This presentation introduces the potential legal issues of the introduction of personalised medicine in Denmark. The Danish government has placed personalised medicine high on the political agenda. Yet, PM also raises relevant legal concerns. Therefore, this presentation presents the results of a literature review of legal issues pertaining to PM raised in international literature between 2000-2017.
The results show that in the context of PM academics have expressed particular concern regarding discrimination and patient autonomy, in particular, informed consent, privacy and confidentiality. These issues are further discussed in the context of Danish law, namely whether Danish law provides adequate protection for the individual, while at the same time providing space for collective goals, such as the good population health and access to effective treatment.
From a legal perspective, the establishment of a Danish National Genome Centre and the corresponding amendment to the Danish Health Act is particularly pressing. The Centre has proven controversial and commentators have argued that the draft legislation breaches individual privacy and violates individuals’ rights. Therefore, the extent to which these concerns are supported by existing practice from Danish and European courts is discussed, as well as relevant principles of international law.