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Transcript of Creating Access for Health Technologies in Poor Countries Harvard University Michael R. Reich 2...
Creating Access for Health Technologies in
Poor Countries
Harvard UniversityMichael R. Reich
2 December 2009
Based on book published by the Harvard Center for
Population & Development
Studies
www.accessbook.org
downloadablefor free
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The Gates Foundation
Bill Gates speaking at the World Health Assembly, 16 May 2005
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Overall Goal
Assist the Gates Foundation in understanding and more effectively planning for success for its product
development portfolio
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These phases provided the structure for the case studies
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One Vaccine: Hepatitis B Vaccine
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One Contraceptive: Norplant
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One Device: Vaccine Vial Monitor
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One Dual-Protection Technology: Female Condom
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One Diagnostic: Malaria Rapid Diagnostic Tests
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Source: Schistosomiasis Control Initiative http://www.schisto.org/Zambia
One Medicine: Praziquantel
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Source: Schistosomiasis Control Initiative http://www.schisto.org/Zambia
Discussion of Praziquantel
The Worm
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Praziquantel: 2-(cyclohexylcarbonyl)-1,2,3,6,7,11b - hexahydro-4H-pyrazino(2,1-a) isoquinolin- 4-one
C 19 H 24 N 2 O 2
The Drug
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The Parasite
• Bloodborne fluke of schistosoma
• 5 species, two dominate in Africa
• endemic in 70 tropical and sub-tropical countries
• chronic and debilitating disease
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Schistosoma Life Cycle
Two-host cycle: Humans are the
definitive host of schistosomes,* while snails are the obligatory (necessary) intermediate host
*except for S. Japonicum, which also has animal hosts
Global Distribution of Schistosomaisis
almost eradicatedongoing large-scale control programmeslimited or no control
Source: WHO, 2000
Status of Control Programs
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Sub-Saharan Africa
• Schistosomiasis is the second most prevalent parasitic disease in Africa and a major source of chronic morbidity in that continent
• Successful cases of national control except in sub-Saharan Africa
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Risk Factors for Transmission
• Exposure to host snail-infested water – Bathing & Swimming– Washing & Drinking– Farming & Fishing
• Irrigation and water projects can expand habitats for snails, facilitate transmission
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High Risk Groups
• School-age children, young adults
• Women• Special occupational groups,
including farmers and fisherman
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Health Consequences:Infection Stage
Signs andSymptoms
Outcomes:Disabling
•Variable hepato-splenomegaly•Abdominal pain, blood in stool•Haematuria•Malnutrition and anemia
•Growth retardation•Cognitive impairment•Increased susceptibility to other infections
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Health Consequences:Severe Disease Stage
Signs and Symptoms
Outcomes:Life-threatening
•Hepatosplenomegaly•Ascites•Dysuria•Renal Colic•Haematuria
•Portal hypertension Haematemesis•Obstructive uropathy Renal failure•Bladder cancer (risk factor for)
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Global Distribution of Schistosomiasis
Total persons infected (global): 200 million
Total persons infected (Africa): 170 million
Persons with associated morbidity: 120 million
Mortality Unknown, but 20 million severely
infected
Chitsulo 2000, citing WHO 1985, 1993
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Breaking the Cycle: Schistosomiasis Control Points
Improve Water and Sanitation:Prevent people from being exposed to
schisto cercariae in infested waters
Stages inSchistosomiasis
Transmission
Chemotherapy:
Treat people toreduce morbidity and
to egg output (re-contamination of
water)
Education/CommunicationChange behaviors to
reduce risk of exposure,reduce contamination of
water
SanitationReduces transmission of eggs
from human to snail host
Molluscucides &Env. Control
Destroy snail habitats
Control snails
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Development of PZQ
• Interfirm collaboration between two German companies, E. Merck and Bayer
• In early 1970s, searching for new tranquilizers with few side effects
• Developed for veterinary market, when found effective against trematodes and cestodes
• Then approached WHO in late 1970s for collaboration to develop for human use
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An Effective Treatment
• Praziquantel became the universal drug of choice for all forms of schistosomiasis
• Single oral dose (40 mg/kg body weight)• Safe with minimal side effects • Efficacious with 60-90% cure rate and
more than 90% egg reduction• 2-3 treatments during childhood reduce
severe morbidity later
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Price of PZQ in 1980s
• Initially, $6.50 per 600 mg tablet in Germany market, $1 per tablet at concessionary WHO price
• No African government could afford
• Foreign assistance supported national control programs, such as GTZ in Mali
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Establishment of SCI
• Gates Foundation gives $28M for Schistosomiasis Control Initiative at Imperial College, London, in 2002:
• “The Schistosomiasis Control Initiative (SCI) aims to encourage treatment of schistosomiasis in sub-Saharan Africa by targeting those at high risk of developing severe morbidity, especially school-aged children, women and those in high risk occupations. By assisting selected countries to achieve successful national control programmes, SCI expects to create a demand for treatment throughout Africa.”
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New Activities in 2000s
• WHO Resolution in May 2001• WHO effort to launch Global
Partnership for Parasite Control• Attention from the Bill and Melinda
Gates Foundation to “integration”• Hashimoto Initiative in Japan• World Food Program• World Bank promotion of school
health programs in education reform
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New Growth in PZQ Suppliers
• Shin Poong in Korea• IDA in Holland• New formulators in Africa, such
as Shelys and TPI in Tanzania• Chinese producers of active
ingredients (Shanghai OSD)
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SCI Strategies to Improve Access to PZQ in Africa -1
• Architecture: Work with UN agencies and NGOs and other NTD organizations to create common recognition about the importance of treating schistosomiasis and the role of PZQ
• Adoption: Collaborate with international agencies to obtain WHO resolution as official global adoption statement and then work to stimulate adoption and demand within countries
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SCI Strategies to Improve Access to PZQ in Africa -2
• Affordability: Use Gates funding to purchase large quantities from different firms and push down prices
• Affordability: Accept PZQ donations to create low-cost supply to support national control programs
• Affordability: Assist registration for external suppliers of PZQ in Africa to promote competitive tenders and reduced prices
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SCI Strategies to Improve Access to PZQ in Africa -3
• Availability: Improve information about PZQ suppliers and prices within countries to improve capacity to purchase supplies from international sources
• Availability: Stimulate local formulation in Africa by firms to assure long-term supply from domestic sources
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Results of SCI Actions
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Study Finding #1
Developing a safe and effective technology is
necessary but not sufficient for ensuring technology
access and health improvement.
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Study Finding #2
End-user adoption of the technology is an essential
but often overlooked component of the access
process.
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Study Finding #3
Creating access depends on effective product advocacy,
including a coordinating architecture, product
champion, and access plan.
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The cost of health technologies and related services is a key barrier, requiring strategies to
address affordability.
Study Finding #4
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Strategies to assure the availability of a technology are
needed to expand access.
Study Finding #5
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Efforts to scale-up access to technologies need to invest in health systems to ensure
sustained access.
Study Finding #6
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Conclusions
• Creating access to good health technologies in poor countries is not easy – but it can be done and it does happen
• Creating access requires attention to processes of agenda-setting and implementation at the global level as well as national level actions
• Creating access requires strategies to manage imperfect markets and imperfect governments