Creating Access for Health Technologies in Poor Countries Harvard University Michael R. Reich 2 December 2009

Based on book published by the Harvard Center for Population & Development Studies downloadable for free

Access 3 The Gates Foundation Bill Gates speaking at the World Health Assembly, 16 May 2005

Access 4 Overall Goal Assist the Gates Foundation in understanding and more effectively planning for success for its product development portfolio

Access 5

6 These phases provided the structure for the case studies

Access 7 One Vaccine: Hepatitis B Vaccine

Access 8 One Contraceptive: Norplant

Access 9 One Device: Vaccine Vial Monitor

Access 10 One Dual-Protection Technology: Female Condom

Access 11 One Diagnostic: Malaria Rapid Diagnostic Tests

Access 12 Source: Schistosomiasis Control Initiative One Medicine: Praziquantel

Access 13 Source: Schistosomiasis Control Initiative Discussion of Praziquantel

The Worm

Access 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

Access The Parasite Bloodborne fluke of schistosoma 5 species, two dominate in Africa endemic in 70 tropical and sub- tropical countries chronic and debilitating disease

Access 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 eradicated ongoing large-scale control programmes limited or no control Source: WHO, 2000 Status of Control Programs

Access 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

Access 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

Access High Risk Groups School-age children, young adults Women Special occupational groups, including farmers and fisherman

Access Health Consequences: Infection Stage Signs and Symptoms Outcomes: Disabling Variable hepato- splenomegaly Abdominal pain, blood in stool Haematuria Malnutrition and anemia Growth retardation Cognitive impairment Increased susceptibility to other infections

Access 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)

Access 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

Access

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

Access An Effective Treatment Praziquantel became the universal d rug 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

Access 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

Access 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. ”

Access 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

Access 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)

Access 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

Access 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

Access 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

Access Results of SCI Actions

Access 37 Study Finding #1 Developing a safe and effective technology is necessary but not sufficient for ensuring technology access and health improvement.

Access 38 Study Finding #2 End-user adoption of the technology is an essential but often overlooked component of the access process.

Access 39 Study Finding #3 Creating access depends on effective product advocacy, including a coordinating architecture, product champion, and access plan.

Access 40 The cost of health technologies and related services is a key barrier, requiring strategies to address affordability. Study Finding #4

Access 41 Strategies to assure the availability of a technology are needed to expand access. Study Finding #5

Access 42 Efforts to scale-up access to technologies need to invest in health systems to ensure sustained access. Study Finding #6

Access 43 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