call to governments: boost innovation for neglected diseases bernard pécoul executive director msf...
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Call to governments: Boost innovation for neglected diseases
Bernard Pécoul
Executive Director
MSF meeting 8 June 2005
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Neglected patients need new drugs, vaccines and diagnostics NOW
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World pharmaceutical market> $518 bn in 2004
Neglected Diseases
Most Neglected Diseases
Global Diseases
Neglected diseases desperately need new therapies
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Sleeping sickness is a most neglected disease
• An estimated 300,000 infected
• 55 million at risk in sub-Saharan Africa
• Difficult to diagnose
• Fatal if untreated
• Existing drugs: old - toxic - resistance - difficult to use - expensive
Sou
rce:
WH
O 2
001
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rce:
WH
O 2
001
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The needs remain huge
Arsenical Anti-cancer drug
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Leishmaniasis: 350 million at risk
• An estimated 12 million people affected in 88 countries Different forms: visceral, (muco)cutaneous, PKDL
• Per year: 1-1.5 million new cases of CL/MCL
500,000 cases of VL
• VL is fatal if left untreated
• Existing drugs: old - toxic - resistance - difficult to use - expensive
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Chagas disease: 18 million infected
• Endemic in Latin America• Threatens 100 million people in 21 countries • In about one-third of the acute cases, chronic forms
develop 10 – 20 years after infection • Severe chronic disease leads to death • Only two drugs for this disease – not effective for
chronic patients
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No drugs at all for Buruli ulcer
Source: WHO, WHO/CDS/CPE/GBUI/2001.1
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But it is still a neglected disease for adults and children living in developing countries
• Drugs not adapted to health systems of endemic countries
• No treatment adapted to children
• Limited tools for diagnosis and follow up
• No field-adapted preventive tools
18 new drugs for AIDS
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The fatal imbalance
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Rest of Europe $9bn (1.8%)
Japan $58bn (11.1%)
Latin America $19bn (3.8%)
Asia, Africa and Australia $40bn
(7.7%)
North America $248bn (47.8%)
EU $144bn (27.8%)
Developing countries have a tiny share of the pharma marketWorld Pharmaceutical Market, 2004: Total $518 billion
Source: IMS Health
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Only 1% of new drugs developed are for neglected diseases
Tropical diseases: 13
Tuberculosis: 3
• Approx. 1-2% is spent on R&D for neglected diseases
• 10/90 gap in health research spending
• 1975-1999: 1,393 new chemical entities marketed
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In spite of
• Huge increase in global funding for health research - from $30 bn in 1986 to US$106bn for 2004
(Monitoring Financial Flows for Health Research, Global Forum for Health Research, 2004)
• Higher levels of intellectual property protection have not resulted in increased drug R&D for global health needs
(UK Commission on Intellectual Property Rights, 2002)
Insignificant progress towards new health tools for the poor
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Gaps exist in the R&D process for neglected diseases
New knowledge on drug targets and lead compounds is published but pre-clinical research does not begin
Validated candidate drugs do not enter clinical
development because of strategic company
choices.
New or existing drugs do not reach patients: registration
problems, lack of production, high prices, or not adapted to
the local conditions of use
mainly public sector
mainly industry (in North)
Availabilityto patients
DevelopmentPre
ClinicalDiscovery
GAP2 GAP3
GAP1
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In recent years…
• Increased awareness from the global community
• Developing countries strengthening their R&D capacity
• New not-for-profit initiatives established
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DNDi is an alternative model
• To develop new drugs for neglected
diseases
• Ensure equitable access to needs-driven
products
• Strengthen existing capacity in disease-
endemic countries
• Build public responsibility and leadership
• Bring together the public sector and
pharmaceutical industry
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DNDi was created in 2003
Kenya Medical Research Institute (KEMRI)
WHO/TDR (permanent observer)
Medecins Sans Frontieres (MSF)
Malaysian Ministry of Health
Institut Pasteur, France
Oswaldo Cruz Foundation, Brazil
Indian Council for Medical Research (ICMR)
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18 projects in DNDi’s portfolio 2005
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• Easy to use: fewer tablets in treatment regimen
• Affordable: Target price for public sector, <$1 for adult and $0.5 for children
• Available: 2006, non exclusive rights
2 new malaria drugs in 2006
e.g. DNDi/sanofi-aventis agree to deliver AS/AQ anti- malarial fixed dose combination
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1. More public leadership
• Make global health and medicines a strategic priority
• Set R&D agenda according to the needs of patients
• More than just philanthropy
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Neglected Diseases Appeal
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2. Sustained financial support
• Raise current levels of funding for neglected diseases by 3 billion euros per year to start to correct the 10/90 gap
• Put in place new, sustainable funding mechanisms (IFF, Global tax, …)
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Neglected diseases Appeal
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2. Sustained financial support
focused on: A needs-driven R&D agenda Maintaining basic scientific
research Translation of basic research into
new medicines Strengthening R&D capacity in
DEC Securing the market
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Neglected Diseases Appeal
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3. New rules to stimulate drug R&D
Regulatory standards
• Streamline approval processes
• Analyse risks and benefits of each drug or vaccine
• Build regulatory capacities in developing countries (support from EMEA and FDA )
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Neglected Diseases Appeal
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3: New rules to stimulate drug R&D
Intellectual Property: develop drugs as public goods
• Ensure that public sector develops open access to information
• Ensure that industry provides sustainable access to knowledge, chemical compounds and tools
• Freedom to operate in R&D for ND
• Make technology transfer to disease-endemic countries happen
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Without bold new steps disease will continue to ravage the developing world, with global consequences.
Governments
should
act NOW
Global Appeal
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