Pricing of Pharmaceuticals and the Fixed Exchange Rate
Healthcare and pharmaceuticals make up a highly regulated industry sector in Turkey, and the pricing of medicines is no exception. The prices of medicines that are to be marketed in Turkey are set in accordance with the Decision on Pricing of Human Medicinal Products (“Decision”) and the Communiqué on the Pricing of Human Medicinal Products (“Communiqué”) of 29 September 2017, issued by the Ministry of Health (“MoH”) who is vested with the competencies to regulate the… »
Market Access-Reimbursement Agreements
Until recently, there was no direct contractual relationship between the SSI and the pharmaceutical companies (“pharma companies”) regarding the pharmaceuticals purchased by the State. The pharma companies applied for the reimbursement of their products to the SSI and, once listed, companies sold their products to warehouses, which then distributed the products to the hospitals and pharmacies. In line with this sale and distribution chain, the SSI reimbursed the hospitals, or… »
Localisation of Previously Imported Products
In Turkey, the innovator pharmaceutical market is dominated by originator companies of foreign origin, with local companies active in the generics market. The government’s unease with the emphasis on imported products in the Turkish market beckoned the state development plan to procure local production in the pharmaceutical market, a political act affecting the activities of many pharmaceutical companies of foreign origin. The aforementioned state development plan triggered… »
Named Patient Programs
Named Patient Programs (“NPP”) is one of the exceptional importation regimes of pharmaceutical products without marketing authorisation (“MA”) in Turkey, or with marketing authorization, but which are unavailable in the Turkish market for various reasons. Only the Turkish Pharmacists’ Association (“TEB”) and the İbn-i Sina Health Social Security Center, established under the SSI, were authorized to import NPP products until December 2018. An amendment in the law was… »
Interactions with HCPs
Promotional activities of human medicinal products (“HCPs”), enteral nutrition products, and infant formulas for special medical purposes, are regulated under the Regulation on the Promotional Activities of Pharmaceutical Products for Human Use (“Promotion Regulation”) dated 3 July 2015. Pursuant to the Promotion Regulation, any advertisement of products to the general public, whether directly or indirectly, through any public media or communication channels, including the… »
Transfer of Value
There is no public disclosure rule for value transfers made by pharmaceutical companies. However, according to the Regulation on the Promotional Activities of Pharmaceutical Products for Human Use (“Promotion Regulation”) dated 3 July 2015, the pharmaceutical companies shall notify TITCK about any value transfers that exceed 10% of the current monthly gross minimum wage, to health institutions, organizations, universities, health professionals, and members of professional… »
Harmonization with the EU Medical Devices Regulation
Regulations on Medical Devices numbered 2017/745 (“MDR”), prepared by the EU Commission, has been published and will enter in force on 26 May 2020. As a non-EU country, TITCK published an announcement on 30 December 2019 that harmonization of the new rules established by the MDR with the Turkish regulations continues. On 1 February 2020, Presidential Circular numbered 2020/1 was published in Official Gazette numbered 31026 on the transition period for the UK’s exit from… »
Promotion of Medical Devices
With medicines, the rule is clear: The general public cannot be the audience to any promotional activity, whatsoever, of pharmaceutical products. However, with medical devices, the rule in place in the Regulation on the Sales, Advertisement and Promotion of Medical Devices (“Medical Device Promotion Regulation”) has caused confusion in the past. The rule states that medical devices that must exclusively be applied by healthcare personnel, and those that are included in the… »
Food Supplements
The Regulation on the Importation, Production, Processing and Supply of the Food Supplements (the “Regulation”) was published by the Ministry of Food and Forestry (the “MoA”) on 2 May 2013 in the Official Gazette, and came into force as of 2 August 2013. The said Regulation is not only the first regulation that has been drafted, particularly on food supplements, but also includes unique provisions with regard to the control and approval mechanism to be established over food… »
Cosmetics
The packaging and labelling requirements for cosmetic products are regulated under Cosmetic Law numbered 5324 (the “Law”) and the Regulation on Cosmetics (the “Regulation”) of the TITCK of the MoH. In addition to the Law and the Regulation, the Guidelines on the Promotional Activities of Cosmetic Products and the Regulation on the Health Claims of the Products that are Offered for Sale with a Health Claim (“Health Claim Regulation”) are still applicable, which means… »
Personal Health Data Protection
The protection of personal data and personal health data is regulated under Personal Data Protection Law (“DPL”) numbered 6698. The DPL provides that the general rule for the processing of personal data is that such data may only be processed with the explicit consent of the data subject. As for sensitive personal data (data relating to race, ethnic origin political beliefs, philosophical beliefs, religion, denomination or other faiths, clothing and attire, membership of an… »
Keyword-Based Searches in Trademarks Law
In a recent decision, the Federal Court of Germany ruled that the platforms displaying third party products as search results for the searches based on keywords that are identical to a trademark on e-commerce web sites shall be liable for breaches in the trademarks rights, in the event that these platforms use an algorithm with an active role in determining the products to be displayed. The Court has also decided that AdWords ads directed to these lists also constitute a… »