Biotech firms that conduct medical diagnostic tests should be regulated as they deal with human specimens, legislator for the medical sector Lo Wing-lok said.
'If you obtain a specimen from a patient with a view to making a clinical diagnosis, it is a clinical diagnostic test. You are dealing with specimens from human beings,' he said. 'The biotech companies providing clinical diagnostics should undergo formal quality assurance either through accreditation or a licensing system.'
Only medical laboratories are regulated, and the Department of Health would not comment on whether this should be extended to biotech laboratories.
The department said only that medical laboratories were monitored and it was 'engaging in active dialogue' with stakeholders to consider 'the best way forward for the provision of laboratory support service for Sars testing'.
The department spokesman added that the Supplementary Medical Professions Council promoted the standards of professional practice and conduct among registered health-care professionals.
The government also plans to expand the coverage of the Hong Kong Laboratory Accreditation Scheme (HKLAS) to cover all medical laboratories in the city, he said, but it would not include labs run by biotech firms.