New Guidelines on Authorisation and Packaging of Homeopathic Medicinal Products
On 24 December 2021, the Regulation on Licensing of Homeopathic Medicinal Products (Regulation) was published in the Official Gazette. Pursuant to the Regulation, on 15 March 2022 the Medicines and Medical Devices Agency published the Guidelines on Licensing of Homeopathic Medicinal Products (Turkish language) and the Guidelines on Packaging and Product Information, Readability and Tracking of Homeopathic Medicinal Products (Turkish language). The Guidelines regulate the… »
A Fairer Way to Determine Royalties in Turkish Compulsory Licensing
Compulsory licensing, which is regulated by both Article 99 of the repealed Decree Law 551 and Article 129 et seq of the Industrial Property Law, which follows Article 31 of the Trade-Related Aspect of Intellectual Property (TRIPs), is a fairly recent institution in Turkey. However, covid-19 has given new urgency to the debate on this issue. Even though it has never actually been applied, compulsory licensing has been widely discussed, not only as a convenient tool to… »
How Should Turkish Private Sector Read the 2021 Corruption Index?
The term corruption is often defined as the abuse of entrusted power for private gain. Corruption does not only kill public trust, but also prevents countries from unleashing their potential. Many studies indicate the negative correlation between corruption and sustainable economic growth. Entrepreneurship, investment, and business expansion all depend on transparency and accountability and may only flourish in an environment where corruptive attempts are fought back… »
Amendments on the Communiqué Concerning the Mergers and Acquisitions Calling for the Authorization of the Competition Board
Merger and Acquisitions of 2021 Being 309 merger and acquisition notifications were notified to and reviewed by the Turkish Competition Authority (“TCA”) in 2021. TCA has granted authorization to 277 of them, conditional authorization to 3 of them, and has found that 29 of them are not subject to an authorization at all. It is seen that 37 of the merger and acquisition notifications examined in 2021, were related to the chemical and mining sectors, 32 of them were related to… »
Recent Developments & Turkey’s Position on SEPs: Navigating The Technology-Driven World
Standard essential patent (SEP) appears to be the new buzzword of patent law considering the upward trend in patent litigation arising from SEPs. Indeed, the continuous technological advancement supports the creation of SEPs so this trend is likely to continue in the near future. Accordingly, SEPs is a concept arising from the interaction between patent rights, which provide exclusive use of an invention and ‘standards’ aimed at the widespread and mandatory use of this… »
Pricing of Pharmaceuticals and the Fixed Exchange Rate
Pharmaceutical prices in Turkey have always been one of the most controversial issues. The prices of medicines that are to be marketed 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”), which is vested with the competencies to regulate this area. The Decision provides for a reference pricing… »
Market Access-Reimbursement Agreements
For an extended period, the pharmaceuticals industry needed a unique model of reimbursement where its conditions could be set together through negotiation with the SSI, and the regular price and reimbursement rules did not apply for innovative products. With the enactment of the Social Security and General Health Insurance Law numbered 6552 in September 2014, alternative reimbursement models also became an essential topic in the Turkish healthcare industry. The complementary… »
Audit Standards for Information Security Processes
Introduction and Developments With the Presidential Circular on Information and Communication Security Measures which came into force once published on July 6, 2019 (the "Circular"), it was aimed to mitigate and neutralize serious security risks encountered in the digitalization process and ensure the security of critical data for public institutions and organizations and enterprises providing critical infrastructure services. The Information and Communication Security Guide… »
New Regulation on Licensing of Human Medicinal Products
The New Regulation on Licensing of Human Medicinal Products (the “Regulation”) prepared by the TITCK entered into force upon its publication in the Official Gazette numbered 31686 and dated December 11 2021. It has been seen that the purpose aimed with the Regulation is reflecting up-to-date processes present in the TITCK practice but did not exist in the previous regulation dated 2005 and providing compatibility of the legislation with the EU directive numbered… »
Challenges and Opportunities When Combatting Counterfeits in Turkey
It is not a secret that Turkey has an important geographical location for production and sales of counterfeit products as well as the ones in transit. Most of the smuggled products entering Turkey also turn out to be counterfeits. This requires brand owners to take an active role in Turkey to combat the counterfeits, cover all possible basis, and also seek alternative and creative approaches. There are certain civil and criminal actions that can be taken while combatting… »
Named Patient Programs
Named Patient Programs (“NPP”) is one of the exceptional importation regimes of pharmaceuticals without marketing authorization (“MA”) in Turkey, or with marketing authorization, but which are unavailable in the Turkish market for various reasons. In cases where a pharmaceutical does not have an MA in Turkey, or has an MA, but cannot be found on the market, and patients are in need the pharmaceutical in question, it is possible to procure the pharmaceutical via this special… »
Interactions with HCPs
Promotional activities of human medicinal products, 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 Internet… »