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