Workshop Berlin 2010 Paslack

From IALS Life Sciences University Network

Rainer Paslack
(IALS, Bad Oeynhausen, Germany)

Synthetic Biology – Ethical and Legal Implications

In the following, at least, I will outline some ethical and legal questions related to a new field of research. But first: What is “synthetic biology”?

The European Commission gives following definition: “Synthetic biology is the engineering of biology: the synthesis of complex, biologically based systems which display functions that do not exist in nature. This engineering perspective may be applied at all levels of the hierarchy of biological structures – from individual molecules to whole cells, tissues and organisms. In essence, synthetic biology will enable the design of 'biological systems' in a rational and systematic way" (European Commission, 2005).

Now, combining molecular biology and biotechnology, synthetic biology is a rapidly developing new field of research that aims at extending the abilities of genetic engineering. The research is often being described as “creating life”, a description that is bound to cause public and political attention.

There are two main approaches within synthetic biology research:

(1) According to the so called top-down approach: Relevant areas within this field include the attempt to reduce the genome of a microorganism to such a degree that the organism is capable of living, but, beyond that, do not express any specific abilities. The idea is to equip such a “platform”-organism with whatever genetically encodable ability one may conceive of.

(2) In the the so called bottom-up approach researchers try to build protocells from the bottom, using smaller, separate molecules. Beyond this, the result could be organisms whose genetic make-up is based on parts not found in naturally occurring organisms.

Overall, we can synthetic biology characterise in a twofold manner:

1. The first is interdisciplinarity. Synthetic biology often combines approaches from various disciplines, such as biotechnology, chemistry, nanotechnology, computing and engineering. So it combines systematic analysis of intracellular genetic, metabolic, and signaling processes with synthesis and rebuilding of novel single cell organisms, using engineering and IT principles.

2. The second is complexity. Synthetic biology often involves many 'parts' or components that work together to achieve a certain effect.

In attempting to alter genetic structures of organisms, synthetic biology is closely related to genetic engineering. Nonetheless, the two fields of research differ in some respects: Synthetic biology is based on a systematic analysis of intracellular processes, it aims at altering metabolic pathways, signaling processes, and DNA-sequences at large scale; and it does so by using engineering principles of modularization and standardization. In order to account for the ethical, social, and legal relevance of synthetic biology, these differences has to be systematically explored and evaluated in future.

As a consequence of extended insights into the functions and modes of action of the genome, our abilities to manipulate and replace genome sequences have increased. What began as simple gene technology in the second half of the 20th century is currently evolving (under the term “synthetic biology”) into a technique that permits single-cell organisms to be tailor-made according to our own wishes, creating completely new forms of life. The preliminary climax of this development, which attracted intense media scrutiny, is the patent application submitted in 2006 by a group of researchers from the USA for a minimal bacterial organism genetically engineered in the laboratory as a “Mycoplasma laboratorium”.

But still the most projects of synthetic biology are in a visionary stage.

Possible goals of the research are
• the production of new drugs (e.g. artemisin against malaria)
• the creation of micro-organisms for medical purposes (e.g for the treatment of cancer) or as “vectors” for gene pharmaceuticals
• the replacement of dead human tissues
• the production of new biological based fuels (e.g. ethanol)
• the production of biosensors and biological chips

Now, which are the relevant implications and possible fields of conflict synthetic biology arise?

[I.] I start with the specific ethical implications or the most important questions related to synthetic biology:

Current social, legal and ethical reflections on synthetic biology focus predominantly on biosafety and biosecurity issues, i.e. issues of side effects on the environment and human health, on the one hand, and issues of intentional misuse, on the other hand. Legal issues and socioeconomic effects have been named but are still awaiting a more thorough analysis. Finally, some efforts have been made to articulate conceptual theological and ethico-philosophical topics regarding the use and meaning of the concepts of life and creation in synthetic biology.

It is hardly surprising that this technology provokes heated response. Colloquially, the term ‘life’, is not merely a descriptive but also a normative concept. Vitality is the nucleus of that which implies worthiness of protection, at the very latest when living things display evidence of pain perception and simple forms of awareness; moreover, we often associate vitality with some sense of an inherent right to exist. So the creation of life in the wakes again old ethical and philosophical issues, expectations and public anxieties.

In addition, from an ethical and philosophical perspective, the shift from manipulation to creation is significant and pertinent. “Life from the lab” is a catchword, which raises fundamental philosophical and anthropological questions: What does “life” mean when the biochemical synthesisation of life is involved? To what extent does synthetic biology seek to create “new life”? What meaning can be attached to such terms as artificial cell”? What are the implications for how we deal with life if this kind of life is dubbed “artificial”? Nonetheless, only few scholars have begun to analyze and pursue these questions further. There are still more important qquestions, but – in a short presentation – it is not possible to discuss all these complex and difficult questions. – Only a few points I will emphasise:

[1.] First, it seems of high ethical importance to analyze descriptions and concepts related to the entities, synthetic biology is about to produce. A term like “artificial cell” may serve as a case in point: Is an artificial cell a living being or an artefact? In what respect can a living cell be artificial? Taking for granted that synthetic biology can create new organisms, it needs to be examined, whether this characteristic is bound up with ethically significant implications.

[2.] A second point of ethical relevance is the question: Could synthetic biology cause effects on the inherent values in living beings, on condition that also non-human organisms have such values? – The term of “inherent value” implies that an organism is worthy of protection for its own sake. Now, although virtually no ethical theory counts single cell organisms among living beings inherently worthy of protection, it will be important to determine at what point in its development life begins to be seen as inherently valuable according to different ethical premises. Such a reflection will help to understand if and in what respect the creation of an organism in general may conflict with its inherent value. Furthermore, it will help to identify distinguishing criteria between organisms worthy of protection and those not worthy of protection.

The question of value inherent in living beings will be particularly pertinent in the case of synthetic multi-cell organisms. Although synthetic biology research is far from accomplishing this task, first steps have been taken to build multi-cellular compounds that may in the future be used to form organs. With regard to this research, it will be important to determine the relationship of synthetic biology and tissue engineering and to assess synthetic biology’s future potential to synthesise whole organisms.

Now, if synthetic biological organisms are interpreted as artificial, machine-like entities without inherent value, it is to be asked whether this may in the long run change our attitude of responsibility and respect for living beings.

[3.] This consideration leads, thirdly, to the philosophical relevant question:
Could synthetic biology open a new perspective on nature?
It has been argued that the shift from manipulation to creation involves a shift in the way scientists and engineers approach the objects of their work. If we suppose that we always act against the background of a general conception of nature, which is a mélange of empirical facts and normative interpretations, the shift from manipulation to creation could have effects not only on our self-conception as “creators” but on our perspective on nature, as well.

All in all, synthetic biology is a field that promises significant enhancements of our understanding of nature. It may also enable us to change nature in novel and useful, but also in risky ways. For an understanding of the ethical, broad societal and legal aspects of synthetic biology, mid and long term prospects of the field are needed. This relates, amongst other things, to the state of the art in the field, its potential social and economic benefits and its risks. However, due to its recent emergence and the highly visionary character of the discourse on synthetic biology, potential effects and implications of the field are difficult to assess. While there are quite a few starting points for benefit- and riskfocused assessments in the case of established fields of research, here we have to deal with extremely high uncertainties and with the scarceness or even absence of evidence that are normally referred to in technology assessment projects.

Concerning technology assessment critics often tend to focus on far-future prospects of the field, from which a highly speculative and strongly polarised debate can evolve. The pitfalls of a highly speculative ethics have been analysed and discussed widely in the context of the debate on nanotechnology and convergence.

[II.] Finally, I will make some short remarks about the special legal implications of synthetic biology.

Regarding the possible risks of synthetic biological research, first of all, we have to distinct between “bio safety” and “bio security”. While the term “bio safety” is used in the sense of safety of the environment, the term “bio security” is used in the sense of security regarding the misuse of synthetic biology, for example for militaristic or terrorist activities through the production of biological weapons. Especially “bio security” has attracted particular attention in the public arena, as some argue that synthetic biology technology could be used to produce harmful microorganisms or viruses. From a practical point of view, it could be argued that nature already provides plenty of harmful microorganisms that would make the generation of new artificial biological agents for use in terrorism seem unlikely. However, the development and intentions in this area are difficult to predict, and so the discussion about the disclosure of scientific papers and patents in this area is likely to continue (Frischknecht, 2003).

Anyways, bio safety and bio security could raise conflicts, so that legal considerations are required. But the question is: Are the existing laws efficient enough to define the conflicting fields of synthetic biology and to solve them, or is it insofar necessary that the parliament should become active? Furthermore: Is the possible legal need for activity a challenge for the national legislator or does this possible regulation have to happen in the first line on the European or international level to be effective? As far as the national legislator could be active and has to be, the question raises, to which extend he has to be active without conflicting with higher ranking European law.

Of interest for the national German law are in particular the Perspective Paper of the Ethics Council from April 2009, and the Common Position Paper to Synthetic Biology of the German Research Foundation (DFG) et al. of 2009. Both papers state that there is no existing need for activity at all. In this perspective the existing laws are sufficient for all conflict fields of synthetic biology, and regulate them as far as necessary. The questions of bio security are already regulated on the international level by the ‚Biological and Toxin Weapons Convention’ (BWTC) and further international regulations, and on the national level among others by the War Weapon Control Law. The questions of bio safety are in particular regulated by the Gene Technology Law (GenTG), the Drug Law (AMG), the Law for the Protection of Infection Diseases (IFSG) and the Law for the Protection against Dangerous Materials (ChemG). In contrast to these mentioned papers other experts like Joachim Boldt from the University of Freiburg state that the possibilities of synthetic biology are not efficiently covered by the existing regulations of bio safety and bio security. Therefore we have a further reaching need for activities and regulations of the legislator, because there are some desiderata.

For example: The application area of the German Gene Technology Law only covers the modification of an already existing biological organism. But if the object is the new production of an in nature not existing organism, the Gene Technology Law is not applicable.

Moreover, the Gene Technology Law is just not applicable, if gene technology should be made applicable for human beings. In this case the German Drug Law (AMG) is applicable first and foremost. But also the Drug Law contains desiderata. For instance certain areas will be taken out of the application area of the Drug Law, because it makes different exceptions of the obligation for permission: So pharmacies, clinics and veterinarians are excluded in certain cases, although drugs could be produced there by methods of synthetic biology. It is also questionable if a synthetically produced virus falls under the legal definition of Art. 3 of the Drug Law.

Furthermore, the monitoring of released new biological organisms, following the German Gene Technology Law, is mainly focused on the release of genetically manipulated organisms in the frame of green gene technology. In the frame of the monitoring, concerning the consequences of synthetically produced organism on the human being, it is also to observe if this could demand the production of long lasting blood and gene profiles of human beings.

Here the question arises how this demand could be realised, because on the one hand the free informed consent of the donor or probationer is necessary, and on the other hand the new German Gene Diagnostic Law (GenDG) only regulates that genetic samples have to be deleted directly after the purpose is fulfilled for what they have been taken. For a monitoring concerning the consequences of synthetic biology on humans a special legal regulation will be necessary.

In view of the fact that the development as well of the gene technology and of synthetic biology is going forward very fast, an analysis of the legal conditions cannot be limited on the actual state of research. In close interdisciplinary co-operation with different scholars and scientists we have to develop scenarios, and for these scenarios it has to be investigated, whether the existing legal regulations are appropriate and sufficient in case that these special scenarios become a reality resp. whether the risks arising in these cases are justifiable. – Facing an utmost innovative research field as that of synthetic biology a comparable innovative and sustainable law is necessary.

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