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The impact of EU law in the health care sector. Access to and quality of care

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Abstract and Figures

Access to healthcare within the EU varies significantly, as competences for public health are mainly those of the Member States (Art. 168 TFEU). However, both the Court of Justice of the EU, as well as soft- (common values and principles) and hard-law (harmonization in selected fields) have had some noteworthy impact; both on national health systems, as well as for patients seeking cross-border healthcare. Quality of care is a vital issue for access to healthcare; thus, this contribution will also shed some light on quality of care and patient safety, as influenced both by case-law and harmonization rules. Finally, against the background of the current migration challenge, this contribution will point out who, under EU law, is genuinely entitled to access healthcare.
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THE IMPACT OF EU LAW IN THE HEALTH CARE
SECTOR: ACCESS TO AND QUALITY OF CARE
Seminar “Research Group Law, Democracy and Welfare” |
Bergen | May 3rd, 2018
N.B. Updated and slightly modified version of keynote at the 6th Conference of the
European Association of Health Law (EAHL) | Bergen | September 29th, 2017
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Chair website | https://jeanmonnet.mci.edu
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Structure
Setting the
agenda
Hard-, soft-
and case-law
Harmonization
concerning
quality of care
Entitled
persons
Conclusion
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Unmet need for health care | statistics
Source: Expert Panel on Effective Ways of Investing In Health (EXPH), 2018, p. 27.
Fell until financial crisis (2008/9),
then slight increase of unmet need
(due to cost, distance or waiting
time).
Source: EXPH, 2016, p. 11 (see also p. 17).
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Unmet need for health care | statistics
Source: EXPH, 2018, p. 26.
Differences in Member States
(due to cost, distance and waiting
time).
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Unmet need for health care | statistics waiting lists
Source: EXPH, 2016, p. 88.
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EU | access to healthcare
Source: European Commission, On effective, accessible and resilient health systems, COM(2014) 215 final 4.4.2014, p. 8.
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Structure
Setting the
agenda
Hard-, soft-
and case-law
Harmonization
concerning
quality of care
Entitled
persons
Conclusion
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Vertical distribution of competences
Art. 168 (7) TFEU: Union action shall respect the responsibilities of the Member States for the
definition of their health policy and for the organisation and delivery of health services and
medical care. The responsibilities of the Member States shall include the management of
health services and medical care and the allocation of the resources assigned to them. […]
“It is true that, in accordance with Article 168(7) TFEU, as interpreted in the case-
law of the Court, EU law does not detract from the power of the Member States to
adopt provisions aimed at organising their health services.
In exercising that power, however, the Member States must comply with EU law,
in particular the provisions of the TFEU on the freedom of establishment, which
prohibit the Member States from introducing or maintaining unjustified restrictions
on the exercise of that freedom in the health care sector […].
Source: CJEU 21.9.2017, Malta Dental Technologists Association, C-125/16, para. 54.
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History | CJEU paving the way | patient mobility
1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021
Kohll Vanbraekel
Smits & Peerbooms
Müller-Fauré
Inizan
Leichtle Watts Stamatelaki Rindal &
Slinning
(EFTA-Court)
EC v Spain
EC v France
Elchinov
EC v LXB
EC v Port
EC v
Germany Luca
Femarbel Široká
Petru
Directive
2011/24/EU
Proposal Implementation
Directive
2006/123/EC
Patient
mobility
established
Waiting lists
Quality
standards
Only care covered in MSA
Gen. conditions still apply
Cost-intensive
infrastructure Austerity
Health values
Nikolaus-
beschluss
(BVerfG)
CJEU = Court of Justice of the EU
MSA = Member State of Affiliation
MST = Member State of Treatment
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Soft law | values | united in diversity
Source: Council Conclusions on Common values and principles in European Union Health Systems, OJ 2006 C 146/1.
“[This statement by the 25 Health Ministers] also explains that the practical ways in which these values and principles become a
reality in the health systems of the EU vary significantly between Member States, and will continue to do so. In particular, decisions
about the basket of healthcare to which citizens are entitled and the mechanisms used to finance and deliver that healthcare, such
as the extent to which it is appropriate to rely on market mechanisms and competitive pressures to manage health systems must be
taken in the national context.”
Universality: “means that no-one is barred access to health care”
Equity: “relates to equal access according to need, regardless of ethnicity, gender, age, social status or ability to pay”
Solidarity: “is closely linked to the financial arrangement of our national health systems and the need to ensure accessibility to all
Cf. also Newdick, 2006: “corroding solidarity”; also critical: Hervey & McHale, 2015, p. 81 (“privileges those patients who are able to behave as consumers”).
On “humanitarian solidarity” see Meulen, 2017, p. 185: (“This principle can be defined as a responsibility to protect those persons whose existence is
threatened by circumstances beyond their control, particularly natural fate or unfair social structures.”).
Health values
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Soft law | values and principles
Acc. to Williams (2010, p. 256) principles possess a deontological character, whereas
values (cf. also Art. 2 TEU) are teleological.
Source: Council Conclusions on Common values and principles in European Union Health Systems, OJ 2006 C 146/1.
Quality: continuous training of healthcare staff based on clearly defined national standards and ensuring that staff have access to
advice about best practice in quality
Safety: monitoring of risk factors and adequate, training for health professional
Care that is based on evidence and ethics: Demographic challenges and new medical technologies can give rise to difficult
questions (of ethics and affordability), which all EU Member States must answer. Ensuring that care systems are evidence-based is
essential, both for providing high-quality treatment, and ensuring sustainability over the long term.
Patient involvement: transparency, information, consent
Redress
Privacy and confidentiality
Health values
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EU | access to healthcare
Source: European Commission, On effective, accessible and resilient health systems, COM(2014) 215 final 4.4.2014, p. 17.
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State-of-the-art | case-law
1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021
Kohll Vanbraekel
Smits & Peerbooms
Müller-Fauré
Inizan
Leichtle Watts Stamatelaki Rindal &
Slinning
(EFTA-Court)
EC v Spain
EC v France
Elchinov
EC v LXB
EC v Port
EC v
Germany Luca
Femarbel Široká
Petru
Directive
2011/24/EU
Proposal Implementation
Directive
2006/123/EC
Quality
standards
Health values
Nikolaus-
beschluss
(BVerfG)
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State-of-the-art | case-law | experimental care
what is considered normal according to the state of international medical science and
medical standards generally accepted at international level(para. 92)
treatment has to be “sufficiently tried and tested” (para. 94)
account has to be taken of “existing scientific literature and studies, the authorised
opinions of specialists [etc.]” (para. 98)
Cf. also Art. 114 (3) TFEU: “high level of protection, taking account in particular of any new
development based on scientific facts(since Amsterdam Treaty)
MST (A) standards considered experimental by MSA
national standards (MSA; NL)
Smits & Peerbooms (CJEU)
if international standard
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State-of-the-art | case-law | lacking infrastructure
“Regulation No 1408/71 does not distinguish between the different reasons for
which a particular treatment cannot be provided in good time” (para. 33)
i.e. rejecting the idea of the Advocate General that in case of “structural and prolonged deficiencies
[the Regulation would not require] Member States to authorise a service” (para. 28-33)
This also includes lack of medication and of medical supplies and infrastructure” (para. 33)
Reference to “all the hospital establishments in the Member State of residence that are capable of
providing the treatment in question” (para. 34)
national standards (MSA; RO)
Petru (CJEU)
equating inadequate care with
unavailable care
“She claims that the hospital did not have basic medical
supplies such as painkillers, antiseptic/disinfectant, absorbent
cotton wool or sterile dressings. Furthermore, the hospital had
a high volume of patients, with, on average, three times as
many patients as beds.”
Source: Advocate General Cruz Villalón in Case C-268/13 Petru EU:C:2014:2023, para 6.
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State-of-the-art | case-law | not cure, only treat
The German Constitutional Court (BVerfG) Nikolausbeschluss
(Decision 6.12.2005, 1 BvR 347/98)
life-threatening and often deadly rare disease; could only be treated, but not healed (para. 20)
In this exceptional situation, the BVerfG accepted a deviation from the state-of-the-art, because it could
only treat but not heal …
… under the condition that the chosen alternative treatment method is based on indications and has
promised some kind of hope of healing, or at least a noticeable positive impact on the course of disease
(para. 64)
Only in exceptional situations; thus, strict interpretation (BVerfG 11.5.2017, 1 BvR 452/17)
Cf. also Case C-173/09 Elchinov ECLI:EU:C:2010:581, para 62 on health baskets only defining types of treatment, and the
obligation under EU law also to take into account different treatment methods
national standards (MSA; DE)
Nikolausbeschluss (BVerfG)
alternative treatment method
exceptionally, because
insufficient
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Structure
Setting the
agenda
Hard-, soft-
and case-law
Harmonizat.
concerning
quality of care
Entitled
persons
Conclusion
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EU cross-border healthcare | stakeholders
Member State Member State
COOPERATION IN HEALTHCARE
Art. 10 Mutual assistance and cooperation
Art. 11 Recognition of prescriptions issued in another MS
Art. 12 European reference networks
Art. 13 Rare diseases
Art. 14 eHealth
Art. 15 Cooperation on HTA
REIMBURSEMENT OF COSTS OF CROSS-BORDER HEALTHCARE
Art. 7 General principles for reimbursement of costs
Art. 8 Healthcare that may be subject to prior authorisation
Art. 9 Administrative procedures regarding cross-border healthcare
RESPONSIBILITIES OF MEMBER STATES
Art. 4 Responsibilities of the Member State of treatment
Art. 5 Responsibilities of the Member State of affiliation
Art. 6 National contact points for cross-border healthcare
1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021
Kohll Vanbraekel
Smits & Peerbooms
Müller-Fauré
Inizan
Leichtle Watts Stamatelaki Rindal &
Slinning
(EFTA-Court)
EC v Spain
EC v France
Elchinov
EC v LXB
EC v Port
EC v
Germany Luca
Femarbel Široká
Petru
Directive
2011/24/EU
Proposal Implementation
Directive
2006/123/EC
Health values
Nikolaus-
beschluss
(BVerfG)
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EU cross-border healthcare | competences
Art. 4: Responsibilities MS of treatment
(para. 2)
Information for patients from national contact points (a)
Information for patients from
healthcare providers (b)
transparent complaints procedures and mechanisms to
seek remedies (c)
systems of professional liability insurance (d)
data protection (e)
medical record (f)
Art. 4: Principles to be taken into
account
Principles of universality, access to good quality care,
equity and solidarity (para. 1)
Legislation of MST, including MST “standards and
guidelines on quality and safety” (para. 1)
Non-discrimination (para. 3)
Art. 5: Responsibilities MS of affiliation
reimbursement of costs (a)
information on patient’s
entitlements (b)
medical follow-up (c)
medical records (d)
In line with CJEU case-law
(e.g. Case Stamatelaki, para. 37)
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Quality of care | selected fields of harmonization
1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021
Kohll Vanbraekel
Smits & Peerbooms
Müller-Fauré
Inizan
Leichtle Watts Stamatelaki Rindal &
Slinning
(EFTA-Court)
EC v Spain
EC v France
Elchinov
EC v LXB
EC v Port
EC v
Germany Luca
Femarbel Široká
Petru
Directive
2011/24/EU
Proposal Implementation
Directive
2006/123/EC
Directive
2002/98/EC
quality and safety
blood etc.
Directive 2004/23/EC
quality and safety
tissues and cells etc.
Council
Recommendation
patient safety etc.
Directive 2010/53/EU
quality and safety
human organs
Council conclusions patient
safety and quality of care etc.
Council Conclusions Common
values and principles in EU
Health Systems
EC Directive (EU) 2017/1572
supplementing Directive
2001/83/EC on principles and
guidelines of good
manufacturing practice for
medicinal products for human
use
Nikolaus-
beschluss
(BVerfG)
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Quality of care | selected fields of harmonization
Establishments and
authorities Staff requirements
Inspection and
control (other) Quality management Traceability
Blood
Directive
(2003)
Art 4(1) [Designation
of
competent authority]
Art 5
(Designation,
authorisation,
accreditation
or licensing of
blood
establishments)
Art 9 (Responsible person)
Art 10 (personnel)
Art 8 (Inspection
and control
measures)
Chapter IV (Quality management, Art 11
-13):
Art 11 (Quality system for blood establishments)
Art 12 (Documentation)
Art 13 (Record keeping)
Chapter VI [Quality and safety with regard to donors]
Art 14
(Traceability)
Tissues
and cells
Directive
(2004)
Art 4(1) [designation
of
competent authority]
Art 6
(Accreditation,
designation, authorisation,
or
licensing of
tissue
establishments and
tissue
and cell
preparation
processes)
Art 5 (Supervision
of
human tissues and
cell
procurement)
Art 17
(Responsible
person)
Art 18 (Personnel)
Art 7
(Inspections and
control
measures)
Chapter III (Donor selection and evaluation)
Chapter IV (Provisions on the quality and safety of
tissues
and cells), and especially
oArt 16 (Quality management)
Art 8 (Traceability)
and Art 25(1)
Organs
Directive
(2010)
Art 17 (Designation and
tasks
of competent
authorities),
defined in Art 3(a) and (b)
Art 5
(Procurement
organisation)
Art 12
(Healthcare
personnel)
Art 4(3), Art 6(1),
Art
7(4), Art 15(2)
Chapter II (Quality and safety of organs)
Art 4 (Framework for quality and safety)
Art 11 (Reporting system and management
concerning
serious adverse events and reactions)
Chapter III (Donor and recipient protection and donor
selection and evaluation)
Art 15 (Quality and safety aspects of living donation)
(Art 18 Records and reports concerning
procurement
organisations and transplantation centres)
Art 10
(Traceability) ,
defined in Art 3(s)
Source: Frischhut, 2017, p. 84.
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Structure
Setting the
agenda
Hard-, soft-
and case-law
Harmonization
concerning
quality of care
Entitled
persons
Conclusion
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CFR | Art. 35
1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021
Kohll Vanbraekel
Smits & Peerbooms
Müller-Fauré
Inizan
Leichtle Watts Stamatelaki Rindal &
Slinning
(EFTA-Court)
EC v Spain
EC v France
Elchinov
EC v LXB
EC v Port
EC v
Germany Luca
Femarbel Široká
Petru
Directive
2011/24/EU
Proposal Implementation
Directive
2006/123/EC
Health values
Austerity
Nikolaus-
beschluss
(BVerfG)
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Individual entitlement:
Human right (“Everyone”); also for “irregular migrants” (Ribarov, 2014, p. 470; Rudolf, 2014, 546; both with reference to the
discussion in the Convention drafting the CFR)
Right, not just a principle (Hervey & McHale, 2014, p. 967; Rudolf, 2014, pp. 546-7); right, although named “principles” in the CFR
explanations (OJ 2007 C 303/17 [27]; Link)
No right to health, but right to health care (Right to benefit from existing treatment; Rudolf, 2014, pp. 548)
Right against state interference, but also right to treatment in case of life-threatening, unpredictable lethal disease, or in case
of a threat of severe disability (i.c.w. Art. 2 [1] and Art. 3 [1] CFR) (Rudolf, 2014, p. 548)
At least minimum approach (Hervey & McHale, 2014, p. 958, with reference to B. Toebes; p. 966; Ribarov, 2014, p. 471;
Rudolf, 2014, p. 547; Frischhut & Fahy, 2016, p. 57)
Limitation: reference to national law; international law (Art. 12 UN Social Pact and ECtHR case-law) as minimum
(Rudolf, 2014, pp. 549-50)
Mainstreaming ->
CFR | Art. 35
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Individual entitlement
Mainstreaming:
Health in all policies
High level of health, not highest (Rudolf, 2014, p. 551)
Principle, which only obliges the EU (Ribarov, 2014, p. 473)
CFR | Art. 35
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Entitlements | EU primary and secondary law
EU Primary law
Art. 35 CFR: Humans (“[e]veryone”);
however, reference to national law!
Fundamental freedoms (‘patient mobility’):
EU citizens (plus EEA, TCN family members
of EU citizens)
EU Secondary law: Directives ->
1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021
Kohll Vanbraekel
Smits & Peerbooms
Müller-Fauré
Inizan
Leichtle Watts Stamatelaki Rindal &
Slinning
(EFTA-
Court)
EC v Spain
EC v France
Elchinov
EC v LXB
EC v Port
EC v
Germany Luca
Femarbel Široká
Petru
Nikolaus-
beschluss
(BVerfG)
Source: European Commission, White paper on the future of Europe,
https://ec.europa.eu/commission/white-paper-future-europe_en, p. 7.
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Entitlements | non-discrimination
Racial Equality Directive (Directive 2000/43/EC, OJ 2000 L 180/22; not amended) Link
Not limited to EU citizens; also applies to TCN (13th recital)
no direct or indirect discrimination based on racial or ethnic origin(Art. 2 (1))
Applies to public and private sectors, including public bodies;
in relation to social protection, including social security and healthcare(Art. 3 (1) lit. e)
Men Woman Equal Treatment Directive (Directive 2004/113/EC, OJ 2004 L 373/37; not amended) Link
Services in the sense of TFEU freedom of services (11th recital), thus also comprising receiving of health
services
Not limited to EU citizens (arg.: “men and women”)
Source: SEC(2008) 2181 final 2.7.2008, p. 3.
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Entitlements | non-discrim. | minim. approach
Asylum Qualification Directive (Directive 2011/95/EU, OJ 2011 L 337/9; not amended) Link
Art. 30 Healthcare (see also Art. 29 Social Welfare)
1. Member States shall ensure that beneficiaries of international protection have access to healthcare
under the same eligibility conditions as nationals of the Member State that has granted such protection.
2. Member States shall provide, under the same eligibility conditions as nationals of the Member State
that has granted protection, adequate healthcare, including treatment of mental disorders when needed,
to beneficiaries of international protection who have special needs, such as pregnant women, disabled
people, persons who have undergone torture, rape or other serious forms of psychological, physical or
sexual violence or minors who have been victims of any form of abuse, neglect, exploitation, torture, cruel,
inhuman and degrading treatment or who have suffered from armed conflict.
“Within the limits set out by international obligations, Member States may lay down that the granting of
benefits with regard to access to employment, social welfare, healthcare and access to integration facilities
requires the prior issue of a residence permit.” (40th recital)
The possibility of limiting such assistance to core benefits is to be understood as covering at least
minimum income support, assistance in the case of illness, or pregnancy, and parental assistance, in so far
as those benefits are granted to nationals under national law.” (45th recital)
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Entitlements | minimum approach
Reception Conditions Directive (Directive 2013/33/EU, OJ 2013 L 180/96; not amended) Link
Art. 19 Health care (see also Art. 17, et passim)
1. Member States shall ensure that applicants receive the necessary health care which shall include,
at least, emergency care and essential treatment of illnesses and of serious mental disorders.
2. Member States shall provide necessary medical or other assistance to applicants who have special
reception needs, including appropriate mental health care where needed.
Reduction or withdrawal of material reception conditions: “Member States shall under all circumstances
ensure access to health care in accordance with Article 19 and shall ensure a dignified standard of living for
all applicants.(Art. 20 (5))
Mass Influx Directive (Directive 2001/55/EC, OJ 2001 L 212/12; not amended) Link
Art. 13
2. The Member States shall make provision for persons enjoying temporary protection to receive necessary
assistance in terms of social welfare and means of subsistence, if they do not have sufficient resources, as
well as for medical care. Without prejudice to paragraph 4, the assistance necessary for medical care shall
include at least emergency care and essential treatment of illness.
4. The Member States shall provide necessary medical or other assistance to persons enjoying temporary
protection who have special needs, such as unaccompanied minors or persons who have undergone
torture, rape or other serious forms of psychological, physical or sexual violence.
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Entitlements | minimum approach
TCN Long-term Resident Directive (Directive 2003/109/EC, OJ 2004 L 16/44; as amended by OJ 2011 L 132/1) Link
With regard to social assistance, the possibility of limiting the benefits for long-term residents to core
benefits is to be understood in the sense that this notion covers at least minimum income support,
assistance in case of illness, pregnancy, parental assistance and long-term care. The modalities for granting
such benefits should be determined by national law.” (13th recital; see also Art. 11 (4))
TCN Return Directive (Directive 2008/115/EC, OJ 2008 L 348/98) Link; see also Art. 2 (2) lit. a, and Art. 4 (4) lit. a
Art. 14 Safeguards pending return
1. Member States shall, with the exception of the situation covered in Articles 16 and 17, ensure that the
following principles are taken into account as far as possible in relation to third-country nationals during
the period for voluntary departure granted in accordance with Article 7 and during periods for which
removal has been postponed in accordance with Article 9:
(b) emergency health care and essential treatment of illness are provided;
Art. 16 Conditions of detention
3. Particular attention shall be paid to the situation of vulnerable persons. Emergency health care and
essential treatment of illness shall be provided.
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Structure
Setting the
agenda
Hard-, soft-
and case-law
Harmonization
concerning
quality of care
Entitled
persons
Conclusion
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Concluding theses
1. We can still observe a lot of diversity (i.e. factual situation) in a ever more “united
(i.e. health systems under the influence of EU law) environment.
2. The same applies to the 2006 EU health values, where a ‘united in diversity’ approach can
also be observed.
3. Although many CJEU judgments were based on the perspective of patient’s rights, the Court
of Justice tries to achieve a balanced situation, also taking into account Member States’
interests.
4. Access to healthcare has different dimensions, which also includes quality of care.
60 The Court has consistently held that, in order to assess whether a Member State has observed the
principle of proportionality in the area of public health, account must be taken of the fact that the health and
life of humans rank foremost among the assets and interests protected by the TFEU and that it is for the
Member States to determine the degree of protection which they wish to afford to public health and the way
in which that degree of protection is to be achieved. Since that level may vary from one Member State to
another, Member States must be allowed a measure of discretion in that area […].
61 At the same time, a particular vigilance is required when examining national measures for the
protection of public health [...].
Source: CJEU 21.9.2017, Malta Dental Technologists Association, C-125/16, paras. 60-1.
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Concluding theses
5. Quality of care has to be determined according to the international state-of-the-art.
6. Decisions should be evidence-based. As Wahlberg et al. (2017) pointed out, there is a need
to take into account both scientific research, as well as proven experience.
7. Importing non-legal concepts (e.g. medical expertise, as well as ethics) has to take place in a
relative way (cf. Frischhut 2015), i.e. taking into account the legal context of patients’ rights
and the EU’s health values.
8. We lack a clear and precise definition of quality of care. Additionally, challenges can arise in
the case of a newly emerging state-of-the-art (cf. Smits & Peerbooms), as well as in situations
where the state-of-the-art is insufficient (for instance if it can only treat but not heal; cf. the
Nikolausbeschluss).
9. Since the 2009 entry into force of the CFR, access to healthcare is a legally binding human
right (not only EU citizens), however, only attributing a self-standing (due to reference to
national law) right to treatment in the case of life-threatening situations etc.
10. Apart from the CFR, different EU Directives also grant rights, both of non-discrimination
when receiving health services, as well as the right of access to healthcare, although mainly
only following a ‘minimum approach’.
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Outlook
1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021
Kohll Vanbraekel
Smits & Peerbooms
Müller-Fauré
Inizan
Leichtle Watts Stamatelaki Rindal &
Slinning
(EFTA-
Court)
EC v Spain
EC v France
Elchinov
EC v LXB
EC v Port
EC v
Germany Luca
Femarbel Široká
Petru
Directive
2011/24/EU
Proposal Implementation
Directive
2006/123/EC
Patient
mobility
established
Waiting lists
Quality
standards
Only care covered in MSA
Gen. conditions still apply
Cost-intensive
infrastructure Austerity
Health values
Nikolaus-
beschluss
(BVerfG) ESA: Case No: 72376
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Literature mentioned on slides | references
Expert Panel on Effective Ways of Investing In Health (EXPH). (2016). Access to health services in the European Union. Luxembourg: Publications
Office.
Expert Panel on Effective Ways of Investing In Health (EXPH). (2018). Benchmarking access to healthcare in the EU. Luxembourg: Publications
Office.
Frischhut, M. (2015). "EU": Short for "Ethical" Union?: The Role of Ethics in European Union Law. Heidelberg Journal of International Law (HJIL),
75(3), 531577.
Frischhut, M., & Fahy, N. (2016). Patient Mobility in Times of Austerity: A Legal and Policy Analysis of the Petru Case. European Journal of Health
Law, 23(1), 3660.
Frischhut, M. (2017). Standards on quality and safety in cross-border healthcare. In A. d. Exter (Ed.), Cross-border health care and European
Union law (pp. 5986). Rotterdam: Erasmus University Press.
Hervey, T., & McHale, J. V. (2014). Article 35 - The Right to Health Care. In S. Peers, T. Hervey, J. Kenner, & A. Ward (Eds.), The EU Charter of
Fundamental Rights. A Commentary (pp. 951968). Oxford: Hart Publishing.
Hervey, T., & McHale, J. V. (2015). European Union health law: Themes and implications. Law in context. Cambridge: Cambridge University Press.
Meulen, R. t. (2017). Solidarity and Justice in Health and Social Care. Cambridge: Cambridge University Press.
Newdick, C. (2006). Citizenship, free movement and health care: Cementing individual rights by corroding social solidarity. Common Market Law
Review, 43(6), 16451668.
Ribarov, G. (2014). Art 35 Gesundheitsschutz. In G. Lienbacher & M. Holoubek (Eds.), Grundrechtecharta der Europäischen Union (pp. 467474).
Wien: Manz.
Rudolf, B. (2014). Artikel 35 Gesundheitsschutz. In J. Meyer (Ed.), Charta der Grundrechte der Europäischen Union (4th ed., pp. 541553).
Baden-Baden: Nomos.
Wahlberg, L., & Persson, J. (2017). Importing Notions in Health Law: Science and Proven Experience. European Journal of Health Law, 126.
Williams, A. (2010). The ethos of Europe: Values, law and justice in the EU. Cambridge studies in European law and policy. Cambridge: Cambridge
University Press.
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Thank you for your attention!
MCI MANAGEMENT CENTER INNSBRUCK
DIE UNTERNEHMERISCHE HOCHSCHULE®
Dr. Markus Frischhut, LL.M.
Jean Monnet Chair “European Integration & Ethics” and
Study Coordinator European Union Law
Management & Recht (BA)
Strategic Management & Law (MA)
Universitaetsstrasse 15, 6020 Innsbruck, Austria
Phone: +43 512 2070 -3632, Fax: -3699
mailto:markus.frischhut@mci.edu, www.mci.edu
JeanMonnet.mci.edu
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In various (binding and non-binding) legal documents, the European Union (EU) refers to “ethics” and “morality”, without providing a definition or even referring to a common understanding. However, if a certain activity is qualified as “unethical”, there can be important consequences, such as stringent ethics reviews in case of the use of human stem cells under the “Horizon 2020” program, or, under the same program, the exclusion from funding, or, under the “EU Patient Mobility Directive”, no right to cross-border healthcare, to name but a few. This article focuses both on EU Primary and Secondary law, with a special emphasis on the latter. I will argue that in a lot of cases, ethics is (only) used in order to avoid interference of the EU in Member States’ competences, especially in sensitive fields, like abortion. However, there are also examples where the relevant content is determined, either by Ethics Committees and/or Code of Conducts, either at EU or at national level. Nevertheless, other situations remain undetermined. I will further argue that the determination of ethics should be carried out by referring to the EU’s values and fundamental rights, especially the “corner stone” of human dignity.
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In this timely book, Ruud ter Meulen argues that the current trend towards individual financial responsibility for health and social care should not be at the expense of the welfare of vulnerable and dependent individuals. Written with a multidisciplinary perspective, the book presents a new view of solidarity as a distinct concept from justice with respect to health and social care. It explains the importance of collective responsibility and takes the debate on access to healthcare beyond the usual framework of justice and rights. Academics from a range of backgrounds, including sociology, ethics, philosophy and policy studies will find new perspectives on solidarity and fresh ideas from other disciplines. Policymakers will better appreciate the contribution of family carers to the well-being of dependent and vulnerable people, and the importance of the support of solidarity in these types of care.
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The case-law of the Court of Justice (ECJ) on patient mobility was recently challenged by a ruling that a patient could go to Germany for treatment when facilities in Romanian hospitals were inadequate. Given the reported impact of austerity measures in the field of health care this raises the question; what is the impact of the ECJ’s ruling on how Member States can manage expenditure and limit outflows of patients and how should such measures be legally evaluated? The objective of this article is to analyse potential impact on health systems in the context of increasing pressure on public financing for health. While the ECJ mainly referred to the requirement of treatment in due time, we also analyse possible austerity reductions of the basket of care against the background of EU law (i.e., ECJ case-law, patient mobility directive, Charter of Fundamental rights and social security regulation).
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61 At the same time, a particular vigilance is required when examining national measures for the protection of public health
61 At the same time, a particular vigilance is required when examining national measures for the protection of public health [...]." Source: CJEU 21.9.2017, Malta Dental Technologists Association, C-125/16, paras. 60-1.
Standards on quality and safety in cross-border healthcare
  • M Frischhut
Frischhut, M. (2017). Standards on quality and safety in cross-border healthcare. In A. d. Exter (Ed.), Cross-border health care and European Union law (pp. 59-86). Rotterdam: Erasmus University Press.
European Union health law: Themes and implications
  • T Hervey
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Hervey, T., & McHale, J. V. (2015). European Union health law: Themes and implications. Law in context. Cambridge: Cambridge University Press.