A rights based model of governance - the case of human enhancement

A Rights-Based Model of Governance: The Case of Human Enhancement and the

Role of Ethics in Europe Daniele RUGGIU

CIGA, University of Padova

Abstract: In Europe, the current model of governance is characterized by the cen-trality of ethics, which has led (at national and supranational levels) to both the in-stitutionalization of ethics (the bureaucratic expression of ethics) and to the ‘ethicization of technoscience’ (the tendency to frame the governance of emerging technologies in ethical terms). This model is unique in the world and, due to the overlapping of the above-mentioned phenomena, has generated a process of blur-ring the boundary between ethics and law, which weakens the action of the regula-tory and ethical tools of governance, especially with regard to human rights. The analysis of the case of human enhancement, with particular regard to stem cell re-search, shows instead how a clearer distinction of the role and functions of ethics and law, as well as the development of mechanisms of self-coordination, can strengthen the current model of governance as a rights-oriented one.1

Keywords: Models of governance; enhancement technologies; metagovernance; human rights; ethics.

Introduction

The current development of technology and scientific research may give rise to several applications on human beings. In this context, emerging technologies can further foster the applications on human beings and pave the way for new and incisive research to-wards human enhancement (HE).2 Thanks to emerging technologies, HE can be more effective and represent a concrete challenge for present societies, also in Europe. Scien-tists of the Northwestern University Feinberg School of Medicine, for instance, re-cently created a brain-synthesized estrogen that influences the synaptic structure, function and cognitive processes by augmenting the networks among neurons (Svriva-stava et al. 2010). Thus it could be a case of future brain-doping. The use of emerging

1 This work was done with the support of the European Commission FP7 Science in Society funded

project, ‘Ethics in Public Policy Making: The Case of Human Enhancement’ (EPOCH), grant number SIS-CT-2010-266660, http://epochproject.com. The views expressed in this article are the sole respon-sibility of the author and do not reflect the opinion of the European Commission or of any partner of the project.

2 For HE I refer to any “modification aimed at improving individual human performance and brought about by science-based or technology-based interventions in the human body”. As it has been under-lined, this definition includes “strong”, “second-stage” forms of human enhancement with long-term ef-fective or permanent results (e.g., genetic enhancements and invasive brain-computer interfaces) as well as “temporary” enhancements (e.g. alleged ”pharmacological cognitive enhancers” with low addiction potential or none at all”). See http://epochproject.com.

104 A Rights-Based Model of Governance

technologies can also meliorate the biological defense mechanisms of the human body. With synthetic biology, it could be possible to create beneficial bacterial infections programmed to augment immunity, or even synth-cells engineered to circulate in the body to extend the human immune system, making the human body resistant to normal illness and infections. The potential of synthetic biology might also lead to inserting artificial chromosomes in the genome of complex organisms, including humans, open-ing the door to the gene-enhancement (EGE 2010, 23). The field of nanotechnology offers new opportunities by designing artificial muscles (Shahinpoor 2011) or contact lens that can lead us toward augmented reality, a dimension where we can experience material reality and immersive computer data simultaneously (Lengley and Parviz 2008). Nanotechnology, synthetic biology, and stem cell research can concretely boost the possible applications of HE both for healthy and disabled people. In this context we should wonder whether the structures of technological governance we built in Europe are capable to face the societal changes that HE entails.

The model of governance, affirmed in Europe over the last thirty years in the con-text of both biotechnologies (Busby et al. 2008) and nanotechnologies (Ruggiu 2012b), shows the centrality of ethics and its participative character. This relevance of ethics can be observed even in the field of the enhancement technologies, such as in the case of stem cell research. The role assumed by ethics in Europe implies several phenomena such as the ‘institutionalization of ethics’ (Tallacchini 2009), the ‘ethicization of tech-noscience’ (MASIS 2009, 32, 38) and the tendency of ethics to incorporate legal tools by blurring boundaries between law and ethics (Plomer 2008). These phenomena are tightly intertwined and the last one, in particular, involves human rights that can play a relevant part in face of HE through two clashing principles: personal dignity and au-tonomy. In this chapter, I will provide a rights-based model of governance and I will argue that governance can be more effective only if we build mechanisms of coordina-tion among all governmental tools, both regulatory and ethical. In this regard, the phe-nomenon of the ‘ethicization of technoscience’, with its blurring of ethical and legal norms, risks weakening the efficacy of human rights in the governance of emerging technologies, especially enhancement technologies. Therefore, I will conclude that a clear division of roles, functions, and structures of law and ethics could strengthen both the human rights penetration into the grammar of the EU governance and the efficacy of technological governance itself.

1. Governance and Metagovernance

By governance I mean the ensemble of processes with reticular character, diffuse among public and private actors both at national and supranational levels made up by norms of soft and hard law, somehow coordinated and aimed to solve conflicts and to make decisions in a particular technological, economic, or financial field (Ruggiu 2012b, 156).3 Scholars increasingly distinguish the concept of governance from that of metagovernance. Metagovernance refers to the organizations, structures, and processes that produce (the conditions of) governance (Jessop 2003) through the arrangement of normative tools (of legal, ethical, technical nature). At the metagovernance level, the relations among organizations and governance structures are characterized by heter-

3 On governance, with special attention to the ‘new governance turn’, see Stokes 1998; Scott and Tru-

beck 2002; Lyall and Tait 2005; with regard to emerging technologies, see Roco 2006.

A Rights-Based Model of Governance 105

archy instead of a kind of framing of hierarchical type. This fact deprives the processes of governance of a centre that can determine all relations of the system, giving a merely eccentric and diffuse character. In this regard the governance appears de facto distri-buted among several subjects and, thus, to be effective any model of governance should be able to involve a wide range of stakeholders (Stokes 1998; Pariotti and Ruggiu 2012). Consider the role of transnational corporations, or the action of NGOs within the worldwide governance (Pariotti 2007; 2013), or, again, the increasing importance of organs without legislative power but absolutely central in Europe, such as ethical committees especially at the Community level (Salter and Jones 2002).

In this context we can distinguish the formalized structures and processes produc-ing governance from the informal ones. Those of the first type encompass the soft and hard law instruments such as EU directives, recommendations, self-regulatory tools (including codes of conduct), third-party certification systems that can nevertheless have legal effects, and human rights. Those of the second type can be, for example, reports and opinions of ethical advisory boards (EABs) such as the EGE, internal documents of corporations without any legal effect, or acts of NGOs that might influ-ence policy making. In other words, the first category of governance structures and processes, with respect to formal procedures and norms of competence, produces legal norms with binding force (hard law norms) or legal norms without binding force but capable of having legal effects (soft law norms); the latter category produces norms (moral, technical etc.) without any legal effects but capable of influencing decision-making processes.

In the great puzzle of governance, any tool, even EU directives and resolutions, represents only a piece of the whole framework and coexists with a plurality of diverse tools with different goals and scope. Thus, to assess the pros and cons of a model, we need to enlarge our sight. In this chapter, I will focus on only two kinds of tools that are tightly intertwined—human rights and the ethical advisements of EGE—and their interplay with regard to HE.

2. A Legal Analysis of Human Rights

As a small piece of the picture of governance, human rights can represent a governance tool in two ways. Due to their dual nature as both moral and legal, they are referred to by legal documents on human rights and by acts of EABs (especially at supranational level).4 From the legal standpoint, human rights are considered by the documents of hard and soft law (for example, the European Convention of Human Rights or ECHR5, the Oviedo Convention6, and the EU Charter7), and, in this latter instance, especially by

4 Human rights can be considered both as legal rights and as moral rights. In the Anglo-Saxon world,

their consideration as moral rights prevails (e.g. Raz 2010; Brownsword 2008), whereas in continental Europe, their consideration as legal rights is consolidated (e.g. Jacobs et al. 2002; Bultrini 2004). These two perspectives are rooted in the different constitutional traditions characterizing the old continent. In this chapter, I will consider both perspectives as legitimate; but I will produce some brief arguments in favor of the legal consideration of human rights.

5 Council of Europe, Convention for the Protection on Human Rights and Fundamental Freedoms (ECHR) (CETS n. 5), adopted in Rome on November 11, 1950 (entered into force on September 3, 1953).

6 Council of Europe, Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine (Convention on Human Rights and Biomedicine


self-regulatory documents (codes of conduct, guidelines, and so forth). In order to ex-press their legal dimension, I will use the following definition: human rights are those rights recognized by the international law rules listed in documents like the Universal Declaration, the Covenants of '66, and the ECHR pertaining to individuals, groups and associations against the state and enforceable in the face of judicial or quasi-judicial organs at a supranational level (the European Court of Human Rights or ECtHR, UN committees on human rights) (Ruggiu 2012a, 337 n. 4; 2012b, 7 n. 1). This definition sees the normativity of human rights as the result of legal texts (e.g. the ECHR) and the supranational courts case law (e.g. the ECtHR decisions) and permits human rights to have both a definite semantic content (e.g. what autonomy means) and a concrete effi-cacy (i.e. any violation is punished). In this regard, despite the common opinion that sees human rights as indeterminate norms (MacIntyre 1981), thanks to the case law of the two main European courts (the ECtHR and the Court of Justice of the EU or CJEU), their semantic content (their meaning) is determinate and complete, at any rate in Eu-rope where there are binding treaties on human rights (the ECHR), as well as an effec-tive system of enforcement able to punish a state’s human rights violations (the ECtHR) and to offer a wide set of decisions in several fields, with regard to scientific and technological developments (Ruggiu 2012b).

In Europe, there are two competing systems of protection of human rights that con-tribute to their enforcement: that of the Council of Europe and that provided by EU (Bultrini 2004). These two protection systems are centred around a couple of hard law instruments (the ECHR with regard to the Council of Europe and the EU Charter) and around the activity of two supranational judicial organs (the ECtHR and the CJEU), which create an efficient and self-coordinated mechanism of enforcement able to strengthen the respect of human rights in the old continent (Spielmann 1999; Bultrini 2004).8 In the case of HE, where we could face (and we actually face) permanent or temporary modifications of the human body, there are two key aspects, in addition to the general theme of the protection of the individual good of health (the right to health): the possibility to exert individual consent to treatment (the self-determination principle), and the protection of human nature, which belongs to every individual (human dignity).

2.1. Human Dignity

In a context characterized by the intertwining of a plurality of actors, jurisprudence is per se a governance factor, alongside the academic world, which is so engaged within the ethical reflection on the implications of technological development. This conclusion is true especially with regard to HE. Indeed, in this field we find some decisions of the European courts of capital importance that will affect the governance of enhancement technologies in future, especially with regard to personal dignity and stem cell research.

or the Oviedo Convention) (CETS n. 164), adopted in Oviedo on April 4, 1997 (entered into force on December 1, 1999).

7 The Charter of Fundamental Rights of the European Union, adopted in Nice on December 7, 2000. 8 Nevertheless, human rights and fundamental rights of the EU cannot be deemed as coincident since

they differ for content (there are some Community rights, such as freedom of research, that are not also human rights in the ECHR), structure (fundamental rights are balanceable with other public interests of the EU, such as free circulation of goods that can predominate) and trait (human dignity is an autono-mous right, whilst personal dignity is the basic value supporting the whole human rights architecture), the spontaneous mechanism of self-coordination between the two courts represents a resource for hu-man rights themselves (Pariotti and Ruggiu 2012).


When the human being is handled as a means and not as an end, human dignity may be called in question (Jacobson 2007, 293, 298). Within human rights law, human dignity is the most pregnant with ethical significance among the other legal concepts (Andorno 2009). This makes hard to give it a legal meaning. Dignity is recalled by several documents at a supranational (e.g. the Universal Declaration on Human Rights9, the Oviedo Convention, the EU Charter etc.) and a national level (e.g. the German Constitution) (Francioni 2007; Jacobson 2007).

From the legal standpoint we can distinguish two basic conceptions of dignity: one conceives dignity as the hidden concept, the architrave, of the whole of human rights law, being implied in several rights and freedoms (Andorno 2009; Jacobson 2007, 296); the latter interprets it as a right as such, which can be exercised by individuals or groups in the face of violations of human dignity (EGE 2000). The first model is proper to the Universal Declaration, the International Covenants of the 1966, and above all the system of the ECHR of the Council of Europe, which, paradoxically, does not men-tion it, not even in its preamble (Beyleveld and Brownsword 2004, 12).10 In this in-stance, individual dignity is protected directly by the state, which arrogates the power of making the trade-off among the opposite interests on behalf of the entire community, or indirectly by individuals that claim the protection of other freedoms and rights (mainly personal integrity, equality, and prohibition of inhuman, degrading treatments). Here, in this latter instance, dignity maintains the right structure (with an individual as right holder and a subject responsible for its protection, i.e. the state) but having a merely accessory character of the other rights. Thus, its legal content is nearly empty since the case law is too limited in this matter. Instead, in the first instance dignity has no right structure (no individual can claim it) and it is a mere public interest protected by the state and, in this sense, it might conflict with other individual interests that can be recognized as legal rights (e.g. autonomy). In order to build dignity as an ‘autono-mous (individual) right’ we could only resort to another model. This latter model, in-deed, is typical of the EU Charter where human dignity is affirmed as an autonomous right, and, as a right, it is protected by the CJEU jurisprudence. Here, the right holders are groups or associations that exercise the right of petition against the state in front of the court on behalf of the community.

What is meaningful is that the jurisprudence of the CJEU on personal dignity is fundamental especially with regard to HE. Extremely relevant is, in fact, the Brüstle Case of the CJEU, because it has provided a definition of human embryo and deter-mined the conditions of patentability of some uses of human embryos.11 In 1997, Mr. Oliver Brüstle, a stem cell researcher, filed a patent related to isolated and purified neural progenitor cells for the treatment of neural defects. The transplantation of brain cells into the nervous system can be a promising method of treatment for numerous neurological diseases. The same techniques could be used also in brain enhancement. Greenpeace filed an appeal before the Bundespatentgericht (the Federal Patent Court in Germany) seeking a ruling of invalidity of the above-mentioned patent. The Bundes-patentgericht decided to stay the proceeding and to refer the question of stem cells patentability to the CJEU. First of all, lacking a uniform definition of human embryo,

9 The Universal Declaration on Human Rights (UDHR) adopted in New York on December 10, 1948 by

the General Assembly of the United Nations. 10 It is expressly embodied in the preamble of the Protocol n. 13 concerning the abolition of death penalty

in all circumstances adopted in Vilnius on May 3, 2002. 11 Judgment of the Court of Justice (Grand Chamber), Oliver Brüstle v. Greenpeace eV (Case C-34/10),

18 October 2011, not yet published.


the CJEU provided one including: a) any human ovum as soon as fertilized; b) any non-fertilized human ovum into which the cell nucleus from a mature human cell has been transplanted; c) any non-fertilized human ovum whose division and further devel-opment have been stimulated by parthenogenesis, including stem cells obtained from a human embryo at the blastocyst stage. Then, it excluded from patentability some uses of human embryos (with industrial, commercial purposes, or for scientific research). Although the aim of the scientific research must be distinguished from industrial and commercial purposes, the use of human embryos for purposes of scientific research cannot be separated from the patent itself and the rights attached to it.12 According to the court, techniques for producing stem cells that require the prior destruction of hu-man embryos are also unpatentable.13

Outside of all those limits, the patentability of stem cells is admitted and it does not infringe human dignity. This decision will also act as landmark for the ECtHR jurisprudence, which can follow its statements in the future thanks to the process of self-coordination existing between the two courts.

2.2. Self-Determination Principle

Autonomy, and the freedom of choice, is one of the pillars of human rights law. The question of the limits of our personal choice in non-medical treatments is one of the most controversial issues at stake (Beghé-Loreti and Marin 1999), especially with re-gard to HE.

In the future, thanks to emerging technologies, the opportunity to use ICT implants, brain-computer interface devices, or artificial limbs could be really advantageous, giv-ing rise to a form of ‘permanent enhancement’.14 In these cases, what will be the judi-cial limits of a treatment as such? It is clear that human dignity and the self-determination principle are in a situation of potential conflict (EGE 2000). No case has (obviously) yet emerged, although nowadays many practices aimed to modify the body, if not directly enhancing it, are already very common.

Within liberal-democratic societies some very invasive treatments such as gender re-assignment surgery are widely recognised.15 Re-assignment surgery can be deemed a kind of ‘irreversible human enhancement’. The ECtHR, for example, recognised that ‘there has been an unmistakable trend in the member States of the Council of Europe towards giving full legal recognition to gender re-assignment’.16 Within the ECHR system, the personal autonomy falls under the provision of Article 8 (respect of private life), which guarantees the personal sphere of each individual, including the right to

12 See Brüstle case, 43. 13 According to Goran Hermerén (2009), if a court has settled the ethical issue of the meaning and scope

of the application of the principle of human dignity (for example, whether the destruction of the blasto-cysts in stem cell research is or not compatible with human dignity) that would seem to be a clear case of blurring normative and legal issues. There are reasons not to agree with this opinion. Indeed, with regard to human rights practice in Europe, it is important to bear into mind that the regulatory frame-work of human rights is the result of the joined work of the regulator (e.g. the Council of Europe or the EU) and judges (mainly the ECtHR and the CJEU). Accordingly the judges’ work is fully normative (it produce norms and therefore it is ‘normogenetic’), even if within the framework of rights set forth by the regulator (i.e. Council of Europe, EU) (Viola and Zaccaria 2001).

14 HE can be temporary or permanent and irreversible (Allhoff et al. 2010). 15 See Christine Goodwin v. The United Kingdom (App. 28957/95), judgment of 11 July 2002, Reports of

Judgments and Decisions 2002-VI. 16 See ibid., 55.


establish details of their identity as individual human beings.17 Can such applications of enhancement technologies be considered forms of reshaping individual identity? This is the question I would like to address here. It is clear that sexual identity is a particular aspect of personal identity, and it is difficult to build an analogical relationship with other medical treatments of the human body. But the delicacy of this issue is that it has a societal basis, and the common consideration of what is the core of our identity is strictly connected to societal development. According to the ECtHR, the matter of gender re-assignment cannot be left to the states’ margin of appreciation. The only limit which the court affirmed is that the treatment, even if painful, must be not ‘arbi-trary or capricious’.18 In this regard we could ask whether a HE intervention, which has by definition no therapeutic character, falls outside or inside those limits. It is necessary to remember that the ECHR is interpreted ‘in the light of the present-day conditions’ with a strong attention to societal evolution. Here the public order and morality clauses could take place. The question of the choice itself to undergo to surgical treatment has not been directly dealt with yet. The cases that dealt with the gender re-assignment in the light of the non-discrimination principle presuppose the legitimacy of the choice to undergo surgical treatment. A currently pending case will now directly deal with this issue and will probably determine limits and conditions of personal choice in its wider meaning.19

In sum, while the EU system of protecting fundamental rights seems to be stronger with regard to the matter of personal dignity, that of the Council of Europe can offer a higher level of protection with regard to the self-determination principle; but the cur-rent mechanism of self-coordination between the two courts permits integrating them in one efficient model (Pariotti and Ruggiu 2012).

3. The Activity of the Ethical Advisory Boards in Europe

In biotechnological matters, the EU has developed a model of governance whose ex-perience represents a benchmark in other fields, as well. In particular, within the Euro-pean governance of emerging technologies, ethics has taken a leading role, which has no equal in the world.20 This fact led to building a bureaucratic apparatus able to sup-port and formally include ethical reflection into EU institutions, giving rise to the phe-nomenon of the progressive ‘institutionalization of ethics’, namely, the integration of ethical reflexivity into public institutions (Talacchini 2009). Tightly connected to this, the phenomenon of the ‘ethicization of technoscience’, that is, the tendency to frame technological innovation merely in ethical terms, has been unavoidably produced within the Union (MASIS 2009; Pariotti 2011). I would like to show that these over-lapping phenomena can be a weakening element in the governance of biotechnological applications on human beings, in particular those that can lead towards enhancement technologies.

The processes of the ‘institutionalization of ethics’ and of the ‘ethicization of tech-noscientific governance’ began in the 1970s and 80s when the lack of acceptable regu-

17 See ibid., 90. 18 See ibid., 81. 19 Y.Y. c. Turquie (Requête no 14793/08), pending case, available at http://hudoc.echr.coe.int/sites/eng/

pages/search.aspx?i=001-114422 (accessed on 4 April 2013). 20 For example, with regard to nanotechnologies, see Kearnes and Rip 2009.


latory capacity of the European Commission led to the adoption of committees, agen-cies, and EABs (Busby et al. 2008). In front of the challenges of biotechnologies the Community authorities addressed the issues of the increasing distrust of the public on the European policies and the legitimacy of the decision-making processes. For this reason, they instituted an organ with ethical competence able to steer the innovation processes among the member states. This body, which aimed to foster public confi-dence, took the name, first, of GAIEB and, then, of EGE.21 Its role and its increasing influence made it a strategic pole within the EU framework and the possible target of a process of instrumentalisation by politics (Plomer 2008).

The route towards a model of governance characterized by the centrality of ethics goes through three fundamental steps. First of all the EGE legal basis was shaped with-out any datum point in the treaties, augmenting de facto its autonomy, especially from the European Parliament. Then, the scope of its remit was enlarged and subsequently posed under the control of the Presidency of the European Commission, weakening thus the requirements of its independency from political power. Finally, the activity of the EAB played a part in determining the European policies in the biotechnological field, in particular in stem cell research, in order to forge a common European identity in those matters among member states.

With regard to the first aspect it is to notice that the Union EAB has benefited from the lack of a clear legal basis. In fact, none of the Treaty on functioning of the Euro-pean Union articles that are usually recalled (Article 168 – public health, Article 169 – consumer protection, Article 114) refer to either GAIEB or EGE activity (Busby et al. 2008, 837). For example, Article 168 on public health provides that the European Commission shall take any useful initiative to promote the coordination among mem-ber states, particularly initiatives aiming at the establishment of guidelines and indica-tors. There is no reference to any EAB such as EGE. Thus, its legal basis seems to rest only on the two EC Decisions of 1998 and 200022 related to its mandate and on the EC Decision of 2005, which directly provide the EGE remit.23 And it is astonishing that no article of the EU Treaties mentions a so strategic organ of the EU. This uncertainty reduces de facto the possibilities of control on its activity, giving the EGE and the EU institutions responsible for it (i.e. the President of the Commission) an extensive au-tonomy (Busby et al. 2008, 838).

As the requirements of its transparency and independency were so fragile, the EGE remit was changed several times by enlarging tasks24, members’ competences25, and membership26, and by introducing tighter dependency relations with the EU institutions (Plomer 2008, 843-844). These changes hide the existing conflict between the Euro-pean Parliament and the Commission on the role and functions of a key committee of

21 The group was instituted in 1991 with the name of Group of Advisers on the Ethical Implications of

Biotechnology to the European Commission. In 1998, it took the name of the European Group on Eth-ics in Science and New Technologies (EGE).

22 Commission Decision dated 16 December 1997 (SEC(97) 2404) creating the European Group on Ethics in Science and New Technologies (EGE); Commission Decision dated 26 March 2001 (C(2001) 691) concerning the amendment to the remit of the European Group on Ethics in Science and New Tech-nologies.

23 Criticisms on the legal basis of the EGE are also in Plomer 2008, 853. 24 In 1998, its mandate was modified by including the tasks of consulting and reporting back to European

Parliament. 25 In 1998, the disciplines of sociology and informatics were included. 26 With this last modification, the members went from six to twelve.


the Union. The main modification occurred with the 2000 mandate (subsequently con-firmed in 200527) when the EGE secretariat was integrated in the Bureau of the Euro-pean Policy Advisors reporting directly to the President of the Commission and acting under his authority. In this moment a weighty legacy, in terms of independency and transparency of the work of the ethical committee of EU, was created.

When the presupposition of its action was set under the control of the Presidency of the Commission, the increasing influence acquired by EGE was thus tightly inter-twined with its vulnerability in front of improper pressures of given political lobbies. Leaving aside the instance of the 1998 Directive28, wherein the clause of ordre public has been created by following two precedent EGE opinions29, the case of the stem cell research is emblematic. In March 2005, an EP resolution30 intervened, calling for the principle of subsidiarity to be applied also to the funding of embryonic stem cell re-search, leaving instead to the member states the responsibility of deciding which re-search should be funded. Immediately after, in September 2005, some members of the Parliament requested in a letter that the President of the Commission should exercise his influence to ensure that funding for research on human embryos would not take place under the Seventh Framework Programme (FP7) (Plomer 2008, 847). In 2007, the EGE adopted the opinion n. 22 on ethical aspects of FP731, drafting a set ethical indications that, then, were consequently included in the FP7. Accordingly, the FP7 prescribed that the research funded should comply with the fundamental ethical princi-ples as reflected in the Charter of fundamental rights of the EU (Plomer 2008, 850)32, taking, then, into account also the opinions of the EGE nearby the other sources of law. Thus legal and ethical norms contribute de facto directly to the EU regulation.33 Ac-cording to FP7 the research aiming at the cloning for reproductive purposes, those intending to modify the genetic heritage of human beings, those intending to create human embryos solely for the purpose of research or for the purpose of stem cell pro-curement, including by means of somatic cell nuclear transfer, should not be funded. Moreover, in regard to the derivation of human embryonic stem cells, institutions, organizations, and researchers are subject to strict licensing and control by members states involved. Thus, the ethical control was further implemented by the legal frame-work of the member states.

27 Commission Decision dated 11 May 2005 (2005/383/EC) on the renewal of the mandate of the Euro-

pean Group on Ethics in Science and New Technologies. 28 Article 37 of Directive 98/44 on the legal protection of biotechnological inventions [1998] OJ L213/13

excludes from patentability those inventions ‘where their commercial exploitation offends ordre public or morality’.

29 Opinion n° 3 - 30/09/1993 - Opinion on ethical questions arising from the Commission proposal for a Council directive for legal protection of biotechnological inventions; opinion n° 8 - 25/09/1996 - Ethi-cal aspects of patenting inventions involving elements of human origin. See Busby, Hervey, and Mohr 2008.

30 Resolution of the European Parliament on the trade in of human egg cells RC B6-0199/2005 of 10 March 2005, para. 10.

31 Opinion n° 22 - 13/07/2007 – Recommendation on the ethical review of hESC FP7 research projects. 32 See also Opinion n° 22, II.4.2. 33 With regard to an analogous influence of EGE on FP5, see Salter and Jones 2002, 812.


4. The Blurring of Ethics and Law

The process of shaping and designing the current scientific and technological develop-ments in ethical terms made the EGE a decisive tool of allocating research funding, giving it an extraordinary political power under the sole control of the President of the Commission. This strategic role assumed by ethics at the Community level has in-creased by the tendency of blurring ethical and legal matters (Plomer 2008, 845-846; Mohr et al. 2012, 106). The beginning of the process of blurring of ethics and law can be located in the opinion n° 8 wherein GAIEB draws the concept of ‘ethics’ widely, including technical legal concerns. Indeed, with regard to the question of the patent-ability of human gene sequences, it added to the legal reasons of non-patentability some ethical concerns relating the non-commercialization of the human body (Busby et al. 2008, 812). The above-mentioned Directive 98/44 with its ordre public clause is, in this framework, a clear sign of this process. This phenomenon is also enlarged by the semantic structuring of the EGE opinions that may contain a mixture of ethical and legal principles in a variety of sources (both at regional and universal level) often with-out detailed analysis of their legal status, contents, attending jurisprudence, and critical literature (Plomer 2008, 845-846).

This approach, which makes human rights balanceable with other pubic interests of the state, appears questionable from the standpoint of the human rights law.34 In this regard, an example could be the opinion n° 20 on ICT implants35, where the ethical principles to be considered are drawn from legal texts of international law mixing hu-man rights (freedom, equality, privacy etc.), basic concepts of human rights law (dig-nity), and other legal principles of international law (precautionary principle), considered indifferently at the same level without any study of their ethical background, attending jurisprudence, and implications.36 An analogous tendency can be also seen in its opinion on nanomedicine, which appears more mature but with the same confusion between ethical and legal fields.37 This weakness in framing the texture of its opinions also risks blurring the roles of ethics and law, whereas they should be distinct to be more efficacious.

This phenomenon leads progressively to imposing ethics as a parallel source of law within the EU, weakening the efficacy of the regulatory tools and eroding the base of the public trust. In this regard, the ‘ethicization’ phenomenon risks compromising the participatory characteristic of EU governance. In this framework, human rights see their forces ineffectively dispersed while they could be used differently, inasmuch as they are a strong pole of motivation. No content, except that given by the ethical reflec-tion, can be found in them. They are semantically empty and therefore only ethics can fill them. The action of the European courts on human rights is, in this conceptual

34 In fact, within the ECHR human rights are derogable only in time of war and other public emergence

(Article 15) and can be restricted only in the cases permitted by the Convention (Article 18). 35 Opinion n° 20 - 16/03/2005 - Ethical aspects of ICT Implants in the Human Body. A different approach

we can find in its Draft Charter on Fundamental Rights of European Union, Brussels, June 15, 2000, available at http://www.europarl.europa.eu/charter/civil/pdf/con233_en.pdf [accessed May 17, 2012]. In this document, the ethical implication of the legal shaping of the rights of the EU is considered with at-tention.

36 Ibid., para. 4: Legal background. On this criticism, see Plomer 2008, 845-846. On the contrary, an excellent examination of fundamental rights from the legal standpoint can be found in the EGE’s draft of the EU Charter. See EGE 2000.

37 Opinion n° 21 - 17/01/2007 - Ethical aspects of nanomedicine.


framework, only a sign that, from the legal standpoint, would have no sense (i.e. it is totally discretional). Their normativity is reduced only to the texts affirming them and, therefore, separated from their practice and application, human rights are completely indeterminate (MacIntyre 1981). What does human dignity mean? Only ethics can say, not the law. Enclosed into mere ethical reflection, human rights lose the possibility of affecting the European governance with the strength of individuals’ positions and inter-ests, becoming a mere moral argument of an opaque (and unfortunately weak) rhetoric (Ruggiu 2012b, 172).38

Conclusions

The model of governance of the EU has elected ethics as the engine for boosting inno-vation (Kearnes and Rip 2009). The virtue of ethics should permit, in fact, thanks to its elasticity, facing the challenges of innovation on a case-by-case basis and involving more stakeholders in the governance processes, augmenting its efficacy. Yet instead, this fact weakens the efficacy of some regulatory instruments such as human rights, by empting them and letting them being absorbed into ethical reflexivity. This overflow-ing role is also witnessed by the process of blurring of ethics and law that characterizes the EGE activity (Plomer 2008). In the current model, we can notice that there are already antibodies to face these impairments. In fact, within the EU model there are some principles that anticipate the choices of decision makers. Those principles are the fundamental rights and they correspond substantially to human rights. They are largely implemented by some regulatory texts (e.g. the EU Charter and the ECHR) and the jurisprudence that is, at the metagovernance level, an actor operating in the framework of other governmental structures.

Fundamental rights work as ‘normative anchor points’ by setting in advance the goals on which governance should be inspired (von Schomberg 2011; 2013). In other words, they work in an anticipatory dimension within European governance. With the entry into force of the EU Charter in the beginning of 2010, these ‘anchor points’ have acquired binding force and have become the ‘polar star’ of the EU governance. They are present both in the hard law instruments (i.e. the EU Charter as implemented by the CJEU) and in the soft law instruments (e.g. declarations, recommendations, the codes of conduct, guidelines, and so forth) and they also contribute to involving stakeholders (Pariotti and Ruggiu 2012). They are the fulcrum of this participatory model that, in-deed, uses them to shape both soft law and self-regulatory tools of governance (mainly guidelines and codes of conduct). In this context, the mechanism of self-coordination between the Council of Europe judicial body (i.e. the Strasbourg Court) and that of the EU (i.e. the CJEU) can help to strengthen the effective penetration of fundamental rights into EU law (Spielmann 1999; Bultrini 2004), especially with regard to emerging technologies aimed at HE wherein the pros and cons of the two systems are equivalent (Pariotti and Ruggiu 2012, 162). It is the case with personal dignity and the self-determination principle, which have great importance in the discourse on HE.

38 An example of this rhetorical use of human rights can be seen in the EU code of conduct for responsible

nanosciences and nanotechnologies research, wherein human rights are referred to only in generic man-ner, as a whole (e.g. point 4.1.17 of the guidelines), without focusing the specific individual positions singularly affected by technological development (e.g. the right to health, self-determination principle, integrity, and so forth). See Ruggiu 2012b, 170.


For this reason, within the great puzzle of European governance, ethical tools should also address the interconnections existing in the composite framework that con-tributes to producing the whole system of governance. In this framework, human rights are certainly interesting tools that will play an increasing role within European govern-ance, and, in part, also thanks to the jurisprudence of the main two European courts (i.e. ECtHR and CJEU), they are already doing so. But they need to be correctly framed, alongside ethics, in order to avoid any overlapping between the two fields. A clearer vision of the roles and functions of law and ethics could empower the respective tools and would permit the development of a model of governance more coordinated and aware of the productive dimension of human rights in building governance in Europe. In other words, this model, already implemented by existing regulation in Europe, in the EU and in the Council of Europe, is the rights-based model of governance.

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A rights based model of governance - the case of human enhancement