Global Funds Essential Drugs and Medicines Policy World
Global Funds Essential Drugs and Medicines Policy World Health Organization October 2002 with thanks to: Stop TB Partnership Global Fund to Fight AID, Tuberculosis, and Malaria
Global Drug Facility (TB) Global Fund Public Private Partnerships 2 Global Funds. ppt
The need for a Global Drug Facility 3 Global Funds. ppt
Global Partners Forum Global TB Drug Facility Coordinating Board Partnership Secretariat W O R K I N G G R WHO Technical Advisory Group O U P S DOTS expansion TB/HIV DOTS-Plus MDR-TB New TB Vaccines New TB Diagnostics New TB Drugs Cross-cutting: Advocacy & Communications/ Financing Global Partnership to Stop TB 4 Global Funds. ppt
What does the GDF offer? n Now ä ä ä n Future ä ä ä n Grants of first line drugs, to support DOTS expansion A direct procurement mechanism for countries and NGOs, for use in DOTS programmes A web-based tool for placing orders and tracking shipments A list of ‘prequalified’ manufacturers of quality TB drugs Diagnostics Second line drugs Other Possibilities ä ä 5 Global Funds. ppt Anti malarials? Products for TB-HIV?
GDF Operations Application Eligibility criteria Specific conditions Standard form Supporting documents Monitoring Review Quarterly reports Existing monitoring Independent verification Results based Independent Committee 12 -15 members meets 3 x/year Country visit Supply Pooled procurement Standard products High quality Low cost 6 Global Funds. ppt
Activity streams for GDF - lessons for others? 7 Global Funds. ppt
www. stoptb. unwebbuy. org 8 Global Funds. ppt
Progress so far: Outcomes n Processed 50 applications from countries, NGOs, states and public-private partnerships n n 32 countries approved for support, and 1 pending Drugs ordered for 21 countries and delivered to 11 n Drugs committed for over 1. 6 million patients n Drug prices down ~30% n Average drug cost per patient (inc freight): ~$11 n Catalyst for introduction and expansion of DOTS n Catalyst for standardisation - FDCs 9 Global Funds. ppt
GDF Products and Prices GDF Catalogue: www. stoptb. unwebbuy. org 10 Global Funds. ppt
Prequalification n n GDF buys from manufacturers meeting international quality standards WHO/EDM is extending the prequalification mechanism for HIV drugs to TB and malaria Following international advertising, 67 manufacturers applied 21 passed prescreening by SGS Full document review and desk audit to be completed by Dec 2002 11 Global Funds. ppt
Performance Monitoring 12 Global Funds. ppt
GDF Lessons n Link demand, supply and monitoring ä n Establish a ‘virtual organisation’ ä n to facilitate increased access whilst ensuring rational use through a partnership of agencies Use product packaging to simplify logistics, promote rational use, enhance patient acceptability and compliance ä Standard list of TB drugs, fixed dose combinations, patient packs n Use grants of drugs to catalyse improvements in quality of health service provision n Diverse funding base ä ä ä 13 Global Funds. ppt Donor grants to GDF Direct procurement - countries and NGOs use own resources Donors/lending agencies (eg WB/GFATM) for support to countries
Global Drug Facility (TB) Global Fund Public Private Partnerships 14 Global Funds. ppt
$2 billion Pledges May-August 2001 US $ millions 15 Global Funds. ppt
The purpose of the Fund is to ä ä 16 Global Funds. ppt attract, manage and disburse additional resources through a new public-private partnership that will make a sustainable and significant contribution to the reduction of infections, illness and death, thereby mitigating the impact caused by HIV/AIDS, tuberculosis and malaria in countries in need, and contributing to poverty reduction as part of the Millennium Development Goals.
Main global fund activities Proposal development 17 Global Funds. ppt Proposal review Agreement of grants Programme implement –ation Monitoring & evaluation
Key points from the first awards: ä ä ä Approved US$378 million over 2 years - 40 programs - 31 countries Provisional awards of US$238 million -18 proposals - 12 countries 3 multi-country proposals 75 % of the funds for HIV/AIDS - single (60%) or HIV/AIDS combined with one or both of the other diseases (15%) Of 28 countries funded for HIV/AIDS, 21 include ARVs 18 Global Funds. ppt
Nearly 50% of requested resources are for commodities and products Percent of two year commitment to approved proposals USD, 100% = 616 million n Data / information systems n n Others Human resources n Outreach services n n Logistics / supplies n 19 Global Funds. ppt Training / supervision Products and commodities
GFATM resources will substantially increase demand - procurement and supply systems must respond HAART recipients - people living with HIV/AIDS (000’s) 450 Demand on procurement systems 2 X 230 All other developing countries 6 X Africa Current HAART recipients 20 Global Funds. ppt Total HAART recipients including programs approved in Global Fund's first round Source: GFATM, August, 2002 ä Increased volume of manufacturing ä Increased volume of QA/inspections of production facilities and products ä Increased warehousing capacity ä Increased distribution security to prevent product diversion
Global Fund administrative arrangements - receives, reviews, funds, monitors proposals Secretariat Instruction to disburse Global Fund The Primary Recipient(s) is the legally accountable party in country which will disburse to subrecipients and ensure M&E reporting to GF – can be a public, NGO or private (or multilateral) party in the CCM Trustee Funds Advice Local Fund Agent Reporting Primary recipient Country Coordinating Mechanism Funds Reporting The Local Fund Agent is the "eyes and ears" of the GF in country, assessing PR and advising the Secretariat on ongoing performance – can be local office of int'l audit/ accounting firm, regional bank, etc. 21 Global Funds. ppt Sub recipient
Procurement occurs at local, regional, or global levels - depending on the health system and the product Global Regional Type of services Examples International low cost procurement services ECHO, MSF , IDA Missionpharma Global partnerships Global TB Drug Facility Green Light Committee Regional pooled procurement ACAME in SSA Gulf Cooperative Council E. Caribbean Drug Serv Union of Arab Maghreb National governments Local NGOs, missions, others Many Joint Medical Stores Uganda MEDS Kenya CHANPHARM Nigeria 22 Source: Procurement Global Funds. ppt and Supply Management – Issues and Options, memo to TWG from WHO Essential Drugs and Medicines (EDM) with MSH
PSM-TF: Global Fund principles for procurement and supply management 1. Least demanding of the Fund and Recipients 2. Leverage and build local capacity 3. Focus on end results for affected populations 4. Lowest possible price 5. Assured product quality and efficacy 6. Consistency with international agreements 7. Transparency, accountability and security of supply 23 Global Funds. ppt
PSM-TF: Critical elements for procurement and supply management A. Selection and rational use – selection of medicines, diagnostics, other products - adherence, resistance, safety B. Quality assurance – compliance to quality standards, drug registration, monitoring product quality C. Procurement and pricing – procurement responsibilities, procurement principles, monitoring suppliers, achieving lowest possible price, international/national law, domestic production D. Supply chain management – supply chain management, forecasting, preventing shortages, preventing diversion E. Budgeting and finance – direct payment, exemption from duties/taxes, ensuring additionality, in-kind donations F. Monitoring and evaluation – indicators and methods 24 Global Funds. ppt
Global Drug Facility (TB) Global Fund Public Private Partnerships 25 Global Funds. ppt
The 1990’s have produced an explosion of publicprivate partnerships for health (PPPH) n n Over 75 PPPHs - 47 established within the last 5 years 45 of which are concerned with developing or improving access to health products for developing countries: ä ä ä HIV/AIDS (16 partnerships) malaria (11) tuberculosis (5) childhood immunization (4) onchocerciasis (4) reproductive health (4) Source: Initiative on Public-Private Partnerships for Health, www. ippph. org, 2002 26 Global Funds. ppt
Some challenging questions n Public health gains must be assessed ä ä n to people in need to health care systems Principles needed ä ä ä 27 Global Funds. ppt ringfencing - areas often limits to partnerships firewalls - protecting some functions from commercial influence speaking out - partnerships should not undermine public policy
Global Drug Facility (TB) Global Fund Public Private Partnerships 28 Global Funds. ppt
Global Funds
What is the GDF? n A novel approach to secure access to high quality drugs to accelerate DOTS expansion, addressing four needs: ä ä n n n The need for more resources for TB drugs The need for high quality TB drugs The need for efficient procurement systems The need for standardised products An initiative of the Global Partnership to Stop TB Housed in WHO and managed by Stop TB partnership secretariat. Aims to provide free drugs for 10 million people with TB by 2005 Needs $250 million over the next 5 years Initial funding from Canada, Netherlands & US 30 Global Funds. ppt
PSM-TF Overview: C. Procurement and pricing 1. Procurement practices ä Interagency Pharmaceutical Procurement Principles 2. Procurement responsibilities ä ä Recipient responsible for all procurement if capable Regional/global procurement encouraged if lowers prices 3. Monitoring supplier performance ä ä 31 Global Funds. ppt Recipient must monitor Fund to report
PSM-TF Overview: C. Procurement and pricing (continued) 4. Lowest possible price ä ä Competitive purchasing from qualified manufacturers Recipients to apply national laws to achieve lowest price Encourages differential pricing Information on prices paid by Recipients to be made public 5. International and national law ä ä Encourages Recipients to use the provisions of the TRIPS and Doha Declaration, including the flexibilities Fund to defer to appropriate dispute resolution mechanisms 6. Domestic production price premium ä 32 Global Funds. ppt No premium OR 15% domestic price premium for 3 years
Countries approved for regular GDF support Countries approved for emergency GDF support Countries under consideration for GDF support Countries 33 Global Funds. ppt
The adoption of a more robust policy framework will instruct the Secretariat and focus the work of the Fund Resource n Targets and landscape for resource mobilization Governance n Procedures for effective and efficient Board engagement Procurement n Minimum guidelines to ensure product safety, quality and value Proposals n Strengthened review process with broader and deeper expertise Monitoring & evaluation n Framework for conducting focused and results-based M&E Communications n Direction on a responsive communications strategy Partnerships n Agreement on priority areas for contractual and strategic relationships mobilization 34 Global Funds. ppt
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