Legal frameworks for bioprospecting and bioinnovation in Polar Regions.

It is an increasing interest in exploring and exploiting marine genetic resources, particularly in the Arctic and Antarctica. Marine natural resources have always been important for Norway. Therefore, the collection of marine genetic material from polar waters is of great significance to promote bioinnovation in Norway. The establishment of MARBANK as an active collection of biological and genetic materials and as a provider of samples for research documents interest in developing a policy for and to regulate research and development based on marine material. Bioprospecting and bioinnovation have potential for creating high value products within pharmacy, cosmetics, food production and other products of life sciences. This has spurred attention to the legal aspects of marine bioprospecting, particular in the Polar Regions. The legal framework for access to and use of marine genetic material is developing. The objective of the project "Legal framework for bioprospecting and bioinnovation in polar areas" (BIOSPOLAR) was to analyse the legal framework for scientific and commercial utilization of genetic material from Polar Regions. The legal aspects are high on the agenda of bodies established under the Antarctic Treaty and are included in the on-going UN negotiations on a legally binding instrument on conservation and sustainable use of biodiversity in areas beyond national jurisdiction (also described as ANBJ). ABNJ includes the waters beyond the 200 nautical miles zones (known as the high seas) and the seabed beyond the continental shelf. The instrument will supplement the 1982 UN Convention on the Law of the Sea. One of the four themes addressed is marine genetic resources involves questions on access and benefit sharing. There is also international attention on how contracts may be used as a legal means to ensure sustainable use of the resources and an equitable distribution of the results of research and commercial utilisation of the resources. The overall objective of BIOSPOLAR has been to contribute to knowledge on how marine genetic resources from the Polar Regions better may be used for commercial and scientific purposes. The project has consisted of four themes or studies: ? Investigation of existing legal framework for marine bioprospecting and bioinnovation in Polar Regions. Extensive analyses of the law have been undertaken to enable assessments of future legal regulations. ? Investigation of whether inventions from Polar Regions are patented, through empirical studies of patent applications and scientific publications. The study has mapped how biological material from the regions are used as basis for innovation and patented inventions. The investigations have identified companies to be further investigated in the third study. ? Investigation of how legal regulations affect actors involved in bioprospecting and bioinnovation. Interviews are made with central actors in companies involved in Arctic marine bioinnovation. The interviewees were concerned with upholding high normative standards in bioprospecting activities. Both sustainable use and equity are used as key concepts by the companies in their presentations. Their main aim in influencing the on-going UN negotiations is to ensure that the regulations adopted does not regulate benefit sharing from bioprospecting. ? Developing alternative legal regulations that may promote scientific and commercial utilisation of marine genetic resources. Based on the previous studies, this study has developed two alternatives: First, one that combines the competence of the flag State with contract law to regulate bioprospecting in ABNJ. Second, a step-wise approach to regulation of marine genetic resources that balances different interests, including divergent positions to access and benefit sharing, promotion of scientific research on samples and date, protection of traditional and local knowledge, solutions that promotes consistency with present legal framework and that addresses lacunas (biosafety). This part of the project has assisted MARBANK in developing their standard agreement (Standard Material Transfer Agreement) for exchange of biological material and samples to be used in research and development.

Achieved and potential outcomes: - The competence has been improved, through interdisciplinary collaboration, providing for a better understanding of the present legal regulations and of the need for improving the international and national legal framework; - A clearer and more realistic picture among researchers and user groups of the realism of bioprospecting in distant polar waters;- - Insights into the strategies of private companies and what affects them (i.e. the legal regulations) when involving in marine bioprospecting; - Possible new approaches to regulating (mixture of private and public regulations). Achieved and potential impacts: - Providing insights to user groups (government as well as industry)on the legal challenges and ways to balance interests in order to foster academic as well as commercial research - Knowledge about the feasibility of conduct of marine scientific research/bioprospecting in polar waters

The project "Legal frameworks for bioprospecting and bioinnovation in Polar Regions"(BIOSPOLAR) will analyse the legal conditions for academic and commercial use of the genetic resources from the polar areas. Legal regulation of the use of genetic material from the polar areas is undergoing political discussions with the potential outcome of amending the legal regulations. At the same time realising the value of Genetic material requires legal protection and regulation. Since international and regional regulations are under development, there is a need for analysis of potential effects of different regulatory models on commercial actors to be fed into the ongoing political discussions to promote academic exploration and commercial exploitation of the genetic resources. The project BIOSPOLAR therefore, looks into three empirical questions and combine them with discussions on the future of Law in this area: What is the current regulation of bioprospecting and bioinnovation in the polar regions? What is the situation regarding patent application and academic publication covering genetic resources from the polar regions. What are perceptions concerning regulation amongst a selection of companies applying for patents to inventions covering this material? The answers to these three questions will be used in the de lege ferenda discussions on how the regulation in these areas should best promote research and development. These advices in how future regulations can be developed will be based on the empirical findings in WP 1-3 and will be draing from theory of Law. The overall aim to which the project aims at contributing is to maintain Norway as a leading policy-developing nation for the polar regions.