Med. pravo., 2017; 1(19): 47-54
Doctor of legal sciences, associate professor, head of the Department of civil, commercial and ecological law of the Poltava Law Institute of National University «Yaroslav the Wise Law Academy of Ukraine»
Permission type of legal regulation in the sphere of health care
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).
When applying the term “licensing” only to the activity of medical drugs circulation and taking into account the requirements of the Ukrainian laws on medical drugs circulation, we can enlist the following types of regulation: general-permission type – dealing with the general permission to perform the activities, which are not prohibited by the law, for example the permission to sell medical drugs without receipts through the general trade chamber; permission type, which deals with a general prohibition, which enables the commercial subjects to perform only those actions, which are foreseen by the law, for example to sell only registered medical drugs in Ukraine and only when a certificate of quality is present.
Meanwhile, theoretical problems of research of the regulatory state influence on economic activity attracted the attention of many scientists. They were studied in particular by: A. Vinnyk, D. Zadyhaylo, O. Zeldin, V. Mamutov, V. Ustymenko, V. Shcherbyna. Problems of 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 to develop the nature of this type of permission 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.
In the majority of the developed counties all medical professions are regulated by law, i.e. every physician shall confirm his qualification, receive, medical license for conducting professional activity. Licensing of professional activity of medical and pharmaceutical professionals shall be also viewed in the context of the activity of self-governing organizations, bearing in mind non conducting of commercial activity but rather receiving the right to professional activity as a permission type of legal regulation.
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. For sure this statement is important only in the context of obtaining the right to perform certain operations by certain subjects of commercial activity. At the same time we do not speak about performing certain actions or utilizing the rights, which are not directly connected with the application of the Law of Ukraine “On licensing of types of commercial activity”. Hence we can define the following features of the general tools of legal regulation of medical drugs circulation: a) positive obligation – subjects of commercial activity, which conduct the circulation of medical drugs are obliged to perform their activity actively, that is register medical drugs, obtain special permission (license) to perform a certain type of activity, observing the rules of standardization and certification, which are aimed at securing the quality of medical drugs; b) permission system – subjects of commercial activity are entitled to perform certain activities actively after receiving special permission (license) within this permission, that is the actions which are connected with manufacturing, importing and wholesale or retail selling of medical drugs; c) system of supervision and prohibition – subjects of commercial activity are obliged to abstain from performing actions under the control of state control bodies of control over the circulation of medical drugs.
Licensing in the sphere of health care as a permission type of legal regulation shall be considered in the context:
- Law of Ukraine “On licensing of types of commercial activity, according to which the following types of commercial activity are licensed: 1) manufacturing of medical drugs, retail and wholesale of medical drugs, importing of medical drugs (except for active pharmaceutical ingredients) – with taking into account, foreseen by the Law of Ukraine “On medical drugs”; 2) medical practice;
- Necessity to obtain a trade license for medical drugs for their following placement of the pharmaceutical market of Ukraine;
- Licensing of professional activity of medical and pharmaceutical professionals in order to obtain the right to conduct professional activity.
Key words: permission in the sphere of health care, licensing in the sphere of health care, license for the profession, trade license for medical drug
1. S.Alekseev. (1981) General Theory of Law. In 2 vols I. M . Jurid. lit. p. 360.
2. N. Saniahmetov. (2001) State Regulation of Economy and Business. N.Saniahmetova. Pidpryemnitstvo, Gospodarstwo I Pravo.7.
3. The draft of a law on specific of implementation of certain provisions of EU legislation on medical drugs. Parliament of Ukraine, the official web portal. Retrieved from:http://w1.c1.rada.gov.ua/pls/zweb2/webproc4_1?id=&pf3511=58784
4. The Ministry of Health of Ukraine intends to introduce individual licenses for doctors. Interfaks. Ukraine. Agency. Retrieved from:http://ua.interfax.com.ua/news/general/381576.html
5. Legal Dictionary Directory. Ed. Y.Shemshuchenko, 1996. 696 p.
6. V.Pashkov. (2004) The legal regulation of drugs. K. Morion,160 p.
7. Licensing in the European Union. The pharmaceutical sector. Ed. VA Usenko, A.Spasokukotsky. K . MORION Ltd., 1998. 381 p.
8. Directive 2001.83. EU of the European Parliament and of the Council. K. Morion, 2013. 120 p.