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We share our knowledge and expertise to update our community and clients about legal developments in Turkey.

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Turkish Court of Appeal Rules on Likelihood of Confusion

The Turkish Court of Appeal has overturned lower court decisions in a case concerning likelihood of confusion between trade marks sharing a common weak element. Güldeniz Doğan Alkan and Ayşenur Çıtak explain. Origins of the dispute Türkiye İş Bankası A.Ş., which is a popular bank and holder of the well-known trade mark Türkiye İş Bankası in Turkey, filed an application for the mark shown on the right in classes 9 and 36. An opposition was filed against the application… »

MedTech Europe Guidance Regarding Conduct During COVID-19 Crisis

In the current COVID-19 crisis medical device companies continue to prove support to healthcare professionals, healthcare organizations, healthcare systems and governments in order to fulfill the urgent needs. However, the local regulations and codes of conduct for the industry on relationship between the medical device companies and governmental organizations are still in force. Therefore, it is likely that some actions taken by the medical device companies in response to… »

European Parliament Approved the Proposal for Postponing the Implementation Date of Medical Device Regulation No (EU) 2017/745 (MDR)

The coronavirus (Covid-19) crisis has created extraordinary circumstances that require substantial additional resources and an increased availability of vitally important medical devices. However, none of this could reasonably have been anticipated at the time of adoption of the Medical Device Regulation numbered (EU) 2017 /745 (“MDR”) to be in the force on 26 May 2020. In this regard, on 3 April 2020, the European Commission has adopted a proposal to postpone by one year the… »

Questionable Approach of Turkish IP Courts in Assessing Bolar Exemption

Article 85(3) (c) of the Industrial Property Law excludes marketing authorisation applications from the scope of patent rights. However, the IP courts’ interpretation of this has been disproportionately weighted against patent holders. Generic pharmaceutical companies can obtain a marketing authorisation by carrying out a number of procedures before the Ministry of Health. As a result, entities that apply for a marketing authorisation seven to eight months before the… »

Key Developments and Predictions for Life Sciences in Turkey

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With Turkey having a population of 80 million that is covered by an extensive social healthcare system, the size and volume of the Turkish life sciences industry is significant. Despite many opportunities that accompany this potential for growth, it should also be noted that both the Turkish pharmaceutical and medical device industries remain heavily regulated in all aspects, ranging from market access, to pricing and reimbursement being covered by industry-specific… »

Pricing of Pharmaceuticals and the Fixed Exchange Rate

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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… »

Localisation of Previously Imported Products

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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 Program

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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

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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

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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

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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

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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… »