1. UNFPA Because everyone counts 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. UNFPA Because everyone counts 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

3. UNFPA Because everyone counts 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. UNFPA Because everyone counts 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. UNFPA Because everyone counts Time line of WHO/UNFPA activities to support the prequalification programme 2002  UNFPA requested to procure RH Essential Medicines and Commodities. WHO/RHR maintains technical and normative role 2003 - 2005  WHO/RHR/WHO/PSM/UNFPA/Stakeholders harmonized evidenced- based list of RH Essential Medicines approved and incorporated into WHO List of Essential Medicines 2005  UNFPA requested to undertake the prequalification of male latex condoms and TCu380A IUDs  WHO/RHR/partners harmonize the scheme for the prequalification for UNFPA with WHO Prequalification Scheme for Essential Medicines 2007- 2009  WHO/RHR/UNFPA/Stakeholder initiate activities to update the specifications for male latex condoms and TCu380A IUDs  TCu380A IUD specification not undated for 20 years  Publish a Cochrane Systematic Review  Identify issues and undertake the research to respond to the issues, such as ageing behaviours of IUDs  Support updating the international standards for male latex condoms and TCu380A IUDs

6. UNFPA Because everyone counts Time line of WHO/UNFPA activities to support the prequalification programme 2007 -2008  WHO/UNFPA Prequalification Scheme for Male Latex condoms and TCu380A approved by Expert Committee for Pharmaceutical Preparations October 2007.  Published WHO Technical Report Series 948, May 2008 2008 - 2009  UNFPA/WHO/RHR/FHI/PATH convene workshops and mentorship training for condom manufacturers, testing laboratories, regulatory authorities and bulk procurement agencies on specifications and prequalification  Botswana, China, India, Indonesia, South Africa, Thailand and Vietnam 2010  WHO/RHR/UNFPA/FHI convene workshop for TCu380A IUD manufacturers to introduce the new specification and prequalification scheme. 2010  WHO//UNFPA/FHI/Stakeholders publish:  Male latex condom: Specification, Prequalification and Procurement, 2010  TCu380A IUD: Specification, Prequalification and Procurement, 2010

7. UNFPA Because everyone counts 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. UNFPA Because everyone counts 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 UNFPA Because everyone counts

11. UNFPA Because everyone counts 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. UNFPA Because everyone counts 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. UNFPA Because everyone counts Thank you