Use the Lexology Navigator tool to compare the answers in this article with those from other jurisdictions.

Trends and developments

Legal developments

Are there any notable trends or recent legal developments in your jurisdiction’s pharmaceutical industry?

In July 2015 the Regulation on Promotional Activities of Human Medicinal Products was amended, introducing certain changes and principles for the promotional activities of pharmaceutical products, including the disclosure of certain value transfers performed by healthcare professionals and institutions. Pursuant to the relevant regulation, given that the marketing authorisation holders are liable to notify the Turkish Pharmaceuticals and Medical Devices Agency (affiliated institution of the Ministry of Health) of the value transfers made during a calendar year within the first six months of the year, the first half of 2017 will be the first time that this rule has been implemented.

As another notable development, the Ministry of Health and the Social Security Institution have taken further steps for motivating local manufacturing of imported medicines in Turkey. In this regard, a commission of transition from import to manufacture has been established and an announcement published stating that relevant firms in the pharmaceutical sector are liable to give commitments for the products within the localisation process or at least to indicate the justifications behind not giving such commitments for related products. In addition to local manufacturing efforts, in 2016 the agency published the Guideline Regarding Working Principles and Procedures of the Human Medicinal Products Prioritisation Commission, which introduced certain rules to be taken into account while prioritising marketing authorisation applications (eg, local manufacturing and burden of the product on the healthcare budget).

The amendment to the Guidelines on Provision and Use of Pharmaceuticals from Abroad is another recent development in Turkey. With the amendment in July 2014, more than 20 alternative warehouses in addition to the Turkish Pharmacists Association (TEB) were authorised to procure named patient supply products, despite the fact that the TEB subsequently challenged this amendment before the administrative courts. The latest version of the guideline, which has been amended several times in the past two years, revoked the authority granted to the alternative warehouses and authorised it again for only the TEB named patient supplies. However, in parallel with the legal proceedings and further guideline amendments, one of the alternative warehouses filed a complaint to the Competition Authority at the beginning of 2015, claiming that the TEB abuses its dominant position in named patient supply activities. The Competition Authority initiated an investigation into TEB activities, which has been recently completed, and found that the TEB had abused its dominant position by concluding exclusive agreements with the suppliers of these products abroad. Therefore, an administrative monetary fine was imposed on the TEB and further changes to the named patient supply system are expected.

As a general development, the Law on Protection of Personal Data came into force in 2016, filling the legal gap in the Turkish regulatory environment that lacked a detailed data protection law. Like many other sectors, the pharmaceutical industry is affected by the rules and requirements of this new law and pharmaceutical companies are undergoing internal procedures to ensure compliance with these obligations. 

Legal framework

Legislation

What is the primary legislation governing medicinal products in your jurisdiction?

The primary legislation governing pharmaceutical products is the Pharmaceuticals and Medical Preparations Law (1262). There are also several regulations specifically and separately governing the authorisation, marketing, sale and supply of pharmaceutical products, including:

  • the Pharmaceuticals Licensing Regulation;
  • the Regulation on the Manufacturing Plants of Pharmaceuticals;
  • the Promotion Regulation;
  • the Pharmaceuticals Packaging and Labelling Regulation;
  • the Regulation on the Classification of Pharmaceuticals;
  • the Regulation on the Safety of Medicines; and
  • the Regulation on Pharmacy Warehouses and the Products Located in Pharmacy Warehouses.

Are any legislative changes proposed or expected in the near future?

The Communiqué Regarding Pricing of Pharmaceuticals is expected to be amended shortly, with amendments to:

  • the general definitions;
  • the pricing regime of some products with special status (eg, orphan drugs, biotechnology products and 20-year old drugs); and
  • the inclusion of country members of the Pharmaceutical Inspection Cooperation Scheme as a reference for products without a price in reference countries.

The Pharmaceuticals and Medical Devices Agency has been working in collaboration with the pharmaceuticals industry on a draft regulation regarding over-the-counter products. The agency has also issued a draft regulation on Pharmacy Businesses and Products Located in Pharmacy Businesses, together with the Guidelines on Good Distribution Practices for Pharmaceutical Products and has circulated it among the industry to collect feedback. 

Regulation

Which bodies regulate medicinal products in your jurisdiction and what is the scope of their powers?

The Ministry of Health, the Pharmaceuticals and Medical Devices Agency and the Social Security Institution are the main bodies responsible for regulating different aspects of medicinal products in Turkey. The scope of the powers of the ministry and the agency is set out in detail in the Decree-Law on Organisations and Duties of the Ministry of Health and its Affiliates (663). In general, the main responsibilities of these bodies include:

  • planning;
  • regulating technical arrangements and permissions;
  • determining healthcare standards;
  • fulfilling relevant transactions for meeting these responsibilities; and
  • market surveillance and inspection in relation to pharmaceuticals, medical devices and relevant sales channels.

On the other hand, the scope of the Social Security Institution’s power is set out in detail in the Law on Organisation of the Social Security Institution (4947) and its regulations. The institution’s powers consist mainly of regulation of public healthcare expenditures and implementation of the reimbursement regime. 

Are any other legal regimes applicable to the trade of medicinal products (eg, competition, international trade, data protection, consumer protection)?

The trade of medicinal products is within the scope of ordinary commercial activity. Therefore, if the trade of medicinal products has an aspect in relation to competition, international trade, data protection, consumer protection, product liability, customs or transport, the relevant specific legal regimes will apply, depending on the case.

Are any medicinal products exempt from regulation (eg, complementary and alternative medicines)?

In Turkey, different product types (ie, medical devices, cosmetics, traditional herbal products and nutritional products) are regulated under specific laws consisting of various regulations and guidelines. Bearing in mind that the regulations governing medicinal products are quite strict in Turkey, particularly the use of any health claims for products, there is no significantly important medicinal product exempt from these regulations. 

Supply

Manufacture

What is the authorisation procedure for the manufacture of medicinal products in your jurisdiction?

In order to obtain authorisation for manufacturing medicinal products, any real or legal entity satisfying the general conditions (ie, employing a responsible manager with a degree in pharmacy, medicine or chemistry, employing certain other personnel, documenting that the facility satisfies technical requirements and compliance with good manufacturing practice requirements) and possessing the required documents (ie, documents relating to employees, buildings, workflow, equipment, workplace opening permits and environmental assessment reports) under the Manufacturing Regulation can apply to the provincial directorates of the Ministry of Health. The ministry will inspect the manufacturing site and, if it determines that the features of the manufacturing site are sufficient and proper, will issue the authorisation.

What is the fee for obtaining authorisation?

The fee for obtaining authorisation varies depending on the type of authorisation.

What is the validity period for authorisation?

There is no explicit provision regulating the validity period of manufacturing authorisations; hence, authorisations are routinely controlled and updated by the Ministry of Health after issuance.

How robust are the standard good manufacturing practices followed in your jurisdiction?

Considering that the issuance of a good manufacturing practice certificate for the relevant manufacturing site by the Pharmaceuticals and Medical Devices Agency is one of the most important conditions for the issuance of a marketing authorisation, manufacturing practices in Turkey are quite robust. Moreover, a good manufacturing practice certificate issued by an EU authority is not by itself acceptable for most imported products, since the agency inspects manufacturing facilities in Turkey and abroad. This condition also reveals the robust application of good manufacturing practice in Turkey.

What are the consequences of failure to obtain manufacturing authorisation and/or follow good manufacturing practices?

The consequences of failure to obtain manufacturing authorisation or follow good manufacturing practices vary depending on the circumstances. For instance, in case of failure, the manufacturing site authorisation for specific pharmaceutics forms may be suspended completely or partially until the deficiencies are fulfilled or revoked. Such deficiencies may cause the suspension or complete revocation of authorisation of the responsible manager. Moreover, failure to follow good manufacturing practices may trigger suspension or revocation of a marketing authorisation for the relevant products by the Pharmaceuticals and Medical Devices Agency, depending on the circumstances.

Distribution

How are the distribution and storage of medicinal products regulated?

The distribution and storage of medicinal products are regulated by the Regulation Regarding Pharmaceutical Warehouses and Products Located in Pharmaceutical Warehouses, together with the Guideline on Good Distribution and Storage Practices for Pharmaceuticals and Products Located in Pharmaceutical Warehouses. Distribution of medicinal products is mainly generated through a channel in which pharmaceutical warehouses buy the products from manufacturers and sell them to pharmacies.

According to the regulation, the wholesale trade of medicinal products requires Ministry of Health authorisation. Any real or legal entities satisfying the general conditions (ie, employing a responsible manager with a pharmacy degree, employing certain other personnel and documenting that the facility satisfies technical requirements) and possessing the required documents (ie, documents relating to employees, buildings, safety precautions and equipment) can apply to the ministry’s provincial directorates. After the examination of the pharmaceutical warehouse, a conformity report will be issued and all documents, including the report, will be sent to the ministry for the final decision. Should the ministry grant an authorisation in accordance with the relevant legislation, it will be issued within 15 days. A pharmaceutical warehouse with such authorisation will perform the wholesale trade of pharmaceutical products in strict accordance with the regulation. 

Import and export

How are the import and export of medicinal products regulated?

The import and export of pharmaceutical products are subject to general import and export provisions with some additional requirements. If the pharmaceutical products contain narcotic or psychotropic substances, special authorisation is required from the Pharmaceuticals and Medical Devices Agency. If they do not contain any of these substances, written confirmation of this fact from the agency is required. In case of the import of medicinal products, marketing authorisation and a certificate of analysis are needed. For export, a certificate of analysis and the documents necessary for the licensing of the product in the destination country are required.

Are parallel imports permitted in your jurisdiction?

The parallel import of medicinal products is permitted in Turkey, which promotes competition in the market. Therefore, provided that the requirements within the general import and export provisions are satisfied, the parallel import of medicinal products is not prohibited. In November 2014 the Ministry of Health published a circular stating that it may prevent the export of medicines imported into Turkey from abroad if Turkish patients need such medicines. Accordingly, the ministry is expected to take measures to prevent parallel exports under certain circumstances; however, the technical preparations for the establishment of an efficient system for this purpose remain unclear.

Sale and purchase

What rules govern the dispensing, sale and purchase of medicinal products?

Rules governing the dispensing, sale and purchase of medicinal products are mainly regulated by the Pharmaceutical Warehouses Regulation and the Regulation on Pharmacists and Pharmacies. Within this procedure, pharmaceutical products which are licensed in Turkey are mostly dispensed through a channel in which the pharmacy warehouses buy the products from the manufacturers and sell them to pharmacies. Depending on the status of the product, patients can purchase pharmaceuticals from the pharmacies with or without a prescription. Another channel for dispensing is hospital tenders, where pharmacy warehouses bid and sell pharmaceutical products directly to hospitals instead of pharmacies. Named patient supply is another route applicable for pharmaceuticals not licensed or commercially available in Turkey, which at present involves Turkish Pharmacists Association as the supplier and the patient as the purchaser.

Are there any restrictions on the online sale and purchase of medicinal products?

Online sales and the purchase of medicinal products via the Internet or any other electronic environment is strictly prohibited in Turkey. The Pharmaceuticals and Medical Preparations Law also regulates that if promotion or sales of medicinal products is made via the Internet, the Ministry of Health will block access and notify the Information Technologies and Communication Institution of its decision for implementation. Moreover, there are certain administrative monetary fines applicable for online sales.

Named patient supply

What rules govern named patient supply of pre-launch medicinal products?

The Guidelines on the Provision and Use of Pharmaceuticals from Abroad govern the rules regarding named patient supply of pre-launched medicinal products in Turkey. Within the named patient supply system, the Pharmaceuticals and Medical Devices Agency allows the import of medicinal products which are not licensed at all in Turkey or not made available in the Turkish market, despite being licensed on a case-by-case basis should a physician prescribe such pharmaceuticals to a patient who cannot be treated with products already available in Turkey. This guideline mainly regulates the procedures and distribution channel details for the products that are imported from abroad on a named patient basis, whereas the Healthcare Implementation Communiqué of the Social Security Institution and its secondary legislation further provide certain rules regarding reimbursement of these products.

Clinical trials

Authorisation

What is the authorisation procedure for conducting clinical trials in your jurisdiction?

Clinical trials for pharmaceutical products are regulated by the Regulation on Clinical Trials of Pharmaceuticals and Biological Products, together with several guidelines published by the Pharmaceuticals and Medical Devices Agency regarding specific topics. In order to undertake a clinical trial, ethics committee approval must first be sought, as well as agency authorisation where necessary. The authorised representative of the sponsor in Turkey or a contract research organisation domiciled in Turkey and authorised by the sponsor can apply for ethics committee approval; if the committee discovers that the trial’s benefits are bigger than its possible risks, ethics committee approval is secured. It may later be necessary to apply to the agency with relevant information and documentation, including ethics committee approval, depending on the subject and subjects of the clinical trial. It is also possible to apply to the ethics committee and agency concurrently if preferred.

Clinical practices

How robust are the standard good clinical practices followed in your jurisdiction?

Good clinical practice is mainly regulated by the Good Clinical Practice Guideline and various supplementary guidelines published by the Pharmaceuticals and Medical Devices Agency in different specific topics. Considering that the clinical trials may be conducted only at centres determined pursuant to good clinical practice, trial applications are prepared in line with good clinical practice. The main issues (ie, determination of the changes that require ethics committee and agency approval or that have informative values only) are regulated by the Good Clinical Practice Guideline. Good clinical practice is well adhered to in Turkey. 

Reporting, disclosure and consent

What are the reporting and disclosure requirements for the results of clinical trials?

Pursuant to the relevant legislation, clinical trials which are approved by the Pharmaceuticals and Medical Devices Agency will be registered in a publicly available database on the condition that confidentiality of personal data is protected. In order to perform such a registration obligation, the agency has created a website (http://kap.titck.gov.tr/). The information provided in this publicly available database for clinical trials on pharmaceuticals and medical devices includes the status, number, type and name of the clinical trial, as well as the names of the coordinator physician and coordinator centre. There is no mandatory requirement to publish clinical trial results.

What are the informed consent obligations with respect to clinical trial subjects?

While conducting a clinic trial, the subject’s consent is obtained confirming willingness to participate freely in a particular trial after having been informed of its nature. The trial subject’s consent is documented in written form, with informed consent forms that include informative matters (ie, the nature, purpose, significance, duration, conditions, implications and risks of the study) and indicate the subject’s right to withdraw from the trial at any time, as regulated by the Regulation on Clinical Trials of Pharmaceuticals and Biological Products. However, receiving informed consent forms does not eliminate the subject’s right regarding the retrieval of loss arising from the trial.

Insurance

What are the insurance requirements for clinical trials?

Insurance procedures within clinical trials are regulated with the Regulation on Clinical Trials of Pharmaceuticals and Biological Products, together with a guideline published by the Pharmaceuticals and Medical Devices Agency. The insurance requirements and guarantees regulated in the said legislations are concerned with the clinical trial subjects participating in the trial and there is no explicit provision or regulation for insurance required for institutions and investigators. Even though a compulsory pecuniary liability insurance exists regarding medical malpractice for doctors, it does not usually include clinical trials. 

Data protection

What data protection issues should be considered when conducting clinical trials?

In addition to the regulations in the recently published Law on the Protection of Personal Data, the clinical trials rules also confer specific importance regarding the protection of the personal information of the trial subjects and provides several restrictions on the data to be accessed by different parties. Accordingly, the sponsors or contract research organisations can access trial data only for monitoring purposes, to the extent allowed by law. Accordingly, these rules specifically govern that neither the case report form nor the adverse event reports will include the identification of the trial subject.

Marketing authorisation

Authorisation

What is the marketing authorisation procedure for medicinal products in your jurisdiction?

In order to obtain marketing authorisation for a pharmaceutical product, a real person or legal entity domiciled in Turkey can make an application to the Pharmaceuticals and Medical Devices Agency in the common technical document form with certain information and documents, depending on the specialties of the product. The agency will complete an initial examination of the application dossier and request additional information and documents if required. According to the Licensing Regulation, in principle, an application must be reviewed and concluded by the agency within 210 days following submission. However, the agency does not follow this regulatory rule strictly and completion of a marketing authorisation issuance process may take approximately a minimum of two to three years, depending on deficiencies in the dossier. On the other hand, a new guideline was published by the agency in 2016, which aims to regulate prioritisation of review and issuance processes for some applications.

What criteria are considered in granting marketing authorisation?

The main criteria for consideration when granting a marketing authorisation should include product efficiency and safety, as well as satisfaction of the required technical and medicinal features. Having said that, the most important criterion for granting marketing authorisation is the issuance of a good manufacturing practice certificate for the relevant manufacturing site by the agency. The agency makes good manufacturing practice site inspections for the manufacturing facilities in Turkey and abroad. In the event of imported products, in most cases the agency will not accept a good manufacturing practice certificate issued by an EU authority only and conducts a site inspection at the facility located abroad.

What is the fee for obtaining marketing authorisation?

Fees for obtaining marketing authorisation vary depending on the status and type of the authorisation and product.

What is the validity period for marketing authorisation?

Pursuant to the Licensing Regulation, an application for the renewal of a marketing authorisation will be submitted to the Pharmaceuticals and Medical Devices Agency at least three months before the end of the first five years as of the marketing authorisation’s issuance date, together with the pharmacovigilance data and information regarding quality, security and operation of the marketing authorisation and details of all changes that have occurred. Marketing authorisations must be renewed every five years accordingly.

What are the consequences of failure to obtain marketing authorisation?

Pursuant to the Licensing Regulation, none of the medicinal products which fail to obtain marketing authorisation from the Pharmaceuticals and Medical Devices Agency will be put on the market. As per the Pharmaceuticals and Medical Preparations Law, failure to obtain marketing authorisation risks imprisonment of between one and five years. Moreover, failure to obtain marketing authorisation for a product offered to the market may trigger certain criminal penalties pursuant to the provisions of the Criminal Code (765).

Pharmacovigilance

Monitoring

What post-market monitoring mechanisms are in place to ensure the ongoing safety and efficacy of medicinal products after marketing authorisation has been granted?

There are several post-market monitoring mechanisms associated with marketing authorisation that are regulated within various regulations. Having said that, the main obligations of a marketing authorisation holder before the Pharmaceuticals and Medical Devices Agency regarding the possessed authorisation include:

  • manufacturing of the product as per agency specifications and scope of the approved marketing authorisation;
  • making approval submissions to the agency for every change required for considering scientific developments, manufacture and control of products in well-accepted methods;
  • updating the summary of product characteristics and instructions for use, if necessary;
  • fulfilling essential responsibilities within the scope of pharmacovigilance practices (although pharmacovigilance services can be outsourced, the marketing authorisation holder still remains responsible);
  • making the products available in the market; and
  • complying with all applicable laws and regulations in its activities (eg, promotional operations).

Data protection

What data protection issues should be considered when conducting pharmacovigilance activities?

Pursuant to the Regulation on the Safety of Medicines, when conducting pharmacovigilance activities, the identification and address of the patient and the healthcare provider notifying the Pharmaceuticals and Medical Devices Agency will be kept confidential within the notifications. This information will not be declared to third parties, other than the Pharmacovigilance Centre personnel, without their consent. The marketing authorisation holders, health institutions and organisations and healthcare providers must comply with these confidentiality principles.

Pricing and reimbursement

Pricing

Are there rules governing the pricing of medicinal products in your jurisdiction?

The rules governing the pricing of pharmaceutical products are regulated by the Decree Regarding Pricing of Pharmaceuticals and the Pricing Communiqué. All pharmaceutical products must obtain a price by making a submission to the Pharmaceuticals and Medical Devices Agency, according to the decree and communiqué. According to the decree and communiqué – which were re-enacted in 2015 and are expected to be amended soon – the Turkish pricing system consists of various pricing rules based on reference pricing and the applicant’s declarations as to the reference prices in five countries (France, Spain, Italy, Portugal and Greece) that are taken into account with regard to the general principles set out. The applicant must notify the agency of subsequent changes to the declared prices within the notification periods regulated by the communiqué. However, the agency may revise the price of a product ex officio if, as a result of its own investigation, it spots changes in the pricing conditions.

Reimbursement

What is the structure for state reimbursement of medicinal product costs?

Under the state reimbursement of medicinal product costs, if the marketing authorisation holder obtains a reimbursement approval from the Social Security Institution following issuance of the sales permit, the Social Security Institution may be one of the payers which would purchase the product on the discounted reimbursement price instead of the initial price approved by the Pharmaceuticals and Medical Devices Agency. The Social Security Institution has strict reimbursement rules as a result of certain concerns regarding the public healthcare budget, and the reimbursed price of a product which is met by the Social Security Institution from the public funds is therefore materially lower than the initial agency-approved price. Still, since the Social Security Institution is the main buyer in the healthcare system, marketing authorisation holders mostly do not prefer to enter the market unless they have obtained reimbursement approval from the Social Security Institution.

Advertising and labelling

Advertising

How is the advertising of medicinal products to healthcare professionals and the general public regulated in your jurisdiction?

Advertising pharmaceutical products to the general public is strictly prohibited in Turkey; whereas promotion of licensed pharmaceuticals to healthcare professionals is allowed and regulated under the Promotion Regulation. According to the regulation, allowable promotional activities include, without limitation, the following:

  • visits to healthcare professionals;
  • the organisation of scientific or product promotion meetings;
  • the distribution of free samples;
  • certain symbolic reminder materials; and
  • printed materials relating to the products.

Do any special rules apply to online advertising of medicinal products?

Online advertising of medicinal products via the Internet or any other electronic environment is strictly prohibited in Turkey.

Labelling

What are the packaging and labelling requirements for medicinal products?

The Labelling Regulation provides the rules in relation to the outer and inner labels of a pharmaceutical product. Accordingly, the necessary information (eg, name, dosage, form and amount of the product, storage conditions and manufacturer’s name and marketing authorisation number) will be provided on the outer packaging in a legible, understandable and non-erasable way. Moreover, a summary of product characteristics and instructions for use in the format required and approved by the Pharmaceuticals and Medical Devices Agency must also be included within the packaging.

How is the promotion of off-label use regulated?

In principle, the promotion of off-label use is prohibited in Turkey, as promotional activities must be in line with the approved product indications. However, there are certain exceptions, such as the promotional activities conducted during the international congresses held in Turkey or the provision of information directly by a medical liaison officer on the written request of a physician, dentist or pharmacist.

Relations with healthcare professionals

Gifts and incentives

What rules apply to the provision of gifts, discounts and other incentives to healthcare professionals?

Gifts to healthcare professionals or organisations are prohibited in Turkey. However, it is possible to distribute certain promotional materials that are strictly defined in the Promotion Regulation, including:

  • symbolic reminder materials;
  • printed materials containing sufficient information on the product;
  • films and slides, visual and aural materials;
  • materials aiming at patient education; and
  • free samples.

Individual donations or grants must not be provided to healthcare professionals; however, marketing authorisation holders may donate to certain healthcare organisations by satisfying certain conditions under the Promotion Regulation. Marketing authorisation holders may also support healthcare professionals for attending a domestic or foreign scientific meeting by covering registration expenses, accommodation and transport. In such cases, the marketing authorisation holder must conform to the Promotion Regulation by obtaining the relevant consent and notifying the Pharmaceuticals and Medical Devices Agency regarding such sponsorship. All value transfers exceeding 10% of the monthly gross minimum wage (including value added tax) are required to be made by obtaining a specific consent from the relevant healthcare professional and disclosing the transfer to the agency.

Liability

Defect products

How can a liability claim for a defective medicinal product be brought?

Given that there is no specific regime regarding the liability of pharmaceutical products, the general doctrinal grounds on product liability will be implemented in the event of a defective medicinal product. Regarding general liability principles, liability may be formed on either a contractual or non-contractual basis. Contractual claims could be initiated under the Law on Obligations and the Law Regarding Protection of Consumers based on the seller’s failure to perform his or her obligations completely or duly or due to a defective product. On the other hand, non-contractual liability may arise from several grounds, including:

  • tort liability;
  • employer’s liability;
  • danger liability; and
  • the liability arising from the Law on Preparation and Implementation of Technical Legislation Regarding Products.

Some of these liability grounds are fault-based and some are strictly liability based, depending on the specialties and factors. 

Which parties can be held liable for a defective medicinal product?

In case of a defective medicinal product, the liable parties may differ in accordance with the grounds of claimed compensation and whether the responsible party is at fault. Even though the party accountable for the liability for pharmaceutical products is potentially the manufacturer, depending on the circumstances of the case, the marketing authorisation holder, seller or importer may also be held liable.

Remedies

What remedies are available to successful claimants?

Successful claimants may claim for both pecuniary and immaterial damages arising from pharmaceutical products. Even though liability on the grounds of materialised damages is commonly seen in practice, the liability of the manufacturer may have arisen from pharmaceuticals that are suitable for generating serious or continual damage, depending on the features of the pharmaceuticals.

Exclusion and limitation

On what grounds can liability be excluded?

First, the manufacturer must issue the recovery proofs as a defence for liability arising from the pharmaceutical products. For instance, in case of employer liability, the manufacturer may claim that it paid the required attention to prevent the damage, giving instruction on the issue and inspecting the employee. Second, it is also possible to claim that the connection of causation is broken down. In relation to the development of risk defence, in case the manufacturer proves that all the requirements are satisfied within the development process, he or she may not be held responsible for defects not discoverable in the existing scientific knowledge in Turkey.

What preventive steps can be taken to limit liability?

As preventive steps, in order to limit liability, companies must provide qualified medicinal products pursuant to the product’s specifications and approvals issued by the Pharmaceuticals and Medical Devices Agency and ensure the required storage and distribution conditions. In addition, considering that the promotion of medicinal products to healthcare providers is essential in order to clarify a product’s effects, companies should consider ensuring that the promotion is performed with explicit accuracy and in detail in order to prevent indirect liability from being triggered by incorrect prescriptions or treatment. 

Compliance and enforcement

Enforcement

What measures are in place to enforce the laws governing medicinal products?

In order to enforce the laws governing medicinal products, the most common enforcement measures are administrative and financial penalties (eg, suspending marketing authorisations, banning promotional activities or imposing administrative fines). Moreover, as per the Law on Preparation and Implementation of Technical Legislation Regarding Products and its secondary legislation, in case of an unsafe product, various penalties – namely, prohibition of placing the product on the market, recalling the product from the market or removing the products from the market partially or completely – can be imposed against manufacturers and distributors. The authority may also order the publication of the decision regarding the unsafe product by announcing to the public details of the unsafe product and the relevant measures imposed by the authority.

Dishonest practices

What mechanisms are in place to combat bribery, fraud, collusion, counterfeiting and other dishonest practices in the pharmaceutical sector?

The mechanisms and regulations combating dishonest practices are performed under different frames. For instance, the Promotion Regulation includes certain provisions against activities which may be interpreted as bribery or dishonest practice in the pharmaceutical sector. In particular, the recently introduced rules on disclosure of value transfers to the Pharmaceuticals and Medical Devices Agency are expected to increase transparency and compliance within the sector. Internally applicable company standard operating procedures and certain industry rules also force pharmaceutical companies to pay the utmost attention to avoiding dishonest practices.

Another mechanism which aims to reduce the likelihood of counterfeit medicinal products is the Pharmaceutical Tracking System. Within such a system, all domestic and imported products can be pursued during their entire life cycle, starting from the manufacturing or importation, through to placing the product on the market and access by the end user. Moreover, the Ministry of Health and security forces conduct several activities to identify and capture individuals or organised groups involved in counterfeiting or smuggling pharmaceutical products. In general, actions arising from such dishonest practices may constitute a crime within different Turkish laws.