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

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