Yolanda Tayler, WB Africa Region HIV-AIDS Consultation Workshop Addis Ababa, Ethiopia February 14 –18, 2005

1. Technical Guidelines to Procurement of HIV-AIDS Medicines and Supplies Yolanda Tayler, WB Africa Region HIV-AIDS Consultation Workshop Addis Ababa, Ethiopia February 14 –18, 2005

2. Battling HIV/AIDS:A Decision Maker’s Guide to the Procurement of Medicines and Related Supplies • What is the purpose of the Guide? • To set out principles and advice for procurement • Who are the target audiences? • Procurement staff using WB, other donor agencies and government funds • The Guide comes with added value • How is the Guide organized? • It is organized in chapters along the elements comprising the Pharmaceutical Supply Cycle.

3. Chapter 2 Intellectual Property Rights Chapter 6 Pricing Chapter 3 Managing the Supply Cycle Chapter 4 Selection Quantification Quality Assurance Chapter 5 Procurement Chaptersof the Guide Chapter 1 Challenges in Scaling up Treatment

4. The Long-run Economic Costs of AIDS The Long-run Economic Costs of AIDS: Theory and an Application to South Africa Clive Bell, Shantayanan Devarajan and Hans Gersbach First version: May 2001 This version: June 2003 “Without AIDS, South Africa showed modest economic growth and universal education in three generations.” “Without anything being done to combat the epidemic, there will be a “complete economic collapse” in three generations.” Bell, Devarajan and Gersbach The World Bank, 2003

5. Key Policy Implications The Long-run Economic Costs of AIDS: Theory and an Application to South Africa Clive Bell, Shantayanan Devarajan and Hans Gersbach First version: May 2001 This version: June 2003 • Spend more on public goods to reduce premature mortality (an additional 3-4% of GDP). • Consider lump-sum subsidies to nuclear families. • Consider school attendance subsidies for young people.

6. Challenges in Scaling Up Treatment Projected Costs of ARV Treatment (drugs only) for all People with AIDS • Resources • Lack of physical and human health infrastructure • Inadequacy of systems to distribute medicines • Adherence • The need for an uninterrupted supply of drugs % Share of Health Budget

7. Intellectual Property Rights • Objective: Become familiar with patents and other IP • Learn how they affect the procurement of HIV-AIDS medicines and supplies • Find out how governments and procurement authorities can overcome patent barriers to buying generic medicines meeting appropriate quality, safety and efficacy standards • Procurement Options would include: Negotiation with Patent Holder, Government Use, Compulsory Licenses, Parallel Importation • Who makes the rules? WTO and National Governments

8. Management Support SELECTION USE PROCUREMENT DISTRIBUTION Policy and legal framework The Medicines Supply Cycle • Who does what? • What tasks need to be done? • Who is already carrying out these tasks? • Who can help in selection and quantification? • Who can help with regulatory, registration, IPRs and import issues? • Who can help with procurement, storage and distribution?

9. Product Selection: Areas of Treatment • Highly Active Antiretroviral Therapy (HAART) for adults and adolescents • Treatment of opportunistic infections • Treatment of HIV infection in women of childbearing potential, or pregnant women • Treatment of HIV in children • Prevention of Mother to Child transmission • Post-exposure prophylaxis

10. What is product quantification? Estimating the quantities of each commodity needed and deciding how much to buy Key principles of quantification Different quantification methods (e.g., usage, adjusted usage and morbidity) Product Quantification

11. Quality Assurance • To introduce non-experts to pharmaceutical quality control and regulation • Drugs must be safe, effective and of consistent quality • Adherence to GMP and compliance with quality specifications are key

12. Yes No Prequalification Is there in-country capacity to conduct prequalification? • Use products prequalified by WHO • Single/limited source approved by DRA in PIC or ICH region • Exceptions: products approved by NDRA • Labs needed for testing • Use a specialized supplier • Practices & standards • Strong Lab Infrastructure • Verification of product compliance with requirements • Evaluation of dossiers • Testing • Verification of GMP • Verification of GDP

13. Triple FDC Cost of treatment (US$/year) (Source: Médecins Sans Frontières) Procurement • Specifics of procurement of ARTS • Assessing capacity of procurement agency • Planning procurement • Registering products • Commodities that support the HIV/AIDS program • Overview of different procurement models • How to choose the “right” procurement model for a particular situation

14. ART ARVdrugs Palliative Care Drugs and consumable medical supplies Lab Infrastructure Treatment Drugs and consumable medical supplies to treat STIs, OIs, and TB Supply Chain Management Detection Diagnostic agents and lab supplies OIs STIs HIV TB Prevention Contraceptives, condoms, lubricants, gloves, protect. gear Family Planning Service Delivery and Provider, Client and Community Education (Reprinted with the permission of John Snow Inc./Deliver, with USAID) Commodities for HIV/AIDS

15. Can procurement be conducted by a qualified national central medical store? NO NO YES YES Outsource procurement to a qualified private agency or a low-cost supplier (e.g., UNFPA, UNICEF, MSF, IDA) Range of medicines and medical products: Procurement Flow Chart Is there internal capacity (e.g., NACs) to procure?

16. Selection of Procurement Method