Juncker’s subsidiarity goals must take health into account

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

With the new European Commission now in place, led by Jean-Claude Juncker, it has been stated already that the principle of subsidiarity will be a cornerstone of this administration.

Subsidiarity – meaning, in this case, that the EU will only perform those tasks which cannot be performed at a more local level – is nothing new, of course, and has been a tenet of the European Union for some years, being widely welcomed.

In his recent statement to the European Parliament, Juncker said: “My agenda will focus on ten policy areas. My emphasis will be on concrete results in these ten areas. Beyond that, I will leave other policy areas to the member states where they are more legitimate and better equipped to give effective policy responses at national, regional or local level.”

“I want a European Union that is bigger and more ambitious on big things, and smaller and more modest on small things,” the Commission president added.

He went on to say that: “Not every problem that exists in Europe is a problem for the European Union. We must take care of the big issues.”

The European Alliance for Personalised Medicine (EAPM) would argue that health is among the biggest issues facing the EU today and into the forseeable future – and that subsidiarity, by itself, has failed to address many health issues arising down the years.

These have included, and still include, inequalities in access to a high standard of treatment for patients in different countries and regions, as well as similar issues affecting citizens’ abilty to take part in clinical trials.

It is absolutely clear that individual countries cannot tackle the enormous health problems thrown up by an ageing population individually. There are too many differences in resources per member state (and regions), differing population sizes, access issues and often huge differences in the standards of health care available. On a positive note, these wide variations in terms of cost and outcomes in health offer hope for substantial efficiency gains.

It is interesting to note that, despite the subsidiarity principles, Europe’s courts have intervened in areas such as determining the right to cross-border health care for all citizens. Such rulings have had the effect of side-stepping a lack of legal competence over health that the EU enjoys elsewhere. In short, there has been a growing influence over the years from the ECJ and other European courts.

Meanwhile, there has been a large amount of change and influence brought about by the impact of guidelines and recommendations in various arenas. With regard to health, these have led to a great deal of self regulation by medical societies and other organisations. In health research, for example, we have seen many instances of self governance in areas covering such issues as the sharing of data and the ongoing exchange of best practice.

The above does not break the subsidiarity rule, nor do pan-EU regulations such as those affecting in vitro diagnostics (IVDs), public health and the internal market. These regulations have undoubtedly made Europe a safer and better place for its citizens and could be taken as an argument for more EU, rather than less.

Regarding IVDs, the current Medical Devices Directives were adopted under Treaty laws covering the establishment and functioning of the internal market. These have been complemented by laws that set high standards for the quality and safety of devices for medical use.

Rules such as these, protecting public health across all member states, can only be employed at European Union level. This stops individual states from adopting different product regulations which would fragment the internal market and the knock-on health benefits to EU citizens are clear.

Such rules alsu allow manufacturers to reduce costs related to national regulatory differences, while ensuring a high and equal level of safety throughout member states. Subsidiarity alone, in these instances, would not do this.

Generally speaking, the EU has always had a patchwork of health care systems but, as a result of the financial crisis, a shift has been occuring that affects – in a surprisingly direct manner - these systems and other issues.

To ensure that EU countries reach their Europe 2020 targets, the Commission has set up a yearly cycle of economic policy coordination called the European Semester. Every year, now, the Commission gives recommendations on member states’ programmes of economic and structural reforms for the next year.

European countries’ large health care expenditures mean that individual health care systems are more than likely targets for such reforms. So the EU’s influence is clearly growing when it comes to the costs and sustainability of its member states’ health systems..

On top of this, as part of the financial crisis bailouts involving Ireland, Greece and Portugal, these countries had to agree economic adjustment programmes, including detailed changes to their health systems. Bailouts aside, all EU countries are under great pressure to ensure cost effectiveness of their health systems. The times they are a-changing…

The EU cannot regulate everything, nor should it. But EAPM believes that for subsidiarity to work in an arena as diverse, complex and important as health, it is vital that there is much more cooperation between member states, cross-border alliances, interaction between disciplines and more. This is a prerequisite if we are to create a broad and effective ‘virtual EU health system’ that satisfies the needs of all 500 million citizens across Europe.

In the end, much as it is to be welcomed, subsidiarity does not come without its issues – especially in a 28-Member State union, and especially in huge areas such as health. Finding the right balance is key, and inter-state cooperation at national level, where EU law does not and perhaps will not exist, is vital.

Throughout 2015, with its ongoing STEPs campaign and many other initiatives, EAPM will continue its drive to help deliver the best standards of health care to all citizens of the EU, now and for generations to come.

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