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Life Sciences Law in Turkey Key Developments and Predictions - 2021

In this year's report, we focus on the key aspects of life sciences in Turkey, the most important and challenging issues in Turkey’s life sciences industry.

With Turkey having a population of more than 80 million, is covered by an extensive social healthcare system, the size and volume of the Turkish life sciences industry is significant.

This growth potential brings with it many opportunities, but also this potential attempted to be balanced with strict regulations that pharmaceutical and medical device industries are subject to, ranging from market access, to pricing and reimbursement. The Turkish Medicines and Medical Devices Agency (“TITCK”), established under the Ministry of Health, and the Social Security Institution (“SSI”), are the main controllers of this balance.

The increase in the quality of health services and patients’ access to medicines has, inevitably, increased the demand for health services, as well as pharmaceuticals, and there has been an associated increase in public spending. This has led to a rigid pharmaceutical pricing policy prompting the government to seek new ways. In addition, the SSI requests a considerable discount for reimbursement. Rigid precautions in pricing and reimbursement may hinder the patient’s access to especially innovative pharmaceuticals. Procurement from abroad (NPP) of pharmaceuticals on a prescription basis that cannot be found in the domestic market due to rigid pricing and reimbursement policy has seriously increased in recent years. Additionally, for the control of health expenditures, alternative reimbursement models, and even localization policies, have been implemented.

Apart from some limitations specific to Turkey and the lack of transparency, it can be said that the healthcare industry regulation in Turkey, in particular licensing, registration systems, ethics and compliance rules, are in line with the standards of developed countries and EU legislation.