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Access to Medicines- OHCHR Geneva, October 11, 2010
Access to Medicines-the Global Fund Experience
Pharmaceutical Management UnitOctober 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
OP/140709/2
100% = US$ 19.4 billion
Access to Medicines- OHCHR Geneva, October 11, 2010
Eastern Europe & Central Asia
7%
Middle East & North Affrica
6%
Latin America & the Caribbean
7%
East Asia & Pacific14%
Sub-Saharan Africa57%
South Asia9%
Introduction: Approved Proposal- by Regions
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
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 TBBranded-34% Branded-70% Branded-22%Generic-66% Generic-30% Generic-78%
Access to Medicines- OHCHR Geneva, October 11, 2010
Existing Challenges: Availability and Affordability
Price difference-Generic vs Originator
Access to Medicines- OHCHR Geneva, October 11, 2010
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;
Existing Challenges: Availability and Affordability
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
37% percent funds are used for medicines and health product procurement;
Use of the Global Fund Grant Funding
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 non-
compliance 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;