Health Union and Bioethical Union: Does Hippocrates Require Socrates?

Health Union raises bioethical questions ranging from resource allocation and risk balancing to respect for specific bioethical prohibitions, as an analysis of the European Parliament’s proposal for such a union shows. To date, European Union (EU) health law has succeeded in avoiding or circumscribing such questions, leading to the limited and inconsistent patchwork of EU bioethical provisions we currently have. Can this continue with a Health Union? This article argues that whilst full harmonisation is neither possible nor desirable, Health Union should entail a deepening of bioethical integration. This should occur via a robust legislative process involving citizen panels and ethical advisory group input; if Treaty change occurs, this process could be included in primary law. This is so for three reasons. First, addressing Health Union’s unavoidable bioethical questions coherently and openly reduces the risk of inadequate protection and, conversely, of interest groups “smuggling in” unsupported answers. Second, this will ensure respect for primary law, including Article 2 TEU and Article 3 CFR. Third, EU biolaw offers a middle ground between limited national and weak international human rights law on bioethics, whilst also consolidating European identity.


I. INTRODUCTION
Coronavirus continues to burn through the human biosphere, exploiting and clogging the arteries of trade and movement on which contemporary civilisation depend. In response, after Economic and Monetary Union, Energy Union and Security Union, a project with an intrinsically human face is at last on the table: Health Union. That face's featureswhich include possible Treaty changeare sketched out in the European Parliament resolution of 10 July 2020 (the EP Resolution). 1 Yet Health Union's humanity brings with it sensitivities. Chief amongst these sensitivities are questions of bioethics, defined here as "the systematic study of human conduct in the area of the life sciences and health care, in so far as examined in the light of moral values and principles". 2 Law incorporating bioethical norms is "biolaw". 3 Two questions thus arise. First, how far would Health Union raise bioethical questions? Second, how far would those questions be for the EU, rather than the Member States, to answer? In short: how far does the great doctor, Hippocrates, need the great moral philosopher, Socrates?
This article will first contend that the core Health Union proposals raise an array of bioethical questions (Section II). It will then argue that whilst Socrates appears to be banned from Brussels, closer inspection reveals that these bioethical questions must be confronted for reasons of balance, law and legitimacy (Section III). It will conclude with broader reflections on the role of ethics and values in the European Union (EU) (Section IV).

II. THE BIOETHICAL IMPLICATIONS OF HEALTH UNION
Whilst there have been a number of calls for deeper health integration in response to COVID-19, 4 the EP Resolution is substantially based on the Progressive Alliance of Socialists and Democrats' proposal (S&D Proposal) of 12 May 2020. 5 The S&D Proposal provides a useful structure to break down the fifty-six-paragraph EP Resolution into its core elements. Table 1 does this. The "No." column contains arbitrary row numbering. The "EP Resolution" column sets out the key 6 EP proposals, structured (save the final two rows) around the S&D Proposal. Paragraph references are to the EP Resolution. The "Bioethical implication(s)" column summarises some of the bioethical questions each set of proposals raises.
As Table 1 outlines, the majority of the EP Resolution's proposals raise bioethical questions of varying degrees of depth and controversy. This serves to illustrate a broader point. Health Union, by definition, entails making "standards, values, guidelines, and 2 W Reich (ed.), Encyclopedia of Bioethics (Cambridge, The Free Press 1978) p xix. This is thus wider than the application of moral values to emerging biotechnology (cf. D Beyleveld and R Brownsword, Human Dignity in Bioethics and Biolaw (Oxford, Oxford University Press 2001) p 44) and includes medical ethics (generally S Pattinson, Medical Law and Ethics (5 th edn, London, Sweet & Maxwell 2017). Conversely, it is narrower than "global bioethics", which includes a broader reflection on humanity's relationship with its environment: H Ten Have, Global Bioethics: An Introduction (Abingdon, Routledge 2016) ch 3. 3 C Lavialle, "Introduction" in C Neirinck (ed.), De la bioéthique au bio-droit (Paris, Librairie générale de droit et de jurisprudence 1994). 4 European Parliament Resolution of 17 April 2020 on EU coordinated action to combat the COVID-19 pandemic and its consequences (2020/2616(RSP)) § §7-17; G Brauzzi, "European Union post Corona Crisis: Lessons learned" (New Europeans, 10 May 2020) <https://neweuropeans.net/article/3252/european-union-post-corona-crisis-lessons-learned> (last accessed 15 September 2020); N Nielsen, "EU Commission aspires for treaty change on health" (EU Observer, 29 May 2020) <https://euobserver.com/institutional/148503> (last accessed 15 July 2020); and "Will Covid-19 lead to increased EU oversight of public health?" (EFNA) <https://www.efna.net/covid-19-will-eusee-more-powers-in-the-field-of-public-health/> (last accessed 15 July 2020). 5 S&D, "A European Health Union: Increasing EU Competence in Health" (S&D, 12 May 2020) <https://www. socialistsanddemocrats.eu/sites/default/files/2020-05/european_health_union_sd_position_30512_1.pdf> (last accessed 15 July 2020). 6 It in particular excludes proposals focused on labour law and various non-binding proposals that do not stem from the S&D Proposal (eg § §48-53 of the EP Resolution). Resource allocation. How much resource should be allocated to strategic reserves? What criteria should be used to determine whether a particular medicine or medical equipment is included in that strategic reserve, and who should decide this? How should shortages be addressed, and at whose cost?   Resource allocation, risk balancing and evidential standards. What criteria should be used to prioritise particular treatments, hospitals or health services, and who should decide this? Ethical bars. Will the ethical review and prohibitions that apply to EU-funded research apply to coordinated national research and to funding for health services, too? How far should other national ethical reviews and research bars be harmonised? 17 These latter two proposals were not included in the S&D Proposal. 21 The S&D Proposal contained stronger language on research coordination but weaker language on the Health Programme: S&D, supra, note 5, pp 7-8. 18 Commission, "A European One Health Action Plan against Antimicrobial Resistance (AMR)" <https://ec.europa. eu/health/amr/sites/health/files/antimicrobial_resistance/docs/amr_2017_action-plan.pdf> (last accessed 15 July 2020). The S&D Proposal envisaged other plans becoming mandatory: S&D, supra, note 5, p 5. 19 The S&D Proposal did not include the information and disinformation proposals. 20 But compare the broader field of "global bioethics": supra, note 2.
legislation : : : more binding and the units : : : more mutually dependent and tied to one another". 23 Whatever the shape of the final legislation, Health Union is thus highly likely to raise bioethical questions. The question that follows is how those should be addressed.

III. HEALTH UNION AND BIOETHICAL UNION
Policymakers' first reaction may be this: bioethical questions are often highly sensitive.
Reaching consensus on such issues may prove painstakingly difficult. History seems to confirm this. For instance, as a result of its bioethical implications, the Biotechnology Directive was "one of the most heavily lobbied and controversial pieces of legislation ever produced through the European democratic process", took a decade of "difficult negotiation" and was followed by a legal challenge and eight sets of infringement proceedings for non-transposition. 24 It may be tempting, then, to try to avoid providing European answers to the above bioethical questions at all.
That temptation finds theoretical support in two common understandings of the EU. First, Floris de Witte's influential article "Sex, Drugs & EU Law: The Recognition of Moral and Ethical Diversity in EU Law" 25 contended that moral and ethical laws are spontaneous exercises in self-expression by a particular community. Yet: The EU itself cannot replicate the institutional and normative preconditions required for it to be a space of communal self-expression. It lacks the sophisticated political framework, its law lacks the capacity for socialization, its system of governance is too rigid to allow for the continuous re-negotiation of first principles, and (therefore) the affective ties between its population are too weak to allow for a meaningful exercise in self-expression of the parameters of permissive behaviour. 26 In the absence of the "institutional preconditions that would allow for self-determination at the transnational level", attempts to Europeanise moral questions would lack legitimacy, "ro[b] citizens of the capacity to make moral sense of the communities in which they live" and be "partisan, hegemonic and authoritarian". 27 Such questions should instead remain within the nation state (where such self-expression is possible), subject to the Court of Justice of the European Union's (CJEU) procedural proportionality review.
The second focuses on the constitutional orientation of the EU, and particularly its supposed "constitutional asymmetry". 28 This image of the EU as fundamentally orientated towards economic and technical integration to the detriment of non-market values is common in the EU health law literature. 29 Consistently with this, Favale and Plomer's seminal article on ethics in EU biotechnology law contended that: As the Union is founded primarily on the economic goal of facilitating the expansion of a free market through the lifting of territorial and cross-border barriers to trade, there is no legal basis under the Treaties for concerted EU action aiming directly at harmonization and unification of national moral norms. They argued that whilst certain political and normative pressures have in fact led to the "infiltration" of moral norms into EU legislation, these were compromised by "the tension between the limits to the EU mandate, which is not supposed to harmonize ethical standards [,] and the growing pressure of fundamental principles", such as human rights. 31 At first sight, the above three pointspractical difficulty, institutional incompetence and constitutional orientationplead against bioethical integration. Health Union should be technical and apolitical, with bioethical questions carved out and left to the Member States.
Closer inspection, however, reveals the flaws with this view. It is illusory and risks imbalances (Section III.1). Moreover, EU primary law and constitutional orientation favours bioethical integration (Section III.2), which would have salutary effects for efficacy, legitimacy and European identity (Section III.3).

Health without bioethics: illusions and imbalances
Hopes for Health Union without (some) Bioethical Union are illusory.
A first, obvious point is that limiting bioethical integration means limiting health integration. 32 To date, EU health law has frequently "abstained" from answering bioethical questions, instead referring to national law or otherwise preserving national diversity. 33 These abstentions limit integration. For instance, EU law extensively regulates the blood, tissue, cell and organ economies and, in principle, opposes persons selling their own body parts (the Voluntary Unpaid Donation (VUD) principle). However, only the Organ Directive includes this prohibition as a hardedged legal obligation, and EU law has not fully defined the line between selling and mere compensation (eg refreshments for donors). 34 The resulting diversity has caused consequences that are "important, with some Member States putting up barriers to the 31 ibid, 103. 32  movement of [blood, tissue and cells]". 35 In the case of Health Union, it is, for instance, difficult to see how any meaningful provision could be included in the flagship minimum healthcare standards directive without significant agreement as to its bioethical questions (Table 1, row 1). 36 Beyond this is a subtler but graver risk. Despite EU law's bioethical "abstentions", a significant body of EU biolaw has been built up since the 1990s. 37 This has developed in a flawed way as a result of the tension analysed by Favale and Plomer. 38 On the one hand, the language of fundamental rights and the "political reality of the forces seeking moral integration in Europe : : : most notably the European Parliament" push for bioethical integration. 39 On the other hand, on their account, the EU is constitutionally limited and Europe fundamentally divided. 40 The EU's largely technical health law "has [thus] had to respond to political pressure to situate the legislation within an ethical frame", through incorporating "the largely open ended and indeterminate norms contained in : : : EU human rights instruments which in turn guide [secondary law's] flexible and more specific ethical constraints". 41 This process sometimes leads to weak or aspirational language; other times, the higher-level ethical norms "infiltrate" the law with binding norms; and still other times, there is a "middle ground" between the two. 42 It in turn leads to three problems.
First, some EU bioethical provisions are weak or of limited relevance. A French Senate report on European ethical law thus derided the reduction of ethics "to an ornament ('placebo' ethics) or even instrument (ethics as 'alibi')". 43 EU provisions on informed consent in clinical trials and in human substances lawcaught between deferring to national and international law and setting EU requirementshave been criticised in this way. 44 Second, conversely, other unsupported biolaw has "infiltrated" EU law. For instance, whilst many scholars (including Floris de Witte) criticise the CJEU for creating an autonomous definition of the "human embryo" in Brüstle, it is strongly arguable that the legislation in fact required this. 45 Relatedly, EU biolaw frequently contains underspecified termsstarting with Article 3(2) of the Charter of Fundamental Rights' (CFR, "the Charter") prohibition of "eugenic practices", which has been variously interpreted as limited to war crimes, as prohibiting gene editing or even as prohibiting two widespread practices (pre-natal diagnosis and pre-implantation screening for serious genetic defects). 46 In the short term, these vague terms may contain conflict, but longer term, they embed legally binding norms that the CJEU must ultimately interpret. As Brüstle and other cases show, this risks Member States and Europeans being surprised by what EU biolaw requires. 47 Third, Lafond's 2005 analysis still rings true: whilst there is a "Europeanization of politics concerning bioethics", the result is "nevertheless still fragmented and disparate". 48 Specific provisions are agreed in individual pieces of sectoral legislation without adding up to a coherent bioethical policy. For instance, the variable approach to VUD noted above is incoherent and arguably inconsistent with the Charter. 49 These problems are manageable whilst EU health law remains itself limited and fragmented. 50 Indeed, the juge rapporteur for several leading bioethical cases has argued that the CJEU was able to extend biolaw rights precisely because it could limit the effects of its judgments to specific sectors of law. 51 However, they become significantly more problematic in a genuine Health Union in which significant competence is transferred to the EU level. The first outcome risks that competence being accompanied by only illusory bioethical protection. For instance, including prohibitions on certain gene therapies or human reproductive cloning 52 in joint procurement or research law (Table 1, rows 2 and 6) may give the appearance of bioethical protection without in fact grappling with the core bioethical challenges these instruments raise. The second outcome risks particular interest groups 53 or legislators 54 "infiltrating" EU law with unsupported bioethical norms. Finally, fragmentation and incoherence undermine the very concept of a maturing policy union.
The risk, then, is that Health Union arrives with the birth defect that has repeatedly afflicted EU policy: imbalance. Worker posting without sufficient worker protection, 55 police and criminal measures without human rights and defence protection, 56 data retention without adequate protection: 57 now, the risk is health integration without adequate and agreed bioethical protection.
To avoid the reality and perception of falling into this trap, policymakers must not shy away from Health Union's bioethical implications. Rather, they should openly, consciously and coherently decide whether to Europeanise those implications and, if so, with what answer. But, returning to the tension highlighted by Favale and Plomer, is this in fact legally and constitutionally possible?

Union primary law and constitutional orientation
Matters have moved on since Favale and Plomer's 2009 article. EU primary law is no longer neutral as to bioethics. Article 3 CFR provides that everyone has the right to respect for their "physical and mental integrity". Within the fields of medicine and biology, this includes respect for informed consent and prohibitions on eugenics, human reproductive cloning and commercialisation of the human body and its parts (Article 3(2)). Article 21 CFR requires non-discrimination in respect of age, disability, genetic features and property. The EU must "promote the application" of these rights. 58 Health Union must thus both respect and promote these bioethical values. For instance, research and treatment funding must respect the Article 3 prohibitions, and decisions as to resource allocation must avoid discrimination. 59 Article 3 appears in the first Title of the Charter, entitled "Dignity". There are strong arguments that this Title fleshes out EU law's concept of human dignity, the first fundamental right (Article 1 CFR) and first Union value (Article 2 TEU). 60 There is no space here to enter into long-standing debates as to the (in)determinacy of "human dignity". But we should notice that human dignity and bioethics are intimately linked, 61 and that the CJEU has begun to shape the legal effect of both the Article 2 TEU values 62 and of the right to human dignity. 63 Health Union must respect and promote these: for instance, this places limits on the basic treatments that can be excluded from the minimum healthcare directive (Table 1, row 1). Moreover, by fleshing out these rights' contours in secondary legislation, the democratic legislature can seek to influence their primary law content. 64 These legal requirements do not, of course, require full bioethical integration. Article 5(3) TEU still requires subsidiarity. Here, as elsewhere, what is likely to emerge is a mixture of harmonisation and heterogeneitythe "internal market as a site of diversity", as Weatherill puts it. 65 Openness and clarity as to which bioethical issues are and are not Europeanised will help reduce the infiltration referred to above. 66 Floris de Witte's fear that ethical union entails "a monolithic creature: an autonomous, European-wide, concept of ordre public, which has (unsurprisingly) deeply majoritarian tendencies" is thus misconceived. 67 This law, moreover, reflects a deeper constitutional point: "the all-market image of the EU legal order has probably always been a misconstrued caricature". 68 The EU is not constitutionally constrained to ignore non-market values. 69 As the Brexit process is making clear, mutual trust depends crucially on certain mutual standards. 70 Indeed, primary law has long required a "high level of human health protection" in all policies (Article 152 TEC (Amsterdam); now Article 168 TFEU). EU law already embeds and spreads values in myriad areas: restricting genetically modified organisms (GMOs), requiring high data protection standards, imposing animal welfare requirements, providing high consumer protection and food standards, including as to ethical concerns, outlawing discrimination and setting minimum standards in criminal law. 71 Neither Union law nor its constitutional orientation requires that bioethics be an area where the EU has a value voidquite the opposite.

Efficacy, legitimacy and European identity
This leads to the final point. It is important not to fetishise national biolaw. Deep bioethical divisions exist in Europebut, as Favale and Plomer concede, the same is true within Member States. 72 "What legislation achieves on [bioethical] matters is at best compromise, not consensus". 73 And "achieves" is the right word: as Brosset notes, biolaw does not merely formalise "an equilibrium between pre-existing values in each State, an equilibrium which incidentally is frequently impossible given how far values diverge. [The law] also participates itself in the 'constitution of these equilibriums' because it 'includes as well : : : ethical concepts which inform our lives'". 74 This role of biolaw in creating as much as reflecting community values is important, and it points towards the role of biolaw in constituting communities and polities themselves. 75 Moreover, purely national biolaw provisions frequently have limited effect. They are vulnerable to "democratically enshrined values [being] systematically annihilated by competition from more permissive judicial orders"so-called "reproductive tourism" being one obvious example. 76 In fact, modern bioethics' roots are deeply international (notably in the Nuremberg Doctors' trial and the Helsinki Declaration of 1964). 77 To date, international human rights law has been the key language of international biolaw. 78 This has had some successes, such as the remarkable rise of autonomyand its corollary, informed consentin many legal orders. 79 But this law is typically soft, underspecified or weakly enforceable. 80 At the same time, it is made by intergovernmental conference or, in the case of the Helsinki Declaration, by a small group of professionals. These seem still further from Floris de Witte's idealised moral community than the EU's legislative process. 81 Here, as elsewhere, the EU potentially offers a middle ground. 82 It could enshrine bioethical values that transcend the nation state and can better resist the ravages of globalisation. These international bioethical standards would potentially be at once more democratic and more binding than international human rights law. In addition to addressing Health Union's biolaw implications openly and robustly, legislators could take up the above French Senate report's suggestion to adopt a legislative procedure similar to French biolaw's, with citizen panels and ethical advisory groups feeding into the law. 83 If Treaty change does occur, such a requirement could moreover be included in a new specific legal basis for biolaw provisions. Building on previous efforts to craft a distinctly European bioethics, 84 this would contribute to constituting the EU's community and polity, and so to the EU's shift from a market-based towards a values-based identity. 85

IV. CONCLUSION
Where Health Union proposals raise bioethical questions, the Parliament and other actors will apply pressure in order to answer them. Ignoring or seeking to confine these is likely to perpetuate the current situation: a fragmented EU biolaw that frequently does less or more than it appears to. As with non-market values generally, 86 legislators should embrace rather than deny these value-laden aspects of their work. They should follow an open and robust process to decide whether or not the bioethical question requires a European answer and, if so, what that should be. The European Group on Ethics in Science and New Technologies and the public should enjoy a genuine role in this, following (for instance) the French model for bioethical legislation. This would avoid the trap of imbalance, ensure compliance with Union primary law and build a stronger international biolaw that, in turn, strengthens the EU's legitimacy and identity.
The EU is now uniquely and powerfully placed to influence the future direction of Europe and of humanity in respect of some of the most important challenges the coming century will bringfrom climate change through artificial intelligence to gene editing. Like the Health Union, each of those areas involves deep value and distributional clashes. 87 Yet the EU continues to set these rules as if they were further 82 aspects of technical legislation, without open value clashes or enhanced democratic input. 88 The Health Union provides a crucial opportunity for the EU to bring these value and ethical clashes out of the shadows. To put it another way: Hippocrates is not the only person who needs Socrates in this Union.