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Market impact of WHO selection and prequalification of priority medicines Hans V. Hogerzeil, MD, PhD, FRCP Edin Director ,...
Second dimension of the concept of essential medicines: WHO's list of not-existing essential medicines <ul><li>No data </l...
Why is WHO / UN Prequalification needed? Basically, because there are large budgets for medicines, inconsistent quality po...
WHO selection and prequalification guide innovation and speed up regulatory approval in countries <ul><li>2002: WHO Model ...
Market impact of the Prequalification Programme Brenda Waning et al, Globalization and Health 2010; 6:9 <ul><li>Study base...
Market impact of the Prequalification Programme (2) Discussion, recommendations  <ul><li>Markets for older ARVs are mature...
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Market impact of WHO selection and prequalification of priority medicines

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Presentation with the occasion of the Technical Briefing at World Halth Assembly, Geneva, 18 May 2011

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Market impact of WHO selection and prequalification of priority medicines

  1. 1. Market impact of WHO selection and prequalification of priority medicines Hans V. Hogerzeil, MD, PhD, FRCP Edin Director , Essential Medicines and Pharmaceutical Policies World Health Organization, Geneva
  2. 2. Second dimension of the concept of essential medicines: WHO's list of not-existing essential medicines <ul><li>No data </li></ul><ul><li>Off-label use of adult medicines, for children </li></ul><ul><li>No dosage data on children's FDCs, e.g. tuberculosis </li></ul><ul><li>No efficacy/safety data, e.g. on new ATCs, children's formulations </li></ul><ul><li>No products </li></ul><ul><li>No children's formulations, e.g. FDCs for HIV/AIDS, malaria </li></ul><ul><li>No heat-stable insulin, oxytocin for tropical countries </li></ul><ul><li>No new TB medicines in the last 30 years, few new antibiotics </li></ul><ul><li>No new medicines for other neglected diseases </li></ul><ul><li>March 2009: WHO Expert Committee accepts a proposed list of missing FDCs for second-line ARV treatment </li></ul>Patent pool !
  3. 3. Why is WHO / UN Prequalification needed? Basically, because there are large budgets for medicines, inconsistent quality policies, and: <ul><li>Tuberculosis : 10 DOTS products in various TB programs (2001) </li></ul><ul><ul><li>6/10 products contain rifampicin that it is not resorbed in body </li></ul></ul><ul><li>Repr.Health : 44 companies in 13 LIC/MIC screened (2008) </li></ul><ul><ul><li>All companies comply with national GMP standards; but only <30% meet global GMP requirements of WHO, PIC/S, SRA; 20% could comply in future with quality investment and improvements; 50% would take years to comply (if at all) </li></ul></ul><ul><li>Malaria : Recent quality survey in six African countries (2009) </li></ul><ul><ul><li>73/184 (39·7%) samples of non-WHO prequalified antimalarials fail quality testing, compared with only 3/83 (3·6%) of WHO-prequalified antimalarials </li></ul></ul>
  4. 4. WHO selection and prequalification guide innovation and speed up regulatory approval in countries <ul><li>2002: WHO Model List of Essential Medicines (EML) linked to evidence-based WHO clinical guidelines. Renewed EML process defines standards for evidence on efficacy and safety </li></ul><ul><li>2003: WHO prequalification defines standards for quality </li></ul><ul><li>2006: WHO identifies missing essential medicines for children and missing paediatric formulations (e.g. ARVs); in 2009 WHO defines missing ARV/FDCs </li></ul><ul><li>Need for future EML listing and prequalification ensures early planning for R&D on clinical evidence, dosage, safety and regulatory requirements (e.g. medicines for malaria, neglected diseases, medicines for children) </li></ul><ul><li>Prequalification speeds up national regulatory approval and serves as basis for subregional harmonization (e.g. EAC) </li></ul>
  5. 5. Market impact of the Prequalification Programme Brenda Waning et al, Globalization and Health 2010; 6:9 <ul><li>Study based on 12.958 ARV purchase transactions 2002-2008 </li></ul><ul><li>WHO guidelines of 2003 and 2006 strongly shaped demand </li></ul><ul><ul><li>5 ARVs in WHO/2003 constituted 98% of ARVs purchased in 2004-2006 </li></ul></ul><ul><ul><li>Price of major FDCs reduced from $484 in 2002 to $88 in 2008 (-82%) </li></ul></ul><ul><ul><li>First generic ARV/FDC was WHO-prequalified in 2003; 8 FDCs by 2006 </li></ul></ul><ul><ul><li>FDA approved first generic FDC in 2006; only then PEPFAR procured </li></ul></ul><ul><ul><li>WHO/2007 change 40>30 mg d4T immediately shaped market: 30mg from 54,000 to 300,000 pyear in 2008; price from $166 to $88/pp/yr </li></ul></ul><ul><ul><li>Purchase volumes of new 2006-drugs increased 16-20x in 2006-2008 </li></ul></ul><ul><li>PEPFAR, GFATM and UNITAID cover 85, 88 and 88% of ARVs, FDCs </li></ul><ul><ul><li>PEPFAR is focusing large volume, 1-3 suppliers at lowest cost </li></ul></ul><ul><ul><li>GFATM and UNITAID involve 4-5 suppliers, to maintain market diversity </li></ul></ul><ul><ul><li>85-90% of ARVs from SRA/PQed sources; rest through ERP </li></ul></ul>
  6. 6. Market impact of the Prequalification Programme (2) Discussion, recommendations <ul><li>Markets for older ARVs are mature and efficient; markets for newer ARVs are not (generic competition severely restricted by TRIPS) </li></ul><ul><li>Certification programmes (FDA 2003-2006) can delay markets </li></ul><ul><li>WHO/2006 guidelines were too diverse; too many combinations created disincentive for the market; was corrected in WHO/2009 </li></ul><ul><li>In 2002-2008, PEPFAR drove down the cost and GFATM/UNITAID maintained the competition </li></ul><ul><li>Large-scale procurement agents may decrease the number of buyers and sellers, making the market less competitive in the long term </li></ul><ul><li>Global policies must be developed with consideration of both short term (lowest cost) and long-term (supplier security, maintain competition and future development) impact on market dynamics </li></ul>

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