RSSВерсія для друку
OMELCHENKO OLHA PETRIVNA

DOI:  https://doi.org/10.25040/medicallaw2018.02.024

Med. pravo., 2018; 2(22): 24-31

UDС: 347.121.2.02:[614.253.84:57.08](477)(045)

OMELCHENKO OLHA PETRIVNA  

Post-graduate student of the Intellectual Property Research Institute  of the National Academy of Legal Sciences of Ukraine 

Legal Regulation оf the Biobanks Activity іn Ukraine

The author explores the issues of biobanking legal regulation in Ukraine. In the article there have been analyzed current legislation from the point of view of biobanking regulation completeness; the conclusions and recommendations for the improvement of the national legislation and adoption of relevant legal acts as to the activities of biobanks have been formulated. It has been concluded that the problem regarding legal regulation of biobank activity exists at international and domestic level of legislation, as well. There is no complex laws for regulation of biobank activity. Donors’ legal status is one of the key issues in the biobanking, that is why it should be foreseen in the law in order to ensure donors’ human rights. Nowadays, there is no relevant legal act in Ukraine to regulate the selection of human biological material for research, and the procedure for carrying out proper medical and biological research on such biological material. One should keep in mind that biobanking covers not only in the issues of law or medicine but also such of ethics, morality, religion and so on. Legislation should be improved taking into account ethical, religious, cultural characteristics and differences in the modern world, it shall help to achieve a reasonable balance between the interests of different interested parties.

Key words: legal regulation, biobank, biological material, donor, biomedical research.

Reference list:

1.       Yvonne G. (2014) De Souza, John S. Greenspan Biobanking Past, Present and Future: Responsibilities and Benefits. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3894636/

2.       Cyvilnyj kodeks Ukrayiny. Retrieved from http://zakon2.rada.gov.ua/laws/show/435-15

3.       Pro zatverdzhennya Poryadku zaboru ta tymchasovogo zberigannya pupovynnoyi (placentarnoyi) krovi ta/abo placenty: Nakaz Ministerstva ohorony zdorovya Ukrayiny vid 10.07.2014. Retrieved from http://zakon0.rada.gov.ua/laws/show/z0869-14

4.       Kinkorova J. (2016) Biobanks in the era of personalized medicine: objectives, challenges, and Innovation. The EPMA Journal. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4762166

5.       Minssen T. (2014) Legal Aspects of Biobanking as Key Issues for Personalized Medicine and Translational Exploitation //Personalized Medicine. Retrieved from https://www.medscape.com/viewarticle/833529

6.       Pro zatverdzhennya Licenzijnyh umov provadzhennya gospodarskoyi diyalnosti bankiv pupovynnoyi krovi, inshyh tkanyn i klityn lyudyny zgidno z perelikom, zatverdzhenym MOZ Ukrayiny: Postanova Kabinetu Ministriv Ukrayiny vid 02.03.2016. 286. Retrieved from http://zakon2.rada.gov.ua/laws/show/286-2016-

7.       Pro zatverdzhennya Licenzijnyh umov provadzhennya gospodarskoyi diyalnosti bankiv pupovynnoyi krovi, inshyh tkanyn i klityn lyudyny: Nakaz MOZ Ukrayiny vid 10.04.2012. 251. Retrieved from http://zakon3.rada.gov.ua/laws/show/z0660-12

8.       Konvenciya pro zahyst prav i gidnosti lyudyny shhodo zastosuvannya biologiyi ta medycyny: Konvenciya pro prava lyudyny ta biomedycynu vid 04.04.1997. Retrieved from http://zakon2.rada.gov.ua/laws/show/994_334

9.       Recommendation CM/Rec (2016) 6 of the Committee of Ministers to member States on research on biological materials of human origin. Retrieved from https://search.coe.int/cm/Pages/result_details.aspx?ObjectId=090000168064e8ff

10.   Human Tissue Act (2004). Retrieved from https://www.legislation.gov.uk/ukpga/2004/30/contents

11.   Human Tissue Act (2008). Retrieved from http://www.legislation.govt.nz/act/public/2008/0028/latest/DLM1152940.html

12.   Human Biomedical Research Act (2015). Retrieved from https://sso.agc.gov.sg/Act/HBRA2015

13.   Biobank Act. Retrieved from http://www.finlex.fi/en/laki/kaannokset/2012/en20120688.pdf

14.   Biobanks in Medical Care Act. Retrieved from http://biobanksverige.se/wp-content/uploads/Biobanks-in-medical-care-act-2002-297.pdf

15.   Voronina I. S. (2014) Pravovi zasady stvorennya ta funkcionuvannya biologichnyh bankiv (biorepozytariyiv) v Ukrayini. Pravo ta innovacijne suspilstvo : elektron. nauk. vyd. 2014. Retrieved from http://apir.org.ua/wp-content/uploads/2014/12/Voronina_I.pdf

16.   Pravove regulyuvannya bankingu stovburovyh klityn pupovynnoyi krovi, inshyh klityn i tkanyn lyudyny ta klinichnyh doslidzhen z yih zastosuvannyam u riznyh krayinah svitu. X. M. Nasadyuk, A. V. Mahinya, V. A. Shablij ta in. Klitynna ta organna transplantologiya. 2016. 1. S. 70–75.

17.   Parks A. (2009) Biobanks 10 ideas changing the world right now. Time Magazine. Retrieved from http://content.time.com/time/specials/packages/article/0

Full text