Strengthening the impact of the WHO prequalification program

1. Strengthening the impact of the WHO prequalification program April 28, 2007

2. Session Objectives • Objectives: • Update on progress with hormonal contraceptive prequalification • Update on the prequalification process for devices: condoms and IUDs • Discussion on effectively linking prequalification to commodity funding and country-level work

3. Prequalification Project • Anticipated outcomes of the prequalification process: • Improved access to low-cost generics • Consistent product quality standards • In-country manufacturing capacity strengthened and regulatory awareness raised

4. Prequalification Process Steps • Publication of Invitation for Expression of Interest (EOI) • Screening of dossiers • Dossier assessment • Site audit • Product testing • Manufacturers listing • Monitoring • Re-qualification

5. Case Study • Expansion of the supplier base • Significant price reductions • In-country industrial capacity building

6. Device Prequalification • Status of Condom program • Status of IUD program

7. Hormonal Contraception EOI • October 2006 Expression of Interest for: • Ethinylestradiol + Levonorgestrel tablet • Levonorgestrel, tablet 30 micrograms, 750 micrograms (pack of 2), 1.5 mg (pack of 1) • DMPA 150 mg/ml • 9 responses received to date • Initial review not promising • 3–5 prequalified manufacturers likely by 2008

8. Core list of RH medicines for priority prequalification • clotrimazole • latex male condoms • ethinylestradiol + levonorgestrel • copper-bearing intrauterine contraceptive devices (IUD) • levonorgestrel for oral hormonal contraception • levonorgestrel for emergency contraception • magnesium sulfate • medroxyprogesterone acetate (DMPA) depot injection • oxytocin Already in WHO’s prequalification program • azithromycin • cefixime  

9. Supporting the prequalification program • Incorporate WHO prequalified sources in direct institutional procurements • Adopt procurement policy similar to the Global Fund • Include the requirement in funding agreements for recipients to use WHO prequalified sources

10. Raising awareness of the prequalification program • Promote the benefits already gained by the inclusion of RH medicines in the WHO program to home organizations • Orient country level colleagues to the prequalification program as it relates to RH supplies

11. Key messages for home organizations RH Prequalification program: • Built on existing WHO program • Ensures quality • Drives lower costs • Strengthens in-country manufacturing capacity • Broad support from international stakeholders

12. Messages for home organizations • Encourage your suppliers to participate in WHO/UN prequalification progamme and submit dossiers • Inform all your suppliers officially that you will procure prequalified products as soon as two products have been prequalified • Inform your local suppliers that WHO can provide technical advice to prepare for prequalification and improve quality where needed • Main message: prequalification is a global support mechanism to improve their quality production, and will establish international export potential

13. Key messages for country-level colleagues Prequalification program: • Ensures quality • Facilitates access to quality products • Reduces cost of quality assurance • Drives lower product costs • Strengthens in-country manufacturing capacity • Is part of a donor trend toward using prequalified sources

14. Open Discussion • Are you able to pursue these implementation steps? • Do you anticipate any concerns or constraints? • Share your experiences at the RHSC October meeting. • WHO Prequalification Web site • http://www.who.int/prequal