Implementation of changes to the Public Health Service Law

Belarus: On December 27, 2014, the Law on “Amendments to the Law on the Public Health Service of the Republic of Belarus” came into effect.

 The new Law introduces a definition of “biomedical cell product (BCP)” to mean a transfer material obtained from human cells, excluding certain cells. The law creates rules on state registration of BCPs, their import, export, realization, medical application, return to the producer or supplier, elimination, and state control of production.

State registration of BCPs is established under Regulation No. 1120 of the Council of Ministers adopted on November 28, 2014 “On state registration of BCPs” in Belarus. In accordance with this document, a certificate of first registration in Belarus of a BCP of national or foreign production will be issued for five years and on later re-registration for an unlimited term. As to registration of BCPs produced by an enterprise or structural subdivision located in different states, a certificate of registration is issued in each of these states. And in the case of several kinds and types of BCPs only a certificate of registration with a list of necessary kinds and types of BCPs will be issued.

A supplement to the Regulation lists BCPs which cannot be registered.

The Law establishes official state lists of medicinal drugs and medical products. Medical preparations and medical products on the official state list form the basis for drawing up and developing annual plans for procurement of medicinal drugs and medical products plus methods of medical treatment.

The Law also extends the list of cases in which breach of medical secrecy is possible. In particular, supply of information comprising medical secrecy without the patient’s consent is allowed at the request of administrative bodies while dealing with emergency situations of natural and human causes, terrorism and civil unrest. A request must be in writing or as an e-document with a digital signature.

The Law enables doctors to refuse to perform an abortion for personal reasons. But it imposes additional duties on the chief of the health institution to organize delivery of this service by another specialist.

Source: National legal Internet portal of the Republic of Belarus (NLIP) 25.06.2014 2/2162

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