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Association of Clinical Trials Organizations (ACTO)
non-commercial organization of the companies/ legal entities and clinical research community engaged in clinical trials in Russia.

Home Page  >  Regulatory Documents: Russian  >  FEDERAL LAW of November 21, 2012, No. 323-FZ On Public Health Protection in the Russian Federation adopted by the State Duma on November 1, 2011 and approved by the Federation Council on November 9, 2011. (excerpts)


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Adopted by the State Duma

on November 1, 2011

 

Approved by the Federation Council

on November 9, 2011

 

FEDERAL LAW of November 21, 2011, No. 323-FZ
On Public Health Protection in the Russian Federation

(excerpts)

 

Article 74. Limitations imposed on medical and pharmaceutical workers in their professional activities

1. Medical workers and heads of medical institutions may not:

1) accept from organizations engaging in the development, manufacturing and/or marketing of medications and medical products; organizations authorized to use trade names of medicines; wholesale businesses dealing in medicines, pharmacies (their representatives, other individuals or corporations acting on behalf of these organizations) (hereafter, accordingly company or company representative) gifts, money (except compensations paid under agreements on clinical trials of medicines and medical products, teaching and or research activity), including money to cover expenses on entertainment, vacations, travel expenses to vacation spots, or participate in entertainment events held at the expense of companies or company representatives;
2) sign with the company or company representative agreements on prescribing or recommending medicines or medical products to patients (except agreements on clinical trials of medicines or medical products);
3) receive from a company or company representative samples of medicines or medical products in order to hand them over to patients (except when conducting clinical trials of medicines or medical products);
4) provide to patient unreliable and/or incomplete information about medicines or medical products used in treatment, or conceal information about market availability of similar medicines or medical products;
5) receive Company Representatives, except for the cases related to clinical trials of medicines or medical products and participation in medical staff meetings and other events aimed at their performance improvement or at presenting information on monitoring medicine safety or medical product safety, all according to the procedure stipulated by the administration of the medical organization;
6) prescribe medicines or medical products using blank forms featuring advertisement or prescription forms with pre-printed name of a medicine or medical product.

2. Pharmaceutical workers and heads of pharmacies may not:

1) accept gifts, money, including covering expenses on entertainment, vacations, travel expenses to vacation spots, or participate in entertainment events held at the expense of companies or company representatives;
2) receive from a company or a company representative samples of medicines or medical products for handing them over to general public;
3) sign with a company or a company representative an agreement for offering certain medicines or medical products to general public;
4) provide to general public unreliable and/or incomplete information about availability of medicines, including medicines having the same international nonproprietary name, or medical products, as well as conceal information about availability of medicines or medical products at a lower price.

3. For violations of provisions of this article, medical and pharmaceutical workers, heads of pharmacies, as well as companies and company representatives shall bear responsibility pursuant to Russian legislation.

Article 75. Settlement of the conflict of interests during conduction of medical and pharmaceutical activities

1. Conflict of interests is a situation when a medical or a pharmaceutical worker during his or her professional activities has a personal interest in getting personally or via a company representative a financial or any other benefit which affects or may affect proper execution of professional duties resulting from contradictions between personal interest of a medical or pharmaceutical worker and interests of the patient.
2. In case of a conflict, a medical or pharmaceutical worker must notify thereof in writing the head of medical organization of pharmacy, and a sole proprietor carrying out medical or pharmaceutical activities should inform a duly Federal executive body authorized by the Government of the Russian Federation about such conflict.
3. Head of medical organization or head of pharmacy shall notify a duly Federal executive body authorized by the Government of the Russian Federation in writing about such conflict of interests within seven days of such knowledge becoming available to him or her.
4. In order to settle the conflict of interests, the duly Federal executive body authorized by the Government of the Russian Federation shall form a commission on settling the conflict of interests.
5. Regulation governing the commission on settling the conflict of interests shall be approved by a duly authorized federal executive body. The commission on settling the conflict of interests shall be formed so as to preclude any conflict of interest which could affect decisions made by the above commission.



 
   
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