PROTECTION OF THE PATIENTS’ RIGHTS DURING THE CLINICAL TESTS OF THE NEWEST ACHIEVEMENTS OF BIOTECHNOLOGY IN MEDICINE
( Pp. 103-105)

In the following article the author explores questions, concerned with the protection of the patients’ rights during clinical tests of the newest achievements of biotechnology in medicine. An actual Russian legislation declares that these tests must be safety. So the author analyses actual laws, including the Federal Law of Russian Federation “About the civil turnover of medicines”, issued 12.04.2010, № 61-FL. Article 43 of this act is dedicated to the patients’ rights during the tests. The exploration led the author to the conclusion that, as for gene-repair and gene-diagnostic, the most important of these rights is the right to get information about the medicine and the process of the test, because of the consequences of the tests can be unexpected and dangerous. All gene-concerned manipulations are now the high-risk activity, because even the scientists can’t foretell all possible consequences of their experiments. Therefore, although this kind of biotechnologies can be extremely useful in many spheres of our life, (including medicine), it is strictly necessary to be very cautious with continuing of its’ progress, because disregard of the rights of individual person or persons, such as patients, breaks human rights at all, which price is too high for possible values of others in democratic state.

Immel L.A., (2014), PROTECTION OF THE PATIENTS’ RIGHTS DURING THE CLINICAL TESTS OF THE NEWEST ACHIEVEMENTS OF BIOTECHNOLOGY IN MEDICINE. Gaps in Russian Legislation, 2 => 103-105.

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clinical trials of medicinal products, patient rights, gene therapy, genodiagnostic, the right to information.