aaaaIn the presence of alternative reimbursement models developed globally for pharmaceutical reimbursement systems, such as payback, value-based, indication-based reimbursements, and performance-based models, the Turkish pharmaceutical industry has also required alternative reimbursement models that fall outside the usual pricing and reimbursement rules for innovative products, and that can be negotiated with the Social Security Institution (SSI) to determine reimbursement…
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The prices of pharmaceuticals to be launched on the market are determined in accordance with the Decision on the Pricing of Medicinal Products for Human Use (”Decision”) and the Communiqué on the Pricing of Medicinal Products for Human Use (“Communiqué”) dated 29 September 2017, published by the Ministry of Health, which has been authorised to regulate this area.
The Decision foresees a reference pricing system in which the lowest wholesaler price for the relevant product in…
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Existing Facilitations for Capital Loss and Over-Indebtedness Calculations are Extended until 2026
Article 376 of the Turkish Commercial Code numbered 6102 (the “TCC”) regulates the measures to be taken and the precautions to be implemented by the board of directors of the company, and the procedures to be followed in cases where the company suffers capital loss or becomes over-indebted, to ensure the protection of the financial structure of the company and to secure the…
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With the Communiqué on Maintenance of Commercial Books Not Related to the Accounting of the Business in Electronic Form (the “Communiqué”) published in the Official Gazette dated 14 February 2025, it has become mandatory for companies to keep their commercial books not related to the accounting of the business electronically as of July 1, 2025.
Books and Enterprises within the Scope of the Communiqué
The commercial books, which have been made mandatory to be kept…
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Protecting patent rights in a timely manner is crucial for original pharmaceutical product manufacturers, particularly in being informed of potential infringements before an infringing product enters the market.
However, information requests submitted by legal representatives of original drug marketing authorisation (MA) holders regarding the authorisation files of generic companies—who seek approval through an abridged application referencing the original pharmaceuticals—are…
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Artificial intelligence (AI) technologies, as one of the fastest-developing and most widely debated fields today, provide significant benefits to individuals and society while also posing various risks in terms of personal data protection. Recently, the widely discussed DeepSeek has been subjected to review by the European Commission and relevant data protection authorities.
The Personal Data Protection Authority (“Authority”) has issued the following recommendations for…
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