Deshko L, Bysaga Y, Vasylchenko O, Nechyporuk A, Pifko O, Berch V
1Taras Shevchenko National University of Kyiv; Ukraine.
2Uzhhorod National University, Ukraine.
Georgian Med News. 2020 Oct(307):180-184.
The issue of technology transfer to the production of medicines, cession of ownership rights to registration certificates and transfer of the production of medicines in the context of modern challenges to international and national security are investigated in the article. The attention is focused on ensuring the public interest in health care. Emphasis is placed on the human right to effective, safe, high-quality medicines, on ensuring the right to entrepreneurial activity in the field of circulation of medicines. The purpose of this article is to identify areas of international cooperation in the field of technology transfer to the production of medicines and new approaches to the application of legal rules governing legal relations by Ukrainian Courts in the field of circulation of medicines related to the cession of ownership of registration certificates for medicines and transferring the production of medicines from one country to another. The object of the study is the public relations that arise during the transfer of technology to the production of medicines and public relations in the field of circulation of medicines, associated with the cession of ownership of registration certificates for medicines and the transfer of production from one country to another. The methodological basis of the research are general and special methods of scientific knowledge (formal-logical method, comparative-legal, structural-logical). As a result of the conducted research, the directions of international cooperation of states in the field of technology transfer to the production of medicines are defined. The idea of the existing in domestic legal science of a special kind of public interest, that is national security, has been improved. It is argued that it is specified not only by the support of the national manufacturer, but also by the central executive body, taking up measures to withdraw from circulation of drugs within one country, that have been manufactured in another country or on the territories not controlled by the Government, motivated by inability to ensure proper quality control of medicines. It is emphasized that decision-making on the issue of re-registration of medicinal products does not provide for the right of the subject of power to act at its own discretion. New approaches to the application of legal norms by the courts of Ukraine governing legal relations in the field of circulation of medicinal products related to the cession of ownership of registration certificates for medicinal products and the transfer of production from one country to another have been revealed.
本文探讨了在国际和国家安全面临现代挑战的背景下,药品生产技术转让、药品注册证书所有权转让以及药品生产转移等问题。重点关注保障公众在医疗保健方面的利益。强调了人们获得有效、安全、高质量药品的人权,以及保障药品流通领域创业活动的权利。本文的目的是确定药品生产技术转让领域的国际合作领域,以及乌克兰法院在药品流通领域适用法律规则以处理与药品注册证书所有权转让和药品生产从一国转移到另一国相关法律关系的新方法。研究对象是药品生产技术转让过程中产生的公共关系以及药品流通领域中与药品注册证书所有权转让和生产从一国转移到另一国相关的公共关系。研究的方法论基础是科学知识的一般和特殊方法(形式逻辑方法、比较法、结构逻辑方法)。研究结果明确了各国在药品生产技术转让领域的国际合作方向。国内法学中关于一种特殊公共利益即国家安全的理念得到了完善。有人认为,这不仅通过支持国内制造商来体现,还通过中央行政机构采取措施,将在另一国家或政府无法控制的领土上生产的、因无法确保适当药品质量控制而生产的药品撤出一国的流通领域来体现。强调药品再注册问题的决策并不赋予权力主体自行其是的权利。揭示了乌克兰法院在适用法律规范处理药品流通领域与药品注册证书所有权转让和生产从一国转移到另一国相关法律关系方面的新方法。