Band 2, Heft 5

Since the Cartagena Protocol on Biosafety came into force, the establishment of national regulatory schemes became one of the most important biosafety issues. Glen Kurokawa and Darryl Macer provide pivotal information about the current legal situation in Southern and Southeastern Asia, i.e. Bangladesh, Bhutan, Brunei, Cambodia, PR China, India, Indonesia, Laos, Malaysia, Myanmar, Nepal, the Philippines, Singapore, Sri Lanka, Thailand, Timor Leste, and Vietnam.

Introduction Biosafety is becoming an ever increasingly important issue as more varieties and greater numbers of living modified organisms (LMOs) move across territorial boundaries. The Cartagena Protocol on Biosafety is a multilateral environmental agreement (MEA) that, at its core, attempts to strike a balance between trade interests in biotechnology and protection of biological diversity. Article 1 of the Protocol succinctly summarizes its objectives: “to contribute to ensuring an adequate level of protection in the field of the safe transfer, handling and use of living modified organisms resulting from modern biotechnology that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health and specifically focusing on transboundary movements”.

Introduction Whether any property right in a human body exists remains a highly debatable and delicate topic worldwide. This sensitive issue raises more and more attention since technology develops enormously fast so that the law-makers can hardly follow, not only because of the constantly increasing development of the growing fields and research areas of medicine, but also because it seems to be a great burden on their shoulders to make proper law, which should neither be too narrow nor too broad. Thus, it remains the question where to draw the line whereby policy, moral and ethical considerations and implications needs to be taken into account.

Introduction With the expectation that future drug approval may hinge on pharmacogenomic testing of patients, what are the advantages of the in-house testing of patient samples compared to supplying diagnostic kits? The genetic testing industry provides an interesting reference from which to examine this question. The genetic testing industry falls chiefly under the less stringent, regulatory oversight of the Centers for Medicare and Medicaid Services (CMS) and not the Food and Drug Administration (FDA). Genetic testing is also a service and not a product, with different, perhaps lesser, legal liabilities. Additionally, in-house testing may provide unique business advantages. This article examines the genetic testing industry and how the benefits of in-house testing may apply to the nascent pharmacogenomics industry.

The phenomenon of “the tragedy of the anticommons” Making decisions in the European Union and transforming them into legal instruments can sometimes become a life-task. Although it took a whole decade to adopt the European Communities “Directive 98/44/EC of the European Parliament and the Council of 6 July 1998 on the legal protection of biotechnological inventions”, the political and legal dispute about ”patents on life” was not settled at all. Some member states – the Netherlands, supported by Italy and Norway – took this issue to the European Court of Justice (ECJ) seeking the annulment of the Directive. The Court dismissed this appeal in 2001. But the discussion about ”patents on life” did not end. Even though it has been a somehow accepted fact that patents on living materials including human DNA are being granted, an even more heated discussion is focusing on the scope of those gene-patents. The question is if it is acceptable to allow the classical scope protection for gene sequences, or if the patent protection should be limited to the specific use disclosed in the patent application (“purpose-bound protection”).

Introduction That the genes are responsible for disease susceptibility, differential drug response and drug toxicity was always suspected; post-genome developments, pharmacogenetics and pharmacogenomics have proven that beyond doubt. The trials of AstraZeneca drug, IRESSA, an EGFR kinase inhibitor approved for non-small lung cancer have clearly shown the consequences of exposing the non-responders to such drugs. It has also initiated an intense debate within the regulatory set up to seek genomic solutions to drug variability during development, clinical testing and their approvals. The strong drug lobby that is used to “one drug for all”, pushing their products across continents to re-coup the heavy ivestments made in R&D and currently fighting for “TRIPS plus” rights over ”Data Protection” may not like the population dynamics. However, one wonders the worth of such clinical data if the drug fails or induces adverse reactions in a different set of population with variation in crucial set of genes that the drug intends to target!

Introduction This is the second report pursuant to Article 16c of the Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions and bears the title “Developments and implications of patent law in the field of biotechnology and genetic engineering” (hereinafter the “second 16c Report”). Its purpose is to set out the key events which have occurred since publication of the first 16c Report, and to comment on two issues identified in the latter: the scope of patents on sequences or partial sequences of genes which have been isolated from the human body; and the patentability of human stem cells and cell lines obtained from them. The Commission’s analysis is based on the Commission staff working paper SEC(2005)943.

Introduction In January 2002, the Commission adopted a Strategy for Europe on Life Sciences and Biotechnology, consisting of two parts – policy orientations and a 30-point plan to transform policy into action. It sets out what is needed from the Commission and the other European Institutions, while also recommending actions for other public and private stakeholders. The Commission intends to report regularly on the progress made. The Commission adopted its second progress report on 7 April 2004, which highlighted the progress made but also pointed out delays in some areas. This Communication is the third such response. As last year, this report is supported by a Commission Staff Working Paper, which provides detailed information on the implementation of the action plan.

Resolution adopted by the General Assembly [on the report of the Sixth Committee (A/59/516/Add.1)] 59/280. United Nations Declaration on Human Cloning The General Assembly , Recalling its resolution 53/152 of 9 December 1998, by which it endorsed the Universal Declaration on the Human Genome and Human Rights, Approves the United Nations Declaration on Human Cloning annexed to the present resolution. 82nd plenary meeting 8 March 2005

In 2003, China became the first country in the world to approve a commercial gene therapy product. Yet serious moral doubts have been raised about the conduct of the experiment. The paper examines the ethical issues (e.g. review mechanism, family consent, and therapeutic misconception) in Chinese culture. It argues that China should review the clinical protocols more stringintly. One reason leading to therapeutic misconception is that investigators prefer to use the term ‘gene therapy’ rather than ‘human gene transfer research’ in the consent process. Family consent, from the point of view of the author, is not in itself sufficient to justify the experimental use of patients. Family-based individual consent could be a better option, especially if there are disagreements between a patient and his family in the consent process.

Throughout human history natural products have provided the basis for medicinal treatment. About 60 years ago the advent of SCUBA diving techniques granted access to a thitherto untapped source of pharmacologically highly active natural products: the marine environment. In the oceans not plants but sessile animals, particularly sponges, have proven to be the most fruitful organisms in this context. Sponges have evolved a vast arsenal of chemical weapons to defend themselves against various threats from their environment. These molecules remarkably often show potent activities in pharmaceutical assays. Several sponge-derived compounds are already in clinical trials as agents against cancer, microbial infections, inflammation and other diseases. However, in many cases drug development is severely hampered by the limited supply of the respective compounds, as they are often present only in minute amounts in the sponge tissue. Big hope to circumvent this obstacle lies on the supposition that sponge-associated bacteria and not the sponges themselves are in many cases the true producers of the pharmaceutically relevant agents. Once these microorganisms are determined and cultivated outside the sponge tissue, they could be fermented for large-scale compound production. This in future could substantially increase the number of powerful sponge-derived drugs on the market.