Recombinant DNA research: actions under the guidelines--NIH. Notice of actions under NIH guidelines for research involving recombinant DNA molecules

This notice sets forth actions taken by the Director, National Institute of Allergy and infectious Diseases (NIAID), by authority of the Director. NIH, under the June 1983 NIH Guidelines for Research Involving Recombinant DNA Molecules (48 FR 24556).     

Biotechnology and law: biotechnology patents. Special considerations on the inventions with human material.

The EC and the US differ considerably in their ruling on the patentability of biotechnological inventions apart from some exceptions. The most extreme positions in either direction with regard to the individual biotechnological inventions mark the margins of the scope which the WTO members may use for the ratification of Art. 27 TRIPS. Rulings which are not in accordance with Art. 27 TRIPS remain without consideration. In the most important point both WTO member agree: Human beings are not patentable. Other regulations could be considered, but one may assume that no member of the WTO intends to make use thereof. Thus the scope involving this option is only a theoretical one. The situation is different when it comes to the components of the human body. These may, provided they are produced artificially or are separated from the human body, be patented. According to the regulations in the US, this applies to all components with the exception of totipotent stem cells. They may be exempted from patenting entirely or their patenting is linked to far reaching conditions. As an example should be named here the regulation of the EPA for patenting gene sequences. The scope of this area is, thus, very great and allows for many options of applying the regulations of Art. 27 TRIPS. With regard to patenting procedures for cloning human beings, the scope is unlimited. These procedures may either be completely excluded from patenting as in the EC or may be considered patentable independent of their purpose as in the US. The same applies to procedures for gathering human stem cells in the US. Exempting procedures with regard to human genes or DNA sequences are, however, only possible in special cases, as for example in the EC with regard to procedures for altering the genetic identity of the germline of human beings. However, the interpretation of general patentability preconditions allows to influence the patenting of such procedures. This means, though, that the scope for interpretation is only a small one in this area.     

Biotechnology and relevant aspects of the New Biosafety law]

On 24 March 2005, the President of the Federative Republic of Brazil approved the New Law on Biosecurity. This law has very diverse aspects, ranging from the genetically modified organisms to the genetic manipulation of human embryos or the liberalisation of the transgenic soy crops during 2004-2005. This article tries to analyse and criticise the content of the law, highlighting the genetic research and experimentation, the GMOs and their effect in the environment and the criminal responsibility derived from such actions. Likewise, it leaves rooms for the reader to reach his/her own conclusions. The author poses the moral dilemma on whether it is legitimate to make governmental decisions solely taking into account the economic and political interests, leaving aside the opinion of society.