The time is now: making the case for compassionate use/pre-approval access to new TB drugs.

Although the majority of people with multidrug-resistant/rifampicin-resistant TB (MDR/RR-TB) can now be successfully treated with all-oral shorter regimens, rising rates of resistance to the components in these regimens are a growing global challenge. The drug development pipeline for TB has more novel compounds in phase 2 trials than ever before, and accessing these agents through systematic compassionate use programmes is an ethical and public health imperative. There is more than a decade of successful experience with compassionate use for MDR/RR-TB, resulting in benefits for people with MDR/RR-TB, novel chemical entity developers, providers, and programmes. Although there are some arguments for delaying access to the new TB drugs in the pipeline, we present reasons why such access should be an urgent priority for all TB stakeholders.