Given the growing popularity of direct-to-consumer (DTC) genetic testing, the Department of Health (MOH) has taken various initiatives to raise awareness of the risks arising from the use of these tests. In addition to various social media advertisements since December 2021 and the publication of a consumer advisory in August 2021, the Department of Health also published a guidance document for non-clinical genetic testing providers in May 2021 (“Advice from the Ministry of Health“).
- Key points to remember
- More in detail
- Main regulatory controls
- Best Practices for DTC Test Providers
- Main risks and recommendations for users
Key points to remember
- The Department of Health will take a risk-based approach to regulating the provision of genetic testing. Clinical genetic testing providers must be licensed under the Health Services Act (HCSA) due to the risks involved.
- Non-clinical genetic testing providers do not need to be licensed due to the comparatively lower risk given that they are used for personal wellness and recreational purposes. Nevertheless, DTC genetic test kit providers are still required to comply with relevant legislation and guidelines.
- Suppliers of DTC genetic test kits should refer to MOH guidelines, which not only outline the applicable compliance framework, but also set out several best practices to ensure they adequately protect the safety, well-being and consumer privacy.
More in detail
Ministry of Health guidelines state that “DTP genetic testing” is a method to provide genetic testing directly to consumers without the involvement of a health care provider (i.e. when these tests are not ordered by a physician).
The terms “clinical genetic testing” and “non-clinical genetic testing” are used to describe nature of genetic testing which is running. The table below outlines the factors determining when a genetic test is considered a clinical genetic test:
|Key factors||When is it considered a clinical genetic test?|
|The purpose of genetic testing andThe terms and conditions reported in the test report.||The test is used to: Confirm or exclude the presence of a genetic disease in a symptomatic person (diagnostic genetic test). that will occur later in life (screening/predictive testing). prevent, relieve or treat a medical condition or disorder. OrThe test flags conditions and terms that evoke similar meanings to medical conditions or cause consumers to seek other medical solutions.|
|The background of the gene(s)/variant(s) selected in the test panel.and If and/or how the genetic test accounts for the association of a medical condition.||If the test That is has the potential to detect variants in genes that cause a single gene disease or medical condition; or may inform an individual’s susceptibility to a clinically significant medical condition.|
On the other hand, non-clinical genetic testing refers to genetic testing for non-clinical purposes, such as general well-being and recreation, when such testing is not used to assess, diagnose, prevent, alleviate, or treat a medical condition or disorder. Examples of non-clinical genetic testing include ancestry testing, innate behavioral lifestyle testing, and nutrigenomics testing.
Any genetic test that performs the same function as the clinical genetic test, as shown in the table above, would be considered clinical, regardless of the disclaimers used.
Main regulatory controls
Under the Code of Practice on Standards for Clinical Genetic/Genomic Testing Services and Clinical Laboratory Genetic/Genomic Testing Services, clinical genetic testing can not be provided or offered directly by manufacturers and providers of genetic testing to consumers in Singapore.
Because providing clinical genetic testing is considered a licensed health care service, providing such testing without a license is an offense under the HCSA. Violators may be subject to fines of up to SGD 100,000 and/or imprisonment for up to two years; and fines of up to SGD 200,000 and/or up to two years imprisonment if previously convicted of the same offence. In addition, DTC genetic test providers should note that other relevant laws and applications may apply to their business, namely the Human Biomedical Research Act (HBRA) and its regulations, as well as the protection of personal data (PDPA).
The HBRA criminalizes a range of activities, such as re-identifying de-identified information or biological material without consent or coercing a person to participate in research. Penalties under the HBRA vary, with fines of up to SGD 100,000 and jail terms of up to 10 years, depending on the specific offense. Companies found guilty of an offense under the HBRA may be subject to more severe penalties, up to twice the amount listed under the HBRA.
Violations of the PDPA include the Company’s use or disclosure of Personal Data without users’ prior consent or the Company’s failure to adequately safeguard Personal Data. The general penalty for violations of the PDPA is a fine of up to SGD 10,000 and/or up to three years imprisonment. In the event of intentional or negligent breaches of data protection obligations, companies may be required to pay a fine of up to SGD 1 million or 10% of the company’s annual turnover if the annual turnover exceeds SGD 10 million, whichever is greater.
Best Practices for DTC Test Providers
The Department of Health guidelines also provide good practice on the provision of non-clinical genetic testing, as it is not a licensable clinical service under the HCSA. Generally speaking, DTC test providers should, among other measures:
- Ensure that any advertisements, marketing materials, test reports containing results, or follow-up services do not contain any medical information and/or medical advice.
- Include relevant disclaimers and key information to help consumers understand how to interpret test results and inform consumers of any risks associated with testing.
- Educate consumers on how raw genetic information should or should not be used, as well as relevant disclaimers and informational notices on the uses and interpretation of this information.
- Avoid misleading or scientifically unsupported statements.
- Disclose the sensitivity, specificity and predictive value of the genetic test.
- Ensure that data submitted by consumers when purchasing genetic testing is not used or disclosed without their prior consent.
- Implement strong data security measures or provisions to prevent unauthorized access to any database containing personal data.
The Ministry of Health guidelines serve as a guidance note and do not strictly have the force of law. However, violating best practices may cause DTP genetic test providers to violate other regulations, such as those described in the section above.
Main risks and recommendations for users
Because DTC genetic testing is unregulated and the number of DTC genetic testing providers is not tracked by the MOH, the MOH cautioned the public to be cautious in interpreting DTC genetic test results. because they are not always reliable. In particular, the Ministry of Health has warned that users should always consult their doctor before making any health decisions.
The Ministry of Health has identified the main risks arising from the use of DTP genetic testing, including:
- The tests may not be based on solid clinical or scientific evidence.
- Suppliers and test reports may contain exaggerated claims.
- Tests often do not have an adequate explanation before or after the test.
- Tests may not be accurate as they are not clinically validated.
- Genetic information may be sold to companies for marketing, service evaluation, or research purposes, where such sale of data may affect not only the user, but also the user’s family members who share similar genetic information.
The Department of Health has also provided recommendations for users to consider before using DTP genetic test kits, which include:
- Beware of exaggerated or unsubstantiated claims.
- On terms and conditions, check whether there are adequate measures to keep user information confidential and the purposes for which user information will be used or disclosed.
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