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Abstract #271  -  The WHO “Prequalification” program origins, deployment and impact on ARVs availability in developing countries
  Authors:
  Presenting Author:   Mr Coriat Benjamin - University Paris 13
 
  Additional Authors:   
  Aim:
In 2001 was launched the WHO programme of drug Prequalification, followed in 2005 by the implementation of the US FDA “fast track”. These programs are major institutional innovations directed to address problems of drugs safety.. We propose, after reconstructing the history of these initiatives, to assess their impact on the market structure of ARVs in terms of quantity and variety
 
  Method / Issue:
Historical and institutional analysis of the implementation of the WHO and FDA “fast track” programs. Quantitative analysis of the types of drugs certified by the WHO and the FDA. Work on more than 22,000 transactions between 2004 and 2008 on the WHO data base in order to detect the major trends that have affected the markets for ARVs after the launching of the programs.
 
  Results / Comments:
From the quantitative analysis - The centrality of Indian manufacturers. 11 Indian generic producers accumulate 69.8% of the 253 prequalified ARVs. - Strong expansion of transactions involving certified generics. - Large variety of producers and certified drugs for fist-line treatments or Reverse-transcriptase inhibitors (RTIs) that contrasts with the monopolistic nature of second-line or Protease inhibitors (PIs) drugs supply. - In 2008, 77.2% of exchanged ARVs were certified against 43.2% in 2004. - Strong expansion of transactions involving first-line drugs (RTIs) while second-line drugs (PIs) represent a minor share of total volume purchased.
 
  Discussion:
In spite of the short observation period (2004-2008) there has been a major shift with a very large increase (absolute and relative) of certified generic drugs transactions. But here we must distinguish clearly between cases of RTIs and PIs. Secondly, if we compare the relative attraction effect of the WHO procedure with the FDA process, launched later and in response to the WHO initiative, we note that the US certification now occupies a dominant position which is reinforcing over time.
 
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