Turkey: Promotion Of Pharmaceuticals Under Turkish Law

Last Updated: 7 April 2009
Article by Selma Toplu Ünlü and E. Sevi Firat

In Turkey, the advertising matter of pharmaceutical products is governed by the Regulation on the Promotion of the Medicinal Products for Human Use ("Promotion Regulation") which is based on Pharmaceutical and Medical Preparations Law numbered 1262 ("Law"). However, the Council of State1 has revoked most of the provisions of the Promotion Regulation relating to advertising to the general public. This decision has created a legal loophole in the system since some of the provisions, such as the meaning of advertisement and advertisement materials are not defined in other sources. Even though the applicability of these cancelled provisions is in question, these provisions should be considered since the MoH still follows the same procedures and rules when examining promotion activities.

Besides, the Act on Protection of Consumers, Regulation on Principles and Fundamentals of Practices regarding Commercial Advertisements and Announcements and Code of Obligations are applicable where the matter is not regulated under the Law or the Promotion Regulation.

Nowadays, since advertisement to healthcare professionals is a hot topic and the status of the healthcare professionals is quite important when advertising to them, below the evaluation of this matter and sensitive points are given clearly.

As a general rule; promotion of pharmaceuticals can only be made to healthcare professionals namely doctors, dentists and pharmacists. Promotion directed to health professionals must contain essential information compatible with the up-dated product information, updated date of preparation, and classification information. As to the distribution of scientific papers to health professionals, the information contained in the promotional documentation has to be accurate, verifiable, and sufficiently complete to enable the recipient to form his or her own opinion about the therapeutic value of the related medicinal product. In addition to that, all the information including tables and other illustrative matters quoted from medical magazines or other scientific works are to be reproduced in a way faithful to the original and with a precise indication of the sources.

Further, it is possible to organise congresses, seminars, symposia, or scientific and instructive conferences with the aim of communicating and discussing the information. Such activities related to medicinal promotion are not to be used for any purpose other than to relate already available medical information or to introduce new information. Such meetings must be held in appropriate locations, forms, and levels. The Ministry must be notified by the holders of the marketing authorisation of all such meetings the year before by means of an annual schedule. A list of the participants must be kept for submission to the Ministry upon its request.

Moreover, pharmaceutical companies are allowed to offer hospitality to health professionals. However, the applicable rules differ between "public health professionals" and "private health professionals" in hospitality activities on account of further limitations legislated under Civil Servants Ethical Conduct Regulation ("Ethics Code"). In other means, despite the fact that Promotion Regulation allows the companies to pay these expenses to the health professionals, Ethics Code forbids paying to civil servants for travel and accommodation expenses. The contradiction regarding expenses of the civil servants, occurred on account of Ethics Code, fixed with a notice of Prime Ministry Ethic Board. According to the notice, the civil servants are allowed to accept travel and accommodation expenses for the congress from a pharmaceutical company provided that the congress has scientific content, the MoH is informed regarding the attendance and the payment does not cover the family member's and relative's expenses. Furthermore, prior to the congress, the authorization of the public institution that the government employee is in charge with the duty should be procured.

It should also be considered by the companies that the hospitality can include payment of reasonable travel expenses, if relevant, accommodation costs, and eventually enrolment fees. Since providing direct financial contributions is not allowed, paying doctors for their time is prohibited. Additionally, it seems important to pay travel agencies or hotels directly in order to prove that no pecuniary advantages or benefits in kind have been supplied, offered, or promised to them.

Pharmaceutical companies are also entitled to give medical professionals gifts of equipment or subscriptions to medical journals, or to provide medical educational literature, such as self-study materials or other non-cash items. No monetary advantages or benefits in kind may be supplied, offered, or promised to HCPs.

These gifts, which will be provided to health professionals should be relevant to the practice of medicine and be reasonably priced. Also, materials which are not related to the scope, objective, and basic principles of the Promotion Regulation, shall not be used as promotional materials.

In this gift matter, the applicable rules also differ between "public health professionals" and "private health professionals" and this differentiation should be considered during promotional activities. In principle, civil servants are not allowed to accept gifts; however, the Ethics Code allows symbolic gifts in its positive list.

Upon giving an overview of applicable rules regarding advertisement matter of pharmaceuticals, it is also important to emphasize possible sanctions in case of any breach of the Promotion Regulation. In this respect, in case of such infringement of the Promotion regulation, the Article 16 which refers to provisions of Act no.4077 on Protection of Consumer Rights, Act no.3984 on the Establishment and Broadcasting Rights of Radios and Televisions, provisions of the Turkish Penal Code no.765, Act No. 4054 on the Protection of Competition and the related provisions of other legislation will be applicable. Determination of applicability of these laws will be made in light of the specifics of the circumstances. Pursuant to Article 21 of the Promotion Regulation, the MoH is the enforcement authority in charge of implementation. It has the authority to inform relevant authorities where necessary.

Prior to submitting official applications, companies are usually trying to resolve disputes relating to unethical promotion practices within the associations of which they are members. Recently, unfair competition actions are initiated by companies because of unethical promotion practices. Unfair competition rules are stipulated in Articles 56 and 57 of the Turkish Commercial Law and according to Article 56, all acts contrary to good faith may constitute legal grounds for an unfair competition action. Article 57 of the same provides a non-restrictive list of the examples of acts incompatible with good faith. The examples are wide enough to cover (some) copyright and (all) industrial property goods. For example, reflecting discredit upon someone or someone's product; conducting commercial transactions by means of incorrect, misleading declarations; and not obeying the law and regulations applicable to all competitors may lead to unfair competition claims.

Footnote

1 On 14.12.2005, the 10th Chamber of Council of State by its decisions numbered 2003/5945E. and 2005/7622K. cancelled Articles 4 ( d )and ( e ), 5,6,7,8,14, and 15 of the Promotion Regulation. In this case, the Pharmacy Association demanded the cancellation of the promotion regulation claiming that advertising to the general public is against the mandatory rules of Turkish law.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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