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3.4 Regulatory Review Although legal issues clearly emerged from the stakeholder consultation as a barrier for the Blue Biotechnology sector, as described in Annex 14, the legal framework for Blue Biotechnology is complex and multi-layered. The question arises as to the extent to which these issues are susceptible to a specific regulatory response. In general terms there seem to be two main ‘problem areas’: challenges relating to intellectual property rights (IPR) and uncertainties with regard to access and benefit sharing (ABS). 3.4.1 Intellectual Property Rights Intellectual Property Rights are fundamental to the Blue Biotechnology sector just as with other biotechnology sectors. Yet the situation is complex. On the one hand by protecting the interests of those who gather data and patent inventions they reward innovation. At the same time, though, by their nature they also have the potential to hinder or restrict the free flow of knowledge. Moreover there is no doubt that IP law is a complex area of law that requires specialist advice from IP laws and patent advisers. For scientists and SMEs this is an additional source of complexity and cost. In terms of overall philosophy with regard to IPR in the Blue Biotechnology research sector there are, broadly speaking, two schools of thought: those who believe that scientific knowledge and information should flow freely and should not be subject to effective ‘privatisation’ (through the acquisition and enforcement of IPR) and those who consider that IPR are a key means of encouraging development and rewarding investment. Moreover in the case of publicly funded research, including research funded by the EU, the question can legitimately be asked as to who should benefit from the knowledge gained? The funder or the researcher? In practice institutions will deal with IPR in accordance with the own individual data and IP policies as well as arrangements made on an ad hoc basis with different partners. But even so there are difficult choices to be made. On the one hand as research funding typically depends to a greater or lesser extent on the number of publications there may be pressure to publish. On the other hand publication may not only alert potential competitors but also prejudice subsequent patent applications in terms of harming the novel characteristics of the inventions to which they relate. Consequently it can be better for research institutions, in particular when they collaborate with commercial partners, to keep the data and knowledge confidential prior to applying for a patent. Even here though there are complex considerations to take into account due to the fact that patents are time-limited. Apply for a patent too soon, before a product can be commercialised, and much of the commercial benefit may be lost. Leave it too late and a competitor may get there first. Of course these are common challenges for technology sectors including other biotech sectors. Although they raise fundamental ethical questions about the nature of knowledge and its relationship to science (is it right that publicly funded data should be privately owned? are gene patents ethical? and so on) these questions are not restricted to the Blue Biotechnology sector. In other words even if there was an obvious solution to these issues – which there is not – it would clearly not be feasible in to seek to modify Intellectual Property (IP) law just to serve the needs of the Blue Biotechnology sector. Having said that it must be recognised that IP issues remain a challenge. As noted in section 3.3, European researchers seem to be better at publishing their findings rather than obtaining patents. This may be for a number of reasons but at the end of the day economic growth in the Blue Biotechnology sector is likely to derive primarily from patents and not from published papers (or for that matter the contents of bioinformatics databases). One implication may be that published European research is helping scientists other parts of the world not simply to expand human Study in support of Impact Assessment work on Blue Biotechnology 51

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