Genomics and mapping potential legal implications ahead

Early March 2019 marked the second annual #GenomicsConversation Week, the Genomics Education Programme’s annual week of action for all health professionals. The goal of this NHS initiative is to encourage conversation and awareness among all health professionals and to help them feel more comfortable discussing genomic testing with patients.

The UK is recognised worldwide as a leader in genomics and the government is keen to ensure this continues.

In June 2018, the Prime Minister highlighted:

The opportunity to lead the world in the use of data and technology to prevent illness, not just treat it; to diagnose conditions before symptoms occur, and to deliver personalised treatment informed not just by general understanding of disease but by your own data including your genetic make-up.

What is genomics?

Put simply, a genome provides the blueprint for everything that happens in our bodies. Within almost every healthy cell in the body, there is a complete set of genes and together with the DNA between them, this is known as a genome.

• Genomics identifies and analyses variations in the DNA.
• When a cell replicates itself e.g. when a new protein needs to be produced or to replace dying cells in a tissue or organ, parts of the chromosome open to expose the required genetic information.
• During this process, malfunctions can lead to errors or variations in newly created proteins. This can result in chronic diseases such as cancer.

What benefits can genomics bring?

Genomics provides clinicians with more information than ever before to enable personalised interventions bespoke to a patient’s unique biochemical needs.

In 2012, the 100,000 Genomes Project was launched to sequence 100,000 genomes (a goal which was met in December 2018), with a focus on patients with a rare disease, their families and patients with cancer. The aim being to set up a genomic medicine service for the NHS.

Genomics England (set up by government to deliver the Genomes Project) describe the potential of genomics as “huge, leading to more precise diagnostics for earlier diagnosis, new medical devices, faster clinical trials, new drugs and treatments and potentially, in time, new cures”.

Some examples of the potential use of genomics are:

• Intervening with predispositions to certain diseases
• Increasing successful treatment of cancer patients via more accurate and earlier diagnosis and more effective use of therapies
• Enabling a quicker diagnosis for patients with a rare disease
• Assisting with informed prescriptions - matching a patient to the most effective medications (pharmacogenomics)
• Reducing the likelihood of an adverse drug reaction.

Product liability and other potential legal, ethical and social implications

As with all advancements, developments in genomics brings potential legal implications.

US case law provides an indication of the types of issues that may fall to be considered in the UK:

• In 2008 the Vaccine Court rejected a genetic predisposition as a superseding cause of vaccine-related injuries, but only “[s]o long as the [product] was a substantial factor”, essentially providing an updated ‘eggshell’ claimant rule i.e. to take your victim as you find them.
• In 2011, a plaintiff made allegations about pharmacogenomically based risks, claiming that her variant gene (CYP) could not metabolise the defendant’s drug as well as most other people. The allegation was not that the drug was defective, because of anything inherent in the drug itself, but because it was less effective due to the plaintiff’s peculiar genetic makeup.

However, such genetic variation claims are currently not considered legitimate product liability claims, since a plaintiff is not asserting the drug caused any injury that would not have happened in any event.

Furthermore, until the Food and Drug Administration decides to assess drug approvals and contraindications on the basis of genetic subgrouping, such a claim is not likely to be recognised in law.

US bloggers are also predicting the use of genomics to detect gene mutations to identify persons at greater risk of idiopathic mesothelioma (i.e. not related to asbestos). This could be a potential game changer for asbestos litigation, if indeed a verifiable alternative cause to the claimant’s mesothelioma can be proven.

Thus, as genomics continues to develop, one’s genetic make-up may be argued as an alternative or contributory cause in future litigation.

Knowledge of a person’s genetic make-up has also prompted fears of potential discrimination by employers and health and life insurers.

It must also be noted that genomics necessitates the requirement for ethical standards and also a consideration of social, cultural and religious perspectives on genetics and health.

The insurer perspective

A voluntary code of practice – The Code on Genetic Testing and Insurance (the Code) - is in place between the government and the Association of British Insurers (ABI) on the role of genetic testing (diagnostic and predictive) in insurance.

Within the Code it is recognised by both the government and ABI that “people should not be discouraged from accessing its benefits because of concerns this might compromise their ability to access insurance cover.”

The Code only concerns “genetic test results that are predictive of future ill health” and limits the types of insurance to which such test results may be relevant.

As the genomics landscape develops further and testing becomes increasingly prevalent, relevant product liability and anti-discrimination laws as well as the Code itself will no-doubt need to be reviewed and revisited accordingly. Either way, this exciting area of medical practice will continue to place the UK at the forefront of both innovative and personalised medical diagnosis and treatment.

Read other items in Healthcare Brief - June 2019