Comprehensive Amendments Proposed to Turkish Healthcare System is on Turkish Parliament Agenda

The Draft Law submitted on 24 June 2025 to the Grand National Assembly of Turkey is a remarkable and important legislative proposal, as it includes many regulations on the provision of health services, professional authorizations, as well as product and service audits related to the Turkish Healthcare System.

In the general justification of the Draft Law, it is stated that various regulations and amendments are planned in line with the “Program for a Healthy Turkey Century” to provide better and higher-quality healthcare services and preserve the country’s strength in the health sector.

This initiative aims to enhance the Turkish Healthcare System to meet the evolving needs of the population.

If the proposal becomes law, there will be significant changes in the obligations of individuals and legal entities operating in the Turkish Healthcare System.

Some important provisions of the Draft Law can be summarized as follows:

Single Tracking of Human Medicinal Products & Special Medical Purpose Foods

• The sanctions to be imposed on pharmacists in case of violations on wholesale drug sales and Pharmaceutical Tracking System (İlaç Takip Sistemi in Turkish, or “İTS”) notifications are revisited.
• A requirement is introduced for marketing authorization holders and pharmaceutical businesses to report all supply chain movements of human medicinal products and special medical-purpose foods to the İTS.

Physicians & Dentists Working with Service Contracts in Maximum Two Healthcare Organizations

• Physicians, dentists, and specialists under medical specialization laws will only be allowed to work at a maximum of two healthcare institutions, under 4/a insured status of Law No. 5510 on Social Insurance & General Health Insurance.

Facilitating Access to Primary Healthcare Services

• In case of need, family health centers, healthy life centers, and emergency health stations can be located in parks.

Supervision of Promotion & Information Activities & Sanctions to be Imposed

• An administrative fine of not less than 100.000-TRY and up to 2% of the gross service revenue of the previous month will be imposed on private healthcare facilities in case of promotional activities that exceed the “promotion and information” limit and that are deceptive, misleading, or cause unfair competition.

Supervision of Sales, Advertising & Distribution of Medical Devices & Sanctions to be Imposed

• It is regulated that administrative fines will be imposed on those who sell, advertise, distribute or market medical devices in violation of the procedures and principles determined by the Ministry of Health, as well as those who provide technical services and those who supply or maintain on the market or put into service counterfeit medical devices. The administrative fines stipulated are from 500.000-TRY to 10.000.000-TRY, depending on the severity of the act.

Electronic Collection of Informed Consent

• Under Article 70 of Law No. 1219, informed consent required before medical intervention can be obtained using methods that allow identity verification through an information technology or electronic communication device.

Regulatory Authority in the Field of Health Informatics & Technology

• The Ministry of Health will determine the criteria for products and services used in healthcare IT and technology and decide on their compliance, and it is regulated that all types of medical devices, information management systems, and software will be inspected.

Evaluation

It can be considered that the Draft Law aims to create a legal infrastructure suitable for digitalized healthcare services. Of course, the adequacy of these regulations are open to discussion.

Amidst discussions on preventing psychologists who do not have the title of clinical psychologist from seeing clients (by evaluating them as auxiliary personnel), changing the titles and statuses of health personnel such as “assistant midwife” and “assistant nurse” and excluding psychologists in this proposal may raise questions about the adequacy of the regulation.

Following the provision of the Law stipulating that the criteria for digital technologies and services will be determined by the Ministry of Health, the needs of the industry should be considered during the creation of secondary legislation, and legal foundations should be laid with the opinions of all stakeholders.

The restriction on physicians and dentists working for a maximum of two health institutions with permanent staff may be taken to the Constitutional Court with the claim that it restricts the freedom to work.

However, it is indisputable that the envisaged regulations will create administrative and technical obligations for the public and private sectors. They will also require a review of legal risk management and compliance processes, especially regarding the provision of healthcare services, and the sales and promotion activities of medical products.