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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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Brown Bag Briefing New York, 3 April 2014
Tenu AvafiaHIV, Health and Development Group
Introduction
1. Impact of NTDs, TB and Malaria on development outcomes
2. Dual challenges of Innovation and Access3. GOJ and UNDP Partnership: Addressing innovation
& Access4. Access and Delivery Partnership: strengthening
capacity across the health system
Impact of NTDs, TB and Malaria on development outcomes
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
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)
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
Dual challenges of Innovation and Access for NTDs, TB and Malaria
The R&D Landscape forTB, 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
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
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
The Government of Japan and UNDP Partnership: Addressing innovation & Access
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
GLOBAL HEALTH INNOVATION TECHNOLOGY
(GHIT) FUND
WHO TDR PATH
NATIONAL PARTNERS UNDP
JAPANESE PHARMACEUTICAL
SECTORBMGF
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
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
• 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
• 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
Access and Delivery Partnership: strengthening capacity across health systems
• 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
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
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 epidemiologic
al studies
OUTPUT 3
Monitoring of Phase IV
clinical trials
Financing for procurement &
innovation
OUTPUT 4a
Financing for new health
technologies
OUTPUT 4b
Commercializationpricing 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
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
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
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
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
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
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
PROCUREMENT AND SUPPLY CHAIN MANAGEMENT
OUTPUT 5Strengthen 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
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
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