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Inter-Agency Guidelines for Good Procurement of Pharmaceuticals

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

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Inter-Agency Guidelines for Good Procurement of Pharmaceuticals

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

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

  3. 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. 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)

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

  6. 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

  7. Practical Issues • 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)

  8. 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.

  9. 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?

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