BioVoice News December 2016-January 2017 Issue 8 Volume 1 - Page 35

sufficient for public procurement . Fixing the broader term strict as a starting position , the WHA Resolution would then have the innate intent to expand procurement to forthwith include a next tier of advanced countries among the sources from which medicines could be purchased to treat multidrug-resistant TB .

The positive development of additional members or observers recently joining ICH and PIC / S , after otherwise years of inaction by TB stakeholders , cannot replace or render WHA Resolution 62.15 obsolete in this regard . A dedicated examination of the Resolution ’ s meaning and its consequences remain indicated , identifying and closing gaps for implementation . Moreover , as established above , it must be concluded that the regulatory authorities having joined ICH as Observers since 2015 nonetheless remain excluded from meeting GDF ’ s and The Global Fund ’ s definition of stringent Regulatory Authorities .
Additionally , the caveats contained in GDF ’ s quality assurance policy in ultimately in fact recognising new members as equivalent , i . e . reserving the right to disregard the status of such new entrants , is not systemic and appears unwarranted .
In considering contenders for such second-tier sourcing opportunities for TB medicines , aside from necessary regulatory , administrative and legislative assessments , annual pharmaceutical export volumes may serve as in indication . According to data published by The International Federation of Pharmaceutical Manufacturers & Associations ( IFPMA ) , the following countries - whose
Table 2 : WHA Resolution 62.15 of 22 May 2009
Resolution WHA 62.15 on Prevention and control of multidrug-resistant tuberculosis and extensively drugresistant tuberculosis ” of 22 May 2009 urged WHO Member States
“ to achieve universal access to diagnosis and treatment of multidrug-resistant and extensively drugresistant tuberculosis … by means of :
( h ) ensuring uninterrupted supply of first- and secondline medicines for tuberculosis treatment , which meet WHO prequalification standards or strict national regulatory authority standards ” ( Art . 1 ( 1 ) ( h ))
national regulatory authorities are currently not ICH Members , Associates or Observers recognised as stringent by the GDF and The Global Fund - are among the leading pharmaceutical exporters in the world , with more than 500 million US $ in annual sales :
Argentina , Australia , China , Hong Kong , India , Israel , Jordan , Mexico , Panama , Russia , Singapore , Turkey
National regulatory authorities from these countries would therefore need to be examined with respect to their qualification as strict national regulatory authorities , or runner-ups thereto . Substantial potential sales in global supply markets for TB-medicines , worth several hundred million US $ annually , are currently also not being realised due to this categorisation , particularly since nearly all TBmedicines are off-patent . Some advanced industrialised countries appear as clear contenders for procurement of TB medicines , particularly those already admitted to PIC / S . Progress in countries such as India and China in recent years to reach global standards has also been noteworthy . Furthermore , national regulatory authorities from countries with lesser sales , but nonetheless reputable regulatory systems may be considered under the new categorisation , such as Indonesia , Malaysia , New Zealand , Thailand , Ukraine , Vietnam and several countries in the Mediterranean Region .
Under the existing quality assurance policies of the major TB medicines procurers considered herein , manufacturers from these next tier countries would be limited in qualifying their products to the WHO Prequalification Programme , applying / awaiting ICH Membership / Observer status , interim procedures with the Canada , EU , US regulatory authorities , or otherwise the exceptional ERP process . This raises also the diplomatic and political question whether manufacturers from these advanced countries can indeed be expected to submit dossiers under the WHO Prequalification Programme in order to be