The European Commission’s report on the Directive on patient’s rights in cross-border healthcare

The European Commission has published a report on the status of the transposition into Member State national law of Directive 2014/24/EU, on patient rights in cross-border healthcare. The Commission found that, particularly in certain Member States, the Directive has not been transposed fully or else obstacles exist around accessibility and reimbursement, for example. Not only does the report provide an update on the progress of the Directive’s implementation, which is of note for eHealth providers, but the Commission also raises a number of unresolved questions in the context of the reimbursement of telemedicine services. Here, Dr. Alexander Csaki and Clarissa Junge-Gierse of Bird & Bird discuss the report’s findings and what this could mean for telemedicine in the EU.

Two years after Directive 2014/24/EU (‘Directive’) came into force at a European level, the European Commission has issued a comprehensive report on the status of the Directive’s transposition into national law. The Commission’s report critically deals with unresolved issues and suggests further steps for the Directive’s successful development. Though patient flows for healthcare services abroad still seem to be low, a certain impact is already being felt. Most importantly, for all kinds of eHealth services, the ongoing transposition process offers opportunities to loosen the tight regulatory framework in some of the European Member States, especially Germany, possibly paving the way for a successful provision of eHealth services.

Background and contents of the Directive (SH)

The Directive came into force on 24 April 2011. The European Member States had to transpose it by 25 October 2013.

In contrast to regulation no. 883/2004/EC, which mainly deals with cases of unplanned emergency treatment abroad, the Directive regulates cases of regular treatment in EU Member States other than the patient’s state of residence. To enable patients to seek EU-wide medical advice and treatment, the Directive implements existing European Court of Justice (‘ECJ’) case law. Hence, the Directive primarily addresses questions of the reimbursement of healthcare services. It obliges Member States to ensure the costs incurred by an insured person who receives cross-border healthcare are reimbursed, if the healthcare in question is among the benefits to which the insured person is entitled in the Member State of affiliation. Utilisation of cross-border healthcare services shall additionally be simplified by the possibility to hand in a foreign prescription in the patient’s resident country. Also, the establishment of national contact points (‘NCPs’) is among the Directive’s regulations. Those NCPs are meant to facilitate the use of cross-border healthcare services for patients by providing the necessary information on reimbursement, conditions and liability.

When creating and adopting the Directive, the European Parliament and the Council of the European Union were fully aware of the importance of a functioning technical and legal eHealth infrastructure. Therefore, the Directive addresses a number of eHealth-related topics. Patients are, amongst others, entitled to a written or electronic medical record of any cross-border treatment. Additionally, guidelines supporting the Member States in developing the interoperability of ePrescriptions (article 11 of the Directive) were adopted and a voluntary network supporting and facilitating cooperation among Member States established (article 14). Those comprehensive measures to facilitate cross-border healthcare services by means of eHealth are completed by strong efforts in the Directive to improve the regulatory framework for ePrescriptions and online pharmacies. Being aware of the accompanying challenges, the Commission’s obligation to review the effectiveness of the Directive was laid down in the Directive, at Article 20.

Current status of implementation (SH)

Recently and two years after the Directive came into force, the European Commission published a report on the application of patients’ rights in cross-border healthcare.

As a result of the Commission’s examinations, it appears that patient mobility for planned healthcare remains low, whilst patient mobility in terms of unplanned healthcare still seems considerably higher.

Though possibly distorted by insufficient data provided by some Member States, for 2014 a total of only 39,826 reimbursements under the provisions of the Directive were reported. However, exemptions to this generally low number of relevant cases apply for France, Luxembourg and to a minor extent to Finland and Denmark. Fourteen Member States have made fewer than 100 reimbursements. One reason for this low number of patients seeking cross-border healthcare seems to be a lack of awareness and a lack of information. Even when patients are aware of their rights, there seem to be significant obstacles placed in the way of patients by public health systems in several Member States. The Commission even believes those obstacles to be a result of intent. Consequently, some infringement proceedings have been launched against 26 Member States, four of them still open. Insufficiencies included a total lack of transposition as well as failure to establish NCPs. Additionally, the Commission observed a severe lack of clarification regarding reimbursement and its conditions, creating an additional barrier for patients in some Member States. More infringement cases are to be expected as the Commission is going to review the transposition by Member States even more closely in the future.

Implications for eHealth, with a focus on telemedicine (SH)

The Commission’s report predicts that eHealth and telemedicine services are likely to become more common and more significant in the immediate future.

Especially with regard to telemedicine services the Commission’s report clarifies that the current status of approximation of laws within the EU is still suffering from an enormous lack of clarity. For telemedicine, the report observes that some Member States reimburse consultations with general practitioners at a distance, whilst others do not. In the case that a patient from a Member State where consultation, diagnosis and treatment by means of telemedicine are neither admissible nor reimbursed by public sickness funds seeks telemedicine advice in a Member State where such consultations are provided, it remains, in the Commission’s view, unclear as to whether the Member State of affiliation may refuse reimbursement. The Commission highlights one of the most relevant questions in telemedicine in the current European process of unification of healthcare services, as the following example regarding the legal situation in Germany will show:

Telemedicine services generally may include all types of remote treatment and/or diagnosis. Especially in rural areas these techniques can be of great benefit for patients who would otherwise not be able to consult a high quality and specialised medical service on a regular basis. However, and despite these obvious advantages, a specific regulation in German Law  generally prohibits every kind of diagnosis or treatment when the attending physician is not on-site. Though there are few exemptions to this general rule, especially if a medical doctor is treating the patient on-site and is ultimately taking the relevant medical decisions, or if the information given is solely general medical information on a healthy lifestyle or regarding the treatment of minor ailments that are usually treated by self-medication, the provision considerably restricts the possibilities for telemedicine providers and patients.

With the Commission raising the issue of unresolved questions in the context of reimbursement regarding telemedicine services, it now needs to be considered whether the provisions of Directive 2011/24/EU might pave a way for a successful provision of telemedicine services. Given the legal hierarchy of national and European law, the provisions of the Directive might even now enable telemedicine providers to provide their services successfully, though some open legal questions like whether the Directive is in fact meant to guarantee the individual right to access telemedicine services still need to be resolved. This might open up opportunities for internationally operating eHealth providers.

The implications of the Directive’s provisions for telemedicine might even become more relevant, as ongoing research regarding the effects of the Directive on patients’ rights in cross-border healthcare  also emphasises the negative effects of the existing legal obstacles for the application and exchange of electronic health applications, especially in a cross-border context.

Summary and outlook (SH)

Though insufficient data might mean that currently we do not have the whole picture of existing patient flows within the European Union, cross-border healthcare still needs to gain in significance. The effectiveness and impact of the Directive on patient’s rights in cross-border healthcare will highly depend on the next few years and the steps taken by the European Commission. Due to inefficient transposition into national law, the Commission is not convinced that the current status of cross-border healthcare with the low number of patients involved reflects the potential demand. Consequently, a number of new infringement proceedings resulting from the insufficient transposition of the Directive is to be expected.

The Commission is also very aware of the regulatory constraints on eHealth and especially telemedicine services in Europe. This fact might lead to relieved legal conditions especially for providers of telemedicine services and give important impulses to legislators in the Member States. The primacy of application of European law together with the Commission’s legal view as stated in the recent report might lead to loosening national regulations; certainly case law can be expected in that context.