1. A Health Innovation Systems Approach: The Opportunity and the Challenge Dr. Padmashree Gehl Sampath Department for Public Health, Innovation and Intellectual Property, WHO, Geneva A Health Innovation Systems Approach: The Opportunity and the Challenge Dr. Padmashree Gehl Sampath Department for Public Health, Innovation and Intellectual Property, WHO, Geneva

2. Where is development in our understanding of innovation? Much more than R&D goes into creating an innovation system for health. Health innovation includes all forms of innovation – process, product and organizational – that are required to conduct basic research and development as well as ensure delivery of marketable drugs of importance to human health. Thus defined, drug R&D at the frontier is one aspect of health innovation. But at the same time, it includes all forms of discovery, development and delivery that may or may not be new at the frontier, but may be new to the firm, the local context or the country in question.

3. Important issues can be addresses: What is the link between the upstream, higher technology initiatives and the struggle in countries to build production capacity? What are the policies that impact the development of successful health innovation systems? How can countries promote health innovation through S-S collaborations, technology transfer and other initiatives.

4. Motivation First, to reconcile theory and evidence on health innovation in the particular context of development. Second, while much progress has been made in the ways evolutionary and institutional economics interprets innovation, technology and learning; studies that advance this scholarship leave behind large sets of countries.

5. Motivation Third, the literature on technology and innovation on the one hand and the so-called new development framework on the other can be made to address broader issues of latecomer development. Fourth, there is a need to move beyond what we know from technology, to understand the broader social processes that explain the structural transformation of countries. Need to broadening of the debate under a health innovation framework might better capture the variegated hues of issues and countries under the label of late development.

6. A health innovation perspective… helps to take a holistic approach by focusing on three main dimensions of sectors: Knowledge and technological domain How is knowledge accumulated and used, the role of tacit (skills) and codified knowledge in capabilities formation Actors and networks a) Diversity of actors has an impact on specialization b) Collaboration between actors impacts upon the development of valuable innovations Institutions provide the basic framework for innovation to flourish. Includes routines, habits of exchange, established practices, rules, laws, standards, etc.

7. Emphasizes on the role of collaboration and extension of existing capabilities.

8. Consists of a wide range of actors and networks… … who impact upon knowledge accumulation and use, and also the way important innovations help development. Includes Private Sector Firms/ government-held enterprises Universities Public Research Institutes Hospitals and Medical Service Agencies Traditional Medicine Healers and Hospitals Governmental Agencies under Ministry of Science & Tech, Ministry of Health and Ministry of Industries, Trade and Commerce Pharma Producers Associations, Pharma Alliances, etc.

9. Limitations in macro, meso & micro environment MACRO LEVEL Lack of coherent policy at the national and sectoral level that sets priorities on the technological side. Lack of institutional apparatus to promote technological and social innovations for health Lack of policy emphasis on collaboration Low funding to public sector science Weak knowledge indicators Low emphasis on local knowledge creation for the sector. MICRO LEVEL Lack of collaborative culture between scientists, researchers and health practitioners Slow uptake of new ideas and incentives by the public sector institutes and universities. Lack of ability to articulate/ gauge local demand Lack of adequate human skills No labour mobility Stunted or completely absent private sector enterprise

10. Institutions and Policies for health innovation Policies and institutions should target the dynamic evolution of the sector from production to innovation Incremental approaches are important, new forms of collaborations and novel hybrid arrangements that promote needs-based innovation A range of policies affect health innovation systems and this includes: –Science and technology policies –Pharmaceutical production policies –Policies fostering small and medium enterprises –2 ary and 3 ary education policies –Technology transfer policy –Intellectual property policy

11. The Health innovation systems approach helps to look at how all these link into various aspects of the health system: –creation of useful medicines, –production of existing medicines and –distribution and access to medicines to all Are treated as equally important Helps us to identify the policies and interventions that were successful and the reasons for failure.

12. Applying this to countries and sectors, two important results stand out: 1.First, while a sectoral innovation system has several components, its success depends on institutions that help coordinate efforts of all actors in the system. Institutions, defined as the “rules of the game” and institutional capacity defined as “the capacity of the state to provide the basic rules for actor interaction and coordination”, lie at the heart of the issue. 2.Second, health innovation is a much broader and complex sector than pharmaceuticals or biotechnology. It not only has a broader technological base and a wider range of actors, but it spans well beyond the realm of mere technological innovation to include social and institutional innovations. It therefore calls for rigorous framework that could help analyse the issues in building capacity.

13. Applying this to countries and sectors, three important results stand out: 3. There are local “push” factors that constantly interact with global “pull” factors in shaping country and regional responses to health innovation. These need to be fostered and strengthened. Push factors: consistent investment in knowledge infrastructure, policy incentives, significant local demand. Pull factors: IPRs and the WTO rules, partnering opportunities, emerging models of S-S collabroation, international acquisitions and value chains.

14. The Context Resolution WHA61.21 The global strategy is designed to promote innovation, build capacity, improve access and mobilize resources. The elements of the plan of action: 1.prioritizing research and development needs 2.promoting research and development 3.building and improving innovative capacity 4.transfer of technology 5.application and management of intellectual property 6.improving delivery and access 7.ensuring sustainable financing mechanisms 8.establishing monitoring and reporting systems

15. Thank You