Volume 4, Issue 1

Editorial Inter- and supranational law knows many examples of specific biotech regulations. The Convention on Biological Diversity with its so-called Biosafety Protocol deals with the access to and use of genetic resources as well as security issues like labelling of living modified organisms. The Council of Europe's Convention on Human Rights and Biomedicine, which is also completed by several Additional Protocols, aims at setting basic standards for biomedical research, especially in the field of patient's rights. The UNESCO contributed (legally non binding) Declarations on the Human Genome and Human Genetic Data. The European Union and the Andean Community established legal frameworks for selected areas of biomedicine and gene technology. However, despite the need for uniform standards in this field, international law does not form a coherent set of norms. According to Catherine Rhodes , who supports effective regulation on the international level, four key roles for the regulation of biotechnology can be identified: promotion of benefits; identification, assessment and management of risks; prevention or minimisation of negative impacts; and promotion of capacity building.

The first stage of the argument in this paper is that regulation of the biotechnology revolution is required. Put simply, this is because there will be both positive and negative impacts of the revolution, and there is also the possibility of misuse. In each area that the revolution impacts upon, there are both harms to be avoided and benefits to be promoted. An important component of this will be identification and assessment of risks. Regulation of the biotechnology revolution at local, national and regional levels is important, but the revolution and its impacts are global, and in several issue areas coordinated state action will be required – here international regulation has an essential part to play. When looking at the global impacts of the revolution it is clear that they are not evenly distributed – the benefits of the revolution may fail to reach those who need them most. From this analysis four key roles fro regulation of the biotechnology revolution can be identified: promotion of benefits; identification, assessment and management of risks; prevention or minimisation of negative impacts; and promotion of capacity building. There are various international regulations relevant to the control of the biotechnology revolution, but they do not form a coherent set. This presents problems for fulfilment of the four roles.

Introduction Three decades of continuing research on assisted reproduction, particularly on IVF, offer us nowadays a large variety of methods and techniques for supporting successfully the human reproductive abilities. To give some figures, according to recent information by the European Society for Human Reproduction and Embryology (ESHRE), during this period, more than 3 million IVF children have been born worldwide, with a pace of 200000 births per year. In Europe, we have the 56% of these births, with an annual increase of about 10%.

Background The rapid biotechnological progress has promoted the development of novel medicinal therapies which are currently changing medical practice substantially. Patients may benefit from new opportunities for the treatment of various diseases, but on the other hand new risks have to be faced. To ensure timely access of patients to innovative medicines while taking safety aspects into consideration, an appropriate legislation is needed. This review aims at giving an overview of the role of the so called “Advanced Therapy Products” in today's medical practice and describes their current regulation in the European Union (EU).

BioTrade and the private Sector The private sector at COP8 The increasing interest in the private sector will feature throughout the deliberations of COP8. Following objective 4.4 of decision VI/26, there has been increasing cooperation between CBD and the private sector. The Working Group on Review of Implementation of the Convention noted that through various tools, standards and guidance, business and industry could contribute to the Convention's 2010 targets.

Introduction Freedom of research is the underlining principle of any scientific activity. It has been restated in many international and national legal instruments. Thus, Article 15 of the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine of 1997 (hereinafter: the Convention on Human Rights and Biomedicine), lays down the general rule: Scientific research in the field of biology and medicine shall be carried out freely, subject to the provisions of this Convention and the other legal provisions ensuring the protection of the human being.

Introduction Since many years the Federal Republic of Germany has an extensive system of ethics committees responsible for reviewing research projects on human subjects. The legal context of their work is complex and can only be understood from a perspective that takes into account the federalism enshrined in the German Constitution, with its division of functions between the federal government ( Bund ) and federal states ( Länder ) – a split that also encompasses the healthcare and medical research sector –, as well as the historical development of the committee system.