TURKEY – CERTAIN MEASURES CONCERNING THE PRODUCTION, IMPORTATION AND MARKETING OF PHARMACEUTICAL PRODUCTS REQUEST FOR CONSULTATIONS BY THE EUROPEAN UNION
Document: REQUEST FOR CONSULTATIONS BY
Date: 10 April 2019
Document codes: WT/DS583/1; G/L/1305; G/TRIMS/D/44; G/SCM/D126/1; IP/D/41
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
REQUEST FOR CONSULTATIONS BY THE EUROPEAN UNION
The following communication, dated 2 April 2019, from the delegation of the European Union to the
delegation of Turkey, is circulated to the Dispute Settlement Body in accordance with Article 4.4 of
the DSU.

My authorities have instructed me to request consultations with the government of the Republic of
Turkey (Turkey) pursua nt to Articles 1 and 4 of the Understanding on Rules and Procedures
Governing the Settlement of Disputes (DSU), Article XXII:1 of the General Agreement on Tariffs and
Trade 1994 (GATT 1994), Article 8 of the Agreement on Trade Related Investment Measures (TRIMs
Agreement), Article 64 of the Agreement on Trade -Related Aspects of Intellectual Property Rights
(TRIPS Agreement), and Article 4.1 of the Agreement on Subsidies and Countervailing Measures
(ASCM) with regard to various measures concerning the produc tion, importation and marketing of
pharmaceutical products.

1. The Measures at issue
a. The localisation requirement
The Turkish authorities have adopted plans to achieve progressively the localisation in Turkey of the
production of a substantial part of the p harmaceutical products consumed in Turkey. In order to
achieve that objective, Turkey requires foreign producers to commit to localise in Turkey their
production of certain pharmaceutical products. If such commitments are not given, are not accepted
by Turkish authorities, or are not fulfilled, the pharmaceutical products concerned are excluded from
the scheme for the reimbursement of the pharmaceutical products sold by pharmacies to patients
operated by Turkey's social security system (the "reimbursement scheme"). That scheme covers the
vast majority of sales of pharmaceutical products by pharmacies to patients. Consequently, if an
imported pharmaceutical product is excluded from the reimbursement scheme, its competitive
opportunities in the Turkish market are significantly impaired, as compared with domestically
produced like products.
In order to comply with the above described localisation requirement (the "localisation
requirement"), certain producers of pharmaceutical products commit to localise their production of
certain pharmaceutical products in Turkey. In those cases where foreign producers do not give the
required commitments to localise (or where their offered commitments are rejected, or are
considered not to be fulfilled, by the Turkish authorities), the pharmaceutical products concerned
are no longer reimbursed. The localisation requirement is designed to apply on an ongoing basis, or
at least until the localisation objectives established by the Turkish government are achieved. T he
localisation requirement is periodically adapted, modified, updated or extended with respect to, inter
alia, the products it applies to and/or the extent of localisation sought.
The specific commitments to be implemented in order to comply with the loca lisation requirement
are established for each foreign producer in a non-transparent manner and may differ from producer
to producer.
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b. The technology transfer requirement
As part of the localisation requirement, or closely connected to it, foreign producers may be required,
in particular, to transfer technology, including patent rights, to a producer established in Turkey (the
"technology transfer requirement "). This requirement does not apply to Turkish producers of
pharmaceutical products. The type of technology transfer may also differ from producer to producer.
c. The import ban on localised products
It appears that where the production of a pharmaceutical product has been localised in Turkey in
accordance with the localisation requirement, applied in conjunc tion with the Turkish rules for
approving the importation and marketing of pharmaceutical products, the importation of that
pharmaceutical product is no longer permitted ("the import prohibition").
d. The prioritization measure
Lastly, it appears that, even in certain cases where imported products are not excluded from the
reimbursement scheme by virtue of the localisation requirement, the Turkish authorities give priority
to the review of applications for inclusion of domestic pharmaceutical products in the list of products
covered by the reimbursement scheme, as well as with respect to any pricing and licensing policies
and processes, over the review of the applications of imported products (the "prioritization"
measure). This measure is also administered in a non-transparent manner.
2. The legal and other instruments relevant to the measures at issue
The various measures at issue described above are put in place and evidenced by, and are
implemented and administered through, inter alia, the following legal and other instruments,
considered alone and in any combination:
− "The Tenth Development Plan 2014 -2018" of 2 July 2013, in particular 1.2 (Program for
Reducing Import Dependency) and 1.16 (Healthcare Related Industries Structural
Transformation Program) under Chapter 3.1 (Priority Transformation Programs);1
− "The Structural Transformation Program for Healthcare Industries Action Plan " of 6
November 2014, coordinated by the Ministry of Health and the Ministry of Development, in
particular Actions 2 and 3 under Policy No 5 (Strengthening the capacity of the procurement
bodies (public institutions) to steer and regulate the sector) of Component-1 (Strengthening
Public Sector 's Steering Capacity ) and Actions 1 and 2 under Policy No 1 ( Developing
Cooperation Models with the domestic Medicines/ Medical Devices Industry While Devising
New Health Schemes ) of Component -3 ( Improvement of Business and Entrepreneurial
Ecosystems);2
− "The 2016 Action Plan of the 64th Government (Implementation an d Reforms) " of 10
December 2015, in particular Action 46 (The reimbursement, pricing and licensing processes
of medical devices and strategic and domestic medicines shall be improved);3

1 Decision No. 1041 of the Grand National Assembly of Turkey of 2 July 2013 on the approval of the
Tenth Development Plan (2014-2018), in accordance with the Law No. 3067, dated 30 October 1984,
http://www.resmigazete.gov.tr/eskiler/2013/07/20130706M1.htm,
http://www.resmigazete.gov.tr/eskiler/2013/07/20130706M1-1.htm and
http://www.resmigazete.gov.tr/eskiler/2013/07/20130706M1-1-1.doc, last accessed on 7 March 2019, and in
English http://www.sbb.gov.tr/wp-content/uploads/2018/11/The_Tenth_Development_Plan_2014-2018.pdf,
last accessed on 7 March 2019.
2 http://strateji.gtb.gov.tr/haberler/10kalkinma-plani-oncelikli-donusum-programlari-aciklandi,
http://strateji.ticaret.gov.tr/data/54a2957ef29370219c5db800/1.%20grup%20eylem%20planları.docx,
http://strateji.ticaret.gov.tr/data/54a2957ef29370219c5db800/2.%20grup%20eylem%20planları.docx,
http://www.sbb.gov.tr/oncelikli-donusum-programlari-eylem-planlari/ and http://www.sbb.gov.tr/wp-
content/uploads/2018/10/16Saglik_Endustrilerinda_Yapisal_Donusum_ProgramiBASKI.pdf, last accessed on 7
March 2019.
3 http://bypass.teskilat.akparti.org.tr/Site/haberler/64.-hukumetin-eylem-plani/81171#1
WT/DS583/1 • G/L/1305 • G/TRIMS/D/44 • IP/D/41 • G/SCM/D126/1

− "The 65 th Government Programme " of 24 May 2016, in particular Part 3 ( Human
Development) and Part 4 (Strong Economy);4
− "The Performance Program for 100 Days" announced on 3 August 2018 by Turkish President
Erdogan for the first 100 days of his Presidency, in particular points 9 and 10 of the actions
falling under the responsibility of the Ministry of Health;5
− "Presidency Decision No. 108 on the New Economy Program for the period 2019 -2021" of
20 September 2018, in particular Part 4 (Current Account Deficit) and 7 (Programs and
Projects – Health);6
− "The SSI Regulation on Drug Reimbursement" of 10 February 2016;7
− "The SSI Regulation on Alternative Reimbursement for Universal Health Insurance " of 10
February 2016;8
− "Regulation amending the Regulation on the Working Procedures and Principles of the Social
Security Institution Healthcare Services Pricing Commission" of 10 February 2016;9
− "Circular 2018/1" from the Prime Ministry of 24 January 2018 on the Localisation Board;10
− "The Health Implementation Notification/Communique", in particular "Annex-4/A";11
− "The Social Security Institution Law Number 5502" of 16 May 2006, as amended by Article
88 of "Decree Law 703 Amending Certain Laws and Decree Laws for the Purposes of
Compliance with the Amendments to the Constitution" of 2 July 2018;12

 and https://www.tusev.org.tr/usrfiles/files/64.HukumetEylemPlaniKitapcik.pdf, last accessed on 7
March 2019.
4 http://reformlar.gov.tr/ui/pdf/65._hukumet_program.pdf, last accessed on 6 June 2018.
5 https://www.tccb.gov.tr/assets/dosya/100_GUNLUK_ICRAAT_PROGRAMI.pdf, last accessed on 7
March 2019.
6 http://www.resmigazete.gov.tr/eskiler/2018/09/20180920M2.htm,
http://www.resmigazete.gov.tr/eskiler/2018/09/20180920M2-1.pdf and
http://www.bumko.gov.tr/Eklenti/11246,yeni-ekonomi-programipdf.pdf?0, last accessed on 7 March 2019, and
in English https://ms.hmb.gov.tr/uploads/sites/2/2019/01/Turkey-NEP-2019-21.pdf, last accessed on 7 March
2019.
7 Published in the Official Gazette of 10 February 2016, page 23,
http://www.resmigazete.gov.tr/eskiler/2016/02/20160210.htm
and http://www.resmigazete.gov.tr/eskiler/2016/02/20160210-7.htm, last accessed on 7 March 2019.
8 Published in the Official Gazette of 10 February 2016, page 16,
http://www.resmigazete.gov.tr/eskiler/2016/02/20160210.htm and
http://www.resmigazete.gov.tr/eskiler/2016/02/20160210-6.htm, last accessed on 7 March 2019.
9 Published in the Official Gazette of 10 February 2016, at page 37,
http://www.resmigazete.gov.tr/eskiler/2016/02/20160210.htm and
http://www.resmigazete.gov.tr/eskiler/2016/02/20160210-8.htm, last accessed on 7 March 2019.
10 Published in the Official Gazette of 24 January 2018, page 8,
http://www.resmigazete.gov.tr/eskiler/2018/01/20180124-5.pdf, last accessed on 7 March 2019.
11 In Turkish the “Sağlık Uygulama Tebliği” (SUT), published in the Official Gazette Number 28597 of 24
March 2013,
http://www.mevzuat.gov.tr/Metin.Aspx?MevzuatKod=9.5.17229&MevzuatIliski=0&sourceXmlSearch
and its annexes http://www.mevzuat.gov.tr/MevzuatMetin/yonetmelik/9.5.17229-EKK.zip, last accessed on 7
March 2019. Latest amendments published in the Official Gazette of 28 December 2018 No 30639,
http://www.resmigazete.gov.tr/eskiler/2018/12/20181228M1.htm and
http://www.resmigazete.gov.tr/eskiler/2018/12/20181228M1-1.pdf, last accessed on 7 March 2019; published
on the Social Security Website on 11 February 2019,
http://www.sgk.gov.tr/wps/portal/sgk/tr/kurumsal/merkez-
teskilati/ana_hizmet_birimleri/gss_genel_mudurlugu/anasayfa_duyurular/guncel_sut_01022019 and
http://www.sgk.gov.tr/wps/wcm/connect/4cd197fc-aa36-45cb-9090-ee8c525b6c18/2019.02.01-
+De%C4%9Fi%C5%9Fiklik+Tebli%C4%9Fi+%C4%B0%C5%9Flenmi%C5%9F+G%C3%BCncel+SUT.zip?MOD
=AJPERES&CONVERT_TO=url&CACHEID=4cd197fc-aa36-45cb-9090-ee8c525b6c18, last accessed on 7 March
2019.
12 Published in the Official Gazette Number 26173 of 20 May 2006,
http://www.resmigazete.gov.tr/eskiler/2006/05/20060520.htm and
http://www.resmigazete.gov.tr/eskiler/2006/05/20060520-2.htm, last accessed on 7 March 2019, including its
amendment by Article 88 of Decree Law 703 of 2 July 2018, “Law on Certain Amendments to the Social
Security Institution Law”,
http://www.mevzuat.gov.tr/Metin1.Aspx?MevzuatKod=1.5.5502&MevzuatIliski=0&sourceXmlSearch=&Tur=1&
WT/DS583/1 • G/L/1305 • G/TRIMS/D/44 • IP/D/41 • G/SCM/D126/1

− "The Social Insurance and Universal Health Insurance Law Number 5510"of 31 May 2006;13
− "Decree Law No. 663 on Organization and Duties of Ministry of Health and its Affiliated
Agencies" of 11 October 2011;14
− "Presidential Decree Number 1 on Organization of Presidency" of 10 July 2018;15
− "Decree Law 703 Amending Certain Laws and Decree Laws for the Purposes of Compliance
with the Amendments to the Constitution" of 2 July 2018;16
− "Presidential Decree Number 4 on Organization of the Ministries, Affiliated, Linked and
Related Agencies and Other Institutions and Agencies" of 15 July 2018;17
− Public announcements on localisation published on: (i) March 2016, 18 April 2016, 19 8
February 2017, 20 16 February 2017, 21 April 2017, 22 January 2018 23 and May 2018 24
informing that the imported medicines listed in the annex(es) to the announcement would
no longer be reimbursed;
− Other instruments through which Turkey implements and administers the measures at issue,
including presentations made by Government officials and letters or other documents making

Tertip=5&No=5502 and http://www.mevzuat.gov.tr/MevzuatMetin/1.5.5502.pdf, last accessed on 7 March
2019.
13 Published in the Official Gazette Number 26200 of 16 June 2006,
http://www.resmigazete.gov.tr/eskiler/2006/06/20060616.htm and
http://www.resmigazete.gov.tr/eskiler/2006/06/20060616-1.htm, last accessed on 7 March 2019.
14 Published in the Official Gazette Number 28103(bis) of 2 November 2011,
http://www.resmigazete.gov.tr/eskiler/2011/11/20111102M1.htm and
http://www.resmigazete.gov.tr/eskiler/2011/11/20111102M1-3.htm, last accessed on 7 March 2019.
15 Published in the Official Gazette Number 30474 of 10 July 2018,
http://www.resmigazete.gov.tr/eskiler/2018/07/20180710.htm and
http://www.resmigazete.gov.tr/eskiler/2018/07/20180710-1.pdf, last accessed on 7 March 2019.
16 Published in the Official Gazette Number 30473 of 9 July 2018,
http://www.resmigazete.gov.tr/eskiler/2018/07/20180709M3.htm and
http://www.resmigazete.gov.tr/eskiler/2018/07/20180709M3-1.pdf, last accessed on 7 March 2019.
17 Published in the Official Gazette Number 30479 of 15 July 2018,
http://www.resmigazete.gov.tr/eskiler/2018/07/20180715.htm and
http://www.resmigazete.gov.tr/eskiler/2018/07/20180715-1.pdf, last accessed on 7 March 2019.
18 https://www.titck.gov.tr/duyuru/2521, https://titck.gov.tr/storage/announcement/fzzD3Hwn.pdf and
https://www.titck.gov.tr/PortalAdmin/Uploads/UnitPageAttachment/fzzD3Hwn.pdf, last accessed on 7 March
2019.
19 https://www.titck.gov.tr/Duyurular/DuyuruGetir?id=2593, last accessed on 23 July 2018.
20 http://www.sgk.gov.tr/wps/portal/sgk/tr/kurumsal/merkez-
teskilati/ana_hizmet_birimleri/gss_genel_mudurlugu/anasayfa_duyurular/duyuru_08022017_00 and
www.sgk.gov.tr/wps/wcm/connect/8fa7cb90-6d4b-41ab-abe8-
05a5a7c6db3e/duyuru_08022017_00.pdf?MOD=AJPERES&CONVERT_TO=url&CACHEID=8fa7cb90-6d4b-41ab-
abe8-05a5a7c6db3e, last accessed on 7 March 2019.
21 http://www.sgk.gov.tr/wps/portal/sgk/tr/kurumsal/merkez-
teskilati/ana_hizmet_birimleri/gss_genel_mudurlugu/anasayfa_duyurular/duyuru_16022017,
http://www.sgk.gov.tr/wps/wcm/connect/731a3892-8950-4d78-a75d-
7cef4d3c6811/duyuru__16022017.pdf?MOD=AJPERES&CONVERT_TO=url&CACHEID=731a3892-8950-4d78-
a75d-7cef4d3c6811 and http://www.sgk.gov.tr/wps/wcm/connect/e4fdaff9-e53c-4a6f-babf-
457c16249f49/ek_25042017.xlsx?MOD=AJPERES&CONVERT_TO=url&CACHEID=e4fdaff9-e53c-4a6f-babf-
457c16249f49, last accessed on 7 March 2019.
22 http://www.sgk.gov.tr/wps/portal/sgk/tr/kurumsal/merkez-
teskilati/ana_hizmet_birimleri/gss_genel_mudurlugu/anasayfa_duyurular/duyuru_25042017 and
http://www.sgk.gov.tr/wps/wcm/connect/22277d4b-1601-46a6-938e-
a8fb97c092c6/duyuru_25042017.pdf?MOD=AJPERES&CONVERT_TO=url&CACHEID=22277d4b-1601-46a6-
938e-a8fb97c092c6, last accessed on 7 March 2019.
23 http://www.sgk.gov.tr/wps/portal/sgk/tr/kurumsal/merkez-
teskilati/ana_hizmet_birimleri/gss_genel_mudurlugu/anasayfa_duyurular/duyuru_19012018_04,
http://www.sgk.gov.tr/wps/wcm/connect/8c5a62b6-2029-4e04-b6fa-
244b5a4edf2c/duyuru_19012018_04.pdf?MOD=AJPERES&CONVERT_TO=url&CACHEID=8c5a62b6-2029-4e04-
b6fa-244b5a4edf2c and http://www.sgk.gov.tr/wps/wcm/connect/3f6b1970-6b26-4fdf-b31e-
6efa89fb4dd8/ek_19012018_04.xlsx?MOD=AJPERES&CONVERT_TO=url&CACHEID=3f6b1970-6b26-4fdf-b31e-
6efa89fb4dd8, last accessed on 7 March 2019.
24 http://www.sgk.gov.tr/wps/portal/sgk/tr/kurumsal/merkez-
teskilati/ana_hizmet_birimleri/gss_genel_mudurlugu/anasayfa_duyurular/duyuru_16052018_02, last accessed
on 7 March 2019.
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requests, communicating decisions or imparting instructions addressed by the Turkish
authorities to individual companies exporting pharmaceutical products to Turkey (or
importing pharmaceutical products in Turkey)";
This request also covers any annexes or schedules thereto, amendments, supplements,
replacements, renewals, extensions, implementing measures or any other related measures.

3. Legal basis for the complaint
The various measures at issue described above appear to be inconsistent with Turk ey's obligations
under the covered agreements, in particular:
− Article III:4 of the GATT 1994, because, by excluding imported pharmaceutical products for
which localisation commitments have not been given, have not been accepted or have not
been fulfilled f rom the reimbursement scheme, the localisation requirement accords to
imported pharmaceutical products treatment less favourable than that accorded to like
products of national origin covered by that scheme in respect of laws, regulations and
requirements affecting their internal sale, offering for sale, purchase, transportation,
distribution or use;
− Article III:4 of the GATT 1994, because, by according priority to the review of applications
for inclusion in the reimbursement scheme, as well as with respect to any other pricing and
licensing policies and processes, of pharmaceutical products of national origin the
prioritization measure accords more favourable treatment to those products than to like
imported products;
− Article X:1 of the GATT 1994, because Turkey has failed to publish all measures of general
application relating to the localisation requirement, the technology transfer requirement and
the prioritization measure promptly, and in such a manner as to enable governments and
traders to become acquainted with them;
− Article X:2 of the GATT 1994, because, through the measures at issue, Turkey applies a
new or more burdensome requirement, restriction or prohibition on imports which is
enforced before being officially published;
− Article X:3(a) of th e GATT 1994, because Turkey has failed to administer its laws,
regulations, decisions and rulings in relation to the localisation requirement, the technology
transfer requirement and the prioritization measure in a uniform, impartial and reasonable
manner;
− Article XI:1 of the GATT 1994, because, once a foreign producer has localised production of
a certain pharmaceutical product pursuant to the localisation requirement, applied in
conjunction with the Turkish rules for approving the importation and marketin g of
pharmaceutical products, that product can no longer be imported, and therefore Turkey
institutes and maintains a prohibition or restriction, other than duties, taxes or other
charges, on the importation of products of other contracting parties ;25
− Article 2.1 of the TRIMs Agreement, because the localisation requirement is an investment
measure inconsistent with Article III:4 of the GATT 1994;
− Article 3.1 of the TRIPS Agreement, because the technology transfer requirement does not
apply to domestic produ cers of pharmaceutical products, and therefore it accords to the
producers of other Members treatment less favourable than that accorded to domestic
producers with regard to the protection of intellectual property;

25 In addition, under Article 5 of “Decision No 1/95 of the EC-Turkey Association Council of 22 December
1995 on implementing the final phase of the Customs Union (96/142/EC)”, Turkey committed to the obligation
that quantitative restrictions on imports and all measures having equivalent effect shall be prohibited between
the Parties. Turkey has not fulfilled that obligation.
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− Article 27.1 of the TRIPS Agreement, because the technology transfer requirement may
cover patent rights and does not apply to domestic producers of pharmaceutical products,
and thus patents are not available and patent rights are not enjoyable without discrimination
as to whether products are imported or locally produced;
− Article 28.2 of the TRIPs Agreement, because the technology transfer requirement may
cover patent rights and because it restricts or infringes on the right of patent owners to
assign, or transfer by succession, the patent and to conclude licensing contracts;
− Articles 39.1 and 39.2 of the TRIPS Agreement, because the technology transfer requirement
may require foreign producers of pharmaceutical products to transfer undisclosed
information protected by those provisions to a Turkish producer; and
− Article 3.1 b) of the ASCM, because the reimbursement scheme operated by the Turkish
social security system involves the granting of a subsidy within the meaning of Article 1.1 of
the ASCM. The localisation requirement makes the granting of that subsidy contingent upon
the use of domestic goods over imported goods, thereby violating Article 3.1 b) of the ASCM.
A statement of available evidence with regard to the existence and nature of that subsidy is
annexed to this request.
The various measures relating to pharmaceutical products identified in this request appear to nullify
or impair the benefits accruing to the European Union directly or indirectly under the covered
agreements.
The European Union reserves the right to address additional measures and claims under other
provisions of the covered agreements regarding the above matters during the course of the
consultations.

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ANNEX
STATEMENT OF AVAILABLE EVIDENCE

For purposes of Article 4.2 of the ASCM, the European Union sets out below evidence available to it
at this time regarding the existence and nature of the subsidies subject to this request for
consultations. The European Union reserves the right to supplement or alter this list in the future,
as required:

− "The Tenth Development Plan 2014 -2018" of 2 July 2013, in particular 1.2 (Program for
Reducing Import Dependency) and 1.16 (Healthcare Related Industries Structural
Transformation Program) under Chapter 3.1 (Priority Transformation Programs);

− "The Structural Transformation Program for Healthcare Industries Action Plan " of 6
November 2014, coordinated by the Ministry of Health and the Ministry of Development, in
particular Actions 2 and 3 under Policy No 5 (Strengthening the capacity of the procurement
bodies (public institutions) to steer and regulate the sector) of Component-1 (Strengthening
Public Sector 's Steering Capacity ) and Actions 1 and 2 under Policy No 1 ( Developing
Cooperation Models with the domestic Medicines/ Medical Devices Industry While Devising
New Health Schemes ) of Component -3 ( Improvement of Business and Entrepreneurial
Ecosystems);

− "The 2016 Action Plan of the 64th Government (Implementation and Reforms) " of 10
December 2015, in particular Action 46 (The reimbursement, pricing and licensing processes
of medical devices and strategic and domestic medicines shall be improved);

− "The 65 th Government Programme " of 24 May 2016, in particular Part 3 (Human
Development) and Part 4 (Strong Economy);

− "The Performance Program for 100 Days" announced on 3 August 2018 by Turkish President
Erdogan for the first 100 days of his Presidency, in particular points 9 and 10 of the actions
falling under the responsibility of the Ministry of Health;

− "Presidency Decision No. 108 on the New Economy Program for the period 2019 -2021" of
20 September 2018, in particular Part 4 (Current Account Deficit) and 7 (Programs and
Projects – Health);

− "The SSI Regulation on Drug Reimbursement" of 10 February 2016;

− "The SSI Regulation on Alternative Reimbursement for Universal Health Insurance " of 10
February 2016;

− "Regulation amending the Regulation on the Working Procedures and Principles of the Social
Security Institution Healthcare Services Pricing Commission" of 10 February 2016;

− "Circular 2018/1" from the Prime Ministry of 24 January 2018 on the Localisation Board;

− "The Health Implementation Notification/Communique", in particular "Annex-4/A";

− "The Social Security Institution Law Number 5502" of 16 May 2006, as amended by Article
88 of "Decree Law 703 Amending Certain Laws and Decree Laws for the Purposes of
Compliance with the Amendments to the Constitution" of 2 July 2018;

− "The Social Insurance and Universal Health Insurance Law Number 5510"of 31 May 2006;

− "Decree Law No. 663 on Organization and Duties of Ministry of Health and its Affiliated
Agencies" of 11 October 2011;
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− "Presidential Decree Number 1 on Organization of Presidency" of 10 July 2018;

− "Decree Law 703 Amending Certain Laws and Decree Laws for the Purposes of Compliance
with the Amendments to the Constitution" of 2 July 2018;

− "Presidential Decree Number 4 on Organization of the Ministries, Affiliated, Linked and
Related Agencies and Other Institutions and Agencies" of 15 July 2018;

− Public announcements on localisation published on: (i) March 2016, April 2016,
8 February 2017, 16 February 2017, April 2017, January 2018 and May 2018 informing that
the imported medicines listed in the annex(es) to the announcement would no longer be
reimbursed;

− Other instruments through which Turkey implements and administers the measures at issue,
including presentations made by Government officials and letters or other documents
making requests, communicating decisions or imparting instructions addressed by the
Turkish authorities to individual companies exporting pharmaceutical products to Turkey (or
importing pharmaceutical products in Turkey)".