WP8 of the U-PGx project provides an Ethical, Legal and Societal Implications (ELSI) expertise and education on ethical and legal aspects regarding Pharmacogenomics (PGx).
We have worked on different European regulations having an impact on PGx, especially the new Regulation on in vitro diagnostic (IVD) medical devices (IVDR) published on 5 April 2017 and that will apply from 26 May 2022. It regulates legal aspects regarding the production of PGx tests and therefore impacts the manufacturers and the different economic operators involved. PGx tests and companion diagnostics are now classified as IVD of Class C. This classification introduces new rules regarding different procedures. e.g. the need of a notified body involvement for the conformity assessment procedure, new traceability and transparency rules with the establishment of the Unique Device Identification (UDI), a summary of safety and performance, and surveillance and vigilance systems. Some provisions of the IVDR gradually come into force; this is the case for the UDI with the designation of attribution entities following the publication of the European Commission Implementation Decision of 6 June 2019.
However, this regulation only deals with legal issues related to the manufacturing of PGx test and only impacts manufacturers. The ethical and legal issues of using these tests in the clinic remain opened and are still discussed in the literature. We contribute to such debates. These questions concern notably the informed consent for processing a genetic test, the disclosure and reporting of unexpected findings or the protection of genetic data. We have provided elements of reflection and answers to these questions through the work done in the framework of the U-PGx project (and an article is currently under review on these issues).
Member States must update their legislation in order to deal with issues raised by the use of PGx tests in the clinic. This is timely in France with the current revision of the law on bioethics that includes the domain of genetic testing. The draft law will be discussed by the French Parliament at the end of September. This revision provides an evolution of provisions relating to genetic tests, e.g. the possibility of returning incidental data medically useful (but not secondary data that cannot be actively searched for “actionable” genes). Of interest for PGx with large scale tests, the introduction of the obligation to inform about the use of an algorithmic processing of massive data and its modalities of action by the healthcare professional who returns the results of these tests.
Finally, all these issues raised and worked during the U-PGx project could be the subject of future researches in the framework of new European projects through the Horizon Europe program; which will be subject of an information day organized in Brussels on September 10th and of an event organised by the European Commission on September 24-26 also in Brussels.
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