Access to Assured-Quality Praziquantel for the Control of Human Schistosomiasis

1. Access to Assured-Quality Praziquantel for the Control of Human Schistosomiasis Dr. Valerio Reggi - Department of Control of Neglected Tropical Diseases

2. Global distribution of schistosomiasis disease caused by worms of the genus Schistosoma 90% of infected people 76% of population at risk From: Gryseels et al. Human schistosomiasis. Lancet 2006; 368: 1106–18

3. Control of schistosomiasis is based on preventive chemotherapy interventions targeting the entire at-risk population

4. Schistosomiasis - estimated infected population and population treated in 2008* * As reported to WHO/NTD ** China: estimated infected: 672,000 treated: 2,987,500

5. How much praziquantel is required/committed? donor-funded demand in recent years: ~ 50 million tablets* * B&M Gates Foundation/Schistosomiasis Control Initiative and Merck KGaA Sudden demand increase: from 50 to 210 million tablets/year

6. Praziquantel is made in large 600mg tablets Each 600mg Praziquantel tablet requires 640mg of API (assuming 94% yield) ~135 tonnes of API required for ~210 million tablets/year

7. API producers & tablet manufacturers These include: Merck KGaA, and Shin Poong – who manfacture PZQ API since the early 80's Merck declares: a) unable to quickly scale up manufacturing capacity; b) have identified one producer able to supply an API suitable for Merck tablets but full regulatory approval estimated to take 24 months. Shin Poong manufactures its own API and tablets and declares to have capacity to scale up production provided 'opportunity' concerns are satisfied. Virtually only 4 large-scale tablet manufacturers: Merck, Shin Poong, EIPICO, Cipla

8. Key concerns Current manufacturers of assured-quality API and finished product may be unable to match demand increase RISKS higher prices • interruption of supply • scale-up failure substandard quality Donor-driven demand and tight deadlines draw 'new' manufacturers into play

9. Proposed approach Current players: DFID, USAID/RTI, WHO JOINT PLANNING OF NATIONAL REQUIREMENTS COORDINATED PROCUREMENT OF PZQ QUALITY ASSURANCE POLICY FOR THE PROCUREMENT AND PROVISION OF PRAZIQUANTEL TABLETS* * adapted from Global Fund Quality Assurance Policy For Pharmaceutical Products - http://www.theglobalfund.org/en/procurement/quality/?lang=en

10. QUALITY ASSURANCE POLICY FOR THE PROCUREMENT AND PROVISION OF PRAZIQUANTEL TABLETS FOR HUMAN SCHISTOSOMIASIS CONTROL (a) authorized for marketing by a stringent MRA; (b) listed as prequalified by the WHO Prequalification Programme; (c) positive opinion under Art. 58 of the EU Regulation 726/2004. Interim Measures a) expand to include MRA based in OECD and PIC/S countries; b) establish consultative mechanism enabling endemic countries MRAs to give advice on the selection of PZQ products on the basis of appropriate documentation; c) establish an expert review panel similar to that established by the Global Fund

11. Expected advantages and benefits of PQ of PZQ API and finished products • PQ of APIs would attract more generic manufacturers and increase competition • PQ of APIs would enable local manufacture in large endemic countries • Compared to stringent MRA's regulatory approval, PQ (both API and FP) can be faster and more flexible (e.g. no jurisdiction limitations, technical advice, capacity building) • PZQ used in preventive chemotherapy of assured quality is reassuring for national authorities engaging in mass treatment campaigns • Donor and national funding not wasted on poor-quality PZQ • PQ capacity building component leads to more effective involvement of MRAs of endemic countries in development of new NTD medicines.

12. PQ of PZQ API and finished products is cost-effective Lost credibility of preventive chemotherapy interventions Incalculable public health damage

13. Thank you