This article first appeared in Forum, The Edge Malaysia Weekly on January 29, 2024 - February 4, 2024

Genetic testing is a laboratory test to examine an individual’s DNA. The test can provide valuable information about an individual’s health, particularly the risk of inherited conditions like cystic fibrosis or Huntington’s disease, as well as a patient’s chances of a good response to specific treatments. The history of genetic testing is relatively recent, with the Human Genome Project successfully sequencing the entire human genome only in 2003, a short 21 years ago.

Genetic testing can transform healthcare in three ways. First, it provides information for precision medicine, which is an innovative approach to tailor disease prevention and treatment. It takes into consideration the differences in people’s genomic makeup, environments and lifestyles. Tailored (case-by-case approach) treatment will increase treatment efficacy and minimise side effects.

Second, genetic testing can diagnose a condition even before symptoms present and identify at-risk individuals. This helps individuals make informed decisions about treatment options, take preventive measures to reduce their risk and even facilitate family planning.

Third, genetic testing can help identify family members of a diagnosed individual well before family members develop any symptoms.

Since genetic screening can “predict a disease before it occurs”, genetic counselling is vital to facilitating clients’ informed decisions and coping with any psychological and social implications. Indeed, genetic counselling may even be considered mandatory before any genetic testing is carried out as well as after the results are ready.

In Malaysia, genetic testing is available in diagnostic laboratories in public hospitals, university hospitals and certain private hospitals as well as in specialised laboratories such as the Institute for Medical Research. In recent years, this service has also been provided by private laboratories and, increasingly, there are also direct-to-consumer (DTC) home-based DNA testing kits.

While DTC genetic testing has become increasingly accessible and affordable, there are two crucial concerns. The first is perverse incentives among patients. For example, individuals may use genetic tests to identify if they are in the high-risk category and then purchase insurance coverage. Conversely, individuals who are low-risk may choose not to purchase insurance coverage, thinking that their low-risk status confers invincibility. This issue of perverse incentives among patients can be resolved by mandatory genetic counselling pre-test and post-test, including for DTC genetic testing.

The second crucial concern is that insurance companies may use genetic testing results to decline insurance coverage for those who are high-risk. Insurance companies may ask applicants for their predictive genetic test results and use the test results to assess the applicant’s health risk profile. The outcomes of these genetic tests can impact an individual’s insurance policy, including denial of coverage for genetic conditions or the imposition of higher premiums. This may result in applicants not getting the benefit of genetic testing. Also, genetic screening, such as newborn screening for inherited conditions, may not be supported. To date, Malaysia lacks defined policies to navigate and resolve this issue of adverse selection on the part of insurers. Therefore, we propose a moratorium to prevent the abuse of genetic test results.

Insurers can and should adopt strategies to increase clarity in applicants’ insurance policies. First, insurers should abide by strict guidelines to ensure ethical practices in handling applicants’ genetic testing results. Applicants should not be compelled to undergo predictive or diagnostic genetic tests before or after purchasing insurance policies and insurers cannot demand disclosure of genetic testing results. Insurance companies are prohibited from accessing results from genetic testing companies without explicit written consent from the applicants.

Second, transparency is key. Insurers must communicate with policyholders and prospective applicants on how voluntary disclosure of genetic test results may affect coverage decisions. If existing clients choose to disclose their genetic testing results voluntarily, insurers should consult qualified clinical geneticists on a case-by-case basis for risk assessment. Premiums for existing coverage must remain unchanged and insurance companies cannot deny, limit or cancel coverage based on abnormal test results. However, certain exceptions may apply, such as when coverage exceeds specific monetary thresholds or for predictive testing of specified diseases like Huntington’s disease.

Third, genetic test results should not impact the insurance policies of the applicant’s blood relatives. Insurance companies should not attempt to obtain a relative’s personal information without explicit consent, even if family members have purchased insurance policies with the same insurance company. The protection of an individual’s genetic information and fair insurance practices are central to safeguarding privacy and upholding public health interests. In the absence of responsible policies implemented by insurance companies, individuals may hesitate to undergo genetic testing, leading to diminished benefits of precision medicine and, consequently, a potential decline in health outcomes.

In the US, the Genetic Information Nondiscrimination Act of 2008 prohibits insurance companies from requesting individuals undergo genetic tests. It also prevents insurers from using any individual’s genetic information to refuse insurance or charge a higher premium. In the UK, signatories to the Code on Genetic Testing and Insurance commit to never requiring applicants to undertake genetic tests (except predictive genetic tests for Huntington’s disease) in applications for life insurance cover over the financial limit of £500,000. Canada and Australia have similar laws prohibiting insurers from using genetic test results to decline coverage or increase premiums.

Other countries have implemented moratoriums on the use of genetic testing information by insurance companies. A moratorium typically involves a temporary restriction on insurers using genetic test results for underwriting. In Singapore, the Ministry of Health and the Life Insurance Association have developed the Moratorium on Genetic Testing and Insurance. Starting October 2021, life insurers in Singapore are not allowed to use predictive genetic test results to assess or decide the outcome of insurance applications, with some science-based exception diseases like Huntington’s or breast cancer.

As the popularity and accessibility of genetic testing rise in Malaysia, the establishment of clear guidelines becomes imperative for both insurers and the public. We call for a moratorium on insurers using genetic testing results to decide on insurance coverage in Malaysia.

The Ministry of Health plays a pivotal role in advocating policies protecting Malaysians from “genetic discrimination” and safeguarding the privacy of an individual’s genetic information. In collaboration with Bank Negara Malaysia, MoH could contribute to legal and ethical discourses, emphasising patient rights and ensuring fair treatment in insurance policies. Bank Negara could assume a regulatory role, ensuring that any implemented moratorium safeguards financial interests while maintaining the stability of the insurance sector. Thus, both sectors can provide hand-in-hand support for a win-win situation.

Besides that, the MoH’s 2019 Guidelines on Ethical Issues in the Provision of Medical Genetics Services may need to be reviewed to include insurance-related implications following genetic testing, with the aim of preventing genetic discrimination and addressing insurers’ concerns about accurate risk assessments. MoH and Bank Negara should also lead an engagement with the Life Insurance Association of Malaysia (LIAM) to establish the framework for a moratorium. LIAM’s involvement is vital in balancing the interests of insurers and the public. To adapt to the evolving genomic and policy landscape, the moratorium should have a lifespan, with a recommended five-year review.

Public awareness and education initiatives led by the government and the scientific community, particularly geneticists and genetic counsellors, should inform the public about the personal health and insurance-related implications of genetic testing. In the absence of a regulatory framework in place, DTC genetic testing has the potential to cause many personal health and insurance-related implications for consumers. Therefore, more defined processes are needed to ensure consumers receive professional pre- and post-test counselling for DTC genetic testing. Regular public consultations should be conducted to understand concerns and societal expectations regarding the impact of genetic testing on insurance policies.

In conclusion, policymakers and stakeholders alike need to come together and find a balance between harnessing the advantages of genetic testing and safeguarding against discriminatory insurance coverage. The need for a moratorium on insurance policies and genetic testing is urgent — not just to keep pace with global developments in genomic medicine but to lay the foundations for how the local healthcare ecosystem can embrace this inevitable frontier of medicine.

Dr Wong Tze Cheng is a physician in Sarikei. Dr Ng Shu Hui is a physician and ethicist, and medical director at Angsana Health. Prof Thong Meow Keong, Malaysia’s first board-certified geneticist and winner of the 2022 Advocacy Award by the American Society of Human Genetics, is a consultant paediatrician and clinical geneticist at Universiti Malaya.

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