TAIPEI (Taiwan News) — Health authorities in Germany, Slovenia, Estonia, Australia, and Canada are examining prenatal test kits that collect women’s DNA and fetus samples for research after it came to light the company behind the kits also conducts research with the Chinese military.
The kits, called NIFTY, are manufactured by Shenzhen-based BGI Group, sold in at least 52 countries, and have been used by 8.4 million women globally, according to a Reuters report released on Tuesday (Sept. 7).
Regulators first raised concerns after a Reuters report in July showed how BGI collaborates with People's Liberation Army (PLA)-run hospitals to analyze pregnant women’s DNA to map genetic traits of populations around the world.
Health regulators in these countries are struggling to find suitable oversight mechanisms to manage this cross-border flow of genetic data.
Slovenian and German regulators say they are looking at the product in light of European Union data protection rules. Meanwhile, Canada's privacy commissioner said it is looking into the matter and is concerned about the transfer of "highly sensitive" information.
The data privacy regulator in Slovenia, where one of BGI's regional partners is based, said the Slovenian government had not yet adapted its laws to fully comply with Europe’s General Data Protection Regulation (GDPR), so it cannot issue fines in the event of GDPR breaches.
Women outside China sign consent forms that grant BGI permission to send their blood samples and DNA data overseas to its labs and use them in research. The privacy policy also states data that is collected may be shared for national security purposes in China — although BGI claims it has not yet been asked to do so.
Regulators in Germany, Australia, Estonia, and Canada said even if data is sent abroad, BGI's local vendors have a duty to uphold users’ data privacy.
"It is vital that the patient is provided with clear information," said Beverley Rowbotham, chairperson of Australia's National Pathology Accreditation Advisory Council.
BGI denies allegations it developed the NIFTY test kit in collaboration with the PLA, saying many other Chinese prenatal test providers work with military hospitals and that the same is true for health companies abroad that regularly work with militaries around the world.
The company said it takes data privacy seriously, complies with applicable laws and regulations, and that only 5% of its NIFTY tests have been used by women overseas.
The military hospital that conducted trials for NIFTY previously worked with BGI to send pathogens into space under a special military research program, according to 12 separate scientific papers. BGI did not respond when asked about that particular program.
