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#EAPM: Where is the insurance that will protect your data?

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Genomics is big, big news these days. Not least in relation to big, big data. The two go hand-in-glove to a large extent, writes European Alliance for Personalised Medicine (EAPM) Executive Director Denis Horgan. 

Both are exceptionally useful when it comes to creating better options for patients, whether in the field of rare diseases, cancers and other areas.  But with the expansion of genetic knowledge and fast, modern ‘Next Generation Sequencing’ techniques, moral and ethical aspects are often uppermost in many citizens’ minds.

The EAPM and its broad stakeholder base acknowledge that there are huge moral and ethical questions about collection, storage, sharing and use of these data.   This must be done within robust frameworks that protect the patient but do not frustrate the need for scientists to keep finding new disease cures and better drugs and treatments.

Readers may know that Europe’s medical Ethics Committees came as a direct result of the post-World War Two Nuremberg Trials. In May 1947, during the trials, ten points emerged to define legitimate medical research. These constituted the ‘Nuremberg Code’, which includes principles such as informed consent and absence of coercion, all geared towards endorsing an experimental approach to medicine while protecting the patient.

Modern-day worries include how the likes of, for example, insurance companies could act in a prejudicial manner against someone with, say, a family genetic make-up that could lead to deadly forms of breast cancer or some serious disease. Employers could also act in a prejudicial way with genetic knowledge of an employee, it is often stated.

There are real and present concerns among patients, clinicians and insurance professionals, of that there can be no doubt.  Such possibilities clearly need to be strongly guarded against, but the fact remains that making better use of Big Data in a medical sense will achieve several things, including reducing current inequalities in access to innovative technologies such as the aforementioned genetics.  Surveys strongly suggest that most patients are happy to share their data for certain types of research – as long as trust is there.

But while Big Data is vital in pushing back the boundaries of medical research, there have been - and still are - many barriers to its optimum and ethical use.  Current research infrastructure remains too compartmentalized, which adds cost and slows down the speed of new discoveries. This can partly, but not wholly, be blamed on proprietary technology but there is also a clear need for greater interoperability, within and between EU member states.

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The European Commission and individual health ministers across the EU can be hugely influential in this regard.  To make the most of all this massive amount of valuable information flowing into super computers and biobanks there needs to be a shared vocabulary and data-set standards, with agreed universal protocols for sending, receiving, and querying the information.

Meanwhile, data storage formats need to be interoperable although, granted, this may prove difficult in a competitive environment such as commercially based pharmaceutical research.

All of this information needs to be interpreted properly too, not least by clinicians working on the front line.  In essence, there is clearly a need to build a health data ecosystem, as shown by mounting evidence that better use of data leads to greater efficiency (and thus lower costs) within member state health systems.

Recent estimates have suggested that there will be five million genomes sequenced worldwide by the year 2020. These will have been sequenced primarily for research but will include a growing use of genomic sequencing and testing by healthcare providers or individuals.

Unfortunately for the advancement of medicine, the concerns mentioned above may cause some patients to avoid genome sequencing, not least because of the ensuing stress that could occur if they felt obliged to share negative hereditary test results with a sibling, child or life-partner.

The modern debate around genetic discrimination came under the microscope in the wake of the international Human Genome Project, which took place in the late 1990s. This brought to the fore concerns about the discriminatory use of genetic information, as mentioned above.  For example, in the UK in 2007, the Government’s disability law review looked at the possibility of legislating to protect against discrimination on genetic grounds. However, the Equality Bill consultation response concluded the following year that, ‘on balance’, there was little evidence to show that discrimination was occurring in these cases.

Part of the conclusion stated that: “Should legislation appear necessary in the future, it may be more appropriate to strengthen data protection legislation or make specific rules as to what can be done with genetic information in this respect.”  And lo-and-behold we now have the EU’s General Data Protection Regulation about to enter into force. A major reason for this is to protect citizens against unethical and/or unauthorized exploitation of their data.

Meanwhile, a non-binding Council of Europe Recommendation set out seven principles based on its own conventions on biomedicine and data processing.

These exist to balance the interests of patients and their families with an insurers’ statutory duties and run as follows, stating that insurers:
• Should justify the processing of health-related personal data • should not process [data] without consent;
• should have adequate safeguards for storage of [data];
• should not require genetic tests for insurance purposes, and;
• should take account of new scientific findings.

Meanwhile, EU member states:
• Should facilitate risks coverage that is socially important, and;
• should ensure adequate mediation, consultation and monitoring.

Thus far, evidence suggests that the insurance industry is managing to self-regulate but, as data grows ever bigger and bigger, this is clearly a vital area that needs constant monitoring while, at the same time, the use of genomic data for medical research must be allowed to continue unabated.

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EU Reporter publishes articles from a variety of outside sources which express a wide range of viewpoints. The positions taken in these articles are not necessarily those of EU Reporter.

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