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WHO Prequalification of Medicines Programme Richard Laing Department of Essential Medicines and Pharmaceutical Policies (EMP) WHO Geneva
An example of an "enabling" and disruptive organizational technology ,[object Object],[object Object],[object Object],[object Object]
Web site updated constantly –  www.who.int/prequal
Prequalification of Medicines Programme ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Prequalification of Medicinal Products: Objectives - Propose a list of  prequalified products   and manufacturers  meeting international norms and standards of which the quality, efficacy and safety has been assessed, inspected and controlled  - Ensure that   international norms and standards  are applied at all the steps of the Prequalification  Programme. - Make sure re-evaluation and  maintenance  of the list are performed and that variations and changes are correctly controlled. - Help the national drug regulatory authorities to build up  capacity in  assessment, inspection and control  meeting international norms and standards.  -  Develop the  local possibilities  of production and clinical studies by offering customized technical assistance.
How prequalification is organized? (I) ,[object Object],[object Object],[object Object],[object Object]
Prequalification: the technical documents are WHO normative documents. When these are "silent" other guidelines such as selected ICH guidelines may be used
Stages Expression of Interest Request for Dossier submission ,[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Prequalification of Priority Essential Medicines Organisation (1)
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Prequalification of Priority Essential Medicines Organisation (2)
Transparency – dossier status information on the web
Transparency – Inspection outcomes on the web
Unintended Benefits  Individualized trainings ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Unintended Benefits Can measure performance of procurement agencies without being concerned about quality ,[object Object],[object Object],[object Object],[object Object],[object Object]
stavudine 15mg Guyana high outlier prices verified Hi gh price outliers:  screens to assess  efficiency, policy, governance nevirapine 200mg Russia 20x times more  expensive than  median price lamivudine 150mg 76 similar high price outliers removed price per tablet volume price per tablet price per tablet volume volume
Generic and Brand ARV Prices: some findings refute conventional wisdom $1.95 $1.71 $1.05 Prices shown are per tablet 7/05-6/06 $1.10 Who pays these prices?
Regression found only 6 of 19 solid dosage forms showed relationship between volume and price - found no relationship in highest volume products linear regression nevirapine 200mg generic p=0.35  brand p=0.47 Dosage Form Low Vol. Middle Vol. High Vol. zidovudine 100mg 7.2% ref sta40+lam +nvp 13.3% 13.7% ref sta30+lam +nvp 10% 13.3% ref stavudine 30mg 13.3% ref stavudine 40mg 16.7% 15.2% ref efavirenz 600mg 14.3%
Implications for Future Health Systems ,[object Object],[object Object],[object Object]

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Beyond Scaling Up: Prequalification of Medicines

  • 1. WHO Prequalification of Medicines Programme Richard Laing Department of Essential Medicines and Pharmaceutical Policies (EMP) WHO Geneva
  • 2.
  • 3. Web site updated constantly – www.who.int/prequal
  • 4.
  • 5. Prequalification of Medicinal Products: Objectives - Propose a list of prequalified products and manufacturers meeting international norms and standards of which the quality, efficacy and safety has been assessed, inspected and controlled - Ensure that international norms and standards are applied at all the steps of the Prequalification Programme. - Make sure re-evaluation and maintenance of the list are performed and that variations and changes are correctly controlled. - Help the national drug regulatory authorities to build up capacity in assessment, inspection and control meeting international norms and standards. - Develop the local possibilities of production and clinical studies by offering customized technical assistance.
  • 6.
  • 7. Prequalification: the technical documents are WHO normative documents. When these are "silent" other guidelines such as selected ICH guidelines may be used
  • 8.
  • 9.
  • 10.
  • 11. Transparency – dossier status information on the web
  • 12. Transparency – Inspection outcomes on the web
  • 13.
  • 14.
  • 15. stavudine 15mg Guyana high outlier prices verified Hi gh price outliers: screens to assess efficiency, policy, governance nevirapine 200mg Russia 20x times more expensive than median price lamivudine 150mg 76 similar high price outliers removed price per tablet volume price per tablet price per tablet volume volume
  • 16. Generic and Brand ARV Prices: some findings refute conventional wisdom $1.95 $1.71 $1.05 Prices shown are per tablet 7/05-6/06 $1.10 Who pays these prices?
  • 17. Regression found only 6 of 19 solid dosage forms showed relationship between volume and price - found no relationship in highest volume products linear regression nevirapine 200mg generic p=0.35 brand p=0.47 Dosage Form Low Vol. Middle Vol. High Vol. zidovudine 100mg 7.2% ref sta40+lam +nvp 13.3% 13.7% ref sta30+lam +nvp 10% 13.3% ref stavudine 30mg 13.3% ref stavudine 40mg 16.7% 15.2% ref efavirenz 600mg 14.3%
  • 18.

Notes de l'éditeur

  1. Rotationals come from the CPH pool of assessors.
  2. Every dosage form tells a different story Every dosage form tells a different story Every dosage form tells a different story