Personalized_Medicine_A_New_Medical_and_Social_Challenge

(Barré) #1

European Convention for the Protection of Human Rights and Fundamental
Freedoms.^16
At the level of the European Union (EU), similar guarantees regarding the right
to the integrity of the person are found in Article 3 of the Charter of Fundamental
Rights of the EU. The right to respect for physical and mental integrity is especially
elaborated for the fields of medicine and biology, where following principles must
be respected: free and informed consent of the person concerned, the prohibition of
eugenic practices, the prohibition of making the human body and its parts a source
of financial gain, the prohibition of the reproductive cloning of human beings.^17
These principles reflect not only the determination of Member States to supervise
and limit potential biomedical manipulations but also the understanding of the
growing number of questions that are yet to arise with further development of
medical sciences and biotechnologies. Article 35 guarantees the right of access to
preventive health care and the right to benefit from medical treatment under the
conditions established by national laws and practices. The principle enshrined in
this provision has its origins in Article 168 of the Treaty on the Functioning of the
European Union (TFEU), Article 11 of the European Social Charter, and Article
13 of the Revised European Social Charter.
Recognizing that accessibility and nondiscrimination are crucial for realization
of the right to health, a variety of instruments of secondary EU legislation, such as
antidiscrimination legislation,^18 have been adopted. Processing of health-related
personal data is another topic of great importance in connection with the protection
of fundamental rights and freedoms of natural persons. Under Data Protection
Directive 95/46/EC,^19 which is currently in force, personal health data is a special
category of data whose processing is prohibited, subject to numerous exemptions
and derogations, such as explicit consent of data subject, or other reasons of
substantial public interest. Prohibition 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.^20 In 2012,
the new legislative package for reform of data protection has been proposed. It


(^16) Convention for the Protection of Human Rights and Fundamental Freedoms ( 1950 ).
(^17) Charter of Fundamental Rights of the EU, Article 2.
(^18) See, e.g., Directive 2006 /54/EC of the European Parliament and of the Council of 5 July 2006 on
the implementation of the principle of equal opportunities and equal treatment of men and women
in matters of employment and occupation (recast); Council Directive 2000 /43/EC of 29 June 2000
implementing the principle of equal treatment between persons irrespective of racial or ethnic
origin.
(^19) Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the
protection of individuals with regard to the processing of personal data and on the free movement
of such data.
(^20) Article 8(3) of Data Protection Directive 95/46/EC.
36 N. Bodiroga-Vukobrat and H. Horak

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