3. Status Quo of Ethics and Morality in EU Law

Analysing the case-law of the CJEU, one has to be aware of cases where the judgment merely quotes EU legislation (as this will be covered separately¹⁰⁰), international or national law. In addition, ethics and morality used as arguments of the parties of a case (EC, other EU institutions, or MS) have to be seen in a different light, the same applies for questions of a national court in a preliminary ruling procedure. Finally, one has to separate arguments of an Advocate General, and the binding judgment of the Court of Justice.

EU law affects almost every aspect of national law, thus also some very sensitive areas. As the Court has held, there are areas “in which there are significant moral, religious and cultural differences between the Member States. In the absence of [EU] harmonisation in the field, it is for each Member State to determine in those areas, in accordance with its own scale of values, what is required in order to ensure that the interests in question are protected”.¹⁰¹ This is the case in the following fields: various games of chance,¹⁰² the import of “articles having an indecent or obscene character”,¹⁰³ protection of children from immoral media,¹⁰⁴ prostitution,¹⁰⁵ or abortion.¹⁰⁶

We have already seen the notion of ‘public morality’, as one of the reasons of justification in the context of the fundamental freedoms of the internal market, where a similar approach was taken in international agreements. Interpreting this reason of justification, the Court held that “in principle it is for each Member State to determine in accordance with its own scale of values and in the form selected by it the requirements of public morality in its territory”.¹⁰⁷ Hence, it is not the EU to determine this notion, nor a majority of MS, but each single MS. Reference is also made to the national values, although one should take into account that this statement (1986) was given roughly 20 years before the Lisbon Treaty inserted Art 2 TEU on the common values.¹⁰⁸ The limitation stated in this case was the one of ‘double morality’, where goods legal in the home country cannot be qualified as obscene, if imported from another MS.¹⁰⁹

‘Ethics’ was an issue for instance in an Austrian case on the protection of pregnant workers against dismissal from work.¹¹⁰ The question was on the beginning of pregnancy in case of in vitro fertilisation (IVF): either already at the time of fertilization of her ova by her partner’s sperm cells, or at the time of transfer into her uterus. Before providing an answer on the details of this case, the Court gave a very important general statement:

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 [EU law].¹¹¹

At the time of this judgment, the Lisbon Treaty had already been signed (2007), although not yet entered into force (2009). Still, the Court referred to the “multiple traditions and value systems”. This Grand Chamber judgment clearly demonstrates the Court’s judicial self-restraint, comprising various dimensions: a vertical one, whereas these questions have to be determined at a national level, as well as a horizontal one, according to which it is for the legislature and not for the courts, to decide on these “sensitive social issue[s]”. As the Court has held in other cases concerning ‘morality’, “[e]ven if the morality of lotteries is at least questionable, it is not for the Court to substitute its assessment for that of the legislatures of the Member States”.¹¹² Even if the Court, in the following, decides this IVF case solely by interpreting the relevant provisions of EU law (i.e. beginning of pregnancy only as of transfer into uterus), in the end this legal interpretation of legal norms will have an indirect impact on the ethical nature of this topic. Moreover, although it is for the MS to take these decisions, the legal interpretation takes place at EU level. Based on this analysis, it is also not really a necessity for the CJEU to determine the content of the concept of ‘ethics’, as this perspective has been clearly excluded for the procedure of solving this case.

Three years later, the Court (again, Grand Chamber) had to decide another case in the field of bioethics, namely on the patentability of neural precursor cells and the processes for their production from embryonic stem cells. This case was about the Directive on biotechnological inventions, which, amongst others, excludes the patentability of “uses of human embryos for industrial or commercial purposes”.¹¹³ The key challenge, thus, centred on the interpretation of the notion of ‘human embryo’. The Court confirmed its statement in Mayr, not to decide questions of ethical nature in very sensitive fields, which are marked by MS’s “multiple traditions and value systems”, such as the definition of human embryo.¹¹⁴ However, it took a different approach, as this statement would suggest. The Court lifted the interpretation of this notion form the MS level at EU level, when stating that the notion of ‘human embryo’ is “an autonomous concept of European Union law which must be interpreted in a uniform manner throughout the territory of the Union”.¹¹⁵ While there are good reasons that notions, which are decisive for the internal market are defined at EU level,¹¹⁶ a consistent application of the ‘multiple value systems’ approach should have led to a definition at national level, only constrained by the limitation of ‘double morality’.¹¹⁷

Based on the concept of ‘human dignity’, which was mentioned in the Directive as a reason to exclude patentability,¹¹⁸ the Court held “that the concept of ‘human embryo’ within the meaning of Article 6(2)(c) of the Directive must be understood in a wide sense”¹¹⁹ and came to the following solution for fertilised and non-fertilised ova.

Accordingly, any human ovum must, as soon as fertilised, be regarded as a ‘human embryo’ within the meaning and for the purposes of the application of Article 6(2)(c) of the Directive, since that fertilisation is such as to commence the process of development of a human being.¹²⁰

That classification must also apply to a non-fertilised human ovum into which the cell nucleus from a mature human cell has been transplanted and a non-fertilised human ovum whose division and further development have been stimulated by parthenogenesis. Although those organisms have not, strictly speaking, been the object of fertilisation, due to the effect of the technique used to obtain them they are, as is apparent from the written observations presented to the Court, capable of commencing the process of development of a human being just as an embryo created by fertilisation of an ovum can do so.¹²¹

It is important to stress, from where the Court got this ‘natural science’ related information. Here, in Brüstle, the Court relied on information presented by the parties of this case, in Mayr¹²² the relevant information was provided by the Commission.

Three years later, in another Grand Chamber judgment, the Court partly had to revoke the approach it took in Brüstle, when interpreting the same legal provision. This case was about unfertilised human ovum (second quotation mentioned above) whose division and development to a certain stage have been stimulated by parthenogenesis. Although in this case the Court itself did not refer to the terms ethics or morality, this judgment is highly relevant to our issue. The Court emphasized that the legal solution in Brüstle had been based on “the written observations presented to the Court”.¹²³

However, in the present case, the referring [N.B. national] court […] stated in essence that, according to current scientific knowledge, a human parthenote, due to the effect of the technique used to obtain it, is not as such capable of commencing the process of development which leads to a human being. That assessment is shared by all of the interested parties who submitted written observations to the Court.¹²⁴

In the following, the Court did not take the final decision itself, but left it to the national court “to determine whether or not, in the light of knowledge which is sufficiently tried and tested by international medical science […], human parthenotes, such as those which are the subject of the applications for registration in the case in the main proceedings, have the inherent capacity of developing into a human being”.¹²⁵

What we can take away from this case is the fact that the Court’s approach in Brüstle, to shift the solution of a “very sensitive” issue at EU level, was a ‘flash in the pan’. It is difficult to verify or falsify the statement that the CJEU’s interpretation of human dignity in Brüstle was “motivated by (covert) religious motives”.¹²⁶ However, we can clearly state that nowadays it is more likely that the CJEU would decide a case such as Brüstle in a more reluctant way, that is to say, not to lift such interpretations of key terms (such as ‘human embryo’) to EU level. The Court also made clear that its statements are “limited to the patentability of biotechnological inventions”.¹²⁷ In other words, the CJEU did not want to decide the issue of the beginning of human life in general. This sectoral approach is also important insofar as otherwise we would have a contradiction between Mayr (transfer into uterus) on the one hand, and Brüstle (human embryo, as soon as fertilised) as well as ISC (“capacity to develop into a human being”¹²⁸), on the other.

Another example of the Court’s more reluctant approach in a sensitive field is ‘surrogacy’, a phenomenon, which, according to the EP, “undermines the human dignity of the woman since her body and its reproductive functions are used as a commodity”.¹²⁹, ¹³⁰ In two judgments, both given nine month before the ISC case, the Court had to decide technical questions of non-discrimination based on gender¹³¹ and disability.¹³² Although surrogacy can easily be qualified as a “very sensitive social issue” as stated in Mayr¹³³ and Brüstle,¹³⁴ the Court (again, Grand Chamber) neither referred to ethics nor morality, and solved this case at a legal level in a very technical way. One explanation could be that the relevant provisions of EU law did not refer to these terms of ‘ethics’ or ‘morality’, which is why the Court saw no necessity to ‘leave the legal turf’.

After these examples related to different EU directives, let us turn back to the fundamental freedoms. Here we have seen the Court’s reluctant approach, leaving more discretion to the MS, which corresponds with the ‘post-Brüstle approach’. The key limitation we have seen there was a prohibition of ‘double morality’.¹³⁵ Apart from this, the CJEU has developed another very acceptable solution to deal with ethically sensitive issues, which is a ‘more generous’ proportionality¹³⁶ review. This has been qualified as a “procedural” review by de Witte in his seminal paper “Sex, drugs & EU law”,¹³⁷ or as a “minimal proportionality control” by Hatzopoulos.¹³⁸ This can be seen as a ‘golden mean’ between either deciding these questions at national level in terms of diversity of moral and ethical choices (argument from self-determination¹³⁹), and the decision of such issues at EU level by “the transnational judiciary” (argument from containment¹⁴⁰). This means that the CJEU intervenes less substantively in the national regulation by means of the proportionality test, or as de Witte puts it:

It is argued that a procedural proportionality test that respects the substance of national moral and ethical choices, and that instead focuses on teasing out discriminatory or protectionist biases, must only assess the normative coherence of national policies, the consistent application of sanctions, and legislative transparency.¹⁴¹

The CJEC would therefore not require a Member State to follow the approach of another Member State. As long as the Member State concerned does not act in contradictory ways within its own legal system, the CJEC will not ‘interfere’. This approach also entails the prohibition of ‘double morality’, as mentioned above.

First of all, it is not possible to disregard the moral, religious or cultural aspects of lotteries, like other types of gambling, in all the Member States. The general tendency of the Member States is to restrict, or even prohibit, the practice of gambling and to prevent it from being a source of private profit. […]¹⁴²

The necessary number of MS having to share a similar view was clarified as follows:

It is not indispensable in that respect for the restrictive measure issued by the authorities of a Member State to correspond to a conception shared by all Member States as regards the precise way in which the fundamental right or legitimate interest in question is to be protected. Although, in paragraph 60 of Schindler [N.B. see supra], the Court referred to moral, religious or cultural considerations which lead all Member States to make the organisation of lotteries and other games with money subject to restrictions, it was not its intention, by mentioning that common conception, to formulate a general criterion for assessing the proportionality of any national measure which restricts the exercise of an economic activity.¹⁴³

Omega was not only an important case in terms of the extent of a consensus between MS, it can also be seen as a landmark case in terms of addressing values,¹⁴⁴ three years before the signing of the Lisbon Treaty. This case was about the possibility to restrict the fundamental freedoms based on “a fundamental value enshrined in the national [i.e. German] constitution, namely human dignity”.¹⁴⁵ The Court allowed this national value, now an EU value, to enter the fundamental freedoms via the notion of ‘public order’, despite the high requirements in this context: first, ‘public policy’ “must be interpreted strictly” and, second, there has to be a “genuine and sufficiently serious threat to a fundamental interest of society”.¹⁴⁶ The strong content-related link between ‘public policy’ as a legal reason of justification and morality also becomes obvious, when the Court states that “the concept of public policy may vary from one country to another and from one era to another”¹⁴⁷; thus, also the regional and evolutionary character, we have already seen for ‘public morality’.

Another sensitive area is genetically modified organisms (‘GMOs’). In this context, a directive emphasizes the importance of “ethical principles recognised in a Member State”, which allows them to “take into consideration ethical aspects when GMOs are deliberately released or placed on the market as or in products”.¹⁴⁸ This might have inspired Poland to argue with ethical principles for defending non-compliance with this Directive, precisely the argument that “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”.¹⁴⁹ In this regard, Poland put forward the following arguments:

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.¹⁵⁰

This case would have allowed the CJEU to broach intriguing questions of the relationship of EU law and ethics. However, the Court did not enter into a substantive analysis. By stating that 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”,¹⁵¹ it is consequently “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 […] derogate from [EU law]”.¹⁵² While it is not surprising that the Court did not allow a MS to deviate from legal obligations of an EU Directive, this statement at least leaves open the possibility of a MS, which is able to comply with this burden of proof, to rely on ethical grounds. This case is also interesting because it does not only address the relationship of EU law and ethics, but also of ethics and religion, precisely, one religion (Christianity), and of humanism.

It is also worth mentioning that Poland has positioned ethics as an argument at different levels, in order to defend its position. Poland referred to both the Polish society which “attaches great importance to Christian and Roman Catholic values”, as well as to the members of the Polish parliament.¹⁵³ It is no surprise, that the Court clearly rejected this possibility by stating “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 [EU] institutions”.¹⁵⁴

Based on the analysis of this case-law the above-mentioned question can clearly be addressed in the sense of a judicial self-restraint. This is true both with regard to ethics and morality, thus in either case, the Court saw no necessity to determine the content of these concepts, as this decision was left to the MS, acting according to their values. This holds true for the above-mentioned sensitive fields, where the Court has observed “significant moral, religious and cultural differences”. However, on a timeline, today, one would have to add the EU’s common values. As stated in Omega, a consensus amongst the MS is no necessity and the Court accepts aspects that are specifically important for a country, such as human dignity for Germany, or for Italy, rejecting the mafia. In the latter situation, the General Court recently has accepted the non-registration of a figurative trademark “La Mafia” emphasizing “accepted principles of morality are not the same in all Member States, inter alia for linguistic, historic, social and cultural reasons”.¹⁵⁵

The Court’s technical legal approach can be welcomed as it leaves these decisions to the national level and to the citizens’ representatives. However, one should not disregard the fact that in an indirect way also the legal approach will determine a medically or ethically sensitive topic. Due to this judicial self-restraint, the Court only provides sectoral solutions, thus no general statement with regard to the beginning of life.¹⁵⁶

The limitations to this national discretion are the prohibition of double morality and the requirements of coherence and legislative transparency, or in other terms, a reduced (or ‘procedural’) proportionality review.

The relationship between law and ethics concerns similar issues, as the one of law and religion. In this context, there would have been very interesting topics in this GMO case, which in the end have not been answered, since Poland has not been able to prove its point of view.

After this qualitative analysis, let us have a brief look at some quantitative findings of analysing the terms of ‘ethics’ and ‘morality’ in CJEU case-law from 1961–2015.¹⁵⁷ Focusing on those cases, where the Court itself has refereed to these terms (thus, excluding quotations of EU law or mere statements of parties, referring to these key terms), this research has revealed that more than 70% of cases have been decided since 1998,¹⁵⁸ with 29% references to ethics, 67% to morality, and 4% to both terms.¹⁵⁹ This roughly corresponds with general ‘ethicalization’ since the 1990s.

Besides a general negative conception of lobbying¹⁶⁵ and information asymmetries,¹⁶⁶ the most common challenges with regard to targets of lobbying are conflicts of interest, acceptance of gifts and corruption,¹⁶⁷ and finally the revolving doors phenomenon. They can be overcome by transparency, other general ‘guiding principles’ on ‘ethical behaviour’, rules on independence and accountability towards citizens and one’s institution, and finally rules on post term-of-office.

Transparency plays a key role for lobbying and can contribute to more ethical lobbying in manifold ways.¹⁶⁸ For instance, it can help to overcome information asymmetries, by enabling more equal access to information. At the same time, it can improve the quality of decisions taken, if these decisions (plus corresponding background information) can be known by others, and therefore be challenged. Transparency is an important principle of EU law, which is enshrined in Art 1 TEU and 10 TEU and in Art 15 TFEU. According to the CJEU, it “enables citizens to participate more closely in the decision-making process and guarantees that the administration enjoys greater legitimacy and is more effective and more accountable to the citizen in a democratic system”.¹⁶⁹

In terms of ‘guiding principles’, the EP provides most principles in its Code of Conduct (EP CoC)¹⁷⁰; these are: “disinterest, integrity, openness, diligence, honesty, accountability and respect for Parliament’s reputation”.¹⁷¹ Integrity is also the principle that plays a key role for the independence of the Commission, whereas its members shall “behave with integrity and discretion”¹⁷² with regard to appointments or benefits, after they have ceased to hold office. In literature, integrity has been defined as “the quality of being honest and morally upright”.¹⁷³ In January 2018, the EC adopted a new Code of Conduct (EC CoC), which requires members to “behave and perform their duties with complete independence, integrity, dignity, with loyalty and discretion”, as well as to “observe the highest standards of ethical conduct”.¹⁷⁴ The fact that these ‘ethical standards’ are not directly determined is less of a problem, as the principles mentioned before will very much contribute to the determination of these ethical standards. Integrity seems to be an important principle in this regard, as it is further determined in Art 6 CoC. This includes the requirement to manage the material resources of the EC in a “responsible manner”, reluctance in the context of free travel offered by third parties and hospitality, not to accept gifts worth more than € 150,¹⁷⁵ as well as notification of any decoration, prize or honour awarded to them. For ‘officials of the Union’, i.e. the staff of EU institutions, several principles are addressed. These comprise objectivity, impartiality and loyalty to the EU,¹⁷⁶ independence and avoidance of “actual or potential conflict of interest”,¹⁷⁷ “integrity and discretion” after leaving the service,¹⁷⁸ as well as requirements for recruitment, “highest standard of ability, efficiency and integrity”.¹⁷⁹ In addition, for the Commission’s staff the relevant document also mentions objectivity and impartiality as key principles, besides the ‘general principles’ of lawfulness, non-discrimination and equal treatment, proportionality and consistency.¹⁸⁰ Although not a target of lobbying, also the CJEU in its recent code of conduct does not refer to ethics or morality as such, but operates based on principles, such as independence, integrity, dignity, impartiality, loyalty, discretion, and avoidance of a conflict of interest.¹⁸¹

Regarding its content, unethical behaviour very often can be explained in terms of a conflict of interest, which occurs in situations, where a person is faced with a clash of a personal interest and the public interest, this person has to represent. According to the EC Code of conduct, “[a] conflict of interest arises where a personal interest may influence the independent performance of their duties”, or negatively defined, a conflict of interest does not exist if a member is only concerned as a member of the general public or of a broad class of persons.¹⁸² Transparency also plays a role here, in the avoidance of conflicts of interest, by means of disclosure obligations with regard to certain financial interests (occupation, board membership, company holdings, etc.).¹⁸³

The phenomenon of ‘revolving doors’ refers to situations, where former public officials start working in the private sector in jobs which target their former field of profession, or where individuals join an EU institution from the private sector.¹⁸⁴ This can result in privileged access of certain interest groups to decision makers. According to the European Ombudsman, implementing rules on this phenomenon “is central to maintaining high ethical standards in public administrations”.¹⁸⁵ Based on recent scandals (e.g. ‘Barrosogate’¹⁸⁶), the EC CoC has strengthened the rules on ‘post term of office activities’, whereby the members continue to be bound by their duty of integrity and discretion (‘cooling-off period’).¹⁸⁷ This comprises, amongst others, the prohibition for former Commissioners to lobby members or their staff “on matters for which they were responsible within their portfolio for a period of two years after ceasing to hold office”.¹⁸⁸ In case of the president, this period is even three years.¹⁸⁹ The EP has softer rules on lobbying, as former members of the EP (MEPs) just have to inform the EP and may not benefit from facilities granted to former MEPs, but lobbying as such is not prohibited.¹⁹⁰ While the only possible argument could be seen in the bigger number of former MEPs, this topic is clearly a possibility for the EP to increase citizens’ trust by strengthening these post-term rules. In terms of EU staff, “appointing authority shall, in principle, prohibit them, during the 12 months after leaving the service, from engaging in lobbying or advocacy vis-à-vis staff of their former institution”.¹⁹¹

All these substantive rules have to be accompanied by procedural safeguards. The EP has established an Advisory Committee on the Conduct of Members (‘the Advisory Committee’), which shall make recommendations in the event of possible breaches of the EP’s code of conduct.¹⁹² The requirements for qualification of its five members¹⁹³ are not very ambitious, since it only requires “taking due account of the Members’ experience and of political balance”.¹⁹⁴ Requested by the president of the EP, the Advisory Committee shall examine the circumstances of the alleged breach, and may hear the MEP concerned. Based on its findings, the Advisory Committee makes a recommendation to the EP president concerning a possible decision.¹⁹⁵ The Committee also has an important preventive function. If a possible conflict of interest occurs, in case of ambiguity a MEP may seek advice in confidence from the Committee.¹⁹⁶

The Commission clearly has set higher demands for the members of its ethics committee. The requirements for becoming a member of the ‘Independent Ethical Committee’ (IEC) are “competence, experience, independence and professional qualities”, in addition to “an impeccable record of professional behaviour as well as experience in high-level functions in European, national or international institutions”; moreover, they have to sign a declaration on the absence of conflicts of interest.¹⁹⁷ The IEC shall advise the EC on “any ethical question” related to the EC CoC and provide general recommendations to the Commission on ethical issues in this regard.¹⁹⁸ Unlike the EP’s committee, the IEC can also include a “dissenting point of view” in its opinion.¹⁹⁹ In case of the EC and a possible conflict of interest, it is not a member (as in case of the EP), but the EC president, who can consult the IEC,²⁰⁰ in a similar way as in cases of post term of office activities,²⁰¹ with the possibility to make public the IEC opinion.²⁰²

As the EC nowadays often relies on outside expertise, rules on experts play an important role for ethical lobbying and can be positioned at the interface of targets and actors of lobbying. In fact, nowadays, it is a huge challenge to determine if in the context of decision-making, information is provided from a true expert, or from a ‘disguised lobbyist’. That is why the EC has established horizontal rules on the creation and operation of EC expert groups, which strive for a balanced composition of expert groups and comprise rules on conflict of interest, in order to “ensure the highest level of integrity of experts”.²⁰³

The EP and the EC have set up a transparency register and a code of conduct for lobbyists, which, unfortunately, is only voluntary.²⁰⁴, ²⁰⁵ The European Council and the Council of the EU have been invited to join the register, but have not done so far. This code of conduct is more concrete and foresees 14 quite detailed obligations for lobbyists, addressing lobbyists’ behaviour with regard to the EU institutions, their members, officials and other staff. It also entails transparency, operates less based on principles for ethical behaviour, and just mentions ‘honesty’ in the context of how information or decisions are obtained.

The overall approach in the context of decision-making is not one as we have seen it so far, i.e. referring to terms of ethics and morality. Rather, the relevant documents refer to certain principles, which are important to attain the same objective, that is to say ethical behaviour of either side, of both actors and targets of lobbying, as well as of ‘true’ experts. One key principle is also to avoid a situation of an actual or potential conflict of interest. Other principles comprise accountability, dignity, diligence, discretion, disinterest, honesty, impartiality, independence, integrity, loyalty, objectivity, openness, responsibility, and transparency. These principles (among which especially transparency) are of utmost importance to (re-)gain citizens’ trust. Intransparent decision-making as well as unethical behaviour will further widen the gap between the EU and its citizens. The already mentioned CETA agreement was a clear example of decreasing trust by not providing sufficient transparency. The Commission seemed to have learned from this example, as the Brexit negotiations are more open and documents more easily accessible.

These principles have to apply both during, and partially also after holding a certain office. Moreover, these substantive rules have to be accompanied by procedural rules, as is the case for the two committees of the EP and the EC. These committees not only play an important role in a concrete situation, but also have an important preventive function. Comparing these two committees, the EC’s IEC is clearly more ambitious with regard to the requirements of becoming a member, and allows for dissenting opinions, where an opinion is not adopted unanimously. Beside this, every ethics or expert committee ideally should strive for a balanced composition of its qualified members. With regard to the legal quality of these documents, we have seen both examples of hard law (e.g. the regulation on EU staff), as well as soft-law documents.

The consequences of (non-)compliance with ethics, if mentioned in an EU legal document, can be seen from various examples. EU rules on authorisation and supervision of genetically modified food and feed require, amongst others “a reasoned statement that the food does not give rise to ethical or religious concerns”.²⁰⁷ In addition, the EU regulation on clinical trials requires prior authorisation, whereby a “clinical trial shall be subject to scientific and ethical review”.²⁰⁸

Moreover, we can see the consequences of unethical behaviour in the context of Horizon 2020, where “[r]esearch and innovation activities supported by Horizon 2020 should respect fundamental ethical principles”.²⁰⁹ A “proposal which contravenes ethical principles […] may be excluded from the evaluation, selection and award procedures at any time”²¹⁰; in addition the Commission “shall systematically carry out ethics reviews for proposals raising ethical issues”,²¹¹ and the grant agreement has to acknowledge “the right of the Commission to carry out an ethics audit by independent experts”.²¹² Based on what we have seen in the chapter on the CJEU’s case-law on stem cell patentability,²¹³ it is no surprise that “[t]he use, if any, of human stem cells, be they adult or embryonic, […] is subject to stringent ethics review”.²¹⁴

Although only soft-law, the ‘European Charter for Researchers’ states that “[r]esearchers need to be aware that they are accountable towards their employers, funders or other related public or private bodies as well as, on more ethical grounds, towards society as a whole.”²¹⁵ In the context of fishery, we find a responsibility for the “correct and appropriate use of the data with regard to scientific ethics”.²¹⁶

In cross-border healthcare, EU patient mobility rights are limited according to the corresponding directive insofar as these rights may not be used in a way which “undermin[es] the fundamental ethical choices of Member States”.²¹⁷ Nevertheless, which kind of medical, health, or related treatment²¹⁸ should be qualified as unethical?²¹⁹ These are only some examples that raise a number of important questions: Is there a definition or at least a certain form of understanding as to what has to be understood by ‘ethical’?

As mentioned above, as part of EU’s common values,²²⁰ the ‘the rule of law’,²²¹ according to the EC’s recent communication,²²² also entails legal certainty. According to the CJEU, this requires that “legislation must be clear and predictable for those who are subject to it”.²²³ Thus, one might wonder, if EU legislation referring to ethics and morality is clear and predictable and “formulated with sufficient precision to enable the individual to regulate his or her conduct”,²²⁴ or whether it remains undetermined in the end?

This might be less of a problem, if legal documents refer to “minor’s physical, mental, spiritual, moral and social development”,²²⁵ the “physical, mental and moral integrity”²²⁶ of victims of crime, or the “morals of young persons”.²²⁷ In the other cases mentioned above, the missing determination of unethical behaviour can have important consequences.

However, before we turn to the determination of content, let us take a closer look at the different language versions of EU documents referring to ethics and morality.

In the context of a Union with 24 different languages,²²⁸ it is important to follow a linguistically holistic²²⁹ approach. As we have just seen, ethics and morality, in theory, have a different meaning and therefore it is astonishing that they are used differently in different language versions. What reads “[c]onsumers in the [EU] would […] find it morally unacceptable that their increased use of biofuels could have the effect of destroying biodiverse lands”²³⁰ in the English version,²³¹ refers to ethics (“ethisch inakzeptabel”) in the German version.²³² However, as those terms are generally distinguished, we can assume that this wording is based on imprecise translation and without further significance.

The same might hold true for the case of the already mentioned Directive Biotech,²³³ which refers to the “ethical or moral principles recognised in a [sic!] Member State”,²³⁴ whereas the German version uses the plural (“in den Mitgliedstaaten”).²³⁵ As mentioned above in the context of human dignity, the number of MS sharing a certain conception can play an important role in case of authorities of a MS issuing a restrictive measure.²³⁶

Although this will be the compelling solution, it might sound funny if only the English version of a code of conduct (relating to transactions in transferable securities) declares the code’s objective as “to establish standards of ethical behaviour on a Community-wide basis”, whereas the other language version examined only refer to loyal behaviour (for example, FR: “comportement loyal”²³⁷).²³⁸

There are other examples of differences in translation which can be clustered into a less problematic category, where the term ‘ethical’ is just explicitly missing—but to some degree implicitly included—in another language version.

A first example refers to the degree to which substances can be tested on animals.²³⁹ Here, only the German version refers to ethics,²⁴⁰ whereas a similar idea is worded in different ways in English (“can humanely be allowed” similarly in ES), and the French (and IT) version referring to the degree of pain suffered by the animal (FR: “sans que cela fasse trop souffrir l’animal”).

A second example refers to doping, where the use of drugs in sport is denounced as “unsporting behaviour” in the English version, whereas all the other examined versions refer to the ethics of the sport (for example, ES: “contrario a la ética deportiva”).²⁴¹ Therefore, in both cases, the result might be the same, but the wording is different.

The same is true, if the term code of conduct (“Verhaltenskodex”) is used in one version (DE), whereas the other languages examined use the term code of ethics, and so on.²⁴² In a similar way, concerning ethical rules of a professional nature, one has to be aware of the fact that often professional rules²⁴³ in one language version (DE: “standesrechtlichen Regeln”) correspond to “rules of professional ethics” in other versions.²⁴⁴

To sum it up, we can say that the general EU rule to take into account not only one language version of course also helps in case of the language inconsistencies in our context. However, in case of fundamental concepts like ‘ethics’ or ‘morality’, more “clarity and consistency”²⁴⁵ would be desirable. Still, it can also rest unclear if the language versions that are ‘united in diversity’ are due to imprecise translations (for example, somewhere in a very comprehensive annex), or are the result of debates on principles.

In EU primary law, we have seen ‘morality’ used as an umbrella to protect MS from EU interference in sensitive fields.²⁴⁶ We can find a similar [1.] ‘protection shield’-approach in EU secondary law. As we have already seen in the context of Horizon 2020, the use of human stem cells is “subject to stringent ethics review”; this provision continues by stating that “[n]o project involving the use of human embryonic stem cells should be funded that does not obtain the necessary approvals from the Member States”.²⁴⁷

The wording is even stronger in case of genetically modified food and organisms, where reference is made to “competence [sic] of Member States as regards ethical issues.”²⁴⁸

The example of EU patient mobility has already been mentioned in terms of consequences of unethical behaviour. According to this directive, patients’ rights are limited insofar as these rights may not be used in a way which “undermin[es] the fundamental ethical choices of Member States”.²⁴⁹ This reference to the term ‘ethics’ in this EU legal document is clearly motivated by the fear that a broad interpretation of the term “health services” could entitle EU citizens to use certain sensitive health services abroad.²⁵⁰ Thus, ethics, again, serves as a protection shield against EU interference.

Moreover, we have also already seen the example of Directive Biotech, which, amongst others, excludes the patentability of “uses of human embryos for industrial or commercial purposes”.²⁵¹ The TRIPs Agreement foresees the possibility to exclude inventions from patentability, if they are against ordre public or morality.²⁵² When making use of this possibility, the directive makes clear that “ordre public and morality correspond in particular to ethical or moral principles recognised in a Member State”²⁵³; hence, not at EU level. Further examples of referring to the national level for the determination of ethics can be found in the field of research.²⁵⁴

After this category of ethics being used as a ‘protection shield’, we find another category, where ethics (or morality²⁵⁵) is used as [2.] a supportive argument for a certain legal solution. Here, it is less of a problem, if the content of ethics is not determined, as the legal solution itself might fulfil the requirements of legal certainty. This is the case for the statement that consumers in the EU would “find it morally unacceptable that their increased use of biofuels could have the effect of destroying biodiverse lands”,²⁵⁶ or that “[c]onsumers’ choices can be influenced by, inter alia, health, economic, environmental, social and ethical considerations”.²⁵⁷ In another example, the killing of seals is qualified as morally problematic as such, beside commercial killing being qualified as more problematic than traditional hunting by Inuit.²⁵⁸

In context of ‘novel food’, we find a supportive argument to contribute to animal welfare and ethics: “[…] tests on animals should be replaced, reduced or refined. Therefore, […] duplication of animal testing should be avoided, where possible. Pursuing this goal could reduce possible animal welfare and ethical concerns with regard to novel food applications”.²⁵⁹

Apart from ethics used as a supportive argument, we can further identify references in order to create [3.] a parallel ethical assessment beside the legal one. In this category, we can identify coexistence of law and ethics (that is to say, a parallel system), with Directive Biotech stating that “substantive patent law cannot serve to replace or render superfluous […] compliance with certain ethical standards”²⁶⁰ and that “ethical or moral principles supplement the standard legal examinations under patent law”.²⁶¹ The same holds true in the field of protection of the EUs financial interests, where the definition of ‘professional misconduct’ “means violation of laws or regulations or of ethical standards of the profession to which the person belongs^”.²⁶²

In the field of transferable securities, we find a noteworthy statement of the European Commission concerning the relationship of EU harmonization and ethics. “This code of conduct, to be issued in the form of a Commission recommendation, must be seen separately from the Commission’s other harmonization work in this sector […] because the ethical approach has been given priority over the legislative approach”.²⁶³

A similar parallelism can be found in case of staff responsibility (of the EU Institute for Security Studies): “Employees shall abstain from any public action or statement or publication if such action, statement or publication is incompatible with the duties or obligations of an international civil servant or liable to involve the moral or material responsibility of the Institute.”²⁶⁴

In addition to the parallelism of law and ethics, a similar relation can be addressed between science and ethics. In the context of Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), we find several references to the requirement of being both “scientifically and ethically justified”.²⁶⁵, ²⁶⁶

These parallel situations are extended to a more holistic view in case of the EC proposal on health technology assessment (HTA), which refers to economic, medical, organisational, social, legal and ethical issues.²⁶⁷

After ethics only serving as a ‘protection shield’, or being used as a ‘supportive argument’, we have now seen ethics in terms of a parallel assessment of legal as well as ethical requirements. Already the last category requires a substantive determination, of what is meant by (un-)ethical behaviour. This leads us to our next (and very important) category, of [4.] ethics being determined by ‘ethics committees’. There are committees, which focus exclusively on ethics, or others, where ethics is one of the aspects to be covered.²⁶⁸ These committees can be installed either at [a.] EU or at [b.] national level and can take various forms. The underlying idea of all these committees is to outsource this ethical assessment, in order to achieve independent, objective and good quality opinions.

However, there are also examples where the EC²⁶⁹ itself is tasked with the assessment at [4.a.] EU level. In Horizon 2020 the EC “shall systematically carry out ethics reviews for proposals raising ethical issues” by verifying “the respect of ethical principles and legislation”.²⁷⁰ From a procedural perspective, this “process of the ethics review [has to be] as transparent as possible and […] carried out in a timely manner”.²⁷¹ The “grant agreement shall, where appropriate, contain provisions ensuring the respect of ethical principles, including the establishment of an independent ethics board and the right of the Commission to carry out an ethics audit by independent experts”.²⁷², ²⁷³

Due to its importance for our topic, the already mentioned EGE will be covered in a distinct chapter.²⁷⁴ However, it has also been tasked by different legal documents with ethical assessments. One year after the EGE’s establishment in 1997, Directive Biotech provided that the EGE “evaluates all [sic!] ethical aspects of biotechnology”.²⁷⁵ In the field of GMOs, the already mentioned Directive on the deliberate release into the environment,²⁷⁶ provides that “the Commission shall, on its own initiative or at the request of the [EP] or the Council, consult any committee it has created with a view to obtaining its advice on the ethical implications of biotechnology, such as [EGE], on ethical issues of a general nature”.²⁷⁷ Such consultation has to be “conducted under clear rules of openness, transparency and public accessibility”.²⁷⁸ Always keeping in mind the fact that EGEs opinions are not legally binding, the wording in ‘Regulation GM food’ is alleviated, as the “Commission, on its own initiative or at the request of a Member State, may consult [EGE] or any other appropriate body”.²⁷⁹ Not as regards the procedure (consultation), but to the output, it is stated that the opinions have to be made “available to the public”.²⁸⁰

Apart from the EGE, there are several other institutional ethics committees, notably in the financial field. The European Investment Bank (EIB) follows a combined institutional and substantive approach, by having established an ‘Ethics and Compliance Committee’, which “shall rule on any potential conflict of interest” based on legal—not ethical—provisions.²⁸¹ Recently, the EIB has strengthened the role of this Committee “by introducing the possibility for this Committee to provide opinions on any ethical matter concerning a member of the Management Committee or of the Board of Directors”.²⁸² In addition, the European Central Bank (ECB) follows a combined approach for the TARGET2-Securities Board, consisting of a code of conduct²⁸³ and an ‘Ethics Officer’.²⁸⁴ Members can contact the Ethics Officer in order to seek advice on an ad hoc basis.²⁸⁵ The ECB²⁸⁶ itself has established an ‘Ethics Committee’, due to the “increased level of public awareness and scrutiny [which] requires the ECB to have in place, and strictly adhere to, state-of-the-art ethics rules in order to safeguard the ECB’s integrity and avoid reputational risks”²⁸⁷; it shall provide advice on questions of ethics based on individual requests.²⁸⁸

Finally, in a similar way as the EGE advises the EC, the ‘European Data Protection Supervisor’ has appointed an ‘Ethics Advisory Group’ as an “external advisory group on the ethical dimensions of data protection”.²⁸⁹ One reason for the establishment of this Body is technological advancement (big data computing and machine learning), which allows for the collection and usage of personal data “in increasingly opaque and complex ways, thus posing significant threats to privacy and human dignity”.²⁹⁰

Apart from ethics committees at EU level, there are also examples of ethics committees at [4.b.] national level.

A combined approach of both EU (the role of the EC has already been described) and national ethical scrutiny can be found in Horizon 2020. There participants are not only obliged to “comply with national legislation, regulations and ethical rules in the countries where the action will be carried out”, but also “[w]here appropriate, [to] seek the approval of the relevant national or local ethics committees prior to the start of the action”.²⁹¹

Also in the field of the research fund for coal and steel, participants shall, where appropriate, “seek the approval of the relevant national or local ethics committees prior to the start of the action”.²⁹²

It is again Directive GMOs, which states “Member States should be able to consult any committee they have established with a view to obtaining advice on the ethical implications of biotechnology”.²⁹³ This statement stands beside the above-mentioned possibility of the EC, to consult the EGE “on ethical issues of a general nature”.²⁹⁴ Evaluation by and consultation with national or local ethics committees is also foreseen for nanosciences and nanotechnologies research,²⁹⁵ or in the case of ionizing radiation.²⁹⁶

In the field of ‘clinical trials’,²⁹⁷ ‘medical devices’²⁹⁸ and ‘in vitro diagnostic medical devices’,²⁹⁹ the three corresponding regulations all operate based on the same following definition of an ethics committee. “‘Ethics committee’ means an independent body established in a Member State in accordance with the law of that Member State and empowered to give opinions for the purposes of this Regulation, taking into account the views of laypersons, in particular patients or patients’ organisations”.³⁰⁰ The ethical review performed by this national ethics committee is a requirement for prior authorisation, where a “clinical trial shall be subject to scientific and ethical review”³⁰¹; similar rules apply for the two other examples mentioned above.³⁰²

Hence, as we have seen, ethics committees cannot only issue opinions on request or on their own initiative (for example, EGE), but can also play a decisive role in authorization procedures, not only for research grants, but also for manufacturing processes.

One task of ethics committees can also be to issue codes of conduct. Codes of conduct have the clear advantage that they are more detailed than just a general reference to ethical standards. These [5.] codes of conduct can be located both at [a.] EU or at [b.] national level.³⁰³

At [5.a.] EU level we find the already mentioned “Code of Conduct for responsible nanosciences and nanotechnologies research”.³⁰⁴ This code is quite detailed, comprising, amongst others, the principles of comprehensibility, respect of fundamental rights, the well-being of individuals and society, sustainability, the precautionary principle, inclusiveness (openness, transparency, and access to information), excellence, innovation, and accountability.³⁰⁵ Hence, ethics is only part of the general principles mentioned therein.

In the case of ‘Directive Services’, we find a provision, which encourages “the setting up of codes of conduct, in particular, by professional bodies, organisations and associations at [EU] level”. Similar to the case of the example of nanosciences, this code of conduct is also not only about (professional) ethics.³⁰⁶

Again at EU level, we find a non-binding recommendation, the already mentioned European Charter for Researchers, which, apart from referring to recognized ethical principles and so forth, also requires researchers to “adhere to […] ethical standards as documented in the different national, sectoral or institutional codes of ethics”.³⁰⁷ It therefore does not create a code of conduct, but just refers to existing ones, also [5.b.] at national level.

Besides examples of non-binding recommendations, we also find an obligation for the MS regarding the transposition of EU directive against child pornography, according to which MS have to undertake preventive action “such as the drawing up and reinforcement of a code of conduct and self-regulatory mechanisms in the tourism industry, the setting-up of a code of ethics” and so forth.³⁰⁸ Although the transposition of the directive into national law is binding in itself, thus the MS enjoy some flexibility as regards the form and methods of achieving this goal.

After ethics committees and codes of conduct, the substance of a reference to ethics can also be determined via references to [6.] other (international) documents.

In the context of the already mentioned three related examples of ‘clinical trials’,³⁰⁹ ‘medical devices’³¹⁰ and ‘in vitro diagnostic medical devices’,³¹¹ reference is made to “the most recent version of the World Medical Association Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects”.³¹² This Helsinki Declaration³¹³ has the advantage not only of having been elaborated at a ‘worldwide’ basis, but also of providing relatively detailed rules as regards ethical behaviour. Of course, it has to be acknowledged that EU law can only refer to such detailed guidelines if they exist and have been elaborated by an acknowledged body in the relevant field.³¹⁴

‘Regulation in vitro medical devices’ replaces the previous directive in this field, which for ethical requirements in the context of the removal, collection and use of tissues, cells and substances of human origin, has referred to the Council of Europe’s Oviedo convention.³¹⁵, ³¹⁶

It is also worth mentioning the example of the directive on statutory audits, which requires adherence to “highest ethical standards”.³¹⁷ In this context, it is the Commission’s task to “adopt implementing measures on professional ethics as minimum standards [and when] doing so, it might consider the principles contained in the International Federation of Accountants (IFAC) Code of Ethics”.³¹⁸ Thus, the Commission is invited to consider this international code.

Finally, yet importantly, there is also one example, where in the context of biocidal products reference is made to “internationally accepted ethical standards”, without further guidance of how these standards are defined.³¹⁹

After ethics committees, codes of conduct, and the determination via references to other (international) documents, we finally come to a category, where some information concerning the content or understanding of ethics can be found [7.] in the relevant legal document itself.

In the field of statutory audit, when mentioning “ethical and independence requirements”, etc., the relevant provision on quality assurance of this regulation refers both to other chapters of the same regulation (as well as to another legal document³²⁰).³²¹

Another example of determination of content in the relevant legal document itself can be found in the field of mining. While “ethical mining” is not explicitly defined, a systematic interpretation of the whole directive on supply chain due diligence obligations clearly refers to the affected region (“in particular in the African Great Lakes Region”), to the goods of import in question (gold, etc.), as well as the reasons of concern (conflicts, child labour, sexual violence, the disappearance of people, etc.). All this exhibits why the mining of these goods in these circumstances is deemed wrong.³²²

In the context of placing of proprietary medicinal products on the market, we find an example of a clear statement what is seen as unethical and what should be the consequences. “Since a full placebo comparison will not often be feasible or ethically acceptable in convulsive epilepsy, it is important in the later phases of evaluation to carry out controlled (randomized) clinical trials […]”.³²³

In addition, in the field of medicinal products for human use we find some thoughts on the treatment of control groups against the background of ethical considerations. “[T]hus it may, in some instances, be more pertinent to compare the efficacy of a new medicinal product with that of an established medicinal product of proven therapeutic value rather than with the effect of a placebo”.³²⁴ The same directive also exempts applicants from certain documentation if “it would be contrary to generally accepted principles of medical ethics to collect such information”.³²⁵

In Horizon 2020 actions, falling within the scope of ‘Regulation participation Horizon 2020’ should “be in conformity […] with ethical principles, which include avoiding any breach of research integrity”.³²⁶ In addition, Art 19 (entitled “Ethical principles”) of ‘Regulation establishing Horizon 2020’, after stipulating that “[a]ll the research and innovation activities carried out under Horizon 2020 shall comply with ethical principles [and human rights]”, excludes the following fields of research from funding: “human cloning for reproductive purposes”, “genetic heritage of human beings”, as well as “research activities intended to create human embryos solely for the purpose of research or for the purpose of stem cell procurement, including by means of somatic cell nuclear transfer”.³²⁷ This can be seen as a European consensus with regard to bioethics, although one could argue that this provision is ‘only’ about funding and not about the legality of these activities.

Although this book is based on a broad understanding of bioethics, the examples mentioned so far always referred to humans. Nonetheless, there are also examples where the beneficiaries of ethical or moral principles are not humans, but animals, plants or the environment.³²⁸ Especially animals are protected by ethical principles in different fields.

Bearing some resemblance to human dignity, the directive on the protection of animals used for scientific purposes asserts that animals “have an intrinsic value which must be respected”.³²⁹ As a practical consequence arising from this approach, “animals should always be treated as sentient creatures and their use in procedures should be restricted to areas which may ultimately benefit human or animal health, or the environment”, and their use “for scientific or educational purposes should therefore only be considered where a non-animal alternative is unavailable”.³³⁰ This directive provides even more detailed statements with respect to the practical consequences of the ‘intrinsic value’ of animals, as there are restrictions for the use of non-human primates.³³¹ Due to ethical considerations, the directive also sets a maximum threshold of permissible pain and therefore prohibits “the performance of procedures that result in severe pain, suffering or distress, which is likely to be long-lasting and cannot be ameliorated”.³³²

Apart from this directive, ethical considerations concerning animals are also the reason why mass slaughtering has been declared as being, amongst other things, “ethically questionable”,³³³ or, why there can even be “an ethical duty to kill productive animals which are in severe pain where there is no economically viable way to alleviate such pain”.³³⁴

After a mere declaration annexed to the Maastricht Treaty³³⁵ and a protocol annexed to the Amsterdam Treaty,³³⁶ Art 13 TFEU now entails a horizontal clause according to which both the EU and the MS shall “pay full regard to the welfare requirements of animals”, because animals are “sentient beings”.³³⁷ In Horizon 2020, this Art 13 TFEU is addressed in the context of respect for “fundamental ethical principles” with the practical consequence that “the use of animals in research and testing should be reduced, with a view ultimately to replacing their use”.³³⁸

Leaving the field of bioethics, the already mentioned directive on statutory audits provides another example pertaining to this category where some understandings of the practical consequences of ethics are provided. After stating that statutory auditors should adhere to “the highest ethical standards”, the directive provides that they should be “subject to professional ethics, covering at least their public-interest function, their integrity and objectivity and their professional competence and due care”³³⁹; further details have to be implemented by the MS.³⁴⁰

In the following example, ethics is not determined by the EU, MS and so forth on a collective basis, but by a single business entity. According to the Regulation on European social entrepreneurship funds, so called “[q]ualifying social entrepreneurship funds should invest in a manner consistent with their ethical investment strategy, for instance they should not undertake investments that finance the weapons industry, that risk breaches of human rights or that entail electronic waste-dumping”.³⁴¹

The combined approach of the ECB, that is to say an Ethics Officer plus principles (such as avoidance of conflicts of interest, confidentiality, transparency and openness, etc.) contained in a code of conduct, has already been mentioned.³⁴² Likewise, the European Anti-Fraud Office (OLAF) merely follows a substantive approach for their Supervisory Committee. Art 4, entitled ‘ethics’, requires the members to act independently, neither seeking nor taking instructions from others, not to deal with matters where they have a personal interest, to demonstrate confidentiality, and to adhere to an obligation of notification if any such situation occurs.³⁴³

In an indirect way, we can also add examples, where reference is made to notions that have a pre-determined meaning from another field, such as public morality,³⁴⁴ which has been shaped by the CJEU,³⁴⁵ or moral hazard,³⁴⁶ as a notion of microeconomics.³⁴⁷ The example of moral hazard also derives from the financial crisis, where the Commission’s banking communication refers several times to ‘moral hazard’.³⁴⁸ In a similar way as for international agreements, moral hazard is addressed in the context of burden sharing.³⁴⁹ This concept can be explained by referring to a situation caused by the immoral behaviour of a single body that is dangerous for a bigger group (society). Most people would agree to qualify the risky behaviour of certain banks to the detriment of taxpayers (whereas bonuses would still be paid, maybe also with the help of those taxpayers’ subsidies) as immoral.³⁵⁰

After having seen determination by ethics committees, codes of conduct, references to international documents and further information provided by EU law itself, we finally arrive at the last category, that is, EU law, where ethics [8.] remains undetermined.

The example of patient mobility has already been mentioned in the category of ‘non-interference’, where patients do not have a right to cross-border healthcare because the directive shall not “undermine the fundamental ethical choices of Member States”.³⁵¹ This undetermined provision can have a significant impact on patients seeking cross-border healthcare. In fact, some MS feared the application of this directive to sensitive issues “like euthanasia, DNA-testing or IVF”.³⁵² Contrary to what one would expect, it was not the Council of Ministers but the EP that at a very early stage of the legislative procedure, proposed amendments making clear that “[n]o provision of this Directive should be interpreted in such a way as to undermine the fundamental ethical choices of Member States”.³⁵³ This was strengthened by emphasizing that “[n]otwithstanding those common values it is accepted that Member States take different decisions on ethical grounds as regards the availability of certain treatments and the concrete access conditions [and that this] Directive is without prejudice to ethical diversity”.³⁵⁴ The question remains, as to whether this provision has to be interpreted in a narrow sense, as it requires ‘fundamental’ ethical choices. Moreover, only the legal materials help to shed more light on the void of this undetermined concept.

While this example refers to the MS to determine ethics in this regard, the following examples provide no information whatsoever on the understanding behind the term of ethics used in those documents, of both a binding and non-binding nature.

One example of a binding nature is about food law, where it has been acknowledged that scientific risk assessment alone might not provide all necessary information for, but where also “societal, economic, traditional, ethical and environmental factors” have to be considered.³⁵⁵ The reference to ethics might be very general (one factor amongst others to be taken into account), but does not mitigate the fact that the concept of ethics remains undetermined.

Other examples of non-determined references to ethics are as follows³⁵⁶: “scientific ethics”,³⁵⁷ “relevant ethical principles”,³⁵⁸ “business ethics standards”,³⁵⁹ “professional ethics”,³⁶⁰ “ethical principles, which include avoiding any breach of research integrity”,³⁶¹ or “environmental and ethical considerations”.³⁶² In another reference to “ethical or environmental reasons”,³⁶³ this regulation further refers to another document,³⁶⁴ but without further clarification on the determination of ethics. In addition, the new General Data Protection Regulation (GDPR)³⁶⁵ refers to “recognised ethical standards for scientific research”,³⁶⁶ as well as “ethics for regulated professions”.³⁶⁷ Besides ethics, in the field of trademark, we find a reference to “accepted principles of morality” in both the corresponding EU directive³⁶⁸ and regulation.³⁶⁹, ³⁷⁰

Another example refers to the European Council,³⁷¹ which expressed in its Stockholm presidency conclusions from 2001 the need to “strengthen the European biotechnology sector’s competitiveness”, while ensuring that this is “consistent with common fundamental values and ethical principles”.³⁷² Some could take the view that there is no need for a (purely) political document to provide detailed statements, nonetheless, also in this case we lack further guidance as to the understanding of ethics.

The Council (of Ministers) resolution concerning fundamental health policy choices is another example of a non-binding document, taking ‘only’ note of some topics, “which warrant joint consideration”, such as “revision of medical studies syllabuses in order to incorporate the relevant economic, legal, ethical and social aspects necessary to ensure that practitioners dispense adequate health care”.³⁷³ This example is comparable to the one of port State inspectors, where the content of ethics as part of a training programme is not determined.³⁷⁴ Although there is no further information on what constitutes an ethical syllabus, the MS competence³⁷⁵ for both education and health might be the legally based reason why this non-legal term should be defined by the MS.

The same idea can hold true for other health related (non-binding) documents in the context of cancer screening³⁷⁶ and hereditary illnesses³⁷⁷ on the one hand, and for lifelong learning³⁷⁸ on the other.

Within the shared competence of the internal market,³⁷⁹ we find one example of a task in the public interest, which is about “doctors or veterinary bodies ensuring that their members conform to ethical or sanitary rules”.³⁸⁰ This example adds up to our list of undetermined references to ethics, where a possible solution could be to see those bodies in charge of defining those ethical rules.

Unethical behaviour can have an impact, both when seeking an authorisation or in the context of research funding. Given the amount of documents that have to be published in the 24 official languages, the inconsistencies identified in this chapter are a minor issue. Nevertheless, it makes a difference whether a document refers to ethics or morality (Directive greenhouse gas emissions), or to ethical or moral principles recognised in one or more MS (Directive Biotech).

Beneficiaries have mainly been humans, however, also animals are protected due to arguments reminding us of ‘human dignity’. In order to achieve ethical behaviour, training plays an important role. Therefore, it is no surprise, that also in case of ‘EU reference centres for animal welfare’ we find the requirement of “suitably qualified staff with adequate training […] in ethical issues related to animals”.³⁸¹ In a completely different field, the importance of “[i]ncreased awareness of […] ethical issues among students and their teachers”³⁸² is also emphasized.

Concerning humans, special groups that have not been mentioned so far, are incapacitated subjects³⁸³ in respect of clinical trials on medicinal products for human use, as well as children,³⁸⁴ where specific ethical concerns might arise and should be addressed.

The numerous EU documents referring to ethics and morality can be clustered in the above-mentioned, inductively developed, categories. It has to be emphasized that some examples are overlapping and, hence, could fall in various categories.

The category of ethics serving as a [1.] ‘protection shield’ clearly is not a very ambitious approach. Using ethics as [2.] a supportive argument is clearly less of a problem, as the legal situation (which it defends) should be able to be self-standing. It is also less of a problem, when ethics is determined by [4.] an ethics committee or via a [5.] code of conduct, in either category either at EU or at national level. Sufficient clarification with regard to the content of references to ethics can also be guaranteed via references to [6.] other (international) documents, such as the Helsinki declaration or the Oviedo convention, or if further information [7.] is provided in the relevant EU document itself.

From the perspective of legal certainty, a [3.] parallel ethical and legal assessment (e.g. Directive Biotech), can be problematic if the criteria for this ethical assessment are not clearly stated, which finally leads us to category [8.], where ethics remains undetermined.

The examples we have seen in the category of ethics committees clearly displays that ethics plays a role in sensitive fields: this is the case for ‘science and new technologies’ (EGE), in the financial field, in data protection and digitalization, or in the health sector (e.g. clinical trials, medical devices and in vitro diagnostic medical devices). Further recent examples of sensitive fields referring to ethics can be found in the context of ‘health in the digital society’,³⁸⁵ ‘artificial intelligence’,³⁸⁶ ‘robotics’,³⁸⁷ and ‘digital ethics’.³⁸⁸