Medical Application: Regulatory Landscape – Principles

Legal frameworks for medical neurotechnologies can be expected to find their normative origin in universally agreed upon principles that have been developed to guide biomedical practice and bioethics. The 2005 Universal Declaration on Bioethics and Human Rights, for example, formulates a set of norms to guide biomedical practice, assigning first place to a principle of respect for “human dignity, human rights and fundamental freedoms” (Article 3.1)  This declaration stipulates in Article 3.2 that “the interests and welfare of the individual should have priority over the sole interest of science or society,” a principle initially outlined in 1964 in the Declaration of Helsinki for medical research on human subjects developed by the World Medical Association. The same principle has been incorporated into the 1997 Universal Declaration on the Human Genome and Human Rights (Article 10) and into the 1997 European Convention of Human Rights and Biomedicine (Article 2).

Recourse to a human rights approach in legal frameworks affords the significant advantage of assisting in the formulation of universal standards, since international human rights law can be grounded on the assumption that basic rights transcend cultural diversity. These rights are conceived as patient entitlements by virtue of their human condition, regardless of ethnic origin, sex, age, socio-economic status, health condition, or religious or political ideas. The linkage between human rights and the application of medical neurotechnologies can thus be understood in the context of a fundamental right of bodily and cognitive well being, namely human life and physical integrity, as well as subsidiary goods like that of privacy.