Africa Pharma Conference 2019, Johannesburg, 4-5 June 2019

1. Technology Transfer and Local Production: Challenges and OpportunitiesOssy MJ Kasilo, Pharm D, PhDWHO/AFRO, Brazzaville Africa Pharma Conference 2019, Johannesburg, 4-5 June 2019

2. WHO Policy Context of local production • 1969: Resolution WHA22.54 Establishment of Pharmaceutical Production in Developing Countries, Geneva • 2000: Resolution AFR/RC50/R3 on Promoting the Role of TM in health Systems: A Strategy for the African Region, Ouagadougou, • 2005: AFR/RC55/10 Technical document on Regional Local production of pharmaceuticals including ARVs, Maputo • 2008: Resolution WHA61.21 on GSPOA on Public Health, Innovation and Intellectual Property, Geneva • 2013: Resolution AFR/RC63/R3 on Enhancing on Promoting the Role of TM in health Systems: A Strategy for the African Region, Brazzaville

3. WHO Policy Context on Local production: 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:evelopmentneeds 1. Prioritizing research and development needs 2. Promoting research and development3. Building and improving innovative capacity 4. Transfer of technology5. Application and management of intellectual property 6. Improving delivery and access 7. Ensuring sustainable financing mechanisms 8. Establishing monitoring and reporting systems oting research and development

4. What, To whom and Why Transfer Technology (1) • What is TT?: Transfer of methods of manufacturing, knowledge, skills, technologies and samples of manufacturing and facilities • To whom should it transferred?: Within or outside an organization, a geography or an industry/discipline • Why TT?: (a) To increase access to scientific and technological developments; (b) To allow further development of the technology into new products, processes, applications, materials or services; (c) Increase manufacturing capacity and access to products; (d) Share Know-How & Intellectual Property; (e) Lower Cost of Goods

5. Definitions of Technology Transfer (2) • Technology transfer (TT): converting scientific findings into useful products for society • Pharmaceutical industry TT: processes needed for successful progress from drug discovery to product development to clinical trials to full-scale commercialization • The process by which a developer of technology makes their technology available to a commercial partner that will exploit the technology • Importance of pharmaceutical TT for health and economic improvement in developing countries demonstrated in article 66.2 of TRIPS & element 4 of GSPOA

6. What is Transfer Technology (ICH Q10) (3) • Systematic transfer of know-how, knowledge, capability, experience and documentation of product, process or methodology between development and manufacturing or between manufacturing sites within the company or at a third party • Technology transfer forms the basis for process validation, manufacturing process, control strategy, and continuous improvement

7. Examples of Types of Technology Transfer (4) • Clinical trials • Health-related technology transfer • Information technology; • Laboratory testing; Local production; • Project / human resource management • Quality assessment; Supply chain management and logistical issues; • R&D capacity; Training of personnel

8. The Principle of Technology Transfer (5) • If you Give a man a fish, he will eat it for one day. • If you Teach a man to fish, he will eat it for a lifetime. • Therefore, Transfer the technology and teach how to apply it in practice

9. Technology Transfer (WHO perspective)

10. Technology Transfer (WHO perspective)

11. Summary of initiatives for local production and technology transfer (1)

12. Summary of initiatives for local production and technology transfer (2)

13. Summary of initiatives for local production and technology transfer (3)

14. Challenges to local production • Governance: Low accountability in use of and, public funds; Lack of incentives to attract and retain technical staff; and weak regulation • High cost of Financial Resources: Lack of working capital, lack of access to capital for recapitalisation, Higher financing costs, Exorbitant utility tariffs • Poor Infrastructure: Translation and information costs, including knowledge of local markets, cultures and conditions; unreliable supporting infrastructure such as electricity, water and transport

15. Challenges to local production • Human resources constraints:Shortages of skilled personnel, Lack of training facilities for industrial pharmacy • Technology:High production costs related to very old plant and equipment; Lack of technology; Lack of integration with APIs suppliers; and patents on medicines • Lack of economies of scale: A combination of weak production capacity and uncertain markets results in limited economies of operation and weak feasibility. • Lack of collaborative linkages: ambiguous policies and lack of policy coordination between various relevant ministries, departments and institutions

16. Opportunities and perspectives • UHC/SDGs agenda: key players at global, regional and country level, promoting access for all through various initiatives • WHO added value and comparative advantage : mandate, expertise and presence • High level commitments : Various declarations and Resolutions at global and regional levels on Access, Regulation, Substandard and Falsified, AMR etc. • Establishment of AMA will provide an enabling regulatory environment

17. Opportunities and perspectives • Increased prevalence of lifestyle diseases can be more comprehensively addressed through enhanced local production and they represent a growing market opportunity. • Training programmes and institutions exist but need to be expanded and scaled up. • More advanced countries can look to export drugs to international markets. • On-going work under the African Medicines Regulatory Harmonization initiative could lead to defragmented markets at the sub-regional level.

18. Thank You