Overview of EU National Legislation on Genomics

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 tremendous impact on many fields of scientific research. The application of genomics inside routine healthcare is boosting preventive medicine practices and can lead to personalised treatments that can highly improve the healthcare services and patients' health, and in the same time provide a wealth of data for medical research. In parallel, this has also led to the spread of commercial opportunities to provide consumers with the possibility of sequencing their genomes in a way which is both appealing and affordable. These commercial offers, however, do not always ensure the security of the generated data. In addition, the accuracy and reliability of the offered findings are not homogenous, as there are no standards to guarantee that the quality of the outputs satisfies minimum requirements - in fact, no agreements yet exist on the definition of these requirements. 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.JRC.F.7-Knowledge for Health and Consumer Safet