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Local Pharmaceutical Production in Africa: Policy Role

Explore the role of policy makers in promoting local pharmaceutical production in Africa at the Africa Pharma Conference on June 4, 2019. Topics include health technology innovation, access to essential medicines, and achieving universal health coverage. Learn about the challenges and opportunities for local production in addressing HIV, TB, malaria, and other diseases. Discover strategies, financing sustainability, and policy coherence to support the development of a robust local production ecosystem.

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Local Pharmaceutical Production in Africa: Policy Role

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  1. Local pharmaceutical production in Africa:What role for policy makers?Africa Pharma Conference4 June 2019 Dr. Tenu Avafia HIV, Health and Development Group UNDP

  2. Agenda 2030 - Health Technology Innovation and Access 2 • End the epidemics of AIDS, TB and Malaria by 2030 • Achieve universal health coverage, including financial risk protection, access to quality essential health-care services and access to safe, effective, quality and affordable essential medicines and vaccines for all • Support the research and development of vaccines and medicines for the communicable and non-communicable diseases that primarily affect developing countries, provide access to affordable essential medicines and vaccines, in accordance with the Doha Declaration on TRIPS and Public Health

  3. Health technologies needed to attain UHC • Drugs • Biologics • Vaccines • Diagnostics • Medical devices • Digital technologies

  4. A long way away from UHC • 36.9 million people are living with HIV, 940 000 deaths in 2017 • 10 million TB infections, 1.6 million deaths • Estimated 400 million people have hepatitis C, 1.4 million deaths • 1.4 billion people at risk of Neglected Tropical Diseases • 219 million cases of malaria, 435,000 deaths • NCDs kill 38 million people each year, 75% of in LMICs

  5. Health treatment and Financing sustainability • ART scale up made possible by multilateral health financing mechanisms (Global Fund, PEPFAR) • Sustainability of funding for multilateral health financing mechanisms is unclear • Eligibility of middle income African countries for funding decreasing • 800 million people spend at least 10% of their household income on health care • Out of pocket expenses drive almost 100 million people into poverty each year

  6. What role for local production in Africa? • UHC requires dual strategies of importation and local production for ANY country • 40% of generics in the US market are from India • 3 manufacturers of APIs in Africa, two in South Africa • Handful of countries with significant local manufacturing capacity • Economies of scale are critical • Local production is not a silver bullet: It is a potentially important tool in a large toolbox

  7. 1. Long term vision enforced by political will • Japanese government’s industrial policy in post WWII identified promising sectors • In 1960s, automobile industry was weak, exports of Toyota to USA failed • Deliberate decision taken to develop automobile sector • Japan banned foreign car imports • Government invested significant public funds to save Toyota from bankruptcy • Government policies in 1970s encouraged increased R&D • Toyota improved its existing technological capabilities, began to invest in R&D • 50 years later, Lexus is a highly desired luxury car brand in the US and elsewhere • India’s generic pharmaceutical manufacturing industry also developed through deliberate government policies

  8. 2. Preserving policy space, promoting coherence • Since formal recognition of IP, exceptions have existed • First US patent law barred foreigners from filing patents 1790-1836 • Brazil & India changed colonial laws to exclude pharmaceutical products from being patented, stimulating innovation • Before the TRIPS Agreement, up to 50 countries did not grant patents for pharmaceutical products • TRIPS prescribes minimum standards for IP protection & enforcement • There are important flexibilities within the TRIPS Agreement • LDC waiver

  9. 2. Preserving policy space, promoting coherence “Ministries in most national cabinets operate in an asymmetrical power structure and do not necessarily coordinate, thus fueling policy incoherence at the national level Country- level, inter-sectoral coordination could be an important catalyst to supporting governments to translate policy space into coherent and comprehensive laws” • Aligning industrial policy with legal and regulatory environment • government procurement favoring local production • Infant industry protection • Fiscal and tariff levers

  10. 3. Addressing the entire local production ecosystem • Addressing regulatory barriers e.g. for registration of medical products • Strengthening Drug Regulatory Authorities for e.g. Pharmacovigilance • Investing in infrastructure • Fostering skilled workforce • Improving procurement efficiencies e.g. incentivizing local manufacturers where appropriate • Addressing supply chain bottlenecks

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