natgillin/translations-raw huggingface dataset:
In the current markets, the refinancing of our debt is simply out of the question’.
Presuda Suda od 14. rujna 1994., Španjolska protiv Komisije, C-278/92 do C-280/92, ECLI:EU:C:1994:325, t.
Some even take the view that the Company would not have been able to find the necessary liquidity on the market in the event of a downgrading of its credit rating.
20. i navedena sudska praksa, i presuda Suda od 8. svibnja 2003., Italija i SIM 2 Multimedia protiv Komisije, C-399/00 i C-328/99, ECLI:EU:C:2003:252, t.
See, for example, page 9 of the abovementioned report by Goldman Sachs of 22 July 2002: ‘If these bonds moved from the investment grade segment of the fixed income market, to “junk”, i.e. high yield, they would swamp the current European high yield market … we believe it would be difficult for the existing European investor base alone to absorb all France Telecom bonds. ’
36. i navedena sudska praksa.
NERA report: ‘The results of an event study analysing the effect on share and bond prices of the announcement on 12 July 2002.
Presuda Suda od 2. rujna 2010., Komisija protiv Deutsche Post, C-399/08 P, ECLI:EU:C:2010:481, t.
The study shows that there is a strong positive effect: as a result of the statement, market participants believed the cash flows that France Télécom would generate were going to be higher than they would have been otherwise.
40. i navedena sudska praksa.
France Télécom LT Rating cut to ‘BBB-’; Off Watch; Outlook Stable; Teleconf 3:30PM BST Today , Standard & Poor's Ratings Direct, 12 July 2002.
Vidjeti izjave Michela Bona, prethodnog direktora društva, objavljene u medijima: članak u La Tribuneu od 16. rujna 2002. „… snižavanje kreditnog rejtinga sprječava predviđena refinanciranja”; članak u Le Mondeu od 16. rujna 2002. „snižavanje kreditnog rejtinga koji je agencija za kreditni rejting Moody's dodijelila dugu društva FT provedeno na kraju lipnja […] onemogućila nam je pristup tržištu”; članak iz časopisa Financial Times od 16. rujna 2002. „FT cannot continue to survive when no one wants to lend us money and, on the contrary, when everyone wants to be paid on the nail.
Board meeting presentation, France Télécom stock-taking exercise, December 2002, p. 36.
In the current markets, the refinancing of our debt is simply out of question.”.
Judgment of the Court, European Commission v Deutsche Post AG, C-399/08 P, ECLI:EU:C:2010:481, paragraph 38 and case law cited.
„Step up” klauzulom određuje se povećanje kuponske stope i kamatnih stopa za kreditne linije paralelno s padom kreditnog rejtinga.
By judgment of 19 March 2013 (‘the Bouygues judgment’), the Court of Justice set aside the judgment of 21 May 2010 and referred Cases T-425/04, T-444/04 and T-450/04 back to the General Court for a ruling on the pleas in law raised and the applications submitted to it which it had not previously ruled on.
247.
Rating agencies and analysts alike were convinced that France Télécom risked not being able to implement the refinancing plan presented by its management in order to meet its maturities.
Vidjeti, na primjer, „Moody's now expects that a combination of this facility headroom under the existing EUR 15 billion syndicated facility and the free cash flow will enable debt maturities of EUR 15 billion to be repaid during the next 12 months.”, Moody's 9. prosinca 2002.
They mention the fact that, on 14 February 2002, France Télécom negotiated the provision of a syndicated credit line of EUR 15 billion and that during the course of 2002 the Company issued bonds, EUR 442,2 million worth of which was repayable in shares.
Raspored dospijeća tog duga karakteriziran je svojim kratkim trajanjem; 12,9 milijardi eura dospijeva na naplatu 2003.
The French authorities also stress that the legitimacy of such a measure could not be challenged because, as is mentioned above, it was based on a credible, detailed plan the content of which was mostly known at the time of the announcement of the loan proposal on 4 December 2002.
Tijekom prve polovine 2004. na naplatu dospijeva iznos od 11,9 milijardi eura, u drugoj polovini 2004. iznos od 5,5 milijardi eura, a tijekom 2005. na naplatu dospijeva ukupni iznos od 18,6 milijardi eura.
Moreover, the State had already received the undertaking, conditional on the presentation to the market of a credible plan, from the banking syndicate and it knew full well at the end of November that that condition would be met given the market's positive reaction to the appointment of the new management.
Relevantni odlomci priopćenja glase kako slijedi: „Francis Mer, ministar gospodarstva, financija i industrije, potvrđuje podršku države akcijskom planu koji je upravni odbor društva France Télécom odobrio 4. prosinca.
(notified under document C(2018) 6943)
(priopćeno pod brojem dokumenta C(2018) 6943)
Having regard to Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, and in particular Article 8(2) thereof,
uzimajući u obzir Direktivu Vijeća 93/42/EEZ od 14. lipnja 1993. o medicinskim proizvodima, a posebno njezin članak 8. stavak 2.,
On 16 August 2016, the French authorities adopted a decision based on the national provisions transposing Directive 93/42/EEC (hereinafter ‘Directive 93/42/EEC’ or ‘the Directive’) with regard to two medical devices with the same composition, the same route of administration and the same purposes, marketed under the names ‘Terrafor’ or ‘Defiligne’ (hereinafter ‘the device’), and manufactured by the Claytone-Terrafor Laboratory (hereinafter ‘the manufacturer’).
Francuska tijela donijela su 16. kolovoza 2016. odluku na temelju nacionalnih odredbi kojima se prenosi Direktiva 93/42/EEZ (u daljnjem tekstu „Direktiva 93/42/EEZ” ili „Direktiva”) koja se odnosi na dva medicinska proizvoda istog sastava, puta primjene i namjene, koji su stavljeni na tržište pod nazivima „Terrafor” ili „Defiligne” (dalje u tekstu „proizvod”) i koje proizvodi laboratorij Claytone-Terrafor (dalje u tekstu „proizvođač”).
As a consequence, the decision provides that ‘the manufacture, placing on the market, distribution, export and use of the Terrafor and Defiligne medical devices […] shall be suspended until the products have been brought into line with the legislative and regulatory provisions which apply to them’.
Stoga se odlukom predviđa da se „proizvodnja, stavljanje u promet, distribucija, izvoz i uporaba medicinskih proizvoda Terrafora i Defilignea […] obustavljaju do njihova usklađivanja s relevantnim zakonima i propisima”; osim toga, „laboratorij Claytone-Terrafor mora povući medicinske proizvode Defiligne i Terrafor od svih predmetnih distributera”.
Moreover, ‘the Claytone-Terrafor laboratory is required to withdraw the Terrafor and Defiligne medical devices from all the distributors concerned’.
Dopisom od 4. listopada 2016. francuska su tijela obavijestila Komisiju o svojoj odluci od 16. kolovoza 2016. u skladu s Direktivom 93/42/EEZ.
By letter of 4 October 2016, the French authorities notified the Commission of their decision of 16 August 2016 in the context of Directive 93/42/EEC.
U okviru savjetovanja iz članka 8. stavka 2.
As part of the consultations referred to in Article 8(2) of Directive 93/42/EEC, the Commission sent the manufacturer an email on 26 October 2016 asking it to state its position on the decision taken by the French authorities.
Direktive 93/42/EEZ službe Komisije pozvale su proizvođača porukom e-pošte od 26. listopada 2016. da navede svoje stajalište o odluci francuskih tijela.
By letter of 30 November 2016, the manufacturer sent the Commission a memorandum setting out its reasons for contesting the decision taken by the French authorities.
Dopisom od 30. studenoga 2016. proizvođač je službama Komisije dostavio memorandum u kojem navodi razloge zbog kojih osporava odluku francuskih tijela.
On 19 December 2016, at the manufacturer's request, a meeting was held between the manufacturer and the Commission.
Dana 19. prosinca 2016. na zahtjev proizvođača održan je sastanak između proizvođača i službi Komisije.
The Commission asked the manufacturer several times to send that document to the French authorities.
U srpnju 2017. proizvođač je Europskom ombudsmanu podnio pritužbu u vezi s kašnjenjem Komisije u donošenju odluke.
The manufacturer did so several months later, in August 2017.
Ombudsman je 5. travnja 2018. odlučio zatvoriti predmet zaključivši da nije bilo nepravilnosti u postupanju Komisije u obradi ovog predmeta.
At the same time, the Commission exchanged e-mails with the French authorities in order to obtain further information.
Porukom e-pošte od 20. studenoga 2017. belgijska tijela obavijestila su Komisiju o svojoj odluci od 28. listopada 2016. o zabrani stavljanja u promet, stavljanja u uporabu, distribucije i uvoza medicinskog proizvoda Terrafora te o povlačenju tog proizvoda iz prometa.
In July 2017, the manufacturer submitted a complaint to the European Ombudsman concerning the Commission's delay in adopting a decision.
Dana 7. veljače 2018. na zahtjev proizvođača održan je sastanak između proizvođača, francuskih i belgijskih tijela, laboratorija NAMSA te službi Komisije.
On 5 April 2018, the Ombudsman decided to close the case, concluding that there had been no maladministration on the Commission's part in its handling of the case.
U ožujku 2018. službe Komisije poslale su dodatna pisana pitanja proizvođaču, njegovu prijavljenom tijelu (TÜV Rheinland LGA Products GMBH) te belgijskim i francuskim tijelima, koji su odgovorili na ta pitanja tijekom ožujka i travnja 2018.
By email of 20 November 2017, the Belgian authorities notified the Commission of their decision of 28 October 2016 to prohibit the placing on the market, putting into service, distribution and importation of the Terrafor medical device, and to order the withdrawal of the device from the market.
ISPITIVANJE OPRAVDANOSTI MJERE
On 7 February 2018, at the manufacturer's request, a meeting was held between the manufacturer, the French authorities, the Belgian authorities, the NAMSA laboratory and the Commission.
Direktivom 93/42/EEZ uspostavlja se sustav prema kojem medicinski proizvodi moraju biti u skladu s bitnim zahtjevima propisanima u Prilogu I. te direktive koji se na njih odnose (članak 3. prvi stavak).
In March 2018, the Commission submitted additional written questions to the manufacturer, to its notified body (TÜV Rheinland LGA Products GmbH) and to the Belgian and French authorities.
Kako bi dokazao poštovanje tih bitnih zahtjeva, proizvođač mora primijeniti jedan od postupaka ocjenjivanja sukladnosti iz te direktive, što omogućuje stavljanje CE oznake sukladnosti na proizvode (članak 11. i članak 17. stavak 1.).
They replied to these questions during March and April 2018.
Proizvodi koji nose CE oznaku sukladnosti, kojom se označava da je ocijenjena njihova sukladnost, mogu se slobodno kretati unutar Unije (članak 4. stavak 1.).
EXAMINATION OF THE JUSTIFICATION FOR THE MEASURE
Međutim, u skladu s člankom 8.
Directive 93/42/EEC establishes a system under which medical devices must meet the essential requirements set out in Annex I to the Directive which apply to them (Article 3, first paragraph).
(Zaštitna klauzula) Direktive 93/42/EEZ, „ako neka država članica utvrdi da proizvodi […] ispravno instalirani, održavani i upotrebljavani u skladu s njihovom namjenom, mogu ugroziti zdravlje i/ili sigurnost pacijenata, korisnika ili, gdje je to primjenjivo, drugih osoba, ona je dužna poduzeti sve odgovarajuće privremene mjere da povuče takve proizvode iz prometa ili zabrani ili ograniči njihovo stavljanje u promet ili stavljanje u uporabu.
In order to prove compliance with these essential requirements, the manufacturer must follow one of the conformity assessment procedures provided for in the Directive, which allows the CE marking to be affixed to the devices (Article 11 and Article 17(1)).
Ta država članica odmah obavješćuje Komisiju o svim takvim mjerama, [i] navodi razloge za svoju odluku […]” (članak 8. stavak 1.).
Devices bearing the CE marking indicating that they have undergone a conformity assessment may move freely within the Union (Article 4(1)).
Komisija tada mora utvrditi jesu li mjere opravdane ili nisu (članak 8. stavak 2.).
However, in accordance with Article 8 (safeguard clause) of Directive 93/42/EEC, ‘where a Member State ascertains that the devices […], when correctly installed, maintained and used for their intended purpose, may compromise the health and/or safety of patients, users or, where applicable, other persons, it shall take all appropriate interim measures to withdraw such devices from the market or prohibit or restrict their being placed on the market or put into service.
Stoga države članice moraju procijeniti može li proizvod ugroziti zdravlje ili sigurnost ljudi i, ako je tako, poduzeti potrebne mjere.
The Member State shall immediately inform the Commission of any such measures, indicating the reasons for its decision […]’ (Article 8(1)).
Taj postupak podrazumijeva da nacionalna tijela možda moraju provesti složene tehničke ili znanstvene ocjene.
The Commission must then determine whether the measures are justified or not (Article 8(2)).
Komisija mora nadzirati opravdanost tih mjera i posebno osigurati osnovanost pravnih i činjeničnih razloga za njihovo donošenje.
It is therefore for the Member States to determine whether a product is liable to compromise the health and safety of persons and, if so, to take the requisite measures.
U tom smislu Komisija uživa znatna diskrecijska prava.
Such an exercise may entail complex technical and scientific assessments on the part of the national authorities.
U predmetnom slučaju francuska tijela u odluci i obavijesti dostavljenima 4. listopada 2016. smatraju da predmetni proizvodi „mogu predstavljati rizik za zdravlje” i „ne poštuju bitne zahtjeve”.
It is for the Commission to verify whether or not these measures are justified, and in particular to make sure that the legal and factual reasons for their adoption are valid.
Postojanje rizika za zdravlje i/ili sigurnost osoba, osobito zbog nepoštovanja bitnih zahtjeva iz Priloga I. Direktivi 93/42/EEZ, podrazumijeva pokretanje postupka zaštitne klauzule na temelju članka 8. stavka 1. te direktive.
The Commission enjoys wide discretion in this context.
Iz toga slijedi da se u ovom slučaju primjenjuje postupak zaštitne klauzule te Komisija mora utvrditi je li mjera koju su poduzela francuska tijela opravdana ili ne.
In the present case, in the decision and note notified on 4 October 2016, the French authorities take the view that the devices in question ‘may pose a risk to health’ and ‘do not comply with the essential requirements’.
U odluci francuskih tijela predviđa se obustava „proizvodnje, stavljanja u promet, distribucije, izvoza i uporabe” proizvoda te povlačenje proizvoda od predmetnih distributera.
However, where there is a risk to the health and/or safety of persons, resulting in particular from failure to comply with the essential requirements referred to in Annex I to Directive 93/42/EEC, a safeguard clause procedure may be initiated under Article 8(1) of that Directive.
Budući da se Direktivom 93/42/EEZ predviđa da se medicinski proizvodi mogu staviti u promet i/ili u uporabu samo ako poštuju zahtjeve Direktive (članak 2.) i da države članice ne smiju stvarati nikakve prepreke stavljanju u promet ili stavljanju u uporabu proizvoda čija je sukladnost ocijenjena u skladu s Direktivom kako bi se dokazalo da poštuju zahtjeve (članak 4.) i s obzirom na to da se člankom 8.
It follows that, in the present case, the safeguard clause procedure applies, with the result that it is for the Commission to determine whether the measure taken by the French authorities is justified or not.
Direktive predmetnoj državi članici nalaže da, ako postoji rizik za zdravlje ili sigurnost, poduzme mjere da „povuče takve proizvode iz prometa ili zabrani ili ograniči njihovo stavljanje u promet ili stavljanje u uporabu” te Komisiji nalaže da ispita opravdanost tih mjera, ova Odluka Komisije odnosi se na mjeru francuskih tijela kojom se ograničava prisutnost predmetnog proizvoda na tržištu.
The decision taken by the French authorities makes provision for suspension of the ‘manufacture, placing on the market, distribution, exportation and use’ of the device and its withdrawal from the distributors concerned.
Iz odluke koju su dostavila francuska tijela i savjetovanja sa zainteresiranim stranama proizlazi da se dovodi u pitanje poštovanje bitnih zahtjeva Direktive koji se odnose na omjer koristi i rizika i svođenje rizika na najmanju moguću mjeru te na ispravnu primjenu normi.
As Directive 93/42/EEC essentially provides that medical devices may be placed on the market and/or put into service only if they meet the requirements of the Directive (Article 2) and that the Member States must not create any obstacle to the placing on the market and/or the putting into service of devices which, in order to prove compliance with the requirements, have been the subject of an assessment of their conformity in accordance with the Directive (Article 4) and as Article 8 of the Directive requires the Member State concerned, where there is a risk to health or safety, to take measures ‘to withdraw such devices from the market or prohibit or restrict their being placed on the market or put into service’ and requires the Commission to verify whether such measures are justified, this Commission Decision relates to the measure taken by the French authorities to restrict the presence on the market of the device in question.
Nepoštovanje bitnih zahtjeva
It is clear from the decision notified by the French authorities and from the consultations conducted with the interested parties that compliance with the essential requirements of the Directive concerning the risk/benefit ratio and minimising risk and the proper application of standards are being called into question.
Bitni zahtjevi koji se odnose na omjer koristi i rizika
Failure to comply with essential requirements
U točki 1.
Essential requirements concerning the risk/benefit ratio
Priloga I. Direktivi 93/42/EEZ utvrđeno je sljedeće: „Proizvodi moraju biti projektirani i proizvedeni tako da, korišteni u predviđenim uvjetima i za predviđenu namjenu, ne ugrožavaju kliničko stanje ni sigurnost pacijenata, ni sigurnost ni zdravlje korisnika ni, gdje je primjenjivo, drugih osoba, uz uvjet da svi rizici koji se eventualno povezuju s njihovom uporabom tvore prihvatljive rizike u usporedbi s korišću za pacijenta i uključuju visoku razinu zaštite zdravlja i sigurnosti […]”.
Section 6 of Annex I to the Directive provides: ‘Any undesirable side-effect must constitute an acceptable risk when weighed against the performances intended’.
Priloga I. toj direktivi utvrđeno je sljedeće: „Svaki štetni događaj mora predstavljati prihvatljivi rizik u usporedbi s namijenjenim učincima.”
As regards the risks, it should be pointed out at the outset that the risk caused by the ingestion of lead is widely documented, in particular in the publications cited by the ‘Guideline for elemental impurities – Q3D’ drawn up by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), in the ‘Report on Carcinogens, fourteenth edition’ of the U.S. Department of Health and Human Services, in the ‘Scientific opinion on lead in food’ of the European Food Safety Authority (EFSA) and in the publications cited by Commission Regulation (EC) No 1881/2006.
Kada je riječ o riziku, treba prije svega reći da je rizik od unosa olova u velikoj mjeri dokumentiran, posebno u publikacijama navedenima u „Smjernicama o elementarnim nečistoćama – Q3D”, koje je sastavilo Međunarodno vijeće za usklađivanje tehničkih zahtjeva za lijekove za ljudsku uporabu (ICH), u „Izvješću o karcinogenim tvarima, četrnaesto izdanje” američkog Ministarstva zdravstva i socijalne skrbi, u „Znanstvenom mišljenju o olovu u hrani” Europske agencije za sigurnost hrane (EFSA) i u publikacijama iz Uredbe Komisije (EZ) br. 1881/2006.
Moreover, the French authorities refer to the ‘Guideline for elemental impurities – Q3D’ (hereinafter ‘Guideline ICH Q3D’), drawn up by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), adopted by the European Medicines Agency (EMA) in December 2014 and applied by it to new applications for authorisation to place medicinal products on the market as of June 2016 and to existing authorisations for placing medicinal products on the market as of December 2017.
U Smjernicama je određena dopuštena dnevna izloženost za elemente koji uzrokuju zabrinutost u pogledu toksičnosti.
This Guideline concerns elemental impurities in medicinal products, namely elements which do not provide any therapeutic benefit to the patient, with the result that their levels must remain within acceptable limits.
Za olovo je navedeno da izloženost tom elementu može utjecati na neurološki, reproduktivni, imunološki i kardiovaskularni sustav te na bubrege; dopuštena dnevna izloženost određena je na 5 μg dnevno, neovisno o putu primjene.
It establishes a permitted daily exposure for elements of toxicological concern.
Prema analizama na koje se pozivaju francuska tijela udio olova u proizvodu iznosi od 16 do 22,9 μg/g.
For lead, the Guideline indicates that exposure to this element may cause neurological, reproductive, immune, cardiovascular and renal health effects; it establishes permitted daily exposure at 5 μg per day, irrespective of the route of administration.
Doza od šest kapsula od 335 mg dnevno (što znači 2 g dnevno), kako je navedeno u uputama za uporabu proizvoda, odgovara količini od 32 do 46 μg konzumiranog olova dnevno, čime se višestruko premašuje referentna granična vrijednost od 5 μg dnevno.
The tests to which the French authorities refer show that the device contains levels of lead between 16 and 22,9 μg/g.
U pogledu primjene Smjernica ICH Q3D treba istaknuti da se one, iako se službeno primjenjuju na lijekove, odnose na prisutnost elemenata (uključujući olovo) koji ne pridonose liječenju (elementarne nečistoće) i koji uzrokuju zabrinutost u pogledu toksičnosti proizvoda koji se unose, među ostalim, oralnim putem.
A course of treatment involving six capsules of 335 mg per day (i.e. 2 g per day), as provided for in the instructions for use of the device, corresponds to an ingested amount of lead of between 32 and 46 μg per day, which is several times higher than the reference threshold of 5 μg per day.
Stoga se mogu smatrati relevantnima za procjenu rizika povezanog s uporabom medicinskog proizvoda koji sadržava olovo kao nečistoću i koji se unosi oralnim putem.
With regard to use of Guideline ICH Q3D, it should be pointed out that this Guideline, while it applies formally to medicinal products, concerns the presence of elements (including lead) which do not provide any therapeutic benefit (elemental impurities) and which raise toxicological concerns in products administered orally, amongst other routes.
Naposljetku, treba napomenuti da proizvođač ne osporava prisutnost olova u proizvodu.
It may therefore be considered relevant in assessing the risk associated with using a medical device which contains lead as an impurity and which is administered orally.
Štoviše, proizvođač ne osporava činjenicu da proizvod ispušta olovo, iako smatra da je to ispuštanje na vrlo niskoj razini.
Finally, it should be pointed out that the manufacturer does not contest the fact that the device contains lead.
Osim toga, proizvođač navodi da su rizici utvrđeni u izvješćima na koja upućuju francuska tijela – odnosno kardiovaskularni, neurološki i nefrotoksični učinci olova kod ljudi – uzeti u obzir u napomenama u uputama za uporabu proizvoda te je time osigurano poštovanje bitnih zahtjeva iz točke 1.
Nor does the manufacturer contest the fact that lead is released by the device, albeit to a minor extent.
Priloga I. Direktivi; on time priznaje da uporaba proizvoda predstavlja rizik, no smatra da je razina rizika prihvatljiva.