Access to Medicines for HIV/AIDS, Tuberculosis and Malaria. WHO/UNICEF Technical Briefing Seminar on Essential Medicines Policies. November 2008 Sophie Logez Pharmaceutical and Health Technology Unit

Presentation Outline Global Fund grants: portfolio update and results Global Fund approach to pharmaceutical and health products management Global Fund contribution to improving access

Status of Global Fund Grants Financing 577 grants in 136 countries (Nov. 08) Status of Global Fund Grants Financial Status Proposals Approved (R1-8) Grants signed US$ Money disbursed Global Fund financing (US$), November 2008 14.9 billion 10.2 billion 6.7 billion 45% Objective of the Global Fund “making a “sustainable and significant” contribution to the achievement of the Millennium Development Goals”

Rapid scaling up of results Global Fund Top 3 result indicators (2008) Intervention mid 2007 mid 2008 % increase since mid 2007 Global Fund target end 2008 HIV: People on ARV treatment 1.1 million 1.75 m 59% 1.8m TB: People treated under DOTS 2.8 million 3,9 m 39% 4.5m Malaria: Insecticide-treated nets distributed 30 million 59 m 97% 70m

Pharmaceutical Health product management a key component About 50 percent of Global Fund grants allocated to management of products Supply chain weaknesses: a leading risk factor in bottlenecks, failures or reduced impact

What it can include Services Activities Products Pharmaceuticals Health products Health equipment Equipment Services Registration Selection Forecasting Procurement Transport Quality control Storage Distribution Monitoring Pharmacovigilance Activities Procurement costs Distribution costs Training Technical Assistance Capacity Building This highlights the large scope of products, activities and services that Management of pharmaceutical and health products consist of. And the list is not exhaustive. Definition of each category of products is included in the R8 Guidelines. Procurement costs is seen in that case in its broad mean: transport, quality control, storage cost…etc

The Global Fund Approach Pharmaceutical and Health Product Management Principles and minimum standards, not detailed procedures Build upon existing systems Principal Recipients responsible for all PSM activities

Guide outlines what PRs need to do Policies Quality-assured products Lowest possible price National laws and international agreements Transparent and competitive procurement Guide outlines what PRs need to do This is essential that applicants read the Guide on Policies before preparing the proposal- the guide exist in four langages. Beside, Guidelines for proposal round 8 And Round 8 frequently asked questions

Policies and Initiatives Quality Assurance Policy for pharmaceutical products Revised by the Board in November 2009 MDR-TB treatment Green Light Committee support services Voluntary Pooled Procurement and Capacity Building Services To be launched early 2009 Affordable Medicine Facility for malaria (AMFm) Approved by the Board in November 2008 There are 3 policies approved by the Board to be highlighted regarding management of pharmaceutical and health products. The QA policy Procurement of medicines for MDR TB including funding for GLC support services And voluntary Pooled procurement services and capacity building services, approved by the Board in April 2007, which is still being operationalized by the Secretariat. Thus, it will have no incidence on the Round 8.

Goals of the Global Fund procurement initiatives Significantly increase speed of grant implementation Reduce the burden on recipient countries by easing procurement bottlenecks in country Develop/review policy procedures and/or requirements for countries Coordination with Partners.

Health System Strengthening Medical Products and Technologies One of the WHO's Six Building Blocks for Health Systems HHS section is an optional additional section for applicants The Global Fund's major objectives in providing funding for health systems strengthening are to: (i) improve grant performance, and (ii) increase overall impact of responses to the three diseases. We recognize that supporting the development of equitable, efficient, sustainable, transparent and accountable health systems furthers achievement of these objectives. One of the 'WHO's Six Building Blocks for health systems' is Medical products, vaccines and technologies “A well-functioning health system ensures equitable access to essential medical products, vaccines and technologies of assured quality, safety, efficacy and cost-effectiveness, and their scientifically sound and cost-effective use.”

HSS cross-cutting interventions What it can include Activities Registration Selection Forecasting Procurement Transport Quality control Storage Distribution Monitoring Maintenance Health Systems NDRA National Committee for Selection of essential medicines STGs committees Logistics and communication systems National Laboratory Control Pharmacovigilance Managing pharmaceutical and health products include the activities as already mentioned AND it involved various national entities and organizations, part of the health systems to perform the required activities, like registration, monitoring pharmaceutical activities, promoting rational use and pharmacovigilance by the national drug regulatory authorities, QC by the laboratory control, etc… These entities might receive support and be strengthened in order to provide the services and activities they are entitled to, in an optimal way And In GF proposal for HHS , it can include pharmaceutical and health products management; Procurement systems; Logistics, including transport and communications; and Technology management and maintenance.

Improving Access Rational Selection: PRs required to Procure only medicines on National, Institutional or WHO Model List of Essential Medicines and Treatment Guidelines Indicate strategies in place to ensure appropriate use of procured medicines Affordable Prices: PRs required to Procure quality assured products at the lowest price Conduct procurement in a transparent and competitive process Encouraged to apply TRIPS flexibilities in a manner consistent with National & International laws

Improving Access/2 Sustainable financing Increased funding made available (sustainability?) Coordination with other donors Reliable Health and Supply Systems Provide funds for health systems strengthening activities Grants funding accessible by all sectors involved in the health system: Public, Private and NGO organizations Policy on Quality Assurance for pharmaceuticals

Procurement and Supply Management http://www. theglobalfund Additional information available on the GF website for PSM and more specifically on the QA policy and its implementation.

Capacity building as planned Planning Technical support PSM plan preparation Team work Technical support to prepare the proposal: PSM experts Laboratory experts Regulatory authorities IPR experts Capacity building as planned TA as planned TA as planned Proposal + Attachment B Proposal writing: Define the best procurement system according to the need of the programme in terms of products, taking into account requirements, resources, weaknesses and gaps. Coordination with other members of the proposal team Medicine selection, Forecasting, estimation of PSM cost: transport, QC, storage, distribution Identify the gaps, needs in the PSM chain, request for TA in specific area Partnership: technical agencies, consultants, national authorities Opportunity to include capacity building activities with adequate costing for various PSM activities The PSM plan: A detailed description of the systems and PR capacity to manage pharmaceutical and health products included in the grants. PSM plan development: the sooner the better. In line with the proposal Before the grant signature. Phase 1 Phase 2 Proposal approved Grant signature Phase 2 review Preparation

PSM Plan Approval Process PR submits PSM Plan to Global Fund GF & LFA assessment process Proposal recommended for funding Revise Plan Implementation of program in line with Grant Global Fund approval & disbursement