Call for evidence outcome

Code on Genetic Testing and Insurance: call for evidence

Updated 25 April 2024

Executive summary

The Code on Genetic Testing and Insurance aims to provide reassurance to the public about how and whether genetic testing could affect their access to certain types of insurance in the UK. This call for evidence will inform whether the Code may need to be revised to reflect the changing genomics landscape and ensure it remains fit for purpose.

The call for evidence will run for a period of 12 weeks and is open to everyone aged 16 and over. You can respond as an individual or on behalf of an organisation.

The call for evidence closes at 11:59pm on 17 October 2023.

The Code on Genetic Testing and Insurance

The Code on Genetic Testing and Insurance (‘the Code’) is a voluntary agreement between the UK government and the Association of British Insurers (ABI), a trade organisation which represents over 200 insurance companies. It provides guidance on the role of genetic testing in insurance across the UK.

The Code is based on 2 core principles:

1. An insurer will not require or pressure an applicant to undertake a predictive or diagnostic genetic test (see definitions under theme 1) in order to obtain insurance.

2. The results of a predictive genetic test may be considered in an application for insurance only when both of the following conditions are met:

• the Code states that the specific predictive genetic test may be considered
• the sum assured exceeds the financial limits set out in the Code

At present under the Code, the only exception where insurers may ask for, and take into account, the result of a test is where a person has had a predictive genetic test for Huntington’s disease, and is applying for life insurance cover which totals over the financial limit of £500,000.

Any predictive test results obtained through participation in research do not need to be disclosed to insurers.

How the Code is kept up to date

In order to keep the Code up to date, the government and ABI publish 3-yearly reviews. The first triennial review of the Code was published in December 2022. It looked at changes in the current genomics landscape and highlighted specific issues raised by stakeholders, which we would now like to explore further to determine whether revisions to the Code may be needed in the future.

Call for evidence

We are seeking views from individuals and organisations, including those with genetic conditions, family members and carers, healthcare professionals, the insurance industry and the public, to ensure the Code remains fit for purpose and beneficial for both consumers and the insurance industry.

The call for evidence is divided into 3 themes which will help us gather views on 2 key topics:

1. Whether the definitions for genetic tests used in the Code remain up to date.
2. The need to outline a transparent and accessible approach to assessing which predictive genetic test results may need to be disclosed under the Code in the future.

Before answering these questions, we recommend that you read the updated consumer guide on ABI’s website, which provides further information on the Code and what it covers. You can also find a glossary of terms below, towards the end of the page.

Theme 1: definitions used for genetic testing

Genetic testing - sometimes called genomic testing - finds changes in genes that can cause health problems. In healthcare, it is mainly used to diagnose rare and inherited health conditions and some cancers.

When applying for life, critical illness and income protection insurance, the Code groups genetic tests into 2 groups:

• diagnostic genetic tests, which confirm or rule out a diagnosis based on existing symptoms, signs or abnormal non-genetic test results, which indicate that the condition in question may be present. Similar to the diagnostic results of a blood test or MRI scan, an existing diagnostic genetic test result could form part of relevant medical information when making an application for insurance
• predictive genetic tests, which predict a future risk of disease in individuals without symptoms of a genetic disorder. Under the Code, insurers cannot ask for results of a predictive test, nor do individuals need to disclose these results, except in the case of Huntington’s disease in applications for life insurance cover which totals over the financial limit of £500,000

It is important to note that even if a predictive test result is mistakenly disclosed in an application, it will be ignored by the insurer and will not impact the insurance premium offered. Under the Code, insurance companies will not require or pressure any applicant to undertake predictive or diagnostic genetic tests to obtain insurance.

Our recent review of the Code highlighted some potential issues surrounding the distinction between predictive and diagnostic tests. The following questions will help us understand whether the definitions currently used in the Code are clear and useful, and whether any changes or additional information are needed.

Question

To what extent do you agree or disagree that you could identify when a genetic test is a predictive test (using the definitions provided in the Code)?

• Strongly disagree
• Disagree
• Neither agree nor disagree
• Agree
• Strongly agree

Question

To what extent do you agree or disagree that you could identify when a genetic test is a diagnostic test (using the definitions provided in the Code)?

• Strongly disagree
• Disagree
• Neither agree nor disagree
• Agree
• Strongly agree

Question

What would help you to identify a genetic test as being predictive or diagnostic?

Question

From your understanding of the Code, do you have any concerns about genetic testing and accessing private affordable insurance?

• Yes
• No
• I don’t know
• Not applicable

Please provide further detail on your concerns and whether they would affect your decision to get a genetic test.

We want to hear from healthcare professionals and the insurance industry to make sure everyone has the information they need to provide accurate advice on which genetic test results need to be disclosed to insurers under the Code.

The following question is aimed at seeking healthcare professionals’ views.

Question

Are the categories ‘predictive’ and ‘diagnostic’ genetic testing used in your area of practice?

• Yes, only these categories are used
• Yes, but other categories are used as well
• No, different categories are used
• No, there are no distinctions used in genetic testing
• I don’t know
• Not applicable to my area

If other categories are used in your area of practice, please list them.

The following question is aimed at seeking the views of healthcare professionals and those working in the insurance industry.

Question

Do you think there are any genetic tests in existence where it is unclear to you whether they would be classified as predictive or diagnostic?

• Yes
• No
• I don’t know

Please specify which genetic tests you think are not clearly identifiable as predictive or diagnostic.

Theme 2: a framework for assessing whether a predictive genetic test should be required to be disclosed under the Code

With rapid advances in genomics, and its increasing incorporation into the healthcare system, the potential impacts of genetic tests on the insurance sector may change. Consequently, we need a robust method for deciding whether or not predictive genetic test results for conditions other than Huntington’s disease may need to be disclosed under the Code in the future. The 2022 review of the Code identified the need for transparency around how predictive genetic tests could be assessed for inclusion in (or exclusion from) a list of exceptions within the Code, should an application be made in the future.

ABI commissioned the Cambridge Centre for Health Services Research (CCHSR) to undertake research to identify the current and potential impact of developments in genetics on the UK insurance industry.

Central to this research was the development of a framework that provides a structured approach to monitoring and assessing developments in genetic testing. This could provide a transparent basis on which to evaluate the potential impacts of a predictive genetic test on the insurance industry (either currently or in the future) and understand the key factors that may influence this.

To assess whether a particular condition should be considered for inclusion in, or exclusion from, the list of exceptions within the Code in the future, information on all factors listed below would need to be collected for the condition. Statistical modelling using this information may be required, as well as consideration of expert perspectives.

In the framework, consideration of a predictive genetic test for inclusion in or exclusion from the list of exceptions within the Code is guided by 4 overarching questions:

1. How useful is the genetic test for characterising the risk of developing a condition?
2. How many people take the test?
3. What is the impact of the condition in terms of the length and quality of life of people who develop it?
4. What is the potential for reducing the risk of developing the condition and managing its effects if it develops?

Below we list a range of key factors that support answering these questions, along with a detailed explanation of each factor. We would like to gather your views on this framework and whether it might provide the basis for an appropriate solution to transparently assessing additional conditions, if required in the future.

It is important to note that the framework is not intended to supersede the Code, but rather to complement the current process for deciding whether a predictive genetic test result needs to be disclosed under the Code. This is explained in further detail in theme 3.

Key factors to consider when determining if a predictive genetic test result should be required to be disclosed under the Code

1. How useful is the genetic test for characterising the risk of developing a condition?

Factor	Detailed explanation
Extra information the test provides	Extent to which the likelihood that someone will develop a condition can be estimated using information other than genetic test results (for example, family history or lifestyle factors such as tobacco use).
Clinical utility	Extent to which clinically relevant action can be taken based on the results of the test. For a test to have clinical utility, it must have demonstrated analytic, scientific and clinical validity.

2. How many people take the test?

Factor	Detailed explanation
Societal interest	Community interest in using genetic tests, which is influenced by whether the community benefits from the tests, as well as personal preferences. Community in this context could be the general population, or those who are already at high risk of developing a condition due to family history or other factors.
Personal utility	Value of the information gained from a genetic test to the person being tested (separate from whether it is useful from a clinical perspective).
Test availability	How a test is accessed in terms of public (or private) medical systems, or whether people access it via the internet (called direct-to-consumer testing). This includes whether there are eligibility criteria for the test, and what sort of clinical support is available to people, both before and after testing.
Cost	Whether an individual has to pay to get access to a genetic test, and if so, how much it costs.

3. What is the impact of the condition in terms of the length and quality of life of people who develop it?

Factor	Detailed explanation
Penetrance	Likelihood that specific forms of a gene or genes (genetic variants) will be expressed in an individual and lead to development of the condition - for many conditions, not everyone who has a genetic variant associated with a condition goes on to develop it.
Health consequences	What impact the condition is likely to have on the health of someone who develops it. This includes, how old they are when they develop it, whether it is likely to shorten their life and how it may affect their quality of life (for example, mobility or ability to care for themselves).
Prevalence	Proportion of people within a population who develop the condition being tested.

4. What is the potential for reducing the risk of developing the condition and managing its effects if it develops?

Factor	Detailed explanation
Risk reduction options	Whether there is anything someone can do to reduce their risk of developing a condition (before they have developed symptoms or when they have developed early symptoms and prevention may still be possible). This can include medical treatments, or changing other risk factors (such as diet).
Treatment options	What treatments for a condition are available for people after they have developed it, with the aim of reducing its impact on their quality of life and/or life expectancy. Again, this can include medical or lifestyle interventions.
Availability of interventions	Whether and by what means people can get access to risk reduction interventions and/or treatments. This includes the cost of accessing them and whether they would be accessible via public and/or private medical systems.

Question

To what extent do you agree or disagree that the questions in the framework are sufficient to identify which predictive genetic tests should be considered for inclusion in or exclusion from the list of exceptions in the Code?

‘Exceptions’ means predictive genetic tests that applicants must disclose to insurers when applying for insurance.

• Strongly disagree
• Disagree
• Neither agree nor disagree
• Agree
• Strongly agree
• I don’t know

Question

Are there any other questions that you think should be included in the framework?

• Yes
• No
• I don’t know

Please explain your answer and outline your reasoning.

Question

Is there anything else you think should be considered regarding the framework?

Theme 3: a refined decision-making process moving forwards

The current process for making changes to the list of predictive genetic tests that must be disclosed under the Code involves a written submission from ABI to the government which would be published by ABI on their website within one month, including evidence to demonstrate that all of the following apply:

• the condition is well understood and carries an increased risk of significant morbidity and/or mortality
• a predictive genetic test is available, which meets certain standards
• there is a high risk that individuals buying insurance based on information that insurers do not know would have an effect on insurance markets and impact individual premiums for other consumers, if not addressed

This application would need to be followed by a stakeholder engagement process, and independent peer review of the application by a panel of experts.

The government would be required to communicate a decision within 6 to 12 months of publication of the application, after which a revised version of the Code would be published.

If the proposed framework developed by CCHSR was to be adopted, it would not replace this process, but would instead be used by ABI to systematically collect and present information when requesting amendments to the list of predictive genetic tests that must be disclosed under the Code. We would like to gather your views on whether this would be appropriate.

It is important to note that ABI and its members currently do not have plans to seek new exceptions to be applied in the Code.

Question

To what extent do you agree or disagree that the addition of the framework will improve the decision-making process (for making changes to the list of predictive genetic tests that must be disclosed under the Code)?

• Strongly disagree
• Disagree
• Neither agree nor disagree
• Agree
• Strongly agree
• I don’t know

Please explain your answer.

Question

Do you think there could be any unintended consequences as a result of adopting the framework?

• Yes
• No
• I don’t know

If you anwered yes, please outline what you think the unintended consequences of adopting this framework could be.

Question

Are there other approaches that you think should be considered instead of, or alongside, the framework developed by Cambridge Centre for Health Services Research (CCHSR)? For example, approaches used in other countries.

How to respond

The easiest way to participate in the call for evidence is by completing the online survey.

If you have any technical problems with using the online survey or if you cannot send your submission via the online portal, please log the issue by emailing abicallforevidence@dhsc.gov.uk. Do not send any personal information to this email address.

Next steps

Results from the call for evidence will be analysed and used to help determine whether the Code requires updating. We will provide more information on our publication plans in due course.

Glossary

This glossary contains a brief definition of key terms referenced in this review including medical conditions and medical tests, which some readers may be less familiar with.

Huntington’s disease

Huntington’s disease is a rare genetic condition inherited from your biological parents that stops parts of the brain working properly over time. It is usually fatal after a period of up to 20 years.

Life insurance

Life insurance is a type of insurance whereby an insurer agrees to pay out a lump sum of money in the event of your death.

Gene

A gene is a small section of DNA which carries the instructions for making a specific protein or set of proteins. It is the basic unit of heredity passed from parent to child.

Genetic testing

Genetic testing is a type of test to look for changes in genes that can cause health problems. It is usually done using a sample of your blood or saliva.

Genomic testing

Genomic testing is a type of test that looks across all of a person’s genes (the genome) for changes that can cause, or contribute to, health problems or responses to treatments.

Genome

A genome is the entire set of an organism’s DNA instructions found in a cell.

Privacy notice

For more information on what you can expect from DHSC when we ask for or hold your personal information, read our personal information charter.

Summary of initiative or policy

The Code on Genetic Testing and Insurance (the Code) is a voluntary agreement between the UK government and the Association of British Insurers (ABI). In order to keep the Code up to date, the government and ABI publish 3-yearly reviews. The first triennial review of the Code was published in December 2022 and highlighted issues which we would like to explore further to determine whether revisions to the Code may be needed in the future.

The government and ABI are seeking views from individuals and organisations, people with genetic conditions, family members and carers, healthcare professionals, the insurance industry, and the public to ensure the Code remains fit for purpose and beneficial for both consumers and the insurance industry through a call for evidence.

As part of this discussion, we will be collecting responses which will contain data that we need to keep safe. This notice explains how we will do that.

Data controller

The Department of Health and Social Care (DHSC) is the data controller.

What personal data we collect

At the beginning of the survey, we will ask whether you are responding as an individual or an organisation. If you are answering on behalf of an organisation or as an individual sharing your professional views, we will ask you to tell us the main area of focus of your work so we can direct you to answering the correct questions. We will ask where you live in the UK or where your organisation operates services to understand if responses received are representative of the UK demographic.

If volunteered by you, we will also collect data on:

• your gender identity
• where you live in England

We will be asking optional demographic questions relating to participants’ sex and ethnicity. We are only collecting this data to analyse any trends and to make sure we have a broad range of people responding to the survey. All of these questions will have a ‘prefer not to say’ option - choosing not to answer these questions will not affect your ability to participate in the survey.

We will give you the option to provide your email address and to tell us whether or not we can use it for the following reasons:

• if you are not able to complete the survey and would like to be reminded
• to verify it is your response
• to allow you to amend or delete your response
• to allow DHSC to contact you for further information about your response (if you have given your consent)

We will also be asking open questions with free text answer boxes. Some people, particularly if they have had personal experiences with a genetic condition, may choose to disclose information about themselves in these boxes. Please do not include any information that could directly identify you in these boxes.

If we receive any responses which include information that we think may directly identify you, we will seek to remove this information where possible.

How we use your data (purposes)

We collect your personal data as part of the call for evidence process:

• for statistical purposes, for example, to understand how representative the results are
• so that DHSC can contact you for further information about your response (if you have given your consent)

We ask for this information so that we can ensure that the Code is fit for purpose for both consumers and the insurance industry. All data will be anonymised when reviewing the responses, which means that nobody who provides a response to this survey will be identifiable from the information we publish, nor will this be shared with ABI.

Legal basis for processing personal data

Under Article 6 of the UK General Data Protection Regulation (GDPR), the lawful base we rely on for processing this information is that it is a necessary task in the public interest or controller’s official authority.

Data processors and other recipients of personal data

All responses to the call for evidence will be seen by:

• professional analysts and policy leads working on the Code on Genetic Testing and Insurance (or overlapping areas) in DHSC
• DHSC’s third-party supplier (SurveyOptic), who is responsible for running and hosting the online survey

DHSC may also share anonymised responses with:

• individuals supporting this review within DHSC’s executive agencies and/or executive non-departmental public bodies, such as NHS England
• ABI and insurers who have signed up to the Code
• other government departments
• devolved administrations
• external researchers if additional support is required to analyse the responses received

International data transfers and storage locations

The information will be stored in DHSC secure systems in the UK.

Retention and disposal policy

The personal data will only be held for a maximum of 24 months after the call for evidence online survey closes, or when instructed to do so by DHSC (whichever happens earlier). We will instruct removal once it has served its intended purpose for informing whether the Code will need revision.

How we keep your data secure

Both DHSC and SurveyOptic have security procedures in place to make sure your information is safe and to make sure it does not get lost or accessed by anyone who does not need to see it.

This includes only allowing authorised persons access to your data via methods like password protection, encryption and making sure that the servers we use are secure.

Your rights as a data subject

By law, data subjects have a number of rights and this processing does not take away or reduce these rights under the EU General Data Protection Regulation (2016/679) and the UK Data Protection Act 2018 apply.

These rights are:

1. The right to get copies of information - individuals have the right to ask for a copy of any information about them that is used.
2. The right to get information corrected - individuals have the right to ask for any information held about them that they think is inaccurate, to be corrected.
3. The right to limit how the information is used - individuals have the right to ask for any of the information held about them to be restricted, for example, if they think inaccurate information is being used.
4. The right to object to the information being used - individuals can ask for any information held about them to not be used. However, this is not an absolute right, and continued use of the information may be necessary, with individuals being advised if this is the case.
5. The right to get information deleted - this is not an absolute right, and continued use of the information may be necessary, with individuals being advised if this is the case.

Comments or complaints

Anyone unhappy or wishing to complain about how personal data is used as part of this programme, should contact data_protection@dhsc.gov.uk in the first instance or write to:

Data Protection Officer
1st Floor North
39 Victoria Street
London
SW1H 0EU

Anyone who is still not satisfied can complain to the Information Commissioner’s Office. Their website address is www.ico.org.uk and their postal address is:

Information Commissioner's Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF

Automated decision-making or profiling

No decision will be made about individuals solely based on automated decision making (where a decision is taken about them using an electronic system without human involvement) which has a significant impact on them.

Changes to this policy

This privacy notice is kept under regular review, and new versions will be available on our privacy notice page on our website. This privacy notice was last updated on 25 July 2023.