Volume 6, Issue 1

The main purpose of this work is to discuss the legal, psycho-social and ethical issues posed when handling genetic information in genomic research within developing countries. Following the method of “reflective equilibrium”(Rawls-Daniels) and from an interdisciplinary approach, I shall go through: (1) current normative laws concerning its regulation, advantages and limitations; (2) the psychosocial impact of genetics on health issues; and (3) the ethical grounds that should be taken into account in establishing the normative framework for the regulation of genetic information. In general terms, my opinion is that the ethical grounds of the normative framework regarding research with human beings cannot be formal or based exclusively on the law (e. g. “bureaucratisation of informed consent”). My suggestions is that a critical notion of real autonomy and material wellbeing of the moral person (following Doyal- Sen-Van Parijs) should be applied to justify the distributive principles implied in any research on human beings, in particular in genomic research (benefit sharing.)

Biobank research contains potentially a lot of ethical issues, because it usually involves large numbers of individuals. So, the necessity of establishing governance framework has been emphasized in biobank research. It can be said that the core of the governance policy is fostering public trust, which also consists of two significant components: accountability and transparency. In this article, I explored how the accountability and transparency have actually been interpreted in the governance framework of Biobank Japan through the interviews with people involved in the ELSI committee. However, it became clear that both factors have not been developed in Biobank Japan owing to the closed culture and independent monitoring body with little authority. Finally, I presented several policy suggestions on how to improve public trust.

The possibilities of human intervention on plants were limited for a long time to simple handling of selection or crossing which were always regarded as essentially biological processes. However, the development of the genetic engineering in the field of plants and the possibilities of plants genetic inheritance handling by the advanced techniques, such as the recombining DNA, evoked debates over the patentability of plant inventions. According to Article 27.3(b) of the TRIPS Agreement, Members may exclude “plants” from patentability, but they shall provide for the protection of “plant varieties” either by patent or by an effective Sui generis system or by any combination thereof. The relationship between plant breeder's rights (as a sui generic system) and plant rights results interesting dynamics in the interface between the systems since the UPOV understanding of plant variety can affect the understanding of the term in the patent system. In view of the importance of the decision of countries to protect plant varieties, the study assesses also the legal positions adopted by jurisprudence or doctrine to determine the scope of the plant varieties exception. It is concluded that the actual and biological differences between “plant” and “plant variety” could give good reason for interpreting the two terms in different ways.