There is scope to relieve some of the strain on public health systems, like the NHS in the UK, if ‘self-test’ medical kits are made more widely available for purchase at retailers, but both suppliers and users of those kits will need to navigate legal issues, an expert has said.
Louise Fullwood of Pinsent Masons was commenting after it was reported that supermarket Tesco and diagnostic tests provider Newfoundland Diagnostics have expanded their partnership to make a wider range of Newfoundland’s testing kits available for sale in Tesco stores and on its website.
According to the Metro, Newfoundland kits that enable the public to test for iron and vitamin deficiencies, kidney dysfunction, thyroid issues, bowel problems, male infertility and the menopause are now available via Tesco, in addition to Covid-19 and flu testing kits which were already available.
The Metro reported that the companies plan to expand the range of kits available to Tesco shoppers further, to include tests for prostate cancer, HIV and urinary tract infections, and that Newfoundland hopes to strike similar partnerships with other retailers too.
Louise Fullwood
Legal Director
The information that the manufacturer provides on leaflets issued alongside the test kits should clearly set out the risks and recommended actions patients should take – if they don’t address that adequately, they risk being found liable for patient harm
Fullwood said: “Self-test kits should be considered a helpful supplement to a patient’s relationship with their GP, rather than a substitute. With widespread adoption, there is the potential for self-test kits to reduce pressures on GPs by helping patients gain basic answers to questions they have about their health and thereby free GPs up to advise on any required treatment at a later stage in the process as well as on more complex cases.”
“Patients should, however, not rely entirely on the results from self-test kits. There are risks with false negatives – patients should not ignore symptoms associated with a health issue just because a self-administered test is negative. The information that the manufacturer provides on leaflets issued alongside the test kits should clearly set out the risks and recommended actions patients should take – if they don’t address that adequately, they risk being found liable for patient harm,” she said.
“If a purchaser were to use a kit to test samples from others without their knowledge or consent then this raises an interesting question under UK law,” Fullwood said. “In the UK, the law places limits on surreptitious DNA testing of samples obtained from another person. This risk is perhaps most stark in the context of the sale of male fertility kits. Under the Human Tissue Act, obtaining or using a sample for the purpose of DNA analysis without consent is an offence. Obtaining and using a sample for other testing purposes is not unlawful. With the rise of self-testing, perhaps this is an opportunity for the law in this area to be reconsidered and updated.”
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