recommendations regarding the most disputable issues. Key messages, among
others, include the requirement that DTC tests (“Direct-to-Consumer” tests offered
over the Internet) should not be permitted because they do not meet the require-
ments of medically and ethically acceptable predictive genetic diagnostics. The
statement contains a clear warning that before integrating predictive genetic diag-
nostics into the health system, evidence of their effectiveness and efficiency must
be provided.^11 This implies not only fundamental genetic research but also evi-
dence regarding profitability and effectiveness, as well as legal, ethical, and psy-
chological aspects.
3 The Right to Health: Level of Access and Level
of Participation
The existence of technically available and possible methods of diagnostic and
treatment raises the question whether there could be a constitutionally guaranteed
fundamental right of access to them. This question incorporates a dilemma in
connection with available medical options, which are still regarded as controversial.
The right to health is widely recognized as a fundamental right of every human
being. While defining health in its widest possible meaning as “a state of complete
physical, mental and social well-being and not merely the absence of a disease or
infirmity,” the World Health Organization (WHO) at the same time declares that
“the enjoyment of the highest attainable standard of health is one of the fundamen-
tal rights of every human being without distinction of race, religion, political belief,
economic or social condition.”^12 The United Nations Millennium Declaration of
2000 takes a much narrower approach to health, focusing more on resource
management and specific targeted actions rather than health as a general human
condition.^13
Within the Council of Europe, the Convention on Human Rights and Biomed-
icine^14 obliges its signatories to provide equitable access to health care of appro-
priate quality, taking into account health needs and available resources. Further
guarantees regarding the protection of human dignity and identity are provided in
the Additional Protocol to the Convention, concerning genetic tests for health
purposes.^15 Protection of privacy is a fundamental right guaranteed under the
(^11) German Academy of Sciences Leopoldina et al. ( 2010 ), p. 14.
(^12) Constitution of the World Health Organisation ( 1946 ).
(^13) United Nations, Millenium Development Goals ( 2000 ).
(^14) Convention for the Protection of Human Rights and Dignity of the Human Being with regard to
the Application of Biology and Medicine ( 1997 ), Article 3.
(^15) Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Genetic
Testing for Health Purposes ( 2008 ).
Challenges of Personalized Medicine: Socio-Legal Disputes and Possible Solutions 35