The Role of Ethics and Bioethics in EU law and ECJ case-law

THE ENTREPRENEURIAL SCHOOL® 6020 Innsbruck / Austria www.mci.edu

MCI MANAGEMENT CENTER INNSBRUCK Universitätsstraße 15 [email protected]

1

THE ROLE OF ETHICS AND BIOETHICS

IN EU LAW AND ECJ CASE-LAW



2

Starting point (examples)

Source: Council Conclusions on Common values and principles in European Union Health Systems, OJ 2006 C 146, p. 1

Source: Directive 2011/24/EU of 9 March 2011 on the application of patients’ rights in cross-border healthcare, OJ 2011 L 88, p. 45 (7th recital)

http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52006XG0622(01)

http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32011L0024&qid=1433309650680



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“While medical ethics now makes up a large and central subsection of bioethics, bioethics extends beyond the realms of medicine and health care to encompass areas including environmental ethics, ethical issues of sexuality and reproduction, and for example what is sometimes now called 'genetics', the ethics of genetic choice and manipulation.” (p. 3) “In short, bioethics investigates ethical issues arising in the life sciences (medicine, health care, genetics, biology, research, and so forth) by applying the principles and methods of moral philosophy to these problems. Medical ethics and genethics (ethical issues arising from the discipline of genetics) are subsets of bioethics.” (p. 4)

Starting point (bioethics)

Source: Harris, J. (Ed.). (2001). Oxford readings in philosophy. Bioethics. New York: Oxford University Press, pp. 3 and 4



4

Ethics – your opinion

pingo.upb.de

0652

Which of the following topics do you perceive to be unethical? • Abortion • Doping • GMOs • Human embryonic stem cell research • IVF • Passive euthanasia • Surrogacy

http://pingo.upb.de/



5

Agenda

Ethics – starting point

EU Primary and Secondary law

ECJ case-law

Conclusion

http://eur-lex.europa.eu/homepage.html?locale=en



6

Starting point

• Research question • How and at which level is ethics determined?

• Methodology • Inductive: database research, analysis and

clustering of relevant documents (see infra)

• Languages: Mainly English and German; in case of inconsistencies: also Spanish, French and Italian

• Documents identified • Number: roughly 80 …

… already having excluding those, which are not in force any more

• Sectors: mainly health related fields

• Areas covered • Ethics in EU Primary, as well as EU Secondary law

• Ethics in ECJ case-law (see infra)

• Not: Agreements, EFTA documents, preparatory acts, parliamentary questions, etc.

http://eur-lex.europa.eu/homepage.html?locale=en



7

United …

• Charter of Fundamental Rights of the EU (CFR) • “peaceful future based on common values ” (preamble, 1st recital)

• “Conscious of its spiritual and moral heritage” (preamble, 2nd recital)

• Treaty on European Union (TEU) • “DRAWING INSPIRATION from the cultural, religious and humanist inheritance of Europe, from

which have developed the universal values of the inviolable and inalienable rights of the human person, freedom, democracy, equality and the rule of law,” (preamble, 2nd recital)

• EU values (Article 2); see infra

The motto: United in diversity Picture credits: http://europa.eu/abc/ euslides/index_de.htm

The EU motto: See Treaty establishing a Constitution for Europe (not entered into force): preamble 4th recital; Article I-8 (Link)

http://europa.eu/abc/symbols/index_en.htm

http://old.eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2004:310:SOM:EN:HTML



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… in diversity

• CFR • “respecting the diversity of the cultures and traditions of the peoples of Europe as well as the

national identities of the Member States and the organisation of their public authorities at national, regional and local levels” (preamble, 3rd recital)

• TEU • “DESIRING to deepen the solidarity between their peoples while respecting their history, their

culture and their traditions” (preamble, 6th recital)

• “It shall respect its rich cultural and linguistic diversity, and shall ensure that Europe's cultural heritage is safeguarded and enhanced.” (Article 3 para. 3 subpara. 4)

• “The Union shall respect the equality of Member States before the Treaties as well as their national identities, inherent in their fundamental structures, political and constitutional, inclusive of regional and local self-government.” (Article 4 para. 2)



9

Primary EU law (protocols)

• Protocol on Article 40.3.3 of the Constitution of Ireland (Maastricht Treaty 7.2.1992, OJ 1992 C 191/94, OJ 2012 C 326, p. 321)

• “Nothing in the Treaties, or in the Treaty establishing the European Atomic Energy Community, or in the Treaties or Acts modifying or supplementing those Treaties, shall affect the application in Ireland of Article 40.3.3 [right to life of the unborn] of the Constitution of Ireland.“

• N.B. Case 4.10.1991, C-159/90, Society for the Protection of Unborn Children Ireland.

• Protocol on abortion in Malta (Accession Treaty CEEC 16.4.2003, OJ 2003 L 236, p. 947)

• “Nothing in the Treaty on European Union, or in the Treaties establishing the European Communities, or in the Treaties or Acts modifying or supplementing those Treaties, shall affect the application in the territory of Malta of national legislation relating to abortion.”

http://old.eur-lex.europa.eu/JOHtml.do?year=1992&serie=C&textfield2=191&Submit=Suche&_submit=Suche&ihmlang=en

http://old.eur-lex.europa.eu/JOIndex.do?year=2003&serie=L&textfield2=236&Submit=Search&_submit=Search&ihmlang=en



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Primary EU law (declarations)

• Declaration (No 39) by the Government of the Republic of Poland

concerning public morality

(Accession Treaty CEEC 16.4.2003 final act, OJ 2003 L 236, p. 983) • “The Government of the Republic of Poland understands that nothing in the provisions of the

Treaty on European Union, of the Treaties establishing the European Communities and the provisions of treaties amending or supplementing those treaties prevents the Polish State in regulating questions of moral significance, as well as those related to the protection of human life.”

• N.B: Restricted by Joint Declaration No 21 (OJ 2003 L 236, p. 978).

• Declaration (No 61) by the Republic of Poland on the CFR (Lisbon Treaty 13.12.2007 final act, OJ 2007 C 306, p. 270)

• “The Charter does not affect in any way the right of Member States to legislate in the sphere of public morality, family law, as well as the protection of human dignity and respect for human physical and moral integrity.“

http://old.eur-lex.europa.eu/JOIndex.do?year=2003&serie=L&textfield2=236&Submit=Search&_submit=Search&ihmlang=en

http://old.eur-lex.europa.eu/JOIndex.do?year=2007&serie=C&textfield2=306&Submit=Search&_submit=Search&ihmlang=en



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Umbrella philosophy (EU Primary law)

Picture sources: http://europa.eu/about-eu, http://all-free-download.com/free-icon/umbrella-icon.html

Public morality (not defined) as reason of justification in the context of the free movement of goods (Art. 36 TFEU)

Nothing in Treaties shall affect Irish constit. law concerning abortion (Prot. Maastricht Treaty 1992) Nothing in Treaties shall

affect nat. law concerning abortion (Prot. Accession Treaty 2003)

Nothing in Treaties shall affect nat. law concerning “questions of moral significance” and “the protection of human life” (Declaration Accession Treaty 2003)

EU Charter does not affect right to legislate “in the sphere of public morality [...] of human dignity and respect for human physical and moral integrity” (Declaration Lisbon Treaty 2007)



12

Secondary law – preliminary remarks

• Lost in translation • Ethics vs. morality

• Ethical vs. similar concept, worded in different way (e.g. “can humanely be allowed”)

• Ethical vs. loyal behaviour

• “Professional ethics” vs. “standesrechtliche Regeln” “Code of ethics” vs. “Verhaltenskodex”

• Beneficiaries (cf. wide definition of bioethics)

• Humans (in general, incapacitated subjects, children)

• Animals (“intrinsic value”)

• Plants and environment



13

Determination of content / Relation law and ethics

• Relation law and ethics • Supporting argument

• Opening clauses (parallelism law & ethics)

• Clash (cf. Radbruch)

• Determination of content / understanding • Category of non-interference (similar as in EU Primary law)

• (1.) Ethics committees, at (a.) EU and/or (b.) at national level

• (2.) Codes of conduct, at (a.) EU and/or (b.) at national level

• (3.) References to other (international) documents

• (4.) Category, where some hints are provided as regard the content or understanding of ethics

• (5.) Category, where ethics remains undetermined

• Excursus: EU institutions



14











Relation law and ethics

Directive 2009/30/EC of 23 April 2009 amending Directive 98/70/EC as regards the specification of petrol, diesel and gas-oil and introducing a mechanism to monitor and reduce greenhouse gas emissions [etc.], OJ 2009 L 140, p. 88 (11th recital)

http://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1433515183285&uri=CELEX:32009L0030



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Relation law and ethics











Source: Directive 98/44/EC of 6 July 1998 on the legal protection of biotechnological inventions, OJ 1998 L 213, p. 13 (39th recital)

Picture credits: http://www.internationalstemcell.com/Parthenogenesis




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Determination of content











Source: Directive 2011/24/EU of 9 March 2011 on the application of patients’ rights in cross-border healthcare, OJ 2011 L 88, p. 45 (7th recital)

Picture credits: Frischhut, M., & Stein, H. (2011). Patientenmobilität: Aktuelle Richtlinie und EuGH-Rechtsprechung. Wien: Facultas.wuv.




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Source: Regulation (EU) No 1291/2013 11 December 2013 establishing Horizon 2020 - the Framework Programme for Research and Innovation (2014-2020) [etc.], OJ 2013 L 347, p. 104 (31st recital; see also Art. 19 para. 4)

Picture credits: https://ec.europa.eu/programmes/horizon2020/en

http://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1433510413176&uri=CELEX:32013R1291



18












Source: Directive 98/79/EC of 27 October 1998 on in vitro diagnostic medical devices, OJ 1998 L 331, p. 1 (Art. 9 para. 4 subpara. 2)




19












Source: Regulation (EC) No 1829/2003 of 22 September 2003 on genetically modified food and feed, OJ 2003 L 268, p. 1 (42nd recital)

http://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:32003R1829&qid=1433511443847



20












Source: Regulation (EC) No 1829/2003 of 22 September 2003 on genetically modified food and feed, OJ 2003 L 268, p. 1 (42nd recital)

http://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:32003R1829&qid=1433511443847



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Source: Directive 98/44/EC of 6 July 1998 on the legal protection of biotechnological inventions, OJ 1998 L 213, p. 13 (Art. 7; see also 44th recital)

Picture credits: http://www.internationalstemcell.com/Parthenogenesis




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Source: Regulation (EU) No 536/2014 of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC, OJ 2014 L 158, p. 1 (Art. 4 para. 2)

http://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1433512217209&uri=CELEX:32014R0536



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Source: Commission Recommendation of 11 March 2005 on the European Charter for Researchers and on a Code of Conduct for the Recruitment of Researchers, OJ 2005 L 75, p. 67 (Annex)

Picture credits: http://commons.wikimedia.org/wiki/File:Researcher_uses_pipettes.jpg

http://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1433512667401&uri=CELEX:32005H0251



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Source: Directive 2001/83/EC of 6 November 2001 on the Community code relating to medicinal products for human use, OJ 2001 L 311, p. 67 (Annex I, 8th recital; consolidated version)

Picture credits: http://en.wikipedia.org/wiki/Pharmaceutical_drug#/media/File:12-08-18-tilidin-retard.jpg

http://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:32001L0083&qid=1433513348650



25












Picture credits: http://en.wikipedia.org/wiki/Pharmaceutical_drug#/media/File:12-08-18-tilidin-retard.jpg

Source: Directive 2001/83/EC of 6 November 2001 on the Community code relating to medicinal products for human use, OJ 2001 L 311, p. 67 (Annex I; consolidated version)

http://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:32001L0083&qid=1433513348650



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Source: Directive 2011/24/EU of 9 March 2011 on the application of patients’ rights in cross-border healthcare, OJ 2011 L 88, p. 45 (7th recital; Article 11 para. 1, see also; 53rd recital)

Picture credits: Frischhut, M., & Stein, H. (2011). Patientenmobilität: Aktuelle Richtlinie und EuGH-Rechtsprechung. Wien: Facultas.wuv.





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(Not only) filling the gap

• Preliminary remark • References to ethics and morality in legal texts have to be seen within the limitation that those

philosophical concepts necessarily have to be reflected (!) within the legal order itself (OGH [Austrian Supreme Court] 18.04.2012, 3 Ob 45/12g)

• Human rights (CFR etc.)

• “The respect of the dignity of the human person is at the root of the ethics of science and new technologies as well as of human rights.” (EGE, CHARTE 4370/00 CONTRIB 233, p. 11)

• Human dignity (humans should be treated as subjects and not as mere objects; cf. Kant) … … and right to integrity



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• Values (Article 2 TEU)

• Not religion • Controversial discussion in CFR Convention and deviating language versions as a result thereof

• Indirect influence of religion on shaping of concept of human dignity (Moyn, 2012, http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2159248)

http://eur-lex.europa.eu/legal-content/DE/ALL/?uri=OJ:C:2012:326:TOC



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Values from 2007-2012

0

10

20

30

40

50

60

Personal values of Europeans

66 (2007)

69 (2008)

72 (2009)

74 (2010)

77 (2012)

• “Respect for human life“ and “Human rights” constantly ranked top • “Respect for other cultures” and “Religion” constantly ranked last

Sources: Eurobarometer 77 (2012), p. 9 and 12; Eurobarometer 74 (2010), p. 32 and 33; Eurobarometer 72 (2009), Vol. 2, p. 148 and 152; Eurobarometer 69 (2008), 1. Values of Europeans, p. 15 and 22; Eurobarometer 66 (2007), p. 28.



30

Values from 2007-2012

0

5

10

15

20

25

30

35

40

45

Values representing the EU

66 (2007)

69 (2008)

72 (2009)

74 (2010)

77 (2012)

• “Respect for human life“ constantly not ranked top • “Respect for other cultures” ranked higher



31

Values (personal and EU) from 2007-2012

0

5

10

15

20

25

30

35

40

45

50

66 (2007) 69 (2008) 72 (2009) 74 (2010) 77 (2012)

Human rights (personal v.)

Human rights (EU v.)

Respect for human life (personal v.)

Respect for human life (EU v.)

Individual freedom (personal v.)

Individual freedom (EU v.)

Tolerance (personal v.)

Tolerance (EU v.)

Respect for other cultures (personal v.)

Respect for other cultures (EU v.)

Religion (personal v.)

Religion (EU v.)

• Biggest gap for “respect for human life”)

• Personal values always ranked

higher (except for “respect for other cultures”)



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• EU vs. Member States (MS) • Need to take into account the vertical distribution of competences,

at least to some extent

• But: Importance of EU values, not restricted to the “applicability of EU law”, … … as this is the case for the CFR (Case C-617/10, Åkerberg Fransson, para. 21)

• At EU level • EGE

• At the moment only advising the European Commission (EC); appointed by EC’s president only (until 01/2016)

• Future: only advising the Commission, or also EP and Council (joint legitimacy vs. diversity)

• 15 member representative for approx. 508 million EU citizens?

• ECJ: judicial self-restraint, but in the end also deciding sensitive issues based on a legal perspective

• Importance of (constant) dialogue etc. • Emphasized in various documents (dialogue between different stakeholders, at different vertical

levels)

• But also mentioning education and training etc. in this field

• Not only at “top level”, also bottom-up (Eurobarometer, citizens’ initiative, etc.)



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Concluding theses (Primary and Secondary law)

1. The EU’s approach with regard to ethics can best be described by its motto: united in diversity.

2. The parallelism between ethics and law (opening clauses) might be welcomed, but it leaves open a lot

of questions in the practical application of those provisions.

3. Nevertheless, we also find some documents which refer to Ethics committees (both at EU and/or

national level), or to other documents, including codes of conduct (again both at EU and/or national –

or even international – level).

4. I argue that in the interpretation of those references to ethics, the EU’s values (especially the corner

stone of human dignity) and the EU’s fundamental rights have to be taken into account. However, I

have to admit that this approach will not provide detailed answers to all possible questions.

5. The controversial discussion in the process of drafting the CFR and the Eurobarometer surveys

mentioned above suggest that religion should not play a decisive role in this regard, at least not a

direct one.



34

Agenda

Ethics – starting point

EU Primary and Secondary law

ECJ case-law

Conclusion

Disclaimer: the following part only touches upon some selected cases.



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• Sensitive cases

• Pornographic goods: Case 34/79 Henn & Darby; Case 121/85, Conegate

• Prostitution: Joined cases 115 & 116/81, Adoui & Cornuaille; Case C-268/99, Jany

• Gambling: Case C-463/13, Stanley International Betting; Case C-243/01, Gambelli and Others

• Other activities which could offend human life and dignity

• Abortion: C-159/90, SPUC

• Laser games offending human dignity: C-36/02, Omega

• ECJ approach

• The “moral, religious or cultural aspects of lotteries, like other types of gambling, in all the Member States” (Case Schindler C-275/92, para. 60) should not be disregarded, …

• …. however, a “conception shared by all Member States” is NO prerequisite in that regard (Case C-36/02 Omega, para. 37)

• Member States enjoy a margin of discretion - within the limits imposed by Treaty (Case C-36/02 Omega, para. 31) …

• …, therefore, only a “procedural” (de Witte, CMLRev 2013, 1573) or “minimal” (Hatzopoulos, Regulating services, 2012, p. 159) proportionality test

• However, double morality is not accepted (e.g. Case 121/85, Conegate)

• Language inconsistencies

• “obligaciones morales” (ES) and “moralische Verpflichtungen” (DE) vs. “ethical obligations” (EN) C-267/95 Merck v Primecrown and Beecham / Europharm, para. 53

Preliminary remarks



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• ECJ judgment

• “As regards the overall context in which the rules at issue were adopted, the Commission could rightly take the view that the general objective of the rules was, as none of the parties disputes, to combat doping in order for competitive sport to be conducted fairly and that it included the need to safeguard equal chances for athletes, athletes’ health, the integrity and objectivity of competitive sport and ethical values in sport.” (para. 43)

ECJ Case Meca-Medina 18.7.2006 (Grand Chamber [GC])

Picture credits: www.fifa.com

Source: The Economist, 6.6.2015, p. 49-50

• “cheating to win (such as doping), • cheating to lose (match-fixing) and • cheating off the field (kickbacks for marketing

rights and other business deals)” (emphases added)

http://curia.europa.eu/juris/liste.jsf?pro=&lgrec=de&nat=or&oqp=&dates=&lg=&language=en&jur=C,T,F&cit=none,C,CJ,R,2008E,,,,,,,,,,true,false,false&num=C-519/04P&td=;ALL&pcs=Oor&avg=&page=1&mat=or&jge=&for=&cid=662597

http://www.economist.com/news/international/21653615-cash-corrupts-it-can-also-help-clean-up-sport-good-money-bad-money?zid=319&ah=17af09b0281b01505c226b1e574f5cc1

http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//TEXT+TA+P8-TA-2015-0233+0+DOC+XML+V0//EN&language=EN



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• Directive 2001/18/EC of 12 March 2001 on the deliberate release into the environment

of genetically modified organisms [etc.], OJ 2001 L 106. p. 1

• The following text excludes later amendments, e.g. by Regulation (EC) No 1829/2003 (see supra)

• “Respect for ethical principles recognised in a Member State is particularly important. Member States may take into consideration ethical aspects when GMOs are deliberately released or placed on the market as or in products.” (9th recital)

• Consultation of EGE “with a view to obtaining advice on ethical issues of a general nature regarding the deliberate release or placing on the market of GMOs. Such consultations should be without prejudice to the competence of Member States as regards ethical issues” (57th recital)

• Member States able to consult national committee “with a view to obtaining advice on the ethical implications of biotechnology” (58th recital)

ECJ Case EC v. Poland 18.7.2006 (2nd Chamber)




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• General public in Poland against GMOs

• “The Republic of Poland also referred to the fears expressed by the general public in Poland concerning the harm posed by GMOs to public health and the environment, and the fact that the Polish general public has shown itself to be strongly opposed to GMOs; additionally, it referred to the need to respect ethical principles, in accordance with recital 9 in the preamble to Directive 2001/18, claiming in that regard that the introduction into the Polish legal system of provisions to which most of the Polish people were opposed would be unethical.” (para. 19)

• “In the present case, the adoption of the contested national provisions was inspired by the Christian and Humanist ethical principles adhered to by the majority of the Polish people.” (para. 30)

• “In that connection, the Republic of Poland goes on to put forward a Christian conception of life which is opposed to the manipulation and transformation of living organisms created by God into material objects which are the subject of intellectual property rights; a Christian and Humanist conception of progress and development which urges respect for creation and a quest for harmony between Man and Nature; and, lastly, Christian and Humanist social principles, the reduction of living organisms to the level of products for purely commercial ends being likely, inter alia, to undermine the foundations of society.” (para. 31)

• “The Republic of Poland also emphasises that it is well known that, at the time of the vote on the contested national provisions, most members of the Polish Parliament belonged to political parties for which the Roman Catholic faith is a fundamental value, so that it is not at all surprising that they were inspired by Christian and Humanist values, which are prevalent and are shared by the electorate, rather than by considerations relating to the environment or public health, which are scientifically complex and more difficult to understand.” (para. 41)





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• ECJ emphasizing that its judgment is not based on ethics

• “In that connection, however, the Court considers that, for the purposes of deciding the present case, it is not necessary to rule on the question whether – and, if so, to what extent and under which possible circumstances – the Member States retain an option to rely on ethical or religious arguments in order to justify the adoption of internal measures which, like the contested national provisions, derogate from the provisions of Directives 2001/18 or 2002/53.” (para. 51)

• If challenging (alleged unethical) EU law, the burden of proof lies upon Member States

• “In the present case, it is sufficient to hold that the Republic of Poland, upon which the burden of proof lies in such a case, has failed, in any event, to establish that the true purpose of the contested national provisions was in fact to pursue the religious and ethical objectives relied upon, which for the Commission is a matter of doubt.” (para. 52)

• “Secondly, and as regards the more specifically religious or ethical arguments put forward by the Republic of Poland for the first time in the defence and rejoinder submitted to the Court, it must be held that that Member State has failed to establish that the contested national provisions were in fact adopted on the basis of such considerations.” (para. 57)





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• Public opinion vs. EU law

• “However, a Member State cannot rely in that manner on the views of a section of public opinion in order unilaterally to challenge a harmonising measure adopted by the Community institutions […]” (para. 56)

• “As regards, more specifically, the justification based on the protection of public morality relied on by the Republic of Poland in the present case, it must be held, first, that the relevant evidentiary burden is not discharged by statements as general as those put forward by that Member State during the pre-litigation procedure and consisting in references to fears regarding the environment and public health and to the strong opposition to GMOs manifested by the Polish people, or even to the fact that the administrative regional assemblies adopted resolutions declaring that the administrative regions are to be kept free of genetically modified cultures and GMOs.” (para. 54)

• “Clearly, in those circumstances, public morality is not really being invoked as a separate justification, but as an aspect of the justification relating to protection of human health and the environment, which is precisely the concern of Directive 2001/18 in the present context […].” (para. 55)

• “However, such considerations [Polish society and Parliament attaching great importance to Christian values] are not sufficient to establish that the adoption of the contested national provisions was in fact inspired by the ethical and religious considerations described in the defence and the rejoinder, especially since the Republic of Poland had, in the pre-litigation procedure, based its defence mainly on the shortcomings allegedly affecting Directive 2001/18, regard being had to the precautionary principle and to the risks posed by that directive to both the environment and human health.” (paras. 58-59)





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• Facts of the case

• Council Directive 92/85/EEC of 19.10.1992 on the introduction of measures to encourage improvements in the safety and health at work of pregnant workers and workers who have recently given birth or are breastfeeding

• At the date, Ms. Mayr was given notice of her dismissal (10.3.2005), the ova taken from her had already been fertilised with her partner’s sperm cells and, therefore, in vitro fertilised ova already existed on that date (para. 20)

• Three days after Ms. Mayr had been informed of her dismissal (i.e. on 13.3.2005), two fertilised ova were transferred into her uterus (para. 21)

• She therefore argues, that she was entitled to the protection against dismissal, as of the date on which the in vitro fertilisation of her ova took place (paras. 22 i.c.w. 13)

• ECJ’s approach

• Sensitive issue, multiple traditions and value systems in the Member States (MS), …

• … therefore not solution from an ETHICAL, but from a purely LEGAL (objective of this directive) perspective (para. 38)

• Solution

• Possibility to store fertilized ova, before transfer into the uterus of the woman concerned (here even up to 10 years) -> no protection under this Directive (92/85/EEC) (para. 42)

• But possible protection according to Directive for equal treatment of men and women in working conditions etc. (76/207/EEC, now 2006/54/EC) (para. 54)

ECJ Case Mayr 26.2.2008 (GC)

Picture credits: Wikipedia Link

http://curia.europa.eu/juris/document/document.jsf?doclang=EN&text=&pageIndex=0&part=1&mode=lst&docid=72369&occ=first&dir=&cid=33384

http://en.wikipedia.org/wiki/In_vitro_fertilisation



42

ECJ Case Mayr 26.2.2008 (GC)

• Definition of IVF / process, i.e. different stages

“As a preliminary point, it should be noted that in vitro fertilisation describes the fertilisation of an

ovum outside a woman’s body. According to the Commission of the European Communities, that

treatment involves a number of stages, such as, inter alia, hormonal stimulation of the woman’s

ovaries intended to bring a number of ova to maturation at the same time; follicular puncture; the

removal of the ova; the fertilisation of one or more ova with previously prepared sperm cells; the

transfer of the fertilised ovum or ova into the uterus, either on the third day, or on the fifth day following

the removal of the ova, except where the fertilised ova are to be frozen, and nidation.” (para. 30)

• Judicial self restraint

“In that regard, it should be pointed out that, although, as the Austrian Government observed, artificial

fertilisation and viable cells treatment is a very sensitive social issue in many Member States,

marked by their multiple traditions and value systems, the Court is not called upon, by the present

order for reference, to broach questions of a medical or ethical nature, but must restrict itself to a

legal interpretation of the relevant provisions of Directive 92/85 [*] taking account of the wording, the

broad logic and the objectives of that directive.” (para. 38)

[*] “Council Directive 92/85/EEC of 19 October 1992 on the introduction of measures to encourage improvements in the

safety and health at work of pregnant workers and workers who have recently given birth or are breastfeeding”

http://curia.europa.eu/juris/document/document.jsf?doclang=EN&text=&pageIndex=0&part=1&mode=lst&docid=72369&occ=first&dir=&cid=33384



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ECJ Cases Brüstle, ISC, etc.

”Parthenogenesis ISCO has pioneered development of a new class of stem cells, human parthenogenetic stem cells (hpSCs) that has the best characteristics of each of the other classes of stem cells. The stem cells are created by chemically stimulating the oocytes (eggs) to begin division. The oocytes are not fertilized and no viable embryo is created or destroyed.“

Source: http://www.internationalstemcell.com/Parthenogenesis

http://www.internationalstemcell.com/Parthenogenesis



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ECJ Cases Brüstle, ISC, etc.

Case Brüstle Case ISC “Crispr-Cas9”

AG: 10.3.2011 Jug: 18.10.2011 (GC)

AG: 17.7.2014 Jug: 18.12.2014 (GC)

Source: Der Spiegel 18/2015, 25.4.2015

• “human dignity” as argument against patentability

• -> broad interpretation of “embryo“

• -> “parthenogenesis” seems to be covered

• ability to develop to human being (totipotent)

• “parthenogenesis” not covered, as here genetic manipulation would be necessary (so far, only observed with mice)

• no ability to develop to human being (only pluripotent)

• genetic manipulation also possible in case of humans (not only mice), developed by Chinese scientists

• therefore, possibility to develop to human beings (totipotent)

• cf. Art. 13 Biomedicine Convention

Source: http://www.internationalstemcell.com/Parthenogenesis

”Parthenogenesis ISCO has pioneered development of a new class of stem cells, human parthenogenetic stem cells (hpSCs) that has the best characteristics of each of the other classes of stem cells. The stem cells are created by chemically stimulating the oocytes (eggs) to begin division. The oocytes are not fertilized and no viable embryo is created or destroyed.“

Directive 98/44/EC on the legal protection of biotechnological inventions

See also The Economist, 2.5.2015, p. 71

http://curia.europa.eu/juris/liste.jsf?language=en&num=C-34/10

http://curia.europa.eu/juris/liste.jsf?pro=&nat=or&oqp=&dates=&lg=&language=en&jur=C,T,F&cit=none,C,CJ,R,2008E,,,,,,,,,,true,false,false&num=C-364/13&td=;ALL&pcs=Oor&avg=&page=1&mat=or&jge=&for=&cid=33357

http://www.internationalstemcell.com/Parthenogenesis



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Law, human rights, ethics and morality

• Human dignity (already mentioned in Directive 98/44/EC) as a limit to patentability in this field • “Directive opens up a space for ethical and moral considerations under the categories of ordre public and

morality” (AG in ISC, para. 39) • Directive 98/44/EC: an example for

• a minimum EU wide compromise (Art. 6 para. 2 leg. cit.), … • … that can be further concretised by Member States (Art. 6 para. 1 leg. cit.)

• “research on human embryonic stem cells derived from embryos raises significant ethical concerns” (AG in ISC, para. 28)

• “emergence of a ‘law of bioethics’” at national level; however, not exempted “from the legal sphere” (AG in ISC, para. 38)

• Judicial self-restraint; legal, not ethical approach (ECJ Brüstle, para. 30)



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ECtHR Case of Lambert and Others v. France (Grand Chamber, 5.6.2015)

• Facts of the case

• Head injuries in road accident –> vegetative or minimally conscious state; receives artificial nutrition and hydrations

• Decision by doctors to withdraw the patient’s nutrition and reduce his hydration

• Family disagrees; he cannot state his will

• Challenged norms (Convention for the Protection of Human Rights and Fundamental Freedoms)

• Article 2 para. 1 (right to life)

• etc.

ECtHR Case Lambert 5.6.2015 (Grand Chamber)

http://conventions.coe.int/treaty/en/Treaties/Html/005.htm



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ECtHR Case of Lambert and Others v. France (Grand Chamber, 5.6.2015)

• Judgment (no violation of Article 2, by 12:5 votes; nor of any other provision)

• “Court stresses that the issue before it in the present case is not that of euthanasia, but rather the withdrawal of life-sustaining treatment“ (para. 141)

• “no consensus exists among the Council of Europe member States in favour of permitting the withdrawal of artificial life-sustaining treatment” (para. 147)

• “Accordingly, the Court considers that in this sphere concerning the end of life, as in that concerning the beginning of life, States must be afforded a margin of appreciation, not just as to whether or not to permit the withdrawal of artificial life-sustaining treatment and the detailed arrangements governing such withdrawal, but also as regards the means of striking a balance between the protection of patients’ right to life and the protection of their right to respect for their private life and their personal autonomy […]. However, this margin of appreciation is not unlimited […] and the Court reserves the power to review whether or not the State has complied with its obligations under Article 2.” (para. 148)

• “The Court is keenly aware of the importance of the issues raised by the present case, which concerns extremely complex medical, legal and ethical matters. […]” (para. 181)

• Joint partly dissenting opinion

• “[the] conscience [of Europe] must not only be well informed but must also be underpinned by high moral or ethical values. […]; it is of the very essence of a conscience, based on recta ratio, that ethical matters should be allowed to shape and guide the legal reasoning to its proper final destination. That is what conscience is all about.” (para. 11)

ECtHR Case Lambert 5.6.2015 (Grand Chamber)



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Concluding theses

1. As clearly pointed out by Sandel, the question remains, what should money

not be able to buy (in the fields of football, surrogacy, stem cell research, etc.)?

2. Law tends to be one step behind science. In addition, scientific developments

can substantially change legal solutions, as we have seen in the cases of

Brüstle and ISC.

3. In this context, it can be challenging for courts to get appropriate scientific

information (e.g. provided by national courts, parties, or institutions).

4. The European Court of Justice of the EU (ECJ), similar to the European Court

of Human Rights of the Council of Europe (ECtHR) grants Member States a lot of discretion in

sensitive fields. However, this discretion is not unlimited.

5. As an overall statement, it can be observed that in that context it might be easier for the ECJ to decide

those sensitive issues based on law, than it is in the case of the ECtHR, as the legal provisions in the

EU (i.e. Secondary law) tend to be more detailed.

6. The ECJ emphasizes the fact that its judgments are based on law and not on ethical considerations,

which it nonetheless observes to exist.

http://www.justiceharvard.org/about/about-what-money-cant-buy/



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Concluding theses

7. As already asserted by others(*), there is no harmonization of sensitive issues like assisted

reproduction, (also) in the EU. However, Directive 98/44/EC could be taken as a role model in order to

strike a balance between “a minimum, Union-wide consensus for all Member States” (AG in ISC, para.

42), and further concretisation by Member States.

(*) Hervey, 1998; Pennings, 2009; Shalev & Werner-Felmayer, 2012; Flatscher-Thöni & Voithofer,

2015, etc.

8. Also in the context of ethics in ECJ case-law, religious considerations play no role, at least not a

direct one.



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Thank you for your attention!

MCI MANAGEMENT CENTER INNSBRUCK THE ENTREPRENEURIAL SCHOOL® Dr. Markus Frischhut, LL.M. Professor & Study Coordinator European Union Law Management & Law (BA) International Business & Law (MA) Universitaetsstrasse 15, 6020 Innsbruck, Austria Phone: +43 512 2070 -3632, Fax: -3699 mailto:[email protected], www.mci.edu

mailto:[email protected]

http://www.mci.edu/

The Role of Ethics and Bioethics in EU law and ECJ case-law

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