On July 05, 2012, the Verkhovna Rada of Ukraine adopted the Law "On amending certain laws of Ukraine as regards enhancing liability for drugs counterfeiting or circulation of counterfeit drugs".

This law set out Article 44-2 in new edition of the Code of Ukraine on Administrative Offenses, which provides that violation in the course of professional activity of the restrictions imposed on the personnel of medical and pharmaceutical institutions (pharmacies) and their heads will entail liability in the form of the fine in the amount of three hundred of tax-free minimum income of citizens.

In case of such repeated violation during one year from the date of imposition of the administrative penalty, the personnel will have to pay a fine in the amount of one thousand tax-free minimum incomes of citizens.

It should be noted that before Article 44-2 had provided for small amounts of fines as the administrative responsibility for drugs counterfeiting. And now, irrespective of the amounts or other qualifying features the offense of drugs counterfeiting is completely criminalised.

The Law also set out new wording of article 321-1 of the Criminal Code of Ukraine. According to such changes, drugs manufacturing, acquisition, transportation, transfer, storage for sales purposes or sale is punishable by 3 to 5 years of imprisonment with confiscation of raw materials and equipment for drugs manufacturing.

The same repeated actions or actions a result of collusion of persons, or in large amounts of money, or resulting in prolonged impairment of health of any person, and drugs manufacturing are punishable by 5 to 8 years of imprisonment with confiscation of property and raw materials and equipment for drugs manufacturing.

Actions described in the first and the second parts of said Article, resulting in person's death or other serious consequences, or actions in large amounts of money are punishable by 8 to 10 years of imprisonment or life imprisonment with confiscation of property and raw materials and equipment for drugs manufacturing.

Any person who has voluntarily surrendered drugs and indicated their source of acquisition or who helped to disclose crimes in connection with drugs circulation will be exempted from criminal liability for manufacturing, acquisition, transportation, transfer or storage for sales purposes or drugs sale, import to and export from or transit through the territory of Ukraine (part one of said  article, if such actions have not resulted in threat to health and life of people).
Upon analysis of the abovementioned changes, it should be noted that newly-established sanctions (3 to 10 years of imprisonment with confiscation of production) are stricter as compared to the current ones.

The established punishment is not in accord with the governmental policy being implemented in the field of economy of criminal repression and non-custodial sentences.

It would be feasible to provide the alternative punishment for crimes, provided for in Article 321-1 of the Criminal Code of Ukraine, for the absence of such alternatives is considered by us as negative.   

The Law has also supplemented the Criminal Code of Ukraine with a new Article 321-2, according to which wilful violation of the determined procedure for preclinical studies, clinical trials, state registration of drugs and counterfeiting drugs is punishable by  3 to 5 years of imprisonment with deprivation of the right to occupy certain positions or practice certain activities for 1 to 3 years.

The same repeated actions or actions as a result of collusion of persons are punishable by 5 to 8 years of imprisonment with deprivation of the right to occupy certain positions or practice certain activities for up to 3 years.

Actions provided for in the first and the second part of said article resulting in death of victim or other serious consequences are punishable by 8 to 10 years of imprisonment with deprivation of the right to occupy certain positions or practice certain activities for 3 years.

It should be noted that, due to absence of dangerous nature of the act, the changes made to Article 321-2 of the Criminal Code of Ukraine seem to be impracticable. It is likely to be relegated to administrative violations. In support of such conclusion it should be noted that not any, even wilful, violation of the established procedure for preclinical studies, clinical trials and drugs registration is dangerous to society and indicates of the drugs counterfeiting and of impossibility to carry out further state registration of drugs and to permit their use. For example, if the authorised person did not sign or date any of the documents in the framework of clinical trial, such failure is considered to be a violation of the respective order, but will it be rational to bring the guilty person to the criminal liability, or even to impose a 3 to 5 years imprisonment on him and deprive him of the right to occupy certain positions or to practice certain activities for 1 to 3 years? Certainly, not.

The action may be recognised a criminal offense if, for example, it was committed for mercenary purposes, led to certain negative consequences or posed a threat to life and health of people. Taking the abovementioned into consideration, it is obvious that the criminalisation of the action mentioned in part 1 of Article 321-2 of the Criminal Code of Ukraine is a controversial decision of the legislator, but it is already the law and we must abide by it.

Secondly, consideration should be given to definitions of sanctions in the article.

Setting the sanction in the form of certain period of imprisonment with deprivation of the right to hold certain posts or practice certain activities for certain period of time without allowing any alternative to this sanction is obviously impracticable.

Besides, it should be mentioned that dispositions of Article 321-2 of the Criminal Code of Ukraine are blanket, i.e. referring to the established procedure for  preclinical studies, clinical trials and state registration of drugs. In their turn, such procedures are set by legislative regulations:

  •    Clinical trials: Order of the Ministry of Health of Ukraine # 690 dated 23/09/2009 "On approval of drugs clinical trials procedure and materials expertise of clinical trials and Standard regulation on ethics commission";
  •    State registration of drugs:  Regulation of the Cabinet of Ministers of Ukraine # 376 dated 25/05/2005 "On approval of the Procedure of state registration (re-registration) of drugs the amount of fees for their state registration (re-registration)".

Blanket dispositions of the norms of Article 321-2 of the Criminal Code of Ukraine refer to the normative legal acts rather than to legislative acts, that is why the stability of legal regulation is not provided since there is an obvious probability of multiple changes of the acts affecting an issue of bringing a person to criminal responsibility. Consequently, there is a high probability of violating the principle of "Nullum crimen sine lege".

It would be practicable to have the blanket norms referring to the legislative act the order of making changes to which is stipulated by the constitutional procedure. However, legislatior, for some reason, has not taken it into account.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.