Acts of the Constitutional Court
JUDGMENT OF THE CONSTITUTIONAL COURT OF THE REPUBLIC OF BELARUS
20 February 2004 № J-170/2004
On the conformity between the Constitution of the Republic of Belarus, Article 15 of the Law of the Republic of Belarus "On public health protection" and Provision on licensing of medical activities, as well as Provision on licensing of pharmaceutical activities approved by Resolution of the Council of Ministers of the Republic of Belarus of 20 October 2003 No. 1378

     The Constitutional Court of the Republic of Belarus in composition of the Presiding Officer- Chairman of the Constitutional Court G.A. Vasilevich, Deputy Chairman A.V. Maryskin, judges G.A. Vorobei, V.V. Podgrusha, A.A. Sarkisova, A.G. Tikovenko, R.I. Filipchik, G.B. Shishko, V. Z. Shuklin

with participation of representatives:

of the House of Representatives of the National Assembly of the Republic of Belarus - V.N. Lektorov, Head of Standing Committee of the House of Representatives of the National Assembly of the Republic of Belarus on public health protection, physical training, family and youth; N.N. Meshkova, Head of State law Division of the Main Expert and Legal Department of the Secretariat of the House of Representatives of the National Assembly of the Republic of Belarus;

Council of Ministers of the Republic of Belarus - A.S. Romanenkov, Deputy Minister of Health Protection of the Republic of Belarus;

has examined in open court session the case "On the conformity between the Constitution of the Republic of Belarus, Article 15 of the Law of the Republic of Belarus "On public health protection" and Provision on licensing of medical activities, as well as Provision on licensing of pharmaceutical activities approved by Resolution of the Council of Ministers of the Republic of Belarus of 20 October 2003 No. 1378".

     The court session was attended by:

V.N. Vyshkevich - Deputy Chairman of the Supreme Court of the Republic of Belarus; L.G. Kozyreva - Deputy Chairman of the Supreme Economic Court of the Republic of Belarus; V.Y. Kalugin - Deputy Minister of Justice of the Republic of Belarus.

     The proceedings have been brought by the Constitutional Court of 8 December 2003 as a result of the constitutional motion of the House of Representatives of the National Assembly of the Republic of Belarus on the grounds of Article 116 of the Constitution of the Republic of Belarus, Articles 5 and 6 of the Law "On the Constitutional Court of the Republic of Belarus" and Article 43 of the Rules of Procedure of the Constitutional Court.

     The House of Representatives of the National Assembly of the Republic of Belarus has made the constitutional motion on verification of the Provision on licensing of medical activities, as well as Provision on licensing of pharmaceutical activities approved by Resolution of the Council of Ministers of the Republic of Belarus of 20 October 2003 No. 1378 (National register of legal acts of the Republic of Belarus, 2003, No. 122, 5/13295), which shall envisage the procedure and conditions of issue of special permissions (licenses) for carrying out medical and pharmaceutical activities.

     The House of Representatives has specified, in particular, that point 9 of the Provision on licensing of medical activities envisages the presence of the first and the higher qualified category of the head of an organization or of the head of an organizational department, which will carry out medical activities, as well as the presence on the staff of the specified organization of the workers who also have the first or the higher category, shall be one of the obligatory conditions for obtaining the license by the legal entity. The similar in its essence requirements towards pharmaceutical workers are also stipulated in point 9 of the Provision on licensing of pharmaceutical activities.

     In the opinion of the House of Representatives additional (in comparison with the Law "On public health protection") requirements fixed in the specified Provisions as regards the level of training of medical personnel will entail closure of many of organizations of public health protection, especially those of primary level, where there is a small number of medical workers with the relevant categories. The House of Representatives shall consider that this is also referring in full to the chemist's organizations.

     According to Article 11 of the Law "On the Constitutional Court of the Republic of Belarus" the limits of solution of the issues put for the consideration of the Constitutional Court shall be determined by the Court. Therefore, based on the essence of the proposals made by the House of Representatives, the Constitutional Court has made verification of the constitutionality of the norms contained in point 9 of the Provision on licensing of medical activities, point 9 and 10 of the Provision on licensing of pharmaceutical activities.

     Having heard the judge-speaker V.V. Podgrusha, representatives as the parties, analyzed the relevant provisions of the Constitution of the Republic of Belarus, Law of the Republic of Belarus of 18 June 1993 "On public health protection" (in wording of Law of 11 January 2002), Decree of the President of the Republic of Belarus of 14 July 2003 No. 17 "On licensing of certain types of activities" (hereinafter Decree No. 17), norms of the provisions on licensing of medical and pharmaceutical activities, other enforceable enactments which are relevant to the issue under consideration, studied other materials of the case, the Constitutional Court found the following.

     Under Article 2 of the Constitution the individual, his rights, freedoms and guarantees for their attainment manifest the supreme goal and value of society and the State.

     Citizens of the Republic of Belarus shall be guaranteed the right to health care. The State shall make health care facilities accessible to all of it citizens (Article 45 of the Basic Law).

     In pursuance of the requirements of Article 13 of the Constitution the State shall regulate economic activities on behalf of the individual and society, shall ensure the direction and co-ordination of state and private economic activity for social purposes. The State shall grant equal rights to all to conduct economic and other activities, other than those prohibited by law, and guarantee equal protection and equal conditions for the development of all forms of ownership.

     According to Article 9 of the Law "On public health protection" public health protection in the Republic of Belarus shall be consisted of the State public health protection and private public health protection. Furthermore, as it is specified in this Law, the State public health protection shall be the basis of the system of public health protection of the Republic of Belarus.

     Article 12 of the Law "On public health protection" specifies that medical and pharmaceutical activities in the territory of the Republic of Belarus shall be carried out by the natural and legal entities only with the presence of the special permission (license).

     The license shall be a special permission for carrying out a type of activity with the obligatory observance of licensing requirements and conditions, issued by the relevant licensing body for the applicant for the license or for the license-holder, which shall confirm that an economic entity undertakes the obligations on ensuring the proper carrying out of the type of activity, which is subject to licensing.

     In the opinion of the Constitutional Court, the norm creating bodies by adopting the acts within their competence, including while regulating medical and pharmaceutical activities, shall have the right to specify the procedure and the conditions for their exercise, to set the limitations which should be in line with the criteria enshrined by the Constitution of the Republic of Belarus, namely: to be based on the law and to be taken only in behalf of national security, public order, protection of morals, health of population, rights and liberties of other persons.

     State regulation in the field of carrying out medical and pharmaceutical activities is conditioned by the necessity to secure life and health protection of citizens. For these purposes the enforceable enactments shall set higher requirements towards the subjects, which carry out those activities, as well as stipulate the obligation to license the specified activities.

     Decree No. 17 shall envisage that the right to carry out by legal and natural persons of certain types of activities, including medical and pharmaceutical activities, may be realized after obtaining under the prescribe procedure the special permissions (licenses). In accordance with sub-item 3.9 of point 3 of Decree No. 17 in case of discrepancy between the norms of the given Decree and other legislative acts regulating carrying out certain types of activities on the basis of special permissions (licenses), there shall be applied the norms of the Decree in question.

     In accordance with point 2 of the provision on licensing of certain types of activities approved by Decree No. 17 licensing requirements and conditions - the complex of the requirements and conditions set by the legislation on the applicants for the license while its issuing and on the license-holder while carrying out the activities which require the license.

     Point 5 of the specified Provision on licensing of certain types of activities stipulates that the Council of Ministers of the Republic of Belarus within its powers shall approve the provisions on licensing of the types of activities which, together with other requirements and conditions should contain the list of licensing requirements and conditions made on legal entities and individual entrepreneurs, as well as the peculiarities of issue of licenses for the certain type of the activities.

     Decree No. 17 has been examined by the House of Representatives and the Council of the Republic of the National Assembly of the Republic of Belarus on 9 and 17 October 2003 and has been taken into consideration without observations.

     In the fulfillment of Decree No. 17 the Council of Ministers of the Republic of Belarus in its Resolution of 20 October 2003 No. 1378 has approved the Provision on licensing of medical activities and the Provision on licensing of pharmaceutical activities.

     Point 9 of the Provision on licensing of medical activities shall envisage that the obligatory conditions for the applicant of license and the license-holder while carrying out medical activities (except for the works and services connected with production and turnover of medical technology and articles for medical purposes) shall be:

     for the legal entity: the presence of the higher medical education, special training, which meet the requirements and the nature of the works to be done and the services to be rendered, of the head of the organization or of the head of organizational department, which will carry out directly medical activities, as well as the presence of the first and the higher qualifying category; the presence on the staff of the given organization of the workers with higher and (or) secondary medical education, special training, which meet the requirements and the nature of the works to be done and the services to be rendered, and the first or the higher qualifying category (for the executive medical staff - the presence of the qualifying category) (sub-item 9.1 of point 9);

     for the individual entrepreneur and the medical workers engaged by them under the specified procedure - the higher and secondary medical education, special training which meet the requirements and the nature of the works to be done and the services to be rendered, and the first or the higher qualifying category (for the executive medical staff - the presence of the qualifying category) (sub-item 9.2 of point 9);

     taking subject improvement within the extent set by the legislation of the Republic of Belarus for the head in the field of medical activities and medical workers of the legal person, as well as for the individual entrepreneur and the medical workers engaged by him/her (sub-item 9.3 of point 9).

     Point 9 of the Provision on licensing of pharmaceutical activities shall envisage the presence of the higher pharmaceutical education, the first or the higher qualifying category of the head of the legal entity (head of organizational department, which carry out pharmaceutical activities) or the individual entrepreneur of the higher pharmaceutical education, the higher or the first qualifying category and profession improvement in accordance with the legislation as the obligatory obligation for obtaining the license to carry out pharmaceutical activities (except for the works and the services related to industrial production of medicine).

     According to point 10 of the Provision on licensing of pharmaceutical activities the applicant for the license should conclude the labour contracts or civil legal contracts with the workers (not less than two persons other than the head of the organizational department) who have special pharmaceutical education (higher or secondary), qualifying category and who had passed the professional improvement in accordance with the legislation.

     Part one of Article 15 of the Law "On public health protection" stipulates that the right to deal with medical and pharmaceutical activities shall have the persons, who was specially educated and reside in the Republic of Belarus. Access to medical and pharmaceutical activities as a physician or a pharmaceutical chemist shall require probation period and the certificate of the relevant profession beyond the special education, and in private health care - also the length of service in the type of activities under licensing of not less than three years.

     The Constitutional Court deems that the norms of part one of Article 15 of the Law "On public health protection" are not connected with the issues of licensing of medical and pharmaceutical activities as those related to the special regulation, but shall specify the conditions and requirements for securing the right of persons to deal with medical and pharmaceutical activities as a physician or a pharmaceutical chemist, and not as the heads of legal entities (heads of organizational departments) and individual entrepreneurs who shall organize carrying out licensing types of activities and bare complete liability for the proper medical or pharmaceutical service.

     Such a conclusion follows from the content of part two of Article 12 of the Law "On public health protection" under which the procedure and the conditions of issue of special permissions (licenses) for carrying out medical and pharmaceutical activities shall be regulated by the acts of legislation, point 5 of Provision on licensing of certain types of activities approved by Decree No. 17, as well as adopted on the basis thereof by the Council of Ministers of the Republic of Belarus of the Provisions on licensing of medical and pharmaceutical activities.

     Physicians and pharmaceutical chemists, under Article 41 of the Constitution, shall realize their right to work, i.e. the right to choose of one's profession, type of occupation and work in accordance with one's vocation, capabilities, education and vocational training, and having regard to social needs, by way of conclusion of labour, civil legal contracts with the relevant economic entities of both state and private forms of ownership, who should organize medical and pharmaceutical activities in accordance with the available state requirements and standards.

     An applicant for the licenses to carry out medical or pharmaceutical activities may be a legal entity or an individual entrepreneur (point 3 of Provision on licensing of medical activities, point 5 of Provision on licensing of pharmaceutical activities). It is the applicant with respect to whom there shall be made the requirements and conditions.

     Due to that the Constitutional Court emphasizes that the requirements specified in the Provisions on licensing of medical and pharmaceutical activities made on the professional level of the heads of organizations of public health protection (heads of organizational departments, individual entrepreneurs are not in conflict with Article 15 of the Law "On public health protection". The Constitutional Court is based here on the fact that the acts in question shall regulate different types of relations: the provisions on licensing - the relations connected with the possibility to carry out by the economic entities of licensing types of medical and pharmaceutical activities, the Law "On public health protection" - relations concerning realization by the citizens of the right to deal with medical and pharmaceutical activities as a physician or pharmaceutical chemist.

     At the same time, the Constitutional Court shall pay attention to different approaches of point 9 of Provision on licensing of medical activities as regards the requirements to the professional level of medical workers who are engaging by the economic entities. If paragraph three of sub-item 9.1 of point 9 which make the requirement to have on staff of the organization of the workers with the first or the higher qualifying category shall make no stipulation for the quantity of those workers (during the court session the representative of the Council of Ministers has expressed the opinion that it is sufficient to have one specialist with the required category under the licensing type of activities), then as regards the individual entrepreneur (sub-item 9.2 of point 9) all the workers engaged by them should have the first or the higher category (for the middle medical staff - qualifying category), even if it he/she will deal with carrying out one type of activities.

     The abovementioned shall signify about the necessity of specification of the content of the provisions on licensing of medical and pharmaceutical activities for the purposes of securing their simple understanding and application in practice. Moreover, the Constitutional Court, proceeding from the constitutional principle of creation of equal conditions for the development of all forms of ownership, deems it necessary to revise the norm of part one of Article 15 of the Law "On public health protection" which specify the restriction to work in private health protection for the doctors and pharmaceutical chemists who have the length of service in the licensing type of activities of less than three years.

     The Constitutional Court finds it worthy of attention the arguments of the House of Representatives as regards making additional requirements on the level of professional training of the heads of organizations (heads of organizational departments) of both the state and the private forms of ownership, as well as individual entrepreneurs will entail for the majority of them the termination (suspension) of the activities owing to the absence of the required qualifying categories.

     Due to that the Constitutional Court emphasizes that in the state public health protection, as of 1 January 2004 - 23,2 per cent of heads of organizations and 38,7 per cent of heads of organizational departments, 42,1 per cent of pharmaceutical chemists - heads of organizations (heads of organizational departments) have no first or higher qualifying category. According to the data of Mr. V.N. Lektorov, the representative of the House of Representatives, only in Vitebsk region, as of 13 November 2003, head physicians of 40 local district hospitals, 13 city and region hospitals, five local region medical associations had no first or higher qualifying category. In addition, three local district hospitals have the status of a legal entity.

     As to the non-governmental organizations of public health protection, according to the data presented, now, medical activities are carrying out by 1,228 legal entities and individual entrepreneurs, where there are 3,060 physicians and among them with higher category - 352 physicians, with the first category - 659 physicians, and that is about 33 per cent. At the same time, the Constitutional Court pays attention to the fact that the absolute majority of specialists engaged in private public health protection have the long length of service: medical occupational life of 9 years and more shall have 2,407 of physicians, from 6 to 8 years - 427 physicians.

     Pharmaceutical activities are carrying out by 1,052 specialists with the higher pharmaceutical education who are working in composition of 416 of legal entities and individual entrepreneurs. From among them the individual entrepreneurs, heads of legal entities and organizational departments with the length of service from 6 to 8 years - 114 persons, with the length of service of 9 years and more - 570 persons.

     The Constitutional Court emphasizes that before the introduction of new requirements made on the applicants for the licenses and license-holders for carrying out medical or pharmaceutical activities, it has been effective the Provision on the procedure of issue for the economic entities (legal persons and entrepreneurs without creation of a legal entity) of special permissions (licenses) for carrying out the types of activities, which are under the authority of the Ministry of Public Health approved by Order of the Ministry of Public Health of the Republic of Belarus of 15 January 1998 No. 15, according to which the issue of licenses for medical practice, for wholesale and retail trade of the medicines and herbs (sub-items 2.3.2 and 2.5 of point 2) has been exercised within the lower extent of the requirements and conditions made on the applicants of licenses (license-holders).

     In accordance with previously effective legislation obtaining by the economic entity of the license for carrying out medical or pharmaceutical activities has not been depended on the presence or absence of the first or the higher qualifying category of the head of the organization (head of organizational department), of individual entrepreneur, as well as of the workers they engaged. Moreover, according to point 5 of the Provision on the procedure of awarding of qualifying categories for medical and pharmaceutical workers approved by Resolution of the Ministry of Public Health of the Republic of Belarus of 1 July 2002 No. 45, awarding of the qualifying category has been made on the initiative and in accordance with the wish of the person who a working in the system of public health protection of the Republic of Belarus, and was one of the conditions for increasing the wages of the workers who have the qualifying categories. Point 36 of the Provision in question shall also specify that for the awarding of the second qualifying category it is necessary to have the length of service in the specialized field of three years, for the first and the higher qualifying category six and nine years.

     Based on the stated above, acknowledging the right of the Council of Ministers of the Republic of Belarus under part five of Article 13 of the Constitution to make the requirements on professional training of medical and pharmaceutical workers while obtaining by them of the licenses for the achievement of the main goal - upgrading the medical care and pharmaceutical services rendered for the population both in state and in private public health protection, the Constitutional Court considers, that by restricting of already acquired rights, it is necessary, in particular, to take into account the principles of fairness, proportionality, maximum regard for private and public interests. Such an approach shall promote the formation of the trust of the citizens in the state. The most important principle of legal regulation of relations in the state ruled by law, as the Republic of Belarus is proclaimed, shall be predictability and reasonable stability of the normative regulation, grounded on combination of the interests of the state and the citizens, as well as the economic entities.

     Therefore, the Constitutional Court deems it lawful to make additional requirements on the new persons who wish to obtain the licenses for carrying out medical or pharmaceutical activities by way of creation of the legal person or working as an individual entrepreneur.

     As for the economic entities of state and private form of ownership who has obtained the licenses for carrying out medical or pharmaceutical activities on the basis of previously effective legislation, the Constitutional Court considers, that for elimination from liquidation (suspension of activities) of the economic entities under the reasons which they had no possibility to foreknow at the moment of their creation, for the heads of the organizations of public health protection, for other persons specified in point 9 of the Provision on licensing of medical activities and points 9, 10 of the Provision on licensing of pharmaceutical activities there should be given the possibility to take part in attestation for the obtaining of the relevant category taking into account their length of service and other worthy of attention circumstances within the time period sufficient for the solution of the specified issues after the adoption of the present Judgment.

     Based on the abovementioned and guided by parts one, four and seven of Article 116 of the Constitution of the Republic of Belarus, Articles 5, 6, 9, 34, 38, 40 and 43 of the Law "On the Constitutional Court of the Republic of Belarus", the Constitutional Court

RULED:

1. To find to be in conformity with the Constitution of the Republic of Belarus and the Law of the Republic of Belarus "On public health protection" the norms of point 9 of the Provision on licensing of medical activities and points 9 and 10 of the Provision on licensing of pharmaceutical activities approved by Resolution of the Council of Ministers of the Republic of Belarus of 20 October 2003 No. 1378.

2. For the Council of Ministers of the Republic of Belarus and for the Ministry of Public Health with a view of elimination from liquidation (suspension of activities) of the economic entities which were involved in carrying out medical or pharmaceutical activities on the grounds if the licenses issued in accordance with the previously effective legislation, for the heads of those organizations of public health protection (for the heads of organizational departments), for the individual entrepreneurs, for the medical staff they engaged to ensure taking part in attestation for obtaining by them of the relevant category taking into account the length of their service, as well as other worthy of attention circumstances within the time period after the adoption of the present Judgment which is sufficient for the solution of the given issues.

As regards the specified persons the authorized state bodies shall be entitled to mitigate the requirements stipulated by the Provision on the procedure of awarding of qualifying categories for the medical and pharmaceutical workers approved by Resolution of the Ministry of Public Health of the Republic of Belarus of 1 July 2002 No. 45 in part of awarding of qualifying categories out of the established sequence, taking into account the length of the service, level of professional training and other circumstances, including also the fact of creation by them of economic entities which had carry out medical or pharmaceutical activities on the basis of the licences issued previously by the state bodies.

3. To publish the present Judgment within the period of time specified by the legislation in newspapers "Zvyazda", "Nationalnaya gazeta", National register of legal acts of the Republic of Belarus, as well as in "Bulletin of the Constitutional Court of the Republic of Belarus".

4. The present Judgment shall come into legal force from the date of its proclamation, is final and subject to no appeal or protest.

Presiding Officer —

Chairman of the Constitutional Court

of the Republic of Belarus                                                                                               G.A. Vasilevich