Corporate report

Code on genetic testing and insurance: the government's annual report 2021

Updated 9 February 2022

This was published under the 2019 to 2022 Johnson Conservative government

Introduction

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 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 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 have agreed to publish annual reports to provide commentary on the state of the insurance market and developments in genomic technologies, as well as details on compliance with the Code. A 3-yearly review will allow for the Code to be kept up to date.

This is the government's second annual report under the Code and provides an update on the changes in the genomics policy landscape since the publication of the first annual report in June 2020. It sits alongside the ABI’s annual report which includes information on compliance as well as additional relevant information on the insurance market.

Genomics policy landscape

Perhaps the biggest impact on the UK genomics landscape during the reporting period has been the COVID-19 pandemic. Although many healthcare services have been disrupted due to the effects of the virus, the pandemic has also raised the profile of genomics and highlighted its significant potential in public health, through government-funded initiatives such as the GENOMICC study (looking at factors in patient genomes which could influence the severity of viral infections), and the COVID-19 Genomics UK (COG-UK) consortium, which has sequenced more than 1.9 million SARS-CoV-2 genomes since its inception in March 2020, enabling the identification of viral variants, monitoring of viral transmission and the development of freely available bioinformatics and data sharing tools. The transfer of COG-UK's national sequencing role to the 4 UK public health agencies, in August 2021, serves as further confirmation of the ongoing importance of genomics as a tool for protecting and improving the nation's health.

Despite the disruptions caused by the pandemic, significant breakthroughs continue to be made in improving the diagnosis and treatment of patients through genomics, particularly in the areas of cancer and rare diseases. The sequencing phase of the 100,000 Genomes Project, completed in December 2018, resulted in actionable findings for between 1 in 4 and 1 in 5 rare disease patients, and approximately half of cancer cases. As part of their consent for the project, participants were offered the option to receive additional health information contained in their genome sequence. These ‘additional findings’ are currently in the process of being returned, with all consenting participants expected to receive their results by spring 2022.

The success of the 100,000 Genomes project proved the value of Whole Genome Sequencing (WGS) in clinical care. It also laid the foundations to launch the NHS Genomics Medicines Service (GMS) in 2018, which is now rolling out the world's first WGS service for patients with a suspected rare disease and certain cancers.

Genome UK: the future of healthcare

The government published its 10-year strategy to extend the UK's leadership in genomic healthcare and research in September 2020. Genome UK: the future of healthcare sets out a vision to create the most advanced genomic healthcare system in the world, using the latest scientific advances to deliver better health outcomes at lower cost.

The strategy focuses on 3 main pillars: diagnosis and personalised medicine, prevention, and research; alongside the 5 cross-cutting themes of public engagement, workforce development, supporting industrial growth, maintaining trust and delivering nationally coordinated approaches to data and analytics. The strategy is UK-wide and has support from all 4 administrations of the UK. It recognises that health policy is devolved and that decisions about whether and how to implement specific elements of the strategy will necessarily be made separately by the 4 administrations. These decisions will differ to accommodate the different needs of the populations in the 4 administrations and the structures and systems of the NHS in each administration.

In May 2021, the government published the first of several phased implementation plans, covering the period 2021 to 2022. This first phase plan was focused on implementation in England. Work is underway to ensure that in future implementation plans all parts of the UK will benefit from the Genome UK vision.

Diagnosis and personalised medicine

The government's commitment to incorporate the latest genomics advances into routine healthcare includes the further development of the NHS GMS. Through the GMS, NHS England and Improvement has committed to sequence 500,000 whole genomes by 2023 to 2024, as part of their world-first WGS service for patients. This has the potential to enable faster diagnosis and more effective use of therapies, resulting in increased survival rates and a reduction in adverse drug reactions. Progress to date includes the introduction of rapid whole exome sequencing (a part of the whole genome) in newborn and paediatric intensive care units (in October 2019), and in foetal medicine (October 2020). Additionally, live clinical testing for whole genome sequencing as part of routine care commenced in November 2020 across the NHS.

With genomic testing set to become part of routine clinical care, it is important to note that the Code states that insurance companies cannot require or pressure any applicant to undertake a predictive or diagnostic genetic test in order to obtain insurance.

Prevention

Genome UK highlights 2 key areas in which genomics may be harnessed to enabling predictive and preventative care, namely, the expansion of genomic testing in the screening of newborns, and targeted screening using genomics to improve population health.

The world-first NHS-Galleri trial led by NHS England in partnership with GRAIL, aims to improve early detection of more than 50 types of cancer, using high intensity sequencing of circulating cell-free DNA (cfDNA). The trial, launched in September 2021, aims to recruit 140,000 volunteers to determine how well GRAIL's Galleri™ blood test works in the NHS, with the ultimate goal of improving outcomes through faster diagnosis and earlier intervention. Initial results are expected by 2023.

The Our Future Health programme (formerly the Accelerating Detection of Disease challenge) is also a major focus of this preventative pillar of the strategy. With the goal of recruiting up to 5 million diverse, healthy participants, Our Future Health will provide a resource for research into early detection, next generation diagnostics and smart clinical trials. The programme will be used to evaluate the clinical utility of polygenic risk scores (PRS), which calculate the combined impact of many variations across the genome in order to create an overall risk score. PRS may then be used in the future, in combination with other risk factors, to identify those at higher risk of certain diseases, potentially enabling earlier clinical and lifestyle interventions.

Whole genome sequencing of newborns could significantly increase the diagnoses of genetic conditions, offering the opportunity for early intervention through pre-symptomatic treatment. In July 2021, Genomics England released the findings of a large-scale dialogue, commissioned with the UK National Screening Committee and with support from the government's Sciencewise programme, looking at public attitudes to whole genome sequencing as part of newborn screening. Dialogue participants were broadly supportive of the potential use of WGS for newborn screening, provided that due consideration was given to the design and planning of any use of this technology, that the public was involved, and that appropriate resources, investment and safeguards were in place. These results will be used to support further scoping and decisions on whether whole genome screening should be used for newborns in the future.

Research

When considering genomics research, it should be noted 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. This includes the Galleri and Our Future Health initiatives mentioned above.

The UK has long been at the forefront of translational genomics research. Building on the pioneering work of the UK Biobank (which at 500,000 participants, is now the largest and most intensively genetically and phenotypically described cohort in the world), the government's vision is to create a secure, integrated system of diverse genomic and phenotypic datasets which can be used to drive new genomics research. This in turn will enable earlier interventions, better diagnostics, and innovative therapies for patients from all backgrounds across the UK.

Sequencing of all 500,000 participants was completed on time in December 2021, through work funded by UK Research and Innovation (UKRI)-MRC, Wellcome Trust, Amgen, AstraZeneca, GSK, and Johnson & Johnson. Sequencing data is being made securely available to researchers via the UK Biobank Research Analysis Platform, enabling the study of the impact of genetic variation on disease in unprecedented detail and scale.

To facilitate genomic research within the NHS GMS, the newly established NHS Genomic Medicine Research Collaborative will bring together NHS England and NHS Improvement, Genomics England and the National Institute for Health Research (NIHR) to support academic and industry projects, with insights being rapidly adopted into the NHS.

A core ambition for the future of genomic research will be to address the historic underrepresentation of data from ethnic minority groups in genomic datasets, which without action will lead to further entrenchment of health inequalities. A number of activities will be required to improve the diversity of genomic data, including bespoke sequencing programmes, community engagement activities and development of novel digital tools to analyse diverse genomic datasets.

The UK also continues to drive global genomics research into COVID-19, including research into the genetics of symptom severity, and the identification and tracking of new virus variants. A collaboration between GenOMICC and Genomics England, examining the genetic mechanisms of critical illness in COVID-19, was recently published in the journal Nature, with the findings informing the selection of drugs for inclusion in trials. This work is ongoing, with the goal of analysing whole genome sequences of approximately 20,000 participants severely affected by COVID-19 and comparing these with the whole genome sequences of 15,000 participants mildly affected, to identify genetic factors which may underpin variations in susceptibility. There are also links to research projects focused on 'long COVID' and infections involving vaccinated patients.

A collaboration between Genomics England and COG-UK also aims to secure viral genome sequences generated from viral isolates from GenOMICC participants, with a view to identifying virus and host factors, as well as any potential interplay of these factors, which may alter the host response to infection.

Public engagement and data protection

Since its publication, the Code has been widely disseminated among genetic counsellor professional bodies, key healthcare professionals and organisations, as well as being signposted to participants in the 100,000 Genomes project and Our Future Health. Efforts to raise awareness of the Code will continue as a constant activity.

Despite the fast pace of advances in genomic technologies, it is important that the public feel confident that their data is secure and that it is used to deliver the best possible care. The government's previous annual report on the Code highlighted the findings of a 2019 public dialogue on genomic medicine, commissioned by Genomics England. This report found that despite widespread enthusiasm for its potential applications, participants had clear red lines on the use of data, including the inappropriate use of genetic information for insurance purposes, and questions about how compliance with the Code would be enforced. The government's commitment to annual reports and 3-yearly reviews on the Code assures that these concerns are being considered.

In terms of data protection, Genomics England is currently working to develop a next-generation Trusted Research Environment to provide secure access to genomic and linked data to researchers (subject to patient consent, confidentiality and relevant data protection provisions). The Global Alliance for Genomics and Health (GA4GH), is also working to develop standards and policies for sharing genomic and related health data, as part of a 5-year project funded by the NIHR, MRC and Wellcome Trust.

Direct to consumer testing

With the cost of genetic testing continuing to fall, increasing numbers of tests are being marketed directly to the public. Following an extensive consultation with stakeholders, the House of Commons Science and Technology Select Committee published a report on direct-to-consumer (DTC) genomic testing in June 2021. This report described the benefits and risks of DTC genomic testing, including concerns regarding the future use of genomic data, insurance, and consent, and provided a series of recommendations for government. The government's response to the report was published in November 2021, welcoming many of the Select Committee's recommendations. The response described planned and ongoing work in the area, such as the Medicines and Healthcare Products Regulatory Agency's (MHRA) public consultation on medical devices regulation including in-vitro diagnostic testing – the category which encompasses DTC genomic testing. It is important to note that the provisions of the Code apply both to tests obtained in healthcare settings, as well as those marketed directly to consumers. Therefore, individuals do not have to share the results of any DTC genomic tests with their insurer, unless it is a diagnostic result of a predictive genetic test for Huntington's disease, in applications for life insurance cover which totals over the financial limit of £500,000.

ABI annual report

In tandem with the government's report, the ABI have also published their annual report which includes information on compliance as well as additional relevant information on the insurance market.

Accompanying their report, the ABI have commissioned an independent research report produced by the Cambridge Centre for Health Services Research (CCHSR). This study assessed the potential impact of predictive genetic testing on insurers who provide life, health, and critical illness protection by using 6 groups of exemplar conditions. The study highlighted that assessment of the risk to the insurance industry presented by genetic tests and associated conditions is determined by a complex interplay of factors related to the genetic test itself, engagement with testing, the genetic architecture of the condition, the capacity for reducing risk and the cost of treatment. While an interesting assessment, the study was not designed to determine whether the exemplar conditions, or any other tests and conditions, should be considered as being exempt from the current Code. This evidence, amongst others, will inform the 3-yearly review of the Code which the government has committed to conduct this year.

Conclusion

In all aspects of the Code, the ABI and its members continue to work closely with government and other stakeholder groups to achieve a balanced relationship regarding the fair and transparent use of genetic test results for insurance purposes. It should be noted, however, 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 will be published on the ABI website.

The significant developments in genomic testing, medicine and research over the past year provide exciting opportunities for improving diagnosis, prevention and treatment of disease. However, as these advances do not alter the landscape of predictive testing in the UK for the foreseeable future, they have no direct impact on the terms of the Code, which remain relevant and effective.