COURT OF JUSTICE

CVRIA
OF THE EUROPEAN UNION

THE COURT OF JUSTICE

AND HEALTHCARE

curia.europa.eu
INTRODUCTION

Since 1952, the Court of Justice of the European

Union (CJEU) has ensured that European Union law is
observed and properly applied in the Member States.
Over time, it has delivered judgments which have
strengthened European integration while granting
citizens increasingly extensive rights, in particular in
the healthcare sector. The following pages present
some leading judgments of the Court of Justice in
that field.

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THE LEGAL SITUATION
UNTIL 1998
Since 1971, the issue of cross-border healthcare has been governed,
at European Union level, by ‘Regulation (EEC) No 1408/71 of
the Council of 14 June 1971 on the application of social security
schemes to employed persons and their families moving within
the Community’.

Broadly, that legislation enables patients to travel to another Member State to

receive treatment after they have obtained the prior authorisation of their health
insurance fund (form S2). Where such authorisation is granted, the treatment costs
are generally paid for or reimbursed to the patient in accordance with the tariffs
applied in the country of treatment, even if those tariffs are higher than the tariffs
in the patient’s country.

At the beginning of the 1990s the European Union became an area without internal
frontiers, which facilitated the free movement of persons. Increasing numbers of
patients then sought to receive treatment from doctors established in another
Member State, and the key issue was whether they systematically required prior
authorisation from their health insurance fund to do so. In 1998, the Court of
Justice adjudicated on two cases in which the patients did not request, or did not
obtain, prior authorisation, but nevertheless wished to be reimbursed by their
health insurance fund.

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THE JUDGMENTS OF 1998
IN KOHLL AND DECKER
The judgment in Kohll : no prior authorisation required for
scheduled outpatient care in another Member State

In 1994, Mr Kohll, a Luxembourg national, wanted his daughter (a minor) to receive

treatment from an orthodontist established in Germany and he requested the
relevant authorisation from the Luxembourg health insurance fund. That fund
refused authorisation on the ground that the treatment was not urgent and
could be provided in Luxembourg. Relying on the freedom to provide services
(and not Regulation No 1408/71), Mr Kohll took the view that he had the right to
seek treatment for his daughter in Germany without prior authorisation and to
claim reimbursement of his costs from his health insurance fund, not in accordance
with the tariffs of the country of treatment (Germany) but in accordance with the
tariffs applied for that type of treatment in his country of insurance (Luxembourg).

The Court of Justice held that treatment performed by a healthcare professional

should be regarded as a service. In those circumstances, rendering payment for
scheduled outpatient treatment, at the tariffs applied in the patient’s country,
subject to prior authorisation constitutes a barrier to freedom to provide services,
since such authorisation deters insured persons from approaching providers of
medical services established in another Member State. The Court furthermore
observed that such rules are not justified either by a risk of seriously undermining
the financial balance of the social security system or on grounds of public health
(28 April 1998, Kohll, C-158/96).

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THE JUDGMENTS OF 1998
IN KOHLL AND DECKER
The judgment in Decker : no prior authorisation required for
the purchase, in another Member State, of medical devices or
medical products on prescription

A patient may be prescribed medicines or medical devices by a doctor established

in a Member State and decide to purchase the products in a pharmacy located in
another Member State (whether by going there in person or by mail order). That
was true in the case of Mr Decker, who, in 1992, purchased a pair of glasses for
himself in Belgium prescribed by an ophthalmologist established in Luxembourg.
The Luxembourg health insurance fund refused reimbursement of those glasses on
the ground that the purchase had taken place abroad without prior authorisation.

The Court of Justice held that the refusal to reimburse medical products purchased
without prior authorisation in another Member State constitutes an unjustified
barrier to the free movement of goods, inasmuch as such a requirement is not
justified on grounds of public health in order to ensure the quality of medical
products supplied in other Member States. Since then, patients have been able to
buy their medical devices or medical products in another Member State without
prior authorisation and to claim reimbursement from their health insurance fund
in accordance with the tariffs applied in their own country (28 April 1998, Decker,
C-120/95).

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THE INFLUENCE OF THE JUDGMENTS
OF THE COURT OF JUSTICE
ON THE EU LEGISLATION
ON HEALTHCARE
In delivering the judgments in Kohll and Decker on 28 April 1998
(see the previous pages), the Court of Justice initiated a long
series of judgments, on the basis of which the European Union
legislature has substantially altered the EU legislation on
healthcare.

The judgments in Kohll and Decker demonstrated that, in parallel to the system
put in place by Regulation No 1408/71 and its implementing regulation (Regulation
No 574/72), which provide for a prior authorisation scheme governing cover for
medical treatment scheduled in another Member State in accordance with the
tariffs applied by that Member State, the fundamental freedoms enshrined in the
Treaties (the freedom to provide services in Kohll and the free movement of goods
in Decker) may be relied upon in order to obtain, without the prior authorisation
of the health insurance fund, payment for outpatient care or purchases of medical
products in another Member State in accordance with the tariffs applied by the
patient’s country.

The Court of Justice has thus, through its case-law, progressively contributed to the
establishment of criteria to be taken into account in order to safeguard the rights
of citizens in this field. That case-law has moreover been codified by the European
Union legislature in the adoption of Regulations No 883/04 and No 987/09 and
Directive 2011/24, which today offer citizens detailed rules on cover for medical
treatment and medical purchases which take place in another Member State.

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THE CASE-LAW OF THE COURT OF
JUSTICE ON THE 1971 REGULATION
(CODIFIED IN THE 2004 AND 2009
REGULATIONS)
After the judgments in Kohll and Decker, the Court of Justice
had the opportunity on several occasions to interpret the 1971
Regulation. It did so in two main fields: scheduled hospital
treatment and non-scheduled hospital treatment.

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THE CASE-LAW OF THE COURT OF
JUSTICE ON THE 1971 REGULATION
(CODIFIED IN THE 2004 AND 2009
REGULATIONS)
Scheduled hospital treatment

Where the authorisation necessary for hospital treatment scheduled in another

Member State has been incorrectly refused and it is, for whatever reason, granted
after that hospital treatment, the patient is entitled to reimbursement of the costs
incurred in the same way as if the authorisation had been granted in due time
(12 July 2001, Vanbraekel and Others, C-368/98).

To be allowed to refuse a patient’s request for authorisation to receive treatment

in hospital abroad on the ground that he could be treated, after a certain waiting
time, in a hospital in his country, the national authorities must ensure that the
waiting time set does not exceed a medically acceptable period in the light of
the patient’s state of health and clinical needs (16 May 2006, Watts, C-372/04). In
addition, prior authorisation may not be refused where a lack of basic medical
commodities prevents the patient from receiving hospital treatment in good time
in his country (9 October 2014, Petru, C-268/13).

On the other hand, prior authorisation may be refused if the medical benefits
provided abroad are not covered under the patient’s social security system.
However, if the treatment method applied abroad corresponds to benefits covered
in the patient’s Member State, it is not permissible to refuse prior authorisation
on the ground that such a method is not practised in that Member State
(5 October 2010, Elchinov, C-173/09).

Where a patient has obtained authorisation for treatment in a hospital in another

Member State and he bears part of the hospital treatment costs, he can request
his health insurance fund to reimburse all or part of those costs in accordance with
the cost of the equivalent treatment in his country (16 May 2006, Watts, C-372/04).

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THE CASE-LAW OF THE COURT OF
JUSTICE ON THE 1971 REGULATION
(CODIFIED IN THE 2004 AND 2009
REGULATIONS)
Non-scheduled hospital treatment

The 1971 Regulation, replaced by Regulation No 883/2004, provides that an employed

or self-employed person whose state of health immediately requires healthcare
during a stay in another Member State (emergency medical care) is entitled to
have that care covered by his health insurance fund, without obtaining its prior
authorisation, in accordance with the tariffs applied in the country of treatment.

Where a pensioner travels to another Member State and must receive emergency
hospital treatment there, his health insurance fund cannot render its provision of
cover for the medical costs dependant on the grant of prior authorisation or on
the requirement that the illness from which that person suffers manifested itself
suddenly, even if that requirement is applicable to employed and self-employed
persons. The difference in treatment between pensioners and workers can be
explained by the legislature’s desire to promote effective mobility of pensioners
having regard to their greater vulnerability and dependence in health terms
(25 February 2003, IKA, C-326/00).

Furthermore, where a person with a prior authorisation is treated in another

Member State and the doctors of that State decide to transfer him, on grounds of
a medical emergency, to a hospital located in a State which does not form part of
the EU (Switzerland, for example), the patient can retain their entitlement to cover
in respect of the medical costs. The patient’s health insurance fund must trust the
doctors in the Member State of treatment, who are the best placed to assess the
treatment required by the patient (12 April 2005, Keller, C-145/03).

Lastly, where emergency hospital treatment is administered during a trip in another

Member State, it is permissible for the patient’s health insurance fund to refuse
to reimburse the costs which, in the State of treatment, are borne by patients
(such as, for example, a patient co-payment) (15 June 2010, Commission v Spain,
C-211/08).

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THE CASE-LAW OF THE COURT OF
JUSTICE IN RESPECT OF THE FREEDOM
TO PROVIDE SERVICES
(CODIFIED IN THE 2011 DIRECTIVE)
After the 1998 judgment in Kohll, the Court of Justice clarified
its case-law in the case where a person decides to receive
treatment in aanother Member State under the freedom to
provide services instead of on the basis of the 1971 Regulation.
Such clarification concerns only scheduled medical treatment
(outpatient or hospital treatment), and not emergency medical
treatment (unexpected treatment).

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THE CASE-LAW OF THE COURT OF
JUSTICE IN RESPECT OF THE FREEDOM
TO PROVIDE SERVICES
(CODIFIED IN THE 2011 DIRECTIVE)
Scheduled outpatient treatment not provided in hospital

Following on from the judgment in Kohll, the Court of Justice held that prior
authorisation was not required for outpatient treatment not provided in
hospital and administered in another Member State by non-approved providers
(13 May 2003, Müller-Fauré and Van Riet, C-385/99). Furthermore, the Member
States may not render the provision of cover for expenses in relation to a spa
cure abroad conditional on the fact that such a spa cure must have much greater
prospects of success (18 March 2004, Leichtle, C-8/02).

Member States must also provide, in their national legislation, that insured
persons have the possibility to be reimbursed for the costs of medical analyses
and laboratory tests carried out in another Member State (27 January 2011,
Commission v Luxembourg, C-490/09). Moreover, it is not permissible for Member
States to restrict cover for outpatient treatment administered abroad to the sole
exceptional circumstance where the national healthcare system cannot provide
the treatment needed for the patient affiliated to that system (27 October 2011,
Commission v Portugal, C-255/09).

However, the Court of Justice has acknowledged that the Member States may provide
that the reimbursement of outpatient treatment provided in another Member State
is conditional on the grant of prior authorisation where such treatment requires
use of major medical equipment (for example an MRI or PET-SCAN). In the light of
the particularly onerous nature of such equipment, it must be possible for it, like
hospital services, to be the subject of planning policy in order to be able to ensure,
throughout national territory, a rationalised, stable, balanced and accessible
supply of treatment and in order to avoid any waste of financial, technical and
human resources. A prior authorisation requirement for that type of treatment
therefore constitutes a justified restriction on the freedom to provide services
(5 October 2010, Commission v France, C-512/08).

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THE CASE-LAW OF THE COURT OF
JUSTICE IN RESPECT OF THE FREEDOM
TO PROVIDE SERVICES
(CODIFIED IN THE 2011 DIRECTIVE)
Scheduled hospital treatment

The Court of Justice has held that, in contrast to outpatient treatment not performed
in a hospital (see the previous page), the requirement of prior authorisation for
hospital treatment can be justified by the need to ensure that there is sufficient
and permanent access to a balanced range of high-quality hospital treatment
in the Member State in question, to control costs and to prevent any waste of
financial, technical and human resources. At the same time, the Court has held
that the conditions for obtaining such prior authorisation must be justified, non-
discriminatory and proportionate (12 July 2001, Smits and Peerboms, C-157/99).
It follows that, for scheduled hospital treatment, prior authorisation is always
required, be it to obtain cover for such treatment in accordance with the tariffs
applied in the country of treatment (the 2004 and 2009 Regulations) or in accordance
with the tariffs applied in the patient’s country (the 2011 Directive).

It is permissible to refuse prior authorisation if treatment which is the same or

equally effective as that envisaged abroad exists in the patient’s country and if that
treatment can be administered without undue delay in the patient’s country. In this
connection, the national authorities must take into account the patient’s medical
condition and history, the probable course of the disease and the degree of pain
or the nature of the disability (13 May 2003, Müller-Fauré and Van Riet, C-385/99).

A Member State cannot restrict the reimbursement of the costs of hospitalisation

either to certain categories of persons (children for example) or according to the
public or private nature of the hospital which administers the treatment. Such
a broad exclusion of reimbursement of the costs of hospital treatment would
be contrary to EU law, since it would deter or even prevent patients from being
admitted to hospital in other Member States (19 April 2007, Stamatelaki, C-444/05).

Lastly, if the tariffs in force in the country of treatment are lower, in respect of
the hospital treatment at issue, than those applicable in the patient’s country, the
patient is entitled to an additional reimbursement corresponding to the difference
between those two tariffs (‘the differential additional amount’) (12 July 2001,
Vanbraekel and Others, C-368/98).

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REIMBURSEMENT OF TRAVEL,
ACCOMMODATION AND
SUBSISTENCE COSTS
When a patient travels to another Member State to receive
treatment there, he necessarily incurs travel costs and, in
some cases, accommodation and subsistence costs. The issue
has thus arisen of whether the patient’s health insurance fund
must also reimburse those costs.

A patient who is authorised by his health insurance fund to travel to another

Member State to receive treatment there under the 1971 Regulation (or the 2004
and 2009 Regulations) cannot claim the reimbursement of his travel costs or, in the
case of outpatient treatment, of his accommodation and subsistence costs. On
the other hand, in respect of scheduled hospital treatment, the accommodation
and subsistence costs will be reimbursed. The obligation to reimburse covers
exclusively the expenses linked to the healthcare treatment received by the patient
in the Member State of treatment (15 June 2006, Herrera, C-466/04).

The same applies where the authorisation is granted by virtue of the freedom
to provide services (the 2011 Directive). However, if the travel, accommodation
and subsistence costs are covered by the patient’s health insurance fund for
treatments provided within national territory, those costs must then be reimbursed
when the patient travels to another Member State to receive treatment there
(16 May 2006, Watts, C-372/04).

The Member States are at liberty in all cases (whether under the regulations or
the directive) to reimburse travel, accommodation and subsistence costs if they
choose to do so.

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PURCHASE OF MEDICAL PRODUCTS OR
DEVICES BY MAIL ORDER
Following the 1998 judgment in Decker, the Court of Justice has
had the opportunity to clarify its case-law, inter alia in the field
of the purchase by mail order of medical products and devices.

A Member State may not prohibit the sale by mail order of medicinal products
authorised on its market and not subject to prescription. By contrast, a national
prohibition on the sale by mail order of medicinal products subject to prescription
can be justified. Allowing those medicinal products to be supplied by mail order
and without any control could increase the risk of prescriptions being abused or
inappropriately used. Furthermore, the possibility that the label of a medicinal
product may be in a different language may have more harmful consequences in the
case of prescription medicines (11 December 2003, Deutscher Apothekerverband,
C-322/01).

Lastly, it is not open to a Member State to set fixed prices for prescription-
only medicinal products, since setting such prices could impede the access of
foreign pharmacies and mail order pharmacies to the market (19 October 2016,
Deutsche Parkinson Vereinigung, C-148/15).

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FOR FURTHER INFORMATION
In every Member State, ‘national contact points’ with expert knowledge of EU
legislation on cross-border healthcare have been established to answer questions
on practical issues from people who wish to be treated in a Member State other
than their own. The updated list of those national contact points may be consulted
on the internet at the following address: https://ec.europa.eu/health/sites/health/
files/cross_border_care/docs/cbhc_ncp_en.pdf

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 Directorate for Communication
Publications and Electronic Media Unit

September 2018

Printed on eco-friendly paper

QD-04-18-747-EN-N ISBN 978-92-829-2948-3 DOI 10.2862/574933