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LETTER OF THE MINISTRY OF HEALTH OF THE REPUBLIC OF BELARUS

of April 26, 2013 No. 03-3-11/823/459

"About carrying out clinical testing"

(as of September, 2013)

To chiefs of managements of health care of regional executive committees

To the chairman of Healthcare Committee of Mingorispolkom

To heads of the organizations subordinated to the Ministry of Health of the Republic of Belarus (according to the list)

Due to the arriving requests concerning carrying out clinical testing of medicines, products of medical prescription and medical equipment the Ministry of Health of the Republic of Belarus explains the following.

Concerning contractual legal relations when carrying out clinical testing

For the purpose of exception of violations of requirements of the civil legislation to perform the conclusion of the contract for carrying out clinical testing of medicines of national (foreign) production only after approval of all interested and approvals in the Ministry of Health of the program (protocol) of clinical testing, and also the draft agreement prepared in accordance with the established procedure including according to the approximate form of the agreement established by the order of the Ministry of Health of the Republic of Belarus of April 28, 2012 No. 467 "About some questions of carrying out clinical testing" in the Ministry of Health.

Exclude cases of the conclusion of contracts for carrying out clinical testing between researchers (physical persons) and customers of researches which contain additional terms of carrying out clinical testing, including additional payment of work of researchers.

Considering importance of question of carrying out clinical testing in the Republic of Belarus the Ministry of Health (in coordination with Council of Ministers of the Republic of Belarus) informs on possibility of use below the reflected approaches on the organization of carrying out clinical testing:

1. in the organizations of system of the Ministry of Health accredited in accordance with the established procedure as the scientific organizations:

1.1. by means of creation of temporary research teams (further - VNK);

1.2. by means of forming of groups of researchers and registration with them the civil relations;

1.3. within the employment contracts signed between the employer and participants of group of researchers;

2. in the organizations of health care of system of the Ministry of Health:

2.1. by means of forming of groups of researchers and registration with them the civil relations;

2.2. within the employment contracts signed between the employer and participants of group of researchers.

Concerning creation of VNK

Creation and activities of VNK is performed according to the Regulations on procedure for creation and on conditions of activities of VNK approved by the Presidential decree of the Republic of Belarus of June 26, 2009 No. 349 "About measures for enhancement of procedure for creation and conditions of activities of temporary research teams".

At the same time work on the signed contract between clinical base and the customer of research shall pass the examination according to the Regulations on procedure for conducting examination of research, developmental and experienced and technological works approved by the resolution of Council of Ministers of the Republic of Belarus of September 30, 2006 No. 1283 "About measures for implementation of the Presidential decree of the Republic of Belarus of May 25, 2006 No. 356" and to be registered in GU "Belarusian Institute of Systems Analysis and Information Support of the Scientific and Technical Sphere" as research, developmental and (or) technological.

Concerning registration of the civil relations

According to the Presidential decree of the Republic of Belarus of June 6, 2005 No. 314 "About some measures for protection of the rights of the citizens performing work on civil and employment contracts" (further - the Decree No. 314) citizens can perform work on civil agreements taking into account the conditions established by this Decree.

After the conclusion clinical agreement base on carrying out clinical testing with the customer (further - the basic agreement) for the organization of work on carrying out clinical testing the head of clinical base the order creates according to the legislation of the Republic of Belarus the working groups of number of persons employed of clinical base and the involved employees (from their consent) with determination of the head of working group (the chief researcher). In such order also the regulations on operating procedure of this working group, including with determination of specific obligations of members of this group according to adopted agenda of clinical testing and the basic agreement shall be approved.

From among determined by the called order the head of clinical base shall sign civil agreements with each worker according to the procedure, established by the Civil code of the Republic of Belarus and the Decree No. 314, on carrying out specific works within execution of obligations by clinical base on the basic agreement. At the same time the civil agreement including shall contain:

subject of the agreement;

the rights and the worker's obligations (taking into account determined by the above-named order);

the size and payment procedure under the agreement.

Concerning compensation (remuneration) of employees of clinical base

Compensation (remuneration) of the workers who are carrying out clinical testing by means of creation of VNK, groups of researchers and registration with them the civil relations can constitute no more than 40% of cash amount arriving the organizations for carrying out clinical testing.

Concerning forming of cost on carrying out clinical testing of medicines, products of medical prescription and medical equipment

For the purpose of increase in export of services and the organization of identical approaches when forming cost for carrying out clinical testing of medicines, products of medical prescription and medical equipment it is necessary to be guided by the Methodical recommendations about forming of rates for carrying out clinical testing of medicines, products of medical prescription and medical equipment (further - Methodical recommendations) approved by the Minister of Health of the Republic of Belarus V.I.Zharko 21.01.2011.

Concerning control of terms of accomplishment of clinical testing

To producers of medicines to send information on all delays with approval of contracts for accomplishment of clinical testing in the state organizations of health care to the deputy minister of health care Lositsky Igor Gennadevich.

At the same time we inform on inadmissibility of delay in case of the conclusion of the contract between clinical base and the research organization. The term of preparation of the draft agreement with calculation of cost of carrying out clinical testing and all list of documents in the organization which is clinical base shall not exceed 10 days from the moment of the appeal of the research organization.

Besides, the notes according to the draft agreement noted by the Ministry of Health by consideration to clinical base shall be corrected by contractors within 1 working day.

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