expert corner
Table 1 : Anti-TB Medicines Sourcing according to GDF and The Global Fund QA Policies
WHO PQ Programme
respective resolution of 2009 .
Resolution WHA 62.15 on Prevention and control of multidrug-resistant tuberculosis and extensively drug-resistant tuberculosis , adopted by the World Health Assembly ( WHA ) on 22 May 2009 , urged Member States in its Art . 1 ( 1 ) ( h ):
“ to achieve universal access to diagnosis and treatment of multidrug-resistant and extensively drug-resistant tuberculosis … by means of :
( h ) ensuring uninterrupted supply of first- and second-line medicines for tuberculosis treatment , which meet WHO prequalification standards or strict national regulatory authority standards ”
The particular wording “ strict ” instead of “ stringent ” in regard to NRA standards was agreed on as a compromise after debate among Member States lasting several days since the start of the WHA on 18 May 2009 . Draft wordings on either end of the spectrum were put forward , favoring no
Anti-TB Medicines Sourcing
Stringent NRA
ERP Process
Member , Observer or Associate of the International Council for Harmonisation ( ICH )
specific qualification in referring to regulatory authority standards ( China ), to maintaining the term “ stringent ” ( US , Canada ). The discussion resulting in the term “ strict ” was driven i . a . by Thailand , supported by other developing and middle income countries . Finally , before closing of the WHA on 22 May 2009 , the proposed wording “ strict ” was agreed upon for Resolution WHA 62.15 .
While reaching agreement on the Resolution in the final session of the 2009 WHA , the text nevertheless omitted to define the new term “ strict ”. Though the change in terminology was recognized in the subsequent period in some discussions or on an individual level , there is no public record of formal attempts of stakeholders to capture or further specify the term . It could e . g . have been expected that a Working Group of Experts had been established , deliberating on the term and advising on possible consequences . A risk-based categorization scheme for procurement could have e . g . been an output from such Group , coupled with recommendations on supplementary needed quality control in procurement ( preshipment inspection , sampling and laboratory testing , postdelivery monitoring and control ). Similarly , proposals for simultaneous strengthening of national regulatory authorities which have thus been newly qualified for sourcing pharmaceuticals could have been made by the Group .
In this vein and / or as a consequence , since 2009 no principle change in approach in pharmaceutical procurement for TB medicines , in particular in respect of the applicable quality assurance policy , could be identified at WHO , the Stop TB Partnership / Global Drug Facility , The Global Fund or UNITAID .
This appeared as a missed opportunity , as the change of terminology provided the chance to strengthen sourcing for TB , i . e . widening the supplier base . For such expansion , improved availability and lead times for pharmaceuticals as well as lower prices could regularly have been expected . This would have freed up funds to reach more patients , particularly for drug-resistant TB , and / or provide TB care or meet other related public health needs , for which there was continuous shortage of funds .
Considering the text of the WHA Resolution and taking into account the history of its drafting process and the achieved agreement among Member States after days of debate , WHA 62.15 appeared as a clear direction to view second-line medicines meeting strict national regulatory authority standards as being
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BioVoiceNews | December 2016 - January 2017