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

2. 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;

3. 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);

4. Access to Medicines- OHCHR Geneva, October 11, 2010 Introduction: Approved Proposals- by Disease OP/140709/2 100% = US$ 19.4 billion

5. Access to Medicines- OHCHR Geneva, October 11, 2010 Introduction: Approved Proposal- by Regions Round 9

6. Access to Medicines- OHCHR Geneva, October 11, 2010 Introduction: Global Fund’s Contribution to Int’l Health Financing HIV- 19%; TB- 64%; Malaria- 57%;

7. Access to Medicines- OHCHR Geneva, October 11, 2010 Introduction: Rapid Scaling Up of Results

8. 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.,

9. 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;

10. 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. :

11. 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:MalariaTB Branded-34%Branded-70%Branded-22% Generic-66%Generic-30%Generic-78%

12. Access to Medicines- OHCHR Geneva, October 11, 2010 Existing Challenges: Availability and Affordability Price difference-Generic vs Originator

13. 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

14. 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

15. 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;

16. 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

17. 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;

18. 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;

19. 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;

20. 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;

21. 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;

22. Access to Medicines- OHCHR Geneva, October 11, 2010 THANK YOU!MERCI! SHOKRAN! SPASIBA!XIE XIE!