In this chapter, some of the legal challenges of research biobanking are discussed and illustrated by examples of possible analogies as well some comparative notes on the regulatory strategies adopted in the Nordic countries. Human biological material is compared with biological waste, raw materials, human beings, personal or nonidentifiable health data, and different kinds of public resources. It is concluded that the complex nature of human biobanks would seem to defy any attempt at a simplified regulatory analogy. Even so, it is clear that the application of more sophisticated analogical reasoning will still be valuable in the regulatory process and that policy makers must try to identify an appropriate combination of diverse approaches. While the international nature of biomedical research provides a strong incentive for more harmonised rules, the regulatory process is here further complicated by the plurality of religious, cultural, social and legal traditions, as well as issues of regulatory competence. Nevertheless, some degree of regional or even international consensus could certainly be reached with regard to less controversial areas and issues, and this potential must be further explored. The regulation of research biobanking should be perceived as an ongoing step-by-step process, rather than a problem that will soon be solved once and for all. In the short-term perspective especially, it must be expected that legal restrictions and administrative inconveniences may cause additional costs and delay or even prevent promising research. The long-term aim must be to serve the best interests of the public, by a careful balancing of the freedom of research against other fundamental rights and values.

Hur har lagstiftaren lyckats med de viktiga intresseavvägningarna mellan integritetsskydd och öppenhet i samband med vetenskaplig forskning? Dessvärre framstår resultatet inte som särskilt väl genomtänkt. Det svårtillgängliga regelverket medger långtgående integritetsintrång som den enskilde inte kan förutse, men också inskränkningar av offentlighetsprincipen i konflikt med grundlagen, samt har indirekt fört Sverige inför Europadomstolen för de mänskliga rättigheterna.

The development of information and communication technology in health care, also called eHealth, is expected to improve patient safety and facilitate more efficient use of limited resources. The introduction of electronic health records (EHRs) can make possible immediate, even automatic transfer of patient data, for health care as well as other purposes, across any kind of institutional, regional or national border. Data can thus be shared and used more effectively for quality assurance, disease surveillance, public health monitoring and research. eHealth may also facilitate patient access to health information and medical treatment, and is seen as an effective tool for patient empowerment. At the same time, eHealth solutions may jeopardize both patient safety and patients’ rights, unless carefully designed and used with discretion. The success of EHR systems will depend also on public trust in their compatibility with fundamental rights, such as privacy and confidentiality. Shared European EHR systems require interoperability not only with regard to technological and semantic standards, but also concerning legal, social and cultural aspects. Since the area of privacy and medical confidentiality is far from harmonized across Europe, we are faced with a diversity that will make fully shared EHR systems a considerable challenge.

Europe is facing a trend of demographic and social change that is likely to have a significant impact on our health systems in the coming decades. The primary concerns are related to the double challenge of population ageing and population decline. These changes will result in a shrinking workforce to handle the steadily increasing healthcare needs of the very old, who will constitute the fastest growing segment of the population. A number of strategies to meet this challenge are suggested and implemented, not least at the EU level. Adaptation of European health systems to the new situation also makes it necessary to revisit familiar medico-legal issues, in order to clarify and consolidate a number of already established patients' rights.

The five Nordic countries — Denmark, Finland, Iceland, Norway and Sweden — share a considerable part of their cultural and historical heritage. They have collaborated closely in their development of legislation during most of the 20th century and are also all traditional welfare states, but nevertheless demonstrate a surprising degree of variety in the area of health law. The Nordic Network for Research in Biomedical Law was founded in 2006, with the aim to promote intra-disciplinary collaboration and stimulate comparative Nordic research in this field of law. Exchange of information on recent legal developments has been a recurrent point on the agenda at the Network meetings.