The government is launching a call for evidence to look into how its code on genetic testing and insurance can better define predictive and diagnostic genetic tests as well as outline a transparent and accessible approach to assessing conditions that may require inclusion into the code in the future.
Plans for the call for evidence feature in the 2022 review of the code, which also commits to the publication of a revised consumer guide next year to ensure the code remains “accessible and useful”.
This first review identified that accessibility of the code could be improved, with wording often leading to confusion among consumers as to how it is applied to real life situations.
The review warned there was a risk that if the code is not easily accessible, members of the public may be put off from seeking insurance policies because they are unsure what information to disclose or whether they would face higher premiums based on results of genetic tests.
Stakeholders also highlighted there were emerging issues surrounding the distinction between predictive and diagnostic tests, as some predictive tests may show an increased risk of developing a condition and as such may result in increased surveillance for the condition.
They questioned whether in this scenario, the enhanced surveillance would count as treatment or management of a condition – causing the predictive test to become a diagnostic one.
Code is working well
However, overall the Department for Health and Social Care (DHSC) concluded that the code was continuing to work well and said there was no evidence of information asymmetry.
“With no complaints reported in 2020, the Code on Genetic Testing and Insurance is providing reassurance on how tests are used and not used by insurers,” it said.
“The code continues to provide reassurance to consumers while providing the flexibility to manage change in the wider genetics landscape to ensure that insurers can effectively assess risk and provide insurance to a wide range of people.”
The code was first published in October 2018, replacing the concordat and moratorium on genetics and insurance.
It is the sixth iteration of a long-standing voluntary agreement between the UK government and the Association of British Insurers (ABI), whereby insurers who are signed up to the code will never require or pressure any applicant to undertake a predictive or diagnostic genetic test and will only consider the result of a predictive genetic test for a very small minority of cases.
To date, there is only one test for which insurers can request disclosure of results, which is a predictive genetic test for Huntington’s disease, in applications for life insurance cover which are over the financial limit of £500,000.
Additionally, genetic testing results obtained through participation in research do not need to be disclosed to insurers. The code is reviewed every three years.
Evidence and workshops
In response to stakeholder feedback, this latest review commits government to a call for evidence and holding additional stakeholder workshops next year to assess views on the most appropriate way to define genetic tests going forwards to ensure the definitions remain relevant and useful for the code.
The DHSC will also be seeking opinion on the Cambridge Centre for Health Services Research (CCHSR) framework, and its future approach to assessing conditions under the code, during the same call for evidence.
This evidence, will help to shape a more transparent and accessible process and will be incorporated into the code going forwards.
DHSC said this process will enable it to gather expert opinion to ensure the code remains mutually beneficial for both consumers and the insurance industry and is representative of a wide variety of views and that the call for evidence will allow it to seek views from vital stakeholders including patients and carers, healthcare professionals, the insurance industry, and the public.
Alongside the call for evidence, DHSC will publish an updated Consumer Guide – incorporating the most frequently asked questions from consumers looking to undertake informative genetic testing as part of their healthcare journey.
It said the refreshed guide would help people better understand the code and feel empowered to respond to its call for evidence and provide users of the code with the information they need to use it effectively.
Looking forward, annual reports will continue to be published and the code will be reviewed again in 2025 as part of its commitment to ensure it remains relevant and fit for purpose in the face of increasing advances in the field of genomics that are shaping the future of healthcare across the UK.