Life Sciences Law in Turkey Key Developments and Predictions - 2020

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 80 million that is covered by an extensive social healthcare system, the size and volume of the Turkish life sciences industry is significant.

Despite many opportunities that accompany this potential for growth, it should also be noted that both the Turkish pharmaceutical and medical device industries remain heavily regulated in all aspects, ranging from market access, to pricing and reimbursement being covered by industry-specific regulations. The said measures are strictly enforced by the Turkish Medicines and Medical Devices Agency (“TITCK”) established under the relevant body of the Ministry of Health, and the Social Security Institution (“SSI”).

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 prompted the government to seek ways of reigning in public expenditure by incorporating a rigid pharmaceutical pricing policy.

In addition, the SSI requests a considerable discount for reimbursements. These difficulties in pricing and reimbursements have caused hindrance in the access to pharmaceuticals. Procurement from abroad of pharmaceuticals that cannot be found in the domestic market has greatly increased. To control the budget, the SSI developed alternative reimbursement models, regulated named patient programs, and even implemented localization policies.

Nevertheless, the healthcare industry regulation in Turkey is mostly aligned with worldwide standards. Promotional restrictions both to pharmaceuticals and medical devices, as well as the rules of ethics and compliance, are in parallel with the EU legislation.