Endeavoring to secure adequate and sustainable financing for research and development

41  TDB sanction: 40.44 million Major projects funded:  Vaccines: Shanvac-B; Revac-B; LARV; FMD Vaccine  Drugs: INF alfa; Indikinase; Cefixine, Betacarotene; Human growth Factor, anti-infectives  Devices: Bone grafts; Membrane oxygenators; microarray chips; telemedicine solutions  Facilities for: Vaccine manufacturing; API manufacturing; Organ transplant; CRO Testing; Tissue based product development for clinical use Global The technical consultation meetings on innovative models for new antibiotic development held in Geneva in 2014 98 and the earlier workshop held in Uppsala Sweden in 2010 54, as described in section 4.3, are examples of expert working groups trying to examine current financing and coordination for health research and development. While product development partnerships PDPs have revitalized the search for drugs, vaccines and other health technologies for the developing world, it is anticipated that they will need more funding in the coming years for expensive late-stage clinical trials as well as for expanded discovery research to replenish their product pipelines. In relation to these needs, current financing for the PDPs can be considered as too short-term, insecure and inflexible. In mid-2008, the 3 leading vaccine PDPs – Aeras Global TB Vaccine Foundation, the International AIDS Vaccine Initiative and Malaria Vaccine Initiative set-up a technical working group to explore innovative ways to finance the 3 PDPs. This group decided to analyze in greater depth the idea of augmenting grants to the PDPs with government-backed bond financing. They proposed the establishment of the PDP Financing Facility PDPFP whose objective is to make available, through government guaranteed loans, some of the economic and social value that their work will create in the future. Proceeds from the sale of bonds in private capital markets would be used to support RD and then repaid when vaccines developed by the 3 PDPs came to market. The funds to repay bonds would derive from a combination of royalties on sales in high and middle-income countries and donor-funded premiums linked to sales of vaccines in low-income countries. 119 Another organization involved in funding health research and development is CIHR. In the early 2000s, CIHR announced that global health research was one of its five major pillars and the Global Health Research Initiative was established. It had limited funding early on, with CIHR, allocating C29.8 million to study Neglected Tropical Diseases from 1999 to 2009. However, since 2008, there has been stronger focus in this area, and more resources were allocated in collaboration with Grand Challenges Canada. Agreements to allocate about 150 million were signed which leveraged more than double the amount of co-funding. 120 42

7.2 Facilitating the maximum use of existing financing Regional

Most of the regional initiatives mentioned earlier in relation to technology transfer Sections 3.4.3.1 and 3.4.2.1 are also examples of various forms of financial support provided to public- private and product development partnerships. During the December 2014 regional meeting on GSPA-PHI assessment, India presented several models they have implemented on resource sharing and collaboration for health research and development. They have successfully implemented several inter-agency joint initiatives, examples of which are: 51 • Joi t e tu e of DBT, ICM‘, MoHFW ith ICM‘ leadi g the i itiati e: I dige ous Diagnostic technologies of TB and MDRXDR TB developed by Indian Scientists Companies • CRDF Global, in partnership with the National Institute of Allergy and Infectious Diseases NIAID, DBT, ICMR and the NIH Office of AIDS research OAR also funds joint teams of U.S. and Indian scientists working in tuberculosis research • DBT – ICMR – DST Programme in Biomedical and Health Research • CONRAD initiated DBT- ICMR joint programme on microbicides • DBT-ICMR –IAVI initiative on HIVAIDS The country has also been successful in financing major innovations through PPP. A listing of such programmes is shown in Table 4 below. Table 4. Programs funded through the PPP scheme in India and corresponding agencies involved AGENCY PPP SCHEME Department of Scientific and Industrial Research Start-ups and MSMEEs scheme PRISM Building Industrial RD promotion Program BIRD Patent acquisition and collaborative research and technology development PACE scheme Technology development and demonstration program TDDP Department of Science and Technology Drug and Pharmaceuticals Research Program Technology Development Board National Innovation Council Cluster Innovation Centers India Inclusive Innovation Fund Department of Information Technology Multiplier Grant Scheme 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