Laws, Acts and other Legal Instruments related to Personalised Medicine

This page provides a curated overview of legal and regulatory instruments relevant to personalised medicine. The list includes laws, regulations, statutory programmes and related legal sources that address areas such as genetic testing, genomic medicine, biobanks, health-data use, secondary use of data, patient rights, research governance, ethical safeguards, reimbursement or implementation structures. Their relevance lies in showing the legal and regulatory conditions under which personalised medicine research, innovation and healthcare implementation can take place. In some cases, a legal instrument may provide a formal basis for infrastructure, data access, genome sequencing, biobanking or patient rights. In other cases, it may provide broader safeguards or governance conditions that are important for responsible implementation.

The list is intended as a living resource and will be updated as further legal or regulatory instruments are identified. Inclusion does not imply that the instrument has been exhaustively interpreted or that it proves practical implementation in healthcare systems. Legal texts should always be checked in the original official source and, where necessary, reviewed by legal experts.

Disclaimer

This list was prepared with the support of artificial intelligence (AI) tools and a subsequential human review and curation. Translations and extracts were AI-generated and edited for clarity, but in some cases they could not be fully verified in the original language of the legal source. They are not legal advice and should not be used as a substitute for formal legal interpretation.

The list is a living resource. If you are aware of a missing legal or regulatory instrument relevant to personalised medicine, please contact EP PerMed at eppermed@dlr.de.

Legal Instruments