Supporting governments to develop or improve national health research programmes

14 India In India, its 2011 National Health Research Policy has the following objectives: 51  Identify priorities for effective and ethical health research in accordance with national health agendas and global commitments such as MDG and IHR.,  Foster inter-sectorial coordination to promote innovation leading to effective translation to indigenous production of diagnostics, vaccines, therapeutics, and medical devices etc.  Focus on the vulnerable, the disadvantaged the marginalized sections of society.  Strengthen national networks  Set strategies and mechanisms to assess the cost effectiveness and cost benefits of health interventions.  Create, nurture human resources and infrastructure, encourage international collaborative research which contributes to national health. In addition to the National Health Research Policy, India also has a number of related policies and bills which promotes its national health research programme. These include:  Food Safety and Standard Amendment Bill 2014 introduced in Rajya Sabha  The Indian Medical Council Amendment Bill 2013  The Drug and Cosmetics Amendment Bill 2013  The National Commission for Human Resources for Health Bill, 2011 Biotech Authority Bill 2013Global A comprehensive listing of the different institutionsorganizations providing support to national health research programs and its components and the mechanisms through which various forms of support are provided was prepared by the WHO Secretariat as a background document for the open-ended meeting in November, 2012. 52 During the III Meeting of BRICS Health Ministers in Cape Town on 7 November, 2013 a communiqué was released summarizing the important decisions reached during the meeting. 53 Two of the items listed in the communiqué were related to GSPA-PHI and the promotion of health RD in BRICS countries, namely: a. Reiterated their support for the full implementation of the WHO GSPA-PHI which gave rise to the Consultative Expert Group on Research and Development, and, in this context, drew attention to WHA Resolutions WHA66.22 and WHA65.24 with specific reference on demonstration projects. Acknowledged the value and need for experience and knowledge sharing. Urged BRICS countries to fully participate in the process of implementation of the identified projects through the establishment of networks and expert committees. b. Focused on the unique strength of BRICS countries such as capacity for RD and manufacturing of affordable health products and capability to conduct clinical trials. Called for enhanced cooperation in application of biotechnology for health benefits for the population of BRICS and other developing countries. 15

2.2 Promoting upstream research and product development in developing countries

Regional Among the new mechanisms for upstream RD collaboration and resource sharing is the use of open source infrastructure. An example is the Open Source Drug Discovery Infrastructure OSDDI hi h is a i itiati e led I dia s Cou il o “ ie tifi a d I dust ial ‘esea h. 54 A more detailed description of this initiative is presented in Section 4.3 .. In Bangladesh, there are 15 companies engaged in the production of Active Pharmaceutical Ingredients APIs. However, only few of these companies have full-fledge RD Laboratories for the development of APIs. Most of them are manufacturing under technology transfer either from India or China. 55 Global Another type of upstream platform which has been implemented is that of the Structural Genomics Consortium SGC. The crystallization facility of the TB Structural Genomics Consortium is one of nine P50 structural genomics centers sponsored by the US National Institutes of Health. It provides TB consortium members with automated crystallization, data collection, and basic molecular replacement structure solution up to bias-minimized maps. In contrast to venture capital -funded commercial enterprises, the TB consortium facilities are decentralized and aim to develop high-throughput crystallography methods and automation on a comparatively small budget. In addition to financial constraints, the logistics and organization of a production environment differ considerably from academic settings. The TB Structural Genomics Consortium crystallization facility may thus provide a model for cost-effective, efficient high-throughput crystallography. 56 The SGC contributed 29.6 of the global output of novel human protein target structures in 2009. These research outputs are free from restrictions on use and are not covered by intellectual property. 54 2.3 Improving cooperation, participation and coordination of health and biomedical research and development Regional The South East Asia Infectious Disease Clinical Research Network SEAICRN, set up in 2005, is a collaborative partnership between hospitals and research institutions within Thailand, Viet Nam and Indonesia, the National Institutes of Allergy and Infectious Diseases USA and the Wellcome Trust UK. 57 it was created in order to develop the necessary partnerships in South East Asia in order to: a. conduct collaborative clinical research that addresses emerging threats; b. increase evidence-based scientific knowledge; and c. directly contribute to improving the clinical management of infectious diseases of public health importance. 16 In 2011, the ASEAN-NDI was launched with the following objectives: 23 1. To develop projects leading to the discovery and development of novel drugs, vaccines, and diagnostics for tropical and other diseases carried out by teams of collaborating investigators and institutions in the network using knowledge management principles; 2. To provide a knowledge management platform and framework for scientific, legal and ethical support that promote investment in projects and partnerships for the discovery and development of pharmaceutical products; and 3. To facilitate creation of South- based cross-border institutions like public private partnerships, networks of academic institutions and not-for profit foundations, focusing on, and dedicated to, innovation for discovery and development of drugs and diagnostic tests in ASEAN network members and the ASEAN dialogue countries. The network is an initiative of ASEAN and is supported by the World Health Organization WHO TDR. Global Another Asian network established in 2009 is the Chinese Network for Drugs and Diagnostic Innovation,. 58 fou ded ith the suppo t of WHOTD‘, Chi a s CDC a d the Mi ist of “ ie e a d Technology. The participants include major universities, research institutes, hospitals, multinational pharmaceutical companies and biotech companies. Its mission is : 1. To establish a network that shares scientific information and technical resources to leverage product RD activities nationwide; 2. To develop workable mechanisms by which public-private partnerships in neglected diseases can flourish in China; and 3. To assist in intellectual property rights protection and advance legitimate interests of the network members. Among the initial activities of the network were the conduct of an RD landscape mapping and the organization of an international workshop on quality in clinical research. The establishment of the African Network for Drugs and Diagnostics Innovation DNDi in 2008 was mentioned earlier in Section 3.1.3.2 of this report. Its vision is to create a sustainable platform for Af i a esea h a d de elop e t i o atio s to add ess Af i a s health eeds. Its p i a objective is to promote and support health product RD led by African institutions for diseases of high prevalence in the continent. The expected outcome is the discovery, development and delivery of affordable new health tools including those based on traditional medicine, as well as the development of capacity and establishment of centres of research excellence. 46