DOI: https://doi.org/10.25040/medicallaw2018.01.042
Med. pravo., 2018; 1(21): 42-53
UDС: 340.6:61047.37
SENYUTA IRYNA YAROSLAVIVNA
Candidate of legal sciences, associate professor, head of the department of medical law of the Danylo Halytskyi Lviv National Medical University, chief editor of the scientific and practical journal “Medical law”, attorney at law, Chief of the Committee on Medical, Pharmaceutical Law and Bioethics of the Ukrainian National Bar Association, president of the NGO “Foundation of Medical Law and Bioethics of Ukraine”, member of the World Association for Medical Law and European Association of Health Law
Civil-Legal Relations in the Sphere of Carrying out Medical Experiments
The definition of a notion and categorical apparatus was suggested, in
particular “medical clinical experiment”, “medical non-clinical experiment”,
“civil-legal relations in the sphere of carrying out medical experiments”.
International standards, national laws and practice of the European Court
of Human Rights in this sphere were analyzed and proposals as regards to
improvement of the legal mechanisms of carrying out medical experiments
were made. Features of the civil relations in the sphere of carrying out medical
experiments and their essence were highlighted. Such features include:
1) relations of carrying out medical experiments are the composing part of the
relations connected with the human right to life and relations in the sphere
of medical care provision; 2) medical experiment is a specific object of these
relations, which is connected with its multidisciplinary character and features; 3) the complexity of the subject construction, which, in particular, is not clearly
defined in the legislation, diversified, double nature of the person, who is being
experimented on, since he or she is both a subject and quasi-subject; 4) specific bioethics content of the legal relations.
Key words: medical experiments, civil-legal relations, medical clinical
experiment, medical non-clinical experiment, human rights.
Reference list:
1. Senyuta I. Ya. (2007) Medychne pravo, pravo lyudyny na okhoronu zdorovya, monohrafiya. Lviv. Astrolyabiya, p. 224.
2. Dyrektyva Komisiyi 2005/28 YeC, shcho vstanovlyuye pryntsypy i detalni pravyla yakisnoyi klinichnoyi praktyky pry provedenni klinichnykh doslidzhen likarskykh zasobiv dlya lyudyny, a takozh vymohy do protsedury vydachi dozvolu na vyrobnytstvo abo import takykh zasobiv vid 08.04.2005 r. Rerievied from http://acto-russia.org/index.php?option=com_content&task=view&id=25
3. Pro pravovi osnovy bioetyky ta harantiyi yiyi zabezpechennya, proekt zakonu 7625 vid 08.06.2005 r. (stan prokhodzhennya ochikuye rozhlyadu) Rerievied from http://w1.c1.rada.gov.ua/pls/zweb2/webproc4_2?id=&pf3516=7625&skl=5
4. Bioetyka E. Zhrechcha, A. Dzh. Spanyolo, M. L. di. Pyetro ta in. per. z ital. V. Y. Shovkun. pidruchnyk. Lviv Vyd-vo LOBF Medytsyna i pravo. 2007. p. 672.
5. Kashyntseva O. Yu.(2010) Pravovyy status lyudyny v biomedychnomu eksperymenti: lyudyna chy animal of necessity. O. Yu. Kashyntseva. Pravo Ukrayiny. 2. p. 114–119.
6. Biomeditsinskoe pravo v Rossii i za rubezhom, monohrafiya. H. B. Romanovskiy, N. N. Tarusina, A. A. Mokhov i dr. Moskva. Prospekt, 2015. p. 368 s.
7. Kashkanova N. H. (2015) Problemy vydilennya pravovykh kryteriyiv klasyfikatsiyi medyko-biolohichnoho doslidzhennya u pravoviy nautsi. N. H. Kashkanova. Teoriya i praktyka intelektual'noyi vlasnosti. 6. p. 114–123.
8. Kh. proty Daniyi (Kh v. Denmark) vid 02.03.1983 r. (zayava 997/82) Rerievied from https://hudoc.echr.coe.int/eng
9. Khartiya pratsivnykiv sluzhby okhorony zdorovya. Lviv. Vydavnytstvo LOBF Medytsyna i pravo, 2010. p. 112.
10. Dyrektyva 2001/20/YeS Yevropeyskoho Parlamentu ta Rady shchodo zblyzhennya zakonodavstv, pravyl i administratyvnykh postanov derzhav uchasnyts' YeS, yaki stosuyutsya realizatsiyi yakisnoyi klinichnoyi praktyky pry provedenni klinichnykh doslidzhen' likars'kykh zasobiv pry zastosuvanni lyudyam vid 04.04.2001 r.Rerievied from www.solyur.ru/images/docs-world/Directive_ru.docx
11. Rishennya YeSPL u spravi Khristozov ta inshi proty Bolhariyi (Hristosov and others v. Bulgaria) vid 13.11.2012 r. Rerievied from https://hudoc.echr.coe.int/eng
12. Rehlament 726/2004 Yevropeyskoho Parlamentu i Rady Pro zatverdzhennya protsedur avtoryzatsiyi ta nahlyadu za medychnymy produktamy dlya vykorystannya shchodo lyudey i tvaryn ta zasnuvannya Yevropeys'koyi medychnoyi ahentsiyi vid 31 bereznya 2004 r. Rerievied from https://ec.europa.eu/health//sites/health/files/files/eudralex/vol-1/reg_2004_726/reg_2004_726_en.pdf
