November 10, 2015

The EU Directive on Cross-Border Healthcare: A Watershed for Harmonised Patient Access?

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The European Commission has recently published a Report on European Member States' transposition of Directive 2011/24/EU on the application of patients' rights in cross-border healthcare (the Directive).

The Directive concerns the rights of patients who are seeking reimbursement for healthcare received in another Member State than the one in which they reside. It attempts to disentangle the traditional regulatory hurdles faced by businesses and patients alike in some Member States and to lighten the regulatory burden overall. This is of particular relevance to mHealth businesses, who may find that the Directive assists them in rolling out their products and services across several EU Member States simultaneously (and, ideally, seamlessly).

All EU directives must be transposed by Member States (i.e. implemented into each national legal system) before they take effect. The deadline for transposing the Directive was 25 October 2013. However, as noted in the Report, transposition has not been wholly effective. In some Member States there has been a total failure to transpose the Directive; other Member States are criticised for piecemeal failures.

It is noteworthy that patient mobility across Member States for planned treatment remains relatively low, in contrast to mobility for unplanned treatment. The reason given for this in the Report is, firstly, a lack of patient awareness regarding their rights of treatment in other Member States and, secondly, intentional obstacles created by some Member States with regard to access for non-resident EU patients.

The Commission envisages that telemedicine (including mobile telemedicine), in particular, will be an increasingly prominent sector or European health services. In its Report, the Commission highlights the lack of clarity regarding existing telemedicine rules. For example, it is not currently clear whether a patient residing in a Member State where consultations, diagnoses or treatments by way of telemedicine are neither admissible nor reimbursable from public funds, may nevertheless claim access or compensation to telemedicine services in a Member State that allows such access and reimbursement.

The Commission has launched several infringement proceedings against Member States to tackle the obstacles and failures of transpositions described above. Whatever their outcome, it is likely that these proceedings have placed Member States legislatures' on alert, hopefully with the effect of speeding up effective transposition of the Directive. The clarity and uniformity of laws resulting from effective transposition ought to be good news for most mHealth businesses that operate internationally. In addition, the Commission's recognition of the significance of the telemedicine market may provide increased impetus for a review (both at EU and national levels) of current laws and regulations relating to mHealth. Watch this space.

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