Regulations for Direct-to-Consumer Genetic Testing Services

Mr Yip Hon Weng asked the Minister for Health (a) whether the Ministry will consider implementing regulations for direct-to-consumer (DTC) genetic testing services to address concerns related to privacy, accuracy and consumer protection; (b) what is the Ministry doing to enhance public awareness about the potential sharing and commercial use of genetic data obtained from DTC tests by third parties; and (c) how will individuals have access to accurate information, genetic counselling and guidance in interpreting test results to mitigate any risks of misinterpretation and unnecessary anxiety.

The Senior Parliamentary Secretary to the Minister for Health (Ms Rahayu Mahzam) (for the Minister for Health): The Ministry of Health (MOH) takes a risk-based approach to the regulation of genetic testing. Aligned to this approach, we regulate clinical genetic testing but not direct-to-consumer (DTC) tests used for general wellness, ancestry and nutrigenomics purposes.

Nevertheless, MOH has issued a guidance document in May 2021 which outlines good practices for providers offering non-clinical genetic testing and educates consumers on the risks of such testing. These risks include exaggerated claims, the possible sharing and commercial use of genetic data obtained from DTC tests by third parties and the lack of proper medical interpretation of test results.

Consumers should exercise care to assess for themselves the suitability and quality of such non-clinical tests. Consumers need to read the test provider's terms and conditions carefully before using such tests, contact the provider or approach their doctors when in doubt.

MOH will continue to monitor the development of DTC genetic testing and review our regulatory initiatives and consumer education efforts to ensure the safety, privacy and welfare of the public.

Mdm Deputy Speaker: Mr Yip Hon Weng.

Mr Yip Hon Weng (Yio Chu Kang): Thank you, Madam. I thank the Senior Parliamentary Secretary for her response. I have two supplementary questions.

First is can the Ministry elaborate why are non-clinical genetic tests allowed to be provided directly to the consumer but not clinical genetic tests?

Second, for users of direct-to-consumer (DTC) genetic tests, how can they be assured that their data will not be sold to third parties, especially in the cases where the tests are sold online but processed overseas?

Ms Rahayu Mahzam: I thank Member for the questions. With regards to non-clinical genetic tests, these are typically those that do not address medical conditions or disorders and are usually use for general wellness or recreational purposes. So, they are assessed to be of lower risk and maybe offered directly to consumers.

Nonetheless, it is important for consumers of non-clinical genetic tests to be informed and take precautions for themselves in looking after their own interests. So, that is why we have developed the guidance document and enhanced consumer education to raise awareness on genetic testing.

In contrast, the clinical genetic tests are used to assess, diagnose, prevent, alleviate and predict risks or treat a medical condition or disorder. So, they should be administered by medical practitioners with the appropriate knowledge and training. So, we make sure that the medical practitioner is involved in order to actually look at the test results property and provide the necessary management to the individual. That responds to the first question.

In respect of the second question, because of this difference with the DTC tests, we take a risk-based approach as I had explained. We use a caveat emptor approach. It means that a consumer has to be responsible, has to be aware that they have to protect themselves. Having said that, as I mentioned, we have guidelines in place. Moving forward, we are also looking at the development of the Health Information Bill. And these are also ways for which we can enhance protection further. But we will watch and see whether there is any need for further regulatory enhancements in this space.