Regulation of DNA vaccines and gene therapy on animals

The Norwegian Biotechnology Advisory Board is an independent body appointed by the Norwegian government and was established in 1991. The Board is founded in the Act relating to the application of biotechnology in medicine and the Act relating to the production and use of genetically modifi ed organisms. The main tasks of the Norwegian Biotechnology Advisory Board are to identify and examine the ethical questions raised by applications of modern biotechnology on humans, animals, plants and microorganisms, provide advice that can assist policy-making and stimulate public debates on the issues. The Board consists of 24 members and has observers from six ministries. The Board's secretariat has fi ve to eight employees. For 2003 the budget of the Biotechnology Advisory Board is 6.3 million NOK (appr. 750.000 €). 3 Regulation of DNA vaccines and gene therapy on animals Werner Christie Chairman At present the Norwegian Gene Technology Act provides no clear answer as to how animals receiving DNA vaccines and gene therapy are to be regulated and whether or not they are to be termed as genetically modifi ed. The Norwegian Biotechnology Advisory Board raised this problem for the fi rst time at an internal seminar in Namsos on 5 September 2001. In the light of the seminar, the Ministry of the Environment asked the Biotechnology Advisory Board to discuss how DNA vaccines and gene therapy on animals should be regulated and what status should be given to DNA-treated animals. Since the problem is highly complex, the Biotechnology Advisory Board's secretariat has drafted this discussion paper setting out the various aspects of the issue. The Biotechnology Advisory Board has discussed regulatory alternatives for DNA vaccines and gene therapy on animals in the light of the internal seminar and the discussion paper. The Biotechnology Advisory Board's recommendations are set out in its reply letter to the Ministry of the Environment dated 26 February 2003, which is an enclosure to this discussion paper. Dr Grethe S. Foss from the Biotechnology Advisory Board's secretariat has been responsible for preparing the discussion paper, and members of the Biotechnology Advisory Board and the secretariat, specialists and others have provided valuable contributions and comments. 5 Regulation of DNA vaccines and gene therapy on animals