Abstract

The emergence of multidrug-resistant tuberculosis (MDR-TB) and extensively drug-resistant tuberculosis (XDR-TB) represents a major threat to TB control globally and, specifically, in Europe. MDR-/XDR-TB is at large due to clinical mismanagement of drug-susceptible and drug-resistant TB cases as well as to transmission of resistant strains [1–3]. Continuous availability of quality-controlled drugs is a prerequisite to ensure correct clinical management of TB patients.
Comprehensive and updated information on the availability and registration procedures of first-line (FLD) and second-line (SLD) anti-TB drugs is not available, neither in Europe nor elsewhere.
Anecdotal evidence suggested that in most European Union (EU) countries, where TB has a low incidence, procurement procedures are decentralised (not through Global Drug Facility, GDF), and with no specific responsibility for TB drug procurement available at the ministerial level. Despite high costs of SLD, registration procedures are strong enough to potentially prevent marketing and prescription of poor quality drugs. FLD and SLD are usually available (with mechanisms to prevent stock-outs), although the low number of drug doses sold can create challenges in assuring their continuous availability.

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