Permission Type of Legal Regulation in the Sphere of Health Care (Дозвільний тип правового регулювання у сфері охорони здоров'я)
Journal Title: Медичне право - Year 2017, Vol 1, Issue 1
Abstract
Considering the types of regulation, which some lawyers are focused on, the major attention should be paid for licensing type, which is based on the total ban. The legislation of Ukraine permissive type of regulation is usually associated with licensing. As a result, for example, some legal scholars, even the Central Scientific Experts Office of the Verkhovna Rada consider such permissive type of regulation only in the light of the Law «On licensing of economic activity». This approach we see in the conclusion of the draft of Law «On peculiarities of implementation of certain provisions of EU legislation on medical drugs» (reg. #4465 dated 18.04.2016). Meanwhile, theoretical problems of research of the regulatory state influence on economic activity attracted the attention of many scientists. They studied in particular: A. Vinnyk, D. Zadyhaylo, O. Zeldin, V. Mamutov, V. Ustymenko, V. Shcherbyna. Problems for medical and pharmaceutical activity highlighted in publications by Z. Gladun, R. Maidanyk, I. Senyuta. However, this application features such as licensing regulation to allow the implementation of actions permitted in some standards, particularly in the health sector, are ignored by scientists. The purpose of this article is figuring out the nature of this type of permit regulation in the health sector as licensing in the broad understanding. In this case, firstly, it discusses the unification of licensing procedures in order to continue further the implementation of EU legislation in the field of public health. These days, however, the concept of the term «license» in most cases, lawyers associate with the norms of the Law of Ukraine «On licensing of economic activity». Now, in actual use we have such thing as a «trade license for the medicinal product». Some experts believe the term above is equal to «certification of drugs» and their registration. Although, there is another point of view exists the state registration of medicines in Ukraine grants the right of use and sale on the territory of Ukraine only. In the EU trade license, except these two concepts, includes permission to import of medicinal product and, therefore, gives permission for use in all EU countries. Licensing of professional medical and pharmaceutical workers should also be considered in the context of self-regulatory and/or self-governing organizations. It is rather all about entitlement to professional activities, such as getting a permit for work, than economic activities. Licensing in the health sector as a permission-type regulation must be seen in context of the Law of Ukraine «On licensing of economic activity» in health care, according to which, subject to licensing are next types of economic activity: 1) the production of drugs, wholesale and retail trade in drugs, importing drugs (except active pharmaceutical ingredients) – with the specifications defined by the Law of Ukraine «On medicines»; 2) medical practice; the need to obtain marketing authorization for medicinal products for their subsequent placement on the pharmaceutical market of Ukraine; professional licensing of medical and pharmaceutical professionals to obtain the right to professional activities.
Authors and Affiliations
Vitalii Pashkov
Keywords
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- EP ID EP429218
- DOI 10.25040/medicallaw2017.01.047
- Views 73
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