China’s Food and Drug Administration has acted to impose regulatory constraints on the provision of clinical genetic tests.
Last month the governmental agency issued a ban on all medical applications of ‘gene sequencing technology products’, including prenatal testing, in the absence of formal regulatory scrutiny and approval. This covered all applications for disease prevention, diagnosis, care, treatment, monitoring, health status evaluation and prediction of genetic diseases, and applies to manufacture, import, sale or use. Software is included in the ban, as well as equipment and reagents (such as the popular Illumina sequencing systems), and it applies to medical institutions as well as other providers. The move was said to be to ensure public safety and strengthen the clinical use of gene sequencing and related products.
China’s regulatory position on genetic tests, previously unclear, is now therefore stringent on the international scale, certainly more so than that of the FDA in the United States which now prohibits direct-to-consumer genetic testing, requiring the involvement of medical professionals to order any form of medical testing.
There has been speculation that the move could stifle the Chinese genome sequencing giant Bejing Genomics Institute (BGI), which last year acquired the US-based Complete Genomics, or that conversely the move may be intended to boost Chinese domination of the internal market by providing a mechanism to exclude foreign test providers.
However, it seems more likely that China is anxious to prevent potential abuses of genetic testing, especially prenatal testing which is specifically referred to in the announcement, which says that new testing capacity poses problems in ethics, privacy, the protection of ‘human heredity resources’ and biological safety, and ‘the management of diagnosis expertise of related medical institutions, their pricing policy and quality controls’.
Most Chinese families still have only one child, and the health of this child is of paramount importance for social as well as practical reasons, so that the demand for prenatal diagnostic testing is already high and likely to rise, especially with the recent advent of non-invasive prenatal testing (NIPT) techniques that can be used early in pregnancy. The new regulatory regime may be to protect Chinese consumers from inappropriate, poor quality or over-priced tests.
It may also have much to do with tackling gender imbalance, which remains a major public health issue in China; social preferences for sons combined with the legacy of the one-child policy (despite recent relaxation) has already resulted in effective sex selection and a shortage of girls and young women. Unrestricted access to prenatal genetic testing could further exacerbate this problem, so the new restriction of clinical gene sequencing applications to pilots approved by the National Health and Planning Commission (the Chinese population control authority) may be highly significant.
Objections to the ban are reportedly already being raised, with fears that the rate of birth defects will rise sharply without access to prenatal testing. However, it would be perfectly possible for the authorities to permit testing for Down’s syndrome and other medical indications via approved providers. It remains to be seen what the purpose and impact of the new regulatory regime will be.