SA regulators derail international clinical trials with permit delays

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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.

African populations are among the most genetically diverse in the world, making them useful in medical trials which benefit from a broader genetic spectrum. But the rapid progress of genetic research has outpaced government regulators who believe African communities should benefit from their own genetic resources. The report says some industry stakeholders believe the government may be deliberately stalling permits until they have implemented their revised protocols regarding HBMs – to the detriment of private labs. Several labs voiced their concerns in a letter sent in March to health department director-general Malebona Precious Matsoso.

“Regular analysis of blood samples is key to patient safety. It is no overstatement to say that it could be life or death,” the letter said. “The department’s failure to issue export permits is not only having a disastrous effect on the applicants’ businesses, but it threatens the entire clinical trial industry in South Africa.”

The backlog relates only to transfers of HBMs used for research purposes, and not in normal medical service provision, for instance when patients need an urgent diagnosis from a foreign lab.

The report says the National Health Act requires that the government issue permits for any human tissue samples (including blood) leaving South Africa. It also makes provision for material transfer agreements to regulate the sharing of the proceeds arising from exploitation. Disagreement over the administration and content of material transfer agreements is a key source of friction between industry and government stakeholders. Industry believes cumbersome paperwork could add to already serious delays of up to several months for export permits, which used to take around three weeks. But those with ethical concerns say the material transfer agreements are a crucial safeguard against exploitation.

The report says 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.

University of Cape Town bioethics professor Jantina de Vries said regulators needed to find a way of balancing the need for a thriving clinical trial industry – South Africa is highly regarded worldwide – and genuine ethical concerns. “Africans are more genetically diverse than people elsewhere in the world,” said De Vries, who likens genetic research to “finding needles in genetic haystacks”. “When you are doing research using African DNA it means the ‘haystack’ is quite a lot smaller.

“The anxiety is that many samples leave the country with little or no tangible benefit other than bringing in research funding or fuelling companies. In similar ways in which it would be a concern in the mining industry, for some people genetic diversity is a resource and it can be used to generate revenue,” De Vries said.

The report says industry sources also spoke of the danger of retarding drug research or sample transfers to global databases, which might result in the further marginalisation of African DNA from mainstream health care. “If we don’t get our blood out there, particularly now in the era of personalised medicine, African genes will not be there, and the lag in health care is going to be greater,” said a senior medical professor attached to one of the country’s biggest labs, who wanted to remain anonymous.

“We are sitting here and can’t start studies. We have five or six studies that we have literally just had to write off – a huge amount of money,” she said.

The report says the health department did not respond to questions.

The Times report

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