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The regulation on the promotion of medicinal products revised

The regulation on the promotion of medicinal products revised

In Turkey, the legal regime regarding the promotion of medicinal products is regulated under the Regulation on Promotional Activities of Medicinal Products for Human Use (“Promotion Regulation”), which was published in the Official Gazette dated August 26, 2011.

According to the Promotion Regulation, the general rule for the promotion of medicinal products in Turkey is that no promotional activities are allowed for products which are not licensed in Turkey. Another important rule is that the pharmaceutical companies shall not direct their promotional activities to the patients, but can promote their products to healthcare professionals under certain conditions.

The Promotion Regulation has been amended and the revised version (“Revised Regulation”) has been published in the Official Gazette on October 14, 2012. As the Promotion Regulation governs the relation between the pharmaceutical companies and the health-care professionals, there is a general rule that companies shall not encourage the prescription of their products by way of offering any kind of benefit to healthcare professionals. In the Revised Regulation, the value of the gifts given by the companies to the healthcare professional has been determined. According to the Revised Regulation the value of such gifts cannot exceed 2,5 % of the applicable minimum wage, which is approximately Euro 11.

With respect to the congress and symposium sponsorships, heavier limitations have been brought in the Revised Regulation.  Namely, a healthcare professional may benefit from sponsorships only 3 times in a year, and at most 2 of them may be of the same pharmaceutical company.  Only 1 out of these 3 sponsorships limit may be used abroad. On the other hand, it has been made clear that the events where the healthcare professionals attend as speakers do not fall into the scope of these limitations. All events and organizations have to be notified to the Ministry of Health (“MoH”). Furthermore, as per the Revised Regulation healthcare professionals must mention the support of the pharmaceutical companies at the beginning of their speeches and/or at the end of their articles.

Another revision has been made on the certification of the promotion personnel.  The certificates will be granted by the MoH after having training on the subject, and will be valid for a period of 4 years. The training will be given either directly by the pharmaceutical company or the company may outsource such training. The graduates of the “Pharmaceutical Promotion and Marketing Program” are exempted from the obligation to have said certificate.

The provisions in the Revised Regulation on sponsorship will be effective as from Jan 1, 2013; whereas the effective date of the provisions on product promotion personnel has been extended until January 1, 2015.

Ozge Atilgan Karakulak
Tugce Avcisert

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