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An innovative approach to collaboration will mean healthier small member states

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

When it comes to access for patients to clinical trials, cross-border treatment and generally the best care that personalised medicine can provide today in Europe, it is fair to say that there are plenty of disparities and inequalities.

This is never more true than when it comes to smaller member states (and, very often, regions within larger ones). Smaller countries with lower GDPs tend to be more vulnerable to imbalances in access to the best health care and, in isolated regions, many citizens find it difficult to hear about clinical trials or, even if they do, access them. Meanwhile, patients in the less well-off countries often suffer inequalities in the reimbursement of, and yet again access to, cross-border health care.

The right of patients to such cross-border treatment – paid for by the home state that either cannot or will not provide it - has been enshrined in the EU Treaties for 20 years, but the reality is that one size does not fit all in an EU of 28 member states and 500 million people.

Costs of treatment and reimbursement levels differ from nation to nation, as does information about new treatments and clinical trials – hence the substantial inequalities mentioned earlier.

In 2015, the rotating presidency of the European Union will see two of the EU’s smaller states take the helm. On 1 January, Latvia will assume the presidency and will be succeeded in the role by Luxembourg on 1 July.

Prior to the 2004 enlargement ‘big bang’, when ten new states joined the EU, smaller countries had to accept an acquis communautaire that often failed to take into account their individual aspects and characteristics. Latterly, however, smaller states have been active in shaping health policy at European level, in no small part because they rely heavily on co-operation, networking and capacity building – something that larger states could certainly learn from.

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The EU’s smaller states tend to suffer from a lack of interest by industry to place medical goods on their markets, a lack of competition between providers as well as the administrative burden of regulation which does little to help patient access and lower prices in these countries.

A key goal of proponents of personalised medicine is to improve access to this innovative, exciting and growing form of health care. But trying to deliver the right treatment to the right patient at the right time is not easy, because, as stated above, there are many barriers standing in the way.

In its ongoing Specialised Treatment for Europe’s Patients campaign, known as STEPs, the European Alliance for Personalised Medicine (EAPM) recognises that Europe needs an environment which allows early patient access to novel and efficacious personalised medicine, and a new form of clinical trials that addresses new discoveries of rarer diseases, smaller patient groups and the geographical spread of these patients.

Moving personalised medicine into its next phase will depend on complex international clinical research involving highly selected patient populations, the collection of biological material and the use of large databases for bioinformatics.

Europe needs a different form of data generation, and the classical approach to clinical trials cannot capture those data adequately. Today, subgroups of patients – across all member states but especially in the smaller ones – need to have their biomarkers validated within larger, spread-out ‘populations’, thus scientific advances in diagnostic refinement and stratification have to be incorporated into trials.

What Europe needs to achieve this is greater innovation, forward thinking and collaboration from all partners - industry and academia, statisticians, clinicians and patients, but also regulators.

Many hurdles must be overcome in order to bring about the proper implementation of personalised medicine into a sustainable EU health strategy. Only by identifying and acknowledging barriers to fair and equal access – especially in small countries and regionscan Europe hope to overcome them.

This needs to happen sooner rather than later in order to speed up the journey towards a better form of health care for all of Europe’s citizens, whether they live in a larger or smaller country, or a richer or poorer one.

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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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