Medical And Pharmaceutical Law: Deepening the Cooperation Between the LMI, KhMAPE* and Estonian Scientific Publishing House SSP OÜ, as Part of the System of Ukraine's Integration into the European Community

Deepening cooperation between the LMI, KhMAPE and the Estonian scientific publishing house SSP OÜ will be part of the system of Ukraine's integration into the European Community by building pharmaceutical companies for the production of domestic drugs. Integration of pharmaceutical production can take into account the problems and risks that arose during the creation of the common economic zone "Yavoriv" on the basis of state guarantees.


Introduction.
Optimizing the level of cooperation between Ukraine, Estonia, and other European Union (EU) countries in the pharmaceutical production of medicines is an important element of the country's future EU membership, which requires the candidate countries to comply with the fundamental principles enshrined in the Washington Treaty on Democracy and Freedom human [1]: • rule of law and protection of human and civil rights; • development of international cooperation in the field of improving and strengthening democratic institutions, rights, freedoms and maintaining stability; • support for peace, good neighborly relations, and conflict resolution at the diplomatic level; • introduction of the European model of control over the domestic armed forces.
• Therefore, we believe that it is necessary to study the experience related to the reform of the pharmacy business in Estonia (started in 2015; completed in April 2020) [2]. The essence of the reform lies in two main aspects: • Pharmacy service providers should be separated from pharmaceutical manufacturers and distributors (vertical integration ban); • The ownership of pharmacies should be transferred only to professional pharmacists.
Experts believed that these conditions guarantee the quality of pharmacy services and increase free competition between pharmacies. The reform is based on the fact that without the influence of wholesale networks, pharmacists are free for professional development and free from the commercial interests of pharmaceutical companies. Although increased competition is one of the goals of the reform, the Office of Competition mentioned possible obstacles to free competition as a result of the reform.
Therefore, the main questions that still need to be answered remain, namely: • Are pharmacists interested in owning and managing a business with all the additional responsibilities and potential responsibilities other than their professional responsibilities (forensic risks)? • Are pharmacists willing to take on the financial risks and economic obligations of an independent company? The interest of pharmacists in purchasing existing pharmacies was really not very great. Professional pharmacists were surprised by the assumption that if they did not own pharmacies, their level of service would be lower, more efficient, and professional, or not in the interests of patients in the doctor-patient-pharmacist / pharmacist chain.
According to the State Medicines Agency, currently about 68% of Estonian pharmacies do not meet the new requirements for the Law on Medicinal Products. Most pharmacies in Estonia are owned by four large networks of wholesale pharmaceutical companies.
After the reform, 469 pharmacies remained in Estonia [3], of which 25 pharmacies were closed, but five were later reopened. At the same time, three new pharmacies appeared in places where they did not exist before; three of them are closed due to repair work. That is, the total number of existing pharmacies is 474. The study of the experience of leading EU countries can be useful for the integration of the pharmaceutical business of Ukraine in the global pharmaceutical market.
The purpose of the study was to study the possibility of deepening cooperation between LMI, KhMAPE and the Estonian scientific publishing house SSP OÜ, as part of the system of Ukraine's integration into the European Community on the principles of medical and pharmaceutical law, organization and economics of pharmacy, drug technology and forensic pharmacy in order to optimize legal relationship between the "doctorpatientpharmacistadvocate".
Materials and methods. Information and analytical basis of the study were scientific papers on the topic of the work. It should be noted that the review of scientific sources of literature was conducted taking into account the recommendations of the Cochrane Society for PICO. The research methods used are normative and legal, documentary, retrospective, comparative, systemic, tabular, forensic, and pharmaceutical and graphic. Microsoft Excel 2010 (descriptive characteristics: minimum and maximum value, average value) was used to process the results and determine the consistency between the studied parameters.
The study of the article is a fragment of research work of LLC "Lviv Medical Institute" on "Improving the circulation of drugs in pharmacotherapy on the basis of evidence and judicial pharmacy, organization, technology, biopharmacy and pharmaceutical law" (state registration number 0120U105348, deadline 2021-2026); Kharkiv Medical Academy of Postgraduate Education on "Improving the organizational and legal procedure for providing patients with drugs from the standpoint of forensic pharmacy, organization and management of pharmacy" (state registration number 0116U003137, deadline 2016-2020) and "Pharmaceutical and Medical Law: integrated approaches to systems of drug circulation from the standpoint of forensic pharmacy and organization of pharmaceutical business "(state registration number 0121U000031, deadline 2021-2026).
Results and discussion. A study of the experience of reforms in the pharmaceutical industry in Estonia, which is part of the EU, showed that there are three levels of circulation of drugs [3]: • 1 st level of drug circulationcirculation of drugs in the system of legal relations "drug manufacturer-distributor of drugs"; • 2 nd level of drug circulationdrug circulation in the system of legal relations "distributor of drugs-pharmacy-health care institution"; • tightening restrictions on the import of drugs produced in Russia and Belarus to Ukraine; • the right of the Ministry of Health of Ukraine to refuse to register drugs, if at least one of its components or stage of production (circulation) was carried out at plants in these two countries; • the right of the Ministry of Health of Ukraine to refuse to register a drug if it is established that the applicant or his representative is directly or indirectly related to economic entities that are directly or indirectly involved in the production of drugs in the aggressor state (Russia or the Republic of Belarus). The established norm allows international pharmaceutical companies to refuse to register drugs even if the drugs are manufactured in other countries; • permission to cancel the state registration of drugs, if the applicant or his representative is associated with Russian pharmaceutical companies; • the right of the Cabinet of Ministers of Ukraine for the period of martial law in Ukraine to temporarily suspend the export of drugs in case of failure to meet the needs of the health care sector of Ukraine in such drugs in full.
In our opinion, it is the leadership of Ukraine that should offer and guarantee favorable conditions for the construction of 15 modern pharmaceutical plants (enterprises) with appropriate infrastructure (houses, shops, schools, kindergartens, etc.) in the regions of Ukraine (Kyiv, Lviv, Vinnytsia, Ivano-Frankivsk, Ternopil, Rivne). To achieve this goal, to involve under state guarantees the 15 largest pharmaceutical companies in the world in 2021 (USA, UK, Switzerland, Japan, France, Denmark) [4], as well as KRKA (Slovenia), Menarini (Italy), Servier (France), Acino Pharma, Novartis, GSK, Sanofi, Takeda, Dr. Reddy`s, Abbott, SUN, AstraZeneca, Novo Nordisk, Hetero.
Good Manufacturing Practice (GMP) standards require special attention to risk assessment and verification procedures [8], and it is important to identify the validation measures needed to demonstrate critical aspects of the control of specific operations. Significant changes to installations, equipment and processes that may affect the quality of pharmaceutical products must be confirmed. A risk assessment procedure should be used to determine the scope and degree of validation.
The master validation plan serves to ensure that all equipment, procedures that may affect the quality, integrity or performance of the product have been validated; it contains the general principles to be followed during the validation task and the action plans to be implemented to that end.
On ; ❖ conducting organizational, legal, and preparatory work in LMI on the opening of the department "Training of specialists in medicine and pharmacy in medical and pharmaceutical law, technology and safety of drugs, organization and economics of pharmacy, forensic, clinical pharmacy, biopharmacy and quality control, specialization (internships) pharmacists-interns ". Also, the peculiarities of specialization for pharmacists-interns who are graduates of higher education institutions in the specialties "Pharmacy" and "Industrial Pharmacy", regardless of the form of studybudget/contract) on the basis of internships [15]; ❖ strengthening the work of the teaching staff of the LMI on R&D. State registration number: 0120U105348. Open R&D, registration date: 09-12-2020 "Improvement of the drug circulation system during pharmacotherapy on the basis of evidence and judicial pharmacy, organization, technology, biopharmacy and pharmaceutical law" (https://medinstytut.lviv.ua/wpcontent/uploads/pdf/Dovidka-pro-zatverdzhennya-temy-LMI.pdf  [35][36][37][38][39]. During the exchange of views between prof. Viktoriia Shapovalova and prof. Valerii Shapovalov noted that Ukraine produces about 30 percent of vital drugs that are in circulation on the shelves of pharmacies and municipal non-profit enterpriseshealth care institutions and proposed the INITIATIVE (previously, for 2 years and 6 months, prof. Valerii Shapovalov tries to bring attention of the General Director of the Lviv Medical Institute (LMI), Doctor of Medical Sciences, Associate Professor Ihor Hayduchok) about the need to find sites and on its basis the construction of three modern pharmaceutical companies in Lviv (together with EU countries -Poland, Germany, Slovakia, the Czech Republic, Estonia, Denmark, etc., as well as the United States, Canada, Great Britain), which in the future could employ graduates not only LMI, but also Lviv National Medical University named after Danylo Halytsky (Rector, Academician of the National Academy of Medical Sciences of Ukraine, Ph.D., Prof. Zimenkovsky B.), which would produce not only original drugs, but also in-bulk, generics, combined drugs for all categories of citizens (patients) [40][41][42][43][44][45][46] of Ukraine (disabled I and II groups, participants in hostilities, liquid initiators of the Chernobyl accident, patients with cardiovascular disease, circulatory system, tuberculosis, type 1 and 2 diabetes, cancer patients, HIV/AIDS, Covid-19, SARS, orphan diseases, drug addiction, etc.), i.e. in accordance with the Resolution of the Cabinet of Ministers of Ukraine of August 17, 1998 No. 1303 "On streamlining free and preferential dispensing of medicines on prescription in the case of outpatient treatment of certain groups and certain categories of diseases" (https://zakon.rada.gov.ua/laws/show/1303-98-%D0%BF#Text).
Construction of modern pharmaceutical enterprises in Lviv could take place (for example) within the special economic zone and "Truskavets Resort" and "Yavoriv" (SEZ "Yavoriv") / for the period up to 1.01.2020 within the administrative and territorial boundaries of Yavoriv district of Lviv oblast, except for the territories of the military range and military units), which was established in accordance with the Law of Ukraine (On the Yavoriv Special Economic Zone, https://zakon.rada.gov.ua/laws/show/402-14#Text/).
It should be noted that SEZ "Yavoriv" was created to attract investment to: create new jobs and ensure employment of employees of Yavoriv State Mining and Chemical Enterprise "Sulfur". A special legal regime of economic activity established by the Law of Ukraine "On General Principles of Establishment and Functioning of Special (Free) Economic Zones" (Vidomosti Verkhovnoi Rady Ukrainy (VVR), 1992, No. 50, p. 676) is established and operates on the territory of SEZ Yavoriv (https://zakon.rada.gov.ua/laws/show/2673-12#Text) taking into account the features established by this Law.
Unfortunately, investments in Special Economic Zones in Lviv Region were significantly declining every year. Foreign investor expects to restore tax and other benefits in special zones (Stadnyk G., Kanevsky D. Special economic zones of Lviv region are of less and less interest to investors // DW, 23.03.2011 (https://www.dw.com/uk/a-14939477, https://p.dw.com/p/10gRJ).
Thus, the deepening of cooperation between LMI, KhMAPO and the Estonian scientific publishing house SSP OÜ, as part of the system of Ukraine's integration into the European Community should take into account the problems that arose during the establishment of SEZ "Yavoriv" and under state guarantees The Council of Ukraine of the relevant laws, and at the level of the Lviv Regional State Administration -the adoption of the necessary regulations of regional content on the basis of medical and pharmaceutical law.
Conclusions. The possibility of deepening cooperation between LMI, KhMAPO and the Estonian scientific publishing house SSP OÜ as part of the system of Ukraine's integration into the European Community on the principles of medical and pharmaceutical law, organization and economics of pharmacy, drug technology and forensic pharmacy to optimize the system of patient-doctor relations pharmacistlawyer ". According to the results of the study, the urgency of creating favorable conditions for state guarantees for the construction of 15 modern domestic pharmaceutical plants in Ukraine together with the world's leading pharmaceutical manufacturers has been proved.