I - Introduction

and Recent News on the Assignment of the Duties to Social Security Institution

In Turkey, import and sale of medicines are subject to

licensing requirements of the Ministry of Health ("Ministry"). The principle is

that medicines which are not licensed in Turkey cannot be put on the Turkish

market. "Procurement of medicines from abroad" mechanism, on the other hand,

brings an exception to this rule.

With the "Procurement of medicines from abroad"

process which is regulated under the Guidelines for Procurement of Medicines

from Abroad ("Guidelines"), as published on the Ministry's website, the

Ministry paves the way for a distinct mechanism allowing the procurement of

medicines that are licensed but not accessible in Turkey for various reasons

(e.g. stock-out) or medicines which are not duly licensed in Turkey, on

prescription basis or in emergent cases, collectively.

The Ministry's current list of approved suppliers, as

attached to Annex 8 of the Guidelines[1],

points out the Turkish Pharmacy Association ("TEB") as the sole supplier

authorized to procure medicines from abroad. Although TEB recaptured its role

as the sole supplier following a public feud with the Ministry[2], there

are news[3]

appeared this year on the media alleging that Social Security Institution

("SSI") will take over TEB's authority to procure medicines from abroad. Apart

from this current media coverage, the legislation in force stands the same and

TEB reserves its title as the sole authorized supplier.

II - Overview of

the Ministry of Health's Guidelines

The Ministry's process of "Procurement of Medicines

from Abroad" is regulated under the Guidelines[4]. The

Guidelines, while setting forth the criteria for procurement, outlines the

rules to be fulfilled both by patients and the supplier approved for the

procurement.

In light of the Guidelines, medicines which are not

licensed in Turkey and/or cannot be found in market (though being licensed),

can be procured from abroad on prescription basis or, in emergent cases, collectively.

Lists of medicines that can be procured from abroad as well as the approved

suppliers authorized to procure such medicines are published on the Ministry's

website. All of the substances listed under the list can only be imported by

those approved suppliers. This said, currently TEB, being the sole entity under

the list, holds the title of the sole supplier authorized for the procurement.

According to the Guidelines, during the import of

these medicines, a Control Certificate should also be prepared by the Ministry

for importation of the medicines containing the active substances listed under

the Ministry's "Active Substance List"[5].

Doctor prescription and patient information form are also sought during the

procurement process each time. Also, procurement consent for the substances is

individual for each patient.[6] A

consent obtained for a specific patient does not set an example for other

patients with same diagnoses yet with different clinical courses, as accepted

by the Ministry.

III - Criteria

for Procurement

In light of the Guidelines, TEB can procure the medicines

from abroad which are not licensed in Turkey or cannot be found in Turkey

despite being licensed, in exceptional cases where all treatment options in

Turkey have been exhausted or where such options cannot be exhausted in certain

patients, for the diagnoses and the treatment of diseases. These medicines can

only be procured by TEB by complying with the following order:

(i) Medicines approved and marketed by FDA/EMA or

manufactured, licensed and marketed in countries which are member to

Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation

Scheme, should be procured.

(ii) In case the medicine cannot be found in or

procured from the countries under (i), the names of the medicines manufactured

and used in countries other than the ones listed under (i) can be added to the

list of "Medicines to be Procured from Abroad", with the approval of the

Chairman of the Turkish Medicine and Medical Device Institution ("Institution")[7],

by collecting the opinion of the relevant scientific commission.

(iii) During the application to be made by TEB to the

Institution for the inclusion of the medicines not licensed by FDA/EMA to the "Medicines

to be Procured from Abroad" list, the following documentation should be

submitted:

a) Certificate of Pharmaceutical Product for the medicine

b) Medicine information (including safety information)

and letter or corporate e-mail from the manufacturing company which includes

the country information where the medicine is used.

c) In cases where the documentation set forth in (a)

and (b) cannot be procured and attested by TEB, letter of corporate e-mail

regarding medicine information (including safety information) from the foreign

supplier warehouse.

To that end, TEB would be the responsible authority

for the duly procurement and supply of the foreign medicines and should comply

with the foregoing criteria, in respective order, for procurement. While the

principle is to procure the product on a prescription basis (with the request

of the doctor), TEB can stock the medicines listed under Medicines to be

Procured from Abroad, as per the Guidelines.

IV - Discussion

of Authorization for Procurement

Back in 2013, the Ministry gave the authority to

procure medicines from abroad to a number of pharmaceutical warehouses by way

of including them to the authorized suppliers list, which triggered controversy

between TEB and the Ministry.

Following certain public announcements criticizing the

Institution's approach[8]

and failed negotiations with the Institution, TEB has initiated a lawsuit

against the Institution before the Council of State alleging that the amendment

made in the legislation which paves the way for other suppliers to enter into

protocols with the Institution for the procurement process is unlawful and

breaches the protocol provisions between TEB and the Institution. As a result,

the Council of State has granted a motion for stay of execution for the

Institution's amendment in the legislation[9].

In light of the foregoing, the Institution re-amended

the Guidelines and published the revised authorized suppliers list in its

website with the following note;

"As per 15th

Department of Council of State's motion for stay of execution, procurement

activities of pharmaceutical warehouses previously authorized by our

Institution for procurement medicines from abroad, have been ceased as of

30.04.2016."

V - List of

Medicines That Can Be Procured From Abroad

The active substance sought for the medicines to be

procured from abroad are listed on an excel sheet announced weekly on the

Institutions website[10].

As per Article 5 of the Guidelines, except for the active substances marked as

the "Medicines that can only be imported with the Ministry's consent", the

Ministry does not seek an import permit for the active substances listed on the

first tab of the excel sheet.

For the active substances that are not included in the

Lists of medicines that can be procured from abroad, an application can be made

to the Institution with the documents listed in Article 5 (4) of the

Guidelines.

VI -

Reimbursement of Procured Medicines

In Turkey, SSI deals with the reimbursement front of

the medicines procured from abroad. In other words, the Ministry is the

authority for the import of the medicine, whereas the SSI is the relevant

authority for the reimbursement thereof. The Ministry's current list of

approved suppliers, points out the TEB as the sole supplier which has arrangements

with the SSI for reimbursement. There is a protocol in place between SSI and

TEB for reimbursement since 2007[11].

VII - Conclusion

"Procurement of medicines from abroad" process without

doubt holds great importance for the health sector and patients seeking

medicines that are short in the Turkish market. Regardless of the controversies

as to suppliers of these medicines, the

Ministry continues to lay the way open for the exporters willing to contribute

in procurement of medicines in to the Turkish market.

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.

Authors: Gönenç Gürkaynak,

Esq., Ceren Yıldız

and Ecem Elver, ELIG,

Attorneys-at-Law

First published in Mondaq on December 7, 2016.

[1] See at http://www.titck.gov.tr/PortalAdmin/Uploads/UnitPages/tedarikci_depolar_listesi_%2029.01.2016.pdf

(latest access on December 6th, 2016)

[2]

See Subtitle IV

below.

[3]

See at http://www.haberturk.com/saglik/haber/1267805-yurtdisindan-ilaci-artik-sgk-getirecek

(latest access on December 6th, 2016) and

http://www.dunya.com/ekonomi/sgk-yurtdisindan-ilac-getirme-isini-buyuk-oranda-ustlenecek-haberi-320214 (latest

access on December 6th, 2016)

[4]

See at http://www.titck.gov.tr/Mevzuat/MevzuatGetir?id=2649

(latest access on December 6th, 2016)

[5] Article

7 (3) of the Guidelines for Procurement of Medicines from Abroad.

[6]

Article 6 (10) of the Guidelines for Procurement of Medicines from Abroad.

[7] Turkish Medicine and Medical Device Institution is a

division of the Ministry of Health.

[8]

See at http://213.153.183.41/news/6325/T%C3%BCrkiyede-Ruhsat%C4%B1-Olmayan-veya-Piyasada-Bulunmayan-%C4%B0la%C3%A7-Temininde-Tart%C4%B1%C5%9Fma-Tekelle%C5%9Fme-De%C4%9Fil-Hasta-Yarar%C4%B1-%C3%9Czerinden-Olmal%C4%B1d%C4%B1r (latest

access on December 6th, 2016) and http://teb.org.tr/news/6684/%C4%B0thal-%C4%B0la%C3%A7-Temini-Konusunda-SGK-ile-Anla%C5%9Fmas%C4%B1-Olan-Tek-Tedarik%C3%A7i-TEB%EF%BF%BD%EF%BF%BDdir

(latest access on December 6th, 2016)

[9]

TEB's

announcement as to Department of Council's verdict can be found at http://www.teb.org.tr/news/6901/Yurtd%C4%B1%C5%9F%C4%B1ndan-%C4%B0la%C3%A7-Temini-Yetkisi-Verilen-Tedarik%C3%A7iler-Konusunda-T%C4%B0TCKya-A%C3%A7t%C4%B1%C4%9F%C4%B1m%C4%B1z-Dava-Sonu%C3%A7land%C4%B1 (latest

access on December 6th, 2016)

[10] As of the publication date of this article, the most

recent list is published on December 2nd 2016. See the current list at http://www.titck.gov.tr/Yurtd%C4%B1%C5%9F%C4%B1%C4%B0la%C3%A7 (latest

access on December 6th, 2016)

[11]

See signed copy of the protocol in Turkish at http://www.istanbuleczaciodasi.org.tr/upload/pdf/20120203_protokol.pdf (latest access on December 6th, 2016)