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Regulatory Dark Horse? EU Directive o...
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May
20
ragupathyrenganathan
Regulatory Dark Horse? EU Directive on Cross-Border Patients’ Rights – Courtesy (pharmaexec.com)
Pharma News, Regulatory Affairs
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The European Union’s directive on patients’ rights in cross-border healthcare was seen as a bit of a damp squib when it was first adopted, but its importance is now coming into view, writes Reflector.

It is always agreeable when buds burst — even a little bit late — into flower, and this spring there are at last some real signs of vigour in the European Union’s directive on patients’ rights in cross-border healthcare. This measure was seen as a bit of a damp squib when it was adopted in 2011. Even at the time, the European Commission — which had proposed it  — admitted that very few EU citizens would be likely to travel to other member states to seek care. But the directive was in reality more of a bombe surprise, designed to tick away quietly for years while some of the obscure processes that it had set in motion were coming to fruition.

Those more discreet elements of the directive are now starting to reveal what the Commission really had in mind when it went to such lengths for a handful of cross-border patients. Most conspicuous is the prominence now being enjoyed by health technology assessment (HTA), which had no legal basis until the cross-border care directive gave it one. Now it is one of the hottest topics in town. But reference networks to focus research and treatment for rare or highly specialized diseases is another esoteric component of the directive that is also finding its feet. And e-health, that longstanding mantra waved by every healthcare futurist for the last decade and more, was also homeless in the EU until the directive officially conferred powers on the EU to do something with it. On all of these, more shortly. But first, a word from, as it were, our sponsors.

Patients’ views

The clue to the ostensible beneficiaries of the directive is in its title — “patients’ rights”. Eurobarometer, the EU’s polling service, has now come up with a report on how the directive has been working since it came into effect in 2013, from the point of view not of economists or specialists or technologists, but of patients. The first conclusion the survey draws is a genuine non-surprise: only a few Europeans have experienced medical treatment abroad in the last year (just 5%). And of these, only a minority had actually planned to do so. More of a surprise is the finding that most people who had treatment in another EU country confirmed they had had no problems getting reimbursed — since only recently, a Romanian patient had a high-profile fight all the way up to the European Court of Justice to get her money back after being treated in Germany.

Patients seem to be opening up to the idea of cross-border care too, according to the poll. Half of the cross-border patients surveyed said they would be willing to do it again, and half of everyone polled showed some willingness to get medical treatment in another EU country.  The main reasons for seeking treatment abroad were because a treatment was not available at home, or was felt to be of less quality, and — again perhaps no surprise — it was people from smaller countries who were most disposed to travel for treatment. But in most cases, there would have to be some serious pathology as a prompt, such as cancer treatment or heart surgery.

Longer-term beneficiaries

The survey also confirms that 95% of the population of Europe is probably getting nothing out of the directive. Not yet, anyway. But they could in time become beneficiaries of some of the other developments, the dark horses of HTA, e-health and reference networks that are now coming up on the inside track.

HTA is now at a crucial point between pilot and practice. The directive set objectives of supporting cooperation between national authorities or bodies in providing objective and transferable information on the relative efficacy and effectiveness of health technologies and to avoid duplication of assessments. The key word here is “transferable”: the EU approach was that this is only valuable if it promotes sharing. And if it doesn’t, the funding for it will dry up. So this spring the HTA community is leaping into a new world of cooperation. It has been developing joint assessments, but it hasn’t been using them. Now it has to move on to the next phase of actually bringing these joint assessments into national practice. The HTA network, made up of national HTA bodies, has just agreed on a set of recommendations for making that happen. It is a crucial moment in the development of a European consensus on evaluating medicines among the people who pay for them or advise on paying for them. This is still a long way short of any European pricing authority, but it nonetheless goes a long way towards setting some common benchmarks about how products should be assessed. And for the international industries that are producing new health technology, that offers some hope of an improvement over battling with the idiosyncracies of nearly thirty different national mindsets. Progress down that path can put new medicines in the hands of doctors — and patients — sooner. And that is progress.

Reference networks

The scheme to create specialized networks across Europe, concentrating expertise discipline by discipline, has also reached a new level of maturity with its announcement during May that it will hold a second conference — scheduled for Lisbon this coming October. It held its first conference last year — but holding a first conference is relatively easy, because all that’s needed is an idea. A second conference is a confirmation that the concept is not just a proposal (which is what it looked like a year ago), but a genuine process. So the second conference on European reference networks will bring together specialized healthcare providers, experts, national authorities, decision–makers and independent bodies with experience in the assessment and evaluation of healthcare providers.

The conference will focus on implementation rather than explanation, as a prelude to a call to be issued before the end of the year for consortia of organizations to make proposals for the creation of a network covering their discipline. Again, the objective is two-edged. In the first place a series of such expert networks will help to provide affordable, high-quality and cost-effective healthcare to patients with conditions requiring a particular concentration of resources or expertise. But over time, it could provide a new basis for recognising and refining the best diagnostic or therapeutic approaches — not just to rare diseases, but to diseases of all types. It is the EU’s foot in the door of member states’ current divergent (and sometimes uneven) approaches to care — an evolution of methodologies that could help all patients in every member state. And that is progress.

E-health disputes demonstrate interest

On the third innovation that the cross-border directive firmly integrated into EU health policy, mid-May witnessed a colourful confrontation that, above all, showed how much e-health has moved beyond the preserve of techno-geeks and now matters to a wide range of stakeholders. The casus belli was not of epic proportions. It looked like a marginal spat among marginal players over marginal issues. But (not unlike the cross-border care directive itself), there was much more there than met the eye at first glance. Half a dozen healthcare organizations wrote to the European health commissioner complaining they had been left out of an upcoming e-health programme, in favour of some other stakeholder. Small stuff? Well in terms of how much money was at stake, yes, very small stuff. But in terms of the political resonance, not small, but huge. The plaintiffs were Europe’s doctors, dentists, pharmacists, nurses, hospitals, and patient groups — an important subset of Europe’s healthcare community. And they were outraged at being excluded, because they now see that this once-marginal subject is moving remorselessly centre-stage, and will increasingly influence the interface between health systems and healthcare professionals and the patients themselves. The cross-border directive foresaw the evolution, and now most other key actors do, and want to be aboard as Europe starts to shape new procedures for new technologies. That’s progress, too.

Perhaps dark horses is the wrong metaphor. What the cross-border directive might most accurately be compared to is another equestrian symbol altogether: the Trojan horse.



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