AMDS Products, events and issues. Dr Vincent Habiyambere TCO/AMDS – HIV Department WHO Geneva, 12 June 2015

HIV and hepatitis @ HIV/WHO World Health Organization HIV and hepatitis @ HIV/WHO 5 December, 2018 New ART guidelines are expected in July 2015: Likely no changes to current preferred regimens. DTG and DRV under discussion as alternatives in first and second line, respectively. TAF not yet available, and therefore not included. Expansion of treatment indications to ""Treat All" under discussion. Increased emphasis on supply continuity as part of recommendations. New Hep C guidelines are expected in Dec 2015: following inclusion of sofosbuvir and simeprevir, ledipasvir and daclatasvir are under consideration as part of preferred regimens. EOI and PQ are moving on hepatitis. Consolidated HIV Strategic Information guidelines were released this month. Stock out of ARV drugs is one of the 10 global indicators. New Consolidated HIV, hepatitis and STI strategy under development. AMDS survives, part of SIP team after August 2015.

Products completed since last IPC Available World Health Organization 5 December, 2018 GPRM : TB transactions included HIV transactions updated incl. Q1 2015 Interface updated ARV regulatory status: 2015 update live on web 2014 PSM country profiles for > 70 countries

Products completed since last IPC Publication imminent, pending internal clearance (but can share) 2015 ARV APIs survey Forecasts of ARV demand up to 2018 and uptake of new ARVs (DTG, TAF, RAL) up to 2024 (with MPP and CHAI) Forecasts of demand for HIV diagnostics up to 2018 Specifications and quantification of essential HIV diagnostics. POC EQA tool developed by WHO in collaboration with CDC

Ongoing work and planned events World Health Organization 5 December, 2018 Work: ARV and HIV diagnostic use survey (with GARPR) – ongoing GPRM update and updated/dissemination of 2015 PSM Country Profiles – Q3 Report on access to ARVs and HIV diagnostics, for AIDS conference in Durban, July 2016 Planned events: Satellite on PSM challenges, posters at 2015 AIDS conference Annual AMDS partners meeting, tentatively 29-30 Sept 2015 TWG meeting on ARV & diagnostic demand, Nov. 2015 Meeting with pharma and diagnostics producers on forecasts and related developments, Feb 2016

World Health Organization Issues World Health Organization 5 December, 2018 STOCK OUTS In last month, South Africa, Mauritania, Congo, and Guinea had stock outs of ARVs, TB medicines and malaria medicines (Congo). Lab stock outs are rarely reported, but a regular occurrence. Emergency TA was provided with high transaction costs We used CPP partners to solve the problem in Guinea Congo was going to use DRC drugs and buy after our help in connecting with IDA, funds disbursement is delayed for procurement: so no effective order placed. The CPPi has insufficient coverage, and is only a firefighting operation We need a more systemic approach to prevent stock outs: role of Interagency Supply Chain Group (ISG)?

What IPC could do to prevent stock outs World Health Organization 5 December, 2018 The current attention given to HIV, TB and malaria, incl. civil society pressure, offers an opportunity to re-open the discussion on the efficiency of health commodity supply chains and mobilize funding to fix the problems. IPC should use this opportunity through: Assessment of causes of stock out in selected countries, identify solutions, and publicize outcome to increase the SCM level on national & international agenda. Document in a few low income countries what it takes to create an effectively operational SCM including LMIS not just for ARVs, but for all essential health commodities, to inform creation of planning templates. Produce (or update if it exists already) normative guidance on the essential components of a functioning supply chains, including for LMIS, and technical guidance on how to plan and cost their development. Country level collaboration between partners & nationals for a stronger SCM with a stronger government leadership.