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NanoEthics

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01.12.2013 | Original Paper

Temporal Perspectives of the Nanotechnological Challenge to Regulation: How Human Rights Can Contribute to the Present and Future of Nanotechnologies

verfasst von: Daniele Ruggiu

Erschienen in: NanoEthics | Ausgabe 3/2013

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Abstract

Expectations play a central role in understanding scientific and technological changes. Future-oriented representations are also central with regard to nanotechnologies as they can guide policy activities, provide structures and legitimation, attract different interests, focus policy-makers’ attention and foster investments for research. However, the emphasis on future scenarios tends to underrate the complexity of the challenges of the present market of nanotechnologies by flattening them under the needs and promises of scientific research. This is particularly apparent if we consider the viewpoint of the regulator who faces two different ranges of problems with regard to the market and research and is expected, simultaneously, to manage two different types of regulatory instruments, pursuing at the same time the same goals. Instead, by favoring only the future scenarios, the regulator runs the risk of abruptly shifting from more flexible and elastic tools to forms of hard legislation, wasting, thus, the resources of the soft-regulation, in particular those of self-regulation. By referring primarily to the European context, human rights, also thanks to their normative structure of principles, can help in strengthening both the legislation needed for regulating the present market and the soft instruments needed for steering research and for fostering the stakeholders’ participation without sacrificing the coherence of the regulatory response.

Vorheriger Artikel The European and Member States’ Approaches to Regulating Nanomaterials: Two Levels of Governance

Nächster Artikel Responsible Management in Private Sector Nano Enterprises: Conversations with Lead Technologists and Managers

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‘Regulation’ refers here to a regulatory landscape of norms of hard and soft law which contribute to the regulation of any aspect of social life, although these norms can have different degrees of legal normativity [59]. Therefore, regulation has no exclusive state-centric connotation, which is typical of hard law instruments, and includes the activity of several public and private actors [56: 515].

In this case, the regulator would face the ‘temporal dilemma’ too early/too late. Given the state of uncertainty, relying upon hard law could either hinder technological development or regulate the matter when the risks and, more generally, impacts of the technology concerned are already present [39].

‘Soft law’ refers here to guidelines, declarations or recommendations containing principles and standards, or voluntary measures (self-regulation tools, voluntary codes of conduct, third-party certification systems), which are not supported by formal legal sanctions, though they can have legal effects [58].

See, e.g., the ongoing research on the toxicology of multiple or single-walled carbon-nanotubes [41, 61], on toxicology and ecotoxicology of titanium dioxide nanoparticles [92], on cyto and geno-toxicology of silver nanospheres [90].

Lisbon European Council 23–24 March 2000: Presidency conclusion, http://www.europarl.europa.eu/summits/lis1_en.htm.

The EC CoC can be described also as a form of meta-regulation [14, 17]. In this instance, the regulator sets forth the norms regulating the act of self-regulation’. Therefore, there is a temporal dissociation between the act of meta-regulation and that of self-regulation, which only partially coincide.

With regard to the EC CoC, two consultation processes were launched by the Commission. The first one was held in 2007 and aimed to provide input for the drafting of the Code. The second one was implemented in 2009/2010 to map stakeholders’ perception of the EC CoC and the ways it should be revised. Then, in 2010/2011, the NanoCode project launched a survey involving 304 European and international experts in order to analyze “the degree of compliance and commitment” with the EC CoC [50]. This latter consultation additionally involved 150 experts from different countries in qualitative interviews [32]. Criticisms on the supposed nexus between the use of horizontal modes of governance among a multitude of actors and their participatory nature are expressed by Smismans [75].

Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).

So far, only the Netherlands has formally adopted it and 21% of the participants of the NanoCode consultation held between October 2010 and January 2011 adopted the EC CoC [17, 32].

Resolution of the European Parliament of 24 April 2009 on regulatory aspects of nanomaterials (2008/2208(INI)), http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+TA+P6-TA-2009-0328+0+DOC+PDF+V0//EN.

Consider, for example, the regulation on cosmetics and on biocidal products (see details in the next section).

Regarding this Kearnes and Rip [39] talked of a phenomenon of “proliferation of codes of conduct”.

Consider, for example, the 2007 and the 2009/2010 consultation processes on EC CoC [17].

It is worth mentioning that the first case of death presumably due to exposure to nanoparticles was reported in 2008 [76].

Resolution of the European Parliament of 24 April 2009 on regulatory aspects of nanomaterials (2008/2208(INI)), p. 5 http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+TA+P6-TA-2009-0328+0+DOC+PDF+V0//EN.

Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetics products, OJ L349/59. The regulation provides a specific mandatory labeling, according to which the names of the ingredients present in the form of nanomaterials shall be followed by the word ‘nano’ in brackets (art. 19.1(g)).

Recommendation of the European Commission of the 18 October 2011 on the definition of nanomaterial, 2011/696/EU, 2011 OJ L275/38.

Regulation (EC) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004, OJ L304/18. The regulation provides a specific mandatory labeling, according to which the names of the ingredients present in the form of nanomaterials shall be followed by the word ‘nano’ in brackets. This provision shall enter into force by December 2014 (art. 18.3).

Resolution of the European Parliament of 19 January 2012 on the Council’s position at first reading with a view to the adoption of a regulation of the European Parliament and of the Council, concerning the making available on the market and use of biocidal products (05032/2/2011 – C7-0251/2011-2009/0076 (COD)), P7_TA-PROV(2012)0010. Also this resolution asked for a nano-specific mandatory labeling (art. 58.3(d)).

To be more precise, both these two dimensions develop under the heritage of past experiences, successes, errors and misevaluations [78].

Notwithstanding they have a dual dimension, both moral and legal, here I will refer to human rights as those ones and exclusively those recognized by international law rules listed in documents like the Universal Declaration, the Covenants of ‘66, the European Convention on Human Rights (ECHR) to individuals, groups and associations to the State and enforceable in the face of judicial or quasi-judicial organs like the European Court of Human Rights (ECtHR) or the UN Committees on Human Rights [58, 69, 70‐72].

United Nations, Universal Declaration on Human Rights (UDHR) adopted in New York on December 10, 1948.

United Nations, International Covenant on Civil and Political Rights (ICCPR), adopted in New York on December 16, 1966 (came into force on March 23, 1976) and International Covenant on Economic, Social, and Cultural Rights (ICESCR), adopted in New York on December 16, 1966 (came into force on January 3, 1976).

UNESCO, Universal Declaration on the Human Genome and Human Rights, adopted by the UNESCO General Conference in November 11, 1997 and subsequently endorsed by the United Nations General Assembly in 1998.

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

Regulation (EC) 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients, Article 5. See [70].

See Article 6, 1 of the Council directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage the improvements in the safety and health of workers at work.

Note that principles can be present also in hard law legislation (e.g. the principle of good faith). In other words, the dichotomy rules/principles does not correspond to the dichotomy hard/soft law.

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

See e.g. X v. Denmark (Appl. 9974/82), decision of the Commission of 2 March 1983, Decision and Reports, 32.

See e.g. Christine Goodwin v. The United Kingdom (App. 28957/95), judgment of 11 July 2002, Reports of Judgments and Decisions 2002-VI; Y.Y. c. Turquie (Requête n^o 14793/08), case pending.

Article 11 of the Oviedo Convention.

See e.g. Open Door Counselling Ltd and Dublin Well Woman v. Ireland (Appl. 14234/88, 14235/88), judgment of 29 October 1992, Series A, No. 246-A

See e.g. Tauira and others v. France (Appl. 28204/95), decision of the Commission of 4 December 1995, Decision and Reports, 83-B.

See Airey v. Ireland (Appl. 6289/73), judgment of 9 October 1979, Series A, No. 32, § 26 «Whilst the Convention sets forth what are essentially civil and political rights, many of them have implications of a social or economic nature».

See [29: 60], [53: 537], [31: 730], [16], [70].

According to the Strasbourg Court the ECHR is a «living instrument which . . . must be interpreted in the light of present day conditions» Tyrer v. the United Kingdom (Appl. 5856/72), judgment of 25 April1978, Series A, No. 26, § 31. This decision can be considered the cornerstone of the future evolution of the ECHR and the prerequisite of the application of human rights to the bioethics field in the ECHR system.

The Charter of Fundamental Rights of the European Union adopted in Nice on December 7, 2000 (came into force on December 1, 2009).

The Nice Charter became legally binding with the entry into force of the Lisbon Treaty. The Lisbon Treaty (Treaty of Lisbon amending the Treaty of the European Union and the Treaties establishing the European Community) was adopted in Lisbon on December 13, 2007 and entered into force on December 1, 2009. See [27].

The Oviedo Convention has been followed by some protocols. Some of them (on the prohibition of human cloning, on human transplantation, on biomedical research) are already in force. Others are already signed, but wait for a sufficient number of ratifications for their entering into force (e.g. on genetic testing for health purposes). Meanwhile, others are anticipated (e.g. xenotransplantation) as a recommendation of the Council of Ministers. An additional protocol or a recommendation on nanotechnologies has been recently requested by the Parliamentary Assembly of the Council of Europe on 26 April 2013.

See e.g. with regard to the participation in chemical experiments and the access to personal health data Roche v. The United Kingdom (App. 32555/96), judgment of 19 October 2005, Reports of Judgments and Decisions, 2005-IX.

See e.g. with regard to nuclear tests Tauira and others v. France (Appl. 28204/95), decision of the Commission of 4 December 1995, Decision and Reports, 83-B.

See e.g. with regard to the retention of biological samples S. and Marper v. the United Kingdom, judgment of 31 July 2012 (application no. 21203/10). Reports of Judgments and Decisions 2008.

See e.g. with regard to stem cell research see e.g. the judgment of the Court of Justice (Grand Chamber), Oliver Brüstle v. Greenpeace eV (Case C-34/10), 18 October 2011, not yet published. On this see [72].

With regard to the disclosure of data on the incomes of employees see e.g. the judgment of the Court of Justice Rechnungshof v Österreichischer Rundfunk and Others and Christa Neukomm and Joseph Lauermann v Österreichischer Rundfunk (Case C-465/00; C-138/01; C-139/01) European Court reports 2003 Page I-04989.

The Treaty of Lisbon EU provides in Article I-6 § 2 that in the near future the EU shall accede to the ECHR. Accordingly on 17 March 2010 the Commission proposed a negotiation directive for the Union’s accession to the Council of Europe’s ECHR and on June 3 and 4 2010, the Council of the European Union adopted the aforementioned negotiating mandate for the EU’s accession.

See the judgment of the Court of Justice (Grand Chamber), Oliver Brüstle v. Greenpeace eV (Case C-34/10), 18 October 2011, not yet published. In addition, von Schomberg [88] mentions the case of the ‘body scanner’ and the German Federal Constitutional Court.

With regard to the participatory attitude of national ethical advisory boards see [47].

The work of the Committee on Bioethics of the Council of Europe (DH-BIO) can be seen as an exemplary case of this balanced approach. The Committee develops its advice with a clear vision of the separation between legal and ethical issues, playing a brokering role between different national ethical boards at European level. See http://www.coe.int/t/dg3/healthbioethic/cdbi/default_en.asp.

For example, even within the EU Charter, fundamental rights themselves coexist with the principle of free circulation of goods (Preamble), public health (art. 35, which theoretically might clash with the individual right to health), the public interest of the environmental protection (art. 37, which theoretically might clash with the individual right to a healthy environment). In other words, the fair balance between individual interests (rights) and public interests of both EU and Member States is not automatically ensured [70, 71]. On this, Article 52(1) of the Charter explicitly affirms that «limitations may be made only if they are necessary and genuinely meet objectives of general interest recognised by the Union».

With regard to the efficacy of human rights among transnational corporations and their role in fostering good practices see also [55, 57].

A first step in this direction has been made by the Parliamentary Assembly of the Council of Europe on 26 April 2013 with the recommendation 2017(2013) ‘Nanotechnology: balancing benefits and risks to public health and the environment’ (provisional version). In this document either a Committee of Ministers recommendation or an additional protocol to the Oviedo Convention is requested [28].

Regarding this, the recent interest of the Council of Europe Committee on Bioethics (DH-BIO) for nanotechnologies is meaningful [28].

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Titel: Temporal Perspectives of the Nanotechnological Challenge to Regulation: How Human Rights Can Contribute to the Present and Future of Nanotechnologies
verfasst von: Daniele Ruggiu
Publikationsdatum: 01.12.2013
Verlag: Springer Netherlands
Erschienen in: NanoEthics / Ausgabe 3/2013
Print ISSN: 1871-4757
Elektronische ISSN: 1871-4765
DOI: https://doi.org/10.1007/s11569-013-0184-4

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