Result card

  • LEG10: Is there a wide variation in the acceptability of Genetic Test for breast cancer across Europe?
Prognostic tests for breast cancer recurrence (uPA/PAI-1 [FEMTELLE], MammaPrint, Oncotype DX )
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Is there a wide variation in the acceptability of Genetic Test for breast cancer across Europe?

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.

On the specific subject of genetic tests we must remember the Additional Protocol to the Convention on Human Rights and Biomedicine concerning Genetic Testing for Health Purposes from 27.11.2008.{2} The object and scope of the Additional Protocol to the Convention on Human Rights and Biomedicine concerning Genetic Testing are:

Article 1 “Parties to this Protocol shall protect the dignity and identity of all human beings and guarantee everyone, without discrimination, respect for their integrity and other rights and fundamental freedoms with regard to the tests to which this Protocol applies in accordance with Article 2”

Article 2 “This Protocol applies to tests, which are carried out for health purposes, involving analysis of biological samples of human origin and aiming specifically to identify the genetic characteristics of a person which are inherited or acquired during early prenatal development (hereinafter referred to as “genetic tests”).{2}

This Protocol does not apply to genetic tests carried out:

  • on the human embryo or foetus
  • for research purposes

For the purposes of paragraph 1 “analysis” refers to:

  1. chromosomal analysis
  2. DNA or RNA analysis
  3. analysis of any other element enabling information to be obtained which is equivalent to that obtained with the methods referred to in sub-paragraphs a.1 and a.2

Through careful research we have found certain documents of the European Union dedicated to the fight against cancer. These show that more than a wide variation in non acceptance of genetic testing is the need to use all tools available to fight cancer in its various forms. These documents are: the document of the European Commission of the 24.06.2009 entitled Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on action against cancer: European Partnership; of the European Parliament Resolution concerning the Commission communication “Action against Cancer: European Partnership” {12}, European Code Against Cancer {13}.

Important
Completely
Casini M et al. Result Card LEG10 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 7 February 2023]. Available from: http://corehta.info/ViewCover.aspx?id=113

References

  • {2}  COUNCIL OF EUROPE, Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Genetic Testing for Health Purposes, Strasbourg, 27-XI-2008.
  • {12}  COMMISSION OF THE EUROPEAN COMMUNITIES, Brussels 24.06.2009, Communication From The Commission To The European Parliament, The Council, The European Economic And Social Committee And The Committee Of The Regions: An Action Against Cancer: European Partnership.
  • {13}  EUROPEAN CODE AGAINST CANCER.