Dr. Tenu Avafia HIV, Health and Development Group UNDP Policy coherence as an enabler for local pharmaceutical production Africa Pharma Conference 5 June 2019 Dr. Tenu Avafia HIV, Health and Development Group UNDP

Underlying Principles of Agenda 2030 UNIVERSALITY INTEGRATION ‘NO ONE LEFT BEHIND’ Policy integration means balancing all three SD dimensions: social, economic growth and environmental protection An integrated approach implies managing trade-offs and maximizing synergies across targets Implies that goals and targets are relevant to all governments and actors: Universality does not mean uniformity. It implies differentiation The principle of ‘no one left behind’ advocates countries to go beyond averages. The SDGs should benefit all – eradicating poverty and reducing inequalities. Building on the unfinished MDG agenda

Global Health Funding Changing Trends Many governments benefit from multilateral health financing programmes like PEPFAR Global Fund and Gavi Several countries are transitioning out of eligibility: burden of disease remains high Botswana, Namibia, Swaziland not eligible for GAVI funds Angola has graduated Ghana on track for accelerated transition Kenya, Sao Tome & Principe, Sudan, Zambia preparing to transition from eligibility from GAVI Funds Countries in transition expected to increase domestic resources for health, may have to pay higher prices

Policy coherence: enabling environment Laws, policies and practices that tailored and harmonized to foster local production Balancing industrial policy and public health objectives (integration) government procurement processes favoring local production E.g. government tenders giving slight price preference to local manufacturers Infant industry protection Fiscal and tariff levers on APIs Laws, policies and incentives promoting local R&D and production Removing barriers to inter and intra regional trade eg Africa Continental Free Trade Area critical

Coherence across multiple stakeholders UN Member States Patients Biomedical private sector industries (originator and generic) Research institutions/academia Financial institutions Regional economic communities (AU, NEPAD,) Development partners Civil society

Preserving policy space, promoting coherence One size does not fit all 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 TRIPS Agreement reflects the fact that governments may want to take different policy approaches There are important flexibilities within the TRIPS Agreement that can be employed alongside voluntary licensing LDC waiver was central to development of industries in Bangladesh and Uganda

Promoting coherence: Governance mechanisms “Ministries in most national cabinets operate in an asymmetrical power structure and do not necessarily coordinate, thus fueling policy incoherence at the national level. “Governments should strengthen policy and institutional coherence by establishing national inter-ministerial bodies to coordinate laws, policies and practices that may impact on health technology innovation and access”

Promoting coherence: multisectoral co-ordination “Appropriate member/s of the national executive who can manage competing priorities, mandates and interests should convene such bodies” UNDP has supported national governments to promote cross-sectoral cooperation and policy alignment for quicker introduction and uptake of new health technologies

Coherence across the health ecosystem “Governments should strengthen policy and institutional coherence by establishing national inter-ministerial bodies to coordinate laws, policies and practices that may impact on health technology innovation and access” “Appropriate member/s of the national executive who can manage competing priorities, mandates and interests should convene such bodies”

Three mutually reinforcing axes Multisectoral coordination platforms for national stakeholders National roadmap for policy and regulatory harmonization Technical and capacity strengthening support to analyse policies, laws and regulations Support sustainable procurement in the health sector Strengthen policy and regulatory harmonization Identify and address specific capacity gaps, and institutionalize good practices within relevant national institutions across the value chain Develop and implement context-specific tools and guidelines Strengthen institutions for accelerating introduction and access Impact beyond focus countries through South-South exchange and learning Develop and disseminate region-specific tools and approaches; e.g., regulatory harmonization Track progress made towards meeting local pharmaceutical production regional and global platforms for technology delivery preparedness Enhanced Availability, Affordability and Accessibility of Quality-Assured Health Technologies

Coherence across the local production ecosystem Addressing regulatory barriers e.g. for registration of medical products Strengthening Drug Regulatory Authorities for e.g. Pharmacovigilance Investing in infrastructure Access to capital (at reasonable interest rates) Fostering skilled workforce Improving procurement efficiencies e.g. incentivizing local manufacturers where appropriate Addressing supply chain bottlenecks