Supplementary protection of intellectual property rights for medicines

The article discusses the issue of extending the legal protection of intellectual property rights for medicines. The research aims to provide a comprehensive overview of the problems related to the implementation of Supplementary Protection Certificates (SPCs) in national legislation and possible solutions. The study also seeks to draw conclusions and make proposals for improving the regulatory framework for the SPCs of medicines. The work utilizes general scientific and specialized methods of scientific cognition, including dialectical, formal-logical, systemic-structural, comparative legal, as well as modeling, analysis, and synthesis methods, which collectively contributed to the organization, planning, and conduct of the research. The study is based on scientific publications from databases and search systems (PubMed, JAMA, Scopus, Springer, BMC, Oxford Academic), international and national regulatory acts, statistical studies by international organizations (Precedence Research), patents for inventions related to medicines, recommendations by national government bodies, as well as prescriptions and guidelines from international and national experts. Considering the analysis of statistical data on the development and implementation of medicines, it has been determined that original biological medicines are a major factor in the rising prices of treating conditions such as diabetes, oncological diseases, and others. Examples of patents for medicines owned by global pharmaceutical companies (Gilead, Bayer Intellectual Property Gmbh, etc.) that have ensured their commercial success and competitive advantages are examined. It has been established that patent protection provides the right holder with the opportunity to maintain a monopoly in the market, thereby compensating for the time spent on the development and research of original medicinal products. Legislative approaches to regulating relationships concerning the supplementary protection of inventions related to medicines in the form of SPCs in Ukraine and the EU are identified. The exclusivity periods for regulatory data protection for medicines in the EU are outlined. Based on the conducted research, it is concluded that the application of the SPC mechanism is a tool to achieve a balance between the protection of intellectual property rights and access to original medicines. Timely entry of generics and biosimilars to the market contributes to reducing market prices but negatively impacts the profitability of manufacturers of original medicines. Attention is drawn to problematic aspects of the legislative implementation of the SPC mechanism in Ukraine, which leads to incorrect interpretation and implementation of relevant provisions and necessitates updating. In light of the aforementioned, there is an urgent need in Ukraine to implement, update, and improve the legislative mechanism for regulating SPCs

Protection from unfair competition on the pharmaceutical market in the conditions of the COVID-19 pandemic

The article reveals the problems and prospects of combating dishonest advertising of medicinal products in the conditions of the COVID-19 pandemic. Using the example of the USA and Ukraine, the criteria for banning the advertising of medicinal products by researching scientific sources, international and domestic legal acts, prescriptions and instructions of state bodies, etc. were analyzed. The differences and specifics of the regulatory requirements for the advertising of medicinal products in Ukraine and the USA have been determined. It has been established that in the USA it is allowed to advertise prescription drugs, and in Ukraine a ban has been introduced to advertise "antiviral drugs of direct action". Attention was drawn to the qualification of the division of advertising slogans in the USA, which made it possible to draw an analogy with Ukrainian advertising of medicinal products. It has been proven that individual pharmaceutical manu­facturers, by providing advertisers with incomplete information about the drug, can mislead consumers about its effecti­veness. The Antimonopoly Committee of Ukraine has demonstrated cases of countering the spread of false information about the properties of medicinal products, which became more frequent in connection with the emergence of the strain (SARS-CoV-2) in 2019. The advantages and disadvantages of a complete ban on medicines on television and radio, as well as other mass media are indicated in connection with the entry into force of the decision of the National Security and Defense Council of Ukraine "On the state of the national health care system and urgent measures to ensure the protection of citizens of Ukraine with medical assistance" dated July 30, 2021. As an alternative to the complete rejection of drug advertising it is proposed, the introduction of the mechanism of "corrective advertising", which is actively used in the USA and consists in correcting or making amendments to already published drug advertising and eliminating statements that mislead consumers, contain incomplete, inaccurate, false information about the medicinal product