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Brown Bag Briefing New York, 3 April 2014 Tenu Avafia HIV, Health and Development Group

The Access and Delivery Partnership - New Health Technologies for TB, Malaria and Neglected Tropical Diseases

May 24, 2015


Health & Medicine

Presentation on the Access and Delivery Partnership by Tenu Avafia, 3 April 2014.

The presentation covered:
-Impact of NTDs, TB and Malaria on development outcomes;
-Dual challenges of Innovation and Access;
-Government of Japan and UNDP Partnership: Addressing innovation & Access
-Access and Delivery Partnership: strengthening capacity across the health system
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  • 1. Brown Bag Briefing New York, 3 April 2014 Tenu Avafia HIV, Health and Development Group

2. Introduction 1. Impact of NTDs, TB and Malaria on development outcomes 2. Dual challenges of Innovation and Access 3. GOJ and UNDP Partnership: Addressing innovation & Access 4. Access and Delivery Partnership: strengthening capacity across the health system 3. Impact of NTDs, TB and Malaria on development outcomes 4. Impact of TB, Malaria & NTDs on Development 8.6 million TB infections a year globally 1.3 million TB deaths a year More than 95% deaths in LMICs 20% of HIV deaths are TB related, Growing levels of MDR TB 207 million cases of malaria globally a year More than 620 000 deaths annually More than 90% among children under 5 in Africa The 17 diseases defined by WHO as NTDs are endemic in 149 countries at least 100 countries are endemic for two or more diseases 30 countries are endemic for six or more NTDs 5. 17 Neglected diseases as identified by WHO Buruli Ulcer (Mycobacterium ulcerans infection) Chagas disease Dengue/Severe dengue Schistosomiasis (bilharzia) Dracunculiasis (guinea- worm disease) Foodborne trematodiases Human African trypanosomiasis (Sleeping sickness) Leishmaniasis Leprosy Lymphatic filariasis Onchocerciasis (River blindness) Rabies Echinococcosis Soil transmitted helminthiases Taeniasis/Cysticercosis Trachoma Yaws (Endemic treponematoses) 6. Impact of TB, Malaria and NTDs on Development outcomes NTDs kill fewer people than TB and Malaria BUT They account for 11.7% of all global disease burden Are responsible for high morbidity and premature death and disability Other impacts include: chronic disability resulting in impaired child growth intellectual and cognitive development impaired pregnancy outcomes decreased worker productivity 7. Dual challenges of Innovation and Access for NTDs, TB and Malaria 8. The R&D Landscape for TB, Malaria and NTDs 2000 2011 850 new therapeutic products registered in 2000-2011 37 (4%) were indicated for neglected diseases 336 new chemical entities only four new chemical entities (1%) were approved for neglected diseases (three for malaria, one for diarrhoeal disease) 148 445 clinical trials registered only 2016 (1%) were for neglected tropical diseases 9. Insufficient innovation for NTDs January 2014, AstraZeneca announces withdrawal from all early R&D for TB, Malaria and NTDs to focus efforts on drugs for cancer and hypertension Pfizer stopped R&D into all anti-infective drugs in 2012 In 2012, only a third of funding required to undertake R&D for new TB products was made available Looming crisis in antibiotic resistance coupled with insufficient innovation 10. NTD treatments, outdated & ineffective MDR-TB treatment takes 2 years and includes: 8 months of daily injections 14 000 tablets to swallow Toxic side effects (deafness, psychosis and severe nausea) AND Less than 50% of patients are cured Treatment can still cost in excess of $ 5000 per patient per year human African trypanosomiasis, Chagas disease, leishmaniasis all need new and safer medicines Innovation is one piece of the puzzle Other is the capacity of a health system to absorb a new product Depends on various factors: including: Legal and regulatory environment Health care delivery systems Supply chain management Medicines regulatory capacity Adequate human resources Sustainable financing mechanism to produce Appropriate pricing policies 11. The Government of Japan and UNDP Partnership: Addressing innovation & Access 12. GOJ and UNDP Partnership Addressing innovation & Access The Government of Japan Global Health Policy 2011-2015 Calls for a new approach & new partnerships to stimulate R&D in TB, malaria and NTDs UNDP Strategic plan 2014-2017 (poverty and inequality reduction, human security) Complementary and synergistic projects: GHIT Fund: GOJ partnership with BMGF & Japanese research organizations to create a fund to promote engagement of Japanese research organizations in product development for global health Access & Delivery Partnership : GOJ funding to strengthen capacities of LMICs to access and absorb new health technologies as they become available 13. GLOBAL HEALTH INNOVATION TECHNOLOGY (GHIT) FUND WHO TDR PATH NATIONAL PARTNERS UNDP JAPANESE PHARMACEUTICAL SECTOR BMGF ACCESS AND DELIVERY PARTNERSHIP TECHNICAL AND POLICY ADVICE CAPACITY BUILDING FOR ABSORPTION PDPS FOR NEW HEALTH TECHNOLOGIES PPPs FOR NEW HEALTH TECHNOLOGIES IMPROVED ACCESS AND DELIVERY OF NEW HEALTH TECHNOLOGIES FOR TB, MALARIA AND OTHER NTDS GHIT, Access and Delivery partnership 14. Government of Japan funded: US$3.5 million per annum over 2013-2018 Comprising 3 implementing global initiatives bodies + partner LMICs + other stakeholders UNDP (HIV, Health and Development Unit, BDP) WHO (The Special Programme for Research and Training in Tropical Diseases) PATH Access and Delivery Partnership 15. To provide technical and policy advice on how to improve access and delivery of health technologies in LMICS and to strengthen capacity in LMICs to achieve this result To develop capacity of LMICs to absorb new health technologies Access and Delivery Partnership: Aims 16. Promoting appropriate linkages between innovation and access Facilitating strategic South-South collaboration Ensuring sustainable and affordable access to health technologies Adding value to existing initiatives Access and Delivery Partnership: Strategic Directions 17. Access and Delivery Partnership: strengthening capacity across health systems 18. Collaborative approach: identifying project activities with stakeholders, including: Policy makers and development partners agencies in select LMICS Members of civil society and Academia Interfacing with UNDP Country Offices (global project) RECs (African Union, ASEAN Secretariat, etc); and Multi-stakeholder expert Advisory Group established to provide strategic and related advice comprising of: Research institutes from the South (Oswaldo Cruz, CSIR) Regional economic organizations Experts in R&D in NTDs Representatives of civil Society/patient groups The Access and Delivery Partnership Approach 19. UNDP Project oversight function Co-ordination of project operations Manage interface with donors Oversee financial resources Co-ordinate partnership with WHO-TDR & PATH Regular audits of Project funding 20. IMPROVED ACCESS AND DELIVERY FOR TB, MALARIA AND OTHER NTDs Integrated public health, innovation and industrial policies OUTPUT 1 Policy & legal frameworks Disease control programmes & drug regulatory frameworks OUTPUT 2 Evaluation of epidemiological studies OUTPUT 3 Monitoring of Phase IV clinical trials Financing for procurement & innovation OUTPUT 4a Financing for new health technologies OUTPUT 4b Commercialization pricing and supply Procurement and supply chain management OUTPUT 5 Supply chain and delivery systems Led by UNDP Led by WHO/TDR Led by PATH Capacity Strengthening Across the Value Chain of Access and Delivery 21. INTEGRATED PUBLIC HEALTH, INNOVATION AND INDUSTRIAL POLICIES OUTPUT 1: Support strengthening of legal and policy frameworks, to expedite access and delivery of new health technologies for TB, Malaria, and NTDs Access and Delivery partnership: Strengthening Capacity across the value chain 22. Defining policy and legal coherence Review of policies and laws at the intersections between public health and drug regulation, industrial policy, innovation, technology transfer and intellectual property rights Analysis of implications of existing policy and legal framework for access and delivery Prioritizing domestic needs to strike an appropriate balance between current/immediate needs and for the development of future capacities Process of consultation, prioritization and reconciling differing objectives and goals 23. Review and analysis of policy & legal framework Success of policy and legal framework in achieving key policy objectives of government: strengthening of health system and multi-sectoral collaboration within relevant ministries Significant developments in country: Phase out of GFATM funding National health insurance universal health coverage Trade, investment and industrial policies promoting local production capacity Revision of patent, medicines, competition laws 24. Coordinate with various ministries >> trade/commerce, health, industry, education, etc. Consult with stakeholders >> HIV networks, patient groups, domestic pharmaceutical industry, etc. Learn from experiences of other countries, both developed and developing Obtain technical advice and support policy advice and technical support from UNDP HIV, Health and Development Practice Provide relevant training for implementation of law national patent examiners training to integrate public interest and public health in patent examination process Design and development of national patent law 25. DISEASE CONTROL PROGRAMMES AND DRUG REGULATORY FRAMEWORKS OUTPUT 2: Build capacity on evaluation of epidemiological studies to understand country specific needs for new health technologies, potential market size, and user perspectives. OUTPUT 3: Strengthen health sector capacity in monitoring of Phase IV trials Access and Delivery partnership: Strengthening Capacity across the value chain 26. FINANCING FOR PROCUREMENT AND INNOVATION OUTPUT 4A: Strengthen capacity within LMICs to ensure the financing of new global health technologies. OUTPUT 4B: Build capacity on comercialization to ensure that new global health technologies are priced appropriately and supply meets population demand Access and Delivery partnership: Strengthening Capacity across the value chain 27. PROCUREMENT AND SUPPLY CHAIN MANAGEMENT OUTPUT 5 Strengthen capacity of delivery systems including supply chain of new global health technologies for TB, Malaria and other NTDs Access and Delivery partnership: Strengthening Capacity across the value chain 28. Access & Delivery partnership country implementation Long list of 10 countries mapped against various criteria Disease burden Legal and regulatory environment Government and potential impact Country office support Proposed that Project be initiated in 3 countries in phase 1 Tanzania Indonesia Ghana More countries may be added in the course of the project cycle on a demand driven process opportunities for south-south capacity strengthening will be prioritized