natgillin/translations-raw huggingface dataset:
As this will mean that they will have to leave the market, only the more expensive products remain available.
Zainteresirane strani trdijo tudi, da obvezni rabat v višini 16 % prihodka sili v stečaj predvsem mala in srednja podjetja, ki so bila pred uvedbo rabata uspešna, vendar njihove stopnje dobička ne zadostujejo za pokritje dodatnih stroškov.
Thus, by granting exemptions and keeping them in the market, the measure actually reduces the costs for the health insurances, meaning that without the measure the costs and the transfers of public funds to pharmaceutical companies will increase.
V zvezi s tem zainteresirane strani zlasti opozarjajo, da kombinacija obvezne zamrznitve cen in moratorija na cene podjetjem preprečuje, da bi dodatne stroške zaradi zamrznitve cen nadomestila s povišanjem cen.
Furthermore, it is argued that the measure is not imputable to Germany, as the foreseen exemptions are merely a mandatory implementation of Article 4(2) of Directive 89/105.
Zato trdijo, da možnost odobritve izvzetij ne ustvarja selektivne prednosti, temveč preprečuje diskriminacijo proti manjšim podjetjem z nizkimi stopnjami dobička.
The interested parties further submit that the mandatory rebate of 16 % of the turnover forces mainly small and medium sized firms into bankruptcy, which were healthy firms before the introduction of the rebate, but whose profit margins are not big enough to be able to bear its additional costs.
V tem smislu je treba ukrep obravnavati kot klavzulo o finančnih težavah, ki zmanjšuje učinek zamrznitev cen na sorazmerno raven.
In this regard the third parties in particular point to the fact that the combination of the mandatory price freeze with the Preismoratorium prevents firms from compensating the additional costs of the former through an increase in prices.
Brez klavzule o finančnih težavah naj bi zamrznitve cen kršile svobodo gospodarske pobude iz člena 16 Listine.
It is, therefore, argued that the possibility of granting exemptions does not lead to a selective advantage, but rather prevents discrimination of smaller undertakings with small profit margins.
V zvezi s tem vsi upravičenci poudarjajo, da brez zamrznitev cen ne bi bili podjetja v finančnih težavah.
In this sense, the measure must be seen as a hardship clause, reducing the impact of the price freezes to a proportionate level.
Upravičenci glede na to neposredno vzročno zvezo med predpisi, s katerimi so bile uvedene zamrznitve cen, in svojimi finančnimi težavami poudarjajo pomembnost klavzule o finančnih težavah.
It is argued that the price freezes would be in breach of the freedom to conduct a business, as laid down in Article 16 of the Charter, without such a hardship clause.
Več zainteresiranih strani poleg tega pojasnjuje, da so bile zamrznitve cen uvedene kmalu po uvedbi strožjih pogojev glede potrjevanja več njihovih izdelkov, ki so znatno povečali njihove stroške.
In this regard all beneficiaries point to the fact that they would not be firms in financial difficulties if it were not for the price freezes.
Predpisi, ki določajo te strožje pogoje, so predvideli, da bodo povzročili dodatne stroške.
In light of this direct causal link between the legislation introducing the price freezes and their financial difficulties, the beneficiaries underline the importance of a hardship clause.
Vendar zaradi moratorija na cene v kombinaciji z obveznim rabatom zadevna podjetja teh dodatnih stroškov niso mogla nadomestiti.
Several of the third parties in addition explain that the price freezes were introduced only shortly after stricter conditions concerning certification of several of their products, significantly increasing their costs, entered into force.
Zato trdijo, da ukrep ni selektiven, saj se uporablja za vsa podjetja s tem dvojnim bremenom.
The legislation laying down these stricter conditions recognised the fact that it will lead to additional costs.
Nazadnje zainteresirane strani navajajo, da zaradi majhnih zneskov, ki so bili vključeni, konkurenca ni bila izkrivljena.
Yet, due to the Preismoratorium in combination with the mandatory rebate, the affected companies were not able to compensate these additional costs.
Prav tako več upravičencev trdi, da ukrep ne vpliva na trgovino med državami članicami, saj poslujejo le v Nemčiji in samo z izdelki, potrjenimi v Nemčiji.
They, therefore, argue that the measure is not selective as it applies to all undertakings subject to this double burden.
PRIPOMBE NEMČIJE
Lastly, due to the small amounts involved the third parties submit that there is no distortion of competition.
Nemčija je vztrajala pri stališču, da ukrep ne pomeni državne pomoči.
Several beneficiaries, furthermore, submit that there is no effect on trade between the Member States, as they only operate within Germany and only with products that are certified in Germany.
Po mnenju Nemčije je ukrep le del splošnega okvira, ki ureja višino cen farmacevtskih izdelkov.
COMMENTS FROM GERMANY
Nemčija poudarja, da cene določenih farmacevtskih izdelkov ali določenih proizvajalcev ureja več različnih mehanizmov, pri čemer je zadevni ukrep v obravnavanem primeru le eden od njih.
Germany maintained its position that the measure does not constitute State aid.
V zvezi s tem Nemčija trdi, da sklep BAFA o odobritvi izvzetij neposredno in sam po sebi ne povzroča prenosa sredstev ponudnikov zdravstvenega zavarovanja na upravičena podjetja, ampak zgolj določa ceno določenega izdelka.
According to the German authorities the measure merely constitutes part of a general framework regulating the price levels for pharmaceuticals.
Tak prenos sredstev se zgodi šele, ko zdravnik predpiše določeno zdravilo, in zato ni neposredno povezan s kakršnim koli ukrepom državnega organa ali javnega ali zasebnega organa, ki ga je država ustanovila za upravljanje sredstev.
Germany points out that there are several different mechanisms regulating prices for certain medical products or certain producers, the measure at stake in the present case merely being one of them.
Poleg tega Nemčija v zvezi s tem navaja, da ukrepa ni mogoče pripisati državi, saj pomeni zgolj izvajanje člena 4(2) Direktive 89/105/EGS.
In this regard Germany argues that the decision by the BAFA to grant exemptions does not directly and in itself lead to any transfer of funds from the health insurances to the eligible undertakings, but merely sets a certain price for a specific product.
Po navedbah Nemčije ta člen določa, da je treba zagotoviti možnost vložitve zahtevka za izvzetje iz zamrznitve cen.
Such transfer of funds only occurs once a doctor prescribes a certain medicine and is, therefore, not directly linked to any action by a State authority or any public or private body set up by the State to administer the funds.
Čeprav pušča odprt natančen pomen izraza „določeni razlogi“, razlaga, ki bi splošno in predhodno onemogočila odobritev izvzetja, ne bi bila združljiva z obveznostjo izvajanja Direktive.
In this regard Germany, in addition, submits that the measure is not imputable, as it is merely an implementation of Article 4(2) of Directive 89/105.
BAFA izvede ocene posameznih zahtevkov in med drugim odobri izvzetje iz zamrznitve cen takrat, ko je prosilec zaradi zamrznitve cen v finančnih težavah.
Germany submits that this Article lays down an obligation to foresee a possibility to apply for an exemption from a price freeze.
Po mnenju Nemčije je edina ustrezna razlaga člena 4(2) Direktive 89/105/EGS tista, v skladu s katero se odobrijo izvzetja za podjetja, ki niso mogla nositi finančnega bremena zamrznitve cen, saj izvzetje podjetij, ki lahko breme nosijo sama (ali podjetja, ki so v težavah celo brez zamrznitve cen), ni potrebno.
Even though it leaves the precise meaning of the term ‘particular reasons’ open, an interpretation that would generally and ex ante make the grant of an exemption impossible would not be in accordance with the obligation to implement the Directive.
V zvezi s tem Nemčija trdi tudi, da iz sklepa o začetku postopka izhaja, da je Komisija sprejela predhodni sklep, da vsako izvzetje iz zamrznitve cen pomeni selektivno prednost in s tem državno pomoč ne glede na podlago, na kateri je bilo odobreno.
The BAFA carries out case-by-case assessments of applications and, amongst other possible grounds, grants exemptions from the price freeze if the applicant is in financial difficulties because of the price freeze.
Vendar člen 4(2) Direktive 89/105/EGS zavezuje države članice k odločanju o zahtevkih za taka izvzetja.
Germany considers that no other interpretation of Article 4(2) of Directive 89/105 than to grant exemptions to undertakings that could not carry the financial burden of a price freeze would be appropriate, as exempting companies that can carry the burden themselves (or companies that are in difficulties even without the price freeze) is not necessary.
Zato ni jasno, ali obstajajo primeri, v katerih je mogoče izvzetje iz člena 4(2) Direktive 89/105/EGS odobriti, ne da bi pomenilo državno pomoč, in, če je odgovor pritrdilen, kako bi lahko to izvedli v skladu z zakonodajo o državni pomoči.
In this regard Germany additionally argues that it follows from the opening decision that the Commission came to the preliminary conclusion that any exemption from a price freeze constitutes a selective advantage and therefore State aid, irrespective of the grounds on which it is granted.
Prav tako Nemčija trdi, da morajo institucije EU preprečevati neskladnosti, ki jih lahko povzroči izvajanje različnih določb zakonodaje EU, zlasti v razmerah, kakršne so v obravnavanem primeru, v katerih imajo pravila o državni pomoči in Direktiva 89/105/EGS skupni cilj.
However, Article 4(2) of Directive 89/105 forces Member States to decide upon applications for such exemptions.
Zato je treba predpostavljati, da so evropski zakonodajalci že ugotovili, da izvzetja iz zamrznitve cen ne izkrivljajo konkurence in da zato ni mogoče izvesti naknadne ocene na podlagi pravil o državni pomoči.
Thus, it is unclear to Germany whether the exemption foreseen in Article 4(2) of Directive 89/105 can ever be granted without constituting State aid and if so how this could be done in conformity with State aid law.
Sklepanje, da taka izvzetja pomenijo državno pomoč, bi člen 4(2) Direktive 89/105/EGS oropalo vsakršne vsebine.
Furthermore, Germany asserts that EU institutions must avoid inconsistencies that might arise in the implementation of various provisions of Union law, especially in circumstances as the present case, where the rules on State aid as well as Directive 89/105 pursue a common objective.
Če bo Komisija sklenila, da ukrep pomeni pomoč, ki ni združljiva z notranjim trgom, Nemčija prosi, naj sklep izjemoma ne odredi vračila pomoči.
It must, thus, be presumed that the European legislature has already assessed that exemptions from price freezes do not distort competition and that there is, therefore, no room for a subsequent assessment under the State aid rules.
Trdi, da to upravičujejo posebne okoliščine primera, zlasti ker člen 4(2) Direktive 89/105/EGS zavezuje države članice, da predvidijo izvzetja iz zamrznitve cen, prav tako pa niti Direktiva niti sodna praksa Sodišča ne nakazujeta, da bi lahko taka izvzetja pomenila državno pomoč.
To conclude that such exemptions constitute State aid would deprive Article 4(2) of Directive 89/105 of any content.
Nemčija v zvezi s tem poudarja tudi, da Komisija pred sklepom o začetku postopka nikoli ni trdila, da izvzetja na podlagi člena 4(2) Direktive 89/105/EGS pomenijo državno pomoč, niti ni pri tekoči reviziji Direktive 89/105/EGS izrazila pomislekov v zvezi s potencialnim navzkrižjem med tem členom in pravili o državni pomoči.
Finally, in case the Commission comes to the conclusion that the measure constitutes incompatible aid, Germany asks that the decision should exceptionally not order recovery of the aid.
OCENA
It argues that this would be justified by the particular circumstances of the case, in particular since Article 4(2) of Directive 89/105 requires Member States to foresee exemptions from prices freezes while there is neither any indication in the Directive nor jurisprudence of the Court that such exemptions could constitute State aid.
Obstoj pomoči
In this regard Germany also points to the fact that the Commission has never argued before the opening decision that exemptions based on Article 4(2) of Directive 89/105 constitute State aid and also did not raise any concerns relating to a possible conflict of that Article with the rules on State aid in the ongoing revision of Directive 89/105.
V skladu s členom 107(1) PDEU „je vsaka pomoč, ki jo dodeli država članica, ali kakršna koli vrsta pomoči iz državnih sredstev, ki izkrivlja ali bi lahko izkrivljala konkurenco z dajanjem prednosti posameznim podjetjem ali proizvodnji posameznega blaga, nezdružljiva z notranjim trgom, kolikor prizadene trgovino med državami članicami“.
ASSESSMENT
Iz tega sledi, da mora državni ukrep za uvrstitev med državno pomoč v smislu člena 107(1) PDEU izpolnjevati naslednja kumulativna merila:
Existence of aid
prisotnost državnih sredstev;
According to Article 107(1) TFEU any aid granted by a Member State or through State resources in any form whatsoever which distorts or threatens to distort competition by favouring certain undertakings or the production of certain goods shall, in so far as it affects trade between Member States, be incompatible with the internal market.
odgovornost do države;
It follows that, for a State measure to be qualified as State aid within the meaning of Article 107(1) TFEU, the following cumulative criteria have to be fulfilled:
Prisotnost državnih sredstev
involvement of State resources;
Da je prednost pomoč v smislu člena 107 PDEU, mora biti dodeljena neposredno ali posredno iz državnih sredstev.
selective advantage to an undertaking; and (potential) distortive effects on competition and intra-Union trade.
Dejstvo, da ukrepa, ki daje prednost, ne financira neposredno država, temveč javni ali zasebni organ, ki ga je država ustanovila ali imenovala za upravljanje pomoči, ne izključuje možnosti, da se ta ukrep financira iz državnih sredstev [10].
Involvement of State resources
V zadevnem primeru ustrezna nemška zakonodaja (z moratorijem na cene in rabatom proizvajalca) določa ceno, ki jo morajo zavarovalnice plačati za farmacevtske izdelke.
For advantages to be capable of being categorised as aid within the meaning of Article 107 TFEU, they must be granted directly or indirectly through State resources.
Z odobritvijo ocenjevanih izvzetij BAFA (zvezni organ) zagotavlja, da te zavarovalnice plačajo višjo ceno za zadevne izdelke, in sicer izdelke podjetij, katerih finančne težave se štejejo za dovolj velike, da upravičujejo izvzetje od splošno veljavne fiksne cene.
The distinction made between ‘aid granted by a Member State’ and aid granted ‘through State resources’ does not mean that all advantages granted by a State, whether financed through State resources or not, constitute aid, but is merely intended to bring within the definition of State aid both, advantages which are granted directly by the State and those granted by a public or private body designated or established by the State to administer the advantages [9].
Kot je navedeno zgoraj (uvodna izjava 16), je 85–90 % nemškega prebivalstva vključenega v javno zdravstveno zavarovanje, za zasebno zdravstveno zavarovanje pa se odloči le preostali del prebivalstva.
The fact that a measure granting an advantage is not financed directly by the State, but by a public or private body established or appointed by the State to administer the aid does not exclude that that measure is financed through State resources [10].
To pomeni, da morajo zaradi zadevnih izvzetij višje cene plačati predvsem javne zdravstvene zavarovalnice.
In the case at hand the relevant German legislation (through the price moratorium and the manufacturer's rebate) lays down the price that the insurance funds have to pay for pharmaceutical products.
Obravnavani ukrep zato ustvarja dodatne stroške za javne zdravstvene zavarovalnice in s tem povzroča izgubo državnih sredstev [11].
By granting the exemptions under assessment, the BAFA (a federal authority) ensures that these funds pay a higher price for the products in question, namely products of companies deemed to be in sufficient financial difficulty to justify an exception to the generally applicable fixed price.
Zato se obravnavani primer razlikuje od zadeve PreussenElektra [12], v kateri je Sodišče proučilo samo, ali je „obveznost zasebnih podjetij za distribucijo električne energije, da odkupijo električno energijo iz obnovljivih virov energije po fiksnih najnižjih cenah“ povzročala „neposreden ali posreden prenos državnih sredstev k zasebnim proizvajalcem te vrste električne energije“ [13].
As indicated above (recital 16), 85-90 % of the population in Germany is covered by public sickness funds, while just a residual part of the population opt for private health insurance.
Na podlagi tega Komisija sklepa, da ukrep vključuje državna sredstva.
This means that it is mainly public sickness funds that have to pay higher prices due to the exemptions in questions.
Odgovornost do države
The present measure therefore creates additional costs for public sickness funds, thereby involving a loss of State resources [11].
Ukrep spada v opredelitev državne pomoči v smislu člena 107(1) PDEU, če ga je mogoče pripisati državi [14].
Thus, the present case is different from the situation in PreussenElektra [12], where the Court only examined whether an ‘obligation imposed on private electricity supply undertakings to purchase electricity produced from renewable energy sources at fixed minimum prices’ involved ‘any direct or indirect transfer of State resources to undertakings which produce that type of electricity’ [13].
Kot je navedeno zgoraj, Nemčija trdi, da ukrepa ni mogoče pripisati državi, saj pomeni zgolj izvajanje obveznosti zagotavljanja izvzetij iz zamrznitve cen iz člena 4(2) Direktive 89/105/EGS.
In the light of the above, the Commission concludes that the measure involves state resources.
Nemčija sicer priznava, da je izraz „določeni razlogi“ nekoliko širok, vendar trdi, da naj bi široka opredelitev državam članicam omogočala, da se odzovejo na spreminjajoče se razmere na trgu.
Imputability to the State
Vendar po mnenju Nemčije to ne spreminja dejstva, da člen 4(2) Direktive 89/105/EGS določa obveznost odobritve izvzetij na podlagi določenih razlogov in tako državam članicam ne daje diskrecijske pravice do odločanja, ali bo izvzetja odobrila ali ne.
In order to fall within the definition of State aid in the meaning of Article 107(1) TFEU, the measure must be imputable to the State [14].
Komisija ugotavlja, da v primerih, v katerih države članice v nacionalno zakonodajo zgolj prenašajo jasno in natančno določeno obveznost, ki jim je bila naložena z zakonodajo EU, dejansko samo izpolnjujejo svojo obveznost iz PDEU glede prenosa zakonodaje EU v nacionalno zakonodajo in da jim zato takega prenosa ni mogoče pripisati.
As stated above, Germany argues that the measure is not imputable to it, as it is merely an implementation of an obligation to foresee exemptions to price freezes laid down in Article 4(2) of Directive 89/105.
V zvezi s tem je Splošno sodišče na primer v zadevi Deutsche Bahn proti Komisiji ugotovilo, da je Nemčija z izvajanjem jasno in natančno določene obveznosti, da z usklajeno trošarino ne obdavči goriva, ki se uporablja za komercialno zračno plovbo, kot je določeno v Direktivi Sveta 92/81/EGS [15], prenašala to obveznost v nacionalno zakonodajo, zato ji tega prenosa ni mogoče pripisati, saj je dejansko izhajal iz pravnega akta zakonodajalca Unije [16].
While Germany admits that the term ‘particular reasons’ is rather broad, it asserts that the reason for this broad formulation is to make it possible for Member States to react to changing market conditions.
Vendar je v zvezi z obravnavanim primerom v šesti uvodni izjavi preambule k Direktivi 89/105/EGS navedeno, da zahteve iz te direktive ne vplivajo na politike držav članic za določanje cen farmacevtskih izdelkov ali na državne politike določanja cen in na določanje programov socialnega zavarovanja, razen če to ni potrebno za pridobitev preglednosti v smislu te direktive.
However, according to Germany, this does not change the fact that Article 4(2) of Directive 89/105 lays down an obligation to grant exemptions on the basis of particular reasons and as such does not give Member States discretion on whether to grant exemptions or not.
Kot potrjuje Sodišče v zadevi Menarini in drugi, iz tega sledi, da Direktiva 89/105/EGS temelji na načelu najmanjšega poseganja v organizacijo notranjih politik na področju socialnega zavarovanja držav članic [17].
The Commission notes that in situations in which Member States merely transpose a clear and precise obligation put on them by a provision of Union legislation into national law, they are indeed only fulfilling their obligation under the Treaty to implement EU law into national law and that such implementation is, therefore, not imputable to them.
V skladu s to temeljno zamislijo je člen 4(2) Direktive 89/105/EGS oblikovan zelo splošno, predvsem pa ne opredeljuje pomena izraza „določeni razlogi“.
In this regard, the General Court held, for example, in Deutsche Bahn v Commission that the implementation by Germany of a clear and precise obligation not to levy the harmonised excise duty on fuel used for the purpose of commercial air navigation laid down in Directive 92/81 [15] was, as an implementation of this obligation into national law, not imputable to Germany but in fact stemmed from an act of the Union legislature [16].
V zvezi s tem je Sodišče pojasnilo, da morajo države članice v skladu s členom 4(2) Direktive 89/105/EGS „za podjetje, ki ga zadeva ukrep zamrznitve cen vseh zdravil ali določenih kategorij zdravil, vedno predvideti možnost, da zaprosi za odstopanje od predpisane cene v skladu s temi ukrepi, pri čemer ta možnost ne vpliva na preverjanje obstoja izjemnih primerov in določenih razlogov v smislu navedene določbe, ki ga opravijo pristojni organi držav članic“ [18].
However, as regards the present case, recital 6 of the preamble of Directive 89/105 clarifies that requirements under that Directive neither affect Member States' policies for determining prices for medicinal products nor national policies on price setting or the determination of social security schemes, except in so far as it is necessary to attain transparency for the purposes of the Directive.
Iz tega sledi, da morajo države članice določiti, kdaj obstajajo določeni razlogi, in da imajo zato precejšnjo diskrecijsko pravico pri določanju, pod katerimi pogoji bodo odobrile izvzetja.
As confirmed by the Court in Menarini and Others, it follows that the underlying principle of Directive 89/105 is the idea of minimum interference in the organisation by Member States of their domestic social security policies [17].
Izraz „določeni razlogi“ iz člena 4(2) Direktive 89/105/EGS ni dovolj jasen in natančen, da bi upravičil enak sklep kot v zadevi Deutsche Bahn, in sicer, da se z nacionalnim ukrepom v nacionalni pravni red zgolj prenese obveznost, ki jo je naložil zakonodajalec Unije.
In accordance with this underlying idea, Article 4(2) of Directive 89/105 is formulated in a very wide manner and, in particular, does not define the meaning of the term ‘particular reasons’.
V zadevi Deutsche Bahn je ustrezna določba zakonodaje EU, in sicer člen 8(1)(b) Direktive 92/81/EGS, jasno in natančno določila obveznost, da se z usklajeno trošarino ne obdavči gorivo, ki se uporablja za komercialno zračno plovbo.