LEADER 03481nam 2200397 c 450 001 9910508410103321 005 20211129120557.0 010 $a9789515169419 035 $a(EXLCZ)9919375582600041 100 $a20211125d2020 uy 0 101 0 $aeng 135 $aur||||||||||| 181 $2rdaco 182 $2rdamt 183 $2rdact 200 10$aPersonalized medicine $elegal and ethical challenges$fedited by Juli Mansne?rus, Raimo Lahti and Amanda Blick 210 1$aHelsinki$cFaculty of Law, University of Helsinki$d2020 215 $a1 online ressource$cillustrations 225 1 $aForum Iuris$x1456-842X 327 $tPreface /$rRaimo Lahti --$tIntroduction /$rJuli Mansne?rus, Raimo Lahti and Amanda Blick --$tRegulatory schemes in innovative healthcare and biomedicine /$rRaimo Lahti --$tBuilding the regulatory framework for personalized medicine : case Finland /$rSandra Liede --$t'Precision medicine' : critical reflections on Europe's latest healthcare paradigm /$rCe?line E. Dujardin --$tGenomic testing and giving consent on behalf of a child /$rMerike Helander --$tGermline gene therapy : safeguarding the best interests of the child /$rAmanda Blick --$tOver ten years since the adoption of the EU regulation on advanced therapy medical products ? lessons learned thus far /$rJuli Mansne?rus --$tOn the lookout for experience : the legislative experiment of conditional pharmaceutical reimbursement in Finland /$rWaltter Roslin --$tTransatlantic comparative perspectives on patenting genome-editing technologies ? a case study of patents on CRISPR/Cas9 technology /$rLiisa Vaaraniemi --$tInterpretation of the patient's need for help can be supported with machine learning /$rLauri Lahti. 330 $aThe paradigm of personalized medicine is an emerging topic, triggering some specific legal and ethical challenges as regards data collection, sharing and use, informed consent, privacy and public trust, and the changing status of patients and social equality. These legislative developments and challenges have been discussed in light of the Finnish and the common-European experiences. During recent years, the Finnish legislative processes aiming at generating ?innovation-friendly? legislation for scientific research purposes as well as integrating genomic research results into the clinical setting have been heavily challenged by rapid developments in technology and medicine. In particular, there is a need to pursue the right balance between scientific and commercial interests, public health, and individual rights. We aim at providing insights into the legislative processes surrounding personalized medicine with a special focus on how the freedom of science, equitable access to healthcare, public health, and commercial issues that must be balanced with individual rights as expressed in the EU Charter and the Council of Europe?s Oviedo Convention on Human Rights and Biomedicine. 410 0$aForum Iuris$x1456-842X 606 $aBiomedical research 606 $aGene editing 606 $aLegislation, Medical 606 $aReimbursement mechanisms 615 2$aBiomedical research 615 2$aGene editing 615 2$aLegislation, Medical 615 2$aReimbursement mechanisms 702 $aMansne?rus$b Juli$f1984-$4edt 702 $aLahti$b Raimo$f1946-$4edt 702 $aBlick$b Amanda$4edt 912 $a9910508410103321 996 $aPersonalized medicine$92412512 997 $aUNINA