New Guidelines on Named Patient Program was Published
The pharmaceuticals not authorized in Turkey or those not available in the market, despite being authorized, shall be procured from abroad upon the request of a physician and special authorization in cases where patients require such pharmaceuticals. Until recently, this exceptional import regime for pharmaceuticals was regulated by the Guidelines on the Supply of Pharmaceuticals from Abroad published by the Turkish Medicines and Medical Devices Agency ("TİTCK").
In line with the new rules stipulated in the Regulation on Supply of Pharmaceuticals from Abroad ("Regulation") published in the Official Gazette dated 3 February 2023 and numbered 32093, the Guidelines on the Supply of Pharmaceuticals from Abroad ("Guidelines"), which indicates the guiding provisions regarding the implementation of the Regulation, has been updated.
The new and notable regulations in the Guidelines concern the foreign pharmaceutical supply source, the obligations of the representative of the foreign pharmaceutical supply source.
i. Regulations on Criteria for Foreign Pharmaceutical Supply Source
For the first time, the Regulation introduces the term "Foreign Pharmaceutical Supply Source" ("Source") in the legislation. The Regulation defines the Source as a institution or organization located abroad that supplies medicinal products for human use to authorized institutions in Turkey and regulates from where and under what conditions the Source may procure products.
Although the Regulation does not provide details on what kind of company the Source can be, the Guidelines specify the criteria the Source should comply with.
According to Article 8 of the Guidelines, the Source must be:
a. A manufacturer/license holder, or
b. A pharmaceutical warehouse licensed by ICH (International Harmonization Council) founding or permanent member competent drug authorities, MHRA (UK Medicines and Healthcare Products Regulatory Agency), or TGA (Australian Therapeutic Goods Administration), or
c. A company authorized by the manufacturer/license holder or a company licensed by the globally or regionally license holder.
Companies not meeting this criteria will not be considered as a Source. Different requirements are set for each type of Source listed above:
a. If the Source is a manufacturer/license holder, it must be verifiable from the accessible databases of the authority where the drug is licensed. If it is not verifiable, the manufacturer/license holder's information must be verified by providing an official, certified, and apostilled or consular-approved document from the health authority where the drug is licensed.
b. If the Source is a pharmaceutical warehouse licensed by ICH founding or permanent member competent drug authorities, MHRA, or TGA, it must be verifiable from the accessible databases of the relevant authorities. If it is not verifiable, the warehouse's license must be verified by providing an official certified and apostilled or consular-approved document from the health authority that issued the license.
c. If the Source is a company authorized by the manufacturer/license holder or a company globally or regionally licensed by the license holder, different requirements are specified depending on the country where the company is established. However, the effective date of these requirements have been set as January 1, 2024.
i. If the Source is a company based in countries where pharmaceutical authorities of ICH founding or permanent members, MHRA, or TGA are authorized, and does not have a pharmaceutical warehouse license, an authorization document proving that the Source is authorized by the manufacturer/license holder or a company globally or regionally licensed by the license holder is expected to be submitted.
However, there are limitations on from whom the Source can procure products. The Source can procure products from the following companies:
- the manufacturer/license holder,
- the company globally or regionally licensed by the license holder,
- the pharmaceutical warehouse licensed by ICH founding or permanent member competent drug authorities, MHRA, or TGA.
ii. If the Source is a company that is neither a manufacturer/license holder nor based in a country where pharmaceutical authorities of ICH founding or permanent members, MHRA, or TGA are authorized, it is expected that the Source will present an authorization document stating that the Source has been exclusively authorized as a single authorized party by the manufacturer/license holder or by a company to which the license holder has granted regional or global license. The Source can only obtain the product from the manufacturer/license holder.
If the Source is not an exclusive authorized company, it can only obtain the product from the following:
- the manufacturer/license holder,
- the licensed pharmaceutical warehouses in countries where the pharmaceutical authorities of ICH founding or permanent member, MHRA, or TGA are authorized.
According to Article 5 of the Regulation,
- In terms of the products licensed by the competent medicines authorities that are founding or permanent members of the ICH, the MHRA or the TGA, by the "Foreign Pharmaceutical Supply Source";
- The supply of products placed on the domestic market of these countries can only be made directly from the manufacturer/license holder companies or pharmaceutical warehouses authorized by the competent authority in the relevant country.
- The supply of products from the domestic market of any country other than these countries can be carried out by submitting a declaration of the manufacturer/license holder company, which undertakes that the product series in the country where the product will be supplied are safe and in compliance with good distribution practices (GDP).
- In terms of the products that have not been authorized by competent medicines authorities that are founding or permanent members of the ICH, the MHRA, or the TGA may only be supplied by the Source from the manufacturer/license holder companies to ensure quality, efficacy, and safety conditions and to prevent fake/smuggled products. Imports of human medicinal products procured by the Source within this scope into Turkey must be made directly from the relevant country.
However, the Guidelines regulates that the product can also be obtained from a company "licensed regionally or globally by the license holder" outside of the two options where the product can be obtained, i.e., other than the manufacturer/license holder or authorized pharmaceutical warehouses authorized by the competent authority in the relevant country. In other words, the Guidelines has expanded the options not foreseen in the Regulation for obtaining products from companies with such licenses.
ii. Regulations on the Obligations of the Representative and the Source
Since the source is a resident abroad, a real or legal person resident in Turkey must be authorized in writing to fulfill the Source’s obligations on its behalf. This person is defined as the Representative.
With the Guidelines, several matters not regulated in the Regulation are shown as the Representative's duties:
- Foreign Drug Suppliers must establish and maintain a pharmacovigilance system but can delegate pharmacovigilance activities to a contracted service provider. Additionally, the Regulation has imposed on Foreign Drug Suppliers the obligation to carry out the encoding processes related to registering the products in Product Tracking System (“ITS”). Therefore, in line with the arrangements in the Guidelines, it is stated that Foreign Drug Suppliers can handle the QR code application and ITS notifications. Besides, the Source can also carry out the encoding process in the customs-free zone.
- It has been regulated that the Representative can meet the financial obligations related to the activities mentioned above depending on the agreement signed with the Source.
While most of the provisions of the Regulation are detailed in the Guidelines, some are not fully rooted in the Regulation. For example, the Regulation contains a provision regarding the authorization document showing the appointment of the Representative by the Source company and even states that the the TİTCK can publish examples of this authorization document. However, the Guidelines has detailed and provided examples for an authorization document type not regulated in the Regulation, which is the authorization between the manufacturer/license holder and the Source.
Nevertheless, it has been regulated that the Foreign Drug Suppliers, the actual importers of the product, can obtain the costs to be incurred to ensure compliance with local requirements regarding the packaging and pharmacovigilance of the product from the Source or its Representative from whom they supply the product. Although the named patient program is an extraordinary import regime on a patient basis, it aims to charge all costs again to the foreign company selling on a prescription basis, similar to ordinary drug imports. While it is not desired that the Turkish Pharmacists Association, and the Social Security Institution cover these costs from their budgets, it could be considered that the state should cover these costs in line with the principle of the social state. Since it is the state's constitutional duty to provide health services to its citizens, the state should cover these costs.