Result card

  • LEG5: Does the use of Genetic Test for breast cancer produce information that would be relevant for the relatives of the patient?
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Does the use of Genetic Test for breast cancer produce information that would be relevant for the relatives of the patient?

Authors: Marina Casini, Emanuela Midolo, Marco Marchetti

Internal reviewers: Judite Neves, Ana Bação, Vesna Kovač

The domain methodology used for this question has been collection, selection and analysis of European norms and sentences.

As far as we know, the genetic tests in question do not provide important information for relatives of the patient. Nevertheless, from a legal perspective, information regarding the health of a patient that also concerns relatives is important. When the patient does not give consent for third parties to be given information that regards them, there is a conflict between opposing rights: the right to privacy of the patient and the right to know of the relatives. Protection of privacy regarding personal health data has an important relevance to Article 8 of the European Convention on Human Rights.{7} Also with reference to the treatment of personal data, it is important to reference Article 8 “The processing of special categories of data” of Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995{8} on the protection of individuals with regard to the processing of personal data and on the free movement of such data which states the following.

  1. “Member States shall prohibit the processing of personal data revealing racial or ethnic origin, political opinions, religious or philosophical beliefs, trade-union membership, and the processing of data concerning health or sex life.
  2. Paragraph 1 shall not apply where:

(a) the data subject has given his explicit consent to the processing of those data, except where the laws of the Member State provide that the prohibition referred to in paragraph 1 may not be lifted by the data subject's giving his consent; or (b) processing is necessary for the purposes of carrying out the obligations and specific rights of the controller in the field of employment law in so far as it is authorized by national law providing for adequate safeguards; or (c) processing is necessary to protect the vital interests of the data subject or of another person where the data subject is physically or legally incapable of giving his consent; or (d) processing is carried out in the course of its legitimate activities with appropriate guarantees by a foundation, association or any other non-profit-seeking body with a political, philosophical, religious or trade-union aim and on condition that the processing relates solely to the members of the body or to persons who have regular contact with it in connection with its purposes and that the data are not disclosed to a third party without the consent of the data subjects; or (e) the processing relates to data which are manifestly made public by the data subject or is necessary for the establishment, exercise or defence of legal claims.

  1. Paragraph 1 shall not apply where processing of the data is required for the purposes of preventive medicine, medical diagnosis, the provision of care or treatment or the management of health-care services, and where those data are processed by a health professional subject under national law or rules established by national competent bodies to the obligation of professional secrecy or by another person also subject to an equivalent obligation of secrecy.
  2. Subject to the provision of suitable safeguards, Member States may, for reasons of substantial public interest, lay down exemptions in addition to those laid down in paragraph 2 either by national law or by decision of the supervisory authority.
  3. Processing of data relating to offences, criminal convictions or security measures may be carried out only under the control of official authority, or if suitable specific safeguards are provided under national law, subject to derogations which may be granted by the Member State under national provisions providing suitable specific safeguards. However, a complete register of criminal convictions may be kept only under the control of official authority. Member States may provide that data relating to administrative sanctions or judgements in civil cases shall also be processed under the control of official authority.
  4. Derogations from paragraph 1 provided for in paragraphs 4 and 5 shall be notified to the Commission.
  5. Member States shall determine the conditions under which a national identification number or any other identifier of general application may be processed.”
Important
Completely
Casini M et al. Result Card LEG5 In: Casini M et al. Legal aspects In: Jefferson T, Vicari N, Raatz H [eds.]. Prognostic tests for breast cancer recurrence (uPA/PAI-1 [FEMTELLE], MammaPrint, Oncotype DX ) [Core HTA], Agenzia nationale per i servizi sanitari regionali (age.na.s), Italy ; 2013. [cited 2 December 2022]. Available from: http://corehta.info/ViewCover.aspx?id=113

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