ESTABLISHING MONITORING AND REPORTING SYSTEMS

46 c. Impact of incentive mechanisms on innovation of and access to health products and medical devices; and d. Investment in research and development to address the health needs of developing countries During the sixty-second World Health Assembly Meeting in 2009, a set of 30 progress indicators were presented to the Executive Board, which would form the basis for regular reporting to the Health Assembly on performance and over-all progress made over a 2-year reporting period, as well as inform the evaluation of the strategy at the end of four years. The indicators covered all the 8 GSPA elements and were applicable to both research-based health pharmaceutical products and traditional medicines. 132 Regional Sri Lanka is the only SEAR country to carry out GSPA-PHI assessment, i. 133 The findings showed the existence of several RD focused institutions, and there is a need for co-ordination, among them to achieve better results. Other countries like Thailand and Indonesia have performed evaluation under COHREDguidance and India is part of EVAL-HEALTH 135 . Global It was reported during the Sixty-seventh World Health Assembly held in March 2014, that the Secretariat, in collaboration with the Regional Office for the Americas, is developing the Global Platform on Innovation and Access which is an online portal for monitoring the progress made by Member States and other stakeholders in implementing the GSPA-PHI. The platform will be comprised of an information hub, a knowledge repository and a virtual forum on innovation. It was scheduled to be launched in April 2014. 137 In Africa, a pilot monitoring tool to monitor the implementation of GSPA-PHI was developed in 2009 by IQSensato and Health Action International HAI Africa. The tool was piloted in Ghana, Uganda, Zimbabwe, Rwanda and Kenya. It is composed of a questionnaire to be accomplished by stakeholders in the RD process ex., officers from the Ministry of Health, the academe, Medical Research Institutes, Intellectual Property Offices, etc.. The pilot phase highlighted the need to prepare a short guide for the questionnaire which forms the basis for data collection. 138 While the systematic and institutionalized monitoring and evaluation of GSPA-PHI can still be considered as work in progress, several major initiatives have long been developed and implemented to monitor and evaluate specific areas related to health research and development. For example, in the area of health research capacity strengthening, a planning, monitoring and evaluation framework has been developed and implemented by the TDR-based ESSENCE Enhancing Support for Strengthening the Effectiveness of National Capacity Efforts on Health Research. This project is an initiative between funding agencies to scale-up coordination and harmonization of research capacity investments. 139 47 It is in the area of monitoring financial flows in support of health research and development where several initiatives by other international organizations have been implemented. During a WHO informal workshop on this topic held in London in February 2013, the following health-focused initiatives were presented, among others. 140 a. G-Finder – This initiative is part of Policy Cures and has been funded by the Bill and Melissa Gates Foundation since 2008. They measure funding on 31 neglected diseases which were identified using a panel of international experts, predominantly focusing on diseases which disproportionately affect low and middle-income countries. 141 b. Health Research Web HRWeb – It provides an online platform to upload as well as share information on RD initiatives, policies and strategies. It aims to provide practical information and includes publications and analysis of health systems. The HRWeb model has allowed the development and publication in different forms of media, analysis about national health research systems in Latin America, and has engaged delegates from the science, technology and health sectors in the Latin American Conferences on Research and Innovation for Health www.paho.orgLACRIH. 142 c. World RePORT – World RePORT http:worldreport.nih.gov is seen as a public tool to track funding and activities so one can analyze the complete landscape of research funding, identify funding gaps and areas where there may be a duplication of efforts, seek problems where collaboration would be useful, and improve efforts to work more effectively and synergize investments in research. The inter-active database provides descriptors of the research collaborations and funding by all NIH Institutes and Centers and its 8 affiliated organizations with institutions in sub-Saharan Africa. 143 Since a number of indicators needed to monitor and evaluate the progress of GSPA implementation cannot be derived from routinely collected data, there is a need to conduct special studies to develop study designs and data collection methodologies to address this need. Like the methoed developed by WHO, Viergever to identify gaps in health RD. . 144 48

9. GSPA elements and way forward: some suggestions

This section presents some suggestions for the next steps to be taken with respect to each of the elements of the GSPA-PHI. The suggestions are culled from recommendations given in some of the literature reviewed. However, this section is still a work in progress since its final version will incorporate the inputs of Member States and research institutions to the questionnaire on Regional Situational Analysis which was sent to the workshop participants to be accomplished prior to the workshop.

1. Prioritizing research and development needs

 In the area of local production of medicines, a primary objective must be to identify therapeutic areas and regions for which existing production does not meet local needs, including needs for long-term sustainable supply. Objectives of the work programmeaction plans to be developed should be designed to address those unmet needs.  Further research is required in two areas: a. Measuring private sector technology transfer flows; and b. Understanding the conditions under which local production leads to improved access to medicines, and the pathways through which such improvements occur

2. Promoting research and development

International partnerships that provide technical assistance and access to technology should be expanded. Although bilateral partnerships like that of PATH and the Bharat rotavirus project in India have been very useful, access to some technologies could be shared on a more open, multi- late al asis. O e su h odel is the WHO te h olog hu fo i flue za a i es hi h ade production know-how available to developing country manufacturers.

3. Building and improving innovative capacity

 Research organizations should engage with country leadership and other stakeholders to assess the adequacy of current national research capacity and use the assessment results as inputs in determining the most effective role they can play to support the development of research capacity that addresses the health and development needs of the country.  Advocate for the development of policies on retention and career development of human resources for health research 49  Expand opportunities for production staff of local drug manufacturers to include practical training which would complement the theoretical training provided by academic institutions. Such type of training is amenable to both north-south and south-south cooperation, since several developing countries are no home to advanced industries that could provide training opportunities to nationals of developing countries.  WHO technical experts can work with private-sector companies to design and make a aila le odula pa kages fo lo al p odu tio fa ilities suited fo de elopi g ou t ies, including advanced formulation facilities. WHO can work with the World Bank to design a financing package for such facilities.

4. Transfer of technology

 Better, stronger and wider dissemination of needs and required procedures -- International health donors and government agencies should send clearer signals to product developers about the products they wish to buy, the technical standards that have to be met, and approval and procurement procedures which need to be followed. This is particularly true for diagnostics where product needs and assessment procedures have not been properly well defined at different levels.  Capacity building on how to negotiate effective technology transfer agreements may be useful, particularly for firms with limited experience in this area. 5. Application and management of intellectual property to contribute to innovation and promote public health  Ongoing efforts in training national drug regulatory authorities and policy makers on how to implement TRIPS in a manner that protects public health and expands the space for local production should be strongly supported and continued.

6. Improving delivery and access

 Countries need to streamline their system for regulating pharmaceutical and biotechnology RD needs, and strengthen their systems and capacity for evaluating new technologies. At the same time, international systems for assessing and e o e di g p odu ts, espe iall WHO s p e ualification program for diagnostics need to be expanded so they can handle more products more rapidly.