procurement of reproductive health essential medicines who/unfpa prequalification scheme
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UNFPABecause 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
UNFPABecause 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
UNFPABecause 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 RHHealth Kits
Pharmaceutical, such as analgesics, antibiotics and other medicines
UNFPABecause 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
UNFPABecause 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 IUDsWHO/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 ReviewIdentify 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
UNFPABecause 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, 2010TCu380A IUD: Specification, Prequalification and Procurement, 2010
UNFPABecause 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
UNFPABecause everyone counts
Factory inspections
Total Number of Condom and IUD Factories Inspected by Year
0
10
20
30
40
50
60
70
2001
2002
2003
2004
2005
2006
2007
2008
2009
Year
No.
Fac
tori
es
Condom Factories
IUD Factories
Total
Inspections / Re-inspections
Inspected/ Re-Inspected Factories by Year
0
24
6
810
12
14
1618
20
2001
2002
2003
2004
2005
2006
2007
2008
2009
Year
No.
Fac
tories
Fresh Inspections
Re-inspections
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 stakeholdersCollaborations with other agenciesISO re-certification of UNFPA Procurement
UNFPABecause everyone counts
UNFPABecause 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
UNFPABecause everyone counts
Future directions
Continue to co-ordinate activities with partners /stakeholders.Work in collaboration with WHO/RHSC to improve procurement
process and proceduresSupport a capacity building process for regional and country
laboratories to conform with ISO 17045Prequalification of new factories and re-qualification
of listed factoriesWith WHO formulate and implement a similar process for
female condomsSupport the capacity building of national regulatory authoritiesPromote the use of Access RH
UNFPABecause everyone counts
Thank you
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