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Yolanda Tayler, WB Africa Region HIV-AIDS Consultation Workshop Addis Ababa, Ethiopia February 14 –18, 2005 PowerPoint Presentation
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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. Battling HIV/AIDS: A Decision Maker’s Guide to the Procurement of Medicines and Related Supplies.

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slide1

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

battling hiv aids a decision maker s guide to the procurement of medicines and related supplies
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.
chapters of the guide

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

the long run economic costs of aids
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

key policy implications
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.
challenges in scaling up treatment
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

intellectual property rights
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
the medicines supply cycle

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?
product selection areas of treatment
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
slide10
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

quality assurance
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
prequalification

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
procurement

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
commodities for hiv aids

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
procurement flow chart

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?