Working Group on Access to Assured Quality Medicines for Neglected Tropical Diseases (WGA)

1. Working Group on Access to Assured Quality Medicines for Neglected Tropical Diseases (WGA) 6th meeting on 20 March 2014 (teleconference)

2. Mission • To promote and strengthen international collaboration to facilitate access to assured-quality, essential medicines for NTDs Members participating in TC • ASAOLU, Samuel • BARRETT, Mike • BLAYNEY, Benedict • DEN BOER, Margriet • DE SILVA, Nilanthi (Chair) • GARRISON, Kama • ROSENBERG, Mark • VESSOTSKIE, Janet

3. Secretariat • ALBAJAR, Pedro • DAGNE, Daniel Argaw • DAUMERIE, Denis • JANNIN, Jean • MONTRESOR, Antonio • PARK, Munjoo • REGGI, Valerio • SUCHET, Corinne

4. 2014 Agenda • Joint forecast for albendazole, mebendazole and praziquantel • Ways to address shortage of quality-assured NTD medicines: Experience with Prequalification and Expert Review Panel • An update on the quality survey concerning albendazole and mebendazole • Management of serious adverse events • Overview of issues affecting availability and quality of selected NTD medicines: • Leishmaniases • Chagas disease

5. 1. Joint forecast Secretariat met with partners on 21 Jan 2014. • USAID, DFID, GSK, J&J, Merck KGaA, RTI, CWW and World Vision • 2014 global forecast for joint supply: • Praziquantel – 262 m tablets to 39 countries; albendazole – 188 m tablets to 33 countries; mebendazole – 135 m tablets to 13 countries Recommendations to the STAG: • To continue to support joint forecast and sharing of information among interested parties • To assist countries in developing plans of action and capacity to distribute available donated NTD medicines and expand coverage

6. 2. Overcoming shortage of quality-assured drugs Invited NTD products: DEC, ALB, MEB, PZQ Pre-Qualification Programme: DEC (+PZQ) Expert Review Panel: 2 applications for ALB and 13 for PZQ Recommendations to the STAG • WHO-NTD, with input from WHO-Pre-Qualification Programme (PQP), to seek technical support from US Pharmacopeia to produce the necessary data that would permit to ascertain whether bioequivalence study requirements could be waived for PZQ without compromising quality. • NTD, with input from PQP, to arrange a meeting with generic manufacturers to encourage them to submit applications for PZQ.

7. 3. Survey on quality of albendazole and mebendazole on open market No new data Recommendations to the STAG • Urge concerned national drug regulatory authorities to address the quality issues identified by the surveys conducted in East Africa and South-East Asia.

8. 4. Management of serious adverse events New EU requirements to report all Adverse Events and not just Serious AE Recommendations to the STAG: • WHO and donation partners to finalize adverse event reporting form that is currently under final editing / revision. • WHO, national NTD control programmes and other concerned parties to develop a document that outlines the peculiarities of preventive chemotherapy and can be used to raise the matter with the European Medicines Agency and seek a different set of reporting requirements for preventive chemotherapy interventions.

9. 5. Medicines for Chagas disease and leishmaniasis Recommendations to the STAG - antileishmanialmedicines • To support  the sustainable production of antileishmanial medicines and ensure adherence to international Good Manufacturing Practice standards, particularly for quality-assured sodium stibo-gluconate and paromomycin, in collaboration with the WHO prequalification program and other international partners; • To continue encouraging generic liposomal amphotericin B manufacturers to undergo prequalification process and strengthen treatment outcome monitoring.

10. Drugs for Chagas disease • To continue studies on pharmacology, drug safety and efficacy of benznidazole and nifurtimox, taking into account the geographical differences on Chagas disease and response to antiparasitic treatment   • To implement a network of sentinel centres to collect data and produce reports in a standardized format.