natgillin/translations-raw huggingface dataset:
In the last two cases the hospital must enter into a contract with the pharmacy concerned, which must agree to carry out all aspects of the supply of medicinal products, that is to say, to make supplies on a regular basis and in emergencies, to give advice to hospital staff on a regular basis and in emergencies, to be involved in selecting medicinal products and to check stocks of medicinal products supplied to the hospital.
V zadnjih dveh primerih mora bolni�nica skleniti pogodbo z zadevno lekarno, ki se mora zavezati, da izvr�i vse sestavine oskrbe z zdravili, torej da redno in v nujnih primerih zagotavlja dostavo, redno in v nujnih primerih svetuje bolni�ničnemu osebju, sodeluje pri izbiri zdravil ter nadzoruje zaloge zdravil bolni�nice, ki jo oskrbuje.
1 — Original language: French.
I-6097, točka 16.
I shall then state that, in the light of the explanations provided by the Federal Republic of Germany, that restriction appears to me to be justified in order to protect public health, so that the present action for failure to fulfil obligations should be dismissed as unfounded.
Nato bom na podlagi razlag Zvezne republike Nemčije navedel, da se mi ta omejitev z vidika varstva javnega zdravja zdi utemeljena, tako da je treba to tožbo zavrniti kot neutemeljeno.
Under that paragraph, hospitals have the choice of obtaining their supplies of medicinal products either from an internal pharmacy, that is to say, a pharmacy operating within the hospital and normally not accessible to the public, or from the pharmacy at another hospital, or from an external pharmacy.
V skladu s tem členom lahko bolni�nice oskrbo z zdravili zaupajo interni lekarni, torej lekarni, ki posluje v prostorih bolni�nice in na splo�no ni dostopna javnosti, ali lekarni druge bolni�nice ali zunanji lekarni.
Where a hospital takes the decision to obtain supplies from the pharmacy at another hospital or from an external pharmacy it must conclude a contract with that pharmacy which is subject to the contested requirements set out in Paragraph 14(4) to (6) of the ApoG.
Če se bolni�nica odloči zaupati oskrbo lekarni druge bolni�nice ali zunanji lekarni, mora s to lekarno skleniti pogodbo, za katero veljajo sporni pogoji iz člena 14(4), (5) in (6) ApoG.
Those provisions, in the version in force since 21 June 2005, read as follows:
Te določbe v različici, ki je v veljavi od 21. junija 2005, urejajo:
Under Paragraph 43(1) of the German Arzneimittelgesetz (Law on Medicinal Products), in Germany medicinal products may be sold only by pharmacies, including sales to hospitals and doctors, and purchasing direct from manufacturers or wholesalers is in principle prohibited.
V skladu s členom 43(1) nem�kega zakona o zdravilih (Arzneimittelgesetz) je prodaja zdravil, vključno s prodajo bolni�nicam in zdravnikom, rezervirana za lekarne, medtem ko je neposreden nakup pri proizvajalcih ali trgovcih na debelo načeloma prepovedan.
The provisions on the supply of medicinal products to hospitals are contained in Paragraph 14 of the German Apothekengesetz (Law on Pharmacies). 3
Določbe v zvezi z oskrbo bolni�nic z zdravili so navedene v členu 14 nem�kega zakona o lekarnah (Apothekengesetz). 3
‘(4) If the body responsible for a hospital intends to obtain supplies for the hospital from the holder of a licence to operate a pharmacy under Paragraph 1(2), or under the laws of another Member State of the European Union or of another State Party to the Agreement on the European Economic Area, it must conclude a contract in writing with that licence-holder.
„(4) Vodstvo bolni�nice, ki želi, da to oskrbuje imetnik dovoljenja za vodenje lekarne v smislu člena 1(2) ali zakonodaje druge države članice Evropske unije ali države pogodbenice Sporazuma o Evropskem gospodarskem prostoru, mora skleniti pisno pogodbo z imetnikom tega dovoljenja.
The place of performance of the contractual supplies shall be the address of the hospital.
Kraj izvr�evanja pogodbenih storitev oskrbe je sedež bolni�nice.
The applicable law shall be German law.
Pravo, ki se uporablja, je nem�ko pravo.
3 — The ‘ApoG’.
3 – V nadaljevanju: ApoG.
(5) In order to be valid, a contract concluded under subparagraph 3 or 4 must be approved by the competent authority.
(5) Da je pogodba, sklenjena na podlagi odstavka 3 ali odstavka 4, veljavna, jo mora odobriti pristojni organ.
Approval shall be given where it is established that the hospital has concluded a contract with a pharmacy under subparagraph 3 or 4, for the supply of medicinal products to the hospital, which satisfies the following requirements:
Odobrena bo, če je dokazano, da pogodba v zvezi z oskrbo bolni�nice z zdravili, ki jo bolni�nica sklene z zadevno lekarno na podlagi odstavka 3 ali odstavka 4, izpolnjuje naslednje pogoje:
the manager of the pharmacy within the meaning of subparagraph 3 or 4, or the pharmacist of the supplying pharmacy authorised by him, personally advises the hospital staff in accordance with what is needed and, in an emergency, without delay; proper provision of supplies of medicinal products is be ensured; in particular, the pharmacy must possess the premises, equipment and staff required under the Apothekenbetriebsordnung [Regulation on the Operation of Pharmacies] or, in the case of pharmacies established in another Member State of the European Union or in another State Party to the Agreement on the European Economic Area, under the provisions in force in that State;
upravitelj lekarne, ki zagotavlja oskrbo v smislu odstavka 3 ali odstavka 4, ali lekarnar, ki ga ta imenuje, bo v nujnih primerih osebju bolni�nice nemudoma ustrezno osebno svetoval; zagotovljena je dobra oskrba z zdravili; dokazano je, da ima lekarna prostore, opremo in osebje, ki jih predpisuje uredba o lekarnah, in če gre za lekarne, ki imajo sedež v drugi državi članici Evropske unije ali v državi pogodbenici Sporazuma o Evropskem gospodarskem prostoru, predpisi, ki veljajo v zadevni državi;
the supplying pharmacy ensures that it provides hospital staff with advice on a continuous basis with a view to effective and economic pharmacotherapy;
lekarna, ki zagotavlja oskrbo, jamči, da bo nenehno svetovala osebju bolni�nice, da bo zdravljenje z zdravili učinkovito in gospodarno;
the pharmacy supplies the hospital with the medicinal products it has ordered directly or, where they are to be sent, in accordance with the requirements laid down in Paragraph 11a;
lekarna bolni�nico oskrbuje z zdravili, ki jih ta naroča neposredno ali pri po�iljanju v skladu z zahtevami iz člena 11a;
the pharmacy makes available to the hospital without delay and in accordance the manager of the supplying pharmacy within the meaning of subparagraph 3 or 4, or the pharmacist authorised by him, is a member of the hospital’s medicinal products committee.
lekarna da nemudoma in na primeren način bolni�nici na voljo zdravila, ki upravitelj lekarne, ki zagotavlja oskrbo v smislu odstavka 3 ali odstavka 4, ali lekarnar, ki ga ta imenuje, je član bolni� -nične komisije za zdravila.
The Commission had challenged the conformity of that principle with Community law in a letter of formal notice dated 11 July 2003 and in a reasoned opinion dated 19 December 2003.
Komisija je prerekala skladnost tega načela s pravom Skupnosti v pisnem opominu z dne 11. julija 2003, nato pa v obrazloženem mnenju z dne 19. decembra istega leta.
Authorisation from the competent authority shall also be required for a hospital pharmacy to supply another hospital for which the same body is responsible. The provisions of the second sentence shall apply mutatis mutandis with regard to the grant of such authorisation.
(6) Upravitelj bolni�nične lekarne v smislu odstavka 1 ali lekarne v smislu odstavka 4 ali lekarnar, ki ga ta imenuje, mora nadzirati zaloge zdravil v bolni�nici, ki jih je treba oskrbovati v skladu z uredbo o poslovanju lekarn, in zlasti skrbeti za neoporečno kakovost zdravil in za njihovo ustrezno shranjevanje. […]“
On 4 November 2004 the German Government approved a draft law amending Paragraph 14 of the ApoG in order to enable hospitals also to conclude different supply contracts for medicinal products with a number of pharmacies.
Nem�ka vlada je 4. novembra 2004 sprejela osnutek zakona o spremembi člena 14 ApoG, ki omogoča bolni�nicam sklepati tudi različne pogodbe o oskrbi z zdravili z več lekarnami.
Until it was amended in June 2005, the ApoG contained rules that were known as ‘the regional principle’, whereby an external pharmacy wishing to conclude a contract to supply medicinal products to a hospital had to be established in the same town or district as that hospital.
Do spremembe junija 2005 je ApoG vseboval pravila, poznana pod imenom „regionalno načelo“, po katerih je morala biti zunanja lekarna, ki je želela z bolni�nico skleniti pogodbo o oskrbi z zdravili, v istem mestu ali v istem okrožju kot bolni�nica.
However, the Bundesrat (Upper Chamber of the Federal Parliament) declined to approve that draft law on the ground that the supply system for medicinal products at regional level had proved successful as regards quality and safety and that the system had not been shown to be incompatible with Community law.
Vendar je Bundesrat (zgornji dom zveznega parlamenta) zavrnil sprejetje tega osnutka zakona zato, ker se je sistem oskrbe z zdravili na regionalni ravni izkazal kot kakovosten in varen in ker ni bila dokazana nezdružljivost tega sistema s pravom Skupnosti.
In addition, a majority of the Länder opposed the possibility of a hospital concluding separate contracts with different suppliers.
Poleg tega je večina zveznih dežel nasprotovala temu, da bi bolni�nica imela možnost sklepanja ločenih pogodb z različnimi dobavitelji.
That is why Paragraph 14 of the ApoG was amended with effect from 21 June 2005 to read as above.
Zaradi tega je bil člen 14 ApoG od 21. junija 2005 spremenjen z zgoraj navedeno vsebino.
III — Procedure before the Court of Justice and forms of order sought
III – Predlogi strank in postopek pred Sodiščem
On 18 October 2005 the Commission sent a further letter of formal notice to the Federal Republic of Germany, in which it stated that the contested requirements imposed on suppliers under the new version of Paragraph 14 of the ApoG were equivalent to maintaining the regional principle in a disguised form.
Komisija je 18. oktobra 2005 Zvezni republiki Nemčiji poslala dodaten opomin, v katerem je navedla, da so sporni pogoji, ki veljajo za dobavitelja v skladu s to novo različico člena 14 ApoG, isto kot ohranitev regionalnega načela v prikriti obliki.
The Federal Republic of Germany lodged its defence on 21 May 2007.
Zvezna republika Nemčija je odgovor na tožbo predložila 21. maja 2007. Komisija je 10. julija 2007 vložila repliko, Zvezna republika Nemčija pa 15. avgusta 2007 dupliko. Stranki nista zaprosili za obravnavo.
By letter of 14 December 2005 the Federal Republic of Germany argued that the contested requirements, designed to assign to a single supplier all the aspects of supplying medicinal products to a hospital, were authorised selling arrangements and, in the alternative, that they were justified in order to protect public health, in accordance with Article 30 EC.
Ta država članica je z dopisom z dne 14. decembra 2005 navedla, da sporni pogoji, ki vse sestavine oskrbe bolni�nice z zdravili poverijo le enemu dobavitelju, pomenijo dovoljene pogoje prodaje in so podredno utemeljeni z varstvom javnega zdravja v skladu s členom 30 ES.
The Commission sent the Federal Republic of Germany a reasoned opinion dated 10 April 2006, in which it maintained its criticisms and rebutted that Member State’s arguments.
Komisija je Zvezni republiki Nemčiji 10. aprila 2006 poslala obrazloženo mnenje, v katerem je vztrajala pri svoji kritiki in zavrnila trditve te države članice.
The Federal Republic of Germany replied to the Commission by letter of 2 June 2006, stating that its position was unchanged.
Navedena država članica je z dopisom z dne 2. junija 2006 Komisiji odgovorila, da vztraja pri svojem stali�ču.
The Federal Republic of Germany contends that the Court should dismiss the application and order the Commission to pay the costs.
Zvezna republika Nemčija predlaga, naj se tožba zavrne in naj se Komisiji naloži plačilo stro�kov.
The Commission states that, as Community law now stands, the sale of medicinal products is subject to harmonisation only in limited areas.
Komisija poudarja, da je glede na sedanje stanje prava Skupnosti prodaja zdravil predmet usklajevanja le na omejenih področ - jih.
Although Member States may therefore legislate in the other areas, they must none the less comply with the rules of the Treaty, in particular those relating to the free movement of goods, irrespective of the provisions of Article 152 EC.
Če države članice lahko tako sestavljajo zakone na drugih področjih, morajo vseeno spo�tovati predpise Pogodbe, zlasti tiste v zvezi s prostim pretokom blaga, ne glede na določbe člena 152 ES.
IV — Arguments of the parties
IV – Trditve strank
The fact noted by the Federal Republic of Germany that in some other Member States only an internal pharmacy may supply medicinal products to a hospital does not reduce the scope of that requirement once the Federal Republic has made provision for an external pharmacy to provide such supplies.
Zvezna republika Nemčija poudarja, da dejstvo, da je v drugih državah članicah oskrba bolni�nic z zdravili rezervirana za interno lekarno, naj ne bi zmanj�alo obsega te obveznosti takrat, ko je ta država članica predvidela možnost take oskrbe pri zunanji lekarni.
A measure having an equivalent effect to a quantitative restriction on imports
Ukrep, ki ima enak učinek kot količinska omejitev pri uvozu
The Commission contends that the contested requirements fall within the scope of Article 28 EC, that they constitute a measure having an equivalent effect to a quantitative restriction on imports, and that that restriction is not justified.
Komisija navaja, da sporni pogoji iz člena 14(5) in (6) ApoG pomenijo pogoje prodaje v smislu zgoraj navedene sodne prakse v zadevi
The Commission states that the contested requirements laid down in Paragraph 14(5) and (6) of the ApoG are selling
Komisija trdi, da sporni pogoji sodijo v področje uporabe člena 28 ES, da predstav -ljajo ukrep, ki ima enak učinek kot količinska omejitev pri uvozu, in da ta omejitev ni utemeljena.
The contested requirements imposed by the ApoG therefore constitute a measure having an equivalent effect to a quantitative restriction on imports.
Sporni pogoji, ki jih predpisuje ApoG, naj bi torej pomenili ukrep, ki ima enak učinek kot količinska omejitev pri uvozu.
This view is not altered by the fact that those requirements also penalise pharmacies located in Germany a long distance from the hospital to be supplied or by the fact that a local supplier can buy the necessary medicinal products from a foreign wholesaler.
Ta analiza naj ne bi bila sporna zaradi dejstva, da ti pogoji bremenijo tudi lekarne v Nemčiji, ki so zelo oddaljene od bolni�nice, ki jo oskrbujejo, in tudi ne zaradi dejstva, da lokalni dobavitelj lahko kupuje potrebna zdravila pri tujem trgovcu na debelo.
The Commission also rejects as irrelevant the Federal Republic of Germany’s argument that pharmacies established in other Member States do not, as a rule, have sufficient stocks of medicinal products authorised in Germany.
Komisija prav tako kot neumestno zavrača trditev Zvezne republike Nemčije, po kateri naj lekarne s sedežem v drugih državah članicah na splo�no ne bi imele zadostnih zalog zdravil, ki so dovoljena v Nemčiji.
Thus the Commission argues that several of the contested requirements imposed on external pharmacies, such as speedy delivery of medicinal products in accordance with what is needed, the task of advising hospital staff in an emergency, membership of the hospital’s medicines committee and checking the hospital’s stocks of medicinal products, require such pharmacies to be located in the close geographical vicinity of the hospital being supplied.
Tako Komisija trdi, da več spornih pogojev za zunanje lekarne, kot so hitra in prilagojena dostava zdravil ter naloga svetovanja osebju bolni�nice v nujnih primerih ter sodelovanje v bolni�nični komisiji za zdravila in nadziranje zalog zdravil v bolni�nici, zahteva, da so lekarne geografsko blizu ustanovi, ki jo oskrbujejo.
No justification
Neobstoj utemeljitve
Requiring a single supplier to fulfil all these requirements therefore has the effect of excluding pharmacies from other Member States from access to the market for supplying medicinal products to German hospitals, and hence of preventing medicinal products from those other Member States from having access to that market.
Dejstvo, da se enemu samemu dobavitelju predpi�e, da mora izpolnjevati vse te pogoje, naj bi torej posledično izključilo lekarne iz drugih držav članic iz dostopa do trga oskrbe nem�kih bolni�nic z zdravili in zdravilom iz drugih držav članic posledično prepovedalo dostop na ta trg.
The Commission states that the burden of proof in justifying a restriction on a ground referred to in Article 30 EC or on the ground of an overriding reason of public interest falls on the Member State which is claiming that justification.
Komisija navaja, da mora dokazno breme o utemeljitvi omejitve zaradi razloga iz člena 30 ES ali nujnega razloga v splo�nem interesu zagotoviti država članica, ki se sklicuje na to utemeljitev.
It notes first of all that it convinced the Federal Republic of Germany of the need to abolish the regional principle applying up until June 2005 and that, in the draft law forwarded to it by that Member State in November 2004, the principle of concentrating all the aspects of a contract for supplying medicinal products to a hospital in a single supplier had been abandoned.
Uvodoma opominja, da je Zvezno republiko Nemčijo obvestila o nujnosti ukinitve regionalnega načela, ki je bilo v veljavi pred junijem 2005, in da je bilo v osnutku zakona, ki ga je ta država članica sporočila novembra 2004, načelo koncentracije vseh elementov pogodbe o oskrbi bolni�nice z zdravili enega samega dobavitelja opu�čeno.
As regards, second, the need for a comprehensive supply contract for medicinal products, the Commission states that the Federal Republic of Germany’s argument that the complexity of supplying medicinal products to hospitals does not allow there to be more than one person responsible for the various aspects of such provision, in particu- lar the supplying of medicinal products and the checking of stocks of medicinal products, is unfounded.
Drugič, v zvezi z nujnostjo pogodbe o splo�ni oskrbi z zdravili Komisija navaja, da trditev Zvezne republike Nemčije, po kateri naj zapletenost oskrbe bolni�nic z zdravili ne bi omogočala sobivanja več odgovornih za različne sestavne dele te oskrbe, posebno ne za dobavo zdravil in nadziranje zalog zdravil, ni utemeljena.
It justifies its position as follows.
Svoje stali�če utemeljuje z naslednjimi točkami.
The Commission also states that the two grounds on which the Federal Republic of Germany maintains that the contested requirements are justified in order to protect public health are unfounded.
Komisija nato poudarja, da nobeden od obeh razlogov, zaradi katerih Zvezna republika Nemčija trdi, da so sporni pogoji utemeljeni z varstvom javnega zdravja, ni utemeljen.
To begin with, there would be no deterioration in the quality of the provision of such supplies if the provision of normal supplies were separated from the provision of emergency supplies.
Po mnenju Komisije je merilo, ki določa kakovost oskrbe v nujnih primerih, to, kako hitro se lahko dostavi naročeno zdravilo, tako da ni treba obvezno povezovati nujne oskrbe z drugimi vidiki oskrbe bolni�nic z zdravili.
As regards, first, the need for a single pharmacy to supply medicinal products to a hospital, the Commission maintains that it does not challenge that requirement.
Prvič, glede potrebe po oskrbi bolni� -nice z zdravili ene same lekarne Komisija poudarja, da ne izpodbija te zahteve.
It simply challenges the fact that only a local pharmacy can conclude a supply contract with a hospital.
Nasprotuje izključno dejstvu, da lahko ena sama lokalna lekarna sklene z bolni�nico pogodbo o oskrbi.
The Commission accepts that a hospital needs the advice of a pharmacist in selecting its medicinal products, but it does not understand why he should be the pharmacist supplying those products. The latter
Bolni�nice bi morale imeti možnost same odločiti, ali želijo zaupati osnovno oskrbo, nujno oskrbo, nadziranje zaloge zdravil in svetovanje bolni�ničnemu osebju eni sami lekarni.
should in any event check the quality of his products.
v bližini bolni�nice, večino časa prisoten v lekarni in ne v bolni�nici.
B — The Federal Republic of Germany
B – Zvezna republika Nemčija
Likewise, there would be no deterioration in the quality of the provision of supplies of medicinal products to a hospital if the supply of medicinal products were separated from the checks on stocks of medicinal products.
Zaradi ločitve dobave zdravil od nadzorovanja zalog zdravil prav tako ni nastala manj kakovostna oskrba bolni�nic z zdravili.
The Commission considers that such separation would, on the contrary, lead to optimum quality being achieved in both activities.
Nasprotno, Komisija meni, da je ta ločitev omogočila optimalno kakovost teh dveh dejavnosti.
The Federal Republic of Germany points out, first of all, that the present proceedings originate, not in a complaint from a pharmacy established in another Member State which is prevented from supplying its products in Germany, but from a company which runs several hospitals in Germany through its subsidiaries and wishes to be able to supply them all through a single pharmacy.
Zvezna republika Nemčija uvodoma poudarja, da ta postopek ni nastal zaradi pritožbe lekarne iz druge države članice, ki ne bi mogla prodajati proizvodov v Nemčiji, ampak zaradi podjetja, ki s svojimi izpostavami posluje z več bolni�nicami v Nemčiji in bi želelo vse bolni�nice oskrbovati z eno samo lekarno.
Lastly, there would be no deterioration in the quality of the provision of such supplies were hospital staff to be given advice by telephone.
Navsezadnje tudi ni bilo slab�e oskrbe z zdravili pri svetovanju bolni�ničnemu osebju po telefonu.
The Commission contends that giving advice on the spot, as point 4 of Paragraph 14(5) of the ApoG requires, is not needed in order to achieve a high level of quality.
Komisija meni, da svetovanje na kraju samem, kot zahteva člen 14(5), točka 4, ApoG, ni nujno za doseganje visoke stopnje kakovosti.
It points out in that regard that in Deutscher Apothekerverband 4the Court of Justice agreed that medicinal products could be sold to patients via the internet, thus dismissing the idea that the absence of advice given in person might endanger their safety.
V zvezi s tem navaja, da je Sodi�če v sodbi z dne 11. decembra 2003 v zadevi Deutscher Apothekerverband 4dopustilo spletno prodajo zdravil bolnikom in s tem odstopilo od mnenja, po katerem naj bi odsotnost osebnega svetovanja lahko ogrozila njihovo varnost.
This view, according to the Commission, applies a fortiori in the case of specialist hospital staff, especially since responsibility for the use of medicinal products always lies with the doctor.
Ta analiza naj bi po mnenju Komisije veljala a fortiori za specializirano bolni�nično osebje in to �e toliko bolj, saj je za uporabo zdravil vedno odgovoren zdravnik.
Moreover, a pharmacist, even one located in the vicinity of the
Poleg tega mora biti lekarnar, čeprav je
It also maintains that the purpose of the contested requirements laid down in Paragraph 14 of the ApoG is to ensure that hos -pitals are supplied with highquality medicin- al products and that the requirements should be assessed in the light of the fact that, in a large number of other Member States, provision of such supplies is restricted to an internal pharmacy.
Prav tako trdi, da je cilj spornih pogojev iz člena 14 ApoG obdržati zelo kakovostno oskrbo bolni�nic z zdravili in da je treba te pogoje upo�tevati glede na dejstvo, da je v mnogih drugih državah članicah za oskrbo odgovorna bolni�nična interna lekarna.