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