Turkish Law Blog
Healthcare Series: 01 The Turkish Pharmaceutical Industry's Regulatory Landscape
The pharmaceutical industry in Turkey has great potential and is notable for its high-tech manufacturing capability. The industry currently ranks 7th in Europe and 16th in the world, in terms of market size, according to the latest reports.1 With a dynamic structure serving human needs, the pharmaceutical industry is intensively controlled and must comply with a variety of regulatory requirements both nationally and internationally.
In this article, we will reveal the general organizational and regulatory landscape of the pharmaceutical industry in Turkey in terms of licensing, advertising and promotion, pricing and reimbursement, and data privacy as a key resource for the industry. And finally, we will scrutinize the competition aspect within the industry.
The pharmaceutical industry in Turkey is governed principally by the Ministry of Health ("MoH") and its subsidiaries who have the authority to issue sectoral regulations and establish a healthcare system.
The Turkish Medicine and Medical Devices Authority ("TITCK") as a regulatory member of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use grants licenses and market authorizations to pharmaceutical companies, monitors their compliance with the regulations, imposes necessary sanctions, approves and controls clinical trials, and takes precautions to ensure products are accessible.
The Social Security Institution ("SSI") which was established by Law No. 5502 published on 16 May 2006, is the authority responsible for the reimbursement of medicines. The objective of the SSI is the realization of a social security system at contemporary standards that provides individuals with an effective, equitable, accessible, and sustainable social and universal health insurance.
In addition to these public institutions, the following industry-based associations also govern and regulate the pharmaceutical industry through their guidelines, codes, and directives:
- Association of Research-Based Pharmaceutical Companies (AIFD),
- Pharmaceuticals Manufacturers Association of Turkey (IEIS), and
- Turkey Pharmaceuticals Industry Association (TISD).
Pharmaceutical and Medical Preparations Law No. 1262 ("Law") published in the Official Gazette numbered 898 and dated 26 May 1928, regulates general principles of medical preparation applications pertaining to licenses and administrative fines in regard to companies that fail to comply with these principles. The Law is the statutory basis for further regulations regarding pharmaceutical and medical preparations.
As per the Law, a pharmaceutical and medical preparation is any basic or formulated curative preparation commercialized in a fixed form consistent with scientific rules under a manufacturer's name or under a specific name.
The licensing of medicines is carried out per the provisions of the Licensing Regulation on Medicinal Products for Human Use ("Licensing Regulation") published by the MoH on 25 December 2005. The Licensing Regulation stipulates the standards and procedures that must be followed to ensure that licensed products fulfill safety and quality criteria.
According to the Licensing Regulation, any medicinal products for human use that are not licensed by the MoH cannot be put on the market. Real or legal persons resident within the borders of Turkey are also required to provide the MoH with the necessary information and documents by preparing an application form for each pharmaceutical to receive a license allowing the product access to the market.
Additionally, to place a product on the market, the Regulation on Labelling and Packaging of Medicinal Products for Human Use which specifies the procedures and necessary information that must be included on labels and packages; and the Regulation on Safety of Medicinal Products for Human Use which stipulates the activities that can be conducted for monitoring, researching, recording, archiving and assessing the safety of medicinal products for human use should also be taken into consideration by pharmaceutical industry actors.
Promotion and Advertising
In Turkey, the advertising of medicinal products is governed by Pharmaceutical and Medical Preparation Law No. 1262, and the procedures and principles regarding advertising activities are strictly regulated in the Regulation on Promotion Activities of Medicinal Products for Human Use ("Promotion Regulation") which came into effect on 3 July 2015.
As a general rule, it is not possible to promote medicinal products to people other than Healthcare Professionals ("HCPs") who are defined as medical doctors, dentists, and pharmacists as per the Promotion Regulation. The promotion of these products to the public, directly or indirectly, through programs, movies, TV series, news, and similar means in all media, including the internet, is prohibited by the said regulation. However, promotion activities for medicinal products for human use can be conducted using promotional materials by visiting HCPs, by product promotion representatives of pharmaceutical companies, and by organizing or supporting scientific meetings and product promotion meetings.
Furthermore, in cases not stipulated under the above-mentioned legislation, to the extent permitted by law the Act on Protection of Consumers, the Regulation on Commercial Advertisements and Unfair Practices, and the Code of Obligations will be applied.
Additionally, the Supreme Council of Radio and Television is authorized to examine radio and television broadcasts in order to evaluate advertising that contradicts the principles established in the Law on Establishment and Broadcasting of Radio and Television Institutions No. 6112.
Pricing and Reimbursement
The Pricing Decree ("Pricing Decree"), and the Pricing Communique that introduced its implementation, established the concept and principles for determining pharmaceutical prices.
The MoH, through the Pricing Committee under the TITCK, is the competent authority regarding the pricing of medicinal products. The committee analyses applications and certifies that they are in accordance with the applicable pricing regulations.
One of the other main issues regarding the pharmaceutical industry is the reimbursement mechanism which supports easily accessible treatment for the public. The Pharmaceutical Reimbursement Regulation determines the types, amounts, and duration of use of the medicines financed by the SSI, the medicines requested to be financed, and the payment procedures and principles of these medicines. Costs are reimbursed by taking into consideration whether medicines are on the SSI reimbursement list.
The process for a medicine to be available on the market in Turkey and to be offered for reimbursement, respectively, consists of the stages of licensing, price determination, and evaluation for reimbursement coverage. Once medicine prices are determined by the MoH, companies apply to the SSI for their medicines to be included within the scope of reimbursement. The SSI then evaluates the medicines and decides whether they will be included.
Personal health data includes all kinds of information regarding the physical and mental health of a real person whose identity is known or can be determined. Health data can be used for various purposes in the pharmaceutical industry and constitute an important resource for providing sustainability and improvement in services and patient treatment, research and development in scientific studies and creating statistical models. Due to the privileged importance of personal health data, it is regulated specifically in both local and international legislation, and requires stricter conditions for processing in comparison to other types of personal data.
Protection of personal data and personal health data is regulated within the scope of the Personal Data Protection Law ("KVKK") numbered 6698 published in the Official Gazette dated 7 April 2016 and numbered 29677. According to KVKK, personal data relating to health or sexual life can only be processed by persons under the obligation of confidentiality with the explicit consent of the person concerned or by authorized institutions and organizations to protect public health, and to develop preventive medicine, medical diagnosis, treatment, and care services.
The Turkish Data Protection Authority (DPA) is responsible for the implementation of the Data Protection Law and data protection awareness in Turkey. In order to overcome the difficulties faced by pharmaceutical companies, the DPA published a Guide on the Protection of Personal Data in Pharmacovigilance Activities ("Guide") on 1 August 2019. It states that it is not necessary to obtain explicit consent from a data owner, regardless of whether the person reporting an adverse event is a patient, healthcare professional or patient relative for the processing of patient data reported within the scope of adverse event reporting.
On the other hand, the MoH released the Personal Health Data Regulation in the Official Gazette on 21 June 2019 and repealed the previous Regulation on Processing and Ensuring the Privacy of Personal Health Data published in the Official Gazette on 20 October 2016. The regulation sets forth the personal health data processing regime, and the procedures and principles with which MoH's organizational units and private legal entities must comply.
Competition is critical in the pharmaceutical sector since it forces the industry to deliver higher quality products and services at lower prices, motivates manufacturers to develop innovative and improved medicines, and encourages generic companies to provide less costly alternatives.
The commercial activities, pricing strategies and relationships between pharmaceutical companies, warehouses and distributors are regularly monitored and mediated by the Turkish Competition Authority ("TCA") due to the fact that the pharmaceutical market ıs strictly regulated and competition in this sector directly affects public access to healthcare.
Turkish Competition Law No. 4054 refers to all undertakings working in a sector for products or services inside Turkey's boundaries. The TCA, which is charged with enforcing this regulation, prevents any threats to the competitive process in the markets for goods and services through the use of the powers granted by law.
In the light of recent technological developments and globalization, the pharmaceutical industry has gained more importance and market volume. Turkish regulations on pharmaceuticals cover a wide range of topics within the industry. Especially during the COVID-19 pandemic, the industry has been under the spotlight. That being the case, legislative regulations will become more of an issue.
This article has aimed to highlight the key points without including all aspects. You can find more detailed information by following our article series. You can also read the regulations mentioned above here. (Available in Turkish only)
This article was first published here.
With thanks to Ayse Gonen Anaeli for her assistance on this article.
1. Turkey's Pharmaceutical Sector Vision 2023 Report