It’s time for an EU-led ‘Joint Action’ on health data

By European Alliance for Personalised Medicine (EAPM) Executive Director Denis Horgan

One of the largest ever planned collections and storage of personal data is currently underway in the United States of America. Back in January, US President Barack Obama launched his Precision Medicine Initiative, or PMI, in his State of the Union Address, stating that the idea was to “bring us closer to curing diseases like cancer and diabetes, and to give all of us access to the personalised information we need to keep ourselves and our families healthier”.

PMI will have as its foundation a precision medicine database that aims, initially, to hold records of one million human subjects.

Generally called ‘personalised medicine’ in Europe, this is a fast-moving field that sees treatments and drugs tailored to a patient’s genes, as well as his or her environment and lifestyle. It relies on DNA sequencing and other new technologies and aims to give the right treatment to the right patient at the right time. It can also work in a preventative sense.

The science and the philosophy are the walls and the roof, but the foundation stones on which the personalised medicine edifice is being built are data. Big Data. This data will, when used properly, ultimately allow patients access to the best treatments available.

For example, the adoption of electronic medical records on a large scale has the potential to generate a great deal of meaningful data via, for instance, patient-reported outcomes. Such data can be used to track the patient’s progress after treatment while monitoring him or her during follow-up. The information can then be used to help other patients decide on a course of treatment, based on their own idea of ‘value’.

But the collection, storage and sharing of such data - vital for research purposes - is fraught with difficulties: interoperability problems, classification issues, a need for tight quality control and more. Add to this the not-insignificant issues of ownership and protecting the privacy of individuals and it is not difficult to see why the explosion in data brings with it specific problems.

For example, back in the US, the Food and Drug Administration has agreed to review a new ‘digital pill’ that will let third parties check patients’ adherence to their medicine regime. It includes a sensor and transmitter that can send a signal to those registered to receive it.

It’s a bit of a stretch but it’s theoretically possible that, using such a pill, your doctor, pharmacist, health insurance company or even your boss would know whether you were taking your medication properly. Would you want them to know that the medicine is, for example, treating you for HIV-related conditions, irritable bowel syndrome, incontinence or clinical depression? Probably not…

So, we have the medical ‘value’ of advancement but it must be weighed, most importantly, against the patient’s idea of ‘value’. He or she should decide when such encroachments on privacy are worth it.

Of course, it will not only be the United States that will have to deal with this and other issues. The EU has a bigger population than the US and also has need of Big Data in the arena of health, especially given the aging population and a potential 500 million patients across 28 member states.

In the ‘Capital of Europe’, the Brussels-based, multistakeholder organization EAPM (the European Alliance for Personalised Medicine) has for some time included within its range of Working Groups a Health Data Task Force.

The Alliance believes that the European Commissioner for Health and DG Connect should bring forward their own proposal for a multi-stakeholder platform to oversee the implementation of the General Data Protection Regulation. This follows the commission’s own communication calling for: ‘A comprehensive approach on personal data protection in the European Union.’

EAPM believes that such an approach should take the form of an official Joint Action on Data with contributions from all stakeholders. This would be a valuable resource for the European Commission in these fast-changing times.

Why? Well, the improved use of health-related data can transform both our healthcare systems and the lives of patients. However, there is also legal uncertainty and a widespread public perception that there are significant risks associated with the sharing of health research.

The Alliance believes that Europe needs a responsive system of regulation that offers high levels of protection for individuals and high-quality data access for researchers and health-care providers.

Back in the US, Obama’s PMI will follow health outcomes over many years, identifying biomarkers predictive of the development of many diseases and bringing new opportunities for prevention and therapy.

As in Europe, PMI will undoubtedly need to draw upon diverse talents via a multi-stakeholder approach taking expertise from academia, industry, health-care organizations, government, policymakers and, of course, patient groups. It will also need a long-term budget commitment in order to succeed.

Data protection is a fundamental and growing issue. EAPM’s taskforce believes that the next steps in improving European healthcare are critically dependent on the use of data. This requires an eco-system in which data can be accessed in a secure and efficient way for appropriate purposes.

The time to move on this is now.

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