Britain says China's BGI must register prenatal tests by Sept 1 (updated)

BGI AD

05/08/2021 20:05

(Adds BGI response)
    LONDON, Aug 5 (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 https://www.reuters.com/investigates/special-report/health-china-bgi-dna
 in collaboration with China's military and uses them to collect
genetic data from millions of women round the world.
 urn:newsml:reuters.com:*:nL3N2OJ350
    However, BGI says it alone produced the NIFTY test, has
never shared data for national security or defence 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." 

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 (Reporting by Alistair Smout in London and Kirsty Needham in
Sydney;
Editing by Andrew Cawthorne)
 ((alistair.smout@thomsonreuters.com; +44 207 542 7064; Reuters
Messaging: alistair.smout.thomsonreuters.com@reuters.net))