Key takeaways
- The MOH will adopt a risk-based approach to regulate the provision of genetic testing. Clinical genetic testing providers are required to be licensed under the Healthcare Services Act (HCSA) due to the risks involved.
- Non-clinical genetic testing providers do not need to be licensed due to the comparably lower risk given that they are used for personal well-being and recreational purposes. Nonetheless, providers of DTC genetic testing kits are still required to comply with the relevant legislation and guidelines.
- Providers of DTC genetic testing kits should refer to the MOH Guidance, which not only outlines the applicable compliance framework but also sets out several good practices to ensure that they adequately safeguard consumer safety, welfare and privacy.
In more detail
The MOH Guidance provides that 'DTC genetic testing' is a method of providing genetic tests directly to consumers without the involvement of a healthcare provider (i.e., where such tests are not ordered by a medical practitioner).
The terms 'clinical genetic testing' and 'non-clinical genetic testing' are used to describe the nature of genetic testing that is being carried out. The table below sets out the factors on when a genetic test is considered a clinical genetic test:
| Key factors |
When is it considered a clinical genetic test? |
- The purpose of the genetic test
and
- The conditions and terms reported in the test report.
|
- The testing is used to/for:
- Confirm or exclude the presence of a genetic disease in a symptomatic person (diagnostic genetic testing).
- Predict the risk of having affected children (carrier testing).
- Predict a genetic condition in an asymptomatic person for a disease that will occur later in life (predictive screening/testing).
- Predict a person's drug response (pharmacogenetic testing).
- Predict a person's risk of developing a disease or condition (whether inherited or not inherited).
- Any purposes that purport to assess, diagnose, prevent, alleviate or treat a medical condition or disorder.
Or
- The test reports conditions and terms that connote meanings similar to medical conditions or induce consumers to seek further medical solutions.
|
- The context of the gene(s)/ variant(s) selected in the test panel.
and
- Whether and/or how the genetic test reports on the association of a medical condition.
|
- If the test either has the potential to detect variants in genes that cause a single gene disorder or medical condition; or may inform the susceptibility of an individual 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 wellness and recreational purposes, where such tests are 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 testing that performs the same function as clinical genetic testing, as set out in the table above, would be considered clinical, regardless of any disclaimers used.
Key regulatory controls
Under the Code of Practice on the Standards for clinical genetic/genomic testing services and clinical laboratory genetic/genomic testing services, clinical genetic tests cannot be provided or offered directly by manufacturers and suppliers of genetic tests to consumers in Singapore.
As the provision of clinical genetic tests is considered a licensable healthcare service, providing such tests without a license is an offense under the HCSA. Offenders may be subject to fines of up to SGD 100,000 and/or up to two years' imprisonment; and fines of up to SGD 200,000 and/or up to two years' imprisonment if previously convicted of the same offense. Additionally, DTC genetic testing providers should take note that other relevant laws and applications may apply to their activities, namely the Human Biomedical Research Act (HBRA) and its regulations, along with the Personal Data Protection Act (PDPA).
The HBRA criminalizes a range of activities, such as re-identifying anonymized information or biological material without consent or compelling a person to participate in research. Penalties under the HBRA vary, where fines can go up to SGD 100,000 and imprisonment terms can go up to 10 years, depending on the specific offense. Companies convicted of an offense under the HBRA may be subject to enhanced penalties, facing fines of up to twice the amount stated under the HBRA.
Breaches of the PDPA include the company's use or disclosure of personal data without users' prior consent or the company's failure to adequately protect personal data. The general penalty for offenses under the PDPA is a fine of up to SGD 10,000 and/or up to three years' imprisonment. For intentional or negligent contraventions of data protection obligations, companies may be required to pay a financial penalty of up to SGD 1 million or 10% of the company's annual turnover if the annual turnover exceeds SGD 10 million, whichever is higher.
Good practices for DTC test providers
The MOH Guidance also provides good practices on the provision of non-clinical genetic testing as it is not a clinical service that is licensable under HCSA. Broadly, DTC testing providers should, among other measures:
- Ensure that any advertisement, marketing material, test report containing results, or follow-up services do not carry any medical information and/or medical advice.
- Include relevant disclaimers and key information to aid consumers in understanding how to interpret test results, and inform consumers of all risks associated with testing.
- Educate consumers on how raw genetic information should or should not be used, along with including the relevant disclaimers and advisory notes on the uses and interpretation of said information.
- Avoid misleading or scientifically unsupported statements.
- Disclose the sensitivity, specificity and predictive value of the genetic test.
- Ensure that any data submitted by the consumers on the purchase of the genetic tests is not used or disclosed without their prior consent.
- Implement robust data security measures or arrangements to prevent the unauthorized access of any databases that contain personal data.
The MOH Guidance serves as a guidance note and does not strictly have force of law. However, contravention of the good practices may result in the DTC genetic testing providers being in breach of other regulations, such as those outlined in the section above.
Key risks and recommendations for users
Given that DTC genetic tests are not regulated and the number of DTC genetic test providers are not tracked by the MOH, the MOH warned the public to be cautious in interpreting DTC genetic test results as they are not always reliable. In particular, the MOH cautioned that users should always consult their doctors before making any health decisions.
The MOH identified key risks arising from the use of DTC genetic tests, which include:
- Tests may not be based on strong clinical or scientific evidence.
- Providers and test reports may carry 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 not only affect the user, but also the user's family members who share similar genetic information.
The MOH also provided recommendations for users to take note of before using DTC genetic test kits, which include:
- Be wary of exaggerated or unsupported claims.
- On the terms and conditions, check if there are adequate measures to keep users' information confidential and the purposes for which users' information will be used or disclosed.
© 2022 Baker & McKenzie.Wong & Leow. All rights reserved. Baker & McKenzie.Wong & Leow is incorporated with limited liability and is a member firm of Baker & McKenzie International, a global law firm with member law firms around the world. In accordance with the common terminology used in professional service organizations, reference to a "principal" means a person who is a partner, or equivalent, in such a law firm. Similarly, reference to an "office" means an office of any such law firm. This may qualify as "Attorney Advertising" requiring notice in some jurisdictions. Prior results do not guarantee a similar outcome.
