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BGI prenatal gene test under scrutiny for Chinese military links

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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.

Consent forms signed by women outside China seek permission for their blood samples and genetic data to be sent abroad to BGI and used for research. The privacy policy on the test’s website also says data can be shared for national security purposes in China – though BGI says it has never been asked to do so.

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.

DOCTORS’ VIEWS

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)

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Eby wants all-party probe into B.C. vote count errors as election boss blames weather

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Premier David Eby is proposing an all-party committee investigate mistakes made during the British Columbia election vote tally, including an uncounted ballot box and unreported votes in three-quarters of the province’s 93 ridings.

The proposal comes after B.C.’s chief electoral officer blamed extreme weather, long working hours and a new voting system for human errors behind the mistakes in last month’s count, though none were large enough to change the initial results.

Anton Boegman says the agency is already investigating the mistakes to “identify key lessons learned” to improve training, change processes or make recommendations for legislative change.

He says the uncounted ballot box containing about 861 votes in Prince George-Mackenzie was never lost, and was always securely in the custody of election officials.

Boegman says a failure in five districts to properly report a small number of out-of-district votes, meanwhile, rippled through to the counts in 69 ridings.

Eby says the NDP will propose that a committee examine the systems used and steps taken by Elections BC, then recommend improvements in future elections.

“I look forward to working with all MLAs to uphold our shared commitment to free and fair elections, the foundation of our democracy,” he said in a statement Tuesday, after a news conference by Boegman.

Boegman said if an independent review does occur, “Elections BC will, of course, fully participate in that process.”

He said the mistakes came to light when a “discrepancy” of 14 votes was noticed in the riding of Surrey-Guildford, spurring a review that increased the number of unreported votes there to 28.

Surrey-Guildford was the closest race in the election and the NDP victory there gave Eby a one-seat majority. The discovery reduced the NDP’s victory margin from 27 to 21, pending the outcome of a judicial review that was previously triggered because the race was so close.

The mistakes in Surrey-Guildford resulted in a provincewide audit that found the other errors, Boegman said.

“These mistakes were a result of human error. Our elections rely on the work of over 17,000 election officials from communities across the province,” he said.

“Election officials were working 14 hours or more on voting days and on final voting day in particular faced extremely challenging weather conditions in many parts of the province.

“These conditions likely contributed to these mistakes,” he said.

B.C.’s “vote anywhere” model also played a role in the errors, said Boegman, who said he had issued an order to correct the results in the affected ridings.

Boegman said the uncounted Prince George-Mackenzie ballot box was used on the first day of advance voting. Election officials later discovered a vote hadn’t been tabulated, so they retabulated the ballots but mistakenly omitted the box of first-day votes, only including ballots from the second day.

Boegman said the issues discovered in the provincewide audit will be “fully documented” in his report to the legislature on the provincial election, the first held using electronic tabulators.

He said he was confident election officials found all “anomalies.”

B.C. Conservative Party Leader John Rustad had said on Monday that the errors were “an unprecedented failure by the very institution responsible for ensuring the fairness and accuracy of our elections.”

Rustad said he was not disputing the outcomes as judicial recounts continue, but said “it’s clear that mistakes like these severely undermine public trust in our electoral process.”

Rustad called for an “independent review” to make sure the errors never happen again.

Boegman, who said the election required fewer than half the number of workers under the old paper-based system, said results for the election would be returned in 90 of the province’s 93 ridings on Tuesday.

Full judicial recounts will be held in Surrey-Guildford and Kelowna-Centre, while a partial recount of the uncounted box will take place in Prince George-Mackenzie.

Boegman said out-of-district voting had been a part of B.C.’s elections for many decades, and explained how thousands of voters utilized the province’s vote-by-phone system, calling it a “very secure model” for people with disabilities.

“I think this is a unique and very important part of our elections, providing accessibility to British Columbians,” he said. “They have unparalleled access to the ballot box that is not found in other jurisdictions in Canada.”

This report by The Canadian Press was first published Nov. 5, 2024.



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Memorial set for Sunday in Winnipeg for judge, senator, TRC chair Murray Sinclair

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WINNIPEG – A public memorial honouring former judge, senator and chair of the Truth and Reconciliation Commission into residential schools, Murray Sinclair, is set to take place in Winnipeg on Sunday.

The event, which is being organized by the federal and Manitoba governments, will be at Canada Life Centre, home of the NHL’s Winnipeg Jets.

Sinclair died Monday in a Winnipeg hospital at the age of 73.

A teepee and a sacred fire were set up outside the Manitoba legislature for people to pay their respects hours after news of his death became public. The province has said it will remain open to the public until Sinclair’s funeral.

Sinclair’s family continues to invite people to visit the sacred fire and offer tobacco.

The family thanked the public for sharing words of love and support as tributes poured in this week.

“The significance of Mazina Giizhik’s (the One Who Speaks of Pictures in the Sky) impact and reach cannot be overstated,” the family said in a statement on Tuesday, noting Sinclair’s traditional Anishinaabe name.

“He touched many lives and impacted thousands of people.”

They encourage the public to celebrate his life and journey home.

A visitation for extended family, friends and community is also scheduled to take place Wednesday morning.

Leaders from across Canada shared their memories of Sinclair.

Premier Wab Kinew called Sinclair one of the key architects of the era of reconciliation.

Prime Minister Justin Trudeau said Sinclair was a teacher, a guide and a friend who helped the country navigate tough realities.

Sinclair was the first Indigenous judge in Manitoba — the second in Canada.

He served as co-chair of the Aboriginal Justice Inquiry of Manitoba to examine whether the justice system was failing Indigenous people after the murder of Helen Betty Osborne and the police shooting death of First Nations leader J.J. Harper.

In leading the Truth and Reconciliation Commission, he participated in hundreds of hearings across Canada and heard testimony from thousands of residential school survivors.

The commissioners released their widely influential final report in 2015, which described what took place at the institutions as cultural genocide and included 94 calls to action.

This report by The Canadian Press was first published Nov. 5, 2024.

The Canadian Press. All rights reserved.



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House of Commons committee looks to recall Tom Clark about New York City condo

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OTTAWA – Members of Parliament studying the federal government’s decision to buy a $9-million luxury condo in Manhattan are preparing to recall Canada’s consul general in New York to answer more questions about his involvement in the purchase.

The Conservatives put forward a motion on Tuesday to have Tom Clark return to the House operations committee. The move was supported by other opposition parties after new information emerged that contradicted his previous testimony.

Clark told the committee in September he had no role whatsoever in the purchase of the new condo, or the sale of the previous residence.

But reporting from Politico on Tuesday indicated Clark raised concerns about the old unit two months after he was appointed to his role as Canada’s representative in New York.

Politico cited documents obtained through access-to-information, which were then shared with other media by the Conservative party.

A May 2023 report from Global Affairs Canada indicates Clark informed government officials the residence needed to be replaced.

“The current (consul general in New York, head of mission) expressed concerns regarding the completion of the … kitchen and refurbishment project and indicated the unit was not suitable to be the (consul general’s) accommodations,” the report reads.

“It does not have an ideal floor plan for (consul general in New York) representational activities.”

The final call on whether Clark will face further questions has not been made, however, because the committee adjourned before the motion went to a vote. The committee’s next meeting is next week.

Tuesday’s meeting featured Foreign Affairs Minister Mélanie Joly as a witness, and she faced questions about Clark’s involvement in the purchase.

“This was not a political decision because this was an operational decision,” Joly told the committee in a testy exchange with Conservative MP Michael Barrett.

“(The committee) had numerous people, officials of mine, that came to see you and said that. So, these are the facts.”

Joly later told the committee she only learned of the decision to purchase a new residence through media reports, even though her chief of staff was notified weeks earlier.

“The department informed my chief of staff once the decision was taken. Because, of course, it was not a political decision,” Joly said.

Shortly before Joly was excused, Conservative MP Stephanie Kusie put forward the motion to recall Clark for two more hours to answer more questions.

Bloc MP Julie Vignola proposed instead to have him testify for only one hour — indicating she would support the motion with that change.

“One hour is more than enough to know whether he lied to us,” Vignola told her colleagues in French.

NDP MP Taylor Bachrach also said he would support the move, given the contrast between the new report and Clark’s testimony about whether he spoke to anyone about a desire to move into a new residence.

“What really irks me is the consul general was so clear in response to repeated questioning at committee,” Bachrach said.

“Mr. Clark said, ‘Never.’ One-word answer, ‘Never.’ You can’t get more unequivocal than that.”

The Liberal government has argued that buying the new residence will save Canadians taxpayers millions of dollars and reduce ongoing maintenance costs and property taxes while supporting future program needs for the consul general.

The former official residence is listed for sale at $13 million, but has yet to be sold.

In her remarks Tuesday, Joly told the committee other like-minded countries have paid more for their Manhattan residences than Canada has — including $11 million for the U.K., and France’s $19 million purchase in 2015.

Joly said among the countries that have residences in New York, only Afghanistan and Bangladesh were not located in Manhattan.

This report by The Canadian Press was first published Nov. 5, 2024.

The Canadian Press. All rights reserved.



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