Singapore: MOH's recent initiatives to raise awareness of the risks of direct-to-consumer genetic testing & More News Here

In transient

Given the growing reputation of direct-to-consumer (DTC) genetic testing, the Ministry of Health (MOH) has taken numerous initiatives to raise awareness of the risks arising from the use of such checks. In addition to numerous social media commercials since December 2021 and issuing an advisory for shoppers in August 2021, the MOH additionally issued a steering doc for suppliers of non-clinical genetic testing in May 2021 (“MOH Guidance“).

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Contents

1. Key takeaways
2. In extra element
3. Key regulatory controls
4. Good practices for DTC check suppliers
5. Key risks and suggestions for customers

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• The MOH will undertake a risk-based method to regulate the provision of genetic testing. Clinical genetic testing suppliers are required to be licensed underneath the Healthcare Services Act (HCSA) due to the risks concerned.
• Non-clinical genetic testing suppliers don’t want to be licensed due to the comparably decrease danger on condition that they’re used for private well-being and leisure functions. Nonetheless, suppliers of DTC genetic testing kits are nonetheless required to adjust to the related laws and tips.
• Providers of DTC genetic testing kits ought to refer to the MOH Guidance, which not solely outlines the relevant compliance framework but additionally units out a number of good practices to make sure that they adequately safeguard shopper security, welfare and privateness.

The MOH Guidance offers that ‘DTC genetic testing’ is a technique of offering genetic checks instantly to shoppers with out the involvement of a healthcare supplier (i.e., the place such checks aren’t ordered by a medical practitioner).

The phrases ‘clinical genetic testing’ and ‘non-clinical genetic testing’ are used to describe the nature of genetic testing that’s being carried out. The desk under units out the elements on when a genetic check is taken into account a scientific genetic check:

Key elements	When is it thought-about a scientific genetic check?
The goal of the genetic check andThe circumstances and phrases reported in the check report.	The testing is used to/for: Confirm or exclude the presence of a genetic illness in a symptomatic individual (diagnostic genetic testing).Predict the danger of having affected kids (service testing).Predict a genetic situation in an asymptomatic individual for a illness that can happen later in life (predictive screening/testing).Predict an individual’s drug response (pharmacogenetic testing).Predict an individual’s danger of creating a illness or situation (whether or not inherited or not inherited).Any functions that purport to assess, diagnose, stop, alleviate or deal with a medical situation or dysfunction. OrThe check experiences circumstances and phrases that connote meanings comparable to medical circumstances or induce shoppers to search additional medical options.
The context of the gene(s)/ variant(s) chosen in the check panel.and Whether and/or how the genetic check experiences on the affiliation of a medical situation.	If the check both has the potential to detect variants in genes that trigger a single gene dysfunction or medical situation; or could inform the susceptibility of a person to a clinically vital medical situation.

On the different hand, non-clinical genetic testing refers to genetic testing for non-clinical functions, comparable to normal wellness and leisure functions, the place such checks aren’t used to assess, diagnose, stop, alleviate or deal with a medical situation or dysfunction. Examples of non-clinical genetic testing embrace ancestry testing, innate behavioral way of life testing and nutrigenomics testing.

Any genetic testing that performs the identical operate as scientific genetic testing, as set out in the desk above, can be thought-about scientific, regardless of any disclaimers used. 

Under the Code of Practice on the Standards for scientific genetic/genomic testing providers and scientific laboratory genetic/genomic testing providers, scientific genetic checks can not be supplied or supplied instantly by producers and suppliers of genetic checks to shoppers in Singapore.

As the provision of scientific genetic checks is taken into account a licensable healthcare service, offering such checks and not using a license is an offense underneath the HCSA. Offenders could also be topic 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 beforehand convicted of the identical offense. Additionally, DTC genetic testing suppliers ought to take notice that different related legal guidelines and functions could apply to their actions, particularly the Human Biomedical Research Act (HBRA) and its rules, together with the Personal Data Protection Act (PDPA). 

The HBRA criminalizes a variety of actions, comparable to re-identifying anonymized info or organic materials with out consent or compelling an individual to take part in analysis. Penalties underneath the HBRA differ, the place fines can go up to SGD 100,000 and imprisonment phrases can go up to 10 years, relying on the particular offense. Companies convicted of an offense underneath the HBRA could also be topic to enhanced penalties, dealing with fines of up to twice the quantity acknowledged underneath the HBRA.

Breaches of the PDPA embrace the firm’s use or disclosure of private information with out customers’ prior consent or the firm’s failure to adequately shield private information. The normal penalty for offenses underneath the PDPA is a positive of up to SGD 10,000 and/or up to three years’ imprisonment. For intentional or negligent contraventions of information safety obligations, firms could also be required to pay a monetary penalty of up to SGD 1 million or 10% of the firm’s annual turnover if the annual turnover exceeds SGD 10 million, whichever is increased.

The MOH Guidance additionally offers good practices on the provision of non-clinical genetic testing as it isn’t a scientific service that’s licensable underneath HCSA. Broadly, DTC testing suppliers ought to, amongst different measures:

• Ensure that any commercial, advertising and marketing materials, check report containing outcomes, or follow-up providers don’t carry any medical info and/or medical recommendation.
• Include related disclaimers and key info to support shoppers in understanding how to interpret check outcomes, and inform shoppers of all risks related to testing.
• Educate shoppers on how uncooked genetic info ought to or shouldn’t be used, together with together with the related disclaimers and advisory notes on the makes use of and interpretation of mentioned info.
• Avoid deceptive or scientifically unsupported statements.
• Disclose the sensitivity, specificity and predictive worth of the genetic check.
• Ensure that any information submitted by the shoppers on the buy of the genetic checks just isn’t used or disclosed with out their prior consent.
• Implement strong information safety measures or preparations to stop the unauthorized entry of any databases that comprise private information.

The MOH Guidance serves as a steering notice and doesn’t strictly have power of regulation. However, contravention of the good practices could lead to the DTC genetic testing suppliers being in breach of different rules, comparable to these outlined in the part above.

Given that DTC genetic checks aren’t regulated and the quantity of DTC genetic check suppliers aren’t tracked by the MOH, the MOH warned the public to be cautious in deciphering DTC genetic check outcomes as they aren’t at all times dependable. In specific, the MOH cautioned that customers ought to at all times seek the advice of their medical doctors earlier than making any well being selections. 

The MOH recognized key risks arising from the use of DTC genetic checks, which embrace:

• Tests might not be primarily based on sturdy scientific or scientific proof.
• Providers and check experiences could carry exaggerated claims.
• Tests typically don’t have an sufficient clarification earlier than or after the check. 
• Tests might not be correct as they aren’t clinically validated.
• Genetic info could also be offered to firms for advertising and marketing, service analysis or analysis functions, the place such sale of information could not solely have an effect on the person, but additionally the person’s relations who share comparable genetic info.

The MOH additionally supplied suggestions for customers to take notice of earlier than utilizing DTC genetic check kits, which embrace:

• Be cautious of exaggerated or unsupported claims.
• On the phrases and circumstances, examine if there are sufficient measures to maintain customers’ info confidential and the functions for which customers’ info will likely be used or disclosed.

© 2022 Baker & McKenzie.Wong & Leow. All rights reserved. Baker & McKenzie.Wong & Leow is included with restricted legal responsibility and is a member agency of Baker & McKenzie International, a world regulation agency with member regulation companies round the world. In accordance with the widespread terminology utilized in skilled service organizations, reference to a “principal” means an individual who’s a associate, or equal, in such a regulation agency. Similarly, reference to an “office” means an workplace of any such regulation agency. This could qualify as “Attorney Advertising” requiring discover in some jurisdictions. Prior outcomes don’t assure the same end result.

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