Recent Legal Developments
| Published date | 01 September 2011 |
| DOI | 10.1177/1023263X1101800310 |
| Date | 01 September 2011 |
| Subject Matter | Recent Legal Developments |
382 18 MJ 3 (2011)
RECENT LEGAL DEVELOPMENTS
e New Directive on Patients’ Rights in Cros s-Border Healthcare
Introduction
On 9 March 2011 the European Parliament a nd the Council adopted Directive 2001/24/
EU on the application of patients’ rights in cross-border healthcare (hereinaer: Patients’
Rights Direct ive – PRD).1 e PRD provides a comprehensive approach on cross-border
care: it contains r ules governing the reimbursement of cross-border hea lthcare, safety
and quality of care and cross-border healt hcare cooperation. e PRD is based on a
proposal of the Commission of 2 July 2008,2 entered into force on 24 April 20113 and will
have to be implemented by 25 October 2013.4
Background
For a proper understanding of the PRD, it is necessary to briey go back in time to
28 April 1998, id es t the date the Court of Justice of the European Union (CJEU) delivered
the well-known r ulings in Decker5 and Kohll.6 Prior to thes e rulings, reimbursement of
cross-border care was governed by Regulations 1408/717 a nd 574/728 (and, of course,
national law). In essence, these Reg ulations intended to ensure that publicly insu red EU
citizens who, whi le living or bei ng present in another Member State than the one in
which they are insured, become in need of healthcare are entitled to the care they need at
the expense of the organ t hey are aliated to (the so-called competent organ). However,
1 [2011] OJ L 88/45.
2 Proposal for a Dire ctive of th e European Parliament and of the Council on the applicati on of pati ents’
rights in cross -border healthcare, COM (20 08) 414 def.
3 Article 22 PR D.
4 Article 21(1) PRD.
5 Case C-120/95 Decker [1998] ECR I-1831.
6 Case C-158/96 Kohll [1998] ECR I-1931.
7 Council Regulation (EC) No 1408/71 of 14 June 1971 on the application of s ocial s ecurity schemes
to employed persons, to self-employed persons a nd to memb ers of t heir fami lies movi ng withi n the
Community, [1997] OJ L 28/1.
8 Council Regulation (EE C) No 574/72 of 21 Ma rch 1972 laying down the proc edure for implement ing
Regulation (EEC) No 1408/71 on the applicat ion of social security schemes to employed pers ons, to self
employed persons , to self-employed p ersons and to their fami lies moving within the Community, OJ
English Spec ial Edition 1972(I), 159, as updated a nd amended by Regulat ion No 118/97.
Recent Legal De velopments
18 MJ 3 (2011) 383
Regulation 1408/71 did not truly fa cilitate the r ight of EU c itizens to tr avel to another
Member State for the sole purpose of obtaining medical treatment. Reimbursement
of costs of such ‘plan ned’ treatment was made conditiona l upon the grant of prior
authorization. e Regulat ion only provided a rig ht to obtai n authorization in the
exceptional cases in which med ical benets are covered by the legislation of the st ate
of residence and cou ld not be provided w ithin the time normally nece ssary for this.9
Basically, the coordination regime le it to the Member States and their organs to decide
on the grant of prior authorizat ion, which the latter, as a rule, only did so in exceptiona l
cases. Authori zation, and thus rei mbursement of the costs of planned treatment, was a
rarely granted priv ilege, not a right.
Decker and Kohl l caused a revolution. By holding th at national rules making the
reimbursement of the costs of healthcare outside the national terr itory conditional
upon prior authorization are at odds with the Treaty rule s on freedom of movement, the
Court, in essence, transformed the aforementioned privilege into a lega lly enforceable
right to be reimbu rsed for pla nned treatment, that cou ld only be denied or restricted
when necessary for protec ting t he nanci al stabi lity of health insuranc e schemes or
the organizationa l in frastructure of healthca re sys tems. e decision as to whether
an i nsured person can go to another Member State for med ical reasons could now b e
made by that person him- or hersel f. Member States c.q. their organs see med to have
lost t hat prerogative, c ausing fears of losing c ontrol over healt hcare expendit ures and
the inabilit y to ma intain proper health care systems . e C ourt was criticized for
applying t he Treaty’s free market r ules to solidar ity-based health c are systems. Marke t
individua lism would undermine the soci al collec tivism on which he althcare regimes
rest.10 Furthe rmore, the creation of a new procedure for reimbursement of cross-border
healthcare costs was said to cause legal uncer tainty; healthcare providers and insura nce
organs as well as patients were le in the dark as to when to follow the ‘1408/71-route’ or
the new ‘Treaty-route’.
Member States responded, rst ly, by calling upon t he Court to limit the scope of the
rulings and to recogni ze the potential dangers of applying the market freedoms to social
healthcare systems. e Court appe ared sensitive to this . While in subs equent case law
it stuck to the view t hat national healthcare rules must obe y the economic market rules,
the Cour t did accept that prior authorization rules may be lawfully applied to medical
benets not included in national insura nce packages, hospital care and ‘non-contracted’
care.11 Secondly, Member States insisted on a political response. Legal certaint y had to be
9 Article 22(2) Reg. 1408/71.
10 See e.g. C. Newdick , ‘Citizenship, Free Movement a nd Health Care: Cement ing Individu al Rights by
Corroding S ocial Solidarit y’, 43 Common Market Law Rev iew 6 (2006), p. 1645.
11 Case C-157/99 Gerae ts-Smits and Pee rbooms [2001] ECR I-5473. Se e further A.P. van der Mei, ‘Cros s-
Border Access to Health are within the Europe an Un ion: Som e Ree ctions on G eraets-Smits and
Peerbooms a nd Vanbraekel’, 9 Maastricht Journ al of European and Comparative Law 1 (2002), p. 189–
213 at 199.
Recent Legal De velopments
384 18 MJ 3 (2011)
enhanced and decision-making in health care had to be moved back from the juridical to
the political sphere.12 e Commi ssion took the initiative.
Aer rst attempts to integrate the new ‘Decker-Kohll proc e du re ’ i n Re g ul at i on 140 8 /71
and to include healthcare in the Bolkestein Services Directive had failed, the Commission,
and more specica lly DG SANCO, launched a public consultat ion in 2006. Most notably,
this consultation revealed that in addition to more clarity about reimbursement of the
costs of cross-border healthcare, there was a desire to broaden the scope of activity so as to
also encompass safety and quality of care and cross-border health cooperation. Following
an impact assessment procedure,13 the Comm issio n na lly ad opted , as p art o f its re newed
social agenda for 21st century Europe’,14 a ‘Proposal for a Directive of the European
Parliament and of the Council on the application of patients’ rights in cross-border health
ca re’, 15 which indeed provided for a more wholesome framework for cross-border care.
e legislative procedure ran far f rom smoothly. In the rst reading the Pa rliament
proposed numerous amendments and in the Counci l there was strong opposit ion from
Member States that insisted on keeping control over their healthcare systems. It took
ultimately more th an two years before a compromise could be reached in December
2010 in the tripart ite negotiations b etween Commission, Council a nd Parliament and
Commission. In the end, the Directive was adopted on 9 March 2011 by majorit y vote.
Poland, Portugal and Romania voted against, thereby stressing that they regret that the
Directive ‘does not provide a sucient guarantee of a high level of qualit y and sa fety
to patients w ishing to receive cross-border healthcare and doe s not entirely respect the
responsibilities and competences of the Member States in relation to the organizat ion
and planning of nationa l health systems’.16
General Aspects
e goa ls of the PRD are (i) to facilitate access to safe and high-qu ality cros s-border
health ca re, (ii) to promote – in full respect of nat ional competencies in organi zing and
delivering healt hcare- cooperation on healthcare between the Member States and (iii) to
clarif y its relationship with the social security coordination regime formerly governed by
the aforementioned Regulation 1408/71 and, since 1 May 2010, Regulat ion 883/2004.17
12 See furt her S. Greer and S. Rauscher, ‘Destabili zation and Restabi lization Politic s: Policy and Politic al
reactions t o European Union Healthcare S ervices Law ’, 18 Journal of Euro pean Public Polic y 2 (2011),
p. 220–240.
13 Commission sta working document of 2 July 2008, accompanying docume nt to the proposed patients’
rights Direc tive: Impact Asses sment, SEC (2008) 2163.
14 Communicat ion from the Com mission to the Eu ropean Parliam ent, the Council , the European
Economic and S ocial Co mmittee a nd the Committ ee of the Re gions, Ren ewed social agend a:
Opportuniti es, access and solid arity in 21st century Europe, COM (20 08) 412 nal.
15 COM (2008) 414 nal.
16 Council of t he European Union, 23 Februa ry 2011, Interinstitutiona l le: 2008/0142 (COD).
17 Article 1(1) PRD.
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