Intellectual property and scientific research using human embryonic stem cells : patent-eligibility for scientific research using human embryonic stem cells and the question of respect for human dignity

Abstract

Biotechnological inventions, particularly those relating to human embryonic stem cells (hESC), have since time immemorial been the subject of several moral and ethical disputes. HESC research was ushered into the limelight twenty years ago, and despite the advent of new technologies, specifically those aimed at reducing the need to destroy human embryos for scientific research, the question as to whether these biotechnological substitutes have or will achieve the desired result, remains ambiguous. The Biotechnology Directive aims at harmonising patent law in Member States in matters relating to biotechnological inventions. However, due to the fact that the European Union (EU) has no competence, except to carry out activities and conduct common policy in areas of research and support, coordinate or supplement actions of the Member States in areas protecting and improving human health, and given the myriad of positions held by the Member States, especially with respect to the legal status of the human embryo, certain issues remain unclear. Whether the aim of the Biotechnology Directive has been achieved or not, may be determined by the manner in which it manages to cater for all the different approaches developed over time, whilst maintaining a comprehensive legal framework. From a local perspective, the development in hESC research and its patentability will, in the near future, require that Maltese legislation be amended or supplemented, especially in light of recent enactments in the health-care sector. Such amendments will promote economic growth and ameliorate public health. However, this rests on the effects of the ordre public in the context of Maltese moral values and cultures.