Introduction Compulsory licensing allows governments to authorize the use of a patented product or process without the consent of the patent holder, typically for reasons related to public health, national emergencies, or anti-competitive practices. Although this mechanism ensures access to essential medicines, it raises concerns for foreign pharmaceutical companies that rely on patent protection for […]
Introduction In the pharmaceutical sector, patent rights play a vital role in protecting innovations and incentivizing research and development (R&D). For foreign pharmaceutical companies, securing patent protection is critical to maintaining market exclusivity and recouping investment in drug development. However, Turkey’s intellectual property framework presents several legal challenges that foreign companies must address to effectively […]
Introduction Turkey operates a reimbursement system that is a critical component of the healthcare sector, aimed at ensuring patients’ access to essential medicines through public funding mechanisms. The Social Security Institution (SGK) manages this system by negotiating prices and determining which medicines are covered. For foreign pharmaceutical companies, understanding and adapting to this framework is […]
Introduction Clinical trials are essential for the development of new drugs and medical treatments, enabling pharmaceutical companies to assess the safety and efficacy of their products. In Turkey, the legal framework governing clinical trials aims to align with international standards while ensuring the protection of public health and the rights of participants. However, foreign pharmaceutical […]
Introduction The pharmaceutical market in Turkey is tightly regulated to ensure the safety, efficacy, and quality of medications available to the public. Foreign pharmaceutical companies aiming to operate in this market must navigate complex licensing processes administered by the Turkish Medicines and Medical Devices Agency (TITCK). While these regulations aim to align with international standards, […]