Pharmaceutical advertising regulation and medical device advertising in Turkey

1.1 Medicines

• Consumer Protection Law No. 6502 (“Law No. 6502”);
  • Trade Advertising and Unfair Trade Practices Regulation;
• Pharmaceuticals and Medical Preparations Law No. 1262 (“Law No. 1262”);
  • Advertising Measures for Medicinal Products for Human Use Regulation ("Medicinal Products Advertising Regulation");
• Establishment and Broadcasting of Radio and Television Services Law No. 6112 ("Law No. 6112"); 
• Organization and Duties of the Ministry of Health and Related Institutions Decree-Law; and
• Turkish Commercial Code No. 6102 ("Law No. 6102").

1.2 Medical devices

• Decree-Law on Organization and Duties of the Ministry of Health and related institutions Decree-Law;
  • Placing on the Market, Advertising and Notification of Medical Devices Regulation ("Medical Devices Advertising Regulation"); 
• Law No. 6502; and
• Law No. 6102.

Yes, there are codes of self-regulation and the most important ones are listed below:

2.1 Medicines

• The Association of Research-Based Pharmaceutical Companies ("AIFD") is a member of the IFPMA Federation of International Pharmaceutical Manufacturers and Associations ("IFPMA") and Federation of European Pharmaceutical Industries and Associations ("EFPIA"). The AIFD consists mainly of foreign pharmaceutical companies such as Amgen and Novartis and provides self-regulatory codes of conduct for its members, such as:
  • Competition Rules Compliance Guideline; and
  • AIFD Code of Practice.
• The Pharmaceutical Manufacturers Association of Turkiye ("IEIS") provides the second major self-regulatory code of conduct for the advertising of medicines. IEIS has implemented its own policy since 1990. Prepared for the purpose of establishing a self-regulatory mechanism among its members, the policy allows for the monitoring of such activities by a Supervisory Board.
• The Pharmaceutical Industry Association of Turkiye ("TISD").
  • The TISD Advertising Guidelines regulate the advertising of medicinal products.
• The Turkish Pharmaceutical Exporters Platform ("TIIP") is an organization linked to the IEIS that develops strategies and guidelines to increase the export volume of Turkish pharmaceutical manufacturers and strengthen the international promotion of Turkish pharmaceuticals.
• Turkish Medical Doctors Association ("TTB").
  • The TTB Principles on Medical Doctors and the Advertisement of Pharmaceutical Products regulates the advertisement of medicinal products. Accordingly, TTB may oversee advertising activities through an ethics committee.

2.2 Medical devices

Although there is no self-regulatory code of conduct specifically for medical devices, the rules of the AIFD and IEIS can also apply to medical devices if companies so wish.

3.1 Medicines

Over-the-counter ("OTC") medicines and prescription medicines may not be advertised to the public. However, the public may be informed about products used in vaccination campaigns, organised actions to combat epidemics or other campaigns of the Ministry of Health ("Ministry") to promote health - as they are important for the protection of public health - with the approval of the Ministry and within the limits of the policies and procedures established by the Ministry for such products.

Apart from that, medicines may be promoted to certain healthcare professionals, namely, doctors, dentists, and pharmacists. Promotion activities may be carried out by:

1. presentation materials advertising to doctors, dentists, and pharmacists,
2. holding or supporting scientific meetings and product advertisement meetings, and,
3. pharmaceutical sales representatives visiting doctors, dentists, and pharmacists.

Products must be registered or authorised in accordance with the relevant Regulation. Accordingly, an authorisation/licence is a certificate issued by the Turkish Agency for Medicine and Medical Devices ("Agency") stating that the product in question can be manufactured and marketed in a specific formulation and in a specific pharmaceutical form or strength in accordance with the approved product information.

In addition, pharmaceutical sales representatives must obtain a "Qualification Certificate" to promote a human medicinal product to:

1. doctors,
2. dentists and
3. pharmacists ("healthcare professionals") through direct calls.

Please also note that the relevant certificate can 

3.2 Medical devices

Medical devices that can only be used or applied by healthcare professionals or required to be applied at medical devices sale centres and medical devices sales, extrapolation and application of which can only be carried out at hearing aid centres, custom-made prosthesis and orthosis centres, opticianry shops, or dental prosthesis laboratories cannot be advertised to the consumer.

According to the Medical Devices Advertising Regulation, and medical devices sales centres should have at least one advertising staff. A certificate of work and an identity card are issued for the advertising staff of the medical device sales centres by the Provincial Directorate of Health, and they must be registered in the Agency's electronic system.

No, according to Law No. 1262 and the Medicinal Product Advertising Regulation, advertising of any type of medicinal product to the public is prohibited and advertising to healthcare professionals is only allowed under certain conditions.

In general, all images, statements or references in advertising that give the impression that a product or service is recommended by health professionals are prohibited.

5.1 Medicines

The advertising of medicinal products to the public, directly or indirectly through any public media or communication channel, including the Internet, is prohibited, whether through programmes, films, television series, news reports or similar media. 

No prescription drug or its reduced sample may be supplied to the public directly or indirectly.

Information for the general public may be provided on occasions such as vaccination campaigns and epidemic control, which are important for the protection of public health, or on other campaigns of the Ministry to promote health, with the approval of the Ministry and within the framework of the policies and procedures established by the Ministry for such products. 

5.2 Medical devices

Medical devices that can only be used or applied by healthcare professionals or require to be applied at medical devices sale centres and medical devices sales, extrapolation and application of which can only be carried out at hearing aid centres, custom-made prosthesis and orthosis centres, opticianry shops, or dental prosthesis laboratories may not be advertised to the public. Announcements approved by the Ministry or the Agency in media channels (i.e. health magazines) aimed at health professionals and website information about distribution centres are not covered by this restriction.

In addition, Law No. 6502 prohibits commercial advertising that misleads consumers or exploits their lack of experience and knowledge, endangers their safety of life and property, encourages the commission of crimes, endangers public health and abuses the sick, the elderly, children and the disabled.

Accordingly, it is prohibited to use the names of the Ministry and associated institutions, as well as the names of health care institutions and persons involved in the research of the medical device, without permission.

According to the provisions of the Medical Devices Advertising Regulation, medical devices sold or used in hearing aid centres, prosthesis and orthosis centres, optician shops and dental prosthesis centres, as well as medical devices that can only be used or applied by healthcare professionals, may not be advertised directly or indirectly to the public. Medical devices that do not fall within this scope may only be advertised in the internet environment where the product is sold. Toothpastes, denture care products for individual use, cotton wool, plasters, etc. are exempt from these restrictions and may be advertised. 

Medical devices shall not be advertised by lottery, games of chance and similar tools.

In summary, advertising of medical devices must not be done in a way that endangers the health of the patient, the user or the environment.

6.1 Medicines

Excluded are advertisements at international congresses held in Turkiye and information activities carried out in person by the scientific service of the licence/permit holder at the written request of the doctor/dentist/pharmacist:

• Products that have not been registered or approved in accordance with the relevant legislation; 
• Indications other than those approved by the Agency for products registered or authorised under the Regulation; and
• With the exception of promotional activities for the purpose of pharmacovigilance of products procured through international suppliers and purchased by the Social Security Agency under alternative reimbursement schemes, of which the Agency is informed; the products registered or authorised under the relevant Regulation, but for which the Agency grants permission to import against prescription because they are not available on the domestic market, may not be promoted to health professionals.

6.2 Medical devices

It is prohibited to use the names of the Ministry and associated institutions, as well as the names of health care institutions and persons who have been involved in the research of the medical device, without permission.

Medical devices shall not be advertised in a manner that endangers the health of the patient, the user or the environment.

Medical devices shall not be advertised by lottery, games of chance and similar tools.

Advertising that may lead to unfair competition may not be made.

7.1 Medicines

Medicinal Product Advertising Regulation does not provide for an obligation to address certain information to healthcare professionals and sets requirements for the information to be given to them.

The promotional activity for a product shall be consistent with the information and data contained in the claims approved by the Agency.

Advertisements must contain informative and evidence-based medical data about the properties of a product that enable healthcare professionals to form their own opinion about the therapeutic value of the product. 

If the advertising involves the use of documentation prepared using quotations, tables or other visual material from medical journals or other scientific publications, these materials must be reproduced authentically, with a full reference to the relevant sources.

When advertising products, doctors, dentists and pharmacists may not be granted, offered or promised any benefits, either in cash or in kind.

7.2 Medical devices

Advertising for medical devices must contain the following information:

• Indication that the display clearly refers to the unit;
• The declaration of conformity of the appliance, its EC certificate, the name and information of the appliance in the documents such as a technical dossier and the compatible appliance names and information;
• Information on the label and in the operating instructions of the appliance compatible with the intended use;
• Scientific reports and certificates relating to the advertisement, date of issue, contact information and the field of expertise of the preparer (person or institution); and
• Evidence-based medical information on any therapeutic effect of the device.

8.1 Medicines

As mentioned above, advertising of products to the public, directly or indirectly, through any public media or communication channel, including the Internet, is prohibited, whether through programmes, films, television series, news reports or similar media.

8.2 Medical devices

Advertising must be in accordance with general principles and the information required by the honesty principle must be made available to the general public.

If the advertising involves the use of documentation prepared using quotations, tables or other visual material from medical journals or other scientific publications, these materials must be reproduced authentically, with a full reference to the relevant sources.

According to Law No. 6502, comparative advertising may be made for competing goods or services that meet the same needs or are directed towards the same purpose. 

Law No. 6102 states that advertising that violates the principle of honesty (e.g. unnecessary disparagement of competing products) may lead to unfair competition. 

Medicinal Product Advertising Regulation provides that advertising must not be made with misleading, exaggerated or unsubstantiated information that could encourage unnecessary use of a product or lead to unexpected risks, or by using enticing imagery that is not directly related to the product. 

Advertising of products to the public directly or indirectly through public media or communication channels, including the Internet, is prohibited, whether through programmes, films, television series, news reports or similar media.

However, the AIFD self-regulatory code regulates the advertising of medicines and provides for this:
Companies are responsible for the websites and social media accounts they have set up or that have been created on their behalf. Appropriate measures must be taken to ensure that there is no content on the websites they support or on their social media accounts that can be perceived as advertising medicines to the general public. 

A company may make information about its medicines available to the general public on the company website, provided this is in accordance with laws and regulations. Pharmaceutical companies may develop and promote websites and social media platforms to inform patients and society about diseases and current medical applications.

Monitoring bodies can be audited under three titles:

Civil law claims 

The allegedly injured party can demand the following from the courts on the basis of unfair competition:

• Declaration of unfair competition;
• Prevention of unfair competition;
• to pay damages; 
• Compensation for non-pecuniary damage;
• restraining order;
• Reimbursement in kind; and
• the profit made from the unfair competition act.

Administrative supervision

• The Turkish Agency for Medicine and Medical Devices monitors violations of the Medicines Advertising Regulation and the Medical Devices Advertising Regulation. 
  • The Agency may issue a warning or ban advertising activities;
  • It may impose fines; and
  • She can file a criminal complaint, which can result in a prison sentence of up to five (5) years.
• The Self-Regulatory Commission for Advertising monitors acts of non-compliance with Act No. 6112 and its regulations. Within the framework of the joint commitment to the public, the advisory decisions are not legally binding, but they are binding in practice. The validity of this binding nature is guaranteed by the professional and business ethical values of the parties. 

Self-audit

Self-regulatory mechanisms have their supervisory boards, which monitor the violations of their members. Although their decisions are not legally binding, they can

• Make an application to medical chambers
• According to the monitoring of the medical associations, 
  • The infringer may be disclosed by TTB);
  • It may be addressed to the TTB Disciplinary Committee; and
  • A report may be made to the Ministry. 

Unfortunately, no developments are currently planned in our area of responsibility.