The chapter is focused on the rules and principles applicable to the research activities in the genetic fields under the European legislations as well as within the international legal sources. The legal sources mainly provide a protection on genetic information of individuals, on the ground of the legislation concerning the personal data, especially in Europe by means the new General Data Protection Regulation (EU) 2016/679, which is going to replace the Directive 95/46/EC. General Data Protection Regulation, in addition to now defining genetic data within sensitive personal data, more than the Directive provides several derogations to the rights of the data subject (mainly right of access; right to rectification; right to restriction of processing; rights to object; right erase, i.e. right «to be forgotten»), which have in the Article 89 the disposition of reference. Furthermore, as it arises from European and international sources, specific provisions are applicable to data processed for scientific purposes in respect to the specificity of consent and for the storing of data, as well for the biological materials from which those data are derived. On the other hand, derogations to discipline on privacy do not cover all issues concerning the experimentation, especially in case of genetic information, which are characterised by features such as «predictability» and «familiarity». Derogations to the discipline of privacy are inspired by the finality to grant research freedom granted by national Constitution and by Charter of the Fundamental Rights of the European Union. However, such freedom cannot be considered as absolute but must be implemented taking into account principles and rules of the constitutional legal system. Research, in addition to the respect of core of the other fundamental rights, and in particular the protection of personal sphere of the persons, has to be consistent with principles fundamental for the EU legal system such as necessity, proportionality, precautionary. To achieve a correct balance within the freedom of research and protection of personal data, it should be advisable to revise proprietary idea of privacy and to consider consent as instrument always necessary and sufficient.
Research on genetic information and exceptions to the protection of personal data
cippitani, r.
2018
Abstract
The chapter is focused on the rules and principles applicable to the research activities in the genetic fields under the European legislations as well as within the international legal sources. The legal sources mainly provide a protection on genetic information of individuals, on the ground of the legislation concerning the personal data, especially in Europe by means the new General Data Protection Regulation (EU) 2016/679, which is going to replace the Directive 95/46/EC. General Data Protection Regulation, in addition to now defining genetic data within sensitive personal data, more than the Directive provides several derogations to the rights of the data subject (mainly right of access; right to rectification; right to restriction of processing; rights to object; right erase, i.e. right «to be forgotten»), which have in the Article 89 the disposition of reference. Furthermore, as it arises from European and international sources, specific provisions are applicable to data processed for scientific purposes in respect to the specificity of consent and for the storing of data, as well for the biological materials from which those data are derived. On the other hand, derogations to discipline on privacy do not cover all issues concerning the experimentation, especially in case of genetic information, which are characterised by features such as «predictability» and «familiarity». Derogations to the discipline of privacy are inspired by the finality to grant research freedom granted by national Constitution and by Charter of the Fundamental Rights of the European Union. However, such freedom cannot be considered as absolute but must be implemented taking into account principles and rules of the constitutional legal system. Research, in addition to the respect of core of the other fundamental rights, and in particular the protection of personal sphere of the persons, has to be consistent with principles fundamental for the EU legal system such as necessity, proportionality, precautionary. To achieve a correct balance within the freedom of research and protection of personal data, it should be advisable to revise proprietary idea of privacy and to consider consent as instrument always necessary and sufficient.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
