Nowadays it is difficult to imagine an economic entity functioning without using any form of advertisement. What about medicinal products? Do life-saving and life-enhancing products also need advertising? Do medicines which have pervaded our daily lives need to be additionally advertised? On the other hand, how do we know whether to choose company A’s medicine or company B’s medicine for a headache?
The rules for advertising medicinal products are laid down by the Act of 6 September 2001 Pharmaceutical Law and the Regulation of the Minister of Health of 21 November 2008 on advertising of medicinal products. The mentioned documents regulate many aspects of advertising of medicinal products, including:
- What is a medicinal product advertisement and what information must it contains;
- What is not an advertisement of a medicinal product;
- What is prohibited in the advertisement of a medicinal product;
- What is the permitted method of advertising;
What is the difference between an advertisement directed to the public and an advertisement directed to Healthcare Professionals
What other information will your doctor hear?
The Regulation of the Minister of Health specifies what data must be included in a medicinal product advertisement. The Regulation contains a detailed list of requirements differentiating advertisements directed into healthcare professionals and advertisements directed into the public.
What more can prescribers learn from an advertisement directed to them?
Advertisement directed at them additionally contains:
- not only the name of the commonly used active substance, but also the entire quantitative and qualitative composition of the medicinal product;
- information on adverse reactions;
- a special warning and precautions for use;
- the marketing authorisation number and the name of the issuing authority.
In addition to the above, any advertisement of a medicinal product (directed both to the public and to Healthcare Professionals) must contain information on the pharmaceutical form, the indications or therapeutic indications for use and the details of the marketing authorisation holder.
It is interesting to note that not all medicinal products can be publicly advertised. Not being a Healthcare Professional, we will not see an advertisement for:
- prescription medicines;
- reimbursed medicines;
- medicinal products containing narcotic or psychotropic substances.
Additionally, regardless of the recipient’s profession, the subject of the advertisement cannot be:
- medicines that are not authorised in Poland;
- medicines imported on a way of target import.
Any advertising directed to the public, regardless of its form, must include a warning to a patient. Its text, the requirement for its duration, or the font size of the inscription are strictly regulated by a Regulation of the Minister of Health. Did you know that this well-known warning must appear on screen for no less than 8 seconds?
In addition, people authorised to write prescriptions may receive a free sample of the product as a part of the advertising. In order to receive it a doctor must file a written request for a sample, which is recorded and strictly quantified, and meet a number of other requirements. Free samples cannot apply to medicinal products containing narcotic or psychotropic substances.
When advertisement is not an advertisement but a medical information?
In the face of all legal requirements, it is crucial to distinguish what is and what is not an advertisement of a medicinal product. Unlike in the case of an ordinary commercial, the definition of which is not regulated in any legal act, advertisement of a medicinal product is precisely defined in Art. 52 of the Pharmaceutical Law. According to the above mentioned article, the advertisement of a medicinal product is:
- advertising directed to the public;
- advertising directed to persons authorised to write prescriptions or persons trading in medicinal products (including: visiting these persons for advertising purposes);
- providing samples of medicinal products;
- sponsoring participation in promotional meetings, conferences, conventions and scientific congresses.
Moreover, the Regulation of the Minister of Health clearly highlights that no material benefit may be offered to a doctor in exchange for prescribing an advertised medicinal product to patients.
On the other hand, advertising of a medicinal product does not include:
- information placed on the packaging of the product;
- correspondence with attached information material linked to a medicine which is not promotional material;
- information announcements relating to packaging changes or adverse-reaction warnings;
- catalogues or price lists.
Take away the aprons from actors
Art. 55 of the Pharmaceutical Law firmly prohibits medicinal products commercial from being presented by public figures, scientists, doctors, pharmacists, or even people whose appearance and outfit may suggest having such expertise. What is more, an advertisement of a medicinal product cannot even refer to the recommendations of these people.
One pill a day keeps the doctor away
According to Art. 55 § 2 of the Pharmaceutical Law, the medicinal product advertisement cannot suggest that it is possible to avoid medical advice, even a healthy person will improve his or her health state by taking the medicinal product or that not taking the medicinal product may worsen health state (this does not apply to vaccines). It is forbidden to suggest that a medicinal product is a consumable product, that its efficacy or safety is due to its natural origin and that side effects and adverse reactions do not exist as in medical series.
Advertisements of a medicinal product cannot be misleading, offer any benefit in exchange for the purchase of the medicinal product, be directed to children or contain any element directed to them.
Too restrictive?
The regulation of medicinal product advertising strongly restricts the freedom of advertisers. However, is it not good that the law ensures patients’ safety and awareness by keeping the creativity of advertisers in check? What is your opinion on this subject?