CYIL vol. 10 (2019)

CYIL 10 ȍ2019Ȏ OPENING THE DOORS FOR DESIGNER BABIES? … syphilis experiment in which Afro-American patients were deliberately not informed of the existence of cures for syphilis, the Beecher’s work provoked a scandal which helped to further develop research ethics. 96 The universal change of healthcare paradigm from paternalism to autonomy of will and informed consent 97 is not the only way the medical ethics answers to unethical research. Desperate people may make desperate decisions, and people who feel that a new therapy could be their last hope may become an easy target for deceivers or reckless scientists 98 . In general, the protection of patients against the potential negative effects of unapproved therapies is relatively strict. The freedom to undergo such a therapy, even if the patient is well informed of the risks and capable of giving consent, is often restricted. Generally, therapies which have not yet been officially approved can only be tested in clinical trials. These are subjected to rigorous regulations aiming at the protection of their subjects. Depending on the jurisdiction, patients suffering from a serious health condition who for some reason cannot participate in a clinical trial are often allowed to receive the therapy when there is no sufficient alternative treatment. However, this so-called compassionate use of medicinal products or similar legal institutes, 99 as a rule, do not permit the use of unregistered therapy in all cases the informed patient grants her consent. Furthermore, they tend to be controversial. For example, in the USA a vivid debate preceded the adoption of Right to Try Act in 2018 which was intended to broaden the possibilities of patients to achieve an unapproved therapy. On the one hand, the need to protect patients from harm was stressed; on the other hand, the existing regulation was criticised as too rigid and depriving some patients of their only hope. 100, 101 96 For a brief overview of the history of medical research ethics, see CHALMERS, Don. Medical research: future directions in the genome era. In JOLY, Yann, KNOPPERS, Bartha Maria (eds.). Routledge Handbook of Medical Law and Ethics. Routledge, Abingdon 2015, pp. 303-307, or ŠOLC, Martin. Právo, etika a kmenové buňky. [Law, Ethics, and Stem Cells.] Wolters Kluwer, Praha 2018, pp. 43-46. 97 For an interesting analysis of the change of healthcare paradigm to the consent-based care in the Czech Republic as a post-communist country, see ŠUSTEK, Petr. Two Decades of the Convention on Biomedicine: Has It Been Any Good? In Czech Yearbook of Public & Private International Law. Česká ročenka mezinárodního práva veřejného a soukromého. Vol. 9. Česká společnost pro mezinárodní právo, Praha 2018, pp. 257-269. Also available at accessed 3 June 2019. For a more detailed analysis of patient’s consent, see SALAČ, Josef. Souhlas. [Consent.] In ŠUSTEK, Petr, HOLČAPEK, Tomáš (eds.). Zdravotnické právo. [Health Law.] Wolters Kluwer: Praha 2016, pp. 250-257. 98 A recent example can be found in many unapproved stem cell therapies which are provided under questionable conditions often illegally or in a legal grey area. See ŠOLC, Martin. Právo, etika a kmenové buňky. [Law, Ethics, and Stem Cells.] Wolters Kluwer, Praha 2018, pp. 47-53. 99 On the level of European law, see Article 83 of Regulation (EC) No. 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, or Article 3 (7) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use. 100 Right to Try Act is not relevant for germline modification. Nevertheless, for an interesting perspective of parents of children suffering from genetic disorders who strongly support germline modification, see BEGLEY, Sharon. As calls mount to ban embryo editing with CRISPR, families hit by inherited diseases say, not so fast. STAT. (17 April 2019.) accessed 6 June 2019. 101 See for example COOK, Michael. “Right to try” bill passed in US Congress: more harm than good? BioEdge. (14 April 2018.) accessed 1 June 2019. For a more general perspective, see also HERRING, Jonathan. Medical Law and Ethics. 5 th ed. Oxford University Press, Oxford 2014, pp. 616-618.

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