The article focuses on whether or not biological material may legally be regarded as database constituents. Bygrave argues that question is a reminder of the need for lawmakers to address rigorously the meaning of information concepts. He suggests that
it can be plausibly argued that biobanking, particularly in the private sector, is a relatively new and cutting-edge industry that fits within the call for ‘investment in all the Member States in advanced information processing systems’ (recital 10). The industry’s youth renders it also arguably in special need of ‘a stable and uniform legal protection regime’ (recital 12) in order to flourish. In Europe, there appears to be little private-sector involvement in biobanking. The bulk of biobank activity is still occurring in the public sector, with only a very small percentage of it being privately funded. As for the regulatory framework for biobanking, analyses frequently point out that this is inchoate, fragmented and plagued with uncertainty and inconsistency.
However, the bulk of such analyses tend to focus on the interests and fundamental rights of the persons from whom the biological samples are derived rather than the interests of those establishing, managing or otherwise investing in biobanks. The analyses rarely take account of the potential or actual application of the database Directive. There also seems to be a paucity of reliable evidence showing, firstly, a significant amount of ‘free-riding’ which is hampering investment in biobanking and indicating, secondly, that such free-riding would probably be reduced were the regulatory framework strengthened by the sort of protection available under the Directive. We must remember too that the treatment of a biobank as a database presumes that the above-noted criteria of independence, accessibility and systematic arrangement are met. If they are met, the protection of such a collection under the sui generis right would presume in turn that ‘substantial investment’ has gone into the obtaining, verification or presentation of its contents (Art.7(1)). Alternatively, the protection of such a collection under copyright (Art. 3(1)) would presume that the selection or arrangement of the contents involves ‘making free and creative choices’ and, concomitantly, a ‘personal touch’ as opposed to simply ‘sweat of the brow’. In other words, a considerable number of hurdles need to be jumped before protection will kick in.He concludes that
Discussion about the precise meaning of ‘data or other materials’ has hitherto been largely confined to the ivory tower of academia. Remarkably, the issue was not salient in the Commission’s first evaluation of the Directive undertaken in the early to mid-2000s. This seems to reflect the fact that national implementations of the Directive have ignored the issue or skirted around it. The issue appears to have attracted little litigation.
More litigation – at least focusing on biobanks – could be a long way off. After all, who (apart from the odd academic commentator) is interested in pushing the view that a database covers collections of biological material (or other physical objects) per se? There do not exist database protection agencies equivalent to the supervisory authorities in the field of data privacy which would be interested in pursuing the matter. Organisations which establish, run or invest in biobanks already have fairly robust legal means of regulating others’ exploitation of the material – first and foremost in the form of contractual mechanisms, such as licensing agreements. If they find it necessary to litigate against ‘free-riders’ that are not parties to a licensing agreement, they will typically be able to sue under other heads of action (e.g., larceny, trespass, undue enrichment) than breach of the sui generis database right or copyright. The importance of the latter rights is also reduced by the fact that biological material is patentable subject matter in many jurisdictions. These observations detract from the practical significance of the issue of whether a biobank can qualify for database protection.
This is not to say that the issue has no practical significance: database protection would undoubtedly be a useful addition to the legal arsenal of biobank managers. And for a large number of reasons, the issue is important in principle and in the broader regulatory context. The overprotective potential of the sui generis database right, the relatively open-ended nature of the database definition and the harmonisation aims of the Directive are three reasons. The ongoing development of biobanking and other forms of biotechnology is another.
Even more significant, is that the issue serves as a pertinent reminder that lawmakers ought not to take for granted the meaning of basic information concepts like ‘data’. Such concepts are increasingly being used as ‘front-line’ legislative terms, not just within the field of intellectual property but more generally. This development partly reflects attempts by lawmakers to keep abreast of technological change by drafting legislation using relatively generic terminology rather than technology-specific rules. Yet as this article highlights, such concepts can be ambiguous. Before employing them in legislation, lawmakers ought to reflect thoroughly over the precise meaning they are to have and to communicate clearly the results of that reflection.
