Ethical Principles in european regulation of biotechnology - possibilities and pitfalls
Nielsen, Linda ; Faber, Berit A.
Publication date: 2002
Citation for published version (APA): Nielsen, L., & Faber, B. A. (2002). Ethical Principles in european regulation of biotechnology - possibilities and pitfalls. Ministry of Economic and Business Affairs, Denmark.
Download date: 23. Sep. 2021 g//
Ethical principles in european regulation of biotechnology
- possibilities and pitfalls
www.biotik.dk by Linda Nielsen | Berit A. Faber for BioTIK
COPENHAGEN 2002 g//
About BioTIK
In 2001 the Danish Parliament launched the BioTIK-project. It is a four-year project focu- sing on both the possibilities that gene tech- nology offers, and the ethical principles that are to be considered in order to make the right decisions. BioTIK is a Danish abbrevia- tion of biotechnology and ethics.
Hence nine Danish Ministries have joined a Task Force with the purpose to incorporate ethical principles in regulation of biotechnology, in decision making processes and as a basis for public perception and information. Read more about the BioTIK-project at www.biotik.dk.
Ethical principles in European regulation of biotechnology - possibilities and pitfalls by Linda Nielsen and Berit A. Faber:
ISBN 87 7408 663 4 The Ministry of Economic and Business Affairs, Denmark 2002 National Consumer Agency, BioTIK-Secretariat, Amagerfaelledvej 56, DK 2300 Copenhagen. Telephone + 45 32 66 90 00 Fax + 45 32 66 91 00 E-mail: [email protected]
Impression: 1000
The report is also available on the Internet at: www.biotik.dk
Translation: Scandinavian Translators A/S
Layout and printing: aparte as 031 Lilla rapport 03/09/02 14:19 Side 1 031 Lilla rapport 03/09/02 14:19 Side 4
Ethical principles in european regulation of biotechnology | Linda Nielsen | Berit A. Faber| April 2002
Foreword
The present report was prepared by Professor Linda Nielsen, PhD, and Berit A. Faber, Head of Secretariat, L.L.M, in collaboration with the BioTIK Secretariat, the National Consumer Agency of Denmark. During the preliminary research and final preparation of the report, Gisela Hildebrandt and Troels Koch, students of law, provided skilled and dedicated assistance with Internet searching and typing up of the final document. The purpose of the report is to describe, analyse and assess the varying methods of operationali- sing ethical principles within European regulation of biotechnology, with the inclusion of proposals for different tools and models for use in future regulation. The aim of the report is first and foremost to serve as a practical resource for use in evolving regulation, political support, and democratic and debating activities in different domains in response to rapid advances in biotechnology, and the ethi- cal concerns that follow in its wake. Accordingly, we have chosen to provide only a limited number of notes to document sources. The individual statements are expanded on in the report’s appendices, where further documentation is provided. We hope that the report will contribute to supporting the aim of developing the life sciences and biotechnology in accordance with ethical values and societal aims, in line with the description in the EU Commission’s strategy on ”Life Sciences and Biotechnology - A Strategy for Europe”, as now ratified by the EU’s Council of Ministers. The EU Commission’s strategy for life sciences and biotechnology testifies to the fact that deliberations on operationalisation of the ethical principles which biotechnology raises are currently ongoing in many countries and at many levels, and it is our hope that this report with its ”toolbox”, ”buffet” and ”menu” may serve to consolidate and inspire these deliberations.
4 031 Lilla rapport 03/09/02 14:19 Side 5
Ethical principles in european regulation of biotechnology | Linda Nielsen | Berit A. Faber| April 2002
Contents
PART ONE: Introduction and general issues
1 INTRODUCTION 10
1.1 Background 10
1.2 Purpose 10
1.3 Methods 11
2 ETHICS AND ACTORS 12
2.1 Fundamental ethical principles 12
2.1.1 Economic and qualitative benefits 12
2.1.2 Autonomy, dignity, integrity and vulnerability 12
2.1.3 Just distribution of benefits and burdens 12
2.1.4 Co-determination and openness 12
2.1.5 General deliberations on the regulation of ethical issues 12
2.2 Different actors 13
2.2.1 Researchers, commercial actors and other affected parties 13
2.2.2 Decision-makers and administrators 14
2.2.3 The media and the general public/lay people 14
3 RISK ASSESSMENT - BETWEEN SCIENCE AND VALUES 15
3.1 Beyond the objective risk concept 15
3.2 Biotechnology as a risk narrative 16
3.3 The communication of risk as a dialogue about uncertainty 18
PART TWO: Regulation of biotechnology at international and national level
4 REGULATION - OVERVIEW 22
4.1 International regulation 22
4.2 The Council of Europe 23
4.3 The EU: 23
4.3.1 The authorisation system for medicinal products 23
4.3.2 EU authorisation system for GMOs, plants and foods 24
4.3.3 Other EU regulation, etc. 25
4.4 National regulation in the field of health 26
4.5 The international picture and differences in the intensity of national
regulatory activity 27
5 031 Lilla rapport 03/09/02 14:19 Side 6
Ethical principles in european regulation of biotechnology | Linda Nielsen | Berit A. Faber| April 2002
5 ANALYSIS OF THE REGULATORY PICTURE 29
5.1 ”Ethics where?” - coverage and scope of ethical principles 29
5.2 Medicinal products, plants and foods - ethics 30
5.3 The ”ethics of how?” - different models for operationalisation 30
5.3.1 Broad, discretionary or precise provisions 30
5.3.2 Regulation of content versus process 33
5.4 Incorporation of the four ethical principles 33
5.5 Summarising analysis - ”gaps in Community regulation” 34
PART THREE: Tools for incorporating ethical principles
6 DEMOCRATISATION TOOLS AND DEBATE MODELS 38
6.1 Ethical councils (debate and advice) 38
6.1.1 Nomination and members 38
6.1.2 Objective 39
6.2 Scientific ethics committees (authorisations) 39
6.2.1 The committees’ composition 39
6.2.2 Areas of responsibility 40
6.2.3 Assessment criteria 40
6.3 Other democratisation tools 41
6.3.1 Technology councils, including consensus conferences 41
6.3.2 Future panel 41
6.3.3 Values workshop - Norway 41
6.4 Cooperation between councils and boards 42
6.5 Analysis and evaluation of democratisation instruments 43
6.5.1 Representation of experts and of lay people 43
6.5.2 The purpose and role of the committees 45
6.5.3 Criteria for ethical evaluation 46
7 REGULATORY INSTRUMENTS 47
7.1 Regulatory function 47
7.1.1 The normative function 47
7.1.2 The protective function 47
7.1.3 The technical function 47
7.2 Different types of regulatory instruments 48
7.3 Advantages and drawbacks of different regulatory models 49
6 031 Lilla rapport 03/09/02 14:19 Side 7
Ethical principles in european regulation of biotechnology | Linda Nielsen | Berit A. Faber| April 2002
8 THE TOOLBOX - CHECK-LIST 52
8.1 Regulatory models 52
8.1.1 Choice of forum 52
8.1.2 Choice of type 52
8.2 Debate models 53
8.2.1 Consensus conferences etc. 53
PART FOUR: Ethical principles in European regulation
9 CONCLUSIONS AND RECOMMENDATIONS 56
9.1 Introduction 56
9.2 Can experience from the human area be applied to the foods area? 56
9.3 Ethical principles in the foods area? 59
9.4 How are ethical principles operationalised in regulations? 60
9.4.1 Regulatory challenges and possible tools 60
9.4.2 Political will and regulatory scope 61
9.4.3 Actors: role and scope of action 62
9.4.4 Debate: polycentrism and timing 65
9.5 A choice of tools 65
9.5.1 The debate models 65
9.5.2 National regulation 66
9.5.3 International regulation 66
9.6 Conclusion 67
10 PROSPECTS AND CHALLENGES 70
11 POSTSCRIPT 71
7 031 Lilla rapport 03/09/02 14:19 Side 8 031 Lilla rapport 03/09/02 14:19 Side 9
Ethical principles in european regulation of biotechnology | Linda Nielsen | Berit A. Faber | April 2002
PART ONE
INTRODUCTION GENERAL ISSUES
• Ethical principles
• Different actors
• Risk assessment - between science and values
9 031 Lilla rapport 03/09/02 14:19 Side 10
Ethical principles in european regulation of biotechnology | Linda Nielsen | Berit A. Faber | April 2002
1 Introduction same time, in recent years, regulation has been introduced in a large number of EU mem- Biotechnology, bioethics and biolaw are impor- ber states, which, with varying aims and inten- tant issues on the agenda both nationally and sity and employing different means, has sought internationally - and not least with regard to to strike a balance between promoting and the EU. One of the reasons for this is the trans- controlling biotechnology. cendental nature of biotechnology as concerns national borders, impacts and cultures. It offers 1.2 Purpose hope of major breakthroughs in a wide range of The purpose of this report is to describe, analy- areas, but, equally, gives rise to concerns se and assess the varying methods of operatio- about the negative impacts and breaches of nalising ethical principles within European regu- fundamental ethical values that it may entail. A lation of biotechnology, with the inclusion of series of questions therefore arise about how proposals for different tools and models for use the positive aspects of biotechnology may be in future regulation. put to use and supported while, at the same time, avoiding potentially undesirable aspects Part One describes the issues, and presents and impacts. In this sense, ethical principles in the ethical principles involved. The fundamental Community regulation of biotechnology are a dilemmas inherent in operationalising ethical central issue. principles in regulation in one way or another are also introduced; similarly, the actors pre- Bioethics can help to provide pointers as to sent in the area and the way in which risk which applications and impacts are to be consi- assessment is situated between science and dered either desirable or undesirable. values are also covered. Regulation can then help to impose limits on the application of biotechnology on the basis of Part Two outlines regulation in the field of bio- these ethical principles, and to ensure that the technology in the EU. The aim here is not to governance and control of such application take offer an exhaustive description of the particu- place in accordance with democratic values, lars of regulation, but to offer an at-a-glance such as dialogue, participation and equity. In view, which, it is hoped, will facilitate delibera- this way, regulation reflects ethics, while also tions on regulatory models from a broader per- serving to guide ethical evaluation. spective. The outline covers general internatio- nal regulation, including regulation ratified by 1.1 Background the European Union, as well as a kaleidoscopic The new biotechnologies, involving genetic eng- picture of national regulation in the individual ineering and cloning as well as genetically EU member states. Additionally, we provide a modified organisms (GMOs), raise a large num- brief walk-through of regulation in the different ber of new and difficult questions about how fields of biotechnology, since regulation varies these technologies are to be tackled - from a considerably according to the issue it covers, political, ethical and legal perspective. We are e.g. medically assisted procreation or foods, faced with a melting pot in which ethical ques- etc. Attention will be drawn to the principal tions and the prospects for governance of common denominators and differences. human health, food and the environment, as well as the rights of different individuals and Part Three describes a range of tools for groups intermingle and become interdepen- operationalising ethical principles, and the dent. The ethical principles have to be weighed advantages and drawbacks of individual tools against each other and operationalised in regu- are described and assessed. The report covers lation. This process is exceptionally difficult, but tools for democratising the decision-making is increasingly necessary in a growing number process (”debate models”), traditional regulato- of areas. ry instruments (legal acts, administrative direc- tives and the like), as well as other instru- The EU has a central role in the process, both ments, including case law, professional stan- by virtue of its directives and its ethics commit- dards and education. We then go on to provide tees and debates in the European Parliament. a ”check-list” for a number of the decisions that Matters of special importance include the EU’s need to be made with respect to choice of role vis-à-vis the moratorium on GM products, forum, form and content of regulation and/or the precautionary principle, the Charter of the democratic process whereby the ethical Fundamental Rights and regulation of the mar- principles are to be operationalised. The various keting of foods and medicinal products. At the options are presented metaphorically in the
10 031 Lilla rapport 03/09/02 14:19 Side 11
Ethical principles in european regulation of biotechnology | Linda Nielsen | Berit A. Faber | April 2002
form of a ”buffet” of different ”dishes” for com- level, and legal work under the auspices of the posing a complete ”meal”. EU and in relation to the Council of Europe. At the same time, we have worked for many years Part Four focuses on how the ”toolbox” can be with ethical issues, both as President/Head of employed constructively. In this context we will Secretariat of the Danish Council of Ethics and be considering how lessons learned in the in relation to the EU (as a member of EGE) and ”human health area” e.g. the treatment of pati- the Council of Europe (participation in the con- ents and scientific ethical evaluations, might be sultations on the Convention on Human Rights incorporated in the foods area. Drawing on the and Biomedicine). Finally, we have attended a analysis of the advantages and drawbacks of large number of conferences, seminars, etc. on the various tools, a series of different proposals biolaw and bioethics at the international level. for solutions will be indicated. In recognition of the fact that different countries have different The deliberations on the advantages and draw- backgrounds and traditions as regards culture, backs, experiences, etc. of different tools are religion, structures, regulatory traditions and so based partly on our own experiences, and part- on, the aim is not to dictate the ”correct” use ly on a series of discussions over the years with of the toolbox, but to propose a range of a range of people familiar with the area. It fol- options. In other words, we return to the idea lows that no attempt is made to present scien- of a ”menu” from which alternative ”meals” tific truths, but rather a number of opinions, may be assembled. which may often be subjective, and which may be expressed differently outside the country For the Danish version of the report, an appen- that originally produced a given instrument. dix section is provided, which includes a more Nonetheless, we have felt it appropriate to detailed report on legislation in the area, a list include these reflections, since, it is hoped, of links and an overview of selected ethical pro- they may aid the process of selecting tools and visions from the EU regulation of medicinal pro- menus. ducts and foods. The last of these appendices is in English. The aim of the report is first and foremost to serve as a practical resource for use in evolving 1.3 Methods regulation, political support, and democratic Relevant, up-to-date legislation on selected bio- and debating activities in different domains in technology areas for selected countries has response to rapid advances in biotechnology, been collated. Since this regulation is evolving and the ethical concerns that follow in its wake. rapidly and is subject to frequent amendment, Accordingly, we have chosen to provide only a a detailed description of legislation in the ind- limited number of notes to document sources, ividual countries has not been attempted, but etc. The individual statements are expanded on instead a panoramic view, as a means of obtai- in the report’s appendices, where further docu- ning a general perspective. As a dynamic, prac- mentation is provided. ticable aid to finding the relevant regulation, etc. Appendix 1 contains a collection of links to We hope that the report will contribute to the appropriate websites. supporting the aim of developing the life scien- ces and biotechnology in accordance with ethi- The selected areas comprise legislation of cal values and societal aims, in line with the medically assisted procreation, genetic testing description in the EU Commission’s strategy on and gene therapy, biobanks, medical research ”Life Sciences and Biotechnology - A Strategy and clinical trials involving humans, cloning, for Europe”, as now ratified by the EU’s Council genetically modified animals, xenotransplanta- of Ministers. tion and genetically modified foods. The coun- The EU Commission’s strategy for life scien- tries selected for detailed study are the UK, ces and biotechnology testifies to the fact that France, Germany, Sweden, The Netherlands, deliberations on operationalisation of the ethical Denmark and Norway (even though Norway is principles which biotechnology raises are cur- outside the EU). rently ongoing in many countries and at many levels, and it is our hope that this report with The report is to a large degree based on our its ”toolbox”, ”buffet” and ”menu” may serve to experience as legal experts, which includes consolidate and inspire these deliberations. participation over many years in legislative work within the Danish framework, collabora- tion on bioethics and regulation at the Nordic
11 031 Lilla rapport 03/09/02 14:19 Side 12
Ethical principles in european regulation of biotechnology | Linda Nielsen | Berit A. Faber | April 2002
2 Ethics and actors 2.1.2 Autonomy, dignity, integrity and vulnerability In the application of biotechnology, regard must 2.1 Fundamental ethical principles be shown for human autonomy and dignity and There can be little doubt that biotechnology for the integrity and vulnerability of human heralds substantial prospects for the positive beings, animals and the natural world. development of both national and international society, yet our ability to unlock these potenti- 2.1.3 Just distribution als is conditional on our response to a number of benefits and burdens of key ethical issues. One of the most funda- Biotechnology should be employed in such a mental aspects is the need to incorporate the way that it does not impede our efforts to crea- ethical principles borne out of concerns about te a society in which benefits and burdens are how biotechnology might impact on values and fairly distributed. This consideration applies rights in a way that is considered undesirable. both within the individual society and in rela- Biotechnology confronts us with a range of tion to the creation of growth which is sustai- ethical and political challenges by putting the nable when seen in relation to other countries, focus on fundamental human values. Once the including developing countries, and in relation individual person, profession, clinic, or country, to future generations. or the European Union, etc. assumes a stance on how biotechnology is to be utilised, ethical 2.1.4 Co-determination evaluations become essential. and openness Decisions to use or not to employ genetic eng- Since the focus in this report is devoted especi- ineering should be made through an open pro- ally to ”tools” for incorporating ethical princi- cess, where respect is given to all viewpoints. ples, no thoroughgoing description and analysis is made of the diversity of ethical viewpoints These four fundamental principles should be and positions that exist within the scientific understood as parameters to be made substan- debate on this question.1 This should also be tive and operationalised through democratic seen in the light of the fact that, within natio- debate. Decisions on the utilisation of biotech- nal boundaries, there will be internal debates nology will often be the result of a series of on how ethics are to be defined and implemen- complicated balances, and these balances may ted in detail, just as at the international level differ within different aspects of life, from coun- there is a difference in which ethical schools try to country, and within different professions and movements are most prominent. It is, and cultures. however, necessary to specify which elements these ethical principles contain in each case. 2.1.5 General deliberations on the This is a question of a choice, which is open to regulation of ethical issues discussion, but which nonetheless is judged to Ethical issues may be embodied in legislative include the most important elements to have regulation in two basic ways. Firstly, ethical gained a foothold in current ethical science and considerations can lead to standardisation of literature. The ethical signposts employed in content, such that the administrative authoriti- the following can be divided into four ”sets”:2 es can instantly determine, on the basis of ethical rules in the legislation, whether somet- 2.1.1 Economic and hing is prohibited or is permissible. An example qualitative benefits of this would be the prohibition of cloning. Biotechnology is to be employed for the benefit Secondly, ethical issues may be embodied in of human beings, society and nature. There is, standardisation of procedure, such that the therefore, an assumption that, for any potential administrative authorities need to make a risk to be acceptable, the technology should ruling on whether something is prohibited or not simply serve financial interests, but also can be permitted, after a closer examination of contribute to an improved quality of life, e.g. in the case, which will also involve assessments the shape of better foods, an improved envi- and decision-making about ethical aspects. An ronment or better health. example of this would be the EU directive on good clinical practice (GCP directive).
1 For discussion of this question, see (inter al.) Jacob Dahl Rendtorff and Peter Kemp: ”Basic ethical principles in European bioethics and biolaw. Report to the European Commission, 2000”, Peter Kemp, Jacob Rendtorff and Niels Mattsson Johansen (eds.): ”Bioethics and biolaw”, Rhodos International Science and Art Publishers and Central for ethics and law, Copenhagen 2000. 12 2 The categorisation was originally produced for a report from the then Danish Ministry of Economic and Business Affairs: ”Regeringens redegørelse til Folketinget om Etik og Genteknologi” [The Danish Government’s Report on Ethics and Genetic Engineering as presented to the Danish Parliament] from 2001. 031 Lilla rapport 03/09/02 14:19 Side 13
Ethical principles in european regulation of biotechnology | Linda Nielsen | Berit A. Faber | April 2002
International regulation will typically contain general viewpoint. These actors may have dif- obligations in relation to the content of national fering viewpoints and interests in respect of legislation, but which permit a certain discre- research, implementation, financial exploita- tion as to the implementation of, for example, tion, administration, control, governance, etc. an international convention in national legisla- of biotechnology. tion. International regulation, however, does not normally impose direct obligations on natio- 2.2.1 Researchers, commercial nal authorities. actors and other affected parties EU regulation does place demands upon natio- The researchers typically work with basic data nal regulation (directives), but can also have an and generate information from them. They thus immediate direct effect in relation to citizens generate expert knowledge, which is often of a and businesses (regulations). technical/scientific nature. One dilemma and point of debate is to what extent researchers Finally, EU regulation may impose requirements can, should or will take an interest in communi- on EU courts or EU decision-making processes cating and supplying information about ethical in so far as the decision-making competence is issues in relation to their research. not purely national. EU regulation of biotechno- logy is content-based in relation to citizens and Other sorts of researchers are interested in the businesses, as well as procedure-based, and, consequences of the utilisation of biotechnolo- for the latter, it involves both decision-making gy, etc. Examples of such researchers might be processes related to EU courts and national ethics specialists, lawyers, sociologists, etc. decision-making processes. who, from information about biotechnology and their own or others’ deliberations of the conse- National regulation applies directly to the ind- quences which the utilisation of different forms ividual citizen or business, and can contain of biotechnology will or may lead to, make standardisation of both content and procedure. assessments of various kinds, including the sig- nificance it will have medically and socially; the Ethical criteria do not come with a handy book changes of our standards and values which of answers in which we can look up whether a may be at issue; the control measures and method of treatment or a GMO-based crop is options which will be required, etc., etc. While permissible or not. But we can point to some ethics will relate the application of biotechnolo- ethical considerations, which should form part gy to various ethical principles (see above), of any overall assessment prior to a ruling on sociology will often take an interest in its more whether a method of treatment or a crop is concrete relevance to specific groups and for permissible. Additionally, it is important to society. Jurisprudence, based on pure scientific ensure the involvement of lay people in an research, the opportunities for utilisation, ethi- open process, so that ethical assessment is not cal principles and sociological considerations, reserved for experts in a closed forum. Finally, will be able to arrive at an idea of the extent to it should be ensured that the ethical assess- which there is a need for democratic processes, ment is of specific applications of genetic eng- control, governance, etc. One might perhaps ineering and not simply of more abstract ques- say that these research areas constitute a sort tions of principle. of metascience, which employs some of the raw materials from the other sciences. This points to procedural standardisation, which, in relation to specific statutory rulings Commercial actors will be interested in finan- on the use of genetic engineering, requires cial exploitation of biotechnology. This applies, that: for examples, to farmers, fishermen, food pro- 1. an ethical assessment is undertaken; ducers, seed producers, etc. 2. this is done on the basis of formulated Affected parties can be a number of different ethical considerations; and groups. One of these will be patient groups, 3. with the involvement of lay people in an who often press for research and utilisation. open process. Another will be environmental groups and other interest groups, who often remain relatively cri- 2.2 Different actors tical of the utilisation of different forms of bio- There are many actors involved, and these may technology. Thus, among the affected parties, have a direct research or financial interest in there will be many heterogeneous and, to some biotechnology, or be affected in a less direct extent, conflicting interests. fashion, or have an interest based on a more 13 031 Lilla rapport 03/09/02 14:19 Side 14
Ethical principles in european regulation of biotechnology | Linda Nielsen | Berit A. Faber | April 2002
2.2.2 Decision-makers for retaining the services of lay people in dif- and administrators ferent organisations, councils and boards may Based on information they receive, decision- be regarded as a recognition of this wisdom. makers, including politicians, will make the po- The crux is that experts, including researchers, litical judgement of the extent to which demo- administrators and politicians, each have their cratic processes, control, governance, etc. own angle, but that these angles perhaps do should be implemented, and, based on their not include considerations which large groups political assessment, the form to be considered of the population wish to see dealt with. desirable. In other words, they will be selecting which tools to use from the toolbox. Decision- makers can be, firstly, at the international level (UN, WTO, European Commission, EU); second- ly, at the national level (governments and parli- aments); thirdly, related to different profes- sions (medical associations and trade organisa- tions); fourthly, individual clinics, hospitals, businesses; and fifthly and lastly, the individual person.
Administrators, including authorities, will often develop the expert knowledge and trans- late it into a concrete utility, e.g. in relation to application, authorisation, policy and transpa- rency. For administrators, there may be relati- vely large scope for selecting tools in connec- tion with preparation of legislation, the execu- tion of decisions made through legislation, and enforcing the legislation. When the regulation is discretionary in nature, more precise guidance is frequently sought as to which principles the ethical assessment will be based on, and how the more precise balancing of the ethical princi- ples will be made.
2.2.3 The media and the general public/lay people The media play a significant role in information about research, ethical principles, concerns, etc. The media often contribute constructively to debate, but have a tendency to polarise stories so that any balanced view is lost. For example, future hopes can be given such an optimistic slant that expectations are created which have no basis in scientific fact. Or concerns may be (over)emphasised. One of these does not pre- clude the other, since the media do not need to be consistent in their treatment of biotechnolo- gy’s ethical dilemmas. In this, they are in con- trast with regulation in the area, which must of necessity be coherent and build on an internal- ly consistent position. Finally, there is the question as to whether there is not, quite besides the above-named actors, a large and important group, viz. the general public. In the general public there can be said to be a wisdom which is of great significance to ethical decision-making proces- ses. The long-standing tradition in Scandinavia
14 031 Lilla rapport 03/09/02 14:19 Side 15
Ethical principles in european regulation of biotechnology | Linda Nielsen | Berit A. Faber | April 2002
3 Risk assessment - consequences. Scientific risk assessments and cost-benefit evaluations are tools employed by between science and technical and financial experts to describe the values3 risk in statistical and mechanical terms. The objective is to provide a qualified basis for poli- tical and administrative decisions, for example, This section has the aim of shedding light on on whether a GMO can be authorised for mar- the risks of biotechnology in the ”crossfield” keting or not. between risk and values. The section is based on a more extensive report by Thomas Breck, Such scientific risk assessments have acquired which is given in Appendix 2. This is interes- ever-greater significance for societal decisions ting, not least in the light of the fact that risk within modern biotechnology. At the same assessment is a key concept in relation to time, however, criticism has been raised in the assessment of parts of EU regulation of bio- public services of these assessments’ inadequa- technology - especially in the foods area - cy - criticism largely concerning the fact that while traditional scientific approaches are scientific risk assessments have a tendency to changing to become more nuanced, with a hig- treat risk as a neutral and objective dimension. her degree of value-based elements. While sci- Risk is not just a question of science, but also entific risk assessment has traditionally been of values. viewed as relatively unambiguous and therefore a solid foundation for regulation, partly as Firstly, scientific risk assessment involves a regards verification, partly as regards creating number of built-in choices of problems, met- a homogeneous legal position in the EU, ethical hods and descriptions. These choices can be assessments are considered to be more discre- both well-founded and necessary, so that the tionary, and this makes them more difficult to risk assessment taken as a whole can provide a validate and makes it easier for different legal result that can be incorporated in a bureaucra- positions to arise in the EU. The difference bet- tic context, but they are never value-free and ween the two approaches is, however, not neutral. Secondly, there is a limit to the risk clear-cut. assessment’s predication, that is to say the relationship to reality on which it can meaning- A glance at the last ten years’ debate on bio- fully pronounce. Scientific risk assessment has technology readily reveals that the risk aspect a tendency to include hard and quantifiable occupies a prominent position. A large part of aspects and conversely to preclude soft and the social conflicts played out around biotech- qualitative aspects of the risk concept. nologies seemingly deal with these technologi- es’ inherent potential for danger - their possible 3.1 Beyond the risks. How will these technologies affect our objective risk concept health and welfare, our social and cultural iden- In its most common sense, the concept of tity and the environment? And what precau- ”risk” alludes to a future unwanted event or tions should society take to minimise or alt- situation which one wants to avoid. A risk will ogether eliminate these risks? often contain an element of unpredictability. We talk about the probability of one or other The word risk is often used to refer to unwan- unwanted event being large or small, and of ted events in the real world, which can be des- one risk being greater than another. This is the cribed in terms of their probability and their concept of statistical risk which has gradually
3 The following is based on a report by Thomas Breck, MA Comms and is largely based on the book entitled ”Dialog om det usikre - nye veje i risikokommunikation” [Dialogue on Uncertainty - New Paths in Risk Communication], published by Akademisk Forlag 2001, and on the articles ”Værdier og risiko” [Values and Risk] by Thomas Breck, Tidsskriftet SALT, 5/2000, ”Den ny sociale risikovirkelighed” [The New Social Risk Reality] by Thomas Breck, AVJ-info 4/2001, ”Risiko og værdier i GMO-debatten” [Risks and Values in the GMO Debate] by Thomas Breck and Peter Sandøe, Alimenta, 8/2002, and ”Sikre fødevarer - også et spørgsmål om værdier” [Food Safety - Also a Question of Values] by Peter Sandøe, Thomas Breck and Karsten Klint Jensen, Alimenta 6/2001. The full text of the report is provided in the appendices section of the Report. Thomas Breck obtained a Masters in communications studies combined with a specialisation in biology in 1988. He has pre- viously worked freelance for the Danish Broadcasting Corporation, as a project manager to the secretariat of the Danish Board of Technology and as an environment affairs consultant to the Danish Consumer Council. He is the author of books on genetic engineering, environmental concerns and risk issues. A PhD research fellow at Roskilde University since 1998, Breck has also for a period been attached to the Centre for Bioethics and Risk Evaluation at the Royal Veterinary and Agricultural University of Copenhagen. 15 031 Lilla rapport 03/09/02 14:19 Side 16
Ethical principles in european regulation of biotechnology | Linda Nielsen | Berit A. Faber | April 2002
gained a foothold throughout society and which The third weakness of the concept of statistical can be immensely useful in many circumstances. risk is that it has a distinct tendency to deal only with the risk of mortality. The obvious This is how engineers, economists and statisti- advantage of this is that all risks can then be cians view risk; as concrete and tangible compared with each other across both individu- unwanted events in the real world, which can al and cultural divides. Seen in isolation this is be described using numbers and probabilities all well and good, but one chooses then to dis- and thereby be made the object of calculations regard some of the dimensions of the concept and rational decisions. But precisely because of risk which are important for understanding the statistical or objective concept of risk is so the conflicts surrounding risk that shape debate widespread, it is important to be aware of its in society. Aspects to do with scientific uncer- limitations. tainty, with a failing confidence in science and the authorities and with value-based and ethi- In the first place, the concept of statistical risk cal questions. is concerned with situations where the probabi- lity and consequences are known and well defi- In summary one can say that the technical/- ned. Either because there is substantial empiri- economic approach to risk, in spite of its indis- cal experience or a well-defined theoretical putable merits, also presents blind spots and cause-effect relationship. When the conditions dead ends, which make it less suited to under- allow, risk assessments can be a splendid standing the many conflicts surrounding risk as instrument on which to base decisions. But characterised by the media and the political many contemporary risks are not simple and agenda in what is referred to as the risk society. well defined. On the contrary, they are often very complex and characterised by scientific To understand the risk society’s conflicts it is uncertainty as concerns both probability and necessary to adopt a broad, social concept of consequences. This is true, for example, in risk, which includes risk as it is perceived and areas involving hormone mimics and gene construed by different individuals and cultures, modification. and which recognises that the conflict between different interpretations and constructs of risks Secondly, the concept of statistical risk presup- has become a fundamental condition for policy- poses that actors think and act rationally. The making. A concept which does not reduce risk reality, however, is that risk is influenced by to numbers and probabilities, but also sees it subjective, cultural and value-laden factors. For as a question of social learning processes and example, the individual context means that the communication. In what one could also call the risk of driving a car, smoking cigarettes or new social risk reality, it is becoming increa- making a parachute jump is perceived to be singly difficult to refer to risks as something more acceptable, since these are our own choi- real and well-defined, which can be communi- ces, under our own control. On the other hand, cated in an effective and targeted fashion. It is chemicals in food, genetic modification and rather a question of contemporary risks occur- similar risks imposed by other parties are seen ring, while we discuss them in a mediated pro- as less acceptable. Psychologists have scientifi- cess, in which science still plays an important cally proved that risks that are known, self- role, but not as a clear and incontrovertible selected, controllable and fair are seen funda- authority. Rather as a store where different mentally as more acceptable than the opposite social contractors acquire ammunition for their type. Added to this is the fact that risk is con- arguments. Arguments which they present to strued differently by different cultures. For the arena constituted by the media, and where example, Europe and the USA have different different interpretations of facts and attributed views on the risk posed by GMOs to the environ- meanings fight over defining the risk and the- ment. There is moreover a tendency for scienti- reby also setting parameters for the political fic experts to prefer risks that can be measured, solutions. for authorities to prefer risks that can be regula- ted etc. Fundamentally, this has something to do 3.2 Biotechnology with the fact that risk concerns unwanted as a risk narrative events, and that the question as to what is Modern biotechnology has from the outset been unwanted, must, of necessity, be connected with associated with risk. As early as 1974 scientists values. It is not least in areas where there is warned the rest of the scientific world that the great scientific uncertainty that value-based dif- newly discovered recombinant DNA technique ferences will inevitably play a large role. poses a potential risk, for example, through
16 031 Lilla rapport 03/09/02 14:19 Side 17
Ethical principles in european regulation of biotechnology | Linda Nielsen | Berit A. Faber | April 2002
genetically-modified pathogenic micro-orga- then come to appear as the absolute truth and nisms spreading outside of the laboratories. A a guarantee against unwanted risk, which they voluntary moratorium was agreed to, until rules can never be. If unexpected and unforeseen were introduced for the use of recombinant events occur all the same (as happened in the DNA. This voluntary halt in the use of genetic BSE case), both the risk assessments, and the engineering is one example of reflexivity and scientific institutions and experts which perform self-policing within the world of scientific rese- them, lose the confidence of the general public. arch, but it can also be seen as an example of There is therefore a need for a change in socie- how scientific risk assessment has come to ty’s use of scientific risk assessment which completely dominate the regulation of genetic allows for the scientific uncertainty of that risk engineering at the expense of ethical and wider assessment. societal perspectives. Biotechnology has beco- me institutionalised in the laws and regulations There are certainly two different ideas of what of society as a potentially risky technology, but a reflexive approach to risk assessment of this the approval of GMOs is almost entirely based nature might look like. One technical/scientific on a scientific risk assessment informed by the and one democratic. The technical/scientific principle of ”if it’s not dangerous, it’s OK”. approach revolves around the idea that science will become better at assessing risks with The risk assessment has, however, limited vanishingly small probability, but potentially powers of predication. The process of hypothe- huge consequences in relation to, for example, tical questions and answers is structured as so- complex ecological systems. The intention is to called decision trees of the type ”if yes, go to incorporate qualitative considerations into the x” and if no, go to y”. In this way, the authoriti- quantitative risk assessment. In this way, one es’ expert advisers can ensure that all the ave- can, as it were, operationalise the use of the nues are covered and the correct questions for precautionary principle, but keep it within a sci- the authorisation procedure are asked. If none entific context. The alternative is a democratic of the questions on these lines produce a nega- approach, which seeks to create greater open- tive answer, an authorisation will be granted. ness about the use of risk assessments - espe- The risk assessment does not, however, take cially the uncertainties and choices associated account of knowledge that is lacking, i.e. situa- with them. Additionally, the aim is to include tions we are unaware of or cannot envisage. In citizens and other non-experts in the process this way, the need for a clear answer calls for sufficiently early on so that the problem, which the risk assessment to deliver the whole ans- the risk assessment is to shed light on, has not wer, by which it has been obliged to provide a already been finally formulated. more certain answer than it is in a position to. In order for a risk assessment to be viable in a Accompanying this necessary discussion of the bureaucratic, regulatory context, the complex capacity of risk assessments to predict reality, realities have to be reduced to something simp- there is, as stated, another discussion, which ler and more tangible. This does not mean that deals with the values underlying the risk risk assessments are useless, just that they assessment. The main assertion here is that have limited validity. risk assessments are not, and can never be, suited to encompass the value-related ques- It is here that the risk assessment loses its sta- tions underlying the entire GMO debate. The tus as a neutral instrument for measuring and challenge therefore consists in breaking the balancing probabilities and impacts, and beco- dominance of risk in the regulation of GMOs mes itself a contributor to construing concep- and to make way for more value-based objec- tions about the nature of the problem. By tions. The view is that the risk aspect may accentuating the significance of certain factors indeed be important but is far from the most and playing down others, experts make a seri- interesting aspect of biotechnology. Indeed, the es of choices, which might be well-founded technique raises a series of fundamental ethical enough, but are never value-free. It is crucial and societal questions. About respect for life; for the validity of the risk assessment that about needs and welfare; about sustainability these choices and uncertainties are clarified. and the need for a more holistic outlook on the When a risk assessment is used in a political, relationship between man and nature; and regulatory context, however, the opposite often about alternatives to centralisation and increa- occurs, namely that the choice and uncertainti- sed efficiency and productivity. Fundamentally, es are played down in favour of an absolute it is a question of which values should charac- assertion about safety. The risk assessments terise future food production. There is a conflict
17 031 Lilla rapport 03/09/02 14:19 Side 18
Ethical principles in european regulation of biotechnology | Linda Nielsen | Berit A. Faber | April 2002
between different world views and between objective level (risk assessment) and the politi- alternative views of humankind’s and society’s cal level, where values are introduced (risk problems and needs. What is immediately governance). As already stated, the reality is apparent here is that the majority of GMOs that have come to market so far are, at the value- completely different. level, tightly bound up with the productivity Firstly, there is rarely one, unambiguous des- paradigm that has characterised industrialised cription of the risk. Scientific risk assessments agriculture over the second half of the last cen- cannot be neutral, but depend on perspective tury. In other words, increased volumes and and are a matter of interpretation. Moreover, productivity, a faster pace and cheaper pro- they are based on a number of assumptions ducts - improvements, which have occurred at and are thus representations of reality, but are the expense of the environment, animal welfare not reality itself. Many of the risks that typify and social sustainability. Some believe that this the risk society are characterised precisely by conflict will change with the second generation our lack of knowledge about the relationship of biotechnology products, which concentrate between cause and effect - this is true of, for precisely on qualitative improvements, but this example, BSE and genetic engineering. In is far from given. these areas, risk assessments become political, and the ”scientificism” of matters political fol- The conclusion is that even though biotechnolo- lows from a politicisation of matters scientific. gy raises questions about both values and risk, This contributes to blurring the sharp divide it is symptomatic that public debate revolves between scientific risk assessments and politi- almost exclusively around risk. At the same cal risk governance. time, the dominance of risk in regulation is a factor in delimiting the objections which can Secondly, risk management has become frag- legitimately be raised. Since risk is the only mented. It is not a matter of offsetting costs recognised yardstick, one must either assert and benefits, as in a well-structured activity, the dangers of biotechnology - or put up with but often rather unstructured and decentralised being ignored. But this trivialises the debate on risk governance under the influence of many both risk and values. It is important for the different actors and interest groups who each reputation of biotechnology, for the public’s consider their balancing (read ‘their values’) to confidence and for public debate to make way be correct and appropriate in the context. for a new reflexivity, which must encompass There is in the public sector a battle to define both the value of risk assessment and the valu- and organise risk and its significance - risk es underlying risk assessment. entrepreneurs propound and refute others’ risk assertions. 3.3 The communication of risk as a dialogue about uncertainty Thirdly, risk communication is not a mechanical Under the auspices of the FAO/WHO, work is work of translation, where the message, e.g. a currently being undertaken to create internatio- warning, a threshold value and so on, is trans- nal standards for risk analysis in the foods ferred to the target group as efficiently as pos- area. In this connection a model has been set sible so that it can then act on the message. out for what might be termed an ”archetypal Risk communication these days is more than risk analysis” consisting of three steps: Risk the communication of risk; it involves extensive assessment, risk governance and risk commu- interpretation and debate about risk as pro- nication. Risk assessment is the scientific part, pounded by different actors with demands for in which the problem is delineated and the risk specific political solutions and consequences, described in objective terms in terms of proba- since whoever controls the definition of risk, bility and impacts. Risk governance is the term also determines which solutions are relevant in for the political part, where the societal bene- the context. Risk is construed, so to speak, by fits and drawbacks are balanced against each the way in which it is communicated, and one other and the safety levels are determined. cannot distinguish between the real (objective) Risk communication is the term for the process risk and the perceived (subjective) risk, where in which the result of the foregoing process is science and values are intermingled and where communicated to citizens or consumers, in the scientific arguments can be difficult to differen- form of a threshold value, dietary advice, tiate from politics and power. The arguments hazard labelling and so on. This tripartition is are typically taken from the scientific domain, problematical, inasmuch as it presupposes a but there is more to do than produce, set out sharp delineation between the scientifically and interpret the results. This is not a case of a
18 031 Lilla rapport 03/09/02 14:19 Side 19
Ethical principles in european regulation of biotechnology | Linda Nielsen | Berit A. Faber | April 2002
classic conflict between lay people and experts, since there are both lay people and experts on both sides of the conflict - and they are fighting for legitimacy.
The conclusion for this new picture of risk - this new social risk reality - is that there is a need for new ways of addressing the issue of risk in society and new ways of making decisions wit- hin areas that are characterised by scientific uncertainty, by conflicts and opposing interests. There is a need for a new concept of risk com- munication - one that dispenses with the notion of effective communication. It is important to enter the process as early as possible, and the ideal must be to create parameters for a mea- ningful public discussion of risk, by ensuring that the relevant actors and interested parties are involved in the formulation of problems and strategies for solutions. This constitutes a major challenge for the authorities that deal with risk communication. The task will be to ensure that the process is as fair, open and transparent as possible, to ensure that all par- ties are heard, that no important arguments are ignored, etc. In other words the authorities will become a sort of procedural consultant on the risk issue. An important objective for democratic and dialogue-oriented risk gover- nance must be to open up the parameters for legitimate objections that would also comprise wider ethical and societal issues.
19 031 Lilla rapport 03/09/02 14:19 Side 20 031 Lilla rapport 03/09/02 14:19 Side 21
Ethical principles in european regulation of biotechnology | Linda Nielsen | Berit A. Faber | April 2002
PART TWO
REGULATION OF BIOTECHNOLOGY AT INTERNATIONAL AND NATIONAL LEVEL
• Regulation - overview
• Analysis of the regulatory picture
21 031 Lilla rapport 03/09/02 14:19 Side 22
Ethical principles in european regulation of biotechnology | Linda Nielsen | Berit A. Faber | April 2002
4 Regulation uniqueness and diversity”. Finally the Declaration prohibits financial gain from the - overview human genome in its natural state, and affirms that the benefits of advances in the technologi- The following section outlines regulation in the es shall be made available to all, and that free- field of biotechnology. The aim is to provide an dom of research is ”necessary for the progress overview of the current status of regulation in of knowledge”. order to localise the description of ”tools” wit- hin a legislative framework. First, in Section 4, The Cartagena Protocol from 2000 concerns we provide examples of international regulation biosafety and recalls the UN Convention on which reflect some of the ethical principles for Biodiversity from 1992. The Protocol prescribes which consensus has been reached in prescri- rules for international trade in living, genetical- bing these as universal standards - at a global ly modified organisms (LMOs). The rules cover level, and at the level of the Council of Europe risk assessment and risk governance for the and at EU level. purpose of protecting human health. The Protocol also contains rules on ”handling, trans- 4.1 International regulation port, packaging and identification”. Since the 1970s a number of attempts have been made to formulate fundamental ethical The Codex Alimentarius Commission was crea- criteria for regulating biotechnology. In the fol- ted jointly by the FAO/WHO to develop global lowing we will be discussing some of the main food standards. Two committees prescribe gen- criteria that have been established. The exam- eral guidelines on risk analysis and labelling of ples are concentrated around human health, genetically modified foods. GMOs and foods, but we have also included examples covering environmental issues and The mission of the WTO is to develop a multila- human rights issues. teral system of trade, the aim of which is to The following examples represent regulation lower customs and trade barriers, and to abo- in which an attempt to incorporate ethical con- lish discrimination in international trade. The cerns is in evidence. WTO has pledged to work for sustainable deve- lopment and protection of the environment. The UN’s Universal Declaration of Human Article XX of the GATT agreement and the SPS Rights and the European Convention for the agreement cover all sanitary and phytosanitary Protection of Human Rights and Fundamental measures that might impact on trade between Freedoms exemplify the attempts to lay down nations and prescribes, for example, that mea- universal normative precepts for fundamental sures may be introduced in contravention of ethical issues. the principle of non-discrimination if these are based on the precautionary principle. In cases The Aarhus Convention on Access to of scientific uncertainty the Member States are Information, Public Participation in Decision- permitted to adopt measures that must be Making and Access to Justice in Environmental based on pertinent scientific information. Since Matters (the ”Aarhus Convention”) from 1988 ethical concerns are difficult to document and affirmed ”the right to the environment”; not as might be perceived as a paving the way for a material right, but as a number of judicial or ulterior national interests that might obstruct formal rights, including the right of access to the WTO’s mission to promote international environmental information, public participation trade, it is difficult to take account of these in decisions on specific activities, and right of concerns. However, the so-called ”Shrimp-Turtle complaint and of access to judicial proceedings Dispute” has eased the constraints on what - for non-governmental organisations also. constitutes an ”exhaustible natural resource”. The Trips Agreement on trade-related aspects The UNESCO Declaration of 1997 concerns the of intellectual property rights also contains a human genome and human rights and pro- provision that Member States may exclude claims, among other things, that the ”human from patentability inventions contrary to ordre genome underlies the fundamental unity of all public or morality or in order to protect human, members of the human family as well as the plant or animal life, or in order to avoid recognition of their inherent dignity and diversi- impacts seriously prejudicial to the environ- ty”. It goes on to assert that ”that dignity ment. makes it imperative not to reduce individuals to their genetic characteristics and to respect their
22 031 Lilla rapport 03/09/02 14:19 Side 23
Ethical principles in european regulation of biotechnology | Linda Nielsen | Berit A. Faber | April 2002
4.2 The Council of Europe The Patent directive on protection of biotechno- The Convention on Human Rights and Bio- logical inventions from 1998 is designed to medicine from 1997. The Convention prescribes ensure effective, legally harmonised protection a number of minimum standards with which of patents and in so doing to serve to encoura- each Member State must comply, while their ge innovation and promote investment in the national legislation and practice may offer grea- field of biotechnology. The directive contains ter protection of the individual than that pre- articles that prescribe restrictions based on scribed by the Convention. The main purpose is ethical concerns. According to these, inventions to protect individuals against exploitation ari- may not be patented if their use in industry sing out of treatment or research. The article would be against ordre public or morality. on purpose and object indicates that the ”parti- Examples include processes for cloning human es to this Convention shall protect the dignity beings; processes for modifying the germ line and identity of all human beings and guarantee genetic identity of human beings; use of everyone, without discrimination, respect for human embryos for industrial or commercial their integrity and other rights and fundamental purposes, and processes for modifying the gen- freedoms with regard to the application of bio- etic identity of animals which are likely to logy and medicine”. The next article affirms cause them suffering with no substantial medi- that ”the interests and welfare of the human cal benefits to man or animal, and also animals being shall prevail over the sole interest of resulting from such processes. Moreover, the society or science”. The Convention also makes directive stipulates that the Commission’s provisions for equitable access to health care; ethics group - EGE - is to assess all ethical for professional standards; for consent and pro- aspects of biotechnology. tection of persons unable to consent; for gen- etic heritage and for scientific research. An 4.3.1 The authorisation system for Explanatory Report is provided as a supplement medicinal products containing comments on the text of the Council regulation on medicinal- Convention. Furthermore, a number of proto- cols have been ratified with a view to develo- products 2309/93/EEC ping, in special fields, the principles contained This regulation lays down procedures for cen- in the Convention, including a supplementary tralised authorisation of medicinal products in protocol prohibiting reproductive cloning of the EU. It prescribes community procedures for human beings. the authorisation and supervision of medicinal COMETH. In connection with the Council of products for human and veterinary use and Europe’s work on bioethics, a provisional bure- calls for the establishment of the EMEA. au known as COMETH (European Conference of According to the centralised procedure, marke- National Ethics Committees) has been appoin- ting applications are to be submitted to the ted to promote cooperation and network forma- EMEA, a European agency for the evaluation of tion among representatives of a number of medicinal products. The EMEA selects one of national bioethics committees. COMETH organi- the Member States as a rapporteur for the ses conferences for its affiliate committees on application. The Member State’s competent general and/or topical issues in the field of bio- authority verifies the documentation submitted ethics. in support of the application, while a scientific committee under the EMEA assesses the appli- 4.3 The EU: cation itself. The EMEA grants a Community Regulations drawn up under EU auspices inclu- marketing authorisation which applies in all EU de a biotechnology patent directive, a system Member States (if the application is authori- for regulating approval of clinical trials on sed). medicinal products for human use, and regula- All medicinal products derived from biotech- tions to provide a framework for trials and nology, including those derived by genetic eng- marketing of GMOs and novel foods. In addition ineering must obtain an EU product authorisa- there is the EU Charter of Fundamental Human tion in accordance with the provisions of the EU Rights; EU-US Biotechnology Consultative regulation on medicinal products. National clini- Forum, the European Commission’s policy cal trials preceding an EU authorisation must paper on life sciences and biotechnology, and observe the rules laid down in the Declaration the work of the EU ethics group - EGE - which of Helsinki, which means, among other things, reveal that efforts are now being made in the that they must be assessed by a scientific EU to incorporate ethical concerns at a more ethics committee. general and fundamental level.
23 031 Lilla rapport 03/09/02 14:19 Side 24
Ethical principles in european regulation of biotechnology | Linda Nielsen | Berit A. Faber | April 2002
Directive on medicinal products tralised and decentralised procedures. The rules for human use 2001/83/EEC regarding good clinical practice promote self- The directive on medicinal products for human determination and autonomy for trial subjects use comprises community code for how natio- and thereby also underpin the principle of nal government authorisation of medicinal pro- openness and transparency. However, this ducts is to be implemented. Once one Member openness applies only to trial subjects specifi- State has carried out an assessment of a medi- cally and not to the general public. In the field cinal product and issued a marketing authorisa- of medicinal product evaluation no tradition tion, the same product must be authorised exists for publicising applications for marketing according to a more rapid and straightforward authorisations with a view to conducting a procedure in the other Member States in which public consultation. This may be ascribed to the manufacturer wishes to market the pro- interests in protecting business secrets and duct. If a Member State disagrees with the researcher rights. The GCP Directive now com- marketing authorisation granted by another prises rules regarding establishment of a Member State the matter may be brought befo- Community database with a view to publicising re the CPMP (Committee for Proprietary extracts from applications and the evaluation Medicinal Products) attached to the EMEA. procedure, including, in particular the publici- sing of adverse effects, though these data are Directive on clinical trials on to be made available solely to the competent medicinal products for human use authorities in the Member States. As such, 2001/20/EC (GCP Directive) openness and transparency is ensured for none This directive fleshes out the ethical principles other than the trial subjects and the competent with specific instructions regarding the compo- authorities. nents of a scientifically-based ethical assess- ment. The purpose is to rationalise the proce- 4.3.2 EU authorisation system for dures involving documentation and administra- GMOs, plants and foods tion required for conducting clinical trials, and A recurrent theme is that the Member States also to ensure patients of the same protection are to employ risk assessment and the precau- in all EU Member States. This is what is often tionary principle when considering applications referred to as a ”minimum directive” in that it for deliberate release and marketing authorisa- is only as prescriptive as the Member States tions. In connection with notification a public themselves deem necessary for the purposes of consultation must be held, and consumer auto- protecting human subjects in clinical trials. nomy must be assured by means of provisions Before clinical trials may commence a number regarding labelling. of criteria must be satisfied, including the weig- hing of predictable risks and drawbacks as Directive on deliberate regards the therapeutic benefit for each trial release 2001/18/EC subject and or society as a whole; respect for The directive on deliberate release lays down the trial subject’s right to physical and mental the rules for environmental and health evalua- integrity and right to personal privacy, and the tion of all genetically modified organisms that obtaining of informed consent and permission are to be released into the environment. All to withdraw such consent. In Denmark, both GMOs contained in products sold on the market the scientific ethical committees and the Danish within the EU must therefore undergo environ- Medicines Agency are each independently mental assessment in pursuance of the princi- responsible for authorising every application. ples in the EU directive on deliberate release. As a basis for conducting inspections, a Authorisations for deliberate release apply European database is to be established to throughout the EU. However, the environmental which the Member States’ competent authoriti- provisions apply solely to LMOs. es are to have access. Inspector visits to selec- ted clinical trials are thus prescribed as a duty. If a GMO is used in a food product or a medici- In this directive the EU has drawn attention to nal product it must be authorised for use as ethical criteria. such in conformance with the Council regula- tion on medicinal products (2309/93). In such Openness and co-determination cases the environmental assessment will be an The authorisation system is founded on the integral component of the product authorisa- requirement that the rules concerning expert tion, though still in accordance with the princi- evaluation as set out in the directive on medici- ples of the directive on deliberate release. All nal products are to be adhered to in both cen- the rules concerning authorisation of GMO-
24 031 Lilla rapport 03/09/02 14:19 Side 25
Ethical principles in european regulation of biotechnology | Linda Nielsen | Berit A. Faber | April 2002
based products, including plants, foods and national identities of the Member States and medicinal products have undergone total har- the organisation of their public authorities. To monisation. this end, it is necessary to strengthen the pro- tection of fundamental rights in the light of The regulation on novel foods 258/97 prescri- changes in society, social progress and scienti- bes requirements for authorisation of novel fic and technological developments by making foods, including GMO-based foods. The regula- those rights more visible in a Charter. The pro- tion also lays down community code for autho- hibitions cover issues such as eugenics practi- risations and the general principles governing ces, making the human body and its parts a labelling. These provisions ensure that consu- source of financial gain and the reproductive mers have access to the necessary information cloning of human beings. once the product has been placed on the market. EU-US Biotechnology Openness and co-determination Consultative Forum The directive on deliberate release prescribes This body was appointed in 2000 by the then that once an application has been received by US President, Bill Clinton, and the President of the competent authority, that authority must the European Commission, Romano Prodi. The publicise it with a view to conducting a public Forum is made up of an independent group of consultation. experts whose task it is to issue a joint assess- ment of a range of complex problems arising in Procedure for authorisation of connection with the application of modern bio- GMO-based products technology in agriculture and the food industry. The actual procedures for authorisation of a The assessment report comprises recommenda- GMO-based product to be placed on the tions concerning mandatory risk assessment, a European market are relatively consistent with number of grants for independent risk rese- regard to plants, foods or medicinal products. arch, etc. Assessment of the risks to human health and the environment is performed by one of the The European Commission’s communication, Member States - either the primary applicant Life Sciences and Biotechnology - a Strategy Member State or one appointed through a cen- for Europe from 2002 (COM 2002 27 final) (The tralised procedure. The application is then for- European Commission’s Policy Paper) proposes warded via the European Commission to the a coherent strategy for biotechnology aimed at other Member States who make their own formulating responsible, science-based and assessment and recommendations regarding people-centred policies on an ethical founda- the application. This procedure forms the basis tion. The European Council of Ministers has for a vote on the application in the respective ratified this strategy. An action plan in support official committees for the individual areas: The of the strategy comprises an overview of committee for deliberate release, the standing various action areas in which concrete initiati- committees for foods and for medicinal pro- ves are to be implemented. The strategy ducts for human/veterinary use. If the official emphasises that the development and applica- committee rejects the application, this is then tion of life sciences and biotechnology must be passed on for a final ruling by the Council of pursued with respect for the fundamental valu- Ministers. If the application is approved, a mar- es recognised by the EU in the Charter of keting authorisation is granted that applies Fundamental Rights. The strategy also stresses throughout the EU. that scientific and technological progress will continue to raise new ethical and social ques- 4.3.3 Other EU regulation, tions, which should be tackled proactively on etc. The EU Charter of the basis of an open and broad debate. The Fundamental Rights action plan also indicates a number of action Proclaimed by the European Parliament, Council areas with a view to strengthening the incorpo- and Commission in 2000, the Charter emphasi- ration of ethical concerns, including information ses that the Union is founded on indivisible and and debate, the elaboration of ethical guideli- universal values of human dignity, freedom, nes/norms and a strengthening of the EGE. equality and solidarity; on the principles of democracy and the rule of law. It contributes to EGE - The European Group on the preservation of these common values while Ethics in Science and New respecting the diversity of the cultures and tra- Technologies ditions of the peoples of Europe, as well as the EGE is an independent, pluralistic and interdis-
25 031 Lilla rapport 03/09/02 14:19 Side 26
Ethical principles in european regulation of biotechnology | Linda Nielsen | Berit A. Faber | April 2002
ciplinary authority appointed to advise the • gestational surrogacy contracts to be European Commission on ethical issues concer- regarded as standard as unenforceable. ning science and new technologies. It consists of 12 members, all of whom have been appoin- b) Areas of dissent comprise: ted for their expertise and personal qualities, • access to insemination and IVF by single and the group represents different disciplines, women and lesbians; including the health sciences and natural scien- • donation of eggs and fertilised eggs; the ces, ethics and theology, and law. Members are legal force of gestational surrogacy con appointed by the Commission for a term of four tracts; and years, which may be renewed once. The group • the method whereby the quality of such publishes Opinions, either on its own initiative services may be assured. or at the request of the Commission. The European Parliament and Council of Europe Genetic testing represents an area in which may draw the Commission’s attention to ques- regulation is less comprehensive. Regulation of tions they consider of major ethical importance. genetic testing is centred on protection against For the purposes of preparing its Opinions, the predictive genetic tests ”imposed” by external Group holds working meetings, invites experts agents, especially employers and insurance to take part, initiates studies and organises companies. This provision is set out in the public Round Tables. If an Opinion is not adop- Council of Europe’s Convention on Human ted unanimously the Group must account for Rights and Biomedicine, Art 12. The issue is any dissenting positions. being deliberated at the EU level generally. EGE, the European Group on Ethics, published 4.4 National regulation in the a report (Genetic Testing in the Workplace) on field of health the issue in 2000. In certain countries the pro- The following presents a kaleidoscopic view of visions in national regulation are more compre- regulation in the human health area. The pur- hensive. Norway, for example, has provisions pose is to provide an overview of areas in on genetic testing, and Denmark has in special which broad agreement has been reached on legislation from 1996 laid down provisions con- the need for regulation, as well as significant cerning the collection and utilisation of health differences between leading EU countries with information in connection with employment regard to the intensity and content of their with the purpose of protecting the right to pri- regulation. vacy and integrity. Gene therapy is an area subject to limited Medically assisted procreation is a classic regulation. Where regulation does exist it is example of ”first generation” legislation in the usually centred on the difference between gene field of biotechnology relating to human health. therapy involving human somatic cells and At the same time, a number of countries exhi- gene therapy on the human germ line. The bit relatively comprehensive regulation, though issue is referred to in Art. 13 of the Convention with a relatively large degree of variation in the on Human Rights and Biomedicine. In the EU method and intensity of regulation. The Council biotechnology patents directive, gene therapy of Europe’s Convention on Human Rights and on the human germ line is given as an instance Biomedicine contains only few and modest pro- in which patenting would be against ordre visions regarding medically assisted procreation public (Art 6 (2b)) National provisions concer- (Art. 14). These focus on non-selection of sex ning, for example, prohibitions against gene except where serious, hereditary gender-rela- therapy on the human germ line also occur. ted disease is to be avoided. Biobanks represent one of the new areas that a) Consensus areas comprise: have begun to attract regulatory interest. One • access to medically assisted procreation of the central issues concerns the extent to restricted to married couples and co-habi- which the use of biological materials for purpo- tees; ses other than that for which they were obtai- • services in medically assisted procreation ned (e.g. research) should be subject to to be offered solely by clinics and/or per- express consent (opt in) or whether it is suffici- sons with a special licence to do so; ent that no express dissent has been voiced • a licence or qualification to provide medi- (opt out). In national regulation specific regula- cally assisted procreation to be granted tions concerning biobanks are (as yet) relative- solely with regard for the principle of non- ly rare, but the issues will often be covered commercialisation; and indirectly by general rules concerning data, etc.
26 031 Lilla rapport 03/09/02 14:19 Side 27
Ethical principles in european regulation of biotechnology | Linda Nielsen | Berit A. Faber | April 2002
A recent, striking example of direct regulation ded as a practice in violation of human dignity. came with the advent of an act on biobanks in In its supplementary protocol to the Convention Iceland in 2000. The purpose of this legislation on Human Rights and Biomedicine, the Council was to authorise the collection, storage, hand- of Europe prohibits cloning, i.e. any interven- ling and utilisation of human biological speci- tion that attempts to create a human being mens in such a way that confidentiality is assu- that would be genetically identical with another red. The issue is currently being discussed in a human being either living or deceased. At the large number of countries and further regula- EU level the patents directive (on the legal pro- tion will thus conceivably appear on the agenda tection of biological inventions) contains a pro- in future. hibition against the patenting of processes aimed at human cloning for example. The Biomedical research represents a classic area national regulation in a large number of coun- for regulatory efforts - albeit more in the natu- tries contains a provision prohibiting cloning. re of soft law. The Declaration of Helsinki has been heavily influential in the formulation of Stem cell research represents the latest in a international standards. The Convention on series of regulations on biotechnology, and is Human Rights and Biomedicine contains the object of much controversy. The Convention requirements regarding professional standards on Human Rights and Biomedicine contains no (Art. 4); rules of consent (Art. 5 and others); a special provisions regarding human stem cell general rule that scientific research shall be research, as this was not on the agenda at the carried out freely subject to the provisions of time of its formulation. There are no EU directi- the Convention and other legal provisions ensu- ves or similar on research on stem cells, but ring the protection of the human being (Art. the issue has attracted widespread interest. In 15); and special conditions governing the pro- May 2002 the EGE published a study on the tection of persons undergoing research (Art. patenting of inventions related to human stem 16). In national regulation we also often find cells. At the national level stem cell research is regulation designed to ensure scientifically- generally not the object of specific regulation. based ethical assessment of biomedical rese- Of particular interest is the new legislation in arch projects. the UK that now authorises stem cell research subject to fulfilment of a number of conditions. Research on embryos was one of the most con- troversial issues to emerge in ”first generation” Transgenic animals and xenotransplantation are regulation in the field of biotechnology. the object of special interest because they Disagreement on the extent to which research represent a ”crossfield” between ethics concer- on embryos should be permissible is reflected ned with human health for both individual pati- in an exceedingly vague general rule in the ents and in relation to the risk of epidemics, Convention on Human Rights and Biomedicine, and ethics in relation to animal welfare. Within which simply states that the law - where the the EU the xenotransplantation issue is being law sanctions such research - shall ensure followed closely, but no directives or other pro- ”adequate protection of the embryo” (Art. 18). visions exist for the area. However, this rule is followed by an explicit sta- tement, according to which ”the creation of 4.5 The international picture and human embryos for research purposes is prohi- differences in the intensity of bited.” At EU level also, we find in one notable national regulatory activity respect a provision regarding human embryos, International provisions in the area of human that is, the biotechnology patents directive, health are centred chiefly on four principles: which contains a specific prohibition against the a) non-commercialisation (regarding the sale patenting of inventions involving the use of of body parts and restrictions regarding human embryos for industrial or commercial patentability, etc.); purposes (Art. 6 (2c)). In the national regula- b) non-discrimination (e.g. non-selection of tion the legal position on embryonic research sex and in relation to genetic heredity); varies considerably. Cloning, like medically assisted procreation, c) autonomy (e.g. rules of consent and the bears on the most fundamental and sensitive of right to know); and considerations, in that it confronts the basic d) the prohibition of reproductive cloning and premise of human conception. In its declaration gene therapy on germ cells. from 1997 UNESCO asserts that the reproducti- ve cloning of the human being is to be regar-
27 031 Lilla rapport 03/09/02 14:19 Side 28
Ethical principles in european regulation of biotechnology | Linda Nielsen | Berit A. Faber | April 2002
At the national level there is a much variation in the extent to which any actual legislation is applied nationally, and hence how binding the obligations are on which regulation is based. If we look at ”first generation” regulation of medi- cally assisted procreation, etc. we can identify the following models:
Laissez-faire means that there is no legislative regulation or only very limited legislation or other form of regulation. This model is found in Italy for example, where it applies to the regu- lation of medically assisted procreation and other areas.
Liberal attitude means that legislative regula- tion (hard law) exists only to a limited extent, but that regulation is in operation through pro- fessional standards or similar (soft law). This model is found in the UK for example, where it applies to medically assisted procreation (and other aspects of health regulation).
Cautious legislative regulation means that rela- tively well-developed regulation exists, also in the form of hard law (in some cases in the form of framework legislation). This model is found in France and Scandinavia for example.
Prohibitive legislation means that full legislation exists, and is focused principally on prohibitions and punitive measures. This model is found in Germany and Austria for example.
Thus we find that there are different reactions in the different countries to what the relations- hip between ”ethics and law” should consist of. The advantages and drawbacks of the different models are discussed in Chapter 8.
28 031 Lilla rapport 03/09/02 14:19 Side 29
Ethical principles in european regulation of biotechnology | Linda Nielsen | Berit A. Faber | April 2002
5 Analysis of the In other areas the scope for incorporating ethi- cal principles, however, is more limited or non- regulatory picture existent, even. This applies especially to GMOs and foods. The foods standards laid down by In the following we analyse the state of the law WHO/FAO in the Codex Alimentarius, like the as regards ethics in regulation in terms of four EU directives and regulations concerning the perspectives. Firstly, ”ethics where?” - that is, marketing of genetically modified products and in which areas regulation stipulates a duty to so forth, contain provisions concerning risk incorporate or omit ethical principles (coverage) assessment, but leave no or little scope for and what scope this affords the individual incorporating ethical concerns in the authorisa- actors. Secondly, ”the ethics of what?”, in tion procedure itself. which we consider the incorporation of ethics in EU regulation in relation to medicinal products There are, nevertheless, certain ”openings” in and foods respectively in terms of research, cli- relation to the directive on deliberate release, nical trials, deliberate release and marketing. the directive on contained use, and the Thirdly, the ”ethics of how?” - that is, by what Cartagena protocol on biosafety. Moreover, the means ethics are operationalised in regulation. requirements regarding labelling and traceabili- Fourthly, ”which ethics?” - that is, differences in ty may be said to offer some scope for addres- incorporation and operationalisation of the four sing ethical concerns. Furthermore, the directi- ethical principles addressed by the present ve on medicinal products for human use con- report. Drawing on this analysis we consider in tains a provision in which although the authori- what areas the incorporation of ethical princi- sation procedure in connection with marketing ples is operationalised more extensively in does not comprise ethical criteria per se, the regulation, and in which areas further incorpo- trials preceding marketing authorisation contain ration and operationalisation of ethical princi- ethical evaluations in accordance with the GCP ples in regulation would seem to be merited. (good clinical practice) Directive. In this way a link is forged between trials and marketing in 5.1 ”Ethics where?” - coverage such a way that ethical criteria are integrated and scope of ethical principles at an earlier stage, which means that marke- The international provisions in pursuance of ting cannot proceed unless certain precondi- which ethical principles are incorporated and tions regarding ethical evaluation have been operationalised in regulation relate chiefly to satisfied. National scope for incorporation of two areas. ethical concerns is in this way limited when it comes to what might be termed ”product regu- Firstly, human rights in relation to the human lation under EU auspices”, since it is based on health area. This applies especially to the UN’s total harmonisation, in which the rules offer no human rights convention, the Council of possibility of ethical considerations - thus Europe’s Convention on Human Rights and making it a contravention of the directives to Biomedicine; UNESCO’s universal declaration on incorporate them. the human genome and human rights, the EU The areas of national regulation are chiefly Charter of Fundamental Rights in its reference confined to the health sector in the form of to, e.g. ”indivisible and universal values” and medically assisted procreation, genetic testing the EU Directive on clinical trials of medicinal and gene therapy, research on human embryos, products for human use. biomedical research and so forth. Ethical evalu- ations are often integral to authorisation proce- Secondly, the environment, biodiversity, biosa- dures, for example, when it comes to biomedi- fety and so forth. This applies to the UN cal research projects. Besides these areas, Convention from 1992 concerning biological ethics may be included when restrictions are diversity; the Cartagena Protocol on biosafety imposed on ethical grounds for what may be and international trade in living, genetically approved; as in, for example, a prohibition modified organisms, as well as the Aarhus against reproductive cloning; against employers’ Convention on right of access to information requiring predictive genetic testing; against cer- about the environment. tain forms of medically assisted procreation such as embryo donation, etc. The existence of In these areas there is thus some degree of restrictions of this nature might be referred to obligation to incorporate ethical principles in in terms of the establishment of a form of ”soci- regulation at the national level. etal ethics” within a given nation, which are subsequently reflected in national regulation.
29 031 Lilla rapport 03/09/02 14:19 Side 30
Ethical principles in european regulation of biotechnology | Linda Nielsen | Berit A. Faber | April 2002
n the absence of such regulation, the stage is kind”, ”human dignity”, ”human integrity”, ”the left to the other actors, that is, individual pro- diversity of the human family”, ”respect for the fessions, scientists, commercial operators and uniqueness and identity of individuals”, ”free- so on. These actors may reach agreement on dom, equality and solidarity”, and ”freedom of certain norms for ethical evaluation. research (and thought)”. In the area of the environment and foods, reference is made to The scope for incorporating ethical evaluations ”biodiversity”, ”biosafety” and ”the right to the is in this way multifaceted: international ethical environment”, as well as ”sustainability”, ”the principles are formulated to uphold human precautionary principle” and so forth. rights and to maintain biodiversity and biosafe- ty. Against that, a number of EU directives and These ethical principles set the parameters for measures inhibit the incorporation of ethical concrete, ethical evaluation of a given appro- principles when it comes to GM products, inclu- ach, application or the like, but owing to the ding foods. At the national level ethical princi- ”elasticity” of the principles they are open to ples are centred on human health, while ethical differing interpretations. In a number of cases principles concerning the marketing of a num- therefore, a decisive factor will be the extent to ber of GM products such as foods are thwarted which the concerns embodied by the principles by the trend for total harmonisation of the EU are actually followed through - in other words on this issue. In this way a number of areas whether or not they are operationalised. are left to other actors, in particular to ”pro- fessional ethics”, ”corporate ethics” and ”indivi- In national regulation also, we occasionally find dualist ethics”. The issue is discussed in more expansive statements of intent. This is the case detail in Chapter 10. for French regulation, where dignity is a keyno- te, and for Norway, which besides respect for 5.2 Medicinal products, human worth, human rights and personal inte- plants and foods - ethics grity emphasises that the medicinal application On pages 31 and 32 we have sought to devise a of biotechnology ”shall be for the common good table to indicate the manner in which interna- of a society that accommodates all”, and that tional requirements regarding medicinal pro- this must be based on ”the ethical norms ducts (for human use) and GMO-based foods embodied in the cultural heritage of the are implemented in respect of the criteria Western world”. Other countries take a more governing research and marketing. In the main, direct approach, dispensing with general pre- the rules aim to ensure consumer protection, ambles in favour of explicit reference to funda- while the chief rationale underlying much of the mental ethical principles. In the UK for examp- international regulation both as regards medici- le, it is customary to open with a set of defini- nal products and foods is to protect freedom of tions, while Danish and Swedish legislation for trade in order thereby to lower the barriers example, typically begins by explaining what that prevent its free flow. area the act/statute covers.
5.3 The ”ethics of how?” - When it comes to the details of how to actually different models for implement ethical principles, these have to be operation alisation translated into more explicit legal provisions. Whenever regulation involves the incorporation The dilemma is that this will often involve a of ethical principles, the manner in which these ”quantum leap” from major, sweeping princi- are operationalised varies considerably. This ples on which everyone is agreed, to more pre- applies to the formulation of ethical provisions cise rules, in which these principles must both as broad in scope, discretionary or precise, and be balanced one against the other, and detailed also applies to the manner in which ethics are out in relation to discrete concerns. It is there- incorporated to regulate either content or fore small wonder that this localisation process process. gives rise to major differences in the extent of deliberations and attention to detail. 5.3.1 Broad, discretionary or precise provisions The dilemma is compounded by the fact that International conventions are - almost by their the rule or provision itself may be discretio- very nature - centred on broad, general provi- nary. This is the case, for example, with the sions, whereby only general ethical principles ordre public clauses in the biotechnology are emphasised. References to the human patents directive and elsewhere, which merely health area cite ”the precedence of human- notes that a matter may be contrary to ordre
30 031 Lilla rapport 03/09/02 14:19 Side 31
Ethical principles in european regulation of biotechnology | Linda Nielsen | Berit A. Faber | April 2002
Medicinal products Plants and foods
Research Ethics: EU: Requirements that scien- Ethics: EU: No general provisions for tists undertaking biomedical research incorporation of ethics. are to set out the ethical considera- tions made during project planning, National regulation: No tradition for and requirements that the EU evalua- ethics in evaluations tion committee assess these conside- rations.
Clinical Name: Name: trials EU Dir. 20/2001: Directive on clinical Dir. 90/219 and Dir. 98/81 on contai- trials of medicinal products. Minimum ned use - large scale and greenhouse directive. trials (minimum directive).
Ethics: The GCP directive, Art. 6 Ethics: Dir. 98/81 Preamble conside- (ethics committees) The remit of ration regarding the requirement that ethics committees is detailed in GCP protection must be in place in order Guidelines (currently under review) to preserve and safeguard the envi- (see Art. 8 of the Dir.). ronment and human health.
NB! Exclusively rules regarding open- Name: ness for research subjects; no rules Directive on deliberate release 2001/18 on public information or consultations. (total harmonisation directive)
Ethics: Preamble consideration
Marketing Name: Name: Regulation on medicinal products Directive on deliberate release 2309/93 2001/18 (distinguishing between medicinal (Plants, but not foods). products for human use and those for veterinary use). Ethics: Preamble consideration no. 9 concer- Ethics: Authorisation is conditional on ning the possibility of incorporating compliance with the procedure laid ethical principles in evaluation of down in the directive on medicinal applications for deliberate release and products (GCP). marketing applications. Marketing authorisations may be granted solely on the basis of GCP Article 9: Public consultation on the and the latest standards of the application (openness and transparen- Declaration of Helsinki. cy surrounding the consultation).
Article 23: Protection clause (health and environment).
NB! Exclusively rules regarding open- Article 29: ness for research subjects; no rules Consultation of EGE or similar ethics on public information or consultations. committee.
Name: Novel foods regulation (258/97).
Ethics: No reference to ethics.
31 031 Lilla rapport 03/09/02 14:19 Side 32
Ethical principles in european regulation of biotechnology | Linda Nielsen | Berit A. Faber | April 2002
Medicinal products Plants and foods
Consumer Requirement regarding product infor- Labelling requirement. protection in mation (package leaflet to be compre- Food labelling of novel foods. connection hensible to lay people). with marketing authorisations.
Consumer Possibly EC Treaty Article 30, protection Urgent action (EC Treaty Article 30, (health/environment/ordre public). post marketing health/environment/ordre public). Rules regarding labelling and traceabili- authorisation Monitoring of adverse effects. ty. No specific monitoring of adverse effects (as regards human health).
Other issues UN - Cartagena Protocol. Introduces post marketing precautionary principle. Informed agreement reg. organisms in transit (AIA - Advance Informed Agreement). Obligatory labelling of GMOs. (Less stringent rules concerning feed and foods).
Article 23: Extended obligation to involve the public in decision-making processes concerning LMOs.
WTO: GATT Article XX, and SPS agre- ement: Tendency to recognise envi- ronmental concerns and exhaustible natural resources as exceptions to the general rule on prohibition of measu- res presenting barriers to trade.
EU recommendations for regulations regarding implementation of the Cartagena Protocol.
In addition to these the EU directive on patents and the TRIPS agreement contain provisions regarding ordre public in connection with the awarding of patents, which comprises both medicinal products and plants/foods.
Areas that impose requirements concerning ethics in evaluations.
Areas for which there are no direct provisions concerning ethics, but which include the possibility of ethical considerations via preambles or provisions regarding purpose.
Areas in which there are no ethical provisions, but which do not stand in the way of the application of general principles.
Areas that do not contain scope for incorporating ethics in evaluations.
Areas that contain principles related to ethical considerations (consumer protection in the form of labelling, traceability, etc.).
Areas in which case law might sanction ethical considerations.
32 031 Lilla rapport 03/09/02 14:19 Side 33
Ethical principles in european regulation of biotechnology | Linda Nielsen | Berit A. Faber | April 2002
public and morality. In the Convention on tion that enables actuation of individualised Human Rights and Biomedicine, the require- ethics. ment that research on embryos be made the Finally, we find that a proportion of the pro- object of ”adequate protection” is also an cess-oriented regulation is geared to sustaining example of an area in which the intention was a democratic process for tackling ethical dilem- to provide discretionary leeway in order to mas in biotechnology, including the appoint- cater for differences in national perceptions. ment of ethical councils of various kinds. These democratisation tools are described in more However, there are also instances in which detail in Chapter 6. more precise provisions have been formulated whereby ethical principles are operationalised When it comes to precise, contextual regula- and acquire prescriptive content. tion, the greatest consistency is achieved in operationalisation of ethical principles. The gre- In such cases the principles ater the discretionary element, the greater may tend especially to relate to be the difference between operationalisation a) non-commercialisation and actuation. When ethical principles are b) non-discrimination incorporated via procedural standardisation this c) prohibitions against human interventions ensures scope and flexibility for ethical evalua- regarded as unethical tion, since an exhaustive tally is rarely made of d) protection of disadvantaged groups which ethical principles are to be incorporated - e) risk assessment and labelling often there will just be a requirement for an ethical evaluation, or for the matter to be 5.3.2 Regulation of brought before an ethics committee such as the content versus process EGE. However, this may produce considerable Ethical concerns may be incorporated in legisla- uncertainty as regards which elements are to tive regulation in the form of content-based be incorporated in an ethical evaluation, and standardisation, in which the rules indicate how different ethical concerns are to be weig- expressly what is permissible or prohibited, or hed against each other. in the form of procedure-based standardisation, in which case-by-case evaluations comprise In this way we find that there is what might be ethical concerns. Content-based standardisation referred to as a ”quantum leap” from broad is exhibited in the examples cited above, as principles or procedure-based standardisation well as a large number of national regulations to ethical evaluation and decision-making. in the area of human affairs (see Part 4). This may be connected with the fact that this is an 5.4 Incorporation of the four area ordinarily regulated in the context of fami- ethical principles ly-based legislation and the like. However, sci- entific research - and to some extent product Economic and qualitative benefits marketing - are not usually the object of con- The Convention on Human Rights and Biome- tent-based regulation. dicine and the UNESCO Declaration both stipu- late that the interests and welfare of the human Procedure-based standardisation occurs in a being are to ”prevail over the sole interest of number of areas and in different formats, in society or science”. Also, when it comes to which the ethical aspect varies. A protocol for medicinal products we find provisions for ensu- authorisation involving the incorporation of ring that an evaluation is made of the ”thera- ethical concerns is the norm when it comes to peutic efficacy” to be derived from the trials trials on human subjects. A typical sphere for forming the basis for authorising the marketing such protocols would be scientifically-based of a product. ethical evaluation of biomedical research pro- In the product area, including GM foods, the jects. In addition to which there is the regula- provisions permit risk assessment in relation to tion of good clinical practice. human health, but do not open up for ethical Rules concerning public consultation, recourse evaluation of what economic and qualitative to raise objections, etc. are also found in the benefits might be derived. foods area, yet in this context ethical principles are not set out in explicit provisions. Autonomy, dignity, Furthermore, the rules concerning labelling and integrity and vulnerability traceability of GMO-based foods might be clas- Human rights criteria and the regular incidence sed as a form of procedure-based standardisa- of rules regarding ”informed consent” in a large
33 031 Lilla rapport 03/09/02 14:19 Side 34
Ethical principles in european regulation of biotechnology | Linda Nielsen | Berit A. Faber | April 2002
number of areas may be taken as evidence of communication, Life Sciences and Biotech- incorporation of the ethical principle of autono- nology - A Strategy for Europe, emphasises the my. The same applies - albeit more indirectly - importance of societal dialogue - proactive civic in rules concerning foods labelling in the sense responsibility - and monitoring, as well as sci- that such rules may be understood as an affir- entifically-based regulation. As cited earlier, the mation of the right of self-determination as Aarhus Convention on public access in environ- regards whether or not people wish to consume mental matters proclaims a number of rights to GM foods. Dignity and integrity are classic ensure openness and co-determination. components in rules of the type that incorpora- Similarly, the rules concerning marketing aut- te ethical principles directly, and which more- horisation for GMO-based foods lay down provi- over often comprise more specific variants, e.g. sions for public consultations. Moreover, all the in relation to the right to privacy (personal data many ethics committees at the national and the protection), etc. The Convention on Human international level have the stated objective of Rights and Biomedicine contains a large num- safeguarding openness, dialogue and co-deter- ber of rules for protecting especially vulnerable mination. However, it is far from clear what the groups of individuals. To these should be added concept of ”co-determination” actually embodi- the rules comprised by national regulation for es. Public consultation and/or dialogue would the protection of children, including future gen- appear to be a given component, yet it is diffi- erations, persons with senile dementia and cult to discern what actual influence the consul- other vulnerable individuals. Finally, there are a tative response and/or outcome of public dialo- number of rules aimed at protecting the vulne- gue is intended to have. rability of nature, including the environment, biodiversity, etc. 5.5 Summarising analysis - ”gaps in Community Just distribution of regulation” benefits and burdens The overall regulatory picture that emerges is Unlike the first two principles, this ethical prin- delineated chiefly by four factors. ciple has not achieved the same fixed, promi- nent status in regulation on ethics in biotech- Firstly: the differences in when ethical princi- nology. However, isolated occurrences do exist: ples are promoted and when they are inhibited. The UNESCO Declaration proclaims that In the area of human rights and health interna- ”advances in biology, genetics and medicine, tional provisions promote ethical concerns in concerning the human genome, shall be made regulation to the extent that it is the duty of available to all”. The Council of Europe’s each nation, profession and individual alike to Convention on Human Rights and Biomedicine address ethical concerns - a duty which com- refers to ”equitable access to health care”. The prises the obligation of each nation to operatio- preamble in the Norwegian Act on nalise certain ethical principles in its regulation. Biotechnology is a national expression of this In the field of GMO-based foods we find that it commitment. However, the principle also has is chiefly international provisions that inhibit importance as an ethical concern, that is, as the incorporation of ethical considerations, justification for approving GM foods, for since, in many instances, total harmonisation example, to the extent that this is to be regar- prevails such that market interests and the ded as a means of helping to feed the world’s commitment to lowering trade barriers override population. However, this is not presented as ethical concerns. an explicit ethical principle underlying any regulation. Secondly, the juxtaposition of medicinal pro- ducts and GM foods. In the area of human d. Openness and co-determination rights and health the scope for incorporating Openness and co-determination are ethical ethical principles in regulation would seem to principles that are increasingly finding general be considerable, especially with regard to clini- consensus. cal trials involving human subjects, since this is In the human health area the Council of ensured by long-standing tradition. In the pro- Europe’s Convention on Human Rights and ducts area, including the foods area, however, Biomedicine refers to the importance of promo- the scope for incorporating ethical considera- ting public debate on this issue. The EU Charter tions would appear to be more restricted, not of Fundamental Rights also proclaims that the least because the area is subject to total har- Union is founded on ”the principles of democra- monisation focused on scientific risk assess- cy and rule of law”. The European Commission’s ment and only limited recourse to incorporating
34 031 Lilla rapport 03/09/02 14:19 Side 35
Ethical principles in european regulation of biotechnology | Linda Nielsen | Berit A. Faber | April 2002
more generalised ethical principles and consi- derations. The challenges in these two areas therefore set them poles apart. In the last- named area further consideration should be given to whether it would indeed be desirable and feasible to incorporate ethical principles to a greater extent by means, for example, of ”gaps” in Community regulation, or, by calling for regulatory amendments. Thirdly, the ”quantum leap” between general ethical principles and the operationalisation required for their actuation. This leap presents problems and often causes agreement on fun- damental ethical principles to give way to dis- sent concerning the details of their interpreta- tion, formulation and actuation. Along the same lines, there is also the tenden- cy to allow a number of procedural rules to prevail. This has the advantage of flexibility, but often becomes an impediment in that the criteria for ethical evaluation are either inade- quate or altogether absent. The challenge lies in filling out this ”vacuum” with ethical princi- ples that can serve as guidelines in concrete ethical evaluations and decision-making processes.
Fourthly, that the ethical principles discussed in the present report are not weighted equally in the regulation that exists in the area. The archetypal areas afforded protection are cen- tred on autonomy, dignity, integrity, etc. in the area of human rights and health, and to some extent economic and qualitative benefits, as well as broad-based principles of just distribu- tion of benefits and burdens. However, these have found their way into regulation in the field of GMO products, including the foods area, only by indirect means. Here the focus is on risk assessment and on labelling such that ethics is limited to ”isolated ethics”. This means that any broader consideration of derivable benefit is not made. The dimension that comprises ”proactive civic responsibility”, debate and dialogue, open- ness and co-determination would appear to have increasing influence, though without any clear perspective on how the right of co-deter- mination is to be exercised.
In order to facilitate discussion of how to operationalise ethical principles in regulation it would seem relevant to take a closer look at the ”tools” at our disposal. These tools will the- refore be the object of a more detailed discus- sion and appraisal in Part Three.
35 031 Lilla rapport 03/09/02 14:19 Side 36 031 Lilla rapport 03/09/02 14:19 Side 37
Ethical principles in european regulation of biotechnology | Linda Nielsen | Berit A. Faber | April 2002
PART THREE
TOOLS FOR INCORPORATING ETHICAL PRINCIPLES
• Democratisation tools and debate models
• Regulatory instruments
• The toolbox - Check-list
37 031 Lilla rapport 03/09/02 14:19 Side 38
Ethical principles in european regulation of biotechnology | Linda Nielsen | Berit A. Faber | April 2002
6 Democratisation President, plus 39 members. 5 members repre- sent the major religious denominations and are tools and debate nominated by the President. 19 members are models selected based on their qualifications and com- petencies and their interest in ethical ques- tions. 15 members work in scientific research. The following presents some of the democrati- There is therefore a high representation of spe- sation tools that have been employed over the cialist members, including specialists in ethics last ten to fifteen years to establish openness and philosophy. and debate. The main tools covered are: ethical councils, ethics committees, scientific ethics The Danish Council of Ethics consists of 17 committees, selected debate models, selected members, made up of a mixture of specialists specialised ethics committees and joint bodies. and lay people. 8 members are nominated by The ensuing discussion about the advantages the Ministry of Health, 9 by the Danish and drawbacks of these resources derives from Parliament’s committee on the Council of a combination of analysis work, interviews with Ethics. The members are nominated for their various people with experience and expertise in public commitment to the Council’s remit, and the area, and our personal findings and they must not be a member of the Danish opinions. Parliament, a local authority or a county coun- cil. The act on the Danish Council of Ethics also 6.1 Ethical councils stipulates equal representation by men and (debate and advice) women. The Danish model for a council of There are now a range of different models for ethics is characterised by its large proportion of ethical councils and committees in Europe. lay representatives. France was the first country in the world to establish an ethical committee; this was in The German council of ethics consists of up to 1983 (Comité Consultatif National d’Ethique 25 members, covering the scientific disciplines pour les sciences de la vie et de la santé). In within the life sciences, medicine, theology, Denmark the Danish Council of Ethics was philosophy, sociology and law, along with established in 1989. Ethical councils were esta- experts in ecology and economic affairs. blished in Germany in 2001; in The Nether- lands in 1999; in Sweden (Swedish National Members of the UK Nuffield Council (ethics Council on Medical Ethics (SMER)) in 1985; in council) are nominated by the council itself and Norway in 1991; and in the UK in 1991, with consist of various experts, of which around half the assistance of private funds, an indepen- represent medical and scientific disciplines. dent, autonomous ethical council was establis- There are also experts in ethics and, for hed, but not, however, based on legislation or example, an anthropologist and a broadcaster. government decision. The UK government deci- Members of the UK advisory ethics commission, ded in 1998-99 to establish, instead of an The Human Genetics Commission, are publicly ethics council along the lines of the French or advertised for and selected by the Ministry of Danish ones, two autonomous councils, each Health. Most of the members are experts in devoted to their own specific field, namely genetics, health, politics, law or bioethics, but human genetics - The Human Genetics there are also others from, for example, trade Commission - and the agricultural and environ- and industry - but no politicians. mental area - The Agriculture and Environment Biotechnology Commission. Additionally, in The Swedish medical ethics council consists of 2000, the Food Standards Agency was set up, a chairman, 8 representatives of the political with the remit of protecting public health from parties and 11 specialist members. risks that may arise in connection with food consumption, and in other ways protecting con- In some countries members serve for a limited sumer interests in relation to foods, including period; e.g. membership of the Danish Council genetically modified foods. of Ethics is limited to a maximum of 2 terms of 3 years, and in Germany members are appoin- 6.1.1 Nomination and members ted for 4 years. The number of members and their backgrounds and representation vary somewhat. The French Sometimes, there are also provisions for equal ethics committee consists of a Chairman and representation of men and women, e.g. in the an Honorary President nominated by the Danish Council of Ethics.
38 031 Lilla rapport 03/09/02 14:19 Side 39
Ethical principles in european regulation of biotechnology | Linda Nielsen | Berit A. Faber | April 2002
6.1.2 Objective meetings where ethical questions are examined The French ethics committee is an independent and reported on with the aim of promoting body linked to the ministries of research and public awareness and debate. From this basis, health. The committee has an exclusively advi- new guidelines are often formulated in a num- sory function, and advises and prepares reports ber of areas. initiated by questions from parliament, the government, an institute of higher education, a The Swedish ethical council is appointed by the public institution or a recognised public rese- government and has the task of shedding light arch foundation, as long as their main activity on medical ethical questions in relation to soci- is research, technological development, or the ety in general. The council provides guidance to promotion or protection of health. The commit- the government and parliament, which includes tee can also take up matters proposed by assessing impacts on the individual and human members of the committee itself or by others. integrity in relation to medical research, diag- nostics and treatment. It functions as a senior The Danish Council of Ethics has two main advisory body, monitors developments in the functions - an advisory function for legislators area and builds bridges between researchers and the government and a dissemination and and decision-makers. debate-promoting function for the public. To a great extent, the Danish Council of Ethics has 6.2 Scientific ethics contributed to broadening the public debate by committees (authorisations) arranging public consultations and debates In a number of countries there is scientific about ethical questions relating to the new assessment of biomedical research projects technologies within biomedicine. The Council involving human subjects. In the following we seeks to communicate ethical issues relating to will be looking at the following countries in biotechnology and human health to non-specia- more detail: The Netherlands (CCMO), Sweden lists. (Swedish National Council on Medical Ethics - SMER), Norway (National Committee for The German council of ethics is also indepen- Medical Research Ethics - NEM) and Denmark dent and sets its own agenda and modus (the scientific ethics committee system - CVK operandi. The aim is to discuss and arrive at an and others). ethical position on questions raised by new developments in the life sciences, as well as 6.2.1 The committees’ their consequences for the individual and for composition society. A particular emphasis is given to links The Dutch committee consists of 11 members with the public domain. and 8 experts (deputies). The committee has at its disposal ethical, legal, medical and pharma- The UK Nuffield Council is also an independent, cological expertise and expertise in nursing. As autonomous ethical council, which, in the well as its members, the committee also has absence of a national ethical committee as attached to it 10 experts with specialist compe- such, has achieved a position as an important tence in gene therapy, xenotherapy, immunolo- player in the UK and international ethical deba- gy, embryo and germ line research as well as te on the new biotechnologies and in the for- legal expertise. The committee is served by a mulation of UK policy in the area. The Council secretariat of 9 staff. sees it as its task to identify and define ethical questions raised by the developments in biolo- The Swedish committee consists of a chairman, gical and medical research, with the aim of 8 representatives of the political parties and 11 responding to and anticipating public concern. specialist members.
To a great extent, the Danish Ethical Council The Norwegian committee has at least 9 mem- has contributed to broadening the public deba- bers and, besides medical competence, has te by arranging public consultations and deba- members with competence in the relevant tes about new technologies within biomedicine. research disciplines and specialist competence The council seeks to communicate ethical issu- in ethics and law. At least one of the medical es relating to biotechnology and human health members has to have clinical competence and to non-specialists. the committee must also have competence in The UK Nuffield Council has published a large genetics and psychology. At least two of the number of reports with comprehensive scienti- committee’s members must be lay representa- fic documentation and has, moreover, set up tives. The committee’s members are nominated
39 031 Lilla rapport 03/09/02 14:19 Side 40
Ethical principles in european regulation of biotechnology | Linda Nielsen | Berit A. Faber | April 2002
by the Ministry of Ecclesiastical Affairs, level. The committee’s job is to be a coordina- Education and Research following recommenda- ting and advisory body on research ethics for tions from the Norwegian Research Council. the regional committees for medical research They are initially appointed for a term of 3 ethics. Additionally, the committee is required years with the possibility of reappointment. to inform researchers, administration and the public about current and potential research The Danish scientific ethics committees usually ethics issues in the field of medicine. In each of have seven members, i.e. four lay people and the country’s 5 health regions, local committe- three specialists. The committees’ period of es for medical research ethics (REK) have been operation follows the county council elections. set up using guidelines laid down by the The members are nominated by the county Ministry of Ecclesiastical Affairs, Education and council. The lay members are generally county Research, which also nominates the committe- council politicians. Their appointment takes es’ members. The committees are required to politics into account. The final nomination of vet all biomedical research projects involving the specialists is also made by the county human subjects. council, but must previously have been appro- ved by the three research forums of the The Danish scientific ethics committee system Universities of Copenhagen, Aarhus and is made up of regional, county-based scientific Odense and by the Danish Medical Research ethics committees and a central scientific ethics Council. This procedure is to ensure that the committee. From 1982, the system worked on specialists have knowledge of research, e.g. the basis of voluntary agreement, but since that they are active researchers. 1992 has been regulated by law. This means that it is illegal to carry out a biomedical rese- 6.2.2 Areas of responsibility arch project without permission from a scienti- The Dutch central committee controls all medi- fic ethics committee. The regional scientific cal research involving human subjects in The ethics committees assess medical trials invol- Netherlands. The committee also supervises ving human subjects, monitor approved trials the regional research ethics review committees, and participate in ethical debate in the region of which there are several dozen in the country. concerning biomedical trials. The Central These local scientific ethics committees (METC) Scientific Ethical Committee is an appeals body must be approved, and there is a condition that for decisions made by the regional scientific the committee fulfils a number of legal require- ethical committees, and this includes disagree- ments as to its composition and articles of ment within individual committees or between association. The assessment of biomedical several committees. The central committee has research involving human subjects will be made no competence to issue binding guidelines to either by a local committee or by the central the regional committees, but can recommend committee, depending on the type of research that they treat certain types of projects using in question; e.g. gene therapy and xenotrans- particular guidelines, with the aim, among plantation trials, as well as certain projects other things, of ensuring consistent treatment involving children, can only be assessed by the nationwide. central committee, which also advises on trials involving the use of embryos and the human 6.2.3 Assessment criteria germ line. The central committee (CCMO) also For the Swedish committee, it is laid down that acts as an appeals body. it must assess whether the project is scientifi- cally beneficial to undertake, including whether The Swedish regional research ethics committe- the anticipated benefits from the project out- es assess research projects involving the use of weigh any potential risks which the execution human subjects in biomedical trials. The activi- of the project may have for the individual sub- ty of these committees is not regulated by law ject/patient. Furthermore, the committee has and they are appointed on a voluntary basis. In to ensure that the subject is given sufficient practice, biomedical research projects in information about the implications of participa- Sweden cannot be undertaken without approval ting in the trial, and to ensure that informed by a regional scientific ethics committee. These consent for participation is given. are primarily based in hospitals and universities. In Danish legislation on the scientific ethical The Norwegian scientific ethics committee is an committee system a number of conditions are independent body, which acts as a ”watchdog”, prescribed which need to be approved before a information service and adviser at national trial can be undertaken. ”In its evaluation, the
40 031 Lilla rapport 03/09/02 14:19 Side 41
Ethical principles in european regulation of biotechnology | Linda Nielsen | Berit A. Faber | April 2002
committee will take especial care that the risks the civic panel produces its final document, from the project are assessed, that subjects or which is presented and published on day three. their guardians are fully informed about the trial and have provided written consent, that The model for consensus conferences consis- the subject understands that he/she can with- ting of dialogue between citizens and experts draw from the trial at any time and that he/she has been adopted in a number of other countri- is apprised of the project’s finances.” es. In the Europe region, consensus conferen- ces have been held on the application of bio- Moreover, the law also demands that emphasis technology in France, Germany, the be given to scientific standards, in that the Netherlands, Norway and the UK. The question committee has to assess whether the trial, in is whether it will eventually be possible to envi- its aims and methodology, meets high scientific sage holding consensus conferences at the standards, and that there are adequate European level, with a panel of citizens from grounds for carrying it out. different countries. This assessment has to be made because it is unethical to include people in a trial which does 6.3.2 Future panel not have sufficiently high scientific standards. In connection with extending the dialogue with politicians in the Danish parliament, the Danish 6.3 Other democratisation tools Board of Technology has established a future 6.3.1 Technology councils, panel of parliamentarians. including consensus The future panel follows, over a number of conferences years, a field of technological development via consultations and other events, and draws up The Danish Board of Technology and its proce- cross-party memoranda on the long-term politi- dures will be used as a basis for analysis, since cal potential and challenges in the field. it has worked with the consensus conference The future panel is a new concept in model over a number of years. Denmark, which makes it difficult at present to discuss its advantages and drawbacks. One The Danish Board of Technology has the job of can, however, say that the intention is to ensu- promoting awareness of technologies, their re that politicians have better opportunity for potentials and consequences for people, society direct dialogue with specialists about issues and and the environment; and this includes genera- problems concerning the future use of techno- ting debate about technologies, assessing tech- logy. nologies and advising Parliament and the government on technological issues. It is an 6.3.3 Values workshop - Norway independent institution with a board of 10 This workshop is interesting because one of its members and a committee of 50. aims is to establish a dialogue with a specific business sector about the ethics relating to the Consensus conferences have the aim of inclu- future development of the business sector. One ding citizens and their experiences in the tech- example was Norway’s fisheries in 2020. nology assessment and are therefore conducted as a dialogue between experts and citizens. The aims included: They normally stretch over 3 days and are - providing a complete and well-founded open to the public as concerns expert presenta- value-based assessment of Norwegian tions and the consensus panel’s questions to fisheries; the experts. The role of the experts is to inform - mapping out relevant values, so that a panel of citizens about the technology and its explicit value choices can be made; implications. The civic panel then jointly drafts - trying out a new method with reference to a final document which contains a concluding structuring ethical considerations as statement and position on the issue. The con- regards strategy choice; and sensus conference is managed by a planning - engaging in debate on ethics in the fishe- group, which advertises for and selects a group ries industry and in society. of 10-15 citizens, summons suitable experts and attends to conference promotion and publi- The strategies included: city. On the first day of the conference the - establishing a network, including a experts have the floor, while the second day working group from Norges Fiskarlag provides the panel members with the opportu- (fisheries union) and other institutions; nity to put questions to the experts. After that,
41 031 Lilla rapport 03/09/02 14:19 Side 42
Ethical principles in european regulation of biotechnology | Linda Nielsen | Berit A. Faber | April 2002
- developing scenarios for the fisheries and the public informed about its work and industry towards 2020, according to which take the initiative in making the ethical pro- four scenarios provided the basis for clari- blems surrounding biotechnology the subject of fying ethical aspects of strategic decisions public debate. in the fisheries industry; - developing an ethical matrix for the fishe- Furthermore, BIOSAM cooperates with the ries industry, in which the ethical values interministerial taskforce for biotechnology and are structured in relation to central ethical ethics (BioTIK), which is responsible for imple- principles and affected parties. The matrix menting a four-year action plan containing a is a diagram consisting of rows and range of initiatives concerning biotechnology columns with a checkbox, called a cell, at and ethics. The BioTIK taskforce coordinates each intersection. There was then produ- statutory work in the field on the basis of ced: an ethical matrix, in which the funda- recommendations from an external BioTIK refe- mental principles of fairness, dignity and rence group, consisting of representatives from welfare were specified for each affected councils and boards, non-governmental organi- party and then weighted to arrive at con- sations and researchers. crete values; an impacts matrix, in which specific options for action were evaluated; b. The Danish Council of Ethics and finally, an evaluation matrix, in which and the Animal Ethics Council numerical values indicate how far the Two councils, the Danish Council of Ethics and impacts described in the action matrix will the Animal Ethics Council, have similarly, over result in respect for the specification and recent years, cooperated more closely, by hol- weighting of the individual ethical values. ding joint information meetings. Additionally, a On the basis of the evaluation matrix, a particular joint focus has been directed at the final estimation of the options for action is question of cloning. Thus, in 2000, the Danish made. Council of Ethics published a discussion paper, dealing principally with issues concerning tech- 6.4 Cooperation between nologies for tissue and organ propagation and councils and boards the future potential for the genetic manipula- The distinguishing traits of biotechnologies, in tion of humans and animals. which different areas, actors and decision- makers need to interact, make it expedient to c. The Danish Council of Ethics open up new avenues for cooperation. and the scientific ethics commit- tee system The following gives examples of such coopera- In accordance with the act on the scientific tion between councils and boards in Denmark. ethics committee system and the act on the Danish Council of Ethics, the Central Scientific a. Biosam Ethical Committee and the Danish Council of In Denmark over the last 5 years, closer coop- Ethics are required jointly to address the more eration and coordination has been implemented fundamental ethical issues concerning biomedi- between councils and boards working with cine. The Danish Council of Ethics’ task is to questions of bioethics as related to human advise the Minister for the Interior and Health, health, animals and biotechnology. This coope- Parliament’s committee on the Danish Council ration is centralised in BIOSAM, which is a joint of Ethics and the health authorities about ethi- body of representatives from The Central cal matters relating to new biomedical techno- Scientific Ethical Committee, The Council of logy and human health. The Council is also Ethics, The Danish Board of Technology, The required to promote public debate about these Animal Ethics Council and The Animal issues. Over the past decade or so, the coope- Experimentation Inspectorate, and which liaises ration has resulted in the holding of information on ethical issues associated with biotechnology meetings in which representatives of the two research and the application of biotechnology, bodies have exchanged information about the including cloning and the genetic transforma- work. Furthermore, in recent years, there has tion of mammals. been closer cooperation between the Central Scientific Ethical Committee and the Danish BIOSAM also contributes to making Parliament Council of Ethics, which, among other things, and the public aware of new developments in has given rise to joint events, in which both research in, and the application of, biotechnology. bodies have planned and implemented the joint The joint body must continually keep Parliament initiatives.
42 031 Lilla rapport 03/09/02 14:19 Side 43
Ethical principles in european regulation of biotechnology | Linda Nielsen | Berit A. Faber | April 2002
d. Cooperation between the Danish Central Scientific Ethical Committee, the Danish Central Scientific Ethical Danish Forest and Nature Agency and the Committee and the Danish Danish Labour Inspectorate, attends to the aut- Medicines Agency horisation of human clinical trials involving The Danish Medicines Agency and the commit- gene therapy. tee system coordinated by the Danish Central 6.5 Analysis and evaluation of Scientific Ethical Committee operate a parallel democratisation instruments procedure for authorisation of biomedical rese- 6.5.1 Representation of experts arch projects involving clinical trials of non- and of lay people approved medicinal products. The Danish Medicines Agency grants the final permission Expert representation comprises groups of for such projects. According to this system of expert delegates representing the disciplines bipartite decision-making competency, it is the concerned, e.g. biotechnology, biomedicine, Danish Medicines Agency that makes the final philosophy and ethics, law, sociology and psy- decision on any authorisation to commence tri- chology along with other disciplines as als on medicinal products involving human sub- required. jects. The Agency’s decisions must be made on the basis of a recommendation from the com- The advantages of having such representation mittee system. Given that it is the committee are that this provides a means of securing system that has the sole authority to conduct a comprehensive and well-founded academic scientifically based ethical evaluation of a pro- expertise for the advisory and decision-making spective biomedical trial, the committee’s services rendered by the various committees. recommendation is in effect binding on the In this context interdisciplinarity is crucial, Medicines Agency as regards the scientific com- since under this concept the representatives of ponent of ethical evaluations. different disciplines can meet and discuss ethi- This bipartite decision-making mandate cal issues as a means of familiarising themsel- entails liaison, and this takes the form of a ves with each other’s terminology, culture and coordinating committee of representatives from scientific traditions. This then serves to promo- each of the two bodies. In recent years coope- te mutual understanding among different scien- ration between the two bodies has been devo- tific domains. ted largely to the EU draft directive on good cli- nical practice (GCP Directive), in which repre- It is essential that the concept of expert repre- sentatives of both the Danish Medicines Agency sentation is not defined too narrowly, and that and the Danish Central Scientific Ethical careful consideration is given to which experts Committee participated in the EU talks. will be the most appropriate, especially with regard to the need to include sociologists, e. Collaboration on gene therapy anthropologists, psychologists and other social In 1999 there was a case in the County of scientists. Aarhus concerning a research project involving gene therapy on human subjects as part of a The drawbacks of establishing forums compri- study of the treatment of patients suffering sed exclusively of experts are that they may from hepatic cancer. have a tendency to become somewhat ”intro- The ”Aarhus Case” revealed the need to esta- verted” in their choice of issues and mode of blish interdisciplinary collaboration among the discourse. Communication with the public and authorities mandated to grant authorisations decision-makers may be hampered by the fact for clinical trials involving gene therapy. Trials that many academics have no particular tradi- of gene therapy involving human subjects tion for opening their debates up so as to make involve major environmental, epidemiological them accessible and comprehensible to the and ethical aspects. general public. In response to this sequence of events a coor- dinating committee was appointed by the Lay representation involves delegations made Danish Medicines Agency for the purpose of up as ”counterweights” to (academic) experts. promoting dialogue among the authorities The involvement of lay people is already a responsible for granting the various authorisa- time-honoured component of the Danish judici- tions. The coordinating committee, made up of al system, the purpose of which is to ensure representatives from the Danish National Board that the public’s sense of justice is reflected in of Health, the Danish Medicines Agency, the criminal procedure. In addition, the involve-
43 031 Lilla rapport 03/09/02 14:19 Side 44
Ethical principles in european regulation of biotechnology | Linda Nielsen | Berit A. Faber | April 2002
ment of lay people occurs in public governance, foundation for decision-making than if all deci- e.g. in central tax administration in Scandina- sions were made solely by such experts. via. In the consensus conference model the use of lay people may be understood as drawing a The drawbacks of retaining the services of lay parallel with jury service in the administration people include the risk that they may become of justice. The experts are comparable with the ”over-qualified” in connection with their invol- witnesses summoned before a court; the panel vement and representative services to expert with the jurors, who, after hearing the expert bodies. A failure to take special account of the testimonies, withdraw to formulate their collec- fact that the role of lay people is precisely to tive response to the conference issues, infor- provide the originally-intended safeguards and med by the presentations of the experts and to approach the issues from new angles might their own common sense. mean that the values and culture of the acade- mic experts might come to dominate the agen- The advantages of drawing on the services of da such that the lay element is at risk of being lay people are, among things, that they have a ”held hostage” by expert opinion. It should the- confidence-building function, whereby the link refore be ensured that the views held by lay with general public opinion and common sense representatives are allowed to evolve freely, may be sustained. Lay people thus serve to and that ”down-to-earth” opinions are not com- contribute an element of ”wisdom”, which ensu- promised. Further problems may arise if exten- res that account is taken of the opinions and sive lay participation displaces the volume of convictions that exist as implicit tenets in the experts deemed necessary without excessively values embraced by a population. This should swelling the ranks of the organisation. also be considered in the light of the fact that lay people are perfectly capable of acquiring Political participation in debate-generating objective and valid insights and that scientific activities will often be useful; the problem experts are just as susceptible as lay people to being that politicians tend to be reluctant to subjectivity and personal factors. Moreover, the get involved at an early stage in issues that involvement of lay people serves a democratic may be regarded as ”dangerous” or ”awkward” function in that it exercises the principle of to take a public stance on. In relation to ethics autonomy and counteracts the formation of committees, one purpose of which is to serve unintended power bases. This serves to esta- as an advisory function, it is doubtful whether blish what might be termed a ”bottom-up” ele- political participation would be of value. ment in decision-making processes, just as it ensures dialogue on the issues that the public The advantages are that this ensures a ”direct finds to be important, and ensures that the line” to the political domain, which in turn concerns deliberated are communicated to the ensures that the advisory element dominates, public in a way that is comprehensible to the and that the political domain becomes accusto- ”man on the street”, and which thereby contri- med to discussing difficult ethical issues in gre- butes to social and democratic learning proces- ater depth. ses. The subjective and personal factors brought into play by lay delegates will thus be The drawbacks may be that politicians run the incorporated in consultations on the issues that risk of backing a given opinion prematurely, present themselves for discussion. which again may pose further problems. The risk is also that the political level engages too Denmark maintains a large body of lay people early in the process, when it may be more in its ethics committees - according to a model helpful if the debate can proceed in the absen- in line with its long-standing tradition for retai- ce of political interests. ning the services of lay people in the judicial system, in connection with jury service in One conclusion on the views presented here appeals courts, for example. The findings of might be that it is vital to ensure broad inter- consensus conferences have been that ordina- disciplinary expert representation - possibly ry, motivated citizens are capable of acquiring complemented by a panel of academic advisers and analysing complex scientific information, who may be consulted on specific matters - but and of drawing their own, independent conclu- that there may equally be a need to ensure lay sions. The ”worldly wisdom” possessed by lay representation, both in the democratisation people serves to complement the more abstract instruments designed to generate debate, and and generalising insights of academic experts in ethics committees - whether these serve an and thereby contributes to a more balanced advisory or controlling function. This ensures
44 031 Lilla rapport 03/09/02 14:19 Side 45
Ethical principles in european regulation of biotechnology | Linda Nielsen | Berit A. Faber | April 2002
an open, transparent system, as well as a important in the light of an evident lack of counterweight to prevent medico-professional public confidence in government-appointed and research-based interests from dominating advisory bodies. It may therefore be preferable in relation to the mechanisms for protection to establish independent bodies of this nature - that may be deemed equally important. At the ideally at the national level - and to furnish same time this promotes valuable dialogue bet- them with sufficient financial resources to allow ween experts and lay people. In this context it them to act in an advisory and debate-promo- is important that lay people are provided with ting capacity. While some countries have a sufficient, readily comprehensible information single, centralised ethics committee and sub- such that they may render their services on a committees to attend to the more detailed par- sufficiently well-informed basis, being apprised ticulars, other countries primarily rely on a of the technical data. number of dedicated committees. Similarly, commissions may be permanent or provisional, The retention of lay services is often endorsed mandated to generate debate, to advise, aut- in relation to debate models proper, which refer horise or regulate, and assigned a more or less to public debate in various forums, etc. explicit remit. However, it is important that the lay contingent and generalised debate are also employed in One essential aspect is to avoid any dispute relation to scientific ethical committee systems over authority among the various bodies in which actual authorisation of biomedical appointed, and prevent overlap and the dupli- research projects is effected, since these com- cation of effort this might give rise to. In this mittees do not necessarily consider broader respect it is important to establish actively coo- ethical implications involving general societal perating bodies. This need also emerges from concerns and regard for future generations. the fact that many of the ethical issues addres- Such aspects may play an important role in sed touch on multiple concerns that may need connection with deliberations on research pro- to be addressed by separate committees. The jects seeking to employ technologies such as need for interdisciplinarity and cooperation is xenotransplantation, stem cell research and therefore pronounced. cloning of human cells. Deliberations on the broader ethical implications of such projects The difference between the desire to achieve should therefore be ensured by retaining the consensus or not is based on a weighing of services of lay people in scientific ethical com- advantages and drawbacks. mittee systems and by incorporation of the debate models proper. The advantages of consensus would appear to be that the greater the level of agreement pre- The question of the term in which lay people sented by a given ethics committee, the grea- should serve has also been debated. The fact ter will be its prospects of bringing influence to that it takes time for lay people to familiarise bear on the regulators. themselves with complex issues speaks in favour of an extended period of service. In con- The drawbacks are that such a committee will trast, the fact that it may be necessary at thereby forfeit much of its impetus, since con- times to ”inject” fresh opinions and new partici- troversial issues and/or principles are usually pants into the debate speaks in favour of a rat- the very aspects that make consensus difficult her more limited period of service. The latter to achieve. It may therefore be helpful to fur- argument would seem to be the more persuasive. nish the decision-makers with detailed informa- tion as to where any dispute might arise, and 6.5.2 The purpose and which ethical principles may be assessed and role of the committees weighed differently such that the decision- It is often emphasised that is of the utmost makers will have the best possible basis of importance for ethics committees to be inde- information at their disposal to assist their deli- pendent. Only in this way can they meet the berations. need for information and debate in a way that comprises an objective stance on current regu- There is also a need to establish cooperation lation and prevailing opinion, even when this is among the various administrative units assig- at odds with the position held by government ned to address ethical concerns - partly in the and parliament for example. The UK Nuffield form of experience exchange, partly with the Council has even gone so far as to stress that aim of ensuring that there is minimal inconsis- independence from national government is tency within a single area and between one
45 031 Lilla rapport 03/09/02 14:19 Side 46
Ethical principles in european regulation of biotechnology | Linda Nielsen | Berit A. Faber | April 2002
area and the next. The same issue may arise Co-determination and openness form the basis among regional, local hospital-based authorisa- for the debate models in the various formats tion bodies, for example, meaning that practi- discussed in the foregoing, and it is encoura- ces may vary in different national regions. This ging to find that these principles are becoming coherency would seem appropriate in the light more widespread all the time and have now of the fact that local variation should be also been identified with great emphasis by the acknowledged, whereas in terms of equality EU in the form of a drive for ”proactive civic this may appear less reasonable. responsibility”. However, in the authorisation system the principle of co-determination and 6.5.3 Criteria for ethical openness in decision-making is far from always evaluation observed, among other things because the One of the difficult questions concerns which issue of intellectual property rights may conflict criteria should determine whether an authorisa- with the provision of more extensive informa- tion is granted or rejected. tion. Greater openness could presumably be achieved without producing any conflict with The ethical principle of economic and qualitati- patent rights and so forth, which would be ve benefit is occasionally comprised by precon- desirable in the case of any applications that ditions dictating the balancing of the risks raise more general ethical issues. against the benefits of carrying out a given bio- medical research project involving human sub- jects. In addition, we occasionally find a requi- rement that there must be justification for car- rying out a project. However, the problem may be that the decision-making process and the decision-making forum concerned may not be geared to or possess the resources to make a broad and more nuanced ethical evaluation, confining itself instead to a more narrow, scien- tifically based ethical angle of approach. In the debate models these ethical principles will often be incorporated, despite the fact that they may be challenging to deal with, since it can be inordinately difficult to predict economic and qualitative benefits balanced against any longer term risks.
Autonomy, dignity, integrity and vulnerability are assured in scientifically-based ethical aut- horisation systems in the shape of the require- ment concerning informed consent. However, it is doubtful whether the principles of dignity, integrity and vulnerability will actually be sub- jected to sufficiently incisive, nuanced and pre- dictive considerations in an authorisation system. Just distribution of benefits and burdens are not incorporated in the authorisation system, save for the requirement that there must be justification for carrying out a trial. However, there is often reason to question whether those research projects that do go ahead actually take sufficient account of the needs assessment that this ethical principle represents. In the debate models, this principle can readily be addressed - which it often is, but here too it will often be difficult to document and analyse its use in any detail.
46 031 Lilla rapport 03/09/02 14:19 Side 47
Ethical principles in european regulation of biotechnology | Linda Nielsen | Berit A. Faber | April 2002
7 Regulatory consent does not offer adequate protection in situations where there is inequality in status. It instruments is therefore not a question of saying yes or no to genetic testing, but of saying yes or no to a In the following we outline the functions of given job or a given insurance policy. regulation and introduce various forms of regu- latory instruments. The advantages and draw- Another example is the function of protecting backs of the various regulatory instruments will future generations. This concern is to be regar- subsequently be analysed and evaluated. ded as of such importance that it must neces- sarily be ensured by legislative means, among 7.1 Regulatory function other things because there can be no certainty Legislation has three primary functions, that is: that this concern will be observed by those normative, protective and regulatory: immediately affected. Besides the physical environment the regard for future generations 7.1.1 The normative function can also be observed by safeguarding the cul- International instruments will to a great extent tural environment, social interactions, etc. often be normative in nature in the interests of achieving consensus. Examples of this may be Finally, protection in the form of legislation may found in the UNESCO Declaration, the Council be appropriate for purposes of risk minimisa- of Europe’s Convention on Human Rights and tion, as exemplified by the precautionary prin- Biomedicine and the EU Charter of ciple. Fundamental Rights (see Section 4 above). Art. 6 of the ordre public clause in the EU patents Many of the areas in which the protection con- directive also contains a provision that can be cern is an issue will be those areas in which characterised as normative. In addition we find informed consent does not provide adequate that national traditions in some countries con- protection, either because those affected are tain examples of provisions with a normative unable to give such consent, or because depen- quality. The normative component of legislation dencies, positions of power and the like effecti- entails that certain values and interests are vely mean that informed consent does not emphasised as worthy of protection. Such valu- afford adequate protection. es and interests might include human dignity, protection against genetic discrimination, prohi- 7.1.3 The technical function bitions against germ line interventions, cloning, The technical function can provide clarity and a hybridisation and research involving embryos reliable method of dealing with controversial (after a certain timespan). This function of the areas in biotechnology. The legal status of legislation is based on a vision that laws may much of what goes on in practice in relation to be educational, a means of exercising ethical biotechnology may be unclear in the absence of principles. explicit rules. Regulation can ensure that those involved know what is acceptable or not accep- 7.1.2 The protective function table so that they can perform their duties and This function of legislation balances protected make their decisions in compliance with this. values against other interests, and prescribes sanctions for abuse, while it seeks to minimise One example is regulation in relation to scien- risk factors for patients and other persons tists performing research involving embryos, affected by biotechnology and its applications. and firms working on xenotransplantation, in which those affected by regulation of what is Examples include the protection of children permissible/ not permissible are provided with born as a result of medically assisted procrea- a legally binding framework such that they do tion and persons in a vulnerable position such not need to assume any personal responsibility as those applying for a position of employment for whether a given research project is to be or for insurance cover, etc. This may produce regarded as ethically defensible. Moreover, legislation to ensure that people cannot be rules concerning confidentiality and duty of legally required to undergo genetic testing, etc. non-disclosure in relation to genetic information in cases where they are applying for a particu- obtained by doctors may also be seen in this lar job, insurance, a pension or the like. In this context. Furthermore, legislation can guarantee way their ”right not to know” about their gen- special rights, for example, patient rights, the etic heritage may be protected. Legislative pro- doctor’s right of refusal, the patient’s right of tection may be necessary because informed refusal and so forth.
47 031 Lilla rapport 03/09/02 14:19 Side 48
Ethical principles in european regulation of biotechnology | Linda Nielsen | Berit A. Faber | April 2002
Overall, one conclusion might be that the tech- the right to be informed of the donor’s identity. nical function is there to prescribe definitive rules for what is ethically acceptable/unaccep- Prohibition and sanction are familiar forms of table, and to define precisely which rights and regulation. Examples of prohibition and punitive obligations must be observed by all parties provisions would include bans on cloning, on concerned - in their mutual dealings and in gene therapy on germ line cells, on ”chimeras”, relation to society. etc. and on retaining embryos in vivo for rese- arch purposes for more than fourteen days. 7.2 Different types of regulatory Other examples would include prohibitions instruments against requiring genetic testing in connection Surveying biolaw across Europe, examples of with employment or insurance. different legislative instruments would include those listed below. Moratoriums are a form of regulation that have acquired status in relation to biotechnology. Framework legislation enables the establish- Moratoriums suspend activity, giving pause for ment of special forums with the right and duty thought so that the actors involved can find to undertake evaluation of ethical implications their ”ethical feet”, and avoid a situation in of selected fields in biotechnology. Examples which it becomes impossible to impose mea- include the appointment of ethical councils, ningful restrictions because a given practice committees for scientific ethical evaluation, has become commonplace before it has under- bodies imbued with the right and duty to award gone ethical evaluation. At the same time the licences under certain terms, authorisation pro- burden of evidence is, as it were, shifted, in cedures and so forth. This form of instrument the sense that those seeking to introduce new ensures, through parliamentary channels, that practices are obliged to argue their case. a domain may be established in which ethical debate can thrive. Professional standards can take the form of soft law, that is, guidelines that are not binding in Informed consent has come to represent one of an official, legal sense. Recommended guideli- the keystones of health legislation in recent nes of this nature may be laid down by a scien- years. Informed consent is consequently a pre- tific association, and any sanctions for non- condition for treatment, medically assisted pro- compliance with the guidelines may vary. A creation, participation in clinical trials, trans- notable example is the World Medical plantation, etc. Rules concerning informed con- Association’s Declaration of Helsinki on medical sent serve to guarantee autonomy. Obviously, research involving human subjects. special problems may arise in relation to chil- dren and other persons unable to give informed Case law, consisting of the written opinions of consent. judges giving the verdict in a particular case, is the standard form of regulation in a number of Directives, authorisation requirements or the common-law countries such as Great Britain. like permit the formulation of provisions that According to this system, the link between certain treatments, research activities, etc. ethics and law is created by case-by-case ver- may be carried out only on condition that a dicts brought before the judiciary. From the licence, authorisation, permit or similar has specifics of case law, more general ethical prin- been obtained. In addition to which there are ciples with legal force can sometimes be elici- the directives prohibiting certain methods, ted. objectives, etc. Regulation of education and research are Rights may be granted by legislation. One important models for ensuring the operationali- example would be patent protection, according sation of ethical principles. This can be a to which a patent holder is accorded the sole means of creating scope and tradition for incor- right for twenty years to industrial use of a porating ethical reflections and considerations patented invention. Another example would be at the earliest possible stage in any procee- the right to retain frozen sperm, eggs or dings. The need to include bioethics as a sub- embryos following the death of the donor, or ject in education comprises both ethical issues the right of relatives to consent to or not give associated with a particular field of research or consent to organ donation. A third example practice, and more general ethical issues. The would be revocation of donor anonymity such connection between natural sciences/health sci- that a child produced by donation is accorded ences, ethics/philosophy and law/social scien-
48 031 Lilla rapport 03/09/02 14:19 Side 49
Ethical principles in european regulation of biotechnology | Linda Nielsen | Berit A. Faber | April 2002
ces means that there is a need for an interdis- rejected. This can come from an assessment of ciplinary approach to the issues raised by the one or more of the ethical considerations that new biotechnologies. This can promote direct have arisen. It may be judged that there is dialogue and thereby mutual inspiration. It is insufficient financial or qualitative gain - e.g. on essential that students be introduced to bioet- the grounds of risk assessments - for a given hical issues early on in their studies. At a later technology to be applied in a particular way, or stage, bioethical topics can then be explored in it is considered to be contrary to considerations greater depth as required, especially in relation of dignity to admit a particular application. to more narrowly defined, subject-specific issu- Formal legislation can be essential when con- es and concerns regarding research ethics. sent does not provide adequate protection, e.g. because the implicated parties’ circumstances One noteworthy example of a drive to ally are not equal, or because a vulnerable individu- research interests with ethics, environment and al is involved. Moreover, formal legislation can safety is found in article 1 of the Norwegian act be necessary where fundamental values are at on genetic engineering, which lays down three stake, e.g. regard for future generations, for general requirements regarding the production the environment and so on - where the indivi- and use of genetic engineering, and regarding dual may not perhaps feel responsible in the applied or commercial research: It must 1) be same way and where the need for a general ethical and socially defensible, 2) be in confor- ruling is therefore imperative. mance with the principle of sustainable deve- lopment, 3) cause no damage to health or the Legislation can play an especially significant environment. role by emphasising the protective function. Finally, formal legislation ensures that the pro- Besides the need to create a common platform cess is open and democratic. for addressing ethical issues, it is important to create a well-founded basis for discussion and A drawback of formal legislation is that it is dif- knowledge exchange among students and wor- ficult to be sufficiently precise as concerns ethi- king scientists, so that they can participate in cal principles. If it becomes too vague, regula- and influence qualified public debate about the tion will fail to provide meaningful protection. If ethical questions linked to these issues. Studies it becomes too heavy-handed, it can risk (made in Denmark by Peter Sandøe and Gitte obstructing progress that is desirable, e.g. by Meyer4) have shown that scientists and the restricting research in an unintended fashion. public not talking the same language repre- Moreover, it can appear as hostile among sents a serious barrier to dialogue - there are affected parties, such as researchers and busi- different conceptual interpretations, in that, for ness people, which can be detrimental. Finally, example, scientists use a broad concept of util- legislation can strip from affected parties their ity and a narrow concept of risk, while the con- individual or professional responsibility and also cerns of the population at large are expressed in this way be detrimental. And the law does as a broad concept of risk and a narrow one of not necessarily render the affected parties ethical. utility, e.g. for fellow human beings in need in the third world, for the sick, or for nature. b. Framework legislation The advantage of framework legislation is that 7.3 Advantages and drawbacks of it indicates the specific forums - and hence different regulatory models actors - who have a particular duty to partici- pate in the ethical debate and decision-making a. Formal regulation process. At the same time, pronounced flexibili- One advantage of formal legislation is that it ty is achieved, since it is up to these different can fulfil the functions described above, namely bodies to determine how a given task is to be to set standards, protect and regulate. performed in detail and when, for example, an
This ensures that the application of biotechno- approval, a licence or similar is to be granted, logy is not undertaken without control and and when refused. governance. One could say that the law is used to delineate which of biotechnology’s potential The drawback can be that it may be difficult for applications are desirable and which are to be the bodies in question to know which criteria to
4 Peter Sandøe and Gitte Meyer: Project report: ”Oplysning og dialog om bioteknologi i forhold til planter” [Information and Dialogue concerning Biotechnology in relation to Plants], supplement to the newsletter 49 ”Bioteknologi i Praksis” [Biotechnology in Practice], Centre for Bioethics and Risk Evaluation, June 2001. 031 Lilla rapport 03/09/02 14:19 Side 50
Ethical principles in european regulation of biotechnology | Linda Nielsen | Berit A. Faber | April 2002
give detailed emphasis to when making an - and, perhaps, abide not only by their letter, assessment for a licence, an approval or simi- but also by their spirit. At the same time, they lar. It is therefore important for such criteria to can be easier to amend than formal regulation be debated and drawn up - although not neces- and so be more suited to the dynamic biotech- sarily in great detail. nology area in a number of cases. They can in this way have a significant conduct-regulating c. Rules regarding consent function. The advantage of rules regarding consent is that decisive emphasis is given to autonomy. The drawback is that they do not include a bro- This is appropriate where there is parity between ader ethical perspective, e.g. not necessarily all the consent giver and the consent receiver. questions relating to just distribution of bene- Moreover there is an assumption that there is a fits and burdens, vulnerability and dignity, etc. coincidence of interest between the person The specialist point of view may often be consenting and anyone consenting on their expected to narrow the aspect of the values behalf. Finally, it is important that the affected and interests involved, since there is not, wit- parties are those embraced by the consent. hin professional standards, the same tradition However, consent is an inappropriate or inade- for taking account of wider concerns of protec- quate form of regulation in situations where no tion. The specialist professional standards are parity exists between whoever is to give con- centred chiefly on the traditional scientific need sent and whoever is asking for it. This will at for quality - and frequently on the need for times be the case, e.g. in relation to emplo- consent, regard for integrity, etc. yee/employer, insured/insurer, etc. Moreover, consent can be problematical where a schism One particular development from soft to hard arises between, for example, allowing the mot- law can occur, in that a regulation which starts her alone or both the future parents to give out as ”soft law” can become a ”locomotive” for consent to research on embryos. Finally, as a a development towards a more detailed legal form of regulation consent assumes that there regulation of an area, and thereby also for is no regard for persons or interests beyond establishing binding legal rights for an area not the parties to the consent, e.g. future genera- previously characterised by legislative codifica- tions, sustainability, the vulnerability of the tion. This was the case, for example, with the natural world and so on. Declaration of Helsinki, which set forth the first guidelines for the conduct of biomedical trials d. Prohibition and sanction on humans. This started out as a voluntary The advantage of prohibition is that no issues professional code, but subsequently created the are allowed to evade social control, out of the background and learning environment for much general principle that what is not prohibited is of the development which biomedical research normally permitted. This presupposes precision and the treatment of patients has undergone in the drawing up of regulations. over the past 30-40 years. In Denmark, for example, the scientific ethical committees’ work The drawback of prohibition can be that it was established by law a decade ago, and this appears to yield a prohibitive legal position will also happen in other countries as a conse- when compared to the needs and benefits that quence of the directive on good clinical practice. arise in practice. It can be difficult to ensure the flexibility which the dynamic development f. Case law of the biotechnology area can be said to create A clarification of the legal position by judges a need for. One example is the prohibition on has the advantage that a position is only taken cloning techniques, which may prove to impose when a matter has evolved into a problem, and tight restrictions on any subsequent intentions that a position is taken only on precisely that concerning stem-cell research, to the extent problem. that these require the use of cloning techniques. The drawbacks, however, are obvious. Case e. Professional standards law, where the legal development is laid down Professional standards have the advantage by judges in the form of a ”patchwork” made that they are agreed upon, and that they the- up of isolated cases, does not generally appear refore may be assumed to arise from internal to be especially suited to biotechnology. Firstly, dialogue and consensus, which means that the there will be uncertainty as regards what is affected parties feel duty-bound to abide by the acceptable or unacceptable until the judgement agreed standards, even if they are not binding is made, and that can take a long time.
50 031 Lilla rapport 03/09/02 14:19 Side 51
Ethical principles in european regulation of biotechnology | Linda Nielsen | Berit A. Faber | April 2002
Secondly, it will be about a specific case, in which only a small facet of biotechnology beco- mes the object of legal clarification. Thirdly, it will often be a question of a post factum ruling, since the applications will be able to continue while the cases are pending. Finally, economic circumstances and, for example, questions about who has the right to prosecute, will lead to positions not being taken on the urgent questions that biotechnology raises.
51 031 Lilla rapport 03/09/02 14:19 Side 52
Ethical principles in european regulation of biotechnology | Linda Nielsen | Berit A. Faber | April 2002
8 The toolbox - will the resulting state of law become too inflexible? - check-list - will it be too difficult to amend? - will it impede progress? The tools consist of two essentially different instruments, which are here termed regulatory Or is formal regulation necessary to models and debate models, respectively. The - protect future generations and culture? following sketches out an abbreviated check- - ensure justice and balance interests? list, which can form the background for deci- - ensure that the Community’s (societal) sions on the application of the different tools as interests prevail over individual demands? concerns operationalisation of the ethical princi- - guarantee individuals’ rights (autonomy, ples. non-discrimination etc.)?
8.1 Regulatory models d. Is international regulation appropriate, since ethical problems are international Toolbox and protection is therefore better and equ- ality is increased, or Regulatory models - will it result in governance by the lowest • International conventions, directives common denominator? • National legislation of a substantive nature, - will decisions be too vague and imprecise? including prohibition, orders, rights, etc. - will protection be too weak? • Framework legislation to ensure authorisa- tion procedures, etc. In choosing a forum, account must obviously • Case law be taken of what is possible, including conside- • Professional standards, etc. ration of the difficulties of, for example, amen- • Provisions or practice concerning educa- ding conventions, regulations, directives, etc. tion, information, debate and dialogue At the same time, the choice of forum must take account of whether the individual country has a tradition of formal regulation or common 8.1.1 Choice of forum law. Finally, it will be crucial for the regulation a. Is non-regulation (laissez-faire) appropriate to offer suitable guidelines on the content of for the area, since supply and demand will the ethical assessment. Here, the type of regu- provide good support and control via the lation chosen will be decisive. usual market mechanisms, or - will the disadvantaged or vulnerable be 8.1.2 Choice of type left in the lurch? a. Precautionary measures, which prescribe - will control by the market be too simplistic? specific conduct? - will non-regulation disregard groups which - might be, for example, a prohibition, an cannot speak for themselves, including order or a licence. future generations? b. Prohibition model b. Are professional standards appropriate, - prohibits some specific research, objective, since there is agreement in the relevant conduct or similar. group and the opportunity for sufficient development of broad and dynamic ethical c. Authorisation model standards, or - possibly with built-in monitoring and - will it become more a question of a nar- inspection. row, specialist point of view? - will regulation become too expert-oriented d. Rights model and without appreciation of the population’s - can create clarity attitudes and the political level? - can be difficult to manage and sanction. - will the ethical point of view become too narrow? e. Discretionary model - can accommodate adjustment in line with c. Is national regulation appropriate, since it new knowledge, methods, etc. ensures democratic control and (reinforced) - many different concerns can be incorpora- normative provisions and protection, or ted and balanced
52 031 Lilla rapport 03/09/02 14:19 Side 53
Ethical principles in european regulation of biotechnology | Linda Nielsen | Berit A. Faber | April 2002
Ethical Councils - important to define and limit what is to be included in a discretionary consideration - ensure that competent individuals feel - openness to interpretation may result in duty-bound to engage in the debate weak protection - can act as advisors to decision-makers - can be difficult to sanction - the question of membership must be care- fully considered, including interdisciplinari- f. Revision model ty, lay representation, parliamentary - frequent assessments as to whether representation, etc. adjustments are required - the question of modus operandi, including - can involve uncertainty working groups, expert involvement, etc. - in practice, can be difficult to carry out must be considered even essential revisions. - How far one should go to achieve consensus must be carefully weighed against the g. Moratorium desire to emphasise the nature and value - provides scope for an ethical pause for of the arguments. thought, without developments continuing unhindered 8.2.1 Consensus conferences etc. - can halt desirable development in a field - consensus conferences, future studies workshops and similar can ensure breadth h. Education in the public debate - can ensure that ethical assessments are - can be inventive with regard to how the inculcated in researchers debate is implemented and ”staged” - can ensure that ethical assessments become - can provide a pointer as to ”public a natural part of the next generation’s opinion” frame of reference. - the media can contribute to extending the debate 8.2 Debate models - narrative writing competitions, essay com- petitions in schools, videos, etc. can be Toolbox used to promote participation by the up and coming generation. • Ethical committees • Ethical councils • Technology councils • Consensus conferences • Future studies panels • Values workshops
Use of this toolbox is an extension of the EU Commission’s recommendation that societal dialogue and monitoring are important factors, which should accompany and direct the deve- lopment of biotechnology. The platforms and the ethical debate are comparable with the classical agora, in which researchers, legisla- tors, administrators, tradespeople and lay people were convened. As emphasised by the EU in its policy paper, public debate on biotech- nology among researchers, industry and civil society should be stimulated, and it is impor- tant here that developers and marketers of products assume a distinct ethical responsibility for clarifying potential drawbacks and risks which may occur in relation to the development and utilisation of these products.
53 031 Lilla rapport 03/09/02 14:19 Side 54 031 Lilla rapport 03/09/02 14:19 Side 55
Ethical principles in european regulation of biotechnology | Linda Nielsen | Berit A. Faber | April 2002
PART FOUR
ETHICAL PRINCIPLES IN EUROPEAN REGULATION
• Conclusions and recommendations
• Prospects and challenges
• Postscript
55 031 Lilla rapport 03/09/02 14:19 Side 56
Ethical principles in european regulation of biotechnology | Linda Nielsen | Berit A. Faber | April 2002
9 Conclusions and recommendations Problem Risk Ethics Process Regulation
9.1 Introduction Biotechnology has much to offer, and much Tools available? Risk assessment hope is pinned on its potential. However, at the Risk management same time, the current and future applications Risk communicaiton of biotechnology are cause for concern to the Tools available? extent that large groups of the general public Elaboration of ethical principles reject certain aspects of it - even where no evi- dence has been found of any direct, substanti- Tools available? ve risk. Debate models
Ethics verbalises the values and the concerns - Tools available? although it necessarily draws on ”yesterday’s Regulatory models words” to convey ”tomorrow’s concerns”. In this report the main emphasis is given to the following four ”sets” of ethical principles: 9.2 Can experience from the human area be applied to the - Economic and qualitative benefits foods area? - Autonomy, dignity, integrity and vulnerability The following section highlights protection issu- - Just distribution of benefits and burdens es, the risk assessments and the ethical princi- - Co-determination and openness ples that have prevailed respectively in the health sector and the foods area, and examines Firstly, we address the question of how experi- the extent to which principles and findings from ence accumulated in the area of human health the health sector might be applied in the foods (the ”human area”) may be applied to the area. This is a key issue in the light of the foods area as regards the incorporation of ethi- trend in food and product regulation whereby cal principles in food control. A large body of scientific risk assessment is made the arbiter of experience has gradually been amassed in this whether marketing authorisations etc. are area, and it would seem pertinent to seek to granted, while in the health area the tradition apply these findings to the foods area; the has to a far greater degree evolved so as to challenge being to determine whether ethical incorporate ethical evaluation. principles should be incorporated more explicit- ly in regulation. a. Protection issues and ethical principles in the health sector Secondly, we consider the question of what Over the last fifteen years the public health barriers and opportunities exist for further system in a number of countries has gradually operationalisation of these ethical principles in distilled off a number of issues concerning the regulating both the human health area and the protection of patients receiving treatment from foods area. To that end, we propose a number the public health system, and serving as rese- of tools that may be employed, while we also arch subjects in biomedical trials. These princi- present an analysis of what role the individual ples have been expressed formally in docu- actors in these areas might play as regards fur- ments such as the Council of Europe’s ther incorporation of ethical principles in deci- Convention on Human Rights and Biomedicine; sion-making processes and regulation. in the EU’s GCP Directive and in a large num- ber of laws in the Member States. ”The Ethical Process” as a concept, and the associated tools available may be illustrated by The ethical principle associated with economic the following model: and qualitative benefits appears to have been perceived as largely self-evident as it applies to the health sector in the sense that health, medical treatment and, by extension, medical research, are regarded as qualitative benefits. Examples of direct incorporation of the principle are found in the requirement that there must
56 031 Lilla rapport 03/09/02 14:19 Side 57
Ethical principles in european regulation of biotechnology | Linda Nielsen | Berit A. Faber | April 2002
be ”justification” for biomedical trials involving Co-determination and openness are emphasi- human subjects, and in the Convention on sed as highly important principles by the EU, Human Rights and Biomedicine’s affirmation the Council of Europe and via a large number that progress should be for the benefit of pre- of national measures (see Chapter 7 for further sent and future generations, and the principle discussion). expressed in both this convention and in the Unesco Declaration and according to which the The principal characteristic of the rules applying interests of the human being are to ”prevail in the health area, and that protect patients over the sole interest of society or science”. and research subjects is primarily the protec- The qualitative benefits in the sense of ”protec- tion of all persons, i.e. a highly individual-ori- tion from risk” are assured through rules con- ented protection issue. Other ethical principles cerning prior approval of biomedical research than respect for the rights of the individual are projects, concerning ”good clinical practice”, found in regulations on artificial insemination, and concerning the responsibility of doctors for which in certain countries entail considerations medical treatment. beyond traditional health issues. Restrictions applying to the individual informed by social The protection issues that characterise protec- and religious values are expressed as restric- tion of patients especially are autonomy, digni- tions on who is entitled to receive artificial ty, integrity and vulnerability. This is illustrated insemination so that, for example, doctors are by the principle that medical treatment must not permitted to artificially inseminate lesbian not be given without the patient’s informed women, or as prohibitions against the donation consent. This also means that medical doctors of eggs and/or embryos. and other health professionals have a duty to inform patients of any undesirable effects asso- b. The foods area - substantial ciated with a treatment, and to inform them of equivalence - the precautionary alternatives to the therapy proposed. The ind- principle - sustainability ividual is also entitled to choose to be informed In the foods area, the basic premise is to of his/her health condition or to refrain from employ the scientific principles that have been receiving such information (the ”right not to elaborated and refined over the years. The fol- know”). Moreover, health legislation comprises lowing section describes the progression in this a number of provisions for protection of especi- area from the principle of substantial equiva- ally vulnerable groups such as the elderly, chil- lence towards, on the one hand, the precautio- dren and individuals incapable of giving infor- nary principle, which has informed international med consent to medical treatment. Protection regulatory efforts over the last few decades, of integrity is ensured through rules governing and on the other hand, the principle of sustai- confidentiality in the doctor-patient relations- nability, and for each of these principles discus- hip, including the doctor’s duty of non disclosu- ses the possibility of transcending purely scien- re, together with the sanctity of private life, tific considerations to incorporate ethical princi- including the right to protection against perso- ples. nal health data being made public, and rules concerning non disclosure of personal data The principle of substantial equivalence5 was relating to medical information. Human dignity first described by WHO and the OECD in special is also emphasised in the Convention on reference to foods derived by modern biotech- Human Rights and Biomedicine. nology. According to the OECD definition, exis- ting whole foods may be used as a basis for Just distribution of benefits and burdens is a comparison when assessing the safety of novel principle implemented primarily at the interna- or modified foods. If the novel food is found to tional level. The Convention on Human Rights be comparable with its traditional counterpart and Biomedicine, for example, emphasises in toxicological and nutrient testing, it may be equal access to health services, while the treated in the same way as that counterpart in Unesco Declaration asserts that the benefits of respect of its safety. Official safety assessments the technologies employed must be made avai- take account of whether proteins are formed lable to all. that might give rise to allergic reactions, and of deviations in constituent protein, fat, vitamins,
5 Source: 97/618/EC: Commission Recommendation of 29 July 1997 concerning the scientific aspects and the presentation of information necessary to support applications for the placing on the market of novel foods and novel food ingredients and the preparation of initial assessment reports under Regulation (EC) No 258/97 of the European Parliament and of the Council (Text with EEA relevance) 57 Official Journal L 253, 16/09/1997 P. 0001 - 0036. 031 Lilla rapport 03/09/02 14:19 Side 58
Ethical principles in european regulation of biotechnology | Linda Nielsen | Berit A. Faber | April 2002
etc. With regard to deviations as compared nary principle would cover a situation in which with traditional counterparts, novel foods must there were no question of scientific uncertainty, be assessed on the basis of their unique consti- but rather a move to reject a product on other tuents and properties. Equating foods in this (ethical) grounds. If we consider a parallel situ- way lends consistency to safety assessments of ation in human health - human cloning - it is GMO-based foods versus non-GMO-based then possible to take into account the view that foods, but constitutes neither a safety assess- has dominated the debate (certainly in the ment nor a foods assessment per se. As such, Western World), this being ”this is unacceptable the principle lends itself purely to scientific risk under any circumstances”. This attitude is infor- assessment, and admits no ethical concerns. med by an altogether different premise from that of scientific risk assessment. But it does The precautionary principle has found favour as not sort as readily under the precautionary a new principle in international legislation. This principle when referring to GMO-based pro- has happened after GMO-based products in ducts. many parts of the world have been met with growing resistance, and doubts as to whether The principle of sustainability rests on the pre- or not they might result in serious, widespread cept that sustainability must be assured with and irreversible damage have been mounting. respect to use of natural resources, to environ- The precautionary principle is gaining ground in mental issues and so forth. The definition per- spite of the fact that EU legislation operates mits ethical evaluation, but has not by tradition with no explicit definition of what the principle been applied with a focus on the ethical slant actually embodies. In a communication from of the principle of sustainability. The move 2000, the European Commission 20006 offers away from the principle of substantial equiva- its recommendations for how the principle lence, the precept of which is presumptive (”If should be interpreted within the EU: ”In order it looks familiar, then that’s good enough”) to protect the environment, the precautionary through the precautionary principle (”If it does- approach shall be widely applied by States n’t look familiar, and might involve a risk to according to their capacity. Where there are human health and the environment, then we threats of serious or irreversible damage lack need proof that it’s not damaging before we of full scientific certainty shall not be used as a can say it is good enough”), to the principle of reason for postponing cost-effective measures sustainability (”If sustainability is at risk, then to prevent environmental degradation.” it has to be rejected”) represents a progression from narrow to broad risk assessment. This The salient issue here is that the precautionary shift consequently affords us more scope in principle can be applied in cases where the sci- determining where the risks lie, how they are entific evidence is insufficient or uncertain, and to be measured and who has to prove what. preliminary scientific assessment indicates that But these principles would all appear to be there is reason to assume that the degree of evolving out of a scientific premise. The ques- risk to the environment and human, animal and tion remains ”Is it safe for humankind and plant health would be in conflict with the high nature?”, but there is no room for the question standard of protection prescribed by the EU. ”Is it right for humankind and nature?”. Application of the precautionary principle also requires that the burden of proof be shifted. The precautionary principle and the principle of Hence it is no longer the authorities or the sustainability allow only limited scope for ethi- public sector that has to provide proof of harm- cal considerations that are not based on scien- ful impacts, but rather the applicant seeking to tific rationale, i.e. in relation to medicinal pro- place GMO-based foods on the market, for ducts, and to a limited extent to the Directive example. The principle also requires that a on Deliberate Release, but not in relation to given application be reasonably certain and concrete ethical provisions concerning authori- that no preferable alternatives exist. Finally, sations for placing such products on the mar- the principle emphasises the necessity of open, ket. The reason that the named principles have democratic decision-making processes. taken on this format and sphere of application The precautionary principle thus permits rejec- presumably derives from the fact that they tion when insufficient scientific certainty exists concern products that are differently and more to vouchsafe the safety of the product. immediately bound up with free mobility, the However, it is far from given that the precautio- wish for non-discrimination, etc. - these being
6 Com (2000) 1 ”Communication from the Commission on the precautionary principle”. The communication states 58 that the precautionary principle was laid down in the Rio Declaration of 1992, in which the quotation appears from Article 15. 031 Lilla rapport 03/09/02 14:19 Side 59
Ethical principles in european regulation of biotechnology | Linda Nielsen | Berit A. Faber | April 2002
key issues for both the EU and the WTO. the public’s perception of their willingness to Consequently, for GMO-based foods, the ten- accept exposure to risk a number of ethical dency has been to allow decisions concerning issues and concerns are also involved, which marketing authorisations in the EU to be based may not necessarily be expressed as such, but solely on scientific risk assessments. that nevertheless strongly influence public opinion. This meant that while the arguments This begs the question of whether scientific were based on scientific risk assessment, the principles should not be complemented by a ” reactions were conceivably based on ethical principle of ethical precaution” in evaluations of evaluations. the extent to which research should be under- taken on a particular product, or whether mar- To take a hypothetical scenario: if we were to keting authorisation should be granted. arrive in a situation where an initiative was proposed in the foods area along the lines of 9.3 Ethical principles the example of human cloning, the problem in the foods area? might occur in a pure form. If, for example, it As highlighted in the section on risk assess- proved cost-efficient and safe (by scientific ment, biotechnology raises issues concerning standards) to produce meat by culturing human both risks and values, and scientific risk muscle tissue outside the body using genetic assessments alone cannot embrace the scope engineering, then the scientific principles would of the value-based issues underlying the entire not necessarily ensure that such a product GMO debate. There is no sharp divide between would be the object of ethical deliberations. scientific risk assessments and political risk Indeed, access to a cheap and perhaps very management; risk management is not a well- healthy and nutritious source of protein might structured balancing of costs and benefits, and conceivably be justified by socio-economic risk communication does not address the interests in access to affordable protein for dilemma between the actual (objective) risk poverty-stricken populations. Nonetheless we and the perceived (subjective) risk in which can readily conjecture that there would be a knowledge and values are commingled. lack of acceptance of a food of this nature based on ethical evaluations - in line with It is our position that the key aim in this con- public rejection of cloning (and possibly dra- text is to link up all the elements of scientific wing on parallels with cannibalism). risk assessment and political risk management and the dialogue on risk management to ethical The need to be able to make ethical evalua- considerations and evaluations. tions with respect to food products also would thus appear to be present. An important objec- Two examples will serve to illustrate the pro- tive for democratic and dialogue-oriented risk blem, and the difference between scientific risk management and risk communication must be assessments and values-based, ethical assess- to open up the parameters for legitimate objec- ments: tions that would also comprise wider ethical In recent years the debate on BSE has indica- issues. Against this background it is useful to ted clearly that it is not merely a matter of sci- examine the four ethical principles addressed in entific risk assessment that determines whet- this report, and to explore whether there is her or not the public can accept exposure to a justification in the foods area as regards pro- risk. And yet the risk of contracting BSE by duct marketing to address the same protection eating beef proved slight, and for the experts issues as those involved in human health con- the force of public reaction was something of a cerns. mystery. The reason for the force of the reac- tion against this particular risk may possibly be The ethical principle associated with economic traced back to the fact that people felt that and qualitative benefits has a more restricted behind it all, certain ethical principles had been role with respect to the marketing of products violated, when it emerged that the disease was in the foods sector than it has in the health thought to have arisen when cattle were fed on sector. Genetically modified foods are scarcely feed enriched with bone-meal, that is, feed perceived as a qualitative benefit comparable containing residues from animal cadavers. with the offerings of the health sector, including Many presumably felt that it was ”unnatural medicinal products. One interesting idea would and against nature” to feed cattle with animal- be an ethical assessment of whether there was based feed, given that cattle are herbivores. In ”justification” for research, deliberate release or this context it is important to recognise that in product marketing on the basis of an assess-
59 031 Lilla rapport 03/09/02 14:19 Side 60
Ethical principles in european regulation of biotechnology | Linda Nielsen | Berit A. Faber | April 2002
ment of economic and qualitative benefit. In respect arguments based on wisdom on an that context it would presumably be most equal footing with those informed by a scienti- realistic to apply any ethical considerations at fic rationale, and to acknowledge that ethical an early stage rather than at the product mar- arguments can be just as valid as economic keting stage. One aspect that also arises in this arguments. Thirdly, it is important to prescribe context is the environmental issue and thereby regulation and practice in such a way that they also concern for future generations. Here it is respect the individual consumer’s autonomy important to consider which decisions would be and freedom of choice so as to prevent ethical irreversible. ”vote-down” of minority views on issues where no positions aimed at the common good and no Autonomy, dignity, integrity, and vulnerability concern for future generations necessitate a do not amount to the same central issue in the common position in violation of the individual’s foods area as they do in the health area. The freedom of choice. To that end, regard for vulnerability of nature is an element in protec- Europe’s new multicultural societies might sup- tion of the environment and biodiversity, while port a move to create regulatory scope for dif- dignity, integrity and vulnerability are principal- ferentiated freedoms of choice that do not con- ly associated with the human area in that they flict with concern for the common good. It is concern protection of the human being. The important to link ethical principles up with dia- principle of autonomy, however, can be readily logue between those directly affected and the applied to the foods and product area. The state, in order to arrive at a viable decision- principle of free information and the individual’s making process on the use of novel biotechno- freedom of choice might suggest a principle of logy in the foods area. autonomy with regard to whether or not the individual wishes to consume genetically mod- 9.4 How are ethical principles ified foods. This would then entail a need for operationalised in regulations? measures to ensure that labelling at every Any detailed discussion of how ethical principles stage in the food processing chain clearly ind- may be incorporated and operationalised in icated genetically modified content. However, it decision-making processes and regulation pre- is arguable whether labelling of this nature supposes that the component barriers, assump- designed to observe the need for autonomy tions and possibilities have been crystallised should be required in instances of significant out, and that a number of central questions GMO content, or in all instances. have been settled concerning political will, scope, actors, timing and choice of tools. But Just distribution of benefits and burdens is a by way of introduction we can now summarise principle found primarily at the international which ethical principles and regulatory chal- level. The Unesco Declaration, for example, lenges are involved: stresses that the benefits of work on the human genome must be made available to all. 9.4.1 Regulatory challenges and In this context it is important to be aware that possible tools while ethical evaluation might result in restric- The object is to ensure that certainly the four tions on GM foods, they might conversely result fundamental ethical principles discussed in the in measures to promote them in so far as they foregoing of benefits, autonomy, just distribu- improve the capacity to feed people in the tion and co-determination are incorporated in developing countries, for example. The princip- regulation of biotechnology. le is also expressed in the principle of sustaina- bility and the Convention on Human Rights and International regulation is characterised by two Biomedicine. different trends: Firstly, there are a number of international Openness and co-determination are emphasi- conventions, declarations, etc. that emphasise sed as key principles by the EU, the Council of very broad, general ethical principles. This Europe, the Aarhus convention on the environ- applies to the human area, e.g. the Unesco ment and a large number of national initiatives Universal Declaration on the Human Genome (see Chapter 5 for a more detailed discussion). and Human Rights, the Council of Europe’s In that context it is important to be aware of at Convention on Human Rights and Biomedicine least three factors. Firstly, that the ethical pro- and the EU Charter of Fundamental Rights from cess seeks consensus, but if this is regarded as 2000. Rights in this context are centred especi- unattainable the process will aim for ”fair play ally on the ethical principle associated with despite differences”. Secondly, it is important to autonomy, dignity and integrity, and to some
60 031 Lilla rapport 03/09/02 14:19 Side 61
Ethical principles in european regulation of biotechnology | Linda Nielsen | Berit A. Faber | April 2002
extent the just distribution of benefits and bur- public order enabling consideration of ”public dens. In the environmental and foods area order and morality”. It is hence worth conside- ethical principles do not apply in a narrow ring to what extent these new trends may be sense, but rather to general principles of ”the employed in introducing ethical considerations right to the environment”, the precautionary when these have sufficient primacy and impor- principle and the principle of sustainability. tance. However, to some extent the ethical principle discussed in the foregoing, of openness and co- This report presents a whole series of tools that determination, comes into force in, for examp- can be used in operationalising ethical princi- le, judicial rules concerning hearings. ples. These are divided up into the so-called ”debate models” and ”regulation models”, and Secondly, there are the precise provisions, the report highlights a number of the benefits directives, etc. in the EU domain governing a and drawbacks of the individual models. number of issues. This applies to the EU direc- tive on clinical trials on medicinal products for The debate models consist of human use. However, it applies especially to EU provisions and directives concerning foods, Toolbox which by means of comprehensive and complex authorisation schemes enforce risk assessment Debate models for health and the environment, and the label- • Ethical committees ling of GM foods. • Ethical councils National regulation is particularly relevant in • Technology councils the human area, especially in connection with • Consensus conferences medical treatment, since the foods area is lar- • Future studies panels gely covered by EU controls - usually in the • Values workshops form of total harmonisation. In the human area regulation varies considerably when it comes to intensity, content and format, thought there The regulation models consist of still a number of areas that have resulted in national regulation, e.g. artificial fertilisation, Toolbox genetic testing and gene therapy, cloning and (future) biobanks. In this way the ethical prin- Regulatory models ciples concerning autonomy, dignity, integrity, • International conventions, directives etc. are often covered. In addition there is the • National legislation of a substantive nature, regulation that creates the framework for ethics including prohibition, orders, rights, etc. committees and the like, the purpose of which • Framework legislation to ensure authorisa- is to secure information and debate on ethical tion procedures, etc. issues relating to biotechnology in one form or • Case law another and/or which have a specific mandate • Professional standards, etc. to grant authorisations for certain applications • Provisions or practice concerning educa- of biotechnology. tion, information, debate and dialogue
In the health area there is thus extensive scope for incorporating ethical principles in decision- A checklist is provided for the purpose of high- making processes and regulation. In the foods lighting a number of factors that in any event area the scope of individual nations for incorpo- should be addressed in considering the applica- rating ethical principles is, however, limited bility of the various models. when it comes to product marketing as a result of the goal of total harmonisation based on 9.4.2 Political will rules that do not give scope for ethical conside- and regulatory scope rations. The foods area is extensively covered If there is to be greater operationalisation of by WTO rules, which give precedence to the ethical principles in regulation than happens principle of free trade, and thereby focus more currently, it is essential that the political will is on eliminating barriers to trade than promoting present to realise this aim. This applies at ethical concerns. Nonetheless, WTO agree- national level to parliaments, governments, ments and rulings reveal that other concerns authorities, etc. It also applies at international do find favour - for example, the concern level to international forums of various kinds. regarding exhaustible natural resources and Under EU auspices it is especially important
61 031 Lilla rapport 03/09/02 14:19 Side 62
Ethical principles in european regulation of biotechnology | Linda Nielsen | Berit A. Faber | April 2002
that a political commitment is expressed by the analysis of actors in order to ensure that the European Parliament and the Council of right ones are involved, and to consider how Ministers to greater operationalisation of ethical the actors themselves can further promote the principles in regulations, and that this is sup- application of ethical principles. ported and implemented by the European Commission. In that context it is significant Actors that the EU Commission in its communication Life Sciences and Biotechnology - A strategy for Who are the actors? Europe, which was ratified by the EU Council of • Researchers Ministers, chose to emphasise that the life sci- • Commercial actors ences and biotechnology should be developed • Affected parties (environmental groups, in conformance with ethical values and social patient associations, other interest groups) objectives. • Decision-makers (politicians) The Commission also emphasises the impor- • Administrators (public authorities) tance of promoting information and dialogue • The media and communication with a view to giving the public and affected • The general public/lay people parties a better means of understanding and assessing the complex issues associated with the application of biotechnology and of develo- a. Researchers are usually first on the scene. ping criteria, including ethical guidelines/norms Researchers have an important role to play as and methods for weighing up the benefits regards observation of ethical principles in the against the drawbacks and risks. Exactly how sense that they are both the suppliers of speci- operationalisation on these lines might be alist knowledge of the research and its possible brought about will depend on what options and applications, and the suppliers of research on restrictions present regulation comprises. ethics and on the social impacts of biotechnolo- gy. While academics in pure science and the The restrictions against incorporating ethical health sciences will often be qualified to com- principles in regulation currently derive from ment on aspirations regarding the application statutory instruments, directives, etc. according of research in industry and in combating disea- to which total harmonisation is achieved for an se, other academics, such as sociologists, psy- entire area. This applies to a proportion of EU chologists will be needed to comment on the regulation in the foods area, for example, consequences for society at large, human inter- which means that it is not possible to incorpo- action, self-perception and so forth. An inter- rate and operationalise ethical principles wit- disciplinary approach to the problems is there- hout amendment of these rules or the introduc- fore crucial. In this context it is also important tion by some other means of, e.g. the ethical for academic institutions to assume a responsi- principle of co-determination and openness. bility for generating and supporting the inter- disciplinary approach required in addressing It is therefore important that this type of regu- biotechnology issues, especially as the initiators lation is elaborated in such a way that it gives of forums for encouraging knowledge exchange scope for ethical considerations. Examples of among the different disciplines. an opening up for the possibility of incorpora- ting ethical considerations exist in the patents directive and the directive on deliberate relea- Generating knowledge se. These directives open up for the possibility • Who possesses what type of knowledge? of consulting the EGE (European Group on • Researchers - typically work with baseline Ethics in Science and New Technologies) on data and generate information from this principal ethical concerns raised by the directi- • They generate expert knowledge, typically ves. However, the difficulty lies in establishing of a technical/scientific nature exactly what the ethical principles cover, how • Generated knowledge: expert knowledge - they should be interpreted and how they information should be incorporated in the processing of • Law, sociology, ethics, philosophy are actual applications. meta-disciplines that incorporate raw data produced by (pure) science 9.4.3 Actors: role and scope of action In connection with operationalisation of the In operationalising ethical principles the roles of ethical principles it is essential to carry out an researchers can be developed in various ways.
62 031 Lilla rapport 03/09/02 14:19 Side 63
Ethical principles in european regulation of biotechnology | Linda Nielsen | Berit A. Faber | April 2002
One approach is for ethics to be incorporated these actors, tools are crucial. more extensively in the training received by In places where no ethical councils exist, these pure scientists so that they may be better should ideally be established to undertake qualified to engage in ethical debate, and per- informative, debate-promoting and advisory haps also have a greater sense of duty to initi- programmes in order to give decision-makers a ate debate in their particular field of research qualified basis for addressing ethical issues. (see Chapter 8). Furthermore there is a need The existence of such ethical councils could for greater involvement of researchers in the also be assured by means of legislation. social sciences and humanities. Finally, it is Furthermore there is of course the key role to vital to establish forums, in which researchers be played by decision-makers, that is, initiating can engage in dialogue with counterpart acade- the incorporation of ethical principles and con- mics and thereby contribute to the factual siderations in definitive rulings and regulatory information generated, while also helping to processes. This could be in the shape of nor- identify present and future ethical dilemmas in mative work on ethical components, but often a given issue. it might also be a pertinent element in regula- tion of processes, in order to ensure the exis- b. Commercial actors and affected parties tence of official bodies and procedures for con- will often have a direct and transparent interest ducting the actual ethical evaluations. However, in a specific application of biotechnology, e.g. to that end it is vital for decision-makers to go as a patient hoping for a new medical cure or one step further and also supervise the elabo- as the manufacturers of GMO-based foods. ration of guidelines by which the ethical princi- Moreover, affected parties may include persons ples may be defined and operationalised. One and groups with a highly differentiated appro- example is the EU directive on good clinical ach to the problems, e.g. as environmental practice and the Danish act on a scientific watchdogs, lobbyists for the precautionary prin- ethics committee system (see Chapter 4 and ciple, etc. Chapter 6), both of which present a detailed check-list for the evaluation to be conducted by When it comes to operationalising the ethical scientific ethics committees in vetting proposed principles, the role of commercial actors can be research projects. extended by promoting their involvement in forums comparable to those for researchers. d. Administrators are mandated to implement This would be valuable for several reasons. the letter and ”spirit” of the law in authorisa- Firstly because ”the ethical dilemma” might be tion procedures, etc. This may be straightfor- ”bad for business” in the sense that sales may ward when the criteria are explicit, but the fail if the product in question is regarded as ethical principles will often be relatively vague ethically undesirable. Secondly, because com- in the sense that they are open to a wide array mercial actors, like other citizens have a shared of interpretations, ranging from the strictest responsibility (and often desire) to engage in, interpretation of what constitutes a violation of and contribute to, ethical debate in their line of the principles of integrity and vulnerability, for business. Other affected parties such as patient example, to a more lax interpretation. The associations could be represented in issue-spe- more accommodating the legal norms are, the cific ethics committees. Interest groups can be greater the decision-making authority will be encourage to participate by means of ”the right among administrators. This makes the way in to know”, hearings, representation in ethics which approval bodies, for example, are committees, the right of complaint, court trials appointed and made up all the more decisive. and the like. The model produced by the Norwegian values workshop on the future of the fisheries industry (see Chapter 6) could be Knowledge governance held up as inspiration for initiating a sector- wide debate in other countries. On these lines • Administrators - work with information, it might be observed that the pharmaceuticals but rarely do more than simplify and com- industry is approaching a stage where ethical municate this knowledge - to affected par- considerations will be a competitive parameter. ties (applicants, etc.), politicians and the public c. Decision-makers are required to draw on • They do not generate a new type of know- facts, evaluations and ethical choices to deter- ledge, but process expert knowledge. mine the extent to which, and the manner in • Generated knowledge: processed expert which, ethical principles are to be observed. For knowledge/information
63 031 Lilla rapport 03/09/02 14:19 Side 64
Ethical principles in european regulation of biotechnology | Linda Nielsen | Berit A. Faber | April 2002
When coordinating process regulation and Wisdom? developing guidelines for decisions on actual applications, administrators, like decision- • Wisdom is generated from data - informa- makers, require ethical information and exter- tion, but who does this, and who posses- nal evaluations. They may also need more ses wisdom? explicit policy-based statements as to which • If scientists and decision-makers process ethical principles are to be incorporated in an information on the basis of ethical princi- administrative regulation; an evaluation of an ples, perhaps wisdom can be generated? application and how these are to be weighted • Is it also true to say that wisdom exists in in relation to each other. the population, when considering ethical decision-making processes - and that Ideally, the EU should play an extended role in Scandinavia’s tradition for using lay people promoting the interdisciplinary approach in in various organisations, councils and relation to the administrative level also in such boards may be interpreted as recognition a way that ethical issues concerning the human of this wisdom? area, animals area, plant area and foods area may be considered and appraised across the board. It is important that lay opinions are made on a well-informed basis. The foundation for lay e. The media and communication The media opinion might be achieved by: a thorough have an important role to play in communica- grounding in the topics to be assessed, inclu- ting information and as initiators and central ding access to expert opinion such as a dedica- co-actors in national debate. They often have a ted secretariat that can provide specialist constructive contribution to make to debate, knowledge geared to lay people so that their but are not bound by the same obligations con- opinions may be well-informed and supported cerning balanced and consistent views that are by the facts. At the same time it must be ensu- imposed on decision-makers, administrators, red that there is scope for lay people to form etc. their opinions without being voted down by for- Ideally, the media should also communicate mally qualified experts. Here again, the and promote debate on topics that transcend Norwegian model, in which lay people help to sensationalism or ”war” between conflicting define and weigh up a number of ethical princi- interests to contribute to a more nuanced ples in an ethical matrix can provide inspira- debate. tion. Lay people should be included both as participants in public debate and as active When it comes to communication of risks, it is members of ethics committees both in consul- important to ensure that this is not regarded as tative forums and on committees set up to vet a one-way push to convince the public that specific projects. genetic engineering per se is to the good and a sign of technological progress. The latest The domain occupied by the actors addressing Eurobarometer polls of public opinions on bio- the new biotechnology creates a need for a technology have also revealed that it is not type of forum in which the term agora from public’s level of understanding of the technolo- ancient Greece can serve as inspiration. This is gies involved that determines their attitudes to a form of market place, established by deci- the technology. Instead, risk communication sion-makers with the aim of convening actors should be a ”multi-channel” communication in (stakeholders) to exchange views with each which several actors join forces and return other and the general public. In ancient Greece input to each other. Scientists, decision-makers this was where public administrators, the judi- and administrators will in this way not only be ciary, philosophers and traders assembled to suppliers of output, but also recipients of out- administrate, exchange views and do business. put from industry, interest groups, lay people, At a time where science and its application is a etc. multinational issue that will also have impact on future generations, should be established at f. The general public/lay people are impor- local, national and international levels alike. tant actors as regards the safeguarding and communication of the ”wisdom” present among them. The public needs to be consulted, and society as a whole needs the public to contribu- te with the wisdom it embodies.
64 031 Lilla rapport 03/09/02 14:19 Side 65
Ethical principles in european regulation of biotechnology | Linda Nielsen | Berit A. Faber | April 2002
9.4.4 Debate: polycentrism placed on the market, and the risk is that there and timing is no issue left to debate. As stated, elements from many different dis- courses and contributions are involved in ethi- If it happens to early the risk is that no one will cal debate and in the decision-making process have any feel for the issues. The questions will concerning regulation. not be taken seriously and ethical debate will The generation of a form of ethical consensus fall by the wayside. Two examples of this will is a process akin to theories concerning poly- serve to illustrate the problem: centrism in law. Law is created not only within In the mid-1980s the then Danish Ministry of a single forum, but in many different centres. Health produced a report for the Danish The formation of laws is therefore not a mono- Parliament, Folketinget, on gene therapy. centric process, but is polycentric in that it This was met by deafening silence - simply goes on in several spheres and is the object of because the issue had been raised too early. dynamic exchange among different centres and The same was the case with the debate on levels. The legal experts Henrik Zahle and Dolly, the first cloned sheep. Everyone claimed Hanne Petersen in Denmark have explored this that the public was astonished that cloning was theory of polycentrism in legal science. even possible, despite the fact that a study of newspaper cuttings revealed that the capability The ethical process is characterised by the had been reported in newspaper articles for same polycentrism. Ethics are no longer formu- several years previously. lated by a single proponent (for example the church) but are evolved in an interaction of for- It thus important to plan the timing of ethical ums and actors. If a legislator or authority wis- debate and the operationalisation of ethical hes to promote ethical debate it is therefore principles. This should be based on an assess- important to analyse out the actors in order to ment of when the debate will be sufficiently initiate an ethical debate among their ranks newsworthy and merited. Perhaps it should be (for example, in the particular sector that will conceded that what is really needed is ”Ethics be affected such as the food industry, agricultu- All the Time” - when research is planned, when re or pharmaceutical industry). It is then also it is carried out, when its results are studied, important to link up the debate ongoing at the and when it is applied. different centres - who will be talking to whom so that we can be sure that an opinion is gen- 9.5 A choice of tools erated on the issue to be settled? Moreover it In the following we discuss the tools available is important to sustain debate and dialogue - in the various areas. It should be strongly how do we ensure that debate and dialogue do emphasised that these are not proposed as not peter out - how is momentum sustained? definitive and absolute solutions, and are rather suggestions for providing a point of departure A polycentric debate should be a phase devoted for forming opinions. In proposing these as to settling issues and discussing them and the- tentative solutions it is in recognition of the reby the precursor of a process to arrive at an fact that it is often more productive to address enhanced regulation strategy based on a clear a concrete issue than to have to begin delibera- perspective of the general public’s and the tions ”from scratch”. The proposed solutions actors’ attitudes to an issue prior to legislation. should, however, be adapted to the given situa- The debate phase calls for both an interdiscipli- tion, culture, tradition, etc. nary component and recourse to the wisdom embodied by the general public. In this context The following also proposes how the ”buffet” of the media have an important role to play, and options can be worked into set ”menus” com- the various forms of debate model can be prising ”starters”, ”main courses” and desserts, employed depending on culture, traditions and i.e. debate models, international regulation and so forth. national regulations (and professional norms).
Timing is an element that is essential to stress 9.5.1 The debate models in connection with ethical debate. The Danish The ”starters” are the debate models. In our Council of Ethics has adopted the motto ”Ethics opinion these are all-essential both as a demo- Just In Time”. As the words suggest, this cratic component for ensuring openness and means that ethical debate must not happen to co-determination, and for testing out the pro- late, but nor must it start too early. If ethical spects of achieving acceptance and even con- debate comes too late, products will already be sensus on a given issue. It is important to
65 031 Lilla rapport 03/09/02 14:19 Side 66
Ethical principles in european regulation of biotechnology | Linda Nielsen | Berit A. Faber | April 2002
establish forums from which ethical debate can there will be a distinct difference in how ethical be initiated. Debate should engage both those opinion ”turns out”. A typical example is ”the directly affected and the general public, who status of the embryo”. Generally there may be should be assured of the right to information a difference among nations (national trade- and participation in decision-making (cf. the marks) as a result of: Aarhus Convention). Both interdisciplinarity and the incorporation of lay wisdom are essential in - religion this context. It is equally important that ethical - state/individual debate is taken seriously rather than ending up - national economy/social conditions as a ”show dish”. If the general position is that - regulatory tradition the application of certain aspects of biotechno- - other logy is undesirable then this should be respec- ted. In order to ensure broad debate, formal It should presumably be accepted that in such regulation - national and international - should cases that it will not possible to reach agree- establish forums in which ethical debate can ment (as things stand) at the international flourish. level, nor within the EU. By achieving the right ”timing” the process involving formal regulation These then are ”menus” offering many varia- will also be able to help to establish the norma- tions on the ”starters”, but these must not be tive function that might promote (wider) accep- omitted, since this would ”send the guests tance of a specific application of biotechnology. home hungry”. However, this should be achieved without any ethical ”vote-down” of minority views. In order 9.5.2 National regulation to guard against ”ethical minimalism” it is Besides ensuring ethical debate, proper formal essential that such principles are contained in regulation at the national level is especially substantive, content-specific regulation. important when it comes to areas not governed Moreover, it may be expedient to aim for more by binding EU regulation, and where the follo- ”process oriented” regulation, for example, in wing circumstances obtain: the form of scientifically-based ethical evalua- tion of specific biotechnological (biomedical) a. Where there is a need to protect future projects. When framework legislation is passed, generations. it is of great importance that relatively detailed In instances where sustainability is an and explicit guidelines are provided for which issue, for example. components are to be comprised by ethical b. Areas where cultural considerations are evaluation, and according to which principles involved. the concerns are to be weighed up. All too Where the issue concerns treatment of often there is a ”quantum leap” between very embryos for example. generally adopted ethical principles and actual c. Protection of groups in the population position, and guidance on how this leap is to be unable to look after their own interests. made should be comprised by motives or admi- (vulnerable groups) nistrative guidelines for the evaluation for Where the issue concerns children, people example. with mental disorders or senile dementia for example. 9.5.3 International regulation d. Situations in which there is inequity Many components laid down in national regula- between those affected (dependency). tions will also have relevance for international The issue might be genetic testing in the regulation. In the following we indicate areas context of employee/employer or that would appear of particular importance and insured/insurer for example. pertinent to take account of in the international e. Cases where competence needs to be domain. ascertained. Concerning the right to artificial insemina- It is essential to establish formal prohibitive tion for example. regulation or the like under international auspi- f. Areas in which automony must be protected. ces in areas where there may be a significant In questions of rules regarding informed risk for the next generation, for example, in consent or information, for example. relation to: - the environment Many of these areas will also be suited to inter- - reproduction (e.g. reproductive cloning) national regulation, but in a number of areas
66 031 Lilla rapport 03/09/02 14:19 Side 67
Ethical principles in european regulation of biotechnology | Linda Nielsen | Berit A. Faber | April 2002
- irreversible damage The EU directive on clinical trials on medicinal - epidemic impacts (xenotransplantation?). products for human use require an ethical eva- luation to be carried out, and require that this Besides these, other notable areas in which must be performed on the basis of predefined international regulation might be appropriate ethical considerations (balancing of benefits would include consumer protection, quality cri- and integrity). The directive also meets the teria for, e.g. biobank storage and labelling requirement for ethical evaluation to be concre- (traceability) of GM foods, for example. Another te in relation to each individual trial. Against area undergoing extensive internationalisation this, the directive does not require the involve- is biomedical trials. The pharmaceuticals indus- ment of lay people following an open consulta- try’s internationalisation of clinical trials has tive process. In the latest review of the directi- stepped up the need for universal rules for ve on deliberate release, the preamble states ensuring sufficient scientifically based ethical that ethical considerations concerned with scrutiny of trials involving human subjects. approval of the release of GM crops are to be Internationalisation calls for international rules, incorporated. However, the directive on delibe- but also for international networks - in the field rate release makes no reference to ethical con- of scientific ethics there will be a need for net- siderations and does not stipulate the involve- working among the committees set up to ment of lay people following an open consulta- address the specific problems associated with tive process. scientifically based ethical scrutiny. If we consider the four ethical criteria, we also A number of the areas discussed in more detail find significant differences among the regulato- below in the context of national regulation (for ry options for translating these into legal example, the protection of employees and the requirements. insured) might also benefit from an internatio- nal format. The issues involve a degree of The criterion of economic and qualitative ”Europeanisation” of the ethical questions and benefit essentially reflects the ethics of utilita- answers, which will presumably result in grea- rism This criterion entails assessment of any ter consensus over time in the areas discussed. potential damage and risks, together with assessment of both economic and qualitative 9.6 Conclusion benefits. An assessment of this nature can be The dilemma facing regulatory bodies is often expressed relatively simply in regulations, and referred to in very negative terms as a choice implemented according to a relatively objectivi- of either major principles and lofty, vague, sed process. The fact that the last-named com- concrete rules borne out of consensus, but ponent amounts to an estimate of whether the which out of ignorance of the technologies are benefit to be derived from an application of condemned to insignificance, or, explicit, preci- genetic engineering would be greater than any se rules that are restrictive and only prescribe damage or risks is not exclusively a regulatory for current issues and are therefore condemned problem. Estimations and weighing up of ”pros to premature obsolescence. and cons” is a common element in much regu- latory work. However, one difficulty might be In our opinion this pessimism is neither helpful that while a criterion may be already establis- nor justified. However, it is true to say that the hed in the human area, and to some extent outcome of research is essentially unpredicta- also as regards animals (higher living orga- ble, and that this presents an obstacle to the nisms), it may only have gained scant recogni- aim for regulation to draw on predictable valu- tion in relation to the food product area, i.e. es. But by employing models that contain both GM foods and crops. In the last-named area, robust international ”brake pads” at the all- the regulatory premise traditionally dictated essential level, and also flexible regulatory that anything that does not carry an unaccep- models, such as debate models and national table risk of damage to human beings or natu- framework legislation, ethical principles can yet re may be placed on the market. This presents be operationalised. This will enable social a fundamental dilemma when it comes to intro- responsibility to be assumed, which will prevent ducing more comprehensive assessments in privatisation of ethical issues and hence ensure connection with product authorisations. that core ethical principles are observed. If we now turn to some of the EU directives, The criterion of integrity/vulnerability and we find that there are differences in which ethi- the criterion of just distribution are probably cal principles they take into account: the two criteria that present the greatest regu-
67 031 Lilla rapport 03/09/02 14:19 Side 68
Ethical principles in european regulation of biotechnology | Linda Nielsen | Berit A. Faber | April 2002
latory challenges. This is primarily due to the another problem in standardising on the appli- fact that these criteria entail broad estimations, cation of ethical criteria in formal regulation. which can be difficult to standardise on to ensure that the result of their application meets Overall, the conclusion has to be that while two fundamental requirements for legal protection, of the ethical criteria may be expressed relati- i.e. predictability. Conversely, it is generally vely simply in procedural regulation in substan- recognised - at least in relation to certain appli- tive terms the two others can be expressed cations of gene technology - that the ethical only in more general terms in regulation. Some considerations involved are of great significan- of the ethical criteria thus entail assessments ce. An obvious example of this is reproductive based largely on estimation. Moreover, there is cloning, which many find should be banned the fact that an overall assessment must be because it is a violation of human integrity. In made of all four ethical criteria, which again, many other areas, however, there will in all will be based largely on estimation. likelihood be great difference in opinion on whether the application of a field of gene tech- The next step is to lay down rules for how the nology would be in violation of the integrity cri- final outcome of the overall ethical evaluation terion. As long as the issue concerns procedural should be incorporated in the scientific risk regulation, however, it should in principle be assessment undertaken in parallel with the possible to incorporate considerations of this ethical evaluation. Thus, a decision must be nature also, though as already stated, it will made on how the ethical evaluation and the scarcely be feasible to legally verify that such scientific risk assessment should be weighted criteria have been met. against each other in a final, official ruling.
The criterion of openness and co-determina- The conclusion is thus that it is feasible from a tion is essentially a procedural requirement legal point of view to incorporate ethical criteria that may be identified with relative ease in in EU regulation of the application of gene regulation in the form of requirements regar- technology. This may be achieved by operatio- ding administrative routines and decision- nalising requirements to that effect in procedu- maker forums. As regards the technicalities of ral regulations comprised of the following com- regulation, the criterion can be translated into ponents: a requirement that the decision entailed must 1) a requirement regarding ethical be made following the involvement of lay peop- evaluation; le and in such a way that the decision-making 2) formulated ethical criteria; process is conducted in the public domain. 3) including an open process to ensure Such requirements could be operationalised eit- co-determination. her at a general level, or in the form of detailed regulation of authorities’ decision-making pro- Against that, it will be inordinately difficult for cesses, including the detailing of rules on the regulation to prescribe the significance or extent to which lay opinion is to carry binding impact of ethical evaluation. Nonetheless it is effect. Standardisation of this criterion may be essential to address these aspects, especially expressed either as requirements regarding the the question as to how far ethical evaluation decision-making processes employed by EU can ”displace” scientific risk assessment both in institutions, or as requirements regarding the a positive and negative sense. This then opens decision-making processes of national authoriti- up for two possible scenarios: A scientific risk es. In the last-named case there will presuma- assessment reveals that the application of a bly be limits to the detail in which the require- field of genetic engineering might be attended ments could be prescribed at the EU level. by a certain degree of risk. If the ethical assessment finds little objection to authorising Finally it should be emphasised that the four this application, should it then be allowed to ethical criteria should all be incorporated in any proceed? Conversely we have a scenario in assessment of gene technology applications. which a scientific risk assessment reveals that The final decision should be made by weighing there is no attendant risk in application of the up the assessment made of each criterion. As field of genetic engineering, while the ethical such there can be no question of straightfor- assessment questions the justification for ward decision-making requirements according approving the application. How would this sce- to which just a single criterion or all four crite- nario be dealt with? ria must be met, but rather a coherent balan- cing of one against the other. This presents yet
68 031 Lilla rapport 03/09/02 14:19 Side 69
Ethical principles in european regulation of biotechnology | Linda Nielsen | Berit A. Faber | April 2002
In considering this dilemma it is important to bear in mind that regulation at the EU level is not driven solely by content-based political assessment, but also by the general aim of ensuring uniform laws and thereby a single market in the EU. This produces two likely con- sequences. The more that ethical evaluation is performed at EU level, the more it can rest on estimation and still produce uniform laws. The more that ethical assessment is performed at national level, the more can it take into account differences in national culture and values, and the more it can ensure an open process and co-determination.
Consequently our position is that while incorpo- ration of ethical criteria in EU regulation is fea- sible it is also associated with considerable challenges. Furthermore it may be noted that regulation will to a large extent amount to pro- cedural standardisation, and that the consequ- ences of a decision-making process at the EU or national level will be significant. The essence of the conclusions presented here may also be expressed to say that the incorporation of ethi- cal consideration in EU regulation concern dia- logue and decision-making processes just as much as they do the legal technicalities of regulation.
Thus is should be expected that there will be a need for both regulation proper - social ethics from the top down - and acceptance from sta- keholders in the broadest sense - i.e. ethics from the bottom up. Top-down and bottom-up will, however, be equally important. Biodiplomacy is one of the new concepts in the area.
69 031 Lilla rapport 03/09/02 14:19 Side 70
Ethical principles in european regulation of biotechnology | Linda Nielsen | Berit A. Faber | April 2002
10 Prospects and One concrete proposal might be a general challenges framework for operationalisation of ethical principles at EU level: In the area of human health a number of ethi- cal principles have now been adopted, but a) A joint European Commission and often after a quantum leap from general mat- Council of Europe resolution concerning, ters of principle to concrete interpretation and which general ethical considerations should evaluation, in which dialogue and debate for- be incorporated in vetting biotechnology appli- ums have often been lacking. cations and the creation of topical dialogue forums There is therefore a need for • national implementation of international b) A joint communication concerning conventions; ”good governance” in respect of • concrete guidance for administrators; decisions/rulings on the application of biotech- • dialogue forums among the different nology - with elements such as scientific risk actors, and assessment, incorporation of ethical considera- • further scope for public debate. tions, openness, information and debate, the use of ethics councils along with lay participa- The tools that serve as aids are the debate tion, etc. models, but discussion of the regulatory models and their application will hopefully also serve as inspiration. It is difficult to prescribe formulae for ethics that will allow them to be operationalised - but In the foods area it has been more difficult to it is important to do so - if necessary by practi- elaborate ethical principles since the ”classical” sing on different models. principles associated with the human area of And it is better to sample the entire ”menu” dignity, integrity and autonomy do not have than ”go to bed on an empty stomach”. quite the same meaning in this area. The foods area therefore involves more scientific risk assessments linked in with the precautionary principle and the like. Tentative efforts have been made to get ethical principles associated with co-determination and openness adopted, but at the same time, the quantum leap from scientific risk assessment to ethical evaluation informed by values has as yet not been made in this area, perhaps because it is difficult to get this assimilated in a more market-oriented and product-based area.
There is therefore a need for • crystallising out ethical values in the foods area; • incorporating ethical assessments; • concrete guidance for administrators; • dialogue forums among different actors, and • further dialogue and debate.
In this area also the debate models should the- refore be expected to have a significant part to play in the future, while the regulatory models especially will be geared to the international level.
70 031 Lilla rapport 03/09/02 14:19 Side 71
Ethical principles in european regulation of biotechnology | Linda Nielsen | Berit A. Faber | April 2002
11 Postscript
In the following we have sought to summarise the conclusions of the report in a mnemonic based on the principle which we regard as pivotal, that is, the need for dialogue:
D Debate - Make room and time for public polycentric debate within the forums between scientists, between decision-makers and between lay people. Make sure that there is room for disagreement and promote ”coope- ration despite disagreement”.
I Interdisciplinarity - Academics from diffe- rent disciplines must exchange experience and work towards the creation of a mutual understanding and interpretation of and implementation of ethical principles in con- cepts involving biotechnology.
A Agora marketplace - governance and deci- sion-makers should facilitate the creation of an agora, where stakeholders can meet and exchange views with each other and the public. In ancient Greece the public admini- stration, the court, the philosophers and the traders met here to govern, exchange views and do business. In a time where science and the application of science is multinational and will have impact on future generations, the creation of agorae should be local, natio- nal and international alike.
L Learning - Children, young persons and lay- men as such should be trained in decision- making with regard to ethical issues, and researchers should be educated in ethical issues concerning their field of research.
O Operationalise - Ensure the operationalisa- tion of ethical principles in politics, regulation and debate.
G Gradualism - If we are to go forward then we should do so step by step. The principle of gradualism should be considered each time we have to make decisions that may be irreversible or may have impact on the envi- ronment and future generations.
U Update -Ethics ”just in time” - timing - renew and update the deliberations and deci- sions. Choose the right time for the debate of a special issue, not too early and not too late.
E Evolution - of ethical principles and their specific application to new areas. 71 031 Lilla rapport 03/09/02 14:19 Side 72
Ethical principles in european regulation of biotechnology | Linda Nielsen | Berit A. Faber | April 2002
Curriculum Vitae
Master of Laws MS BERIT ANDERSEN FABER Born 1956, LLM from the University of Copenhagen in 1985, multidisciplinary courses in the Department of Education, Philosophy and Rhetoric 1982-83 in philosophy of science and argumentation theory. Head of secretariat in the Danish Council of Ethics in 2002, acting head of secretariat 1997- 2000. Has previously worked as: special con- sultant at the Centre for Bioethics and Risk Assessment, the Royal Veterinary and Agricultural University, consultant for the Management Secretariat at the University of Copenhagen - committee work on university faculty networking in connection with biotech- nology, chief consultant for the Danish Central Scientific Ethical Committee and administrative officer in the Danish Ministry of Health.
Rector, Professor, Doctor of Law LINDA NIELSEN Born 1952, LLM from the University of Copen- hagen 1976. After a period as civil servant Linda Nielsen joined the Faculty of Law at the University of Copenhagen in 1979. She comple- ted her doctoral thesis in 1993, and was ap- pointed professor of Law in 1996. Rector of the University of Copenhagen since February 2002. Linda Nielsen has been chairman and member of a great number of Councils, Law Reform Commissions etc. nationally and international- ly: From 1997 to 2000 chairman of the Danish Council of Ethics; former chairman of the Nordic Committee of Bioethics, and presently chairman of an expert group on biotechnology and ethics, serving as advisory body to a task force set down by the Danish Government. Linda Nielsen is a member of EGE, (European Group on Ethics in Science and New Techno- logies), advisory board to the European Com- mission and is serving as an expert in the eva- luation of EU-Biotech projects (Ethical, Legal and Social aspects). Additionally, she was from 1998 to 2001 member of The Council of Euro- pes`s standing bureau on ethics committees (COMETH). She is the author of numerous articles, papers and international presentations on comparative bio-law, including the relation between bio-law and bio-ethics in different legal systems.
72 031 Lilla rapport 03/09/02 14:19 Side 73
Notes: 031 Lilla rapport 03/09/02 14:19 Side 74
Notes: g//
About BioTIK
In 2001 the Danish Parliament launched the BioTIK-project. It is a four-year project focu- sing on both the possibilities that gene tech- nology offers, and the ethical principles that are to be considered in order to make the right decisions. BioTIK is a Danish abbrevia- tion of biotechnology and ethics.
Hence nine Danish Ministries have joined a Task Force with the purpose to incorporate ethical principles in regulation of biotechnology, in decision making processes and as a basis for public perception and information. Read more about the BioTIK-project at www.biotik.dk.
Ethical principles in European regulation of biotechnology - possibilities and pitfalls by Linda Nielsen and Berit A. Faber:
ISBN 87 7408 663 4 The Ministry of Economic and Business Affairs, Denmark 2002 National Consumer Agency, BioTIK-Secretariat, Amagerfaelledvej 56, DK 2300 Copenhagen. Telephone + 45 32 66 90 00 Fax + 45 32 66 91 00 E-mail: [email protected]
Impression: 1000
The report is also available on the Internet at: www.biotik.dk
Translation: Scandinavian Translators A/S
Layout and printing: aparte as g//
Ethical principles in european regulation of biotechnology
- possibilities and pitfalls
www.biotik.dk by Linda Nielsen | Berit A. Faber for BioTIK
COPENHAGEN 2002