Remarks On 2021 Corruption Perceptions Index
Transparency International, a non-governmental organization combatting corruption worldwide, released the 2022 Corruption Perceptions Index (“CPI”) on January 25, 2021. As a composite indicator, the Index combines various sources to measure the perceptions of businesspeople and country experts, on corruption in the public sector. Accordingly, it ranks 180 countries/territories by their perceived level of public sector corruption on a scale from 0 (highly corrupt) to 100 (very… »
Istanbul IP Court Reaches Landmark Decision on Precautionary Injunction
The trigger point and the timing of a request for a precautionary injunction (PI) is crucial. However, in pharmaceutical patent enforcement, most damage occurs from the launch of the Gx product, which can account for a price cut of as much as 40% from the originator’s drug. Therefore, the PI must be filed and granted before the Gx launches, yet while there is sufficient proof available to overcome the so-called Bolar exemption hurdle. The PI filing date serves this aim… »
Removal of Products From Named Patient Programme List
The Turkish named patient programme (NPP) is an exceptional importation regime for pharmaceutical products. Following a 5 December 2018 amendment to Law No 984 on Commercial Pharmaceutical Warehouses and Shops that Sell Poisonous Chemical Substances Used in Arts and Agriculture (Law on Warehouses), it is mandatory to apply for marketing authorisation within three years of a drug's inclusion on the NPP list. It is also mandatory to obtain marketing authorisation within two… »
New Regulation on Licensing of Medicinal Products For Human Use
The Turkish Medicines and Medical Devices Agency has published a new regulation on Licensing of Medicinal Products for Human Use in the Official Gazette (Turkish language) numbered 31686 of 11 December 2021. This Regulation introduces new provisions that amount to a comprehensive amendment of the abolished Regulation of the same name. The noteworthy new provisions of the Regulation are as follows: In the definitions section of the Regulation, some of the concepts are defined… »
The Long - Awaited Amendments in Turkish Data Protection Law
The Turkish data protection authority, Kişisel Verileri Koruma Kurumu, has proposed amendments to the most controversial provisions of the Law on Personal Data Protection numbered 6698. The provisions have been heavily criticized by academia and business circles due to their inapplicability and inadequacy to meet needs. The amendments were actually part of the Economic Reforms, and specific tasks were introduced under the Economic Reforms to comply with the EU General Data… »
Updates on NPP Products in Turkey
The Turkish Medicines and Medical Devices Agency ("Agency") published the new Guidelines for Drug Supply and Use from Abroad ("Guidelines") on 23 October 2021. The Guidelines regulate the procedure of drug supply from abroad for drugs that are not authorized in Turkey or authorized but not available in the market for various reasons. The Guidelines were first published in 2014, updated in 2015, 2017, and 2020 and finally, the final version was published on 23 October… »