The Basic Law on Health Services No. 3359 is the primary legislation in Turkey regarding implementation principles and procedures of healthcare services in Turkey. The law covers both the private and public healthcare services and facilities.
With the Law No. 7496 published in the Turkish Official Gazette dated 01.03.2024, significant changes were made regarding regulations on human clinical trials in Turkey.
Accordingly, with the Additional Article 10 added to the Basic Law on Health Services No. 3359, in order for human medical products and medical devices to be used on humans for scientific research, even if any treatment method or license or permission has been obtained, it is required to comply with certain criteria in addition to obtaining permission from the Ministry of Health.
In order to start human experiments the following conditions must be met:
- The research must be conducted primarily in a non-human experimental environment or on a sufficient number of animals,
- Scientific data obtained as a result of experiments carried out in non-human experimental environments or on animals require these to be carried out on humans in order to achieve the desired goal,
- The research does not leave a foreseeable harmful and permanent effect on human health,
- During the research, painful methods that are incompatible with human dignity should not be applied to the person,
- The purpose to be achieved by the research outweighs the burden it imposes on the person and the danger to the person’s health,
- The person concerned on whom the research will be conducted must have written consent based on adequate information about the nature and results of the research, and this consent is not dependent on obtaining any benefit,
- The research to be conducted will be approved by the relevant ethics committee.
In addition, studies of cosmetic products on humans are initiated by obtaining permission from the Ministry of Health, following the approval of the ethics committee determined by the Ministry of Health.
Humanized clinical research can only be carried out in health institutions and organizations and research and development centers that have personnel, equipment and laboratory facilities suitable for the qualifications of the research and that are suitable for ensuring the safety of the people to be researched and for the research to be carried out in a healthy way, to be followed up and to provide emergency intervention when necessary. Clinical trial types will be determined by the Ministry of Health. In these researches, the protection of the individual’s rights and health will be prioritized above all else. The volunteer on whom research will be conducted or on whom research has been conducted can withdraw his/her consent at any stage of the research and without any conditions. Depending on the type of research, it will be mandatory for volunteers to have liability insurance to insure them against damages that may arise from the research.
Last of all, with the provision added to Law No. 3359, the Ministry of Health will be able to immediately stop the clinical research if it detects that one of the existing conditions for allowing the research has disappeared during the conduct of the research. If these conditions are not fulfilled within the specified period, or if it is understood that it is not possible to fulfill them, or if the volunteer’s health is endangered, the research may be terminated directly.
