natgillin/translations-raw huggingface dataset:
In another case, the Court considered a refusal to supply in times of shortage, during the oil crisis of the 1970s, 62 and allowed BP to reduce its supply of crude oil to an occasional customer, the Netherlands cooperative ABG, by a higher percentage than that applied to its traditional customers in order to avoid those customers being more ser -iously prejudiced, by comparison. 63
V drugi zadevi je Sodi�če obravnavalo zavrnitev oskrbe ob pomanjkanju, med naftno krizo v sedemdesetih letih preteklega stoletja, 62 in družbi BP dovolilo, da za prilož -nostnega kupca, nizozemsko zadrugo ABG, uporabi odstotek zmanj�anja dobave surove nafte, vi�ji od odstotka, ki ga uporablja za stalne stranke, da te ne bi utrpele večje relativne �kode 63.
All the arguments put forward by GSK in the observations submitted to the Court concerning reduced income due to loss of market share in favour of the wholesalers and its effect on recouping investment in research and development (‘R & D’) relate to the protection of legitimate interests. 104.
Od trditev, ki jih je navedla GSK v pisnih stali�čih, predloženih Sodi�ču, vse, ki se nana�ajo na upad prihodkov zaradi izgube tržnih deležev v korist trgovcev na debelo in na njegov vpliv na amortizacijo naložb v razis -kave in razvoj (v nadaljevanju: R in R), zadevajo obrambo zakonitih interesov.
Thus, for example, the Commission accepts that a dominant producer can review its commercial relations when a customer changes its policy so that its main activity is the promotion of a competing brand. 64
Tako je na primer Komisija dovolila, da prevladujoči proizvajalec znova preuči poslovne odnose, kadar stranka spremeni politiko in se posveti promociji konkurenčne znamke. 64
Both GSK and some of the legal literature cite the enormous cost of investing in the R & D for the launch of a medicinal product; they add that the average time between obtaining the patent for the active 61 — United Brands, paragraph 191 et seq.62 — Case 77/77 BP v Commission [1978] ECR 1513 (‘Oil crisis’).63 — Ibid., paragraphs 32 and 33.
GSK in tudi nekateri pravni avtorji navajajo ogromne stro�ke naložb v R in R za lansiranje zdravila; dodajajo, da obdobje, ki preteče med pridobitvijo patenta za aktivni
64 — Commission Decision 87/500/EEC of 29 July 1987 relating to a proceeding under Article [82] of the [EC] Treaty (IV/32.279 — BBI/Boosey & Hawkes: Interim measures) (OJ 1987 L 286, p. 36), point 19. 65 — Van Bael, I. and Bellis, J.-F., op. cit., p. 957.
64 – Odločba Komisije 87/500/EGS z dne 29. julija 1987 v zvezi s postopkom uporabe člena 86 Pogodbe EGS (IV/32.279 – BBI/Boosey & Hawkes: začasni ukrepi, UL L 286, str. 36, točka 19). 65 – Van Bael, I./Bellis, J.-F., op. cit., str. 957.
LÉLOS KAI SIA AND OTHERS ingredient and the product becoming available for therapeutic purposes is 12 or 13 years, and consequently the period during which the marketing of the product produces returns is only 7 or 8 years.
LÉLOS KAI SIA IN DRUGI princip in njegovo razpoložljivostjo za zdrav -ljenje, povprečno traja 12 ali 13 let, tako da je čas, v katerem trženje ustvarja prihodke, omejen na sedem ali osem let.
66 experiencing how it feels to enjoy rights for a limited period only.
66 pravice uživa omejen čas.
I would even hazard a guess that there are other sectors in which something similar occurs in relation to this type of intangible property.
Upam si celo domnevati, da obstaja več sektorjev, v katerih se s to vrsto nematerialne lastnine dogaja nekaj podobnega.
GSK was free to design its own distribution system in Europe.
GSK je lahko svobodno uredila distribucijo svojih proizvodov v Evropi.
It decided on a strategy which incorporated the Greek wholesalers because it considered it more economically efficient and advantageous.
Izbrala je strategijo, ki je upo�tevala prisotnost gr�kih trgovcev na debelo, ker je z gospodarskega vidika menila, da je najkoristnej�a in najdonosnej�a.
It could have opted instead for a vertically integrated system for the distribution of its medicines, as it did in November 2000. Even
Lahko bi dala prednost vertikalno integriranemu sistemu distribu-
OPINION OF MR RUIZ-JARABO — JOINED CASES C-468/06 TO C-478/06 from business rivalry to research policy, an area which the European Union has taken on since the Single European Act incorporated Title XVIII, ‘Research and technological development’, into the EC Treaty.
SKLEPNI PREDLOGI RUIZ-JARABOJA – ZADEVA C-468/06 unija dodala med svoje naloge, ko je bil z Enotnim evropskim aktom v Pogodbo ES uveden naslov XVIII, „Raziskave in tehnolo�ki razvoj“.
Thirdly, looking at the figures provided in the literature referred to in point 107 of this Opinion, which show that the market share of the parallel importers increased from 1.8% to 6.8% between 1998 and 2003, 67one has the impression that the real battle is about winning back these profit margins which the rivals of the big pharmaceutical companies have appropriated.
Tretjič, primerjava �tevilk, ki jih navajajo pravni avtorji, navedeni v točki 107 teh sklepnih predlogov, po katerih naj bi se med letoma 1998 in 2003 tržni delež vzporednih uvoznikov povečal z 1,8 % na 6,8 %, 67daje vtis, da se prava bitka nana�a na izterjavo dobička, ki so ga ustvarili tekmeci velikih farmacevtskih družb.
The European Union offers undertakings a favourable environment in this respect by encouraging them, through the granting of a block exemption for horizontal agreements of this type, 68 to minimise R & D costs because it realises that cooperation in this area and in the exploitation of the results promotes technical and economic progress by increasing the dissemination of knowhow; it also avoids duplication of R & D work, stimulates advances through the exchange of complementary discoveries and encourages greater rationalisation of the manufacture of the products or application of the methods arising out of the R & D. 69 115.
Tako Evropska unija ponuja podjetjem naklonjeno okolje in jih spodbuja k znižanju stro�kov za R in R prek skupinskih izjem za tovrstne horizontalne sporazume, 68zave-dajoč se, da sodelovanje na tem področju in skupna uporaba rezultatov na splo�no prispevata k tehničnemu in gospodarskemu napredku, tako da izbolj�ata �irjenje znanja med strankami, preprečujeta dvojno delo v raziskavah in razvoju, spodbujata nov napredek z izmenjavo dodatnega znanja ter racionalizirata izdelavo proizvodov ali uporabo postopkov, izhajajočih iz raziskav in razvoja. 69
Against this background, I find the argument that the loss of income resulting from parallel imports of patented medicines acts as a disincentive misleading, since it is aimed only at seducing public opinion, which is sensitised to the vital importance of R & D for competitiveness, by shifting the focus 68 — Commission Regulation (EC) No 2659/2000 of 29 November 2000 on the application of Article 81(3) of the Treaty to categories of research and development agreements (OJ 2000 L 304, p. 7).
68 – Uredba Komisije (ES) �t. 2659/2000 z dne 29. novembra 2000 o uporabi člena 81(3) Pogodbe za skupine sporazumov o raziskavah in razvoju (UL L 304, str. 7).
69 — Recital 10 in the preamble to Regulation No 2659/2000.
69 – Deseta uvodna izjava Uredbe �t. 2659/2000.
LÉLOS KAI SIA AND OTHERS ates competition in distribution within Europe by smothering parallel imports from Greece.
LÉLOS KAI SIA IN DRUGI odpravlja konkurenco v distribuciji v Evropi, tako da zatira vzporedni uvoz iz Grčije.
burse medical costs.
povračilo zdravstvenih stro�kov.
It contrasts this with the healthy profits obtained by the wholesalers from the sale of the goods in countries where the price paid by health insurance is higher than it is in Greece, whilst lamenting the loss of the large amounts of money which GSK itself no longer receives.
To dokazuje s sklicevanjem na velike dohodke, ki jih imajo trgovci na debelo od prodaje teh proiz -vodov v državah, v katerih je cena, plačana za zdravstveno zavarovanje, vi�ja kot v Grčiji, in se pritožuje glede velikih zneskov, ki jih izgublja.
Net positive economic effect
Pozitivna gospodarska bilanca
So, apart from the description of the ‘horrors’ caused by parallel trade, GSK does not indicate any positive aspect resulting from its restriction of supplies of medicinal products to the wholesalers, except that its profit margins recover, which is irrelevant for the purposes of classifying the conduct as an abuse, or for the purposes of justifying it, as the Polish Government correctly points out.
Vendar GSK razen opisa „strahot“, ki jih povzroča vzporedna trgovina, ne navaja nobenega pozitivnega učinka svoje omejitve dobav zdravil trgovcem na debelo, razen izterjave svojega dobička, okoli�čine, ki je, kot pravilno trdi poljska vlada, nepomembna za označitev ravnanja za zlorabo ali njegovo upravičenje.
The Commission’s discussion paper on the application of Article 82 EC includes this in its line of approach, 70 responding to the legal writers who had lamented its absence. 71
pravnim avtorjem, ki so obžalovali, da ta učinkovitost ni bila upo�tevana. 71
I understand from the observations submitted by GSK that its arguments relating to the perverse consequences of parallel trade in prescription medicines should be classified under this heading.
Iz stali�č družbe GSK sklepam, da bi bilo treba v to rubriko uvrstiti njen zagovor v zvezi z negativnimi posledicami vzporedne trgovine z zdravili, ki se izdajajo samo na zdravni�ki recept.
GSK submits that it is not to the advantage of either patients or the social insurance bodies which reim-
Trdi, da ta vzporedna trgovina ne koristi niti bolnikom niti organom socialne varnosti, ki zagotavljajo
Even if one supports the view that undertakings in a dominant position are entitled to demonstrate the economic benefits of their abuses, GSK has not been able to point to anything capable of tipping the balance in its favour, despite the fact that matters relating to the welfare of patients and the reduction of public health costs are deserving of special attention in the main
Tudi če trdimo, da imajo podjetja s prevladujočim položajem možnost dokazati gospodarsko utemeljenost svojih zlorab, je treba ugotoviti, da GSK ni navedla nobenega elementa, ki bi lahko tehtnico prevesil v njeno korist, čeprav si merila v zvezi z dobrim počutjem bolnika in znižanjem stro�kov za javno zdravje zaslužijo posebno pozornost v sporu o glavni stvari. Tako ni treba preučiti
Consequently, there is no need to look at proportionality, which would have been the final step in the analysis, had a justification been established.
– dokaza o sorazmernosti ravnanja, kar bi bila zadnja faza analize, če bi sprejeli upravičenost ravnanja družbe GSK.
— matters relating to market regulation which constrain it to behave in this manner, given that it is unable to change such regulation, disregarding, in the present case, the setting of prices for medicinal products and the obligation to maintain stocks in order to supply patients;
elemente o ureditvi trga, ki jih ne more spremeniti in na podlagi katerih je prisiljeno tako ravnati, pri čemer se v tem primeru ni mogoče sklicevati na določitev cen zdravil in obveznost vzdrževanja zalog za oskrbo bolnikov;
Proposed answer to the second question
Predlog odgovora na drugo vpra�anje za predhodno odločanje
— evidence that its sole motivation was the protection of its legitimate business interests, which do not include, in the present case, the impact on incentives to innovate; and
– dokaz, da je bil njegov edini namen obramba njegovih zakonitih poslovnih interesov, med katerimi v tem primeru ni vpliva na spodbude za inovacije;
— the economic benefits of the conduct in question.
– koristi očitanega in gospodarske ravnanja.
In the light of the foregoing, I recommend that the Court’s reply to the second question should be that when an undertaking in a dominant position reduces the number of wholesalers’ orders which it pro -cesses to the levels necessary to meet demand in a domestic market, with the intention of preventing parallel imports to other Member States by such wholesalers, this in principle constitutes an abuse of a dominant position within the meaning of Article 82 EC.
Glede na zgornje razmisleke Sodi�ču priporočam, naj na drugo vpra�anje za predhodno odločanje odgovori tako, da zmanj�anje naročil trgovcev na debelo, ki ga opravi podjetje s prevladujočim položajem, na raven količin, ki pokrivajo povpra�evanje na nacionalnem trgu, z namenom, ustaviti vzporedni uvoz teh trgovcev na debelo v druge države članice, načeloma pomeni zlorabo prevladujočega položaja na podlagi člena 82 ES.
Once the grounds for justification have been established, the proportionality test should not be overlooked, in other words, the behaviour must be shown to be both unavoidable and appropriate.
Če bi bilo upravičenje utemeljeno, ne smemo pozabiti na analizo sorazmernosti, to je preučitev nepogre�ljivosti in ustreznosti takega ravnanja.
However, the potentially abusive undertaking can point to any matters it considers relevant in order to justify its behaviour objectively, in particular:
Vseeno lahko osumljeno podjetje navede ustrezna dejstva za objektivno utemeljitev svojega vedenja, zlasti:
In the light of the foregoing, and taking a different view from that taken by Advocate General Jacobs in Syfait and Others, I propose that the Court give the following answers to the questions referred to it by the Trimeles Efetio Athinon:
Glede na zgornje ugotovitve in z odstopanjem od zgoraj navedenih sklepnih predlogov generalnega pravobranilca Jacobsa v zadevi Syfait Sodi�ču predlagam, naj na vpra�anja za predhodno odločanje, ki jih je postavilo Trimeles Efeteio Athinon, odgovori:
However, the undertaking may produce the relevant evidence in order to justify its behaviour objectively, in particular:
Vseeno lahko podjetje predloži ustrezne dokaze za objektivno utemeljitev svojega vedenja, zlasti:
— matters relating to market regulation which constrain it to behave in this manner, given that it is not within its power to change such regulation, disregarding, in the present case, the setting of prices for medicinal products and the obligation to maintain reserves in order to supply patients;
– elemente o ureditvi trga, ki jih ne more spremeniti in na podlagi katerih je prisiljeno tako ravnati, pri čemer se v tem primeru ni mogoče sklicevati na določitev cen zdravil in obveznost vzdrževanja zalog za oskrbo bolnikov;
— proof that its only purpose was to protect its legitimate business interests, which do not include, in the present case, the impact on incentives to in -novate; and
– dokaze, da je želelo izključno braniti svoje zakonite poslovne interese, med katerimi v tem primeru ni vpliva na spodbude za inovacije;
— the economic benefits of the conduct in question.
– in gospodarske koristi očitanega ravnanja.“
JUDGMENT OF 16. 9.
SODBA Z DNE 16. 9.
2008 — JOINED CASES C-468/06 TO C-478/06
2008 – ZADEVE OD C-468/06 DO C-478/06
16 September 2008 *
SODBA SODIŠČA (veliki senat) z dne 16. septembra 2008 *
REFERENCES for a preliminary ruling under Article 234 EC from the Efetio Athinon (Greece), made by decisions of 3 March 2006 (C-468/06 to C-474/06), 17 March 2006 (C-475/06 and C-476/06) and 7 April 2006 (C-477/06 and C-478/06), received at the Court on 21 November 2006, in the proceedings
V združenih zadevah od C-468/06 do C-478/06, katere predmet so predlogi za sprejetje predhodne odločbe na podlagi člena 234 ES, ki jih je vložilo Efeteio Athinon (Grčija) z odločbami z dne 3. marca 2006 (od C-468/06 do C-474/06), 17. marca 2006 (C-475/06 in C-476/06) in 7. aprila 2006 (C-477/06 in C-478/06), ki so na Sodi�če prispele 21. novembra 2006, v postopkih
2008 — JOINED CASES C-468/06 TO C-478/06
2008 – ZADEVE OD C-468/06 DO C-478/06 erta, sodnica, K. Schiemann in J. Makarczyk, sodnika, P. Lindh, sodnica, ter J.-C. Bonichot, T. von Danwitz in A.
Advocate General: D. Ruiz-Jarabo Colomer, Registrar: L. Hewlett, Principal Administrator, having regard to the written procedure and further to the hearing on 29 January 2008, after considering the observations submitted on behalf of:
Hewlett, glavna administratorka, na podlagi pisnega postopka in obravnave z dne 29. januarja 2008, ob upo�tevanju stali�č, so jih predložili:
These references for a preliminary ruling concern the interpretation of Article 82 EC.
Predlogi za sprejetje predhodne odločbe se nana�ajo na razlago člena 82 ES.
The references were made in proceedings brought by Sot.
Predlogi so bili vloženi v sporih med Sot. Lélos kai Sia EE, Farmakemporiki AE Emporias kai Dianomis Farmakeftikon Proïonton, Konstantinos Xydias kai Sia OE, Ionas Stroumsas EPE, Pharmakapothiki Pharma-Group Messinias AE, K. P. Marinopoulos AE Emporias kai Dianomis Pharmakeftikon Proïonton in Kokkoris D. Tsánas K.
2008 — JOINED CASES C-468/06 TO C-478/06 in the main proceedings’) against GlaxoSmithKline AEVE Farmakeftikon Proionton, formerly Glaxowellcome AEVE, (‘GSK AEVE’) in respect of the latter’s refusal to meet those wholesalers’ orders for certain medicinal products.
2008 – ZADEVE OD C-468/06 DO C-478/06
Council Directive 89/105/EEC of 21 December 1988 relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of national health insurance systems (OJ 1989 L 40, p.
Direktiva Sveta 89/105/EGS z dne 21. decembra 1988 v zvezi s preglednostjo ukrepov, ki urejajo določanje cen zdravil za člove�ko uporabo in njihovo vključitev v področje nacionalnih sistemov zdravstvenega zavarovanja (UL 1989, L 40, str.
8) lays down certain requirements for Member States when applying national measures to control the prices of medicinal products for human use or to restrict the range of medicinal products covered by their national health insurance systems.
8) določa nekatere zahteve, ki jih morajo države članice spo�tovati pri uporabi nacionalnih ukrepov za nadziranje cen zdravil za člove�ko uporabo ali za omejitev vrste zdravil, ki jih zajemajo njihovi nacionalni sistemi zdravstvenega zavarovanja.
The second to fourth recitals to that directive read as follows:
Druga, tretja in četrta uvodna izjava te direktive določajo:
‘Whereas Member States have adopted measures of an economic nature on the marketing of medicinal products in order to control public health expenditure on such products; whereas such measures include direct and indirect controls on the prices of medicinal products as a consequence of the inadequacy or absence of competition in the medicinal products market and limitations on the range of products covered by national health insurance systems;
„ker so države članice sprejele ukrepe gospodarske narave glede prometa z zdravili, da bi nadzorovale javne izdatke za zdravstveno varstvo za te izdelke; ker tak�ni ukrepi vključujejo neposreden in posreden nadzor cen zdravil kot posledico neustreznosti ali odsotnosti konkurence na trgu zdravil in omejitev obsega izdelkov, ki ga vključujejo nacionalni sistemi zdravstvenega zavarovanja;
Whereas the primary objective of such measures is the promotion of public health by ensuring the availability of adequate supplies of medicinal products at a reasonable cost; whereas, however, such measures should also be intended to promote efficiency in the production of medicinal products and to encourage research and development into new medicinal products, on which the maintenance of a high level of public health within the Community ultimately depends;
LÉLOS KAI SIA IN DRUGI ker je prvotni cilj tak�nih ukrepov pospe�evanje javnega zdravja z zagotavljanjem razpoložljivosti ustrezne preskrbe z zdravili po razumni ceni; ker bi tak�ni ukrepi morali biti namenjeni pospe�evanju učinkovitosti pri proizvodnji zdravil ter spodbujanju raziskav in razvoja novih zdravil, od katerih je končno odvisno vzdrževanje visoke ravni javnega zdravja ljudi v Skupnosti; ker lahko odstopanja pri tak�nih ukrepih ovirajo ali izkrivljajo promet z zdravili v Skupnosti in tako neposredno vplivajo na delovanje skupnega trga zdravil“.
Article 81 of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ 2001 L 311, p.
Člen 81 Direktive 2001/83/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v humani medicini (UL L 311, str.
67), as amended by Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 (OJ 2004 L 136, p.
67), kot je bila spremenjena z Direktivo Evropskega parlamenta in Sveta 2004/27/ES z dne 31. marca 2004 (UL L 136, str.
34), (‘Direct- ive 2001/83’) provides:
34, v nadaljevanju: Direktiva 2001/83), določa:
‘With regard to the supply of medicinal products to pharmacists and persons authorised or entitled to supply medicinal products to the public, Member States shall not impose upon the holder of a distribution authorisation which has been granted by another Member State any obligation, in particular public service obligations, more stringent than those they impose on persons whom they have themselves authorised to engage in equivalent activities.
„V zvezi z dobavo zdravil farmacevtom in osebam, ki imajo dovoljenje za izdajo ali smejo izdajati zdravila �ir�i javnosti, države članice imetniku dovoljenja za promet z zdravili na debelo, ki mu ga je izdala druga država članica, ne nalagajo nobenih obveznosti, zlasti obveznosti javnih storitev, ki bi bile strožje od obveznosti, naloženih osebam, katerim so same izdale dovoljenje za opravljanje enakovrednih dejavnosti.
The holder of a marketing authorisation for a medicinal product and the distributors of the said medicinal product actually placed on the market in a Member State shall, within the limits of their responsibilities, ensure appropriate and continued supplies of that medicinal product to pharmacies and persons authorised to supply medicinal products so that the needs of patients in the Member State in question are covered.
Imetnik dovoljenja za promet z zdravilom in distributerji omenjenega zdravila, ki je dejansko na trgu v državi članici, v okviru svojih pristojnosti zagotovijo ustrezno in neprekinjeno dobavo tega zdravila farmacevtom in osebam, ki imajo dovoljenje za prodajo zdravil, tako da so pokrite potrebe bolnikov v zadevni državi članici.
The arrangements for implementing this Article should, moreover, be justified on grounds of public health protection and be proportionate in relation to the objective of such protection, in compliance with the Treaty rules, particularly those concerning the free movement of goods and competition.’
Načini izvajanja tega člena morajo biti utemeljeni, predvsem z varovanjem javnega zdravja, biti v sorazmerju s ciljem takega varovanja in v skladu z določbami Pogodbe [ES], zlasti z določbami glede prostega pretoka blaga in konkurence.“
Article 2 of Greek Law 703/1977 on the control of monopolies and oligopolies and the protection of free competition (FEK A’ 278) essentially corresponds to the provisions of Article 82 EC.
Člen 2 gr�kega zakona �t. 703/1977 o nadzoru monopolov in oligopolov ter varstvu svobodne konkurence (FEK A’ 278) se v bistvu ujema z določbami člena 82 ES.
Under Article 29 of Greek Law 1316/1983, holders of an authorisation to market pharmaceutical products are required to supply the market regularly with the goods which they manufacture or import.
Na podlagi člena 29 gr�kega zakona �t. 1316/1983 je obveznost vsakega imetnika dovoljenja za dajanje farmacevtskih proizvodov v promet, da redno oskrbuje trg s proizvodi, ki jih proizvaja ali uvaža.
Furthermore, Greek legislation requires persons carrying out the business of pharmaceuticals wholesaler to obtain a specific licence and to supply the needs of a defined geographical area with a range of pharmaceutical products.
Poleg tega je v gr�ki zakonodaji določeno, da je za dejavnost trgovcev na debelo s farmacevtskimi proizvodi potrebno posebno dovoljenje in da morajo slednji z vrsto farmacevtskih proizvodov pokrivati potrebe določenega geografskega območja.
The main proceedings and the reference for a preliminary ruling
Spor o glavni stvari in vprašanja za predhodno odločanje