Pharmaceuticals and Life Sciences Law in Turkey Key Developments and Predictions - 2023

The year 2022, in which we have left behind the significant effects of the Covid-19 pandemic, has been a hectic year for the life sciences industry. It is expected that 2023 will be at least as busy as 2022 due to the amendments in the pharmaceutical and medical device legislation in the EU and the fact that presidential elections will be held in Turkey.

The increase in the quality of health services and patients’ access to medicines has inevitably increased the demand for health services and pharmaceuticals, and there has been an associated increase in public spending. This increase led public institutions to impose a rigid pharmaceutical pricing policy. However, especially the rapid increase in currency exchange rates and adverse economic developments cause some products to become challenging to find on the market, and even pharmaceutical companies to exit the Turkish market partially or entirely or abandon the decision to offer new products on the market.

The Turkish Medicines and Medical Devices Agency (“TMMDA”), established under the Ministry of Health (“Ministry”), and the Social Security Institution (“SSI”) have started to take several measures to ensure the continuity of the supply of products. However, the irregularities in some procedures and the allegations of counterfeit drug supply indicate that stricter measures should be taken.

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. We will closely follow the developments of the year 2023 in this field and continue to inform our stakeholders about these developments.

With this paper, we are pleased to outline the most up-to-date issues in life sciences.


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