Objective: Review of animal cloning legislation (legal restrictions) and its potential impact on the competitiveness of the European biotech industry.Material and methods: Review and comparison of enacted and pending international legislation on animal cloning techniques (US and EU), analyzing materials obtained by database searches and direct contact with EU and US officials. Market prices on therapeutic hormones were provided by Apoteksbolaget, Sweden. The estimations for the production capacity of transgenic animals are based on information from Genzyme USA, and include results obtained from a review of international articles on animal cloning.Results: Recent scientific and technological progress in modern cloning techniques holds promise to be able to produce an increased amount of cheaper human therapeutics (growth hormone, factor IX, etc.) in the near future. Animal cloning restrictions, as recently introduced in Holland, could thus, if spread to other EU Member States, have a stigmatizing effect upon these developments. This, of course, would have serious implications for the competitiveness of the European biotech industry, reducing the expected employment potential in this field. The European situation can be usefully compared with the developments in the US, where no animal cloning restriction is foreseen in the currently debated US cloning legislation, which refers exclusively to human cloning restrictions. A relocation of the European biotech industry to the US has already been reported on, a process that would, if continued, subsequently diminish the European potential for influencing future developments in the area.