Biobanking in Denmark is regulated via patients' rights laws, data protection laws, and research ethics reviews. Danish law recognizes tissue samples as personal data for purposes of the data protection laws, meaning research with tissue samples may be subject to research ethics review, data protection laws, and patients' rights requirements depending on the circumstances of collection. However, research on information gained through whole genome sequencing is subject only to data protection laws, despite the similarity in the nature of the information. The regulatory framework treats biobank samples collected from patients differently than samples collected from research participants, particularly with respect to autonomy. Importantly, biobanks established for future unspecified research are not subject to research ethics review. Biobank-based research has gained more prominence on the national level recently, and the potential for a less fragmented and more consistent regulatory approach may emerge from this attention.
Most pharmaceutical research carried out today is focused on the treatment and management of the lifestyle diseases of the developed world. Diseases that affect mainly poor people are neglected in research advancements in treatment because they cannot generate large financial returns on research and development costs. Benefit sharing arrangements for the use of indigenous resources and genetic research could only marginally address this gap in research and development in diseases that affect the poor. Benefit sharing as a strategy is conceptually problematic, even if one, as we do, agrees that impoverished indigenous communities should not be exploited and that they should be assisted in improving their living conditions. The accepted concept of intellectual property protection envisages clearly defined originators and owners of knowledge, whereas the concept of community membership is fluid and indigenous knowledge is, by its very nature, open, with the originator(s) lost in the mists of time. The delineation of 'community' presents serious conceptual and practical difficulties as few communities form discrete, easily discernable groups, and most have problematic leadership structures. Benefit sharing is no substitute for governments' responsibility to uplift impoverished communities. Benefit sharing arrangements may be fraught with difficulties but considerations of respect and equity demand that prior informed consent and consultation around commercialisation of knowledge take place with the source community and their government.