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Article title The Right to Participate in Clinical Trials of Medicines Through the Prism of The Right to Health
Authors
OLHA OMELCHENKO
Doctor of Philosophy in Law, Research Associate at the Department of Research on Intellectual Property Rights and Human Rights in the Sphere of Healthcare of the Research Institute of Intellectual Property of the National Academy of Sciences of Ukraine (Kyiv, Ukraine) ORCID ID: https://orcid.org/0000-0002-3265-205X olhap.omelchenko@ukr.net
Magazine name Legal journal «Law of Ukraine» (Ukrainian version)
Magazine number 8 / 2024
Pages 61 - 70
Annotation

Global crises, such as pandemics or war, undermine especially the resilience of health care systems, challenging the realization of fundamental human rights to life and health.

The progress of the pharmaceutical industry is accompanied by an increase in the number of clinical trials in which the participation of patients is their opportunity to receive a potentially promising therapy for themselves, and healthy volunteers are a contribution to the development of medicine.

Ensuring the safety and protection of the rights of research subjects is a principle of clinical trials in accordance with the norms of international and national legislation. The general trends of the intensity of medicines development, the increase in the number of clinical trials indicate an increase in the involvement of people in such trials as research subjects.

The purpose of the article is to study the legal nature of the right to participate in clinical trials of medicines and establish the specifics of its implementation in the context of the right to health. The article analyses the relationship between the right to participate in clinical trials of medicines and the right to health as a part and as a whole. It has been established that the right to participate in clinical trials of medicines belongs to personal non-property rights and is a component of the right to health, since clinical trials cannot be separated from the scope and purpose of their implementation – health care. The social value of the right to participate in clinical trials is manifested due to its complex nature, because it is not only a component of the right to health, but also the right to participate in scientific progress, therefore, its implementation serves to satisfy general human needs. It was noted that it is necessary to ensure equal and fair access to clinical trials of medicines so that different groups of patients are represented in the trials.

Keywords clinical trials; right to health; access to medicines; human rights; intellectual property
References

Bibliography

Journal articles

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Conference papers:

 6. Buletsa S, ‘Deiaki aspekty poniattia prava na okhoronu zdorovia, medychnu dopomohu ta bioetyky v Ukraini, Slovachchyni ta Uhorshchyni’ Medychne pravo Ukrainy: problemy stanovlennia ta rozvytku: materialy I Vseukrainskoi naukovo-praktychnoi konferentsii (Lviv, 19–20.04.2007 r.) 38–44.

7. Moskalenko V, Hruzieva T, ‘Inshakova H. V. Rehlamentatsiia prava na okhoronu zdorovia u mizhnarodnykh normatyvno-pravovykh aktakh’ Medychne pravo Ukrainy: pravovyi status patsiientiv v Ukraini ta yoho zakonodavche zabezpechennia (henezys, rozvytok, problemy i perspektyvy vdoskonalennia): materialy II Vseukrainskoi naukovo praktychnoi konferentsii (Lviv, 17–18.04.2008 r.) 186–201.

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