1. Key Issues from DAY 2 31 st January 2006 Jane Masiga & Val Remedios

2. 2 2006/07 Consolidated Technical Support Plan for Aids TA required and funds available Access not coordinated and harmonised UN Agencies come together and identified a key role for each in one or more of 17 areas UNICEF lead agency in PSM (single entry for requesting for TA at country level – 5 priority areas identified – recommendations to countries –PSM Working Group – highest level in Govt + all stakeholders –Baseline assessment – avoid duplication, use existing and recent assessments –PSM Plan – not only for GF but to improve whole supply system, need to include TA and capacity building budget in Plan GIST set-up to work with countries which have problems utilising and at risk of losing GF allocations – have already assisted two countries and others on the line

3. PRODUCT SELECTION AND GFATM OPTION FOR SUPPLIER SELECTION

4. 4 Product Selection HIV Treatment WHO Treatment guidelines to ensure uniformity within countries – 2003 version in process of being updated Seriousness of disease in practical terms – 300 dying /hr ~ big plane crashing/ hr Universal access – no one dying due to lack of treatment Complexities of selection– who (pregnancy, age, weight, prevention, co-infection), when (staging, resistance) and what (ART, OI, essential commodities), dosage (FCD, doses in unit pack for children) Issues arising –Rape – first dose within 72 hrs before investigations –Treatment interruptions – too early –Cotrimoxazole prophylaxis to delay progression of disease

5. 5 Product Selection Opportunistic Infections Need to know common OIs Complexities Drug pricing and availability –MDR can be USD 25,000/yr/pt compared to USD 10/yr/pt –few suppliers limits price negotiations Issues – quantification of OIs when scaling up ARVs – reduction of OIs with increased use of ART?

6. 6 Product Selection TB Medicines and Supplies Bio-availability and bio-equivalence are essential GLC approval required for MDR treatment FDC vs monotherapy Rifampicin protection against development of resistance – only use for TB Important to involve the private sector in selection process Blue book for treatment guidelines.

7. 7 Product Selection Malaria Treatment ACT as 1st line treatment, adopted by 56 countries over past few years Artemisinin/ artemether discouraged as monotherapy except as injections Not used in 1 st trimester of pregnancy or prophylaxis Issues –One PQ supplier of AL – potential for global shortages –Only one formulation of combined A, all rest are co-blistered – hydroscopic - limited shelf life –Needs to be used at community level yet caution in pregnancy

8. QUANTIFICATION AND FORECASTING

9. 9 Generalities on Quantification & Forecasting Methods Methods for quantification –Morbidity based –Consumption based –Adjusted-consumption based (can be used in combination or either can be used depending on the reliable data available) Need to adjust morbidity figures against consumption method figures taking into account capacity to deliver and enroll patients

10. 10 Quantification and Forecasting HIV Programme ART programmes remain largely for adults Steps in estimating number of treatments for children – complex Products needed to provide PMTCT/HIV services (reproductive health, laboratory services, medical equipment, pharmaceuticals, nutritional support) Challenge in quantification for doses requiring fraction of whole packs e.g. PMTCT Quantification tools available e.g. Clinton Foundation spreadsheet

11. 11 Quantification and Forecasting TB Programme Quantification difficulties –Must know accurate numbers at all levels –Must know numbers in each category –Need to avoid under or over stocking To make quantification easier, reduce the number of products to count by –Using FDCs –Using patient kits (packs)

12. 12 MALARIA PROGRAMME MOSQUITO NETS Targets –Abuja – one net per 2 vulnerable persons by 2010 –RBM Partnership – half the burden of malaria by 2010 Vulnerable population –Pregnant women –Children under 5 years old Inputs from stakeholders (RBM partners, National programmes, Governments, NGOs, Procurement agencies, etc.) Demand outstrips supply (funding, capacity to produce)

13. 13 MALARIA PROGRAMME ACTs Implementation rely mostly on financing from international community Forecast on market data for each country taking into consideration –Raw material available * –Production capacity * –Grants from donors* –Morbidity/consumption data Issue Need for RBM to share information on * with country programmes and sharing within the country

14. QUALITY ASSURANCE AND WHO PREQUALIFICATION

15. 15 Prequalification Why prequalification –No harmonized quality assurance system for procurement organizations –Quality of pharmaceuticals a real problem For transparency, at least 2 assessors are used for each dossier and never from country of manufacture of product There is a change in global fund quality assurance policy – registration by country local authority not acceptable in lieu of WHO/stringent authority prequalification

16. 16 Prequalification continued Firms that have submitted applications for prequalification will be given priority over other GMP qualified manufacturing plants Issues –Procurement agencies to ensure competition by not limiting tender to only WHO or stringent authority prequalified suppliers –Limitation of GF policy is major differences in requirements of each stringent regulatory authority

17. 17 Quality Assurance Processes TB Medicines Comparative rifampicin bioavailability in FDC should be equivalent to that in single products Issue – Need to harmonize the policies of GF and WHO Compliance lists which are causing confusion

18. 18 Approval Mechanism for Suppliers Malaria Medicines Studies using QA tests –60% antimalarials failed –50% ACTs failed Many manufacturers are in developed countries yet producing for developing countries –Concern that not governed by GMP standards of manufacturing country –There is need to test for stability in zone 4

19. 19 Approval Mechanism for Suppliers Nets WHOPES testing/evaluation LLINs and pesticides includes –Laboratory testing –Small scale field trials –Medium and large scale trials Only 3 approved manufacturers for LLINS recommended by WHO (one A to Z in Tanzania)

20. PRICING

21. 21 Options to reduce price - TRIPS TRIPS agreements / IPR are viewed as barriers to access –Some of the perceived barriers are due to lack of information or ignorance of governments –Some countries unnecessarily doing more than required –Failure in using clauses e.g. compulsory licensing (why have only 5 countries taken advantage of this clause?) Transition period for least developing countries to give patent protection for pharmaceutical products extended to 2016

22. 22 Options to reduce price – TRIPS continued The clause requiring that drugs produced under compulsory licence be predominantly for domestic market was removed No country has made use of WTO 30 August 2003 Decision to help counties with insufficient manufacturing capacity - allows drugs produced under compulsory licence by India before 2005 to be exported (too complicated to be implemented)

23. 23 FINALLY Day 2 was rather a long day for many who had homework and in spite of good weather NO HAPPY HOUR!