Britain says China’s BGI must register prenatal tests by Sept 1

By Reuters Staff

LONDON (Reuters) – China’s largest gene company BGI Group must register its prenatal test with local regulators by Sept. 1 if it wants to keep offering products in Britain, a minister said on Thursday.

A Reuters report found BGI Group developed the tests in collaboration with China’s military and uses them to collect genetic data from millions of women round the world.

However, BGI says it alone produced the NIFTY test, has never shared data for national security or defense purposes, and complies with European privacy laws. Reuters found no evidence BGI violated privacy agreements or regulations.

British junior health minister James Bethell said the British Medicines and Healthcare products Regulatory Agency (MHRA) expected BGI’s devices to need oversight before being placed on the local market.

“The MHRA understand BGI genetic screening tests are currently available for sale in the UK. These devices do not appear to have been registered with the MHRA at this time,” Bethell said in a written response to a question on BGI’s tests from a member of Britain’s upper chamber of parliament.

“However, due to their risk classification, registration will be required from 1 September 2021 in order to continue placing the products on the market.”

Bethell said there had been no specific assessment of BGI’s tests, but that neither the state-run National Health Service (NHS) nor the Public Health England (PHE) agency used its technology.

The tests have been available in some private clinics in England since at least 2014, however.

“There are no grounds to prevent BGI Groups operating in the UK provided they comply with UK legislation and regulatory requirements,” Bethell added.

In an emailed statement, BGI said it “strictly complies with local laws, guidelines, and protocols, while adhering to internationally recognized ethical and legal standards.”

UK should be concerned at Chinese gene data harvesting, lawmaker says

By Alistair Smout

LONDON (Reuters) -Britain should be concerned about the harvesting of genetic data from millions of women by a Chinese company through prenatal tests, a senior British lawmaker told Reuters.

A Reuters review of scientific papers and company statements found that BGI Group developed the tests in collaboration with the Chinese military and is using them to collect genetic data around the world for research on the traits of populations.

“I’m always concerned when data leaves the United Kingdom, that it should be treated with the respect and privacy that we would expect here at home, and the concern that this raises is that it may not be so,” Tom Tugendhat, chairman of the British parliament’s Foreign Affairs Select Committee, told Reuters.

“The connections between Chinese genomics firms and the Chinese military do not align with what we would normally expect in the United Kingdom or indeed many other countries.”

The privacy policy on the website for the Non-Invasive Prenatal Test (NIPT), sold under the brand name NIFTY in Britain, says data collected can be shared when it is “directly relevant to national security or national defense security” in China.

BGI says it has never shared data for national security purposes and has never been asked to.

The company said that it fully complied with European GDPR data protection rules and also had the British certification for personal information management.

“BGI’s NIPT test was developed solely by BGI – not in partnership with China’s military. All NIPT data collected overseas are stored in BGI’s labs in Hong Kong and are destroyed after five years,” it said in an email to Reuters, adding that it took data protection, privacy and ethics extremely seriously.

Tugendhat is one of nine British lawmakers who has been sanctioned by China for highlighting alleged human rights abuses in Xinjiang, which Beijing describes as “lies and disinformation.”

He co-leads the China Research Group, a group of Conservative lawmakers which looks to rebalance the strategic relationship with China.

He said that any British companies using the tests should be clear where the data is going, who holds it, and what access others, including other governments, would have to it.

“Unless a company has done that, I think it’s perfectly reasonable for British people to be extremely concerned with these connections,” he said.

(Reporting by Alistair Smout in London, additional reporting by Kirsty Needham in Sydney; Editing by Kate Holton and Pravin Char)