by Denis Horgan, Executive Director, European Alliance for Personalised Medicine

The message to MEPs from the health sector is clear: Do not impose an opt-in on genomic data if you value the health of EU populations, patients and healthcare systems, and if you really want Europe to be a home for innovative approaches to care.

The impending European Parliament committee vote on the proposal for a European Health Data Space presents MEPs with a real choice on whether to advance citizens’ access to better healthcare, or to frustrate it.

Sharing of data – the essence of the EHDS proposal – is correctly regarded as a benefit, for patients, for the wider population, for health systems, and for research and innovation. It is at the heart of the draft legislation.

The need for careful safeguards is also widely recognised. But here is where MEPs should reflect on what sort of safeguards are appropriate. Because of the far-reaching consequences of the way this legislation is framed, a truly patient-centric focus is urgently needed in the upcoming vote on the specific provisions relating to genomic data.

Concerns among some MEPs about confidentiality are causing them to favour very restrictive conditions on this category of data. But if, as some amendments urge, secondary use of genomic data is only to be allowed where individuals have specifically and deliberately opted in to authorise this, invaluable information risks being discarded, immediately, and in the future. Early detection and diagnosis, which is what genomic data can offer, have an unparalleled contribution to make in permitting timely and appropriate treatment, in boosting survival and in reducing morbidity - with consequent positive impacts on the overall burden on healthcare budgets and economic activity.

The requirement to opt in will limit the collection and utilisation of genomic data, and consequently will harm rather than protect the interests of patients and the population. It threatens to create barriers to innovation that could postpone indefinitely many significant advances. This is why the majority of the member states, as well as the patient, scientific, medical and innovators communities, have already made clear their view that an opt-in system would be counterproductive to the intentions of the legislation.

Unhappy lessons from the past

There is a growing awareness in Europe that insufficiently considered legislation in the health field over recent years has already generated unnecessary barriers to care. Regulations on crucial areas including clinical trials, data protection and diagnostics have been adopted without taking into consideration all their implications, and have accordingly introduced confusion and conflicts into the operating framework for the European health sector. The lack of a strategy-by-design horizontal approach in assessing the interplay of related legislation has had a negative impact on patient lives and on the ability to foster innovation in Europe. Inconsistencies, ambiguities or oversights have repeatedly caused delays in implementation, deferrals of deadlines, and problems in practice that have even required corrective legislation.

The use of genomic data is similarly in jeopardy with this vote. This is what is at risk from imposing an opt-in requirement to permit genomic data use. The risks from opt-in systems, for all their apparent merits, is that so few people take the trouble to opt in that the systems envisaged fail to perform adequately. The German organ transplant system, in which the default was donation permission at death, except when individuals opted out, functioned well until the system switched to an opt-in – at which point the shortage of organs became acute. There was analogous hesitancy 20 years ago at the prospect of a cross-border exchange of forensic DNA data, but the system has long proved its worth and its ethical legitimacy is unquestioned.

One of the arguments advanced in support of the restrictions implicit in an opt-in system is that leakage of personal genomic data might result in discrimination against individuals who had, or have, or might have some medical condition. But it is not an opt-in system that would be the cause of that, and already the EU has provided a wealth of legal instruments to sanction any discrimination based on such grounds. To guard against that eventuality by voiding EHDS of much of its value is in effect to undermine public confidence in EU institutions, since it is tantamount to saying that they cannot be the guarantor of the data and the reliable gatekeeper of trust.  In a vigorous democracy, the way ahead is to strengthen and empower its institutions, not to legislate in a way that openly questions their efficacy. Nor is the argument that potential deliberate misuse of the data justifies tight restrictions – since the criminal law offers recourse against that as it does against other malign acts. MEPs should rather demand better or more functional safeguards, and even sanctions for misuse, than a system of opt-in that will not work, nor benefit patients, nor innovators.

A straight choice

MEPs should consider, before they vote, just what they intend to achieve by imposing an opt-in system. It is the time for a considered decision based on the longer term consequences of the choice, and not the time for a rash and simplistic option. The message is simple. Do not impose an opt-in on genomic data if you value the health of EU populations, patients and healthcare systems, and if you really want Europe to be a home for innovative approaches to care.