Inter-Agency Guidelines for Good Procurement of Pharmaceuticals Regina M. Mbindyo WHO Kenya

Outline Why the Guidelines? 4 Strategic Principles The 10 Guidelines Practical Issues

Why the Guidelines? Inadequate rules, regulations, policies Human resources capacity limitations Conflicting regulations – donors, governments Lack of unbiased market information Fast-changing market situations Health reforms - decentralization

4 Strategic Principles Cost-effectiveness and Quantification Obtain the most cost-effective product & quantify accurately Quality and Reliability Pre-select reliable suppliers of high quality products Timeliness Ensure timely delivery (CMS facility Patient Total Cost minimization Achieve the lowest cost possible (time, morbidity, stock holding, etc)

Cost-Effectiveness and Quantity Selection for optimum therapeutic value Essential Medicines List (EML) Accurate Quantification Accurate records (patients, drugs, etc) Information (feedback) system

The 10 Guidelines Separation of responsibilities Transparency and documentation (procedures) Proper planning, monitoring & Audits Procurement based on EML/Formulary Use of INN (generic name) in tendering Accurate quantification of requirements Reliable financing; good financial management Bulk procurement (economies of scale) Competitive procurement methods Sole source commitments enforced Supplier selection and performance monitoring Reliable Quality Assurance mechanisms

Practical Issues Selection – Supplier pre-selection If EML not updated – what should be the reference document (Rx Guidelines?) e.g. ACT Therapeutic class tendering – how practical is it? Supplier pre-selection Open tender Government policy Vs ‘Rule of 5’ Lengthy procedures for ‘single source’ approval Non-pre-qualified local manufacturers Unclear/ambiguous criteria for inclusion (e.g how to verify WHO pre-qualification for a supplier)

Practical Issues (2) Product Selection (Quality & Efficacy) What evidence constitutes ‘poor quality’ or poor supplier performance’? Monitor for quality and supplier performance critical (product defect reporting, targeted QC analysis) Monitoring process must be documented and transparent Implications of price differences for bulk procurement - lack of objective information can lead to unnecessarily high prices, loss of confidence, etc. The higher the volumes – the higher the stakes.

Practical Issues (3) Quantification Inadequate record-keeping & feedback at user points - Quantification should be bottom-up Mandate of procurement agency Vs Division of pharmacy (who should build capacity – define roles & expectations and implementation plan. Scale economies Vs space availability: New therapies are mostly imports – freight costs are significant. Inadequate funding – how to prioritize?