Advertise medicines or not: what does the new draft prescribe?
Andrii Gorbatenko, partner, attorney-at-law at Legal Alliance Company
On January 21 st, 2020 the website of the Ministry of Health of Ukraine published draft order on amendments to criteria applied to determine medicines which cannot be advertised.
Review at amending the registration dossier
The draft prescribes enlargement of the list of cases when it is assessed and decided whether a medicine is subject to advertisement prohibition, and the respective information is entered on the State Register of Medicines of Ukraine.
The current edition of the order describes 2 cases: registration and re-registration, however, considering infinite registration of medicines, this approach is outdated and needs actualization. Therefore, the Ministry of Health proposes to carry such assessment every time while amending registration file.
On the one hand, this approach solves the problem of revision of decision whether a medicine is subject to advertisement prohibition. On the other – looks exaggerated since changes in registration file can be technical (for example, change in package design) which for sure cannot cause grounds for prohibiting advertisement of such a medicine.
Is it worth spending resources of the Ministry of Health to make a decision whether a medicine is subject to advertisement prohibition while making any changes in the registration dossier? Such frequent inspections usually increase corruption risks. In this context it would be more logical to carry such an inspection when changes related to modification of the instruction for use are made.
Similarity of names
Furthermore, the draft provides for changes in the very criteria of declaring a medicine subject to advertisement prohibition.
The draft proposes to prohibit advertisement of over-the-counter medicines whose name contains similar name of a prescription drug. Reasons for such an initiative of the Ministry of Health are understandable. However, in our opinion, this means does not justify the purpose. In particular, a name of medicine can be both created by the applicant (manufacturer) and general or scientific which can be followed by a trademark or the applicant’s (manufacturer’s) name.
Therefore, if the manufacturer used a general name for its over-the-counter medicines, there will always be a risk that advertisement of such a medicine can be prohibited only based on the reason that another manufacturer will register a prescription medicine with the same general name, but higher dose of active ingredient.
Moreover, we know cases when a ground for declaring a medicine prescription was the number of pills in a package, for example all packages (No. 10, No. 20, etc.) are over-the-counter, except for packages No. 100 which were declared prescription. Therefore introduction of this criterion can make manufacturers cancel registration certificates of such increased packages which are of prescription status.
In our opinion promotion of prescription medicines at the expense of advertisement of over-the-counter medicines is not as widely used as the consequences of introduction of name similarity criterion will be.
The current edition of the order, among other things, extends prohibition of advertisement to medicines which meet the following two criteria:
- Exclusively for treatment of women during pregnancy and breastfeeding
- Exclusively for treatment of children under 12 years old
The draft offers to modify both abovementioned criteria by removing the word “exclusively”.
One of the main prerequisites to granting a medicine over-the-counter status is its security profile. Usually over-the-counter medicines cannot cause serious harm to patients’ health as a result of their misuse.
This security profile as a rule makes it possible to use such medicines for treatment, among other things, of such sensitive groups of patients as women during pregnancy and breastfeeding, and children under 12 years old.
Therefore new offered modification of the mentioned criteria will lead to prohibition of advertisement of the most innocent medicines.
The current edition of the order extends prohibition of advertisement to medicines used for treatment of tuberculosis, sexually transmitted diseases, extremely dangerous infectious diseases, HIV/AIDS.
The draft offers to substitute the listed criteria with the list of extremely dangerous, dangerous infectious and parasitic diseases of humans and carriers of pathogens of these diseases (now approved by order of the Ministry of Health No. 133 as of July 19th, 1995).
Here it is also offered to enlarge the list of cases when advertisement of over-the-counter medicines must be prohibited, namely in what concerns:
- Dangerous diseases;
- Parasitic diseases of humans and carriers of pathogens of these diseases
When first approached from such an innovation, sorbents, which are used, in particular, for acute intestinal infections which are dangerous infectious diseases, various antipruritic agents, including those for chicken pox, and antiparasitic agents, will suffer.
Sleep disorders and cardio-vascular diseases
The current order lists as prohibited for advertisement medicines for treatment of chronical insomnia. The draft offers to enlarge this criterion to cover any sleep disorders. This approach will exclude the possibility of advertising any lightest sedative substance, even one which balances the line between a medicine and dietary supplement.
The draft also offers to supplement the list of nosologies prohibited for advertising with cardio-vascular diseases.
Adoption of the draft in the offered edition will significantly reduce the list of over-the-counter medicines whose advertisement will be allowed. As a result of such changes, answer to the question “Is advertisement of medicines allowed in Ukraine?” will be “More probably no than yes”.
Generally, the situation around prohibition of advertising some groups of over-the-counter medicines which is ongoing in Ukraine looks like an attempt to compensate problems of division of medicines into prescription and over-the-counter ones.