natgillin/translations-raw huggingface dataset:
By its application the Commission of the European Communities seeks a declaration from the Court that, by providing in Paragraph 14(5) and (6) of the Law on Pharmacies (Apothekengesetz) in the version applicable from 21 June 2005 (the ‘ApoG’) that the conclusion of a contract for the supply of medicinal products is subject to cumulative conditions whose effect is to make it impossible in practice for a hospital in the Federal Republic of Germany to be supplied on a regular basis by pharmacies established in other Member States, the Federal Republic of Germany has failed to fulfil its obligations under Articles 28 EC and 30 EC.
Komisija Evropskih skupnosti s tožbo Sodi�ču predlaga, naj ugotovi, da Zvezna republika Nemčija, s tem da je v členu 14(5) in (6) zakona o lekarnah (Apothekengesetz), v različici, ki velja od 21. junija 2005 (v nadaljevanju: ApoG), za sklenitev pogodbe za oskrbo z zdravili določila kumulativne zahteve, s katerimi postane redna oskrba bolni�nic iz lekarn, ustanovljenih v drugih državah članicah, ne v Zvezni republiki Nemčiji, skoraj nemogoča, ni izpolnila obveznosti iz členov 28 ES in 30 ES.
National law
Nacionalni pravni okvir
The provisions on the supply to hospitals of medicinal products are contained in Paragraph 14(1) to (6) of the ApoG.
Pravila v zvezi z oskrbo bolni�nic z zdravili so navedena v členu 14, od (1) do (6), ApoG.
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 within the premises of the hospital concerned and in general not accessible to the public, or from the pharmacy of another hospital, or from a pharmacy situated outwith hospital premises (an ‘external pharmacy’).
V skladu s tem členom lahko bolni�nice svojo oskrbo z zdravili zaupajo notranji lekarni, torej lekarni, ki posluje v prostorih bolni�nice in na splo�no ni dostopna javnosti, ali lekarni druge bolni�nice ali lekarni, ki je zunaj bolni�nice (v nadaljevanju: zunanja lekarna).
Where a hospital decides to obtain its supplies from the pharmacy of another hospital or from an external pharmacy, it must enter into a contract with that pharmacy which is subject to the conditions laid down in Paragraph 14(4) to (6) of the ApoG (‘the contested provisions’).
Če se bolni�nica odloči zaupati svojo oskrbo lekarni druge bolni� -nice ali zunanji lekarni, mora s to lekarno skleniti pogodbo, za katero veljajo pogoji iz člena 14, od (4) do (6), ApoG (v nadaljevanju: sporne določbe).
Paragraph 14(1) to (6) of the ApoG provides:
Člen 14, od (1) do (6), ApoG določa:
‘(1) A licence to operate a hospital pharmacy must be granted on request to the body responsible for a hospital if:
„(1) Vodenje bolni�nične lekarne se odobri na zahtevo vodstva bolni�nice, če bolni� -nica dokaže:
1. it demonstrates that it has recruited a pharmacist who satisfies the conditions laid down in Paragraph 2(1), points 1 to 4, 7 and 8, and (3), in conjunction with (2) or (2a), and
1. da je zaposlila farmacevta, ki izpolnjuje pogoje iz člena 2(1), točke od 1 do 4, 7 in 8, in (3) v povezavi odstavkom 2 ali 2a, in
2. it demonstrates that it has the premises prescribed for hospital pharmacies by the Apothekenbetriebsordnung [Regulations on the Operation of Pharmacies].
2. da ima na voljo prostore za bolni�nično lekarno, predvidene v deontolo�kem kodeksu farmacevtov [(Apothekenbetriebsordnung)].
The manager of the hospital pharmacy or a pharmacist authorised by him must give information and advice to the medical staff of the hospital on the medicinal products, in particular for the purposes of effective and economical pharmacotherapy; the same applies in relation to out-patient treatment.
Vodja bolni�nične lekarne ali od njega poobla�čeni lekarnar mora obve�čati in svetovati zdravnikom v bolni�nici o zdravilih, zlasti z vidika učinkovitega in ekonomičnega zdravljenja z zdravili; to velja tudi glede ambulantnega zdravljenja.
(2) The licence must be withdrawn if it is subsequently discovered that, at the time of issue, one of the necessary conditions under the first sentence of subparagraph (1) was not satisfied.
(2) To dovoljenje je treba odvzeti, če se naknadno izve, da med postopkom njegove pridobitve eden od nujnih pogojev iz odstavka 1, prva poved, ni bil izpolnjen.
It must be revoked if one of the necessary conditions under subparagraph (1) is no longer satisfied or if the conduct of the licence holder or a person authorised by him grossly or persistently infringes the provisions of this Law, the regulation adopted on the basis of Paragraph 21 or the provisions relating to the manufacture or marketing of medicinal products.
Treba ga je preklicati, če eden od nujnih pogojev iz odstavka 1 ni več izpolnjen ali če imetnik dovoljenja oziroma njegov poobla�čenec z očitnim ali ponavljajočim ravnanjem kr�i določbe zgoraj navedenega zakona, uredbe, sprejete na podlagi člena 21, ali določbe v zvezi z izdelavo ali prometom z zdravili.
The same action must be taken, as regards the approval issued in accordance with the first and third sentences of subparagraph (5), if the conditions laid down in the second sentence of subparagraph (5) were not satisfied or are no longer satisfied.
Glede dovoljenja, izdanega skladno z odstavkom 5, prva in tretja poved, se je treba odzvati enako, če pogoji iz odstavka 5, druga poved, niso izpolnjeni ali niso več izpolnjeni.
(3) A holder of a licence to operate a hospital pharmacy, under subparagraph (1), who intends to supply medicinal products to another hospital for which he is not responsible must for that purpose conclude a contract in writing with the body responsible for that hospital.
(3) Vsak imetnik dovoljenja za vodenje bolni�nične lekarne, skladno z odstavkom 1, ki želi dobavljati zdravila bolni�nici, od katere ni odvisen, mora za to delo skleniti pisno pogodbo z vodstvom bolni�nice.
(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 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 jo 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 applicable law shall be German law.
Uporablja se nem�ko pravo.
(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
Odobrena bo, če se ugotovi, da pogodba v zvezi z oskrbo
COMMISSION v GERMANY 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:
KOMISIJA PROTI NEMČIJI bolni�nice z zdravili, ki jo bolni�nica sklene z zadevno lekarno na podlagi odstavka 3 ali odstavka 4, izpolnjuje te pogoje:
1. proper provision of supplies of medicinal products is ensured; the pharmacy must, in particular, possess the premises, equipment and staff required under the Regulations 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;
1. zagotovljena je dobra oskrba z zdravili; ugotovi se zlasti, da ima lekarna prostore, opremo in osebje, ki jih predpisuje uredba o lekarnah, če gre za lekarne, ki imajo svoj sedež v drugi državi članici Evropske unije ali v državi pogodbenici Sporazuma o Evropskem gospodarskem prostoru, pa predpisi, ki veljajo v tej državi;
2. 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;
2. lekarna bolni�nici dobavlja zdravila, ki jih ta naroča neposredno ali v primeru po�iljanja v skladu z zahtevami iz člena 11a;
3. the pharmacy makes available to the hospital, without delay and in accordance with what is needed, the medicinal products it requires particularly urgently for acute medical treatment;
3. lekarna da nemudoma in na primeren način bolni�nici na voljo zdravila, ki jih ta �e zlasti nujno potrebuje za akutno zdravljenje;
4. 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 hospital staff in accordance with what is needed and, in an emergency, without delay;
4. upravitelj lekarne, ki zagotavlja oskrbo v smislu odstavka 3 ali odstavka 4, ali od njega poobla�čen lekarnar osebju bolni�nice ustrezno svetuje in v nujnih primerih nemudoma;
5. the supplying pharmacy ensures that it provides hospital staff with advice on a continuous basis with a view to effective and economical pharmacotherapy;
5. lekarna, ki zagotavlja oskrbo, jamči, da bo nenehno svetovala osebju bolni�nice, da bo zdravljenje z zdravili učinkovito in ekonomično;
6. 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.
6. upravitelj lekarne, ki zagotavlja oskrbo v smislu odstavka 3 ali odstavka 4, ali od njega poobla�čen lekarnar je član bolni�nične komisije za zdravila.
Authorisation from the competent authority shall also be required for a hospital pharmacy to supply another hospital for which the same body is responsible.
Oskrba druge bolni�nice s strani bolni�nične lekarne, ki jo organizira isti organ, je prav tako odvisna od dovoljenja pristojnega organa.
The provisions of the second sentence shall apply mutatis mutandis with regard to the grant of such authorisation.
Določbe druge povedi se smiselno uporabljajo za dodelitev tega dovoljenja.
(6) The manager of the hospital pharmacy within the meaning of subparagraph (1) or of a pharmacy within the meaning of subparagraph (4), or a pharmacist authorised by him, must check stocks of the medicinal products at the hospital to be supplied, in accordance with the Regulation on the operation of pharmacies, and must in par -ticular in that regard ensure that the medicinal products are of faultless quality and are properly stored. …’
(6) Upravitelj bolni�nične lekarne v smislu odstavka 1 ali lekarne v smislu odstavka 4 ali od njega poobla�čen lekarnar mora nadzirati zaloge zdravil v bolni�nici, ki jo je treba oskrbovati v skladu z uredbo o lekarnah, in zlasti skrbeti za neoporečno kakovost zdravil in za njihovo ustrezno shranjevanje. […]“
The pre-litigation procedure
Predhodni postopek
Until 20 June 2005 the original version of the ApoG contained rules, known as the ‘regional principle’, which imposed the restriction that contracts for the supply of medicinal products by external pharmacies could be entered into only with those pharmacies which were established in the same town, city or district as the hospital to be supplied.
Do 20. junija 2005 je prvotna različica ApoG vsebovala pravila, poznana pod imenom „regionalno načelo“, na podlagi katerih so bile sklenjene pogodbe o oskrbi z zdravili z zunanjimi lekarnami samo z lekarnami, ki so imele sedež v istem mestu ali okrožju kot oskrbovana bolni�nica.
By letter of formal notice dated 11 July 2003, and then by reasoned opinion dated 19 December 2003, the Commission challenged the compatibility of that principle with Community law; in particular, with the provisions of the EC Treaty on the free movement of goods.
Komisija je s pisnim opominom z dne 11. julija 2003 in nato z obrazloženim mnenjem z dne 19. decembra 2003 prerekala skladnost tega načela s pravom Skupnosti, zlasti z določbami Pogodbe ES o prostem pretoku blaga.
On 4 November 2004 the German Government approved a draft law amending Paragraph 14 of the ApoG, the purpose of which was to ensure that hospitals could also enter into separate supply contracts with a number of pharmacies.
Nem�ka vlada je 4. novembra 2004 sprejela predlog zakona o spremembi člena 14 ApoG, ki bolni�nicam omogoča sklepanje tudi različnih pogodb o oskrbi z zdravili z več lekarnami.
However, the Bundesrat (Upper Chamber of the Federal Parliament) did not approve that draft law.
Vendar Bundesrat ni sprejel osnutka tega zakona.
The German Government therefore made changes to the draft law, with the result that on 21 June 2005 Paragraph 14 of the ApoG, in the form set out in paragraph 4 of this judgment, was adopted.
Zato je nem�ka vlada sprejela določene spremembe k temu osnutku zakona in člen 14 ApoG je bil 21. junija 2005 sprejet v različici, kot je navedena v točki 4 te sodbe.
On 18 October 2005, since it considered that, notwithstanding the amendments made to Paragraph 14, the Federal Republic of Germany had not yet brought to an end its failure to comply with the obligations in question, the Commission sent to that Member State an additional letter of formal notice.
Ker Zvezna republika Nemčija kljub spremembam tega člena 14 �e vedno ni odpravila očitane neizpolnitve obveznosti, je Komisija 18. oktobra 2008 poslala tej državi članici dodatni pisni opomin.
In that letter it stated that the cumulative conditions imposed on the conclusion of a contract for the supply of medicinal products, in accordance with Paragraph 14 of the ApoG, were equivalent to maintaining a disguised ‘regional principle’, which was incompatible with the provisions of the Treaty on the free movement of goods as laid down in Article 28 EC.
V njem ugotavlja, da so kumulativni pogoji iz člena 14 ApoG, ki jim je podvržena sklenitev pogodbe o oskrbi z zdravili, enaki ohranitvi „regionalnega načela“ v prikriti obliki, kar ni združljivo s Pogodbenimi določbami o prostem pretoku blaga, kot je določen v členu 28 ES.
In its reply of 14 December 2005 to that letter of formal notice, the Federal Republic of Germany questioned whether Article 28 EC applied and expressed the view that, in any event, the domestic legislation was justified in the light of Article 30 EC.
Zvezna republika Nemčija je v odgovoru na ta pisni opomin v dopisu z dne 14. decembra 2005 podvomila o primernosti uporabe člena 28 ES in menila, da je pravilnost nacionalne zakonodaje v vsakem primeru utemeljena glede na člen 30 ES.
On 10 April 2006 the Commission sent that Member State a reasoned opinion in which it adhered to the analysis set out in the letter of formal notice.
Komisija je 10. aprila 2006 na to državo naslovila obrazloženo mnenje in v njem vztrajala pri analizi iz zgoraj navedenega pisnega opomina.
On 2 June 2006 the Federal Republic of Germany informed the Commission that it also adhered to its views as regards Paragraph 14 of the ApoG.
Zvezna republika Nemčija je 2. junija 2006 obvestila Komisijo, da glede člena 14 ApoG ravno tako vztraja na svojem stali�ču.
The Commission accordingly decided to bring this action.
Zato se je Komisija odločila, da vloži to tožbo.
In support of its action, the Commission claims that the cumulative conditions laid down by the contested provisions relating to contracts for the supply of medicinal products constitute a selling arrangement within the meaning of Joined Cases C-267/91 and C-268/91 Keck and Mithouard [1993] ECR I-6097 but none the less fall within the scope of Article 28 EC, given that the effect of those conditions is that access to the market is more difficult for goods from Member States other than the Federal Republic of Germany than it is for domestic products.
Komisija v podporo svoji tožbi trdi, da kumulativni pogoji v zvezi s pogodbo o oskrbi z zdravili, določeni v spornih določbah, pomenijo način prodaje v smislu sodbe z dne 24. novembra 1993 v zadevi Keck in Mithouard (C-267/91 in C-268/91, Recueil, str. I-6097), ki vendar spadajo na področje uporabe člena 28 ES, ker bolj ovirajo dostop na trg izdelkom, ki izvirajo iz drugih držav članic, ne iz Zvezne republike Nemčije, kot nacionalnim proizvodom.
Under the contested provisions the contracting pharmacy is responsible for the provision of all of the services associated with the supply of medicinal products.
Lekarna pogodbenica bi morala biti v skladu s spornimi določbami zadolžena za vse storitve, povezane z oskrbo z zdravili.
Since some of those services, such as provision of emergency supplies, can only be provided by a pharmacist who has his dispensary in the vicinity of the hospital to be supplied, the choice of such a pharmacy is necessarily restricted to those situated near to that hospital, which amounts to the introduction of an ‘unwritten’ regional principle.
Ker nekatere od teh storitev, kot je nujna oskrba, lahko nudi samo lekarnar s prostori, ki so blizu oskrbovane bolni�nice, se naj bi izbira te lekarne nujno omejila na tiste, ki so v bližini te bolni�nice, kar naj bi uvedlo „nepisano“ regionalno načelo.
In this way, goods from other Member States have access to the market which is more restricted than that of domestic products.
Tako je bolj oviran dostop na trg proizvodom iz drugih držav članic kot nacionalnim proizvodom.
Those provisions are therefore a measure having equivalent effect to a quantitative restriction, which is prohibited by Article 28 EC.
Navedene določbe naj bi zato pomenile ukrep z enakim učinkom kot količinske omejitve, prepovedan s členom 28 ES.
Those cumulative conditions are moreover not justified on grounds of the protection of public health.
Ti kumulativni pogoji naj med drugim ne bi bili utemeljeni z razlogi varovanja javnega zdravja.
On that point, the Commission explains that it does not challenge the requirement that only one pharmacist should supply a hospital with medicinal
Komisija v tem pogledu natančneje pojasnjuje, da ne izpodbija zahteve, da
COMMISSION v GERMANY products, but solely the fact that only a local pharmacist can enter into a supply contract with a German hospital.
KOMISIJA PROTI NEMČIJI bolni�nico oskrbuje z zdravili en sam lekarnar, ampak samo dejstvo, da lahko samo lokalni lekarnar z nem�ko bolni�nico sklene pogodbo o oskrbi.
As regards the need to enter into a comprehensive supply contract, the Commission claims that to separate the provision of standard supplies from the provision of emergency supplies does not adversely affect the quality of the supply of products to the hospital concerned.
Komisija glede nujnosti sklenitve pogodbe o oskrbi navaja, da ločitev osnovne oskrbe od nujne oskrbe ne �kodi kakovosti oskrbe zadevne bolni�nice.
In addition, while it cannot be denied that a hospital needs, in order to select its medicinal products, the advice of a pharmacist who is familiar with the needs of the hospital, such advice need not necessarily be given by the pharmacist who is subsequently to provide supplies to that hospital.
Čeprav ni sporno, da bolni�nica pri izbiri zdravil potrebuje nasvete lekarnarja, ki pozna potrebe ustanove, ni nujno, da bo take nasvete dal lekarnar, ki bo nato to bolni�nico oskrbel.
Similarly, if a second pharmacist were responsible for the monitoring of stocks of medicinal products, that would not affect the quality of the supply of products.
Ravno tako dejstvo, da se pooblasti drugega lekarnarja za nadzor zalog zdravil, naj ne bi poslab�alo kakovosti oskrbe.
On the contrary, it is advisable to separate the responsibility for monitoring from the responsibility for providing supplies in order to guarantee optimal quality in both respects.
Priporočeno je ravno nasprotno, in sicer ločitev med nalogami nadzora in nalogami dobave za zagotovitev optimalne kakovosti na obeh ravneh.
Lastly, given the communication technology now available, it is not necessary for advice to given in situ in order to ensure a high level quality of supply.
Nazadnje, glede na obstoječa tehnična sredstva komuniciranja naj ne bi bilo nujno, da se s svetovanjem na mestu zagotovi visoka stopnja kakovosti oskrbe.
The Commission observes, in that context, that the Court, in Case C-322/01 Deutscher Apothekerverband [2003] ECR I-14887, paragraph 113, accepted that medicinal products might be sold to patients on the internet.
V tem pogledu Komisija poudarja, da je Sodi�če v točki 113 v sodbi z dne 11. decembra 2003 v zadevi Deutscher Apothekerverband (C-322/01, Recueil, str. I-14887) dopustilo, da se pacientom lahko prodaja zdravila prek interneta.
The Federal Republic of Germany does not accept that the contested provisions are a measure having equivalent effect to a quantitative restriction on imports.
Zvezna republika Nemčija ugovarja temu, da sporne določbe pomenijo ukrep z enakim učinkom kot količinske omejitve uvoza.
In its opinion, those provisions satisfy the conditions stated by the Court in Keck and Mithouard and therefore fall outside the scope of Article 28 EC.
Po njenem mnenju naj bi te določbe izpolnjevale pogoje, ki jih je Sodi�če, da bi se izognilo uporabi člena 28 ES, določilo v zgoraj navedeni sodbi Keck in Mithouard.
The Federal Republic of Germany contends first that, in general, medicinal products authorised in Germany are not available in a pharmacy established in another Member State.
V tem pogledu Zvezna republika Nemčija najprej navaja, da lekarna, ustanovljena v drugi državi članici, ne razpolaga z zdravili, odobrenimi v Nemčiji.
Consequently, the fact that a lesser quantity of medicinal products from other Member States is supplied to German hospitals is not due to the contested provisions.
Zato naj dejstva, da se nem�kim bolni�nicam iz drugih držav članic dostavi manj�a količina zdravil, ne bi bilo mogoče pripisati spornim določbam.
Moreover, pharmacies established in other Member States have the opportunity to supply medicinal products to a hospital’s internal pharmacy or to an external pharmacy which satisfies the conditions laid down by the contested provisions, and are not obliged to conclude a supply contract for that purpose.
Poleg tega naj bi imele lekarne, ustanovljene v teh državah, možnost dostave zdravil internim lekarnam bolni�nic ali zunanjim lekarnam, ki izpolnjujejo pogoje iz spornih določb, ne da bi bilo treba za ta namen skleniti pogodbo o oskrbi.
Article 28 EC does not require that it should be possible for medicinal products to be supplied to hospitals situated in one Member State by pharmacies established in
Člen 28 ES naj ne bi zahteval, da se bolni�nicam v državi članici lahko dostavlja zdravila iz lekarn, ki so ustanovljene v drugih
2008 — CASE C-141/07 other Member States.
2008 – ZADEVA C-141/07 državah članicah.
The Federal Republic of Germany also contends that the sale of medicinal products from other Member States is no more affected than the sale of medicinal products from regions of Germany which are remote from the hospital to be supplied.
Zvezna republika Nemčija ravno tako navaja, 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.
Furthermore, a pharmacy established outside German territory is able to enter into a supply contract with a German hospital provided that it satisfies the conditions.
Poleg tega lahko lekarna, ustanovljena zunaj nem�kega ozemlja, sklene pogodbo o oskrbi z nem�ko bolni�nico, ko izpolni omenjene pogoje.
In addition, according to the Federal Republic of Germany, the specification of arrangements for the provision of supplies to hospitals, which is a fundamental decision of the national legislature, falls exclusively within the powers of the Member States, in accordance with Article 152(5) EC.
Poleg tega po mnenju te države članice opredelitev načinov oskrbe bolni�nic, ki je temeljna zakonska določba, skladno s členom 152(5) ES spada samo v pristojnost držav članic.
The Commission’s action seeking a declaration that the contested provisions are contrary to Article 28 EC is a way of circumventing the limits on Community action in the field of public health.
S tožbo Komisije, s katero naj bi se ugotovilo, da so sporne določbe v nasprotju s členom 28 ES, naj bi se ob�lo omejitve ukrepov Skupnosti na področju javnega zdravja.