<?xml version="1.0" encoding="UTF-8"?><CONCLUSION NNC="YES" xmlns:fmx="http://opoce" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xsi:noNamespaceSchemaLocation="http://formex.publications.europa.eu/schema/formex-05.55-20141201.xd"><BIB.CONCLUSION><REF.CASE FILE="n.a."><NO.CASE>C‑296/15</NO.CASE></REF.CASE><NO.CELEX>62015CC0296</NO.CELEX><NO.ECLI ECLI="ECLI:EU:C:2016:922">EU:C:2016:922</NO.ECLI><NO.SEQ>0001</NO.SEQ><PAGE.FIRST.ECR>1</PAGE.FIRST.ECR><PAGE.SEQ>1</PAGE.SEQ><PAGE.LAST.ECR>24</PAGE.LAST.ECR><PAGE.TOTAL>24</PAGE.TOTAL></BIB.CONCLUSION><CURR.TITLE><PAGE.HEADER><P>OPINION OF MR SAUGMANDSGAARD ØE — CASE C‑296/15</P><P>MEDISANUS</P></PAGE.HEADER></CURR.TITLE><TITLE><TI><P><HT TYPE="UC">Opinion of Advocate General</HT></P><P><HT TYPE="UC">Saugmandsgaard Øe</HT></P><P>delivered on <DATE ISO="20161201">1 December 2016</DATE><NOTE TYPE="FOOTNOTE" NUMBERING="ARAB" NUMBERING.CONTINUED="YES" NOTE.ID="E0001"><P>Original language: French.</P></NOTE></P></TI><STI><P><HT TYPE="BOLD">Case C‑296/15</HT></P><P><HT TYPE="BOLD">Medisanus d.o.o.</HT></P><P><HT TYPE="BOLD">v</HT></P><P><HT TYPE="BOLD">Splošna Bolnišnica Murska Sobota</HT></P><P><HT TYPE="NORMAL">(Request for a preliminary ruling from the Državna revizijska komisija za revizijo postopkov oddaje javnih naročil (National Commission for the review of awards of public procurement procedures, Slovenia))</HT></P></STI></TITLE><INDEX><KEYWORD>Reference for a preliminary ruling</KEYWORD><KEYWORD>Article 267 TFEU</KEYWORD><KEYWORD>Status of a <QUOT.START CODE="2018" REF.END="QE0001" ID="QS0001"/>court or tribunal<QUOT.END REF.START="QS0001" CODE="2019" ID="QE0001"/></KEYWORD><KEYWORD>Directive 2004/18/EC</KEYWORD><KEYWORD>Public procurement</KEYWORD><KEYWORD>Articles 2 and 23</KEYWORD><KEYWORD>Equal treatment and non-discrimination</KEYWORD><KEYWORD>Directive 2001/83/EC– Medicinal products for human use</KEYWORD><KEYWORD>Medicinal products derived from industrially prepared plasma</KEYWORD><KEYWORD>Directive 2002/98/EC</KEYWORD><KEYWORD>Human blood and blood components</KEYWORD><KEYWORD>National rules requiring supplies to be obtained as a matter of priority from medicinal products manufactured on the basis of plasma collected in the territory of the Member State concerned</KEYWORD><KEYWORD>Article 34 TFEU</KEYWORD><KEYWORD>Free movement of goods</KEYWORD><KEYWORD>Discrimination between imports</KEYWORD><KEYWORD>Article 36 TFEU</KEYWORD><KEYWORD>Justification</KEYWORD><KEYWORD>Promotion of blood donations</KEYWORD><KEYWORD>National self-sufficiency</KEYWORD><KEYWORD>Autarky</KEYWORD></INDEX><CONTENTS.CONCLUSION><GR.SEQ LEVEL="1"><TITLE><TI><NP><NO.P>I –</NO.P><TXT><HT TYPE="BOLD">Introduction</HT></TXT></NP></TI></TITLE><NP.ECR IDENTIFIER="NP0001"><NO.P>1.</NO.P><TXT>By decision of <DATE ISO="20150514">14 May 2015</DATE>, received at the Court on <DATE ISO="20150618">18 June 2015</DATE>, the Državna revizijska komisija za revizijo postopkov oddaje javnih naročil (National Commission for the review of awards of public procurement procedures, Slovenia) requested the Court to give a preliminary ruling on the interpretation of Article 2 and Article 23(2) and (8) of Directive 2004/18/EC,<NOTE TYPE="FOOTNOTE" NUMBERING="ARAB" NUMBERING.CONTINUED="YES" NOTE.ID="E0002"><P>Directive 2004/18/EC of the European Parliament and of the Council of <DATE ISO="20040331">31 March 2004</DATE> on the coordination of procedures for the award of public works contracts, public supply contracts and public service contracts (<REF.DOC.OJ COLL="L" NO.OJ="134" PAGE.FIRST="114" DATE.PUB="2004">OJ 2004 L 134, p. 114</REF.DOC.OJ>, and corrigendum <REF.DOC.OJ COLL="L" NO.OJ="351" PAGE.FIRST="44" DATE.PUB="2004">OJ 2004 L 351, p. 44</REF.DOC.OJ>), as most recently amended by Commission Regulation (EU) No 1336/2013 of <DATE ISO="20131213">13 December 2013</DATE> (<REF.DOC.OJ COLL="L" NO.OJ="335" PAGE.FIRST="17" DATE.PUB="2013">OJ 2013 L 335, p. 17</REF.DOC.OJ>) (<QUOT.START CODE="2018" REF.END="QE0002" ID="QS0002"/>Directive 2004/18<QUOT.END REF.START="QS0002" CODE="2019" ID="QE0002"/>).</P></NOTE> Article 83 of Directive 2001/83/EC,<NOTE TYPE="FOOTNOTE" NUMBERING="ARAB" NUMBERING.CONTINUED="YES" NOTE.ID="E0003"><P>Directive 2001/83/EC of the European Parliament and of the Council of <DATE ISO="20011106">6 November 2001</DATE> on the Community code relating to medicinal products for human use (<REF.DOC.OJ COLL="L" NO.OJ="311" PAGE.FIRST="67" DATE.PUB="2001">OJ 2001 L 311, p. 67</REF.DOC.OJ>), as most recently amended by Directive 2012/26/EU of <DATE ISO="20121025">25 October 2012</DATE> (<REF.DOC.OJ COLL="L" NO.OJ="299" PAGE.FIRST="1" DATE.PUB="2012">OJ 2012 L 299, p. 1</REF.DOC.OJ>) (<QUOT.START CODE="2018" REF.END="QE0003" ID="QS0003"/>Directive 2001/83<QUOT.END REF.START="QS0003" CODE="2019" ID="QE0003"/>).</P></NOTE> Article 4(2) of Directive 2002/98/EC<NOTE TYPE="FOOTNOTE" NUMBERING="ARAB" NUMBERING.CONTINUED="YES" NOTE.ID="E0004"><P>Directive 2002/98/EC of the European Parliament and of the Council of <DATE ISO="20030127">27 January 2003</DATE> setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC (<REF.DOC.OJ COLL="L" NO.OJ="033" PAGE.FIRST="30" DATE.PUB="2003">OJ 2003 L 33, p. 30</REF.DOC.OJ>), as most recently amended by Regulation (EC) No 596/2009 of the European Parliament and of the Council of <DATE ISO="20090618">18 June 2009</DATE> (<REF.DOC.OJ COLL="L" NO.OJ="188" PAGE.FIRST="14" DATE.PUB="2009">OJ 2009 L 188, p. 14</REF.DOC.OJ>) (<QUOT.START CODE="2018" REF.END="QE0004" ID="QS0004"/>Directive 2002/98<QUOT.END REF.START="QS0004" CODE="2019" ID="QE0004"/>).</P></NOTE> and Article 18 TFEU.</TXT></NP.ECR><?PAGE NO="2"?><NP.ECR IDENTIFIER="NP0002"><NO.P>2.</NO.P><TXT>That request was submitted in the context of an action brought by Medisanus d.o.o. against the Splošna Bolnišnica Murska Sobota (Murska Sobota general hospital, Murska Sobota, Slovenia) concerning the legality of a clause in the tender specifications relating to a public procurement procedure for the supply of medicinal products launched by that hospital. Under that clause, the medicinal products forming the subject matter of that procedure had to be manufactured on the basis of Slovenian plasma (<QUOT.START CODE="2018" REF.END="QE0005" ID="QS0005"/>the national origin requirement<QUOT.END REF.START="QS0005" CODE="2019" ID="QE0005"/>).</TXT></NP.ECR><NP.ECR IDENTIFIER="NP0003"><NO.P>3.</NO.P><TXT>That clause was introduced by the Murska Sobota general hospital in order to comply with national rules under which imports of medicinal products manufactured on the basis of plasma collected in another Member State may be authorised only if the medicinal products manufactured on the basis of plasma collected in the national territory are not sufficient to cover the needs of the national population (<QUOT.START CODE="2018" REF.END="QE0006" ID="QS0006"/>the priority supply principle<QUOT.END REF.START="QS0006" CODE="2019" ID="QE0006"/>).</TXT></NP.ECR><NP.ECR IDENTIFIER="NP0004"><NO.P>4.</NO.P><TXT>For the reasons which I shall set out below, I consider that Directive 2004/18 and Articles 34 and 36 TFEU must be interpreted as meaning that they preclude both the priority supply principle and the national origin requirement.</TXT></NP.ECR></GR.SEQ><GR.SEQ LEVEL="1"><TITLE><TI><NP><NO.P>II –</NO.P><TXT><HT TYPE="BOLD">Legal framework</HT></TXT></NP></TI></TITLE><GR.SEQ LEVEL="2"><TITLE><TI><NP><NO.P>A –</NO.P><TXT><HT TYPE="ITALIC">EU law</HT></TXT></NP></TI></TITLE><GR.SEQ LEVEL="3"><TITLE><TI><NP><NO.P>1.</NO.P><TXT>Directive 2004/18</TXT></NP></TI></TITLE><NP.ECR IDENTIFIER="NP0005"><NO.P>5.</NO.P><TXT>Article 1(2)(a) Directive 2004/18 defines <QUOT.START CODE="2018" REF.END="QE0007" ID="QS0007"/>public contracts<QUOT.END REF.START="QS0007" CODE="2019" ID="QE0007"/> as <QUOT.START CODE="2018" REF.END="QE0008" ID="QS0008"/>contracts for pecuniary interest concluded in writing between one or more economic operators and one or more contracting authorities and having as their object the execution of works, the supply of products or the provision of services within the meaning of this Directive<QUOT.END REF.START="QS0008" CODE="2019" ID="QE0008"/>.</TXT></NP.ECR><NP.ECR IDENTIFIER="NP0006"><NO.P>6.</NO.P><TXT>Article 2 of that directive, entitled <QUOT.START CODE="2018" REF.END="QE0009" ID="QS0009"/>Principles of awarding contracts<QUOT.END REF.START="QS0009" CODE="2019" ID="QE0009"/>, states that contracting authorities are to treat economic operators equally and non-discriminatorily and are to act in a transparent way.</TXT></NP.ECR><NP.ECR IDENTIFIER="NP0007"><NO.P>7.</NO.P><TXT>Article 23 of that directive concerns technical specifications.</TXT></NP.ECR><NP.ECR IDENTIFIER="NP0008"><NO.P>8.</NO.P><TXT>That concept of <QUOT.START CODE="2018" REF.END="QE0010" ID="QS0010"/>tender specifications<QUOT.END REF.START="QS0010" CODE="2019" ID="QE0010"/> is defined in point 1 of Annex VI to that directive. As regards, in particular, public supply and public service contracts, point 1(b) contains the following definition:</TXT><P><QUOT.S LEVEL="1"><P><QUOT.START CODE="2018" REF.END="QE0011" ID="QS0011"/>… a specification in a document defining the required characteristics of a product or service, such as quality and environmental performance levels, design for all requirements (including accessibility for people with disabilities), and conformity-assessment, performance, use of the product, its safety or dimensions, including requirements relevant to the product as regards the name under which the product is sold, terminology, symbols, testing and test methods, packaging, marking and labelling, user instructions, production methods and procedures, as well as conformity assessment procedures<QUOT.END REF.START="QS0011" CODE="2019" ID="QE0011"/>.</P></QUOT.S></P></NP.ECR><NP.ECR IDENTIFIER="NP0009"><NO.P>9.</NO.P><TXT>In the words of Article 23 of that directive:</TXT><P><QUOT.S LEVEL="1"><P><QUOT.START CODE="2018" REF.END="QE0012" ID="QS0012"/>…</P><PARAG IDENTIFIER="023.002"><NO.PARAG>2.</NO.PARAG><ALINEA>Technical specifications shall afford equal access for tenderers and not have the effect of creating unjustified obstacles to the opening up of public procurement to competition.</ALINEA></PARAG><?PAGE NO="3"?><P>…</P><PARAG IDENTIFIER="023.008"><NO.PARAG>8.</NO.PARAG><ALINEA>Unless justified by the subject matter of the contract, technical specifications shall not refer to a specific make or source, or a particular process, or to trade marks, patents, types or a specific origin or production with the effect of favouring or eliminating certain undertakings or certain products. …<QUOT.END REF.START="QS0012" CODE="2019" ID="QE0012"/></ALINEA></PARAG></QUOT.S></P></NP.ECR></GR.SEQ><GR.SEQ LEVEL="3"><TITLE><TI><NP><NO.P>2.</NO.P><TXT>Directive 2002/98</TXT></NP></TI></TITLE><NP.ECR IDENTIFIER="NP0010"><NO.P>10.</NO.P><TXT>Article 2(1) of Directive 2002/98 defines the scope of that directive as follows:</TXT><P><QUOT.S LEVEL="1"><ALINEA><QUOT.START CODE="2018" REF.END="QE0013" ID="QS0013"/>This Directive shall apply to the collection and testing of human blood and blood components, whatever their intended purpose, and to their processing, storage, and distribution when intended for transfusion.<QUOT.END REF.START="QS0013" CODE="2019" ID="QE0013"/></ALINEA></QUOT.S></P></NP.ECR><NP.ECR IDENTIFIER="NP0011"><NO.P>11.</NO.P><TXT>Article 4(2) of that directive provides:</TXT><P><QUOT.S LEVEL="1"><ALINEA><QUOT.START CODE="2018" REF.END="QE0014" ID="QS0014"/>This directive shall not prevent a Member State from maintaining or introducing in its territory more stringent protective measures which comply with the provisions of the Treaty.</ALINEA><ALINEA>In particular, a Member State may introduce requirements for voluntary and unpaid donations, which include the prohibition or restriction of imports of blood and blood components, to ensure a high level of health protection and to achieve the objective set out in Article 20(1), provided that the conditions of the Treaty are met.<QUOT.END REF.START="QS0014" CODE="2019" ID="QE0014"/></ALINEA></QUOT.S></P></NP.ECR><NP.ECR IDENTIFIER="NP0012"><NO.P>12.</NO.P><TXT>In the words of Article 20(1) of that directive:</TXT><P><QUOT.S LEVEL="1"><ALINEA><QUOT.START CODE="2018" REF.END="QE0015" ID="QS0015"/>Member States shall take the necessary measures to encourage voluntary and unpaid blood donations with a view to ensuring that blood and blood components are in so far as possible provided from such donations.<QUOT.END REF.START="QS0015" CODE="2019" ID="QE0015"/></ALINEA></QUOT.S></P></NP.ECR></GR.SEQ><GR.SEQ LEVEL="3"><TITLE><TI><NP><NO.P>3.</NO.P><TXT>Directive 2001/83</TXT></NP></TI></TITLE><NP.ECR IDENTIFIER="NP0013"><NO.P>13.</NO.P><TXT>Article 1 of Directive 2001/83 contains, in particular, the following definitions:</TXT><P><QUOT.S LEVEL="1"><ALINEA><LIST TYPE="OTHER"><ITEM><NP><NO.P><QUOT.START CODE="2018" REF.END="QE0016" ID="QS0016"/>2.</NO.P><TXT>Medicinal product:</TXT><P><LIST TYPE="alpha"><ITEM><NP><NO.P>(a)</NO.P><TXT>Any substance or combination of substances presented as having properties for treating or preventing disease in human beings, or;</TXT></NP></ITEM><ITEM><NP><NO.P>(b)</NO.P><TXT>Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.</TXT></NP></ITEM></LIST></P></NP></ITEM></LIST><P>…</P><LIST TYPE="OTHER"><ITEM><NP><NO.P>10.</NO.P><TXT>Medicinal products derived from human blood or human plasma: Medicinal products based on blood constituents which are prepared industrially by public or private establishments, such medicinal products including, in particular, albumin, coagulating factors and immunoglobulins of human origin.</TXT></NP></ITEM></LIST><P>…</P><?PAGE NO="4"?><LIST TYPE="OTHER"><ITEM><NP><NO.P>17.</NO.P><TXT>Wholesale distribution of medicinal products: All activities consisting of procuring, holding, supplying or exporting medicinal products, apart from supplying medicinal products to the public. Such activities are carried out with manufacturers or their depositories, importers, other wholesale distributors or with pharmacists and persons authorised or entitled to supply medicinal products to the public in the Member State concerned.<QUOT.END REF.START="QS0016" CODE="2019" ID="QE0016"/></TXT></NP></ITEM></LIST></ALINEA></QUOT.S></P></NP.ECR><NP.ECR IDENTIFIER="NP0014"><NO.P>14.</NO.P><TXT>According to Article 2(1) of Directive 2001/83, that directive is to apply to medicinal products for human use intended to be placed on the market in Member States and either prepared industrially or manufactured by a method involving an industrial process.</TXT></NP.ECR><NP.ECR IDENTIFIER="NP0015"><NO.P>15.</NO.P><TXT>Article 83 of Directive 2001/83, which is part of Title VII, on wholesale distribution and brokering of medicinal products, provides:</TXT><P><QUOT.S LEVEL="1"><ALINEA><P><QUOT.START CODE="2018" REF.END="QE0017" ID="QS0017"/>The provisions of this Title shall not prevent the application of more stringent requirements laid down by Member States in respect of the wholesale distribution of:</P><P>…</P><LIST TYPE="DASH"><ITEM><P>medicinal products derived from blood,</P></ITEM></LIST><P>…<QUOT.END REF.START="QS0017" CODE="2019" ID="QE0017"/></P></ALINEA></QUOT.S></P></NP.ECR><NP.ECR IDENTIFIER="NP0016"><NO.P>16.</NO.P><TXT>Article 109 of Directive 2001/83, under Title X on special provisions on medicinal products derived from human blood and plasma, states that Directive 2002/98 is to apply for the collection and testing of human blood and human plasma.</TXT></NP.ECR><NP.ECR IDENTIFIER="NP0017"><NO.P>17.</NO.P><TXT>In the words of Article 110 of Directive 2001/83:</TXT><P><QUOT.S LEVEL="1"><ALINEA><QUOT.START CODE="2018" REF.END="QE0018" ID="QS0018"/>Member States shall take the necessary measures to promote Community self-sufficiency in human blood or human plasma. For this purpose, they shall encourage the voluntary unpaid donation of blood and plasma and shall take the necessary measures to develop the production and use of products derived from human blood or human plasma coming from voluntary unpaid donations. They shall notify the Commission of such measures.<QUOT.END REF.START="QS0018" CODE="2019" ID="QE0018"/></ALINEA></QUOT.S></P></NP.ECR></GR.SEQ></GR.SEQ><GR.SEQ LEVEL="2"><TITLE><TI><NP><NO.P>B –</NO.P><TXT><HT TYPE="ITALIC">Slovenian law</HT></TXT></NP></TI></TITLE><GR.SEQ LEVEL="3"><TITLE><TI><NP><NO.P>1.</NO.P><TXT>The Law on medicinal products</TXT></NP></TI></TITLE><NP.ECR IDENTIFIER="NP0018"><NO.P>18.</NO.P><TXT>Concerning the definition of the priority supply principle in medicinal products industrially manufactured from plasma collected in Slovenia, Article 6(71) of the Zakon o zdravilih (Law on medicinal products) of <DATE ISO="20140304">4 March 2014</DATE> (Uradni list RS, No 17/2014) provides:</TXT><P><QUOT.S LEVEL="1"><ALINEA><QUOT.START CODE="2018" REF.END="QE0019" ID="QS0019"/>The priority supply of medicinal products industrially manufactured from Slovenian plasma (that is to say, from frozen fresh plasma for processing, collected in Slovenia) constitutes a principle whereby medicinal products obtained from foreign plasma originating in the European Union are to be supplied on the basis of a marketing authorisation, in the event that medicinal products prepared from Slovenian plasma fail to cover the total demand for such products in Slovenia, except where the introduction or importation of a specific medicinal product obtained from foreign plasma is justified on scientific or strategic grounds, as defined by the Strateški svet za zdravila (Strategic Council for pharmaceutical products) and by the Strokovni svet za preskrbo s krvjo in z zdravili iz plazme (Scientific Council for the supply of blood and medicinal products obtained from plasma)<QUOT.END REF.START="QS0019" CODE="2019" ID="QE0019"/>.</ALINEA></QUOT.S></P></NP.ECR><?PAGE NO="5"?><NP.ECR IDENTIFIER="NP0019"><NO.P>19.</NO.P><TXT>Paragraph 106 of that article defines <QUOT.START CODE="2018" REF.END="QE0020" ID="QS0020"/>medicinal products obtained from blood or plasma<QUOT.END REF.START="QS0020" CODE="2019" ID="QE0020"/> as follows:</TXT><P><QUOT.S LEVEL="1"><P><QUOT.START CODE="2018" REF.END="QE0021" ID="QS0021"/>Medicinal products obtained from blood or plasma are industrially manufactured pharmaceutical products, such as, for example, medicinal products containing, in particular, human albumin and human immunoglobulin, which are produced for that purpose by specialist operators using blood compounds which are obtained in accordance with the rules governing the supply of blood and blood products and the rules governing medicinal products.<QUOT.END REF.START="QS0021" CODE="2019" ID="QE0021"/></P></QUOT.S></P></NP.ECR><NP.ECR IDENTIFIER="NP0020"><NO.P>20.</NO.P><TXT>Article 11(6) of the Law on medicinal products defines the scope of that law as follows:</TXT><P><QUOT.S LEVEL="1"><ALINEA><QUOT.START CODE="2018" REF.END="QE0022" ID="QS0022"/>The provisions of the present law shall not apply to … blood, plasma or blood cells, which are subject to the legislation on the supply of blood, with the exception of plasma which is prepared using a method involving an industrial process and is used in the manufacture of medicinal products<QUOT.END REF.START="QS0022" CODE="2019" ID="QE0022"/>.</ALINEA></QUOT.S></P></NP.ECR></GR.SEQ><GR.SEQ LEVEL="3"><TITLE><TI><NP><NO.P>2.</NO.P><TXT>The Law on the supply of blood</TXT></NP></TI></TITLE><NP.ECR IDENTIFIER="NP0021"><NO.P>21.</NO.P><TXT>The Zakon o preskrbi s krvjo (Law on the supply of blood) of <DATE ISO="20061005">5 October 2006</DATE> (Uradni list RS, No 104/2006) contains the following definitions in Article 3(11) to (13), (18) and (27), respectively:</TXT><P><QUOT.S LEVEL="1"><PARAG IDENTIFIER="003.011"><NO.PARAG><QUOT.START CODE="2018" REF.END="QE0023" ID="QS0023"/>11.</NO.PARAG><ALINEA>Blood: whole human blood; …</ALINEA></PARAG><PARAG IDENTIFIER="003.012"><NO.PARAG>12.</NO.PARAG><ALINEA>blood component: active component of blood (… plasma), which may be prepared from blood by various methods;</ALINEA></PARAG><PARAG IDENTIFIER="003.013"><NO.PARAG>13.</NO.PARAG><ALINEA>blood product: any therapeutic product (component or agent) which is derived from human blood or human plasma;</ALINEA></PARAG><P>…</P><PARAG IDENTIFIER="003.018"><NO.PARAG>18.</NO.PARAG><ALINEA>self-sufficiency: principle relating to the supply of blood and blood products under which the State is to meet its demand for blood and blood products using its own resources;</ALINEA></PARAG><P>…</P><PARAG IDENTIFIER="003.027"><NO.PARAG>27.</NO.PARAG><ALINEA>blood-based medicinal product: any medicinal product prepared from human blood or human plasma.<QUOT.END REF.START="QS0023" CODE="2019" ID="QE0023"/></ALINEA></PARAG></QUOT.S></P></NP.ECR><NP.ECR IDENTIFIER="NP0022"><NO.P>22.</NO.P><TXT>Article 2 of that Law, relating to the supply of blood, is worded as follows:</TXT><P><QUOT.S LEVEL="1"><ALINEA><QUOT.START CODE="2018" REF.END="QE0024" ID="QS0024"/>The supply of blood forms part of transfusion activities, including the planning, collection, processing, testing, storage, distribution, treatment and regular, adequate supply of blood and blood products to the population, and the marketing of blood and such products. Those activities shall be carried out in accordance with the principles of national self-sufficiency and the voluntary unpaid donation of blood, in order to guarantee an adequate number of donors and the safety of blood transfusions.<QUOT.END REF.START="QS0024" CODE="2019" ID="QE0024"/></ALINEA></QUOT.S></P></NP.ECR><NP.ECR IDENTIFIER="NP0023"><NO.P>23.</NO.P><TXT>Article 5(1) of that Law, which concerns, in particular, the collection of blood, provides:</TXT><P><QUOT.S LEVEL="1"><ALINEA><QUOT.START CODE="2018" REF.END="QE0025" ID="QS0025"/>The activity of collecting and testing human blood and blood components, whatever their intended purpose, and their processing, storage and distribution when intended for transfusion shall constitute a public service. The service shall be performed by the Institute [of Transfusion Medicine] or by the transfusion centre designated and licensed by the Agency.<QUOT.END REF.START="QS0025" CODE="2019" ID="QE0025"/></ALINEA></QUOT.S></P></NP.ECR><?PAGE NO="6"?><NP.ECR IDENTIFIER="NP0024"><NO.P>24.</NO.P><TXT>Article 10(1) and (2) of that Law determines the function of the Zavod Republike Slovenije za transfuzisko medecino (Institute of Transfusion Medicine of the Republic of Slovenia, <QUOT.START CODE="2018" REF.END="QE0026" ID="QS0026"/>the ZTM<QUOT.END REF.START="QS0026" CODE="2019" ID="QE0026"/>) as follows:</TXT><P><QUOT.S LEVEL="1"><PARAG IDENTIFIER="010.001"><NO.PARAG><QUOT.START CODE="2018" REF.END="QE0027" ID="QS0027"/>1.</NO.PARAG><ALINEA>The [ZTM] is a transfusion institute responsible at national level for the supply of blood and blood products to professional bodies, and for the integration of transfusion medicine in hospital practice.</ALINEA></PARAG><PARAG IDENTIFIER="010.002"><NO.PARAG>2.</NO.PARAG><ALINEA>The [ZTM] shall coordinate all activities concerning donor selection, the collection, testing, processing, storage and distribution of blood and blood products, and the clinical use of blood.<QUOT.END REF.START="QS0027" CODE="2019" ID="QE0027"/></ALINEA></PARAG></QUOT.S></P></NP.ECR></GR.SEQ></GR.SEQ></GR.SEQ><GR.SEQ LEVEL="1"><TITLE><TI><NP><NO.P>III –</NO.P><TXT><HT TYPE="BOLD">The main proceedings and the question for a preliminary ruling</HT></TXT></NP></TI></TITLE><NP.ECR IDENTIFIER="NP0025"><NO.P>25.</NO.P><TXT>On <DATE ISO="20150114">14 January 2015</DATE>, Murska Sobota general hospital decided to launch a tendering procedure for the supply of medicinal products.</TXT></NP.ECR><NP.ECR IDENTIFIER="NP0026"><NO.P>26.</NO.P><TXT>It is apparent from the tender specifications for the call for tenders that that public contract concerned medicinal products having the following characteristics:</TXT><P><QUOT.S LEVEL="1"><LIST TYPE="DASH"><ITEM><P><QUOT.START CODE="2018" REF.END="QE0028" ID="QS0028"/>human blood albumin 200 mg/ml infusion solution, obtained from Slovenian plasma<QUOT.END REF.START="QS0028" CODE="2019" ID="QE0028"/>,</P></ITEM><ITEM><P><QUOT.START CODE="2018" REF.END="QE0029" ID="QS0029"/>human immunoglobulin for intravenous administration, 50 mg/ml or 100 mg/ml, obtained from Slovenian plasma<QUOT.END REF.START="QS0029" CODE="2019" ID="QE0029"/>.</P></ITEM></LIST></QUOT.S></P></NP.ECR><NP.ECR IDENTIFIER="NP0027"><NO.P>27.</NO.P><TXT>In answer to an economic operator which had objected to the national origin requirement, Murska Sobota general hospital claimed that that requirement was consistent with the priority supply principle in medicinal products manufactured industrially on the basis of Slovenian plasma, as provided for in Article 6(71) of the Law on medicinal products. It stated, moreover, that another call for tenders had been published jointly with the Ministry of Health concerning human albumin and human immunoglobulin obtained from foreign plasma.</TXT></NP.ECR><NP.ECR IDENTIFIER="NP0028"><NO.P>28.</NO.P><TXT>On <DATE ISO="20150225">25 February 2015</DATE>, Medisanus, a company having its seat in Ljubljana (Slovenia), requested the contracting authority to review the tender specifications. In support of its request, Medisanus claimed that only the ZTM was in a position to satisfy the national origin requirement as it had an exclusive right in respect of blood collected in Slovenia, from which it followed that the ZTM was the only operator able to supply medicinal products obtained from plasma collected in Slovenia. Medisanus was therefore of the view that such a requirement was incompatible with EU law, as regards industrially-manufactured medicinal products.</TXT></NP.ECR><NP.ECR IDENTIFIER="NP0029"><NO.P>29.</NO.P><TXT>On <DATE ISO="20150323">23 March 2015</DATE>, Murska Sobota general hospital rejected that request for review as unfounded, for the following reasons. First of all, the national origin requirement followed from domestic law. Next, that requirement was scientifically justified. Last, the requirement was consistent with an objective of self-sufficiency promoted within the European Union. In the latter regard, the hospital in question referred to Article 83 of Directive 2001/83 and stated that the objective pursued was to ensure not absolute territorial self-sufficiency but the adequate use, limited to certain medicinal products, of the proportion of plasma collected in Slovenia that is available for the production of medicinal products derived from blood. It further stated that a certain percentage of its needs was covered by a call for tenders relating to the acquisition of medicinal products derived on blood from other Member States.</TXT></NP.ECR><?PAGE NO="7"?><NP.ECR IDENTIFIER="NP0030"><NO.P>30.</NO.P><TXT>Following the rejection of its request, Medisanus submitted a request for revision to the Državna revizijska komisija za revizijo postopkov oddaje javnih naročil (National Commission for the review of awards of public procurement procedures). That commission has doubts as to the compatibility of the national origin requirement with Articles 2 and 23 of Directive 2004/18, in that it might give rise to a breach of the principle of equal treatment and respect for competition between economic operators.</TXT></NP.ECR><NP.ECR IDENTIFIER="NP0031"><NO.P>31.</NO.P><TXT>That commission observes, however, that that requirement is based on Slovenian law. Article 6(71) of the Law on medicinal products imposes a priority supply of medicinal products produced industrially from plasma collected in Slovenia. Furthermore, the Law on the supply of blood establishes the principle of self-sufficiency, under which the Republic of Slovenia is to cover its needs for blood by its own resources. That law entrusts the ZTM with carrying out the public service relating to the activity of collecting and testing blood and blood components, independently of their intended use, and also with their preparation, storage and distribution when they are intended for transfusion.</TXT></NP.ECR><NP.ECR IDENTIFIER="NP0032"><NO.P>32.</NO.P><TXT>In that context, the Državna revizijska komisija za revizijo postopkov oddaje javnih naročil (National Commission for the review of awards of public procurement procedures) decided to stay proceedings and to refer the following question to the Court for a preliminary ruling:</TXT><P><QUOT.S LEVEL="1"><P><QUOT.START CODE="2018" REF.END="QE0030" ID="QS0030"/>Must Directive 2004/18, in particular Article 23(2), Article 23(8) and Article 2 thereof, read in conjunction with</P><LIST TYPE="DASH"><ITEM><P>Directive 2001/83, in particular Article 83 thereof,</P></ITEM><ITEM><P>Directive 2002/98, in particular Article 4(2) thereof, and with</P></ITEM><ITEM><P>the TFEU, in particular Article 18 thereof,</P></ITEM></LIST><P>be interpreted as precluding a specification that industrially manufactured medicinal products must be obtained from <QUOT.START CODE="201C" REF.END="QE0031" ID="QS0031"/>Slovenian plasma<QUOT.END REF.START="QS0031" CODE="201D" ID="QE0031"/> (a requirement based on the domestic legislation …)?<QUOT.END REF.START="QS0030" CODE="2019" ID="QE0030"/></P></QUOT.S></P></NP.ECR></GR.SEQ><GR.SEQ LEVEL="1"><TITLE><TI><NP><NO.P>IV –</NO.P><TXT><HT TYPE="BOLD">Procedure before the Court</HT></TXT></NP></TI></TITLE><NP.ECR IDENTIFIER="NP0033"><NO.P>33.</NO.P><TXT>The request for a preliminary ruling was lodged at the Court Registry on <DATE ISO="20150618">18 June 2015</DATE>.</TXT></NP.ECR><NP.ECR IDENTIFIER="NP0034"><NO.P>34.</NO.P><TXT>Written observations have been submitted by Medisanus, the Slovenian and Spanish Governments and the European Commission.</TXT></NP.ECR><NP.ECR IDENTIFIER="NP0035"><NO.P>35.</NO.P><TXT>The representatives of Medisanus, the Slovenian Government and the Commission appeared at the hearing on <DATE ISO="20160922">22 September 2016</DATE> and presented oral argument.</TXT></NP.ECR></GR.SEQ><GR.SEQ LEVEL="1"><TITLE><TI><NP><NO.P>V –</NO.P><TXT><HT TYPE="BOLD">Analysis of the question for a preliminary ruling</HT></TXT></NP></TI></TITLE><NP.ECR IDENTIFIER="NP0036"><NO.P>36.</NO.P><TXT>I consider that the question for a preliminary ruling referred by the referring body should be reformulated, for the following reasons.</TXT></NP.ECR><NP.ECR IDENTIFIER="NP0037"><NO.P>37.</NO.P><TXT>First of all, the question submitted to the Court refers to the principle of non-discrimination as provided for in Article 18 TFEU. However, it follows from its wording that that provision is to apply without prejudice to any special provisions contained in the Treaties. Consequently, and as the Court has explained on numerous occasions, that article is to apply independently only to situations governed by EU law in regard to which the Treaty lays down no specific prohibition of<?PAGE NO="8"?> discrimination.<NOTE TYPE="FOOTNOTE" NUMBERING="ARAB" NUMBERING.CONTINUED="YES" NOTE.ID="E0005"><P>See, in particular, judgments of <REF.DOC.ECR><DATE ISO="19940714">14 July 1994</DATE>, <NAME.CASE><HT TYPE="ITALIC">Peralta</HT></NAME.CASE> (<NO.CASE>C‑379/92</NO.CASE>, <NO.ECLI ECLI="ECLI:EU:C:1994:296">EU:C:1994:296</NO.ECLI>, paragraph <REF.NP.ECR REF="NP0018">18</REF.NP.ECR></REF.DOC.ECR>); of <REF.DOC.ECR><DATE ISO="20071218">18 December 2007</DATE>, <NAME.CASE><HT TYPE="ITALIC">Laval un Partneri</HT></NAME.CASE> (<NO.CASE>C‑341/05</NO.CASE>, <NO.ECLI ECLI="ECLI:EU:C:2007:809">EU:C:2007:809</NO.ECLI>, paragraphs <REF.NP.ECR REF="NP0054">54</REF.NP.ECR> and <REF.NP.ECR REF="NP0055">55</REF.NP.ECR></REF.DOC.ECR>); and of <REF.DOC.ECR><DATE ISO="20101216">16 December 2010</DATE>, <NAME.CASE><HT TYPE="ITALIC">Josemans</HT></NAME.CASE> (<NO.CASE>C‑137/09</NO.CASE>, <NO.ECLI ECLI="ECLI:EU:C:2010:774">EU:C:2010:774</NO.ECLI>, paragraphs <REF.NP.ECR REF="NP0051">51</REF.NP.ECR> and <REF.NP.ECR REF="NP0052">52</REF.NP.ECR></REF.DOC.ECR> and the case-law cited).</P></NOTE></TXT></NP.ECR><NP.ECR IDENTIFIER="NP0038"><NO.P>38.</NO.P><TXT>In fact, it has consistently been held that Article 34 TFEU reflects, inter alia, the obligation to comply with the principle of non-discrimination.<NOTE TYPE="FOOTNOTE" NUMBERING="ARAB" NUMBERING.CONTINUED="YES" NOTE.ID="E0006"><P>See, to that effect, judgments of <REF.DOC.ECR><DATE ISO="19970507">7 May 1997</DATE>, <NAME.CASE><HT TYPE="ITALIC">Pistre and Others</HT></NAME.CASE> (<NO.CASE>C‑321/94 to C‑324/94</NO.CASE>, <NO.ECLI ECLI="ECLI:EU:C:1997:229">EU:C:1997:229</NO.ECLI>, paragraphs <REF.NP.ECR REF="NP0049">49</REF.NP.ECR> and <REF.NP.ECR REF="NP0054">54</REF.NP.ECR></REF.DOC.ECR>); of <REF.DOC.ECR><DATE ISO="20101202">2 December 2010</DATE>, <NAME.CASE><HT TYPE="ITALIC">Ker-Optika</HT></NAME.CASE> (<NO.CASE>C‑108/09</NO.CASE>, <NO.ECLI ECLI="ECLI:EU:C:2010:725">EU:C:2010:725</NO.ECLI>, paragraph <REF.NP.ECR REF="NP0048">48</REF.NP.ECR></REF.DOC.ECR>); and of <REF.DOC.ECR><DATE ISO="20120426">26 April 2012</DATE>, <NAME.CASE><HT TYPE="ITALIC">ANETT</HT></NAME.CASE> (<NO.CASE>C‑456/10</NO.CASE>, <NO.ECLI ECLI="ECLI:EU:C:2012:241">EU:C:2012:241</NO.ECLI>, paragraph <REF.NP.ECR REF="NP0033">33</REF.NP.ECR></REF.DOC.ECR>).</P></NOTE> Since the priority supply principle and the national origin requirement come under Article 34 TFEU,<NOTE TYPE="FOOTNOTE" NUMBERING="ARAB" NUMBERING.CONTINUED="YES" NOTE.ID="E0007"><P>See points 90 to 99 of this Opinion.</P></NOTE> I shall examine them in the light of that article, as the Commission has suggested.</TXT></NP.ECR><NP.ECR IDENTIFIER="NP0039"><NO.P>39.</NO.P><TXT>Next, the question refers to Article 4(2) of Directive 2002/98 and Article 83 of Directive 2001/83. For the reasons which I shall set out in points 155 to 164 of this Opinion, I consider that those provisions are not relevant in the circumstances of the main proceedings.</TXT></NP.ECR><NP.ECR IDENTIFIER="NP0040"><NO.P>40.</NO.P><TXT>Last, it is necessary to take account of the respective scope of Directive 2004/18 and of Article 34 TFEU and also of the existence of two national measures at issue in the main proceedings:</TXT><P><LIST TYPE="DASH"><ITEM><P>the priority supply principle and</P></ITEM><ITEM><P>the national origin requirement.</P></ITEM></LIST></P></NP.ECR><NP.ECR IDENTIFIER="NP0041"><NO.P>41.</NO.P><TXT>The priority supply principle cannot be appraised, as such, by reference to Directive 2004/18, which applies only in the context of public contracts. Conversely, that principle must be appraised by reference to Article 34 TFEU, which guarantees the free movement of goods.<NOTE TYPE="FOOTNOTE" NUMBERING="ARAB" NUMBERING.CONTINUED="YES" NOTE.ID="E0008"><P>See points 91 and 92 of this Opinion.</P></NOTE></TXT></NP.ECR><NP.ECR IDENTIFIER="NP0042"><NO.P>42.</NO.P><TXT>On the other hand, the national origin requirement comes within the scope of both Directive 2004/18 and Article 34 TFEU.<NOTE TYPE="FOOTNOTE" NUMBERING="ARAB" NUMBERING.CONTINUED="YES" NOTE.ID="E0009"><P>See points 93 and 94 of this Opinion.</P></NOTE></TXT></NP.ECR><NP.ECR IDENTIFIER="NP0043"><NO.P>43.</NO.P><TXT>In the light of the foregoing, I propose that the question for a preliminary ruling should be reformulated as follows. By its question, the referring body asks the Court:</TXT><P><LIST TYPE="DASH"><ITEM><P>whether Articles 34 and 36 TFEU must be interpreted as meaning that they preclude the priority supply principle; and</P></ITEM><ITEM><P>whether Article 2 and Article 23(2) and (8) of Directive 2004/18 and Articles 34 and 36 TFEU must be interpreted as meaning that they preclude the national origin requirement.</P></ITEM></LIST></P></NP.ECR><NP.ECR IDENTIFIER="NP0044"><NO.P>44.</NO.P><TXT>For the reasons which I shall set out below, I consider that the abovementioned provisions must be interpreted as meaning that they preclude both the priority supply principle and the national origin requirement.</TXT></NP.ECR><NP.ECR IDENTIFIER="NP0045"><NO.P>45.</NO.P><TXT>Before addressing those questions, however, I must ascertain whether the Court has jurisdiction to answer the question referred, by examining the status as a <QUOT.START CODE="2018" REF.END="QE0032" ID="QS0032"/>court or tribunal<QUOT.END REF.START="QS0032" CODE="2019" ID="QE0032"/> within the meaning of Article 267 TFEU of the referring body. I shall then set out a number of considerations on the factual and legal context of the main proceedings.</TXT></NP.ECR><?PAGE NO="9"?><GR.SEQ LEVEL="2"><TITLE><TI><NP><NO.P>A –</NO.P><TXT><HT TYPE="ITALIC">The jurisdiction of the Court</HT></TXT></NP></TI></TITLE><NP.ECR IDENTIFIER="NP0046"><NO.P>46.</NO.P><TXT>It follows from Article 267 TFEU that the Court has jurisdiction only to answer questions referred by <QUOT.START CODE="2018" REF.END="QE0033" ID="QS0033"/>courts or tribunals<QUOT.END REF.START="QS0033" CODE="2019" ID="QE0033"/>.</TXT></NP.ECR><NP.ECR IDENTIFIER="NP0047"><NO.P>47.</NO.P><TXT>In accordance with settled case-law, in order to determine whether a body making a reference is a <QUOT.START CODE="2018" REF.END="QE0034" ID="QS0034"/>court or tribunal<QUOT.END REF.START="QS0034" CODE="2019" ID="QE0034"/> for the purposes of Article 267 TFEU, which is a question governed by EU law alone, the Court takes account of a number of factors, such as whether the body is established by law, whether it is permanent, whether its jurisdiction is compulsory, whether its procedure is <HT TYPE="ITALIC">inter partes</HT>, whether it applies rules of law and whether it is independent.<NOTE TYPE="FOOTNOTE" NUMBERING="ARAB" NUMBERING.CONTINUED="YES" NOTE.ID="E0010"><P>Judgments of <REF.DOC.ECR><DATE ISO="20151006">6 October 2015</DATE>, <NAME.CASE><HT TYPE="ITALIC">Consorci Sanitari del Maresme</HT></NAME.CASE> (<NO.CASE>C‑203/14</NO.CASE>, <NO.ECLI ECLI="ECLI:EU:C:2015:664">EU:C:2015:664</NO.ECLI>, paragraph <REF.NP.ECR REF="NP0017">17</REF.NP.ECR></REF.DOC.ECR> and the case-law cited), and of <REF.DOC.ECR><DATE ISO="20160524">24 May 2016</DATE>, <NAME.CASE><HT TYPE="ITALIC">MT</HT> <HT TYPE="ITALIC">Højgaard and Züblin</HT></NAME.CASE> (<NO.CASE>C‑396/14</NO.CASE>, <NO.ECLI ECLI="ECLI:EU:C:2016:347">EU:C:2016:347</NO.ECLI>, paragraph <REF.NP.ECR REF="NP0023">23</REF.NP.ECR></REF.DOC.ECR>).</P></NOTE></TXT></NP.ECR><NP.ECR IDENTIFIER="NP0048"><NO.P>48.</NO.P><TXT>I consider that it follows from the following factors, communicated by the referring body, that the latter does indeed have the status of a <QUOT.START CODE="2018" REF.END="QE0035" ID="QS0035"/>court or tribunal<QUOT.END REF.START="QS0035" CODE="2019" ID="QE0035"/> for the purposes of Article 267 TFEU:</TXT><P><LIST TYPE="DASH"><ITEM><P>it was set up by the national legislation on public contracts;</P></ITEM><ITEM><P>it is permanent;</P></ITEM><ITEM><P>its jurisdiction is compulsory, since its competence does not depend on the parties’ agreement and its decisions are binding;<NOTE TYPE="FOOTNOTE" NUMBERING="ARAB" NUMBERING.CONTINUED="YES" NOTE.ID="E0011"><P>See in that regard judgment of <REF.DOC.ECR><DATE ISO="20151006">6 October 2015</DATE>, <NAME.CASE><HT TYPE="ITALIC">Consorci Sanitari del Maresme</HT></NAME.CASE> (<NO.CASE>C‑203/14</NO.CASE>, <NO.ECLI ECLI="ECLI:EU:C:2015:664">EU:C:2015:664</NO.ECLI>, paragraph <REF.NP.ECR REF="NP0023">23</REF.NP.ECR></REF.DOC.ECR> and the case-law cited).</P></NOTE></P></ITEM><ITEM><P>the procedure before it is <HT TYPE="ITALIC">inter partes</HT>;</P></ITEM><ITEM><P>it applies rules of law; and</P></ITEM><ITEM><P>the guarantees of its independence and the independence of its members are analogous to those applicable to the ordinary courts and tribunals.</P></ITEM></LIST></P></NP.ECR><NP.ECR IDENTIFIER="NP0049"><NO.P>49.</NO.P><TXT>In addition, it should be borne in mind that, when appraising the legal status of national non-judicial bodies referred to in Article 2(9) of Directive 89/665/EEC<NOTE TYPE="FOOTNOTE" NUMBERING="ARAB" NUMBERING.CONTINUED="YES" NOTE.ID="E0012"><P>Council Directive of <DATE ISO="19891221">21 December 1989</DATE> on the coordination of the laws, regulations and administrative provisions relating to the application of review procedures to the award of public supply and public works contracts (<REF.DOC.OJ COLL="L" NO.OJ="395" PAGE.FIRST="33" DATE.PUB="1989">OJ 1989 L 395, p. 33</REF.DOC.OJ>), as most recently amended by Directive 2014/23/EU of the European Parliament and of the Council of <DATE ISO="20140226">26 February 2014</DATE> (<REF.DOC.OJ COLL="L" NO.OJ="094" PAGE.FIRST="1" DATE.PUB="2014">OJ 2014 L 94, p. 1</REF.DOC.OJ>).</P></NOTE> responsible for public procurement review procedures, the Court has already confirmed that several other national bodies essentially comparable to the referring body in the present case were <QUOT.START CODE="2018" REF.END="QE0036" ID="QS0036"/>courts or tribunals<QUOT.END REF.START="QS0036" CODE="2019" ID="QE0036"/>.<NOTE TYPE="FOOTNOTE" NUMBERING="ARAB" NUMBERING.CONTINUED="YES" NOTE.ID="E0013"><P>See, in particular, judgments of <REF.DOC.ECR><DATE ISO="19970917">17 September 1997</DATE>, <NAME.CASE><HT TYPE="ITALIC">Dorsch Consult</HT></NAME.CASE> (<NO.CASE>C‑54/96</NO.CASE>, <NO.ECLI ECLI="ECLI:EU:C:1997:413">EU:C:1997:413</NO.ECLI>, paragraphs <REF.NP.ECR REF="NP0022">22</REF.NP.ECR> to <REF.NP.ECR REF="NP0038">38</REF.NP.ECR></REF.DOC.ECR>); of <REF.DOC.ECR><DATE ISO="19990204">4 February 1999</DATE>, <NAME.CASE><HT TYPE="ITALIC">Köllensperger and Atzwanger</HT></NAME.CASE> (<NO.CASE>C‑103/97</NO.CASE>, <NO.ECLI ECLI="ECLI:EU:C:1999:52">EU:C:1999:52</NO.ECLI>, paragraphs <REF.NP.ECR REF="NP0016">16</REF.NP.ECR> to <REF.NP.ECR REF="NP0025">25</REF.NP.ECR></REF.DOC.ECR>); of <REF.DOC.ECR><DATE ISO="20140918">18 September 2014</DATE>, <NAME.CASE><HT TYPE="ITALIC">Bundesdruckerei</HT></NAME.CASE> (<NO.CASE>C‑549/13</NO.CASE>, <NO.ECLI ECLI="ECLI:EU:C:2014:2235">EU:C:2014:2235</NO.ECLI>, paragraphs <REF.NP.ECR REF="NP0020">20</REF.NP.ECR> to <REF.NP.ECR REF="NP0023">23</REF.NP.ECR></REF.DOC.ECR>); and of <REF.DOC.ECR><DATE ISO="20151006">6 October 2015</DATE>, <NAME.CASE><HT TYPE="ITALIC">Consorci Sanitari del Maresme</HT></NAME.CASE> (<NO.CASE>C‑203/14</NO.CASE>, <NO.ECLI ECLI="ECLI:EU:C:2015:664">EU:C:2015:664</NO.ECLI>, paragraphs <REF.NP.ECR REF="NP0017">17</REF.NP.ECR> to <REF.NP.ECR REF="NP0027">27</REF.NP.ECR></REF.DOC.ECR>).</P></NOTE></TXT></NP.ECR><NP.ECR IDENTIFIER="NP0050"><NO.P>50.</NO.P><TXT>Consequently, I consider that the Državna revizijska komisija za revizijo postopkov oddaje javnih naročil (National Commission for the review of awards of public procurement procedures) has the status of a <QUOT.START CODE="2018" REF.END="QE0037" ID="QS0037"/>court or tribunal<QUOT.END REF.START="QS0037" CODE="2019" ID="QE0037"/> for the purposes of Article 267 TFEU and that the Court therefore has jurisdiction to answer the question referred by that body.</TXT></NP.ECR></GR.SEQ><GR.SEQ LEVEL="2"><TITLE><TI><NP><NO.P>B –</NO.P><TXT><HT TYPE="ITALIC">Considerations concerning the factual and legal context of the main proceedings</HT></TXT></NP></TI></TITLE><NP.ECR IDENTIFIER="NP0051"><NO.P>51.</NO.P><TXT>Before answering the question submitted by the referring body, it seems to me to be important to provide certain information, derived from the observations submitted to the Court, concerning the legal and factual context of the main proceedings.</TXT></NP.ECR><?PAGE NO="10"?><NP.ECR IDENTIFIER="NP0052"><NO.P>52.</NO.P><TXT>I recall that the call for tenders at issue in the main proceedings related to the acquisition not of blood or blood components but rather of medicinal products manufactured industrially on the basis of plasma. The national origin requirement was imposed by the awarding authority in order to comply with the priority supply principle provided for in Article 6(71) of the Zakon o zdravilih (Law on medicinal products).</TXT></NP.ECR><NP.ECR IDENTIFIER="NP0053"><NO.P>53.</NO.P><TXT>Within the system established by the Law on the supply of blood, and in particular by Article 10 thereof, the ZTM is responsible at national level for the supply of blood and blood products to bodies and for the integration of transfusion medicine in hospital practice.</TXT></NP.ECR><NP.ECR IDENTIFIER="NP0054"><NO.P>54.</NO.P><TXT>According to the observations submitted by Medisanus, the Slovenian Government and the Commission, that law confers exclusive competence on the ZTM for the collection of blood and blood products in the territory of the Republic of Slovenia. It follows from that exclusive competence that only the ZTM is authorised to supply medicinal products based on Slovenian plasma, in such a way that the ZTM was in practice the only operator capable of supplying medicinal products in conformity with the national origin requirement.</TXT></NP.ECR><NP.ECR IDENTIFIER="NP0055"><NO.P>55.</NO.P><TXT>The Slovenian Government has explained that the blood collected by the ZTM is primarily intended to be used for transfusion purposes. Only the surplus amounts of blood collected are intended to be processed into medicinal products such as human albumin or human immunoglobulin, which form the subject matter of the call for tenders at issue in the main proceedings.</TXT></NP.ECR><NP.ECR IDENTIFIER="NP0056"><NO.P>56.</NO.P><TXT>It also follows from the observations submitted by the Slovenian Government that the ZTM does not itself process the blood collected in Slovenian territory into medicinal products, but sends that blood to a private operator which manufacturers the medicinal products by means of an industrial process. The ZTM selects that operator within the framework of an open procurement procedure in accordance with Directive 2004/18.</TXT></NP.ECR><NP.ECR IDENTIFIER="NP0057"><NO.P>57.</NO.P><TXT>The medicinal products thus obtained are intended exclusively for the Slovenian market. The ZTM distributes those medicinal products to other public health services in Slovenia, and in particular to the hospitals. By way of consideration, the ZTM receives only the costs of manufacturing the medicinal products and does not make a profit.</TXT></NP.ECR><NP.ECR IDENTIFIER="NP0058"><NO.P>58.</NO.P><TXT>Furthermore, it is only if and in so far as the quantity of medicinal products manufactured on the basis of Slovenian plasma is not sufficient to satisfy the needs of the Slovenian population that medicinal products manufactured on the basis of foreign plasma are bought, within the framework of an open public procurement procedure in accordance with Directive 2004/18.</TXT></NP.ECR></GR.SEQ><GR.SEQ LEVEL="2"><TITLE><TI><NP><NO.P>C –</NO.P><TXT><HT TYPE="ITALIC">The infringement of Directive 2004/18</HT></TXT></NP></TI></TITLE><NP.ECR IDENTIFIER="NP0059"><NO.P>59.</NO.P><TXT>In this section, I shall consider whether Article 2 and Article 23(2) and (8) of Directive 2004/18 must be interpreted as meaning that they preclude the national origin requirement.</TXT></NP.ECR><NP.ECR IDENTIFIER="NP0060"><NO.P>60.</NO.P><TXT>In order to do so, it is necessary to assess (i) the applicability of Directive 2004/18 in the circumstances of the main proceedings and (ii) the existence of an infringement of the abovementioned provisions.</TXT></NP.ECR><?PAGE NO="11"?><GR.SEQ LEVEL="3"><TITLE><TI><NP><NO.P>1.</NO.P><TXT>The applicability of Directive 2004/18</TXT></NP></TI></TITLE><NP.ECR IDENTIFIER="NP0061"><NO.P>61.</NO.P><TXT>In the first place, it is clear from the Slovenian Government’s observations that Murska Sobota general hospital is a public body created by the Republic of Slovenia. On that basis, it must be regarded as a <QUOT.START CODE="2018" REF.END="QE0038" ID="QS0038"/>contracting authority<QUOT.END REF.START="QS0038" CODE="2019" ID="QE0038"/> within the meaning of Article 1(9) of Directive 2004/18; moreover, that capacity has not been disputed by any of the parties which have submitted observations to the Court.</TXT></NP.ECR><NP.ECR IDENTIFIER="NP0062"><NO.P>62.</NO.P><TXT>Nor, in the second place, to my mind, can it be disputed that the medicinal products at issue in the main proceedings constitute <QUOT.START CODE="2018" REF.END="QE0039" ID="QS0039"/>products<QUOT.END REF.START="QS0039" CODE="2019" ID="QE0039"/> within the meaning of Article 1(2)(a) and (c) of Directive 2004/18.</TXT></NP.ECR><NP.ECR IDENTIFIER="NP0063"><NO.P>63.</NO.P><TXT>Admittedly, the Slovenian Government has claimed that those medicinal products were not <QUOT.START CODE="2018" REF.END="QE0040" ID="QS0040"/>products<QUOT.END REF.START="QS0040" CODE="2019" ID="QE0040"/> within the meaning of that directive or <QUOT.START CODE="2018" REF.END="QE0041" ID="QS0041"/>goods<QUOT.END REF.START="QS0041" CODE="2019" ID="QE0041"/> for the purposes of Article 34 TFEU, on the ground that the ZTM and the Slovenian hospitals together provided a public service of general interest consisting in the supply of medicinal products manufactured on the basis of plasma.</TXT></NP.ECR><NP.ECR IDENTIFIER="NP0064"><NO.P>64.</NO.P><TXT>In that regard, I would emphasise that the Court established long ago a particularly broad definition of <QUOT.START CODE="2018" REF.END="QE0042" ID="QS0042"/>goods<QUOT.END REF.START="QS0042" CODE="2019" ID="QE0042"/> for the purposes of the FEU Treaty provisions on the free movement of goods, as referring to any product that can be valued in money and thus be the subject of commercial transactions.<NOTE TYPE="FOOTNOTE" NUMBERING="ARAB" NUMBERING.CONTINUED="YES" NOTE.ID="E0014"><P>Judgment of <REF.DOC.ECR><DATE ISO="19681210">10 December 1968</DATE>, <NAME.CASE><HT TYPE="ITALIC">Commission</HT> v <HT TYPE="ITALIC">Italy</HT></NAME.CASE> (<NO.CASE>7/68</NO.CASE>, <NO.ECLI ECLI="ECLI:EU:C:1968:51">EU:C:1968:51</NO.ECLI>, p. <REF.NP.ECR REF="NP0626">626</REF.NP.ECR></REF.DOC.ECR>). This judgment concerned a tax imposed by the Italian Republic on exports of objects of artistic or historic interest.</P></NOTE> In the absence of a different definition within Directive 2004/18, that definition seems to me to be capable of being transposed to the concept of <QUOT.START CODE="2018" REF.END="QE0043" ID="QS0043"/>product<QUOT.END REF.START="QS0043" CODE="2019" ID="QE0043"/> within the meaning of that directive.</TXT></NP.ECR><NP.ECR IDENTIFIER="NP0065"><NO.P>65.</NO.P><TXT>To my mind, there is scarcely any doubt that the medicinal products at issue in the main proceedings are products that can be valued in money and as such be the subject of commercial transactions. The fact that the supply of such medicinal products pursues an objective of general interest is not in my view capable of calling in question the quality of <QUOT.START CODE="2018" REF.END="QE0044" ID="QS0044"/>products<QUOT.END REF.START="QS0044" CODE="2019" ID="QE0044"/> or <QUOT.START CODE="2018" REF.END="QE0045" ID="QS0045"/>goods<QUOT.END REF.START="QS0045" CODE="2019" ID="QE0045"/> of the medicinal products at issue, but may, if appropriate, be taken into consideration at the justification stage.</TXT></NP.ECR><NP.ECR IDENTIFIER="NP0066"><NO.P>66.</NO.P><TXT>My conviction in that respect is borne out by the Court’s case-law on the free movement of goods. The Court has considered on numerous occasions that medicinal products came within the scope of Articles 34 and 36 TFEU.<NOTE TYPE="FOOTNOTE" NUMBERING="ARAB" NUMBERING.CONTINUED="YES" NOTE.ID="E0015"><P>See, in particular, judgments of <REF.DOC.ECR><DATE ISO="19760520">20 May 1976</DATE>, <NAME.CASE><HT TYPE="ITALIC">de Peijper</HT></NAME.CASE> (<NO.CASE>104/75</NO.CASE>, <NO.ECLI ECLI="ECLI:EU:C:1976:67">EU:C:1976:67</NO.ECLI></REF.DOC.ECR>); of <REF.DOC.ECR><DATE ISO="19840228">28 February 1984</DATE>, <NAME.CASE><HT TYPE="ITALIC">Commission</HT> v <HT TYPE="ITALIC">Germany</HT></NAME.CASE> (<NO.CASE>247/81</NO.CASE>, <NO.ECLI ECLI="ECLI:EU:C:1984:79">EU:C:1984:79</NO.ECLI></REF.DOC.ECR>); of <REF.DOC.ECR><DATE ISO="19940601">1 June 1994</DATE>, <NAME.CASE><HT TYPE="ITALIC">Commission</HT> v <HT TYPE="ITALIC">Germany</HT></NAME.CASE> (<NO.CASE>C‑317/92</NO.CASE>, <NO.ECLI ECLI="ECLI:EU:C:1994:212">EU:C:1994:212</NO.ECLI></REF.DOC.ECR>); and of <REF.DOC.ECR><DATE ISO="20080911">11 September 2008</DATE>, <NAME.CASE><HT TYPE="ITALIC">Commission</HT> v <HT TYPE="ITALIC">Germany</HT></NAME.CASE> (<NO.CASE>C‑141/07</NO.CASE>, <NO.ECLI ECLI="ECLI:EU:C:2008:492">EU:C:2008:492</NO.ECLI></REF.DOC.ECR>).</P></NOTE> Furthermore, the Court held in the judgment in <HT TYPE="ITALIC">Humanplasma</HT> that a prohibition on the importation and marketing of blood and blood components obtained from paid blood donations constituted a measure having equivalent effect to a quantitative restriction on imports within the meaning of Article 34 TFEU.<NOTE TYPE="FOOTNOTE" NUMBERING="ARAB" NUMBERING.CONTINUED="YES" NOTE.ID="E0016"><P>Judgment of <REF.DOC.ECR><DATE ISO="20101209">9 December 2010</DATE>, <NAME.CASE><HT TYPE="ITALIC">Humanplasma</HT></NAME.CASE> (<NO.CASE>C‑421/09</NO.CASE>, <NO.ECLI ECLI="ECLI:EU:C:2010:760">EU:C:2010:760</NO.ECLI>, paragraphs <REF.NP.ECR REF="NP0024">24</REF.NP.ECR> and <REF.NP.ECR REF="NP0030">30</REF.NP.ECR></REF.DOC.ECR>).</P></NOTE></TXT></NP.ECR><NP.ECR IDENTIFIER="NP0067"><NO.P>67.</NO.P><TXT>In the third place, the Slovenian Government has disputed the pecuniary nature, for the purposes of Article 1(2)(a) of Directive 2004/18, of the supply of medicinal products manufactured on the basis of Slovenian plasma, relying on the fact that the ZTM was prohibited from making a profit on that supply.<NOTE TYPE="FOOTNOTE" NUMBERING="ARAB" NUMBERING.CONTINUED="YES" NOTE.ID="E0017"><P>It will be recalled that, in practice, the ZTM is the only operator able to supply medicinal products that conform to the national origin requirement and therefore to participate in the call for tenders at issue in the main proceedings. See point 54 of this Opinion.</P></NOTE></TXT></NP.ECR><?PAGE NO="12"?><NP.ECR IDENTIFIER="NP0068"><NO.P>68.</NO.P><TXT>I recall, in that regard, that a contract cannot fall outside the definition of <QUOT.START CODE="2018" REF.END="QE0046" ID="QS0046"/>public contract<QUOT.END REF.START="QS0046" CODE="2019" ID="QE0046"/> merely because the remuneration remains limited to reimbursement of the expenditure incurred in providing the agreed good or service.<NOTE TYPE="FOOTNOTE" NUMBERING="ARAB" NUMBERING.CONTINUED="YES" NOTE.ID="E0018"><P>See, in particular, judgments of <REF.DOC.ECR><DATE ISO="20121219">19 December 2012</DATE>, <NAME.CASE><HT TYPE="ITALIC">Ordine degli Ingegneri della Provincia di Lecce and Others</HT></NAME.CASE> (<NO.CASE>C‑159/11</NO.CASE>, <NO.ECLI ECLI="ECLI:EU:C:2012:817">EU:C:2012:817</NO.ECLI>, paragraph <REF.NP.ECR REF="NP0029">29</REF.NP.ECR></REF.DOC.ECR>), and of <REF.DOC.ECR><DATE ISO="20141211">11 December 2014</DATE>, <NAME.CASE><HT TYPE="ITALIC">Azienda sanitaria locale n. 5 ‘Spezzino’ and Others</HT></NAME.CASE> (<NO.CASE>C‑113/13</NO.CASE>, <NO.ECLI ECLI="ECLI:EU:C:2014:2440">EU:C:2014:2440</NO.ECLI>, paragraph <REF.NP.ECR REF="NP0037">37</REF.NP.ECR></REF.DOC.ECR>).</P></NOTE> In the present case it is apparent from the observations submitted by the Slovenian Government, that the ZTM requests, by way of consideration for the supply of the medicinal products manufactured on the basis of Slovenian plasma, reimbursement of the costs of manufacturing the medicinal products. In doing so, it passes on to the purchasers the expenditure incurred in the processing, by a third operator, of the surplus blood collected in Slovenian territory. Accordingly, the supply of medicinal products manufactured on the basis of Slovenian plasma must, in those circumstances, be characterised as a <QUOT.START CODE="2018" REF.END="QE0047" ID="QS0047"/>contract for pecuniary interest<QUOT.END REF.START="QS0047" CODE="2019" ID="QE0047"/>.</TXT></NP.ECR><NP.ECR IDENTIFIER="NP0069"><NO.P>69.</NO.P><TXT>In the fourth place, under the first indent of Article 7(b), the applicability of Directive 2004/18 is also subject to the condition that the estimated value, exclusive of value added tax (VAT), of the public contract must be equal to or greater than a threshold of EUR <FT TYPE="NUMBER">207000</FT>, that being the threshold applicable in the case of public supply contracts awarded by contracting authorities other than those referred to in Annex IV, such as Murska Sobota general hospital.</TXT></NP.ECR><NP.ECR IDENTIFIER="NP0070"><NO.P>70.</NO.P><TXT>In answer to a question for clarification addressed to it by the Court, the referring body stated that the estimated value, exclusive of VAT, of the public contract at issue in the main proceedings was EUR <FT TYPE="NUMBER">791476</FT>. That contract is therefore above the threshold provided for in the first indent of Article 7(b) of Directive 2004/18.</TXT></NP.ECR><NP.ECR IDENTIFIER="NP0071"><NO.P>71.</NO.P><TXT>In the fifth place, the Slovenian Government has also relied on the exception established by the Court in the judgment of <DATE ISO="20090609">9 June 2009</DATE>, <HT TYPE="ITALIC">Commission</HT> v <HT TYPE="ITALIC">Germany</HT>,<NOTE TYPE="FOOTNOTE" NUMBERING="ARAB" NUMBERING.CONTINUED="YES" NOTE.ID="E0019"><P><REF.DOC.ECR><NO.CASE>C‑480/06</NO.CASE>, <NO.ECLI ECLI="ECLI:EU:C:2009:357">EU:C:2009:357</NO.ECLI></REF.DOC.ECR>.</P></NOTE> in support of its contention that Directive 2004/18 is not applicable. To my mind, however, that exception does not seem to be applicable to the circumstances of the main proceedings.</TXT></NP.ECR><NP.ECR IDENTIFIER="NP0072"><NO.P>72.</NO.P><TXT>That judgment concerned a contract concluded for a period of 20 years between the City of Hamburg (Germany) and four Landkreise, for the purpose of establishing long-term cooperation between those local authorities for reciprocal treatment of waste. Thus, that contract, which had been concluded without launching a call for tenders, formed both the basis and the legal framework for the future construction and operation of facility intended to perform a public service, namely thermal incineration of waste. The Court held that such a contract was not required to be the subject matter of a prior call for tenders.<NOTE TYPE="FOOTNOTE" NUMBERING="ARAB" NUMBERING.CONTINUED="YES" NOTE.ID="E0020"><P>Judgment of <REF.DOC.ECR><DATE ISO="20090609">9 June 2009</DATE>, <NAME.CASE><HT TYPE="ITALIC">Commission</HT> v <HT TYPE="ITALIC">Germany</HT></NAME.CASE> (<NO.CASE>C‑480/06</NO.CASE>, <NO.ECLI ECLI="ECLI:EU:C:2009:357">EU:C:2009:357</NO.ECLI>, paragraphs <REF.NP.ECR REF="NP0005">5</REF.NP.ECR>, <REF.NP.ECR REF="NP0006">6</REF.NP.ECR>, <REF.NP.ECR REF="NP0031">31</REF.NP.ECR>, <REF.NP.ECR REF="NP0037">37</REF.NP.ECR>, <REF.NP.ECR REF="NP0044">44</REF.NP.ECR> and <REF.NP.ECR REF="NP0049">49</REF.NP.ECR></REF.DOC.ECR>).</P></NOTE></TXT></NP.ECR><NP.ECR IDENTIFIER="NP0073"><NO.P>73.</NO.P><TXT>Admittedly, the circumstances of the main proceedings bear certain resemblances to those of the judgment in <HT TYPE="ITALIC">Commission</HT> v <HT TYPE="ITALIC">Germany</HT>, and in particular the public nature of the contracting parties, namely Murska Sobota general hospital and the ZTM. However, in that judgment it was not the Court’s intention to exclude all contracts between public entities<NOTE TYPE="FOOTNOTE" NUMBERING="ARAB" NUMBERING.CONTINUED="YES" NOTE.ID="E0021"><P>It will be recalled that contracts between public entities are not for that reason excluded from the scope of the EU legislation on public contracts. See the definition of <QUOT.START CODE="2018" REF.END="QE0048" ID="QS0048"/>economic operator<QUOT.END REF.START="QS0048" CODE="2019" ID="QE0048"/> provided for in Article 1(8) of Directive 2004/18 and also the judgment of <REF.DOC.ECR><DATE ISO="20151006">6 October 2015</DATE>, <NAME.CASE><HT TYPE="ITALIC">Consorci Sanitari del Maresme</HT></NAME.CASE> (<NO.CASE>C‑203/14</NO.CASE>, <NO.ECLI ECLI="ECLI:EU:C:2015:664">EU:C:2015:664</NO.ECLI>, paragraph <REF.NP.ECR REF="NP0034">34</REF.NP.ECR></REF.DOC.ECR> and the case-law cited).</P></NOTE> from the rules applicable to public contracts, but only those forming both the basis and the legal framework for long-term co-operation with the intention of carrying out a public service. That is not the case of the contract at issue in the main proceedings, the object of which is limited to the occasional supply of medicinal products manufactured on the basis of human plasma.</TXT></NP.ECR><NP.ECR IDENTIFIER="NP0074"><NO.P>74.</NO.P><TXT>Consequently, I consider that the contract at issue in the main proceedings does not come within the exception established by the Court in the judgment in <HT TYPE="ITALIC">Commission</HT> v <HT TYPE="ITALIC">Germany</HT>.</TXT></NP.ECR><?PAGE NO="13"?><NP.ECR IDENTIFIER="NP0075"><NO.P>75.</NO.P><TXT>It follows from the foregoing that Directive 2004/18 is applicable in circumstances such as those of the main proceedings.</TXT></NP.ECR></GR.SEQ><GR.SEQ LEVEL="3"><TITLE><TI><NP><NO.P>2.</NO.P><TXT>The existence of an infringement of Article 2 of Directive 2004/18</TXT></NP></TI></TITLE><NP.ECR IDENTIFIER="NP0076"><NO.P>76.</NO.P><TXT>Under Article 2 of Directive 2004/18, the contracting authorities are required to treat economic operators equally and non-discriminatorily.</TXT></NP.ECR><NP.ECR IDENTIFIER="NP0077"><NO.P>77.</NO.P><TXT>According to the Court’s case-law, in application of the principle of equal treatment as between tenderers, the aim of which is to promote the development of healthy and effective competition between undertakings taking part in a public procurement procedure, all tenderers must be afforded equality of opportunity when formulating their tenders, which therefore implies that the tenders of all competitors must be subject to the same conditions.<NOTE TYPE="FOOTNOTE" NUMBERING="ARAB" NUMBERING.CONTINUED="YES" NOTE.ID="E0022"><P>Judgment of <REF.DOC.ECR><DATE ISO="20150312">12 March 2015</DATE>, <NAME.CASE><HT TYPE="ITALIC">eVigilo</HT></NAME.CASE> (<NO.CASE>C‑538/13</NO.CASE>, <NO.ECLI ECLI="ECLI:EU:C:2015:166">EU:C:2015:166</NO.ECLI>, paragraph <REF.NP.ECR REF="NP0033">33</REF.NP.ECR></REF.DOC.ECR> and the case-law cited).</P></NOTE></TXT></NP.ECR><NP.ECR IDENTIFIER="NP0078"><NO.P>78.</NO.P><TXT>Strictly speaking, the national origin requirement distinguishes not between economic operators but between products, by excluding medicinal products not manufactured on the basis of Slovenian plasma.</TXT></NP.ECR><NP.ECR IDENTIFIER="NP0079"><NO.P>79.</NO.P><TXT>Nonetheless, it has consistently been held that the principle of equal treatment, of which Article 2 of that directive is a particular expression, prohibits not only overt discrimination based on nationality but also all covert forms of discrimination which, by applying other distinguishing criteria, in fact achieve the same result.<NOTE TYPE="FOOTNOTE" NUMBERING="ARAB" NUMBERING.CONTINUED="YES" NOTE.ID="E0023"><P>See, to that effect, judgments of <REF.DOC.ECR><DATE ISO="19891205">5 December 1989</DATE>, <NAME.CASE><HT TYPE="ITALIC">Commission</HT> v <HT TYPE="ITALIC">Italy</HT></NAME.CASE> (<NO.CASE>C‑3/88</NO.CASE>, <NO.ECLI ECLI="ECLI:EU:C:1989:606">EU:C:1989:606</NO.ECLI>, paragraph <REF.NP.ECR REF="NP0008">8</REF.NP.ECR></REF.DOC.ECR>); of <REF.DOC.ECR><DATE ISO="20000926">26 September 2000</DATE>, <NAME.CASE><HT TYPE="ITALIC">Commission</HT> v <HT TYPE="ITALIC">France</HT></NAME.CASE> (<NO.CASE>C‑225/98</NO.CASE>, <NO.ECLI ECLI="ECLI:EU:C:2000:494">EU:C:2000:494</NO.ECLI>, paragraph <REF.NP.ECR REF="NP0080">80</REF.NP.ECR></REF.DOC.ECR>); of <REF.DOC.ECR><DATE ISO="20080221">21 February 2008</DATE>, <NAME.CASE><HT TYPE="ITALIC">Commission</HT> v <HT TYPE="ITALIC">Italy</HT></NAME.CASE> (<NO.CASE>C‑412/04</NO.CASE>, <NO.ECLI ECLI="ECLI:EU:C:2008:102">EU:C:2008:102</NO.ECLI>, paragraph <REF.NP.ECR REF="NP0066">66</REF.NP.ECR></REF.DOC.ECR>); and of <REF.DOC.ECR><DATE ISO="20080717">17 July 2008</DATE>, <NAME.CASE><HT TYPE="ITALIC">ASM Brescia</HT></NAME.CASE> (<NO.CASE>C‑347/06</NO.CASE>, <NO.ECLI ECLI="ECLI:EU:C:2008:416">EU:C:2008:416</NO.ECLI>, paragraph <REF.NP.ECR REF="NP0060">60</REF.NP.ECR></REF.DOC.ECR>).</P></NOTE></TXT></NP.ECR><NP.ECR IDENTIFIER="NP0080"><NO.P>80.</NO.P><TXT>A clause requiring that a medicinal product be manufactured on the basis of plasma collected in the national territory is liable to operate mainly to the detriment of economic operators of other Member States, since they will find it more difficult to have access to plasma collected in the national territory than the economic operators of the Member State concerned.<NOTE TYPE="FOOTNOTE" NUMBERING="ARAB" NUMBERING.CONTINUED="YES" NOTE.ID="E0024"><P>See, by analogy with the criterion of residence on the national territory, judgment of <REF.DOC.ECR><DATE ISO="20030116">16 January 2003</DATE>, <NAME.CASE><HT TYPE="ITALIC">Commission</HT> v <HT TYPE="ITALIC">Italy</HT></NAME.CASE> (<NO.CASE>C‑388/01</NO.CASE>, <NO.ECLI ECLI="ECLI:EU:C:2003:30">EU:C:2003:30</NO.ECLI>, paragraph <REF.NP.ECR REF="NP0014">14</REF.NP.ECR></REF.DOC.ECR>).</P></NOTE></TXT></NP.ECR><NP.ECR IDENTIFIER="NP0081"><NO.P>81.</NO.P><TXT>In the circumstances of the main proceedings, the discriminatory effects of that national origin requirement are all the more apparent because the ZTM, a Slovenian body, is in practice the only economic operator capable of supplying medicinal products manufactured on the basis of Slovenian plasma, which precludes all operators in other Member States.</TXT></NP.ECR><NP.ECR IDENTIFIER="NP0082"><NO.P>82.</NO.P><TXT>I conclude from the foregoing that Article 2 of Directive 2004/18 of Directive 2004/18 must be interpreted as meaning that it precludes the national origin requirement.<NOTE TYPE="FOOTNOTE" NUMBERING="ARAB" NUMBERING.CONTINUED="YES" NOTE.ID="E0025"><P>As regards the existence of possible justification, see points 105 to 164 of this Opinion.</P></NOTE></TXT></NP.ECR></GR.SEQ><GR.SEQ LEVEL="3"><TITLE><TI><NP><NO.P>3.</NO.P><TXT>The existence of an infringement of Article 23(2) and (8) of Directive 2004/18</TXT></NP></TI></TITLE><NP.ECR IDENTIFIER="NP0083"><NO.P>83.</NO.P><TXT>Article 23 of Directive 2004/18 imposes a number of obligations in relation to technical specifications. According to the definition provided in point 1(b) of Annex VI to that directive, <QUOT.START CODE="2018" REF.END="QE0049" ID="QS0049"/>technical specification<QUOT.END REF.START="QS0049" CODE="2019" ID="QE0049"/> covers, in particular, any specification defining <QUOT.START CODE="2018" REF.END="QE0050" ID="QS0050"/>the required characteristics of a product or service<QUOT.END REF.START="QS0050" CODE="2019" ID="QE0050"/>, including requirements relevant to the product as regards <QUOT.START CODE="2018" REF.END="QE0051" ID="QS0051"/>production processes and methods<QUOT.END REF.START="QS0051" CODE="2019" ID="QE0051"/>.</TXT></NP.ECR><?PAGE NO="14"?><NP.ECR IDENTIFIER="NP0084"><NO.P>84.</NO.P><TXT>In the light of that definition, it seems indisputable — and, moreover, it has not been disputed by the parties which have submitted observations to the Court — that the national origin requirement is a technical specification for the purposes of Article 23 of Directive 2004/18.</TXT></NP.ECR><NP.ECR IDENTIFIER="NP0085"><NO.P>85.</NO.P><TXT>According to Article 23(2) of that directive, technical specifications are to afford equal access for tenderers and are not to have the effect of creating unjustified obstacles to the opening up of public procurement to competition. For the reasons set out in points 79 to 81 of this Opinion, I consider that the national origin requirement does not permit equal access for tenderers within the meaning of that provision.</TXT></NP.ECR><NP.ECR IDENTIFIER="NP0086"><NO.P>86.</NO.P><TXT>In addition, that requirement is contrary to Article 23(8) of Directive 2004/18, in that it refers to a specific source or origin, which has the effect of eliminating medicinal products manufactured on the basis of plasma of foreign origin.</TXT></NP.ECR><NP.ECR IDENTIFIER="NP0087"><NO.P>87.</NO.P><TXT>I conclude from the foregoing that Article 2 and Article 23(2) and (8) of Directive 2004/18 must be interpreted as meaning that they preclude the national origin requirement.<NOTE TYPE="FOOTNOTE" NUMBERING="ARAB" NUMBERING.CONTINUED="YES" NOTE.ID="E0026"><P>As regards the existence of possible justification, see points 105 to 164 of this Opinion.</P></NOTE></TXT></NP.ECR></GR.SEQ></GR.SEQ><GR.SEQ LEVEL="2"><TITLE><TI><NP><NO.P>D –</NO.P><TXT><HT TYPE="ITALIC">The infringement of Article 34 TFEU</HT></TXT></NP></TI></TITLE><NP.ECR IDENTIFIER="NP0088"><NO.P>88.</NO.P><TXT>In the context of this section, I shall consider whether Article 34 TFEU must be interpreted as meaning that it precludes the priority supply principle and the national origin requirement.<NOTE TYPE="FOOTNOTE" NUMBERING="ARAB" NUMBERING.CONTINUED="YES" NOTE.ID="E0027"><P>I would point out that I have reformulated the question for a preliminary ruling, which referred to Article 18 TFEU, for the reasons set out in points 36 to 43 of this Opinion.</P></NOTE></TXT></NP.ECR><NP.ECR IDENTIFIER="NP0089"><NO.P>89.</NO.P><TXT>In order to do so, it is necessary to assess (i) the applicability of Article 34 TFEU in the circumstances of the main proceedings and (ii) the existence of an infringement of that article.</TXT></NP.ECR><GR.SEQ LEVEL="3"><TITLE><TI><NP><NO.P>1.</NO.P><TXT>The applicability of Article 34 TFEU</TXT></NP></TI></TITLE><NP.ECR IDENTIFIER="NP0090"><NO.P>90.</NO.P><TXT>A number of questions must be examined before it can be concluded that Article 34 TFEU is applicable.</TXT></NP.ECR><NP.ECR IDENTIFIER="NP0091"><NO.P>91.</NO.P><TXT>In the first place, it is necessary to assess whether Article 34 TFEU is still applicable in the circumstances of the main proceedings when it has just been established that there has been an infringement of Article 2 and Article 23(2) and (8) of Directive 2004/18.</TXT></NP.ECR><NP.ECR IDENTIFIER="NP0092"><NO.P>92.</NO.P><TXT>I would emphasise in that regard that the scope of the priority supply principle, as provided for in Article 6(71) of the Law on medicinal products, is not limited to the sphere of public contracts. It is therefore necessary to determine whether that principle is compatible with Article 34 TFEU in all situations not coming under Directive 2004/18.</TXT></NP.ECR><NP.ECR IDENTIFIER="NP0093"><NO.P>93.</NO.P><TXT>Furthermore, as regards the situations that do come within the scope of Directive 2004/18, it is necessary to determine whether that directive brings about exhaustive harmonisation, which would mean that the national measures in question could not be assessed in the light of the provisions of primary law.<NOTE TYPE="FOOTNOTE" NUMBERING="ARAB" NUMBERING.CONTINUED="YES" NOTE.ID="E0028"><P>On the concept of <QUOT.START CODE="2018" REF.END="QE0052" ID="QS0052"/>exhaustive harmonisation<QUOT.END REF.START="QS0052" CODE="2019" ID="QE0052"/>, see, in particular, judgments of <REF.DOC.ECR><DATE ISO="20041214">14 December 2004</DATE>, <NAME.CASE><HT TYPE="ITALIC">Swedish Match</HT></NAME.CASE> (<NO.CASE>C‑210/03</NO.CASE>, <NO.ECLI ECLI="ECLI:EU:C:2004:802">EU:C:2004:802</NO.ECLI>, paragraph <REF.NP.ECR REF="NP0081">81</REF.NP.ECR></REF.DOC.ECR>); of <REF.DOC.ECR><DATE ISO="20150716">16 July 2015</DATE>, <NAME.CASE>UNIC <HT TYPE="ITALIC">and Uni.co.pel</HT></NAME.CASE> (<NO.CASE>C‑95/14</NO.CASE>, <NO.ECLI ECLI="ECLI:EU:C:2015:492">EU:C:2015:492</NO.ECLI>, paragraph <REF.NP.ECR REF="NP0033">33</REF.NP.ECR></REF.DOC.ECR>); and of <REF.DOC.ECR><DATE ISO="20151112">12 November 2015</DATE>, <NAME.CASE><HT TYPE="ITALIC">Visnapuu</HT></NAME.CASE> (<NO.CASE>C‑198/14</NO.CASE>, <NO.ECLI ECLI="ECLI:EU:C:2015:751">EU:C:2015:751</NO.ECLI>, paragraph <REF.NP.ECR REF="NP0040">40</REF.NP.ECR></REF.DOC.ECR>).</P></NOTE></TXT></NP.ECR><?PAGE NO="15"?><NP.ECR IDENTIFIER="NP0094"><NO.P>94.</NO.P><TXT>I consider that Directive 2004/18 does not bring about exhaustive harmonisation of the aspects relating to the free movement of goods,<NOTE TYPE="FOOTNOTE" NUMBERING="ARAB" NUMBERING.CONTINUED="YES" NOTE.ID="E0029"><P>I find confirmation of that interpretation in recital of Directive 2004/18, which states that that directive lay downs coordinating provisions which are to be interpreted in accordance with the principle of free movement of goods</P></NOTE> in such a way that the national origin requirement may be assessed in the light of Article 34 TFEU.<NOTE TYPE="FOOTNOTE" NUMBERING="ARAB" NUMBERING.CONTINUED="YES" NOTE.ID="E0030"><P>This approach was taken by the Court in the judgment of <REF.DOC.ECR><DATE ISO="19930622">22 June 1993</DATE>, <NAME.CASE><HT TYPE="ITALIC">Commission</HT> v <HT TYPE="ITALIC">Denmark</HT></NAME.CASE> (<NO.CASE>C‑243/89</NO.CASE>, <NO.ECLI ECLI="ECLI:EU:C:1993:257">EU:C:1993:257</NO.ECLI></REF.DOC.ECR>), in which it was found that there had been an infringement of both the EU legislation on public contracts and Article 34 TFEU. In the judgment of <REF.DOC.ECR><DATE ISO="20101209">9 December 2010</DATE>, <NAME.CASE><HT TYPE="ITALIC">Humanplasma</HT></NAME.CASE> (<NO.CASE>C‑421/09</NO.CASE>, <NO.ECLI ECLI="ECLI:EU:C:2010:760">EU:C:2010:760</NO.ECLI></REF.DOC.ECR>), which also concerned a call for tenders for the supply of blood products, the Court held that there had been an infringement of Article 34 EU, but was not asked whether there had been an infringement of EU law relating to public contracts.</P></NOTE> The Commission has rightly claimed, in that regard, that that requirement was imposed by a public body, namely Murska Sobota general hospital,<NOTE TYPE="FOOTNOTE" NUMBERING="ARAB" NUMBERING.CONTINUED="YES" NOTE.ID="E0031"><P>See point 61 of this Opinion.</P></NOTE> which as such is subject to the obligations arising under the free movement of goods.<NOTE TYPE="FOOTNOTE" NUMBERING="ARAB" NUMBERING.CONTINUED="YES" NOTE.ID="E0032"><P>According to settled case-law, the obligations arising under the free movement of goods also apply to autonomous bodies established by the State. See, to that effect, judgments of <REF.DOC.ECR><DATE ISO="19750618">18 June 1975</DATE>, <NAME.CASE>IGAV</NAME.CASE> (<NO.CASE>94/74</NO.CASE>, <NO.ECLI ECLI="ECLI:EU:C:1975:81">EU:C:1975:81</NO.ECLI>, paragraph <REF.NP.ECR REF="NP0011">11</REF.NP.ECR></REF.DOC.ECR>); of <REF.DOC.ECR><DATE ISO="19831213">13 December 1983</DATE>, <NAME.CASE><HT TYPE="ITALIC">Apple and Pear Development Council</HT></NAME.CASE> (<NO.CASE>222/82</NO.CASE>, <NO.ECLI ECLI="ECLI:EU:C:1983:370">EU:C:1983:370</NO.ECLI>, paragraph <REF.NP.ECR REF="NP0017">17</REF.NP.ECR></REF.DOC.ECR>); of <REF.DOC.ECR><DATE ISO="19901212">12 December 1990</DATE>, <NAME.CASE><HT TYPE="ITALIC">Hennen Olie</HT></NAME.CASE> (<NO.CASE>C‑302/88</NO.CASE>, <NO.ECLI ECLI="ECLI:EU:C:1990:455">EU:C:1990:455</NO.ECLI>, paragraphs <REF.NP.ECR REF="NP0013">13</REF.NP.ECR> to <REF.NP.ECR REF="NP0016">16</REF.NP.ECR></REF.DOC.ECR>); and of <REF.DOC.ECR><DATE ISO="20021105">5 November 2002</DATE>, <NAME.CASE><HT TYPE="ITALIC">Commission</HT> v <HT TYPE="ITALIC">Germany</HT></NAME.CASE> (<NO.CASE>C‑325/00</NO.CASE>, <NO.ECLI ECLI="ECLI:EU:C:2002:633">EU:C:2002:633</NO.ECLI>, paragraphs <REF.NP.ECR REF="NP0017">17</REF.NP.ECR> to <REF.NP.ECR REF="NP0020">20</REF.NP.ECR></REF.DOC.ECR>).</P></NOTE></TXT></NP.ECR><NP.ECR IDENTIFIER="NP0095"><NO.P>95.</NO.P><TXT>In the second place, the Slovenian Government has claimed that the priority supply principle comes within an exclusive power afforded to the Member States by Article 168(7) TFEU in connection with the allocation, use, processing and distribution of human blood.</TXT></NP.ECR><NP.ECR IDENTIFIER="NP0096"><NO.P>96.</NO.P><TXT>In that regard, the Court has already had occasion to rule that, in accordance with Article 168(7) TFEU, EU law does not affect the power of the Member States to adopt provisions intended to organise health services. In exercising that power, however, the Member States must respect EU law, in particular the FEU Treaty provisions on freedoms of movement.<NOTE TYPE="FOOTNOTE" NUMBERING="ARAB" NUMBERING.CONTINUED="YES" NOTE.ID="E0033"><P>See, as regards freedom of establishment, judgment of <REF.DOC.ECR><DATE ISO="20130926">26 September 2013</DATE>, <NAME.CASE><HT TYPE="ITALIC">Ottica New Line</HT></NAME.CASE> (<NO.CASE>C‑539/11</NO.CASE>, <NO.ECLI ECLI="ECLI:EU:C:2013:591">EU:C:2013:591</NO.ECLI>, paragraph <REF.NP.ECR REF="NP0024">24</REF.NP.ECR></REF.DOC.ECR> and the case-law cited). See also judgment of <REF.DOC.ECR><DATE ISO="20120621">21 June 2012</DATE>, <NAME.CASE><HT TYPE="ITALIC">Susisalo and Others</HT></NAME.CASE> (<NO.CASE>C‑84/11</NO.CASE>, <NO.ECLI ECLI="ECLI:EU:C:2012:374">EU:C:2012:374</NO.ECLI>, paragraphs <REF.NP.ECR REF="NP0026">26</REF.NP.ECR> and <REF.NP.ECR REF="NP0027">27</REF.NP.ECR></REF.DOC.ECR> and the case-law cited). That broad interpretation of the scope of the freedoms of movement is not limited to the areas referred to in Article 168(7) TFEU. See, in particular, judgments of <REF.DOC.ECR><DATE ISO="20110127">27 January 2011</DATE>, <NAME.CASE><HT TYPE="ITALIC">Commission</HT> v <HT TYPE="ITALIC">Luxembourg</HT></NAME.CASE> (<NO.CASE>C‑490/09</NO.CASE>, <NO.ECLI ECLI="ECLI:EU:C:2011:34">EU:C:2011:34</NO.ECLI>, paragraph <REF.NP.ECR REF="NP0032">32</REF.NP.ECR></REF.DOC.ECR>) and of <REF.DOC.ECR><DATE ISO="20150204">4 February 2015</DATE>, <NAME.CASE><HT TYPE="ITALIC">Melchior</HT></NAME.CASE> (<NO.CASE>C‑647/13</NO.CASE>, <NO.ECLI ECLI="ECLI:EU:C:2015:54">EU:C:2015:54</NO.ECLI>, paragraph <REF.NP.ECR REF="NP0021">21</REF.NP.ECR></REF.DOC.ECR>), and order of <REF.DOC.ECR><DATE ISO="20151117">17 November 2015</DATE>, <NAME.CASE><HT TYPE="ITALIC">Plaza Bravo</HT></NAME.CASE> (<NO.CASE>C‑137/15</NO.CASE>, <NO.ECLI ECLI="ECLI:EU:C:2015:771">EU:C:2015:771</NO.ECLI>, paragraph <REF.NP.ECR REF="NP0019">19</REF.NP.ECR></REF.DOC.ECR>).</P></NOTE></TXT></NP.ECR><NP.ECR IDENTIFIER="NP0097"><NO.P>97.</NO.P><TXT>Contrary to what the Slovenian Government’s apparent contention, therefore, Article 168(7) TFEU does not confer on the Member States any exemption from the obligations imposed on them by Article 34 TFEU or other provisions of EU law.</TXT></NP.ECR><NP.ECR IDENTIFIER="NP0098"><NO.P>98.</NO.P><TXT>In the third place, I would observe that, for the reasons set out in points 62 to 66 of this Opinion, medicinal products manufactured on the basis of blood or blood components are <QUOT.START CODE="2018" REF.END="QE0053" ID="QS0053"/>goods<QUOT.END REF.START="QS0053" CODE="2019" ID="QE0053"/> within the meaning of Article 34 TFEU.</TXT></NP.ECR><NP.ECR IDENTIFIER="NP0099"><NO.P>99.</NO.P><TXT>Consequently, it is necessary to consider whether the priority supply principle and the national origin requirement establish a difference in treatment prohibited by Article 34 TFEU.</TXT></NP.ECR></GR.SEQ><GR.SEQ LEVEL="3"><TITLE><TI><NP><NO.P>2.</NO.P><TXT>The existence of an infringement of Article 34 TFEU</TXT></NP></TI></TITLE><NP.ECR IDENTIFIER="NP0100"><NO.P>100.</NO.P><TXT>It is apparent from the observations submitted by the Slovenian Government and from those submitted by the Commission that the medicinal products manufactured on the basis of Slovenian plasma are prepared not in Slovenian territory, but in another Member State. As the Republic of Slovenia does not have plasma fractionation facilities in its territory, the ZTM has the surplus blood collected processed by a private operator established in another Member State.<NOTE TYPE="FOOTNOTE" NUMBERING="ARAB" NUMBERING.CONTINUED="YES" NOTE.ID="E0034"><P>See point 56 of this Opinion.</P></NOTE></TXT></NP.ECR><?PAGE NO="16"?><NP.ECR IDENTIFIER="NP0101"><NO.P>101.</NO.P><TXT>Accordingly, the priority supply principle does not distinguish between medicinal products manufactured in the Republic of Slovenia and those imported from other Member States, but, rather, distinguishes between medicinal products imported from other Member States. Among the latter medicinal products, only those manufactured on the basis of Slovenian plasma at the request of the ZTM can be freely imported, whereas other medicinal products, manufactured on the basis of foreign plasma, can be imported only if the former do not permit the needs of the Slovenian population to be covered.</TXT></NP.ECR><NP.ECR IDENTIFIER="NP0102"><NO.P>102.</NO.P><TXT>Such a difference in treatment, which leads to the channelling of imports in the sense that only certain economic operators can import the products concerned while others are precluded from doing so, constitutes a measure having equivalent effect to a quantitative restriction on imports, as the Commission has claimed.<NOTE TYPE="FOOTNOTE" NUMBERING="ARAB" NUMBERING.CONTINUED="YES" NOTE.ID="E0035"><P>See, in that regard, judgments of <REF.DOC.ECR><DATE ISO="19740711">11 July 1974</DATE>, <NAME.CASE><HT TYPE="ITALIC">Dassonville</HT></NAME.CASE> (<NO.CASE>8/74</NO.CASE>, <NO.ECLI ECLI="ECLI:EU:C:1974:82">EU:C:1974:82</NO.ECLI>, paragraphs <REF.NP.ECR REF="NP0008">8</REF.NP.ECR> and <REF.NP.ECR REF="NP0009">9</REF.NP.ECR></REF.DOC.ECR>), and of <REF.DOC.ECR><DATE ISO="19760520">20 May 1976</DATE>, <NAME.CASE><HT TYPE="ITALIC">de Peijper</HT></NAME.CASE> (<NO.CASE>104/75</NO.CASE>, <NO.ECLI ECLI="ECLI:EU:C:1976:67">EU:C:1976:67</NO.ECLI>, paragraph <REF.NP.ECR REF="NP0013">13</REF.NP.ECR></REF.DOC.ECR>).</P></NOTE></TXT></NP.ECR><NP.ECR IDENTIFIER="NP0103"><NO.P>103.</NO.P><TXT>For the same reasons, the national origin requirement also constitutes a measure having equivalent effect to a quantitative restriction on imports, since only suppliers of medicinal products manufactured on the basis of Slovenian plasma are authorised to participate in the public procurement procedure at issue in the main proceedings.</TXT></NP.ECR><NP.ECR IDENTIFIER="NP0104"><NO.P>104.</NO.P><TXT>I conclude from the foregoing that Article 34 TFEU must be interpreted as meaning that it precludes the priority supply principle and the national origin requirement.</TXT></NP.ECR></GR.SEQ></GR.SEQ><GR.SEQ LEVEL="2"><TITLE><TI><NP><NO.P>E –</NO.P><TXT><HT TYPE="ITALIC">The existence of justification on the basis of Article 36 TFEU</HT></TXT></NP></TI></TITLE><NP.ECR IDENTIFIER="NP0105"><NO.P>105.</NO.P><TXT>After having established that Article 2 and Article 23(2) and (8) of Directive 2004/18 and Article 34 TFEU must be interpreted as meaning that they preclude the priority supply principle and the national origin requirement, it remains to be ascertained whether those measures may be justified by an objective recognised as legitimate by EU law.</TXT></NP.ECR><NP.ECR IDENTIFIER="NP0106"><NO.P>106.</NO.P><TXT>As regards the differences in treatment prohibited by the provisions of Directive 2004/18, I would observe that that directive does not effect an exhaustive harmonisation of the aspects relating to the grounds of justification, in such a way that those differences may be assessed, in that regard, in the light of the relevant provisions of primary law and the relevant case-law of the Court.<NOTE TYPE="FOOTNOTE" NUMBERING="ARAB" NUMBERING.CONTINUED="YES" NOTE.ID="E0036"><P>See the case-law on the concept of <QUOT.START CODE="2018" REF.END="QE0054" ID="QS0054"/>exhaustive harmonisation<QUOT.END REF.START="QS0054" CODE="2019" ID="QE0054"/> cited in footnote 28. Only Article 23(8) of Directive 2004/18 refers to the possibility of justification <QUOT.START CODE="2018" REF.END="QE0055" ID="QS0055"/>by the subject matter of the contract<QUOT.END REF.START="QS0055" CODE="2019" ID="QE0055"/>, which has not been relied on as such in the observations submitted to the Court. I observe that the Court examined the grounds of justification based on the provisions of primary law, when faced with a national measure contrary to EU legislation on public service contracts, in the judgment of <REF.DOC.ECR><DATE ISO="20100429">29 April 2010</DATE>, <NAME.CASE><HT TYPE="ITALIC">Commission</HT> v <HT TYPE="ITALIC">Germany</HT></NAME.CASE> (<NO.CASE>C‑160/08</NO.CASE>, <NO.ECLI ECLI="ECLI:EU:C:2010:230">EU:C:2010:230</NO.ECLI>, paragraphs <REF.NP.ECR REF="NP0073">73</REF.NP.ECR> to <REF.NP.ECR REF="NP0086">86</REF.NP.ECR> and <REF.NP.ECR REF="NP0125">125</REF.NP.ECR> to <REF.NP.ECR REF="NP0130">130</REF.NP.ECR></REF.DOC.ECR>).</P></NOTE></TXT></NP.ECR><NP.ECR IDENTIFIER="NP0107"><NO.P>107.</NO.P><TXT>In the judgment in <HT TYPE="ITALIC">Humanplasma</HT>,<NOTE TYPE="FOOTNOTE" NUMBERING="ARAB" NUMBERING.CONTINUED="YES" NOTE.ID="E0037"><P>Judgment of <REF.DOC.ECR><DATE ISO="20101209">9 December 2010</DATE>, <NAME.CASE><HT TYPE="ITALIC">Humanplasma</HT></NAME.CASE> (<NO.CASE>C‑421/09</NO.CASE>, <NO.ECLI ECLI="ECLI:EU:C:2010:760">EU:C:2010:760</NO.ECLI></REF.DOC.ECR>).</P></NOTE> the Court set out the principles applicable to the grounds of justification based on the protection of health and life of humans referred to in Article 36 TFEU.</TXT></NP.ECR><NP.ECR IDENTIFIER="NP0108"><NO.P>108.</NO.P><TXT>First of all, public health ranks foremost among the assets or interests protected by Article 36 TFEU and it is for the Member States, within the limits imposed by the Treaty, to decide on the degree of protection which they wish to afford to human health and on the way in which that protection is to be achieved. Since the level may vary from one Member State to another, Member States should be allowed some measure of discretion.<NOTE TYPE="FOOTNOTE" NUMBERING="ARAB" NUMBERING.CONTINUED="YES" NOTE.ID="E0038"><P>Judgment of <REF.DOC.ECR><DATE ISO="20101209">9 December 2010</DATE>, <NAME.CASE><HT TYPE="ITALIC">Humanplasma</HT></NAME.CASE> (<NO.CASE>C‑421/09</NO.CASE>, <NO.ECLI ECLI="ECLI:EU:C:2010:760">EU:C:2010:760</NO.ECLI>, paragraphs <REF.NP.ECR REF="NP0032">32</REF.NP.ECR> and <REF.NP.ECR REF="NP0039">39</REF.NP.ECR></REF.DOC.ECR> and the case-law cited). See also judgments of <REF.DOC.ECR><DATE ISO="20080911">11 September 2008</DATE>, <NAME.CASE><HT TYPE="ITALIC">Commission</HT> v <HT TYPE="ITALIC">Germany</HT></NAME.CASE> (<NO.CASE>C‑141/07</NO.CASE>, <NO.ECLI ECLI="ECLI:EU:C:2008:492">EU:C:2008:492</NO.ECLI>, paragraphs <REF.NP.ECR REF="NP0046">46</REF.NP.ECR> and <REF.NP.ECR REF="NP0051">51</REF.NP.ECR></REF.DOC.ECR>) and of <REF.DOC.ECR><DATE ISO="20161019">19 October 2016</DATE>, <NAME.CASE><HT TYPE="ITALIC">Deutsche Parkinson Vereinigung</HT></NAME.CASE> (<NO.CASE>C‑148/15</NO.CASE>, <NO.ECLI ECLI="ECLI:EU:C:2016:776">EU:C:2016:776</NO.ECLI>, paragraph <REF.NP.ECR REF="NP0030">30</REF.NP.ECR></REF.DOC.ECR>).</P></NOTE></TXT></NP.ECR><?PAGE NO="17"?><NP.ECR IDENTIFIER="NP0109"><NO.P>109.</NO.P><TXT>Next, it follows from the case-law that a provision which is capable of restricting a fundamental freedom guaranteed by the Treaty, such as the free movement of goods, can be properly justified only if it is appropriate for securing the attainment of the legitimate objective pursued and does not go beyond what is necessary in order to attain it.<NOTE TYPE="FOOTNOTE" NUMBERING="ARAB" NUMBERING.CONTINUED="YES" NOTE.ID="E0039"><P>Judgment of <REF.DOC.ECR><DATE ISO="20101209">9 December 2010</DATE>, <NAME.CASE><HT TYPE="ITALIC">Humanplasma</HT></NAME.CASE> (<NO.CASE>C‑421/09</NO.CASE>, <NO.ECLI ECLI="ECLI:EU:C:2010:760">EU:C:2010:760</NO.ECLI>, paragraph <REF.NP.ECR REF="NP0034">34</REF.NP.ECR></REF.DOC.ECR> and the case-law cited). See also judgment of <REF.DOC.ECR><DATE ISO="20080911">11 September 2008</DATE>, <NAME.CASE><HT TYPE="ITALIC">Commission</HT> v <HT TYPE="ITALIC">Germany</HT></NAME.CASE> (<NO.CASE>C‑141/07</NO.CASE>, <NO.ECLI ECLI="ECLI:EU:C:2008:492">EU:C:2008:492</NO.ECLI>, paragraph <REF.NP.ECR REF="NP0048">48</REF.NP.ECR></REF.DOC.ECR>).</P></NOTE></TXT></NP.ECR><NP.ECR IDENTIFIER="NP0110"><NO.P>110.</NO.P><TXT>Last, as regards, more specifically, the assessment of the proportionate nature of the provision at issue, it follows from the Court’s case-law that since Article 36 TFEU constitutes an exception, which is to be strictly interpreted, to the rule of free movement of goods within the European Union, it is for the national authorities to demonstrate that that provision is necessary in order to achieve the declared purpose and that that objective could not be achieved by less extensive prohibitions or restrictions, or by prohibitions or restrictions having less effect on trade between Member States.<NOTE TYPE="FOOTNOTE" NUMBERING="ARAB" NUMBERING.CONTINUED="YES" NOTE.ID="E0040"><P>Judgment of <REF.DOC.ECR><DATE ISO="20101209">9 December 2010</DATE>, <NAME.CASE><HT TYPE="ITALIC">Humanplasma</HT></NAME.CASE> (<NO.CASE>C‑421/09</NO.CASE>, <NO.ECLI ECLI="ECLI:EU:C:2010:760">EU:C:2010:760</NO.ECLI>, paragraph <REF.NP.ECR REF="NP0038">38</REF.NP.ECR></REF.DOC.ECR> and the case-law cited). See also judgment of <REF.DOC.ECR><DATE ISO="20080911">11 September 2008</DATE>, <NAME.CASE><HT TYPE="ITALIC">Commission</HT> v <HT TYPE="ITALIC">Germany</HT></NAME.CASE> (<NO.CASE>C‑141/07</NO.CASE>, <NO.ECLI ECLI="ECLI:EU:C:2008:492">EU:C:2008:492</NO.ECLI>, paragraph <REF.NP.ECR REF="NP0050">50</REF.NP.ECR></REF.DOC.ECR>).</P></NOTE></TXT></NP.ECR><NP.ECR IDENTIFIER="NP0111"><NO.P>111.</NO.P><TXT>In application of that case-law, it is appropriate to examine the legitimacy of the objectives put forward by the Slovenian Government and also the appropriateness and necessity, in the light of those objectives, of the priority supply principle and the national origin requirement imposed in the call for tenders at issue in the main proceedings.</TXT></NP.ECR><NP.ECR IDENTIFIER="NP0112"><NO.P>112.</NO.P><TXT>The Slovenian Government has invoked the objective of encouraging voluntary unpaid blood donations in the national territory and also the objective of national self-sufficiency in blood and in blood products, including medicinal products manufactured on the basis of blood. The Commission has, in essence, examined the same grounds of justification under the more general objective of protection of the health and life of humans referred to in Article 36 TFEU.</TXT></NP.ECR><NP.ECR IDENTIFIER="NP0113"><NO.P>113.</NO.P><TXT>I would emphasise that the Slovenian Government has not claimed, as a ground of justification, that medicinal products manufactured on the basis of non-Slovenian plasma might be dangerous. I also note, in that regard, that the competent authorities import such medicinal products when the medicinal products manufactured on the basis of Slovenian plasma are exhausted.<NOTE TYPE="FOOTNOTE" NUMBERING="ARAB" NUMBERING.CONTINUED="YES" NOTE.ID="E0041"><P>See point 58 of this Opinion.</P></NOTE></TXT></NP.ECR><NP.ECR IDENTIFIER="NP0114"><NO.P>114.</NO.P><TXT>I shall examine separately the two objectives invoked by the Slovenian Government, in the light of the case-law cited above.</TXT></NP.ECR><GR.SEQ LEVEL="3"><TITLE><TI><NP><NO.P>1.</NO.P><TXT>The objective of encouraging voluntary unpaid blood donations</TXT></NP></TI></TITLE><NP.ECR IDENTIFIER="NP0115"><NO.P>115.</NO.P><TXT>In the first place, to my mind there is scarcely any doubt that encouraging voluntary unpaid blood donations is a legitimate objective forming part of the more general objective of protecting the health and life of humans.</TXT></NP.ECR><?PAGE NO="18"?><NP.ECR IDENTIFIER="NP0116"><NO.P>116.</NO.P><TXT>I would emphasise that that objective has been supported on many occasions by the Parliament, the Council and the Commission since the 1990s,<NOTE TYPE="FOOTNOTE" NUMBERING="ARAB" NUMBERING.CONTINUED="YES" NOTE.ID="E0042"><P>See, in particular, Resolution of the Parliament of <DATE ISO="19930914">14 September 1993</DATE> on self-sufficiency in and safety of blood and its derivatives in the European Community (<REF.DOC.OJ COLL="C" NO.OJ="268" PAGE.FIRST="29" DATE.PUB="1993">OJ 1993 C 268, p. 29</REF.DOC.OJ>); Resolution of the Parliament of <DATE ISO="19931118">18 November 1993</DATE> on safe blood transfusions and use of blood derivatives (<REF.DOC.OJ COLL="C" NO.OJ="329" PAGE.FIRST="268" DATE.PUB="1993">OJ 1993 C 329, p. 268</REF.DOC.OJ>); Council Conclusions of <DATE ISO="19931213">13 December 1993</DATE> on self-sufficiency in blood in the European Community (<REF.DOC.OJ COLL="C" NO.OJ="015" PAGE.FIRST="6" DATE.PUB="1994">OJ 1994 C 15, p. 6</REF.DOC.OJ>); Communication from the Commission of <DATE ISO="19930525">25 May 1993</DATE> on blood self-sufficiency in the European Community (COM(93) 198 final); Communication from the Commission of <DATE ISO="19941221">21 December 1994</DATE> on Blood safety and self-sufficiency in the European Community (COM(94) 652 final); Council Resolution of <DATE ISO="19950602">2 June 1995</DATE> on blood safety and self-sufficiency in the Community (<REF.DOC.OJ COLL="C" NO.OJ="164" PAGE.FIRST="1" DATE.PUB="1995">OJ 1995 C 164, p. 1</REF.DOC.OJ>); Resolution of the Parliament of <DATE ISO="19950714">14 July 1995</DATE> on blood safety in the European Union (<REF.DOC.OJ COLL="C" NO.OJ="249" PAGE.FIRST="231" DATE.PUB="1995">OJ 1995 C 249, p. 231</REF.DOC.OJ>); Resolution of the Parliament of <DATE ISO="19960417">17 April 1996</DATE> on the communication from the Commission on blood safety and self-sufficiency in the European Community (<REF.DOC.OJ COLL="C" NO.OJ="141" PAGE.FIRST="131" DATE.PUB="1996">OJ 1996 C 141, p. 131</REF.DOC.OJ>); and Council Resolution of <DATE ISO="19961112">12 November 1996</DATE> on a strategy towards blood safety and self-sufficiency in the European Community (<REF.DOC.OJ COLL="C" NO.OJ="374" PAGE.FIRST="1" DATE.PUB="1996">OJ 1996 C 374, p. 1</REF.DOC.OJ>).</P></NOTE> following, in particular, the <QUOT.START CODE="2018" REF.END="QE0056" ID="QS0056"/>contaminated blood<QUOT.END REF.START="QS0056" CODE="2019" ID="QE0056"/> affair in France.<NOTE TYPE="FOOTNOTE" NUMBERING="ARAB" NUMBERING.CONTINUED="YES" NOTE.ID="E0043"><P>This affair, which concerned inoculation with the AIDS virus in the course of blood transfusions in the 1980s, was revealed by the press in the course of 1991.</P></NOTE></TXT></NP.ECR><NP.ECR IDENTIFIER="NP0117"><NO.P>117.</NO.P><TXT>Encouraging blood donations is a legitimate objective having regard to the considerable therapeutic importance of blood and blood products. In a communication of <DATE ISO="19941221">21 December 1994</DATE>, the Commission wrote in that respect:</TXT><P><QUOT.START CODE="2018" REF.END="QE0057" ID="QS0057"/>Blood and the products derived from it have become an indispensable facet of modern medicine. Their use has brought about dramatic advances in therapy and surgery, saved countless lives, and improved significantly the longevity as well as the quality of life for those who suffer from long-term blood disorders such as haemophilia. Ensuring the safety and the supply of blood and blood products, therefore, is of vital importance. …<QUOT.END REF.START="QS0057" CODE="2019" ID="QE0057"/><NOTE TYPE="FOOTNOTE" NUMBERING="ARAB" NUMBERING.CONTINUED="YES" NOTE.ID="E0044"><P>Communication COM(94) 652 final, p. 2. See also 2<HT TYPE="SUP">nd</HT> Report from the Commission of <DATE ISO="20110323">23 March 2011</DATE> on Voluntary and Unpaid Donation of Blood and Blood Components (COM (2011) 138 final), p. 3.</P></NOTE></P></NP.ECR><NP.ECR IDENTIFIER="NP0118"><NO.P>118.</NO.P><TXT>As emphasised in recital 2 of Directive 2002/98, the availability of blood and blood components used for therapeutic purposes is dependent largely on Community citizens who are prepared to donate.</TXT></NP.ECR><NP.ECR IDENTIFIER="NP0119"><NO.P>119.</NO.P><TXT>In addition, the voluntary and unpaid nature of these donations is the consequence of ethical and sanitary considerations put forward by the Slovenian Government. First of all, the principle of inalienability and non-commercialisation of the human body operates against the purchase and sale of blood.<NOTE TYPE="FOOTNOTE" NUMBERING="ARAB" NUMBERING.CONTINUED="YES" NOTE.ID="E0045"><P>See, in particular, Resolution of the Parliament of <DATE ISO="19930914">14 September 1993</DATE> on self-sufficiency in and safety of blood and its derivatives in the European Community, point F; Communication COM(94) 652 final, p. 8; Resolution of the Parliament of <DATE ISO="19960417">17 April 1996</DATE> on the communication from the Commission on blood safety and self-sufficiency in the European Community, point 7.</P></NOTE> Next, the fact that no payment is made for donations makes it possible to preserve the health of donors by ensuring that they are not exploited, in particular those among the most vulnerable categories of the population.<NOTE TYPE="FOOTNOTE" NUMBERING="ARAB" NUMBERING.CONTINUED="YES" NOTE.ID="E0046"><P>See, in particular, Communication COM(93) 198 final, p. 4, and Communication COM(94) 652 final, p. 8.</P></NOTE> Last, the fact that no payment is made makes it possible to protect the health of recipients, by eliminating the risk that a donor may conceal certain relevant medical information in order to receive payment.<NOTE TYPE="FOOTNOTE" NUMBERING="ARAB" NUMBERING.CONTINUED="YES" NOTE.ID="E0047"><P>See, in particular, Communication COM(93) 198 final, p. 4; Report from the Commission of <DATE ISO="20160421">21 April 2016</DATE> on the implementation of Directives 2002/98/EC, 2004/33/EC, 2005/61/EC and 2005/62/EC setting standards of quality and safety for human blood and blood components (COM(2016) 224 final), p. 10.</P></NOTE></TXT></NP.ECR><NP.ECR IDENTIFIER="NP0120"><NO.P>120.</NO.P><TXT>That political will was implemented by a legal obligation which is now found in Article 20 of Directive 2002/98 and Article 110 of Directive 2001/83, which require Member States to take the necessary measures to encourage voluntary and unpaid blood donations.<NOTE TYPE="FOOTNOTE" NUMBERING="ARAB" NUMBERING.CONTINUED="YES" NOTE.ID="E0048"><P>See also recital 19 of Directive 2001/83 and recital 23 of Directive 2002/98.</P></NOTE></TXT></NP.ECR><NP.ECR IDENTIFIER="NP0121"><NO.P>121.</NO.P><TXT>Having regard to the foregoing, encouraging voluntary and unpaid blood donations constitutes a legitimate objective with regard to Article 36 TFEU.</TXT></NP.ECR><?PAGE NO="19"?><NP.ECR IDENTIFIER="NP0122"><NO.P>122.</NO.P><TXT>As regards, in the second place, the appropriateness of the measures at issue in the main proceedings, it must be ascertained whether the priority supply principle and the national origin requirement are capable of achieving that legitimate objective of encouraging voluntary and unpaid blood donations.</TXT></NP.ECR><NP.ECR IDENTIFIER="NP0123"><NO.P>123.</NO.P><TXT>I must confess to having serious doubts in that regard. I see no obvious relationship between those measures, which seek to steer national <HT TYPE="ITALIC">demand</HT> towards products manufactured on the basis of national plasma, and the objective of promoting voluntary and unpaid donations, which seeks to increase the <HT TYPE="ITALIC">supply</HT> of blood and blood components in the national territory.</TXT></NP.ECR><NP.ECR IDENTIFIER="NP0124"><NO.P>124.</NO.P><TXT>More specifically, how can the fact that Murska Sobota general hospital is required to obtain its supplies from medicinal products manufactured on the basis of national plasma, as is the case in the main proceedings, encourage potential donors to make voluntary and unpaid donations of blood or blood components?</TXT></NP.ECR><NP.ECR IDENTIFIER="NP0125"><NO.P>125.</NO.P><TXT>The Slovenian Government has claimed, in that regard, that it is important to prohibit the commercial exploitation of the blood and blood components collected, in order to preserve the motivation of potential donors.</TXT></NP.ECR><NP.ECR IDENTIFIER="NP0126"><NO.P>126.</NO.P><TXT>From that viewpoint, the priority supply principle and the national origin requirement again seem to me to be incapable of achieving the objective ascribed to them, since those measures do not directly or indirectly prohibit the commercial exploitation of the blood collected in the national territory. Furthermore, those measures fail the necessity test, since it is sufficient in that regard to impose a ban on commercial exploitation on the ZTM and on any other person involved in the collection, processing or distribution of the blood collected.</TXT></NP.ECR><NP.ECR IDENTIFIER="NP0127"><NO.P>127.</NO.P><TXT>Having regard to the foregoing, I consider that the priority supply principle and the national origin requirement cannot be justified by the objective of encouraging voluntary and unpaid donations of blood.</TXT></NP.ECR></GR.SEQ><GR.SEQ LEVEL="3"><TITLE><TI><NP><NO.P>2.</NO.P><TXT>The objective of national self-sufficiency (or sufficiency)</TXT></NP></TI></TITLE><NP.ECR IDENTIFIER="NP0128"><NO.P>128.</NO.P><TXT>The Slovenian Government has also relied on the objective of national self-sufficiency in blood and blood products in order to justify the priority supply principle and the national origin requirement.</TXT></NP.ECR><NP.ECR IDENTIFIER="NP0129"><NO.P>129.</NO.P><TXT>Like the promotion of voluntary and unpaid donations, the objective of self-sufficiency in blood and in blood products has been supported on many occasions by the Parliament, the Council and the Commission.<NOTE TYPE="FOOTNOTE" NUMBERING="ARAB" NUMBERING.CONTINUED="YES" NOTE.ID="E0049"><P>See documents cited in footnote 42.</P></NOTE></TXT></NP.ECR><NP.ECR IDENTIFIER="NP0130"><NO.P>130.</NO.P><TXT>That political will has also been implemented by a legal obligation, now provided for in Article 110 of Directive 2001/83,<NOTE TYPE="FOOTNOTE" NUMBERING="ARAB" NUMBERING.CONTINUED="YES" NOTE.ID="E0050"><P>This provision was first introduced into the EU legal order by Article 3(4) of Council Directive 89/381/EEC of <DATE ISO="19890614">14 June 1989</DATE> extending the scope of Directives 65/65/EEC and 75/319/EEC on the approximation of provisions laid down by Law, Regulation or Administrative Action relating to proprietary medicinal products and laying down special provisions for medicinal products derived from human blood or human plasma (<REF.DOC.OJ COLL="L" NO.OJ="181" PAGE.FIRST="44" DATE.PUB="1989">OJ 1989 L 181, p. 44</REF.DOC.OJ>).</P></NOTE> which provides that Member States are to take the necessary measures to promote EU self-sufficiency in human blood or in human plasma.</TXT></NP.ECR><NP.ECR IDENTIFIER="NP0131"><NO.P>131.</NO.P><TXT>However, the concept of ‘self-sufficiency’ contains two ambiguities that affect its ability to justify the priority supply principle and the national origin requirement. It should be emphasised in that regard that that concept has not been defined by the EU legislature, in particular not in either Directive 2001/83 or Directive 2002/98.</TXT></NP.ECR><?PAGE NO="20"?><NP.ECR IDENTIFIER="NP0132"><NO.P>132.</NO.P><TXT>The first ambiguity concerns the territorial scale of the objective of self-sufficiency in blood and blood products. Must that objective be pursued at EU level or may it be pursued at national level? I note that that question is not novel within the EU.<NOTE TYPE="FOOTNOTE" NUMBERING="ARAB" NUMBERING.CONTINUED="YES" NOTE.ID="E0051"><P>See written question E-146/95 submitted by José Valverde Lopez (PPE) to the Commission on <DATE ISO="19950208">8 February 1995</DATE>, on difficulties with interpretation of the concept of blood self-sufficiency (<REF.DOC.OJ COLL="C" NO.OJ="152" PAGE.FIRST="34" DATE.PUB="1995">OJ 1995 C 152, p. 34</REF.DOC.OJ>).</P></NOTE></TXT></NP.ECR><NP.ECR IDENTIFIER="NP0133"><NO.P>133.</NO.P><TXT>None of the parties which have submitted observations to the Court has disputed the fact that self-sufficiency in blood and blood products is a legitimate objective at EU level.<NOTE TYPE="FOOTNOTE" NUMBERING="ARAB" NUMBERING.CONTINUED="YES" NOTE.ID="E0052"><P>As regards human blood and human plasma, that objective is clear from Article 110 of Directive 2001/83.</P></NOTE> However, although the objective of self-sufficiency at EU level may justify restrictions on products imported from third countries,<NOTE TYPE="FOOTNOTE" NUMBERING="ARAB" NUMBERING.CONTINUED="YES" NOTE.ID="E0053"><P>See, in particular, Resolution of the Parliament of <DATE ISO="19950714">14 July 1995</DATE> on blood safety in the European Union, point 3.</P></NOTE> it cannot readily justify a restriction on imports between Member States, such as those at issue in the main proceedings.</TXT></NP.ECR><NP.ECR IDENTIFIER="NP0134"><NO.P>134.</NO.P><TXT>Therefore, the question that arises in the context of the present case is that of the legitimacy of the objective of self-sufficiency pursued <HT TYPE="ITALIC">at national level</HT>. I consider that that objective of national self-sufficiency is legitimate for the following reasons.</TXT></NP.ECR><NP.ECR IDENTIFIER="NP0135"><NO.P>135.</NO.P><TXT>First, I recall the considerable therapeutic importance assumed by the use of blood and blood products.<NOTE TYPE="FOOTNOTE" NUMBERING="ARAB" NUMBERING.CONTINUED="YES" NOTE.ID="E0054"><P>See point 117 of this Opinion.</P></NOTE> In the light of the objective of protecting the health and life of humans referred to in Article 36 TFEU, it is therefore legitimate for a State to ensure that the health services in its territory have sufficient quantities of blood and blood products, without being dependent in that regard on any imports from other Member States.</TXT></NP.ECR><NP.ECR IDENTIFIER="NP0136"><NO.P>136.</NO.P><TXT>Second, it is apparent from the Commission’s observations that lightly populated States, such as the Republic of Slovenia, may encounter difficulties in obtaining supplies on the international markets. According to the Commission, the tendency on those markets, on which the demand for medicinal products derived from blood exceeds the supply of plasma, should encourage undertakings to sell the final product, out of preference, in countries that can pay a higher price or that buy larger quantities. Accordingly, it is legitimate for a lightly populated State to adopt measures to ensure that it is self-sufficient in blood and blood products.</TXT></NP.ECR><NP.ECR IDENTIFIER="NP0137"><NO.P>137.</NO.P><TXT>Third, and as the Commission has claimed, in the absence of harmonisation at EU level, the objective of self-sufficiency pursued at the level of each State contributes indirectly to the self-sufficiency of the European Union in blood and blood products, an objective the legitimacy of which is not disputed.</TXT></NP.ECR><NP.ECR IDENTIFIER="NP0138"><NO.P>138.</NO.P><TXT>Fourth, I note that a number of documents issued by the EU institutions approve of the objective of self-sufficiency in blood and in blood products pursued at Member State level.<NOTE TYPE="FOOTNOTE" NUMBERING="ARAB" NUMBERING.CONTINUED="YES" NOTE.ID="E0055"><P>See, in particular, Resolution of the Parliament of <DATE ISO="19930914">14 September 1993</DATE> on self-sufficiency in and safety of blood and its derivatives in the European Community points D and 2; Communication COM(93) 198 final, p. 8; Council conclusions of <DATE ISO="19931213">13 December 1993</DATE> on self-sufficiency in blood in the European Community; Council Resolution of <DATE ISO="19950602">2 June 1995</DATE> on blood safety and self-sufficiency in the Community.</P></NOTE></TXT></NP.ECR><NP.ECR IDENTIFIER="NP0139"><NO.P>139.</NO.P><TXT>Having regard to the foregoing, I consider that national self-sufficiency in blood and in blood products constitutes a legitimate objective in the light of Article 36 TFEU.</TXT></NP.ECR><NP.ECR IDENTIFIER="NP0140"><NO.P>140.</NO.P><TXT>A second ambiguity concerns the material scope of the concept of ‘self-sufficiency’, which may be interpreted in two appreciably different ways. According to a first, more moderate, approach, the objective of national self-sufficiency consists in promoting the capacity of the population of a Member State to satisfy its needs, whether by means of its own resources or by means of imports.</TXT></NP.ECR><?PAGE NO="21"?><NP.ECR IDENTIFIER="NP0141"><NO.P>141.</NO.P><TXT>According to a second, more radical, approach, that objective means that the needs of the population of a Member State are satisfied solely by means of its own resources, to the exclusion of any imports. This second approach to national self-sufficiency thus promotes an objective of autarky, namely satisfaction, in a closed circuit, of national demand by national supply.<NOTE TYPE="FOOTNOTE" NUMBERING="ARAB" NUMBERING.CONTINUED="YES" NOTE.ID="E0056"><P>The Republic of Slovenia adopted this second approach when defining the concept of self-sufficiency provided for in Article 3(18) of the Law on the supply of blood.</P></NOTE></TXT></NP.ECR><NP.ECR IDENTIFIER="NP0142"><NO.P>142.</NO.P><TXT>I would emphasise that, in a recent working document of the Commission’s services,<NOTE TYPE="FOOTNOTE" NUMBERING="ARAB" NUMBERING.CONTINUED="YES" NOTE.ID="E0057"><P>Commission Staff working document of <DATE ISO="20160421">21 April 2016</DATE> on the implementation of the principle of voluntary and unpaid donation for human blood and blood components as foreseen in Directive 2002/98/EC on setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC [SWD(2016) 130 final].</P></NOTE> these two approaches were designated respectively by the expressions <QUOT.START CODE="2018" REF.END="QE0058" ID="QS0058"/>national sufficiency<QUOT.END REF.START="QS0058" CODE="2019" ID="QE0058"/><NOTE TYPE="FOOTNOTE" NUMBERING="ARAB" NUMBERING.CONTINUED="YES" NOTE.ID="E0058"><P>Ibid., p. 4: <QUOT.START CODE="2018" REF.END="QE0059" ID="QS0059"/>National sufficiency means fulfilling the needs of blood, blood components and plasma derivatives for medical application of the resident population by accessing resources from within the country and through regional/international co-operation<QUOT.END REF.START="QS0059" CODE="2019" ID="QE0059"/>. See also the answer to the written question E-146/95, submitted by José Valverde Lopez (PPE) to the Commission on <DATE ISO="19950208">8 February 1995</DATE>, on difficulties with interpretation of the concept of blood self-sufficiency (<REF.DOC.OJ COLL="C" NO.OJ="152" PAGE.FIRST="34" DATE.PUB="1995">OJ 1995 C 152, p. 34</REF.DOC.OJ>): <QUOT.START CODE="2018" REF.END="QE0060" ID="QS0060"/>The concept of Community self-sufficiency implies that patients should always have access to the medicinal products they need<QUOT.END REF.START="QS0060" CODE="2019" ID="QE0060"/>.</P></NOTE> and <QUOT.START CODE="2018" REF.END="QE0061" ID="QS0061"/>national self-sufficiency<QUOT.END REF.START="QS0061" CODE="2019" ID="QE0061"/><NOTE TYPE="FOOTNOTE" NUMBERING="ARAB" NUMBERING.CONTINUED="YES" NOTE.ID="E0059"><P>Ibid.: <QUOT.START CODE="2018" REF.END="QE0062" ID="QS0062"/>National self-sufficiency means fulfilling the needs of human blood, blood components and plasma derivatives for medical application of the resident population by accessing resources from within the country’s population<QUOT.END REF.START="QS0062" CODE="2019" ID="QE0062"/>. See also Communication COM(93) 198 final, p. 7: ‘Self-sufficiency — Provision of human blood and blood products from within a population to satisfy the clinical needs of that population’.</P></NOTE> and, in the interest of clarity, I shall use those terms.</TXT></NP.ECR><NP.ECR IDENTIFIER="NP0143"><NO.P>143.</NO.P><TXT>It should be strongly emphasised that the objective of national self-sufficiency, based on the idea of autarky, represents the simple negation of the freedoms of movement and the internal market. Since exceptions to the free movement of goods must be interpreted strictly,<NOTE TYPE="FOOTNOTE" NUMBERING="ARAB" NUMBERING.CONTINUED="YES" NOTE.ID="E0060"><P>See 110 of this Opinion.</P></NOTE> it does not seem to me to be possible to describe that objective as <QUOT.START CODE="2018" REF.END="QE0063" ID="QS0063"/>legitimate<QUOT.END REF.START="QS0063" CODE="2019" ID="QE0063"/> in the light of Article 36 TFEU.</TXT></NP.ECR><NP.ECR IDENTIFIER="NP0144"><NO.P>144.</NO.P><TXT>Admittedly, I cannot rule out the possibility that the second sentence of Article 4(2) of Directive 2002/98 allows Member States to pursue such an objective by prohibiting imports of blood. However, that provision refers to blood and blood products <HT TYPE="ITALIC">to the exclusion</HT> of medicinal products manufactured industrially on the basis of plasma, such as those at issue in the main proceedings.<NOTE TYPE="FOOTNOTE" NUMBERING="ARAB" NUMBERING.CONTINUED="YES" NOTE.ID="E0061"><P>See points 157 to 159 of this Opinion.</P></NOTE></TXT></NP.ECR><NP.ECR IDENTIFIER="NP0145"><NO.P>145.</NO.P><TXT>I recall, moreover, that such medicinal products come under Directive 2001/83 and, accordingly, under the rules of free movement based on mutual recognition of marketing authorisations as provided for in Articles 28 to 39 of that directive.<NOTE TYPE="FOOTNOTE" NUMBERING="ARAB" NUMBERING.CONTINUED="YES" NOTE.ID="E0062"><P>See point 160 of this Opinion.</P></NOTE> The fact that those medicinal products are included in those rules on free movement shows that the EU legislature did not intend to allow Member States to pursue an objective of autarky with respect to those products.</TXT></NP.ECR><NP.ECR IDENTIFIER="NP0146"><NO.P>146.</NO.P><TXT>To my mind, therefore, it must be precluded that the objective of national self-sufficiency, based on the idea of autarky, may constitute a legitimate objective in the case of medicinal products manufactured industrially on the basis of plasma, such as those at issue in the main proceedings.</TXT></NP.ECR><NP.ECR IDENTIFIER="NP0147"><NO.P>147.</NO.P><TXT>On the other hand, I consider that the objective of national sufficiency, conceived as the promotion of the capacity of the population of a Member State to satisfy its needs, whether by means of its own resources or by means of imports, represents such a legitimate objective, for the reasons set out in points 135 to 138 of this Opinion.</TXT></NP.ECR><?PAGE NO="22"?><NP.ECR IDENTIFIER="NP0148"><NO.P>148.</NO.P><TXT>In addition, that approach seems to me to be consistent with the ultimate objective of the blood policy conducted by the EU and the Member States, which is to ensure the availability of blood products. The fact of authorising imports of blood products makes it possible to counteract, to a certain degree, the risks affecting the collection of blood in the national territory. In other words, the availability of blood and blood products seems to me to be better ensured where there are two supply channels, the national offer and imports from other Member States.<NOTE TYPE="FOOTNOTE" NUMBERING="ARAB" NUMBERING.CONTINUED="YES" NOTE.ID="E0063"><P>On the positive effect of trade between Member States on safety of supply in blood and blood products, see, in particular, Resolution of the Parliament of <DATE ISO="19930914">14 September 1993</DATE> on self-sufficiency in and safety of blood and its derivatives in the European Community, points B and 3(i); Resolution of the Parliament of <DATE ISO="19950714">14 July 1995</DATE> on blood safety in the European Union, point 1; and Resolution of the Parliament of <DATE ISO="19960417">17 April 1996</DATE> on the communication from the Commission on blood safety and self-sufficiency in the European Community, point 1.</P></NOTE></TXT></NP.ECR><NP.ECR IDENTIFIER="NP0149"><NO.P>149.</NO.P><TXT>It nonetheless remains to be ascertained whether that objective of national sufficiency, conceived as promoting the ability of the population of a Member State to satisfy its needs, whether by means of its own resources or by means of imports, may justify the priority supply principle and the national origin requirement.</TXT></NP.ECR><NP.ECR IDENTIFIER="NP0150"><NO.P>150.</NO.P><TXT>To my mind, those measures are not appropriate for the pursuit of that objective.</TXT></NP.ECR><NP.ECR IDENTIFIER="NP0151"><NO.P>151.</NO.P><TXT>The priority supply principle and the national origin requirement have the effect of restricting imports of medicinal products manufactured on the basis of plasma collected in another Member State. By limiting the potential of that first channel of the supply of blood products, those measures reduce the ability of the national population to satisfy its needs.</TXT></NP.ECR><NP.ECR IDENTIFIER="NP0152"><NO.P>152.</NO.P><TXT>Furthermore, the priority supply principle and the national origin requirement do not have a positive impact on the second channel of supply of blood products, namely the national offer. I have already set out the reasons why those measures, which seek to steer national demand towards products manufactured on the basis of national plasma, are not in my view capable of promoting the collection of blood in the national territory.<NOTE TYPE="FOOTNOTE" NUMBERING="ARAB" NUMBERING.CONTINUED="YES" NOTE.ID="E0064"><P>See points 122 to 127 of this Opinion.</P></NOTE></TXT></NP.ECR><NP.ECR IDENTIFIER="NP0153"><NO.P>153.</NO.P><TXT>Consequently, I consider that the priority supply principle and the national origin requirement cannot be justified by the objective of national self-sufficiency in blood products.</TXT></NP.ECR><NP.ECR IDENTIFIER="NP0154"><NO.P>154.</NO.P><TXT>Having regard to the foregoing, I consider that the infringements of Article 2 and Article 23(2) and (8) of Directive 2004/18 and of Article 34 TFEU, which result from those measures, are not justified in the light of the objective of protection of the health and life of humans referred to in Article 36 TFEU.</TXT></NP.ECR></GR.SEQ><GR.SEQ LEVEL="3"><TITLE><TI><NP><NO.P>3.</NO.P><TXT>The irrelevance of Article 4(2) of Directive 2002/98 and Article 83 of Directive 2001/83</TXT></NP></TI></TITLE><NP.ECR IDENTIFIER="NP0155"><NO.P>155.</NO.P><TXT>The question for a preliminary ruling expressly mentions Article 4(2) of Directive 2002/98 and Article 83 of Directive 2001/83. Both of those provisions permit the Member States to introduce more stringent requirements or measures than those laid down in those directives.</TXT></NP.ECR><NP.ECR IDENTIFIER="NP0156"><NO.P>156.</NO.P><TXT>In the interest of completeness, I wish to set out briefly the reasons why those provisions are not relevant in the circumstances of the main proceedings.</TXT></NP.ECR><NP.ECR IDENTIFIER="NP0157"><NO.P>157.</NO.P><TXT>As regards Directive 2002/98, it follows from Article 2(1) thereof that the distribution of medicinal products manufactured industrially on the basis of plasma, such as those at issue in the main proceedings, does not fall within the scope of that directive.</TXT></NP.ECR><?PAGE NO="23"?><NP.ECR IDENTIFIER="NP0158"><NO.P>158.</NO.P><TXT>As the Court explained in the judgment in <HT TYPE="ITALIC">Octapharma France</HT>,<NOTE TYPE="FOOTNOTE" NUMBERING="ARAB" NUMBERING.CONTINUED="YES" NOTE.ID="E0065"><P>Judgment of <REF.DOC.ECR><DATE ISO="20140313">13 March 2014</DATE>, <NAME.CASE><HT TYPE="ITALIC">Octapharma France</HT></NAME.CASE> (<NO.CASE>C‑512/12</NO.CASE>, <NO.ECLI ECLI="ECLI:EU:C:2014:149">EU:C:2014:149</NO.ECLI>, paragraph <REF.NP.ECR REF="NP0040">40</REF.NP.ECR></REF.DOC.ECR>): <QUOT.START CODE="2018" REF.END="QE0064" ID="QS0064"/>plasma from whole blood which is prepared by a method involving an industrial process and which is intended for transfusions comes, in accordance with Article 109 of Directive 2001/83, within the scope of Directive 2002/98 with respect to its collection and testing, and within the scope of Directive 2001/83, as amended by Directive 2004/27, with respect to its processing, storage and distribution, on condition that it satisfies the definition of a medicinal product under Article 1(2) of the latter directive.<QUOT.END REF.START="QS0064" CODE="2019" ID="QE0064"/></P></NOTE> the collection and testing of plasma fall within the scope of Directive 2002/98 even where an industrial process is involved, as confirmed by Article 109 of Directive 2001/83. On the other hand, the intervention of an industrial process removes the processing, storage and distribution of plasma from the scope of Directive 2002/98.</TXT></NP.ECR><NP.ECR IDENTIFIER="NP0159"><NO.P>159.</NO.P><TXT>Consequently, Article 4(2) of Directive 2002/98 is not applicable in the circumstances of the main proceedings, as Medisanus, the Spanish Government and the Commission have claimed. I find confirmation of that interpretation in the wording of the second sentence of Article 4(2) of Directive 2002/98, which provides that a Member State may prohibit or restrict <QUOT.START CODE="2018" REF.END="QE0065" ID="QS0065"/>imports of blood and blood components<QUOT.END REF.START="QS0065" CODE="2019" ID="QE0065"/>. That provision cannot be interpreted as referring to the import of medicinal products manufactured industrially on the basis of plasma, such as those at issue in the main proceedings.</TXT></NP.ECR><NP.ECR IDENTIFIER="NP0160"><NO.P>160.</NO.P><TXT>As regards Directive 2001/83, it cannot be disputed that the medicinal products at issue in the main proceedings fall within its scope, since they constitute medicinal products based on blood components and prepared industrially. That solution follows from Article 2(1) of that directive, which defines its scope, and also from the definitions in Article 1(1) and (10) of that directive.<NOTE TYPE="FOOTNOTE" NUMBERING="ARAB" NUMBERING.CONTINUED="YES" NOTE.ID="E0066"><P>See also judgment of <REF.DOC.ECR><DATE ISO="20140313">13 March 2014</DATE>, <NAME.CASE>Octapharma <HT TYPE="ITALIC">France</HT></NAME.CASE> (<NO.CASE>C‑512/12</NO.CASE>, <NO.ECLI ECLI="ECLI:EU:C:2014:149">EU:C:2014:149</NO.ECLI>, paragraphs <REF.NP.ECR REF="NP0038">38</REF.NP.ECR> and <REF.NP.ECR REF="NP0039">39</REF.NP.ECR></REF.DOC.ECR>).</P></NOTE></TXT></NP.ECR><NP.ECR IDENTIFIER="NP0161"><NO.P>161.</NO.P><TXT>Article 83 of Directive 2001/83 comes under Title VII of that directive, which lays down certain requirements that must be met when carrying out the activities of wholesale distribution and brokerage of medicinal products. In particular, Article 77 requires Member States to ensure that wholesale distribution is subject to the requirement of an authorisation, while the conditions on which such authorisation may be granted are defined in Articles 79 and 80.</TXT></NP.ECR><NP.ECR IDENTIFIER="NP0162"><NO.P>162.</NO.P><TXT>It is in that context that Article 83 of Directive 2001/83, which allows Member States to impose more stringent requirements in respect of the wholesale distribution of certain medicinal products, including medicinal products derived from blood, must be interpreted. In fact, that article refers only to the conditions of the exercise of the activity of wholesale distribution, as defined in the provisions of Title VII of that directive, and which may be supplemented by other obligations determined by the Member States, as confirmed in recital 38 of that directive.</TXT></NP.ECR><NP.ECR IDENTIFIER="NP0163"><NO.P>163.</NO.P><TXT>The priority supply principle and the national origin requirement relate not to the conditions of the activity of wholesale distribution of medicinal products derived from blood, but to the conditions in which such medicinal products may be imported from another Member State. Consequently, Article 83 of Directive 2001/83 is not relevant in the circumstances of the main proceedings, as Medisanus, the Slovenian and Spanish Governments and the Commission have correctly maintained.</TXT></NP.ECR><NP.ECR IDENTIFIER="NP0164"><NO.P>164.</NO.P><TXT>It follows from the foregoing that neither Article 4(2) of Directive 2002/98 nor Article 83 of Directive 2001/83 is relevant in the circumstances of the main proceedings.</TXT></NP.ECR></GR.SEQ></GR.SEQ></GR.SEQ><?PAGE NO="24"?><GR.SEQ LEVEL="1"><TITLE><TI><NP><NO.P>VI –</NO.P><TXT><HT TYPE="BOLD">Conclusion</HT></TXT></NP></TI></TITLE><NP.ECR IDENTIFIER="NP0165"><NO.P>165.</NO.P><TXT>Having regard to the foregoing, I propose that the Court should answer the question for a preliminary ruling referred by the Državna revizijska komisija za revizijo postopkov oddaje javnih naročil (National Commission for the review of awards of public procurement procedures, Slovenia) as follows:</TXT><P><LIST TYPE="DASH"><ITEM><P>Articles 34 and 36 TFEU must be interpreted as meaning that they preclude national rules authorising the import of medicinal products manufactured on the basis of plasma collected in another Member State only if the medicinal products manufactured on the basis of plasma collected in the national territory are not sufficient to cover the needs of the national population, and</P></ITEM><ITEM><P>Article 2 and Article 23(2) and (8) of Directive 2004/18/EC of the European Parliament and of the Council of <DATE ISO="20040331">31 March 2004</DATE> on the coordination of procedures for the award of public work contracts, public supply contracts and public service contracts must be interpreted as meaning that they preclude a clause requiring, in accordance with those national rules, medicinal products forming the subject matter of a public supply contract procedure to be manufactured on the basis of plasma collected in the national territory.</P></ITEM></LIST></P></NP.ECR></GR.SEQ></CONTENTS.CONCLUSION></CONCLUSION>