Peter Graaff

Department of Essential Drugs and Medicines Policy

Department of HIV

World Health Organization

Access to essential medicines for HIV/AIDS update on WHO activities within UN access framework

Access HIV 2 Department of Essential Drugs and Medicines Policy

1. Rational selection and use

2002: WHO guidelines for a public health approach to on scaling up

antiretroviral therapy in resource limited settings :

http://www.who.int/HIV

standardized and simplified regimens simplified patient monitoring

12 ARVs on WHO Model EML & WMF

2003 (planned) Update and prioritization ? Global stand. 1st line

Selection

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2. Affordable prices for governments, healthcare providers and consumers - strategies:

National policy exemption from taxes, import duties price regulation (producer prices, distribution margins) WTO/TRIPs provisions

Market dynamics generic competition

Procurement management price information patent status and regulatory status price negotiation group purchasing (public, NGO - national, regional)

Affordable prices

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MSH-WHO essential drugs price indicator

UNICEF, UN-AIDS, WHO Sources and Prices (selected medicines and diagnostics)

Pharmaceutical starting materials

Antiretroviral drugs in the Americas

AFRO Essential Drugs

Indicative price information promotestransparency and competition

Affordable prices

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Annual cost per person for triple therapy (US $)

$0

$2,000

$4,000

$6,000

$8,000

$10,000

$12,000

1991 1993 1995 1997 1999 2001 2003

UN Drug Access Initiative

Generic competition in Brazil

5-company offer

Generic company offer

Advocacy, corporate responsiveness, & market forces have reduced antiretrovial prices >95% in a few years

UNDCP

UNDP

UNESCO

UNFPA

WIPO

Affordable prices

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3. Sustainable financing

In over 38 countries public drug expenditures are<US$2 per capita - inadequate by most estimates

Key actions: Increase public funding for cost-effective drugs Expand drug benefits in health insurance Seek external funding for the poorest populations (e.g. Global

Fund)

Financing

NB: This “leg” of the access table needs to be strengthened

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Pilot Procurement, Quality and Sourcing Project

Objective: Establish a Model Quality Assurance System for

Procurement of Pharmaceuticals Pre-qualification of suppliers of HIV/AIDS-related

pharmaceutical products Quality standards of newer HIV medicines Improved capacity of national regulatory bodies

Partners: UNAIDS, UNFPA, UNICEF, WHO, World Bank

Products: 50 ARVs, 44 mono, 5 double and 1 triple combination

Reliable systems

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New developments …….. 3x5Scale up access to ARV to 3million by 2005

300,000 out of 6,000,000 who should be on treatment in the developing world receive ARVs(Africa: 50,000 out of 4,000,000)

22/09/03 emergency declaration 01/12/03 World AIDS day. Present implementation

plan to include: Intensified country support (priority countries) Tools (simplified) to move beyond capital and medical

doctor “AIDS drug and diagnostic facility” ……..

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4. Summary

UN, WHO and partners are active in all aspects of access to HIV/AIDS medicines

Key tools available to governments and NGOs: Treatment guidelines and essential medicines list Price information Pre-qualified suppliers and products Patent status and regulatory status Guidance on use of TRIPS safeguards Policy and training tools in supply management

(pricing, donations, procurement and supply management)

3x5 should “affect” us all