Ethical issues in clinical genomic data sharing

Tom Finnegan

28 October 2014

Improved access to patient data from NHS genetics laboratories can facilitate better medical care, as we discussed in our recent briefing note Sharing clinical genomic data for better diagnosis. However, widening access to patient data also raises ethical issues, especially when that data goes outside the NHS.

The value of data sharing

Determining the genetic cause of a patient’s disease requires knowledge about possible pathogenic mutations. It is therefore important for clinicians and scientists to access existing information about known genetic variants and associated clinical characteristics relevant to their patient’s disorder for comparison with the patient’s genome. To realise the benefits of genomic medicine in the NHS, increased data sharing between NHS genetics laboratories (currently far from routine) is essential.

Ethical issues in data sharing

The use of data, especially health-related data, for purposes for which they were not originally collected is the subject of debate. The debate is often characterised as a balancing of the interests of the individual (such as their autonomy) against other interests (such as population health, private profit or the autonomy of other people). 

The sharing of patient data between NHS laboratories for the purposes of improved diagnosis and care within the NHS is arguably relatively uncontentious – provided the system is adequately secured and authorised access to the data is restricted to those who genuinely need it. This is by no means guaranteed – ‘secured’ is a term open to an unfortunate amount of interpretation, and restricting data access in huge organisations like the NHS is notoriously difficult. 

However, the principle of securely sharing personal information within the NHS to improve care is not intrinsically problematic. Those who see individual autonomy as an absolute will object to any use of their data that they have not explicitly authorised, and may see any privacy violation as a harm in itself regardless of whether any ‘actual’ harm resulted. Nevertheless, the determination of which interests outweigh others and in what circumstances is, at least in practice, a societal decision. 

Balancing the benefits

This is a key challenge facing society today: how much privacy is it worth sacrificing for what products and services? At heart, it is a trade-off, though a significant problem is how rarely the existence and nature of the trade-off is made explicitly and honestly at societal and individual levels. It is a matter for empirical research whether it would be acceptable to most patients that the sharing of patient data between NHS laboratories be mandated. 

It is likely to be far more controversial to allow access to this kind of data by third parties outside of the NHS, especially profit-oriented organisations. The main concern here is not simply access to patient data without patient consent – or even that a quantifiable harm might result, important as these things are. Instead, the problem is the idea that the perceived value (whether personal or societal) of the access is not sufficient. Patients might decide there is insufficient value to themselves or to society in allowing access by, for example, a non-commercial research entity outside the NHS (such as a foreign university) – the outcome of the research is a non-specific, future benefit. Access by a private, profit-motived organisation (such as to develop pharmaceuticals) might be objected to on the basis that the company is being enriched by data collected from people who do not derive any direct benefit.

There is an argument that patient data is so intrinsic to scientific and medical progress that we, as a society, have an obligation to allow wider access if we wish to continue reaping the benefits of advanced medical technology. This is quite compelling when applied to non-profit research organisations because the benefits (the research findings) are more likely, but not guaranteed, to be publicly available. 

The problem of profit

This argument is far less compelling when applied to profit-making organisations, unless a fair price is paid by those organisations for access to those data. Unless such a price is paid either to the individual (unlikely, given the extreme complexity of doing so) or to society (the NHS or the government?), it is likely to be difficult to demonstrate sufficient reciprocity – profit-making organisations do provide benefit to society through the development of their products and services, but these are provided at a price. The patient data are a resource used to help develop those products and services. Consequently, a key question for policy-makers is whether the value of those data to the profit-making organisation is properly reflected in the cost of accessing them? And what should be the nature of that cost: a flat fee; a proportion of profits; easier and cheaper access to products developed using those data?

Wider access to patient data can be a very good thing, but it is not an unalloyed good. There are always contending interests to balance and for continuing, ethical, medical progress to be made there must be greater transparency in how and why these interests can and should be balanced. Determining what is appropriate access to personal data is one of the defining societal challenges of our time, and patient data is no exception.  

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