Final Report Summary - NANOETHICS 2011 (Governance and ethics of nanosciences and nanotechnologies)
Executive Summary:
The main objective of the Nanoethics 2011 project was to raise awareness of policy makers, experts, scientists, representatives of industry, third sector and general public as regards the Code of conduct for responsible nanosciences and nanotechnologies research as well as other developments in governance and ethics of such research. The general goal was to be achieved by the organization of the Governance and ethics of nanosciences and nanotechnologies NANOETHICS 2011 conference, follow-up activities and the overall promotion of the project.
The Nanoethics 2011 conference was organized on 2021 October 2011 in Warsaw by the Polish Academy of Sciences in cooperation and with support provided by the European Commission. The conference was held as an event included in the official calendar of the Polish Presidency of the EU Council, under the patronages granted by the Polish Minister of Science and Higher Education and the President of the Polish Academy of Sciences. The conference primary aimed at providing an overview of main issues concerning governance and ethics of nanosciences and nanotechnologies (N&N).
The conference was attended by 120 participants from countries all over the world, representing various groups of stakeholders, including representatives of the European Commission, NGOs, policy makers from the EU Member States, scientists, experts, entrepreneurs, and the general public.
The 2-day event was divided into four sessions. The first one constituted an introduction to nanosciences and nanotechnologies, discussing their cross-disciplinary nature, tangible current and possible future applications and directions of development, and covering the general overview of the complexity of issues connected with this emerging field. The second one provided an overview of the current regulatory framework regarding nanoscale materials and technologies, forming the basis for discussions on further steps required and recommendations to be taken into account in order to achieve comprehensive and encompassing regulations to govern this demanding field. The third session focused on delivering a broader context to the conference subject matter fostering the confrontation of opinions of stakeholders coming from various backgrounds by involving them, apart from standard presentations, in a roundtable discussion. The last, fourth session was devoted specifically to the Code of Conduct for responsible nanosciences and nanotechnologies research as a non-regulatory tool enabling to address N&N governance also from an ambiguous, ethical perspective.
The conference helped to summarize current developments relating to the vast, emerging field of nanosciences and nanotechnologies, providing all stakeholders with an opportunity to share their standpoints, identifying hopes and fears connected with the field, as well as discussing problems absolutely needing to be resolved as soon as possible and specific challenges faced by regulators. In particular, the necessity to involve public dialogue and ethics in policy making was emphasised.
Further details, including full video coverage of the conference as well as presentations made available by speakers can be found at the webpage of the event, www.nanoethics2011.pan.pl.
Project Context and Objectives:
BACKGROUND
In the last years we have witnessed a very dynamic expansion of nanosciences and nanotechnologies (N&N) in the world. It is estimated that by 2015 about 15% of all products will be produced with the use of nanotechnology. Nanotechnology is considered a new key technology with a potential to impact all industrial sectors and spheres of human life. It is likely to contribute to the development of new therapies, reduction of the use of raw materials, faster and safer manufacturing, production of smaller and quicker devices, obtaining an increased life-cycle of products and many other improvements to existing products. In view of this revolutionary potential, it is not surprising that this technology has ignited great interest in science from the part of the media and the public.
While N&N may bring about important advances and benefits for our society and may improve the quality of our lives, some risk is inherent, as for any technology. Certain risks and side effects associated with N&N have already been identified. In the Opinion on the ethical aspects of nanomedicine, prepared by the European Group on Ethics in Science and New Technologies (EGE), it was stated that the use of nanomaterials may have health effects in the case when these materials are dispersed in the environment. Toxic effects of some nanoparticles have been already demonstrated in cells, tissues and small animal experiments. However, at this stage, potential risks for the environment and human health related to the application and use or misuse of nano-related products are not fully identified. Specific studies dedicated to the assessment of risks posed by engineered nanomaterials have highlighted they are not generally simple, with clear-cut cause-and-effect connections. Instead, risk problems in nanotechnology are dominated by complexity, high degree of uncertainty and ambiguity in current knowledge about the response of humans to the use of nano-related products.
In February 2008, the European Commission adopted the recommendation for the Code of Conduct for responsible nanosciences and nanotechnologies research which provides principles and guidelines for actions to be taken by the EU Member States in the course of formulation of their N&N strategies, and development of sectoral and institutional research and development standards. The Code is voluntary and there are no authoritative sanctions for failure to adopt it. It was intended to facilitate and underpin the regulatory and non-regulatory approaches indicated in the 20052009 N&N Action Plan for Europe, improving the implementation of existent regulation and coping with scientific uncertainties. The Code sets out general principles and guidelines on actions to be taken in order to achieve good governance of N&N research. The recommendation should be reviewed every two years and the extent to which relevant stakeholders have adopted and implemented the Code of Conduct is to be monitored.
Code of conduct is one of the forms of governance of new technologies. The philosophy behind the Commissions Code of Conduct is to support and promote active and inclusive governance and communication. It assigns responsibilities to stakeholders beyond governments, and promotes their involvement. It also regards the EU Member States as responsible actors, and invites them to use the Code as an instrument to encourage dialogue between policy makers, researchers, industry, ethics committees, civil society organizations and society at large.
OBJECTIVES
The above mentioned problems fitted perfectly into the Nanoethics 2011 project objective which was the organization of the conference entitled Governance and ethics of nanosciences and nanotechnologies. The conference constituted one of the major events during the Polish Presidency of the European Council. The honorary patronages were granted by Professor Barbara Kudrycka, Polish Minister of Science and Higher Education and Professor Micha? Kleiber, President of the Polish Academy of Sciences.
Main objectives of the Nanoethics 2011 project were:
to provide an overview of issues concerning governance and ethical aspects of nanosciences and nanotechnologies;
to present the Code of Conduct for responsible development of nanosciences and nanotechnologies research and its revision process;
to present developments in the Member States with reference to the Code of Conduct;
to identify and discuss problems arising in the process of adoption of the Code of Conduct in the Member States;
to present various stakeholders opinions concerning the Code of Conduct;
to develop recommendations concerning the adoption of the Code of Conduct in the Member States;
to present results of selected EU-funded projects in the area of governance and ethics in N&N;
to present an overview of current developments in the field of N&N.
CONTENT AND RESULTS
The conference was attended by 120 participants from different countries all over the world (Austria, Belgium, Bulgaria, the Czech Republic, Finland, France, Germany, Hungary, Indonesia, Italy, the Republic of Korea, Lithuania, Malaysia, the Netherlands, Norway, Poland, Russia, the Republic of South Africa, Singapore, Spain, Sweden, Thailand, Turkey, the United Kingdom, the United States of America), including:
? Representatives of the European Commission;
? Policy makers from the EU Member States;
? Representatives of institutions developing and implementing initiatives in the area of governance and ethics in N&N;
? Experts in the field of ethics, risk assessment, governance and standardization;
? Scientists in the field of N&N, ethics, medicine and technology;
? Delegates from national academies of sciences;
? Representatives of companies conducting research and developing products in the field N&N;
? Representatives of environmental and consumer NGOs, and industry associations;
? Representatives of international organisations;
? Trade unions delegates;
? General public interested in the subject;
? Media.
The 2-day conference, which took place at the conference venue in the Institute of Biocybernetics and Biomedical Engineering of the Polish Academy of Sciences, included several sessions:
First day
Opening
The opening speeches were given by Dr Gilles Laroche from European Commission, DG Research & Innovation, Directorate B: European Research Area, Head of Unit B.6: Ethics and Gender and Prof. Micha? Kleiber, President of the Polish Academy of Sciences.
Session 1: Introduction to N&N, risks and ethical aspects
The session was chaired by Prof. Harald Fuchs, Scientific Director of the Institute of Nanotechnology in Münster, co-director of the Institute of Nanotechnology in Karlsruhe. The part of the conference was divided into two parts. The first part comprised 5 lectures given by high-level experts from the USA, Belgium, Germany and Poland and was followed by a 15-minute discussion. The second part consisted of 4 presentations given by invited speakers from Poland, the Republic of South Africa and the UK. Session was closed by a further 15-minute discussion.
During the session, general introduction to the topic of the conference was provided. It was stressed that N&N is a specific domain as it is not localized in one particular technology area, but it constitutes a cross-disciplinary field relating to all kinds of existing technologies, including medicine, environmental issues etc. The comprehensiveness of the issues discussed during the session, comprising not only various possible applications of nanotechnologies, but also their current status, overview to ethical challenges and education fostering its future development, translated into the basis for a multifaceted approach to the subject charactering the whole Nanoethics 2011 conference.
Session 2: Governance
This session was chaired by Prof. Pavel Kashkarov, Deputy Director of the National Research Centre Kurchatov Institute. It contained 11 talks presented by specialists from the EC, Norway, France, Poland, Austria, The Netherlands and Russia. It offered the participants two possibilities for discussion, in the middle of the session and at the end of it.
During the session, speakers focused on discussing problems relating to several aspects connected with the broadly understood N&N governance, such as existent regulations concerning N&N in general, and their specific applications (e.g. to nanomaterials, workplace safety) in particular, as well as the need and possible directions for further steps in this regard, standardization and legal problems. The session helped to summarize the current status of the regulatory framework and, in a way, to define aspects and requirements which need to be taken into account while addressing N&N governance in the future.
Second day
Session 1: Stakeholders
The session started with the Roundtable of stakeholders with the participation of 5 experts from Germany, Belgium and France. The roundtable discussion was followed by 5 lectures delivered by specialists from the Netherlands, the UK and Belgium, and a 15-minute discussion.
The importance of having a successful governance of nanosciences and nanotechnologies was emphasised, otherwise, as it was noted, the position of Europe in general and MS in particular could become endangered. The roundtable took place in an interesting time when issues discussed stayed open, as the roadmap for 20112015 was still under consideration at the EC level. Therefore, the roundtable aimed at providing a useful input to the discussion on the best possible governance for N&N not only in terms of recommendations, but in raising questions as regards the issue, questions which might be of value also in wider, regional and international aspects.
Session 2: Beyond regulation: the Code of Conduct for responsible nanosciences and nanotechnologies research
The session was chaired by Prof. Zbigniew Szawarski from the University of Warsaw, chairman of the Committee for Bioethics of the Polish Academy of Sciences and consisted of two presentations given by the representatives of the EC and the Italian Centre for Nanotechnology, followed by the Roundtable with representatives of the EU Member States: discussion about adoption of the Code of Conduct. In the roundtable discussion 10 experts from France, Germany, Poland, Sweden, the UK, the Czech Republic, Italy, Finland, Hungary and Austria took part.
During the session, tremendous impact of nanotechnologies on social life as well as on lives of individuals was emphasised. It was a common understanding that they can bring a lot of hopes of a better future and great advantages, but at the same time threats and fears. It is also obvious that time cannot be reversed and scientific progress will not be stopped. The conference in general, and the session in particular, constituted an opportunity to discuss these topics providing for the involvement of all interested parties in common debates, sharing views and identifying differences of opinions, which, as it was stressed, is the only way enabling people to learn and understand more and by this means to increase their capability to control the whole process of development. Throughout the session, however, it was particularly emphasised that the debate essentially would need to be complemented by the aspects of ethics, values and philosophy.
Closing remarks were given by Prof. Andrzej Górski Chair of Conference.
The conference did not provide definite answers, however, which is perhaps more important, active participation of stakeholders from all various backgrounds interested (policy makers, scientists, NGOs, industry, general public) helped to formulate tangible questions and identify problematic issues and fields of differences which need to be addressed in the future. However, some areas of general consent have also been determined. There seemed to be a common view that the Code of Conduct, despite its drawbacks or limitations which were discussed during the event (unclear language, unspecified target audience, excessive complexity), and a need of its review, is a right tool to address the issues it is designed for, i.e. form the basis for further discussion, and to implement its 7 principles, the philosophy behind which did not raise doubts either. At the same time, however, the Code cannot be regarded as a substitution for legislation, but it plays a complementary role to hard law instruments.
The participants also agreed that the current general publics attitude towards nanotechnologies, apart from relatively low knowledge on the field, is highly ambiguous. Enthusiastic expectations mix with scepticism or even fears. The first feelings are associated with enormous potential of the applications of nanotechnologies, particularly in medicine, while the second with considerable, though unknown risks, knowledge gaps, uncertainties. These require intensification of awareness raising activities and can be answered by transparency of research, increased stakeholders involvement and public engagement which were unanimously called for by the conference participants.
It is a general consent that scientific progress cannot be stopped, which concerns not only nanotechnologies. As one of the participants quoted a thesis of a recently published book The God Species by Mark Lynas: we already are playing God, we have the power over life and death, we can change colour of the sky, all we have to do is to play God in a much better way than it was the case in the past. In order to do so, much higher awareness of both benefits and risks (or dangers) associated with nanosciences and nanotechnologies is essential, as only knowledge can give control over the future.
Further details, including full video coverage of the conference as well as presentations made available by speakers can be found at the webpage of the event, www.nanoethics2011.pan.pl
IMPACT
The conference raised awareness of the issues of governance and ethics in N&N among policy makers, experts, industry and NGOs representatives and general public. It was a forum for the discussion on the Code of Conduct for responsible development of nanosciences and nanotechnologies research in the Member States which resulted in concrete recommendations.
The conference website proved to be a valuable tool for promotion of knowledge about the governance and ethical aspects of nanosciences and nanotechnologies, as, since its launching on 25 May 2011, it has been visited more than 10,000 times.
Project Results:
The following section shall present an overview of main outcomes of the project achieved both as results of the Nanoethics 2011 conference, and of other, supplementary activities undertaken by the Polish Academy of Sciences in the course of the project execution. At the same time, the contents below contains some selected, abbreviated statements of the post-conference report whose full version is available at www.nanoethics2011.pan.pl. For a more detailed account of the Nanoethics 2011 conference outcomes, please refer to the report.
Main objectives of the Nanoethics 2011 project included:
to provide an overview of issues concerning governance and ethical aspects of nanosciences and nanotechnologies;
to present the Code of Conduct for responsible development of nanosciences and nanotechnologies research and its revision process;
to present developments in the Member States with reference to the Code of Conduct;
to identify and discuss problems arising in the process of adoption of the Code of Conduct in the Member States;
to present various stakeholders opinions concerning the Code of Conduct;
to develop recommendations concerning the adoption of the Code of Conduct in the Member States;
to present results of selected EU-funded projects in the area of governance and ethics in N&N;
to present an overview of current developments in the field of N&N.
The results obtained as regards presenting various stakeholders opinions for the purpose of this report shall be considered as exercising (possibly future) socio-economic impact and as such shall be discussed in the relevant section of the report. In this section, the remaining outcomes, achieved to answer the project objectives, shall be presented. For clarity purposes, they have been divided according to the goal categories listed above, while some related categories were merged, however, in some cases such division could seem unavoidably simplified.
I. An overview of issues concerning governance and ethical aspects of nanosciences and nanotechnologies
1. Survey concerning governance of N&N in the EU Member States
In an attempt to summarize the variety of undertaken initiatives within a comprehensive overview, the Polish Academy of Sciences, as part of the Nanoethics 2011 project, drafted a Questionnaire concerning governance and ethical aspects of nanosciences and nanotechnologies research in the EU Member States and, having identified competent respondents in each of 27 MS, predominantly ministries and governmental organizations responsible for the governance of new technologies/nanosciences, sent the survey by e-mail to the recipients. Reluctance in responding, initially encountered, was, after some amendments applied to the list of addressees and three subsequent dispatches, partially overcome and ultimately collected 22 responses were assembled and processed, giving rise to the Summary concerning governance of N&N in the EU Member States, submitted to the European Commission in December 2011 as Deliverable 2.1. The Summary provides detailed information regarding the existence and localization within state structures of bodies responsible specifically for controlling N&N research, its ethical aspects and safety, as well as on any activities undertaken as regards the European Commission Recommendation of 8 February 2008 on the Code of conduct for responsible nanosciences and nanotechnologies research. The Summary can be considered an indication of weaknesses of the N&N regulations implementations on the European level and, consequently, as a hint on possible remedial measures.
2. Overview provided by the Nanoethics 2011 conference
During the conference it was underlined on numerous occasions that N&N is a specific domain as it is not localized in one particular technology area, but it constitutes a cross-disciplinary field relating to all kinds of existing technologies. This, along with the fact that the field, still relatively new and unstudied, rises various fears and doubts as to the number and nature of possible risks, and adds up to the need for it to be treated with particular caution, especially as far as governance and ethical issues are concerned.
In the course of the Nanoethics 2011 conference, several speakers focused their contributions specifically on these aspects.
Prof. Julian Kinderlerer, as Chair of the European Group on Ethics in Science and New Technologies, commented on problems associated with working on a comprehensive, coherent advice, expected from the part of EGE, while dealing with limitations imposed by the request to look at ethical issues and the perceived enormity of the topic. He also mentioned the Precautionary Principle according to which if there is a real significant danger, one has to think of its possible implications and of implementing systems of protection against this danger. However, the Principle does not entail resigning from research entirely, but imposes making a judgement whether benefits and risks associated with the said research are proportional. Further, he discussed regulatory concerns identified by EGE and relating to the comprehensiveness and clearness of the legislation, whether it provides adequate protective measures including evaluation of health-related risks, whether the implementation is proper and what challenges it faces. The major finding was that no new regulations are needed, but the implementation of existing ones and the manner in which particular products are tested whether they meet requirements of relevant regulations has to be examined. He underlined that taking specific efforts to develop measures for implementing existing regulations that would respond to the implications of nanomedicine is required. He discussed problems and concerns associated with ethics, governance and policies and connected with safety (which is a major issue in his opinion, involving the assessment of benefits/risks associated with new technologies in general), as well as risk governance (consisting of difficulties in identifying, estimating and managing risks in the area where there are considerable uncertainties and knowledge gaps, and short- and long-term risks can be different.
Henrik Laursen (EC DG Environment) in his talk discussed regulatory aspects of nanomaterials, more specifically nanochemicals, from the EC perspective. First, he briefly commented on the key actions adding to the regulatory approach of the Commission to nanomaterials:
- Communication on Regulatory Aspects 2008;
- REACH CASG NANO 2008;
- REACH Guidance;
- Recommendation on the definition of nanomaterials;
- Several pieces of legislation with specific provisions for nanomaterials.
The European Parliaments response to the first document was the Resolution on regulatory aspects of nanomaterials published in 2009. Clue observations made in the Resolution were:
- The use of nanomaterials should respond to real needs of citizens;
- Appropriate data and risk assessment methods are lacking, consequently nano risk cannot be addressed.
The EP disagreed with the Commission that current legislation covers risk of nanomaterials. It also pointed out that there is a lack of information on nanomaterials already marketed.
Current works of the EC, being key deliverables in 2011 and 2012, partly constitute the answer to EPs objections. The latest developments include:
- Bringing RIPoN (REACH Implementation Project on Nanomaterials);
- 2nd regulatory review of nanomaterials; accompanied by
- Report on nanomaterials types and uses on the market and safety;
- Definition of a nanomaterial published in October 2011.
The review mentioned above is due to be published in the first half of 2012. Henrik Laursen shared his observation on its, though not finished yet, contents. The documents confirms the point that nanomaterials are covered by legislation. At the same time, data is lacking as to the actual types and quantities of these substances on the market. However, the belief that our everyday is more and more flooded with nanomaterials seems not to be necessarily substantiated by available information. A few nanomaterials apparently are dominant in terms of volume and there is a greater complexity of nanomaterials present on the market in small amounts. No conclusions were to be drawn yet, he continued, but obviously there are some sectors in which nanotechnology is advancing faster, though in some (chemicals included) not as fast as people might have thought a few years back. It might be good from regulatory bodies, such as ECs, point of view, as such situation gives them more time to catch us versus risk assessment of nanomaterials. Legislation must be evidence-based, so it is unable to exceed developments, but in this case it may deliver better results than the general public expect.
Definition of a nanomaterial, introducing some significant changes, was published two days before the conference in a form of a recommendation in view of facilitation of its use in direct references in different types of legislation in the future. If it is successful, it would be consequently updated as still there are some areas where data is lacking but, as H. Laursen noted basing on former experience, without any definition in place finding missing information would not be feasible. Next review of the recommendation is scheduled for 2014.
Dr Philippe Martin (EC Directorate-General for Health and Consumers) focused his contribution on EU regulations concerning N&N. He started by elaborating on the following key messages: firstly, handling nanomaterials or nanosystems requires care, hence due diligence needs to be performed; and secondly: the definition of a nanomaterial mentioned earlier is a game-changer. However, in order for it to be successfully implemented, further dialogues with scientists and with the industry are needed, as there are areas where the definition can be applied immediately, while in others it requires a qualifier, e.g. because it does not establish a demarcation line between natural and engineered products.
Having commented on nanoproducts in general, risk assessments aspect along with its three elements subject to examination: exposure, hazard and the combination of those two, Dr Ph. Martin focused on existing or developed regulations applying to cosmetics and food. The first group of products is covered by regulation which includes a definition of a nanomaterial and provisions regarding its obligatory assessment by the scientific Committee for Consumer Safety as well as labelling if one of a product ingredients is nano. In the case of food, there are provisions regarding ingredients in additives and food contact products. Nanoaspects of novel food applications are being discussed (revised after the blockage of a previous proposal).
He concluded his talk by sharing his view that further steps should consist of taking key elements from the definition and applying it to legislation, both current and proposed.
Agata Wnukiewicz-Koz?owska (Chair of Public International and European Law, University of Wroc?aw) concentrated on legal problems of nanotechnologies research on human beings, being closely associated with ethical aspects of such research. She shared her view on main problems connected with the topic of her speech: legal basis for nanoresearch, protection of research subjects and unpredictability of nanotechnology research effects. The way of solving the problem, in her opinion, would be developing and respecting good law. She discussed various possible approaches in this respect: applying ethical rules only, legal rules only, opposing ethical rules to legal rules and, finally, applying both ethical and legal rules at the same time. The last solution she highlighted as the best and the most natural one, as, to her knowledge, currently all legal rules binding in this field are based on ethical rules.
She also elaborated on the role of international organizations in rules by issuing opinions, recommendations and similar instruments which formally are not legally binding, but in practice their legal meaning depend on particular states. For researchers their legal character is not significant, but the situation of research subjects is different, as in the case of damage they might have not the right for compensation. Her suggestion of a possible solution to the problems would consist in the transition from soft into hard law, i.e. translating said recommendations or opinions into general principles like international treaties. However, achieving it would not be easy, since directives, in opposition to regulations, are not directly binding, but need implementation by Member States, and the implementation entails yet more fields of differences amongst the States.
II. Code of Conduct for responsible development of nanosciences and nanotechnologies research and its revision process
In 2004, the Commission adopted the Communication Towards a European Strategy of Nanotechnology in which a safe, integrated and responsible strategy was proposed. In 2005, after an extensive consultation with stakeholders, the EC adopted the Communication from the Commission to the Council, the European Parliament and the Economic and Social Committee Nanosciences and nanotechnologies: An Action plan for Europe 20052009 which defines a series of actions for immediate implementation that should be undertaken by the Commission and the EU Member States in order to develop competitive and safe N&N. It announced an increase in funding for research, infrastructure and human resources development in the field of N&N. Societal dimension was taken into consideration as well. The document states that an essential element of the responsible strategy for N&N is to integrate health, safety and environmental aspects to the development of N&N and to establish an effective dialogue with all stakeholders. It was decided that the implementation of the Action Plan will be monitored and the Commission will report on progress made in this respect every two years. In the first Implementation Report, published in 2007, the EC announced an intention to adopt a voluntary Code of Conduct for N&N.
In February 2008, the European Commission adopted the recommendation for a Code of Conduct for responsible nanosciences and nanotechnologies research which provides principles and guidelines for actions to be taken by the EU Member States in the course of formulation of their N&N strategies, and development of sectoral and institutional research and development standards. It is also recommended that the Member States encourage voluntary adoption of the Code of Conduct by relevant national and regional authorities, employers, research funding bodies, researchers, individuals and CSOs involved in N&N research. The Code is voluntary and there are no authoritative sanctions for failure to adopt it. The Code sets out general principles and guidelines on actions to be taken in order to achieve good governance of N&N research. The recommendation is subject to revisions every two years and the extent to which relevant stakeholders have adopted and applied the Code of Conduct is being monitored.
The Code of Conduct as such and its various aspects was discussed throughout the conference. The following account features two of the most direct and comprehensive references.
Dr Rene von Schomberg (EC DG Research & Innovation, Directorate B: European Research Area) focused in his contribution not only on the philosophy behind the Code of Conduct (CoC), but also on the developed Framework for Research and Innovation. Rules, as he emphasized, can be changed, amended over the time, but the philosophy relates to ideas which need to be implemented in the context. He pointed out that it has to be realized that the Framework, the CoC or any other instruments called soft law cannot be considered as replacement or substitution of legislation, e.g. in the case of its absence. Their idea is to have a different governance model where something can be achieved which would not be achieved by means of legislation. On the other hand, he underlined that legislation will always be needed. Further, he discussed basic goals of this governance model which absolutely could not be achieved by means of legislation:
1. Timely Intervention consisting in inclusive governance, ethics, promotion of pro-active communication and knowledge sharing between all sorts of stakeholders. Legislators have limited power in terms of intervening, as they depend on knowledge and developments in science, industry and society, in some cases, like in the case of nanotechnologies, legislation can be too early or too late.
2. Organising collective responsibility: the code addresses individual researchers, organisations, government bodies and supports various parties to play their roles in the overall system, encourage partnership and facilitate mechanisms for interventions and conflict solving enabling to take up collective responsibility. Effective implementation of CoC requires efficient structure and coordination and regular consultations with MS and stakeholders. It has been done on numerous occasions and generally a positive feedback has been received from CSOs and industry, but at the same time some reluctance can be perceived in MS. Some of their governments expressly referred to the Code implementing activities indicated in the document, but the philosophy behind these activities was not necessarily the same, and without good coordination effectiveness cannot be achieved. Moreover, the Code assigns and allocates tasks and responsibilities beyond governments and makes actors responsible by promoting their involvement.
3. Promoting dialogue and public debate: the Code constitutes an instrument to encourage dialogue amongst policy makers, researchers, industry, ethics committees, civil society organisations and society at large, however, as R. von Schomberg remarked, the dialogue should be linked with policy making. He also underlined the need for permanent deliberation as opposed to one-off exercises.
4. Promoting responsible development by fostering the application of the Precautionary Principle, promoting research on risk and knowledge gaps and promoting research on societal-driven goals (serving sustainable objectives of the Community and Millennium goals).
The Code, also from the point of view of practical aspects of its implementation, was also discussed Dr Elvio Mantovani who noticed that the document itself provides the Member States, individuals, CSOs with guidelines based on general principles, favouring a responsible and open approach to NN research. Its principles include: meaning (comprehensiveness to the public), sustainability (contribution to sustainable development), precaution (anticipation of EHS and ELSA impacts), inclusiveness (participation of stakeholders in the process), excellence (meeting best scientific standards), innovation (encouraging maximum creativity) and accountability (researchers or research organizations are accountable for EHS/ELSA impacts). The Code also provides guidelines how to comply with the principles.
III. Developments in the Member States with reference to the Code of Conduct and problems arising in the process of adoption of the Code of Conduct in the Member States
During the Roundtable with representatives of the EU Member States held as part of the 2nd day of the conference, representatives of several EU MS discussed recent developments concerning the implementation of the Code in their respective countries and the field of nanosciences and nanotechnologies governance in general. Such form of organizing the discussion helped to directly confront and compare various approaches applied by particular states.
UK Prof. Richard Jones (University of Sheffield, Royal Society) informed that 18 months before a governance strategy on nanotechnologies was introduced, but it met with extensive criticism. The successive government has not committed to its implementation. According to him, current approach in the UK was underpinned by a view that nanoscale technologies should be considered on the case-by-case basis given the wide range of materials, processes with diverse properties or applications. Consequently, in the UK nanotechnology increasingly ceases to be regarded as a single field, a useful category or concept for organizing scientific research. Presently there is no national nanotechnologies programme, although much nanotechnology research is conducted and supported. The idea of CoC in this context is problematic, as there is no strong demarcation line of what is nanotechnology and what is not. However, many ideas of the Code are being incorporated for strategies, with particular focus on responsible innovation (projects underway in Research Councils), two-way public engagement (universal and mainstream in the country, RCUK published the Concordat on public engagement which is a condition for receiving public funding for science), and ethics (the Universal Ethical Code for Scientists issued by the government). He emphasized that a lot on responsible research has been learned from nanotechnologies and he shared his observation that perhaps it is time to apply those lessons to other types of innovation.
France Prof. Patrick Gaudray (Director of Research, CNRS; French National Ethics Advisory Committee) presented his Committee, the oldest national ethics committee in the world. It is multidisciplinary, meaning that it is even more concerned with such multidisciplinary fields as nanotechnologies. Apart from the Committees interest, there was a number of initiatives in relative issues in France. One of them was a national dialogue on the environment which resulted in the law of August 2009 calling for complete transparency about everything which deals with the environment. In particular, it stated that manufacture, importation and marketing of nano-scale substances or of materials intended to reject such substances should be the matter of information to the public and to consumers. The provisions became a matter of concern for CCNE, as every time the committee tackled ethical questioning, they met a problem of communicating scientific and medical information. The issue was a subject of an opinion issued by the Committee. Yet another opinion issued by CCNE in 2007 called, similarly to the CoC, for major efforts on standardization issues, on research and development, on nanometrology and on enabling a European law similar to REACH for nanoproducts. The opinion also discussed the lack of fundamental research when compared to its technological counterpart. It concluded that we should not allow nanotechnology to supersede nanoscience. Moreover, it considered that the balance between technological performance, commercial profitability and the perception of potential risks should not mask the ethical dimension of the philosophical man-machine issue raised by nanosystems. Further to the control of engineering, one can find the emergence of the unpredictable, e.g. constructing molecular objects capable of self-assembly or even self-replication.
The nanoscale sciences and technologies were subject of a number of other initiatives. 7 different ministries called for a public debate. One of the examples of such initiatives is the French Agency for Environmental and Occupational Safety which acknowledged a need for a comprehensive analysis of available scientific knowledge, in particular current and future fields in which nanomaterials are or will be used. The Agency considered nanomaterials as being potentially dangerous materials for which the control of risk necessitates the control of exposure.
Germany Prof. Joerg Hasford (IBE, Ludwig-MaximiliansUniversität München, Vice-President of the Permanent Working Party of Research Ethics Committees in Germany) commented on the constitutional situation in his country. Freedom of research is a constitutional right in the country and as such it can only be limited if other fundamental rights, e.g. human dignity, are at risk. In order to mitigate the conflict between two constitutional rights, such as the one mentioned, in the field of medicines and medical devices, the Research Ethics Committee have a legal basis and task that have been specified in the federal law. All paramedical research involving humans must be reviewed beforehand by a competent research ethics committee, one of 53 in Germany. The work of the committees is governed by specific laws and ordinances. Accepted principles of ethical review, such as autonomy and dignity of the research subject, beneficence, non-maliciousness and justice are also applicable to nanotechnologies. However, potential risks need special consideration. As risk of nanoparticles is not sufficiently known, the expected added benefit has to be substantially compared to conventional products. He stated that up to that time extremely few nanomedicines had been approved in Germany (though the situation with nanodiagnostics was a little different). At the same time he admitted that the use of nanoparticles in cosmetics is fairly unlimited and extensive.
As regards the CoC in Germany, in his words the document seemed not to play an important role in the discussion on nanotechnologies. It was not even mentioned in the German Nano-Initiative Action Plan 2015, part of Hi-Tech Strategy 2020. The Code, however, highlights important aspects and its visibility should be improved.
Sweden Prof. Göran Hermerén (Swedish National Council on Medical Ethics, former Chair, European Group on Ethics and New Technologies) noted that despite the CoC urges Member States to provide its dissemination, notably through public research bodies, and ensure that researchers are familiar with its contents, very little had been done in this respect in Sweden. Four ministries (the Ministry of Enterprise, Energy and Communications, Ministry of Education and Research, Ministry of Health and Social Affairs, and Ministry of Environment), had nano-related questions on their agenda, however, none of them made a priority of the implementation of the CoC. As far as agencies are concerned, one of them, the Swedish Chemicals Agency was commissioned to analyse the need for regulations and other measures in the EU and Sweden in order to make a satisfactory assessment of risks posed by nanomaterials to human health and the environment. As a result of its work, the Safe Use of Nanomaterials report was presented to the government in February 2010. Vinnova, the Swedish Governmental Agency for Innovation Systems, also in February 2010 published a report National Strategy for Nanotechnology. However, it contained no ethical analysis of the problem, almost no mention of legitimacy. It focused on innovations useful for society, and the only ethical issue addressed was safety. As a result, the National Council on Medical Ethics issued a critical statement on the report, in which, in line with the CoC, it stresses the importance of inclusive dialogue, also towards future nanoresearch and states that competence in ethics should be included in delegacy for N&N research proposed by Vinnova. Prof. Hermerén also briefly commented on other activities implemented by agencies and scientific societies.
Basing on the Swedish experience, he proposed the following recommendations:
- Inclusive dialogue, replacing one-way information and not limited to the N&N community;
- Application and development of better methods of risk assessment, taking into account current uncertainties and knowledge gaps;
- Ethical aspects of safety and other issues should be considered;
- Ethics of risk and price of precaution need to be studied further.
Outcome of the on-going consultation process is a wish of several stakeholders to revise the Code making it broader and more specific.
Czech Republic Prof. Josef Ku?e (University Centre for Bioethics, Masaryk University) described his pursuit of information concerning the awareness of CoC in Czech researchers. In the first step, he questioned several nanoresearchers, the results proved to be very poor. Next, he searched the Czech National Bibliography. According to the results he obtained, 47 and 183 books mentioned nanotechnologies, 5 of the articles to some extent referred to social and ethical implications of nanotechnologies, although none of publications mentioned the Code. He proceeded with searching several international databases looking for comments by Czech authors bearing any reference to the CoC and found only one presentation included in the NANOCON 2010 conference proceedings. As far as implementation of the Code in the Czech Republic is concerned, to his knowledge no single step was made in this respect on the level of policymaking or legislation. He concluded his presentation with an observation that even in such a vague regulatory framework, some aspects can be regulated by soft law, as in the example of human subject research to which no specific law applies, but it is regulated in such a way that leading research agencies automatically reject any applications to which ethics clearance has not been incorporated.
Italy Daniela Marrani (Italian National Bioethics Committee) presented the position of the Italian National Bioethics Committee (NBC) towards some aspects of nanosciences and nanotechnologies in Italy and the CoC itself. She stated that the implementation of the Code by particular entities is quite difficult to investigate. There are, however, some studies conducted by such actors as AIRI and Nanotec IT. There is no national initiative for nanosciences and nanotechnologies in Italy at the moment, which might be the reason why there is not enough awareness on any N&N governance instruments such as the CoC. Even in the absence of binding regulations and voluntary rules, various entities conduct innovative research on N&N in Italy.
As far as the engagement of NBC in the field of nanosciences and nanotechnologies is concerned, in line with its mandate to address the ethical and legal problems that may arise as a result of the progress in scientific research and technological applications on life, the Committee has been studying the ethical, societal and legal implications of N&N since 2004. It was one of the first national ethics committees to adopt an opinion on the subject it 2006. The opinion contained some ethical recommendations which were highly consistent with the later CoC, as it recommended the consideration of balance between benefits and risks of N&N and future development of such emerging technologies with rationality and moral sense of responsibility, as well as the adoption of a precautionary principle which cannot be perceived as an obstacle in the development of innovative research, but a flexible instrument allowing to adopt risk management measures to case by case risk management.
Finland Dr Janne Nikkinen (University of Helsinki) began his presentation by describing current developments relating to nanotechnologies in Finland, where business of the range of EUR 300 mln (2008) in value specializes in such products as innovative nanomaterials, nanosensors or printed intelligence and atomic layer disposition technologies. FinNANO was a primary tool for funding in the years 20052010 introduced by the Academy of Finland, Finnish Funding Agency for Technology and Innovation (Tekes) and the Ministry of Education. The funding amounted to EUR 70 mln and over 100 R&D projects were involved. FinNANO brought some positive and negative results. The first group included a significant increase of the number of nanotech companies in Finland (from 61 to 202) and of Finnish nanotechnologies review articles (five times).
Nanotechnology Cluster Programme implemented in the years 20112013 is a worldwide network combining 90% of activities, involving 8 regional centres of excellence, providing services to companies, as well as contacts to Finnish stakeholders and information.
Further, Dr Nikkinen discussed the issue of the implementation of the CoC in Finland, where the Finnish Funding Agency for Technology and Innovation requires applicants to note the Code, however, no follow-up or workshops are provided. Further, he commented on remarks obtained in result of a scientific studies and requests for information from key actors, e.g. a note that as far as responsible nanotechnologies are concerned, ELS issues should always be explored, but the ELSA question has been mentioned rarely. The survey also demonstrated that the Finnish Institution for Occupational Health proposed nanosafety for a theme for government programme, but it has not been adopted yet. However, no need for nano-specific legislation was indicated. For the aims of advancing the CoC implementation, he suggested that the following issues need to be discussed: whether the target audience consist of researchers with prior training in research ethics, funding issues (research funding is not applicable, e.g. Nanocluster is designed for funding purposes) and who is required to perform the task (governmental officials are primary interested regulation). In terms of advancing ELSA in Finland, he proposed some future actions to be focused on the public (democs games were in course of translation into Finnish and Swedish), industry (ELSA issues information to be introduced into funding scope), and researchers (CoC events, workshops).
Hungary Dr László Sz?nyi (Semmelweis University, Budapest, Medical Research Council Scientific and Ethical Committee) shared a positive overview of nanotechnologies and CoC-related developments in Hungary. The Code is very well known among researchers who are active in the field. The EC Recommendation almost immediately translated into Hungarian, which facilitates accessing its contents. As far as current situation regarding nanotechnologies in Hungary is concerned, the number of articles has been increasing over the latest period, however, the general publics awareness is not as high and the reason for this, in his opinion, might be the lack of scandal involving nanotechnologies whereas such situation considerably increases general awareness of a subject in question. He also shared some ideas implemented in his country, such as the Nanobus (as a mobile way of providing information on nanosciences and nanotechnologies to students in Hungarian villages) or webpages which meet with high interest. He presented an extensive list of Hungarian universities with either departments or project dealing specifically with nanotechnologies. Also, some events have been held in Hungary, such as the 3-day EuroNanoForum Conference, organized by the National Innovation Office under the Hungarian EU Presidency and supported by EC and the Hungarian National Innovation Fund, gathering 1200 participants from over 50 countries. The nanotechnologies issues are also an interesting subject to students (the example was the Night of Researchers during which the nanotechnologies site proved extremely popular).
Austria Dr Doris Wolfslehner (Austrian Bioethics Commission) briefly commented on the Austrian activities in the discussed field, in particular the Austrian Nanotechnologies Action Plan developed with the participation of all stakeholders and adopted by the Austrian government. However, she focused her contribution on the concepts of responsible research and responsible innovation.
Poland Prof. Jerzy K?tckis presentation, in opposition to those briefed above, was part of Session 1 of the conference. The first part of his contribution was devoted to presenting recent investments implemented in Poland and financed from the European Regional Development Fund. Resources allocated under the ERDF allowed numerous Polish laboratories to achieve nanotechnology standards and permitted the creation of nanotechnology centres which were built or are under construction in many academic cities: Szczecin, Gdansk, Krakow, Rzeszow. Lodz, Gliwice, Poznan or Wroclaw. More details concerning members of consortia or fields of interests were being provided on two facilities which are being built in Warsaw: the Centre for Advanced Materials and Technologies (CEZAMAT) and the Electronic Microsystems and Nanotechonologies for Innovative Technology (MINTE). Moreover, he described the activities and achievements of the Centre of Nanophotonics opened also in Warsaw in January 2011. He discussed some projects implemented by Polish consortia and financed in the framework of the EU Innovative Economy Programme, e.g. NanoMat, NANOBIOM or MNS-DIAG. An Eniac Joint Undertaking-financed Nanoelectronics for Safe, Fuel Efficient and Environment Friendly Automotive Solutions (SE2A) project, involving 20 partners from 7 countries, was also mentioned.
A certain achievement of the Polish nanotechnology, i.e. the detection of Copernicium (Cn) thanks to detectors developed and fabricated in Poland was also discussed, as well as two companies: AMMONO and TopGaN, both international leaders in Gallium Nitride manufacturing (but using different methods).
IV. Recommendations concerning the adoption of the Code of Conduct in the Member States
Recommendations, or simply suggestions in the form of personal opinions, mostly concerning the Code, its drawbacks, amendments leading to the improvement of the document and the scope of its implementation, were presented on numerous occasions during the conference by most speakers. There seemed to be a common view that the Code of Conduct, despite of its drawbacks or limitations which were discussed during the event (unclear language, unspecified target audience, excessive complexity), and a need of its review, is a right tool to address the issues it is designed for, i.e. form the basis for further discussion, and to implement its 7 principles, the philosophy behind which did not raise doubts either. At the same time, however, the Code cannot be regarded as a substitution for legislation, but it plays a complementary role to hard law instruments.
The recommendations can be summarized within Dr Elvio Mantovanis points concluding his presentation on the NanoCode project, constituting comments as regards the future path for the Code developed as the project outcomes:
- The Code should be easy, simple, format should be short;
- Awareness raising tool (it should remain voluntary);
- Systematic approach is needed more than specific guidance (process rather than result);
- General code to be complemented by sector codes/assistance tools;
- Code extended to research in general / innovation;
- Process that can become, in the long run, a standard;
- Establish well defined responsibilities and commitments at institutional level;
- Extend beyond Europe;
- Code Meter as an instrument for self-assessing the compliance with the Code, but also for promoting the engagement with the Code for company activities;
- A learning tool for raising awareness on responsible innovation.
The form of the Code itself, indicated by the above mentioned project, can be either a reference document, a voluntary standard or even an international code on responsible research and innovation.
It was agreed that the Code needs revision which has to take into consideration the following issues: role/scope, contents and implementation. The following recommendations in this respect were formulated. There is a need for:
- Clarifying the strategic role and scope of the Code;
- Resolving contents-related and structural issues;
- Establishing a framework/instruments for implementation and monitoring;
- Providing tools to evaluate the compliance with the Code principles and this task is addressed by the developed Master Plan and Code Meter tools.
V. Projects concerning the Code of Conduct, governance and ethics in N&N
Along with the rapid development of nanosciences and nanotechnologies, in view of their comprehensiveness and relative ambiguity, a number of projects regarding various aspects of N&N have been implemented, both EU- and state- or-business-funded. The Nanoethics 2011 created an opportunity to summarize the initiatives and discuss the assumptions and outcomes, often drafted also in the form of recommendations, of the following projects:
1. NANOPLAT: Development of a Platform for Deliberative Processes on Nanotechnology in the European Consumer Market
Eivind Stø (National Institute for Consumer Research, Norway), the project coordinator, presented Nanoplat, a project implemented under the EC 7FP Science in Society Programme in 20082009. The aim of Nanoplat was to review deliberative processes (understood as free, reasoned discourse of equal participants generally leading to a rational motivated consensus) taking place in Europe. The project resulted in conclusions that deliberative processes in nanotechnologies are driven by a wide spectrum of organization (academia, public authorities etc.) and that they are enacted for different purposes: identification and assessment of public attitudes, experimenting with a new form of public dialogue in order to learn about its potentials and shortcomings and informing of specific decision. Three main conclusions resulted from the project: consumer products are not often at the focus of deliberative processes, the organization of these processes is costly and takes different forms of various lengths, and that participation of ordinary people, not necessarily experts, seems to be possible and bring about good results.
In the further part of his talk he commented on common arguments against deliberative processes:
- New processes do not create more knowledge;
- Increased use of the processes leads to higher public expectations which are not met;
- They constitute a threat to the numerical democracy.
website: www.nanoplat.org
2. NANOTRUST: Dr Andre Gazsó from the Austrian Academy of Sciences depicted the NanoTrust project, a solution applied by the Austrian Academy of Sciences. It is funded by the Ministry of Transportation, Innovation and Technology, and was initially scheduled for 3 years, but then prolonged for the next 3 years, until September 2013. In is executed by an interdisciplinary 4-person team and external contractors commissioned with specific tasks. Goals of the project comprise two main areas: firstly, to survey, collect, analyse and summarize information on environmental, health and security topics relating to nanotechnologies, and secondly: to serve as promoter of discussion by organizing workshops, networking activities. NanoTrust dissemination activities also include online publication of the NanoTrust Dossiers, short summaries on recent state of knowledge on topics selected according to the high information demand, controversy criteria, addressed to a broad spectrum of interested audience and publicly available in English on the project website.
website: http://nanotrust.ac.at/nano.ita.en/index.html
3. RISKBRIDGE: Building robust, integrative inter-disciplinary governance models for emerging and existing risks, 20062009,
Mario Willems, as a member of the project staff, discussed RiskBridge, a coordinative action aimed to develop an integrative approach to risk governance, to make bridges between different cases (called riskfields). 6 riskfields have been identified for the aims of the project, for each one a particular organization was responsible and groups were nominated. Each riskfield was rated in terms of complexity and agreement on risk governance approach and consequently framed into a diagram. Nanotechnology was one of the fields and because of low agreement on the method of risk assessment and high complexity as new and enabling technology it was identified as being in a difficult position.
In course of the process, a need for a tool fostering the creation of a common language became apparent, and as a result the Framework for Policy Learning was drafted. It contained a list of aspects that need to be taken into account when comparing different riskfields. They included the following issues: is the problem global or local (where does the risk originate, where does it have impact, on what level it is dealt with), the history of the risk controversy (events which had a profound impact in the past), distribution of risk and benefits, level of uncertainty or ambiguity, information on the process (how the participation is organized and is it open for all stakeholders), institutionalization and how the success of risk governance can be defined.
M. Willems commented on the chief outcomes with respect to the Framework of the nanotechnology group: comparing to stem cells, for example, not much controversy was associated with this field in the past. As nanotechnology is an emerging technology, rather deep uncertainty can be considered than quantifiable risk, and the impact on human health and environment was in general unknown. He noted that although the project ended in 2011 and now much is being done in nanotechnologies, the situation has not changed significantly. As far as participation is concerned, there was a common consensus that it is imperative to organize stakeholder involvement and citizen participation in the process in order to avoid scepticism. However, nanotechnologies seem to be a too narrow and at the same time too broad subject for a debate.
He discussed common features which have been identified in all riskfields, including nanotechnology:
- Limited capability to understand and quantify risks;
- R&D can fill some knowledge gaps, but create new ones;
- Generally there are no established standards (or they are not complete, lagging etc.) for risk assessment;
- Multiple Framings: perspectives/values/Truths can coexist;
- Policy makers challenge: take decisions even if not all facts are known.
web site: www.riskbridge.eu
4. NANOCOMMISSION
Wolf-Michael Catenhusen in 2006 was selected by the German government chairman of a newly created national stakeholders dialogue called NanoCommission. The Commission integrated stakeholders originating from the civil society, consumer and environmental organizations, industry, science and representatives from several governments. The aim of the project was to take an opportunity of that time to develop a culture of innovation rooted in the Precautionary Principle. The process, in his opinion, was unique, as it was the first dialogue initiated in order not to end an existing conflict as it had been the case in the past, but started in an early stage before potential grounds for conflicts were realized. He noted that this was a chance for the process, as conflict-based dialogues often fail, while initiating dialogue in such an early stage that many stakeholders even have not taken a specific position yet is a different situation. The dialogue lasted four years and would be replaced by other tools. It brought significant results, some of which were discussed, e.g.:
- Remarkable progress was made in serious knowledge-based and effective communication between the industry, science, ministries, governmental agencies and stakeholders in the civil society;
- Consensus was made on five principles for responsible use of nanomaterials to be implemented by industry. He admitted that although they are only self-binding, voluntary principles, but they are important as commitments were made on the manner of evaluation which makes the process transparent.
- First steps were taken to develop tools for risk prevention;
- Guidelines for preliminary benefit/risk assessment for nanomaterials at early stage of development were prepared.
W. M. Catenhusen shared his opinion that stakeholder dialogue is a supplement to representative democracy in the innovation process as it can be helpful in identifying social needs, benefits, recommending ways and priorities in closing information gaps in risk assessment and can make contribution helping to concentrate political discussions on concrete options for decision. However, he emphasized that dialogue cannot replace political decision-making process, in particular within regulation, with consensus amongst stakeholders. At the same time he admitted that the influence of NanoCommission outcomes on the decision-making process was significant.
5. NANOCAP: Nanotechnology Capacity Building NGOs
Pieter van Broekhuizen (IVAM UvA BV, Netherlands), the project coordinator, discussed the Nanocap project implemented for the EC in the years 20062009, aimed at involving NGOs and trade unions in the nano-debate. The University of Amsterdam was the coordinator of the project and its participants included 5 trade unions, 5 environmental organizations and 5 universities. Activities comprised capacity building within civil society organizations (occupational health, environment and ethics) and developing well balanced positions in the nano-debate, which not necessarily had to be shared by all participants, but within their respective groups of interests (e.g. common resolution of trade unions). Instruments applied in order to achieve respective goals included visiting companies manufacturing and using nanomaterials, discussing with national and European authorities, implementing awareness campaigns, participating in consultative and deliberative bodies, executing actions plans, issuing nano-positioning statements and nano-resolutions and, finally, organizing a conference in cooperation with STOA and the European Parliament.
The debate focused on the following issues which were identified as problems to deliberate:
- Dealing with scientific uncertainties needs special attention;
- How to make the precautionary principle operational for health and the environment;
- Precaution is not equivalent to prevention as it deals with unknown risks and thus needs to go further in terms of measures;
- Putting responsibilities on the right actor here he underlined that a recent change of paradigm needs to be taken into consideration, in particular in the chemical sector, consisting in the guilty unless proven innocent rule being applied instead of the former, innocent unless proven guilty, one;
- Critical assessment of the actual performance of products.
He summarized CSOs nano demands organized in this project focusing on the precautionary approach and consisting of four elements:
1. Risk Assessment Emission Control: no data no exposure and no data no emission. He pointed out, however, that the type of data needs to be taken into account. Many standardized tests provided for in REACH under the no data no market principle apply to soluble substances, and therefore not to nanomaterials, whereas with the no data no exposure principle the situation is different, as the data demanded under it include the question of toxicity for non-soluble particles which might need different tests and does not depend on the market volume or registration. Identified need for nano reference values as a kind risk management tools was also discussed.
2. Pre-market approval involving the questions of the adaptation of REACH to nanoproducts (three groups worked on three different aspects: substance identification, information requirement and hazard and exposure assessment).
3. Transparent communication referring to the traceability of MNM (Marketed Nano Materials) in products, known and unknown risks and MSDS information.
4. Proactive registration involving the registration of exposed workers and an early warning system.
He finished his speech by briefly elaborating on the following conclusions developed under the project:
- Stakeholders interest may be hidden even in the smallest details;
- Participation of civil society organizations in the public dialogue and deliberative circuits is essential for the acceptance of nano;
- Mobilization of facilities for capacity building of CSOs is essential;
- Privatizing workers regulations has its limits;
- Traceability is the following hurdle to take into nano regulations.
coordinator: Peter van Broekhuizen (IVAM UvA BV, Netherlands)
web site: www.nanocap.eu
5. Learning communications lessons from GM, Asbestos and other techno-disasters
Hilary Sutcliffe (Director of MATTER) presented a business-funded project called Learning communications lessons from GM, Asbestos and other techno-disasters. The objective of the project was to help businesses understand what the public and other stakeholders expect from them in terms of the engagement in communications, what are the needs of information from the part of the public about the business use of new technologies, in particular nanotechnologies. Phase Two of the project consisted in the creation of two tools to help companies respond to stakeholders expectations, and Part Three involved the assessment of the tools by both companies and other stakeholders.
Public opinions have been examined on the basis of a review of over 20 dialogues and research projects in the fields of nanotechnologies, synthetic biology and stem cell research in the UK, the US and Europe. Conclusions show that there are three main needs of the public towards the companies:
1. More openness, better explanations and not hiding problematic issues: information is required as regards when and why nanotechnologies is used. She agrees that it is not a question of knowing everything on everything, but in some circumstances, such as nanotechnologies with which uncertainties and opposing voices in the society are associated, the public have the right to access the information if they need them.
H. Sutcliffe briefly presented the Nano&Me project, consisting of a website sponsored by the UK government and developed around 4 years before as a way of providing basis for accessible public information on nanotechnologies divided into various sections, such as: products, regulations, safety, etc. However, that was a pilot project only and although it has not received further funding, the website still records ca. 10,000 hits monthly, which indicates the need for such solutions. She also mentioned some other examples of outreach initiatives of bringing life debates and giving helpful information, such as Nanopodium, the German NanoCommission, EC Nanochannels.
2. Information on the reasons for pursuing nanotechnologies, a clearer picture about the benefits for people or for the environment, as well as on what problems are being solved or how does it improve on existing solutions. The public also have doubts regarding the comprehensiveness of information and if all possible issues have been considered.
3. Information on who would be held liable when there is a problem (she emphasized that the question specifically was when, and not if, since the public understand the risks connected with innovativeness and do not regard them as a particular issue, but need to have information on accountability and liability as well as on recovery measures). More importance is obviously attached to safety concerns as regards the technology as such, not particular consumer products. The public need independent reassurance by entities whom they trust.
As regards other stakeholders, they expressed concerns that there are companies using technologies in secret, and nanotechnology products are being forced into the society making them impossible to make informed choices.
However, at the same time all dialogues show genuine support for products where benefit is clear, safety and efficacy proven, and meaningful information available.
The following conclusions for companies have been drawn:
- The product needs to be demonstrated, not hidden;
- Support should be provided to independent public information websites;
- Robust benefit and risk assessments should be implemented;
- Independent assessments should be applied to support internal results;
- Innovative ways of communication should be applied;
- A richer picture why it is a good idea should be provided;
- The actual development process should be demonstrated;
- Communication across the supply chain should be maintained;
- Transparent recognized governance mechanism should be adopted (e.g. pursuant Stakeholder Engagement Standard AA 100 SES);
- Toxicological data should be shared;
- Stakeholders should be engaged (understand, involve, collaborate).
She concluded her contribution saying that one should not understand communication as PR only. Transparency from governments and business is critical.
6. DEEPEN: Deepening Ethical Engagement and Participation with Emerging Nanotechnologies
The DEEPEN project was presented by Dr Mathew B. Kearnes from the Durham University who at the last moment substituted the project coordinator, Prof. Phil MacNaghten, in his capacity as the Nanoethics speaker. The initiative was implemented in the years 20062009 under the EC Science in Society Programme and was a cross-European, interdisciplinary (combining different disciplines from the social sciences and humanities) initiative aiming at addressing the question on how to understand latent public opinion in a situation of a challenge where: the technology is unfamiliar, largely about future promises and fears, uncanny, poses certain risks and rests a methaphysical research programme that has broadly shared visions of controlling and manipulating matter at atomic and molecular scales. Response to the challenge was to be provided by in-depth public discussion groups and, in Phase 2, staged performances and stranger and constituted groups (in the UK and Portugal).
The following results were obtained it terms of characterizing public attitudes:
- Ambivalence, leading to collective doubt after discussion and connected to the impossibility of separating risks and benefits;
- No clear distinction across gender, class, lifestage;
- Nanotechnologies as intensifying existing concerns and hopes;
- Ethical positions are not straightforward, but dilemmatic.
M. Kearnes discussed some positive attitudes observed entailing excitement concerning nanotechnology benefits already mentioned during the conference, such as potential applications in medicine. However, he focused on concerns revealed in the project and relating to the effects on what it means to be human, including a focus on superficial qualities, a possible loss of personal identity, potential dual use danger, worries of excessive hype. The chief concern in his opinion, which was elaborated in details, was connected with a sense of impending disaster connected to a general conviction that a technology project is always doomed to fail in some respect. It results from narratives (meaning arche stories rooted so deeply in the society that they do not need footnotes) of technoscientific failure such as: the kept in the dark, the rich get richer, the Pandora Box, the messing with nature and the be careful what you wish for narratives. Consequently, such approach poses a question for governance to understand the conditions under which people envision nanotechnology to fail and entails some implications for responsible innovations forcing it to regard unforeseen, inevitable consequences resulting from the technology with higher care and attentiveness.
In the end, he shared the following conclusions of the project:
1. The promise of responsible innovation in European research policy is a way for science to reflexively engage with its indirect effects;
2. Over the last 5 years nanotechnology has been a site where these debates have been playing out in Europe (however, he noted, not the only site);
3. DEEPEN provides compelling evidence that citizens across Europe are profoundly pessimistic about nanotechnologies (but the feeling mixes with a sense of hope);
4. Policy needs to engage with public categories such as: nature, finitude, limits, it requires experimentation and reflexivity, dangers of playing God and dangers of false humility;
5. Responsible innovation provides an opportunity to reshape research agendas in such a way that they resonate with European values and contribute to the public good.
web site: www.geography.dur.acuk/projects/deepen/Home
6. NANOSOC Nanotechnologies for tomorrows society
Professor Lieve Goorden presented the project Nanotechnologies for tomorrows society funded by the Flemish government and implemented in close cooperation of social scientists from the Universities of Antwerp and Leuven on the one hand, and nanoscientists from the University of Antwerp and the Nanoelectronic Research Institute (IMEC) on the other. As part of the project, a stakeholders forum was organized, 36 organizations from various backgrounds were invited to take part in this one-day event to discuss with nanoscientists on the potential for nanotechnologies in the future. The main message of the forum was: how to tune research agendas to public expectations? However, at the same time a paradox was observed as there was noticeable reluctance from the side of the scientists to answer questions concerning their research agenda. They were willing to discuss present developments, but not to talk about future plans or ambitions. As a result, the following three constraints for an adequate communication about research agendas along with possible answers to them were identified:
a. Progress of technosciences follows a technology-driven and open agenda. The agenda of technosciences is open, which means that in opposition to traditional, fundamental or applied approaches it is not easy to define, and, consequently, talk about, a clear objective. In order to deal with the constraint, research planning should do justice to the open future of the technosciences recognizing that research plans never include objective projections of the future, they are not neutral, but reflect interests, expectations of authors. It can be done by a gradual matching of dreams circulating in society with available capacities needed for their realization and adjusting technical capacities to the realization of dreams.
b. Scientists are threatened to get trapped in a global race to complexity and keeping balance between creating more complexity and controlling it, while there is a gap between knowing things and understanding them. Scientists find it difficult to communicate about complexity and uncertainties and it nourishes a defensive communication strategy. Research planning to deal with this issue should recognize that predictions of future risks and benefits can never be adequate and are always preliminary, so there might be an option to explore already on this stage of building agenda alternative, parallel research paths in terms of the selection of technological solutions, target groups etc., which then can be assessed from different angles (i.e. scientific, technical, ethical feasibility, social usability).
c. Absence of a moral horizon in society for judging scientific progress, as in a modern liberal democracy there are no forums enabling public reflection on the good life in a hi-tech society and everyone is forced to make their own choices in this respect. That is why controversies on emerging technologies will not easily obtain the status of public debate, but they will be more and more a rule that exemption. A possible way of addressing this constraint would be inviting outsiders to the dialogue already on the stage of research planning to ensure timely orchestration of roles and actions.
The manner in which the technosciences progress complicated a debate between science and society entails the need of new practices of research programming, better suited to the changing situation.
7. NANOPODIUM
Dr Christien Enzing (Technopolis Group, Amsterdam), introducing the Nanopodium initiative, briefly described developments in the Netherlands which contributed to its creation. The nanotechnologies issues started to be addressed in the country as early as in 2004, since from this year the Rathenau Institute had been conducting a number of studies and small debates on the impacts of nanotechnologies. In 2008 the Institute published Ten lessons for a public debate on nanotechnologies postulating the separation between debates on risks from the one concerned with ethical, social, legal, economic aspects in a broader sense. The Dutch government took into consideration the lessons while facilitating, under the National Action Plan for nanotechnologies issued in 2008, the Committee Societal Dialogue Nanotechnology comprising 9 members from academia and industry, however without the involvement of NGOs, whose tasks included preparing agenda for the dialogue and stimulating it. The Committee applied a bottom-up approach avoiding being directly engaged in the debate and encouraging stakeholders to initiate and organize respective activities. Nanopodium was created in March 2009 with budget amounting to EUR 4.5 mln provided by the government. Following consultations with stakeholders, in late 2009 two calls for proposals were launched, while the first one was more information-focused, and the second more debate-oriented. Altogether, 35 projects were selected out of 140 (16 publications, TV programmes, YouTube projects, teaching materials for secondary schools development; 3 exhibitions or artists impressions; and 16 debates). As part of Nanopodium, also public knowledge and attitudes were measured twice, in August 2009 and November 2010. The online surveys demonstrated that knowledge of the existence and the essence of nanotechnologies have significantly improved in the course of the initiative (64% vs. 54% and 36% vs. 30% respectively), however, most citizens still had only a vague concept on nanotechnologies.
All projects coordinators were required to submit reports addressing main issues discussed, the ways of conducting discussions, what were the opinions and concerns of stakeholders. The Committee, basing on these reports, summarized the nano-dialogue and drew conclusions. The main message was: nanotechnologies research can be continued, but in the responsible manner. Specific outcomes regarding particular topic of interest such as health, food, privacy, environment and economy were also summarized. Recommendations drawn were as follow: in fields of interests, citizens should be kept informed about nanotechnologies and their applications, and openness about risks is an important prerequisite for a meaningful dialogue. Recommendations also applied to the types of activities: teaching materials for young people, providing information should be combined with activities aimed at opinion forming and exchange of opinions, artist projects are a very good channel of communication and dialogues should be organized in the form of small-scale meetings, and not Internet panels. Conditions for effective dialogue have also been identified: it should focus on nanoproducts, and not nanotechnologies in general, vignettes (small stories about future products) are good tools of information about soft impacts of nanotechnologies, and in order for the dialogue to be rich in opinions, participants with different values orientations, but at certain balance in terms of types of stakes, should be involved. Asked in a discussion following the session for which stakeholders the project proved to be most beneficial she shared her opinion that for companies and researchers developing nanoproducts, as they were provided with a current overview of attitudes in the general public.
NANOCODE: a multi-stakeholder dialogue providing inputs to implement the European Code of Conduct for Responsible Nanosciences & Nanotechnologies Research
Dr Elvio Mantovani (AIRI / Nanotec IT Italian Centre for Nanotechnology) presented the Nanocode project, a dialogue about EC CoC involving researchers, business people, CSOs, institutions providing inputs/suggestions that can favour/promote the adoption of the Code, which was started in January 2010 and finished in November 2011. Its participants involved 11 partners from 11 countries (8 from EU along with Argentina, South Africa and South Korea). Its objective was to develop a framework (Master Plan) enabling the successful integration and implementation of the Code at the European level (and beyond EU) and a tool (Code Meter) to (self) evaluate the compliance with it. First step consisted in the evaluation in European countries and some countries outside the continent of what is going on as regards the code or similar instruments, or in the aspects of responsible innovation in general. Then, stakeholder consultations in all participating countries were carried out in order to verify attitudes of stakeholders (civil society, institutions, business, research) towards the Code. This step resulted in the development of 11 country reports and a synthesis report. Pros and cons of the Code were identified in course of the process. The pros include the following aspects: there were unambiguous agreement on the 7 Principles, and the Code was perceived as an appropriate tool to implement them, the Code can be an early warning system to address EHS and ELSA problems and can encourage dialogue amongst stakeholders. As far as cons are considered, the following problems were recognized: some principles and guidelines were perceived as too general, there is an ambiguity of the meaning of some principles, which puts in question their acceptability, the Code was seen as interfering with national initiatives or policies (here the notion of accountability was the most significant issue, as it can be associated to legal liability), as another level of bureaucracy, lack of clear benefits and incentives for the adoption, as well as on adequate communication / endorsement on institutional level were also pointed out.
The Code Meter refers to the operational level and comprises methodological and practical issues of how to engage with the Code principles and guidelines and includes a set of normalized questions. Scores, depending on answers, are graphically visualised in the form of a 7-arm spider web. Master Plan, on the other hand, concerns strategic level and includes recommendations for changes of the CoC and its further implementation and integration in the political context. During the process of developing the Code Meter and the Master Plan some recommendations were prepared in order to make it more acceptable, more easily adopted. They were focused around the following issues: execution of the Code, clarifying the process, structure and language, awareness/dissemination, incentives/disincentives. The first draft of the tools was presented at national workshops in partners countries, the second one during an international conference in September 2011. Inputs provided by the events demonstrated consensus on the recommendations, especially as far as structure and language are concerned, generally perceived the weakest points of the Code.
web site: www.nanocode.eu
VI. Overview of current developments in the field of N&N
The conference evidenced a generally recognized specifics of nanosciences and nanotechnologies, i.e. that, in opposition to other technologies, the domain is not localized in one particular technology area, but it constitutes a cross-disciplinary field relating to all kinds of existing technologies, including medicine, environmental issues , etc. and should be regarded rather as an approach to research, that a field on its own. During the Nanoethics 2011 conference, more details concerning the N&N applications to IT, material sciences and medicine were presented.
Prof. Ehrenfried Zschech (Fraunhofer Institute for Non-Destructive Testing IZFP, Dresden) Nanomaterials for information technology challenges to materials science and engineering
Professor Ehrenfried Zschech focused his speech on three main points:
1. At the moment we are at the point where hard nanotechnology meets soft nanotechnology. It particularly concerns the performance of artificial computers which is, at least in some parameters, equivalent to the performance of human brain. He reminded the audience of the IBMs Watson computer system which in March 2011 for the first time in history outperformed the human brain, but consumed 10,000 more energy than the organ over the same period of time. Hence, the increase of efficiency and reduction of power loss is a challenge microelectronics is currently facing.
2. Hard nanotechnology is existing in the global IT industry and it has to be made clear that this industry will go ahead, even if the effects of nanostructures are not fully understood. This is why, he emphasised, such meetings are very important to demonstrate the effects of nanotechnology and he expressed the opinion that the industry would appreciate it.
3. Microelectronics is a driving industry for leading edge analytical techniques in nanotechnology. Forces nanoanalysis to be standardized and to have a standardized metrology. He admitted, concluding his talk, that, in his opinion, the next two decades in IT/microelectronics are the decades of materials science and engineering, which stresses the need to characterize nanostructures and nanoparticles and to validate respective models.
Prof. Krzysztof J. Kurzyd?owski (Warsaw University of Technology) Subtle balance: opportunities and threats related to the development of nano-technologies
Professor Krzysztof J. Kurzyd?owski focused his contribution on nanomaterials. While beginning his speech, he emphasized that some nanomaterials do not involve any risk, in particular to biological species, which concerns agglomerates, such as nanometals. He briefly commented on opportunities brought about by nanotechnologies, such as considerable improvement of the properties of materials (relating to strength, magnetic, electric conductivity, optoelectronics, corrosion resistance, friction and wear, melting point depression or altered phase equilibrium), as well as on the more and more wide use of nanomaterials. He also enumerated potential benefits concerning: materials (light as plastic, strong as steel), water (clean water any time, any place), medicines (smart drugs killing the disease, not patient) or energy (PowerPlastic to convert light into energy).
The second part of the speech was devoted to potential risks associated with the use of nanomaterials divided into two categories: the first one concerning possible adverse effects of nanomaterials on living species (they can be more reactive and possibly more toxic, there is no natural barrier to prevent the penetration of nanoparticles into the body and once inside, they can travel more easily though the body), which are of interest to medical doctors. He focused on the second, non-medical category of potential risks including:
- Unknown long-term properties of nanomaterials which are potentially subject to changes in microstructure upon exposure to normal in-service conditions such as temperature, loads, chemical interactions;
- Undeveloped methods of re-use / recycling (in many countries required by law), where the major challenge is the separation of nano from standard composites;
- Economic aspects leading to i.e. possible exclusion of SMEs, as nanotechnologies require access to relatively expensive infrastructure, which puts bigger companies with larger resources in a favourable position in terms of competition. An answer to this problem can be provided e.g. by a solution mentioned by Professor Kurzyd?owski in a discussion which followed the presentation, implemented by the Warsaw University of Technology and consisting in providing SMEs with a system of open access to infrastructure as long as they can satisfactory justify the intended research;
- Unfriendly attitude of general public according to him, people tend to overestimate the risks related to the agents defying recognition through senses. He enumerated three major areas of concern: environment, health, as well as ethics and society (where possibilities of nanotechnologies can significantly broaden the gap between rich and poor countries).
In conclusion he emphasized that nanotechnology provides enormous opportunities, however, at the same time it requires a thoughtful intervention of states which should help to reduce the risks and assist the advancement of nano-based solutions. He also pointed out that discussing risks can help to minimize them.
Prof. Aleksander P. Mazurek (Medical University of Warsaw) Nanotechnology in medicine scientific and ethical issues
Professor Aleksander P. Mazurek, having briefly commented on the history of the development of nanosciences and nanotechnologies, emphasized that nanomaterials, apart from various applications, are particularly desirable in medicine. Three major areas for the use of nanomaterials in medicinal products were listed and elaborated in details:
- Drug delivery systems and modified release formulations;
- Diagnostics;
- Structures in regenerative medicine.
Professor Mazurek also provided examples of particular nanoscale materials finding their application in medicine (such as dendrimers, magnetic nanoparticles, nanocrystals, or nanobombs novel way of fighting cancer, still under investigation), as well as already registered nanomedicines used in treatment, in particular in oncology.
He also devoted a part of his speech to discussing initiatives undertaken by the European Medicines Agency as far as nanotechnology development in concerned (Reflection Paper of 29 June 2006 on nano-based medicinal products; a meeting on nanomedicines in 2009 and an international scientific workshop on nanomedicines, gathering 200 participants from 27 countries).
He concluded his contribution with the following recommendations:
1. Translational activity from nanoscience to nanomedicine should be enhanced;
2. Toxicological hazard and acceptance criteria from ethical perspective should be set up;
3. Risk / benefit ratio for nanomedicine applications should be quantified and regulated;
4. Nanoscience and nanotechnology achievements in medicine should be balanced;
5. Worldwide regulatory framework for nanomedicine should be formed as there is an obvious lack (e.g. there is no clear protocol for clinical trials involving nanoproducts).
Based on the above section, it should be underlined that the Nanoethics 2011 project met its main objectives and constitutes a basis for further developments in the respective area. As in the case of similar projects, the impact is not directly visible and cannot be measured, but is to be reflected in the improvement of general knowledge in the field of N&N, clarification of ambiguous areas, recognition of differences of opinions, which should form basis for future actions enabling to overcome problematic issues and to ensure the continuation of wide-ranging dialogue within the society.
Potential Impact:
The following section shall constitute an abbreviated overview of expressed, confronted, discussed and summarized opinions of representatives of different stakeholder groups relating to socio-economic aspects of nanosciences and nanotechnologies. Again, the nature of the project makes it impossible to point on its directly visible impact on the society or economy. However, the participation of various stakeholders in the conference, such as representatives of science, regulatory bodies, NGOs and business facilitated discussions encompassing social and economic concerns, needs and expectations, as well as such notions as responsibility, liability and social dialogue, in a comprehensive manner. Identification of common and split views perhaps may not cause immediate effects, but, in a longer perspective, only broad, cross-societal opinion-sharing can lead to developing an accurate assessment of current status of the problem and to agreeing upon, acceptable to all interested parties, solutions. The Nanoethics 2011 project, by providing an opportunity to confronting different positions, can be considered as only one of many, but needed, step in this direction.
Moreover, because of the high ambiguity accompanying new technologies, an nanotechnologies in particular, where rather strongly voiced doubts are associated with insufficient knowledge, in order for the field to gain more recognition within the society consisting of consumers, the need for awareness raising and education activities towards the general public and for conducting an inclusive dialogue was emphasized and generally agreed upon by the conference participants.
The following part features an account of contributions of selected stakeholders: regulators, scientists, business and CSO representatives.
Prof. Elke Anklam (EC Joint Research Centre, Institute for Health and Consumers Protection) Connecting science and policy to bolster innovation and nanotechnology acceptance among consumers
Professor E. Anklam focused her presentation on the need of bringing science and policy more closely together to make best use of the emerging nanotechnologies and to ensure that they are better accepted among consumers. She underlined that nanotechnology has a great potential, at the same time, however, it poses a serious challenge, as innovative products on the market may not necessarily find acceptance amongst consumers. She expressed her opinion that consumers nowadays are more and more critical, have higher expectations, in particular concerning safety. She enumerated prerequisites for consumers acceptance (transparency of knowledge transfer from key players, translational science, harmonization and standardization, ethical and value for money aspects), while emphasizing safety by design as the most important.
Prof. Richard A.L. Jones (University of Sheffield) The UK experience of public engagement and nanotechnology: what have we learned?
Professor Richard Jones began by discussing the assumptions of the Ethical, legal, social aspects (ELSA) research which involve multidimensional and multidisciplinary approach to such questions as public attitudes and engagement, governance and institutional structures in the framework of which science is done and regulated, science studies (hidden assumptions and visions of science at work), as well as two points generally not considered part of ELSA which are: innovation theories (while they deserve a more nuanced view, as some technologies advance much faster that others) and toxicology and ecotoxicology. He commented on the benefit of society which is the point of the ELSA research adding at the same time his opinion that also science and agencies to which science findings have to be delivered can largely benefit from it, as reflexive science can improve and recommendations can be helpful to moderate the way science goes, while agencies can produce better science policy when informed of societal context.
Concluding his contribution, he expressed his personal opinion as regards responsible research issues. Responsible nanoscience, in his opinion, does not depend totally on responsible nanoscientists. He pointed out that researchers work in constrained circumstances within their institutions environments, a company or a government research laboratory. A problem with codes of conduct is that they are, in his opinion, focused on individuals. The problem arises with the principle of accountability: how to divide responsibility between individual researchers and institutions they work for and they are funded by; moreover, how to divide responsibility between scientists who work on original research and institutions or people who develop and market, often in a way which could not be anticipated, technologies based on their work. The need to concentrate just as much on making responsible institutions as responsible scientists, in his view, is crucial.
Dr Rene von Schomberg (EC DG Research & Innovation, Directorate B: European Research Area) Responsible research and innovation: the case of nanosciences and nanotechnologies
Dr Rene von Schomberg began his attempt to conceptualize the notion of responsible research and innovation and to specify it to nanotechnology from describing the background. In the mid-2000s under the EC Science in Society Programme, a deliberative approach to nanotechnology was started. A couple of projects were implemented involving at least two elements: 1. Public engagement in research and technology development in order to address societal issues. The projects resulted in quite influential outcomes: an observation that all public engagements are beneficial, however, a general lack of feedback to policy can be noted as they were rather of one-off nature. Conclusion was drawn that there is a need of an ongoing monitoring of public debate. 2. Understanding innovation as a process is too limited and has to be improved in order to successfully address the issue. Findings from the projects formed part of the later framework for innovative research.
A question on which values should be taken into consideration when assessing research was then discussed. Basing on the Treaty on the European Union, the following fundamental objectives to address societal needs can be distinguished: sustainable development, full employment and social progress, high level of protection, and the quality of environment. Consequently, they all should be considered as legitimate basis in attempts to redirect research to societal needs. All EU policies are based on these fundamental values, however, as far as research is concerned, not quite consistently yet. Consequently, a challenge and task for the framework is a programme helping to address normative anchor points derived from the Treaty:
- Promotion of scientific and technological advance;
- Promotion of social justice, equality of women and men, solidarity, fundamental rights;
- Quality of life, high level of protection, human health and environment;
- Sustainable development;
- Competitive social market economy.
Dr Jorge Costa David (EC DG Employment, Social Affairs and Inclusion) Nanomaterials risks to workers and workplace regulatory strategies
Dr Jorge Costa David began his presentation with an observation that in the particular field of nanotechnology some terminology can have different meaning to different people. He commented on the legislation dividing it, quoting the document mentioned earlier by Professor Elke Anklam, into horizontal (general in terms of its goals and addressed situations) in opposition to vertical (specific pieces of legislation, e.g. referring to a particular sector) one. As an example of the horizontal legislation he mentioned the Framework Directive on Health and Safety at Work. It contains provisions concerning both employers and workers obligations aiming at ensuring protection against potential risks which might be encountered at a workplace. They are of general nature, i.e. they are applicable to any sector, including nanotechnologies. However, in his opinion performing employers obligations consisting of providing proper information, training and risk assessment in a situation of the relevant lack of data in the field resembles taking measures in a vacuum of information and renders it impossible to adopt correct solutions. In this case specific actions need to be undertaken.
He also commented on an open invitation to tender No VT/2011/039 issued by EC for a study service contract to accommodate corresponding risks/concerns to ensure adequate protection of workers from risks connected with the expose to nanomaterials and/or nanotechnologies. Goals of the assignment include:
- Analysis of sustainability of the EU-OSH legal framework in its current form relative to the nano specific workplace;
- Elaboration of possible scenarios individually or combined;
- Elaboration of a Guidance document that is to address actual shortcomings in a realistic matter.
Dr Jorge Costa David also discussed specific problems associated with the workplace risk management measures for nanomaterials which consist of particular factors: the number of nanomaterials is significant and likely to grow, the paucity of hazard information, a small number of nanomaterials studied and few long-term studies were performed, occupational exposure scenarios are not sufficiently characterized and, lastly, workers are already exposed. He commented on elements of ensuring workers protection:
- Hazard identification;
- Exposure assessment;
- Risk characterization;
- Risk management.
Possible measures to be considered by employees, such as NRV (defining a maximum generic level for the concentration of nanoparticles in workplace atmosphere and constituting a warning factor) were also discussed.
He concluded his talk with an observation that actions to be undertaken differ depending on the timeframe in mind, and while in the present precautionary principle is to be applied, for the near future diligence, for farther future regulatory measures are relevant.
Prof. Ruediger Iden (BASF) he explained his background as consisting of 30 years of industrial experience with 10 years of developing nanoproducts and 56 years of marketing them. At BASF, a leading chemical company worldwide, contrary to what might be thought, nanoproducs represent only less than 1% in sales, however, taking into consideration overall sales, it is still an impressive figure with huge potential. Also, evaluation of the market share can differ significantly depending to approach adopted, as nanoproducts can have an added value to other materials (such as organic nanoparticles influencing plastic properties) and as such impact end products.
As an active member of the German NanoCommission he considered crucial that the dialogue had been initiated at an early stage and constituted a success, as all stakeholders reached a common conclusion and although there are still discussions, common ground for understanding had been created and differences between NGOs and industry are not as huge, as long as they are free of fears.
Professor Iden shared his thesis that sustainability is a key factor for businesses to survive. Therefore, in lots of cases, nanotechnologies included, special attention should be paid not to apply excessive regulations or overemphasize governance principles, as chemical companies are more and more sustainable, otherwise they would cease to exist. In his opinion, no governance principles can withdraw the responsibility from manufacturers. He commented on differences in this respect as regards the situation in Europe and in the US, since in Europe there are tendencies to regulate (or even over-regulate) businesses of innovation processes, while in the US responsibility for ensuring that end products are not harmful for consumers is put on marketing companies. He emphasized that it should not be forgotten that industry itself must stay in responsibilities, while excessive governance can result in delegating them to more or less unanimous institutions. He underlined that it is probably not a commonly shared view, but innovation process is becoming more and more democratic. It is not the case with science, but innovation, ultimately resulting in selling product to the market, is a different story. Dialogue with all potentially interested stakeholders starts playing a crucial role in the process and it needs a right framework.
Sylvia Maurer (BEUC The European Consumers Organisation) presented her organization as one of the oldest NGO in Brussels established in 1962 originally by 6 consumer organizations, now having 42 members in 31 European countries. Product safety is a high priority topic in the works of the organizations aiming at improving general safety of products sold on the EU market and at raising awareness with decision-makers concerning risks posed by chemical substances on health and the environments, as well as at minimizing the exposure of consumers to dangerous chemicals including nanomaterials.
She discussed a leaflet published already twice by BEUC with its sister organization ANEC How much nano do we buy? and constituting an inventory concerning product claims. It is designed as an added value to regulators, in order to provide them with an overview in which categories of products nano claims are used, how many claims are there and to give them an opportunity to decide on possible further testing or following up particular situations, for EU has some legislation in place which does not allow to mislead the consumer about certain properties.
She briefly commented on problems which were encountered: in some products the notion nano is used merely as a marketing term in order to make a product seem more innovative, but possible new properties are not obvious; while, in opposition there are areas where it may be possible that nanotechnology is already used but the consumer has no clue about it, especially such a situation concerns food additives and food contact materials. Here the issue of the need of transparency and clarity for consumer arises. Transparency is also connected with some problematic issues, such as whether all products should be labelled or whether such a label would not scare off the consumer. She expressed her opinion that putting the term nano is a neutral way of communicating.
Sylvia Maurer also presented opinions on some of the issues being in the focus of attention of BEUC: first of all, the organization has concerns that there are some gaps in the regulatory framework and agrees with the European Parliament that consumer safety legislation should be reviewed and that nanosafety provisions need to be included in this sector. The second issue she commented on was the need for increasing the traceability of nanomaterials by implementing a mandatory register covering information on which nanomaterials are used and in which consumer products. She also shared her view on a report published a few days before the conference by JRC and concerning risk/benefits analysis. She mentioned a point contained in the report that the exposure of consumers is very likely to grow in the coming years and that is why it is crucial that products available to consumers are assessed properly before marketing and quoted the REACH principle no data no market as applicable in this respect. Lastly, she discussed the most recent EC Recommendation containing a definition of a nanomaterial. She expressed her view that it provides clear frames of reference, however, she remarked, a current challenge would be to check its adequacy in use.
The contributors to the Nanoethics 2011 conference agreed that the current general publics attitude towards nanotechnologies, apart from relatively low knowledge on the field, is highly ambiguous. Enthusiastic expectations mix with scepticism or even fears. The first feelings are associated with enormous potential of the applications of nanotechnologies, particularly in medicine, while the second with considerable, though unknown risks, knowledge gaps, uncertainties. These require intensification of awareness raising activities and can be answered by transparency of research and information, increased stakeholders involvement and public engagement which were unanimously called for by the conference participants.
It was stressed that stakeholders dialogue has become more and more significant within N&N because it gives the society, consisting of individuals, a tool for getting a position on the subject. The influence of stakeholders contributions on the perception of new technologies developments is remarkably high, so more considerable openness of the society for scientific basis for their judgement is a good investment in the future.
The need for transparency, fostering the involvement of the general public and the significance of societal factor in the development of science and technology were emphasized by nearly all speakers and disputants and gained unanimous understanding by the conference participants.
List of Websites:
PROJECT WEBSITE: www.nanoethics2011.pan.pl;
CONTACT DETAILS:
Andrzej Górski
Polish Academy of Sciences;
Pl. Defilad 1, 00-901 Warsaw, Poland;
e-mail: agorski@ikp.pl
The main objective of the Nanoethics 2011 project was to raise awareness of policy makers, experts, scientists, representatives of industry, third sector and general public as regards the Code of conduct for responsible nanosciences and nanotechnologies research as well as other developments in governance and ethics of such research. The general goal was to be achieved by the organization of the Governance and ethics of nanosciences and nanotechnologies NANOETHICS 2011 conference, follow-up activities and the overall promotion of the project.
The Nanoethics 2011 conference was organized on 2021 October 2011 in Warsaw by the Polish Academy of Sciences in cooperation and with support provided by the European Commission. The conference was held as an event included in the official calendar of the Polish Presidency of the EU Council, under the patronages granted by the Polish Minister of Science and Higher Education and the President of the Polish Academy of Sciences. The conference primary aimed at providing an overview of main issues concerning governance and ethics of nanosciences and nanotechnologies (N&N).
The conference was attended by 120 participants from countries all over the world, representing various groups of stakeholders, including representatives of the European Commission, NGOs, policy makers from the EU Member States, scientists, experts, entrepreneurs, and the general public.
The 2-day event was divided into four sessions. The first one constituted an introduction to nanosciences and nanotechnologies, discussing their cross-disciplinary nature, tangible current and possible future applications and directions of development, and covering the general overview of the complexity of issues connected with this emerging field. The second one provided an overview of the current regulatory framework regarding nanoscale materials and technologies, forming the basis for discussions on further steps required and recommendations to be taken into account in order to achieve comprehensive and encompassing regulations to govern this demanding field. The third session focused on delivering a broader context to the conference subject matter fostering the confrontation of opinions of stakeholders coming from various backgrounds by involving them, apart from standard presentations, in a roundtable discussion. The last, fourth session was devoted specifically to the Code of Conduct for responsible nanosciences and nanotechnologies research as a non-regulatory tool enabling to address N&N governance also from an ambiguous, ethical perspective.
The conference helped to summarize current developments relating to the vast, emerging field of nanosciences and nanotechnologies, providing all stakeholders with an opportunity to share their standpoints, identifying hopes and fears connected with the field, as well as discussing problems absolutely needing to be resolved as soon as possible and specific challenges faced by regulators. In particular, the necessity to involve public dialogue and ethics in policy making was emphasised.
Further details, including full video coverage of the conference as well as presentations made available by speakers can be found at the webpage of the event, www.nanoethics2011.pan.pl.
Project Context and Objectives:
BACKGROUND
In the last years we have witnessed a very dynamic expansion of nanosciences and nanotechnologies (N&N) in the world. It is estimated that by 2015 about 15% of all products will be produced with the use of nanotechnology. Nanotechnology is considered a new key technology with a potential to impact all industrial sectors and spheres of human life. It is likely to contribute to the development of new therapies, reduction of the use of raw materials, faster and safer manufacturing, production of smaller and quicker devices, obtaining an increased life-cycle of products and many other improvements to existing products. In view of this revolutionary potential, it is not surprising that this technology has ignited great interest in science from the part of the media and the public.
While N&N may bring about important advances and benefits for our society and may improve the quality of our lives, some risk is inherent, as for any technology. Certain risks and side effects associated with N&N have already been identified. In the Opinion on the ethical aspects of nanomedicine, prepared by the European Group on Ethics in Science and New Technologies (EGE), it was stated that the use of nanomaterials may have health effects in the case when these materials are dispersed in the environment. Toxic effects of some nanoparticles have been already demonstrated in cells, tissues and small animal experiments. However, at this stage, potential risks for the environment and human health related to the application and use or misuse of nano-related products are not fully identified. Specific studies dedicated to the assessment of risks posed by engineered nanomaterials have highlighted they are not generally simple, with clear-cut cause-and-effect connections. Instead, risk problems in nanotechnology are dominated by complexity, high degree of uncertainty and ambiguity in current knowledge about the response of humans to the use of nano-related products.
In February 2008, the European Commission adopted the recommendation for the Code of Conduct for responsible nanosciences and nanotechnologies research which provides principles and guidelines for actions to be taken by the EU Member States in the course of formulation of their N&N strategies, and development of sectoral and institutional research and development standards. The Code is voluntary and there are no authoritative sanctions for failure to adopt it. It was intended to facilitate and underpin the regulatory and non-regulatory approaches indicated in the 20052009 N&N Action Plan for Europe, improving the implementation of existent regulation and coping with scientific uncertainties. The Code sets out general principles and guidelines on actions to be taken in order to achieve good governance of N&N research. The recommendation should be reviewed every two years and the extent to which relevant stakeholders have adopted and implemented the Code of Conduct is to be monitored.
Code of conduct is one of the forms of governance of new technologies. The philosophy behind the Commissions Code of Conduct is to support and promote active and inclusive governance and communication. It assigns responsibilities to stakeholders beyond governments, and promotes their involvement. It also regards the EU Member States as responsible actors, and invites them to use the Code as an instrument to encourage dialogue between policy makers, researchers, industry, ethics committees, civil society organizations and society at large.
OBJECTIVES
The above mentioned problems fitted perfectly into the Nanoethics 2011 project objective which was the organization of the conference entitled Governance and ethics of nanosciences and nanotechnologies. The conference constituted one of the major events during the Polish Presidency of the European Council. The honorary patronages were granted by Professor Barbara Kudrycka, Polish Minister of Science and Higher Education and Professor Micha? Kleiber, President of the Polish Academy of Sciences.
Main objectives of the Nanoethics 2011 project were:
to provide an overview of issues concerning governance and ethical aspects of nanosciences and nanotechnologies;
to present the Code of Conduct for responsible development of nanosciences and nanotechnologies research and its revision process;
to present developments in the Member States with reference to the Code of Conduct;
to identify and discuss problems arising in the process of adoption of the Code of Conduct in the Member States;
to present various stakeholders opinions concerning the Code of Conduct;
to develop recommendations concerning the adoption of the Code of Conduct in the Member States;
to present results of selected EU-funded projects in the area of governance and ethics in N&N;
to present an overview of current developments in the field of N&N.
CONTENT AND RESULTS
The conference was attended by 120 participants from different countries all over the world (Austria, Belgium, Bulgaria, the Czech Republic, Finland, France, Germany, Hungary, Indonesia, Italy, the Republic of Korea, Lithuania, Malaysia, the Netherlands, Norway, Poland, Russia, the Republic of South Africa, Singapore, Spain, Sweden, Thailand, Turkey, the United Kingdom, the United States of America), including:
? Representatives of the European Commission;
? Policy makers from the EU Member States;
? Representatives of institutions developing and implementing initiatives in the area of governance and ethics in N&N;
? Experts in the field of ethics, risk assessment, governance and standardization;
? Scientists in the field of N&N, ethics, medicine and technology;
? Delegates from national academies of sciences;
? Representatives of companies conducting research and developing products in the field N&N;
? Representatives of environmental and consumer NGOs, and industry associations;
? Representatives of international organisations;
? Trade unions delegates;
? General public interested in the subject;
? Media.
The 2-day conference, which took place at the conference venue in the Institute of Biocybernetics and Biomedical Engineering of the Polish Academy of Sciences, included several sessions:
First day
Opening
The opening speeches were given by Dr Gilles Laroche from European Commission, DG Research & Innovation, Directorate B: European Research Area, Head of Unit B.6: Ethics and Gender and Prof. Micha? Kleiber, President of the Polish Academy of Sciences.
Session 1: Introduction to N&N, risks and ethical aspects
The session was chaired by Prof. Harald Fuchs, Scientific Director of the Institute of Nanotechnology in Münster, co-director of the Institute of Nanotechnology in Karlsruhe. The part of the conference was divided into two parts. The first part comprised 5 lectures given by high-level experts from the USA, Belgium, Germany and Poland and was followed by a 15-minute discussion. The second part consisted of 4 presentations given by invited speakers from Poland, the Republic of South Africa and the UK. Session was closed by a further 15-minute discussion.
During the session, general introduction to the topic of the conference was provided. It was stressed that N&N is a specific domain as it is not localized in one particular technology area, but it constitutes a cross-disciplinary field relating to all kinds of existing technologies, including medicine, environmental issues etc. The comprehensiveness of the issues discussed during the session, comprising not only various possible applications of nanotechnologies, but also their current status, overview to ethical challenges and education fostering its future development, translated into the basis for a multifaceted approach to the subject charactering the whole Nanoethics 2011 conference.
Session 2: Governance
This session was chaired by Prof. Pavel Kashkarov, Deputy Director of the National Research Centre Kurchatov Institute. It contained 11 talks presented by specialists from the EC, Norway, France, Poland, Austria, The Netherlands and Russia. It offered the participants two possibilities for discussion, in the middle of the session and at the end of it.
During the session, speakers focused on discussing problems relating to several aspects connected with the broadly understood N&N governance, such as existent regulations concerning N&N in general, and their specific applications (e.g. to nanomaterials, workplace safety) in particular, as well as the need and possible directions for further steps in this regard, standardization and legal problems. The session helped to summarize the current status of the regulatory framework and, in a way, to define aspects and requirements which need to be taken into account while addressing N&N governance in the future.
Second day
Session 1: Stakeholders
The session started with the Roundtable of stakeholders with the participation of 5 experts from Germany, Belgium and France. The roundtable discussion was followed by 5 lectures delivered by specialists from the Netherlands, the UK and Belgium, and a 15-minute discussion.
The importance of having a successful governance of nanosciences and nanotechnologies was emphasised, otherwise, as it was noted, the position of Europe in general and MS in particular could become endangered. The roundtable took place in an interesting time when issues discussed stayed open, as the roadmap for 20112015 was still under consideration at the EC level. Therefore, the roundtable aimed at providing a useful input to the discussion on the best possible governance for N&N not only in terms of recommendations, but in raising questions as regards the issue, questions which might be of value also in wider, regional and international aspects.
Session 2: Beyond regulation: the Code of Conduct for responsible nanosciences and nanotechnologies research
The session was chaired by Prof. Zbigniew Szawarski from the University of Warsaw, chairman of the Committee for Bioethics of the Polish Academy of Sciences and consisted of two presentations given by the representatives of the EC and the Italian Centre for Nanotechnology, followed by the Roundtable with representatives of the EU Member States: discussion about adoption of the Code of Conduct. In the roundtable discussion 10 experts from France, Germany, Poland, Sweden, the UK, the Czech Republic, Italy, Finland, Hungary and Austria took part.
During the session, tremendous impact of nanotechnologies on social life as well as on lives of individuals was emphasised. It was a common understanding that they can bring a lot of hopes of a better future and great advantages, but at the same time threats and fears. It is also obvious that time cannot be reversed and scientific progress will not be stopped. The conference in general, and the session in particular, constituted an opportunity to discuss these topics providing for the involvement of all interested parties in common debates, sharing views and identifying differences of opinions, which, as it was stressed, is the only way enabling people to learn and understand more and by this means to increase their capability to control the whole process of development. Throughout the session, however, it was particularly emphasised that the debate essentially would need to be complemented by the aspects of ethics, values and philosophy.
Closing remarks were given by Prof. Andrzej Górski Chair of Conference.
The conference did not provide definite answers, however, which is perhaps more important, active participation of stakeholders from all various backgrounds interested (policy makers, scientists, NGOs, industry, general public) helped to formulate tangible questions and identify problematic issues and fields of differences which need to be addressed in the future. However, some areas of general consent have also been determined. There seemed to be a common view that the Code of Conduct, despite its drawbacks or limitations which were discussed during the event (unclear language, unspecified target audience, excessive complexity), and a need of its review, is a right tool to address the issues it is designed for, i.e. form the basis for further discussion, and to implement its 7 principles, the philosophy behind which did not raise doubts either. At the same time, however, the Code cannot be regarded as a substitution for legislation, but it plays a complementary role to hard law instruments.
The participants also agreed that the current general publics attitude towards nanotechnologies, apart from relatively low knowledge on the field, is highly ambiguous. Enthusiastic expectations mix with scepticism or even fears. The first feelings are associated with enormous potential of the applications of nanotechnologies, particularly in medicine, while the second with considerable, though unknown risks, knowledge gaps, uncertainties. These require intensification of awareness raising activities and can be answered by transparency of research, increased stakeholders involvement and public engagement which were unanimously called for by the conference participants.
It is a general consent that scientific progress cannot be stopped, which concerns not only nanotechnologies. As one of the participants quoted a thesis of a recently published book The God Species by Mark Lynas: we already are playing God, we have the power over life and death, we can change colour of the sky, all we have to do is to play God in a much better way than it was the case in the past. In order to do so, much higher awareness of both benefits and risks (or dangers) associated with nanosciences and nanotechnologies is essential, as only knowledge can give control over the future.
Further details, including full video coverage of the conference as well as presentations made available by speakers can be found at the webpage of the event, www.nanoethics2011.pan.pl
IMPACT
The conference raised awareness of the issues of governance and ethics in N&N among policy makers, experts, industry and NGOs representatives and general public. It was a forum for the discussion on the Code of Conduct for responsible development of nanosciences and nanotechnologies research in the Member States which resulted in concrete recommendations.
The conference website proved to be a valuable tool for promotion of knowledge about the governance and ethical aspects of nanosciences and nanotechnologies, as, since its launching on 25 May 2011, it has been visited more than 10,000 times.
Project Results:
The following section shall present an overview of main outcomes of the project achieved both as results of the Nanoethics 2011 conference, and of other, supplementary activities undertaken by the Polish Academy of Sciences in the course of the project execution. At the same time, the contents below contains some selected, abbreviated statements of the post-conference report whose full version is available at www.nanoethics2011.pan.pl. For a more detailed account of the Nanoethics 2011 conference outcomes, please refer to the report.
Main objectives of the Nanoethics 2011 project included:
to provide an overview of issues concerning governance and ethical aspects of nanosciences and nanotechnologies;
to present the Code of Conduct for responsible development of nanosciences and nanotechnologies research and its revision process;
to present developments in the Member States with reference to the Code of Conduct;
to identify and discuss problems arising in the process of adoption of the Code of Conduct in the Member States;
to present various stakeholders opinions concerning the Code of Conduct;
to develop recommendations concerning the adoption of the Code of Conduct in the Member States;
to present results of selected EU-funded projects in the area of governance and ethics in N&N;
to present an overview of current developments in the field of N&N.
The results obtained as regards presenting various stakeholders opinions for the purpose of this report shall be considered as exercising (possibly future) socio-economic impact and as such shall be discussed in the relevant section of the report. In this section, the remaining outcomes, achieved to answer the project objectives, shall be presented. For clarity purposes, they have been divided according to the goal categories listed above, while some related categories were merged, however, in some cases such division could seem unavoidably simplified.
I. An overview of issues concerning governance and ethical aspects of nanosciences and nanotechnologies
1. Survey concerning governance of N&N in the EU Member States
In an attempt to summarize the variety of undertaken initiatives within a comprehensive overview, the Polish Academy of Sciences, as part of the Nanoethics 2011 project, drafted a Questionnaire concerning governance and ethical aspects of nanosciences and nanotechnologies research in the EU Member States and, having identified competent respondents in each of 27 MS, predominantly ministries and governmental organizations responsible for the governance of new technologies/nanosciences, sent the survey by e-mail to the recipients. Reluctance in responding, initially encountered, was, after some amendments applied to the list of addressees and three subsequent dispatches, partially overcome and ultimately collected 22 responses were assembled and processed, giving rise to the Summary concerning governance of N&N in the EU Member States, submitted to the European Commission in December 2011 as Deliverable 2.1. The Summary provides detailed information regarding the existence and localization within state structures of bodies responsible specifically for controlling N&N research, its ethical aspects and safety, as well as on any activities undertaken as regards the European Commission Recommendation of 8 February 2008 on the Code of conduct for responsible nanosciences and nanotechnologies research. The Summary can be considered an indication of weaknesses of the N&N regulations implementations on the European level and, consequently, as a hint on possible remedial measures.
2. Overview provided by the Nanoethics 2011 conference
During the conference it was underlined on numerous occasions that N&N is a specific domain as it is not localized in one particular technology area, but it constitutes a cross-disciplinary field relating to all kinds of existing technologies. This, along with the fact that the field, still relatively new and unstudied, rises various fears and doubts as to the number and nature of possible risks, and adds up to the need for it to be treated with particular caution, especially as far as governance and ethical issues are concerned.
In the course of the Nanoethics 2011 conference, several speakers focused their contributions specifically on these aspects.
Prof. Julian Kinderlerer, as Chair of the European Group on Ethics in Science and New Technologies, commented on problems associated with working on a comprehensive, coherent advice, expected from the part of EGE, while dealing with limitations imposed by the request to look at ethical issues and the perceived enormity of the topic. He also mentioned the Precautionary Principle according to which if there is a real significant danger, one has to think of its possible implications and of implementing systems of protection against this danger. However, the Principle does not entail resigning from research entirely, but imposes making a judgement whether benefits and risks associated with the said research are proportional. Further, he discussed regulatory concerns identified by EGE and relating to the comprehensiveness and clearness of the legislation, whether it provides adequate protective measures including evaluation of health-related risks, whether the implementation is proper and what challenges it faces. The major finding was that no new regulations are needed, but the implementation of existing ones and the manner in which particular products are tested whether they meet requirements of relevant regulations has to be examined. He underlined that taking specific efforts to develop measures for implementing existing regulations that would respond to the implications of nanomedicine is required. He discussed problems and concerns associated with ethics, governance and policies and connected with safety (which is a major issue in his opinion, involving the assessment of benefits/risks associated with new technologies in general), as well as risk governance (consisting of difficulties in identifying, estimating and managing risks in the area where there are considerable uncertainties and knowledge gaps, and short- and long-term risks can be different.
Henrik Laursen (EC DG Environment) in his talk discussed regulatory aspects of nanomaterials, more specifically nanochemicals, from the EC perspective. First, he briefly commented on the key actions adding to the regulatory approach of the Commission to nanomaterials:
- Communication on Regulatory Aspects 2008;
- REACH CASG NANO 2008;
- REACH Guidance;
- Recommendation on the definition of nanomaterials;
- Several pieces of legislation with specific provisions for nanomaterials.
The European Parliaments response to the first document was the Resolution on regulatory aspects of nanomaterials published in 2009. Clue observations made in the Resolution were:
- The use of nanomaterials should respond to real needs of citizens;
- Appropriate data and risk assessment methods are lacking, consequently nano risk cannot be addressed.
The EP disagreed with the Commission that current legislation covers risk of nanomaterials. It also pointed out that there is a lack of information on nanomaterials already marketed.
Current works of the EC, being key deliverables in 2011 and 2012, partly constitute the answer to EPs objections. The latest developments include:
- Bringing RIPoN (REACH Implementation Project on Nanomaterials);
- 2nd regulatory review of nanomaterials; accompanied by
- Report on nanomaterials types and uses on the market and safety;
- Definition of a nanomaterial published in October 2011.
The review mentioned above is due to be published in the first half of 2012. Henrik Laursen shared his observation on its, though not finished yet, contents. The documents confirms the point that nanomaterials are covered by legislation. At the same time, data is lacking as to the actual types and quantities of these substances on the market. However, the belief that our everyday is more and more flooded with nanomaterials seems not to be necessarily substantiated by available information. A few nanomaterials apparently are dominant in terms of volume and there is a greater complexity of nanomaterials present on the market in small amounts. No conclusions were to be drawn yet, he continued, but obviously there are some sectors in which nanotechnology is advancing faster, though in some (chemicals included) not as fast as people might have thought a few years back. It might be good from regulatory bodies, such as ECs, point of view, as such situation gives them more time to catch us versus risk assessment of nanomaterials. Legislation must be evidence-based, so it is unable to exceed developments, but in this case it may deliver better results than the general public expect.
Definition of a nanomaterial, introducing some significant changes, was published two days before the conference in a form of a recommendation in view of facilitation of its use in direct references in different types of legislation in the future. If it is successful, it would be consequently updated as still there are some areas where data is lacking but, as H. Laursen noted basing on former experience, without any definition in place finding missing information would not be feasible. Next review of the recommendation is scheduled for 2014.
Dr Philippe Martin (EC Directorate-General for Health and Consumers) focused his contribution on EU regulations concerning N&N. He started by elaborating on the following key messages: firstly, handling nanomaterials or nanosystems requires care, hence due diligence needs to be performed; and secondly: the definition of a nanomaterial mentioned earlier is a game-changer. However, in order for it to be successfully implemented, further dialogues with scientists and with the industry are needed, as there are areas where the definition can be applied immediately, while in others it requires a qualifier, e.g. because it does not establish a demarcation line between natural and engineered products.
Having commented on nanoproducts in general, risk assessments aspect along with its three elements subject to examination: exposure, hazard and the combination of those two, Dr Ph. Martin focused on existing or developed regulations applying to cosmetics and food. The first group of products is covered by regulation which includes a definition of a nanomaterial and provisions regarding its obligatory assessment by the scientific Committee for Consumer Safety as well as labelling if one of a product ingredients is nano. In the case of food, there are provisions regarding ingredients in additives and food contact products. Nanoaspects of novel food applications are being discussed (revised after the blockage of a previous proposal).
He concluded his talk by sharing his view that further steps should consist of taking key elements from the definition and applying it to legislation, both current and proposed.
Agata Wnukiewicz-Koz?owska (Chair of Public International and European Law, University of Wroc?aw) concentrated on legal problems of nanotechnologies research on human beings, being closely associated with ethical aspects of such research. She shared her view on main problems connected with the topic of her speech: legal basis for nanoresearch, protection of research subjects and unpredictability of nanotechnology research effects. The way of solving the problem, in her opinion, would be developing and respecting good law. She discussed various possible approaches in this respect: applying ethical rules only, legal rules only, opposing ethical rules to legal rules and, finally, applying both ethical and legal rules at the same time. The last solution she highlighted as the best and the most natural one, as, to her knowledge, currently all legal rules binding in this field are based on ethical rules.
She also elaborated on the role of international organizations in rules by issuing opinions, recommendations and similar instruments which formally are not legally binding, but in practice their legal meaning depend on particular states. For researchers their legal character is not significant, but the situation of research subjects is different, as in the case of damage they might have not the right for compensation. Her suggestion of a possible solution to the problems would consist in the transition from soft into hard law, i.e. translating said recommendations or opinions into general principles like international treaties. However, achieving it would not be easy, since directives, in opposition to regulations, are not directly binding, but need implementation by Member States, and the implementation entails yet more fields of differences amongst the States.
II. Code of Conduct for responsible development of nanosciences and nanotechnologies research and its revision process
In 2004, the Commission adopted the Communication Towards a European Strategy of Nanotechnology in which a safe, integrated and responsible strategy was proposed. In 2005, after an extensive consultation with stakeholders, the EC adopted the Communication from the Commission to the Council, the European Parliament and the Economic and Social Committee Nanosciences and nanotechnologies: An Action plan for Europe 20052009 which defines a series of actions for immediate implementation that should be undertaken by the Commission and the EU Member States in order to develop competitive and safe N&N. It announced an increase in funding for research, infrastructure and human resources development in the field of N&N. Societal dimension was taken into consideration as well. The document states that an essential element of the responsible strategy for N&N is to integrate health, safety and environmental aspects to the development of N&N and to establish an effective dialogue with all stakeholders. It was decided that the implementation of the Action Plan will be monitored and the Commission will report on progress made in this respect every two years. In the first Implementation Report, published in 2007, the EC announced an intention to adopt a voluntary Code of Conduct for N&N.
In February 2008, the European Commission adopted the recommendation for a Code of Conduct for responsible nanosciences and nanotechnologies research which provides principles and guidelines for actions to be taken by the EU Member States in the course of formulation of their N&N strategies, and development of sectoral and institutional research and development standards. It is also recommended that the Member States encourage voluntary adoption of the Code of Conduct by relevant national and regional authorities, employers, research funding bodies, researchers, individuals and CSOs involved in N&N research. The Code is voluntary and there are no authoritative sanctions for failure to adopt it. The Code sets out general principles and guidelines on actions to be taken in order to achieve good governance of N&N research. The recommendation is subject to revisions every two years and the extent to which relevant stakeholders have adopted and applied the Code of Conduct is being monitored.
The Code of Conduct as such and its various aspects was discussed throughout the conference. The following account features two of the most direct and comprehensive references.
Dr Rene von Schomberg (EC DG Research & Innovation, Directorate B: European Research Area) focused in his contribution not only on the philosophy behind the Code of Conduct (CoC), but also on the developed Framework for Research and Innovation. Rules, as he emphasized, can be changed, amended over the time, but the philosophy relates to ideas which need to be implemented in the context. He pointed out that it has to be realized that the Framework, the CoC or any other instruments called soft law cannot be considered as replacement or substitution of legislation, e.g. in the case of its absence. Their idea is to have a different governance model where something can be achieved which would not be achieved by means of legislation. On the other hand, he underlined that legislation will always be needed. Further, he discussed basic goals of this governance model which absolutely could not be achieved by means of legislation:
1. Timely Intervention consisting in inclusive governance, ethics, promotion of pro-active communication and knowledge sharing between all sorts of stakeholders. Legislators have limited power in terms of intervening, as they depend on knowledge and developments in science, industry and society, in some cases, like in the case of nanotechnologies, legislation can be too early or too late.
2. Organising collective responsibility: the code addresses individual researchers, organisations, government bodies and supports various parties to play their roles in the overall system, encourage partnership and facilitate mechanisms for interventions and conflict solving enabling to take up collective responsibility. Effective implementation of CoC requires efficient structure and coordination and regular consultations with MS and stakeholders. It has been done on numerous occasions and generally a positive feedback has been received from CSOs and industry, but at the same time some reluctance can be perceived in MS. Some of their governments expressly referred to the Code implementing activities indicated in the document, but the philosophy behind these activities was not necessarily the same, and without good coordination effectiveness cannot be achieved. Moreover, the Code assigns and allocates tasks and responsibilities beyond governments and makes actors responsible by promoting their involvement.
3. Promoting dialogue and public debate: the Code constitutes an instrument to encourage dialogue amongst policy makers, researchers, industry, ethics committees, civil society organisations and society at large, however, as R. von Schomberg remarked, the dialogue should be linked with policy making. He also underlined the need for permanent deliberation as opposed to one-off exercises.
4. Promoting responsible development by fostering the application of the Precautionary Principle, promoting research on risk and knowledge gaps and promoting research on societal-driven goals (serving sustainable objectives of the Community and Millennium goals).
The Code, also from the point of view of practical aspects of its implementation, was also discussed Dr Elvio Mantovani who noticed that the document itself provides the Member States, individuals, CSOs with guidelines based on general principles, favouring a responsible and open approach to NN research. Its principles include: meaning (comprehensiveness to the public), sustainability (contribution to sustainable development), precaution (anticipation of EHS and ELSA impacts), inclusiveness (participation of stakeholders in the process), excellence (meeting best scientific standards), innovation (encouraging maximum creativity) and accountability (researchers or research organizations are accountable for EHS/ELSA impacts). The Code also provides guidelines how to comply with the principles.
III. Developments in the Member States with reference to the Code of Conduct and problems arising in the process of adoption of the Code of Conduct in the Member States
During the Roundtable with representatives of the EU Member States held as part of the 2nd day of the conference, representatives of several EU MS discussed recent developments concerning the implementation of the Code in their respective countries and the field of nanosciences and nanotechnologies governance in general. Such form of organizing the discussion helped to directly confront and compare various approaches applied by particular states.
UK Prof. Richard Jones (University of Sheffield, Royal Society) informed that 18 months before a governance strategy on nanotechnologies was introduced, but it met with extensive criticism. The successive government has not committed to its implementation. According to him, current approach in the UK was underpinned by a view that nanoscale technologies should be considered on the case-by-case basis given the wide range of materials, processes with diverse properties or applications. Consequently, in the UK nanotechnology increasingly ceases to be regarded as a single field, a useful category or concept for organizing scientific research. Presently there is no national nanotechnologies programme, although much nanotechnology research is conducted and supported. The idea of CoC in this context is problematic, as there is no strong demarcation line of what is nanotechnology and what is not. However, many ideas of the Code are being incorporated for strategies, with particular focus on responsible innovation (projects underway in Research Councils), two-way public engagement (universal and mainstream in the country, RCUK published the Concordat on public engagement which is a condition for receiving public funding for science), and ethics (the Universal Ethical Code for Scientists issued by the government). He emphasized that a lot on responsible research has been learned from nanotechnologies and he shared his observation that perhaps it is time to apply those lessons to other types of innovation.
France Prof. Patrick Gaudray (Director of Research, CNRS; French National Ethics Advisory Committee) presented his Committee, the oldest national ethics committee in the world. It is multidisciplinary, meaning that it is even more concerned with such multidisciplinary fields as nanotechnologies. Apart from the Committees interest, there was a number of initiatives in relative issues in France. One of them was a national dialogue on the environment which resulted in the law of August 2009 calling for complete transparency about everything which deals with the environment. In particular, it stated that manufacture, importation and marketing of nano-scale substances or of materials intended to reject such substances should be the matter of information to the public and to consumers. The provisions became a matter of concern for CCNE, as every time the committee tackled ethical questioning, they met a problem of communicating scientific and medical information. The issue was a subject of an opinion issued by the Committee. Yet another opinion issued by CCNE in 2007 called, similarly to the CoC, for major efforts on standardization issues, on research and development, on nanometrology and on enabling a European law similar to REACH for nanoproducts. The opinion also discussed the lack of fundamental research when compared to its technological counterpart. It concluded that we should not allow nanotechnology to supersede nanoscience. Moreover, it considered that the balance between technological performance, commercial profitability and the perception of potential risks should not mask the ethical dimension of the philosophical man-machine issue raised by nanosystems. Further to the control of engineering, one can find the emergence of the unpredictable, e.g. constructing molecular objects capable of self-assembly or even self-replication.
The nanoscale sciences and technologies were subject of a number of other initiatives. 7 different ministries called for a public debate. One of the examples of such initiatives is the French Agency for Environmental and Occupational Safety which acknowledged a need for a comprehensive analysis of available scientific knowledge, in particular current and future fields in which nanomaterials are or will be used. The Agency considered nanomaterials as being potentially dangerous materials for which the control of risk necessitates the control of exposure.
Germany Prof. Joerg Hasford (IBE, Ludwig-MaximiliansUniversität München, Vice-President of the Permanent Working Party of Research Ethics Committees in Germany) commented on the constitutional situation in his country. Freedom of research is a constitutional right in the country and as such it can only be limited if other fundamental rights, e.g. human dignity, are at risk. In order to mitigate the conflict between two constitutional rights, such as the one mentioned, in the field of medicines and medical devices, the Research Ethics Committee have a legal basis and task that have been specified in the federal law. All paramedical research involving humans must be reviewed beforehand by a competent research ethics committee, one of 53 in Germany. The work of the committees is governed by specific laws and ordinances. Accepted principles of ethical review, such as autonomy and dignity of the research subject, beneficence, non-maliciousness and justice are also applicable to nanotechnologies. However, potential risks need special consideration. As risk of nanoparticles is not sufficiently known, the expected added benefit has to be substantially compared to conventional products. He stated that up to that time extremely few nanomedicines had been approved in Germany (though the situation with nanodiagnostics was a little different). At the same time he admitted that the use of nanoparticles in cosmetics is fairly unlimited and extensive.
As regards the CoC in Germany, in his words the document seemed not to play an important role in the discussion on nanotechnologies. It was not even mentioned in the German Nano-Initiative Action Plan 2015, part of Hi-Tech Strategy 2020. The Code, however, highlights important aspects and its visibility should be improved.
Sweden Prof. Göran Hermerén (Swedish National Council on Medical Ethics, former Chair, European Group on Ethics and New Technologies) noted that despite the CoC urges Member States to provide its dissemination, notably through public research bodies, and ensure that researchers are familiar with its contents, very little had been done in this respect in Sweden. Four ministries (the Ministry of Enterprise, Energy and Communications, Ministry of Education and Research, Ministry of Health and Social Affairs, and Ministry of Environment), had nano-related questions on their agenda, however, none of them made a priority of the implementation of the CoC. As far as agencies are concerned, one of them, the Swedish Chemicals Agency was commissioned to analyse the need for regulations and other measures in the EU and Sweden in order to make a satisfactory assessment of risks posed by nanomaterials to human health and the environment. As a result of its work, the Safe Use of Nanomaterials report was presented to the government in February 2010. Vinnova, the Swedish Governmental Agency for Innovation Systems, also in February 2010 published a report National Strategy for Nanotechnology. However, it contained no ethical analysis of the problem, almost no mention of legitimacy. It focused on innovations useful for society, and the only ethical issue addressed was safety. As a result, the National Council on Medical Ethics issued a critical statement on the report, in which, in line with the CoC, it stresses the importance of inclusive dialogue, also towards future nanoresearch and states that competence in ethics should be included in delegacy for N&N research proposed by Vinnova. Prof. Hermerén also briefly commented on other activities implemented by agencies and scientific societies.
Basing on the Swedish experience, he proposed the following recommendations:
- Inclusive dialogue, replacing one-way information and not limited to the N&N community;
- Application and development of better methods of risk assessment, taking into account current uncertainties and knowledge gaps;
- Ethical aspects of safety and other issues should be considered;
- Ethics of risk and price of precaution need to be studied further.
Outcome of the on-going consultation process is a wish of several stakeholders to revise the Code making it broader and more specific.
Czech Republic Prof. Josef Ku?e (University Centre for Bioethics, Masaryk University) described his pursuit of information concerning the awareness of CoC in Czech researchers. In the first step, he questioned several nanoresearchers, the results proved to be very poor. Next, he searched the Czech National Bibliography. According to the results he obtained, 47 and 183 books mentioned nanotechnologies, 5 of the articles to some extent referred to social and ethical implications of nanotechnologies, although none of publications mentioned the Code. He proceeded with searching several international databases looking for comments by Czech authors bearing any reference to the CoC and found only one presentation included in the NANOCON 2010 conference proceedings. As far as implementation of the Code in the Czech Republic is concerned, to his knowledge no single step was made in this respect on the level of policymaking or legislation. He concluded his presentation with an observation that even in such a vague regulatory framework, some aspects can be regulated by soft law, as in the example of human subject research to which no specific law applies, but it is regulated in such a way that leading research agencies automatically reject any applications to which ethics clearance has not been incorporated.
Italy Daniela Marrani (Italian National Bioethics Committee) presented the position of the Italian National Bioethics Committee (NBC) towards some aspects of nanosciences and nanotechnologies in Italy and the CoC itself. She stated that the implementation of the Code by particular entities is quite difficult to investigate. There are, however, some studies conducted by such actors as AIRI and Nanotec IT. There is no national initiative for nanosciences and nanotechnologies in Italy at the moment, which might be the reason why there is not enough awareness on any N&N governance instruments such as the CoC. Even in the absence of binding regulations and voluntary rules, various entities conduct innovative research on N&N in Italy.
As far as the engagement of NBC in the field of nanosciences and nanotechnologies is concerned, in line with its mandate to address the ethical and legal problems that may arise as a result of the progress in scientific research and technological applications on life, the Committee has been studying the ethical, societal and legal implications of N&N since 2004. It was one of the first national ethics committees to adopt an opinion on the subject it 2006. The opinion contained some ethical recommendations which were highly consistent with the later CoC, as it recommended the consideration of balance between benefits and risks of N&N and future development of such emerging technologies with rationality and moral sense of responsibility, as well as the adoption of a precautionary principle which cannot be perceived as an obstacle in the development of innovative research, but a flexible instrument allowing to adopt risk management measures to case by case risk management.
Finland Dr Janne Nikkinen (University of Helsinki) began his presentation by describing current developments relating to nanotechnologies in Finland, where business of the range of EUR 300 mln (2008) in value specializes in such products as innovative nanomaterials, nanosensors or printed intelligence and atomic layer disposition technologies. FinNANO was a primary tool for funding in the years 20052010 introduced by the Academy of Finland, Finnish Funding Agency for Technology and Innovation (Tekes) and the Ministry of Education. The funding amounted to EUR 70 mln and over 100 R&D projects were involved. FinNANO brought some positive and negative results. The first group included a significant increase of the number of nanotech companies in Finland (from 61 to 202) and of Finnish nanotechnologies review articles (five times).
Nanotechnology Cluster Programme implemented in the years 20112013 is a worldwide network combining 90% of activities, involving 8 regional centres of excellence, providing services to companies, as well as contacts to Finnish stakeholders and information.
Further, Dr Nikkinen discussed the issue of the implementation of the CoC in Finland, where the Finnish Funding Agency for Technology and Innovation requires applicants to note the Code, however, no follow-up or workshops are provided. Further, he commented on remarks obtained in result of a scientific studies and requests for information from key actors, e.g. a note that as far as responsible nanotechnologies are concerned, ELS issues should always be explored, but the ELSA question has been mentioned rarely. The survey also demonstrated that the Finnish Institution for Occupational Health proposed nanosafety for a theme for government programme, but it has not been adopted yet. However, no need for nano-specific legislation was indicated. For the aims of advancing the CoC implementation, he suggested that the following issues need to be discussed: whether the target audience consist of researchers with prior training in research ethics, funding issues (research funding is not applicable, e.g. Nanocluster is designed for funding purposes) and who is required to perform the task (governmental officials are primary interested regulation). In terms of advancing ELSA in Finland, he proposed some future actions to be focused on the public (democs games were in course of translation into Finnish and Swedish), industry (ELSA issues information to be introduced into funding scope), and researchers (CoC events, workshops).
Hungary Dr László Sz?nyi (Semmelweis University, Budapest, Medical Research Council Scientific and Ethical Committee) shared a positive overview of nanotechnologies and CoC-related developments in Hungary. The Code is very well known among researchers who are active in the field. The EC Recommendation almost immediately translated into Hungarian, which facilitates accessing its contents. As far as current situation regarding nanotechnologies in Hungary is concerned, the number of articles has been increasing over the latest period, however, the general publics awareness is not as high and the reason for this, in his opinion, might be the lack of scandal involving nanotechnologies whereas such situation considerably increases general awareness of a subject in question. He also shared some ideas implemented in his country, such as the Nanobus (as a mobile way of providing information on nanosciences and nanotechnologies to students in Hungarian villages) or webpages which meet with high interest. He presented an extensive list of Hungarian universities with either departments or project dealing specifically with nanotechnologies. Also, some events have been held in Hungary, such as the 3-day EuroNanoForum Conference, organized by the National Innovation Office under the Hungarian EU Presidency and supported by EC and the Hungarian National Innovation Fund, gathering 1200 participants from over 50 countries. The nanotechnologies issues are also an interesting subject to students (the example was the Night of Researchers during which the nanotechnologies site proved extremely popular).
Austria Dr Doris Wolfslehner (Austrian Bioethics Commission) briefly commented on the Austrian activities in the discussed field, in particular the Austrian Nanotechnologies Action Plan developed with the participation of all stakeholders and adopted by the Austrian government. However, she focused her contribution on the concepts of responsible research and responsible innovation.
Poland Prof. Jerzy K?tckis presentation, in opposition to those briefed above, was part of Session 1 of the conference. The first part of his contribution was devoted to presenting recent investments implemented in Poland and financed from the European Regional Development Fund. Resources allocated under the ERDF allowed numerous Polish laboratories to achieve nanotechnology standards and permitted the creation of nanotechnology centres which were built or are under construction in many academic cities: Szczecin, Gdansk, Krakow, Rzeszow. Lodz, Gliwice, Poznan or Wroclaw. More details concerning members of consortia or fields of interests were being provided on two facilities which are being built in Warsaw: the Centre for Advanced Materials and Technologies (CEZAMAT) and the Electronic Microsystems and Nanotechonologies for Innovative Technology (MINTE). Moreover, he described the activities and achievements of the Centre of Nanophotonics opened also in Warsaw in January 2011. He discussed some projects implemented by Polish consortia and financed in the framework of the EU Innovative Economy Programme, e.g. NanoMat, NANOBIOM or MNS-DIAG. An Eniac Joint Undertaking-financed Nanoelectronics for Safe, Fuel Efficient and Environment Friendly Automotive Solutions (SE2A) project, involving 20 partners from 7 countries, was also mentioned.
A certain achievement of the Polish nanotechnology, i.e. the detection of Copernicium (Cn) thanks to detectors developed and fabricated in Poland was also discussed, as well as two companies: AMMONO and TopGaN, both international leaders in Gallium Nitride manufacturing (but using different methods).
IV. Recommendations concerning the adoption of the Code of Conduct in the Member States
Recommendations, or simply suggestions in the form of personal opinions, mostly concerning the Code, its drawbacks, amendments leading to the improvement of the document and the scope of its implementation, were presented on numerous occasions during the conference by most speakers. There seemed to be a common view that the Code of Conduct, despite of its drawbacks or limitations which were discussed during the event (unclear language, unspecified target audience, excessive complexity), and a need of its review, is a right tool to address the issues it is designed for, i.e. form the basis for further discussion, and to implement its 7 principles, the philosophy behind which did not raise doubts either. At the same time, however, the Code cannot be regarded as a substitution for legislation, but it plays a complementary role to hard law instruments.
The recommendations can be summarized within Dr Elvio Mantovanis points concluding his presentation on the NanoCode project, constituting comments as regards the future path for the Code developed as the project outcomes:
- The Code should be easy, simple, format should be short;
- Awareness raising tool (it should remain voluntary);
- Systematic approach is needed more than specific guidance (process rather than result);
- General code to be complemented by sector codes/assistance tools;
- Code extended to research in general / innovation;
- Process that can become, in the long run, a standard;
- Establish well defined responsibilities and commitments at institutional level;
- Extend beyond Europe;
- Code Meter as an instrument for self-assessing the compliance with the Code, but also for promoting the engagement with the Code for company activities;
- A learning tool for raising awareness on responsible innovation.
The form of the Code itself, indicated by the above mentioned project, can be either a reference document, a voluntary standard or even an international code on responsible research and innovation.
It was agreed that the Code needs revision which has to take into consideration the following issues: role/scope, contents and implementation. The following recommendations in this respect were formulated. There is a need for:
- Clarifying the strategic role and scope of the Code;
- Resolving contents-related and structural issues;
- Establishing a framework/instruments for implementation and monitoring;
- Providing tools to evaluate the compliance with the Code principles and this task is addressed by the developed Master Plan and Code Meter tools.
V. Projects concerning the Code of Conduct, governance and ethics in N&N
Along with the rapid development of nanosciences and nanotechnologies, in view of their comprehensiveness and relative ambiguity, a number of projects regarding various aspects of N&N have been implemented, both EU- and state- or-business-funded. The Nanoethics 2011 created an opportunity to summarize the initiatives and discuss the assumptions and outcomes, often drafted also in the form of recommendations, of the following projects:
1. NANOPLAT: Development of a Platform for Deliberative Processes on Nanotechnology in the European Consumer Market
Eivind Stø (National Institute for Consumer Research, Norway), the project coordinator, presented Nanoplat, a project implemented under the EC 7FP Science in Society Programme in 20082009. The aim of Nanoplat was to review deliberative processes (understood as free, reasoned discourse of equal participants generally leading to a rational motivated consensus) taking place in Europe. The project resulted in conclusions that deliberative processes in nanotechnologies are driven by a wide spectrum of organization (academia, public authorities etc.) and that they are enacted for different purposes: identification and assessment of public attitudes, experimenting with a new form of public dialogue in order to learn about its potentials and shortcomings and informing of specific decision. Three main conclusions resulted from the project: consumer products are not often at the focus of deliberative processes, the organization of these processes is costly and takes different forms of various lengths, and that participation of ordinary people, not necessarily experts, seems to be possible and bring about good results.
In the further part of his talk he commented on common arguments against deliberative processes:
- New processes do not create more knowledge;
- Increased use of the processes leads to higher public expectations which are not met;
- They constitute a threat to the numerical democracy.
website: www.nanoplat.org
2. NANOTRUST: Dr Andre Gazsó from the Austrian Academy of Sciences depicted the NanoTrust project, a solution applied by the Austrian Academy of Sciences. It is funded by the Ministry of Transportation, Innovation and Technology, and was initially scheduled for 3 years, but then prolonged for the next 3 years, until September 2013. In is executed by an interdisciplinary 4-person team and external contractors commissioned with specific tasks. Goals of the project comprise two main areas: firstly, to survey, collect, analyse and summarize information on environmental, health and security topics relating to nanotechnologies, and secondly: to serve as promoter of discussion by organizing workshops, networking activities. NanoTrust dissemination activities also include online publication of the NanoTrust Dossiers, short summaries on recent state of knowledge on topics selected according to the high information demand, controversy criteria, addressed to a broad spectrum of interested audience and publicly available in English on the project website.
website: http://nanotrust.ac.at/nano.ita.en/index.html
3. RISKBRIDGE: Building robust, integrative inter-disciplinary governance models for emerging and existing risks, 20062009,
Mario Willems, as a member of the project staff, discussed RiskBridge, a coordinative action aimed to develop an integrative approach to risk governance, to make bridges between different cases (called riskfields). 6 riskfields have been identified for the aims of the project, for each one a particular organization was responsible and groups were nominated. Each riskfield was rated in terms of complexity and agreement on risk governance approach and consequently framed into a diagram. Nanotechnology was one of the fields and because of low agreement on the method of risk assessment and high complexity as new and enabling technology it was identified as being in a difficult position.
In course of the process, a need for a tool fostering the creation of a common language became apparent, and as a result the Framework for Policy Learning was drafted. It contained a list of aspects that need to be taken into account when comparing different riskfields. They included the following issues: is the problem global or local (where does the risk originate, where does it have impact, on what level it is dealt with), the history of the risk controversy (events which had a profound impact in the past), distribution of risk and benefits, level of uncertainty or ambiguity, information on the process (how the participation is organized and is it open for all stakeholders), institutionalization and how the success of risk governance can be defined.
M. Willems commented on the chief outcomes with respect to the Framework of the nanotechnology group: comparing to stem cells, for example, not much controversy was associated with this field in the past. As nanotechnology is an emerging technology, rather deep uncertainty can be considered than quantifiable risk, and the impact on human health and environment was in general unknown. He noted that although the project ended in 2011 and now much is being done in nanotechnologies, the situation has not changed significantly. As far as participation is concerned, there was a common consensus that it is imperative to organize stakeholder involvement and citizen participation in the process in order to avoid scepticism. However, nanotechnologies seem to be a too narrow and at the same time too broad subject for a debate.
He discussed common features which have been identified in all riskfields, including nanotechnology:
- Limited capability to understand and quantify risks;
- R&D can fill some knowledge gaps, but create new ones;
- Generally there are no established standards (or they are not complete, lagging etc.) for risk assessment;
- Multiple Framings: perspectives/values/Truths can coexist;
- Policy makers challenge: take decisions even if not all facts are known.
web site: www.riskbridge.eu
4. NANOCOMMISSION
Wolf-Michael Catenhusen in 2006 was selected by the German government chairman of a newly created national stakeholders dialogue called NanoCommission. The Commission integrated stakeholders originating from the civil society, consumer and environmental organizations, industry, science and representatives from several governments. The aim of the project was to take an opportunity of that time to develop a culture of innovation rooted in the Precautionary Principle. The process, in his opinion, was unique, as it was the first dialogue initiated in order not to end an existing conflict as it had been the case in the past, but started in an early stage before potential grounds for conflicts were realized. He noted that this was a chance for the process, as conflict-based dialogues often fail, while initiating dialogue in such an early stage that many stakeholders even have not taken a specific position yet is a different situation. The dialogue lasted four years and would be replaced by other tools. It brought significant results, some of which were discussed, e.g.:
- Remarkable progress was made in serious knowledge-based and effective communication between the industry, science, ministries, governmental agencies and stakeholders in the civil society;
- Consensus was made on five principles for responsible use of nanomaterials to be implemented by industry. He admitted that although they are only self-binding, voluntary principles, but they are important as commitments were made on the manner of evaluation which makes the process transparent.
- First steps were taken to develop tools for risk prevention;
- Guidelines for preliminary benefit/risk assessment for nanomaterials at early stage of development were prepared.
W. M. Catenhusen shared his opinion that stakeholder dialogue is a supplement to representative democracy in the innovation process as it can be helpful in identifying social needs, benefits, recommending ways and priorities in closing information gaps in risk assessment and can make contribution helping to concentrate political discussions on concrete options for decision. However, he emphasized that dialogue cannot replace political decision-making process, in particular within regulation, with consensus amongst stakeholders. At the same time he admitted that the influence of NanoCommission outcomes on the decision-making process was significant.
5. NANOCAP: Nanotechnology Capacity Building NGOs
Pieter van Broekhuizen (IVAM UvA BV, Netherlands), the project coordinator, discussed the Nanocap project implemented for the EC in the years 20062009, aimed at involving NGOs and trade unions in the nano-debate. The University of Amsterdam was the coordinator of the project and its participants included 5 trade unions, 5 environmental organizations and 5 universities. Activities comprised capacity building within civil society organizations (occupational health, environment and ethics) and developing well balanced positions in the nano-debate, which not necessarily had to be shared by all participants, but within their respective groups of interests (e.g. common resolution of trade unions). Instruments applied in order to achieve respective goals included visiting companies manufacturing and using nanomaterials, discussing with national and European authorities, implementing awareness campaigns, participating in consultative and deliberative bodies, executing actions plans, issuing nano-positioning statements and nano-resolutions and, finally, organizing a conference in cooperation with STOA and the European Parliament.
The debate focused on the following issues which were identified as problems to deliberate:
- Dealing with scientific uncertainties needs special attention;
- How to make the precautionary principle operational for health and the environment;
- Precaution is not equivalent to prevention as it deals with unknown risks and thus needs to go further in terms of measures;
- Putting responsibilities on the right actor here he underlined that a recent change of paradigm needs to be taken into consideration, in particular in the chemical sector, consisting in the guilty unless proven innocent rule being applied instead of the former, innocent unless proven guilty, one;
- Critical assessment of the actual performance of products.
He summarized CSOs nano demands organized in this project focusing on the precautionary approach and consisting of four elements:
1. Risk Assessment Emission Control: no data no exposure and no data no emission. He pointed out, however, that the type of data needs to be taken into account. Many standardized tests provided for in REACH under the no data no market principle apply to soluble substances, and therefore not to nanomaterials, whereas with the no data no exposure principle the situation is different, as the data demanded under it include the question of toxicity for non-soluble particles which might need different tests and does not depend on the market volume or registration. Identified need for nano reference values as a kind risk management tools was also discussed.
2. Pre-market approval involving the questions of the adaptation of REACH to nanoproducts (three groups worked on three different aspects: substance identification, information requirement and hazard and exposure assessment).
3. Transparent communication referring to the traceability of MNM (Marketed Nano Materials) in products, known and unknown risks and MSDS information.
4. Proactive registration involving the registration of exposed workers and an early warning system.
He finished his speech by briefly elaborating on the following conclusions developed under the project:
- Stakeholders interest may be hidden even in the smallest details;
- Participation of civil society organizations in the public dialogue and deliberative circuits is essential for the acceptance of nano;
- Mobilization of facilities for capacity building of CSOs is essential;
- Privatizing workers regulations has its limits;
- Traceability is the following hurdle to take into nano regulations.
coordinator: Peter van Broekhuizen (IVAM UvA BV, Netherlands)
web site: www.nanocap.eu
5. Learning communications lessons from GM, Asbestos and other techno-disasters
Hilary Sutcliffe (Director of MATTER) presented a business-funded project called Learning communications lessons from GM, Asbestos and other techno-disasters. The objective of the project was to help businesses understand what the public and other stakeholders expect from them in terms of the engagement in communications, what are the needs of information from the part of the public about the business use of new technologies, in particular nanotechnologies. Phase Two of the project consisted in the creation of two tools to help companies respond to stakeholders expectations, and Part Three involved the assessment of the tools by both companies and other stakeholders.
Public opinions have been examined on the basis of a review of over 20 dialogues and research projects in the fields of nanotechnologies, synthetic biology and stem cell research in the UK, the US and Europe. Conclusions show that there are three main needs of the public towards the companies:
1. More openness, better explanations and not hiding problematic issues: information is required as regards when and why nanotechnologies is used. She agrees that it is not a question of knowing everything on everything, but in some circumstances, such as nanotechnologies with which uncertainties and opposing voices in the society are associated, the public have the right to access the information if they need them.
H. Sutcliffe briefly presented the Nano&Me project, consisting of a website sponsored by the UK government and developed around 4 years before as a way of providing basis for accessible public information on nanotechnologies divided into various sections, such as: products, regulations, safety, etc. However, that was a pilot project only and although it has not received further funding, the website still records ca. 10,000 hits monthly, which indicates the need for such solutions. She also mentioned some other examples of outreach initiatives of bringing life debates and giving helpful information, such as Nanopodium, the German NanoCommission, EC Nanochannels.
2. Information on the reasons for pursuing nanotechnologies, a clearer picture about the benefits for people or for the environment, as well as on what problems are being solved or how does it improve on existing solutions. The public also have doubts regarding the comprehensiveness of information and if all possible issues have been considered.
3. Information on who would be held liable when there is a problem (she emphasized that the question specifically was when, and not if, since the public understand the risks connected with innovativeness and do not regard them as a particular issue, but need to have information on accountability and liability as well as on recovery measures). More importance is obviously attached to safety concerns as regards the technology as such, not particular consumer products. The public need independent reassurance by entities whom they trust.
As regards other stakeholders, they expressed concerns that there are companies using technologies in secret, and nanotechnology products are being forced into the society making them impossible to make informed choices.
However, at the same time all dialogues show genuine support for products where benefit is clear, safety and efficacy proven, and meaningful information available.
The following conclusions for companies have been drawn:
- The product needs to be demonstrated, not hidden;
- Support should be provided to independent public information websites;
- Robust benefit and risk assessments should be implemented;
- Independent assessments should be applied to support internal results;
- Innovative ways of communication should be applied;
- A richer picture why it is a good idea should be provided;
- The actual development process should be demonstrated;
- Communication across the supply chain should be maintained;
- Transparent recognized governance mechanism should be adopted (e.g. pursuant Stakeholder Engagement Standard AA 100 SES);
- Toxicological data should be shared;
- Stakeholders should be engaged (understand, involve, collaborate).
She concluded her contribution saying that one should not understand communication as PR only. Transparency from governments and business is critical.
6. DEEPEN: Deepening Ethical Engagement and Participation with Emerging Nanotechnologies
The DEEPEN project was presented by Dr Mathew B. Kearnes from the Durham University who at the last moment substituted the project coordinator, Prof. Phil MacNaghten, in his capacity as the Nanoethics speaker. The initiative was implemented in the years 20062009 under the EC Science in Society Programme and was a cross-European, interdisciplinary (combining different disciplines from the social sciences and humanities) initiative aiming at addressing the question on how to understand latent public opinion in a situation of a challenge where: the technology is unfamiliar, largely about future promises and fears, uncanny, poses certain risks and rests a methaphysical research programme that has broadly shared visions of controlling and manipulating matter at atomic and molecular scales. Response to the challenge was to be provided by in-depth public discussion groups and, in Phase 2, staged performances and stranger and constituted groups (in the UK and Portugal).
The following results were obtained it terms of characterizing public attitudes:
- Ambivalence, leading to collective doubt after discussion and connected to the impossibility of separating risks and benefits;
- No clear distinction across gender, class, lifestage;
- Nanotechnologies as intensifying existing concerns and hopes;
- Ethical positions are not straightforward, but dilemmatic.
M. Kearnes discussed some positive attitudes observed entailing excitement concerning nanotechnology benefits already mentioned during the conference, such as potential applications in medicine. However, he focused on concerns revealed in the project and relating to the effects on what it means to be human, including a focus on superficial qualities, a possible loss of personal identity, potential dual use danger, worries of excessive hype. The chief concern in his opinion, which was elaborated in details, was connected with a sense of impending disaster connected to a general conviction that a technology project is always doomed to fail in some respect. It results from narratives (meaning arche stories rooted so deeply in the society that they do not need footnotes) of technoscientific failure such as: the kept in the dark, the rich get richer, the Pandora Box, the messing with nature and the be careful what you wish for narratives. Consequently, such approach poses a question for governance to understand the conditions under which people envision nanotechnology to fail and entails some implications for responsible innovations forcing it to regard unforeseen, inevitable consequences resulting from the technology with higher care and attentiveness.
In the end, he shared the following conclusions of the project:
1. The promise of responsible innovation in European research policy is a way for science to reflexively engage with its indirect effects;
2. Over the last 5 years nanotechnology has been a site where these debates have been playing out in Europe (however, he noted, not the only site);
3. DEEPEN provides compelling evidence that citizens across Europe are profoundly pessimistic about nanotechnologies (but the feeling mixes with a sense of hope);
4. Policy needs to engage with public categories such as: nature, finitude, limits, it requires experimentation and reflexivity, dangers of playing God and dangers of false humility;
5. Responsible innovation provides an opportunity to reshape research agendas in such a way that they resonate with European values and contribute to the public good.
web site: www.geography.dur.acuk/projects/deepen/Home
6. NANOSOC Nanotechnologies for tomorrows society
Professor Lieve Goorden presented the project Nanotechnologies for tomorrows society funded by the Flemish government and implemented in close cooperation of social scientists from the Universities of Antwerp and Leuven on the one hand, and nanoscientists from the University of Antwerp and the Nanoelectronic Research Institute (IMEC) on the other. As part of the project, a stakeholders forum was organized, 36 organizations from various backgrounds were invited to take part in this one-day event to discuss with nanoscientists on the potential for nanotechnologies in the future. The main message of the forum was: how to tune research agendas to public expectations? However, at the same time a paradox was observed as there was noticeable reluctance from the side of the scientists to answer questions concerning their research agenda. They were willing to discuss present developments, but not to talk about future plans or ambitions. As a result, the following three constraints for an adequate communication about research agendas along with possible answers to them were identified:
a. Progress of technosciences follows a technology-driven and open agenda. The agenda of technosciences is open, which means that in opposition to traditional, fundamental or applied approaches it is not easy to define, and, consequently, talk about, a clear objective. In order to deal with the constraint, research planning should do justice to the open future of the technosciences recognizing that research plans never include objective projections of the future, they are not neutral, but reflect interests, expectations of authors. It can be done by a gradual matching of dreams circulating in society with available capacities needed for their realization and adjusting technical capacities to the realization of dreams.
b. Scientists are threatened to get trapped in a global race to complexity and keeping balance between creating more complexity and controlling it, while there is a gap between knowing things and understanding them. Scientists find it difficult to communicate about complexity and uncertainties and it nourishes a defensive communication strategy. Research planning to deal with this issue should recognize that predictions of future risks and benefits can never be adequate and are always preliminary, so there might be an option to explore already on this stage of building agenda alternative, parallel research paths in terms of the selection of technological solutions, target groups etc., which then can be assessed from different angles (i.e. scientific, technical, ethical feasibility, social usability).
c. Absence of a moral horizon in society for judging scientific progress, as in a modern liberal democracy there are no forums enabling public reflection on the good life in a hi-tech society and everyone is forced to make their own choices in this respect. That is why controversies on emerging technologies will not easily obtain the status of public debate, but they will be more and more a rule that exemption. A possible way of addressing this constraint would be inviting outsiders to the dialogue already on the stage of research planning to ensure timely orchestration of roles and actions.
The manner in which the technosciences progress complicated a debate between science and society entails the need of new practices of research programming, better suited to the changing situation.
7. NANOPODIUM
Dr Christien Enzing (Technopolis Group, Amsterdam), introducing the Nanopodium initiative, briefly described developments in the Netherlands which contributed to its creation. The nanotechnologies issues started to be addressed in the country as early as in 2004, since from this year the Rathenau Institute had been conducting a number of studies and small debates on the impacts of nanotechnologies. In 2008 the Institute published Ten lessons for a public debate on nanotechnologies postulating the separation between debates on risks from the one concerned with ethical, social, legal, economic aspects in a broader sense. The Dutch government took into consideration the lessons while facilitating, under the National Action Plan for nanotechnologies issued in 2008, the Committee Societal Dialogue Nanotechnology comprising 9 members from academia and industry, however without the involvement of NGOs, whose tasks included preparing agenda for the dialogue and stimulating it. The Committee applied a bottom-up approach avoiding being directly engaged in the debate and encouraging stakeholders to initiate and organize respective activities. Nanopodium was created in March 2009 with budget amounting to EUR 4.5 mln provided by the government. Following consultations with stakeholders, in late 2009 two calls for proposals were launched, while the first one was more information-focused, and the second more debate-oriented. Altogether, 35 projects were selected out of 140 (16 publications, TV programmes, YouTube projects, teaching materials for secondary schools development; 3 exhibitions or artists impressions; and 16 debates). As part of Nanopodium, also public knowledge and attitudes were measured twice, in August 2009 and November 2010. The online surveys demonstrated that knowledge of the existence and the essence of nanotechnologies have significantly improved in the course of the initiative (64% vs. 54% and 36% vs. 30% respectively), however, most citizens still had only a vague concept on nanotechnologies.
All projects coordinators were required to submit reports addressing main issues discussed, the ways of conducting discussions, what were the opinions and concerns of stakeholders. The Committee, basing on these reports, summarized the nano-dialogue and drew conclusions. The main message was: nanotechnologies research can be continued, but in the responsible manner. Specific outcomes regarding particular topic of interest such as health, food, privacy, environment and economy were also summarized. Recommendations drawn were as follow: in fields of interests, citizens should be kept informed about nanotechnologies and their applications, and openness about risks is an important prerequisite for a meaningful dialogue. Recommendations also applied to the types of activities: teaching materials for young people, providing information should be combined with activities aimed at opinion forming and exchange of opinions, artist projects are a very good channel of communication and dialogues should be organized in the form of small-scale meetings, and not Internet panels. Conditions for effective dialogue have also been identified: it should focus on nanoproducts, and not nanotechnologies in general, vignettes (small stories about future products) are good tools of information about soft impacts of nanotechnologies, and in order for the dialogue to be rich in opinions, participants with different values orientations, but at certain balance in terms of types of stakes, should be involved. Asked in a discussion following the session for which stakeholders the project proved to be most beneficial she shared her opinion that for companies and researchers developing nanoproducts, as they were provided with a current overview of attitudes in the general public.
NANOCODE: a multi-stakeholder dialogue providing inputs to implement the European Code of Conduct for Responsible Nanosciences & Nanotechnologies Research
Dr Elvio Mantovani (AIRI / Nanotec IT Italian Centre for Nanotechnology) presented the Nanocode project, a dialogue about EC CoC involving researchers, business people, CSOs, institutions providing inputs/suggestions that can favour/promote the adoption of the Code, which was started in January 2010 and finished in November 2011. Its participants involved 11 partners from 11 countries (8 from EU along with Argentina, South Africa and South Korea). Its objective was to develop a framework (Master Plan) enabling the successful integration and implementation of the Code at the European level (and beyond EU) and a tool (Code Meter) to (self) evaluate the compliance with it. First step consisted in the evaluation in European countries and some countries outside the continent of what is going on as regards the code or similar instruments, or in the aspects of responsible innovation in general. Then, stakeholder consultations in all participating countries were carried out in order to verify attitudes of stakeholders (civil society, institutions, business, research) towards the Code. This step resulted in the development of 11 country reports and a synthesis report. Pros and cons of the Code were identified in course of the process. The pros include the following aspects: there were unambiguous agreement on the 7 Principles, and the Code was perceived as an appropriate tool to implement them, the Code can be an early warning system to address EHS and ELSA problems and can encourage dialogue amongst stakeholders. As far as cons are considered, the following problems were recognized: some principles and guidelines were perceived as too general, there is an ambiguity of the meaning of some principles, which puts in question their acceptability, the Code was seen as interfering with national initiatives or policies (here the notion of accountability was the most significant issue, as it can be associated to legal liability), as another level of bureaucracy, lack of clear benefits and incentives for the adoption, as well as on adequate communication / endorsement on institutional level were also pointed out.
The Code Meter refers to the operational level and comprises methodological and practical issues of how to engage with the Code principles and guidelines and includes a set of normalized questions. Scores, depending on answers, are graphically visualised in the form of a 7-arm spider web. Master Plan, on the other hand, concerns strategic level and includes recommendations for changes of the CoC and its further implementation and integration in the political context. During the process of developing the Code Meter and the Master Plan some recommendations were prepared in order to make it more acceptable, more easily adopted. They were focused around the following issues: execution of the Code, clarifying the process, structure and language, awareness/dissemination, incentives/disincentives. The first draft of the tools was presented at national workshops in partners countries, the second one during an international conference in September 2011. Inputs provided by the events demonstrated consensus on the recommendations, especially as far as structure and language are concerned, generally perceived the weakest points of the Code.
web site: www.nanocode.eu
VI. Overview of current developments in the field of N&N
The conference evidenced a generally recognized specifics of nanosciences and nanotechnologies, i.e. that, in opposition to other technologies, the domain is not localized in one particular technology area, but it constitutes a cross-disciplinary field relating to all kinds of existing technologies, including medicine, environmental issues , etc. and should be regarded rather as an approach to research, that a field on its own. During the Nanoethics 2011 conference, more details concerning the N&N applications to IT, material sciences and medicine were presented.
Prof. Ehrenfried Zschech (Fraunhofer Institute for Non-Destructive Testing IZFP, Dresden) Nanomaterials for information technology challenges to materials science and engineering
Professor Ehrenfried Zschech focused his speech on three main points:
1. At the moment we are at the point where hard nanotechnology meets soft nanotechnology. It particularly concerns the performance of artificial computers which is, at least in some parameters, equivalent to the performance of human brain. He reminded the audience of the IBMs Watson computer system which in March 2011 for the first time in history outperformed the human brain, but consumed 10,000 more energy than the organ over the same period of time. Hence, the increase of efficiency and reduction of power loss is a challenge microelectronics is currently facing.
2. Hard nanotechnology is existing in the global IT industry and it has to be made clear that this industry will go ahead, even if the effects of nanostructures are not fully understood. This is why, he emphasised, such meetings are very important to demonstrate the effects of nanotechnology and he expressed the opinion that the industry would appreciate it.
3. Microelectronics is a driving industry for leading edge analytical techniques in nanotechnology. Forces nanoanalysis to be standardized and to have a standardized metrology. He admitted, concluding his talk, that, in his opinion, the next two decades in IT/microelectronics are the decades of materials science and engineering, which stresses the need to characterize nanostructures and nanoparticles and to validate respective models.
Prof. Krzysztof J. Kurzyd?owski (Warsaw University of Technology) Subtle balance: opportunities and threats related to the development of nano-technologies
Professor Krzysztof J. Kurzyd?owski focused his contribution on nanomaterials. While beginning his speech, he emphasized that some nanomaterials do not involve any risk, in particular to biological species, which concerns agglomerates, such as nanometals. He briefly commented on opportunities brought about by nanotechnologies, such as considerable improvement of the properties of materials (relating to strength, magnetic, electric conductivity, optoelectronics, corrosion resistance, friction and wear, melting point depression or altered phase equilibrium), as well as on the more and more wide use of nanomaterials. He also enumerated potential benefits concerning: materials (light as plastic, strong as steel), water (clean water any time, any place), medicines (smart drugs killing the disease, not patient) or energy (PowerPlastic to convert light into energy).
The second part of the speech was devoted to potential risks associated with the use of nanomaterials divided into two categories: the first one concerning possible adverse effects of nanomaterials on living species (they can be more reactive and possibly more toxic, there is no natural barrier to prevent the penetration of nanoparticles into the body and once inside, they can travel more easily though the body), which are of interest to medical doctors. He focused on the second, non-medical category of potential risks including:
- Unknown long-term properties of nanomaterials which are potentially subject to changes in microstructure upon exposure to normal in-service conditions such as temperature, loads, chemical interactions;
- Undeveloped methods of re-use / recycling (in many countries required by law), where the major challenge is the separation of nano from standard composites;
- Economic aspects leading to i.e. possible exclusion of SMEs, as nanotechnologies require access to relatively expensive infrastructure, which puts bigger companies with larger resources in a favourable position in terms of competition. An answer to this problem can be provided e.g. by a solution mentioned by Professor Kurzyd?owski in a discussion which followed the presentation, implemented by the Warsaw University of Technology and consisting in providing SMEs with a system of open access to infrastructure as long as they can satisfactory justify the intended research;
- Unfriendly attitude of general public according to him, people tend to overestimate the risks related to the agents defying recognition through senses. He enumerated three major areas of concern: environment, health, as well as ethics and society (where possibilities of nanotechnologies can significantly broaden the gap between rich and poor countries).
In conclusion he emphasized that nanotechnology provides enormous opportunities, however, at the same time it requires a thoughtful intervention of states which should help to reduce the risks and assist the advancement of nano-based solutions. He also pointed out that discussing risks can help to minimize them.
Prof. Aleksander P. Mazurek (Medical University of Warsaw) Nanotechnology in medicine scientific and ethical issues
Professor Aleksander P. Mazurek, having briefly commented on the history of the development of nanosciences and nanotechnologies, emphasized that nanomaterials, apart from various applications, are particularly desirable in medicine. Three major areas for the use of nanomaterials in medicinal products were listed and elaborated in details:
- Drug delivery systems and modified release formulations;
- Diagnostics;
- Structures in regenerative medicine.
Professor Mazurek also provided examples of particular nanoscale materials finding their application in medicine (such as dendrimers, magnetic nanoparticles, nanocrystals, or nanobombs novel way of fighting cancer, still under investigation), as well as already registered nanomedicines used in treatment, in particular in oncology.
He also devoted a part of his speech to discussing initiatives undertaken by the European Medicines Agency as far as nanotechnology development in concerned (Reflection Paper of 29 June 2006 on nano-based medicinal products; a meeting on nanomedicines in 2009 and an international scientific workshop on nanomedicines, gathering 200 participants from 27 countries).
He concluded his contribution with the following recommendations:
1. Translational activity from nanoscience to nanomedicine should be enhanced;
2. Toxicological hazard and acceptance criteria from ethical perspective should be set up;
3. Risk / benefit ratio for nanomedicine applications should be quantified and regulated;
4. Nanoscience and nanotechnology achievements in medicine should be balanced;
5. Worldwide regulatory framework for nanomedicine should be formed as there is an obvious lack (e.g. there is no clear protocol for clinical trials involving nanoproducts).
Based on the above section, it should be underlined that the Nanoethics 2011 project met its main objectives and constitutes a basis for further developments in the respective area. As in the case of similar projects, the impact is not directly visible and cannot be measured, but is to be reflected in the improvement of general knowledge in the field of N&N, clarification of ambiguous areas, recognition of differences of opinions, which should form basis for future actions enabling to overcome problematic issues and to ensure the continuation of wide-ranging dialogue within the society.
Potential Impact:
The following section shall constitute an abbreviated overview of expressed, confronted, discussed and summarized opinions of representatives of different stakeholder groups relating to socio-economic aspects of nanosciences and nanotechnologies. Again, the nature of the project makes it impossible to point on its directly visible impact on the society or economy. However, the participation of various stakeholders in the conference, such as representatives of science, regulatory bodies, NGOs and business facilitated discussions encompassing social and economic concerns, needs and expectations, as well as such notions as responsibility, liability and social dialogue, in a comprehensive manner. Identification of common and split views perhaps may not cause immediate effects, but, in a longer perspective, only broad, cross-societal opinion-sharing can lead to developing an accurate assessment of current status of the problem and to agreeing upon, acceptable to all interested parties, solutions. The Nanoethics 2011 project, by providing an opportunity to confronting different positions, can be considered as only one of many, but needed, step in this direction.
Moreover, because of the high ambiguity accompanying new technologies, an nanotechnologies in particular, where rather strongly voiced doubts are associated with insufficient knowledge, in order for the field to gain more recognition within the society consisting of consumers, the need for awareness raising and education activities towards the general public and for conducting an inclusive dialogue was emphasized and generally agreed upon by the conference participants.
The following part features an account of contributions of selected stakeholders: regulators, scientists, business and CSO representatives.
Prof. Elke Anklam (EC Joint Research Centre, Institute for Health and Consumers Protection) Connecting science and policy to bolster innovation and nanotechnology acceptance among consumers
Professor E. Anklam focused her presentation on the need of bringing science and policy more closely together to make best use of the emerging nanotechnologies and to ensure that they are better accepted among consumers. She underlined that nanotechnology has a great potential, at the same time, however, it poses a serious challenge, as innovative products on the market may not necessarily find acceptance amongst consumers. She expressed her opinion that consumers nowadays are more and more critical, have higher expectations, in particular concerning safety. She enumerated prerequisites for consumers acceptance (transparency of knowledge transfer from key players, translational science, harmonization and standardization, ethical and value for money aspects), while emphasizing safety by design as the most important.
Prof. Richard A.L. Jones (University of Sheffield) The UK experience of public engagement and nanotechnology: what have we learned?
Professor Richard Jones began by discussing the assumptions of the Ethical, legal, social aspects (ELSA) research which involve multidimensional and multidisciplinary approach to such questions as public attitudes and engagement, governance and institutional structures in the framework of which science is done and regulated, science studies (hidden assumptions and visions of science at work), as well as two points generally not considered part of ELSA which are: innovation theories (while they deserve a more nuanced view, as some technologies advance much faster that others) and toxicology and ecotoxicology. He commented on the benefit of society which is the point of the ELSA research adding at the same time his opinion that also science and agencies to which science findings have to be delivered can largely benefit from it, as reflexive science can improve and recommendations can be helpful to moderate the way science goes, while agencies can produce better science policy when informed of societal context.
Concluding his contribution, he expressed his personal opinion as regards responsible research issues. Responsible nanoscience, in his opinion, does not depend totally on responsible nanoscientists. He pointed out that researchers work in constrained circumstances within their institutions environments, a company or a government research laboratory. A problem with codes of conduct is that they are, in his opinion, focused on individuals. The problem arises with the principle of accountability: how to divide responsibility between individual researchers and institutions they work for and they are funded by; moreover, how to divide responsibility between scientists who work on original research and institutions or people who develop and market, often in a way which could not be anticipated, technologies based on their work. The need to concentrate just as much on making responsible institutions as responsible scientists, in his view, is crucial.
Dr Rene von Schomberg (EC DG Research & Innovation, Directorate B: European Research Area) Responsible research and innovation: the case of nanosciences and nanotechnologies
Dr Rene von Schomberg began his attempt to conceptualize the notion of responsible research and innovation and to specify it to nanotechnology from describing the background. In the mid-2000s under the EC Science in Society Programme, a deliberative approach to nanotechnology was started. A couple of projects were implemented involving at least two elements: 1. Public engagement in research and technology development in order to address societal issues. The projects resulted in quite influential outcomes: an observation that all public engagements are beneficial, however, a general lack of feedback to policy can be noted as they were rather of one-off nature. Conclusion was drawn that there is a need of an ongoing monitoring of public debate. 2. Understanding innovation as a process is too limited and has to be improved in order to successfully address the issue. Findings from the projects formed part of the later framework for innovative research.
A question on which values should be taken into consideration when assessing research was then discussed. Basing on the Treaty on the European Union, the following fundamental objectives to address societal needs can be distinguished: sustainable development, full employment and social progress, high level of protection, and the quality of environment. Consequently, they all should be considered as legitimate basis in attempts to redirect research to societal needs. All EU policies are based on these fundamental values, however, as far as research is concerned, not quite consistently yet. Consequently, a challenge and task for the framework is a programme helping to address normative anchor points derived from the Treaty:
- Promotion of scientific and technological advance;
- Promotion of social justice, equality of women and men, solidarity, fundamental rights;
- Quality of life, high level of protection, human health and environment;
- Sustainable development;
- Competitive social market economy.
Dr Jorge Costa David (EC DG Employment, Social Affairs and Inclusion) Nanomaterials risks to workers and workplace regulatory strategies
Dr Jorge Costa David began his presentation with an observation that in the particular field of nanotechnology some terminology can have different meaning to different people. He commented on the legislation dividing it, quoting the document mentioned earlier by Professor Elke Anklam, into horizontal (general in terms of its goals and addressed situations) in opposition to vertical (specific pieces of legislation, e.g. referring to a particular sector) one. As an example of the horizontal legislation he mentioned the Framework Directive on Health and Safety at Work. It contains provisions concerning both employers and workers obligations aiming at ensuring protection against potential risks which might be encountered at a workplace. They are of general nature, i.e. they are applicable to any sector, including nanotechnologies. However, in his opinion performing employers obligations consisting of providing proper information, training and risk assessment in a situation of the relevant lack of data in the field resembles taking measures in a vacuum of information and renders it impossible to adopt correct solutions. In this case specific actions need to be undertaken.
He also commented on an open invitation to tender No VT/2011/039 issued by EC for a study service contract to accommodate corresponding risks/concerns to ensure adequate protection of workers from risks connected with the expose to nanomaterials and/or nanotechnologies. Goals of the assignment include:
- Analysis of sustainability of the EU-OSH legal framework in its current form relative to the nano specific workplace;
- Elaboration of possible scenarios individually or combined;
- Elaboration of a Guidance document that is to address actual shortcomings in a realistic matter.
Dr Jorge Costa David also discussed specific problems associated with the workplace risk management measures for nanomaterials which consist of particular factors: the number of nanomaterials is significant and likely to grow, the paucity of hazard information, a small number of nanomaterials studied and few long-term studies were performed, occupational exposure scenarios are not sufficiently characterized and, lastly, workers are already exposed. He commented on elements of ensuring workers protection:
- Hazard identification;
- Exposure assessment;
- Risk characterization;
- Risk management.
Possible measures to be considered by employees, such as NRV (defining a maximum generic level for the concentration of nanoparticles in workplace atmosphere and constituting a warning factor) were also discussed.
He concluded his talk with an observation that actions to be undertaken differ depending on the timeframe in mind, and while in the present precautionary principle is to be applied, for the near future diligence, for farther future regulatory measures are relevant.
Prof. Ruediger Iden (BASF) he explained his background as consisting of 30 years of industrial experience with 10 years of developing nanoproducts and 56 years of marketing them. At BASF, a leading chemical company worldwide, contrary to what might be thought, nanoproducs represent only less than 1% in sales, however, taking into consideration overall sales, it is still an impressive figure with huge potential. Also, evaluation of the market share can differ significantly depending to approach adopted, as nanoproducts can have an added value to other materials (such as organic nanoparticles influencing plastic properties) and as such impact end products.
As an active member of the German NanoCommission he considered crucial that the dialogue had been initiated at an early stage and constituted a success, as all stakeholders reached a common conclusion and although there are still discussions, common ground for understanding had been created and differences between NGOs and industry are not as huge, as long as they are free of fears.
Professor Iden shared his thesis that sustainability is a key factor for businesses to survive. Therefore, in lots of cases, nanotechnologies included, special attention should be paid not to apply excessive regulations or overemphasize governance principles, as chemical companies are more and more sustainable, otherwise they would cease to exist. In his opinion, no governance principles can withdraw the responsibility from manufacturers. He commented on differences in this respect as regards the situation in Europe and in the US, since in Europe there are tendencies to regulate (or even over-regulate) businesses of innovation processes, while in the US responsibility for ensuring that end products are not harmful for consumers is put on marketing companies. He emphasized that it should not be forgotten that industry itself must stay in responsibilities, while excessive governance can result in delegating them to more or less unanimous institutions. He underlined that it is probably not a commonly shared view, but innovation process is becoming more and more democratic. It is not the case with science, but innovation, ultimately resulting in selling product to the market, is a different story. Dialogue with all potentially interested stakeholders starts playing a crucial role in the process and it needs a right framework.
Sylvia Maurer (BEUC The European Consumers Organisation) presented her organization as one of the oldest NGO in Brussels established in 1962 originally by 6 consumer organizations, now having 42 members in 31 European countries. Product safety is a high priority topic in the works of the organizations aiming at improving general safety of products sold on the EU market and at raising awareness with decision-makers concerning risks posed by chemical substances on health and the environments, as well as at minimizing the exposure of consumers to dangerous chemicals including nanomaterials.
She discussed a leaflet published already twice by BEUC with its sister organization ANEC How much nano do we buy? and constituting an inventory concerning product claims. It is designed as an added value to regulators, in order to provide them with an overview in which categories of products nano claims are used, how many claims are there and to give them an opportunity to decide on possible further testing or following up particular situations, for EU has some legislation in place which does not allow to mislead the consumer about certain properties.
She briefly commented on problems which were encountered: in some products the notion nano is used merely as a marketing term in order to make a product seem more innovative, but possible new properties are not obvious; while, in opposition there are areas where it may be possible that nanotechnology is already used but the consumer has no clue about it, especially such a situation concerns food additives and food contact materials. Here the issue of the need of transparency and clarity for consumer arises. Transparency is also connected with some problematic issues, such as whether all products should be labelled or whether such a label would not scare off the consumer. She expressed her opinion that putting the term nano is a neutral way of communicating.
Sylvia Maurer also presented opinions on some of the issues being in the focus of attention of BEUC: first of all, the organization has concerns that there are some gaps in the regulatory framework and agrees with the European Parliament that consumer safety legislation should be reviewed and that nanosafety provisions need to be included in this sector. The second issue she commented on was the need for increasing the traceability of nanomaterials by implementing a mandatory register covering information on which nanomaterials are used and in which consumer products. She also shared her view on a report published a few days before the conference by JRC and concerning risk/benefits analysis. She mentioned a point contained in the report that the exposure of consumers is very likely to grow in the coming years and that is why it is crucial that products available to consumers are assessed properly before marketing and quoted the REACH principle no data no market as applicable in this respect. Lastly, she discussed the most recent EC Recommendation containing a definition of a nanomaterial. She expressed her view that it provides clear frames of reference, however, she remarked, a current challenge would be to check its adequacy in use.
The contributors to the Nanoethics 2011 conference agreed that the current general publics attitude towards nanotechnologies, apart from relatively low knowledge on the field, is highly ambiguous. Enthusiastic expectations mix with scepticism or even fears. The first feelings are associated with enormous potential of the applications of nanotechnologies, particularly in medicine, while the second with considerable, though unknown risks, knowledge gaps, uncertainties. These require intensification of awareness raising activities and can be answered by transparency of research and information, increased stakeholders involvement and public engagement which were unanimously called for by the conference participants.
It was stressed that stakeholders dialogue has become more and more significant within N&N because it gives the society, consisting of individuals, a tool for getting a position on the subject. The influence of stakeholders contributions on the perception of new technologies developments is remarkably high, so more considerable openness of the society for scientific basis for their judgement is a good investment in the future.
The need for transparency, fostering the involvement of the general public and the significance of societal factor in the development of science and technology were emphasized by nearly all speakers and disputants and gained unanimous understanding by the conference participants.
List of Websites:
PROJECT WEBSITE: www.nanoethics2011.pan.pl;
CONTACT DETAILS:
Andrzej Górski
Polish Academy of Sciences;
Pl. Defilad 1, 00-901 Warsaw, Poland;
e-mail: agorski@ikp.pl
