Turkey amended the Pharmaceutical Preparations Law (Law No. 1262) (the "Medicine Law"), effective January 18, 2014, increasing the penalties for manufacturing, marketing and selling counterfeit and fake medicines and for violation of promotion rules.
What the amendments do
With the amendments:
Manufacturing counterfeit medicines is now subject to imprisonment for one to five years. The penalty is increased one-third if the products do not actually have the claimed treatment benefits. Previously, this was only subject to a fine of up to TRY 25,000.
Selling, marketing or advertising a product that is not a medicine by claiming it has medicinal function is subject to imprisonment of one to five years. Previously this was not subject to any criminal sanction. Additionally, if the product is promoted or advertised online or by other electronic means, the Ministry of Health is now authorized to have access to the website blocked.
Marketing authorization holders of, and those who willingly sell, fake medicines are subject to a fine of TRY 10,000 to 500,000. Previously, the maximum fine was TRY 25,000.
The amendments also introduce fines for violating promotion rules under the Medicine Law:
Violating promotion rules and off-label marketing is now subject to a fine of up to five times the product's turnover for the previous year. For online promotion or advertising, the Ministry of Health is authorized to have access to the website blocked.
Promoting or selling products with health claims without the authorities' authorization or in violation of an authorization is subject to a fine of TRY 20,000 to 300,000.
Actions to consider
Pharmaceutical companies must ensure that:
their products are in technical compliance with their marketing authorization;
the liability provisions of toll manufacturing agreements are carefully formulated;
they do not conduct off-label marketing activities except under exceptions stated in the Turkish Regulation on the Promotion of Medicines for Human Use;
their online platforms and social media tools do not include anything that is open to the public and can be interpreted as the marketing of medicines; and
general compliance with medicine promotion rules.
Finally, food supplement manufacturers must ensure their advertisements and health claims comply with the Turkish Food Codex and advertising rules.
With Turkey's more severe sanctions on both counterfeit and falsified medicines, compliance in the pharma sector has become more important than ever.