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
BIOVOICENEWS . COM 35