natgillin/translations-raw huggingface dataset:
Der bør skabes retssikkerhed, og samarbejdet mellem de nationale sundhedssystemer bør støttes i patienternes interesse.
Legal certainty should be ensured, and support provided for cooperation between national healthcare systems, in the interest of the patient.
Med henblik herpå er det vigtigt at forbedre bestemmelserne om garanti for patientadgang til information og for informationskildernes troværdighed i forbindelse med levering af sundhedsydelser, lægemidler og medicinske behandlinger.
In order to achieve this, it is important to improve the provisions on the guarantee of patients’ access to information and the credibility of sources of information on the provision of healthcare, pharmaceutical products and medical treatment.
Kommissionen foreslår desuden, at man danner et netværk af nationale myndigheder og organer med ansvar for sundhedsteknologivurdering med henblik på en optimal udnyttelse af ny teknologi, således at der kan garanteres sikre og effektive sundhedsydelser af høj kvalitet.
The European Commission has also proposed that a network of national authorities or bodies responsible for health technology assessment (HTA) be set up, with a view to an optimum harnessing of new technologies, in order to ensure the provision of safe, effective and high‑quality healthcare.
Denne idé er selvfølgelig værd at støtte, men de praktiske regler for dette netværk kunne godt udspecificeres yderligere.
While this idea is worthy of support, the practical arrangements for that network could be amplified.
På samme måde må det siges at være essentielt at fremme et øget samarbejde inden for akutmedicinydelser, så deres koordinering forbedres.
Similarly, it would seem vital to facilitate greater cooperation between emergency medical services in order to improve their coordination.
Dette behov er specielt åbenlyst i grænseområder.
This need is all the more apparent in cross‑border areas.
Ud over problematikken omkring selve de grænseoverskridende sundhedsydelser bør dette initiativ gøre det muligt at identificere udfordringerne og de nødvendige reformer på sundhedsområdet.
Beyond the issue of cross‑border healthcare itself, this initiative should make it possible to pinpoint the challenges and necessary reforms in the field of healthcare.
Forslag til EUROPA-PARLAMENTETS OG RÅDETS DIREKTIV om patientrettigheder i forbindelse med grænseoverskridende sundhedsydelser
Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the application of patients’ rights in cross-border healthcare
Forslag til EUROPA-PARLAMENTETS OG RÅDETS DIREKTIV om patienters ret til adgang til sikre og effektive sundhedsydelser af høj kvalitet på lige vilkår
Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the application of patients’ rights to access to safe, high-quality and effective healthcare , under equitable conditions
Det foreslås, at direktivforslaget ikke koncentreres om patientmobilitet, men om de tre grundlæggende punkter, som Kommissionen har struktureret sit forslag om, nemlig fælles principper for alle EU's sundhedssystemer, europæisk samarbejde på sundhedsområdet og en særlig ramme for grænseoverskridende sundhedsydelser.
It is proposed that the proposal for a directive should not focus chiefly on patient mobility but on the three fundamental strands around which the Commission has structured its proposal: common principles in all EU health systems, European cooperation on healthcare and a specific framework for cross-border healthcare.
Med hensyn til langtidspleje gælder direktivets bestemmelser ikke bistand og støtte til familier eller enkeltpersoner, der i en længere periode har et særligt behov for pleje, støtte eller hjælp, hvis dette indebærer specifik ekspertbehandling eller hjælp, der ydes gennem en socialsikringsordning .
As regards long-term care, the Directive does not apply to assistance and support for families or individuals who are, over an extended period of time, in particular need of nursing, support or care in so far as this involves specific expert treatment or help provided by a social security system.
Dette gælder først og fremmest de langtidsplejeydelser, der skønnes nødvendige for at den person, der behøver pleje, kan leve et så fuldstændigt og uafhængigt liv som muligt.
This covers above all such long ‑term care services as are considered necessary in order to provide the person in need of care with as full and independent a life as possible.
Dette ændringsforslag har til formål at præcisere, at ydelser inden for området social bistand eller pleje, revalidering med henblik på at genoptage arbejdet og langtidspleje er udelukket fra dette direktivs anvendelsesområde.
This amendment serves to clarify the fact that services in the area of social assistance or care, rehabilitation with a view to resuming work and long-term care are excluded from the scope of this directive.
(25) Dette direktiv har heller ikke til formål at skabe krav på godtgørelse af behandling i en anden medlemsstat, hvis en sådan behandling ikke indgår i de ydelser, som er omfattet af lovgivningen i forsikringsmedlemsstaten.
(25) This Directive does not aim either to create entitlement for reimbursement of treatment in another Member State, if such a treatment is not among the benefits provided for by the legislation of the patient’s Member State of affiliation.
(25) Dette direktiv har heller ikke til formål at skabe krav på godtgørelse af behandling i en anden medlemsstat, hvis en sådan behandling ikke indgår i de ydelser, som er omfattet af lovgivningen i forsikringsmedlemsstaten , eller at ændre betingelserne for dette krav, hvis disse er fastlagt i forsikringsmedlemsstatens lovgivning .
(25) This Directive does not aim either to create entitlement for reimbursement of treatment in another Member State, if such a treatment is not among the benefits provided for by the legislation of the patient’s Member State of affiliation , or to modify the conditions for that entitlement, if they are provided for by the legislation of the Member State of affiliation .
Organisation af sundhedsydelser hører under medlemsstaternes kompetence, jf. artikel 152 i TEF.
Competency as regards the organisation of health services rests with the Member States in accordance with Article 152 of the EC Treaty.
(27) Dette direktiv giver også en patient ret til at gøre brug af et hvilket som helst lægemiddel, som det er tilladt at markedsføre , eller en hvilken som helst sundhedsydelse i den medlemsstat, hvor sundhedsydelsen leveres, selv om lægemidlet eller sundhedsydelsen ikke er tilgængelige i forsikringsmedlemsstaten, da det er nødvendigt for at få effektiv behandling i en anden medlemsstat.
(27) This Directive provides also for the right for a patient to receive any medicinal product authorised for marketing or healthcare services in the Member State where healthcare is provided, even if the medicinal product or healthcare services are not available in the Member State of affiliation, as it is an indispensable part of obtaining effective treatment in another Member State.
Det er afgørende, at en patient i en anden medlemsstat end bopælsmedlemsstaten kan modtage sundhedsydelser og lægemidler, selv når de ikke er tilgængelige i forsikringsmedlemsstaten.
It is essential that a patient in a Member State other than that of residence can benefit from healthcare services and medicines even where they are not available in the Member State of affiliation.
Samarbejde om evaluering af nye sundhedsteknologier kan gavne medlemsstaterne, fordi der opnås stordriftsfordele og dobbeltarbejde undgås, og et sådant samarbejde giver desuden et bedre erfaringsgrundlag for optimal anvendelse af nye teknologier, så der opnås sikre og effektive sundhedsydelser af høj kvalitet .
Cooperation in the evaluation of new health technologies can support Member States through economies of scale and avoiding duplication of effort, and provide a better basis of evidence for optimal use of new technologies to ensure safe, high-quality and efficient healthcare.
Et sådant samarbejde kræver vedvarende strukturer, der involverer alle medlemsstaternes relevante myndigheder, og disse bør bygge på eksisterende pilotprojekter .
Such cooperation requires sustained structures involving all the relevant authorities of all the Member States, building on existing pilot projects.
Evaluering af sundhedsteknologier såvel som mulig begrænsning i adgangen til nye teknologier som følge af visse beslutninger truffet af administrative organer rejser dog en række grundlæggende samfundsspørgsmål, som kræver deltagelse af en omfattende gruppe aktører såvel som iværksættelse af en model for bæredygtig forvaltning .
However, the evaluation of health technologies and the potential restriction of access to new technologies owing to administrative decisions pose a number of basic social questions which call for the involvement of an extensive group of stakeholders and the introduction of a viable model of governance .
Derfor bør ethvert samarbejde ikke bare omfatte de kompetente myndigheder fra alle medlemsstaterne, men også alle de berørte parter, inklusive fagfolk i sundhedssektoren, patientrepræsentanter og industrien.
Consequently, any cooperation should include not only the competent authorities in all the Member States, but also all the stakeholders, including healthcare professionals, patients’ representatives and industry.
Derudover bør dette samarbejde bygge på bæredygtige principper for god forvaltning som gennemsigtighed, åbenhed, objektivitet og upartiskhed i forbindelse med procedurerne.
Moreover, that cooperation should be based on viable principles of good governance such as the transparency, openness, objectivity and impartiality of procedures.
Kommissionen bør sikre, at det kun tillades de organer for sundhedsteknologivurdering, der følger disse principper, at deltage i netværket.
The Commission should ensure that only health technology assessment bodies which adhere to those principles are allowed to join that network.
Udveksling af information mellem organer for sundhedsteknologivurdering forudsætter og kræver gennemførelse af principper for god praksis (f.eks. god forvaltning, gennemsigtighed og inddragelse af de berørte parter) i forbindelse med de vurderinger, medlemsstaterne foretager.
The exchange of information between health technology assessment bodies presupposes and requires the implementation of principles of good practice (such as good governance, transparency and stakeholder participation) in the assessments conducted by the Member States.
Sundhedsteknologivurderinger skal således opfylde kriterierne åbenhed og objektivitet, og de skal baseres på dialog og inddragelse af de berørte parter, herunder patienterne og industrien.
Health technology assessments must therefore fulfil the criteria of openness and objectivity and must be based on dialogue and involvement of all stakeholders, including patients and industry.
(45) Kommissionen bør navnlig tillægges beføjelser til at træffe følgende foranstaltninger: en liste over behandlinger, der uden at kræve indlæggelse skal være omfattet af de samme bestemmelser som hospitalsbehandling, ledsageforanstaltninger, hvorved bestemte kategorier af lægemidler eller stoffer udelukkes fra at være omfattet af den anerkendelse af recepter fra andre medlemsstater, som dette direktiv giver mulighed for; en liste over særlige kriterier og betingelser, som europæiske netværk af referencecentre skal opfylde, og proceduren for etablering af europæiske netværk af referencecentre .
(45) In particular, power should be conferred on the Commission to adopt the following measures: a list of treatments, other than those requiring overnight accommodation, to be subject to the same regime as hospital care; accompanying measures to exclude specific categories of medicinal products or substances from the recognition of prescriptions issued in another Member State provided for in this Directive ; a list of specific criteria and conditions that European reference networks must fulfil; the procedure for establishing European reference networks .
Da der er tale om generelle foranstaltninger, der har til formål at ændre ikke-væsentlige bestemmelser i dette direktiv eller at supplere det med nye ikke-væsentlige bestemmelser, bør foranstaltningerne vedtages efter forskriftsproceduren med kontrol i artikel 5a i afgørelse 1999/468/EF.
Since those measures are of general scope and are designed to amend non-essential elements of this Directive, or to supplement this Directive by the addition of new non-essential elements, they should be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC .
(45) Medlemsstaternes kompetente myndigheder bør navnlig tillægges beføjelser til at træffe følgende foranstaltninger: en liste over behandlinger, der uden at kræve indlæggelse skal være omfattet af de samme bestemmelser som hospitalsbehandling, og ledsageforanstaltninger, hvorved bestemte kategorier af lægemidler eller stoffer udelukkes fra at være omfattet af den anerkendelse af recepter fra andre medlemsstater, som dette direktiv giver mulighed for.
(45) In particular, power should be conferred on the Member States’ competent authorities to adopt the following measures: a list of treatments, other than those requiring overnight accommodation, to be subject to the same regime as hospital care; accompanying measures to exclude specific categories of medicinal products or substances from the recognition of prescriptions issued in another Member State provided for in this Directive.
Med dette direktiv fastlægges en generel ramme for levering af sikre og effektive grænseoverskridende sundhedsydelser af høj kvalitet , idet EU-borgerne garanteres adgang til disse sundhedsydelser på lige vilkår og de nationale beføjelser med hensyn til organisation og levering af sundhedsydelser respekteres .
This Directive establishes a general framework for the provision of safe, high quality and efficient cross-border healthcare , while ensuring that EU citizens have fair access to this care and respecting national competences as regards the organisation and provision of healthcare .
Dette direktiv finder anvendelse på levering af sundhedsydelser, uanset hvordan de tilrettelægges, finder sted og finansieres, og om det sker i offentligt eller privat regi .
This Directive shall apply to provision of healthcare regardless of how it is organised, delivered and financed or whether it is public or private .
Hvis direktiv og forordninger overlapper hinanden, giver det mulighed for to parallelle systemer for grænseoverskridende sundhedsydelser: enten i overensstemmelse med forordningerne om koordinering af de sociale sikringsordninger eller i overensstemmelse med dette nye direktiv, hvilket vil skabe retlig usikkerhed.
Any overlapping of the directive and regulations would make it possible to establish two parallel systems for cross-border healthcare: under the regulations on the coordination of social security and under this new directive, which would give rise to legal uncertainty.
Grænsen mellem anvendelsesområdet for forordning (EF) nr. 883/2004 og for det foreliggende direktiv bør nøje fastlægges.
The borderline between the scope of Regulation 883/2004 and this directive should be well defined.
Dette direktiv finder ikke anvendelse på ydelser med sigte på langtidspleje.
This Directive shall not apply to services mainly geared to long-term care.
Disse omfatter navnlig ydelser, der strækker sig over en længere periode og har til formål at hjælpe personer med generelt at tilrettelægge deres dagligliv.
These include in particular services provided over an extended period that are designed to assist people with the general organisation of their day-to-day lives.
a) "sundhedsydelser": sundhedsvirksomhed, der udføres af eller under opsyn af en sundhedsprofessionel som led i udøvelsen af vedkommendes erhverv, uanset hvordan den tilrettelægges, udføres og finansieres, og om det sker i offentligt eller privat regi
a) "healthcare" means a health service provided by or under the supervision of a health professional in exercise of his profession, and regardless of the ways in which it is organised, delivered and financed at national level or whether it is public or private ;
a) "sundhedsydelser": sundhedsvirksomhed, der udføres for patienter med henblik på at vurdere, vedligeholde eller genetablere deres sundhedstilstand.
a) "healthcare" means a health service provided to patients to assess, maintain or restore their state of health .
I artikel 6-11 forstås ved "sundhedsydelser" behandlinger, der indgår i de sundhedsydelser, som er fastsat i forsikringsmedlemsstatens lovgivning
For the purpose of Articles 6 to 11, "healthcare" means treatments that are among the healthcare benefits provided for by the legislation of the Member State of affiliation ;
b) "grænseoverskridende sundhedsydelser": sundhedsydelser, der leveres i en anden medlemsstat end forsikringsmedlemsstaten , eller sundhedsydelser, der leveres i en anden medlemsstat end den, hvor sundhedstjenesteyderen har bopæl, er registreret eller etableret
(b) ‘cross-border healthcare’ means healthcare provided in a Member State other than that where the patient is an insured person or healthcare provided in a Member State other than that where the healthcare provider resides, is registered or is established ;
b) "grænseoverskridende sundhedsydelser": sundhedsydelser, der leveres i en anden medlemsstat end forsikringsmedlemsstaten
(b) ‘cross-border healthcare’ means healthcare provided in a Member State other than that where the patient is an insured person;
Artikel 4 – litra g
Article 4 – point g
g) "forsikret": en person, der er forsikret i overensstemmelse med definitionen i artikel 1, litra c), i forordning (EF) nr. 883/2004
(g) ‘insured person’ means a person who is insured in accordance with the definition in Article 1(c) of Regulation (EC) 883/2004;
Forordning (EF) nr. 883/2004 træder i kraft den 1. januar 2009.
Regulation (EC) No 883/2004 comes into force on 1 January 2009.
Kapitel II – overskrift
Chapter II – title
MYNDIGHEDER I MEDLEMSSTATERNE MED ANSVAR FOR OVERHOLDELSE AF DE FÆLLES PRINCIPPER FOR SUNDHEDSYDELSER
MEMBER STATE AUTHORITIES RESPONSIBLE FOR COMPLIANCE WITH COMMON PRINCIPLES FOR HEALTHCARE
MEDLEMSSTATERNES ANSVAR FOR OVERHOLDELSE AF DE FÆLLES PRINCIPPER FOR SUNDHEDSYDELSER
MEMBER STATES RESPONSIBLE FOR COMPLIANCE WITH COMMON PRINCIPLES FOR HEALTHCARE
Hvis begrebet "myndigheder" anvendes, skal det defineres.
If used, the term ‘authorities’ would need to be defined.
Ansvar påhvilende behandlingsmedlemsstaten
Responsibilities of the Member State of treatment
Der skabes overensstemmelse med ændringen af overskriften til kapitel II.
To be consistent with the amendment to the title of Chapter II.
Leveres sundhedsydelser i en anden medlemsstat end forsikringsmedlemsstaten, sker behandlingen i overensstemmelse med lovgivningen i behandlingsmedlemsstaten .
Where healthcare is dispensed in a Member State other than that in which the patient is affiliated, treatment shall take place in accordance with the legislation of the Member State where the treatment is dispensed.
Sundhedsydelserne leveres i henhold til de kvalitets- og sikkerhedsstandarder , behandlingsmedlemsstaten har fastsat.
Healthcare shall be provided in accordance with the quality and safety standards and guidelines defined by the Member State in which the treatment takes place.
Denne medlemsstat skal sikre, at:
That Member State must ensure that:
Denne omformulering underbygger princippet om, at organisation og levering af sundhedsydelser sorterer under medlemsstaterne.
This rewording reinforces the principle that the organisation and provision of healthcare falls within the national competence of the Member States.
Principperne om universalitet, kvalitet, lighed og solidaritet i forbindelse med sundhedsydelser bør medtages i artikel 1 om direktivets formål.
The principles of universality, quality, equity and solidarity of healthcare should be included in Article 1 on the objectives of the directive.
a) der findes ordninger, der sikrer, at sundhedstjenesteyderne kan overholde sådanne standarder under hensyntagen til international lægevidenskab og alment anerkendt god medicinsk praksis
a) mechanisms are in place for ensuring that healthcare providers are able to meet such standards, taking into account international medical science and generally recognised good medical practices;
a) der findes ordninger, der sikrer, at sundhedstjenesteyderne og akutmedicinydelserne kan overholde sådanne standarder under hensyntagen til udviklingen i international lægevidenskab og alment anerkendt god medicinsk praksis
a) mechanisms are in place for ensuring that healthcare providers and emergency medical services are able to meet such standards, taking into account developments in international medical science and generally recognised good medical practices;
Det er vigtigt, at kvalitetsstandarderne også dækker akutmedicinydelserne.
It is important for quality standards to also cover emergency medical services.
b) sundhedstjenesteydernes anvendelse af sådanne standarder i praksis overvåges løbende, og at der gribes ind, hvis de relevante standarder ikke overholdes, idet der tages hensyn til udviklingen inden for lægevidenskab og sundhedsteknologi
b) the application of such standards by healthcare providers in practice is regularly monitored and corrective action is taken when appropriate standards are not met, taking into account progress in medical science and health technology;
b) sundhedstjenesteydernes og akutmedicinydelsernes overholdelse af sådanne standarder i praksis overvåges løbende, og at der gribes ind, hvis de relevante standarder ikke overholdes, idet der tages hensyn til udviklingen inden for lægevidenskab og sundhedsteknologi
b) the application of such standards by healthcare providers and emergency medical services in practice is regularly monitored and corrective action is taken when appropriate standards are not met, taking into account progress in medical science and health technology;
Dette stykke bør udgå, eftersom den måde, hvorpå Kommissionen har udarbejdet retningslinjerne, strider direkte mod medlemsstaternes eksklusive kompetence til at organisere og levere sundhedsydelser.
It is preferable to delete this paragraph, given that the way in which the guidelines have been developed by the Commission interferes directly with exclusive national competencies in the area of the organisation and provision of healthcare.
Patienterne har ret til godtgørelse for behandlingsmetoder, selv om disse ikke godtgøres i deres egen medlemsstat, forudsat at dette er tilfældet i værtsmedlemsstaten, og metoden er godkendt af den internationale lægevidenskab .
Patients shall be entitled to reimbursement for methods of treatment, even where those methods are not reimbursed in their own Member State, provided that this is the case in the host Member State and that the method is recognised by international medical science;
Medlemsstaterne skal have ret til at udforme deres egne socialsikringsordninger.
Member States must have the right to design their own social security systems.
Behandlingsmetoden beror dog ofte på praksis inden for sundhedspersonalet baseret på dets uddannelse og specialisering.
However, the method of treatment used is often a question of practice within the medical profession based on its training and specialisation.
Dette bør ikke være et vejledende princip ved fastsættelse af godtgørelsen, som bør afhænge af, hvilke resultater der er opnået i patientens interesse.
This should not be a guiding principle in determining reimbursement, which should be dependent on the results achieved for the patient.
Dette berører ikke godtgørelsens beløb, men giver blot patienterne større valgfrihed, hvilket er særlig vigtigt for patienter med nye eller sjældne sygdomme.
This does not affect the level of reimbursement but simply gives patients greater freedom of choice, which is particularly important for patients with new or rarer diseases.