Five countries' health regulators are looking into a prenatal test that gathers DNA from women and their foetuses to conduct research. This is after it was discovered that the manufacturer of the test has links with China's military.
Some clinics and doctors that sold the test under the brand Nifty were unaware that Shenzhen's BGI Group also conducted research with the Chinese military.
It is available in at least 52 countries, and 8.4 million women have taken it. It can screen for Down syndrome and more than 80 other conditions genetically.
Canada's privacy commissioner stated that a Reuters report about the matter raised important questions regarding highly sensitive information. The matter is being investigated by the commission. Two European regulators, one in Germany and one in Slovenia, said that they were looking into the matter in light of European Union data privacy rules.
Canada, Australia, Estonia, and Australia called for transparency in BGIs use and disclosure of genetic data about women. They stated that even if the data were sent overseas, BGIs local vendors were responsible to ensure data privacy. The European Data Protection Supervisor stated that it was closely monitoring the situation.
Beverley Rowbotham is the chairperson of Australia's National Pathology Accreditation Advisory Council.
These concerns are a reminder of the difficulties in regulatory oversight as genetic data is transmitted from one country to the next.
Slovenia's data privacy regulator, which is also the home of one of the regional BGIs partners, stated that it was concerned about the export of data from the BGI test and would investigate data protection issues.
Reuters reported that BGI had conducted more than a dozen clinical trials and scientific studies to prove the test was improved in collaboration with Peoples Liberation Army hospitals. BGI uses genetic data from pregnant women to study the characteristics of populations. It collaborates with the PLA on other areas of research.
BGI denied any suggestion that the Nifty test was developed in collaboration with the military and stated that working with military hospitals was not the same. It stated that it had worked with thousands upon thousands of healthcare providers. It stated that it takes data privacy seriously and adheres to all applicable laws and regulations. Only 5% of its Nifty tests were conducted on women from overseas.
Reuters did not find any evidence that BGI had violated privacy regulations or agreements. The company stated it obtained signed consent and destroyed overseas data and samples after five years. The company stated that BGI does not have access to identifiable personal data at any stage of the research or testing process.
Women outside China sign consent forms to allow their blood and genetic data to travel to BGI for research. BGI claims that data may be shared in China for national security purposes, but the privacy policy states otherwise.
Reuters was told by an Ontario regulator that it is now advising women to get tests done in Canada or other countries where data security standards are comparable. Quebec's regulator stated that prenatal genetic tests, such as consumer genetic tests, can lead to people losing control of their genetic information. For breaches of privacy or genetic disclosure laws, maximum penalties in Canada can be as high as C$250,000 to C$1m. Exemptions for scientific research are also possible.
According to the Office of the Information and Privacy Commission of Ontario, genetic information is valuable not only to data brokers and marketers, but also for foreign states and cybercriminals.
Reuters previously reported that BGIs joint work with PLA medical institutions is extensive. It includes efforts to protect soldiers against altitude sickness and mass testing for pathogens. In March, US government advisors warned that China could have a huge bank of genomic data that BGI is analysing with artificial Intelligence. This could lead to an economic and military advantage.
Reuters was informed by labs in Slovenia and Spain that the genetic data of a client had already been used in research by BGI in China.
GenePlanet in Slovenia, which sells Nifty test across Europe, also offers its own brand test using BGIs technology. The company claims that the Slovenian customer consented to a research test.
GenePlanet stated that it operates according to EU regulations, and had an agreement signed with BGI to ensure that no GenePlanet patient information generated by [the] Nifty process will be going to mainland China.
BGI also manages China's National GeneBank which contains data on 542 women from Spain and Slovenia. BGI stated that the data on the 542 women was not used for any other purpose and that it uses only anonymised data in its scientific research.
Eluthia GmbH in Germany, which sells BGIs tests, stated that it had stopped the transfer of blood from women and patient data to BGI by the Hesse data protection regulator while it investigated whether any rules were broken.
BGI stated to Reuters that it provided information to Eluthia, and other relevant authorities to show it complies data protection laws.
