Project: Dengue Vaccine Development WHY Dengue?? Burden of disease health needs driven R&D Resolutions: 55 th WHA ; (SEA/RC61/R5) Political commitment: National Vaccine Strategy approved by the Cabinet in 2011 Existing efforts: work of different groups Existing expertise 24 24
Collaborative Project on Dengue Vaccine Development Efforts of existing institutions/bodies involved in dengue vaccine development should be consolidated Mapping of the strengths and current work on dengue vaccine development of each institution A higher body/national body should lead this collaborative effort and a technical body be established to be composed of representatives of the particpating institutions Maximize the forthcoming national meeting of research institutions involved in dengue research on the second week of September 2013 in Bangkok 25 25
Collaborative project on Melioidosis Why? Endemic in Southeast Asia Cost of treatment is a big challenge Existing efforts - e.g. border collaboration 26 26
Collaborative project on Melioidosis The institutions currently working on melioidosis can organized and develop the proposal for a collaborative project on melioidosis taking into consideration the current efforts of the different institutions on the subject, expertise and resources available in each institutions. A project organizational structure should be established to delineate clearly the roles and responsibility of the institutions to be involved 27 27
Projects on diagnostics/screening kits and the drug development using natural products/medicinal herbs Interested institutions should work together to come up with more detailed plan. More detailed discussions should precede the development of the project proposals Knowledge gained and products of these projects should be shared throughout the region to ensure equitable access of the needy population. 28 28
Funding Mechanisms Similar to the Global Fund: National Level- Country Coordinating Mechanisms Regional Level- Regional Secretariat Global level - Global Secretariat WHO should play a major role Bodies at different levels should be composed of representatives of the different stakeholders aside from donors and development agencies With an independent Technical Review Group 29 29
Thank you Sawadee Kha 30 30