Transcript Access to essential medicines for HIV/AIDS - WHO archives

Access to essential medicines for HIV/AIDS
- update on WHO activities within UN framework
Paula Munderi
Department of Essential Drugs and Medicines Policy
World Health Organization
Aims

enhance access to affordable HIV/AIDS medicines
of assured quality

promote rational use of these drugs by
professionals and consumers

provide technical support to the most affected
countries towards integration of HIV/AIDS
medicines into national essential drugs
programmes
Access HIV 2
Department of Essential Drugs and Medicines Policy
1. Rational selection and use
Recent developments:

WHO guidelines for a public health approach to on
scaling up antiretroviral therapy in resource limited
settings : http://www.who.int/HIV_AIDS



standardized and simplified regimens
simplified patient monitoring
12 ARVs on WHO Model EML & WMF
Access HIV 3
Department of Essential Drugs and Medicines Policy
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
• price negotiation
• group purchasing (public, NGO - national, regional)
Access HIV 4
Department of Essential Drugs and Medicines Policy
Affordable prices
Indicative price information promotes
transparency and competition

MSH-WHO essential drugs price indicator

Drugs and diagnostics for HIV/AIDS

Pharmaceutical starting materials

Antiretroviral drugs in the Americas

AFRO Essential Drugs
Access HIV 5
Department of Essential Drugs and Medicines Policy
Advocacy, corporate responsiveness, & market forces
have reduced antiretrovial prices 95% in 2 years
Annual cost per person for triple therapy (US $)
$12,000
$10,000
$8,000
$6,000
$4,000
UN Drug Access Initiative
Generic competition in Brazil
5-company offer
$2,000
Generic company offer
$0
1991
Access HIV 6
1993
1995
1997
1999
Department of Essential Drugs and Medicines Policy
2001
2003
UNDCP
UNDP
UNESCO
UNFPA
WIPO
Access HIV 7
Department of Essential Drugs and Medicines Policy
WHO policy and technical support on TRIPS to over 60
countries - health, trade and patent officials
Meeting on TRIPS in OAPI countries (Yaoundé, May 2002)
(15)
Meeting on the impact of globalization (Jakarta, May 2000)
(9)
Briefing on TRIPS (SADC) South Africa, June 2000)
(7)
Workshop on TRIPS (Harare, August 2001)
(4)
Participants in both, South Africa and Harare meetings
(11)
Intercountry meeting on the TRIPS Agreement (Warsaw, September 2001)
(22)
Country support
Access HIV 8
(9)
Department of Essential Drugs and Medicines Policy
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)
Access HIV 9
Department of Essential Drugs and Medicines Policy
Reliable systems
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
Access HIV 10
Department of Essential Drugs and Medicines Policy
4. Summary

UN framework for access includes rational selection,
affordable prices, sustainable financing and reliable systems

UN, WHO and partners are active in all aspects of access

Key tools available to governments and NGOs:

Treatment guidelines and essential medicines list

Price information; pre-qualified suppliers and products

Guidance on use of TRIPS safeguards

Policy and training tools in supply management
(pricing, donations, procurement and supply management)
Access HIV 11
Department of Essential Drugs and Medicines Policy
what remains to be done

Adaptation of National Standard Treatment Guidelines

Adaptation of National Essential Medicines Lists

Training in Rational Use for Health Workers & Consumers

Updated review of Global Patent Status of HIV medicines

Specific guidance and country support on patents, IPR and
procurement of limited-source HIV medicines

More in area of financing options

Technical assistance for in-country supply systems

Systems of Drug Safety Monitoring
Access HIV 12
Department of Essential Drugs and Medicines Policy