TRENDS AND DEVELOPMENTS
Are there any notable trends or recent legal developments in your jurisdiction's pharmaceutical industry?
A recent development relating to the pricing of pharmaceuticals came with the "Decision Amending the Decree Regarding Pricing of Pharmaceuticals" in the Official Gazette on February 10 2018. As a result, a provisional article has been added to the Pricing Decree which states that: "1 (one) Euro rate value in Turkish Liras to be used in pricing of pharmaceuticals for 2018 shall not exceed 15% of value of 1 (one) Euro rate used in the previous year." This amendment states that while determining the exchange rate for 2018, the Price Evaluation Committee will consider and apply this new criteria along with the 70% of annual average Euro value criteria determined in the existing Pricing Decree and the Pricing Communique.
The Ministry of Health and the Social Security Institution have been taking further steps to encourage the local manufacturing of imported medicines in Turkey. In this regard, a commission of transition from import to manufacture has been established and an announcement made stating that relevant firms in the pharmaceutical sector are liable to provide commitments for the products within the localisation process or at least to indicate the justifications behind not giving such commitments for related products. The authorities have been working on expanding the scope of the localised products, which are divided into five stages.
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).
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.
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 (amended on October 21 2017);
- the Promotion Regulation;
- the Regulation on the Packaging, Information, Inserts and Tracking of Medicinal Products for Human Use;
- 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 following regulations are expected to be amended in the coming months:
- the Promotion Regulation; and
- the Pharmaceuticals Licensing Regulation.
On January 19 2018 the Turkish Medicines and Medical Devices Agency announced that the legislative process for the adoption of EU Regulation 2017/745 on Medical Devices is in progress. Accordingly, the Regulation of Medical Devices will also be amended in the near future.
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:
- 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 regulating public healthcare expenditure and implementing 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 relating 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 (eg, medical devices, cosmetics, traditional herbal products and nutritional products) are regulated under specific laws consisting of various regulations and guidelines. Considering that the regulations governing medicinal products are quite strict in Turkey, particularly the use of any health claims for products, no significant medicinal products are exempt from regulation.
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. According to the recent changes in legislation, warehouses providing secondary packaging services shall be evaluated as manufacturing facilities and further procedural requirements will also be applied to these services.
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.
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. However, the Competition Board has also recently been carrying out investigations relating to parallel export restrictions in vertical agreements.
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.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.