Volume 3, Issue 5

Editorial Biomedical research raises manifold ethical and legal questions. Matthew Rimmer's article considers whether the granting of patents in respect of biomedical genetic research should be conditional upon the informed consent of research participants. He focuses upon several case studies like Moore v the Regents of the University Of California, Greenberg v Miami Children's Hospital , or the approach of PXE International. In light of these studies, it is contended that there is a need to reform patent law, so as to recognise the bioethical principles of informed consent and benefit-sharing. According to the author, the 2005 UNESCO Declaration on Bioethics and Human Rights provides a model for future case law and policy-making.

This article considers whether the granting of patents in respect of biomedical genetic research should be conditional upon the informed consent of research participants. It focuses upon several case studies. In Moore v the Regents of the University Of California , a patient sued his physician for breach of fiduciary duty and lack of informed consent, because the doctor had obtained a patent on the patient's cell line, without the patient's authorisation. In Greenberg v Miami Children's Hospital , the research participants, the Greenbergs, the National Tay Sachs and Allied Diseases Association, and Dor Yeshorim brought a legal action against the geneticist Reubon Matalon and the Miami Children's Hospital over a patent obtained on a gene related to the Canavan disease and accompany genetic diagnostic test. PXE International entered into a joint venture with Charles Boyd and the University of Hawaii, and obtained a patent together for ‘methods for diagnosing Pseudoxanthoma elasticum’ . In light of such case studies, it is contended that there is a need to reform patent law, so as to recognise the bioethical principles of informed consent and benefit-sharing. The 2005 UNESCO Declaration on Bioethics and Human Rights provides a model for future case law and policy-making.

Introduction Governance of cloning is a controversial national and international issue. It has occupied the time of legislatures across different countries and even the United Nations General Assembly. Despite attempts at obtaining clarity and coherence in rules governing human reproductive and therapeutic cloning, many countries have adopted a vague and uncertain policy. This is in the nature of the issue under consideration, given that rapid advancements in science and technology can quickly make laws redundant. As law increasingly moves in to regulate private matters of citizens, it takes a big risk, in terms of becoming outdated soon and being poorly enforced. This article delves into the laws and policies of a cross section of countries in an attempt to succinctly present the state of the law in cloning research and other allied areas. This is followed by an international public law approach to governance of cloning, in the light of the 2005 declaration on human cloning.

Rights of Patents' Owner Among the rights are to exploit the patented invention; to assign or transmit the patent; and, to conclude licence contracts without the consent of the patent owner. Exploitation includes, in relation to a products, to make, import, offer for sale sell or use such products; stocking such product for the purpose of offering for sale, selling or using it; and in respect of a process, exploitation means using the process and doing any acts referred to above in respect of a product obtained directly as a result of the process.

Preamble: 1 In recent years, the field of genetics has undergone rapid change and development. The areas of gene therapy and genetic engineering and the development of new technology have presented possibilities inconceivable only decades ago. 2 The Human Genome Project opened new spheres of research. Its applications also proved useful to clinical care, by allowing physicians to utilize knowledge of the human genome in order to diagnose future disease as well as to individualize drug therapy (pharmacogenomics). 3 Because of this, genetics has become an integral part of primary care medicine. Whereas at one time, medical genetics was devoted to the study of relatively rare genetic disorders, the Human Genome Project has established a genetic contribution to a variety of common diseases. It is therefore incumbent upon all physicians to have a working knowledge of the field. 4 Genetics is an area of medicine with enormous medical, social, ethical and legal implications. The WMA has developed this statement in order to address some of these concerns and provide guidance to physicians. These guidelines should be updated in accordance with developments in the field of genetics.