natgillin/translations-raw huggingface dataset:
Retten til at anmode om forhåndstilladelse bør sikres elektronisk for patienter, som ikke opholder sig i forsikringsmedlemsstaten på ansøgningstidspunktet.
The right to apply for prior authorisation should be granted electronically for patients not staying in the Member State of affiliation in the time of application.
Medlemsstaterne tilrettelægger i alle tilfælde, hvor og når det er passende, overførsel af betaling for de relevante omkostninger for grænseoverskridende sundhedsydelser direkte mellem de kompetente institutioner.
Member States shall organise, in all cases where and when appropriate, transfer of funds of corresponding costs of cross border healthcare directly between the competent institutions.
This would enable patients receiving cross border healthcare under the provisions of this directive to benefit, when and where possible, of the same system than the one set in the regulation 2004/883/2004.
This would enable patients receiving cross border healthcare under the provisions of this directive to benefit, when and where possible, of the same system than the one set in the regulation 2004/883/2004.
When and where it is concretely feasible, depending on national healthcare invoice system ('forfait' or not, ...etc), this will avoid to patients to pay up front and to wait for being reimbursed.
When and where it is concretely feasible, depending on national healthcare invoice system ('forfait' or not, ...etc), this will avoid to patients to pay up front and to wait for being reimbursed.
This will not create an extra charge for MS because it will be based on the same practices that the ones already set and used in the regulation.
This will not create an extra charge for MS because it will be based on the same practices that the ones already set and used in the regulation.
I andre tilfælde sikrer forsikringsmedlemsstaten, at patienterne modtager godtgørelsen uden unødig forsinkelse.
In the other cases, the Member State of affiliation shall ensure that patients will receive reimbursement without undue delay.
Såfremt det ikke er muligt at tilrettelægge direkte overførsel af betaling for omkostninger ved grænseoverskridende sundhedsydelser mellem de relevante institutioner, og såfremt der er givet forhåndstilladelse, bør forsikringsmedlemsstaterne sikre, at patienterne modtager godtgørelse uden unødig forsinkelse.
When and where not possible to organise the direct transfer of funds corresponding to the costs of cross border healthcare between the competent Institutions, and when prior authorisation has been granted, Member State of affiliation shall guarantee patients to receive reimbursement without undue delay.
I betragtning af at de behandlinger, der forudsætter forhåndstilladelse, generelt er dyrest, er dette en afgørende bestemmelse for patienterne og navnlig for patienter med en anstrengt økonomi.
Taking into account that care submitted to prior authorisation are in general the more expensive ones, this is a crucial provision for patients especially for ones who have less financial means.
Medlemsstaterne skal, når de fastsætter frister for behandlingen af ansøgninger om grænseoverskridende sundhedsydelser, og når de behandler disse ansøgninger, sørge for, at der tages hensyn til:
Member States shall, when setting out the time limits within which requests for cross-border healthcare must be dealt with and, when considering these requests, take into account:
b) patientens personlige omstændigheder
(b) individual circumstances,
c) patientens smerteniveau
(c) the patient's degree of pain,
d) arten af patientens handicap og
(d) the nature of the patient's disability, and
e) patientens evne til at udøve erhvervsmæssig virksomhed.
(e) the patient's ability to carry out a professional activity.
(EP's holdning, artikel 9, stk. 4))
(EP position Article 9(4))
Førstebehandling - ændringsforslag 87.
1st reading - AM 87
Medlemsstaterne sikrer, at administrative afgørelser om brug af grænseoverskridende sundhedsydelser og godtgørelse af udgifter til sundhedsydelser i en anden medlemsstat kan påklages administrativt og indbringes for domstolene, herunder at der findes foreløbige retsmidler.
Member States shall ensure that administrative decisions regarding the use of cross-border healthcare and reimbursement of costs of healthcare incurred in another Member State are subject to administrative review and are capable of being challenged in judicial proceedings, which include provision for interim measures.
Medlemsstaterne skal sikre, at administrative eller lægelige afgørelser om brug af grænseoverskridende sundhedsydelser og godtgørelse af udgifter til sundhedsydelser i en anden medlemsstat i det enkelte tilfælde kan gøres til genstand for en appelordning, en supplerende lægevurdering eller kan påklages administrativt og indbringes for domstolene, herunder at der findes foreløbige retsmidler.
Member States shall ensure that any administrative or medical decisions regarding the use of cross-border healthcare and reimbursement of costs of healthcare incurred in another Member State are subject, on a case-by-case basis, to an appeal procedure, to an additional medical opinion or an administrative review and are capable of being challenged in judicial proceedings, which include provision for interim measures.
Medlemsstaterne yder hinanden den bistand, der er nødvendig for gennemførelsen af dette direktiv, herunder udveksling af oplysninger om standarder og retningslinjer for kvalitet og sikkerhed, herunder bestemmelser om tilsyn, for at lette gennemførelsen af artikel 7, stk. 9, og omfattende gensidig bistand til at afklare fakturaers indhold.
Member States shall render such mutual assistance as is necessary for the implementation of this Directive, including the exchange of information about standards and guidelines on quality and safety, including provisions on supervision, in order to facilitate the implementation of Article 7(9), and including mutual assistance to clarify the content of invoices.
Medlemsstaterne yder hinanden den bistand, der er nødvendig for gennemførelsen af dette direktiv, herunder udveksling af oplysninger , navnlig mellem deres kontaktpunkter, jf. artikel 4, 5 og 6, om standarder og retningslinjer for kvalitet og sikkerhed, herunder bestemmelser om tilsyn, for at lette gennemførelsen af artikel 7, stk. 9, og omfattende gensidig bistand til at afklare fakturaers indhold.
Member States shall render such mutual assistance as is necessary for the implementation of this Directive, including the exchange of information , especially between their national contact points in accordance with A rticles 4, 5 and 6 and about standards and guidelines on quality and safety, including provisions on supervision, in order to facilitate the implementation of Article 7(9), and including mutual assistance to clarify the content of invoices.
Medlemsstaterne fremmer samarbejdet om levering af grænseoverskridende sundhedsydelser på regionalt og lokalt plan.
Member States shall facilitate cooperation in cross-border healthcare provision at regional and local level.
Medlemsstaterne fremmer samarbejdet om grænseoverskridende sundhedsydelser udført på regionalt og lokalt plan samt ved hjælp af ikt og andre former for grænseoverskridende samarbejde .
Member States shall facilitate cooperation in cross-border healthcare provision at regional and local level as well as through information and communication technologies and other forms of cross-border cooperation.
(EP's holdning, artikel 15, stk. 2)
(EP position Article 15(2))
Kommissionen tilskynder medlemsstaterne, navnlig nabolande, til at indgå indbyrdes aftaler og udvikle fælles handlingsprogrammer.
The Commission shall encourage Member States, particularly neighbouring countries, to conclude agreements among themselves and to develop joint action programmes.
Kommissionen tilskynder desuden medlemsstaterne til at samarbejde om at skabe områder, hvor adgangen til sundhedsydelser for patienterne forbedres, navnlig i grænseområder.
The Commission shall also encourage the Member States to cooperate to create areas in which patients will have improved access to health care, particularly in cross-border areas.
Medlemsstaterne sikrer, at registre over sundhedsprofessionelle er tilgængelige for andre medlemsstaters relevante myndigheder.
Member States shall guarantee that registers in which health professionals are listed are available to relevant authorities of other Member States.
(EP's holdning, artikel 15, stk. 4)
(EP position Article 15(4))
Ændringsforslag 100 fra førstebehandling.
am 100 of first reading
Artikel 10 – stk. 2 c (nyt)
Article 10 – paragraph 2c (new)
Medlemsstaterne udveksler straks og proaktivt oplysninger om resultaterne af disciplinær- og straffesager mod sundhedsprofessionelle, når sådanne sager indvirker på deres registrering og deres ret til at levere ydelser.
Member States shall immediately and proactively exchange information about disciplinary and criminal findings against health professionals where they impact upon their registration or their right to provide services.
(EP's holdning, artikel 15, stk. 5)
(EP position Article 15(5))
Artikel 11 – stk. 1 – afsnit 1 – indledning
Article 11 – paragraph 1 – subparagraph 1 – introductory part
Artikel 11 – stk. 1 – afsnit 2 og 3
Article 11 – paragraph 1 – subparagraphs 2 and 3
Anerkendelsen af recepter berører ikke nationale bestemmelser vedrørende udlevering af lægemidler , hvis disse bestemmelser er forenelige med EU-retten, og heller ikke bestemmelser vedrørende generiske lægemidler eller anden substitution.
The recognition of prescriptions shall not affect national rules governing dispensing , if those rules are compatible with Union law, and shall not affect rules governing generic or other substitution.
Anerkendelsen af recepter berører ikke bestemmelser vedrørende godtgørelse af lægemidler.
The recognition of prescriptions shall not affect the rules on reimbursement of medicinal products.
Godtgørelse af udgifter til lægemidler er omfattet af dette direktivs kapitel III.
Reimbursement of costs of medicinal products is covered by Chapter III of this Directive.
Anerkendelsen af recepter berører ikke nationale bestemmelser vedrørende ordinering og udlevering af lægemidler , herunder generiske lægemidler eller anden substitution.
The recognition of such prescription shall not affect national rules governing prescribing and dispensing, including generic or other substitution.
Godtgørelse af udgifter til grænseoverskridende recepter på lægemidler er omfattet af dette direktivs kapitel III.
Reimbursement of costs of cross-border prescriptions of medicinal products is covered by Chapter III of this Directive.
Dette stykke gælder også for medicinsk udstyr, der lovligt bringes i omsætning i den pågældende medlemsstat.
This paragraph shall also apply to medical devices that are legally placed on the market in the respective Member State.
Anerkendelsen af recepter berører ikke en erhvervsmæssig eller etisk pligt for farmaceuten til at nægte at udlevere det ordinerede lægemiddel, hvis recepten havde været udstedt i forsikringsmedlemsstaten.
The recognition of prescriptions shall not affect any professional or ethical duty that would require the pharmacist to refuse to dispense , had the prescription been issued in the Member State of affiliation.
(EP's holdning, artikel 16, stk. 1, nr. i), ii) og iii)).
(EP position Article 16(1) points (i),(ii) and (iii))
Førstebehandling - ændringsforslag 101.
1st reading - AM 101
For at lette gennemførelsen af stk. 1 vedtager Kommissionen:
In order to facilitate implementation of paragraph 1, the Commission shall adopt:
For at lette gennemførelsen af stk. 1 vedtager Kommissionen senest den …* :
In order to facilitate implementation of paragraph 1, the Commission shall adopt no later than ….* :
a) senest … foranstaltninger, der gør det muligt for en sundhedsprofessionel at kontrollere, om recepten er ægte, og om den i en anden medlemsstat er udstedt af et medlem af et lovreguleret sundhedserhverv, som lovligt har ret til dette, idet der udarbejdes en ikke-udtømmende liste over elementer, som skal forefindes på recepter
(a) no later than ….* measures enabling a health professional to verify the authenticity of the prescription and whether the prescription was issued in another Member State by a member of a regulated health profession who is legally entitled to do so through developing a non-exhaustive list of elements to be included in the prescriptions ;
a) foranstaltninger, der gør det muligt for en sundhedsprofessionel at kontrollere, om recepten er ægte, og om den i en anden medlemsstat er udstedt af et medlem af et lovreguleret sundhedserhverv, som lovligt har ret til dette, idet der udarbejdes en fælles grænseoverskridende EU-receptmodel til fremme af interoperabilitet mellem recepter.
(a) measures enabling a pharmacist or other health professional to verify the authenticity of the prescription and whether the prescription was issued in another Member State by a member of a regulated health profession who is legally entitled to do so through developing single EU cross-border prescription template and supporting interoperability of prescriptions;
b) retningslinjer til at støtte medlemsstaterne i udviklingen af interoperabilitet for e-recepter
(b) guidelines supporting the Member States in developing the interoperability of ePrescriptions;
c) senest … foranstaltninger, der skal lette korrekt identifikation af lægemidler eller medicinsk udstyr, som er ordineret i en medlemsstat og udleveret i en anden medlemsstat, herunder foranstaltninger til varetagelse af hensynet til patientsikkerheden ved substitution i forbindelse med grænseoverskridende sundhedsydelser, hvis lovgivningen i udleveringsmedlemsstaten tillader en sådan substitution.
(c) no later than ….* measures to facilitate the correct identification of medicinal products or medical devices prescribed in one Member State and dispensed in another, including measures to address patient safety concerns in relation to their substitution in cross-border healthcare where the legislation of the dispensing Member State permits such substitution.
Kommissionen skal bl.a. overveje anvendelsen af et internationalt fællesnavn og doseringen af lægemidler
The Commission shall consider, inter alia , using the International Non-proprietary Name and the dosage of medicinal products;
c) foranstaltninger, der skal lette korrekt identifikation af lægemidler eller medicinsk udstyr, som er ordineret i en medlemsstat og udleveret i en anden medlemsstat, herunder foranstaltninger til varetagelse af hensynet til patientsikkerheden ved substitution i forbindelse med grænseoverskridende sundhedsydelser, hvis lovgivningen i udleveringsmedlemsstaten tillader en sådan substitution.
(c) measures to facilitate the correct identification of medicinal products or medical devices prescribed in one Member State and dispensed in another, including measures to address patient safety concerns in relation to their substitution in cross-border healthcare where the legislation of the dispensing Member State permits such substitution.
d) senest …* foranstaltninger, der skal lette forståeligheden af oplysningerne til patienten om recepten og den medleverede vejledning om anvendelse af lægemidlet eller det medicinske udstyr.
(d) no later than …* measures to facilitate the comprehensibility of the information to patients concerning the prescription, and the instructions included therein, on the use of the medicinal products or medical devices.
d) foranstaltninger, der skal lette forståeligheden af oplysningerne til patienten om recepten og den medleverede vejledning om anvendelse af lægemidlet eller det medicinske udstyr , herunder at der hersker klarhed med hensyn til anvendelsen af forskellige navne for det samme lægemiddel eller medicinske udstyr .
(d) measures to facilitate the comprehensibility of the information to patients concerning the prescription, and the instructions included therein, on the use of the medicinal products or medical devices , including clarity as to different names used for the same medicinal product or medical device ;
(EP's holdning, artikel 16, stk. 2, litra a) og b)).
(EP position Article 16(2) points (a) and (b))
Ændringsforslag 101 fra førstebehandling.
am 101 of first reading
Artikel 11 – stk. 2 – litra d a (nyt)
Article 11 – paragraph 2 – point d a (new)
da) foranstaltninger, der, i fald der er behov herfor, sikrer kontakt mellem den receptudstedende part og den part, der udleverer lægemidlet, for at sikre, at der hersker fuldstændig klarhed med hensyn til behandlingen samtidig med, at fortroligheden omkring patientoplysninger respekteres.
(d a ) measures to ensure, if needed, contact between the prescribing party and the dispensing party in order to ensure complete understanding of the treatment, whilst maintaining confidentiality of patient s' data .
(EP's holdning, artikel 16, stk. 2, litra d))
(EP position Article 16(2)(d))
Foranstaltningerne og retningslinjerne i stk. 2, litra a)-d), vedtages efter forskriftsproceduren i artikel 15, stk. 2.
The measures and guidelines referred to in points (a) to (d) of paragraph 2 shall be adopted in accordance with the regulatory procedure referred to in Article 15(2).
Foranstaltningerne i stk. 2, litra a)-da), vedtages efter forskriftsproceduren i artikel 15, stk. 2.
The measures referred to in points (a) to (da ) of paragraph 2 shall be adopted in accordance with the regulatory procedure referred to in Article 15(2).
Artikel 11 – stk. 5 – afsnit 1 a (nyt)
Article 11 – paragraph 5 – subparagraph 1 a(new)
I tilfælde, hvor der i behandlingsmedlemsstaten udstedes recept på lægemidler eller medicinsk udstyr, der ikke normalt kan fås på recept i forsikringsmedlemsstaten, er det imidlertid op til sidstnævnte medlemsstat at afgøre, om lægemidlet undtagelsesvis kan udleveres, eller om der skal udleveres et alternativt lægemiddel, som anses for at have den samme terapeutiske virkning.
However, where a prescription is issued in the Member State of treatment for medicinal products or medical devices which are not normally available on prescription in the Member State of affiliation, it shall be for the latter to decide whether to authorise exceptionally or to provide an alternative medicinal product deemed to have the same therapeutic effect.
(EP's holdning, artikel 9, stk. 3)
(EP position Article 9(3))
Kommissionen støtter medlemsstaterne i udviklingen af europæiske netværk af referencecentre mellem sundhedstjenesteydere og ekspertisecentre i medlemsstaterne.
The Commission shall support Member States in the development of European reference networks between healthcare providers and centres of expertise in the Member States.
Netværkene er baseret på medlemmernes frivillige deltagelse, og medlemmerne deltager og bidrager til netværksaktiviteterne i henhold til lovgivningen i den medlemsstat, hvor medlemmerne er etableret.
The networks shall be based on the voluntary participation of their members, which shall participate and contribute to the networks' activities in accordance with the legislation of the Member State where the members are established.
Kommissionen støtter medlemsstaterne i udviklingen af europæiske netværk af referencecentre mellem sundhedstjenesteydere og ekspertisecentre i medlemsstaterne , navnlig på området sjældne sygdomme, som skal trække på samarbejdserfaringer på sundhedsområdet, der er høstet i europæiske grupper for territorialt samarbejde (EGTS) .
The Commission shall support Member States in the development of European reference networks between healthcare providers and centres of expertise in the Member States , in particular in the area of rare diseases, which shall draw on the health cooperation experience acquired within the European groupings of territorial cooperation (EGTCs) .
Disse netværk skal til enhver tid være åbne for nye sundhedstjenesteydere, som måtte ønske at deltage i dem, forudsat at disse sundhedstjenesteydere opfylder de fastsatte betingelser og kriterier.
Those networks shall at all times be open to new healthcare providers which might wish to join them, provided that such healthcare providers fulfil all the required conditions and criteria.
(EP's holdning, artikel 17, stk. 1)
(EP position Article 17(1))
Førstebehandling - ændringsforslag 102.
1st reading - AM 102
Formålet med europæiske netværk af referencecentre er at bistå
The aim of European reference networks shall be to help :
Formålet med europæiske netværk af referencecentre er
The objective of European reference networks shall be:
a) med at realisere potentialet ved europæisk samarbejde om højt specialiserede sundhedsydelser for patienter og sundhedssystemer, ved at udnytte innovationer inden for lægevidenskab og medicinsk teknologi
(a) realise the potential of European cooperation regarding highly specialised healthcare for patients and for healthcare systems by exploiting innovations in medical science and health technologies;
a) at bistå med at realisere potentialet ved europæisk samarbejde om højt specialiserede sundhedsydelser for patienter og sundhedssystemer, ved at udnytte innovationer inden for lægevidenskab og medicinsk teknologi
(a) to help realise the potential of European cooperation regarding highly specialised healthcare for patients and for healthcare systems by exploiting innovations in medical science and health technologies;
aa) at bidrage til pooling af viden om sygdomsforebyggelse og behandling af vigtige, almindeligt forekommende sygdomme
( aa ) to contribute to the pooling of knowledge regarding sickness prevention and the treatment of major commonly occurring disorders;
b ) med at fremme forbedringer inden for diagnosticering og levering af omkostningseffektive sundhedsydelser af høj kvalitet for alle patienter, hvis sundhedsmæssige tilstand kræver en særlig koncentration af ekspertise
(b ) facilitate improvements in diagnosis and the delivery of high quality and cost-effective healthcare for all patients with a medical condition requiring a particular concentration of expertise;
b) at bistå med at fremme adgang og forbedringer inden for diagnosticering og levering af omkostningseffektive sundhedsydelser af høj kvalitet for alle patienter, hvis sundhedsmæssige tilstand kræver en særlig koncentration af ekspertise
(b) to help promote access and facilitate improvements in diagnosis and the delivery of high quality and cost-effective healthcare for all patients with a medical condition requiring a particular concentration of expertise;
c) med at gøre udnyttelsen af ressourcerne så omkostningseffektiv som muligt
(c) maximise cost-effective use of resources;
c) at gøre udnyttelsen af ressourcerne så omkostningseffektiv som muligt
(c) to maximise cost-effective use of resources;
d) med at forstærke forskningsindsatsen, den epidemiologiske overvågning såsom registre og med at tilbyde uddannelse for sundhedsprofessionelle
(d) reinforce research, epidemiological surveillance like registries and provide training for health professionals;
d) at forstærke forskningsindsatsen, den epidemiologiske overvågning såsom registre og med at tilbyde uddannelse for sundhedsprofessionelle
(d) to reinforce research, epidemiological surveillance like registries and provide training for health professionals;
e) med at lette ekspertisemobiliteten, virtuelt og fysisk, og med at udvikle, dele og formidle information, viden og bedste praksis inden for og uden for netværkene
(e) facilitate mobility of expertise, virtually or physically, and to develop, share and spread information, knowledge and best practice within and outside the networks;
e) at lette ekspertisemobiliteten, virtuelt og fysisk, og udvikle, dele og formidle information, viden og bedste praksis og navnlig fremme udvikling inden for diagnosticering af sjældne sygdomme inden for og uden for netværkene
(e) facilitate mobility of expertise, virtually or physically, and to develop, share and spread information, knowledge and best practice and to foster developments of the diagnosis and treatment of rare diseases, within and outside the networks;
ea) at fastsætte benchmarks for kvalitet og sikkerhed og at bistå med at udvikle og formidle bedste praksis inden og uden for netværket
( ea ) to provide quality and safety benchmarks and to help develop and spread best practice within and outside the network;