AMDS Contribution to the Technical Briefing Seminar

1. AMDS Contribution to the Technical Briefing Seminar October 2007

2. AMDS Secretariatwithin the New Organizational Structure - HIV/AIDS DEPARTMENT

3. What is AMDS • AMDS is a network of partner organisations working in procurement and supply management of HIV commodities. • The secretariat of this network is in WHO/HIV Department.

4. AMDS Partners

5. Why do we need partnership • Drug procurement is more than "shopping" drugs

6. Demand Creation Drug procurement is more than "shopping" Procurement Cycle Monitoring Product Selection Effective Use Forecasting Receipt, Storage, Distribution Financing Product Procurement Quality Assurance Supplier Agreements

7. How we work • Open ended partnership, loose network structure • Work on concrete problems as opportunities arise or needs become acute: GFATM Supply Chain planning; GPRM; regulatory database, IMAI module; forecasting ARV market; Training in drug supply management for HIV programmes. • Work in under-laboured HIV-specific domains: prices of production, data production for strategy development (ex. API) • Foster collaboration in and outside WHO based on areas of drug supply chain management.

8. Results and influence • Procurement and supply management plans to support Global Fund PR • Strategic information highly valued : GPRM, Regulatory status • Strong support from partners for strategic orientation chosen: keep network open, no need for MOUs; focus collaboration on problem solving and practical issues • Expectations of partners for WHO work increasing: support creation of national level SM coordination groups, organisation of partners in technical communities, broker collaboration between partners, map TA sources, provide normative leadership, increase visibility and commitment to strengthening supply chain management at country level

9. Strategic Information: Global Observatory • Why • Collect, consolidate and disseminate strategic information regarding affordability, accessibility, and availability of HIV drugs: • In-house Products • Global Price Reporting Mechanism - on AMD website • API prices -on AMD website • Regulatory status database - on AMD website

10. Global Price Reporting Mechanism (GPRM) http://www.who.int/hiv/amds/price/hdd/ • Why • To improve price transparency on ARV market • To inform MoHs, state and non state procurement officers and favour price negotiation • To inform WHO management in their strategic decision in advocacy How • Collection and disseminate transactional data of ARV drugs prices on the web • Produce summary analysis of trend and prices of ARVs (Summary report) • Contributors: CHAI, Crown Agents, GFATM, IDA HIV Group, JSI, MSH, UNICEF, UNDP, WHO-CPS, WHO NPO, Mission Pharma, SCMS. Achievements • Features and reports improved • Number of contributors improved • Scope expanded from HIV products to TB, malaria medicines and substitution therapy

11. API Price and producer databasehttp://www.who.int/hiv/amds/sourcespricesAPI.pdf • Why • Improve price transparency and favour price negotiation • Anticipate potential shortage in APIs and inform API producers • Inform WHO management in their strategic decision for advocacy How • Collect and disseminate lowest and highest prices of each API on AMD website • Analyse API price trends • Contributors: all Generic API producers – contact details on AMD website Achievement • Tool and product Refined • Updated information • Increased number of companies reporting to AMDS

12. Regulatory status database http://ftp.who.int/htm/AMDS/drugsdatabase.pdf • WHY • Limited access to information on ARV marketing authorizations by countries • Inform WHO management team in making strategic decision and advocacy • Inform state and non state procurement officers, donation programmes, countries using the GFATM grant on which drug is registered and where How • Collect regulatory information and make it available in the public domain • Contributors: all R&D and generic ARV producers Achievements • Searchable database • Cross check information at country level with support from AMD partners

13. Forecasting of the ARV market • Why • To avoid global supply shortages of antiretroviral drugs as it happened during the scaling-up efforts. • How we took it forward • Production of draft ARV forecasts 2007-2008 for discussion with manufacturers • Consortium of partners: UNAIDS, UNICEF, PfSCM, USAID, Clinton Foundation, Mexico National Inst of Public Health • Approaches: normative and consumption models. • Survey 2006: uptake of ARVs in low & middle income countries. Published in AIDS Journal, July 2006

14. Country Support in Supply Management • Rationale • PSM constraints are major obstacles in the health system • Access to HIV commodities requires wide partnership • Several partners at country level work in isolation sometimes in competition • Lack of sharing of information/harmonization of practices • Two major areas of focus • Increase collaboration to strengthen the supply management in program planning and implementation processes (Unicef, TCM, WB, GF, DELIVER, IDAsolution) • Support the creation of national PSM coordination groups to achieve integrated national supply chain management systems.

15. Country support in Supply Management Capacity building for PSM planning, training and TA • PSM workshops for national professionals (e.g. IDAsolution, Global Fund) • Exchange of information and experience sharing among participants • Consultant database in PSM • TA to urgent request for PSM support when no other partner is available.

16. Country support in Supply Management: The Future • Increase visibility and commitment of PSM in planning process • Collaborate with RCC in RO & CO planning processes to ensure that PSM issues are well addressed • Support creation of national PSM coordination groups • Map country level presence of partners and their PSM area of work • Increase WHO capacity to play its convening role of partners at country level: work with TCM, ROs and COs • Foster collaboration for technical support between WHO and the AMDS Network Organizations: Global Fund, SCMS, WB, UNICEF, etc.

17. Tool Development Reporting and M&E • Importance • Vertical reporting puts a huge burden on national programmes • Lack of clarity at implementing levels of the reporting requirements • Harmonized reporting helps decide where to start improving supply chain management system • Opportunity • High level of consensus that "verticalization" in reporting requirements by donors has gone too far: harmonization needed at country level • The need for AMD network partners (esp. PfSCM) to develop/implement a harmonized and M&E PSM system. • Partners asked WHO to take this process forward

18. Tool Development: Reporting and M&E; Handbook of supply management at first-level health care facilities • What we did • Reporting and M&E of ART-PSM system • Get the facts and move towards consensus • JSI, MSH, PfSCM, • Programme experts from Rwanda, Tanzania, Uganda, Vietnam • CHMP, CRS, Global Fund, IDA, PEPFAR/OGAC, UNAIDS, UNICEF, World Bank • Develop outline interagency document • Constitute a working group on content • Next steps • Draft ART-PSM M&E document developed • Field-test and finalise the document • Handbook of supply management at first-level health care facilities • Manual published and ready for use

19. Conclusion • AMDS is part of health system strengthening Unit of HIV Department • PSM is a wide area requiring strong partnership: AMDS works by fostering partnership among technical institutions working in PSM • Major areas of AMDS work to increase access to HIV commodities: • Strategic information: GPRM, regulatory status, API, patent (in progress) • Forecasting of HIV drug needs • Regional and country support including capacity building: support in planning (PSM plans) and training of professionals working in national supply chain management systems. • M&E