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