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Medicinal Products Advertising is Considerably Changing

12/20/2011 Verkhovna Rada of Ukraine adopted the Law “On the Amendments to Certain Healthcare Legislation” (regarding strengthening control over the turnover of medicinal products, food products for special dietary consumption, functional food products and dietary additives), more commonly known under the number 7007.

We shall remind that this project was adopted on the first reading at the end of the previous year. It gained such popularity because it introduced a total ban on advertising of medicines. The whole year this project hung as a "sword of Damocles" over the pharmaceutical business, and only at the end of the year project №7007 began to move on. At first its second reading was planned for 7/12/2011, but it failed to happen. The draft has been temporarily removed from the agenda, till 12/20/2011 when it was discussed again and finally adopted.

What is interesting is that the latest version of the draft significantly differs from the one which has passed its first reading.

On the one hand we cannot but rejoice that draft, which passed the second reading, does not contain a complete ban on advertising of medicinal products, but on the other hand – the resolution embodied in the draft on situation around advertising of medicines is somewhat alarming.

According to the Draft advertising of medicinal products which are sold without medical prescription and not included in the list of medicines, prohibited for advertising, is allowed. The list of medicinal products prohibited for advertising shall be approved by the central executive authority in the field of health care. Criteria used in determining medicinal products advertising of which should be banned, shall be approved by the central executive body in health care sphere in accordance with the law. The decision to classify medicinal product as the one advertising of which should be prohibited, shall be taken during medicinal product state registration (reregistration) with the submission of relevant information to the State Register of Medicinal Products in Ukraine. Advertising of medicinal products use and supply of which is permitted only on medical prescription, as well as those included in the list of medicinal products prohibited for advertising is forbidden.

Thus, in the near future the Ministry of Health has to adopt the criteria for classification of medicinal products to this list. Currently it is difficult to determine what will be the basis of such criteria, but we can already conclude that they may have unstable character. This approach is far away from being called progressive.

It is interesting that the decision on determining medicinal products as those advertising of which is prohibited shall be made during the State registration (reregistration) of medicinal products. Therefore, the list of such medicinal products may be augmented exclusively in the course of the procedure of the State registration/reregistration of medicinal products. That being said, one may think if there is a valid registration certificate for a certain medicinal product sold without prescription (OTC products), the issue with regard to determining such medicinal products as those advertising of which is prohibited may arise only when the term of such Certificate validity comes to the end and when it is necessary to perform the reregistration. However, it is not true. According to the final provisions of the Draft, advertising of the medicinal products registered in Ukraine prior to the Draft’s entering into force may be performed only after introducing the corresponding amendments to the State Register of Medicinal Products of Ukraine.

Therefore, effective from the moment the corresponding provisions of the Draft come into force, advertisement of medicinal products may disappear for a certain time and the producers of medicinal products will align to the Ministry of Health of Ukraine to perform the reregistration of their medicinal products.

Moreover, since the decision on determining the medicinal products as those advertising of which is prohibited shall be made in each case separately, it may not occur that the same in essence medicinal product but of different producers may fall in different categories.

It is worth noting that the changes relating to advertising of medicinal products in accordance with the Draft shall become effective in 6 months from the moment of the Law’s publication.

That being said, we shall hope that within this period of time the Ministry of Health of Ukraine will develop transparent, understandable and justified criteria for determining medicinal products as those advertising of which is prohibited.

In general, the Draft introduces changes to the Fundamentals of the legislation of Ukraine on healthcare, the laws “On Medicinal products”, “On Licensing of Certain Types of Economic Activity”, “On Advertising”. Except for medicinal products advertising, the changes are related to licensing of medicinal products production and dissemination of the information regarding unregistered medicinal products.