Strengthening the impact of the WHO prequalification program

April 28, 2007

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

• 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

Prequalification Project

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

Case Study

• Expansion of the supplier base

• Significant price reductions

• In-country industrial capacity building

Device Prequalification

• Status of Condom program

• Status of IUD program

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

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  

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

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

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

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

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

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