Markus Frischhut examines effect of the EU directive on patients' rights

 

Due to a lack of specific legal provisions on patient mobility (the so-called social security regulation will not be considered here), the European Court of Justice has developed a comprehensive case-law on patient’s rights in cross-border healthcare since 1998. After healthcare services have been excluded from the much contested service-Directive, the Commission has proposed a self-contained Directive which was finally adopted in March 2011. Without being too technical, the legal situation is clear as follows: the Directive is so-called secondary EU law, which has to correspond with the requirements of primary EU law, especially the freedom of services. The latter is interpreted by the ECJ (the mentioned case-law on patient mobility), so consequently, the EU Directive has to be in line with the ECJ’s case-law.

Which provisions fall into the green, the yellow or the red traffic light rating system?

As the legal situation is complex enough, Directive and ECJ case-law will be compared according to a traffic light rating system (Although it has been rejected for the EU rules on food-labelling, it will be used here for this summary).

To cut a long story short: most parts of the Directive correspond (green category) with the case-law (for further details see slides 5-6 of my presentation at EMTC 2012).

  • The Directive also contains some new aspects, which nevertheless also fall into the green category. Healthcare may also be subject to prior authorisation if it “involves treatments presenting a particular risk for the patient or the population”, or if there are “serious and specific concerns relating to the quality or safety of the care”.
  • Also the new concept, according to which the health of patients can have priority over a “treatment without undue delay” is most likely in conformity with the ECJ case-law.
  • Up until now, all cases decided by the ECJ have concerned restrictions for outgoing patients (as they faced problems in terms of reimbursement of costs). The Directive now also allows for restrictions on incoming patients.

Last but not least, there is a bunch of provisions which also fall into the green category, but where proposals during the legislative process have been more ambitious than the final Directive . Nevertheless, they are not to be contested from a legal perspective, as they do codify the ECJ’s case-law requirements.

  • Member States can decide to reimburse the full costs of cross-border healthcare (in the case of treatment abroad being more expensive), although they only have to reimburse up to the amount of their home tariffs.
  • The same applies to additional costs in the case of persons with disabilities. They also depend on the good-will of their Member State of insurance (hopefully no “mission impossible” in times of austerity).
  • The Directive emphasises the necessity of patients being able to make “informed choices”. However, it is not mandatory (Member States have free discretion here also) that the Member State of treatment delivers “information in other [author's emphasis] languages than those which are official languages in the Member State concerned”. The same voluntary system applies for information given by national contact-points.
  • Let me indicate one last example where discussions before the adoption of the Directive have been more ambitious than the outcome. According to the Directive, healthcare received in another Member State of the EU has to be paid up-front. The proposed voucher system (which would have been more patient friendly) has failed. At least Member States may “offer patients a voluntary system of prior notification whereby, in return for such notification, the patient receives a written confirmation of the amount to be reimbursed on the basis of an estimate”.

Although the Directive does not contain provisions falling into the red traffic light category, there are examples of provisions falling into the yellow category.

  • A patient reading through the text of the Directive might assume that “other related costs such as accommodation and travel costs” (author's emphasis) don’t have to be reimbursed on a mandatory basis, and therefore fall into the free discretion of the relevant Member State also. However, the ECJ has decided that a principle of non-discrimination applies in this field. Consequently, they have to be reimbursed for cross-border cases if similar costs are reimbursed in purely national situations.
  • The Directive does not apply for “services in the field of long-term care”, “allocation of and access to organs for the purpose of organ transplants” and finally “public vaccination programmes against infectious diseases”. Although some uncertainty remains, it cannot be excluded that those exceptions might not be accepted by the ECJ in specific situations. One side note: in a recent ECJ judgement from mid July 2012 (C-562/10) the Court had to deal with the question, whether existing case-law concerning “medical services” (the mentioned case-law on patient mobility) also applies to “care services”. The ECJ has answered this question negatively (for the sake of completeness it has to mentioned, that the EU Directive was not applicable ratione temporis in this case, so one can wait how future cases will be decided).

Does the Directive bring added value for patients (in comparison to the existing ECJ case-law)?

Besides the traffic light rating system, the Directive also brings some added value to the patient in comparison to those rights already existing under the ECJ case-law; of course the disadvantage of the latter is that – although in theory perfectly accessible (via Eur-Lex) – hardly anyone knows about the complex situation (for further details cf. slides 3-5 of my presentation at EMTC 2012).

  • First of all, the Directive clarifies the responsibilities of the Member State of affiliation on the one hand, and of the Member State of treatment on the other. The first is responsible for reimbursement of costs, information on patient’s entitlements, the availability of the necessary medical follow-up, and medical records. The latter is responsible for information for patients (from both national contact points and from healthcare providers), transparent complaints procedures (and mechanisms to seek remedies), systems of professional liability insurance, data protection, and medical records.
  • Especially those medical records which concern both Member States, might bring a practical added value to patients seeking cross-border healthcare.
  • In traditional EU law the freedom of services does not only include the freedom of the service provider and the service receiver to cross the border, but also cases where only the service crosses the border. It can therefore be seen as a user-friendly clarification that the Directive also applies for “healthcare provided in another Member State through other means, for example through eHealth services”. However, the Directive mainly only concerns “public” eHealth (between Member States) and not so much “private” eHealth (between patients and healthcare providers). Consequently, the latter category is “only” governed by the general EU provisions (for an overview see a study report from 2008) on distance contracts, e-commerce, etc. One clarification which might be of interest in case of a phenomenon like www.dred.com: in the case of “telemedicine, healthcare is considered to be provided in the Member State where the healthcare provider is established”; consequently, e.g. in this mentioned case, British law applies, although the webpage offered in German language is addressed mainly to German and Austrian patients.
  • Last but not least there might be sort of an indirect added value, as the Directive also provides for an individual chapter on Member States’ cooperation in cross-border healthcare. It is important to mention that also this chapter is voluntary, so Member States are not forced to cooperate. This chapter includes general provisions on mutual assistance and cooperation, the recognition of prescriptions issued in another Member State, provisions on European reference networks (especially in case of rare diseases), the already mentioned (public) eHealth and finally, the cooperation on health technology assessment (HTA).

Summing up, it can be said that basically the Directive which has to be implemented into national law by October 25th 2013 at latest is in line with the case-law. There are some small gaps (travel and accommodation costs), but the Directive can also bring some added value, both at a direct (eHealth, medical records) and at an indirect (cooperation between Member States) level.

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