TURKEY – CERTAIN MEASURES CONCERNING THE PRODUCTION, IMPORTATION AND MARKETING OF PHARMACEUTICAL PRODUCTS STATUS REPORT BY TÜRKIYE
Document: arbitration award
Date: 28 April 2023
Document codes: WT/DS583/18
Complainant: EU
Respondent: Turkey
Third parties: Brazil, Canada, China, India, Indonesia, Japan, Russia, Switzerland, Ukraine, U.S.
Dispute stage: Panel
Agreements cited: Art. III:4, X:1, XI:1  GATT 1994Art. 3.1(b)  Subsidies and Countervailing Measures (SCM)Art. 2.1  Trade-Related Investment Measures (TRIMs)

TURKEY – CERTAIN MEASURES CONCERNING THE PRODUCTION,
IMPORTATION AND MARKETING OF PHARMACEUTICAL PRODUCTS
STATUS REPORT BY TÜRKIYE
The following communication, dated 25 April 2023, from the delegation of Türkiye to the Chairperson
of the Dispute Settlement Body, is circulated at the request of that delegation.

STATUS REPORT REGARDING IMPLEMENTATION OF THE
RECOMMENDATIONS AND RULINGS BY TÜRKİYE

Türkiye submits this status report under Article 21.6 of the Understanding on Rules and Procedures
Governing the Settlement of Disputes (DSU) to inform the Dispute Settlement Body (DSB) of its
progress in the implementation of the arbitration award in DS583.

On 25 July 2022, the Arbitrators issued their award ( and
) in the dispute Türkiye – Certain Measures concerning the Production,
Importation and Marketing of Pharmaceutical Products (DS583). On the same day, in accordance
with Article 25.3 of the DSU, the Award was notified to the DSB, the Council for Trade in Goods, the
Committee on Subsidies and Countervailing Measures and the Committee on Trade -Related
Investment Measures. Pursuant to paragraph 15 of the Agreed Procedure s for Arbitration
(), the Award was not adopted by the DSB.

Consequently on 18 August 2022, Türkiye informed the DSB in writing () that,
pursuant to Article 21.3 of the DSU, it intended to implement the recommendations and rulings of
the Arbitrators and the Panel in this dispute in a manner that respects its WTO obligations, but that
it needed a reasonable period of time to do so. Türkiye reiterated this statement at the DSB meeting
of 29 August 2022.

On 10 January 2023, Türkiye and the European Union informed the DSB () that they
had agreed, pursuant to Article 21.3(b) and Article 25.4 of the DSU that the reasonable period of
time for Türkiye to implement the recommendations of the Award of the Arbitrators would expire
on 25 April 2023.

Türkiye hereby informs the DSB that it has taken appropriate steps to implement the
recommendations and rulings in this dispute.

First, the Social Security Institution published the new Drug Reimbursement Regulation in the Official
Gazette dated 25 August 2022 which came into force on that same day and has replaced the
previously applicable regulation. The new regulation fully respects Türkiye's WTO obligations.

Second, the Health Industries Steering Committee which is the policy -making body for the
localization measure, met in December 2022 and recommended the Social Security Institution to
initiate the application process for relevant pharmaceutical companies regarding the re-activation of
their products in the reimbursement system. Con sequently, the Health Services Pricing Committee
adopted this recommendation at its meeting in January 2023.

In accordance with these decisions and for transparency purposes, the Turkish Medicines and Medical
Devices Agency issued an announcement on 18 A pril 2023 stating that "Transition from Import to
Manufactured Products Project" has been terminated. Social Security Institution is now expected to
initiate the process for reactivation of the relevant pharmaceutical products in the reimbursement
list.

Third, the Social Security Institution has prepared the new draft Alternative Drug Reimbursement
Regulation taking into account the recommendations issued in this dispute and shared it with the
relevant stakeholders. Once the consultations are completed, th e new Alternative Drug
Reimbursement Regulation, which fully respects Türkiye's WTO obligations, will be published in the
Official Gazette.

Finally, the relevant authorities are also currently preparing amendments to the Guideline for
Working Principles and Procedures of Human Medicinal Products Priority Assessment Commission.

Türkiye considers that the above -described actions bring it into compliance with the arbitration
award.

Türkiye stands ready to respond to the questions the European Union may have in relation to the
implementation in this dispute.