KILINÇ LAW & CONSULTING | View firm profile
The cosmetic and pharmaceutical industries are subject to different regulations than the marketing and advertising of other products, since it is directly related to human health in general. Moreover, the health services are not considered as a “consumption” in general, such services is basic need on the basis of human rights. In this regard, especially in pharmaceutical industry, the strict limitations for advertisement and marketing methods on the cosmetic and pharmaceutical industries are in question.
2. ADVERTISEMENT PROHIBITION ON PHARMACEUTICAL INDUSTRY IN GENERAL MANNER
The pharmaceutical product has been defined in the Pharmaceuticals and Medical Preparations Law numbered 1262 (“Pharmaceutical Product Law”) as substances called pharmaceuticals and medicinal preparations to any simple and complex therapeutic measures applying in medicine and traded under the name of the product or under the specific name to be made in a specific and fixed manner in accordance with the medical rules, except for the form and formula written in the coding. In the article 4 of the Regulation on Clinical Research of Pharmaceuticals and Biological Products, the pharmaceutical product has been defined as a natural, synthetic or biotechnological active substance or combination of substances applied to human in order to prevent, diagnose or treat disease, correct, regulate or change a physiological function.
Based on these definitions, pursuant to article 13 of the Pharmaceutical Product Law indicating “It is forbidden to advertise on the way to heal the preparations and the healing sensitivity they do not possess, or by enlarging the existing healing effects on fixed or proprietary cinema films, illuminated or non-illuminated advertising, radio or any means by citing the preparations. Insofar, advertisements such as “It is useful to use in diseases …” can be allowed in the prospectus and newspapers. However, the pharmaceutical product cannot be advertised in other places than medical magazines, unless they are allowed to be sold without a prescription. Advertising samples must be approved by the Ministry of Health and Counsel.”, the advertisement of the human products being within the scope of the pharmaceutical product is strictly prohibited.
3. PROMOTION ON PHARMACEUTICAL INDUSTRY
As mentioned above, although it is forbidden to advertise pharmaceutical products in accordance with the Pharmaceutical Product Law, it is not completely forbidden for the relevant institutions to be informed and acquainted. In accordance with the Regulation Regarding the Promotion Activities of Human Medicinal Products (“Promotion Regulation”), the promotion of the human medicinal products is allowed and promotion is defined as “All the information activities organized by the license / permit holders about the medical-scientific properties of the products covered by this Regulation or all the information activities organized with the name, request, contribution and support of the license / permit holders to be carried out to healthcare professionals; within this framework, the activities of product promotion representatives, announcements to be given to medical and professional books and magazines, announcements to be made through direct mail or other communication tools, scientific meetings and product promotion meetings and similar activities and activities to be carried out.” in such regulation.
Hence, we would like to point out that, pursuant to article 5 of the Promotion Regulation, the promotion of the products shall not be made directly or indirectly to the society in any media and communication medium, including the internet, through programs, films, series films, news and similar means. The newspapers / magazines announcing to the healthcare professionals that the product is placed on the market, are outside the scope of this provision.
In addition, as stated in Article 5 of the Promotion Regulation, promotional activities and products to be carried out in accordance with the law should be for doctors, dentists and pharmacists. In other words, the promotion of drugs to people other than doctors, dentists and pharmacists is strictly prohibited, otherwise administrative sanctions are applied in accordance with Article 13 of the Promotion Regulation.
In accordance with article 5 of the Promotion Regulation, the promotion is made;
- By using the promotions products to the doctors, dentists and pharmacists,
- By arranging or sponsoring the scientific meeting and product promotion meetings,
- By visiting the doctors, dentists and pharmacists by product promotion representatives.
Furthermore, the instructions for use / usage areas of the products approved by Turkey Pharmaceuticals and Medical Devices Agency may only be published on the channels defined by Turkey Pharmaceuticals and Medical Devices Agency and on the internet website of the license / permit holder. The publicity and information activities regarding the products by wholly or partially using the short product information / instructions for use / areas of use approved by Turkey Pharmaceuticals and Medical Devices Agency cannot be carried out.
The healthcare professionals and the universities, the professional organizations operating in the field of health, associations or foundations are also prohibited to act in such promotional activities without the permission of the Ministry of Health in principle.
The society can be informed regarding the products to be used in vaccination campaigns that are important in terms of public health and in the campaigns, which are carried out by the Ministry of Health for the promotion of health or in situations such as fighting epidemic diseases, by obtaining permission from the Ministry of Health and within the framework of the procedures and principles to be determined by the Ministry of Health.
With regards to which pharmaceutical products shall not be promoted in accordance with Article 6 of the Regulation on Promotion; it is clearly regulated that
- the products that are not licensed or authorized under the relevant legislation
- the making promotions of the products licensed or permitted according to applicable legislation except the usage areas approved by Turkey Pharmaceuticals and Medical Devices approved by the Authority,
- the products licensed or permitted by relevant legislation but since not available in the local market, allowed to be purchased from abroad in exchange by Turkey Pharmaceuticals and Medical Devices Agency for a prescription from abroad in exchange
cannot be promoted except the promotions to be made in international congresses organized in the country and the information provided by the scientific service of the license / permit holder upon the written request of the doctors / dentist / pharmacist.
In this context, the main purpose of the promotion in the pharmaceutical industry is to help healthcare professionals form their own opinions about the therapeutic value of the product, and such promotions should contain informative and evidence-based medical information about the qualifications of the product. It should be mentioned that, the images that are not interesting by providing misleading, exaggerated or unverified information that may unnecessarily promote product use or cause unexpected risky situations; or that are not directly related to the product itself cannot be used while promoting the product.
The promotions made in accordance with the Promotional Regulation as different from the advertisements made within the scope of Commercial Advertising and Unfair Commercial Practices Regulation, cannot be made with sweepstakes and games of chance etc. While promoting the products to the doctors, dentist and pharmacist, no cash or in-kind advantage can be provided, not even offered and promised.
In case that any promotion and / or advertisements in violation of the relevant legislation in order to circumvent these regulations, are subject to administrative sanctions in article 18 of the Pharmaceuticals Law in accordance with the reference in the Regulation.
4. DIFFERENCE BETWEEN THE PHARMACEUTICAL AND COSMETIC PRODUCTS
When the cosmetic definitions stated in the Cosmetics Law Numbered as 5324 (“Cosmetics Law”) and Cosmetics Regulation are evaluated, it seems that the main difference between medicines and cosmetics is to treat or cure. It is possible to mention that the products within the scope of the Cosmetics Law and related legislation, effect on appearance rather than treating or improving.
In accordance with clause a, paragraph 5 of article 7 of the Regulation on Commercial Advertising and Unfair Commercial Practices, advertisements that may mislead the consumer directly or indirectly regarding its features such as its structure, composition, supply, benefit, risk, accessories, production method and date, suitability, usage, life and areas, technical characteristics, yield and performance, quantity, origin of the good, environmental impact, are prohibited. In this context, creating the impression that the cosmetic products have therapeutic or healing qualification by presenting them as if they possess the pharmaceutical product quality, is also prohibited under this article.
5. ADVERTISEMENT ON THE COSMETIC INDUSTRY
As mentioned above, it is legally possible to advertise cosmetic products. However, as is the case with the advertisement of any product, it is particularly subject to restrictions in the following regulations:
- Law on the Protection of the Consumer Numbered 6502
- Commercial Advertising and Unfair Commercial Practices Regulation
- Cosmetics Law
- Cosmetic Regulation
- Regulation on Health Declaration and Health Declaration of the Products Offered for Sale
Especially as mentioned in the Regulation on Health Declaration and Health Declaration of the Products Offered for Sale, in the advertisement of cosmetic products;
- Phrases or implications for treating or preventing any disease, helping to cure, diagnosing, or correcting, regulating or modifying a physiological function,
- Statements that claim or imply that, as a result of pharmacological, immunological or metabolic effects, they renew, correct or change physiological functions,
- Statements referring to the effect of human medicinal product
cannot be used.
In this context, the audits of the Advertising Board are very strict and in a decision of the Advertising Board; it is stated that the definition of the cosmetic product is “all preparations or substances prepared to be applied to different external parts of the human body such as epidermis, nails, hairs, hair, lips and external genital organs, teeth and oral mucosa and its sole or primary purpose is to clean these parts, smell them, change their appearance and / or correct and / or protect body odours or keep them in good condition”; all cosmetic products subject to cosmetic legislation should be products that are applied to the outer parts of the human body and whose effects should be temporary; in this context, the statements regarding the products mentioned in the advertisements and promotions subject to the examination have been evaluated in a misleading manner and exceeding the definition of the cosmetic product specified in the relevant legislation; also all these claims are not proven with the “scientific work” and “test results” taken from the relevant departments of the universities operating in the Republic of Turkey in universities or from the accredited a test and evaluation organization.
Within the scope of the issues explained in detail above; the concepts of pharmaceutical products and cosmetics are completely different from each other and they are also subject to different legal regulations.
In general, it is also prohibited to advertise pharmaceutical products, and only promotions for healthcare professionals are considered legally valid.
In the cosmetics sector, even if advertising is allowed as a rule, the certain restrictions have been set to prevent cosmetic products from being shown especially therapeutic and curative. In this regard, it should also be noted that the Advertisement Board is working very meticulously and strictly and imposes strict sanctions to ensure that the advertisements and promotions carried out illegally for the pharmaceuticals and cosmetics sectors in both the visual and print media as well as on the internet are deterrent.