WHO regulation hits African ARV production, The Lancet claims

A discussion of the benefits of local antiretroviral drug manufacture in Africa, compared with occasionally failing aid programs, notably from Canada, is discussed in The Lancet. The report's authors conclude that regulations that are ostensibly geared at preventing substandard drugs from being distributed are so expensive as to deter small private operators from developing solutions to the lack of available drugs in the poorest regions of Africa.

In April this year, Canada's Access to Medicines Program was reviewed by the government, after the scheme had been in existence for two years. The audit found that the "CAMR has yet to see a single pill exported to countries in need." The explanation given was that the program was so bureaucratic that only one generic drugmaker, Apotek, "made any serious attempt" to work with the CAMR, the Lancet reports.

By contrast, Ghana-based drug firm DanAdams has developed a generic version of a triple-fixed dose ARV, which has been purchased by the Ghanaian government for local distribution. The Lancet's article claims that the African firm cannot afford to carry out the tests that are required to demonstrate it meets the World Health Organization's bioequivalence standards.