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