Webinar: Current challenges in Nordic law on personalised medicine

Johanna Chamberlain is a doctor of law in Private Law at the Uppsala University Faculty of Law. Her research focuses on the protection of privacy in Swedish law, specifically privacy torts but also constitutional, EU, administrative and criminal law aspects. She teaches tort law, IT law and administrative law at basic and advanced levels and supervises Master thesis students.

Jane Reichel is professor in Administrative Law at the Faculty of Law, Stockholm University. She is the vice head of the Department and the head of the Public Law group. She is associated to Center for Research Ethics & Bioethics, Uppsala University and the editor of the Swedish Administrative Law Review (Förvaltningsrättslig tidskrift). Her research focuses on Global and European administrative law, especially good administration, transparency and data protection. In recent years, focus has been laid on the balance between data protection and transparency within the public domain and in research. Amongst other, she was the leader of the work package for law and ethics in the Horizon 2020-project BiobankBridge Africa.

Public health registries as a common good?

Openness and transparency have been part of Swedish constitutional identity since the first Freedom of the Press Act was enacted in 1766. A core part of the Swedish understanding of openness is the principle of public access to official documents. In order for this principle to function properly, an administrative infrastructure governing how documents are to be collected and stored is elaborated in detail by Swedish law. Accordingly, Sweden has a long tradition of publicly held registries, for example on health and living conditions. Since 1947, all Swedish residents have been assigned a personal identification number, PIN, which is also used in registries to identify individuals. The combination of the right to access to official documents and publicly held registries based on the official PIN provides a fertile ground for register-based research, enabling the combining of data from registers on the individual level, including retrospective cohort studies. The question raised here is how the Swedish tradition of transparency and publicly held registries can meet more recent demands on data privacy for the data subjects. Are publicly held health registries to be seen as a common good or a potential threat to a legitimate right to privacy?

Dr. Sirpa Soini, lawyer by training, biobank director, member and vice-chair of ethics review board in the University Hospital of Helsinki. Longstanding practice and research activities within biomedical law, genomics, privacy, regulatory issues and ethics. Core interests include public health, genomics, personalized medicine and international data sharing. My doctoral dissertation in medical and biolaw studied legal pluralism of genetic tests regulation, and addressed also the relationship between law, moral and bioethics, and the role of the health care system in genetic testing.

Genetic testing and the Spirit of Laws – study on legal regulation on genetic testing

This study examines legal regulation of genetic testing in the health care setting and on the consumer markets, and the various factors behind. Genetic applications for human health hold great promises for precision medicine, but raise also morally sensitive and controversial issues. Values and moral need to be integrated when addressing law in this field, thus the relationship of law, moral, and bioethics is analyzed.

The regulatory scene in the biomedical field is complex with transnational laws, ethical codes, guidelines, and other policy papers. For many, the picture is unclear which maintains insecurity in practice, as it may be challenging to separate law from non-law. The notion of legal pluralism is particularly interesting in this context, and is discussed in the study. To manage the scene and pluralism, this study aims to map relevant laws, and other quasi-normative instruments.

Europe is fragmented in legal approaches to many treatments. Services, goods, and people cross borders. EU and Council of Europe have influence on the member states’ regulation, even though they enjoy a wide margin of appreciation in many health-related matters. Biomedical field is dynamic and evolving in science. Therefore, regulatory approaches need careful assessment in terms of need and accuracy, so that basic research and adoption of new applications are not unnecessary hindered. Moral issues and concrete physical risks need to be addressed, but shall not be confused with each other in this regard. The claim for the 4th generation human rights, biorights, aims to protect peoples’ genetic integrity against rapid biomedical progress.

The need for and the legitimacy of biomedical regulation should be addressed in multidisciplinary fora, for which bioethics provides a good platform. However, methodology is needed to support its normative suggestions. Moral philosophy can be seen as to lay the ground and concepts for bioethics, thus enabling proper elaboration of moral beliefs.

Mirva Lohiniva-Kerkelä is an Associate Professor in welfare law at University of Lapland/Faculty of Law.  Her research interests have varied from tax law trough administrative law to health law with publicity and data protection issues as a unifying factor. The focus of her current research is on social and health law. Her expertise covers especially issues of social and health rights and the respective responsibilities of the state authorities and professionals in guaranteeing access to health care. She has also researched children´s and elder´s rights in social and health care.  Recently she has been doing multidisciplinary research concerning  the  questions at the intersection between legal and social. 

In Finland, the right to health is guaranteed by the constitutional obligation of the public authorities to ensure adequate health services for everyone and to promote the health of the population as provided for by law. The regulation is targeted at the structures of the health system, guaranteeing the quality and safety of care, professional obligations and patient rights. In particular, due to the rapid development of medicine, but also due to its wide scope, regulation typically takes place by flexible standards that leave a margin of discretion.  When defining the content of adequate health services, it is necessary to coordinate, on the one hand, system-level solutions, physicians treatment methods and the patient's right to individually assessed medically justified treatment.

The determination of the range of healthcare services is based on a comprehensive assessment, which must consider research data and other evidence in different fields, as well as ethical and organisational aspects of health care. The increase in research data, genetic information, the development of new diagnostic methods, equipment and treatments on a broad front as well as possibilities to tailoring medication individually to the patient's needs and treatment of the disease are bringing new opportunities and challenges. The question is what kind of a governance system can guarantee rights of individual, needs of different patient´s groups and equal access to health care services.