Facilitating the maximum use of existing financing Regional

43 CSIR New Millenium Indian Technology Leadership Initiative NMITLI TIFAC The Advanced Composites Program TIFAC-SIDBI Program BIRACDepartment of Biotechnology Biotechnology Ignition Grant BIG Contract Research Scheme CRS Small Business Innovation Research Program of India SBIRI Biotechnology Industry Partnership Program BIPP Advanced Technology Scheme ATS Global Part 3 of the 2012 CEWG Report by the Secretariat presented a comprehensive description of existing financial mechanisms for health RD in various areas, and provided options on how to approach the increase of RD funding related to Type II and III diseases and the specific needs to developing countries in relation to type I diseases. 121 The options are either to establish a new financing mechanism or to use an existing vehicle. It also identified a number of factors which are critical for the success of any new financing mechanism which are:  Political commitment for the establishment of the mechanisms and its mission  An inclusive governance which represents the interests of the various stakeholders  A broad, stable and predictable financial basis and a financial structure that minimizes procedural obstacles for contributors;  A clearly defined, focused and realistic objective of the mechanism and a clear implementation model; and  An effective system of monitoring the disbursement of funds and evaluation of success A follow-up to the 2012 Report of the Secretariat is Draft Working Paper 3 on Financing Mechanisms for health RD circulated in May 2013. 122 The paper identified a number of mechanisms that could be suitable starting points and presents possible criteria that could be used to assess the suitability of a range of existing mechanisms. The criteria presented are more detailed that the one earlier developed by the Secretariat and includes the following items:  Adaptability  Scope of research in terms of 1 disease areas covered; and 2 technologies covered  Geographical scope  Governance  Experience in funding RD  Experience if managing RD; and  Transparency Twelve existing financing mechanism for health RD were identified ANDI; DNDI; EMBL; GAVI Alliance; Global Fund; IARC; IVI; MMV; PATH; RBM; WHOTDR; and UNITAID and assessed using the proposed criteria. Results were color-coded reflecting varying degrees of meeting the criteria 44 with green indicating that the criterion has been fulfilled and red indicating that it is not fulfilled. WHOTDR and the Global Fund fully satisfied the highest number of criteria at 3 each. In June 2014, a meeting on Sustainable Investment in Research for Health was held in Berlin, Germany by COHRED, in partnership with the West African Health Organization WAHO and NEPAD. 123 The meeting had 4 key discussion topics, namely: developing an integrated system for i o atio ; shifti g f o the otio of fu di g to i est e t ; creating an African research space; and engaging in advocacy for research for health financing. Some of the major recommendations arrived at during the meeting corresponding to each discussion topic are shown below. Table 5. Major recommendations given during meeting on Sustainable Investment in Research for Health: Berlin, Germany June 2014 Developing an integrated system for innovation Make an economic case for research by linking research to cost-effectiveness and return- on-investment studies Show the actual investments made in research to demonstrate tangible return on investment Increase cross-sectoral research collaboration to make research more efficient and sustainable Shifting from a funding to an investment perspective Show the impact of research on GDP to demonstrate the economic value of research in its own right Track research through open data systems to show impact and return on investment Create integrated research and innovation platforms to make efficient use of existing resources and thereby incentive investments Creating an African research space Harmonize stewardship through tapping into regional leadership bodies and establishing common regulation processes and research agendas Engage all stakeholders through open dialogue and continuous feedback, both during the creation of this space and its operation Secure consistent funding by identifying a range of funding mechanism to ensure sustainability of the research space Engaging in advocacy Establish a regional peer-review mechanism to incentivize follow-up of key declarations, using a defined set of indicators Engage the media as an advocate by maximizing opportunities to communicate research findings through research-savvy journalists and media-savvy researchers Widen the scope of the audience to include for example, other ministries and stakeholders 45 The same meeting report presents, as an Appendix, a comprehensive and detailed listing of innovative financing mechanism for health RD including those which are already currently operational, as well as those which are still in the proposal stage. The listing was put-together by combining information derived from the work of three groups who have made in-depth studies of various funding mechanisms, namely: 1. CEWG which provided, as part of its 2012 report, a review of innovative financing proposals, and assessed these based on a number of pre-determined criteria; 124 2. Michaud and Kates who outlined a classification system of the different types of innovative financing mechanism for global health and provided an inventory of those that are either proposed or currently being used. 125 This work was commissioned by the Henry J. Kaiser Family Foundation in 2011 to identify how the US government can or should participate in such mechanisms; and 3. The Milken Institute who convened a Financial Innovations Lab in 2012 to map current and potential innovative financing models with the goal of leveraging traditional sources of aid to attract private-sector investment and increase sustainable funding for RD. 126

8. ESTABLISHING MONITORING AND REPORTING SYSTEMS

Monitoring and evaluation is an integral component of the WHO strategy on research for health. In order to monitor the implementation of the elements and their impact a framework has been developed. under which , the elements of the strategy were organized usi g the logi odel of inputsactivities, outputs, outcomes and impacts, and corresponding indicators were defined. 127 The development of the framework and methodologies for assessment of national health research systems in general started in 2001 by COHRED. 128 The COHREDassessment methodology has been extensively applied covering several countries all over the world, including SEARO-member countries. A ME framework for GSPA-PHI was formulated during 2011 discussion focused solely on element 8 of GSPA. 8.1 Measuring performance and progress towards objectives contained in the strategy and plan of action Element 8 of the GSPA calls for the establishment of systems to monitor performance and progress of the implementation of each element, particularly on the following areas: a. Gaps and needs related to health products and medical devices in developed and developing countries; b. Impact of intellectual property and other issues addressed in the CIPIH report on the development of, and access to health care products from a public health perspective; 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