Strategic Directions for Pharmaceutical Sector Work

1. Strategic Directions for Pharmaceutical Sector Work Andreas Seiter July 2008 First Draft for Review

2. HNP Strategy: Better Health Outcomes Through Improved Health Systems Access to and appropriate use of medicines is an essential element of a functioning health system Accessibility Availability Acceptability Affordability Source: MSH

3. AvailabilityFunctioning marketProcurement, supply chain AffordabilityFinancingPurchasing efficiencyPricing AccessibilityHealthcare service infrastructureHuman resourcesTransportation AcceptabilityTechnical StandardsRegulation & enforcementInformationTransparency of rules and decisions UtilizationRational prescribing and use Medicines Supporting Health Outcomes Which of these areas should HNP support through a pharmaceuticals work program (based on skills available, leveraging potential by/for other activities or partnerships, areas not well covered by other agencies, high impact on outcomes, measurable results)?

4. AvailabilityFunctioning marketProcurement, supply chain AffordabilityFinancingPurchasing efficiencyPricing AccessibilityHealthcare service infrastructureHuman resourcesTransportation AcceptabilityTechnical StandardsRegulation& enforcementInformationTransparency of rules and decisions UtilizationRational prescribing and use Medicines Supporting Health Outcomes First cut – areas of interest where we may be in a good position to provide support Areas covered by other functions or by partners, or areas with no specific skills advantage on our side

5. AvailabilityProcurement, supply chain (LICs) AffordabilityFinancingPurchasing efficiency (MeTA) Pricing (MeTA) AcceptabilityRegulation(MICs)Transparency of rules and decisions (MeTA, GAC) UtilizationRational prescribing and use (MeTA, GAC) Medicines Supporting Health Outcomes Areas of direct interest to operations Areas where we can leverage partnerships

6. Strategy Outline The “Pharmaceutical Expert” function in the HNP Anchor supports operations • Within the framework of general health systems development work • With a focus on Good Governance and Management Practices in the Pharmaceutical Sector (covering financing, purchasing efficiency, pricing, selection, procurement, supply chain management and rational use of medicines) • Considering public as well as private sector solutions • Providing also regulatory support relevant to the above areas • Assisting in establishing transparent and effective tools and processes for decision making • Guided by data and verified by measurable outcome or proxy indicators • Considering viewpoints of different stakeholders (including civil society) in the sector and aware of the strong commercial influences on policy • In close collaboration with technical agencies such as WHO or procurement specialists such as UNICEF – on which we rely in their special areas of expertise • Through programmatic work, TA and policy dialogue in countries as well as through knowledge products and training tools designed for TTLs and technical level staff in client countries

7. Working Effectively, Efficiently and Sustainably • “Good Practice and doable” is better than “Best Practice but unrealistic” in a given political environment • Identify and work with “champions” and “early adopters” rather than trying to convince those who are reluctant to try new things • “You can only manage what you can measure” – systems to collect and analyze data are essential for improving governance and management • Learning by example – for technical experts, detailed case studies are better learning tools than textbooks or academic overview papers • Pick the best people – only hire consultants that have a track record of providing excellent quality of work • Leverage knowledge available in other institutions and networks (Bank/IFC, WHO, other UN agencies, GFATM, academia, PPRI, PIC/s Scheme, NICE, MeTA etc) • Use networks and networking tools for dissemination and learning • Build critical mass and visibility to attract external funding and become independent from BB • Early prototyping and learning from pilot implementation is better than “analysis-paralysis” • Take a long term perspective – pharmaceutical sector reform is an ongoing challenge and major changes can take years to show their full effect

8. How to Remain Focused • Limiting ourselves to a single issue focus such as “procurement only” or “financing only” is not an option if we want to improve complex systems • Focus has to be designed into each project – addressing key issues or bottlenecks for which informal “political economy” indicators show a solid chance for successful implementation of agreed policy changes • This contrasts with many past consulting projects that led to comprehensive analytical reports and a multitude of recommendations – sometimes overwhelming the client and leading to no change or follow-up at all • Example for focus: Ghana 2007/2008 – recommendations limited to three issues (unclear pricing rules, double-billing for subsidized “program” drugs and lack of baseline data for drug utilization) that threaten sustainability of health insurance but can be addressed in reasonable time with limited efforts; all other issues are mentioned but will not be pursued at the time

9. Why should we be doing this (demand, strategic fit, innovation, scale of impact..)? What exactly are we doing (clear objectives, tasks and deliverables defined, realistic timelines and resource allocation..)? How are we doing it (methodology, process, decision making, dissemination..)? Whom are we working with (core team, TTL(s), client country champion(s), consultants, partner organization experts..) How do we measure success (output, impact indicators, outcome measures..)? How can we use leverage (leverage partnerships and networks, knowledge from previous projects, country-internal partners and networks; leverage opportunities from the project for future projects..) How can we share knowledge and learnings gained during the project (training, workshops, reports, databases, expert networks, web based tools..)? Project Selection Checklist

10. Short Term Work Program • Learning ICR India Food and Drugs Capacity Building Program • DIR follow-up in India, focus on medicines procurement (certification of a state procurement agency); contract with MSH • Work with OPCPR to address procurement roadblocks • Multi-country work program to improve pharmaceutical governance and management (Ghana, Indonesia, Peru, Timor-Leste, Benin, WBG, Yemen, Zambia, Jordan, Uganda, Kyrgyzstan) in partnership with DFID, WHO and NICE; TF and EFO funded • MIC technical support as part of DPL or RTA (Bulgaria, Turkey, KSA); emerging partnership with NICE • New Flagship Module on pharmaceutical governance and management (in partnership with DFID, Harvard and WHO) • Strengths: Clear focus on core areas of competence important for health systems strengthening; high relevance to stakeholders and Bank clients; fully leveraged partnerships; growing body of competent and tested consultants • Weaknesses: not all objectives clear yet; management process not yet streamlined

11. Mid-Term Goals, Ideas and Options • Stronger internal partnership with OPCS and INT to address governance issues in pharmaceutical procurement and supply chain management • Providing 24/7 technical “hotline” service for TTLs and procurement staff on pharmaceuticals, medical supplies and devices through contract with specialized firm • Develop practical know-how on framework contracts for pharmaceuticals and contracting out of entire supply chains and provide TA to clients • Develop tools for rational decision making on inclusion of new drugs in reimbursement lists, in partnership with NICE • Work with IFC on public-private synergies; business environment; impact of industrial development in manufacturing and distribution on regulatory quality • Work with academia and industry on differential pricing and access programs for “new essential drugs” that are still under patent