Beyond Scaling Up: Prequalification of Medicines


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This presentation was given at the 'Beyond Scaling Up: Pathways to Universal Access' workshop which was held at the Institute of Development Studies, Brighton on the 24-25 May, 2010. This event was co-sponsored by the Future Health Systems Research Programme Consortium and the STEPS Centre. Laing presented on the WHO Prequalification of Medicines Programme.

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  • Rotationals come from the CPH pool of assessors.
  • Every dosage form tells a different story Every dosage form tells a different story Every dosage form tells a different story
  • Beyond Scaling Up: Prequalification of Medicines

    1. 1. WHO Prequalification of Medicines Programme Richard Laing Department of Essential Medicines and Pharmaceutical Policies (EMP) WHO Geneva
    2. 2. An example of an &quot;enabling&quot; and disruptive organizational technology <ul><li>While initially developed as an aid for procurement for UN and related organizations has evolved into a powerful tool for improving access to quality medicines </li></ul><ul><li>Has enabled Indian and other manufacturers to compete effectively often driving the agendas for big Pharma </li></ul><ul><li>Has helped national regulators in poor countries to use existing resources to improve performance </li></ul><ul><li>Not clear how far the approach can go </li></ul>
    3. 3. Web site updated constantly –
    4. 4. Prequalification of Medicines Programme <ul><li>The UN Prequalification Programme is ensuring that medicines procured with international funds are of assessed and inspected quality, efficacy and safety . </li></ul><ul><li>The Prequalification Programme is an action plan for expanding access to priority essential medicines in the following four areas: </li></ul><ul><li>- HIV/AIDS </li></ul><ul><li>- Tuberculosis </li></ul><ul><li>- Malaria </li></ul><ul><li>- Reproductive Health </li></ul><ul><li>A UN Prequalification Program of Quality Control Laboratories exists to facilitate the quality control of the prequalified products. </li></ul>
    5. 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. 6. How prequalification is organized? (I) <ul><li>Role of WHO : Managing and organizing the project on behalf of the United Nations. </li></ul><ul><ul><li>provides technical and scientific support and g uarantee that international norms and standards are applied all through the process including assessment, inspection (GMP, GCP, GLP) and quality control </li></ul></ul><ul><li>Partners : </li></ul><ul><ul><li>UNICEF, UN Population Fund (UNFPA), UNAIDS and with the support of the World Bank (IPC group); WHO disease oriented programs </li></ul></ul>
    7. 7. Prequalification: the technical documents are WHO normative documents. When these are &quot;silent&quot; other guidelines such as selected ICH guidelines may be used
    8. 8. Stages Expression of Interest Request for Dossier submission <ul><li>Application to include a product on Expression of Interest (EOI) Lists published comes from WHO disease oriented programs </li></ul><ul><li>Products should be of high public health value </li></ul><ul><li>Products must be in line with WHO treatment guidelines </li></ul><ul><li>Products must be in line with Essential Medicines List </li></ul><ul><li>Rare exceptions from these principles, if justified </li></ul>
    9. 9. <ul><li>Assessment of the product dossier i.e. quality specifications, pharmaceutical development, stability, bioequivalence… </li></ul><ul><ul><li>Copenhagen assessment week </li></ul></ul><ul><ul><li>- 15 to 20 assessors during one week at least every two months </li></ul></ul><ul><ul><li>- Every dossier is assessed by at least two assessors including one senior assessor for the second assessment </li></ul></ul><ul><ul><li>- An assessment report is issued </li></ul></ul><ul><ul><li>- Letter summarizing the findings and asking for clarification and additional data if necessary; sent first by e-mail to the applicant followed by surface mail </li></ul></ul><ul><ul><li>Handling of variations of already prequalified products </li></ul></ul><ul><ul><ul><li>- Done in house and during Copenhagen-week </li></ul></ul></ul>Prequalification of Priority Essential Medicines Organisation (1)
    10. 10. <ul><li>Inspections of manufacturers of Finished Products (FP) Active Pharmaceutical Ingredient (API) and also Contract Research Organizations (CRO, which carry out bioequivalence studies) </li></ul><ul><ul><li>Team of inspectors </li></ul></ul><ul><ul><li>- WHO representative (qualified GMP inspector) </li></ul></ul><ul><ul><ul><li>- Inspector from well-established inspectorate </li></ul></ul></ul><ul><ul><ul><li>- National inspectors invited to be part of the team but have no decision making power (different GMP standards, potential conflict of interest) </li></ul></ul></ul><ul><ul><ul><li>- Inspector of developing countries as observer, for capacity building purpose. </li></ul></ul></ul>Prequalification of Priority Essential Medicines Organisation (2)
    11. 11. Transparency – dossier status information on the web
    12. 12. Transparency – Inspection outcomes on the web
    13. 13. Unintended Benefits Individualized trainings <ul><li>Involvement of assessors from NRAs in Assessment sessions </li></ul><ul><li>Involvement of inspectors from NRAs in PQ inspections </li></ul><ul><li>3-month rotation of assessors from NRAs* at WHO HQ </li></ul><ul><ul><li>Capacity building of experts from NRAs (regional resource </li></ul></ul><ul><ul><li>persons - improvement of NRA practices/procedures, trainings, </li></ul></ul><ul><ul><li>networking, product issues) </li></ul></ul>
    14. 14. Unintended Benefits Can measure performance of procurement agencies without being concerned about quality <ul><li>Brenda Waning (BUSPH) has shown: </li></ul><ul><li>Volume rarely leads to better prices </li></ul><ul><li>Originator products may be cheaper then generics </li></ul><ul><li>Intermediaries such as Clinton Foundation have short term effect </li></ul><ul><li>Great variation in prices paid for same products at same time (5-20* variation) </li></ul>
    15. 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. 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. 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. 18. Implications for Future Health Systems <ul><li>The prequalification programme challenges strongly held beliefs about local production, pooled procurement and decision making between national and global organizations </li></ul><ul><li>Combining norms and standards with transparent implementation can empower organizations to challenge conventional wisdoms </li></ul><ul><li>Some global initiatives can have unintended impacts that can be seen as &quot;disruptive organizational technologies.&quot; </li></ul>