The Turkish Pharmaceutical Industry's Regulatory Landscape

by Altug Ozgun /Emre Dirik Aug 03, 2022

Contents

  1. Introduction

  2. Organization

  3. Regulatory Landscape

  4. Licensing

  5. Promotion and Advertising

  6. Pricing and Reimbursement

  7. Data Privacy

  8. Competition

  9. Conclusion

1. Introduction

The pharmaceutical industry in Turkey has great potential and is notable for its high-tech manufacturing capability. The sector currently ranks 7th in Europe and 16th in the world regarding market size.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. Finally, we will scrutinize the competition aspect within the industry.

2. Organization

The pharmaceutical industry in Turkey is governed principally by the Ministry of Health ("MoH") and its subsidiaries which have the authority to issue sectoral regulations and establish a healthcare system.

As a regulatory member of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), the Turkish Medicine and Medical Devices Authority ("TITCK") 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") established by Law No. 5502 published on May 16, 2006, is the authority responsible for the reimbursement of medicines. The SSI's objective is to realize a social security system at contemporary standards that provides individuals with 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).

3. Regulatory Landscape

Pharmaceutical and Medical Preparations Law No. 1262 (hereafter referred to as the Law) published in the Official Gazette on May 26, 1928, regulates general principles of medical preparation applications pertaining to licenses and administrative fines regarding 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.

4. Licensing

The licensing of medicines is carried out per the provisions of the Licensing Regulation on Medicinal Products for Human Use (hereafter referred to as the Licensing Regulation) published by the MoH on December 25, 2005. The Licensing Regulation stipulates that the standards and procedures shall 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 residing 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 marketing license.

Additionally, the Regulation on Labelling and Packaging of Medicinal Products for Human Use specifies the procedures for placing a product on the market and necessary information on labels and packages. The Regulation on Safety of Medicinal Products for Human Use stipulates that pharmaceutical industry actors should obey rules on monitoring, researching, recording, archiving and assessing the safety of medicinal products for human use.

5. Promotion and Advertising

In Turkey, the advertising of medicinal products is governed by Pharmaceutical and Medical Preparation Law No. 1262. The procedures and principles regarding advertising activities are strictly regulated by the Regulation on Promotion Activities of Medicinal Products for Human Use (hereafter referred to as the Promotion Regulation) which came into effect on July 3, 2015.

Generally, it is impossible 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. It is prohibited to promote these products to the public, directly or indirectly, through programs, movies, TV series, news, and similar means in all media, including the internet. However, it is permitted to pay visits to HCPs with promotional materials and hold/support scientific/promotional meetings.

The Act on Protection of Consumers, the Regulation on Commercial Advertisements and Unfair Practices, and the Code of Obligations also apply to medicine promotion activities.

Additionally, the Supreme Council of Radio and Television is authorized to examine radio and television broadcasts to evaluate whether the advertising contradicts the principles in the Law on Establishment and Broadcasting of Radio and Television Institutions No. 6112.

6. Pricing and Reimbursement

The Pricing Decree and the Pricing Communique 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 analyzes applications and certifies that they are in accordance with applicable pricing regulations.

One of the other main issues regarding the pharmaceutical industry is the reimbursement mechanism to make treatments easily accessible to the public. The Pharmaceutical Reimbursement Regulation determines the types, amounts, and duration of using the medicines financed by the SSI, the medicines requested to be financed, and the payment procedures and principles. Costs are reimbursed for medicines 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 submit applications to the SSI to include their medicines within the reimbursement scope. The SSI then evaluates the medicines to decide whether they will be included.

7. Data Privacy

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. It constitutes an important resource for providing and improving sustainable treatments and services, conducting scientific researches, 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.

The Personal Data Protection Law (hereafter referred to as KVKK) published in the Official Gazette on April 7, 2016, regulates the protection of personal data, including the health data. According to KVKK, personal data relating to health or sexual life can only be processed by persons under the confidentiality obligation with the explicit consent of the relevant person or by authorized institutions and organizations to protect public health, develop preventive medicines, and provide medical diagnosis, treatment, and healthcare services.

The Turkish Data Protection Authority (DPA) is responsible for implementing the Data Protection Law and promoting data protection awareness in Turkey. In order to overcome the difficulties faced by pharmaceutical companies, the DPA published the Guide on the Protection of Personal Data in Pharmacovigilance Activities (hereafter referred to as the Guide) on August 1, 2019. The Guide states that to process patient data reported in the scope of adverse events, it is not mandatory to obtain explicit consent from the data owner, regardless of whether the person who reports an adverse event is a patient, healthcare professional, or patient relative.

On the other hand, the MoH released the Personal Health Data Regulation in the Official Gazette on June 21, 2019, and repealed the previous Regulation on Processing and Ensuring the Privacy of Personal Health Data published in the Official Gazette on October 20, 2016. The currently-effective 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.

8. Competition

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 enforces this regulation, prevents any threats to the competitive process of supplying goods and services in the markets.

9. Conclusion

In the light of recent technological developments and globalization, the pharmaceutical industry is becoming more important with an increasing market volume. Turkish pharmaceutical regulations 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 aims 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)

With thanks to Ayse Gonen Anaeli for her assistance on this article.


Disclaimer

This article is originally published by CETINKAYA Attorneys-at-Law

CETINKAYA is a full-service law firm based in Istanbul servicing local and international clients. CETINKAYA lawyers have extensive expertise in advising on dispute resolution, business crime, technology, data protection, and intellectual property. 

CETINKAYA prides itself on helping clients navigate their way through a constantly changing and challenging legal landscape. With a seamless multi-disciplinary approach positioned at the intersection of industry knowledge and legal expertise, CETINKAYA provides clients with legal solutions that are tailored to their needs in Turkey.

Altug Ozgun
Partner at CETINKAYA
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Emre Dirik
Associate at CETINKAYA
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