Organization of the Pharmaceutical Business, Drug Technology and Forensic Pharmacy: Modern Trends in The Development of the Science of Pharmaceutical Law During the Covid-19 Pandemic

. The COVID-19 pandemic has affected modern trends in the training of doctors and pharmacists and their professional development. At the same time, the pandemic contributed to the development of the science of pharmaceutical law, as a basis for optimizing the legislation of Ukraine regarding the organization of pharmaceutical affairs in pharmacies and health care institutions, and thanks to modern research on the search for drug technology, it contributed to the creation of vital vaccines for the prevention of the SARS-CoV-2 coronavirus. At the same time, during the COVID-19 pandemic, the health care and pharmaceutical industry, based on the principles of medical and pharmaceutical law, showed that specialists can minimize forensic pharmaceutical risks in the system of legal relations "doctor-patient-pharmacist-lawyer" by ensuring the access of patients, the population and health care institutions to the circulation of medicinal products of all clinical and pharmacological groups, nomenclature and legal groups and classification and legal groups, in accordance with ICD-11. certain types of economic activity; problems associated with falsification of pharmaceuticals; circulation systems of prescription and over-the-counter drugs; control regime and organization of quality control of pharmaceuticals in pharmacies and health centers of all forms of ownership. It is proposed for introduction into the undergraduate and postgraduate forms of education of bachelors, masters, students of thematic improvement cycles (pharmacists, pharmacist assistants, masters of pharmacy, doctors, nurses), pharmacist-interns, master's students, postgraduates, employees of law enforcement, control, advocacy bodies and structures, whose activities are related to the circulation of drugs.

Introduction. In the current conditions of the COVID-19 pandemic [1-5], pharmacy specialists play the most important role in all regions of Ukraine in ensuring patient access to the circulation of medicinal products (pharmaceuticals) of all clinical and pharmacological groups, nomenclature and legal groups and classification and legal groups [6][7][8][9][10][11] in accordance with ICD-11 in health care facilities [12][13]. In such difficult conditions, we see a great dependence on the organization and competences of the work of pharmacies not only in cities, but also in rural areas in the support of patients undergoing outpatient treatment of health disorders complicated by covid, post-covid and long-covid diseases. That is, the competences of pharmacy specialists regarding the organization of the logistical work of pharmacies, simultaneous training (courses of thematic improvement, pre-certification cycles, internships, internships), quality control of vital drugs continue to play one of the main roles in the system of legal relations "doctor-patient-pharmacist-lawyer" [14][15]. It is in pharmacies that patients and citizens receive professional organizational and legal assistance and pharmaceutical care during the circulation of drugs (storage, dispensing according to a doctor's prescription, application, interaction, side effects, etc.). Therefore, research on the organization of the pharmaceutical business, drug technology and forensic pharmacy during the COVID-19 pandemic requires improvement of the control and authorization system, the control regime, and the rules for the circulation of pharmaceuticals of all clinical and pharmacological groups, nomenclature and legal groups and classification and legal groups on the basis of pharmaceutical law [16][17][18].
Integration processes into the European Union require the bringing of pharmaceutical legislation and regulatory acts to European standards. The organization of drug circulation in pharmacies and healthcare institutions based on the principles of pharmaceutical law will contribute to the personalization of the selection of medications to the needs of different contingents of patients, solving the problem of individual intolerance of the drug (interaction of several drugs) thanks to the possibility of dose selection, exclusion or replacement of active pharmaceutical ingredients (APIs) of drugs of all clinical and pharmacological groups, nomenclature and legal groups and classification and legal groups during outpatient or inpatient treatment [19][20][21].
In the conditions of the pandemic of the coronavirus disease and the infectious spread of monkeypox [22,23], the issues of correct interpretation of the terminological apparatus and the addition of the necessary terms to the legislation (for example, pharmacy, etc.) for further improvement of the rules of drug circulation remain relevant [24][25][26][27][28][29]. On the other hand, the optimization of the system of legal relations "doctorpatient-pharmacist-lawyer" as a component of the organizational-legal system of medical care for patients based on the principles of pharmaceutical law in accordance with international GxP standards [30-56] is a guarantee of the exclusion of forensic pharmaceutical risks and doctor's mistakes, provision of high-quality, timely and safe medical and pharmaceutical care, as well as further improvement of the Law of Ukraine "On Medicinal Products" as a legal basis for reforming competences in the field of health care and the pharmaceutical industry [57].
The purpose of the work to consider of modern trends in the development of pharmaceutical law and its impact on the improvement of the organization of the pharmaceutical case, drug technology and forensic pharmacy during the COVID-19 pandemic.
Materials and methods. The basis was the works of interdisciplinary research on modern European legislation and forensic pharmacy, as the basis of pharmaceutical law and their influence on the development of the control and licensing system regarding the improvement of the organization of pharmaceutical business and drug technology. The empirical method and the subject of the research work became the national legislation and regulatory legal acts regulating pharmaceutical activity during the circulation of medicinal products of all clinical and pharmacological groups, nomenclature and legal groups and classification and legal groups using methods of analysis, synthesis, regulatory and comparative methods of establishing regularities and interpreting of the norms of law.
The conducted research is a fragment of the research works of the Department of Military Pharmacy of the Ukrainian Military Medical Academy, and the Department of Organization and Economy of Pharmacy of the P.L. Shupyk National Medical Academy of Postgraduate Education on the topic "Scientific and theoretical justification of the accelerated development of pharmacy, reengineering of processes and human resources from neopharmaceutical and emergent positions" (state registration number 0112U002362, implementation period 2012-2021) and the Department of Pharmacology, Clinical Pharmacology, Pathological Physiology of Kyiv Medical University on the topic "Experimental substantiation of mechanisms of action and pharmacological effects of biologically active substances" (state registration number 0121U109202, implementation period 2020-2024).
Results and their discussion. In recent years (2011-2022), the activation and productivity of rule-making processes contributed to the improvement of most laws to EU standards and the preparation of new normative legal acts, in particular, the preparation of a new edition of the Law of Ukraine "On Medicinal Products". The work carried out contributed to the optimization of the system of legal relations "doctorpatient-pharmacist-lawyer" during the circulation of pharmaceuticals of all clinical and pharmacological groups, nomenclature and legal groups and classification and legal groups on the basis of pharmaceutical law [58,59].
Determining the affiliation of laws and regulations to the pharmaceutical industry is relevant because of the following: -firstly, it has not only general theoretical knowledge, but also a practical point of view, because such clarification serves as the basis for solving urgent problems of pharmaceutical legislation and makes it possible to improve the rule-making process in a specific sphere of social relations, for example, replenishing the terminological apparatus of the Law of Ukraine "On Medicinal Products"; -secondly, the solution to the problem of separating the criteria of one branch of law from another in legal theory was, is and remains in the zone of heated discussions (for example, theories of the state and law, criminal legislation, administrative legislation, etc.); -thirdly, to define the field of lawpharmaceutical law, as a relatively independent set of legal norms that regulates a qualitatively homogeneous sphere of social relations by a specific method of legal regulation; -fourthly, the general legislative properties of the system of legal relations "doctorpatient-pharmacist-lawyer", i.e., systems that are not statutory and are not identified, but are specified according to the sectoral pharmaceutical law; -fifthly, the criteria for the division of law; consist of legal institutes built in the field of law according to their own subject and method of legal regulation; relatively independent from other associations of legal norms in the pharmaceutical law system; -sixthly, the place of pharmaceutical law in the state administrative and delict authority is determined by several factors, namely: Ukraine's integration into the European and world economic society, global revolutionary processes in the domestic economy, the existing state of circulationprovision of the population (sick) with medical care, etc.
-seventh, the outdated system of legal relations and the creation of a modern legal array, which acts as a legislative regulator for the analysis of the reasons and conditions that inhibit the improvement of legal relations in the medical and pharmaceutical sectors of Ukraine; -eighthly, the subject of the state administrative tort of legal regulation is social relations, which objectively require actual regulation with the help of generally recognized specific and relevant legal norms (-participation in scientific research work; -participation in the preparation of regulatory and legal acts); -ninthly, the subject of legal regulation is primarily social relations. Undoubtedly, these relations are strong-willed and purposeful, because they are the embodiment of the internal conviction of all participants of the pharmaceutical market in the fulfillment of current legal relations regarding their rights and obligations, that is, the patient exercises his right to receive drugs, the pharmacistto engage in pharmaceutical activities in accordance with the obtained specialty and circulation of drugs registered on the territory of Ukraine; -tenth, the element of the subject of legal regulation is "focus on the patient", the ultimate goal of which is to provide the population with effective, safe, high-quality, and affordable drugs, consideration and discussion of the draft and adoption of the Law of Ukraine "On Pharmaceutical Activity"; -eleventh, ensuring the circulation of pharmaceuticals as a type of activity of the pharmacy regarding production (manufacturing), accounting, storage, dispensing, transportation, sale, disposal, destruction of pharmaceuticals, accounting of prescriptions, etc.; -twelfth, ensuring control over the quality of drugs during circulation in a pharmacy (detection of falsified drugs) and development of legal relations in the chain "pharmacist-drug quality control-lawyer-law enforcement agencies"; -thirteenth, execution by all participants who are on the pharmaceutical market of the State Pharmacopoeia of Ukraine; -fourteenth, organization, holding, discussion and generalization of proposals at scientific and practical conferences, for example, November 17-18-19, 2022, the annual XIX Multidisciplinary scientific and practical conference "Medical and pharmaceutical law of Ukraine: organization of pharmaceutical business, general, forensic and clinical pharmacy, pharmacotherapy of health disorders" in the conditions of the coronavirus pandemic (interdisciplinary relations of medical and pharmaceutical law in the field of health care and the pharmaceutical industry in the conditions of the COVID-19 pandemic; State Pharmacopoeia of Ukraine; evidence pharmacy and evidence-based medicine) [60]. Complex scientific and theoretical substantiation of the regularities of the development of the system of medical provision of the population of Ukraine from the neo-pharmaceutical and emergent positions. Using the capabilities of the European Committee regarding the compliance of the situation with the provisions of the "European Social Charter", as of 2013, problematic issues regarding the pharmaceutical provision of the population of Ukraine were identified in Ukraine. The organizational and legal measures of state influence on the reform and modernization of the health care sector on the basis of pharmaceutical and medical law are defined. It was noted that clarifying the norms of medical and pharmaceutical law, implementing the principles of medical and pharmaceutical legislation, forensic pharmacy, evidence-based medicine, and evidence-based pharmacy in the practical activities of pharmacy specialists and doctors will contribute to the formation of a highly educated specialist in the field of health care. Pharmacy specialists have theoretical foundations and practical skills regarding: clinicalpharmacological, classification-legal and nomenclature-legal classification of drugs; legislative, regulatory and instructional-methodical documents regulating the legal circulation of drugs; rational and safe use of drugs; safe self-medication; licensing of certain types of economic activity; problems associated with falsification of pharmaceuticals; circulation systems of prescription and over-the-counter drugs; control regime and organization of quality control of pharmaceuticals in pharmacies and health centers of all forms of ownership. It is proposed for introduction into the undergraduate and postgraduate forms of education of bachelors, masters, students of thematic improvement cycles (pharmacists, pharmacist assistants, masters of pharmacy, doctors, nurses), pharmacist-interns, master's students, postgraduates, employees of law enforcement, control, advocacy bodies and structures, whose activities are related to the circulation of drugs.
Needs to note that at the meeting of the 72 nd World Health Assembly held in May 2019, the WHO countries undertook to recognize patient safety as one of the priority tasks in the field of health care and to take all necessary measures to reduction of harm caused to patients in medical institutions. The World Health Assembly approved the establishment of World Patient Safety Day, which will be celebrated every year on September 4, 2019 (Decree of the President of Ukraine No. 648/2019 on the annual observance of "Patient Safety Day"). International conferences are held every year, in particular, on November 17-19, 2022, the XIX Multidisciplinary scientific and practical conference "Medical and pharmaceutical law of Ukraine: organization of pharmaceutical business, general, forensic and clinical pharmacy, pharmacotherapy of health disorders in the conditions of the coronavirus pandemic" will be held (Invitation, https://medinstytut.lviv.ua/invitation-to-the-xixmultidisciplinary-scientific-and-practical-conference/) [60]. The conference program includes three main directions: 1interdisciplinary relations of medical and pharmaceutical law in the field of health care and the pharmaceutical industry in the conditions of the COVID-19 pandemic; 2state control over circulation of pharmaceuticals of all clinical and pharmacological groups, nomenclature and legal groups and classification and legal groups, State Pharmacopoeia of Ukraine; 3evidence-based pharmacy and evidence-based medicine (Table 2).   clinical trials of pharmaceuticals) in accordance with ICD-11. Adverse drug reactions (registration and reregistration of drugs, vaccines, etc.). Addictive health disorders. Safe self-medication. The formulary system of Ukraine, the USA, Germany, Israel, etc. countries (state, regional and local formularies) and the international classification of primary medical care (ICPC-2) In the following, the experience of the teaching staff of the Department of Medical and Pharmaceutical Law, General and Clinical Pharmacy of the KhMAPE, Ukrainian Military Medical Academy and Kyiv Medical University regarding the educational process during the quarantine period caused by the acute respiratory disease COVID-19 due to the SARS-CoV-2 coronavirus were summarized. On the example of cycles of professional development of medicine and pharmacy specialists using distance learning technologies. It is noted that anti-epidemic measures are being taken at the KhMAPE in order to prevent the spread of acute respiratory disease COVID-19 in the educational process. The Department of Medical and Pharmaceutical Law, General and Clinical Pharmacy successfully conducts courses for doctors and pharmacists using distance learning technologies. The positive feedback from doctors and pharmacists about the organization of distance learning by the Department of Medical and Pharmaceutical Law, General and Clinical Pharmacy of the Khmapo Polytechnic University (95% of students were satisfied with the completed advanced training courses) is emphasized.
It should be noted that the day before (July 28, 2022), the Verkhovna Rada of Ukraine adopted the final version of the relevant project of the Law of Ukraine No. 5547 "On Medicinal Products" proposed by the Committee on National Health, Medical Care and Medical Insurance in the repeated second reading as a whole as law. The proposed new version of the Law of Ukraine "On Medicinal Products" defines [61][62][63][64][65]: -the law will come into force in 2.5 years from the date of adoption by the Parliament and how long it will take the Ukrainian Farm Industry to retool production in accordance with EU requirements, i.e., after the end of martial law (2D coding, which was planned to be introduced from January 1, 2028, will be introduced after 5 years after the end of martial law; -circulation conditions (creation, pharmaceutical development, preclinical research, clinical trials (research), state registration of pharmaceuticals; -circulation conditions (production, manufacture) in the conditions of pharmacy, appointment, use, import, wholesale and retail trade, distance trade, quality control, pharmacovigilance of drugs; -the rights and obligations of legal entities and individuals, as well as the powers of state authorities and officials in the relevant field; -creation of conditions for the development of the pharmaceutical industry, formation of a favorable investment climate, overcoming technical barriers in the international trade (circulation) of drugs.
However, the harmonization of the medical field and the pharmaceutical industry to the requirements of the EU Directives (laws) is based on the components of medical and pharmaceutical law, namely medical legislation, pharmaceutical legislation, forensic pharmacy, evidence-based medicine, evidence-based pharmacy, the drug control regime, quality control and the safety of drugs of all pharmaceuticals of all clinical and pharmacological groups, nomenclature and legal groups and classification and legal groups, which indicate the control regime in the system of overthe-counter and prescription drug circulation.
Thus, during the Covid-19 pandemic, modern trends contributed to the development of the science of pharmaceutical law, as a basis for optimizing the legislation of Ukraine (approval of the new version, corresponding to the project of the Law of Ukraine No. 5547, "On medicinal products"), the organization of pharmaceutical affairs in pharmacies and health centers, and thanks to modern research on the search for drug technology, it contributed to the creation of vital vaccines for the prevention of the SARS-CoV-2 coronavirus, as well as to the minimization of forensic pharmaceutical risks in the system of legal relations "doctor-patientpharmacist-lawyer".
Conclusions. Based on the analysis of the points of view of representatives of the theory of law, as well as scientists of pharmacy, we made a conclusion, namely: 1. Pharmaceutical law as a set of legal norms has the characteristics of a branch of law, namely, its subject, that is, social relations that arise during the implementation of pharmaceutical activity. As well as the method of legal regulation as methods, methods and means of legal regulation of social relations established by the norms of law related to the subject of pharmaceutical law. 2. The main ways of regulating relations in pharmaceutical law are permission, obligation, and prohibition. 3. The well-founded criteria for the existence of pharmaceutical law make it possible to move on to the consideration of other independent features -the existence of science, the field of legislation, issues of the complex sectoral nature of the field, as well as the relationship of pharmaceutical law with other tangential branches of law, primarily with medical, constitutional, administrative, and criminal law.
Conflict of interest. The authors declare that the study was conducted in the absence of any commercial or financial relationships that could be considered a potential conflict of interest.
Funding. This study was not funded by any public or private institutions.