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knowledge about marine biotechnology but to derive commercial advantage through the acquisition of patents. In short there does not seem to a specific regulatory solution to this issue. It does not, though, mean that IPRs are not a barrier for the sector. Possible non-regulatory solutions might include the established of focussed development support system for the Blue Biotechnology sector in connection with IP issues through training and capacity building, networking and information sharing systems and so forth. 3.4.2 Access and benefit sharing As regards the issue of access and benefit sharing it is necessary to distinguish two sources of marine genetic resources: (1) areas beyond national jurisdiction (ABNJ); and (2) areas under national jurisdiction. Under the first scenario there are two main issues. First of all the manner in which marine genetic resources are obtained is largely unregulated at the level of international law meaning that there may be a risk of irreparable damage to fragile seabed ecosystems. However, it is pertinent to note the UN Convention on the Law of the Sea obliges States Parties to assess the potential effects of planned activities on the marine environment (Art 206 UNCLOS). The second issue concerns the related subjects of the allocation of benefits derived from such resources as well as the sharing of any of the benefits. In short can financial benefits be effectively privatised through the grant of patents and given that genetic resources from ABNJ are un-owned, should any benefits derived from their utilisation be shared among the international community (as is the case for deep sea mining in ABNJ)? International consensus on this issue has yet to be reached leading to a high level of uncertainty for the sector, which may deter investment. As described in Annex 14, this topic is the subject of a debate at the international level and is not susceptible of resolution through unilateral EU legislative action. Indeed EU action on this topic might have the risk of destabilising the on-going international discussions. Even attempting to regulate the acquisition of marine genetic resources in ABNJ may have a destabilising effect and in any event there is, as yet, no hard evidence that damage is actually taking place given the (small) size of samples recovered from the seabed (and there is not likely to be any significant impact from collections from the water column) although the UNCLOS obligation to assess potential effects of planned human activities on the marine environment also applies in such cases. Seeking to regulate this issue at the EU level may also be seen as an additional hurdle for European researchers. On the other hand, though, the patent profiling exercise did not reveal the source of the genetic material used in connection with Blue Biotechnology patents and indeed certain commentators have questioned the extent to which this is really a problem for the sector. The available literature suggests that most marine genetic material connected to patents is sourced from waters under national jurisdiction. As regards ABS in waters under the national jurisdiction of coastal States the legal framework is at least clearer in terms both of UNCLOS and the Nagoya Protocol which will be implemented in the EU through the ABS Regulation89. Pending the entry into force of the Nagoya Protocol it is of course premature to assess how effective this framework will be. In terms of marine research it seems relatively clear, however, that the regime may be challenging to implement at a practical level in terms of coordinating coastal permission for research cruises with the need to conclude specific ABS agreements in part due to the specific nature of Blue Biotechnology. Given that this topic has only recently been legislated at the EU level, there is no question of a specific regulatory response to the legal challenges faced by the Blue Biotechnology sector in terms of the 89 Regulation (EU) No 511/2014 of the European Parliament and of the Council of 16 April 2014 on compliance measures for users from the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization in the Union Text with EEA relevance (OJ L 150, 20/05/2014, p. 59). 52 Study in support of Impact Assessment work on Blue Biotechnology

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