Regulatory strategies for chimaera research
v/Elisabeth Rynning, professor, dr.jur., Juridiske Fakulteten, Uppsala Universitet, Sverige
Varighed: 22:46
When society is faced with emerging new phenomena or technologies, not least in the area of biomedical research, issues of regulation sooner or later arise. While some policy makers and stake holders will call for protective legislation, restricting the area of lawful activities and providing public control, others will advocate extensive freedom, often in the interest of scientific and economical development. The overall picture is rarely simple, since conflicting and coinciding private and public interests tend to form irregular and complex patterns. Furthermore, the balancing and protection of important interests in society, by the application of existing legal norms or the introduction of new ones, can be done in many different ways and at various levels, in domestic as well as international law. It may also be argued that not all fields of biomedicine are suited to legal regulation, for example due to the need for flexibility in areas of rapid development. Alternative or complementing steering modes can be used to influence the behaviour of the parties concerned, including for example information and public debate, self-regulation and various types of financial incentives.
There may be both advantages and disadvantages to extending the application of already existing more general regulation and procedures. This discussion is well known from the area of genetic analysis, where the justification of so-called genetic exceptionalism has been debated. Considering regulation of the creation and use of human-animal chimeras and hybrids, however, the determination of appropriate criteria for the legal distinction between animal and human constitutes a paramount challenge. In most European countries, laws on for example reproduction, justifiable research or general individual rights and duties, are based on the assumption that there exists a clear distinction between humans and animals, but the legal system offers no actual defining criteria. Thus, policy makers and legislators need to decide whether different forms of human-animal mixtures should be placed within the regulatory framework applicable to humans or that which is applicable to animals, or whether new legal standards should be created for certain categories of chimeras and hybrids.
To achieve a well-balanced regulation for this complex issue, which is likely to have implications also for our fundamental perception of our identity as human beings, must be considered a highly demanding task. It could certainly be argued that we should not put ourselves in a position where uncertainty may arise as to whether a living creature produced should be defined as human beings or animals, but issues of definition have to be handled already at the level of cellular research, for example when deciding what counts as a human embryo. The application of precautionary principles to this field of research would at least seem to imply a need for particularly careful monitoring and a well-developed vigilance system coupled with case-by-case decision-making. With regard to certain activities, prohibition, moratoria or restrictions may also be called for, but the overall regulation would also need to be flexible and subject to revision, based on step-by-step consensus on scientific knowledge and sufficiently informed public debate.
In my presentation, I will also provide a few examples of how this regulatory challenges has been handled in practice. |
