natgillin/translations-raw huggingface dataset:
Behandlingsmedlemsstaten kan dog pålægge betingelser, kriterier og formaliteter vedrørende kliniske forhold, såsom vurdering af patientsikkerhedsrisici forbundet med at gennemføre en særlig procedure på en bestemt patient.
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.
Disse betingelser, kriterier og formaliteter kan endvidere omfatte en procedure, der sikrer, at en person, som ønsker at gøre brug af sundhedsydelser i en anden medlemsstat, forstår, at de modtagne sundhedsydelser vil være underkastet behandlingsmedlemsstatens love og bestemmelser, herunder kvalitets- og sikkerhedsstandarder og andre gældende standarder i denne medlemsstat, og at personen har modtaget tilstrækkelig teknisk, faglig og medicinsk støtte til at kunne træffe et informeret valg af sundhedstjenesteyder, i det omfang denne procedure ikke er hverken diskriminerende eller udgør en hindring for den frie bevægelighed for varer, personer eller tjenesteydelser.
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) Ifølge Domstolens faste retspraksis kan medlemsstaterne kræve forhåndstilladelse fra det nationale system til godtgørelse af udgifter til hospitalsbehandling i en anden medlemsstat.
(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.
Domstolen har vurderet, at dette krav er både nødvendigt og rimeligt, eftersom antallet af hospitaler, deres geografiske fordeling, deres organisation, deres faciliteter, og selve arten af de medicinske ydelser, som de kan tilbyde, alle er områder, hvor planlægning, der almindeligvis er udformet til at opfylde forskellige behov, skal være mulig.
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.
Domstolen finder, at en sådan planlægning har til formål at sikre, at der i den pågældende medlemsstat er tilstrækkelig og permanent adgang til et afbalanceret udvalg af hospitalsbehandling af høj kvalitet.
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.
Endvidere skal planlægningen medvirke til at kontrollere omkostningerne og så vidt muligt at undgå spild af økonomiske, tekniske og menneskelige ressourcer.
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.
Ifølge Domstolen vil et sådant spild være så meget desto mere skadeligt, fordi det er alment anerkendt, at hospitalssektoren indebærer betydelige omkostninger og må opfylde stigende behov, samtidig med at de økonomiske ressourcer, som stilles til rådighed til sundhedsydelser, ikke er ubegrænsede, uanset hvilken form for finansiering der anvendes.
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) Den foreliggende dokumentation tyder på, at anvendelsen af principperne om fri udveksling af tjenesteydelser på brug af sundhedsydelser i en anden medlemsstat inden for de dækningsrammer, som den lovpligtige sygesikringsordning i forsikringsmedlemsstaten giver, ikke vil være et indgreb i medlemsstaternes sundhedssystemer eller bringe deres socialsikringsordninger ud af økonomisk ligevægt.
(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.
Domstolen har imidlertid fastslået, at det ikke kan udelukkes, at risiko for et alvorligt indgreb i den sociale sikringsordnings økonomiske ligevægt eller målet om at opretholde en stabil læge- og hospitalstjeneste, som alle har adgang til, kan udgøre et tvingende alment hensyn, som kan begrunde en begrænsning af princippet om fri udveksling af tjenesteydelser.
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.
Domstolen har også fastslået, at spørgsmål som antallet af hospitaler, deres geografiske fordeling, deres organisation, det udstyr, de er forsynet med, og de lægelige ydelser, de kan tilbyde, skal kunne planlægges.
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.
Dette direktiv bør indeholde bestemmelser om en ordning med forhåndstilladelse i forbindelse med godtgørelse af udgifter til hospitalsbehandling i en anden medlemsstat, hvis følgende betingelser er opfyldt: Hvis behandlingen havde fundet sted på den berørte medlemsstats område, ville den være blevet dækket af dens socialsikringsordning, og hvis udstrømningen af patienter som følge af direktivets anvendelse er eller forventes at være et alvorlig indgreb i socialsikringsordningens økonomiske ligevægt, og/eller denne udstrømning af patienter har eller forventes at få alvorlige konsekvenser for den planlægning og rationalisering i hospitalssektoren, der gennemføres for at undgå overkapacitet på hospitalerne, ubalance i udbuddet af hospitalsbehandling samt logistisk og økonomisk spild, opretholdelsen af et afbalanceret system for læge- og hospitalsbehandling, der er tilgængeligt for alle, eller opretholdelsen af behandlingskapacitet eller medicinsk kompetence på den berørte medlemsstats område.
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.
Da vurderingen af den præcise virkning af den forventede udstrømning af patienter kræver komplekse antagelser og beregninger, åbner direktivet mulighed for et system med forhåndstilladelse, hvis der er tilstrækkelig grund til at antage, at socialsikringsordningen bringes i alvorlig fare.
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.
Dette bør også omfatte allerede eksisterende systemer med forhåndsgodkendelse, som er i overensstemmelse med betingelserne i artikel 8.
This should also cover cases of already existing systems of prior authorisation which are in conformity with conditions laid down in Article 8.
(EP's holdning, betragtning 38)
(EP position recital 38)
(36a) Sjældne sygdomme har en prævalenstærskel på højst fem berørte personer ud af 10.000 personer i overensstemmelse med Europa-Parlamentets og Rådets forordning (EF) nr. 141/2000 om lægemidler til sjældne sygdomme*, og de er alle alvorlige, kroniske og ofte livstruende.
(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 .
Patienter, der er berørt af sjældne sygdomme, støder på vanskeligheder, når de søger efter en diagnose og en behandling, der kan forbedre deres livskvalitet og øge deres forventede levetid.
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;
*EFT L 18 af 22.1.2000, s. 1.
*OJ L18, 22.1.2000 p.1.
(38) Eftersom medlemsstaterne har ansvaret for at fastlægge reglerne for forvaltningen af, kravene til, kvalitets- og sikkerhedsstandarderne for samt tilrettelæggelsen og leveringen af sundhedsydelser, og planlægningsbehovene afviger fra en medlemsstat til en anden, bør det være op til medlemsstaterne at beslutte, om der er behov for at indføre en ordning med forhåndstilladelse, og hvis dette er tilfældet, at fastlægge, hvilke sundhedsydelser der kræver forhåndstilladelse i deres system, i overensstemmelse med kriterierne i dette direktiv og i lyset af Domstolens retspraksis.
(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.
Information om disse sundhedsydelser bør gøres offentligt tilgængelig.
The information concerning this healthcare should be made publicly available.
Information om disse sundhedsydelser bør gøres offentligt tilgængelig på forhånd .
The information concerning this healthcare should be made publicly available in advance .
(39) De kriterier, der knyttes til tildelingen af forhåndstilladelse, bør være begrundede ud fra tvingende almene hensyn, som kan berettige en begrænsning af den frie udveksling af sundhedsydelser.
(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.
Domstolen har fastlagt flere potentielle faktorer: risikoen for alvorlig forstyrrelse af en socialsikringsordnings økonomiske ligevægt, målet om af hensyn til folkesundheden at opretholde et afbalanceret udbud af læge- og hospitalsydelser, som alle har adgang til, og målet om på det nationale område at opretholde behandlingskapacitet eller medicinsk kompetence, som er af afgørende betydning for folkesundheden eller endog for befolkningens overlevelse.
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.
Ved forvaltningen af forhåndstilladelsesordningen er det også vigtigt at tage hensyn til det almindelige princip om sikring af patientens sikkerhed i en sektor, som er kendt for informationsasymmetri.
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.
Omvendt kan et afslag på forhåndstilladelse ikke alene begrundes med, at der er ventelister på det nationale område med henblik på planlægning og administration af udbuddet af hospitalsydelser på baggrund af generelt fastsatte lægelige prioriteter , uden at der har været foretaget en objektiv medicinsk vurdering af patientens sygdomstilstand, baggrunden for og den forventede udvikling af sygdommen, omfanget af patientens smerter og/eller arten af vedkommendes handicap på tidspunktet for anmodningen om tilladelse eller for fornyelse af anmodningen om tilladelse.
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) Domstolen har fastlagt flere potentielle faktorer: risikoen for alvorlig forstyrrelse af en socialsikringsordnings økonomiske ligevægt, målet om af hensyn til folkesundheden at opretholde et afbalanceret udbud af læge- og hospitalsydelser, som alle har adgang til, og målet om på det nationale område at opretholde behandlingskapacitet eller medicinsk kompetence, som er af afgørende betydning for folkesundheden eller endog for befolkningens overlevelse.
(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.
Omvendt kan et afslag på forhåndstilladelse ikke begrundes med, at der er ventelister på det nationale område med henblik på planlægning og administration af udbuddet af hospitalsydelser på baggrund af generelt fastsatte lægelige prioriteter.
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.
Der kan kun gives afslag på forhåndsgodkendelse, hvis patienten ikke har ret til den pågældende behandling, enten på grundlag af en klinisk vurdering eller fordi befolkningen generelt er udsat for en alvorlig sikkerhedsrisiko.
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.
(41) Hvis en medlemsstat beslutter at indføre en ordning med forhåndstilladelse i forbindelse med godtgørelse af udgifter til hospitalsbehandling eller specialistbehandling i en anden medlemsstat i henhold til dette direktiv, bør udgifterne til en sådan behandling i en anden medlemsstat også godtgøres af forsikringsmedlemsstaten op til et beløb, der svarer til de udgifter, der ville være blevet godtgjort, hvis de samme sundhedsydelser var blevet leveret i forsikringsmedlemsstaten, uden at beløbet dog kan overstige de faktiske udgifter til de pågældende sundhedsydelser.
(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.
Hvis betingelserne i forordning (EØF) nr. 1408/71 eller forordning (EF) nr. 883/2004 er opfyldt, bør tilladelsen gives og ydelserne leveres i overensstemmelse med de nævnte forordninger, medmindre patienten anmoder om andet .
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 .
Dette bør særligt gælde tilfælde, hvor tilladelsen gives efter en administrativ eller retslig prøvelse af anmodningen, og den pågældende person har modtaget behandlingen i en anden medlemsstat.
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.
I så fald bør artikel 7 og 8 i dette direktiv ikke finde anvendelse.
In that event, Articles 7 and 8 of this Directive should not apply.
Dette er i overensstemmelse med Domstolens praksis, ifølge hvilken patienter, der har fået afslag på forhåndstilladelse, har ret til at få udgifterne til behandling i en anden medlemsstat fuldt godtgjort i overensstemmelse med lovgivningen i behandlingsmedlemsstaten, hvis afslaget senere viser sig at være uberettiget.
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) Hvis en medlemsstat beslutter at indføre en ordning med forhåndstilladelse i forbindelse med godtgørelse af hospitalsbehandling eller specialistbehandling i en anden medlemsstat i henhold til dette direktiv, bør udgifterne til en sådan behandling i en anden medlemsstat også godtgøres af forsikringsmedlemsstaten med et beløb, der svarer til de udgifter, der ville være blevet godtgjort, hvis en behandling, som er den samme eller lige så effektiv for patienten, var blevet leveret i forsikringsmedlemsstaten, uden at beløbet dog kan overstige de faktiske udgifter til de pågældende sundhedsydelser.
(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.
Hvis betingelserne i artikel 22, stk. 2, i forordning (EØF) nr. 883/2004 er opfyldt, bør tilladelsen gives og ydelserne udføres i overensstemmelse med den nævnte forordning .
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) Medlemsstaternes procedurer for grænseoverskridende sundhedsydelser bør give patienterne sikkerhed for objektivitet, ikke-diskriminering og gennemsigtighed, så det sikres, at de nationale myndigheders afgørelser træffes i tide og under behørig hensyntagen til både disse overordnede principper og de individuelle forhold i hver sag.
(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.
Dette bør også gælde den faktiske godtgørelse af udgifter til sundhedsydelser i en anden medlemsstat, efter at patienten har modtaget behandling.
This should also apply to the actual reimbursement of costs of healthcare incurred in another Member State after the patient has received treatment.
Patienter bør normalt have en afgørelse vedrørende grænseoverskridende sundhedsydelser inden for 15 kalenderdage.
It is appropriate that patients should normally have a decision regarding the cross-border healthcare within fifteen calendar days .
(EP's holdning, betragtning 42)
(EP position recital 42)
(43) Det er nødvendigt med passende information om alle vigtige aspekter af grænseoverskridende sundhedsydelser, hvis patienterne skal have mulighed for at gøre brug af deres ret til grænseoverskridende sundhedsydelser i praksis.
(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.
For grænseoverskridende sundhedsydelser er en af måderne at give denne information på at oprette nationale kontaktpunkter i hver medlemsstat.
For cross-border healthcare, one of the mechanisms for providing such information is to establish national contact points within each Member State.
Det bør præciseres, hvilke oplysninger det skal være obligatorisk at give patienterne.
Information that has to be provided compulsorily to patients should be specified.
De nationale kontaktpunkter kan dog frivilligt give yderligere information, også med støtte fra Kommissionen.
However, the national contact points may provide more information voluntarily and also with the support of the Commission.
De nationale kontaktpunkter bør give patienterne informationen på et de officielle sprog i den medlemsstat, hvor kontaktpunkterne ligger.
Information should be provided by national contact points to patients in any of the official languages of the Member State in which the contact points are situated.
Informationen kan også , men skal ikke, gives på et andet sprog.
Information may , but does not have to, be provided in any other language.
Informationen kan også gives på et andet sprog.
Information may be provided in any other language.
Der bør bl.a. være fjernadgang til al denne information ad elektronisk vej.
All that information should be inter alia remotely accessible by electronic means.
Da spørgsmål om aspekter af grænseoverskridende sundhedsydelser også vil kræve koordinering mellem myndighederne i forskellige medlemsstater, bør disse kontaktpunkter også indgå i et netværk, som mest effektivt kan behandle sådanne spørgsmål.
Since questions about aspects of cross-border healthcare will also require liaison between authorities in different Member States, those contact points should also constitute a network through which such questions can be most efficiently addressed.