Strategic Directions for Pharmaceutical Sector Work

Strategic Directions for Pharmaceutical Sector Work

Andreas Seiter

July 2008

First Draft for Review

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

Interventions

Drug Supply-Type

-Quantity

Drug Demand-Type

-Quantity

UserLocation

Drug SupplyLocation

User'sAttitudes/

Expectationsof Products

and Services

Characteristicsof Products and

Services

User's Incom eAbility to Pay

Prices of DrugProducts and

Services

Quality ofProducts

& Services

Accessibility Availability

Acceptability Affordability

Source: MSH

Availability Functioning marketProcurement, supply chain

Affordability FinancingPurchasing 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)?

Availability Functioning marketProcurement, supply chain

Affordability FinancingPurchasing 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

Availability Procurement, supply chain (LICs)

Affordability FinancingPurchasing 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

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

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

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

Project Selection Checklist

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..)?

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

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