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Pashkov V.M.


Med. pravo., 2015; 2(16): 52-62

UDC: 347.1


doctor of juridical sciences, associate professor, head of the Department of civil, commercial and ecological law of the Poltava Law Institute of the National University “Yaroslav the Wise Law Academy of Ukraine”, leading staff scientist of the Scientific Research Institute of Legal Provision of Innovation Development of the National Academy of Legal Sciences of Ukraine.

Public and legal means of medical and pharmaceutical activity self-regulation

In this article the issues of provision of the self-regulatory organizations’ and/or self-governing organizations’ activity in the sphere of health care are researched. Historical aspects of founding such organizations as well as experience of other countries including Russian Federation are elucidated. Concrete steps concerning the development of medical and pharmaceutical self-regulation are suggested. Possible risks, which may arise in case of a slowdown of the processes, connected with the development of such institutes of civil society, are analyzed.

 Formulation of the problem. The dynamics of processes, which are taking place in national economy as well as signs of state’s inability to effectively regulate the economy in general and the sphere of health care in particular, quite often become an impulse for the development of the civil society institutes such as self-regulation and professional self-government.   

These are the self-regulatory organizations (hereinafter – SRO) and/ or professional self-governing (PSO), professional associations, which sole interest is neither connected with gaining profits nor winning a state power, rather it is directed at joint solution of branch and professional problems. And in the context of health care sphere it is the protection of not only the professional interests of medical and pharmaceutical professionals but also the protection of patients by way of establishing rules of professional behavior and supervision over the observance of these rules.

Analysis of the recent research results and publications. In general, important theoretical issues of providing a state’s regulatory influence on commercial activity take an important place in scientific works of scholar researching commercial law such as: O.M. Vinnyk, D.V. Zadyhailo, O.R. Zel’dina, V.K. Mamutova, O.P. Podcerkovnyi, V.A. and/or professional self-governing institutes were researched at foremost in scientific works of A.F. Cherdancev, Y.A. Tyhomyrova etc. On the current stage in the context of socio-economic development the issues connected with the development of the self-regulatory and professional self-governing organizations were elucidated in research works of V.V. Suslova, V.V. Dolyns’ka, D.O. Grachov etc.

But the abovementioned scholars, who researched these issues left aside their attention the peculiarities connected with the establishment of such organizations in particular those in the health care sphere.   

Setting the goals. The aim of this article is to elucidate the essence of the activity of self-regulatory and professional self-governing organizations in the health care sphere and to research the peculiarities of commercial-law regulation of self-regulation in order to protect both the rights of medical and pharmaceutical professionals as well as patients’ rights.

Presentation of the main part of the research. Self-regulation has a long history within the European continent. In ancient Rome in particular in the Law of the Twelve Tables it was mentioned about the ability to create private boards and to adopt any charter, in case such charter did not violate the state law. Currently the SROs are existing in EU-member states and encompass different spheres of economy and social life. At the same time the criteria for the identification of the legal regime of self-regulation in EU-member states differ one from another. 

Modern self-regulation entails establishment of strict rules for the market participants, including sanctions for violations of these rules and mechanisms of solving conflicts between the market participants. All this to certain amount limits the freedom of economic agents – participants of the SRO. But on the other hand – the rules of carrying out the activity and the resolution of conflicts and disputes is conducted by the market participants themselves without direct interference of the authorities or under their supervision.

The unique character of the SRO is on the one hand that such organizations actually take over the functions of state regulation. On the other hand, their activity does not contradict the rules, established by the state. On the modern stage of the economy’s development self-regulation appears to be the most perfect model of relations between the producers of goods and services and the consumers.  

Also certain interest arises in terms of procedure of providing access to the specialty, which in our opinion, among other things, foresees individual responsibility of a professional, in particular a physician (medical professional) or a pharmacist (pharmaceutical professional) before the patient and the society. And, today, it is known that the health care facility is responsible before the patient and role of the professional is minimized. In this respect a professional, that is, a medical or pharmaceutical worker is not interested and motivated to observe appropriate standards, rules and ethical codes and as a result the patient suffers.    

Conclusions. In the sphere of health care it is suggested to self-regulate not the whole branch but its separate part – professional activity of medical and pharmaceutical professionals by way of creating PSO. To do this it is suggested to foresee in the laws the ability of the Ministry of Health to delegate some of its functions, which are connected with professional activity, for self-regulation conducted by a single professional and pharmaceutical organization. These functions may include: providing access to professional activity, issues of ethics and deontology, increasing the qualification of physicians, adoption of clinical protocols and methodic recommendations, protection and insurance of professionals, evaluation of the medical care quality and pharmaceutical services provision, carrying out independent medical and pharmaceutical examination, participation in solving professional conflicts etc. 

Hence, not denying the necessity of existence of the SRO and PSO, it is worth noting that these institutes are not state bodies, therefore the powers of conducting constant control over the observance by members of these organizations the rules, standards and requirements; imposing sanctions and applying measures of influence on their members, who violate the requirements of current laws; supporting the state authorities in supervising the market of medical services and provision of pharmaceutical services shall be done by the central bodies of state executive power. In its turn the PSOs must represent the interests of members of such PSOs. In other words PSOs shall not be a part of the state bodies’ structure. On the contrary they should be their opponents by protecting the subjects, who are under their control.   

Consequently, it is worth establishing a unitary professional organization, which is founded on the basis of joint efforts of regional organizations.

             Key words: self-regulatory organizations, professional self-governing organizations, civil society institutes, state regulation and self-regulation.

Reference list

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