natgillin/translations-raw huggingface dataset:
Indeed, parallel imports enjoy a certain amount of protection in Community law because they encourage trade and help reinforce competition (Case C-373/90 X [1992] ECR I-131, paragraph 12).
Vzporedni uvoz namreč uživa določeno varstvo v pravu Skupnosti, saj spodbuja razvoj trgovine in krepi konkurenco (sodba z dne 16. januarja 1992 v zadevi X, C-373/90, Recueil, str. I-131, točka 12).
In its written observations, GSK AEVE contends that the factors mentioned by the referring court in its questions constitute objective considerations, on the basis of which it cannot be regarded as an abuse for a pharmaceuticals company to limit supplies of medicines to the needs of a given national market when confronted with orders from wholesalers involved in parallel exports to other Member States where the selling prices of those medicines are set at a higher level.
GSK AEVE v pisnih stali�čih trdi, da so dejavniki, ki jih omenja predložitveno sodi�če v svojih vpra�anjih za predhodno odločanje, objektivni preudarki, na podlagi katerih dejstvo, da farmacevtsko podjetje omeji dobavo zdravil v skladu s potrebami danega nacionalnega trga, ne more pomeniti zlorabe, če se to podjetje srečuje z naročili trgovcev na debelo, vključenih v vzporedni izvoz v druge države članice, kjer so prodajne cene teh zdravil vi�je.
In order to determine whether the refusal by a pharmaceuticals company to supply medicinal products to such wholesalers indeed falls within the prohibition laid down in Article 82 EC, in particular at point (b) of the second paragraph of that article, it must be examined whether, as GSK AEVE maintains, there are objective considerations based on which such a practice cannot be regarded as an abuse of the dominant position occupied by that undertaking (see, to that effect, United Brands and United Brands Continentaal v Commission, paragraph 184, and Case C-95/04 P British Airways v Commission [2007] ECR I-2331, paragraph 69).
Da bi se ugotovilo, ali zavrnitev s strani farmacevtskega podjetja, da dobavi zdravila takim trgovcem na debelo, spada v prepoved, ki jo določa člen 82 ES, zlasti njegov drugi odstavek, točka b), je treba preučiti, ali, kot navaja GSK AEVE, obstajajo objektivni preudarki, na podlagi katerih take prakse ne moremo �teti za zlorabo prevladujočega položaja, ki ga ima to podjetje (v tem smislu glej zgoraj navedeno sodbo United Brands in United Brands Continentaal proti Komisiji, točka 184, ter sodbo z dne 15. marca 2007 v zadevi British Airways proti Komisiji, C-95/04 P, ZOdl., str. I-2331, točka 69).
The abusive nature of the refusal to supply
Značilnosti zlorabe zavrnitve dobave
As a preliminary point, GSK AEVE observes, citing United Brands Continentaal v Commission, that a dominant undertaking is not under an obligation to honour orders that are out of the ordinary and that it may take reasonable steps in order to protect its legitimate commercial interests.
Sklicujoč se na zgoraj navedeno sodbo United Brands in United Brands Continentaal proti Komisiji, GSK AEVE primarno ugotavlja, da podjetje s prevladujočim položajem ni zavezano izpolnjevati naročil, ki niso običajna, in da lahko sprejme razumne ukrepe, s katerimi za�čiti svoje legitimne trgovske interese.
With regard more specifically to the pharmaceuticals sector, GSK AEVE argues, first, that the general logic behind protecting competition within a brand does not function in that sector, where the intervention of the public authorities of Member States prevents the manufacturers of medicines from developing their activities in normal competitive conditions.
Natančneje glede sektorja farmacevtskih proizvodov GSK AEVE trdi, prvič, da splo�na logika varstva konkurence znotraj znamke ne deluje v navedenem sektorju, kjer bi posredovanje javnih organov držav članic preprečilo proizvajalcem zdravil, da razvijajo svoje dejavnosti v normalnih konkurenčnih pogojih.
On the one hand, the pharmaceuticals companies do not control the prices of their products, those prices being fixed at various levels by the public authorities, which are, at the same time, the buyers of the medicines wherever there are national health systems.
Po eni strani farmacevtska podjetja ne nadzirajo cen svojih proizvodov, saj jih na različnih ravneh določajo javni organi, ki so obenem kupci zdravil, če obstaja nacionalni zdravstveni sistem.
Even where those prices are the result of negotiations between the authorities and the pharmaceuticals companies, the fact that those companies accept them does not in itself imply that the prices cover all the fixed costs connected with the
Celo kjer so te cene rezultat pogajanj med navedenimi organi in farmacevtskimi podjetji, dejstvo, da jih podjetja sprejmejo, samo po sebi ne pomeni, da cene pokrivajo vse fiksne stro�ke, povezane z razvojem farmacevtskih
LÉLOS KAI SIA AND OTHERS development of the pharmaceutical products.
LÉLOS KAI SIA IN DRUGI proizvodov.
Moreover, even if such a system of agreed prices exists, Member States are still in a position to impose cuts in those prices.
Poleg tega bi, če bi tak sistem dogovorjenih cen obstajal, lahko države članice �e vedno naložile znižanje teh cen.
On the other hand, the producers of medicines are subject to precise obligations with regard to their distribution.
Po drugi strani so proizvajalci zdravil podrejeni določenim obveznostim glede njihove distribucije.
While pharmaceuticals companies are required by law to deliver their products in all Member States where they are authorised to do so, parallel exporters are free to shift their activities from one product or market to the next if the latter product or market offers a higher profit margin, which can lead to shortages in some exporting Member States.
Medtem ko so farmacevtske družbe zakonsko zavezane, da dobavijo svoje proizvode v vse države članice, v katerih imajo za to dovoljenje, pa lahko vzporedni izvozniki prosto prena�ajo svoje dejavnosti od enega proizvoda in trga na drugega, če ponujata vi�ji dobiček, kar lahko vodi do pomanjkanja v nekaterih državah članicah izvoza.
Thus parallel trade has negative consequences for the planning of production and distribution of medicines.
Tako ima vzporedna trgovina negativne posledice za načrtovanje proizvodnje in distribucije zdravil.
Second, GSK AEVE points out that parallel trade in medicines reduces the profits that pharmaceuticals companies can invest in research and development activities on which they depend in order to remain competitive and attractive to investors.
Drugič, GSK AEVE poudarja, da vzporedna trgovina z zdravili zmanj�uje dobiček, ki bi ga farmacevtska podjetja lahko vložila v raziskovalne in razvojne dejavnosti, od katerih so odvisne, če hočejo ostati konkurenčne in privlačne za vlagatelje.
By contrast, distributors which profit from parallel trade make no contribution to pharmaceutical innovation.
Nasprotno distributerji, ki imajo dobiček od vzporedne trgovine, nikakor ne prispevajo k farmacevtskim odkritjem.
Furthermore, in the Member States where the prices of medicines are fixed at relatively low levels, the marketing of new medicines might be affected if it became impossible for pharmaceuticals companies to hold back supplies with the aim of limiting parallel trade.
Poleg tega obstaja v državah članicah, kjer so cene zdravil relativno nizke, tveganje, da bi bilo trženje novih zdravil prizadeto, če bi se farmacevtskim podjetjem onemogočilo omejevanje oskrbe, da bi se omejila vzporedna trgovina.
In such circumstances, those companies would have an interest in delaying the launch of new products in Member States where the prices are low.
V takih okoli�činah bi imela ta podjetja v državah članicah, kjer so cene nizke, interes odložiti dajanje novih proizvodov na trg.
Third, GSK AEVE contends that parallel trade provides no genuine benefit to the ultimate consumers.
Tretjič, GSK AEVE trdi, da vzporedna trgovina dejansko ne koristi končnim potro� -nikom.
Since the greater part of the price difference which makes the business profitable is taken up by intermediaries, parallel trade does not result in genuine pressure on the prices of medicines in the Member States where those prices are higher.
Ker večji del razlike v ceni, ki dela njegovo trženje dobičkonosno, poberejo posredniki, vzporedna trgovina ne povzroča resničnega pritiska na cene zdravil v državah članicah, kjer so te cene vi�je.
Equally, in the case of Member States where certain medicinal requirements are covered by public tender, parallel importers are not in a position to reduce price levels in view of their sporadic presence on the market.
Enako v državah članicah, kjer so določene potrebe po zdravilih pokrite z javnimi naročili, tudi vzporedni uvozniki, upo�tevajoč občasnost njihovega posredovanja, niso v takem položaju, da bi lahko nižali cene.
While recognising that the prohibition in Article 82 EC does not apply when the conduct of an undertaking in a dominant position is objectively justified, the Polish Government and the Commission point out that it is for that undertaking to establish that there are circumstances that are capable of justifying its practice.
Poljska vlada in Komisija pritrjujeta, da prepoved iz člena 82 ES ne velja, če je ravnanje podjetja v prevladujočem položaju objektivno utemeljeno, in poudarjata, da je to podjetje pristojno, da dokaže okoli�čine, ki lahko upravičijo njegovo prakso.
The appellants in the main proceedings, as well as the Polish Government and the Commission, consider that Article 82 EC cannot be applied differently in the pharmaceuticals sector simply because the prices in that sector are directly or indirectly fixed by the public authorities.
Tožeče stranke v postopku v glavni stvari tako kot poljska vlada in Komisija ocenjujejo, da uporaba člena 82 ES ne more biti drugačna v farmacevtskem sektorju le zato, ker v tem sektorju cene določijo, neposredno ali posredno, javni organi.
Even in the Member States where prices are low, the price of a medicinal product is the result of negotiations with the pharmaceuticals companies, which will not put their products on the market if the prices proposed are not acceptable to them.
Dejansko so cene zdravil tudi v državah članicah, kjer so cene nizke, posledica pogajanj s farmacevtskimi podjetji, ki ne tržijo svojih zdravil, če jim ponujene cene ne ustrezajo.
Furthermore, there is no causal link between the repercussions of parallel trade on the revenues of pharmaceuticals companies and those companies’ investments in research and development.
Poleg tega ni vzročne zveze med učinkom vzporedne trgovine na prihodek farmacevtskih podjetij in naložbami slednjih na področju raziskav in razvoja.
Finally, parallel trade in medicinal products brings clear advantages to patients and is likely to enable national social security systems to make savings.
Končno vzporedna trgovina zdravil vodi do jasnih prednosti za bolnike in lahko omogoči prihranke nacionalnim sistemom socialne varnosti.
The appellants in the main proceedings add that taking into account the justifications advanced by GSK AEVE would run counter to the Court’s caselaw relating to the free movement of goods, which accepts only the justifications listed in Article 30 EC.
Tožeče stranke v postopku v glavni stvari dodajajo, da upo�tevanje utemeljitev, ki jih je podala GSK AEVE, nasprotuje sodni praksi Sodi�ča na področju prostega pretoka blaga, na podlagi katere so sprejemljive le utemeljitve, navedene v členu 30 ES.
It should be recalled that in paragraph 182 of its judgment in United Brands and United Brands Continentaal v Commission the Court held that an undertaking in a dominant position for the purpose of marketing a product — which cashes in on the reputation of a brand name known to and valued by consumers — cannot stop supplying a long-standing customer who abides by regular commercial practice, if the orders placed by that customer are in no way out of the ordinary.
V zvezi s tem je treba spomniti, da je Sodi�če v točki 182 zgoraj navedene sodbe United Brands in United Brands Continentaal proti Komisiji razsodilo, da podjetje s prevladujočim položajem za trženje proizvoda – ki uživa ugled znamke, ki jo potro� -niki poznajo in cenijo – ne sme prenehati dobavljati stalni stranki, ki spo�tuje trgovsko rabo, če naročila te stranke niso neobičajna.
In paragraph 183 of the same judgment, the Court held that such conduct is inconsistent with the objectives laid down in Article 3(f) of the EEC Treaty (Article 3(g) of the EC Treaty, and now Article 3(1)(g) EC), which are set out in detail in Article 86 of the EEC Treaty (Article 86 of the EC Treaty, and now Article 82 EC), particularly in points (b) and (c) of the second paragraph of that article, since the refusal to sell would limit the
V točki 183 iste sodbe je Sodi�če menilo, da je tako ravnanje v nasprotju s cilji, navedenimi v členu 3(f) Pogodbe EGS (postal člen 3(g) Pogodbe ES, zdaj člen 3(1)(g) ES), ki so podrobno določeni v členu 86 Pogodbe EGS (postal člen 86 Pogodbe ES, zdaj člen 82 ES), predvsem drugi odstavek,
LÉLOS KAI SIA AND OTHERS markets to the prejudice of consumers and would amount to discrimination which might in the end eliminate a trading party from the relevant market.
LÉLOS KAI SIA IN DRUGI točki b) in c), le-tega, ker bi zavrnitev prodaje omejevala trge na �kodo potro�nikov in bi vodila do diskriminacije, ki bi na koncu lahko odstranila trgovca z zadevnega trga.
In paragraph 189 of the judgment in United Brands and United Brands Continentaal v Commission, the Court stated that, although the fact that an undertaking is in a dominant position cannot deprive it of its right to protect its own commercial interests if they are attacked, and that such an undertaking must be conceded the right to take such reasonable steps as it deems appropriate to protect those interests, such behaviour cannot be accepted if its purpose is specifically to strengthen that domin- ant position and abuse it.
V točki 189 zgoraj navedene sodbe United Brands in United Brands Continentaal proti Komisiji je Sodi�če navedlo, da čeprav podjetje s prevladujočim položajem ne sme biti prikraj�ano za pravico do varovanja svojih trgovskih interesov, če so ti napadeni, in da je treba dati takemu podjetju v razumni meri možnost, da naredi, kar meni, da je primerno za varovanje navedenih interesov, tako ravnanje ne more biti sprejeto, če je njegov namen prav krepitev tega prevladujočega položaja in njegova zloraba.
It must be examined in this context whether, as GSK AEVE claims, particular circumstances are present in the pharmaceuticals sector, by reason of which the refusal by an undertaking in a dominant position to supply clients in a given Member State who engage in parallel exports to other Member States where prices for medicines are higher does not, generally speaking, constitute an abuse.
V tem okviru je treba preučiti, če obstajajo, kot to trdi GSK AEVE, v sektorju farmacevtskih proizvodov posebne okoli�čine, na podlagi katerih zavrnitev podjetja s prevladujočim položajem, da dobavlja v določeni državi članici strankam, ki opravljajo vzporedni izvoz v druge države članice, kjer so cene zdravil vi�je, na splo�no ne pomeni zlorabe.
The first thing to consider is GSK AEVE’s argument that parallel trade in any event brings only few financial benefits to the ultimate consumers.
Najprej je treba preučiti trditev GSK AEVE, da vzporedna trgovina v vsakem primeru prina�a le malo finančne koristi za končne potro�nike.
In that connection, it should be noted that parallel exports of medicinal products from a Member State where the prices are low to other Member States in which the
V zvezi s tem je treba omeniti, da vzporedni izvoz zdravil iz države članice, v kateri so cene teh zdravil nizke, v države članice, v katerih so cene vi�je, načeloma kupcem
2008 — JOINED CASES C-468/06 TO C-478/06 prices are higher open up in principle an alternative source of supply to buyers of the medicinal products in those latter States, which necessarily brings some benefits to the final consumer of those products.
2008 – ZADEVE OD C-468/06 DO C-478/06 teh zdravil v slednjih državah daje na voljo alternativni vir oskrbe, kar gotovo pomeni določeno prednost za končnega potro�nika teh zdravil.
It is true, as GSK AEVE has pointed out, that, for medicines subject to parallel exports, the existence of price differences between the exporting and the importing Member States does not necessarily imply that the final consumer in the importing Member State will benefit from a price corresponding to the one prevailing in the exporting Member State, inasmuch as the wholesalers carrying out the exports will themselves make a profit from that parallel trade.
Res je, kot je navedla GSK AEVE, da za zdravila, ki so predmet vzporednega izvoza, obstoj cenovnih razlik med državami članicami izvoza in državami članicami uvoza ne pomeni nujno, da bo imel končni potro�nik v državi članici uvoza koristi od cene, ki ustreza tisti v državi članici izvoza, če bodo trgovci na debelo, ki opravljajo ta izvoz, sami pridobili koristi iz navedene vzporedne trgovine.
Nevertheless, the attraction of the other source of supply which arises from parallel trade in the importing Member State lies precisely in the fact that that trade is capable of offering the same products on the market of that Member State at lower prices than those applied on the same market by the pharmaceuticals companies.
Vendar je privlačnost drugega vira dobave, ki nastopi z vzporedno trgovino v državi članici uvoza, prav v dejstvu, da lahko ta trgovina ponuja iste proizvode na trgu te države članice po nižji ceni od tiste, ki jih uporabljajo farmacevtska podjetja na istem trgu.
As a result, even in the Member States where the prices of medicines are subject to State regulation, parallel trade is liable to exert pressure on prices and, consequently, to create financial benefits not only for the social health insurance funds, but equally for the patients concerned, for whom the proportion of the price of medicines for which they are responsible will be lower.
Kot posledica se lahko tudi v državah članicah, v katerih so cene zdravil predmet državne ureditve, z vzporedno trgovino izvaja pritisk na cene in posledično ustvarijo finančne ugodnosti ne le za sklade zdravstvenega zavarovanja, temveč tudi za zadevne bolnike, za katere bo delni znesek cene zdravila, ki ga plačajo sami, nižji.
At the same time, as the Commission notes, parallel trade in medicines from one Member State to another is likely to increase the choice available to entities in the latter Member State which obtain supplies of medicines by means of a public procurement procedure, in which the parallel importers can offer medicines at lower prices.
Obenem, kot to omenja Komisija, lahko vzporedna trgovina z zdravili iz ene države članice v drugo poveča izbiro, ki jo imajo pravne osebe v slednji državi članici, ki pridobi zaloge zdravil na podlagi postopka javnega naročila, v okviru katerega lahko vzporedni uvozniki ponujajo zdravila po nižjih cenah.
Accordingly, without it being necessary for the Court to rule on the question whether it is for an undertaking in a dominant position to assess whether its conduct vis-à-vis
Zato, ne da bi se bilo treba Sodi�ču opredeliti glede vpra�anja, ali mora podjetje s prevladujočim položajem presoditi, ali njegovo ravnanje v razmerju do trgovca
LÉLOS KAI SIA AND OTHERS a trading party constitutes abuse in the light of the degree to which that party’s activities offer advantages to the final consumers, it is clear that, in the circumstances of the main proceedings, such an undertaking cannot base its arguments on the premiss that the parallel exports which it seeks to limit are of only minimal benefit to the final consumers.
LÉLOS KAI SIA IN DRUGI pomeni zlorabo glede na stopnjo, po kateri dejavnosti slednjega ponujajo prednosti končnemu potro�niku, je treba ugotoviti, da se v okoli�činah zadeve v glavni stvari tako podjetje ne more opreti na predpostavko, da ima vzporedni izvoz, ki ga sku�a omejiti, le majhno korist za končnega potro�nika.
The impact of State price and supply regulation in the pharmaceuticals sector
Vpliv državne ureditve cen in oskrbe v sektorju farmacevtskih proizvodov
Turning, next, to the argument based on the degree of regulation of the pharmaceuticals markets in the Community, it must first be examined whether State regulation of the prices of medicinal products has an impact on the assessment of whether a refusal to supply those products constitutes abuse.
Dalje glede trditve, ki temelji na stopnji ureditve farmacevtskih trgov v Skupnosti, je treba najprej preučiti morebiten vpliv državne ureditve cen zdravstvenih proizvodov na presojo, ali zavrnitev dobave zdravil pomeni zlorabo.
It is clear that, in the majority of Member States, medicines, in particular those available only on prescription, are subject to regulation aimed at setting, at the request of the manufacturers concerned and on the basis of information provided by them, selling prices for those medicines and/or the scales of reimbursement of the cost of prescription medicines by the relevant social health insurance systems.
Treba je namreč ugotoviti, da so v večini držav članic zdravila, predvsem tista, ki morajo biti predpisana na zdravni�ki recept, predmet ureditve, ki določa, na zahtevo zadevnih proizvajalcev in na podlagi informacij, ki jih ti podajo, prodajne cene teh zdravil in/ali tarife, na podlagi katerih bo izdajo recepta za dano zdravilo kril zadevni sistem zdravstvenega zavarovanja.
The price differences between Member States for certain medicines are thus the result of the different levels at which the prices and/or the scales to be applied to those medicines are fixed.
Cenovne razlike za nekatera zdravila med državami članicami izhajajo torej iz različnih ravni, na katerih so določene cene in/ali tarife, uporabljene za ta zdravila.
The main proceedings relate to a non-harmonised area in which the Community legislature has limited itself, in adopting Directive 89/105, to placing Member States under a duty to guarantee that decisions in respect of the regulation of prices and reimbursement are taken with complete transparency, without discrimination and within certain specific time-limits.
Postopki v glavni stvari se nana�ajo na neusklajeno področje, na katerem se je zakonodajalec Skupnosti, s sprejetjem Direktive 89/105, omejil na to, da je državam članicam naložil dolžnost zagotoviti, da so odločbe glede ureditve cen in povračila sprejete popolnoma pregledno, brez diskriminacije in v določenih časovnih rokih.
In that respect, it should be noted, on one hand, that the control exercised by Member States over the selling prices or the reimbursement of medicinal products does not entirely remove the prices of those products from the law of supply and demand.
V zvezi s tem je treba spomniti, da po eni strani nadzor, ki ga izvajajo države članice nad prodajnimi cenami ali povračili zdravni�kih proizvodov, ne zavaruje popolnoma cene teh proizvodov pred zakonom ponudbe in povpra�evanja.
Thus, in some Member States, the public authorities do not intervene in the process of setting prices or limit themselves to setting the scale of reimbursement of the cost of prescription medicines by the national health insurance systems, thereby leaving to the pharmaceuticals companies the task of deciding their selling prices.
Tako v nekaterih državah članicah javni organi ne posredujejo v postopku določanja cen ali se omejijo na določitev tarif, na podlagi katerih bo izdajo recepta za zdravilo kril sistem zdravstvenega zavarovanja, in tako farmacevtskim podjetjem prepustijo skrb za določitev njihovih prodajnih cen.
Furthermore, even though the public authorities in other Member States set the selling prices of medicines as well, that does not in itself mean that the manufacturers of the medicines concerned have no influence upon the level at which the selling prices are set or the proportion of those prices which is reimbursed.
Poleg tega, čeprav javni organi v drugih državah članicah določijo tudi prodajne cene zdravil, to samo po sebi ne pomeni, da proizvajalci zadevnih zdravil nimajo vpliva na raven, na podlagi katere se določijo prodajne cene, ali na znesek njihovega povračila.