1. Overview of Procurement and Supply Management Policies Meeting of WHO Prequalification Programme with European manufacturers and EU marketing authorisation holders Copenhagen, November 2009 Carmen Perez Casas Pharmaceutical Management Unit

2. WHO/EURO, November 2009 Presentation Outline 1.Global Fund grants 2.Overview of procurement volumes by grantees 3.Quality assurance policy 4.Procurement and Supply Management Policy 5.Most frequently purchased medicines

3. WHO/EURO, November 2009 The Global Fund Extract of TGF Guiding principles : Operate as a financial instrument, not implementing agency Make available and leverage additional financial resources Support programs that evolve from national plans and priorities Performance-based funding mechanism “Making a “sustainable and significant” contribution to the achievement of the Millennium Development Goals” 678 grants in 140 countries (Nov. 09)

4. WHO/EURO, November 2009 Rapid scaling up of results Intervention mid 2007mid 2008July 2009 HIV: People on ARV treatment 1.1 million1.75 m2.3 m TB: People treated under DOTS 2.8 million3,9 m5.4 m Malaria: Insecticide-treated nets distributed 30 million59 m 88 m Malaria treatments.. 74 m Global Fund Top 3 result indicators (2009)

5. WHO/EURO, November 2009 Global Resources Distribution Rounds 1-8, (July 2009) 100% = US$ 15.9 billion % of total funds approved by the Board, including Phase 2 & RCC by Regions OP/140709/2 Expenditure Component (July 2009) Estimates from Rounds 2-8 proposals 100% = $8.2 billion USD

6. WHO/EURO, November 2009 Disease Components Distribution Rounds 1-8, (July 2009) Global Fund Resources by Disease Component 100% = US$ 15.9 billion Percentages of total funds approved by the Board, including Phase 2 & RCC OP/140709/3

7. WHO/EURO, November 2009 Overview of procurement of medicines by value Data from 2006-2007

8. WHO/EURO, November 2009 The Global Fund Approach for procurement Principles and minimum standards, not detailed procedures Build upon existing systems Principal Recipients responsible for all PSM activities –Even if contracted out Operational principles for Good Pharmaceutical Procurement.

9. WHO/EURO, November 2009 Policies and Principles Quality-assured products Lowest possible price National laws and international agreements Conduct procurement processes in a transparent and competitive manner Guide outlines what PRs need to do

10. WHO/EURO, November 2009 Procurement mechanisms PRs use own purchasing system, Or subcontract procurement agent – mandatory in case insufficient capacity exist, – most commonly used procurement agents : UNICEF, IDA, WHO PPS... MDR-TB treatment : mandatory Green Light Committee support services Voluntary Pooled Procurement and Capacity Building Services : Launched in June 2009 Affordable Medicine Facility for malaria (AMFm): Approved in November 2008

11. WHO/EURO, November 2009 QA Policy for Pharmaceutical Products “Global Fund resources may only be used to procure medicines that have been authorized for use by the NDRA in the recipient country in accordance with its standard practices for drug registration (or other forms of authorization)”

12. WHO/EURO, November 2009 QA Policy for Pharmaceutical Products For medicines prequalified by the WHO PQ, NDRAs are encouraged to expedite the process for authorizing their use –by accepting the PQ approval letter and supporting documentation, including WHO PQ report and the manufacturer's summary of information relating to the quality, safety and efficacy For medicines authorized for use by an SRA, NDRAs are encouraged to expedite the process for authorizing their use –by accepting the executive summary of the Common Technical Document for the Registration of Pharmaceutical Products for Human Use (CTD) or sections of the CTD relating to the quality, safety and efficacy and all necessary information to perform quality control testing of products and necessary reference standards.

13. WHO/EURO, November 2009 QA policy for ARVs, antiTB and antimalarials Antiretrovirals, antituberculosis, and antimalarial pharmaceutical products can be purchased using Global Fund resources if they are, prequalified by the WHO Prequalification Programme, and/or authorized for marketing in a country with a stringent drug regulatory authority (SRA) (registration "for export only" is not sufficient), or

14. WHO/EURO, November 2009 QA policy for ARVs, antiTB and antimalarials for products marketed exclusively outside ICH region, approved or subject to a positive opinion under one of the following schemes: –Canada S.C. 2004, c. 23 (Bill C-9) procedure (HIV medications), –Art. 58 of European Union Regulation (EC9 No. 726/2004), –US-FDA tentative approval (ARVS) or

15. WHO/EURO, November 2009 QA policy for ARVs, antiTB and antimalarials if there are <2 products available on the market from previous categories (WHO prequalified or registered by a SRA), Alternative products can accepted for purchase by the Global Fund based on the recommendation of an independent panel of technical experts (ERP) –independent technical body hosted by WHO

16. WHO/EURO, November 2009 QA Policy for Procurement of All Other Pharmaceuticals All FPPs, other than ARVs, anti-TB and antimalarials, need only to comply with the relevant quality standards that are established by the National Drug Regulatory Authority (NDRA) in the country of use PRs must ensure that all FPPs are procured in accordance with principles set forth in the Interagency Guidelines: “A Model Quality Assurance System for Procurement Agencies “ (WHO, 2006)

17. WHO/EURO, November 2009 Monitoring quality product Monitoring quality of products all along the supply chain Systematic random quality control testing Recipients report testing results to Global Fund Manufacturers must provide methods used for quality control of products not published in pharmacopoeia

18. WHO/EURO, November 2009 Which medicines can be procured? Medicines listed in WHO or national or institutional Standard Treatment Guidelines or essential medicines list grant applicants or PRs to provide technical justification for selection of unlisted products in one of the STGs

19. WHO/EURO, November 2009 Which medicines are procured? Tuberculosis WHO PQ EOI First line medicines: –Single ingredient products –Fixed dose combinations Second-line TB medicines : – procured through the Green Light Committee Plus Adjunctive therapies in MDR-TB treatment: –Low volumes –Nutritional support –Corticosteroids –Medicines for management of side effects

20. WHO/EURO, November 2009 GUIDELINES FOR THE PROGRAMMATIC MANAGEMENT OF DRUG- RESISTANT TUBERCULOSIS, WHO 2006 (2008) Metoclopramide, dimenhydrinate, prochlorperazine, promethazine, bismuth subsalicylate H2-blockers (ranitidine, cimetidine, famotidine, etc.), ulcer proton pump inhibitors (omeprazole, lansoprazole, etc.) Fluconazole, clotrimazole lozenges Loperamide Selective serotonin reuptake inhibitors (fluoxetine, sertraline), tricyclic antidepressants (amitriptyline) Lorazepam, diazepam, clonazepam Dimenhydrinate Haloperidol, thorazine, risperidone (benzotropine or biperiden ) Phenytoin, carbamazepine, valproic acid, phenobarbital Pyridoxine (vitamin B6)

21. WHO/EURO, November 2009 Amitriptyline Meclizine, dimenhydrinate, prochlorperazine, promethazine Ibuprofen, paracetamol, codeine Hydrocortisone cream, calamine, caladryl lotions Antihistamines (diphenhydramine, chlorpheniramine, reactions dimenhydrinate), corticosteroids (prednisone, dexamethasone) Inhaled beta-agonists (albuterol, etc.), inhaled corticosteroids (beclomethasone, etc.), oral steroids (prednisone), injectable steroids (dexamethasone, methylprednisolone) Levothyroxine Potassium and magnesium replacement GUIDELINES FOR THE PROGRAMMATIC MANAGEMENT OF DRUG- RESISTANT TUBERCULOSIS, WHO 2006 (2008)

22. WHO/EURO, November 2009 Which medicines are procured? AIDS Antiretrovirals Medicines to treat HIV/AIDS related conditions: –Mainly those listed in WHO-PQ EOI –Some additions depending on country: Methadone and buprenorphine Metronizadole Amoxicillin, erythromycin, cloxacillin

23. WHO/EURO, November 2009 Medicines to treat HIV/AIDS related conditions, WHO PQ, EOI July 2009

24. WHO/EURO, November 2009 Which medicines are procured? Malaria WHO PQ EOI ACTs Artemisinin-based single-ingredient formulations –Artemether, oily injection –Artesunate, powder for injection –Artesunate, suppositories –Artesunate, tablet* * GF discourages the use of Artemisnin- based monotherapy products

25. WHO/EURO, November 2009 Other antimalarial medicines –Mefloquine, tablet 250 mg –Sulfadoxine + Pyrimethamine, tablet 500 mg + 25 mg –Amodiaquine tablet 153 mg (or 200 mg as hydrochloride) Some additions to those listed in WHO PQ EOI : –Quinine Di Hydrocloride 300mg/ml inj, or Sulphate 300mg tab –Chloroquine 150mg tab –Primaquine tab 15mg

26. WHO/EURO, November 2009