Health regulators in five countries are examining a prenatal test that collects the DNA of women and fetuses for research, while some doctors that promoted it and clinics that sell it say they were unaware the company that produces it also conducts research with the Chinese military.
The test, made by Shenzhen-based BGI Group and marketed under the brand name NIFTY, is sold in at least 52 countries. It screens for Down syndrome and more than 80 other genetic conditions, and has been taken by 8.4 million women globally.
The regulators’ concerns, raised in response to a Reuters report, highlight the challenges of regulatory oversight when genetic data is sent from one country to another. Canada‘s privacy commissioner said the report raised important questions about “highly sensitive” information and it is looking into the matter. Two regulators in Europe – in Slovenia and in Germany – said they were examining the test in light of European Union data protection rules.
The data privacy regulator in Slovenia, where one of BGI’s regional partners is based, said it was concerned by the exporting of data from the BGI tests and would examine data protection issues. But it added that Slovenia has not yet adopted the changes to its national laws to make Europe’s General Data Protection Regulation (GDPR) fully applicable, so it cannot issue fines in the event of GDPR breaches.
Reuters reported in July that more than a dozen scientific studies – including clinical trials – showed BGI developed and improved the test in collaboration with People’s Liberation Army hospitals. BGI uses the pregnant women’s genetic data for research into the traits of populations. It also collaborates with the PLA in other areas of research.
BGI rejects any suggestion that it developed the NIFTY test in collaboration with the military, and says working with military hospitals is not equivalent. It said it works with thousands of healthcare providers, that other prenatal test providers in China work with military hospitals, and that many companies worldwide work with militaries. It said it takes data privacy seriously, complies with applicable laws and regulations, and only 5% of its NIFTY tests have been conducted on women overseas.
Regulators in Germany, Australia, Estonia and Canada called for transparency in BGI’s use of women’s genetic data, and said even if data was sent abroad, BGI’s local vendors are responsible for ensuring data privacy. The European Data Protection Supervisor said it was monitoring the situation.
“It is vital that the patient is provided with clear information,” said Beverley Rowbotham, chairperson of Australia’s National Pathology Accreditation Advisory Council.
A regulator in Ontario told Reuters it is now advising women to seek tests from providers in Canada, or places where data security is “comparable” to the protections mandated in Canada. The regulator in Quebec said prenatal tests – like consumer genetic tests – can result in people losing control over their genetic information. Canadian privacy and genetic disclosure laws can impose maximum fines of C$250,000 to C$1 million for breaches, and set strict conditions for exemptions for scientific research.
“Genetic information is not only valuable to marketers and data brokers, but also to foreign states and cybercriminals as well,” the Office of the Information and Privacy Commission of Ontario told Reuters.
Fertility Partners, a clinic network in Canada, said it had no prior knowledge of BGI’s work with the PLA, and had stopped selling NIFTY through its clinics in April for unrelated reasons.
Reuters has previously reported that BGI’s joint research with PLA medical institutes is wide ranging, from efforts to protect soldiers from altitude sickness to mass testing for pathogens. U.S. government advisers warned in March that a vast bank of genomic data that BGI is amassing and analyzing with artificial intelligence could give China a path to economic and military advantage.
The same military hospital that ran clinical trials for NIFTY also collaborated with BGI to send pathogens into space under a military equipment research program, according to 12 scientific papers, which has not previously been reported. BGI did not respond to a request for more information about that research program.
In the United Kingdom, where NIFTY tests are only sold through private clinics, the government said BGI would need to register its test before Sept. 1 to continue selling them. BGI told Reuters it submitted a voluntary registration to the UK medical regulator in August. The UK Medicines and Healthcare products Regulatory Agency (MHRA) told Reuters it had received BGI’s registration but said the application had not yet had data validation and scrutiny by the regulator’s registration and software team.
NIFTY tests are sold overseas through three business models: local clinics collect blood samples to send to BGI in Hong Kong; labs sequence the DNA from blood samples locally and share the data with BGI in Hong Kong where it is stored for five years; or labs complete the entire process locally using BGI technology.
Labs in Spain and Slovenia each told Reuters the genetic data of a client had been used by BGI in mainland China for research, with informed consent.
Slovenia-based GenePlanet, which says it sells NIFTY tests across Europe and also offers its own-branded test using BGI’s technology, said the Slovenia customer gave consent for a “research test.”
GenePlanet says it operates according to EU regulations and has an agreement with BGI that “none of the GenePlanet patient data generated from (the) NIFTY process is going to mainland China.”
The Slovenian and Spanish women’s data was among that of 542 women stored in China’s National GeneBank, which BGI also runs. BGI said the data of the 542 women has not been used for other purposes, and its “scientific research only uses anonymised data.”
Eluthia GmbH, a laboratory in Germany which sells BGI’s test, said its transfer of women’s blood and patient data to BGI had been suspended by the data protection regulator for the Hesse region while it investigates whether the rules had been violated.
Eluthia said it did not know when it could resume sending tests to BGI. Its Chief Executive Ramon Enriquez Schaefer said doctors had called the suspension “excessive” since patients had “expressly consented to the shipment to Hong Kong.” He also said Eluthia hasn’t been able to make “concrete progress” on the regulator’s concerns about BGI’s military collaboration.
BGI told Reuters it is providing information to Eluthia and relevant government authorities to demonstrate it complies with data protection laws.
One UK doctor who promoted BGI’s test in an online video when it first became available said he would now advise women not to take the BGI test, due to privacy concerns.
“My personal view now would be to advise anybody not to use the BGI NIFTY test – not from a clinical point of view – but because the data from it might be misappropriated or used for reasons that neither the clinician nor the patient would ever have imagined,” said Bryan Beattie, a fetal medicine consultant.
Reuters contacted Beattie and two other UK doctors who also promoted the test on BGI’s YouTube channels in 2014 for their reactions. The doctors said they were unaware of BGI’s military links. BGI said the doctors were not paid to participate and it had told them the videos were for educational and marketing purposes.
The NIFTY test captures more genetic information about the mother and the fetus than the results patients see, said Beattie, which has previously been reported by Reuters and BGI has confirmed.
“If you were able to link that to large numbers of patients in a foreign country, you would have a fairly good idea of their health profile over the next sort of 20 or 30 years,” said Beattie.
Beattie said he had supported the relatively new technology because it was an improvement on previous methods, but his clinic had switched to a different supplier for reasons unrelated to privacy.
An Estonian scientist who turned down an offer from BGI in 2020 to replace a test developed by his lab with NIFTY said he was concerned European health services, whom he declined to name, were choosing BGI’s test because of its cheaper cost and not considering data security.
“It is a stupidly easy way to earn money for taking a blood sample,” said Kaarel Krjutskov, who runs the Estonian lab.
BGI declined to sell his lab a DNA sequencer unless it also began selling NIFTY, email correspondence seen by Reuters showed.
BGI’s marketing material promotes its sequencing of genes as the lowest cost in the industry. BGI told Reuters it was “always striving to make our NIFTY pricing even more affordable,” without providing further details.
(Reporting by Clare Baldwin in Hong Kong and Kirsty Needham in Sydney; Additional reporting by Allison Martell in Toronto, Allison Lampert in Montreal, Douglas Busvine in Berlin, Tarmo Virki in Tallinn, Alistair Smout and Tom Bergin in London, Krisztina Than in Budapest, Robert Muller and Jan Lopatka in Prague, Radu Marinas in Bucharest, Nathan Allen in Madrid, Joanna Plucinska and Alicja Ptak in Warsaw, Ludwig Berger in Frankfurt, Foo Yun Chee in Brussels, Michael Martina in Washington and Antoni Slodkowski in Tokyo; Editing by Sara Ledwith, Kevin Krolicki and Bill Rigby)
The 2 Michaels are home. But what about the 115 Canadians still detained in China? – Global News
Heartwarming images and video surfaced of the two reuniting with their families. Prime Minister Justin Trudeau on Friday called their homecoming “good news for all of us,” noting that they had both gone through an “unbelievably difficult ordeal.”
But as of Sunday at least 115 Canadians remain in custody in Chinese prisons, Global Affairs Canada said in an emailed statement to Global News. Not all Canadians imprisoned in China are in arbitrary detainment, but the agency said at least four of those jailed are on death row.
“Canada opposes the death penalty in all cases, everywhere,” Global Affairs Canada said.
“We have raised our firm opposition to the death penalty with China and continue to call on China to grant clemency for all Canadians sentenced to death.”
“Two Michaels” and Meng Wanzhou return home
The agency said it reviews each detention on a case-by-case basis, as consular officials often require a “tailored approach” that can adapt to different local contexts and circumstances.
Here’s a look at the four Canadians currently on death row.
Michael Kovrig, Michael Spavor arrive in Canada after almost 3 years in Chinese prison
Of those sentenced to death, the most recent is Canadian Robert Schellenberg of Abbotsford, British Columbia. The Liaoning High Court upheld his death sentence on Aug. 10 following an appeal made over the summer.
Schellenberg was detained on drug charges in China in 2014 and was formally charged with drug smuggling in January 2015. Initially, a Chinese court had sentenced him to 15 years in prison. But four years later, his verdict was overturned following a retrial and he was sentenced to death.
Canadian Foreign Affairs Minister Marc Garneau said in August that Canada “strongly” condemned the court’s decision to uphold the death penalty for Schellenberg.
“We have repeatedly expressed to China our firm opposition to this cruel and inhumane punishment and will continue to engage with Chinese officials at the highest levels to grant clemency to Mr. Schellenberg,” he said, shortly after the ruling was delivered.
“We oppose the death penalty in all cases, and condemn the arbitrary nature of Mr. Schellenberg’s sentence.”
In an emailed statement to Global News, Global Affairs Canada reiterated that the federal government remains “strongly opposed” to the decision to arbitrarily impose and uphold the death penalty for Schellenberg.
The agency added it “will continue to engage with Chinese officials at the highest levels to seek clemency for Mr. Schellenberg.”
Chinese court upholds death sentence against B.C. man
Canadian Xu Weihong was sentenced to death by the Guangzhou Municipal Intermediate Court over drug manufacturing charges on Aug. 6, 2020. They also handed down a life sentence to Wen Guanxiong, whom they claim helped Xu make ketamine.
Chinese foreign ministry spokesperson Wang Wenbin justified Xu’s death sentence during a briefing last year, saying that death penalties would help “deter and prevent” similar crimes in the future.
“I would like to stress that China’s judicial authorities handle the relevant case independently in strict accordance with Chinese law and legal procedures,” Wang had said.
He added that “this case should not inflict any impact on China-Canada relations.”
China defends death sentence for Canadian convicted of making illegal drugs
Ye Jianhui is the fourth Canadian to receive the death penalty in China.
His sentence was handed down in August of last year over charges to manufacture and transport drugs by the Foshan Municipal Intermediate Court, just one day after Xu’s.
Ye and co-defendant Lu Hanchang conspired with others to manufacture and transport drugs between May 2015 and January 2016, the Associated Press reported last year.
Asked last year if the sentencing of the Canadian drug offenders was linked to Meng’s case, Wang said China’s judicial organs “handle cases independently,” while also adding that “the Canadian side knows the root cause” of difficulties in China-Canadian relations.
Fan Wei was given the death penalty on April 30, 2019 along with 11 others over his involvement in an international methamphetamine operation.
Speaking to Global News the day of his sentencing, Global Affairs Canada said officials attended the sentencing and reading of the verdict. They called on China to grant clemency, adding the decision to apply the “cruel and inhumane” death penalty to Fan’s case was of “extreme concern” to their government.
“Obtaining clemency for Xu Weihong, Ye Jianhui and Fan Wei is also of primary importance given China’s decision to impose the death penalty in these cases,” Global Affairs Canada said, in an emailed statement to Global News on Sunday.
“Canada will continue to provide consular services to Robert Schellenberg, Xu Weihong, Ye Jianhui and Fan Wei, as well as to their families.”
— With files from Global News’ Saba Aziz and Aaron D’Andrea, as well as the Canadian Press, Associated Press and Reuters.
© 2021 Global News, a division of Corus Entertainment Inc.
Michael Kovrig and Michael Spavor have finally landed in Canada – CTV News
Two Canadians who’ve been imprisoned in China for more than 1,000 days have arrived safely in Canada.
Michael Spavor and Michael Kovrig, detained on espionage charges since Dec. 10, 2018, arrived at the Calgary International Airport early Saturday morning, following an overnight fuel stop in Alaska.
Footage from CTV News on the tarmac shows several passengers greeted by Prime Minister Justin Trudeau with a hug, though everyone in the footage is wearing a mask.
A spokesperson for the Prime Minister’s Office told CTV News’ Bill Fortier at the airport that the passengers are indeed the two Michaels. The spokesperson added that it is very emotional moment for both of them and they would not be taking questions.
Later in the day, a smiling Kovrig landed at Toronto’s Pearson International Airport, where he was met by his sister and wife. Kovrig briefly spoke to media, where he issued his thanks for the support and said he would have more to say in due time.
“It’s wonderfully fantastic to be back home in Canada,” he told reporters. “I’m so grateful for everybody who worked so hard to bring both of us back home.”
Trudeau announced the two would be returning to Canada in a late-night press conference on Friday, only once the two had left Chinese airspace.
“Welcome home, Michael Kovrig and Michael Spavor,” Trudeau wrote in a tweet on Saturday. “You’ve shown incredible strength, resilience, and perseverance. Know that Canadians across the country will continue to be here for you, just as they have been.”
News of their release has garnered celebration from across Canada, including from Conservative Leader Erin O’Toole and NDP Leader Jagmeet Singh, as well as from people who knew the two Canadians.
“It’s hard to describe but I’m just so thrilled for him and his family more than anybody else,” Praveen Madhiraju, a colleague of Kovrig’s, told CTV News Channel on Saturday. “This has been a long time coming and we’re just thrilled for this next chapter.”
Deputy Prime Minister Chrystia Freeland said the two Michaels showed “incredible strength” during their detention.
“Michael Kovrig and Michael Spavor are now home — they, as well as their families, have shown incredible strength, bravery and resilience,” she tweeted on Saturday. “The Canadian government has worked hard to secure their release. We thank everyone involved who helped make it possible.”
The Michaels arrived in Canada just one day after a British Columbia court dropped the extradition case against Huawei executive Meng Wanzhou over fraud and conspiracy charges related to American sanctions against Iran.
Meng had earlier Friday pleaded not guilty to all charges in a virtual appearance in New York court, where the judge signed off on a deferred prosecution agreement.
The two Michaels were both convicted of spying in closed Chinese courts earlier this year. Spavor was sentenced to 11 years in Chinese prison, while Kovrig had yet to be sentenced.
The detainment of the two Canadians has largely been seen as retaliation for Meng’s arrest, though China has repeatedly denied any connection between the Michaels and Meng.
Colin Robertson, a former Canadian diplomat, told CTV News Channel on Saturday that the swift release of the two Michaels shows that their detainment was in fact retaliatory.
“Obviously this is the acknowledgment that this was really a retaliatory hostage taking for Meng Wanzhou,”
“I think (this is) a triumph for quiet diplomacy, because this was kept very much to wraps. Nobody knew what was going on. I was as surprised as the rest of Canada.”
With files from The Canadian Press
Coronavirus: What's happening in Canada and around the world on Sunday – CBC.ca
The U.S. Travel Association said the ongoing closure of the land borders with Canada and Mexico is costing U.S. businesses an estimated $1.5 billion a month in “travel exports,” which the association defines as spending by foreign residents while visiting the U.S.
Canada reopened its air, land and sea borders to Americans fully vaccinated against COVID-19 on Aug. 9. However, the ban on non-essential land travel from Canada and Mexico to the United States was extended last Monday for a 19th month, until Oct. 21.
“My constituents are deeply frustrated by this, particularly given the trade and the relationships that people have across the border,” Michigan Sen. Gary Peters said last week during national security hearings with Homeland Security Secretary Alejandro Mayorkas.
“We are very mindful of the economic consequences, and not only the economic consequences but the consequences on family members who haven’t seen one another for quite some time,” Mayorkas replied.
He said the progression of the delta variant of the coronavirus “is not yet where we need it to be” in the U.S., and that there are communities near the U.S.-Mexico border that are also suffering as a result of the closure.
“We are looking at the situation, not only at the ports of entry on our northern border, but also on our southern border,” Mayorkas said.
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“We have heard similar concerns with respect to border communities on the South and the impact, economic and family impact, of the restrictions. We are looking at what we can do operationally, and we are moving in a very sequential and controlled manner.”
Canada, meanwhile, remains the largest single U.S. export market, accounting for nearly 18 per cent of all American goods sent out of the country last year. The two countries trade $1.7 billion worth of goods and services each day, for a total of $614.9 billion in 2020.
What’s happening across Canada
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- N.L. reports 14 new case as 80 per cent of eligible residents now fully vaccinated.
What’s happening around the world
As of Sunday morning, more than 231.6 million cases of COVID-19 had been reported worldwide, according to Johns Hopkins University’s case tracking tool, which collects data from around the world. The reported global death toll stood at more than 4.7 million.
In Europe, Russian President Vladimir Putin announced in mid-September that he would have to spend a “few days” in self-isolation after dozens of people in his entourage fell ill with COVID-19.
The results of his time away from official duties, after he cancelled his trip to Tajikistan for a security summit, could be seen in photos released on Sunday, showing him fishing in Siberia.
Putin has cultivated a macho image, appealing to many Russians, and has previously been pictured riding a horse bare-chested and in sun glasses, as well as carrying a hunting rifle and piloting a fighter jet.
In Asia, China has provided more than 1.25 billion doses of COVID-19 vaccines to other countries, Foreign Minister Wang Yi said on Sunday. President Xi Jinping announced recently that China will provide a total of two billion doses of vaccines for the rest of the world by the end of this year.
In the Asia-Pacific region, Australia’s most populous state of New South Wales recorded 961 new locally acquired cases of COVID-19 and nine deaths, government data showed on Sunday.
The state’s first dose vaccination rate has climbed to 85.2 per cent of its population over 16 years of age, while 59.1 per cent of the population has had their second doses.
New South Wales is expected to relax harsh lockdown restrictions that have been in place since June, when its population reaches 80 per cent double vaccinated some time in November.
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