1. M ODULE 5 PART 2: Introduction to Pharmaceutical and Health Product Management (PHPM) - Country Profile Approach GLOBAL FUND GRANT CONSOLIDATION WORKSHOP DATE

2. OVERVIEW Background Key Features: Country Profile Approach Key Components of Proposed Country Profiles PHPM Country Profile Approach Procurement Planning in the PHPM country profile approach Potential Benefits : PHPM Country Profile approach Key Messages 2

3. BACKGROUND Traditionally, the Global Fund requires a standard set of documents for each Grant to be signed Performance Framework PSM Plan Detailed Workplan and Budget The proposed Country Profile Approach moves to a model where a standard set of information on PHPM systems is available for each country: “The Country Profile” Holistic Review of systems used for program implementation Done once Updated at regular intervals Comprehensive and available as a public document 3

4. Based on indicators esp. those of country health systems Provides a more holistic view of the systems used for program implementation through a country program-focused assessment Aims to avoid submission of repetitive information in the form of PSM Plans for each new grant. Provides a standard set of information on policies, systems and structures of a country’s Pharmaceutical Sector. Country Profile has 3 parts: 1. Context and systems description 2. Operational Systems 3. Action plan based on 1&2 4 KEY FEATURES: COUNTRY PROFILE APPROACH

5. SCENARIO FOR COUNTRY X WITH MULTIPLE GRANTS AND PHPM COUNTRY PROFILE PSM Plan HIV R7 PSM Plan HIV R6 PSM Plan HIV R3 PSM Plan TB R6 PSM Plan TB R4 PSM Plan Mal R8 PSM Plan Mal R5 PSM Plan Mal R3 Country Profile

6. KEY COMPONENTS: PROPOSED COUNTRY PROFILE Narrative section of traditional PSM Plan replaced by focused questions on: 1.Context and Systems Description 2.Operational systems in place 6

7. PART 1 AND 11: PHPM COUNTRY PROFILE 7

8. PART 3: ACTION PLAN – COUNTRY PROFILE MONITORING PLAN 8 ACTION PLAN – COUNTRY PROFILE MONITORING PLAN STRENGTHSWEAKNESSES Section1 : Pharmaceutical and health products policies, laws, regulations and standards Section2 : Pharmaceutical Quality Assurance System ACTION PLAN Detailed Description of the Strengthening Measure ResponsibilityTimeline Total Funding* (Specify amount) Funding Source(s) (Specify funding organization and amount) Technical Assistance (Specify type of TA and amount, if needed)

9. P ROCUREMENT P LAN The “Procurement Plan” is disease specific Includes: List of health products to be procured with Grant resources, including quantities and unit costs; Forecasting methodology; Procurement schedule; Compliance with the Global Fund’s QA Policy. NB: The narrative Sections of the PSM Plan have been removed as a requirement - simplified 9

10. P ROCUREMENT P LAN Table of contents: Table 1: Procurement and Pharmaceutical Management Cost Summary Table 2: Selection in compliance with standards Table 3: Compliance with the Global Fund’s Quality Assurance Policy Table 4: List of pharmaceutical products, estimated quantities and cost Table 5: List of non-pharmaceutical products, estimated quantities and cost Table 6: Procurement schedules Table 7: Overview of funding for antiretroviral, anti- malarial and anti-TB medicines and health products 10

11. E XAMPLE - P ROCUREMENT P LAN R2 RCC 11 Table 4List of pharmaceutical products, estimated quantities, and cost Product / Dosage Form Strength Unit of measure ment (Tab, ml, pack) Estimated Unit cost (incoterm s) Year 1Year 2Year 3 ( if applicable ) Procurement conducted by Procureme nt method Quantity Total Cost Quantity Total Cost Quantity Total Cost Antiretroviral medicines Lamivudine 150mg One oral solid 0.0325070469,610539,710 Abacavir 300mg One oral solid 0.2444,060230,130278,060 Nevirapine 200mg One oral solid 0.04070,50077,800 Lopinavir/ritonavir 200/50mg One oral solid 0.2479,140171,660214,220 Antimalarial medicines Antituberculosis medicines Other medicines Total Cost per year

12. E XAMPLE - P ROCUREMENT P LAN SSF 12 Table 4List of pharmaceutical products, estimated quantities, and cost Product / Dosage Form Strength Unit of measure ment (Tab, ml, pack) Estimated Unit cost (incoterm s) Year 1Year 2Year 3 ( if applicable ) Procurement conducted by Procureme nt method Quantity Total Cost Quantity Total Cost Quantity Total Cost Antiretroviral medicines Lamivudine 150mg One oral solid 0.03469,610539,710494,800 Abacavir 300mg One oral solid 0.24230,130278.060202,850 Nevirapine 200mg One oral solid 0.0470,50077,800 Lopinavir/ritonavir 200/50mg One oral solid 0.24171.660214,22094,700 Antimalarial medicines Antituberculosis medicines Other medicines Total Cost per year

13. P ROCUREMENT P LAN Table 4: List of pharmaceutical products, estimated quantities and cost Takes into consideration Quantities on hand Number of patients on treatment Emergency procurements made prior to SSF signing Period of overlap 13

14. 14 PROPOSED PROCUREMENT PLAN APPROVAL PROCESS WITH COUNTRY PROFILE Country Profile + LFA PHPM Assessment LFA Assessment: Procurement plan Procurement plan Prior to grant negotiations During grant negotiations Procure- ment plan Approval

15. C ONSOLIDATING PROCUREMENT PLAN UNDER THE PHPM COUNTRY PROFILE When a PHPM country profile is available Consolidate procurement plans per disease per PR Reflect detailed list of health products to be procured under the consolidated grant 15

16. COMPARISON OF THE TWO APPROACHES PSM PLAN 1. PR system 2. Describes PR’s institutional capacity for PSM 3. Elements of PSM cycle COUNTRY PROFILE 1. Country systems 2. Context and Systems Description 3. Operational systems in place 16

17. 17 WHAT ARE THE POTENTIAL BENEFITS OF THE COUNTRY PROFILE APPROACH? PARTICIPANT TEAZER !

18. 18 Reinforce focus on National Systems vs. required documents Assist countries to plan how grant resources can help to strengthen systems Use information in the Country Profiles to assist PRs to identify capacity building needs Provides avenue to engage national stakeholders on health and pharmaceutical PSM issues Improve TGF knowledge of the systems used for program implementation Streamline and speed-up the grant signing process by de-linking the LFA PHPM Assessment and the grant signing Others? POTENTIAL BENEFITS OF THE COUNTRY PROFILE APPROACH

19. REQUIREMENTS FOR GRANT SIGNATURE WITH A PHPM COUNTRY PROFILE 1. Assessed Country Profile (not older than 12 months) 2. Update on the sections of the existing PHPM country profile that may have changed 3. Revised procurement plan for the disease component 4. Desk review by the LFA of the revised Procurement Plan and of any sections of the Country Profile that have changed 5. A scheduled LFA Assessment not linked to grant negotiations 19

20. KEY MESSAGES Use of the PHPM Country Profile is replacing the PSM Plan in future grants For GC, implementation arrangements in consolidated PSM/ Procurement Plan should be harmonized with individual PSM/ Procurement plans or have plans to manage transition In consolidated grants, lists of health products and quantities (Annexes 1a&b) should be aligned to consolidated PF targets, work plan and budget 20

21. FOR MORE INFORMATION Contact Global Fund Pharmaceutical Management Advisory Services Team Email: luca.libassi@theglobalfund.org luca.libassi@theglobalfund.org UNAIDS Technical Support Facility EA & SA WHO EPM 21

22. ACKNOWLEDGEMENTS Grant Management Solutions The Global Fund Secretariat UNAIDS Technical Support Facility The AIDS Alliance AIDSPAN 22

23. DISTRIBUTE EXAMPLE OF PHPM COUNTRY PROFILE IF AVAILABLE OR PROVIDE DETAILS OF A LINK TO A PHPM COUNTRY PROFILE 23