natgillin/translations-raw huggingface dataset:
As the Commission has pointed out, even in the Member States where the selling prices or the amounts of reimbursement of medicines are set by the public authorities, the producers of the medicines concerned take part in the negotiations which are initiated by those producers and take their price proposals as a starting point and end with the setting of the prices and the amounts of reimbursement to be applied.
Kot je navedla Komisija, tudi v državah članicah, v katerih prodajne cene ali zneske povračila za zdravila določajo javni organi, proizvajalci zadevnih zdravil sodelujejo v pogajanjih, ki se, na zahtevo proizvajalcev in ob upo�tevanju njihovega začetnega predloga cene, končajo z določitvijo cen in zneskov povračila, ki jih je treba uporabiti.
As the second and third recitals to Directive 89/105 state, the task of the authorities when setting prices of medicines is not only to control expenditure connected with public health systems and to ensure the availability of adequate supplies of medicinal products at a reasonable cost, but also to promote efficiency in the production of medicinal products and to encourage research and development into new medicinal products.
Kot je navedeno v drugi in tretji uvodni izjavi Direktive 89/105, naloga javnih organov pri določitvi cen zdravil ni le nadzorovanje izdatkov, povezanih s sistemom javnega zdravja, in zagotavljanje razpoložljivosti ustrezne preskrbe z zdravili po razumni ceni, temveč tudi pospe�evanje učinkovitosti proizvodnje zdravil ter spodbujanje raziskav in razvoja novih zdravil.
As the Advocate General indicated in points 90 to 93 of his Opinion, the level at which the selling price or the amount of reimbursement of a given medicinal product is fixed reflects the relative strength of both the public authorities of the relevant Member State and the pharmaceuticals companies at the time of the price negotiations for that product.
Kot je navedel generalni pravobranilec v točkah od 90 do 93 sklepnih predlogov, je raven, na kateri je določena prodajna cena ali znesek povračila za dano zdravilo, izraz moči, ki jo imajo med zadevnimi pogajanji o cenah javni organi zadevne države članice in farmacevtska podjetja.
On the other hand, it should be recalled that, where a medicine is protected by a patent which confers a temporary monopoly on its holder, the price competition which may exist between a producer and its distributors, or between parallel traders and national distributors, is, until the expiry of that patent, the only form of competition which can be envisaged.
Po drugi strani je treba spomniti, da kjer je zdravilo za�čiteno s patentom, ki podeljuje začasen monopol njegovemu imetniku, je cenovna konkurenca, ki lahko obstaja med proizvajalcem in njegovimi distributerji ali med vzporednimi trgovci in nacionalnimi distributerji, do poteka tega patenta edina predvidljiva oblika konkurence.
In relation to the application of Article 85 of the EEC Treaty (Article 85 of the EC Treaty, now Article 81 EC), the Court has held that an agreement between producer and distributor which might tend to restore the national divisions in trade between Member States might be such as to frustrate the objective of the Treaty to achieve the integration of national markets through the establishment of a single market.
V okviru uporabe člena 85 Pogodbe EGS (postal člen 85 Pogodbe ES, zdaj člen 81 ES) je Sodi�če razsodilo, da sporazum med proizvajalcem in distributerjem, s katerim se vzpostavijo nacionalne pregrade v trgovini med državami članicami, lahko ogroža cilje Pogodbe za dosego integracije nacionalnih trgov z vzpostavitvijo enotnega trga.
In the light of the abovementioned Treaty objective as well as that of ensuring that competition in the internal market is not distorted, there can be no escape from the prohibition laid down in Article 82 EC for the practices of an undertaking in a dominant position which are aimed at avoiding all parallel exports from a Member State to other Member States, practices which, by partitioning the national markets, neutralise the benefits of effective competition in terms of the supply and the prices that those exports would obtain for final consumers in the other Member States.
Z vidika omenjenega cilja Pogodbe in cilja, na podlagi katerega ne sme priti do izkriv -ljanja konkurence na notranjem trgu, se tej prepovedi iz člena 82 ES prav tako ne morejo izogniti prakse podjetja s prevladujočim položajem, s katerimi se sku�a izogniti vsem vzporednim izvozom iz države članice v drugo državo članico, to so prakse, ki z deljenjem nacionalnih trgov nevtralizirajo koristi učinkovite konkurence v smislu oskrbe in cen, ki bi jih ti izvozi zagotovili končnim potro�nikom v drugih državah članicah.
Although the degree of price regulation in the pharmaceuticals sector cannot therefore preclude the Community rules on competition from applying, the fact none the less remains that, when assessing, in the case of Member States with a system of price regulation, whether the refusal of a pharmaceuticals company to supply medicines to wholesalers involved in parallel exports constitutes abuse, it cannot be ignored that such State intervention is one of the factors liable to create opportunities for parallel trade.
Čeprav stopnja ureditve cen v sektorju farmacevtskih proizvodov ne more izključiti uporabe pravil Skupnosti o konkurenci, ostaja dejstvo, da pri ocenjevanju – v primeru držav članic s sistemom ureditve cen – ali zavrnitev farmacevtskega podjetja, da dobavi zdravila trgovcem na debelo, ki so vključeni v vzporedni izvoz, pomeni zlorabo, ni mogoče spregledati, da je to državno posredovanje dejavnik, ki lahko ustvari priložnosti za vzporedno trgovino.
Furthermore, in the light of the Treaty objectives to protect consumers by means of undistorted competition and the integration of national markets, the Community rules on competition are also incapable of being interpreted in such a way that, in
Dalje, pravil Skupnosti o konkurenci z vidika ciljev Pogodbe glede varstva potro�nika z neizkrivljeno konkurenco ter s povezovanjem nacionalnih trgov niti ni mogoče razlagati tako, da je za namene varstva lastnih trgovskih interesov edina možnost
2008 — JOINED CASES C-468/06 TO C-478/06 order to defend its own commercial interests, the only choice left for a pharmaceuticals company in a dominant position is not to place its medicines on the market at all in a Member State where the prices of those products are set at a relatively low level.
2008 – ZADEVE OD C-468/06 DO C-478/06 farmacevtskega podjetja s prevladujočim položajem, da svojih zdravil sploh ne da na trg v državi članici, kjer so cene teh proizvodov določene relativno nizko.
It follows that, even if the degree of regulation regarding the price of medicines cannot prevent any refusal by a pharmaceuticals company in a dominant position to meet orders sent to it by wholesalers involved in parallel exports from constituting an abuse, such a company must nevertheless be in a position to take steps that are reasonable and in proportion to the need to protect its own commercial interests.
Tako tudi če stopnja ureditve cen zdravil ne more zagotoviti, da nobena zavrnitev farmacevtskega podjetja s prevladujočim položajem, da izpolni naročila, ki so mu jih poslali trgovci na debelo, dejavni pri vzporednem izvozu, ne pomeni zlorabe, mora biti tako podjetje vseeno sposobno sprejeti ukrepe, ki so razumni in sorazmerni s potrebo po varstvu lastnih trgovskih interesov.
In that respect, and without it being necessary to examine the argument raised by GSK AEVE that it is necessary for pharmaceuticals companies to limit parallel exports in order to avoid the risk of a reduction in their investments in the research and development of medicines, it is sufficient to state that, in order to appraise whether the refusal by a pharmaceuticals company to supply wholesalers involved in parallel exports constitutes a reasonable and proportionate measure in relation to the threat that those exports represent to its legitimate commercial interests, it must be ascertained whether the orders of the wholesalers are out of the ordinary (see, to that effect, United Brands and United Brands Continentaal v Commission, paragraph 182).
V zvezi s tem, ne da bi bilo treba preučiti trditev GSK AEVE, da morajo farmacevtska podjetja omejiti vzporedni izvoz, da bi se izognila tveganju zmanj�anja njihovih naložb v raziskave in razvoj zdravil, zadostuje spomniti, da je treba zaradi presoje, ali zavrnitev dobave farmacevtskega podjetja trgovcem na debelo, ki so dejavni pri vzporednem izvozu, pomeni razumen in sorazmeren ukrep glede na grožnjo, ki jo predstavlja ta izvoz za njegove legitimne trgovske interese, ugotoviti, ali so naročila teh trgovcev na debelo neobičajna (v tem smislu glej zgoraj navedeno sodbo United Brands in United Brands Continentaal proti Komisiji, točka 182).
Thus, although a pharmaceuticals company in a dominant position, in a Member State where prices are relatively low, cannot be allowed to cease to honour the ordin- ary orders of an existing customer for the sole reason that that customer, in add -ition to supplying the market in that Member State, exports part of the quantities ordered to other Member States with higher prices, it is none the less permissible for that company to counter in a reasonable and proportionate way the threat to its own commercial interests potentially posed by the activities of an undertaking which wishes to be supplied in the first Member State with significant quantities of products that are essentially destined for parallel export.
Čeprav farmacevtskemu podjetju s prevladujočim položajem v državi članici, v kateri so cene relativno nizke, ni dovoljeno, da preneha izpolnjevati običajna naročila stalne stranke iz edinega razloga, da ta stranka poleg oskrbovanja trga navedene države članice izvaža določene naročene količine v druge države članice z vi�jimi cenami, pa je vendarle dovoljeno, da se to podjetje razumno in sorazmerno zoperstavi grožnji zoper njegove lastne interese, ki jo predstavljajo dejavnosti podjetja, ki želi biti oskrbovano v prvi državi članici z znatnimi količinami proizvodov, ki so v bistvenem namenjene vzporednemu izvozu.
In the present cases, the orders for reference show that, in the disputes which gave rise to those orders, the appellants in the main proceedings have demanded not that GSK AEVE should fulfil the orders sent to it in their entirety, but that it should deliver them quantities of medicines corresponding to the monthly average sold during the first 10 months of 2000.
V tej zadevi iz predložitvenih odločb izhaja, da v sporih, ki so podlaga zanje, tožeče stranke v postopku v glavni stvari niso zahtevale, da GSK AEVE v celoti izpolni naročila, naslovljena nanjo, temveč da jim ta družba proda količine zdravil, ki ustrezajo povprečni mesečni prodaji v prvih desetih mesecih leta 2000.
In 6 of the 11 actions in the main proceedings, the appellants asked for those quantities to be increased by a certain percentage, which was fixed by some of them at 20%.
V �estih od enajstih tožb v postopku v glavni stvari so tožeče stranke zahtevale, da se te količine povečajo za določen odstotek, ki so ga nekatere med njimi določile na 20 %.
In those circumstances, it is for the referring court to ascertain whether the abovementioned orders are ordinary in the light of both the previous business relations between the pharmaceuticals company holding a dominant position and the wholesalers concerned and the size of the orders in relation to the requirements of the market in the Member State concerned (see, to that effect, United Brands and United Brands Continentaal v Commission, paragraph 182, and Case 77/77 Benzine en Petroleum Handelsmaatschappij and Others v Commission [1978] ECR 1513, paragraphs 30 to 32).
V teh okoli�činah mora predložitveno sodi�če odločiti o običajnosti navedenih naročil glede na obstoječa trgovska razmerja med farmacevtskim podjetjem s prevladujočim položajem in zadevnimi trgovci na debelo ter glede na obseg naročil v razmerju do potreb na trgu v zadevni državi članici (v tem smislu glej zgoraj navedeno sodbo United Brands in United Brands Continentaal proti Komisiji, točka 182, ter sodbo z dne 29. junija 1978 v zadevi Benzine en Petroleum Handelsmaatschappij in drugi proti Komisiji, 77/77, Recueil, str. 1513, točke od 30 do 32).
Those considerations equally deal with the argument raised by GSK AEVE, namely the impact of State regulation on the supply of medicinal products, and more par -ticularly the argument that undertakings that engage in parallel exports are not subject to the same obligations regarding distribution and warehousing as the pharmaceuticals companies and are therefore liable to disrupt the planning of production and distribution of medicines.
Ti preudarki ustrezajo tudi trditvi, na katero se sklicuje GSK AEVE glede vpliva državne ureditve v zvezi z oskrbo z zdravili, in predvsem trditvi, da za podjetja, ki opravljajo vzporedni izvoz, ne veljajo iste obveznosti distribucije in skladi�čenja, kot veljajo za farmacevtska podjetja in lahko zato zmotijo načrtovanje proizvodnje in distribucije zdravil.
It is true that in Greece, as is apparent from paragraph 8 of this judgment, national legislation places pharmaceuticals wholesalers under an obligation to supply the needs of a defined geographical area with a range of pharmaceutical products.
V Grčiji, kot izhaja iz točke 8 te sodbe, imajo v skladu z nacionalno ureditvijo trgovci na debelo s farmacevtskimi proizvodi res obveznost, da pokrivajo z vrsto farmacevtskih proizvodov potrebe določenega geografskega področja.
It is equally true that, in cases where parallel trade would effectively lead to a shortage of medicines on a given national market, it would not be for the undertakings holding a dominant position but for the national authorities to resolve the situation, by taking
Res je tudi, da v primeru, ko bi vzporedni izvoz dejansko privedel do pomanjkanja zdravil na danem nacionalnem trgu, podjetja s prevladujočim položajem niso pristojna za ureditev položaja, temveč so za to pristojni nacionalni organi, z uporabo primernih in sorazmernih
2008 — JOINED CASES C-468/06 TO C-478/06 appropriate and proportionate steps that were consistent with national legislation as well as with the obligations flowing from Article 81 of Directive 2001/83.
2008 – ZADEVE OD C-468/06 DO C-478/06 ukrepov v skladu z nacionalno ureditvijo in obveznostjo, ki izhaja iz člena 81 Direktive 2001/83.
However, a producer of pharmaceutical products must be in a position to protect its own commercial interests if it is confronted with orders that are out of the or -dinary in terms of quantity.
Vendar mora biti proizvajalec farmacevtskih proizvodov v položaju, da lahko za�čiti lastne trgovske interese, ko se sreča z neobičajnimi količinami naročil.
Such could be the case, in a given Member State, if certain wholesalers order from that producer medicines in quantities which are out of all proportion to those previously sold by the same wholesalers to meet the needs of the market in that Member State.
Tak je lahko primer v dani državi članici, če nekateri trgovci na debelo temu proizvajalcu naročijo zdravila v količinah, ki niso sorazmerne količinam, ki so jih poprej prodajali isti trgovci na debelo za zadovoljevanje potreb na trgu v tej državi članici.
In view of the foregoing, the answer to the questions referred should be that Article 82 EC must be interpreted as meaning that an undertaking occupying a dominant pos -ition on the relevant market for medicinal products which, in order to put a stop to parallel exports carried out by certain wholesalers from one Member State to other Member States, refuses to meet ordinary orders from those wholesalers is abusing its dominant position.
Glede na vse navedeno je treba na postavljena vpra�anja odgovoriti, da je treba člen 82 ES razlagati tako, da podjetje, ki ima prevladujoč položaj na zadevnem trgu zdravil in ki – da bi preprečilo vzporedni izvoz, ki ga opravljajo nekateri trgovci na debelo iz ene države članice v druge države članice – zavrne izpolnitev naročil običajne narave teh trgovcev na debelo, zlorablja svoj prevladujoči položaj.
It is for the national court to ascertain whether the orders are ordinary in the light of both the size of those orders in relation to the requirements of the market in the first Member State and the previous business relations between that undertaking and the wholesalers concerned.
Predložitveno sodi�če mora odločiti o običajnosti teh naročil glede na obseg teh naročil v razmerju do potreb na trgu navedene države članice in glede na obstoječa trgovska razmerja med tem podjetjem in zadevnimi trgovci na debelo.
Article 82 EC must be interpreted as meaning that an undertaking occupying a dominant position on the relevant market for medicinal products which, in order to put a stop to parallel exports carried out by certain wholesalers from one Member State to other Member States, refuses to meet ordinary orders from those wholesalers, is abusing its dominant position.
Člen 82 ES je treba razlagati tako, da podjetje, ki ima prevladujoč položaj na zadevnem trgu zdravil in ki – da bi preprečilo vzporedni izvoz, ki ga opravljajo nekateri trgovci na debelo iz ene države članice v druge države članice – zavrne izpolnitev naročil običajne narave teh trgovcev na debelo, zlorablja svoj prevladujoči položaj.
It is for the national court to ascertain whether the orders are ordinary in the light of both the size of those orders in relation to the requirements of the market in the first Member State and the previous business relations between that undertaking and the wholesalers concerned.
Predložitveno sodišče mora odločiti o običajnosti teh naročil glede na obseg teh naročil v razmerju do potreb na trgu navedene države članice in glede na obstoječa trgovska razmerja med tem podjetjem in zadevnimi trgovci na debelo.
Case C-288/07
Zadeva C-288/07
Commissioners of Her Majesty’s Revenue and Customs v Isle of Wight Council and Others
Commissioners of Her Majesty’s Revenue & Customs proti Isle of Wight Council in drugim (Predlog za sprejetje predhodne odločbe, ki ga je vložilo High Court of Justice (England & Wales) (Chancery Division)) „Šesta direktiva o DDV – Člen 4(5) – Dejavnosti, ki jih opravljajo osebe javnega prava – Izkori�čanje zaprtih avtomobilskih parkiri�č – Izkrivljanje konkurence – Pomen izrazov ‚bi […] povzročila‘ in ‘znatno‘“
Tax provisions — Harmonisation of laws — Turnover taxes — Common system of value added tax — Taxable persons — Bodies governed by public law
Davčni predpisi – Usklajevanje zakonodaj – Prometni davki – Skupni sistem davka na dodano vrednost – Davčni zavezanci – Osebe javnega prava
(Council Directive 77/388, Art. 4(5), second subpara.)
(Direktiva Sveta 77/388, člen 4(5), drugi pododstavek)
SUMMARY — CASE C-288/07
POVZETEK – ZADEVA C-288/07
The second subparagraph of Article 4(5) of Sixth Directive 77/388 on the har -monisation of the laws of the Member States relating to turnover taxes is to be interpreted as meaning that the significant distortions of competition, to which the treatment as nontaxable persons of bodies governed by public law acting as public authorities would lead, must be evaluated by reference to the activity in question, as such, without such evaluation relating to any local market in particular.
Člen 4(5), drugi pododstavek, Šeste direktive 77/388 o usklajevanju zakonodaje držav članic o prometnih davkih je treba razlagati tako, da je treba znatno izkrivljanje konkurence, ki bi ga povzročila obravnava oseb javnega prava, ki delujejo kot organi oblasti, kot da niso davčni zavezanci, presoditi glede na zadevno dejavnost kot tako, ne pa glede na določen lokalni trg.
event’, unless they are negligible, to be subject to valued added tax, even when they are carried on by bodies governed by public law acting as public authorities.
v prilogi D k tej direktivi, „v vsakem primeru“ obdavčijo z davkom na dodano vrednost, razen če je obseg teh dejavnosti tako majhen, da bi bil zanemarljiv, čeprav jih opravljajo osebe javnega prava, ki delujejo kot organi oblasti.
In other words, the treatment of bodies governed by public law as nontaxable persons in respect of value added tax and those activities is, unless such activities are negligible, presumed to lead to distortions of competition.
Z drugimi besedami, domneva se, da bi obravnava oseb javnega prava, kot da niso davčni zavezanci za davek na dodano vrednost za te dejavnosti, povzročila izkrivljanje konkurence, razen če bi bil obseg teh dejavnosti tako majhen, da bi bil zanemarljiv.
It is thus clear from the third subparagraph of Article 4(5) of the Sixth Directive that the treatment of those bodies as taxable persons in respect of that tax results from the carrying-on, as such, of the activities listed in Annex D to that direct- ive, irrespective of the question whether or not a particular body governed by public law faces competition at the level of the local market on which it carries on those same activities.
Iz besedila člena 4(5), tretji pododstavek, Šeste direktive tako izhaja, da je obravnava navedenih oseb, kot da so davčni zavezanci za davek na dodano vrednost, posledica opravljanja dejavnosti, ki so navedene v prilogi D k tej direktivi, ne glede na vpra�anje, ali ima določena oseba javnega prava konkurenco na ravni lokalnega trga, na katerem opravlja te dejavnosti.
A body governed by public law may be responsible, under national law, for carrying on certain activities of an essentially economic nature under the special legal regime applicable to them where those same activities can also be carried on in parallel by private operators, with the result that the treatment of that body as a nontaxable person in respect of value added tax may give rise to certain distortions of competition.
Osebi javnega prava je namreč mogoče na podlagi nacionalnega prava naložiti, da opravlja določene dejavnosti, ki so v bistvu gospodarske dejavnosti, v okviru posebne javnopravne ureditve, s tem da lahko te dejavnosti vzporedno opravljajo tudi zasebni subjekti, tako da obravnava navedene osebe, kot da ni davčni zavezanec za davek na dodano vrednost, lahko povzroči določeno izkrivljanje konkurence.
The third subparagraph of Article 4(5) of the Sixth Directive is intended to avoid that undesirable result by providing that the activities specifically listed in Annex D to that directive are, ‘in any
Namen člena 4(5), tretji pododstavek, Šeste direktive je izogniti se tej nezaželeni posledici s tem, da se določi, da se dejavnosti, ki so natančno na�tete
Furthermore, there may exist, on the national level, other activities of an essentially economic nature, not listed in Annex D to the Sixth Directive, the list of which may vary from one Member State to another or from one economic sector to another, which are carried on in parallel both by bodies governed by public law in their capacity as public authorities and by private operators.
Poleg tega lahko na nacionalni ravni obstajajo druge dejavnosti, ki so v glavnem gospodarske, vendar niso na�tete v prilogi D k Šesti direktivi, in katerih seznam je lahko različen glede na državo članico ali glede na gospodarski sektor ter jih vzporedno opravljajo osebe javnega prava kot organi oblasti in zasebni subjekti.
It is precisely to those activities that the second subparagraph of Article 4(5) of the Sixth Directive applies, in providing
Ravno za te dejavnosti se uporablja člen 4(5), drugi pododstavek, Šeste direktive, ki določa,
ISLE OF WIGHT COUNCIL AND OTHERS that bodies governed by public law, even when they act as public authorities, are to be considered taxable persons where their treatment as nontaxable persons would lead to significant distortions of competition.
ISLE OF WIGHT COUNCIL IN DRUGI da je treba osebe javnega prava, čeprav delujejo kot organi oblasti, obravnavati, kot da so davčni zavezanci, če bi njihova obravnava, kot da niso davčni zavezanci, povzročila znatno izkrivljanje konkurence.