Esin / Healthcare & Life Sciences - August 2023

The Turkish Pharmaceuticals and Medical Devices Authority (“TİTCK”) recently published the Regulation on Promotion and Information Activities in Healthcare Services.

The TİTCK also amended the Guideline on Phase 1 Clinical Research Centers and the Guideline on Application for Good Clinical Practice Audits. In addition, the Presidency amended the Decree on the Pricing of Pharmaceuticals.

Decree on the Pricing of Pharmaceuticals

On 23 July 2023, the Presidency published the Decree Amending the Decree on the Pricing of Pharmaceuticals. The main amendments introduced by the Decree are as follows:

• The value of EUR 1 in TRY to be used in the pricing of pharmaceuticals was increased by 30.5% to TRY 14.0387 in July 2023. This increase will not be applied to products for which the Price Evaluation Commission has made a product-specific price increase.
• The thresholds are set at TRY 48.41 for price-protected products and TRY 25.30 for other products.
• In the periodic euro value update, increases of up to TRY 4 in the detailed drug price list and applied to the sales price to the warehouse will not be taken into account. Increases of up to TRY 4 to be applied after the euro value update will be added to the sale prices of the products to the warehouse without making any changes to the TRY value.

The Decree is available here (in Turkish). 

Regulation on Promotion and Information Activities in Healthcare Services

On 29 July 2023, the Ministry of Health published the Regulation on Promotion and Information Activities in Healthcare Services. The main developments introduced by the Regulation are as follows:

• Implicit or explicit advertisement in health service provision is prohibited.
• Promotion and information in the field of health must comply with public morality, medical deontology and professional ethics.
• Information on health service provision must only be provided by legally authorized health professionals.
• For healthcare facilities, promotion and information must only cover the specialties for which patients are admitted and treated, address and contact information, and health-protective and health promoting information related to the field of the health service provided. For doctors and dentists, it must cover main and sub-specialists, academic titles, days and hours of examination, time and location of patient admission, and health-protective and health-promoting information related to the field of the health service provided.
• Activities that create the impression that patients are expressing gratitude for health services must not be conducted.
• Promotion and information must not be in a form that will directly or indirectly lead the patient to the health professional or healthcare facility.
• Scientific terms, research results, and quotations from scientific publications and statistical data must not be presented in such a way as to produce different results from their actual meaning.
• The information on websites must clearly indicate the date of the last update and the website editor’s contact information.
• Without people’s knowledge and consent, their personal phones cannot be called, and advertisements and promotions cannot be sent by letters, short messages, electronic mail and messages via social networking tools.
• Health services must not be offered for marketing purposes, such as incentives, draws and gifts. Advertising, promotion and information must not be provided for this purpose.
• Prior authorization must be obtained from the Ministry of Health for promotional and informational activities to be carried out within the scope of social responsibility projects and campaigns to be carried out for health services. Promotion and information must be limited to the scope and duration of the social responsibility project and to the persons or organizations that will benefit from the project.
• Promotion and information activities must be carried out in accordance with the provisions of the Patient Rights Regulation and the Regulation on Personal Health Data.
• Health professionals and healthcare facilities are prohibited from including before and/or after images that are comparative and demand-generating in their promotions and information regarding the health services they provide.
• To use visual content belonging to the patient, the explicit consent of the patient or, if the patient is a minor or interdicted, of their parent or guardian must be obtained and the Patient Rights Regulation must be complied with. The patient has the right to see the visual content to be shared in advance and can withdraw their permission to share images at any time without any procedure or condition.

The Regulation is available here (in Turkish).

Guideline on Phase 1 Clinical Research Centers

On 31 July 2023, the TİTCK updated the Guideline on Phase 1 Clinical Research Centers. In this regard, the regulations regarding phase 1 clinical research centers to be conducted with patient volunteers were updated. The main amendments introduced by the Guideline are as follows:

• Centers to conduct phase 1 clinical research involving only volunteers with the investigated medical condition or disease can be established within the relevant department’s clinic. In such centers, the clinical, resting and dining areas can be combined. The beds allocated for the phase 1 clinical research center within the clinic must not be used for other purposes. If the beds are used for force majeure, the issue in question must be justified and properly documented.
• In the phase 1 clinical research centers, the sponsor must be allowed to monitor the studies, audit the relevant areas and be provided with a suitable office space for these activities.
• Clinical study areas must be appropriately separated from routine clinical activities and other patients, and volunteers’ access to other areas outside the clinical area must be restricted.
• The quality assurance unit must verify all activities performed during the study.

The Guideline is available here (in Turkish).

Guideline on Application for Good Clinical Practice Audits

On 2 August 2023, the TİTCK updated the Guideline on Application for Good Clinical Practice Audits. In this regard, the regulations on the processes related to the issuance, suspension and revocation of activity authorization certificates were updated. The main amendments introduced by the Guideline are as follows:

If it is determined that the requirements have been met as a result of the audits and assessments to be carried out in the facilities where the clinical and/or bioanalytical parts of the Bioavailability/Bioequivalence (“BA/BE”) studies are carried out and in the phase 1 clinical research centers, an activity authorization certificate will be issued.

Changes related to the physical space, such as relocation of the center, inclusion of a new physical space and/ or closure/relocation of an existing space, must be notified to the TİTCK in advance with the justification. If changes other than the relocation of the center require the center to be re-audited, the activity authorization certificate issued for the center will be suspended. If the center moves to a new address or to a new area within the same building/campus, a new opening audit will be carried out for the center and a new activity authorization certificate will be issued.

The audits of the centers where phase 1 clinical trials and BA/BE studies are conducted will be carried out within the scope of risk-based routine audits or audits for a specific reason. If a critical finding or a large number of major findings are detected as a result of routine audits or audits for a specific reason, depending on the nature of the finding(s), the activity authorization certificate may be revoked or suspended until the nonconformities have been eliminated.

The Guideline is available here (in Turkish).

Conclusion

The TİTCK continues to provide guidance for companies working in the healthcare industry. Companies should carefully review the TİTCK’s announcements and take necessary actions to ensure compliance.