natgillin/translations-raw huggingface dataset:
The ‘health fund’ then pays each provider a lump-sum per member, with the amount per member depending on the members' age, gender and health condition.
„Zdravstveni sklad“ nato vsakemu ponudniku plača pavšalni znesek na člana, ki je odvisen od starosti, spola in zdravstvenega stanja člana.
Private health insurance:
Zasebno zdravstveno zavarovanje:
10-15 % of the population opt for private health insurance.
10–15 % prebivalstva se odloči za zasebno zdravstveno zavarovanje.
This private system is financed exclusively by the premiums paid by its members which are based on individual agreements with the insurance company defining the set of covered services and the percentage of coverage, which depend on the amount of services chosen and the person's risk and age of entry into the private system and which are also used to build up savings for the rising health costs at higher age as required by law.
Ta zasebni sistem se financira izključno s premijami, ki jih plačajo člani in ki so določene z individualnimi pogodbami z zavarovalnico, v katerih sta opredeljena sklop zajetih storitev ter delež kritja, ta pa je odvisen od obsega izbranih storitev ter tveganja in starosti osebe ob vključitvi v zasebno zavarovanje.
Exemption from the manufacturer's rebate on pharmaceutical products under German law
Premije se uporabljajo tudi za oblikovanje zakonsko predpisanih starostnih rezervacij za zdravstvene stroške, ki se povišujejo s starostjo.
Between August 2010 and December 2013 pharmaceutical undertakings in Germany were generally obliged to grant rebates of 16 % of the price of patented prescription medicines outside the fixed-price system to all health insurances, i.e. to public sickness funds as well as private health insurance companies.
Izvzetje od rabata proizvajalca za farmacevtske izdelke po nemškem pravu
Between 1 January 2014 and 31 March 2014 this mandatory rebate was lowered to 6 %, from 1 April 2014 onwards the rebate was slightly increased to 7 % (with the exception of generic drugs, for which the rebate remains 6 % also after 1 April 2014).
Farmacevtske družbe v Nemčiji so bile med avgustom 2010 in decembrom 2013 na splošno zavezane vsem ponudnikom zdravstvenega zavarovanja, tj. javnim in zasebnim zdravstvenim zavarovalnicam odobriti rabate v višini 16 % cene za patentirana zdravila na recept zunaj sistema fiksnih cen.
At the same time, pharmaceutical undertakings are, until 31 December 2017, obliged to keep their prices at the level as of 1 August 2009 (Preismoratorium).
Ta obvezni rabat se je med 1. januarjem in 31. marcem 2014 znižal na 6 %, po 1. aprilu 2014 pa se je nekoliko povišal na 7 % (razen pri generičnih zdravilih, za katera je rabat ostal na 6 % tudi po 1. aprilu 2014).
Both, the mandatory rebates (regardless of the exact percentage) as well as the Preismoratorium, constitute a ‘price freeze’ in the meaning of Article 4(1) of Directive 89/105 [4].
Poleg tega morajo farmacevtske družbe do 31. decembra 2017 ohranjati cene na ravni iz 1. avgusta 2009 (moratorij na cene).
Article 4(2) of that Directive lays down that in exceptional circumstances any holder of a marketing authorisation for medical products has the right to apply for a derogation from such a price freeze if justified by ‘particular reasons’.
Obvezni rabati (ne glede na točen odstotek) in moratorij na cene pomenijo „zamrznitev cen“ v smislu člena 4(1) Direktive Sveta 89/105/EGS [4].
According to the Court of Justice, Member States are, on the basis of this Article, obliged to provide, in all cases, a possibility to apply for such a derogation [5].
Člen 4(2) te direktive določa, da lahko izjemoma oseba, ki je imetnik odobritve za trženje farmacevtskih izdelkov, zaprosi za odstopanje od zamrznitve cen, če to upravičujejo „določeni razlogi“.
German law foresees that pharmaceutical undertakings can apply for an exemption [6] from the mandatory rebate and that a federal authority, the Federal Office of Economics and Export Control (Bundesamt für Wirtschaft und Ausfuhrkontrolle, hereinafter ‘BAFA’), decides whether to grant this exemption on a case-by-case basis.
Države članice morajo v skladu s stališčem Sodišča na podlagi tega člena vedno predvideti možnost vložitve zahtevka za tako odstopanje [5].
More specifically, under section 130a paragraph 4 of Book V of the German Social Security Code, and as further clarified by an information sheet published by BAFA concerning its decision making process [7], ‘particular reasons’ are given if the price freeze puts an unacceptable financial burden on the affected business group (or individual undertaking but only if said undertaking does not belong to a business group).
Nemška zakonodaja določa, da lahko farmacevtske družbe zaprosijo za izvzetje [6] od obveznega rabata in da se zvezni organ, tj. nemški zvezni urad za gospodarstvo in nadzor izvoza (Bundesamt für Wirtschaft und Ausfuhrkontrolle, v nadaljnjem besedilu: BAFA), za vsak primer posebej odloči, ali bo odobril izvzetje.
A financial burden is assumed to be unacceptable if the affected undertaking is unable to avoid illiquidity through its own resources, contributions of its shareholders or other measures.
Natančneje, v skladu z razdelkom 130a(4) knjige V nemškega zakonika o socialni varnosti in dodatnimi pojasnili v informativnem listu, ki ga je objavil BAFA v zvezi s svojim postopkom odločanja [7], „določeni razlogi“ obstajajo, če zamrznitev cen naloži nesprejemljivo finančno breme zadevni poslovni skupini (ali posameznemu podjetju, vendar samo, če ne pripada poslovni skupini).
According the information sheet published by BAFA, the decisive elements taken into account by it for establishing whether an exemption is to be granted are the following:
Finančno breme se šteje za nesprejemljivo, če zadevno podjetje ne more preprečiti nelikvidnosti z lastnimi sredstvi, prispevki delničarjev ali drugimi ukrepi.
Operating earnings before tax of the previous three business years;
V informativnem listu, ki ga je objavil BAFA, so navedeni naslednji odločilni elementi, ki se upoštevajo pri odločanju o odobritvi izvzetja:
A demonstration by the applicant for an exemption of the development of its earnings and liquidity during the previous three years on the basis of its key business indicators (e.g. its EBIT margin, return on equity, equity and debt ratio, liquidity and debt ratio) and an explanation of the effects of the price freeze on these indicators;
prihodek iz poslovanja pred obdavčitvijo za pretekla tri poslovna leta;
A demonstration by the applicant of the additional burden introduced on the business group/undertaking by the price freeze on the basis of a proof of the actual amount of the rebates already paid;
dokazilo prosilca za izvzetje o razvoju njegovih prihodkov in likvidnosti v preteklih treh letih na podlagi ključnih poslovnih kazalnikov (tj. stopnja dobička pred obrestmi in davki, stopnja donosnosti kapitala, razmerje med dolžniškim in lastniškim kapitalom, količnik likvidnosti in delež dolga) in pojasnilo učinkov zamrznitve cen na te kazalnike;
An assessment of the overall financial and economic situation of the applicant which takes, in addition to the revenue/profit situation, in particular also its assets and liquidity into account.
dokazilo prosilca o dodatnem bremenu, ki ga je zamrznitev cen naložila poslovni skupini/podjetju na podlagi dokazila o dejanskem znesku že plačanih rabatov;
To this end a retrospective cash flow statement as well as a prospective cash flow statement (financial pan), as well as a liquidity plan for the coming three years and a short-term financial plan for the coming 12 months have to be submitted by the applicant.
ocena splošnih finančnih in gospodarskih razmer prosilca, ki poleg stanja na področju prihodka/dobička zlasti upošteva tudi njegova sredstva in likvidnost.
Applicants for an exemption have to prove a direct causal link between the price freeze and their financial difficulties.
Zato mora prosilec predložiti izkaz denarnih tokov za nazaj in izkaz pričakovanih denarnih tokov (finančni načrt), pa tudi likvidnostni načrt za prihodnja tri leta in kratkoročni finančni načrt za prihodnjih 12 mesecev.
It must, in particular, be shown that there are no structural causes for the financial difficulties and if there are any business measures suited for avoiding or limiting the financial difficulties still available, these must primarily be taken.
Prosilci za izvzetje morajo dokazati neposredno vzročno zvezo med zamrznitvijo cen in svojimi finančnimi težavami.
Any business measures already taken to that end need to be described by the affected undertaking in its application.
Zlasti morajo dokazati, da ni strukturnih vzrokov za finančne težave; če so še vedno na voljo morebitni poslovni ukrepi, namenjeni preprečevanju ali omejevanju finančnih težav, jih je treba čim prej sprejeti.
The applicant has to prove the fulfilment of all eligibility criteria for an exemption on the basis of an expert opinion by a certified accountant.
Kakršne koli poslovne ukrepe, ki so že bili sprejeti v ta namen, mora podjetje opisati v zahtevku.
This expert opinion must expressly confirm the direct causal link between the price freeze and the financial difficulties of the applicant and must provide reasons.
Prosilec mora dokazati, da izpolnjuje vsa merila za izvzetje na podlagi strokovnega mnenja računovodje ali zapriseženega revizorja.
To this end the accountant must analyse the financial statements of the previous three years as well as the liquidity plan of the coming three years with regard to the effect of the rebates on the financial situation of the applicant.
To strokovno mnenje mora izrecno potrditi neposredno vzročno zvezo med zamrznitvijo cen in finančnimi težavami prosilca ter navesti razloge.
The accountant must verify the calculations and submissions concerning the key business indicators and the revenue and liquidity situation.
Zato mora računovodja ali zapriseženi revizor analizirati računovodske izkaze iz preteklih treh let in likvidnostni načrt za prihodnja tri leta glede učinka rabatov na finančni položaj prosilca.
Against this background the accountant must assess whether the additional burden introduced by the price freeze is so significant that the financial capacities of the undertaking are in danger in the short to medium term.
Preveriti mora izračune in predloženo dokumentacijo v zvezi s ključnimi poslovnimi kazalniki ter stanje na področju prihodkov in likvidnosti.
Applications for exemptions have to be based on the audited financial statements of the previous year (year n-1).
Na podlagi tega mora računovodja ali zapriseženi revizor oceniti, ali je dodatno breme, ki ga je ustvarila zamrznitev cen, tako veliko, da so kratko- do srednjeročno ogrožene finančne zmogljivosti podjetja.
If the conditions for an exemption are fulfilled, the BAFA grants a ‘preliminary exemption’ for the current business year (year n) plus 180 days.
Zahtevki za izvzetje morajo temeljiti na revidiranih računovodskih izkazih za preteklo leto (leto n-1).
The applicant is obliged to provide the updated data for the current year (year n) within 120 days after the end of the business year.
Če so pogoji za izvzetje izpolnjeni, BAFA odobri „predhodno izvzetje“ za tekoče poslovno leto (leto n), ki mu prišteje 180 dni.
If this updated information is not provided within the 120 days deadline, the BAFA automatically hands down a final negative decision, which repeals the previous preliminary decision.
Prosilec mora predložiti posodobljene podatke za tekoče leto (leto n) v 120 dneh po koncu poslovnega leta.
If the updated data shows that the conditions for an exemption were actually fulfilled during year n, the BAFA hands down a final positive decision (‘final exemption’).
Če teh posodobljenih informacij ne predloži v roku 120 dni, BAFA samodejno sprejme končni negativni sklep, ki razveljavlja prejšnji predhodni sklep.
If, however, the data shows that the conditions were not fulfilled during year n, the BAFA hands down a final negative decision, which repeals the previous preliminary decision.
Če posodobljeni podatki kažejo, da so bili pogoji za izvzetje v letu n dejansko izpolnjeni, BAFA sprejme končni pozitivni sklep („končno izvzetje“).
Based on information provided by the German authorities, nine companies were granted preliminary or final exemptions between August 2010 and December 2013 for different periods (no company was granted an exemption for the whole period 2010-2013).
Če pa podatki kažejo, da pogoji v letu n niso bili izpolnjeni, BAFA sprejme končni negativni sklep, ki razveljavlja prejšnji predhodni sklep.
In addition, two companies were first granted a preliminary exemption, which was however repealed by a final negative decision.
Na podlagi informacij, ki so jih predložili nemški organi, so bila devetim podjetjem med avgustom 2010 in decembrom 2013 odobrena predhodna ali končna izvzetja za različna obdobja (nobenemu podjetju ni bilo odobreno izvzetje za celotno obdobje 2010–2013).
Thus, the total amount of exemptions granted (either final or preliminary) is, according to the German submissions, around EUR 12-13 million.
Ker pojem „določenih razlogov“ v Direktivi 89/105/EGS ni opredeljen dovolj jasno in natančno, zaradi česar imajo države članice diskrecijsko pravico pri njegovi opredelitvi, je Komisija izrazila mnenje, da je ta ukrep mogoče pripisati Nemčiji.
Grounds for initiating the procedure
Poleg tega je Komisija zaradi odsotnosti jasno opredeljenega akta o pooblastitvi za vsako izvzetje zavrnila trditev, da bi se lahko ukrep štel za ukrep splošnega gospodarskega pomena.
On 24 July 2013 the Commission decided to open the formal investigation procedure in accordance with Article 108(2) TFEU (hereinafter ‘opening decision’).
Namesto tega ga je obravnavala kot selektivno prednost v korist določenih farmacevtskih družb, ki se ukvarjajo s proizvodnjo določenega blaga.
The Commission preliminarily concluded that the measure involves State resources, in particular due to the finding that German legislation lays down the prices that insurance funds (public and private) have to pay for pharmaceutical products and that the BAFA, a State authority, by granting exemptions from the mandatory rebates, ensures that these funds pay a higher price for the products in question.
Nazadnje je Komisija izrazila mnenje, da ukrep verjetno izkrivlja konkurenco in vpliva na trgovino med državami članicami.
As the notion of ‘particular reasons’ is not defined sufficiently clear and precise in Directive 89/105, but leaves the Member States discretion in how to define it, the Commission considered that the measure is imputable to Germany.
Na podlagi tega je Komisija zavzela predhodno stališče, da ukrep pomeni državno pomoč.
The Commission, furthermore, due to a lack of a clearly defined entrustment act for each exemption rejected the argument that the measure could be regarded as a measure of general economic interest but rather considered it to constitute a selective advantage in favour of certain pharmaceutical companies active in the production of certain goods.
Komisija je izrazila resne pomisleke glede združljivosti pomoči z notranjim trgom.
Lastly, the Commission considered that it is likely that the measure distorts competition and affects trade between Member States.
Ugotovila je, da je treba upravičence v okviru sheme obravnavati kot podjetja v težavah v smislu smernic za reševanje in prestrukturiranje ter da bi bilo zato treba te smernice uporabiti kot pravno podlago za ocenjevanje združljivosti pomoči.
Against this background the Commission preliminarily considered that the measure constitutes State aid.
Ker se zdi, da ukrep ne izpolnjuje pogojev iz teh smernic o pomoči za reševanje ali prestrukturiranje, je Komisija sprejela predhodni sklep, da pomoč ni združljiva z notranjim trgom.
The Commission raised serious doubts as to the compatibility of the aid with the internal market.
PRIPOMBE ZAINTERESIRANIH STRANI
It observed that the beneficiaries under the scheme have to be considered as firms in difficulty in the meaning of the R&R Guidelines and that those Guidelines should, therefore, be the legal basis on which to assess the compatibility of the aid.
Med formalnim postopkom preiskave je Komisija prejela pripombe pritožnika in več zainteresiranih strani, med drugim obsežno dokumentacijo nemškega zveznega združenja farmacevtske industrije (Bundesverband der Pharmazeutischen Industrie, v nadaljnjem besedilu: BPI) in dokumentacijo farmacevtskih družb, ki jim je bilo odobreno izvzetje v okviru sheme ali pa so zanj zaprosile.
As the measure does not seem to fulfil the conditions under these Guidelines for rescue or restructuring aid, the Commission came to the preliminary conclusion that the aid is not compatible with the internal market.
Pritožnik je vztrajal pri navedbah, da ukrep pomeni nezdružljivo državno pomoč.
COMMENTS FROM INTERESTED PARTIES
Zlasti je poudaril, da je ukrep mogoče pripisati Nemčiji, saj Direktiva 89/105/EGS zgolj določa postopkovno zahtevo glede zagotovitve možnosti vložitve zahtevka za izvzetje, vendar odločitev o odobritvi takega izvzetja prepušča državam članicam.
In the course of the formal investigation procedure the Commission received comments from the complainant as well as from several interested parties, amongst them a substantial submission by the Bundesverband der Pharmazeutischen Industrie (hereinafter ‘BPI’) and submissions by pharmaceutical companies that were either granted an exemption under the scheme or had applied for such an exemption.
Združenje BPI je poudarilo, da sklep o začetku postopka ni upošteval, da morajo prosilci za izvzetje iz zamrznitve cen dokazati vzročno zvezo med svojimi finančnimi težavami in zadevno zamrznitvijo cen, kar pomeni, da brez zamrznitve cen uspešni prosilci ne bi bili v finančnih težavah.
The complainant upheld its arguments that the measure constitutes incompatible State aid.
Poleg tega je trdilo, da niso bila vključena državna sredstva, saj je treba tako zasebne kot javne ponudnike zdravstvenega zavarovanja šteti za neodvisne od države.
In particular it stressed that the measure is imputable to Germany, as Directive 89/105 merely lays down a procedural requirement to foresee the possibility to apply for exemptions but leaves the decision whether to ever grant such exemptions to the Member States.
Po analogiji s podobno sodno prakso Sodišča na področju splošnih davčnih ukrepov je navedlo, da ukrep ni selektiven, temveč splošen, saj nemška ustava od zakonodajalcev zahteva sprejetje klavzule o finančnih težavah, da bi se preprečilo pretirano poseganje v pravice zasebnih strank.
The BPI stressed that the opening decision did not take into account that applicants for exemptions from the price freeze must prove a causal link between their financial difficulties and said price freeze, meaning that the successful applicants would not have been in financial difficulties if it were not for the price freeze.
Združenje BPI je trdilo tudi, da ukrepa ni mogoče pripisati Nemčiji, saj ji izvajanje člena 4(2) Direktive 89/105/EGS neposredno narekuje primarna zakonodaja EU, in sicer členi 15, 16 in 52 Listine Evropske unije o temeljnih pravicah (v nadaljevanju: Listina) [8].
It, furthermore, argued that no State resources are involved as both private and public health insurances should be regarded as being independent from the State.
Če pa bi Komisija kljub temu sklenila, da ukrep pomeni državno pomoč, združenje BPI navaja, da imajo smernice za reševanje in prestrukturiranje drugačne cilje (prestrukturiranje podjetij v težavah) kot ukrep (klavzula o finančnih težavah, ki nemški zakonodaji preprečuje, da bi prisilila v stečaj sicer uspešna podjetja) in da se zato ne bi smele uporabljati.
It submitted, in analogy to similar case law by the Court concerning general tax measures, that the measure is not selective but constitutes a general measure as the German constitution requires the legislature to foresee hardship clauses to prevent excessive interferences into the rights of private parties.
Glede na to bi bilo treba združljivost z notranjim trgom oceniti neposredno na podlagi PDEU.
Furthermore, the BPI argued that the measure is not imputable to Germany, as the German implementation of Article 4(2) of Directive 89/105 is directly required by EU primary law, namely Articles 15, 16 and 52 of the Charter of Fundamental Rights [8].
BPI zlasti poudarja, da mora EU v skladu s členom 168(7) PDEU upoštevati odgovornosti držav članic za opredelitev njihove zdravstvene politike ter za organizacijo in zagotavljanje zdravstvenih storitev in zdravstvenega varstva, vključno z razporejanjem sredstev, dodeljenih za zdravstvene storitve in zdravstveno varstvo.
In case the Commission, nevertheless, concludes that the measure constitutes State aid, the BPI submits that the R & R Guidelines pursue different aims (restructuring of firms in difficulties) than the measure (hardship clause preventing German legislation from forcing otherwise healthy undertakings into bankruptcy) and should, therefore, not be applicable.
Kot je navedeno zgoraj, je Komisija poleg dokumentacije pritožnika in BPI prejela pripombe devetih farmacevtskih družb.
Thus, the compatibility should rather be assessed directly on the basis of the Treaty.
Vse te družbe so upravičenke v okviru sheme ali pa so neuspešno zaprosile za izvzetje.
In particular, the BPI points out that Article 168(7) TFEU states that the EU must respect the responsibilities of the Member States for the definition of their health policy and for the organisation and delivery of health services and medical care, including the allocation of the resources assigned to health services and medical care.
Zaradi delno prekrivajočih se navedb so pripombe teh devetih zainteresiranih strani skupaj povzete v nadaljevanju.
As stated above, in addition to the submissions by the complainant and the BPI, the Commission received comments by 9 pharmaceutical companies.
V skladu s temi pripombami ukrep pomeni zgolj uravnavanje cen in ne vključuje državnih sredstev, saj niso bila prenesena nobena sredstva z države na upravičence.
All these companies are either beneficiaries under the scheme or had unsuccessfully applied for an exemption.
Zadevni denar je mogoče pripisati izključno upravičencem.
Due to partly overlapping arguments, the submissions by these 9 interested parties are summarised together below.
Poleg tega se postavlja vprašanje, ali je država sploh kdaj nadzorovala denar, saj naj bi bile zdravstvene zavarovalnice organi, ki so neodvisni od države, in da zato njihovih finančnih sredstev ni mogoče šteti za državna sredstva.
According to these submissions the measure merely constitutes a price regulation and, due to the lack of a transfer of resources from the State to the beneficiaries, does not involve State resources.
Dodatno več zainteresiranih strani trdi, da njihovi izdelki sodijo med najcenejše na trgu.
The money involved is rather money that is exclusively attributable to the beneficiaries.
To zlasti velja za vzporedne uvoznike, ki uvožene izdelke ponujajo po znatno nižji ceni kot proizvajalci.
Furthermore, it is also questioned whether the money is ever under the control of the State, as it is argued that the health insurance funds are bodies independent from the State and as such their financial means should not be regarded as State resources.
Zainteresirane strani trdijo, da bodo brez izvzetij iz zamrznitve cen prisiljene v stečaj.
In addition, several of the third parties submit that their products are amongst the cheapest on the market.
Ker bodo morale zaradi tega zapustiti trg, bodo na voljo samo dražji izdelki.
This is in particular true for parallel-importers, who offer the imported products at a price considerably lower than their producers.
Z odobritvijo izvzetij in ohranitvijo podjetij na trgu ukrep dejansko znižuje stroške za zdravstvene zavarovalnice, kar pomeni, da se bodo brez ukrepa stroški in prenosi javnih sredstev na farmacevtske družbe povečali.
The third parties argue that without the exemptions to the price freeze they will be forced into bankruptcy.
Poleg tega je navedeno, da ukrepa ni mogoče pripisati Nemčiji, saj načrtovana izvzetja pomenijo zgolj obvezno izvajanje člena 4(2) Direktive 89/105/EGS.