April 1, 2014
China’s Food and Drug Administration (CFDA) has acted to impose regulatory constraints on the provision of clinical genetic tests. The announcement appeared vague as although the ban on prenatal DNA testing is unambiguously stated, it is not known whether the ban would apply to other kinds of testing as well (for e.g. screening/testing for cancer). In effort to uphold the ban, CFDA has also prohibited the continuance of all current projects except those approved by the government relating to clinical genetic testing. They will now require all related medical devices to be licensed by the government “before they can be manufactured, imported, sold or used, potentially covering the world’s most popular gene-sequencing equipment, made by San Diego-based Illumina, Inc”. There is also an overwhelming possibility that this move could significantly restrict the efforts of the Chinese genome sequencing giant Bejing Genomics Institute (BGI).
It is speculated that China is anxious to prevent potential abuses of genetic testing, especially prenatal testing and this extreme measure is to ascertain that the rise in the new testing capacity, especially non-invasive prenatal testing (NIPT) techniques does not “hamper social and ethical values and ‘human heredity resources’ are protected”. However, banning prenatal DNA testing especially, affects the Chinese population looking to have children due to the strict policies on the number of children they are allowed, so it is of paramount importance that the children that are born are healthy. It is also speculated that this move is to curb the gender inequality in China which remains a huge concern, due to parents preferring males over females for children, even though sex determination is routinely performed by an ultrasound scan and not genetic testing.