Cross-border telemedicine before the ECJ – country-of-origin or country-of-destination principle?

Authors: Gisela Ernst and Dominique Korbel

Telemedicine is gaining ground internationally and nationally. As promising and valuable as these procedures are for healthcare, their legal classification is often difficult, both nationally and at the EU level.

The legal questions under EU law are, on the one hand, of a secondary law nature. The central question here is what is to be understood as telemedicine within the framework of EU law and whether EU law regulates the practice of telemedicine. In this context, it is necessary to examine the applicability of the Patients’ Rights Directive (Directive 2011/24/EU), the Professional Qualifications Directive (Directive 2005/36/EC), and the E-Commerce Directive (Directive 2000/31/EC). On the other hand, at the level of primary law, the question arises as to whether national provisions that regulate the practice of telemedicine in more detail impair the exercise of fundamental freedoms (in particular the freedom of establishment).

All these questions are the subject of a current preliminary ruling procedure (ECJ C-115/24) in which our law firm is involved. The recently published Opinion of the Advocate General provides a preliminary assessment of these questions and indicates an initial tendency. The Advocate General’s assessment can be summarized as follows:

If services, as in the case at hand, are provided partially in person (with the simultaneous presence of doctor and patient) and not solely via ICT (information and communication technology), the Advocate General is of the opinion that this does not constitute telemedicine within the meaning of Directive 2011/24/EU. What is crucial is that the services are inextricably linked. Only services that are exclusively provided via ICT qualify as telemedicine.
For such “purely” telemedical services, in the opinion of the Advocate General, Article 3 (d) of Directive 2011/24/EU stipulates that the law of the Member State in which the healthcare provider is established is to be applied (country-of-origin principle). This applies not only to the question of reimbursement, but also to the standards and quality assurance measures for these healthcare services.
According to the Advocate General, (purely) telemedical services are to be regarded as information society services which are subject to Directive 2000/31/EC. According to this regime, the country-of-origin principle also applies to the coordinated area in question here. Article 3 of Directive 2000/31/EC also prohibits the imposition of requirements falling within the coordinated field by another Member State on a provider of an information society service who wishes to provide that service in another Member State.
With regard to the Professional Qualifications Directive, the Advocate General states that the provision of telemedical services does not constitute a “movement” to another Member State within the meaning of Art. 5 para. 3 of Directive 2005/36/EC, which would require a physical crossing of the border. Therefore, requirements of the Member State of destination (where the telemedicine services are “consumed”) cannot be held against service providers.
In the context of examining the fundamental freedoms, the Advocate General questions several aspects of the specific case, such as whether the initial case (physical services provided by a treating dentist) constitutes a cross-border activity at all, since the German company could be considered as being based in Austria due to the dentist practicing there.
If the answer to this question is affirmative, it must be examined whether national provisions (in this case: the requirement that “group practices,” within which dentists may practice their profession, must operate in the form of a limited liability company, and that all shareholders must be members of the dental profession entitled to practice independently) restrict the freedom of establishment and, if so, whether such a restriction is justified.
With regard to the possibility of justifying such national provisions in the interest of public health, the Advocate General refers to several sources indicating that, even in this case, a justification assessment would be positive in light of the protection of public health.

The Advocate General thus clearly answers the long-debated question of whether the country-of-origin principle or the country-of-destination principle applies in the case of cross-border telemedicine in favor of the country-of-origin principle. If a service is permitted in the Member State from which the treatment is provided, then it may be delivered cross-border via ICT to another Member State. However, this does not apply to services that are also partially provided physically, as this does not constitute telemedicine.

It remains to be seen whether the ECJ will follow the Advocate General’s assessments. In addition, several follow-up questions remain open for all telemedicine providers and all those entrusted with the organization and financing of the healthcare system. The decision will be of significant relevance far beyond the individual case.

Our healthcare law experts will be happy to keep you up to date on all these developments and are available to answer any further questions you may have on the topics of telemedicine and digitalization in the healthcare sector.

Disclaimer

This article is for general information only and does not replace legal advice. Haslinger / Nagele Rechtsanwälte GmbH assumes no liability for the content and correctness of this article.