Lord Bethell, the Department of Health and Social Care, has provided the following answer to your written parliamentary question (HL2139):
Question by Lord Alton of Liverpool:
To ask Her Majesty’s Government what assessment they have made of reports (1) that UK clinics are selling BGI Group’s tests for genetic conditions such as Down’s syndrome, and (2) that BGI Group is (a) using these tests to harvest the genetic data of millions of women and their unborn children, and (b) storing this data on a gene database funded by the government of China; and what plans they have to ban BGI Group in the UK. (HL2139)
Tabled on: 19 July 2021
There has been no specific assessment of BGI Group’s tests. Public Health England and NHS England have confirmed they do not use BGI technology in their genomic screening services.
On the information provided, the Medicines and Healthcare products Regulatory Agency (MHRA) would anticipate that this type of device would be classified as a List B In-Vitro Diagnostic, which requires the oversight of a conformity assessment body before being placed on the United Kingdom market. The device must comply with the Medical Devices Regulations 2002 No.618. 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, however, due to their risk classification, registration will be required from 1 September 2021 in order to continue placing the products on the market.
Access to health data is controlled by the Data Protection Act 2018 (which incorporates GDPR in UK domestic law) and the common law duty of confidentiality and we have no plans to change these. The Government is clear that health and care data should only ever be used and/or shared where used lawfully, treated with respect, held securely and where the right safeguards are in place. The UK’s high standards of data protection will be maintained and enforced.
As outlined in the Genome UK strategy, all our genomic data systems will continue to apply consistent high standards around data security and our intention is that the UK model will be recognised as being the gold standard for how to apply strong and consistent ethical and regulatory standards that support rapid healthcare innovation, adhere to legal frameworks, and maintain public and professional trust.
There are no grounds to prevent BGI Groups operating in the UK provided they comply with UK legislation and regulatory requirements.
Date and time of answer: 05 Aug 2021 at 13:00.