Mare Geneticum : Balancing Governance of Marine Genetic Resources in International Waters

Peer reviewedPublisher PD

Marine genetic resources and the access and benefit-sharing legal framework

The legal landscape regulating the access to and utilization 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. This has clear implications for scientists working on genetic resources, including those doing taxonomic and biotechnology research on marine micro-organisms. The first part of this chapter informs the scientific community on the Access and Benefit-Sharing legal framework, including 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 are 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

Mare geneticum : towards an implementing agreement for marine genetic resources in international waters

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

Mare geneticum : towards an implementing agreement for marine genetic resources in international waters

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.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.B

Dedicated Bifurcation Stent for the Treatment of Bifurcation Lesions InvolvingLarge Side Branches: Outcomes From the Tryton Confirmatory Study

Objectives: The aim of this study was to prospectively study and confirm the safety and efficacy of the Tryton Side Branch Stent in the treatment of coronary artery bifurcations involving large side branches (SBs). Background The TRYTON Pivotal randomized controlled trial (RCT) was designed to compare the Tryton stent with standard provisional SB stenting in large vessels. The trial inadvertently enrolled patients with too small SBs ( < 2.25 mm). The overall trial did not meet its primary endpoint, because of an increased rate of periprocedural myocardial infarction in the Tryton stent arm. A post hoc analysis restricted to the intended population showed that the trial would have met its endpoint if only patients with SBs ≥2.25 mm in diameter (by core laboratory quantitative coronary angiography) had been enrolled.MethodsThe Tryton Confirmatory Study was a prospective, single-arm extension of the TRYTON Pivotal RCT that enrolled an additional 133 patients treated with the Tryton Side Branch Stent. It was designed to confirm the results of the post hoc analysis and emphasized the inclusion of appropriately sized SBs. The primary endpoint was noninferiority with regard to periprocedural myocardial infarction (creatine kinase myocardial band 3 times the upper limit of normal) compared with a performance goal based on the TRYTON Pivotal RCT.ResultsAmong the 133 enrolled patients, 132 (99.2%) had SBs ≥2.25 mm. Baseline clinical and angiographic parameters were similar in this study and the RCT. Periprocedural myocardial infarction occurred in 10.5% of patients, which was numerically lower than the provisional group in the TRYTON Pivotal RCT (11.9%). The 95% confidence bounds did not extend beyond the pre-defined performance goal of 17.9%, meeting the noninferiority primary endpoint.ConclusionsThe Tryton Confirmatory Study, in conjunction with the post hoc analysis of the intended population in the TRYTON Pivotal RCT, supports the safety and efficacy of the Tryton Side Branch Stent for treatment of bifurcation lesions involving large SBs