G(e)nomes and trolls – DNA sequencing and risk

2017 was intended to be a landmark year for the development of ‘genomic services’ – a term coined by the Department for Health in 2012 when it launched the Genomes project. Whilst this year’s initial deadline has passed and been pushed back to 2018, all signs are still pointing towards DNA sequencing being the next big revolution in healthcare advances, with the intention of sequencing 100,000 genomes from NHS patients.

In the early noughties, scientists were hard at work developing the publication of the first complete genome in an effort to provide a DNA bible by which future medicine would abide. However, in 2017 DNA sequencing is now making itself uncompromisingly known in the daily lives of healthcare practitioners in some of the most important fields of treatment.

It’s often hard to anticipate how quickly society will make the bridge between science fiction and mainstream medical practice. However, this medical revolution is creating a sprawling mass of new data with which to develop treatments for previously untouchable diseases. Big corporates such as Philips and IBM are fast investing in research and the production of a complete DNA sequence can now be achieved in little under a day, at a cost that is dropping rapidly. It is soon projected to cost a mere $100 for this process. But, as well as representing a fundamental step-shift in treatment science, there are of course associated risks.

Medical insurers are rightly doing their due diligence for current and future policy. Interestingly, while insurers might have once been predominantly concerned with issues of negligence and malpractice in treatment, the threat profile is following general insurance practice and moving in the direction of the IT department. However, it is for this reason that questions begin to arise as to questions of ownership where data is concerned. Is our genetic information ‘property’?

This then raises further questions such as who owns it and what rights does the owner have over it? One of the co-discoverers of the BRCA1 and BRCA2 genes (that signal an increased risk of developing breast cancer) sought to patent its discovery in the US.  A US court held that the genetic information already existed in nature and that naturally occurring compositions are (at least in the US) incapable of being patented.  Elsewhere in the world though, companies have been able to patent naturally occurring genetic information.

Since the usual aim of obtaining a patent is to allow an invention to be maximised for commercial gain, this raises the spectre of the testing and treatment for certain genetic conditions being available only to those with deep enough pockets.

In the UK, our genetic data satisfies the definition of sensitive personal data within the Data Protection Act 1998, consisting of information regarding our “physical or mental health”. Such data must be held and processed within the strict provisions of the Act, in recognition of its value and sensitivity and the potential for it to be exploited.  For example, how would we feel about the idea of an employer, or an insurer, having access to our genetic data?  This then lays open the opportunity for decision making that is potentially discriminatory on genetic grounds – not necessarily for what is, but for what might be.

The uses to which our genetic data might be put are many and varied.  There is huge potential for medical advancement, such as bespoke cancer treatments and also the risk of significant harm.  In 2013, the US Food and Drug Administration determined that a particular genotyping test was intended for the “diagnosis of disease…or in the cure, mitigation, treatment or prevention of disease” and warned of the potential consequences of false positive or false negative results.

Worse still is the prospect of our genetic data falling into the ‘wrong hands’. A biological data breach is much more invasive than someone stealing your bank details – your biological passport can’t be restored and once it’s out there, your entire genetic make up is available to the highest bidder. As it becomes increasingly easier and cheaper to get hold of the data, obvious questions arise – how is my genetic data held?  How securely, by whom and to what end?

The raw data from one genome alone amounts to around 200GB, with every genome offering millions of variants from a reference model. The data generated by the NHS Genomes project alone is therefore significant in itself, and all of it needs to be protected from those wanting to exploit it for the wrong reasons.

It is not only the data itself that is pointing out new and inevitable risk, but also how it is analysed. The huge numbers of DNA combinations inevitably require the assistance of artificial intelligence. This then opens up another door to cyber risk and extends the product liability chain beyond medical practitioners and manufacturers.

The potential for DNA Sequencing, both positive and negative, is clearly huge and it is very likely to pave the way towards significant and ground breaking medical advancements over the not too distant future.  With the costs involved falling rapidly as technology advances, it’s not hard to see this very quickly becoming an industry in itself. And as with any industry, insurers will need to be prepared.


mcewen_g-21_web Written by Greg McEwen, partner at BLM

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