The regulation of biotechnology is determined by a number of often conflicting legal values and social-economic interests. Human dignity, freedom of research, the right to family life and the right of health inspire regulatory models in the field of bio-medicine and reproduction techniques. Scientifically corroborated risk assessment and interest free trade competes with social-economic considerations in highly risk-averse societies. In the area of patents and other forms of intellectual property, liberties and rights based on innovation meet claims to equal access to genetic resources as encoded information.
The legal approaches to genetic engineering reveal fundamental differences in regulatory philosophies, e.g. between the United States and the European Union. Fundamental rights or guarantees under human rights treaties as well as free trade regimes have become the battleground for preempting or challenging political process in increasingly heterogeneous societies. Salient issues are:
- Human dignity: stem cell research, cloning, “enhancement”;
- The right to family life: in vitro fertilization, pre-implantation diagnostics;
- Risk assessment and risk management: scientific evidence and “phantom risks”, deference to social-economic considerations which conflict with free trade;
- Environmental antinomies in the agricultural sector (transgenic crops v. use of pesticides);
- Patents on human DNA sequences, on animals and plants;
- Human and fundamental rights: preemption of the democratic process?