Personalized Medicine: Legal and Ethical Challenges

Juli Mansnerus (Toimittaja), Raimo Lahti (Toimittaja), Amanda Augusta Blick (Toimittaja)

Tutkimustuotos: Kirja/raporttiKirjaTieteellinenvertaisarvioitu


The paradigm of personalized medicine is an emerging topic, triggering some specific legal and ethical challenges as regards to data collection, sharing and use, informed consent, privacy and public trust, and the changing status of patients and social equality. These legislative developments and challenges have been discussed in light of the Finnish and the common-European experiences. During the recent years, the Finnish legislative processes aiming at generating ‘innovation-friendly’ legislation for scientific research purposes as well as integrating genomic research results into the clinical setting have been heavily challenged by rapid developments in technology and medicine. In particular, there is a need to pursue the right balance between scientific and commercial interests, public health and individual rights. We aim at providing insights to the legislative processes surrounding personalized medicine with a special focus on how the freedom of science, equitable access to healthcare, public health, and commercial issues that must be balanced with individual rights as expressed in the EU Charter and the Council of Europe’s Oviedo Convention.
A wide spectrum of different types of challenges arises; among other things, there is a need to discuss the Finnish and international legislation of genome testing in terms of consent on behalf of a young child. Also the legal and ethical aspects of CRISPR/Cas9 and prime editing, the disruptive gene-editing technologies need to be analyzed; How should we interpret the concept of human dignity in the bioethical discussion surrounding germline editing?
Furthermore, an overview of ongoing initiatives to accelerate the market-entry of advanced therapy medicinal products will be provided. The European regulators are now taking measures to create a facilitative regulatory environment that encourages innovation, protects public health, and enables timely patient access to innovative, new therapies whilst ensuring patient safety. The role of risk-proportionate adaptations to clinical trials and GMP manufacture along with the European Medicines Agency’s early-access incentives and initiatives are presented as potential facilitators of market entry. Furthermore, in this context, the role of conditional reimbursement schemes and risk sharing-agreements is also discussed in light of the newest Finnish experiences. Furthermore, in terms of patent law, some specific challenges arise; in this anthology, attention is paid to the recent transatlantic legal dispute over a patent concerning the use of the CRISPR/Cas9 system in eukaryotic cells. Finally, some considerations beyond legal or ethical aspects of personalised medicine are presented: How machine learning can be used to to support personalized care that addresses the patient’s needs?
KustantajaUniversity of Helsinki, Faculty of Law
ISBN (painettu)978-951-51-6940-2
ISBN (elektroninen)978-951-51-6941-9
DOI - pysyväislinkit
TilaJulkaistu - 2020
OKM-julkaisutyyppiC1 Kustannettu tieteellinen erillisteos


NimiForum Iuris
ISSN (painettu)1456-842X
ISSN (elektroninen)2342-8996


  • 513 Oikeustiede
  • Human Rights
  • Medical and Biolaw
  • Personalised Medicine
  • Genetics
  • commercialization
  • Data Protection
  • Medical research
  • ATMP
  • reimbursement
  • Genome editing
  • gene patents
  • Pediatrics
  • right to health
  • advanced therapies
  • risk
  • market access
  • clinical trials

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