Access to Medicines- OHCHR Geneva, October 11, 2010 Access to Medicines- the Global Fund Experience Pharmaceutical Management Unit October 11, 2010

Access to Medicines- OHCHR Geneva, October 11, 2010

Access to Medicines-the Global Fund Experience

Pharmaceutical Management UnitOctober 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;


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);


Introduction: Approved Proposals- by Disease

OP/140709/2

100% = US$ 19.4 billion


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


Introduction: Global Fund’s Contribution to Int’l Health Financing

HIV- 19%;

TB- 64%;

Malaria- 57%;


Introduction: Rapid Scaling Up of Results


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.,


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;


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.

:


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%



Price difference-Generic vs Originator


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: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


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;


Existing Challenges: Health System Strengthening

37% percent funds are used for medicines and health product procurement;

Use of the Global Fund Grant Funding


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;


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;


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;


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;


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;


THANK YOU! MERCI!

SHOKRAN!

SPASIBA! XIE XIE!

Documents

Access to Medicines- OHCHR Geneva, October 11, 2010 Access to Medicines- the Global Fund Experience Pharmaceutical Management Unit October 11, 2010