Corporate report

Code on genetic testing and insurance: the government's annual report 2019

Published 9 June 2020

This was published under the 2019 to 2022 Johnson Conservative government

Introduction and context

The Code on Genetic Testing and Insurance (the code) was published in October 2018, replacing the Concordat and Moratorium on Genetics and Insurance.

The code is a voluntary agreement between government and the Association of British Insurers (ABI), whereby insurers signed up to the code will never require or pressure any applicant to undertake a predictive or diagnostic genetic test, and only consider the result of a predictive genetic test for a very small minority of cases. To date, there is only one approved relevant predictive genetic test, which is a predictive genetic test for Huntington’s disease, in applications for life insurance cover which total over the financial limit of £500,000.

The government is of the view that it is important everyone has access to good insurance at the right price. The code aims to provide reassurance to the public about how and whether genetic testing could affect their access to life, critical illness and income protection insurance products in the UK.

A Consumer Guide to the Code and responses to FAQs were published alongside the code.

Annual reporting

The code is open-ended with no expiry date. To ensure that the code remains fit for purpose, the government and ABI agree that they must have a well-informed, shared understanding of the current state of genomic technologies and the insurance market.

Under the code, the government and the ABI therefore agreed to publish an annual report to provide a commentary on the state of the market and developments in genomic medicine, as well as looking a compliance with the code. A 3-yearly review will allow for the code to be kept up-to-date.

This is the first annual report under the code from the government and provides an update on the changes in genomic policy landscape over the last year. It sits alongside the ABI’s annual report which includes information on compliance as well as additional relevant information on the insurance market. The ABI annual report can be found on their website.

Genomics policy landscape

This report briefly explores how UK genomics has evolved in 2019 in 4 main areas:

• diagnosis
• prevention
• research
• public engagement

Diagnosis

There have been significant breakthroughs in using genomic technologies to improve diagnosis and treatment of patients, most notably in cancer and rare disease. One major achievement was the completion of the sequencing phase of the 100,000 Genomes Project in December 2018.

The project has delivered life-changing results for many patients, with one in four participants with rare diseases expected to receive a diagnosis for the first time and providing potential clinically actionable findings in up to half of cancer patients.

Based on the achievements of the project, NHS England announced the Genomics Medicine Service (GMS) in October 2018, which will make the UK the first in the world to integrate whole genome sequencing into routine clinical care. The service will provide equitable access to genomic analyses across England. The GMS is supported by a National Genomic Test Directory, which provides for the first time a comprehensive list of genomic tests available in NHS in England, the technology by which they are available and the patients who will be eligible to access them.

The NHS is already offering whole exome sequencing capable of rapidly diagnosing rare diseases for critically ill babies and children, as part of its Long Term Plan to use world leading technologies to improve care for the sickest infants.

Government plans to continue building on this with an NHS pilot, using whole genome sequencing to rapidly diagnose critically ill babies and children with a suspected genetic condition

Prevention

Significant commitments to further utilise genomics for prevention of disease have been made since publication of the code.

The Accelerating Detection of Disease (ADD) challenge aims to recruit up to 5 million diverse, healthy participants into a world-leading research cohort in order to shed new light on the detection and treatment of chronic diseases.

An important part of the ADD challenge will be to offer as many participants as possible a polygenic risk score, which calculate the combined impact of many variations across the genome in order to create an overall risk score. Data will be made available to researchers, whilst participants themselves will receive personalised feedback on their results. The project will help to generate evidence to better inform whether and how polygenic risk scores could be implemented in the health service in the future.

Research

When considering genomics research, it should be remembered that under the code, any predictive genetic test result obtained exclusively in the context of scientific research does not need to be disclosed to an insurer, regardless of the test or the level of cover.

The UK leads the way in genomic research and the Life Sciences Sector Deal 2, published in December 2018, highlighted the importance of supporting genomic research for translation into healthcare.

As was cemented in the sector deal, the government set out an ambitious vision for genomics in October 2018, announcing a new goal to sequence 5 million genomes over the next 5 years, including 1 million whole genomes from NHS patients and UK Biobank participants.

In September 2019, a £200 million investment from government, industry and charity was announced to secure the whole genome sequencing of all 500,000 UK Biobank participants, with the first tranche of data available by 2021 and all data available by 2023. The project is unique worldwide – nowhere else is whole genome sequencing being undertaken at this scale, with this level of commitment to open access to researchers.

Although this does not fall into the reporting period, it is important to mention the role of genomics in the UK’s response to the global COVID-19 pandemic which started in early 2020. Genetic differences can have an effect on how individuals respond to infection. To understand this, the government is co-funding research into the human response to coronavirus infection to inform future patient management and improve patient outcomes. These include the UK’s contribution to the Genetics Of Mortality In Critical Care (GenOMICC) study by a global network of doctors and scientists working on severe COVID-19 and other infections; and an associated study led by Genomics England which aims to use whole genome sequencing of patients affected by COVID-19 to determine genomic factors in the severity of symptoms experienced.

National Genomic Healthcare Strategy

A National Genomic Healthcare Strategy has been developed by the Office for Life Sciences and will set out how the UK intends to have the world’s best genomic healthcare system. The strategy is expected to be published later in 2020.

Public engagement

To raise awareness of the code in the workforce, the code has been widely disseminated among genetic counsellor professional bodies, key healthcare professionals and organisations. Efforts to ensure wide dissemination of the code will continue as a constant activity.

Whilst the advances in genomic technology and its applications for healthcare are undoubtedly exciting, patients and the public in particular must be confident that their data is safe and that it is being used to deliver the best possible care. Genomics England, with support from Sciencewise, commissioned Ipsos MORI to carry out a public dialogue exploring how the public feel that the NHS should best take forward genomic medicine, including exploration of public opinion around the Code and the use of genomic information by insurance companies. The final report, published in April 2019, found that whilst the dialogue participants were enthusiastic and optimistic about the potential for genomic medicine, they had clear red lines on use of data including the inappropriate use of genetic information for targeted marketing or insurance purposes and had questions about how compliance with the code would be enforced.

The government recognises these concerns and is committed to careful and robust monitoring of code compliance by way of the new annual reports and three-yearly review. In all aspects of the code, the ABI and its members will continue to work with government, patient, consumer and health professional representatives to achieve a well-balanced relationship regarding the fair and transparent use of genetic test results in insurance.

It should be noted that while all ABI members are automatically bound by the code, not all insurers offering life, income protection and critical illness insurance are signed up to the code. A full list of insurance companies who have signed up to the code can be found on the ABI website.

International recognition

Internationally, the code has been widely regarded as an effective and robust model to balance the interests of the public and insurers.

The code was identified by the Council of Europe Committee on Bioethics as an exemplar of the adoption of the Council’s Recommendation (2016)8, which aims to set out and safeguard “fundamental rights of individuals whose personal data are processed for insurance purposes, while recognising the insurer’s legitimate interest in assessing the level of risk to be covered”. Researchers in the United States have also called for the US to adopt a similar approach as the UK and establish a voluntary moratorium^{[footnote 1]}.

Conclusion

The developments in genomic testing, medicine and research over the last year will improve prevention, diagnosis, and treatment of patients with genetic diseases. Such developments do not change the landscape of predictive genetic testing in the UK for the foreseeable future, nor the terms of the code, which remain relevant and effective.

It is also important to note that many of developments in genomics described in this report are currently in the research phase and that under the code, a predictive genetic test result obtained exclusively in the context of scientific research does not need to be disclosed to an insurer, regardless of the test or the level of cover.

1. Bélisle-Pipon, J., Vayena, E., Green, R.C. et al. Genetic testing, insurance discrimination and medical research: what the United States can learn from peer countries. Nat Med 25, 1198–1204 (2019) doi:10.1038/s41591-019-0534-z ↩