Legal requirements and human rights

In 2019, the SIENNA project delivered an analysis of the legal and human rights requirements for the applications of the existing and emerging genomics technologies in and outside the EU. The work also covered some aspects of animal research as a stage in clinical research.

In the report, we document and deliver a critical assessment of the legal, including human rights, requirements that are relevant in relation to human genomics applications. The report includes an analysis of EU law and international and regional legal orders. It also includes comparative insights in national laws and an assessment of how national standards relate to international and regional norms and human rights requirements. The report shows overlaps, distinctions and a number of challenges in responding to technological advances in genomics. It argues that a human rights framework may provide for an important point of reference for shaping future legal responses in the field.

Highlights from the report were presented in a webinar in 2020. Below, you will find links to a recording of that presentaton, an abstract and a link to the full report.

Highlights from our work

Santa Slokenberga from Uppsala University presents the results from SIENNA's legal analysis of human genomics.

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The SIENNA report

Abstract

The overall aim of this report is twofold. First, to examine how the law currently responds to challenges in the area of genetics and genomics, and identify what challenges, limitations and gaps emerge. Secondly, to identify key human rights norms and regulatory approaches that could be examined further for shaping legal responses to the new and emerging technology in the area with due regard to competences and authority of various actors regulating and/or contributing to shaping the regulatory environment in the area. The two aims are interrelated, so that aim two builds on the analysis of the current legal responses.

The report shows overlaps and distinctions in regulating questions about genomics. While the UNESCO and CoE are considered as “frontrunners” in the area, many of the challenges can also be addressed in other legal orders of concern with due regard to the general human rights frameworks in place. Genomics touches upon a number of sensitivities where neither a straightforward human rights response exist, nor through the balancing act of competing rights and interests, the ultimate and right conclusion can be achieved. Although commonly reflections regarding the adequacy of the existing regulatory responses have been made about the surveyed national legal orders, a key question vis-a-vis SIENNA aims is whether given various sensitivities the area of genomics raises, a common approach could be found, and if so, what elements would constitute this approach. A common denominator might not necessarily be an adequate regulatory approach. Instead, in the subsequent tasks of SIENNA project account for tools that could help to find the balance might need to be given.

Full text

Slokenberga S, et al. D2.2 Analysis of the legal and human rights requirements for genomics in and outside the EU, 2019, Public deliverable report from the SIENNA project. Download the D2.2 report from the Cordis Portal

Scientific publications building on these results

Slokenberga S & Howard HC, The right to science and human germline editing. Sweden, its external commitments and the ambiguous national responses under the Genetic Integrity Act, Förvaltningsrättslig Tidskrift, 2019;2:199-222.