of June 8, 2009 No. P-334/2009
About compliance of the Constitution of the Republic of Belarus of the Law of the Republic of Belarus "About modification and amendments in some laws of the Republic of Belarus concerning drug circulation"
Having heard the judge-speaker to Sergeyev O. G., having analysed provisions of the Constitution of the Republic of Belarus (further - the Constitution), the Civil code of the Republic of Belarus (further - the Civil code), the laws of the Republic of Belarus "About modification and amendments in some laws of the Republic of Belarus concerning drug circulation", "About medicines", "About health care", other regulatory legal acts of the Republic of Belarus, the Constitutional Court of the Republic of Belarus established:
The law of the Republic of Belarus "And amendments in some laws of the Republic of Belarus concerning drug circulation" (further - the Law) is adopted about modification by the House of Representatives of National assembly of the Republic of Belarus on May 15, 2009, approved by Council of the Republic of National assembly of the Republic of Belarus on May 29, 2009 and provided to the President of the Republic of Belarus for the signature.
The law structurally consists of four Articles. Article 1 of the Law makes changes to article 39 of the Law "About Health Care", by Article 2 changes and amendments in a row of articles of the Law "About Medicines". Besides, the Law "About Medicines" is supplemented with several new Articles regulating questions of the State pharmacopeia of the Republic of Belarus, quality and medical application of medicines. Article 3 of the Law contains regulation of poruchenchesky nature, and Article 4 determines date of the introduction of the Law in force.
By introduction of amendments and amendments to the Law "About Medicines":
quality requirements of medicines and to their medical application are established;
the procedure for state registration (re-registration) for medicines, their import, export and realization, including after the termination of effective period of the registration certificate is specified;
new are given and the operating determinations of some terms are specified. At the same time regulations of the above-named Decree of the President of the Republic of Belarus of July 14, 2003 No. 17 regarding establishment of the subjects having the right to special permission (license) for implementation of separate types of activity are considered.
The law consequences of recognition of medicines low-quality change. In the new edition article 22 of the Law "About Medicines" is provided that such medicines after retirement can be not only are destroyed, but also returned to the producer or the supplier. Changes of similar nature are made also to article 39 of the Law "About Health Care".
In case of the solution of question of constitutionality of the Law the Constitutional Court proceeds from the following.
Article 1 of the Constitution provides that the Republic of Belarus as the constitutional state has supremacy and completeness of the power in the territory, independently performs domestic and foreign policy. From this the right of the legislator to determine legal regulation of the public relations proceeding from interests of citizens, the organizations and the state follows.
According to article 21 of the Constitution providing the rights and freedoms of citizens of the Republic of Belarus is the prime target of the state; the state guarantees the rights and freedoms of citizens of Belarus enshrined in the Constitution and the laws.
In the Republic of Belarus the principle of supremacy of law (part one of article 7 of the Constitution) is established. With respect thereto, according to the Constitutional Court, legal regulation of the public relations shall be exact, clear, complete and approved.
According to article 45 of the Constitution the right to health protection is guaranteed to citizens of the Republic of Belarus. The constitutional court considers that establishment and refining in the Law of quality requirements and to procedure for drug circulation, rules of their state registration (re-registration) - one of the measures undertaken by the state on ensuring the specified constitutional right.
Streamlining of legal regulation of drug circulation is also expression of execution by the state of the obligation enshrined in article 59 of the Constitution to take all available measures for creation of the internal procedure necessary for complete implementation of the rights and freedoms of citizens of the Republic of Belarus.
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