The Principle of the Rule of Law Is An Attribute of the Modern Legislation Reform
According to the Association Agreement between Ukraine, on the one hand, and the European Union (EU), the European Atomic Energy Community and their member states, on the other hand, the agreement was ratified with a declaration by Law No. 1678-VII dated 16.09.2014, Ukraine’s integration into the European Union, involves the harmonization of the main elements of the legal systems, the use of uniform terminology and, of course, compliance with the principle of the rule of law in law-making and law-enforcement activities.
Adhering to international obligations, a complex process of changing the system of national legislation and adapting it to the EU standards continues in Ukraine. Corresponding changes affected the main branches of legislation: both private law and public law. Currently, work continues on the development of the new Criminal and Civil Codes, a need for codification of legislation in the field of medical law, etc. is being discussed in the paper.
Considering the large volume of legislation, which is in need to be analyzed, changed/augmented, agreed upon, it is extremely necessary to adhere to the principles of law, in particular the principle of the rule of law; the elements of which, in turn, are the principles of equity and justice, legal certainty, clarity and unambiguity of the legal norm, as nothing else can ensure its equal application, does not exclude unlimited interpretation in law enforcement practice and inevitably leads to arbitrariness.
Taking into consideration the different terminology, which is used to denote the same phenomena in different spheres of legislation, its unification is not just necessary, but a requirement for compliance with the principle of legal certainty, which in turn, as noted, is a sign of the rule of law. The principle of legal certainty stands for the notion that: “… the restriction of the basic rights of the person and the citizen and the implementation of these restrictions in practice is permissible only under the condition of ensuring the predictability of the application of legal norms established by such restrictions. That is, the restriction of any right should be founded on criteria that will enable a person to distinguish the legitimate behavior from illegal behavior, to predict the legal consequences of his behavior”.
In the current legislation of Ukraine, the following terms are used to denote the intellectual creative activity aimed at obtaining new knowledge concenring the regularities of the organization and the development of nature, the things, the society, the human, their interrelationships and (or) the search for ways of their application for practical purposes: “medical , scientific experiments” (Article 28 of the Constitution of Ukraine; Part 3 of Article 281 of the Civil Code (CC)), “scientific research” (the Law of Ukraine "On Scientific and Scientific-Technical Activity); “clinical trials” (Part 3 of Article 281 of the Civil Code; Article 7 of the Law of Ukraine “On Medicinal Products”, 1996; Orders of the Ministry of Health of Ukraine (MOH) No. 95, 1169, 690); “medical-biological, scientific-research, therapeutic experiments” (Article 45 of the Law of Ukraine "The Fundamentals of the Legislation of Ukraine on Health Protection" (Basics)); “clinical research” (clause 35 of article 2 of the Law of Ukraine "On Medicinal Products", 2022); “preclinical studies” (Orders of the Ministry of Health No. 944, 22) “medical and biological experiments” (Article 142 of the Criminal Code (CC)).
In addition to the afore-mentioned terms, the theory of law operates the following terms: "”therapeutic and non-clinical experiment”; “medical and biological experiment"”
International law in its acts mostly uses the term "research", which is translated to the Ukrainian language as “study” (not “experiment”, not “experiment”, not “trial”). This term is used in Art. 6 of the Declaration of Helsinki of the World Medical Association’s “Ethical principles of medical research with the participation of a person as an object of research” (Helsinki, June 1964), in the joint work of the Council of International Scientific and Medical Organizations (CISMO) and the World Health Organization (WHO), which resulted in the Proposed International Ethical Guidelines for Biomedical Research Involving Human Subjects, the Convention on the Protection of Human Rights and Dignity in the Application of Biology and Medicine: Convention on human rights and biomedicine (Oviedo, 04.04.1997) (Ch. 5) and the Additional Protocol to the Convention on Human Rights and Biomedicine in the Field of Biomedical Research (Strasbourg, 25.01.2005), the Universal Declaration on Bioethics and Human Rights (UNESCO , 2005), part 3 of Art. 3 of Directive No. 2001/83/EC of the European Parliament and of the Council "Community Code relating to medicinal products (for human use)". Thus, in most international documents, the term “research” is used to denote the concept of general scientific research and the concept of “clinical trial” to denote the conduct of research/tests in relation to medicinal products.
Adhering to Ukraine's obligations for the adoption of the national legislation to EU legislation/law, the terminology should be harmonized not only in the national legal system, but also with international documents.
Let us analyze the national legislation. The Constitution of Ukraine (Article 28), the Civil Code (Article 281) and the Criminal Code (Article 142) uses the term "experiments". Article 45 of the Fundamentals is generally “dead”, because the terminology used in it is not utilized in the legislation. Scientists suggest the use of the term “experiments”, which, at first glance, may harmonize the domestic legislation (Civil Code, Criminal Code and the Fundamentals, subject to changes). However, even under this view, there will be no complete harmonization of terminology, because the term “research” is used in the Law of Ukraine “On Scientific and Scientific-Technical Activity”. Taking into account the above-mentioned conceptual apparatus, which is used in international normative acts, we believe that it is appropriate to use the concept of “research” at the national level, which will absorb all the other concepts, which are discussed. All the other names of methods of scientific knowledge in the course of scientific research, which are given a lot of attention at the doctrinal level, will be covered by the normative regulation of “research”, which will include the peculiarities of regulation and methods of its conduct, depending on their type (in relation to medicinal products or others).
This position is supported by the adoption of the new Law of Ukraine “On Medicinal Products” from 2022, in which the term “research” is already used in relation to clinical trials of medicinal products. In the explanatory note to the draft of this law, it is stated that the choice of such terminology was made in order to unify the legislation of Ukraine and the EU.
However, the replacement of all other terms with the term “research” in the acting legislation is not completely possible. Thus, making changes to laws and by-laws (orders of the Ministry of Health) is an incomparably easier procedure than making changes to Art. 28 of the Constitution of Ukraine, in which the term “experiments” is used. Therefore, for consistency of terminology in the system of national legislation, the terms “experiments” and “research” should be linked. This approach will provide an opportunity to refrain from unnecessary changes to the acting legislation, if it is purely related to a change in terminology (not introducing other changes in the essence of the legal norm). For example, do not enter changes in terminology, at least in the current Criminal Code to the acting Art. 142. It is expedient to use the new terminology already in the new Criminal Code, which is currently being prepared. For this purpose, it is expedient to amend the Law of Ukraine "On Scientific and Scientific-Technical Activities", a general framework act, defining the two afore-mentioned terms, which will make it possible to retain the term "research" in the Constitution.
It should be noted that according to the academic explanatory dictionary of the Ukrainian language, these two terms can be equated in a broad sense: the search for new knowledge or “experiment” is defined as a stage of research. An example of “linking” the provisions of current and “future” laws was provided by the legislator in the new Law of Ukraine "On Medicinal Products" in 2022. For instance, in the clause no. 35 of Article 2 of this law, the legislator uses a partially-changed term, namely “clinical research (trial) of medicinal products”, with the indication of the previous term ("trial") in it, thus connecting these two terms “clinical trial of medicinal products”, which was agreed with the Civil Code and was in the law “On medicinal products”, 1996, and "clinical research (trial) medicinal products”, which is already used in the 2022 law. Thus, this use of a legislative technique releases the legislator from making changes to the Civil Code, which are related to the change of terminology only, although other changes are essentially required (in order to harmonize the provisions of the Civil Code and this new act).
Taking into account the above-mentioned conclusions, it is proposed to make the following changes to the acting legislation:
Article 1 of the Law of Ukraine “On Scientific and Scientific-Technical Activity”, in which the applicable terminology is provided, to augment the following paragraph “paragraph 34) research – experiment/experiments, in a broad sense - acquisition of new knowledge; a stage, method of research can be an experiment/experiments; the provisions of this law apply to the conduct of research/experiments.”
The orders of the Ministry of Health regarding the conduct of clinical trials of medicinal products, which are listed above, which have passed the examination in the Ministry of Justice, and are registered in it, and do not duplicate the provisions of the new law, may be left in the old version.
Such changes will correspond to the observance of the principle of the rule of law, in particular its feature, namely, the legal certainty at the domestic level, and will correspond to the idea of unification, globalization of the international legislative space, which will simplify the law enforcement and improve the protection of human rights and interests, and thus guarantee compliance with the safety of the existence of the ecosystem and humanity as a part of it, which, in turn, is the compliance with the bioethical principle of the safety of life.
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