natgillin/translations-raw huggingface dataset:
This Directive should provide for the right for a patient to receive any medicinal product authorised for marketing in the Member State of treatment, even if the medicinal product is not authorised for marketing in the Member State of affiliation, as it is an indispensable part of obtaining effective treatment in another Member State.
Ta direktiva bi morala pacientu zagotoviti pravico do kakršnega koli zdravila, odobrenega za trženje v državi članici zdravljenja, tudi če zdravilo ni odobreno za trženje v državi članici zdravstvenega zavarovanja, saj je nepogrešljiv del učinkovitega zdravljenja v drugi državi članici.
Nothing should oblige a Member State of affiliation to reimburse an insured person for a medicinal product prescribed in the Member State of treatment, where that medicinal product is not among the benefits provided to that insured person by the statutory social security system or national health system in the Member State of affiliation.
Država članica zdravstvenega zavarovanja z ničemer ne bi smela biti obvezana, da zavarovani osebi povrne stroške za zdravilo, predpisano v državi članici zdravljenja, če to zdravilo ni med storitvami, ki so zavarovani osebi zagotovljene v okviru obveznega sistema socialne varnosti ali nacionalnega zdravstvenega sistema države članice zdravstvenega zavarovanja.
Member States may maintain general conditions, criteria for eligibility and regulatory and administrative formalities for receipt of healthcare and reimbursement of healthcare costs, such as the requirement to consult a general practitioner before consulting a specialist or before receiving hospital care, also in relation to patients seeking healthcare in another Member State, provided that such conditions are necessary, proportionate to the aim, not discretionary or discriminatory.
Države članice lahko ohranijo splošne pogoje, merila o izpolnjevanju pogojev ter regulativne in upravne formalnosti za prejemanje zdravstvenega varstva in povračilo stroškov za zdravstveno varstvo, kot je na primer zahteva za posvetovanje s splošnim zdravnikom pred posvetovanjem s specialistom ali pred prejemom bolnišnične oskrbe, tudi za paciente, ki iščejo zdravstveno varstvo v drugi državi članici, pod pogojem, da so takšni pogoji nujni, sorazmerni s ciljem, niso samovoljni ali diskriminatorni.
This may include an assessment by a health professional or healthcare administrator providing services for the statutory social security system or national health system of the Member State of affiliation, such as the general practitioner or primary care practitioner with whom the patient is registered, if this is necessary for determining the individual patient’s entitlement to healthcare.
To lahko vključuje oceno, ki jo opravi zdravstveni delavec ali uradnik zdravstvenega varstva, ki storitve opravlja za obvezni sistem socialne varnosti ali nacionalni zdravstveni sistem države članice zdravstvenega zavarovanja, na primer splošni zdravnik ali zdravnik, ki izvaja osnovno zdravstveno dejavnost, pri katerem je pacient registriran, če je to potrebno za ugotovitev upravičenosti posameznega pacienta do zdravstvenega varstva.
It is thus appropriate to require that these general conditions, criteria and formalities should be applied in an objective, transparent and non-discriminatory way and should be known in advance, based primarily on medical considerations, and that they should not impose any additional burden on patients seeking healthcare in another Member State in comparison with patients being treated in their Member State of affiliation, and that decisions should be made as quickly as possible.
Tako je primerno zahtevati, da bi se ti splošni pogoji, merila in formalnosti uporabljali na objektiven, pregleden in nediskriminatoren način ter da bi morali biti znani vnaprej, temeljiti predvsem na zdravniških ugotovitvah in ne bi smeli biti dodatno breme za paciente pri iskanju zdravstvenega varstva v drugi državi članici v primerjavi s pacienti, ki se zdravijo v državi članici svojega zdravstvenega zavarovanja, ter da bi se odločitve morale sprejemati čim hitreje.
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.
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.
In the light of the case-law of the Court of Justice, making the assumption by the statutory social security system or national health system of costs of healthcare provided in another Member State subject to prior authorisation is a restriction to the free movement of services.
Z vidika sodne prakse Sodišča zahteva po predhodni odobritvi kritja stroškov zdravstvenega varstva, zagotovljenega v drugi državi članici, iz obveznega sistema socialne varnosti ali nacionalnega zdravstvenega sistema pomeni omejevanje prostega pretoka storitev.
Therefore, as a general rule, the Member State of affiliation should not make the assumption of the costs of healthcare provided in another Member State subject to prior authorisation, where the costs of that care, if it had been provided in its territory, would have been borne by its statutory social security system or national health system.
Zato država članica zdravstvenega zavarovanja povračila stroškov v drugi državi članici zagotovljenega zdravstvenega varstva praviloma ne bi smela pogojevati s predhodno odobritvijo, če bi bili stroški takšnega varstva, če bi se to izvedlo na njenem ozemlju, plačani iz njenega obveznega sistema socialne varnosti ali nacionalnega zdravstvenega sistema.
Patient flows between Member States are limited and expected to remain so, as the vast majority of patients in the Union receive healthcare in their own country and prefer to do so.
Pretok pacientov med državami članicami je omejen in se pričakuje, da bo takšen tudi ostal, saj v Uniji velika večina pacientov daje prednost koriščenju zdravstvenega varstva v svoji državi.
However, in certain circumstances patients may seek some forms of healthcare in another Member State.
Ne glede na to lahko pacienti v določenih primerih poiščejo nekatere oblike zdravstvenega varstva v drugi državi članici.
Examples include highly specialised care or healthcare provided in frontier areas where the nearest appropriate facility is on the other side of the border.
Primeri vključujejo visoko specializirano oskrbo ali zdravstveno varstvo na obmejnih območjih, kjer je najbližja ustrezna ustanova na drugi strani meje.
Furthermore, some patients wish to be treated abroad in order to be close to their family members who are residing in another Member State, or in order to have access to a different method of treatment than that provided in the Member State of affiliation or because they believe that they will receive better quality healthcare in another Member State.
Poleg tega se nekateri pacienti želijo zdraviti v tujini, da bi bili blizu svojih družinskih članov, ki bivajo v drugi državi članici, ali pa zato, da bi imeli dostop do drugačnega načina zdravljenja kot je zagotovljen v državi članici zdravstvenega zavarovanja, ali pa zato, ker menijo, da bodo prejeli bolj kakovostno zdravstveno varstvo v drugi državi članici.
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.
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.
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 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 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.
Sodišče je ugotovilo, da je cilj takšnega načrtovanja zagotoviti zadosten in stalen dostop do uravnotežene ponudbe visokokakovostne bolnišnične oskrbe v zadevni državi članici.
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.
Poleg tega to prispeva k želenemu obvladovanju stroškov in, kolikor je mogoče, tudi preprečevanju odvečne porabe finančnih, tehničnih in človeških virov.
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.
Po mnenju Sodišča bi bila takšna odvečna 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.
The same reasoning applies to healthcare not provided in a hospital but subjected to similar planning needs in the Member State of treatment.
Enako velja za zdravstveno varstvo, ki se ne zagotavlja v bolnišnici, vendar zanj veljajo podobne potrebe po načrtovanju v državi članici zdravljenja.
This may be healthcare which requires planning because it involves use of highly specialised and cost-intensive medical infrastructure or medical equipment.
To je lahko zdravstveno varstvo, pri katerem je načrtovanje potrebno zato, ker vključuje uporabo visoko specializirane in drage medicinske infrastrukture ali medicinske opreme.
In light of technological progress, the development of new methods of treatment and the different policies of the Member States regarding the roles of hospitals in their healthcare systems, the question of whether this kind of healthcare is delivered within hospital or ambulatory care facilities is not the decisive factor for deciding whether it requires planning or not.
Z vidika napredka tehnologije, razvoja novih metod zdravljenja in različnih politik držav članic glede vloge bolnišnic v njihovih sistemih zdravstvenega varstva, vprašanje, ali se ta vrsta zdravstvenega varstva izvaja v bolnišnicah ali v ambulantah, ni odločilen dejavnik pri odločanju o tem, ali je zanj potrebno načrtovanje ali ne.
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.
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.
The information concerning this healthcare should be made publicly available in advance.
Informacije o tem zdravstvenem varstvu bi morale biti vnaprej javno dostopne.
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, such as planning requirements relating to the aim of ensuring sufficient and permanent access to a balanced range of high-quality treatment in the Member State concerned or to the wish to control costs and avoid, as far as possible, any waste of financial, technical and human resources.
Merila, povezana s predhodno odobritvijo, bi morala temeljiti na prevladujočih razlogih v splošnem interesu, na podlagi katerih je mogoče utemeljiti ovire za prosti pretok zdravstvenega varstva, kot so potrebe za načrtovanje v zvezi z namenom zagotavljanja zadostnega in stalnega dostopa do uravnoteženega obsega visokokakovostnega zdravljenja v zadevni državi članici, ali z namenom obvladovanja stroškov in, kolikor je mogoče, preprečevanja odvečne porabe finančnih, tehničnih in človeških virov.
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.
Sodišče je opredelilo več možnih dejavnikov: tveganje za resno ogrožanje finančnega ravnotežja sistema socialne varnosti, cilj vzdrževati uravnotežene in vsem dostopne zdravstvene in bolnišnične storitve iz razlogov javnega zdravja in cilj ohraniti zmogljivosti zdravljenja ali zdravstvene stroke, bistvenih za javno zdravje, na nacionalnem ozemlju in celo preživetje prebivalstva.
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.
Prav tako je pri upravljanju sistema predhodne odobritve pomembno upoštevati splošno načelo zagotavljanja varnosti pacienta v sektorju, ki je znan po asimetričnosti informacij.
Conversely, the refusal to grant prior authorisation may not 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, without carrying out an objective medical assessment.
Nasprotno pa se predhodna odobritev ne sme 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, ne da bi bila prej izvedena objektivna zdravstvena ocena.
According to the constant case-law of the Court of Justice, the criteria for granting or refusing prior authorisation should be limited to what is necessary and proportionate in the light of these overriding reasons in the general interest.
Iz stalne sodne prakse Sodišča izhaja, da bi morala biti merila za odobritev ali zavrnitev predhodne odobritve omejena na to, kar je nujno in sorazmerno glede na te prevladujoče razloge v splošnem interesu.
It should be noted that the impact on national health systems caused by patient mobility might vary between Member States or between regions within a Member State, depending on factors such as geographical location, language barriers, location of hospitals in border regions or the size of the population and healthcare budget.
Opozoriti bi bilo treba, da bi se lahko posledice mobilnosti pacientov na nacionalne zdravstvene sisteme razlikovale po državah članicah ali regijah v državi članici, odvisno od dejavnikov, kot so zemljepisna lega, jezikovne pregrade, lokacija bolnišnic v obmejnih območjih ali velikost prebivalstva in proračun za zdravstveno varstvo.
It should therefore be for Member States to set such criteria for refusing prior authorisation that are necessary and proportionate in that specific context, also taking into account which healthcare falls within the scope of the prior authorisation system, since certain treatments of a highly specialised nature will be more easily affected even by a limited patient outflow than others.
Države članice bi morale zato določiti takšna merila za zavrnitev predhodne odobritve, ki so nujna in sorazmerna v danem kontekstu, pri čemer se upošteva, katere vrste zdravstvenega varstva sodijo v sistem predhodne odobritve, saj ima lahko omejen odhod pacientov večji vpliv na določena visoko specializirana zdravljenja kot na druge vrste zdravljenja.
Consequently, Member States should be able to set up different criteria for different regions or other relevant administrative levels for the organisation of healthcare, or indeed for different treatments, as long as the system is transparent and easily accessible and the criteria are made public in advance.
Posledično bi moralo biti državam članicam omogočeno, da določijo različna merila za organizacijo zdravstvenega varstva za različne regije ali druge ustrezne upravne ravni ali celo različna zdravljenja, pod pogojem, da je sistem pregleden in lahko dostopen ter da so merila vnaprej objavljena.
Where the patient is entitled to healthcare and that healthcare cannot be provided within a time limit which is medically justifiable, the Member State of affiliation should in principle be obliged to grant prior authorisation.
Če je pacient upravičen do zdravstvenega varstva, ki ga ni mogoče zagotoviti v roku, ki je utemeljen z medicinskega vidika, bi morala biti država članica zdravstvenega zavarovanja načeloma dolžna izdati predhodno odobritev.
However, in certain circumstances, cross-border healthcare may expose the patient or the general public to a risk which overrides the interest of the patient to receive the cross-border healthcare sought.
Vendar pa čezmejno zdravstveno varstvo lahko v določenih okoliščinah izpostavi pacienta ali širšo javnost tveganju, ki presega interes pacienta, da prejme iskano čezmejno zdravstveno varstvo.
In such instances, the Member State of affiliation should be able to refuse the request for prior authorisation, in which case the Member State of affiliation should direct the patient towards alternative solutions.
V takšnih primerih bi morala imeti država članica zdravstvenega zavarovanja možnost, da zavrne zahtevo za predhodno odobritev pri čemer bi morala država članica zdravstvenega zavarovanja pacienta napotiti k nadomestnim rešitvam.
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.
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.
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 Regulation (EC) No 883/2004 unless otherwise requested by the patient.
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 Uredbo (ES) št. 883/2004, razen če pacient ne zahteva drugače.
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.
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.
In that event, Articles 7 and 8 of this Directive should not apply.
V tem primeru se člena 7 in 8 te direktive ne bi smela uporabljati.
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.
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.
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.
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.
This should also apply to the actual reimbursement of costs of healthcare incurred in another Member State after the patient has received treatment.
To bi se moralo prav tako uporabljati pri dejanskem povračilu stroškov za zdravstveno varstvo, ki nastanejo v drugi državi članici po pacientovem zdravljenju.
It is appropriate that, under normal circumstances, patients be entitled to receive decisions regarding cross-border healthcare within a reasonable period of time.
Primerno je, da so pacienti upravičeni, da v običajnih okoliščinah prejmejo odločitve glede čezmejnega zdravstvenega varstva v razumnem roku.
However, that period should be shortened where warranted by the urgency of the treatment in question.
Vendar bi bilo treba ta rok skrajšati, kadar to upravičuje nujnost zadevnega zdravljenja.
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.
Ustrezne informacije o vseh bistvenih vidikih čezmejnega zdravstvenega varstva so potrebne, da lahko pacienti uveljavljajo svoje pravice do čezmejnega zdravstvenega varstva v praksi.
For cross-border healthcare, one of the mechanisms for providing such information is to establish national contact points within each Member State.
Eden od mehanizmov za zagotavljanje takšnih informacij pri čezmejnem zdravstvenem varstvu je vzpostavitev nacionalnih kontaktnih točk v vsaki državi članici.
Information that has to be provided compulsorily to patients should be specified.
Določiti bi bilo treba, katere informacije se obvezno zagotovijo pacientom.
However, the national contact points may provide more information voluntarily and also with the support of the Commission.
Nacionalne kontaktne točke lahko prostovoljno in tudi ob podpori Komisije zagotovijo dodatne informacije.