Should pharmacists stop advertising until “advertising status” is defined?

Lately pharmaceutical market is overfilled with legislative initiatives in the field of drugs advertising in Ukraine. In 2012 a few bills appeared which were either intended to make regulations of medicinal drugs stricter or to prohibit such advertising at all. And if one adds innovations related to liability of medical and pharmaceutical employees regarding all sorts of advertising of medicines manufacturers (it can be either use of stationery with trademarks or demonstration of products samples of a particular manufacturer), it becomes clear that the state is intended to take this market sector under its control.

The situation is “heated” by some mass media and internet resources which give categorical evaluations of amendments which however are not true. For example one of websites published a material dedicated to summaries of a round table called “Clean Thursday before Friday, the 13th. New regulations on provision of information about medicines” which included information according to which amendments to Article 26 of the Law of Ukraine “On medicinal drugs” would result in prohibition of all advertising of medicinal drugs in specialized periodicals and at thematic medical events. Also it was pointed out that it will be impossible to place not only advertising but other information about prescription drugs. However this statement is false.

Generally it should be mentioned that on the 14th of July of current year amendments to Article 26 of the Law on medical drugs entered into force and provide significant innovations related to advertising regulation. Thus it was completely prohibited to advertise medicinal drugs which can be dispensed only with a doctor’s prescription. Besides, it is prohibited to advertise medicinal drugs which do not require prescription for sale but are included in the List of medicinal drugs prohibited for advertising (hereinafter – the List) that is approved by the Ministry of Healthcare of Ukraine.

Development of criteria of a medicinal drug inclusion in category of drugs that are prohibited to be advertised is also a duty of the Ministry of Healthcare of Ukraine, however as of today the document is undergoing the stage of discussion.

At the same time new version of Article 26 of the mentioned Law provides a wider interpretation of term “information about medicinal drug” by including its name, characteristics, treatment features and possible side effects. It allows to place such information in periodicals that are published for medical and pharmaceutical employees as well as to spread it at symposium, conferences, etc. It should be mentioned that it is allowed to place information both about ordinary medicinal drugs and those which require prescription.

For the time being lawyers are not in a hurry to give their categorical opinions about such information. On the one hand information about goods that is spread by any means and designed to inform undefined number of people about such goods is considered to be advertising according to the legislation. Article 26 of the Law on medicinal drugs does not directly provide that “information about medicinal drugs” from Section 3is unconsidered to be advertising. But on the other hand the same Article allows placement of such information in specialized sources and does not limit range of medicinal drugs only to prescription drugs and those included in the List. Also Article 21 of the Law “On Advertising” defines specialized sources from general ones and sets that requirements regarding advertising of medicinal drugs are not applied to advertising in such sources.

Taking into consideration grounds of the presented positions one can reach a more apparent conclusion that spread of information about medicinal drugs (from the perspective of the very Law) will not be considered advertising. So there will be no limitations related to medicinal drugs the information about which is spread (prescribed drugs/ dispensed without prescription, ones included in the List or not). Generally it is quite logical: specialized sources are intended to be used by medical and pharmaceutical employees who use similar information in their day to day practice. And the bill number 10560 is intended to eliminate transition of the information though them. It has already been sent to be signed by the President. It, in particular, includes provisions which prohibit actions which can be considered as advertising of a drug or manufacturer by medics and pharmacists.

When going back to the Criteria of “advertising capability” of medicinal drugs it should be mentioned that the Ministry of Healthcare of Ukraine is already late with their approval. Because law number 4196, which amended Article 26 of the Law on medicinal drugs , provides that advertising of medicinal drugs can be performed only after appropriate changes are made (apparently this means information about “advertising capability” of medicinal drugs) in the State Register of Medicinal Drugs and it is possible only after the abovementioned criteria are approved. Moreover, the Committee of the Verkhovna Rada of Ukraine on healthcare pointed out that not only the Criteria are missing but also it is required for a related Order of the Ministry of Healthcare of Ukraine to enter into force (“On some issues related to prohibition of medicinal drugs advertising” number 422 dated 06.06.2012).

Thus, as of today there formally exists a prohibition to advertise all medicinal drugs which are not included in the State Register (if they are allowed to be advertised). At the same time such information cannot be included since the Criteria of “advertising capability” is not approved and some related changes are not made. Based on this it is doubtful that one will face liability for advertising of medicinal drugs until the Criteria are approved. But it is impossible to be absolutely sure.

The very Criteria are undergoing the procedure of public hearing so participants of pharmaceutical market can contribute to their development. Among other things it is suggested to prohibit advertising of medicinal drugs which are made for treatment of women during pregnancy, drugs which contain narcotic substances as well as those price of which is subject to reimbursement in accordance with legislation in force.

By the way, bill of the Order that is to approve the Criteria includes provision according to which data of the State Register of Medicinal Drugs can be used as the List of medicinal drugs that are prohibited to advertise. Thus, the Ministry of Healthcare of Ukraine is not planning to approve the List as a separate document. This is for the better since such approach will help to avoid possible inconsistencies which could occur if it was required to have two separate documents (different dates, names, advertising status, etc.).

When summarizing analysis of new regulations of medicinal drugs advertising market it should be mentioned that a bill number 10563 “On amendments to some regulatory acts of Ukraine related to prohibition of advertising of medicinal drugs” was registered in the Verkhovna Rada of Ukraine. The mentioned bill provides prohibition of advertising of medicinal drugs except for advertisements placed in specialized periodicals for medical establishments and which is spread at thematic medical events. So it is possible that changes may get even more revolutionary. As of today pharmaceutical companies are awaiting for approval of the Criteria of “advertising capability” and more or less clear explanation of amendments that have already entered into force. Possibly formation of practice related to advertising of medicinal drugs with consideration of “formal” prohibition will occur even sooner.

Publication date: 20/07/2012

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