In line with ongoing work on strengthening the regulation of drug advertising, next year we may hear changes to the wording of warnings against the misuse of these products in advertising messages.
The Medical Devices Act of 7 April 2022 adapts the Polish medical device market to EU regulations, namely Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices and the Regulation of the European Parliament and of the Council (EU) 2017/746 of April 5, 2017 relating to in vitro diagnostic medical devices. It is important to note that none of the regulations introduce detailed rules for the advertising of medical devices, leaving the determination of these rules to the Member States.
– In addition to tools or devices traditionally recognized in the wider social perception as medical devices such as implants, orthoses or diagnostic equipment, more and more often the term medical device also applies to capsules, tablets and syrups. Although such a qualification of a product most often surprises the average consumer, it is legally permissible. Until now, many preparations, for example cough syrups, sore throat tablets or indigestion capsules marked “medical device”, could be advertised under very less restrictive than drugs. This will change from January 1, 2023, with the entry into force of the new medical device advertising rules introduced by the Medical Devices Act of April 7, 2022 – says Joanna Wajdzik, Senior Associate at law firm Wolf Theiss .
Advertising must be formulated in a way understandable to a layman
According to the regulations already adopted, the advertising of a product to the public must not be misleading and must be formulated in a way understandable to a layman, i.e. a person without training in the relevant field of the protection of health or medicine. This requirement also applies to advertisements in which, to reinforce the message, medical and scientific formulations or references to scientific research, opinions, literature and studies intended for professionals will be used – these advertisements must also be understandable for laymen.
– As with drug advertising, medical device advertising will no longer be able to use the image of or claim to be a medical professional, or portray people presenting the device in a way that suggests they exercise such profession. This means the end of the advertising of medical devices with actors dressed as doctors, in pharmacies, dentists’ surgeries or doctors, eagerly used by pharmaceutical companies in the advertising of products classified as medical devices – adds Joanna Wajdzik.
This is not the end of the bans. As experts point out, the most problematic in practice may be the prohibition of advertising products intended for use by users other than lay people, ie specialists and professionals. The question arises of the scope of the expression “to be used”. It is unclear whether use of the device should also include assembly by a physician, or only wearing by a patient. There are products where the end user is only the patient, but at the same time they must be installed with the help of a specialist, for example breast implants or prostheses. The resolution of doubts as to whether this type of medical device will be subject to the advertising ban must be made by interpreting the provisions to be issued by the Minister of Health.
– The key element of the new law is also to extend the prohibitions to other advertising activities, such as advertising a company with the use of a given product, presenting products at meetings during which the purchase of medical devices is encouraged or the sending of notices to the public by the users of these products, how many advantages do they receive. As the bill’s rationale admits, such a broad approach to advertising “will eliminate the adverse phenomena currently encountered.” One cannot help but think that this is a reference, among other things, to the growing influence of the influencer industry on the medical device sector and so-called experience-based advertising. personal – notes Joanna Wajdzik.
Changes from 2023
The so-called transitional period, thanks to which advertising of products, the broadcast of which began before 2023, which does not meet the requirements specified in the law, may be further broadcast, but no longer than until June 30, 2023.
In parallel with the evolution of the rules for the advertising of medical devices, work is underway to strengthen the provisions relating to the advertising of medicinal products within the framework of the draft amendment to the regulation on the advertising of medicinal products. Draft regulation of the Minister of Health of April 5 of this year. provides for changes in three areas: the content of warnings concerning the safety of the drug, the indication of contraindications to the use of the drug in advertising addressed to the public and the updating of the nomenclature.
As the Ministry points out in the explanatory memorandum to the regulations, current messages and warnings in drug advertisements are often incomprehensible and unclear to the recipient. Moreover, they have not changed for 14 years, i.e. since the date of entry into force of the regulation on the advertising of medicinal products of November 28, 2008. The regulation also provides for the derogation from the obligation to indicate the contraindications. indications for the use of a drug produced in the ad. It seems to be the right direction – the text on contraindications, if it is at all noticeable to the recipient in the case of an audiovisual advertisement, will generally not be retained by the recipient before the actual use of the medicine – says Joanna Wajdzik.
As admitted in the project’s explanatory memorandum, ignoring the wording of the warning, which has already been heard and read many times, can contribute to the spread of “self-medication” among Poles, and thus to the taking medication without medical supervision. To change this, the project includes warnings in three different versions, each with the main message saying “This is a medicine. For safety reasons, use it according to the package leaflet.” We will hear new warnings in advertisements, certainly not until next year, because in the prepared draft, the regulation will come into force 6 months from the date of the announcement. The transitional provisions also provide that advertising whose broadcast began before the date of entry into force of the regulation, which does not meet the requirements contained therein, may be broadcast after the date of its entry into force, but no later long as for a period of 6 months.
The changes will have a significant impact on the advertising and promotional activities of pharmaceutical companies and producers associated with the FMCG market, whose products, depending on the classification, may be listed as drugs, medical devices or cosmetics (e.g. toothpaste). Due to the transition periods, producers and distributors should have no problems with the implementation of the new regulations, although in some cases this will require significant changes in the communication of individual brands.