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 – 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)

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?