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
Neglected patients need new drugs, vaccines and diagnostics NOW
World pharmaceutical market> $518 bn in 2004
Neglected Diseases
Most Neglected Diseases
Global Diseases
Neglected diseases desperately need new therapies
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
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The needs remain huge
Arsenical Anti-cancer drug
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
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
No drugs at all for Buruli ulcer
Source: WHO, WHO/CDS/CPE/GBUI/2001.1
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
The fatal imbalance
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
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
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
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
In recent years…
• Increased awareness from the global community
• Developing countries strengthening their R&D capacity
• New not-for-profit initiatives established
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
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)
18 projects in DNDi’s portfolio 2005
• 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
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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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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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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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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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
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