natgillin/translations-raw huggingface dataset:
To ne bi smelo posegati v pravice držav članic, da določijo merila ali pogoje za predhodno odobritev v primeru, da pacienti iščejo zdravstveno varstvo v državi članici njihovega zdravstvenega zavarovanja.
This should be without prejudice to the rights of the Member States to lay down criteria or conditions for prior authorisation in the case of patients seeking healthcare in their Member State of affiliation.
Ker so pogoji, merila in formalnosti v zvezi s pravicami do zdravstvenega varstva, kot je na primer opredelitev stroškovne učinkovitosti specifičnega zdravljenja, v pristojnosti države članice zdravstvenega zavarovanja, se ti pogoji, merila in formalnosti ne smejo zahtevati tudi v državi članici zdravljenja, saj bi to pomenilo oviro za prosti pretok blaga, oseb in storitev.
Since conditions, criteria and formalities relating to entitlements to healthcare, such as determining the cost-effectiveness of a specific treatment, is a matter for the Member State of affiliation, such conditions, criteria and formalities cannot be required in the Member State of treatment as well, as this would constitute an obstacle to the free movement of goods, persons and services.
Vendar lahko država članica zdravljenja določi pogoje, merila in formalnosti, povezane s kliničnimi okoliščinami, kot je na primer ocena tveganja za varnost pacienta povezana z izvajanjem določenega postopka na določenem pacientu.
However, the Member State of treatment may impose conditions, criteria and formalities relating to clinical circumstances, such as assessing the patient-safety risks involved in performing a specific procedure on a specific patient.
Poleg tega lahko ti pogoji, merila in formalnosti vključujejo postopek, s katerim se zagotovi, da pacient, ki išče zdravstveno varstvo v drugi državi članici, razume, da za prejeto zdravstveno varstvo veljajo zakoni in predpisi države članice zdravljenja, vključno s standardi kakovosti in varnosti ter drugimi standardi, ki jih zahteva ta država članica, in da je ta oseba prejela vso tehnično, strokovno in zdravstveno podporo, potrebno za sprejetje ozaveščene odločitve glede izbire izvajalca zdravstvenega varstva, dokler ta postopek ni niti diskriminatoren niti ne predstavlja ovire za prosti pretok blaga, oseb ali storitev.
Furthermore, these conditions, criteria and formalities may include a procedure that ensures that a person seeking healthcare in another Member State understands that the healthcare received will be subject to laws and regulations of the Member State of treatment, including standards on quality and safety and other standards required by that Member State, and that this person has been provided with all technical, professional and medical support required for making an informed choice of healthcare provider, so long as such a procedure is neither discriminatory nor an obstacle to the free movement of goods, persons or services.
(36) Iz stalne sodne prakse Sodišča izhaja, da lahko države članice za kritje stroškov bolnišnične oskrbe v drugi državi članici iz nacionalnega sistema zahtevajo predhodno odobritev.
(36) According to the constant case law of the Court of Justice, Member States may make the assumption of costs by the national system of hospital care provided in another Member State subject to prior authorisation.
Sodišče je presodilo, da je takšna zahteva nujna in razumna, saj so število bolnišnic, njihova geografska razporeditev, način njihove organizacije in prostori, ki jih imajo na razpolago, ter celo narava zdravstvenih storitev, ki jih lahko ponudijo, vprašanja, za katera mora biti omogočeno načrtovanje, ki je v splošnem namenjeno izpolnjevanju različnih potreb.
The Court of Justice has judged that this requirement is both necessary and reasonable, since the number of hospitals, their geographical distribution , the way in which they are organised and the facilities with which they are equipped, and even the nature of the medical services which they are able to offer, are all matters for which planning, generally designed to satisfy various needs, must be possible.
Sodišče je ugotovilo, da je cilj takšnega načrtovanja zagotoviti zadosten in stalen dostop do uravnotežene ponudbe visokokakovostne bolnišnične oskrbe v zadevni državi članici.
The Court of Justice has found that such planning seeks to ensure that there is sufficient and permanent access to a balanced range of high-quality hospital treatment in the Member State concerned.
Poleg tega to prispeva k želenemu obvladovanju stroškov in, kolikor je mogoče, tudi preprečevanju nenamenske porabe finančnih, tehničnih in človeških virov.
In addition, it assists in meeting a desire to control costs and to prevent, as far as possible, any wastage of financial, technical and human resources.
Po mnenju Sodišča bi bila takšna nenamenska poraba toliko bolj škodljiva, ker sektor bolnišnične oskrbe, kot je splošno znano, povzroča znatne stroške in mora izpolnjevati vse večje potrebe, medtem ko finančni viri, namenjeni zdravstvenemu varstvu, niso neomejeni, in to ne glede na način financiranja.
According to the Court of Justice, such wastage would be all the more damaging because it is generally recognised that the hospital care sector generates considerable costs and must satisfy increasing needs, while the financial resources made available for healthcare are not unlimited, whatever mode of funding is applied.
(36) Razpoložljivi podatki kažejo, da uporaba načel prostega pretoka v zvezi z uporabo storitev zdravstvenega varstva v drugi državi članici v mejah kritja, ki ga zagotavlja sistem obveznega zdravstvenega zavarovanja države članice pacientovega zdravstvenega zavarovanja, ne ogroža zdravstvenih sistemov držav članic ali finančne vzdržnosti njihovih sistemov socialne varnosti.
(36) The evidence available indicates that the application of free movement principles regarding use of healthcare in another Member State within the limits of the cover guaranteed by the statutory sickness insurance scheme of the Member State of affiliation will not undermine the health systems of the Member States or financial sustainability of their social security systems.
Vendar je Sodišče potrdilo, da ne more biti izključeno, da je lahko morebitna resna ogrozitev finančnega ravnotežja sistema socialne varnosti ali cilja ohranitve uravnotežene in vsem dostopne zdravstvene in bolnišnične storitve glavni razlog javnega interesa, ki lahko utemelji omejitev načela svobodnega opravljanja storitev.
However, the Court of Justice has recognised that it cannot be excluded that the possible risk of seriously undermining a social security system's financial balance or the objective of maintaining a balanced medical and hospital service open to all may constitute overriding reasons in the general interest capable of justifying a barrier to the principle of freedom to provide services.
Sodišče je prav tako potrdilo, da mora biti omogočeno načrtovanje za vprašanja, kot so število bolnišnic, njihova geografska razporeditev, način organizacije in prostori, ki jih imajo na razpolago, ter celo narava zdravstvenih storitev, ki jih lahko ponudijo.
The Court of Justice has also recognised that the number of hospitals, their geographical distribution , the way in which they are organised and the facilities with which they are provided, and even the nature of the medical services which they are able to offer, are all matters for which planning must be possible.
Ta direktiva bi morala zagotoviti sistem predhodne odobritve za prevzem stroškov za bolnišnično oskrbo v drugi državi članici, kadar so izpolnjeni naslednji pogoji: če bi bilo zdravljenje zagotovljeno na ozemlju matične države članice, bi ga kril njen socialnovarstveni sistem, posledični odhod pacientov zaradi izvajanja direktive pa resno ogroža ali bo verjetno resno ogrožal finančno ravnotežje sistema socialne varnosti in/ali ta odhod pacientov resno ogroža ali bo verjetno resno ogrožal načrtovanje in racionalizacijo v sektorju bolnišnic za zmanjšanje preobremenjenosti bolnišnic, neuravnoteženosti zagotavljanja bolnišnične oskrbe ter logistični in finančni izgubi, vzdrževanje vsem dostopne uravnotežene zdravniške in bolnišnične storitve ali vzdrževanje zmogljivosti zdravljenja ali zdravniških kompetenc na ozemlju zadevne države članice.
This Directive should provide for a system of prior authorisation for assumption of costs for hospital care received in another Member State, where the following conditions are met : had the treatment been provided on its territory, it would have been assumed by its social security system and the consequent outflow of patients due to the implementation of the directive seriously undermines or is likely to seriously undermine the financial balance of the social security system and/or that outflow of patients seriously undermines, or is likely to seriously undermine, the planning and rationalisation carried out in the hospital sector to avoid hospital overcapacity, imbalance in the supply of hospital care and logistical and financial wastage, the maintenance of a balanced medical and hospital service open to all, or the maintenance of treatment capacity or medical competence on the territory of the Member State concerned.
Ocena natančnega učinka pričakovanega odhoda pacientov zahteva kompleksne predpostavke in izračune, zato ta direktiva omogoča sistem predhodne odobritve, če se lahko na podlagi zadostnih razlogov pričakuje, da bo sistem socialne varnosti resno ogrožen.
As the assessment of the precise impact of an expected outflow of patients requires complex assumptions and calculations, this Directive allows for a system of prior authorisation if there is sufficient reason to expect that the social security system will be seriously undermined.
To bi moralo zajemati tudi primere že obstoječih sistemov predhodne odobritve, ki so v skladu s pogoji iz člena 8.
This should also cover cases of already existing systems of prior authorisation which are in conformity with conditions laid down in Article 8.
(Stališče EP o uvodni izjavi 38)
(EP position recital 38)
(36a) Redke bolezni dosegajo prag razširjenosti do največ pet obolelih na deset tisoč oseb, v skladu z Uredbo (ES) št. 141/2000 Evropskega parlamenta in Sveta z dne 16. decembra 1999 o zdravilih sirotah*, vse pa so resne, kronične ter pogosto življenjsko nevarne.
(36a) R are diseases meet a prevalence threshold of not more than five affected persons per 10 thousand , in line with Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products *, and they are all serious, chronic and often life threatening .
Pacienti, oboleli za redko boleznijo, se soočajo s težavami pri iskanju diagnoze in zdravljenja, da bi izboljšali kakovost svojega življenja in podaljšali pričakovano življenjsko dobo.
P atients affected by rare diseases face difficulties in their quest for a diagnosis and treatment to improve their quality of life and to increase their life expectancy;
(38) Glede na to, da so države članice odgovorne za določitev pravil o upravljanju, zahtevah, standardih kakovosti in varnosti ter organizaciji in izvajanju zdravstvenega varstva in da se potrebe po načrtovanju razlikujejo od ene države članice do druge, bi morale zato države članice v skladu z merili, določenimi v tej direktivi, in ob upoštevanju sodne prakse Sodišča odločiti, ali je treba uvesti sistem predhodne odobritve, in če da, v okviru svojega sistema opredeliti vrste zdravstvenega varstva, pri katerih naj bi bila potrebna predhodna odobritev.
(38) Given that the Member States are responsible for laying down rules as regards the management, requirements, quality and safety standards and organisation and delivery of healthcare and that the planning necessities differ from one Member State to another, it should therefore be for the Member States to decide whether there is a need to introduce a system of prior authorisation, and if so, to identify the healthcare requiring prior authorisation in the context of their system in accordance with the criteria defined by this Directive and in the light of the case law of the Court of Justice.
Informacije o tem zdravstvenem varstvu bi morale biti javno dostopne.
The information concerning this healthcare should be made publicly available.
Informacije o tem zdravstvenem varstvu bi morale biti vnaprej javno dostopne.
The information concerning this healthcare should be made publicly available in advance .
(39) Merila, povezana s predhodno odobritvijo, bi morala temeljiti na nujnih razlogih v splošnem interesu, na podlagi katerih je mogoče utemeljiti ovire za prosti pretok zdravstvenega varstva.
(39) The criteria attached to the grant of prior authorisation should be justified in the light of the overriding reasons of general interest capable of justifying obstacles to the free movement of healthcare.
Sodišče je opredelilo več možnih dejavnikov: tveganje za resno ogrozitev finančnega ravnotežja sistema socialne varnosti, cilj vzdrževanja uravnotežene in vsem dostopne zdravstvene in bolnišnične storitve iz razlogov javnega zdravja in cilj ohranitve zmogljivosti zdravljenja ali zdravstvene stroke, bistvenih za javno zdravje, na nacionalnem ozemlju in celo preživetje prebivalstva.
The Court of Justice has identified several potential considerations: the risk of seriously undermining the financial balance of a social security system, the objective of maintaining on grounds of public health a balanced medical and hospital service open to all and the objective of maintaining treatment capacity or medical competence on national territory, essential for the public health, and even the survival of the population.
Prav tako je pri upravljanju sistema predhodne odobritve pomembno upoštevati splošno načelo zagotavljanja varnosti pacienta v sektorju, ki je znan po nesimetričnosti informacij.
It is also important to take into consideration the general principle of ensuring the safety of the patient, in a sector well known for information asymmetry, when managing a prior authorisation system.
V nasprotnem primeru pa se predhodna odobritev ne sme zavrniti zgolj iz razloga, da so na nacionalnem ozemlju čakalne liste, katerih namen je omogočiti načrtovanje in upravljanje bolnišnične oskrbe na podlagi vnaprej določenih splošnih kliničnih prioritet , ne da bi bila prej izvedena objektivna zdravstvena ocena pacientovega zdravstvenega stanja, zdravstvene anamneze in verjetnega poteka njegove bolezni, stopnje bolečine in/ali narave njegove invalidnosti v času, ko je vložil zahtevek za odobritev ali njeno obnovitev.
Conversely, the refusal to grant prior authorisation may not be based solely on the ground that there are waiting lists on national territory intended to enable the supply of hospital care to be planned and managed on the basis of predetermined general clinical priorities, without carrying out an objective medical assessment of the patient's medical condition, the history and probable course of his illness, the degree of pain he is in and/or the nature of his disability at the time when the request for authorisation was made or renewed.
(39) Sodišče je opredelilo več možnih dejavnikov: tveganje za resno ogrozitev finančnega ravnotežja sistema socialne varnosti, cilj vzdrževanja uravnotežene in vsem dostopne zdravstvene in bolnišnične storitve iz razlogov javnega zdravja in cilj ohranitve zmogljivosti zdravljenja ali zdravstvene stroke, bistvenih za javno zdravje, na nacionalnem ozemlju in celo preživetje prebivalstva.
(39) The Court of Justice has identified several potential considerations: the risk of seriously undermining the financial balance of a social security system, the objective of maintaining on grounds of public health a balanced medical and hospital service open to all and the objective of maintaining treatment capacity or medical competence on national territory, essential for the public health, and even the survival of the population.
V nasprotnem primeru pa se predhodna odobritev ne more zavrniti iz razloga, da so na nacionalnem ozemlju čakalne liste, katerih namen je omogočiti načrtovanje in upravljanje bolnišnične oskrbe na podlagi vnaprej določenih splošnih kliničnih prioritet .
Conversely, the refusal to grant prior authorisation cannot be based on the ground that there are waiting lists on national territory intended to enable the supply of hospital care to be planned and managed on the basis of predetermined general clinical priorities.
Predhodna odobritev se lahko zavrne le, če pacient ni upravičen do zadevnega zdravljenja, ali na podlagi klinične ocene oziroma na podlagi izpostavljenosti širše javnosti velikemu varnostnemu tveganju.
Prior authorisation may be refused only if the patient is not entitled to the treatment in question, or on the bas is of a clinical evaluation, or on the bas is of exposure of the general public to a substantial safety hazard.
Odločitev mora temeljiti na objektivni oceni pacientovega zdravstvenega stanja, zdravstvene anamneze in verjetnega poteka njegove bolezni, stopnje bolečine in/ali narave njegove invalidnosti v času, ko je vložil zahtevek za odobritev ali njeno obnovitev.
The decision should be based on an objective assessment of the patient's medical condition, the history and probable course of his illness, the degree of pain he is in and/or the nature of his disability at the time when the request for authorisation was made or renewed.
V primeru zavrnitve mora biti na voljo pritožbeni postopek.
In the event of refusal, an appeal procedure should be available.
(41) V vsakem primeru, če se država članica odloči vzpostaviti sistem predhodne odobritve za kritje stroškov za bolnišnično ali specializirano oskrbo v drugi državi članici v skladu z določbami te direktive, bi morala stroške za takšno oskrbo v drugi državi članici povrniti država članica zdravstvenega zavarovanja do višine stroškov, ki bi bili prevzeti za enako zdravstveno varstvo v državi članici zdravstvenega zavarovanja, ne da bi bili preseženi dejanski stroški za prejeto zdravstveno varstvo.
(41) In any event, if a Member State decides to establish a system of prior authorisation for assumption of costs of hospital or specialised care provided in another Member State in accordance with the provision of this Directive, the costs of such care provided in another Member State should also be reimbursed by the Member State of affiliation up to the level of costs that would have been assumed had the same healthcare been provided in the Member State of affiliation, without exceeding the actual costs of healthcare received.
Kadar pa so izpolnjeni pogoji iz Uredbe (EGS) št. 1408/71 ali Uredbe (ES) št. 883/2004, bi morala biti odobritev dana in storitve izvedene v skladu z navedenima uredbama, razen če pacient ne zahteva drugače .
However, when the conditions set out in Regulation (EEC) No 1408/71 or Regulation (EC) No 883/2004 are fulfilled, the authorisation should be granted and the benefits provided in accordance with those Regulations unless otherwise requested by the patient .
To bi se moralo zlasti uporabljati v primerih, kadar je odobritev dana po upravnem ali sodnem pregledu zahtevka in se je zadevna oseba zdravila v drugi državi članici.
This should apply in particular in instances where the authorisation is granted after an administrative or judicial review of the request and the person concerned has received the treatment in another Member State.
V tem primeru se člena 7 in 8 te direktive ne bi smela uporabljati.
In that event, Articles 7 and 8 of this Directive should not apply.
To je v skladu s sodno prakso Sodišča, ki določa, da so pacienti, katerim je bil zahtevek za predhodno odobritev zavrnjen, a se je kasneje izkazalo, da zavrnitev ni bila utemeljena, upravičeni do povračila celotnih stroškov zdravljenja, prejetega v drugi državi članici, v skladu z določbami zakonodaje države članice zdravljenja.
This is in line with the case law of the Court of Justice which has specified that patients who were refused prior authorisation on grounds that were subsequently held to be unfounded, are entitled to have the cost of the treatment obtained in another Member State reimbursed in full according to the provisions of the legislation in the Member State of treatment.
(41) V vsakem primeru, če se država članica odloči vzpostaviti sistem predhodne odobritve za kritje stroškov za bolnišnično ali specializirano oskrbo v drugi državi članici v skladu z določbami te direktive, bi morala stroške za takšno oskrbo v drugi državi članici povrniti država članica zdravstvenega zavarovanja do višine stroškov, ki bi bili prevzeti za enako ali enako učinkovito zdravljenje pacienta v državi članici zdravstvenega zavarovanja, ne da bi bili preseženi dejanski stroški za prejeto zdravstveno varstvo.
(41) In any event, if a Member State decides to establish a system of prior authorisation for assumption of costs of hospital or specialised care provided in another Member State in accordance with the provision of this Directive, the costs of such care provided in another Member State should also be reimbursed by the Member State of affiliation up to the level of costs that would have been assumed had treatment which is the same or equally effective for the patient been provided in the Member State of affiliation, without exceeding the actual costs of healthcare received.
Kadar pa so izpolnjeni pogoji iz Uredbe (EGS) št. 883/2004, bi morala biti odobritev dana in storitve izvedene v skladu s to uredbo .
However, when the conditions set out in Regulation (EC) No 883/2004 are fulfilled, the authorisation should be granted and the benefits provided in accordance with th at Regulation .
(42) Postopki v zvezi z čezmejnim zdravstvenim varstvom, ki jih uvedejo države članice, bi morali pacientom dati jamstva objektivnosti, nediskriminatornosti in preglednosti na tak način, da se zagotovi, da nacionalni organi odločitve sprejemajo pravočasno in skrbno ter pri tem upoštevajo navedena splošna načela in okoliščine posameznega primera.
(42) Procedures regarding cross-border healthcare established by the Member States should give patients guarantees of objectivity, non-discrimination and transparency, in such a way as to ensure that decisions by national authorities are made in a timely manner and with due care and regard for both those overall principles and the individual circumstances of each case.
To bi se moralo prav tako uporabljati pri dejanskem povračilu stroškov za zdravstveno varstvo, ki nastanejo v drugi državi članici po pacientovem zdravljenju.
This should also apply to the actual reimbursement of costs of healthcare incurred in another Member State after the patient has received treatment.
Primerno je, da pacienti odločitev glede čezmejnega zdravstvenega varstva običajno prejmejo v petnajstih koledarskih dneh.
It is appropriate that patients should normally have a decision regarding the cross-border healthcare within fifteen calendar days .
Rok pa bi moral biti krajši, kadar to upravičuje nujnost zadevnega zdravljenja.
However, that period should be shorter where warranted by the urgency of the treatment in question.
(Stališče EP o uvodni izjavi 42)
(EP position recital 42)
(43) Ustrezne informacije o vseh bistvenih vidikih čezmejnega zdravstvenega varstva so potrebne , da lahko pacienti uveljavljajo svoje pravice do čezmejnega zdravstvenega varstva v praksi.
(43) Appropriate information on all essential aspects of cross-border healthcare is necessary in order to enable patients to exercise their rights on cross-border healthcare in practice.
Eden od mehanizmov za zagotavljanje takšnih informacij pri čezmejnem zdravstvenem varstvu je vzpostavitev nacionalnih kontaktnih točk v vsaki državi članici.
For cross-border healthcare, one of the mechanisms for providing such information is to establish national contact points within each Member State.
Določiti bi bilo treba, katere informacije se obvezno zagotovijo pacientom .
Information that has to be provided compulsorily to patients should be specified.
Nacionalne kontaktne točke lahko prostovoljno in tudi ob podpori Komisije zagotovijo dodatne informacije .
However, the national contact points may provide more information voluntarily and also with the support of the Commission.