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PICT1963By Anastassia Negrouk, Head of International Regulatory and Intergroup Office, EORTC, Chair of Liên minh châu Âu cho Cá nhân Y học (EAPM) Working Group on Regulatory Affairs, Magdda Chlebus, Director Science Policy, Denis Horgan, EAPM Executive Director.

One of the basic tenets of the European Union is equality. In a multi-cultural union of 28 states with 500 million citizens, that equality is a challenge in any EU policy area, but in healthcare it’s arguably the greatest challenge of all.

Not only are there disparities in wealth between individuals and, of course, whole countries, but there are also differences in the standards of healthcare systems and treatment across the member states.

Europe has an aging population and, at any one time, millions are ill to some degree or another. The difficulty is that the EU ideal of equality has not been achieved when it comes to patients gaining access to existing best treatments, or even advice, equally across the Union.

In addition, scientific advances continue, leading to better treatments and medicines (especially in cancer and rare diseases) being developed all the time. With the advances in genomic science, personalised medicine and individually targeted treatments for rare cancers, there has never been a better opportunity to improve patient outcomes across the EU as a whole.

Well, one would think so. But as these treatments progress from bench to bedside we see a long, laborious approval and reimbursement process in Europe.

A necessary part of this process involves clinical trials. But because new, targeted medicines are by definition designed for smaller groups, those suffering from a particular disease can be spread across many countries depending on the disease incidence rate. Because of this smaller concentration, patients not living near a major city or teaching hospital are often unaware of, or cannot get access to, a potential breakthrough treatment being tested in a clinical trial. Yet these are the very people who would be most aided, and potentially gain the greatest benefit, from any trials set up to address their particular condition.

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While the current application of clinical trials is certainly a challenge, it is only one of the bottlenecks. Other healthcare challenges include the debate over a patient’s right to own and access his or her medical data; the expense of cross-border treatment; and a lack of standardized, equal, and fair reimbursement when they do have to travel for treatment.

The EU also lacks a clear line of communication from doctors through to patients that would allow the latter to actively participate in decisions regarding their own health.

A complicating factor is that many medical practitioners are often unaware of a new treatment when it becomes available. Additionally, if and when they are aware, they often lack the proper ongoing training to make the best use of the new technology.

There are myriad problems that need to be overcome. If the EU is to achieve its stated goal of equality in healthcare for all citizens, then the time to act is now.

A new Parliament has been elected and a new Commission will soon be named. These newly placed politicians will have a five-year mandate, but they must plan much further into the future than that.

An ever increasing number of patient groups and individual citizens are becoming aware personalised medicine’s ability to give them the right treatment at the right time. Personalised medicine is a cost-effective way of treating patients in that, in many cases, ir allows patients to carry on working while undergoing treatment. This frees up expensive hospital beds and clinicians.

The new Parliament and Commission need to look to the future, but not just from a financial perspective. The EU has a moral and ethical duty to put patients at the heart of health care by creating frameworks for research and development to thrive, thus making it easier to access clinical trials as well as take advantage of cross-border care.

The EU also has a duty to tackle and solve the current uncertainties surrounding Big Data’s ownership and effective use.

Only by taking a moral and ethical stance alongside the ever-present fiscal considerations can the EU ever hope to reach the Holy Grail of equal healthcare for all, at the highest standards possible.

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