Bioethics and Modern biotechnology

A D V A N C E D   L E V E L

Synthetic biology is a recent extension of biotechnology in which genes and proteins are viewed as parts or devices, with the goal of rearranging and/or assembling these parts in novel ways to create new and useful functionality.

Contents

 

Synthetic Biology and Cloning

Introduction

Synthetic biology is a recent extension of biotechnology in which genes and proteins are viewed as parts or devices, with the goal of rearranging and/or assembling these parts in novel ways to create new and useful functionality. Recent advances in biofuel generation, biochemical production, and minimal genome understanding all benefit from synthetic biology approaches. Often, these projects rely on the ordered assembly of multiple DNA sequences to create large, artificial DNA structures. To this end, methods have evolved to simplify this process.

Synthetic biology combines molecular biology and systems biology with engineering principles to design biological systems and biofactories. The goal is to create improved biological functions to address current and future challenges.

What “Synthetic Biology” means

For well over a decade, the term “synthetic biology” (Synbio for short) has been used to describe research projects, methods, and procedures to “rebuild natural organisms.” This goes further than was previously possible with the help of genetic engineering. The approaches extend to the creation of (complete) artificial “biological” systems. The short- and medium-term significance as well as the longer-term potential of this very heterogeneous field are assessed quite differently within science, industry and politics, which is also due to the still lacking stringent definition.

The basic distinction of synbio in the narrower and synbio in the broader sense is made and used for the impact analysis and debate:

Synbio in the narrow sense refers to the production of cells or organisms (or cell-free biological or biochemical systems) designed “on the drawing board” and constructed de novo. These are intended to be used for the production of any, even completely novel substances or visionary applications in the fields of health, energy or the environment. Characteristic research approaches and methods

(1.) the production of complete synthetic genomes,

(2.) the construction of so-called “minimal cells” (either “top down” by reducing natural cells or “bottom up” or “from the scratch” from basic biochemical components), and

(3.) the use of non-natural molecules (“xenobiology”).

Synbio in the broader sense, on the other hand, is a collective term for all currently pursued, increasingly information-based and mostly application-oriented approaches to molecular biological modification of known organisms. These aim at the construction of new synthetic pathways for the production of chemicals or the design of genetic circuits for new sensory and regulatory functions in existing organisms. Synbio in a broader sense goes beyond previous simple genetic engineering approaches to influence the metabolism of organisms (so-called “metabolic engineering”). Increasingly, computer-aided design and modeling processes are being used.

Synbio in the broader sense also includes genome editing processes, which have hardly been covered under the Synbio label so far. In spring 2015, their rapid development and possible application to plants, animals and also humans provided the impetus for an intensification of the genetic engineering debate at both international and national level, which will also include synbio as a research area and funding object.

In other words, synbio brings together various scientific disciplines such as molecular biology, organic chemistry, nanotechnology, information sciences, and areas of medicine to purposefully modify biological organisms, combine them with artificial elements, or create completely artificial organisms (“arificial life” or “ALife”).

It is described as one of the newest and most promising developments in modern biology. It is part of the new and emerging science and technology (NEST). So far, no unified scientific – and therefore even more so no legal – definition has been found. Ethical, theological and legal challenges related to synbio are widely discussed in view of its implementation orientation, the enormous scientific progress and the considerable (concrete) application potential of synthetic biology.

Five subgroups are defined as the main application areas of Synbio:

(a) DNA synthesis: chemical construction of genetic codes based on the matrix of a genetic code of an existing organism (with known nucleic acids).

  1. b) DNA-based biological circuits: Transfer of complete biological systems from biobricks.
  2. c) Minimal genome or minimal life form (top-down process)
  3. d) Protocells: living cells that are re-engineered from the bottom-up
  4. e) Xenobiology: creation of orthogonal biological systems not found in nature, based on biochemical principles not found in nature (XNA).

These five subgroups can be reduced to three main elements:

  1. modification,
  2. copying and
  3. new creation of “life.”

The only regulatory gap that could be identified concerns the element of “new creation”; thus, the question arises whether also a “de novo” synthetically created cell or an orthogonal biological system that does not occur in nature is a “biological entity capable of reproducing or exchanging genetic material” within the meaning of the GenTG. The Central Commission for Biological Safety (ZKBS) in Germany stated in its current interim report of 06.11.2012 that most scientific approaches to synthetic biology fall within the scope of the GenTG. Only novel living systems such as artificial cells (bottom-up approach) without a model in nature are not covered by the GenTG. In this respect, a small clarifying addition to the legal definition of the term organism in the GenTG would be sufficient to close the gap. The addition could be worded as follows: “any biological entity capable of reproducing or transferring genetic material, including microorganisms, as well as any biological entity created by technical means that does not occur under natural conditions and that contains genetic material that does not occur in nature.” A corresponding amendment would clarify that synthetically produced or modified organisms or biological entities and even the use of naked, synthetically produced DNA would definitely fall within the scope and control of the GenTG.

Although synthetic biology does not appear to be a fundamentally new technology – especially in the legal sense – but more or less a direct continuation of modern molecular biology, genetic research or genetic engineering, the question arises whether the existing laws are sufficient or whether new laws are necessary, given the considerable (concrete) potential for application of synthetic biology.

In its most recent decision on the GenTG, the Federal Constitutional Court clarified that the legislature has a special duty of care in assessing the long-term consequences of genetic engineering because the state of scientific knowledge is not yet complete. In this respect, the mandate of Article 20a of the German Basic Law (GG) must be observed, which calls on the legislature to assume its responsibility for future generations by protecting the natural foundations of life. “This mandate calls for both hazard prevention and risk precaution. Among the environmental goods protected by Article 20a of the Basic Law are the preservation of biological diversity and the protection of a species-appropriate life for endangered animal and plant species.”  In this context, the Federal Constitutional Court has made it clear that the regulations of the GenTG are intended in particular to ensure protection against the uncontrolled spread of genetically modified organisms. However, the legislator must take into account new findings and new scientific knowledge and examine whether changes in the practice of risk assessment are necessary. If this is the case, the legislator must react accordingly and adapt the legislation. If the new level of risk exceeds the socially acceptable level of risk, the legislature must take action. Legislators have a duty to maintain a high, if not the highest possible, level of protection for human health. If they fail to comply with this duty, case law may ultimately find a violation of the precautionary principle.

Safety issues in synthetic biology

Questions of biological safety have accompanied the internal and external scientific debate on synbio from the outset. Since most Synbio products and processes are at the beginning of their development, their possible safety-relevant properties such as toxicity, allergenicity, dispersal behaviour or survivability are also largely unknown. In connection with the discussion about the nature and novelty of synbio, the safety debate on biosafety has for some time focused on the politically significant question or examination of whether the current and foreseeable developments (still) fall under the current regulations for medicinal products, advanced therapies, medical devices, chemicals and, above all, genetically modified organisms (GMOs) or are adequately covered by them – or whether the category boundaries are being blown up and previous risk assessment and risk management procedures are no longer effective. A second complex of topics concerns questions of biosecurity, i.e. the illegal (biocrime) or even malicious (bioterror) use of biological agents or the underlying knowledge. Even though much-discussed and controversial experiments (for example, bird flu viruses) that have been associated with the danger of such misuse have so far not primarily come from Synbio research projects. But scenarios of a future synthetic biology are associated with far-reaching fears and have already led to initial regulatory efforts.

Biosafety issues – challenges for risk assessment and risk regulation

A current need for a revision of risk regulation for GMOs in Germany and Europe, specifically with regard to “synthetically” modified organisms (SVOs), is still evident today. However, in view of the dynamics of scientific and technological development as well as the regulatory differences in various regions of the world, a forward-looking, more intensive consideration of the risk regulation of a possible future release of SVOs appears to be entirely appropriate.

The central issue for the risk assessment and risk-benefit evaluation of future SVOs is the question of how a safety assessment without substantial equivalence to a familiar parent organism would have to be conducted in such a way that the result could be accepted by actors in research, industry, politics as well as by civil society organisations and the public/citizens as a basis for approval for field application. In the case of plants, this question arises from a major genetic engineering “conversion” onwards; in the case of microorganisms, it basically arises with every type of field application, for example with an open microalgae culture for biofuel production, because these have so far been used almost exclusively in closed systems. Interventions in human intestinal and other microflora could become a highly explosive issue because the regulatory responsibilities are unclear here: The German Genetic Engineering Act (GenTG) does not refer to the application of genetic engineering to humans and thus probably not to the components of the human microbiome as long as they are in the human body.

The Joint Policy Paper of the German Research Foundation concludes that there is currently no need for action, or at least no significant need for action. The areas of conflict in synthetic biology are covered by existing law and are thus sufficiently regulated. The German government comes to the same conclusion.  Questions of biosafety are covered by the Genetic Engineering Act (GenTG), the Medicines Act (AMG), the Infection Protection Act (IFSG) and the Chemicals Act (ChemG). In the view of the German Research Foundation, these regulations are currently largely sufficient, so that there is no acute need for action. This is also the predominant view of the German authorities.

The German Ethics Council also sees no need for action, since synthetic biology in Germany falls entirely within the scope of the GenTG and aspects of biosafety are therefore largely irrelevant. The most important task at present is probably to develop a consistent definition of synthetic biology, to clearly distinguish it from other technologies and to formulate an answer to the question of what the essential novelty of this technology actually consists of. The Council also recognizes that the development of synthetic biology may create new problems and security risks that require a response or debate on how to respond. For this reason, the importance of some kind of monitoring process and its continuous improvement is emphasized. This monitoring process must be constantly improved. Monitoring is required by law. The ZKBS (Central Commission for Biological Safety) has already responded to the call for monitoring of synthetic biology and has submitted a first report on its observations/on the topic (1st Interim Report of the Central Commission for Biological Safety (ZKBS) of November 6, 2012, “Monitoring of Synthetic Biology in Germany”). In this report, the ZKBS, in accordance with an assessment and monitoring duty assigned to it (ZKBS 2012), examines several new techniques that belong to synthetic biology and concludes that they either fall within the scope of the GenTG or – if this is not the case – do not generate risks that require regulation. The same applies to cells generated de novo or to orthogonal biological systems.

An addition to the purpose of the law within the meaning of Section 1 GenTG is merely declaratory and thus not necessary. In its most recent decision on the GenTG, the Federal Constitutional Court clarified that the purpose of the regulations contained in the GenTG is, in particular, to ensure protection against the uncontrolled spread of genetically modified organisms.

In addition, Testbiotech demands that § 16 GenTG be supplemented as follows: “(2) A release of genetically modified or synthetically produced organisms shall be prohibited if their spread cannot be controlled or their retrieval cannot be ensured.”

In principle, such a regulation is not objectionable from a constitutional perspective.  The assessment of the risk of danger falls within the prerogative of the legislature and does not require scientific-empirical proof of the actual potential danger posed by genetically modified organisms and their progeny. In a situation that cannot be scientifically clarified, the legislature is entitled to assess the danger and risk, especially since the protected legal interests are constitutionally fixed and have a high value, and the existing risk of undesirable or harmful, perhaps even irreversible effects should be controlled in the sense of the greatest possible precaution. The Federal Constitutional Court also refers to Explanatory Memorandum No. 4 and No. 5 to Directive 2001/18/EC.

Ultimately, it will hardly be possible to provide conclusive evidence that the unintentional spread of genetically modified or synthetically produced organisms can be controlled and that their recovery / retrieval is guaranteed in any case. The addition to § 16 GenTG postulated by TestBiotech would not only affect synthetic biology. Rather, it would establish a ban on the release of genetically modified organisms into the environment for all areas of genetic engineering, i.e. for all genetically modified organisms.  A restriction that has been postulated since the first genetic engineering debates would thus be put into effect. Therefore, such a demand will hardly be politically enforceable. The demand for such a restrictive regulation regarding the release of GMOs gives rise to the assumption that the critics/opponents of genetic engineering will use the supposed novelty of synthetic biology to discuss and finally enforce their old demands for a limitation of genetic engineering. This would probably mean the end of synthetic biology and genetic engineering in Germany. The long-term study of environmental compatibility demanded by the EGE would also hardly be feasible/possible, because such a study would ultimately require the release of organisms. Only a controlled release of GMOs can provide “real” and comprehensive findings on environmental compatibility in the natural environment.

Another issue could become the renewed consideration of safety requirements for production organisms also in contained systems (“contained use”), especially with regard to possible “fully synthetic”, largely newly engineered or xenobiologically massively modified organisms. Even though they are still far from being ready for use, they have been increasingly put up for discussion by some scientists as a supposedly particularly safe future option because of their fundamental biochemical differences, which, among other things, are supposed to make functional gene exchange with natural organisms impossible.

In all likelihood, the risk debate on genetically modified insects or animals in general will gain in importance in the coming years – especially due to the increasing possibilities of genome editing techniques. In view of the experience gained with the approval of transgenic plants, a consensual positive risk assessment of genetic engineering interventions in animals, especially those with a high potential for dissemination such as insects, seems very unlikely in the EU.

Biosecurity issues – protection against misuse

Deliberate misuse of bioscientific findings can include not only the targeted development, production and transfer of biological weapons/combatants by regular military institutions or terrorist organizations, but also criminal activities such as the production of drugs, doping substances or counterfeit medicines. By their very nature, little is known about these either clandestine or illegal activities, which is why a detailed, fact-based debate to assess the dangers of “bioterror” and “biocrime” (as a result of synbio activities, but also otherwise) cannot actually be conducted publicly. However, questions can be raised in principle about the potential misuse of technologies that can be used both for societal good and deliberately for harmful purposes – so-called “dual-use technologies.”

This involves two levels:

  1. the generation of sensitive knowledge – e.g., for the synthesis and production of toxic substances, highly pathogenic viruses, or resistant bacterial pathogens – and
  2. access to this knowledge and to the technologies or apparatus (laboratory equipment) necessary for its realization.

Control of the undesired proliferation of knowledge and technologies in the life sciences faces major technical, but also conceptual, legal and ethical challenges. The latter are rooted in questions about the restriction of the constitutionally protected freedom of research as well as concrete, potentially important possibilities for health research and health care; but also in questions about whether and how knowledge can be selectively passed on to selected groups and who could or should decide about this knowledge and the selection of those “entitled to receive” it. There is consensus that, in addition to international arms control agreements, legal export restrictions on dual-use goods and technologies, and possible other legal regulations, additional governance measures are needed to reduce the risk of misuse of bioscience research in general and synthetic biology in particular. All those working with biologically active substances should develop a strong awareness of safety and have knowledge of whom, if anyone, they can involve in assessing the danger of their projects without feeling unduly monitored. As may be the case in the U.S., where the Federal Bureau of Investigation [FBI] seeks to ensure preventive control of biosecurity threats and has systematically designated liaison officers for the DIY bioscene, among others).

In Germany, the dual-use problem with regard to biosecurity-relevant research projects (“Dual Use Research of Concern” /DURC) has been taken up with commitment and intensively discussed by scientific organizations, non-governmental organizations (NGOs) and politicians in recent years. As a result, the German government commissioned the German Ethics Council to prepare a statement on the topic of “Biosafety – Freedom and Responsibility in Science”. This was presented in May 2014 and is likely to form the reference point for further political treatment of the topic in Germany in the coming years. The German Ethics Council calls for a legal regulation of dual use research of concern. Core points of the further recommendations are the creation of a nationwide, i.e. for all types of public and private research institutions, valid research code for a responsible handling of biosecurity issues as well as the establishment of a central, interdisciplinary DURC commission, which all researchers have to inform before conducting DURC projects.

With a view to the concrete reduction of abuse potentials of a significantly more powerful, cheaper and possibly decentralized gene (om)synthesis in the future, a reporting obligation for “gene synthesizing” facilities as well as a registration of DNA synthesizers also appears to be an option that could at least be tested – even if biocrime and bioterror risks are most likely to result from actors from organizations and countries that precisely cannot be controlled by (supra)governmental regulations.

Sustainable Models for the Protection and Use of Intellectual Property

The question of how intellectual property generated by modern life sciences can and should be protected is one of the most hotly contested in the genetic engineering debate, for both economic and ethical reasons. Among other things, with regard to future, for example “designed” molecular structures, genes or even organisms, it should be noted that commercial protection will be much more plausible for these than for primarily analytical results in the form of naturally occurring DNA sequences. Another novelty is that, in addition to the established (bio)patent law, copyright law is increasingly being discussed as a future protection and utilisation concept. This applies in particular to the assumption that the future of Synbio will involve the design of biological information, including DNA, and then other molecules or properties of synthetic systems, similar to the programming of software codes.

For research policy, the question arises as to whether or which forms and projects of funding can be linked to specifications for access and conditions of use of the results. This question has been intensively discussed for years in science and politics far beyond the field of the life sciences. It is evident that the handling of intellectual property under the conditions of an increasingly digital economy will remain one of the major issues for science as well as research and economic policy in the coming years. The development of scientifically, economically, socially, politically and legally realistic, innovative regulatory models would be a very challenging, costly task for an in-depth technology assessment. The issue of intellectual property rights (IPR) is regularly associated with patents, although the latter are only one type of IPR, albeit the most important. A first question with regard to possible challenges in patenting synthetic biology inventions is whether the patent procedure for synthetic biology is significantly different from the current patenting system, and secondly, whether the traditional patenting system is effective enough to deal with the new developments. With regard to current patent law in general, we can state that the patentability of microorganisms and higher life forms, including genetically modified organisms, has been confirmed by the European Patent Convention and its case law. It is therefore not a problem specific to synthetic biology (“essence of life” issue).

Challenges of the foreseeable new genetic engineering debate.

While the perspectives and potentials of Synbio in the restricted sense, i.e. the production of cells or organisms designed and constructed in a novel way “on the drawing board”, still have the status of a vision of the future in spring 2015, the situation with synbio in the broader sense, understood as the next stage of biotechnology or genetic engineering, has changed massively in recent times. The discussion about the new possibilities and consequences of genome editing procedures has become so widespread and intensified in the last few weeks of the report’s preparation that a fundamental change in the debate about the further development and use of gene manipulation techniques can be assumed.

It is foreseeable that the problem of a safety assessment or risk assessment without a substantially similar, familiar comparative organism will take on a much greater urgency if genome editing techniques are used worldwide in the coming period for the extensive modification of genomes. In this respect, an intensification of biosafety research is likely to be inevitable, both nationally and through international cooperation. The global extent and consequences of this development can hardly be predicted in detail. But it is clear that in the coming years, not only for research policy and many new, sometimes only renewed questions will arise about funding, socio-economic and ethical evaluation as well as regulation of the applications of genetic engineering and bioethics, for which it ultimately does not matter much whether the technologies and processes are called synthetic biology. What is also new about this is the increased importance of the international dimension of the issues, which results not least from the growing and further increasing scientific and technological capacity of the emerging countries. Continuous monitoring of global developments using scientifically valid indicators and regular reporting therefore seem obvious.

Overall assessment

Overall, it can be concluded that the development and application status of synbio is not yet very advanced and that the future superiority and economic feasibility of synbio approaches cannot be seriously assessed. The latter applies in particular to the potential uses of synbio in the broader sense, which are still primarily visionary today. It is not foreseeable whether (more or less completely) artificial organisms or “bio-like” systems will ever become of major importance for efficient, reliable and safe “bio-based” production.

Synbio methods and processes in the broad sense must also assert themselves against existing options and others that are also being developed. Individual projects and products are already competitive today, mostly small-volume but high-priced products (speciality chemicals, flavourings, pharmaceuticals, vaccines). For these, neither cost issues nor biosafety aspects play such a major role because the existing or alternative processes are also costly and because either work can be done in safer closed systems (bioreactors) or potential risks/side effects are more readily accepted (pharmaceuticals/therapeutics). It should not be overlooked that the most discussed product examples of Synbio, the malaria drug artemisinin, the flavouring vanillin produced with the help of modified yeast cells and a palm oil substitute from microalgae, are not very far away from “conventional” genetic engineering applications.

The prospects of success of therapeutics, vaccines and gene therapy approaches cannot be assessed in general terms. In medicine in particular, efficacy and relative excellence often only become apparent in very late stages of development or even application. Therefore, the main benefit-risk debate on Synbio applications in the health sector is currently directed at other levels: at the ecological risks of using modified mosquito populations and at questions of global social justice in new methods of producing drugs and vaccines. The significance of Synbio is likely to vary greatly in the different areas of application depending on economic success and social acceptance, analogous to the situation with “conventional” (green, red and white) genetic engineering. The consumer-sensitive area of flavourings and fragrances or other ingredients for the food, cosmetics and detergent industries will occupy a special position.

Cloning of Animals and Humans

Introduction

In 1997, the cloned sheep Dolly was presented to the world public. Since then, the topic of cloning has repeatedly made the headlines. She has three mothers and no biological father. She is genetically identical to one of her mothers. She is the first cloned mammal that is not the result of a new combination of father and mother, but was conceived from a body cell of one of her mothers. But while in Dolly’s day some researchers vehemently opposed the cloning of human cells, today they themselves work with embryonic stem cells in the hope of someday combating diseases such as cancer or Parkinson’s disease. Cloning, then, in the context of medicine, biotechnology and molecular biology, is the production of entities, individuals and populations that are genetically identical or nearly identical to the original organism or part of an organism from which they are derived. In its spontaneously occurring form, cloning is the way bacteria and some plants and animals reproduce asexually.

The most dramatically controversial area is human cloning for reproductive purposes, i.e. to produce babies that will grow into full-grown adults and full members of their society. Research on human embryos, including cloning with nuclear transfer, is widely permitted fourteen days after conception; and the subsequent cultivation and scientific and therapeutic use of human embryonic stem cells is accepted in most countries (not all). Human reproduction is at the heart of the cloning issue, ethically, with the ideas of design and the historically ever-popular theme of improving individuals and improving the human race.

Artificial cloning exploits the potential of particular, undifferentiated cells to differentiate into cells of a particular type under appropriate conditions. These cells are called stem cells. They are found both in small numbers in the body of an adult, to replace missing or dead cells there, and in early embryonic stages, from about the fourth to the seventh day after fertilisation. Only the e Only embryonic stem cells up to about the eight-cell stage can still develop into all tissue types and thus into a whole organism; they are totipotent (= omnipotent). In contrast, no whole organism can be formed from all other stem cells. They can only give rise to many different cell types or only one specific cell type, they are pluripotent or multipotent.

Biomedical research and application

Clones of higher organisms are of great interest for biomedical basic research as well as application-oriented medical research. Currently, four main possible fields of application of nuclear transfer-based cloning for medical purposes are being discussed. A first area is so-called gene pharming, i.e. the use of transgenic animals to produce therapeutically useful (human) proteins, e.g. in milk. In the foreseeable future, this will be one of the main potential applications of nuclear transfer-based cloning, as it makes the production of the corresponding transgenic animals more effective and targeted compared to conventional methods. Advantages of these active substances obtained by biogenetic manufacturing processes, such as insulin or blood factors or other human endogenous substances, are that these active substances can be obtained in a much purer way than in the conventional method via animal and human intermediates. If such animals are available, active substances can be produced in large quantities and relatively cheaply. However, there are also risks for the animals due to the genetic (transgenic) manipulation, the biological activity of the protein produced and the cloning process itself. Risks for humans can arise from changes in the products as well as from possible disease (pathogen) transmission, so they must be ruled out as far as possible by careful drug testing.

Another area where cloning could potentially be used is in the production of transgenic animals as animal models for human diseases. A major obstacle in the further development of animal models has been shown to be the fact that so far it has only been possible in mice to integrate genetically manipulated cells into the germ line of a recipient animal in such a stable way that the genetic changes can be inherited. However, the physiological and anatomical differences between mice and humans are so great that the symptoms of the genetic modification introduced in mice often do not correspond to the clinical picture observed in humans. Cloning by means of nuclear transfer using somatic cells opens up the possibility of inducing targeted genetic changes in different species (gene targeting and gene knockout). This would also make it possible for the first time to create disease models in transgenic large animals which, depending on the disease to be investigated, could be superior to previous mouse models in terms of anatomical, physiological or genetic characteristics. It is generally expected that in the medium term this will contribute to a better understanding of the clinical pictures of genetically caused human diseases and, based on this, to the development of effective treatment options. Cloning could also make a technical contribution to the transplantation of autologous tissue and to so-called cell therapy. The optimal transplant tissue is easy to characterise: its cells should be as genetically identical as possible to those of the recipient. The patient’s immune system would then no longer recognise it as foreign, and any problem of rejection would be eliminated. Therefore, an optimal solution would be to create genetically identical replacement tissue. Research results suggest that this could now be achieved by means of nuclear transfer-based cloning. In principle, another way of cultivating human replacement tissue is conceivable: With the help of the nuclear transfer method, an early embryo would be created, from which pluripotent embryonic stem cells could be obtained in culture. However, it has not yet been possible to obtain such cells in humans, even from embryos created in vitro. Moreover, such a procedure would require the ethically and legally highly problematic creation and utilisation of a human embryo, unless oocytes from animals could be used as recipients of the cell nuclei. But this development is still in its infancy and involves problems of its own, especially ethical problems that are also serious.

A fourth area in which the use of (transgenic) cloned animals is conceivable is xenotransplantation (transplantation of animal organs into humans). However, in order to construct “donor animals”, up to about a dozen genes would have to be altered in pigs, for example. This is practically impossible with conventional methods of genetic modification. Cloning could now make it possible to first provide cells in culture with the desired genetic changes before a multiply genetically modified animal could be created from them with the help of nuclear transfer-based cloning. But even if the “ideal” donor animal could be created in this way, the fundamental problems of rejection would probably remain. It is also uncertain whether the foreign animal organ will actually fulfil its function in the human recipient. The problem of animal viruses adapting to humans also remains, with the possible consequence of epidemics.

Legal aspects

From a legal point of view, it is particularly important to answer the question of which regulations govern animal cloning in Germany (and abroad), and under which conditions cloning is or is not legally permissible. There is no explicit consideration of cloning techniques in the Federal Republic in the Animal Protection Act, for example. However, the cloning of animals could be covered by the provisions of Section 7 (1) of the Animal Protection Act, as this paragraph contains provisions on animal experiments and the cloning procedures are predominantly still at the experimental stage. However, the application and impact of this paragraph are discussed in very different ways: If one does not regard the de-nucleation of the egg cell as a genetic modification in the legal sense, the transfer of the egg cell into the gestating animal does not constitute an animal experiment either. However, if one comes to the conclusion that cloning by means of nuclear transfer falls under the provisions of Section 7, Paragraph 1, Sentence 2 of the Animal Protection Act, because this involves interventions on the genetic material and, in addition, the cloning experiments can be associated with pain or harm for the genetically modified animals (or carrier animals), cloning experiments by means of nuclear transfer would clearly be subject to authorisation.

From a constitutional point of view, a cloning ban in the Federal Republic of Germany would violate the fundamental rights of researchers and professionals under Article 5(3) (freedom of research) and Article 12(1) GG (freedom of occupation). A cloning ban or other restrictions on cloning would also constitute an encroachment on the constitutionally guaranteed freedom of science. A constitutional barrier that could justify the encroachment obviously does not exist. According to Article 12 (1) of the Basic Law, a ban on cloning, for example, would therefore be unconstitutional, as it would not be compatible with the public good and would not be covered by the legal reservation of Article 12 (1) sentence 2 of the Basic Law. The cloning of animals is thus permissible in principle under the current conditions and is subject to only limited restrictions under valid law. A “state goal of animal protection” does not exclude the use of animals by humans per se, but it increases the requirements for the necessary justification.

Ethical aspects

Different positions in the social discussion and evaluation of animal cloning can partly be traced back to different fundamental value assumptions. These also determine whether the cloning of animals is considered to have a new quality compared to conventional or other new methods of animal breeding. Some theologically based positions regard cloning, for example, as an intervention in creation to which humans have no right. Those who ascribe an “intrinsic value” or a “dignity of creation” to animals will generally consider animal cloning to be at least morally problematic. From an anthropocentric perspective, the question of the safety of products produced with the help of the cloning procedure and the ecological (impoverishment of genetic diversity) and social (industrial mass production, concentration of capital, new dependency relationships) risks and dangers possibly associated with its use are in the foreground. In view of the difficulty of reaching a moral consensus, it is necessary to consider which ethical principles should guide the possible use of animal cloning.

As a rule, ethicists consider goals in biomedical research and application to be of high priority if they are particularly urgent or even vital with regard to human health and can only be achieved with the help of cloning from higher animals. Objectives in the field of basic research can also be considered of high priority and justify cloning of higher animals if no alternative methods are available. However, should cloning be associated with considerable suffering for the animal concerned, it must be examined whether the mere interest of humans in knowledge already constitutes a sufficient reason for justification or whether justifications are only possible for certain objectives, i.e. when they are necessary to avoid considerable human suffering. Goals in the field of livestock breeding are usually mentioned as subordinate to the goals mentioned, unless they explicitly serve to secure the food basis for humans.

Conclusions and options for action

In applied research, nuclear transfer-based cloning opens up new ways to produce transgenic animals. Some therapeutically effective proteins can be produced cheaply in this way. The production of autologous replacement tissue appears to be promising from a medical and ethical point of view, and corresponding research activities are therefore particularly worthy of support. It is unclear whether it will be possible to create better examination models for human diseases in farm animals, but because of the not insignificant medical importance, efforts should also be intensified and supported in this area. Overall, the potential benefit of nuclear transfer-based cloning for the fields of research and medicine appears to be relatively high.

From an ethical point of view, an evaluation of animal cloning must in principle be based on the same criteria that are (or should be) applied to traditional animal breeding. In this regard, the establishment of a national ethics commission, which would have to deal with the moral-ethical questions of the progress of biological and biomedical technology as a whole or with the consequences of progress in biology and medicine in the non-human sphere, is also problematised in various places. Its task would be to advise political decision-makers and inform the public.

Law and Ethics in the Field of Environmental Sustainability

Introduction

The principle of sustainability or sustainable development is the subject of a wide range of international, national and local activities, theoretical efforts, legal and planning measures. They are accompanied by an almost unmanageable abundance of publications and documentation. However, essential questions regarding the interpretation of this principle remain unanswered.

The principle of sustainability is widely understood on the basis of the 1987 report of the World Commission on Environment and Development (the so-called Brundtland Report), whose definition is often regarded as the standard: “Humanity has the ability to make development sustainable – to ensure that it meets the needs of the present without compromising the ability of future generations to meet their own needs. The core element of this conceptualisation is environmental protection from the perspective of intergenerational and international justice. However, the report contains a second, less well-known definition, which emphasises the radical social changes required and the process character of sustainable development: “Sustainable development is (…) a process of change in which the exploitation of resources, the direction of investments, the orientation of technological development, and institutional change are made consistent with future as well as present needs.

Europe’s commitment to sustainable development

Sustainable development has been at the heart of European policy for many years and the Treaties of Europe recognize the economic, social and environmental dimensions. Economic prosperity, efficiency, peaceful societies, social inclusion and responsibility, with dignity for all in their environment, is the basis of sustainable development. Sustainable development is therefore a cross-cutting issue that affects all states. Europe is therefore obliged to meet the needs of the present and it must not risk that future generations will not be able to meet their own needs.

Ensuring sustainability is a challenge for Europe, because it ranges from youth unemployment, climate change, pollution, energy and migration policies to population aging. We must prepare for current and future challenges and respond to rapid and complex global changes and the needs of the world’s growing population. To preserve the European social model and social cohesion, it is essential to invest in our youth, promote inclusive and sustainable growth, address inequalities and manage migration prudently. The sustainability of our health and pension systems will be improved by pursuing responsible fiscal policies and reforms, because if we are to protect our natural capital, we must accelerate the transition to a competitive low-carbon, climate-resilient and resource-efficient circular economy. Thus, a strong commitment to research and innovation is needed to turn these challenges into opportunities for new businesses and jobs.

Regulation of environmental behaviour

The understanding of the sustainability principle is spread as a standard by the report of the World Commission on Environment and Development published in 1987: “Humanity has the ability to make development sustainable – to ensure that it meets the needs of the present without compromising the ability of future generations to meet their own needs.”

Intergenerational and international equity makes environmental protection a core element of the conceptualization. But the report contains a second, less known definition, which emphasizes the necessary radical social changes and the process character of sustainable development: “Sustainable development is ((…)) a process of change in which the exploitation of resources, the direction of investments, the orientation of technological development, and institutional change are made consistent with future as well as present needs.”

The so-called three-pillar model is, however, the definition most frequently used in the sustainability discourse: “Sustainability is the conception of a permanently sustainable development of the economic, ecological and social dimensions of human existence. These three pillars of sustainability interact with each other and require balanced coordination in the long term.”

Sustainability is future-oriented and at the same time utopian, i.e. it is a utopia, but not in the sense of “illusory carelessness” but rather “as an expression of a departure into a future offensively oriented towards gaining new perspectives” – especially in view of the narrowing of future options by economic, ecological and social problems.

The EU is therefore committed to a development that meets the needs of the present without risking that future generations will not be able to meet their own needs. A life in dignity for all with the resources available on this planet, characterized by economic prosperity, efficiency, peaceful societies, social inclusion and environmental responsibility, is the basis of sustainable development.

Instruments

Instruments to enforce the environmental policy (environmental planning)

Environment policy has developed in the industrialised countries primarily as a reaction to a high environment intensive growth of the industry at the beginning of the seventies in the last century as a special government department. At first it confined itself mainly to the activity of the state. In the meantime however more and more environment relevant protagonists (so called “stakeholders”) are called to account for environmental matters. Especially the direct responsibility of the producer of (potential) environmental problems plays an increasing significant role. There is also the need to exert eco-political goals and strategies in other departments: e.g. in the energy -, transport -, and industry -, agricultural – or building and construction policy. “Hard” eco-political instruments (as laws and regulations) are side by side with the “soft” methods of behavioural control.

Beside the environmental law the environmental planning forms the central set of tools, insofar ecological policy wants to take effect not only as regulatory but also as formative policy. The environmental planning can be regarded as the development of sustainable environmental strategies, which are to facilitate the achievement of regional and/or sectoral environment protection goals within a certain timeframe: e.g. the reduction of CO2-emissions by 25% within the next ten years. In the eighties of the last century the passage of national environmental plans in Denmark, Netherlands and Finland played a pioneering role in this. Therefore we will first expand on the possibilities of the environmental planning.

For enforcing the environmental policy principles and objectives two instruments are implemented in the legal framework of many states within the EU, means the different types of environmental planning and the different measures for regulation environmental behaviour. Environmental planning is an important means of precautionary protection. Such planning takes place as a multi-stage process, involving registering the current situation, forecasting future developments, and conflicts of objectives and interests. Plans can take the form of laws, statutory regulations, statutes, administrative regulations, or administrative acts, each of which has different legal consequences

Two forms of environmental planning are dominant: The so called “comprehensive planning”. It is the task of comprehensive planning concerning the environment is to determine, while exercising foresight, land use for residential, economic, and leisure purposes for a certain area, irrespective of any specific project and not limited to any specific sector. And the second one is sectoral planning: By contrast, sectoral planning is concerning the environment serves to establish environmental protection plans. They are mainly the landscape plans, clean air plans, noise abatement plans, water conservation plans, and waste management plans, all of which require additional enforcement measures.

Another important instrument to enforce the environmental policy demands is the „Environmental impact assessment” (EIA). The primary objective of this instrument is to inform the administration in good time and comprehensively about the environmental impacts of environmentally significant projects. Environmental impact Assessment is to identify, describe, and assess all of the direct and indirect impacts of a planned project on the environment, including ecological interactions, in good time, thus allowing the taking of precautionary measures, across all media and sectors, and involving the public.

Instruments to regulate the environmental behaviour

Environmental behaviour is perhaps the most important objective for environmental policy and education. There are some instruments for regulation the environmental behaviour. One has to distinguish between direct and indirect forms of regulation:

Direct regulation of behaviour pertains to legal measures designed to immediately affect environmental behaviour. The “classical” instrument of this type is environmental regulatory law, which originates from police and regulatory law and generally punishing non-compliance by imposing sanctions. Accordingly, actions with adverse environmental impact are subject to administrative control, which is characterized by legal requirements of notification, registration, licensing, authorization, approval, and other procedures of granting permission to engage in such activity. In addition, direct regulation is also exercised by means of expressly (absolutely) prohibiting or requiring certain behaviour by law.

Principles for political and legal measures

Important is to distinguish and explain the principles guiding environmental law both in a national and an international frame and understand the meaning of ‘environmental sustainability’ and ‘sustainable development’ in the context of nature protection  Serious and substantial environmental law has to be guided by some high-ranking principles. For many international and and national regulations in the field of environmental law within the European Union (e.g. in Germany), four basic principles are the basis for all processes of environmental law-making regarding the precautionary principle, the polluter-pays principle, the principle of sustainable development (concerning the integration of environmental protection and economic development) and the cooperation principle.

Other principles are often mentioned, which complete the four main principles or define them in a particular way. Some examples are Environmental procedural rights, common but differentiated responsibilities, international and intergenerational equity, common concern of humankind and the common heritage.

Precautionary principle

In its origin, the precautionary principle is rather a political than a philosophical principle and was first introduced as ‘Vorsorgeprinzip’ (principle of precaution) in the German-speaking area. It was incorporated into several national legal texts and international treaties or declarations. A good definition was given by Per Sandin: “The basic message of the precautionary principle is that on some occasions, measures against a possible hazard should be taken even if the available evidence does not suffice to treat the existence of that hazard as a scientific fact.” It can therefore be stated that the precautionary principle is based on hazard detection and scientific uncertainty. As a consequence, the burden of proof (that an action might cause severe harm to the public or the environment) falls on those who plead for measures to prevent such an harm. Whenever one can anticipate plausible harm for society or the environment, the precautionary principle should be applied. But often it is not clear whether a planned action will cause harm to the public or the environment or not, because the possible impact of human actions on the environment or human health often depends on the dynamics of complex systems, so the real consequences of actions may be unpredictable. Therefore further scientific research is required – but also caution if a current action intervenes in complex (human or natural) systems.

Nowadays the precautionary principle is incorporated into many European and international contracts and treaties. In its 1976 Report on the Environment, for example, the German Federal Government describes the precautionary principle as follows: Environmental policy is not limited to averting imminent danger and remedying damage that has already occurred. Precautionary environmental policy furthermore demands that the natural environment be protected and treated with care. The precautionary principle is embodied in a number of environmental provisions, and also involves resource conservation in addition to risk precaution.

The precautionary principle is especially important in legal regulations and decisions concerning potential risks to public health, such as the marketing of genetically modified foods, the use of growth hormones in cattle raising, or measures to prevent ‘mad cow’ disease.

Nevertheless, in real cases the policy-makers often have to struggle with a lack of valid scientific information or with irreducible conflicts between the interests of different stakeholders. Sometimes it is very difficult to estimate or assess the potential harm and to find an acceptable political compromise. But anyway, rigorous application of the precautionary principle should be avoided when there is insufficient knowledge of whether there is a real potential risk from an innovative product or an activity or not. In this case the principle could be taken immoderately as an absolute ban on all actions – which could stall all technological innovation and progress.

Polluter-pays principle (versus community-pays principle)

The polluter-pays principle states that the one causing environmental impact is principally held responsible—materially and financially—for protecting the environment and is required to prevent, correct, or financially compensate such impact. But a problem arises in cases of inherited pollution where the responsible parties often cannot be held liable and—if no other party can be held responsible—the general public must bear the cost. In such cases the polluter-pays principle would be replaced by the community-pays principle.

In environmental law, the polluter-pays principle is enacted to make the party responsible for producing pollution responsible for paying for the damage done to the natural environment. It is regarded as a general custom because of the strong support it has received in most Organisation for Economic Co-operation and Development (OECD) and European Community (EC) countries. In international environmental law it is mentioned in Principle 16 of the Rio Declaration on Environment and Development (1992).

The polluter-pays principle is an important element of environmental policy and influences, for example, political measures for reducing greenhouse gas emissions. Often this principle will be applied as the so-called ‘extended polluter responsibility’ (EPR). This concept was probably first formulated by the Swedish government in 1975. For instance, EPR can help to shift the responsibility for dealing with waste from governments and taxpayers to the real producers of the waste. OECD defines EPR as: a concept where manufacturers and importers of products should bear a significant degree of responsibility for the environmental impacts of their products throughout the product life-cycle, including upstream impacts inherent in the selection of materials for the products, impacts from manufacturers’ production process itself, and downstream impacts from the use and disposal of the products. Producers accept their responsibility when designing their products to minimise life-cycle environmental impacts, and when accepting legal, physical or socio-economic responsibility for environmental impacts that cannot be eliminated by design.

The principle of sustainability (sustainable development)

Another important principle is the principle of sustainable development, which may be viewed as an instance of applying the precautionary principle to resources. This principle is a pattern of resource use that aims to meet human needs while preserving the environment so that these needs can be met not only in the present, but also for future generations. For the first time, the term “sustainable development” was used by the Brundtland Commission (1987), which has given the most famous definition of sustainable development as development that “meets the needs of the present without compromising the ability of future generations to meet their own needs” (United Nations 1987).

The term ‘sustainable development’ seeks to combine the resources and processes of natural systems with the human needs and economic activities of social systems. Already in the 1970s the term ‘sustainability’ had been used for an economy “in equilibrium with basic ecological support systems”. On the base of the idea of sustainability and according to the alarming theses of “The Limits to Growth” many ecologists tried to create the new concept of a “steady state economy”, especially with respect to environmental concerns. In this context, ‘sustainable development’ does not refer solely to environmental issues, but also takes into account social and economic considerations: the resolving of conflicts between different competing goals and stakeholders, and the harmonising of economic growth and social welfare with environmental quality. The concept of sustainable development—both of nature and society – points out that the survival of mankind depends essentially on the survival of nature (or the natural environment), because economic and socio-cultural welfare is directly coupled with the the welfare of nature – resources, plants, animals, etc. Ultimately, the exploitation and degradation of nature can result in the inability to maintain human life and even in the extinction of mankind. The theory of sustainable development is therefore based on the assumption that societies have to manage three forms of non-substitutable capital: economic, social and natural capital.

It may be that we can find ways to replace some natural resources, but it is unlikely that we will ever be able to replace the services provided by the eco-system: for example, to protect us against dangerous cosmic radiation with an intact ozone layer, or to supply us with sufficient oxygen as the tropical forests or the algae of the oceans do. The multi-functionality of many natural resources and also biodiversity are irreplaceable. Moreover, the deterioration of natural resources and the loss of natural services (e.g. the absorption of nutrients by a lake) are often irreversible processes – like the loss of ethnic and cultural diversity (e.g. indigenous languages). Therefore only a sustainable development can secure both: the protection of a functional intact environment and the survival and welfare of human beings.

Cooperation principle

‘The cooperation principle underscores that environmental protection is the responsibility of all of society and not just of the state: accordingly, all parts of society and the state are called on to cooperate’ (Knopp 2008: 49) The cooperation principle is the weakest of the four environmental principles, and it can hardly be considered as satisfying the requirements demanded of a guiding principle of law.

Other principles in national and international environmental law

Apart from the four basic principles, there are a number of others guiding national and international environmental law, such as the ‘grandfathering principle’ or the ‘principle that action may not result in a significant deterioration of environmental conditions’. Last but not least, we should also mention the principle of trans-boundary environmental protection: this principle mirrors the insight that environmental problems do not stop at national borders. For instance, this principle underpins much of the Water Framework Directive of the European Union where it covers the trans-boundary management of water resources in natural river basins.

National as well as international environmental laws are often based on the above called principles, especially the trans-boundary principle. This is important, because many environmental problems are border-crossing problems, for example, climate change, sea water and air pollution.

Regulation of Environmental Behaviour

Instruments to enforce environmental policy (planning)

Environmental policy has developed in the industrialised countries primarily as a reaction to the highly intensive growth of the environment industry at the beginning of the 1970s into special government departments. At first policy confined itself mainly to the activity of the state. Over the years, however, more and more protagonists with any interests in the environment field (so-called ‘stakeholders’) are being called to account on environmental matters. In particular, the responsibility of the producer of (potential) environmental problems is becoming increasingly significant. There is also a need to exert eco-political goals and strategies in other departments, for example, in policy for energy, transport and industry, agriculture, and building and construction. ‘Hard’ eco-political instruments (such as laws and regulations) exist side by side with the ‘soft’ methods of behavioural control (such as education of engineers concerning environmental awareness), for example, in the case of projects that involve many private stakeholders or the public.

Besides environmental law, environmental planning forms are a central set of tools to the extent that environmental policy tries to operate not only as a regulatory but also as a formative instrument. Environmental planning can be regarded as the development of sustainable environmental strategies to facilitate the achievement of regional or sectoral environment protection goals within a certain time-frame, for example, the reduction of CO2 emissions by 25% within the next ten years. In the 1980s the implementation of national environmental plans in Denmark, Netherlands and Finland played a pioneering role in this. We will, therefore, first expand on the possibilities of environmental planning.

To enforce environmental policy principles and objectives two instruments are implemented in the legal framework of many states within the EU that means different types of environmental planning and the different measures for regulating environmental behaviour.

Environmental planning provides an important means of precautionary protection. Planning takes place as a multi-stage process, involving registering the current situation and forecasting future developments; moreover, it has to take into account possible conflicts of interests.

Plans can take the form of laws, statutory regulations, statutes, administrative regulations or administrative acts, each of which has different legal consequences. In addition, environmental planning may involve comprehensive planning or sectoral planning. Two forms of environmental planning are dominant, the comprehensive planning. The task of comprehensive planning is ‘to determine, while exercising foresight, land use for residential, economic and leisure purposes for a certain area, irrespective of any specific project and not limited to any specific sector’ and the sectoral planning. By contrast, sectoral planning serves to establish environmental protection plans for specific sectors, chiefly landscape, clean air, noise abatement, water conservation and waste management, all of which require additional enforcement measures

Another important instrument for enforcing environmental policy demands is environmental impact assessment (EIA). The primary objective of this instrument is ‘to inform the administration comprehensively and in good time about the environmental impacts of environmentally significant projects’ EIA is used to identify, describe and assess all of the direct and indirect impacts of a planned project on the environment, including ecological interactions, in good time, thus allowing precautionary measures to be taken across all media and sectors, and involving the public.

Instruments to regulate environmental behavior

Environmental behaviour is perhaps the most important target for environmental policy and education. There are various instruments for regulating environmental behaviour, which can be distinguished as direct or indirect forms of regulation: as (1) direct regulation and (2) indirect regulation of behavior.

Direct regulation of behaviour

Direct regulation of behavior pertains to legal measures designed to immediately affect environmental behaviour. The traditional instrument of this type is environmental regulatory law, ‘which originates from police and regulatory law and generally punishes non-compliance by imposing sanctions’. Accordingly, actions with adverse environmental impact are subject to administrative control, which is characterised by legal requirements of notification, registration, licensing, authorisation, approval and other procedures of granting permission to engage in such activity. In addition, direct regulation is also exercised by means of expressly prohibiting or requiring certain behaviour by law.

Absolute legal bans (e.g. in Germany under the Federal Nature Protection Act, 2002, §§ 23 [2], 42 [1] and [2]), directly forbid certain behaviour with adverse impact on the environment. However, legislators only rarely employ measures of this type. By contrast permission procedures are the key instrument in current environmental regulatory law in many European states. Projects subject to permission are strictly prohibited without permission. ‘Erecting or operating an installation of environmental significance, using environmental media, or producing and distributing certain products may all be subject to permission’. Thus a permit is a constitutive administrative act in that it grants the applicant the right of lawfully engaging in an otherwise prohibited activity. Environmental law includes a number of so-called environmental obligations, of which basic obligations are of special significance. They impose certain obligations either on everyone or on a certain group of people. Normally, these basic obligations involve preventive and precautionary measures, most notably the conservation of resources (e.g. water or soil). Apart from those basic obligations, there are ‘numerous collateral obligations that may benefit the environment, such as promotion and performance obligations, monitoring and protection obligations, obligations to cooperate and continuously disclose information, organisational obligations and obligations to tolerate certain actions.

Indirect regulation of behaviour

Indirect regulation of behaviour does not rely on norms mandating behaviour, but aims to influence motivation: incentives are provided for environmentally friendly behaviour while leaving discretion to the addressee. The means of indirect regulation behaviour notably include informational instruments, economic instruments, such as levies certificates, and subsidies.

Information, appeals and warnings, means that according to the German Environmental Information Act (1994), providing free access to environmental information is viewed as a means of sharpening the awareness of citizens and public authorities of the need for effectively protecting the environment. These means of raising environmental awareness range from political and moral appeals to warnings, recommendations and other forms of information, such as labels and product and usage information. The most important means to indirectly regulate behaviour are environmental levies. ‘They place a price tag on the use of the environment and leave it to market participants to decide if and how they will react based on their individual cost–benefit analyses’. In practice, the inability to precisely affect behaviour via environmental levies can pose a problem. If they are set too low, polluters will opt for paying the levy instead of altering behaviour harmful to the environment. If levies are set too high, they may impede economic competitiveness. For instance, the following environmentally relevant charges are being levied in Germany in 2012 for example waste water charges, countervailing charges under nature conservation law and forest protection charges in various German States, water abstraction fees in some German States (‘water penny’) and the waste transportation charges (consumer law).

Environmental levies may be imposed as taxes, fees and contributions for benefits incurred, and special levies. Granting benefits to users of environmentally friendly products, means ‘Benefits for use’ refers to provisions that relax or lift general limitations imposed on the use of environmentally harmful products in the case of products that comply with standards that, although not required by law, are considered desirable, thus rendering such a product more environmentally friendly than others of the same kind. ‘Although this instrument does not involve financial incentives in the medium and long term, changes in consumer behaviour may be expected that may lead to crowding environmentally more harmful products out of the market’.

Or the subsidies, that means providing financial assistance is a form of indirect behaviour regulation. Subsidies are monetary or non-monetary benefits granted by the state, without any product or service being provided in return. Subsidies are generally viewed with scepticism, since they are considered to be prone to abuse and to place the cost burden of environmental protection on the general public. In the European Union there has been a tendency to cut back on environmental protection subsidies.

And finally the idea of environmental certificates is based on a market-compatible form of quantity control by the state. Certificate-based schemes do not take prices as their starting point but define an admissible level for a certain future use of the environment in quantitative terms, leaving the formation of process up to the market. This instrument has been employed for climate protection under the Kyoto Protocol. The allocated emission allowances grant the holder the right to pollute the environment only to a certain extent. Should the holder pollute the environment to a lesser degree than permitted, the holder may sell the unused pollution allowances to another polluter. ‘Enterprises may thus elect to either reduce emissions from their installations or to acquire additional emission allowances from other enterprises that have been able to reduce emissions at lower cost’. Future experience will show whether this instrument will indeed prove successful in reducing greenhouse gas emissions. Economic instruments are gaining increasing significance as a complement to environmental regulatory law. There is no single answer to the question as to what is actually the ‘proper’ choice of instruments in order to achieve an adequate balance between various environmental user interests, the interests of affected neighbours, the interests of the general public and the protection of the environment. Legislators and administrations are thus ultimately compelled to rely on trial and error to reach an appropriate decision.

The Multidimensional Sustainability Strategy

Social justice, prosperity and peace, with nature to overcome global crises, are to be seen as three interrelated and equally weighted goals of sustainability. But it remains unclear how to make a multidimensional sustainability strategy politically viable in individual countries as well as in the global community. There is indeed a great danger that this promising societal strategy will end up in the vicinity of utopia and wishful thinking based only on moral normative grounds.

An integrative sustainability strategy in the comprehensive sense is first of all about coordinating the different normatively based life perspectives of individuals, social groups, nations, present and future generations. In the process of searching for and shaping a globally sustainable development, innumerable agreements will have to be reached, both within society and internationally, which would have to be morally motivating for all actors involved.  So motivating, in fact, that these agreements could attain a degree of binding force that would allow possible violations of the agreements to be punished with sanctions. The consensus to be reached therefore goes beyond the mere coordination of different, normatively based perspectives: rather, it presupposes a generally accepted ethical framework as well as principles and standards that are ethically valid for all participants. In other words: Sustainability needs a morally suitable, politically viable and pluralistic guiding ethic that is socially and spatially and temporally transcendent, that has a high level of acceptance comparable to fundamental freedoms, and that allows operationalizable and targeted, detailed standards to be developed for ecological, economic, social, political and cultural sustainability dimensions. However, this ethic has been lacking up to now.

Precisely because of the lack of an acceptable ethics of sustainability, the uncertainty of formulating social and economic sustainability rules and justifying morally consensual action steps remains very high. Moreover, the lack of an acceptable and comprehensive ethics of sustainability favors the current dominance of one-dimensional, ecological-economic considerations in the sustainability debate and at the same time hinders the coordination, cooperation and mutual adaptation of promising actually integrative sustainability approaches and their respective goals.

The debate on ethics, which was originally conducted independently of the sustainability debate, has not yet provided any decisive impetus either, although the irreversible consequences of scientific and technological development have triggered a lively ethical debate on the responsibility of the present towards future generations. This debate was followed by the discussion on ecological justice and, more recently, on sustainability. Understandably, the first step in this discussion is to examine the extent to which previously accepted ethics of justice can be applied to ecological justice. The meager result of this discussion was, however, pre-programmed. The common justice ethics suffer from the one-dimensionality of their frame of reference. In them, social justice is a parameter of some other overarching goal.

  • In utilitarianism, social justice is dependent on the maximization of total utility;
  • in Marxism, social justice is only possible in a communist society, i.e., when the conditions for the equality of all people have been historically established;
  • and in liberalism, social justice is a parameter of the goal of the greatest possible basic freedoms.

Seen in this light, these ethics are already inadequate for treating social justice as an independent and immediate socio-political goal. Their inadequacies become even greater, and their binding force for policy becomes weaker, if they were also to provide moral standards of value for additional and qualitatively new dimensions of justice, such as ecological, international, and intergenerational justice.

Equal opportunities as a universal ethic of globally integrative sustainability

The question thus arises whether a different ethics that takes into account the requirements of integrative sustainability is conceivable. In the opinion of the author and on the basis of his insights gained so far, which of course have a provisional character, equal opportunities as an independently conceived universalistic ethics could fill the demonstrably existing orientation gap. The core of his considerations is the definition of equal opportunities as “equal starting conditions for individuals, social groups, peoples of different color, religion, culture, language, for people of different genders, and for different generations to determine their own needs, lifestyles, and options, and to have equal access to natural resources, goods, and positions. Equality of opportunity is a condition that must be constantly re-established against both historically evolved and newly emerging inequality trends”.

However, it needs to be argued in more detail whether and in what way equality of opportunity, understood in this way as a universal action-oriented ethic, can make a central contribution to overcoming the deficits outlined above for a policy of inclusive sustainability. The following considerations are taken as a starting point: The conclusion of the prevailing liberal view that the realization of equality of opportunity “precisely because of the principled universality of the individual reference cannot be specified in terms of content” and that “the magic and allure, the seductiveness and vagueness” make this concept “universally and all-roundly usable as a political fighting term”   is logically not at all compelling. Every organized individualistic society must follow general norms and rules in the interest of all individuals.  The universality of the idea of equality of opportunity consists precisely in the fact that individuals both animate each other to mutual claims and enter into obligations among themselves. It corresponds to the moral standards and conceptual logic of the principle that no individual may impair the opportunities of other individuals entirely in the sense of Kant’s categorical imperative “act in such a way that the maxim of your will could at the same time at any time be regarded as the principle of a general legislation.” Furthermore, the substantial as well as indispensable condition of equality of opportunity is equality of starting conditions. This condition is morally as well as logically integral to the principle.

The exclusion of historically grown inequalities, fortunes and positions, which have not arisen on one’s own merit but by allocation, precludes the realization of equality of opportunity. In this respect, the assumption of vagueness and complete openness of the principle for political practice is an arbitrary one and results rather from the conception of justice of classical liberalism itself. Equality of opportunity can be interpreted not only intrageneratively, but also in an intergenerational sense universal interpretation. Kant’s categorical imperative, strictly speaking, becomes normatively consequential only through an ethics of equal opportunity, thus overcoming its reputation of a merely formal principle with which no justifications of particular ends or maxims can be provided. With regard to its inter-generationally universal scope, the idea of equal opportunity also takes into account the legitimacy dilemma often problematized by ethicists but not solved: Every society would have its own ideas of needs and well-being. The present generations would not have the right to define the needs of future generations and, moreover, to prescribe the technological and social conditions for them.  This objection cannot be denied a comprehensible moral justification.

The positive turn of this objection, however, leads to the moral maxims of action for present generations that allow future generations equal opportunities to use nature according to their ideas of need, well-being, and happiness. “Our ignorance should not serve as a justification for limiting the life chances of those to come”.

Weighty arguments thus condense and underpin the view that equality of opportunity can be made fruitful as a foundation for a social theory of integral sustainability that transcends space and time across disciplines. Equal opportunity as a universal ethic and integrative sustainability as a multidimensional framework for action require an inter- or transdisciplinary (socioeconomic, ecological, political science, sociological, and philosophical) approach.

The following principles, which are still preliminary are considered to be fundamental for specifying and achieving equal opportunities

  • Principle of freedom: Every human being has the same right to the most extensive total system of equal basic freedoms possible for all. A less extensive freedom must strengthen the overall system of freedoms for all (Rawls’ first principle).
  • Diversity principle: Every human being has the right to cultivate and maintain specific characteristics of his or her own, such as aptitude, lifestyle and life planning, and to use them in the sense of his or her own self-realization.
  • Autonomy principle: Every person has the right to the fruits of his or her own labor (the idea of self-ownership according to classical liberalism and Marxism).
  • Freedom of access principle: Every person has the same right of access to natural resources and to social positions. A restriction of this right must lead to the strengthening of the same for all people living in the present as well as for future generations.
  • Principle of care: Everyone is obliged to care for disadvantaged and dependent people. The restriction of autonomy accepted in this process must strengthen the overall system of autonomy for all. The definition of equal opportunities and the formulation of its principles are preliminary. It remains to be verified to what extent both the definition of equal opportunity and its individual principles are complete, each individual principle is consistent in itself and these together can be integrated into an overall concept, and finally whether these individual principles can also be anthropogenically underpinned.

The question of the hierarchy of these principles must remain open for the time being; whether an evaluative hierarchy or equal ranking is morally compelling requires detailed investigation, although there is already much to suggest that these principles would have to stand in an indissoluble relationship to each other. However, there is sufficient evidence for the hypothesis that equality of opportunity meets the requirements of a multidimensional ethics and the politics of integral sustainability much more strongly than the ethics of justice known so far. It is conceived as an integrative further development of those common ethics of justice in which either the principle of equality or the principle of freedom is absolutely dominant. Freedom, autonomy, self-realization and care, justice of achievement and justice of need give equality of opportunity a moral fitness and political capability of the highest order.

Test: LO8 Advanced Level

Welcome to your LO8_AL: Law and Ethics in the Field of Environmental Sustainability

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  • Krämer L. 2013. Genetically Modified Living Organisms and the Precautionary Principle, http://www.testbiotech.org/node/904
  • Luttermann C. 2011. Synthetic Biology: Building Blocks for Life and Jurisprudence. JZ, 195.
  • Mooney P. 2010. Next Bang! Wie das riskante Spiel mit Megatechnologien unsere Existenz bedroht, Munich.
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  • Presidential Commission for the Study of Bioethical Issues. 2010. New Directions. The Ethics of Synthetic Biology and Emerging Technologies, Washington, p. 140 ff.
  • Robienski J, Simon J, Paslack R. 2016. Legal Aspects of Synthetic Biology. In: Joachim Boldt (Hg.): Synthetic Biology, Bd. 493. Wiesbaden, pp. 123–140
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  • Schmidt M. 2011. Biosicherheit und Synthetische Biologie. In: Pühler, A., Synthetische Biologie – Die Geburt einer Technikwissenschaf, p. 112 f.
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  • Niemann H. 1997. Vermehrung genetisch identischer Tiere durch Klonen. Manuskript und Beantwortung des Fragenkataloges zur Anhörung im
  • Ausschuss für Ernährung, Landwirtschaft und Forsten des Deutschen Bundestages am 11.6.1997.
  • Podschun TE. 1999. Sie nannten sie Dolly – Von Klonen, Genen und unserer Verantwortung, Weinheim.
  • Thomson JA, Marshall VS. 1998. Primate Embryonic Stem Cell Lines. Curr. Top. Dev. Biol., 38: 133-165
  • Tinneberg HR, Ottmar C. 1995. Moderne Fortpflanzungsmedizin – Grundlagen, IVF, ethische und juristische Aspekte, Stuttgart
  • Travis J. Human Embryonic Stem Cells Found?, in: ScienceNewsOnline, Altner G. 1982. Grundlagen. In: Kalberlah, F., Michelsen, G. & Rühling, U. (eds), Der Fischer Öko-Almanach. Daten, Fakten, Trends der Umweltdiskussion, Frankfurt am Main, pp.13-50 (16).
  • Berkes F, Colding J, Folke C. 2003. Navigating social-ecological systems: building resilience for complexity and change, Cambridge University Press, Cambridge.
  • Bick H. 1987. Ökologie – Wissenschaft von den wechselseitigen Beziehungen zwischen Organismen und Umwelt. In: Calließ, J. &Lob, R.E. (eds), Handbuch Praxis der Umwelt- und Friedenerziehung. Vol. 1: Grundlagen, Düsseldorf, pp.16-27 (21).
  • Bückmann W, Leo YH, Simonis UE. 2003. Nachhaltigkit und das Recht, Bundeszentrale für politische Bildung, 1.7.2003, Aus Politik und Zeitgeschicht (B27/2003), Umwelt und Klimapolitik
  • Bundesregierung. 2002. Perspektiven für Deutschland. Unsere Strategie für eine nachhaltige Entwicklung, Berlin.
  • Enquete-Kommission des Deutschen Bundestages. 1994. Schutz des Menschen und der Umwelt, Die Industriegesellschaft gestalten. Perspektiven für einen nachhaltigen Umgang mit Stoff- und Materialströmen, Bonn.
  • Meadows DH, Meadows DL, Randers J, Behrens III, William W. 1971. The Limits to Growth; A Report for the Club of Rome’s Project on the Predicament of Mankind, New York.
  • Partelow S. 2018. A review of the social-ecological systems framework: applications, methods, modifications, and challenges. Ecology and Society, 23(4): 36.
  • Paslack R. 1991. Urgeschichte der Selbstorganisation. Zur Archäologie eines wissenschaftlichen Paradigmas. Vol. 32, in series: Wissenschaftstheorie: Wissenschaft und Philosophie. Braunschweig/Wiesbaden.
  • Paslack R. 2012. The challenge to environmental ethics, in: Vromans, K., Paslack, R., Isildar, G. Y., deVrind, R. & Simon, J. W. (eds), Environmental Ethics – An Introduction and Learning Guide. Greenleaf Publishing, Sheffield, pp. 65-82.
  • Sandin P, Peterson M, Hansson SO, Rudén C, Juthe A. 2002. Five charges against the precautionary principle. Journal of Risk Research, 5 (4): 287-299.
  • Stivers PE. 1976. The Debate Goes On: Science and Policy; Policy and Science, April 1.
  • UBA. 2002. Nachhaltiges Deutschland. Wege zu einer dauerhaft-umweltgerechten Entwicklung, Berlin 1997; auch in Englisch: Sustainable Development in Germany. Progress and Prospects, Berlin 1998; vgl. auch UBA, Nachhaltige Entwicklung in Deutschland. Die Zukunft dauerhaft umweltgerecht gestalten, Berlin.
  • Van den Belt H. 2003. Debating the Precautionary Principle: “Guilty until Proven Innocent” or “Innocent until Proven Guilty”? pp. 1122-1126.
  • Weidner H. 1995. 25 Years of Modern Environmental Policy in Germany. Treading a well-worn path to the Top of the International Field, Wissenschaftszentrum Berlin für Sozialforschung, pp. 1-99.