Procurement of reproductive health essential medicines WHO/UNFPA Prequalification Scheme

1. Procurement of reproductive health essential medicines WHO/UNFPA Prequalification Scheme Agnes Chidanyika on behalf of David Smith, Chief UNFPA Procurement Services Branch Copenhagen and Margaret Usher-Patel, Department of Reproductive Health and Research, World Health Organization

2. Overview of the presentation Brief summary UNFPA Procurement Products being procured Products being prequalified WHO/UNFPA Prequalification Scheme Time-line Key Activities Achievements Challenges Future requirement UNFPA Because everyone counts

3. Lead Agency in the procurement of Reproductive Health Essential Medicines and commodities The contraceptive basket includes: • Oral contraceptives • Emergency contraceptives • Implants and Injectables • IUDs and male and female condoms Medical equipment including Emergency RH Health Kits Pharmaceutical, such as analgesics, antibiotics and other medicines

4. Specifications and Prequalification scheme • Since 1989 WHO/RHR has prepared the Male Latex Condom Specification and detailed the procedures and promoted the concept of prequalification. • Objectives of the scheme • Ensure high quality commodities • Access generic medicines and low cost devices • Harmonize quality standards through pooled procurement • Ensure safety and efficacy throughout shelf life • Individual agencies implemented the scheme with a number of variations and considerable duplication of effort

5. Time line of WHO/UNFPA activities to support the prequalification programme

6. Time line of WHO/UNFPA activities to support the prequalification programme UNFPA Because everyone counts

7. Key Activities • Prequalification • Review of Product Dossiers • Testing of products • Factory inspections / re-inspections • On-site factory inspections for quality systems and quality standards • Workshops / mentoring activities • Manufacturers/factories • Regulatory bodies • Governments / other partners • Continuous Quality Assurance control • Pre-shipment sampling compliance testing • In some cases countries undertake post shipment testing • Product quality monitoring

8. Factory inspections

9. Inspections / Re-inspections

10. Achievements • Out of 55 condom factories • 24 Prequalified (16 due re-inspections 2010) • 7 Long Term Agreements • Out of 8 IUD manufacturers • 8 Prequalified (6 due re-inspections 2010) • 4 Long Term Agreements • Consultative meetings with key stakeholders • Collaborations with other agencies • ISO re-certification of UNFPA Procurement

11. Challenges • Scheme heavily reliant on funding • Factory inspections • Capacity building • Collaborative activities with programme and procurement officers • Gaps • Products being prequalified only limited to condoms and IUDs – expand to cover pharmaceuticals • Laboratory testing is not of uniform standard • Regulatory processes may be non-existent

12. Future directions • Continue to co-ordinate activities with partners /stakeholders. • Work in collaboration with WHO/RHSC to improve procurement process and procedures • Support a capacity building process for regional and country laboratories to conform with ISO 17045 • Prequalification of new factories and re-qualification of listed factories • With WHO formulate and implement a similar process for female condoms • Support the capacity building of national regulatory authorities • Promote the use of Access RH

13. Thank you