natgillin/translations-raw huggingface dataset:
COMMISSION v GERMANY in Keck and Mithouard, whereby selling arrangements do not fall within Article 28 EC, are met.
KOMISIJA PROTI NEMČIJI v zadevi Keck in Mithouard, po katerih za pogoje prodaje ne velja člen 28 ES.
The Federal Republic of Germany contends in its defence that the contested requirements do not constitute a restriction on the free movement of goods and, in the alternative, that such a restriction is justified in order to protect public health.
Zvezna republika Nemčija v obrambo navaja, da sporni pogoji ne pomenijo omejevanja prostega pretoka blaga in, podredno, da je to omejevanje utemeljeno z varstvom javnega zdravja.
No restriction on the free movement of goods
Neobstoj omejevanja prostega pretoka blaga
On one hand, the contested requirements are applicable without distinction.
Po eni strani naj bi namreč sporni pogoji veljali brez razlikovanja.
On the other hand, they do not hinder access to the market for medicinal products from other Member States any more than access for domestic medicinal products, on the following grounds:
Po drugi strani naj ne bi bolj ovirali dostopa na trg zdravilom iz drugih držav članic kot domačim zdravilom, in to iz naslednjih razlogov:
The Federal Republic of Germany states, first, that the contested requirements do not constitute a measure having an equivalent effect to a quantitative restriction on imports and, second, that it is not for the Commission to require a Member State, under cover of Article 28 EC, to amend legislation that falls within the powers of that Member State.
Zvezna republika Nemčija navaja, prvič, da sporni pogoji niso ukrep, ki ima enak učinek kot količinska omejitev pri uvozu, in, drugič, da Komisija v skladu s členom 28 ES ne more od države članice zahtevati, naj spremeni zakonodajo, ki je v njeni pristojnosti.
— Pharmacies established in other Member States, as a rule, do not stock medicinal products covered by a marketing authorisation for Germany, so the fact that they do not sell many medicinal products in that Member State is not attributable to Paragraph 14 of the ApoG.
lekarne v drugih državah članicah naj na splo�no ne bi imele na voljo zdravil, ki imajo dovoljenje za vstop na trg v Nemčiji, tako da dejstva, da v tej državi članici prodajo malo zdravil, ne gre pripisovati členu 14 ApoG; a) Neobstoj ukrepa, ki ima enak učinek
— Foreign pharmacies could perfectly well deliver medicinal products to a hos -pital’s internal pharmacy or to an external pharmacy meeting the contested requirements.
Zvezna republika Nemčija trdi, da sta izpolnjena oba pogoja iz navedene sodbe tuje lekarne bi lahko brez vsakih težav dobavljale zdravila interni bolni�nični lekarni ali zunanji lekarni, ki izpolnjuje sporne pogoje;
(b) Article 28 EC does not affect the powers of Member States in public health matters
– b) Člen 28 ES ne more prizadeti pristojnosti držav članic na področju javnega zdravja.
— Foreign pharmacies could conclude a supply contract with a German hospital where the contested requirements are met, which presupposes that they are located in the vicinity of that hospital.
tuje lekarne bi lahko takoj, ko bi bili izpolnjeni sporni pogoji, z nem�ko bolni� -nico sklenile pogodbo o oskrbi, za kar bi morale biti v bližini te bolni�nice;
The Federal Republic of Germany notes that, according to Article 152(5) EC, European Community action in the field of public health must fully respect the responsibilities of the Member States for the organisation and delivery of health services and medical care.
Zvezna republika Nemčija opozarja, da mora Evropska skupnost v skladu s členom 152(5) ES na področju javnega zdravja v celoti spo�tovati odgovornost držav članic pri organizaciji in nudenju zdravstvenih storitev in storitev zdravstvene oskrbe.
It states that the contested requirements were laid down under a basic legislative provision, adopted in response to the difficulties experienced earlier in supplying medicinal products to hospitals.
Navaja, da sporni pogoji načeloma izhajajo iz zakonske določbe, ki je bila sprejeta kot odziv na težave, ki so se pred tem pojavljale pri oskrbi bolni�nic z zdravili.
Justification on the ground of protecting public health
Utemeljitev varstva javnega zdravja
— Article 28 EC does not require pharmacies of other Member States to be able to supply medicinal products directly to the hospitals of a Member State.
– člen 28 ES naj ne bi predpisoval, da lahko lekarne iz drugih držav članic neposredno dobavljajo zdravila bolni�nicam druge države članice.
That contention is contradicted by the fact that in many Member States medicinal products may be supplied to hospitals only by internal pharmacies and by the caselaw whereby a State monopoly in the sale of medicinal products can be compatible with Community law. 5
Ta analiza naj bi po eni strani nasprotovala dejstvu, da v �tevilnih državah članicah bolni�nice oskrbuje z zdravili interna lekarna, po drugi strani pa sodni praksi, po kateri je monopol države pri trgovanju z zdravili lahko združljiv s pravom Skupnosti. 5
5 — The Federal Republic of Germany cites Case C-438/02 Hanner [2005] ECR I-4551.
5 – Zvezna republika Nemčija navaja sodbo z dne 31. maja 2005 v zadevi Hanner (C-438/02, Recueil, str. I-4551).
The Federal Republic of Germany states that the contested requirements are designed to ensure reliable and highquality supplies by assigning to a single pharmacy responsibility for all the tasks involved in supplying medicinal products to hospitals.
Zvezna republika Nemčija navaja, da je namen spornih pogojev, da se odgovornost za vse naloge v zvezi z oskrbo bolni�nic z zdravili poveri eni sami lekarni, zagotoviti zanesljivo in kakovostno oskrbo.
It contends that to separate those tasks and have them coordinated by the hospital management would not ensure such a high level of quality.
Trdi, da če bi bile te naloge ločene in bi jih bolni�nična uprava usklajevala, to ne bi zagotavljalo tako visoke stopnje kakovosti.
It puts forward the following arguments in that regard.
V zvezi s tem navaja naslednje trditve.
Moreover, the stock of medicinal products needed to supply a hospital is different from that of a ‘normal’ pharmacy.
Poleg tega naj bi bila zaloga zdravil, potrebnih za oskrbo bolni�nice, drugačna od zaloge „običajne“ lekarne.
The Federal Republic of Germany names several medicinal products which a hospital would need but which a ‘normal’ pharmacy would not keep in stock.
Zvezna republika Nemčija navaja več zdravil, ki naj bi jih bolni�nica potrebovala in ki naj jih „običajna“ lekarna ne bi imela na zalogi.
Therefore, in the view of that Member State, linking provision of normal supplies to provision of emergency supplies ensures that the necessary medicinal products are available and that hospitals have more effective and better targeted provision of supplies of medicinal products.
Po mnenju te države članice naj bi povezovanje osnovne oskrbe in nujne oskrbe posledično zagotavljalo razpoložljivost potrebnih zdravil, pa tudi učinkovitej�o in bolj usmerjeno oskrbo bolni�nic z zdravili.
The Federal Republic of Germany states that a hospital which takes the decision to obtain its supplies of medicinal products from an external pharmacy does so mainly in order to ensure effective provision of supplies with low storage costs and low stocks of medicinal products.
Zvezna republika Nemčija navaja, da bolni�nica, ki se odloči zaupati oskrbo z zdravili zunanji lekarni, to stori načeloma zato, da zagotovi učinkovito oskrbo z nizkimi stro�ki skladi�čenja in z malo zdravili na zalogi.
That hospital will, therefore, order the medicinal products it needs for each patient in the quantities required, so there is not really any distinction between emergency supplies and normal supplies, which also require speedy and frequent delivery.
Ta bolni�nica tako naroča zdravila, ki jih potrebuje za vsakega bolnika v zahtevanih količinah, tako da v bistvu ni razlike med nujno oskrbo in osnovno oskrbo, ki prav tako zahteva hitro in pogosto dostavo.
(b) Separation of the provision of normal supplies from the selection of medicinal products
b) Ločevanje med osnovno oskrbo in izbiro zdravil
The Federal Republic of Germany states that the pharmacist responsible for supplying a hospital with the medicinal
Zvezna republika Nemčija trdi, da se lekarnar, ki je zadolžen za dobavo zdravil
Moreover, the selection of medicinal products needed in an emergency requires knowledge of the hospital’s stock and also requires a system of coordination if the hospital uses various suppliers.
Poleg tega naj bi izbira zdravil, potrebnih v nujnem primeru, zahtevala poznavanje bolni�nične zaloge in narekovala vzpostavitev usklajevanja, če bi se bolni�nica obrnila na različne dobavitelje.
(c) Separation of the provision of normal supplies from the checking of a hospital’s stocks of medicinal products
in c) Ločevanje med osnovno oskrbo nadzorom zalog zdravil v bolni�nici
Practice shows that even doctors need advice on pharmaceutical matters.
Praksa naj bi dokazala, da celo zdravniki potrebujejo nasvet s farmacevtskega področja.
Personal contact between a pharmacist and hospital teams enables the pharmacist to be a member of the treatment team and to improve the safety of medicinal products while optimising the success of the treatment provided.
Osebni stik med lekarnarjem in bolni�ničnim osebjem naj bi lekarnarju omogočal biti član zdravstvene ekipe, izbolj�ati varnost zdravil in s tem optimizirati uspeh zdravljenja.
This personal contact cannot be replaced by giving advice over the telephone in individual cases.
Tega osebnega stika ne more nadomestiti telefonsko svetovanje za vsak posamezni primer.
Moreover, the presence of the pharma -cist in person is particularly essential in emergency cases.
Poleg tega naj bi bila osebna prisotnost lekarnarja v nujnem primeru �e posebno nepogre�ljiva.
The principle of a single supplier providing supplies of medicinal products to a hospital also gives optimum synergy between the supply of medicinal products, advice to hospital staff and the checking of stocks of medicinal products.
Načelo oskrbe bolni�nic z zdravili pri enem dobavitelju naj bi zagotovilo optimalno sinergijo med dobavo zdravil, svetovanjem bolni�ničnemu osebju in nadziranjem bolni� -ničnih zalog zdravil.
This principle has proved its effectiveness, and has resolved the problems in connection with supplying medicinal products to hospitals which existed up to 1980.
To načelo naj bi se dokazalo kot učinkovitost in pomagalo najti re�itve za težave pri oskrbi bolni�nic z zdravili, ki so obstajale vse do leta 1980.
In connection with such checking, that pharmacist is also better informed by the hospital staff about any issues relating to obtaining supplies of medicinal products and to the use, selection and dosage of such products.
V okviru tega nadzora naj bi bolni�nično osebje navedenega lekarnarja tudi bolje obve�čalo o vseh težavah, povezanih z zalogami zdravil, njihovo uporabo, njihovo izbiro in doziranjem.
V — Analysis be considered in the light of the freedoms of movement provided by the Treaty. 7
V – Analiza pretoka, ki ga predpisuje Pogodba, preučiti te pogoje. 7
A — Application of Article 28 EC
A – Uporaba člena 28 ES
Second, the contested requirements may affect whether it is possible for a German hospital to purchase medicinal products from a pharmacy located in another Member State.
Sporni pogoji pa lahko neugodno vplivajo na možnost, da bi nem�ka bolni�nica kupila zdravila v lekarni s sedežem v drugi državi članici.
Moreover, even though those requirements apply to the service of selling between a pharmacy and a German hospital and impose a number of service obligations on the pharmacy, the requirements mainly determine the way in which medicinal products may be supplied to a hospital by an external pharmacy.
Poleg tega ti pogoji kljub temu, da se uporabljajo za storitve prodaje med lekarno in nem�ko bolni�nico in predvidevajo več obveznih storitev na stro�ke prve, načeloma določajo, kako naj zunanja lekarna bolni�nici dobavlja zdravila.
The contested requirements are therefore likely to affect mainly the free movement of goods. 8
Sporni pogoji lahko torej prizadenejo predvsem prosti pretok blaga. 8
First, the supplying of medicinal products to hospitals has not been the subject of legislation or even harmonisation within the Union.
Oskrba bolni�nice z zdravili namreč ni bila urejena s predpisi niti ni bila usklajena znotraj Unije.
6Those conditions should therefore
6 Zato je treba z vidika prostega
I share the Commission’s view that the contested requirements constitute a measure having an equivalent effect to a quantitative restriction on imports prohibited by Article 28 EC.
Kot Komisija tudi jaz menim, da so sporni pogoji ukrep, ki ima enak učinek kot količinska omejitev pri uvozu, ki ga člen 28 ES prepoveduje.
7 — See, to that paragraph 102.
7 – Glej v tem smislu zgoraj navedeno sodbo v zadevi Deutscher Apothekerverband (točka 102).
6 — The movement of medicinal products within the Union was facilitated by the adoption of a number of directives which harmonised the conditions for issuing a national marketing authorisation and the rules applying to wholesale distribution, classification of medicinal products, labelling and advertising.
6 – Pretok zdravil znotraj Unije je olaj�alo sprejetje več direktiv, s katerimi so bili usklajeni pogoji za izdajo nacionalnega dovoljenja za vstop na trg,in predpisi, ki se uporabljajo za grosistično distribucijo, razvr�čanje zdravil, opremljanje z nalepkami in reklamo.
The content of those directives was combined in Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ 2001 L 311, p. 67).
Vsebina teh direktiv je bila povzeta v Direktivi evropskega parlamenta in Sveta 2001/83/ES z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v humani medicini (UL L 311, str. 67).
The Community legislature also instituted a Community marketing authorisation, valid in all Member States, which is currently governed by Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ 2004 L 136, p. 1).
Zakonodajalec Skupnosti je prav tako vzpostavil dovoljenje za vstop na trg Skupnosti, veljavno v vseh državah članicah, ki ga trenutno ureja Uredba evropskega parlamenta in Sveta �t. 726/2004 z dne 31. marca 2004 o postopkih Skupnosti za pridobitev dovoljenja za promet in nadzor zdravil za humano in veterinarsko uporabo ter o ustanovitvi Evropske agencije za zdravila (UL L 136, str. 1).
Lastly, the free movement of medicinal products was also facilitated by the adoption in 1985 of directives laying down the minimum level of training for pharmacists and the range of occupational activities they may pursue.
Navsezadnje je prosti pretok zdravil leta 1985 olaj�alo tudi sprejetje direktiv, ki določajo minimalno stopnjo izobrazbe lekarnarjev in področje strokovnih dejavnosti, ki jih lahko izvajajo.
Those directives were replaced by Direct- ive 2005/36/EC of the European Parliament and of the Council of 7 September 2005 on the recognition of professional qualifications (OJ 2005 L 255, p. 22).
Te direktive je nadomestila Direktiva Evropskega parlamenta in Sveta 2005/36/ES z dne 7. septembra 2005 o priznavanju poklicnih kvalifikacij (UL L 255, str. 22).
8 — See, to that effect, Case C-36/02 Omega [2004] ECR I-9609, paragraph 26 and caselaw cited.
8 – Glej v tem smislu sodbo z dne 14. oktobra 2004 v zadevi Omega (C-36/02, Recueil, str.
First, those requirements should be regarded as selling arrangements which affect the marketing of medicinal products from other Member States more than the marketing of domestic medicinal products.
Po eni strani bi te pogoje morali preučiti kot pogoje prodaje, ki na trgovanje z zdravili iz drugih držav članic vplivajo bolj kot na trgovanje z domačimi zdravili.
Second, that view, in my opinion, does not have the effect of undermining the powers of the Federal Republic of Germany in public health matters and the provisions of Article 152 EC.
Po drugi strani pa ta preučitev po mojem mnenju ne prizadene pristojnosti Zvezne republike Nemčije na področju javnega zdravja in določb iz člena 152 ES.
I will deal with these two points in turn.
Zaporedoma bom obravnaval ti točki.
Of course, in Keck and Mithouard the Court limited the scope of that caselaw by excluding from the scope of Article 28 EC measures that relate not to the properties of the product concerned but to the selling arrangements, so long as those measures apply irrespective of the product concerned and affect in the same manner, in law and in fact, the marketing of domestic products and that of products from other Member States. 11
Seveda je v navedeni sodbi v zadevi Keck in Mithouard Sodi�če omejilo pomen te sodne prakse, ko je s področja uporabe člena 28 ES izključilo ukrepe, ki se ne nana�ajo na značilnosti zadevnega proizvoda, ampak na pogoje prodaje, in sicer pod pogojem, da ti ukrepi veljajo brez razlikovanja in da na isti način tako pravno kot dejansko vplivajo na trgovanje z domačimi proizvodi in na trgovanje s proizvodi iz drugih držav članic. 11
The existence of a measure having an equivalent effect to a quantitative restriction on imports
Obstoj ukrepa, ki ima enak učinek kot količinska omejitev pri uvozu
Like both parties in the case, I am of the view that the contested requirements should be regarded as selling arrangements within the meaning of that judgment.
Kot obe stranki v sporu tudi sam menim, da je treba preučiti sporne pogoje kot pogoje prodaje v smislu omenjene sodne prakse.
Those requirements do not concern the properties of medicinal products but the requirements that an external pharmacy must comply with under a contract for the supply of medicinal products concluded with a hospital.
Ti pogoji se namreč ne nana�ajo na značilnosti zdravil, ampak na zahteve, ki jih mora upo�tevati zunanja lekarna v okviru pogodbe o oskrbi z zdravili, ki jo je sklenila z bolni�nico.
Those requirements therefore lay down the proced- ure under which medicinal products may be sold. 12
Omenjeni pogoji torej res določajo pogoje, pod katerimi se lahko prodajajo zdravila. 12
The free movement of goods is a fundamental principle guaranteed by the Treaty, which is expressed in the prohibition, laid down in Article 28 EC, on quantitative restrictions on imports between Member States and all measures having an equivalent effect.
Prosti pretok blaga je temeljno načelo Pogodbe ES in je izraženo v prepovedi, določeni v členu 28 ES, glede količinskih omejitev pri uvozu in vseh ukrepov z enakim učinkom med državami članicami.
9 That prohibition of measures having an equivalent effect to quantitative restrictions is very broad since, according to caselaw, it applies to all legislation of the Member States that is capable of hindering, directly
9Ta prepoved ukrepov z enakim učinkom, kot so količinske omejitve, ima precej ob�irno vsebino, saj se glede na sodno prakso nana�a na vse predpise držav članic, ki bi lahko neposredno ali
10 — Case C-170/04 Rosengren and Others [2007] ECR I-4071, paragraphs 31 and 32.
10 – Sodba z dne 5. junija 2007 v zadevi Rosengren in drugi (C-170/04, Recueil, str. I-4071, točki 31 in 32).
11 — Keck and Mithouard, paragraph 16.
11 – Zgoraj navedena sodba Keck in Mithouard (točka 16).
9 — Case C-147/04 De Groot en Slot Allium and Bejo Zaden [2006] ECR I-245, paragraph 70.
9 – Sodba z dne 10. januarja 2006 v zadevi De Groot en Slot Allium in Bejo Zaden (C-147/04, Recueil, str. I-245, točka 70).
12 — See, to that effect, Case C-254/98 TK-Heimdienst [2000] ECR I-151, paragraph 24.
12 – Glej v tem smislu sodbo z dne 13. januarja 2000 v zadevi TK-Heimdienst (C-254/98, Recueil, str. I-151, točka 24).
It is also common ground that the contested requirements apply indiscriminately, since they make no distinction between pharmacies according to the Member State in which they are located.
Res je tudi, da sporni pogoji veljajo brez razlikovanja, ker ne razlikujejo med lekarnami na podlagi tega, v kateri državi članici se nahajajo.
foreign pharmacies to bear costs and overcome difficulties which are not encountered by operators that are already located in the vicinity of that hospital.
v njeni bližini odprejo drugo lekarno. Tak�ni ukrepi tem tujim lekarnam torej nalagajo stro�ke in težave, s katerimi se ne spopadajo dobavitelji, ki so že blizu bolni�nice.
It can therefore be deduced from this that the effect of the contested requirements is to hinder more seriously the marketing of medicinal products from other Member States.
Iz tega lahko sklepamo, da sporni pogoji torej bolj ovirajo prodajo zdravil iz drugih držav članic.
However, those requirements hinder the marketing of medicinal products from other Member States more than the marketing of domestic medicinal products, for the following reasons.
Vendar ti pogoji bolj ovirajo trgovanje z zdravili iz drugih držav članic kot z domačimi zdravili in to iz naslednjih razlogov.
The Federal Republic of Germany raises a number of arguments against this position, which to my mind do not alter it.
Zvezna republika Nemčija v nasprotju s to analizo navaja več trditev, ki je po mojem mnenju ne morejo ovreči.
As the Commission has shown, and as the Federal Republic of Germany has expressly acknowledged, the requirement that an external pharmacy should undertake, using its own resources, all aspects of supplying medicinal products can be met only by operators who are located in the vicinity of the hospital being supplied.
Kot je dokazala Komisija in kot je tudi Zvezna republika Nemčija izrecno priznala, obveznosti, ki jo ima zunanji lekarnar, da s svojimi sredstvi skrbi za vse sestavine oskrbe z zdravili, lahko izpolnijo samo dobavitelji, ki so blizu bolni�nice, ki jo oskrbujejo.
That Member State thus contends, first, that a foreign pharmacy can conclude a contract for the supply of medicinal products with a German hospital if it meets the contested requirements and, second, that the sale of medicinal products from other Member States is not affected to a greater extent than the sale of medicinal products from other parts of Germany that are distant from the hospital being supplied.
Ta država članica namreč trdi, da tuja lekarna z nem�ko bolni�nico lahko sklene pogodbo o oskrbi z zdravili, če izpolnjuje sporne pogoje, in da naj prodaja zdravil iz drugih držav članic ne bi bila bolj prizadeta kot prodaja zdravil iz nem�kih regij, ki so oddaljene od oskrbovane bolni�nice.
The contested requirements therefore oblige a pharmacist operating a pharmacy in another Member State who seeks to conclude a contract for the supply of medicinal products with a German hospital to relocate his dispensary and set it up in the vicinity of that hospital or to open another pharmacy in the area. Such measures, therefore, require
Sporni pogoji lekarnarje, ki poslujejo v lekarni v drugi državi članici in bi želeli skleniti pogodbo o oskrbi z zdravili z nem�ko bolni�nico, posledično silijo v to, da preselijo svojo lekarno v bližino bolni�nice ali da
These arguments do not affect the existence of the barrier resulting from the contested requirements. In TK-Heimdienst,
Te trditve ne zanikajo obstoja ovir, ki jih pomenijo sporni pogoji.
The Federal Republic of Germany also disputes the existence of a barrier to the marketing of medicinal products from other Member States, on the ground that the pharmacies of those States, as a rule, do not stock medicinal products covered by a marketing authorisation for Germany.
Zvezna republika Nemčija prav tako zanika, da bi bilo ovirano trgovanje z zdravili iz drugih držav članic, ker naj lekarne v teh državah na splo�no ne bi imele na voljo zdravil, ki imajo dovoljenje za vstop na trg v Nemčiji.
the Court was faced with similar arguments concerning legislation of a Member State which created the same geographical partitioning as those requirements.
navedena sodba TK-Heimdienst, Sodi�če naletelo na isto trditev v zvezi z zakonodajo države članice, ki je povzročala isto geografsko zaprtost kot omenjeni pogoji.