natgillin/translations-raw huggingface dataset:
On 15 March 2005, the Commission received a notification of a proposed concentration pursuant to Article 4 of Regulation (EC) No 139/2004 (Merger Regulation) by which the undertaking Johnson & Johnson (J & J, USA) acquires within the meaning of Article 3(1)(b) of that Regulation control of the whole of the undertaking Guidant Corporation (Guidant, USA) by way of purchase of shares.
Komisija je 15. marca 2005 v skladu s členom 4 Uredbe (ES) št. 139/2004 („Uredbe o združitvah“) prejela priglasitev predlagane koncentracije, s katero podjetje Johnson & Johnson, ZDA („J & J“) z nakupom delnic pridobiva, v smislu člena 3(1)(b) Uredbe o združitvah, nadzor nad celotnim podjetjem Guidant Corporation, ZDA („Guidant“).
The Parties
Stranki
J & J is a company incorporated in the USA.
J & J je podjetje s sedežem v ZDA.
In 2003, it had 111000 employees worldwide and generated a turnover of around EUR 37 billion. Its activities span over three main businesses: consumer goods (18 % of turnover), pharmaceuticals (47 %) and medical devices and diagnostics (MD & D, 36 % of turnover).
Leta 2003 je imelo po vsem svetu 111000 zaposlenih in promet v višini približno 37 milijard EUR. Svoje dejavnosti opravlja na treh glavnih poslovnih področjih: izdelki široke porabe (18 % prometa), farmacevtski izdelki (47 %) ter medicinski pripomočki in diagnostika („MPD“, 36 % prometa).
Guidant is a company incorporated in the United States of America (USA) that is active in the design and development of cardiovascular medical products.
Guidant je podjetje s sedežem v ZDA, ki je dejavno na področju načrtovanja in razvoja kardiovaskularnih medicinskih proizvodov.
In 2003, it had around 12000 employees worldwide and a turnover of around EUR 3,3 billion. Guidant’s presence covers four main areas within the fast-growing cardiovascular medical products business: cardiac rhythm management, interventional cardiology, endovascular devices and cardiac surgery.
Leta 2003 je imelo po vsem svetu 12000 zaposlenih in promet v višini približno 3,3 milijarde EUR. V hitro rastočem sektorju kardiovaskularnih medicinskih proizvodov Guidant pokriva štiri glavna področja: uravnavanje srčnega ritma, interventno kardiologijo, endovaskularne pripomočke in srčno kirurgijo.
The operation
Obravnavano dejanje
The concentration is an acquisition of sole control by J & J over Guidant, within the meaning of Article 3(1)(b) of the EC Merger Regulation.
Obravnavana koncentracija je prevzem, s katerim podjetje J & J pridobi izključni nadzor nad podjetjem Guidant, v smislu člena 3(1)(b) Uredbe o združitvah.
THE RELEVANT MARKETS
ZADEVNI TRGI
The market investigation confirmed that the areas mostly affected by the merger are the following: 1. interventional cardiology devices; 2. endovascular devices; 3. cardiac surgery devices; and 4. cardiac rhythm management devices.
Tržna preiskava je potrdila, da so področja, ki jih združitev najbolj prizadene, naslednja: 1. pripomočki za interventno kardiologijo; 2. endovaskularni pripomočki; 3. pripomočki za srčno kirurgijo; 4. pripomočki za uravnavanje srčnega ritma.
In the latter, there are no overlaps, as J & J is currently not active in the business.
V zadnjem ni nikakršnih prekrivanj, ker podjetje J & J trenutno ni dejavno v tem sektorju.
The relevant product markets
Zadevni proizvodni trgi
Interventional cardiology devices
Pripomočki za interventno kardiologijo
Interventional cardiology devices are designed to treat, through minimally invasive procedures, coronary artery diseases.
Namen pripomočkov za interventno kardiologijo je zdravljenje bolezni koronarne arterije z minimalnimi invazivnimi posegi.
In this area the main device is the stent, a small expandable wire tube that is placed in an occluded coronary artery to remove the plaque and support the walls of the vessel, thus enabling the blood to flow properly.
Glavni pripomoček na tem področju je stent (žilna opornica), majhna raztegljiva cevka, ki se vstavi v zamašeno koronarno arterijo, da odstrani obloge in podpre žilne stene ter tako omogoči normalen pretok krvi.
Bare metal stents (BMS) and drug eluting stents (DES) are two separate product markets for the following reasons: no significant price correlation, no supply side substitutability, very significant differences in clinical outcomes, and different reimbursement systems.
Nepokriti kovinski stenti (BMS) in stenti, ki sproščajo zdravila (DES), predstavljajo dva ločena proizvodna trga iz naslednjih razlogov: ni znatne korelacije cen, ni zamenljivosti na strani ponudbe, obstajajo zelo pomembne razlike pri kliničnih rezultatih, sistemi za povrnitev stroškov so različni.
Moreover, despite the fact that BMS and DES share the same stent structure and delivery system, a number of components are specifically important to a coronary DES (the drug, drug dosage and rate of release, and polymer coatings).
Poleg tega, kljub dejstvu da imata BMS in DES enako strukturo stenta in dozirni sistem, obstaja več sestavin, ki so posebej pomembne za koronarne DES (zdravilo, doziranje zdravila in hitrost sproščanja, polimerne prevleke).
Concerning the accessories coronary guiding catheters, coronary steerable guidewires, coronary PTCA balloon catheters, the Commission’s market inquiry has established that each of these products constitutes a separate relevant product market.
V zvezi s pripomočki koronarni vodeči katetri, koronarne vodeče žice, koronarni balonski katetri za perkutano transluminalno koronarno angioplastiko (PTCA) je bilo v okviru tržne preiskave Komisije ugotovljeno, da vsak posamezen proizvod predstavlja ločen trg za zadevne proizvode.
Most interventions will require a specific set of accessories, with different dimensions and shape.
Pri večini posegov je potrebna posebna skupina pripomočkov različnih dimenzij in oblik.
Endovascular devices
Endovaskularni pripomočki
Endovascular devices are used for the minimally invasive treatment of peripheral vascular (or endovascular) diseases such as the build up of plaque (i.e. vessel calcification) in peripheral vessels (peripheral arterial disease) and aneurysm (the enlargement of a weak area of an artery).
Endovaskularni pripomočki se uporabljajo za minimalno invazivno zdravljenje perifernih vaskularnih (ali endovaskularnih) bolezni, kot sta kopičenje oblog (tj. kalcifikacija žil) v perifernih žilah (periferna arterijska bolezen) in anevrizma (razširitev oslabljenega območja arterije).
Similar to interventional cardiology stents, endovascular stents are small expandable tubes designed to treat a narrowing or blockage in a peripheral artery.
Podobno kot stenti za interventno kardiologijo so endovaskularni stenti majhne raztegljive cevke, namenjene zdravljenju oženja ali zamašitve periferne arterije.
The parties submitted, and the Commission’s market inquiry confirmed, that two separate markets should be identified for endovascular stents: a market for balloon expandable stents (BX) (usually made of stainless steel and which come mounted on a PTA balloon catheter), and a market for self-expandable stents (SX), which use a different deployment technology.
Stranki sta izjavili, da je treba za endovaskularne stente določiti dva ločena trga, kar je Komisija potrdila: trg za stente, ki se razširijo z balonom (BX) (običajno narejene iz nerjavnega jekla in vgrajene v balonski kateter PTA), in trg za stente, ki se razširijo same (SX), z drugačno tehnologijo uporabe.
The Commission inquiry established a clear trend towards more specialisation in the endovascular area, both for BX stents (e.g. segments for renal (BX) stents and for iliac-femoral (BX) stents) and for SX stents (e.g. segments for femoral (SX) stents, iliac (SX) stents and carotid stents).
Preiskava Komisija je pokazala jasen trend k specializaciji na endovaskularnem področju, tako v primeru stentov BX (npr. segmenti ledvičnih stentov (BX) in kolčno-stegenskih stentov (BX)), kakor tudi v primeru stentov SX (npr. segmenti stegenskih stentov (SX), kolčnih stentov (SX) in karotidnih stentov).
As far as the accessories are concerned, endovascular guiding catheters, steerable guidewires and PTA balloon catheters perform a similar function to the corresponding products in interventional cardiology.
Kar zadeva pripomočke, endovaskularni vodeči katetri, vodeče žice in balonski katetri PTA opravljajo podobno funkcijo kot enakovredni proizvodi v interventni kardiologiji.
Similarly to the coronary area, a relevant market should be defined for each of these accessories, due to the high degree of supply side substitutability and the fact that all major manufacturers offer, within each accessory, a very broad range of models in terms of dimensions and shapes.
Podobno kot na koronarnem področju bi moral biti za vsakega od teh pripomočkov opredeljen zadevni trg, zaradi visoke stopnje zamenljivosti na strani ponudbe in dejstva, da vsi veliki proizvajalci v okviru vsakega pripomočka ponujajo zelo široko paleto različnih velikosti in oblik modelov.
Cardiac surgery devices
Pripomočki za srčno kirurgijo
Coronary artery bypass graft surgery (CABG) is used to treat coronary artery disease; the blocked artery is ‘bypassed’ by sewing (grafting) another blood vessel to the aorta at one end and to the coronary artery beyond the damaged area the other end.
Koronarna premostitev („CABG“) se uporablja za zdravljenje bolezni koronarne arterije; zamašena arterija se „premosti“ s šivanjem („presaditvijo“) druge krvne žile na aorto na enem koncu in na koronarno arterijo izven poškodovanega območja na drugem koncu.
After the operation, blood flows through the new grafted vessel to the heart muscle.
Po operaciji se kri do srčne mišice pretaka skozi novo presajeno žilo.
The vessel used for the bypass is removed (harvested) from the leg (saphenous vein graft), chest or arm.
Žila, ki se uporabi za premostitev, se odstrani („izloči“) iz noge („presadek nožne vene“), prsnega koša ali roke.
The following markets are affected in the cardiac surgery area: (i) beating-heart CABG products (stabilisation systems and accessories as blowers/misters); and (ii) endoscopic vessel harvesting (EVH) devices.
Na področju srčne kirurgije so prizadeti naslednjih trgi: (i) kirurški sistemi na utripajočem srcu CABG (stabilizacijski sistemi in pripomočki kot aspiratorji/pršila); (ii) endoskopski žilni sistemi („EVH“).
The relevant geographic markets
Zadevni geografski trgi
The market investigation confirmed that relevant geographic markets are all national because of significant differences between reimbursement schemes and procurement processes; price variations between countries; need to establish a local sales office; the parties’ and competitors’ market share variations across Member States.
Tržna preiskava je potrdila, da so vsi zadevni geografski trgi nacionalni trgi zaradi bistvenih razlik med sistemi za povrnitev stroškov in postopki naročanja, cenovnih razlik med državami, potrebe po ustanovitvi lokalne prodajne službe, razlik v tržnih deležih strank in tekmecev v državah članicah.
COMPETITIVE ASSESSMENT
PRESOJA KONKURENČNOSTI
Interventional cardiology
Interventna kardiologija
Interventional cardiology is a relatively recent, innovation driven business which is characterised by significant barriers to entry, i.e. R & D financing, intellectual property rights for product development, long time-to-market for new products, clinical trials, and product range.
Interventna kardiologija je razmeroma nova dejavnost, ki jo ženejo inovacije in za katero so značilne precejšnje vstopne ovire, tj. financiranje raziskav in razvoja, pravice intelektualne lastnine za razvoj proizvodov, dolgo obdobje uvajanja novih proizvodov na trg, klinična testiranja, ponudba proizvodov.
In the area of interventional cardiology there are two leagues of players: large global companies competing on a worldwide level (J & J, Guidant, Medtronic, Boston Scientific and Abbott) and ‘local players’ (Sorin, Biotronik and others).
Na področju interventne kardiologije obstajata dve skupini akterjev: velika globalna podjetja, ki tekmujejo drugo z drugim v svetovnem merilu (J & J, Guidant, Medtronic, Boston Scientific in Abbott), in „lokalni akterji“ (Sorin, Biotronik in drugi).
Drug-eluting stents
Stenti, ki sproščajo zdravila
In the market for DES, the concentration would result in the removal of a potential competitor given that Guidant is present only in BMS and not yet in DES, while J & J is one of the only two players already active in this segment, the other being Boston Scientific.
Na trgu DES bi koncentracija privedla do odstranitve potencialnega konkurenta, upoštevajoč dejstvo, da je Guidant dejaven samo na področju BMS, na področju DES pa še ne, medtem ko je J & J eden od zgolj dveh velikih akterjev, ki sta že dejavna v tem segmentu, pri čemer je drugi Boston Scientific.
Despite the fact that there is an indication that Guidant would likely have been one of the key players in the market for DES, acting as a major competitive constraint vis-à-vis the two current competitors J & J and Boston Scientific, the evidence collected in the investigation also proved that the other new entrants will be likely to exert sufficient competitive constraints on the market for DES, compensating for the loss of competition resulting from J & J’s acquisition of Guidant (Medtronic, Abbott, Conor/Biotronik and Sorin).
Kljub dejstvu, da obstajajo znaki, da bi lahko bil Guidant eden od ključnih akterjev na trgu DES, zaradi česar bi deloval kot konkurenčna omejitev v odnosu do sedanjih konkurentov J & J in Boston Scientific, so dokazi, zbrani med preiskavo, med drugim pokazali, da bodo drugi novi konkurenti zelo verjetno ustvarili zadostno konkurenčno omejitev na trgu DES, kar bi nadomestilo izgubo konkurence zaradi prevzema Guidanta s strani J & J (Medtronic, Abbott, Conor/Biotronik in Sorin).
The Commission, therefore, concluded that the notified concentration does not raise any serious doubts as to its compatibility with the common market with regard to DES and thus, the concentration will not significantly impede effective competition in the common market for DES.
Komisija je zato sklenila, da priglašena koncentracija v zvezi z DES ne odpira nikakršnih resnih dvomov v združljivost s skupnim trgom in da koncentracija zato ne bo bistveno ovirala učinkovite konkurence na skupnem trgu za DES.
Steerable guidewires
Vodeče žice
In the interventional cardiology market for steerable guidewires virtually all national markets are strongly affected by the concentration (above 40 % and with an increment of at least 5 %), and in many of these, including the largest countries of the EU, the parties’ combined market shares are above (65 to 75 %) and even (75 to 85 %).
Na trgu interventne kardiologije za vodeče žice koncentracija močno prizadene praktično vse nacionalne trge (preko 40 %, s prirastkom najmanj 5 %), pri čemer skupni tržni delež strank v veliko državah, vključno z največjimi državami članicami EU, presega [65 %–75 %] in celo [75 %–85 %].
The Commission, therefore, concluded that the notified concentration raises serious doubts as to its compatibility with the common market by enabling the merging parties to strengthen Guidant’s uncontested leadership, in so far as it removes one of the only two main competitors in this market.
Komisija je zato ugotovila, da priglašena koncentracija odpira resne dvome v svojo združljivost s skupnim trgom, s tem, da strankama, ki se združujeta, omogoča okrepitev nespornega vodilnega položaja Guidanta, saj bi odstranila enega od zgolj dveh glavnih tekmecev na tem trgu.
Further, the remaining firms in the market may even be expected to benefit from the reduction in competition which will result from the merger; the increase in concentration will enable them to attain higher prices than would otherwise have been the case.
Nadalje, preostala podjetja bodo predvidoma imela koristi od zmanjšanja konkurence, ki bo posledica združitve; povečanje koncentracije jim bo omogočilo, da dosežejo cene, ki bodo višje, kakor če ne bi prišlo do koncentracije.
Both J & J and Guidant are leading suppliers in the area of endovascular devices in the EEA.
J & J in Guidant sta vodilna dobavitelja na področju endovaskularnih pripomočkov v EGP.
Although there is a fair number of competitors in the endovascular markets (Abbott, Bard, Boston Scientific, B.Braun, Cook, Edwards Lifesciences, ev3, Invatec, Medtronic, Sorin and Terumo), not all players have the same strength or are present in all product or geographic markets.
Čeprav je število konkurentov na trgih endovaskularnih pripomočkov dokaj visoko (Abbott, Bard, Boston Scientific, B. Braun, Cook, Edwards Lifesciences, ev3, Invatec, Medtronic, Sorin in Terumo), vsi akterji nimajo enake moči oziroma niso prisotni s svojimi proizvodi na vseh proizvodnih ali geografskih trgih.
Moreover, the market investigation has highlighted that the disappearance of Guidant as a competitor will eliminate the closest substitute to J & J stents.
Poleg tega je tržna preiskava poudarila, da bo izginotje Guidanta kot konkurenta odpravilo najbližje nadomestke za stente podjetja J & J.
In the endovascular market for balloon expandable stents, at EEA level, the combined market share of the merging parties amounts to (60 to 70 %), (J & J, (30 to 40 %), Guidant, (25 to 35 %)).
Na endovaskularnem trgu za stente, ki se razširijo z balonom, skupni tržni delež strank, ki se združujeta, na ravni EGP znaša [60 %–70 %], (J & J, [30 %–40 %], Guidant, [25 %–35 %]).
Those market shares have been relatively stable for the past four years.
Ti trgi so bili v zadnjih štirih letih razmeroma stabilni.
When looking at the relevant geographic markets, i.e. each Member State, for the purpose of the competitive assessment, there are nine countries more substantially affected, namely: Austria, Belgium, France, Germany, Italy, Luxembourg, Netherlands, Portugal and Spain.
Če za zadevne geografske trge, tj. posamezne države članice, opravimo oceno konkurenčnosti, lahko ugotovimo, da je 9 držav, ki so občutneje prizadete, in sicer: Avstrija, Belgija, Francija, Nemčija, Italija, Luksemburg, Nizozemska, Portugalska in Španija.
Having regard to the fact that the merger combines the strongest and second strongest player, it will create a dominant position in virtually all the markets considered and will lead to a significant impediment to effective competition.
Ob upoštevanju dejstva, da se združujeta najmočnejši in drugi najmočnejši udeleženec na trgu, bo združitev ustvarila prevladujoči položaj na praktično vseh obravnavanih trgih in pripeljala do znatnega oviranja učinkovite konkurence.
In the endovascular market for Carotid stents in the EEA, the member States most substantially affected are: Austria, Belgium, Finland, France, Germany, Italy, the Netherlands, Portugal and Spain.
Najbolj prizadete države članice na endovaskularnem trgu za karotidne stente v EGS so: Avstrija, Belgija, Finska, Francija, Nemčija, Italija, Nizozemska, Portugalska in Španija.
There are three main players in the carotid stent market: J & J, Guidant and Boston Scientific.
Na trgu karotidnih stentov so trije glavni tekmeci: J & J, Guidant in Boston Scientific.
Together they account for 83 to 96 % of the market.
Njihov skupni delež na trgu znaša od 83 % do 96 %.
The concentration will either reinforce the leadership of J & J or Guidant (in Austria, Finland, the Netherlands, Portugal and Spain) or combine the second and third player to create a new market leader (Belgium, Germany and Italy).
Koncentracija bo bodisi okrepila vodilni položaj J & J ali Guidanta (v Avstriji, na Finskem, Nizozemskem, Portugalskem in v Španiji) ali združila drugega in tretjega tekmeca ter ustvarila novega vodilnega na trgu (Belgija, Nemčija in Italija).
In the above national markets, given the degree of concentration, barriers to entry, customer loyalty, closeness of substitution and, as a result of the elimination of a major competitive constraint, the operation will give rise to unilateral adverse effects in those markets and therefore impede effective competition in the common market.
Na zgoraj navedenih nacionalnih trgih bo združitev, glede na stopnjo koncentracije, vstopne ovire, zvestobo strank, možnost nadomestkov in posledično odpravo pomembne konkurenčne omejitve, povzročila enostranske negativne učinke in zato tudi ovirala učinkovito konkurenco na skupnem trgu.
In the endovascular devices market for non-carotid stents, the Member States most substantially affected are: Austria, Belgium, Germany and the Netherlands.
Na trgu endovaskularnih pripomočkov za nekarotidne stente so najbolj prizadete naslednje države članice: Avstrija, Belgija, Nemčija in Nizozemska.
In most of these markets, J & J is market leader and Guidant is one of the leading players and is considered by the majority of the customers as the closest substitute to J & J.
Na večini teh trgov ima J & J vodilni položaj, Guidant pa je eden od vodilnih akterjev, pri čemer ga večina strank šteje za najbližji nadomestek J & J.
With regard to non-carotid SX stents in the above national markets, the concentration will give rise to non-coordinated adverse effects in those national markets and therefore impede effective competition in the common market and the EEA as a result of the creation or strengthening of a dominant position.
V zvezi s karotidnimi stenti SX na zgoraj navedenih nacionalnih trgih bo na teh trgih koncentracija zaradi vzpostavitve ali okrepitve prevladujočega položaja sprožila neusklajene negativne učinke in zato ovirala učinkovito konkurenco na skupnem trgu in v EGP.
The Commission, therefore, concluded that the notified concentration raises serious doubts as to its compatibility with the common market with regard to endovascular stents market.
Komisija je zato sklenila, da priglašena koncentracija v zvezi s trgom endovaskularnih stentov odpira resne dvome v njeno združljivost s skupnim trgom.
The concentration will create a dominant position in balloon expandable stents market and will give rise to unilateral adverse effects in carotid and non-carotid stents markets and therefore will impede effective competition in the common market.
Koncentracija bo vzpostavila prevladujoči položaj na trgu stentov, ki se razširijo z balonom, in sprožila enostranske negativne učinke na trgih karotidnih in nekarotidnih stentov, zaradi česar bo ovirala učinkovito konkurenco na skupnem trgu.
Cardiac surgery: endoscopic vessel harvesting systems
Srčna kirurgija: Endoskopski žilni sistemi
The EEA sales of EVH systems are significantly lower than in the United States but show a growing trend.
Prodaja endoskopskih žilnih sistemov v EGS je znatno nižja od prodaje v ZDA, vendar je v porastu.
In Europe, traditional vessel harvesting is used in the large majority (98 %) of procedures.
V Evropi se v veliki večini postopkov (98 %) uporabljajo tradicionalni žilni sistemi.
J & J and Guidant are virtually the only two suppliers of EVH systems, with market shares estimated at 90 to 95 % by the parties and 100 % by market players across Europe.
J & J in Guidant sta praktično edina dva dobavitelja endoskopskih žilnih sistemov, pri čemer njun tržni delež po ocenah strank znaša 90–95 %, po ocenah tržnih akterjev po vsej Evropi pa 100 %.
The Commission, therefore, concluded that the notified concentration raises serious doubts as to its compatibility with the common market with regard to the EVH systems and will result in creation of a virtual monopoly across Europe.
Komisija je zato sklenila, da priglašena koncentracija odpira resne dvome v njeno združljivost s skupnim trgom v zvezi z endoskopskimi žilnimi sistemi, in da bo v Evropi vzpostavila dejanski monopol.
COMMITMENTS OFFERED BY THE PARTIES
ZAVEZE, PONUJENE S STRANI STRANK
In order to address the aforementioned competition concerns in the steerable guidewires, the endovascular and the cardiac surgery markets, the Parties submitted the undertakings described below:
Za odpravo zgoraj navedenih pomislekov o konkurenci na trgu vodečih žic, trgu endovaskularnih pripomočkov in trgu srčne kirurgije sta se stranki zavezali, da bosta ukrepali na naslednji način:
in the steerable guidewires business, the parties propose to divest the assets associated predominantly with the supply, marketing and sale of J & J steerable guidewires business in the EEA.
V sektorju vodečih žic stranki predlagata opustitev sredstev, povezanih večinoma z dobavo, trženjem in prodajo vodečih žic J & J v EGP.