Result card

  • LEG23: Are Genetic Tests for breast cancer so novel existing legislation was not designed to cover its regulation?
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Are Genetic Tests for breast cancer so novel existing legislation was not designed to cover its regulation?

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.

Our research found a lack of European legislation specifically for these genetic tests, but there are European standards of health policy regarding breast cancer, aimed at the creation of tools to implement the prevention, diagnosis and treatment of these tumours: Decision n. 1350/2007/EC of the European Parliament and of the Council from 23 October 2007 establishing a second program of Community Action in the field of health (2008–2013){10}; the White paper of the European Commission “Together for Health: A Strategic Approach for the EU 2008–2013”{14}; the Communication from the Commission to the Council, the European parliament, the European economic and social committee and the committee of the regions e-Health - making healthcare better for European citizens: An action plan for a European e-Health Area{15}; the Decision of the Commission of the 23 February of 2009 that adopted the plan of action for 2009 for the actualization of the second Community action plan for the health care (2008–2013){16}; the Council Recommendation on a European action in the field of rare diseases from 11.11.2008{17}; the P5_TA(2003)0270 breast cancer, the Resolution of European Parliament on breast cancer in the EU  (2002/2279(INI)){18}; the Recommendation no. R (89) 13 of the Committee of Ministers to Member States on the Organization of Multidisciplinary care for cancer patients of the 24.10.1989{19}; the Recommendation no. r (80) 6 of the Committee of Ministers to Member States concerning cancer control of the 30.4.1980{20}; the Directive CEE/CEEA/CE n° 79 of the 27/10/1998 98/79/EC of the European Parliament and the Council of the 27 October of 1998 concerning in vitro diagnostic medical devices (21); and the Communication from the Commission Consultation regarding Community action in health services, 26.9.2006{22}.

Critical
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Casini M et al. Result Card LEG23 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

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