safeguards can be found in the 1997 EuropeanConventiononHumanRightsandBiomedicine, 15 and in the 2014 eu Regulation on Clinical Trials, 16 which will replace the currently applicable 2001 eu Clinical Trials Directive 17 in 2016.
2.1 Council of Europe
The Council of Europe’s Convention on
principles established by Arts. 12 of the un Conventions on the Rights of the Child (1989) signed in Oviedo, and 6 of the EuropeanConventiononHumanRightsandBiomedicine of the Council of Europe (both ratified by Italy). See L. Stultiins, T. Goffin, P. Borry, K. Dierickx and H. Nys, ‘Minors and
clinical trials under the revised Declaration of Helsinki and the EuropeanConventiononHumanRightsandBiomedicine”, European Journal of Health Law , 2000, 105-121; S. Gevers, “Medical research involving human subjects: towards an international legal framework?”, European Journal of Health Law , 2001
tissue for transplant or research purposes 15 is absolutely necessary. Lastly, the EuropeanConventiononHumanRightsandBiomedicine does not forbid the use of fetal tissue for grafting; only the creation of human embryos for research is strictly prohibited (Art. 18.2). e. The ‘line’ for an organ In
views freely in all matters aﬀ ecting the child, the view of the child being given due weight in accordance with the age and maturity of the child.’ Signatories to the Council of Europe’s EuropeanConventiononHumanRightsandBiomedicine 1 must abide by Article 6, which leaves each country to deﬁ ne
, Law and Practice’ (1986) Bull. No. 14, p. 8 usefully deﬁnes the acceptable risk levels in relation to death, major and minor complications. 22 The EuropeanConventiononHumanRightsandBiomedicine, Strasbourg 1997 broadly follows this approach: <http://conventions.coe.int>; Treaty 164. 23 E.g. BMA
,b including the European Convention on Human Rights. While the Council of Europe's ConventiononHumanRightsandBiomedicine covers all types of biomedical research on human beings, the aforementioned European Union Directive on good clinical practise deals only with pharmaceutical research. In regard to
control?’ The Lancet Oncology 11(1) (2010) 9.
J. Wright et al. / European Journal of Health Law 17 (2010) 455-469 459 the freedom of scientiﬁc research (Article 15) and the right to health care of an individual (Article 3) found in the Council of EuropeConventiononHumanRightsandBiomedicine
EuropeConventiononHumanRightsandBiomedicine 1997, Strasbourg 23 June 2003 CDBI/INF (2003).
4) See further e.g. T. Hervey, and J. Kenner (eds.), Economic and Social Rights under the EU Charter of Fundamental Rights: A Legal Perspective (Oxford: Hart Publishing, 2003); M. Cartabia, “Europe and
HumanRightsandBiomedicine , Article 3.
4 un Committee on Economic, Social and Cultural Rights, General Comment No. 14, The right to the highest attainable standard of health (Art. 12) , u.n. Doc. E/C.12/2000/4 (2000), Section 1.1.
5 B. Toebes, ‘The Right to Health and Other Health