Serialization as new quality control system of medicinal products.

OBJECTIVE: Introduction: medicinal products are special goods which the quality of life and health of the population directly depends on. Therefore, ensuring the quality of medicinal products is central to state policy of developed countries in the conditions of free movement of goods and services. High quality of medicinal products should be supported in the context of pharmaceutical market globalization by using exclusively a modern quality control system such as serialization. The aim: the rationale for the need to use the serialization system of medicinal products by European countries which are not a part of the EU is the goal of our research. PATIENTS AND METHODS: Materials and methods: the research is based on EU law (Directive 2001/83/EC, Directive 2011/62/EU, Delegated Regulation (EU) 2016/161), Ukrainian legislation, statistics of WHO, General Prosecutor's Office, European Union Intellectual Property Office, Court judgment of the Ukrainian courts, legal doctrine in the field of medical law. The research is also based on general and special scientific research methods. CONCLUSION: Conclusions: existing quality control mechanisms do not cope with the task of providing the people with access to high quality and safe medicinal products. The serialization of medicinal products provides an opportunity to raise the quality control of medicinal products to a new level in the process of globalization. Serialization of medicinal products is important for Ukraine and other country's not in EU, it will fill the internal pharmaceutical market with a qualitative product and will allow the export of medicinal products.

Screening and periodical medical examinations as important part of public health: problem of the legal implementation.

OBJECTIVE: Introduction: Public health is an important concept, which is continually being globalized and integrated into today's society. It helps to improve and prolong the quality of life of people and prevent the spread of epidemics and serious incurable diseases. The components of public health include protection, prevention, and promotion. Prevention, the measures taken to prevent disease as opposed to treatment consist of screening and periodical medical examinations. There are two types of screening- universal screening and case finding (individual screening). Universal screening and periodical medical examination are identical concepts; the terms dispensary and individual screening (case finding) have similar meanings and can be used interchangeably. These concepts and their importance are analyzed in this research. The aim: A research on the legal regulation of periodic health examinations and screening as a two systems, which provides the implementation of prevention within the public health. Analysis of foreign experience such countries as: Great Britain, USA, Austria, Germany, Australia, France, Italy and others. PATIENTS AND METHODS: Materials and methods: The research based on: Ukrainian legislation, European Union's Law Acts, decisions of the ECHR, EU's member-states law, WHO Acts and Recommendations, scientific articles. The research is also based on general scientific and special research methods (such as dialectical, comparative, analytic, synthetic). RESULTS: Review: In Europe (except Germany and Austria) is happening the transition from the system of mandatory periodical medical examination to new screening system. However, despite this, periodical medical examinations of Europeans held in connection with exist system health insurance (both voluntary and mandatory). CONCLUSION: Conclusions: Screening and periodical medical examinations are two of the most important aspects of public health as they help to diagnose diseases at an early stage, even before showing any symptoms. Screening and periodical medical examinations ensures the safety and health of the entire population as opposed to certain individuals and therefore be mandatory procedure in today's society.

Reproductive function: the protection of the rights of the people which are sent to the area of the fighting.

OBJECTIVE: Introduction: The issues of problems of the legal regulation of posthumous reproduction in Ukraine and foreign countries are analysis in the article. The author substantiates the necessity in the creation and acceptance of the State Program of the retrieval of reproductive cells in people who are sending to the area of the fighting. The aim:the purpose of our work is a comprehensive study of post-mortem (post-mortem) reproduction and substantiation of the possibility and necessity of adopting a state program for the selection of reproductive cells of individuals who are sent to a combat zone to ensure their full social protection and assistance in the realization of the right to fatherhood or motherhood. PATIENTS AND METHODS: Materials and methods: the experience of certain countries is analyzed in the research. Additionally, we used statistical data of international organizations, conclusions of experts and foreign legal acts dealing with posthumous reproduction and auxiliary reproductive technologies, judicial practice, doctrinal ideas and views on this issue. RESULTS: Review: there are medical (practical) preconditions for the introduction of posthumous reproduction programs. Among them is the technology of obtaining reproductive cells (post-mortem too), their preservation and successful subsequent use. In addition, foreign experience shows the success of the application of these technologies and the real guarantee of full implementation of the range of rights to the family, fatherhood or maternity. CONCLUSION: Conclusions: we note the urgent need to develop and adopt a state reproductive cell selection program for individuals who are sent to the combat zones (according to a model that exists in such countries as the USA and Israel).

Protecting the rights of producers original medicines.

INTRODUCTION: the article analyzes the state of protection of intellectual property rights of original medicine producers, its accordance with international standards. Attention is focused on the importance of exclusivity of medicine market. AIM: the analysis of protection of intellectual property rights of medicine producers in Ukraine and determination of its conformity or non-conformity to the international standards. MATERIAL AND METHODS: the experience of certain countries is analyzed in the research. Additionally, we used statistical data of international organizations, conclusions of experts. RESULTS: there are numerous cases of state registration of generic medicinal products using the registration information of original medicinal products and delict of the rights of patent holders. CONCLUSIONS: an effective mechanism of judicial protection of the original medicine producers` intellectual property rights from disorders that affect the profit was elaborated in Ukraine.

Principle of serviceability and gratuitousness in transplantation?

INTRODUCTION: the issue of commercialization of transplantation analyses in the article. Attention is paid to the importance of transplantation as a method of treatment and saving human lives. AIM: the clarify the feasibility of the introduction of donation commercialization as an avenue to solve the shortage of donor organs and means of combating with black organ market and finding alternative avenues solving these problems, which are more morally acceptable for society is the aim of this article. MATERIALS AND METHODS: the experience of foreign countries has been analyses in the research. Additionally, we used data from international organizations, conclusions scientists and report of Global Financial Integrity in the research. RESULTS: it is impossible to solve most problems by means of paid donation. CONCLUSIONS: therapeutic organ and tissue cloning based on genetic technology is the best way out and solving ethical transplantation problems.

Principle of serviceability and gratuitousness in transplantation?

INTRODUCTION: the issue of commercialization of transplantation analyses in the article. Attention is paid to the importance of transplantation as a method of treatment and saving human lives. AIM: the clarify the feasibility of the introduction of donation commercialization as an avenue to solve the shortage of donor organs and means of combating with black organ market and finding alternative avenues solving these problems, which are more morally acceptable for society is the aim of this article. MATERIALS AND METHODS: the experience of foreign countries has been analyses in the research. Additionally, we used data from international organizations, conclusions scientists and report of Global Financial Integrity in the research. RESULTS: it is impossible to solve most problems by means of paid donation. CONCLUSIONS: therapeutic organ and tissue cloning based on genetic technology is the best way out and solving ethical transplantation problems.