Access to Medicinesthe Global Fund Experience
Pharmaceutical Management Unit
October 11, 2010
Access to Medicines- OHCHR
Geneva, October 11, 2010
Presentations Outline
1) Introduction to Global Fund
2) Existing Challenges-Global Fund’s Approach
 Sustainable Financing;
 Procurement and Supply Chain Management;
 Quality Assured Medicines;
 Availability and Affordability;
 Capacity Building and Technical Assistance;
 Health System Strengthening;
 Harmonization;
3) Human Rights Principles- Global Fund’s Approach
4) Emerging Issues and Way Forward;
Access to Medicines- OHCHR
Geneva, October 11, 2010
Introduction: The Global Fund
• To raise and disburse substantial new funds to achieve
sustained impact to fight HIV, TB and Malaria;
• Financing mechanism but not an implementing or technical
agency;
• Partnership between governments, civil society, the private
sector and affected communities;
• Performance based funding and Country ownership;
• Proposals are submitted by Country Coordinating
Mechanism (CCM);
Access to Medicines- OHCHR
Geneva, October 11, 2010
Introduction: Approved Proposals- by Disease
100% = US$ 19.4 billion
Access to Medicines- OHCHR
Geneva, October 11, 2010
OP/140709/2
Introduction: Approved Proposal- by Regions
Middle East &
North Affrica
6%
East Asia &
Pacific
14%
Eastern Europe
& Central Asia
7%
Sub-Saharan
Africa
57%
Latin America &
the Caribbean
7%
South Asia
9%
Round 9
Access to Medicines- OHCHR
Geneva, October 11, 2010
Introduction: Global Fund’s Contribution to Int’l
Health Financing
HIV- 19%;
TB- 64%;
Malaria- 57%;
Access to Medicines- OHCHR
Geneva, October 11, 2010
Introduction: Rapid Scaling Up of Results
Access to Medicines- OHCHR
Geneva, October 11, 2010
Existing Challenges: Sustainable Financing
• Global Fund outlined funding scenarios of between US$13
billion and US$20 billion needed for the next three years;
• Donor funding is being difficult due to:
– Global financial crisis,
– Severe restrictions in ODA;
– Competing priorities;
– Budgeting challenges in donor countries;
• Global Fund is pursuing various innovative financing options:
– Product Red, Debt 2 Health, Exchange Fund, UNITAID,
American Idol, Chevron, etc.,
Access to Medicines- OHCHR
Geneva, October 11, 2010
Existing Challenges: Procurement and Supply
Management (PSM)
Global Fund PSM
Policy
based on principle and minimum standards
rather detailed procedures.
• Quality-assured products;
• Lowest possible price;
• Transparent, fair and
competitive procurement;
• National laws and international
agreements;
• Build on existing systems;
• Recipients responsible for all
PSM activities;
• Value for Money;
Access to Medicines- OHCHR
Geneva, October 11, 2010
Existing Challenges: Quality Assured Medicines
Global Fund Quality Assurance Policy ensures quality assured
medicines:
– Option A: WHO prequalification approval;
– Option B: Stringent Regulatory Authority (SRA) approval;
– Option ERP: Premitted for time-limited procurement upon
risk/benefit assessment (of FPPs not yet WHO-PQ or SRA-authorized)
by an Expert Review Panel (ERP) hosted by WHO;
• QC Testing: PR is responsible to conduct systematic random QC
testing all along the supply chain and report to the Global Fund.
Access to Medicines- OHCHR
Geneva, October 11, 2010
Existing Challenges: Availability and Affordability
• List of ARV, TB and Malaria- An overview (not exhaustive)
of products and manufacturers classified according to the
Global Fund Quality Assurance Policy to assist countries to
identify and select quality assured medicines;
Products/Manufacturers distribution:
ARV:
Malaria
Branded-34%
Generic-66%
Branded-70%
Generic-30%
Access to Medicines- OHCHR
Geneva, October 11, 2010
TB
Branded-22%
Generic-78%
Existing Challenges: Availability and Affordability
Price difference-Generic vs Originator
Access to Medicines- OHCHR
Geneva, October 11, 2010
Existing Challenges: Availability and Affordability
Price Difference Across Countries
• Global Fund encourages recipients to apply the flexibilities
within national laws and TRIPS agreement (Doha
Declarations), in a manner that achieves the lowest possible
price for assured quality products;
• Wide spectrum of countries among grantees:
 Unequal access to differential price programs of
pharmaceutical companies;
 Different level of patent protection/ TRIPS implementation;
 Bilateral and regional trade agreements;
 Unequal level of knowledge in IP;
Access to Medicines- OHCHR
Geneva, October 11, 2010
Existing Challenges:
Capacity Building & Technical Assistance
• Assistance with Procurement Supply Management (PSM) Plan
during grant life cycle;
• Facilitating access to TA and capacity building services for
strengthening supply/pharmaceutical national systems in
recipient countries in partnerships with technical agencies and
partners;
• Examples:
•
•
•
Pharmaceutical Management Advisory Services (PMAS)
• Country Profile/ PSM Plan Assessment
Procurement Support Services (PSS)
Pharmacovigilance / Pharmacoresistance
• Monitoring of quality services, strengthening NDRA
Access to Medicines- OHCHR
Geneva, October 11, 2010
Existing Challenges: Health System Strengthening
• Dedicated Health System
Strengthening grants;
• 6% funding budget is used on Health
System Strengthening activities in all
grants:
Human resources ● Strategic information
•Infrastructure ● Enabling policy
environment • Health financing ●
Community Systems Strengthening;
• Work in progress with GAVI and
World Bank of various options for
joint HSS funding and programming;
Access to Medicines- OHCHR
Geneva, October 11, 2010
Existing Challenges: Health System Strengthening
Use of the Global Fund Grant Funding
37% percent funds are used for medicines and health product procurement;
Access to Medicines- OHCHR
Geneva, October 11, 2010
Existing Challenges: Harmonization
• Quality Assurance Policy with other partners-UNITAID, GDF,
etc.,
• PSM Country Profile - Comprehensive and simplified PSM for
one country rather per grant/disease;
• National Strategy Application (NSA)-69 countries approved;
• New Grant Architecture:
- Improved alignment (consolidation/single stream of
funding to align with national cycle and system);
- Decreased transaction costs for implementers and
Secretariat( reduction in reporting and disbursement requests);
• Joint HSS Platform with Partners;
Access to Medicines- OHCHR
Geneva, October 11, 2010
HR Principles:
Equity, Non Discrimination, & Participation
Framework document of the Global Fund states that:
• Equitable access to services;
• Eliminate stigmatization and discrimination against those
infected and affected, especially for women, children and
vulnerable groups;
• Strengthen participation by communities, infected and
affected people;
• Gender Equality and SOGI strategies- 87% of R9 HIV funded
proposals included SOGI focus;
• Representation in CCM also increased in R8/ R9;
Access to Medicines- OHCHR
Geneva, October 11, 2010
HR Principles:
Transparency and Accountability
• Price and Quality Reporting (PQR): Web based system for
tracking the pharmaceutical procurement;
• Reporting is mandatory- data and reports are publicly available;
• Grant related information ( proposal, budget, disbursement,
etc.,), donor pledges and contributions are available on web;
• QA Compliance Report/Phase 2 Review: monitor noncompliance of drug procurement by countries;
• Corrective measures for non compliance including no
disbursement, Conditions Precedents, leading up to grant
closure;
Access to Medicines- OHCHR
Geneva, October 11, 2010
Emerging Issues
• Scarcity of Quality Assured products-e.g., malaria;
• Increasing difficulties expected for countries:
– on the implementation of treatment guidelines, including
newer medicines, if these are not accessible at lower prices;
– to deal with patent issues, as new recommended ARV are
widely patented;
• Many countries are focused on short term rather long term
solution- e.g, health system;
Access to Medicines- OHCHR
Geneva, October 11, 2010
Way Forward
• Need sustainable solutions:
• to strengthen the PSM capacity and health system;
• to ensure production of lower priced generics and in
adequate formulations;
• to simply the IP management by importing countries;
• to ensure countries taking full advantage of the TRIPS
flexibilities;
• to provide incentives for new drugs in the market;
• Continued monitoring and evaluation of access to medicines;
• Greater cooperation/harmonization with donors and partners;
• Strong leadership and advocacy toward access to medicines;
Access to Medicines- OHCHR
Geneva, October 11, 2010
THANK YOU!
MERCI!
SHOKRAN!
SPASIBA!
Access to Medicines- OHCHR
Geneva, October 11, 2010
XIE XIE!