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SA regulators derail international clinical trials with permit delays

SA Health Department delays issuing export permits for human tissue is having severe consequences for international medical research trials, with some believing the delays are deliberate, linking to tensions over the the commercial use of human biological materials from Africa. The permit backlog, which prevents labs exporting samples for research purposes, prompted a coalition of labs to deliver an ultimatum last month. In response, the department promised to issue all outstanding permits – but has so far failed to do so.

The Times reports that last year, the department acknowledged capacity problems resulting in delays. But several commentators this week said the backlog was also linked to tensions over the commercial use of human biological materials (HBMs) from Africa.

The report says key stakeholders in the government, academia and private industry are at loggerheads over how to regulate transfers of African HBMs, which are prized for a range of reasons including their genetic diversity. Several medical experts confirmed disagreement over the export permits, which flared up several years ago when a US laboratory patented genes acquired from a Khoisan tribe. Recently there was concern over possible commercial exploitation of South African DNA in a deal involving Discovery Health and US firm Human Longevity Inc.

 

[link url="https://www.timeslive.co.za/sunday-times/news/2019-05-05-human-tissue-delays-derail-clinical-research-trials/"]The Times report[/link]

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