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In brief

Given the increasing popularity of direct-to-consumer (DTC) genetic testing, the Ministry of Health (MOH) has taken various initiatives to raise awareness of the risks arising from the use of such tests. In addition to various social media advertisements since December 2021 and issuing an advisory for consumers in August 2021, the MOH also issued a guidance document for providers of non-clinical genetic testing in May 2021 (“MOH Guidance“).


Contents

  1. Key takeaways
  2. In more detail
  3. Key regulatory controls
  4. Good practices for DTC test providers
  5. Key risks and recommendations for users

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 factorsWhen is it considered a clinical genetic test?
The purpose of the genetic test andThe 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. OrThe 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.
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Author

Andy Leck is the head of the Intellectual Property and Technology (IPTech) Practice Group and a member of the Dispute Resolution Practice Group in Singapore. He is a core member of Baker McKenzie's regional IP practice and also leads the Myanmar IP Practice Group. Andy is recognised by reputable global industry and legal publications as a leader in his field. He was named on "The A-List: Singapore's Top 100 lawyers" by Asia Business Law Journal 2018. In addition, Chambers Asia Pacific notes that Andy is "a well-known IP practitioner who is highlighted for his record of handling major trade mark litigation, as well as commercial exploitation of IP rights in the media and technology sectors. He's been in the industry for a long time and has always been held in high regard. He is known to be very fair and is someone you would like to be in the trenches with you during negotiations." Furthermore, Asian Legal Business acknowledges Andy as a leading practitioner in his field and notes that he “always gives good, quick advice, [is] client-focused and has strong technical knowledge for his areas of practice.” Andy was appointed by the Intellectual Property Office of Singapore (IPOS) as an IP Adjudicator to hear disputes at IPOS for a two-year term from April 2021. He has been an appointed member of the Singapore Copyright Tribunal since May 2010 and a mediator with the WIPO Arbitration and Mediation Center. He is also appointed as a Notary Public & Commissioner for Oaths in Singapore. He previously served on the International Trademark Association’s Board of Directors and was a member of the executive committee.

Author

Ren Jun Lim is a principal with Baker McKenzie Wong & Leow. He represents local and international clients in both contentious and non-contentious intellectual property matters. He also advises on a full range of healthcare, as well as consumer goods-related legal and regulatory issues. Ren Jun co-leads Baker McKenzie Wong & Leow's Healthcare as well as Consumer Goods & Retail industry groups. He sits on the Law Society of Singapore IP Committee and on the Executive Committee of the Association of Information Security Professionals. He is also a member of the Vaccines Working Group, Singapore Association of Pharmaceutical Industries, a member of the International Trademark Association, as well as a member of the Regulatory Affairs Professionals Association. Ren Jun is ranked in the Silver tier for Individuals: Enforcement and Litigation and Individuals: Prosecution and Strategy, and a recommended lawyer for Individuals: Transactions by WTR 1000, 2020. He is also listed in Asia IP's Best 50 IP Expert, 2020, recognised as a Rising Star by Managing IP: IP Stars, 2019 and one of Singapore's 70 most influential lawyers aged 40 and under by Singapore Business Review, 2016. Ren Jun was acknowledged by WTR 1000 as a "trademark connoisseur who boasts supplementary knowledge of regulatory issues in the consumer products industry." He was also commended by clients for being "very responsive to enquiries and with a keen eye for detail, he is extremely hands-on. His meticulous and in-depth approach to strategising is key to the excellent outcomes we enjoy."

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