REGULATION ON PROMOTION AND INFORMATION ACTIVITIES IN HEALTH SERVICES Introduction

The Regulation on Promotion and Information Activities in Healthcare Services (“Regulation”) issued by the Ministry of Health entered into force with the Official Gazette published on 29 July 2023.

The purpose of the Regulation is to determine the basic principles and criteria regarding promotion and information activities in healthcare services, to regulate the procedures and principles regarding the supervision of these activities and the sanctions to be imposed.

The scope of promotional and informative activities regulated by the Regulation includes promotional and informative activities carried out by healthcare professionals, all healthcare institutions, organisations, establishments and international health tourism intermediary organisations belonging to real and private legal entities providing healthcare services and operating with a permit, certificate of conformity or licence issued by the Ministry of Health in accordance with the relevant legislation, and persons, institutions and organisations that do not have authorisation, permission or licence in the field of healthcare service provision.

Advertising & Promotion and Information

Article 4 of the Regulation, titled ‘Definitions’, clarifies the definition of advertisement. Although the definitions of commercial advertisement and advertisement are included in the Regulation on Commercial Advertisement and Unfair Commercial Practices or the Law on the Organisation of the Press Advertisement Agency, these definitions differ from each other. Although it is accepted in the literature that it is necessary to interpret the dominant elements of advertisement in order to make an inclusive legal definition of advertisement in the field of health, it can be considered as a positive development to include definitions for advertising, promotion and information activities with the Regulation in order to clarify these diverse definitions in practice. In this context

Advertisement; in connection with private health facilities, health service delivery or medical professions in the field of health; announcements in the nature of commercial marketing communication made through written, visual, auditory and similar means in any medium in order to create demand for a product or service or to increase demand and to persuade people,

Promotional and informative activities; for private health care facilities, the branches of expertise, address and contact information and health protective and health-promoting information related to the field of health provided; for physicians, the professional and academic title, the main branch and sub-branch specialities specified in the Law No. 1219, the days and hours of examination, the time and place of patient admission and the health protective and health-promoting information related to the health service they are authorised to provide; activities that are not misleading and deceptive, do not endanger human health, do not create demand and unfair competition and do not fall under the definition of advertisement.

Limits of Advertising, Promotion & Information

Pursuant to Article 5 of the Regulation, it is prohibited to make or have made implicit or explicit advertisements in health service provision. However, publicity and information may be provided provided that the following principles and guidelines are complied with:

Promotion and information must comply with general morality, medical deontology and professional ethics.
Information on health service provision may only be provided by legally authorised healthcare professionals.

Authorised healthcare professionals are defined in Article 4 of the Regulation as physicians, dentists, pharmacists, nurses, midwives, opticians and other healthcare professionals defined in the additional Article 13 of the Law No. 1219.

Promotion and information that misleads and misdirects the public, endangers personal and public health, creates a demand and unfair competition environment in a way to create the impression that health facilities accept and treat patients other than the specialities in which they treat patients cannot be made.
Promotion and information shall not include explanations about medical and treatment methods whose accuracy has not been scientifically and clinically proven, which have not become established medical methods, which have not been defined and regulated as medical procedures by the Ministry, even if they are performed by a healthcare professional, and statements that diseases are treated or assisted in treatment with these methods may not be used.
Promotions and information shall be limited to the branches of specialisation, address and contact information of health care facilities that accept and treat patients, and information that is protective and health-promoting in relation to the field of health provided; and for physicians and dentists, the main branch and sub-branch specialisations determined by the Law No. 1219, academic title, examination days and hours, time and location of patient acceptance, and information that is protective and health-promoting in relation to the field of health provided.
In publicity and information, speciality titles other than the main and sub-speciality specialities specified in Law No. 1219 may not be written or used.
Activities that may create the impression that patients are making a thank-you announcement for health services may not be carried out.

The paragraph in question is also stipulated in the Medical Deontology Regulation: ‘A physician and a dentist may not print thank-you advertisements in newspapers and other means of publication in the form of advertisements.’ It is also prohibited for a physician to advertise with his/her own writings or with thank-you advertisements published in the media on his/her behalf. However, the circumstances and conditions under which thank-you advertisements will be considered as advertisements are not clearly defined. There are many recent decisions of the Advertisement Board (“Board”) similar to the example decision[1] below, in which the Board considers thank-you advertisements as commercialisation of healthcare services:

However, it would be more appropriate to exclude from this prohibition thank-you advertisements that may be encountered in the ordinary course of life and whose promotional aspect is not prominent. Otherwise, advertisements that do not aim to give a commercial appearance and are given without even the physician’s knowledge may result in the physician being held liable. In this context, the inclusion of information that can only be learnt from the physician, such as the physician’s professional success and experience and the treatment method used, in the advertisement of thanks may be seen as a sign of the physician’s intervention in the content of this text.

Promotions and information cannot be in a content that will direct the patient directly or indirectly to the healthcare professional or healthcare institution.
No referral may be made to a specific healthcare professional or healthcare institution through intermediary organisations, publications and communication channels for reasons such as medical assistance services, general health check-ups, health screening, consultancy and information.
Scientific terms, research results or quotations from scientific publications and statistical data may not be presented in such a way as to produce different results than they actually are.
Promotion and information that abuses people’s trust or exploits their lack of knowledge in a way that creates the perception that the goods or services subject to health care are different or superior to others cannot be provided.
The date of the last update of the information on the websites and the contact details of the website editor shall be clearly stated.
Health facilities and physicians may register with internet search engines. However, the keywords to be used and all information on the result page of the search engines cannot be contrary to the principles in this Regulation.
Personal telephones may not be called without the knowledge and consent of the persons, and advertisements and promotions may not be made by sending letters, short messages, electronic mail and messages through social networking tools.
Health services cannot be offered for marketing purposes such as incentives, sweepstakes and gifts, and advertising, promotion and information cannot be provided for this purpose.

It is obligatory to comply with the principles stipulated in this Regulation in the promotion and information made on social networking and internet sites. Those who carry out promotional and informative activities in violation of these principles and those who share them are equally responsible. Except for the distribution of scientific, statistical and newsworthy information, all kinds of advertisements, promotions and similar activities related to organ and tissue harvesting and donation are prohibited.

Evaluation of the Use of Visual Content

Article 6 of the Regulation titled “Respect for privacy and keeping information confidential” stipulates that promotional and informative activities must be carried out in accordance with the provisions of the Law on the Protection of Personal Data (“Law” or “KVKK”) and the Regulation on Personal Health Data.

In practice, it is known that patient images before and after treatment are published on platforms such as websites and/or social media, and the relevant issue has been on the agenda of many authorities. When the issue is considered from the perspective of the Law and the Personal Data Protection Board (“PDP Board”), it is frequently witnessed that attempts are made to circumvent the advertisement ban imposed on healthcare professionals by obtaining explicit consent from the relevant persons. However, it should be emphasised that compliance with the LPPD should be adopted with a holistic approach and the decisions of the relevant legislation and independent administrative authorities should be taken into consideration.

The realisation of advertising activities prohibited by the health law legislation with explicit consent will cause a violation of the law and the rule of honesty, one of the basic principles of the KVKK. The decision dated 11.05.2023 published by the PDP Board can be given as an example.[2] Pursuant to the relevant decision; it has been stated that the explicit consent obtained by the data controller from the data subjects for the processing of health data within the scope of advertising and promotional activities is not in accordance with the law, and thus, it has been emphasised that the advertising ban imposed on healthcare professionals cannot be overcome based on the legal reason of explicit consent and the multidisciplinary structure has been drawn attention.

Article 7 of the Regulation, titled ‘Use of visual content in promotions and information’, prohibits the use of before and/or after visuals comparing the effects of the treatment and creating demand in the promotions and information to be provided by healthcare professionals and healthcare facilities regarding the healthcare services they provide, but allows the use of visual content provided that certain principles and principles are complied with.

The inclusion of before and after treatment images on platforms such as websites or social media, etc., which have been the subject of many Board decisions before, has caused the Board to impose advertising suspension penalties on physicians on the grounds that it gives a commercial appearance to the profession of medicine.

Although it is ruled that the continuation of the relevant activity in line with the principles and principles that will be detailed below will not cause a violation of the law, it can be said that it is very difficult to draw the boundary since it can be interpreted that all kinds of posts containing before and after images, which are comparative and demand-generating in nature, are within the scope of advertising by nature.

In the visual content to be shared; images and expressions that are contrary to the general rules of morality, threatening public health and well-being, harming personal rights and freedoms, exploiting the private or social life of the patient, alarming or misleading the society cannot be included.
In order to use the visual content of the patient, it is essential to obtain the explicit consent of the patient himself/herself, or his/her parent or guardian if he/she is a minor or incapacitated, and to comply with the Patient Rights Regulation. While obtaining explicit consent, the Consent Form for Recording and Processing Visual Content (“Consent Form”) in Annex-1 is used.

When the Consent Form included in Annex-1 to the Regulation is examined; it is seen that the use of visual personal data is conditioned on the condition of keeping the identity confidential. Personal data, as defined in the Law, refers to any information relating to an identified or identifiable natural person. The scenario in which the identity of the person is not identifiable under the relevant form may be interpreted as the scope goes beyond the KVKK. As a result of this interpretation, it can be concluded that the aforementioned Consent Form does not constitute an explicit consent declaration within the scope of the LPPD; however, it can be concluded that it should be used for all kinds of photographs/video images by professionals operating in the field of health for promotional and informative activities.

In the light of these comments, to go through an example; if the pre- and post-operative photographs of a person who has undergone a nose operation will be shared in such a way that the person cannot be identified, although the Consent Form brought with Annex-1 must be used, an explicit consent will not be required within the scope of observing KVKK compliance since it will not have a personal data nature.

Although it is not included in the Regulation, the issue of keeping the identity confidential, which is introduced with the Consent Form, is at a risky point and causes uncertainties due to both the evaluation of the nature of personal data processing activities and the fact that it is brought to the agenda within the annex although it is not included in the actual legislation. As a matter of fact, it is not clear from the provisions of the legislation whether keeping the identity confidential is a condition that must be strictly complied with.

The patient has the right to see the visual content to be shared in advance. The permission to share the visual content may be withdrawn at any time upon the request of the patient himself/herself or, if the patient is a minor or incapacitated, upon the request of his/her parent or guardian, without being bound by any procedure or condition. The health facility or the relevant health professional is obliged to process and finalise the patient’s withdrawal request immediately.
Patients who do not give permission for image sharing must be informed and assured that there will be no change in diagnosis and treatment practices and the fees to be charged.
No payment or discount can be made to the patient in return for permission to use the visual content, and no gift can be given.
The media of the videos and photographs to be used in promotion and information, the techniques used must not be contrary to the reality, and they must be displayed without misleading make-up Technological changes or corrections cannot be applied to the visual contents afterwards. It is obligatory to specify the date of processing and the date the image was displayed in visual contents.
Even if it has been made in other media, patient comments on visual content or expressions that will mean a thank you announcement cannot be shared. It is mandatory to completely close the posts of visual content to comments.

As we have already mentioned above, patient comments on visual content or expressions that will mean a declaration of thanks may cause the physician to be held responsible. In this respect, it is an appropriate regulation to make it mandatory to completely close the posts to comments.

Patient images cannot be shared during surgery or medical intervention and in the operating theatre.
Visual contents of the intimate parts of the body cannot be shared in a way that contradicts the rules of public morality.

It can be said that the boundary of the intimate parts of the body expressed as ‘contrary to the rules of public morality’ is ambiguous. For example; it is a question mark whether sharing the pre- and post-operative photographs of a person who has undergone a breast reduction operation by a plastic surgeon, where only the operation area is displayed, will be considered as an activity contrary to the relevant provision even if the photographs are anonymised by various methods (blurring, etc.) and the Consent Form is used. Moreover, considering subparagraph (a) of the relevant regulation, which stipulates that “images and expressions contrary to the general rules of morality… cannot be included in visual content” and which is inclusive of subparagraph (ğ), it is not understood why there is a need for a separate regulation regarding intimate areas.

Posts with visual content must be made by the health facility or the relevant healthcare professional. The fact that these posts are made by others does not eliminate the responsibility of the relevant health facility or healthcare professional.

In a decision of the Personal Data Protection Board (“PDP Board”) regarding the above provision, it was observed that the hospital obtained explicit consent from the patient in order to publish the photographs of the relevant person on social media, but the images of the relevant person were shared by the doctor working in the hospital and conducting the operation, and it was decided to impose an administrative fine on the data controller hospital on the grounds that the party to which the relevant person gave explicit consent was the data controller hospital, and that there was no explicit consent statement regarding the sharing of the images taken while unconscious by the said doctor.[3]

 

The shared visual content cannot be published in media such as print and visual media, social media platforms, websites, etc., either sponsored or paid.

Considering that most of the decisions of the Board are based on the justification of commercialisation of healthcare services, it can be said that the relevant paragraph is an appropriate regulation.

Images related to the region, location, medical devices, equipment, tools, equipment or personnel or any similar element cannot be shared in order to give the impression that the healthcare professional or healthcare institution is superior or better than other healthcare professionals or healthcare institutions.

 

Audit and Sanction

Pursuant to Article 8 of the Regulation, titled “Supervision and evaluation of promotional and informative activities in the field of health”, press and media organs will be regularly scanned by the General Directorate of Health Services and Provincial Health Directorates through their websites within the framework of promotional and informative activities.

In addition, it is important to note that pursuant to Article 9 of the Regulation, healthcare professionals who participate in promotional and informative programmes on radio and television channels broadcasting via cable, satellite, terrestrial and similar transmission media, and who make speeches and explanations are obliged to sign the Letter of Undertaking attached as Annex-3 in two copies before the programme. One copy of the Letter of Undertaking will be kept by the relevant broadcasting organisation and one copy will be sent to the Ministry of Health.

Considering that it is quite common for healthcare professionals to appear on various broadcasting channels for information purposes, the relevant regulation is striking. As a matter of fact, the Regulation stipulates that Provincial Evaluation Commissions for Information and Promotion Activities in Health will be established in the provinces in order to examine and evaluate the compliance of the promotion and information activities with the legislation, and that administrative sanctions will be imposed on healthcare professionals who are found to have provided information, speeches or statements contrary to public and personal health within the framework of the relevant legislation.

GRC LEGAL Commentary and Final Word

In the light of our examination and the comments we have made above, it can be said that the Regulation, which entered into force on 29 July 2023, was expected to clarify the grey areas in the healthcare sector, but it failed to meet this expectation.

When the decisions of authorities such as the Board and the PDP Board are examined in practice, it is evident that the points described as grey areas and criticised in this article were carried out in this way before the Regulation, most of the issues introduced by the Regulation have not succeeded in reaching the quality that will give a new direction to the practice, uncertainties continue and some issues have even become more uncertain. Therefore, it seems that the fact that this Regulation, which will start to gain a place in the decisions in the coming days, will go beyond the characteristic of an ineffective element, again depends on the practitioners and decision-making mechanisms in practice.

[1] Advertisement Board, Meeting No: 335, 11/07/2023, File No: 2023/560

[2] Decision of the Personal Data Protection Board dated 11/05/2023 and numbered 2023/787 (Access Date: 13.09.2023)

[3] Summary of the Decision of the Personal Data Protection Board dated 29/06/2022 and numbered 2022/630 (Access Date: 13.09.2023)