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News article17 December 2018

Genomics in Society: the European regulatory landscape

Overview of EU National Legislation on Genomics
© 2018, Mopic-

JRC scientists compiled information on current legislation of EU Member States, as well as of Switzerland, Iceland and Norway, applying to genomics technologies, and draw the attention to some fragmentation and heterogeneity in addressing genomics in policy.

With the advent of fast, high efficiency and low cost DNA sequencing techniques, the ability to study the human genome by reading the sequence of its DNA is growing exponentially, with a resulting significant impact on many fields of scientific research.

Application of genomics-based technologies inside routine healthcare is boosting preventive medicine practices and has the requisites to lead to personalised treatments as it can both improve the healthcare services together with patients' health, and provide a wealth of data for medical research in the same time.

In addition to that, these technologies have also led to the development of commercial opportunities to provide citizens with the possibility of having their genomes sequenced in a way which is both appealing and affordable.

Such commercial offers, however, do not always ensure the confidentiality of the generated data. In addition, the accuracy and reliability of the offered findings are not homogenous, as there are no standards in place to guarantee the quality of the results.

In this frame, a comprehensive knowledge of what is present at the legislative level in the member states of the European Union (plus Switzerland, Iceland and Norway) regarding the regulatory oversight of genomics technologies is of fundamental importance to frame the status of existing European norms, to understand whether possible incompatibilities might arise between frameworks and to highlight eventual gaps.

Therefore, this JRC report presents a mapping, as complete as possible, of existing national legislations linked to genomics. It may be used as a baseline for the analyses of possible consequences for EU policies already in place, and to forecast policy gaps and eventual interventions.

Read more in: JRC F7 - Knowledge Health and Consumer Safety, Overview of EU National Legislation on Genomics, JRC Science for Policy Report, Luxembourg: European Commission, EUR 29404 EN, ISBN 978-92-79-96740-5, doi: 10.2760/04463, PUBSY No. JRC113479

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Overview of EU National Legislation on Genomics


Publication date
17 December 2018