On July 04, 2012 the Verkhovna Rada of Ukraine has adopted the law "On amending basic legislation of Ukraine in the domain of health care as regards restrictions in the professional activities of the heads and personnel of medical and pharmaceutical institutions (pharmacies)" # 10560 (hereinafter referred to as the Law).
The text of the adopted Law has not been made public yet. However, we may rely (yet with some reservations about possible editorial changes) on the text prepared for the second reading, since, in accordance with the Congressional Record of the Verkhovna Rada of Ukraine, it was discussed for 3 minutes only and no changes were made to it.
First of all, it should be noted that the second version of the Law has been greatly improved in terms of rule-making techniques, however, some discrepancies still continue to exist.
In accordance with the accepted version of the Law it is proposed to introduce restrictions on the medical and pharmaceutical personnel, without singling out the heads and personnel of medical institutions individually.
As compared to the first version of the Draft Law, the adopted Law has significantly edited the provisions providing that medical and pharmaceutical personnel has limited opportunities to receive remuneration from pharmaceutical companies and distributors. The adopted version of the Law rejected the concept of a complete ban on the receipt by such categories of persons of the remuneration and it is proposed now to exclusively prohibit them to receive unlawful benefit. The new rule is neutral and generally does not change the market situation since the ban on obtaining illegal benefits has already been introduced by the Law of Ukraine "On the principles of preventing and combating corruption." Herewith, such concern will definitely encourage medical and pharmaceutical personnel to be more careful.
The situation regarding prohibition against provision of product samples has been somewhat improved. The legislator refused from the conception of complete ban on receiving samples, determining that the medical and pharmaceutical personnel do not have any right to receive from the producers and distributors of drugs and medical substances the samples of drugs and medical substances for use in their professional activity (except as related to the conduct in accordance with agreements of clinical trials of drugs or clinical trials of medical substances). That is, doctors and pharmacists may obtain drug samples, provided that such samples will not be used by doctors in their professional activities (in particular, be transferred to patients transferred and be used for treatment purposes). In addition, it should be remembered that the legislation contains no clear definition of "sample product" and, moreover, "a drug sample". Taking the abovementioned into consideration, application of such provision should be officially interpreted.
In fact, no changes were made to the provisions of the first version of the Draft Law prohibiting promotion by doctors of drugs and medical substances. They have been changed insignificantly. Thus, in accordance with the adopted version of the Draft Law, doctors and pharmacists will be banned from promoting drugs and medical substances as well as from prescribing drugs in the blank forms containing advertisements and mentioning drugs manufacturers (trademarks). Accordingly, upon entry into force of such provision, any doctors' attempts to give booklets, leaflets, information materials, advice on a specific drug, etc. to patients may be regarded as a violation of this restriction.
To our mind, this rule is controversial, inconsistent with the norms of other laws, and may cause some problems in the course of its application. It should be separately noted that the term "advertise" has not been defined itself by the current legislation, therefore, one should refer to the definition of the term "advertisement" to understand this provision.
In particular, according to paragraph 10 of Article 1 of the Law of Ukraine "On Advertising", advertisement is an information about a person or product, distributed in any form or by any means, and intended to form or maintain awareness of consumers of advertisement and their interest in respect of such person or product. According to paragraph 17 of this article, the consumers of advertisement t are the general public for whom the advertisement is intended. Thus, advertisement is definite information intended for the general public. Taking the abovementioned into consideration, the information provided by a doctor during the individual visit of a patient, may not be considered as an advertisement.
Herewith, before the establishment of practice of application of the disputed norm and given the general repressive nature and ideology of the rules, doctors bear the risk of liability in the form of a fine under the Law of Ukraine "On amending certain laws of Ukraine as regards enhancing liability for drugs counterfeiting or circulation of counterfeit drugs" which provides for the presentation of a new version of Article 442 of the Code of Ukraine on Administrative Offenses.
The new version of the Article provides that personnel of medical and pharmaceutical institutions (pharmacies) and their heads will pay a fine in the amount of three hundred tax-free minimum incomes of citizens (5100 UAH.) - for an offense committed for the first time, and one thousand two hundred tax-free minimum incomes of citizens (20400 UAH.) - for the offense which was committed more than once. The abovementioned Law was adopted by the Verkhovna Rada of Ukraine on July 05, 2012.
The adopted version of the Law differs significantly from the first version of the Draft Law in regard of the norms providing for prohibition against incomplete information on cheaper analogues of certain drugs. According to the adopted version of the Law, the liability for failure to provide full information about drugs with the same active chemical agent will be placed exclusively on pharmacists. Moreover, liability of pharmaceutical personnel will arise only if such information was not provided at the request of the consumer.
The Law will enter into force on August 1, 2012 upon signature thereof by the President of Ukraine.
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