Abstract This chapter describes and interprets the system for sharing the benefits arising from activities with respect to marine genetic resources (MGR) and digital sequence information (DSI) on MGR of areas beyond national jurisdiction (ABNJ) that is being set up by the Agreement under the United Nations Convention on the Law of the Sea on the Conservation and Sustainable use of Marine Biological Diversity of Areas Beyond National Jurisdiction. The chapter provides an overview of discussions and rationales behind the negotiations of this system. It highlights the crucial compromises made to find a creative solution for a de-coupled monetary benefit sharing in the first phase of implementation, and to include digital sequence information in the scope of application and in the operational provisions. It also shows the contribution that the Agreement will make to the harmonisation and further improvement of best scientific practices in disclosing certain data in open access and in involving developing countries’ scientists in the research pipelines. Moreover, the chapter shows how important novelties have been integrated and made legally binding: the deposit of available samples in publicly accessible repositories, thus amplifying access to MGR of ABNJ; and the use of a batch identifier to ensure that samples are linked to materials stored in collections and to the relevant data stored in databases, and that these three elements are retrievable with the use of one single batch identifier. The chapter concludes that several open questions remain, related to modalities for monetary benefit sharing to be decided by the Conference of the Parties, and to the requirement that the monetary benefit-sharing solution related to DSI is mutually supportive of and adaptable to other access and benefit-sharing instruments.

A fair and effective regime regulating benefit-sharing of marine genetic resources (MGR) in areas beyond national jurisdiction (ABNJ) must consider the inclusion of developing states, support scientific research and safeguard investments of the private sector. The present innovative proposal ensures a delicate balance through an approach based on open access, albeit with limitations. Access to MGR in ABNJ is facilitated, but conditional on the public release of collected samples and raw data. Adoption of the open access principle guarantees a powerful form of non-monetary benefit-sharing. The balance is maintained by the option for an extended embargo period, allowing samples and data to be kept confidential for a certain period, against payment to a biodiversity contribution fund. Monetary benefit-sharing, as a sector-negotiated percentage on revenue, could be imposed at the point of product commercialisation, and would offer a tangible payment system with a low transaction cost.

The legal landscape regulating the access to and utilisation of genetic resources has changed with the entry into force of the Nagoya Protocol in 2014 and the adoption of the related EU Regulation on user compliance in 2014. Moreover, many countries are now adopting laws that regulate access to their genetic resources and thier utilisation. This has clear implications for scientists working on genetic resources, including those doing biotechnology research on marine organisms, as well as any user of genetic resources along the biodiscovery pipeline. This chapter informs users on their obligations under the access and benefit-sharing legal framework, with a focus on their application to marine genetic resources, for which the United Nations Convention on the Law of the Sea (1982) is also relevant. The difference between (domestic) access legislation to genetic resources and the compliance mechanisms, such as the Nagoya Protocol and the EU Regulation 511/2014, is explained in detail. A more practical description is then presented in a step-by-step approach, which can serve as a basic guideline for scientists.

A fair and effective regime regulating benefit-sharing of marine genetic resources (MGR) in areas beyond national jurisdiction (ABNJ) must consider the inclusion of developing states, support scientific research and safeguard investments of the private sector. The present innovative proposal ensures a delicate balance through an approach based on open access, albeit with limitations. Access to MGR in ABNJ is facilitated, but conditional on the public release of collected samples and raw data. Adoption of the open access principle guarantees a powerful form of non-monetary benefit-sharing. The balance is maintained by the option for an extended embargo period, allowing samples and data to be kept confidential for a certain period, against payment to a biodiversity contribution fund. Monetary benefit-sharing, as a sector-negotiated percentage on revenue, could be imposed at the point of product commercialisation, and would offer a tangible payment system with a low transaction cost.

This conclusion presents some closing thoughts on the concepts discussed in the preceeding chapters of the book. The book focuses on the institutional changes in the genetic resources regime complex. It explores the theory that intentionally neglects the domestic sources of foreign policy in order to achieve greater parsimony. The book explains both club cooperation and institutional layering as distinct types of institutional change in regime complexes. It presents case studies regarding pre-existing disclosure regimes in several European Union (EU) member states and Switzerland, which would have limited the legislative and regulatory changes necessary for complying with an international obligation to require disclosure of origin. The EU's bargaining behavior is thus the result of complex, internal coordination processes among member states and the supranational institutions. Situation structure also promises …

This paper aims to get a better understanding of the motivational and transaction cost features of building global scientific research commons, with a view to contributing to the debate on the design of appropriate policy measures under the recently adopted Nagoya Protocol. For this purpose, the paper analyses the results of a world-wide survey of managers and users of microbial culture collections, which focused on the role of social and internalized motivations, organizational networks and external incentives in promoting the public availability of upstream research assets. Overall, the study confirms the hypotheses of the social production model of information and shareable goods, but it also shows the need to complete this model. For the sharing of materials, the underlying collaborative economy in excess capacity plays a key role in addition to the social production, while for data, competitive pressures amongst scientists tend to play a bigger role.

This chapter illustrates an innovative perspective aimed at demonstrating that the inception of the international legal regime related to the management of genetic resources and traditional knowledge long predates the discussion on ABS of the CBD, and is the product of the interaction of different legal fields: the international law on development, trade, environment and intellectual property protection.

Marine genetic resources are a subject of a growing body of research and development activities, as demonstrated by the abundance of marine patented genes reported in GenBank. Given the lack of a comprehensive legal regime for the management of marine genetic resources in areas beyond national jurisdiction, the General Assembly of the United Nations met in 2006 to discuss whether there are regulatory or governance gaps and how to address them. Besides the crystallization of the different political positions, the process is now advancing towards making a decision about whether to develop an international instrument under the United Nations Convention on the Law of the Sea (UNCLOS) for the conservation and sustainable use of marine biological diversity, within which the regulation of access to genetic resources and the sharing of benefits from their utilization has emerged as an in-dissociable issue. In order to propose concrete options to be considered for the establishment of a legal framework addressing these issues, policy-makers need to better understand the feasibility, the costs and the modalities of scientific activities undertaken, together with the actual level of commercialization of new products. They also need to be aware of the already advanced practices in place within the scientific community, especially regarding sharing of non-monetary benefits. This paper particularly highlights and discusses practical scenarios to advance in the international process, based on the approaches adopted in other regional and international regimes for the management of genetic resources and on the best practices developed within the scientific community.

This report summarizes the activities and outcomes of the second workshop of the US Culture Collection Network, formally an activity of the US National Science Foundation sponsored Research Coordination Network for a Community of ex situ Microbial Germplasm Repositories. The workshop included presentations on topics as diverse as permitting for genetically engineered plant pest organisms to facilitating strain exchange via formal material transfer agreement systems and codes of conduct. Short talks introduced diverse collections held by government, university, and private entities. Participants visited living microbe collections as well as active research and production facilities.

This chapter highlights the social motivations that play a role in the complex non-monetary incentive mechanisms that drive science and innovation in the research commons. It contributes to better global regulation of the scientific research commons in the specific context of the obligations under the Nagoya Protocol on access and benefit-sharing (ABS). The chapter presents the survey on access and use patterns in the global scientific research commons, by focusing on the particular case of globally networked public collections of genetic resources. It also analyses how to create the best possible institutional fit with the access and use patterns highlighted through the surveys, by discussing respectively a set of institutional and legal options for implementing the Nagoya Protocol in the scientific research commons. Keywords:access and benefit-sharing (ABS); access and use patterns; genetic resources; global scientific research commons; Nagoya Protocol

This section aims to update readers on decisions related to marketing products of modern biotechnology (e.g., GMOs, animal clones) at EU level and on national measures concerning their production. Special attention is devoted to problems of competence between Member States and the EU in regulating biotechnology issues; the institutional dynamics of decision making regarding products derived from modern biotechnology; the relationship between the EFSA and the EU institutions on green biotech-related issues; the evolution of EU regulatory framework and of national attitudes towards the risks and benefits of biotechnology derived products and their production. This section will also delve into the interaction between the EU legislation and WTO law regarding advances in the application of biotechnology within the agri-food value chain.

Sharing of basic research assets in so-called scientific research commons has proven key to research contributing to the conservation and sustainable use of biodiversity, and in the life sciences more generally. As a result, in practice, many research assets are accessed and exchanged under public domain-like conditions. This chapter aimed to show that it is possible to build upon these practices in the implementation of the Nagoya Protocol, so as to ensure that this implementation is supportive both of the scientific research commons and the objective of fair and equitable access and benefit-sharing. In particular, we showed that this is possible by further building upon the standard contracts for the access of public research assets that are currently in use in many areas of the scientific research commons, by adopting a broad interpretation of the notion of non-commercial research under the Protocol in combination with appropriate benefit-sharing conditions for capacity building and technical services with basic research assets in the provider countries. In addition, to take this vision forward, this chapter discussed three institutional options for building standardised ABS approaches in global research commons.