Criteria of medical products’ “advertising capability” – article for weekly periodical “Lawyer and Law”
Svyatoslav Bolinskyi, lawyer of our law firm prepared an article about new criteria of medical products’ “advertising capability”for analytical weekly periodical “Lawyer and Law”. Editorial name of the article is “Under cross prohibition”.
Unabridged text of the material (translation from Russian):
“The Ministry of Healthcare of Ukraine defined the criteria of medical products’ “advertising capability” and partially duplicated already existing prohibitions”
On the 14th of July 2012 amendments to the law of Ukraine “On medical products” and law “On advertising” entered into force and made requirements for medical products advertising stricter as well as limited the list of products that are allowed to be advertised by certain criteria.
From now on all medical products that are prohibited to advertise will be included in a special list which must be approved by the Ministry of Healthcare of Ukraine. Also the Ministry will have a function of “advertising capability” criteria development for medical products that should be approved before abovementioned amendments enter into force. On the 6th of July 2012 a corresponding Order of the Ministry of Healthcare of Ukraine number 422 was approved and as of today it is being prepared for official publication and entry into force.
It is notable that the bill of the Order which was planned to approve “advertising capability” criteria and was proposed for public discussion contained a stipulation according to which data of the State Register of Medical Products was to be recognized as the list of medical products that are prohibited to advertise. It is possible that the Ministry of Healthcare was trying to avoid possible inconsistencies between State Register of Medical Products and List of medical products that are prohibited to advertise by excluding necessity to present a “superfluous” document. However the approved version does not stipulate this rule anymore. Probably the Ministry of healthcare will have to create the List or to lobby legislation amendments related to it.
As for the criteria themselves the approved list was not very creative. In particular it contains provisions which were in force before with slight influence of new requirements. For example prohibition against advertising of prescribed medical products was duplicated. Also medical products for treatment of intractable diseases (tuberculosis, HIV, cancer, diabetes, impotence) turned out to fall under “cross prohibition”. Besides medical products that contain narcotic substances or cause addiction are considered as such that cannot be advertised.
Particular attention was paid to pregnant women and children under 12. Medicines that are to be used exclusively by these categories of consumers will be left without “trade engine”. And while it is possible to find specific medicines for the first category, it is hard to do the same with the second one. Have anybody seen medicines that have instructions which specify: “For children under 12”?
At the same time some specialists say that such criteria do not comply with the original purpose. They do not limit advertising of many “unnecessary” medicines. These medicines are not dangerous but they are definitely useless.
Generally the very fact of Criteria approval is important to pharmaceutical companies because from now on during registration/ re-registration of medicines it becomes possible to include information about “advertising capability” in the State Register which is basically an obligatory condition of advertising campaigns. As for the quality of these Criteria it looks like their revision is quite predictable.”