The Verkhovna Rada of Ukraine registered a draft Law of Ukraine dated 21 5547 dated 21.05.2021, which proposes to restate the Law of Ukraine dated 04.04.1996 № 123 “On Medicinal Products” (hereinafter – the Draft Law).
If adopted, it will take effect in 12 months. after its official publication.
The bill with accompanying documents is posted at the link.
The bill was adopted as the basis on 09.09.2021.
The document is currently being prepared for the second reading, the wording of which has not been made public at the time of writing.
Therefore, for the analysis of the existence of certain provisions on the market of medical devices, the wording of the Draft Law of 21.05.2021 was taken.
Thus, it was established that the Bill provides for a significant change in the approach to advertising, namely, in fact, to establish a ban on the advertising of medical devices.
The draft law proposes a new version of Article 21 “Advertising of Medicines, Medical Equipment, Methods of Prevention, Diagnosis, Treatment and Rehabilitation” of the Law of Ukraine “On Advertising” (Vedomosti Verkhovnoi Rady Ukrainy, 1996, № 39, p. 181 ) provide for the following, in particular:
Advertising is allowed only for such medical devices that are duly permitted by the central executive body implementing the state policy in the field of health care for use in Ukraine (Ministry of Health of Ukraine).
It should be noted that currently, the Ministry of Health of Ukraine does not issue permits for the use of medical devices in Ukraine. In this version of the article of the Bill, there is a risk of banning the advertising of virtually all medical devices.
Mandatory elements of advertising medical devices are defined.
Advertising of medical devices may not contain references to therapeutic effects in relation to diseases that are not amenable or difficult to treat, or materials that are incorrect, alarming, or misleading, refer to recovery with the use of such a product.
Advertising of medical devices is prohibited:
- information that may give the impression that, in the case of a medical device, consultation with a specialist or surgery is not necessary, in particular due to advertising recommendations for diagnosis or offering remote treatment;
- information that the therapeutic effect of the use of a medical device is guaranteed, materials that incorrectly, by alarming or misleading, use images of changes in the human body due to disease, injury or the action of a drug on the human body or part of the body;
- allegations that contribute to the emergence or development of fear of getting sick or deteriorating their health due to non-use of advertised medical devices; this ban does not apply to vaccination campaigns approved by the central executive body that ensures the formation and implementation of state policy in the field of health care (Ministry of Health of Ukraine);
- allegations, materials, which, as a result of describing or demonstrating the history of the disease contribute to the possibility of erroneous self-diagnosis of diseases, pathological human conditions and their self-treatment with the use of advertised medical products;
- references to medical devices as the most effective, safest, exceptional in the absence of side effects;
- references to specific cases of successful use of medical devices;
- recommendations or references to the recommendations of medical, pharmaceutical specialists (employees), scientists, medical institutions and organizations regarding the advertised product or service;
- special expressions of gratitude, appreciation, letters, excerpts from them with recommendations, stories about the use and results of the advertised goods or services from individuals;
- images and mentions of names of popular people, heroes of film, TV and animated films, authoritative organizations;
- information that may mislead the consumer regarding, in particular, the composition, origin, effectiveness, patent protection of the advertised product;
- materials intended exclusively or mainly for children.
In the advertising of medicines is prohibited the participation of medical, pharmaceutical professionals (employees), as well as persons whose appearance mimics the appearance of the latter.
Persons who manufacture and/or sell medical equipment may sponsor television, radio, and program programs by providing information of an advertising nature about the name or designation, a mark for goods and services, except for any reference to medical equipment, the application of which requires special knowledge and training.
Teleshopping of medical equipment, the use of which requires special knowledge and training, is prohibited.
It should be noted that in the draft Law of Ukraine “On Medical Devices” of October 20, 2021, published at https://moz.gov.ua/article/public-discussions/proekt-zakonu-ukraini-pro-medichni-virobi article 10 also establishes rules for the advertising of medical devices, namely, it is provided that the advertising of medical devices of class I, medical devices for self-control.
Requirements for advertising of such medical devices are established by the Law of Ukraine “On Advertising”, the Law of Ukraine “On Medicinal Products”.
Thus, both draft acts on the provisions of advertising of medical devices 1) contradict each other; 2) to some extent, establish a ban on advertising of medical devices, in particular, such a ban may include such medical devices as condoms, which are an indispensable means of contraception to reduce the burden of HIV in Ukraine.
The draft law uses outdated terminology, namely the concept of “medical equipment”, “medical equipment”, which are currently completely absent in the system of legal regulation of the market of medical devices.
In Ukraine, there are three technical regulations in the market of medical devices, namely:
– Technical regulations on medical devices, approved by the resolution of the Cabinet of Ministers of Ukraine dated 02.10.2013 № 753;
-Technical regulations on medical devices for in vitro diagnostics, approved by the resolution of the Cabinet of Ministers of Ukraine dated 02.10.2013 № 754;
– Technical regulations on active implantable medical devices, approved by the resolution of the Cabinet of Ministers of Ukraine dated 02.10.2013 № 755.
Technical regulations establish requirements for medical devices provided on the market of Ukraine, including the rights and obligations of economic entities and other persons to place medical devices on the market and make them available on the market.
The Technical Regulations define the general concept of “medical device” – any instrument, apparatus, device, device, software, material, or other device used alone or in combination with each other (including software provided by the manufacturer for use specifically for diagnostic and/or therapeutic purposes and necessary for the proper functioning of the medical device), intended by the manufacturer for use in diagnosing, preventing, monitoring, treating or alleviating the patient’s disease in case of injury or disability or compensation, research, replacement, modification or maintenance of anatomy or physiological process, control of the fertilization process and the main expected effect of which in the body or on the human body is not achieved by pharmacological, immunological or metabolic means, but which such tools can help.