Medical experiment - legal situation after the amendment of the Medical Act

Abstract

            The subject of the arcticle are the changes in the Act of Dec. 5th 1996 on physicians and dentists professions, made by the amendment thereof in July 2020, in the part concerning medical experimentation (Chapter 4 of the Act). The following matters have been discussed and subject to critical scrutiny: extending the scope of the law to include testing of biological samples taken from humans for scientific purposes (including any research outside of biology and medicine), a new legal definition of an experiment participant, formal and factual competences required from the person in charge for an experiment, limitations and prohibitions concerning participation of certain categories of people, the scope of proper information for the participant, the consent of the participant, the exceptional possibility of undertaking an experiment in urgent situations without any consent, i.e. own (participant's), substitute or court consent (Article 25a), prohibition of remunerating participants (but with exceptions), exclusion from experiments of persons being in a „forced” situation (i.e. whose freedom of consent is actually restricted), the rules for treating people in control groups, admissibility of using a placebo in such groups, the obligation to insure participants, the functioning of bioethical committees and finally – new criminal regulations. As for the conclusions: the new provisions appear very imperfect (to say it the moderate way) – they are mostly ill-considered, they lack good rational justification, are technically poorly formulated and potentially harmful for scientific research.