FrancophonIA/Publications_Medical_Domain_UE huggingface dataset:
English: After the transposition deadline, the Commission launched 26 infringement procedures for late or incomplete notification of transposition measures.
Danish: Efter udløbet af gennemførelsesfristen indledte Kommissionen 26 traktatbrudsprocedurer om forsinket eller ufuldstændig meddelelse af gennemførelsesforanstaltninger.
English: In particular, it includes joint work on clinical assessments, joint scientific consultations and emerging health technologies.
Danish: Det omfatter navnlig fælles arbejde om kliniske vurderinger, fælles videnskabelige høringer og nye sundhedsteknologier.
English: It may also be partly due to the collaboration between the Commission and the Member States regarding its proper implementation and the interaction between the Directive and social security coordination Regulations, not least via the work done with NCPs and through the own-initiative investigations of the Commission (see Chapter 1).
Danish: Det kan også til dels skyldes samarbejdet mellem Kommissionen og medlemsstaterne om den korrekte gennemførelse og samspillet mellem direktivet og forordningerne om koordinering af social sikkerhed, ikke mindst via det arbejde, som er gjort med de nationale kontaktpunkter, og gennem undersøgelser foretaget på eget initiativ af Kommissionen (se kapitel 1).
English: The current Joint Action, EUnetHTA 3, launched in June 2016, runs until 2020 and includes more than 80 partners, relevant HTA bodies that carry out assessments and not-for-profit organisations contributing to HTA in Europe.
Danish: Den nuværende fælles aktion EUnetHTA 3, der blev lanceret i juni 2016, løber frem til 2020 og omfatter mere end 80 partnere, relevante MTV-organer, der foretager vurderinger, og almennyttige organisationer, der bidrager til MTV i Europa.
English: Indeed, the sworn translation can represent a disproportionate obstacle to free movement of services, for example in several countries the cost of the translation could be higher than the reimbursement of the outpatient service.
Danish: Den autoriserede oversættelse kan udgøre en uforholdsmæssig hindring for den frie bevægelighed for tjenesteydelser; f.eks. kan udgifterne til oversættelse i flere lande være højere end godtgørelsen for ambulant behandling.
English: According to a survey of NCPs, a number of Member States continue to express concern about communicating the complexities of the current legal situation.
Danish: Ifølge en undersøgelse af de nationale kontaktpunkter udtrykker en række medlemsstater fortsat bekymring med hensyn til formidling af den nuværende komplekse juridiske situation.
English: Although the Commission has received no specific notifications under Article 7(9), certain transposition measures could be questioned as limiting the level of reimbursement for cross-border healthcare.
Danish: Selv om Kommissionen ikke har modtaget nogen decideret underretning i henhold til artikel 7, stk. 9, kunne visse gennemførelsesforanstaltninger anfægtes som en begrænsning af niveauet for godtgørelse for grænseoverskridende sundhedsydelser.
English: Health Technology Assessment
Danish: Medicinsk teknologivurdering
English: [12: Directive 2011/24/EU was due to be transposed by the EFTA countries Iceland, Liechtenstein and Norway no later than 1 August 2015.
Danish: [12: Direktiv 2011/24/EU skulle være gennemført af EFTA-landene Island, Liechtenstein og Norge senest den 1. august 2015.
English: The eHealth Network is a voluntary network composed of national authorities responsible for eHealth that works towards interoperable applications and enhanced continuity of and access to care.
Danish: E-sundhedsnetværket er et frivilligt netværk bestående af nationale myndigheder med ansvar for e-sundhed, der arbejder hen imod interoperable applikationer og øget kontinuitet og adgang til pleje.
English: Most of the Member States reported having in place a national HTA system for medicinal products (26 Member States and Norway) and/or medical devices (20 Member States and Norway).
Danish: De fleste medlemsstater rapporterede, at de havde indført en national MTV-ordning for lægemidler (26 medlemsstater og Norge) og/eller medicinsk udstyr (20 medlemsstater og Norge).
English: According to Article 17 of the Directive, the power to adopt delegated acts envisaged therein shall be conferred on the Commission for a period of 5 years from its entry into force.
Danish: Ifølge direktivets artikel 17 tillægges Kommissionen beføjelser til at vedtage de delegerede retsakter, der er omhandlet deri, i en periode på fem år fra ikrafttrædelsesdatoen.
English: Their aim is to help diagnose and treat patients suffering from rare, complex and low prevalence diseases that require highly specialised healthcare and a concentration of knowledge and resources.
Danish: Deres mål er at bidrage til at diagnosticere og behandle patienter, der lider af sjældne sygdomme, komplekse sygdomme og sygdomme med lav prævalens, der kræver højt specialiseret behandling og koncentration af viden og ressourcer.
English: The main difference between the Directive and the Regulations as regards the reimbursement rights is that under the Regulations, patients are entitled to healthcare abroad as if they were insured under the social security system of the Member State of treatment.
Danish: Den vigtigste forskel mellem direktivet og forordningerne med hensyn til godtgørelsesrettigheder er, at i henhold til forordningerne har patienterne ret til behandling i udlandet, som om de var forsikret under den sociale sikringsordning i behandlingsmedlemsstaten.
English: Among more than 400 initiatives analysed in the mapping exercise, the large majority took place between countries with similar welfare state traditions and concerned knowledge sharing and management and shared treatment and diagnosis of patients.
Danish: Blandt mere end 400 initiativer, der blev analyseret i kortlægningen, fandt størstedelen sted mellem lande med lignende velfærdsstatstraditioner og vedrørte videndeling og forvaltning og fælles behandling og diagnosticering af patienter.
English: Information should be made available by electronic means and in formats accessible for persons with disabilities (Article 6(5)) and additional costs for persons with disabilities may be taken into account (Article 7(4)).
Danish: Oplysningerne skal gøres tilgængelige elektronisk og i formater, der er tilgængelige for handicappede (artikel 6, stk. 5), og ekstraudgifter for handicappede kan tages i betragtning (artikel 7, stk. 4).
English: Another Member State required a certificate from the foreign National Contact Point attesting that the healthcare to be provided within its territory would be compliant with the necessary safety and quality standards in place.
Danish: En anden medlemsstat krævede et certifikat fra det udenlandske nationale kontaktpunkt som bevis for, at de sundhedsydelser, der skulle ydes på dens område, var i overensstemmelse med de nødvendige gældende sikkerheds- og kvalitetsstandarder.
English: Such choice may be driven by a desire to return ‘home' to a country of birth for healthcare, or to bring a relative closer to a place where a family member can care for them or it may be driven by a desire to find expertise not available in their home country.
Danish: Sådanne valg kan være drevet af et ønske om at vende "hjem" til et fødeland for at modtage sundhedsydelser, bringe slægtninge tættere på et sted, hvor et familiemedlem kan tage sig af dem, eller finde ekspertise, som ikke er til rådighed i deres hjemland.
English: These reports cover healthcare with or without prior authorisation, requests for information about healthcare, healthcare provided, reimbursements made and reasons for which healthcare was reimbursed, or not.
Danish: Disse rapporter dækker sundhedsydelser med eller uden forhåndstilladelse, anmodninger om oplysninger om sundhedsydelser, leverede sundhedsydelser, godtgørelser og begrundelser for, at sundhedsydelser er blevet godtgjort eller ej.
English: This may partly be due to the gradual improvements in the information of citizens regarding the Directive and a better awareness on patient rights as a possible consequence.
Danish: Dette kan til dels skyldes de gradvise forbedringer af oplysninger til borgerne om direktivet og større opmærksomhed om patienters rettigheder som en mulig konsekvens.
English: a) Systems of reimbursement of costs for cross-border healthcare
Danish: a) Systemer til godtgørelse af udgifter til grænseoverskridende sundhedsydelser
English: A key principle of ERNs is to let the knowledge travel rather than the patient.
Danish: Et centralt princip for ERN'er er at lade viden bevæge sig frem for patienterne.
English: By June 2018 165 panels had been opened, the number growing daily, with the first patients directly benefiting.
Danish: I juni 2018 var der blevet åbnet 165 paneler - et antal, der stiger dagligt, og de første patienter kunne udnytte systemet direkte.
English: Under the eHDSI Infrastructure, the first wave of voluntary cross-border exchanges of patient summaries and ePrescriptions is set to begin by a few pioneering countries by the end of 2018; with around 20 Member States expected to participate by 2020.
Danish: I henhold til eHDSI-infrastrukturen begynder den første bølge af frivillig grænseoverskridende udveksling af patientjournaler og e-recepter mellem en række førende lande inden udgangen af 2018, idet omkring 20 medlemsstater forventes at deltage fra 2020.
English: Based on the reported data for planned cross-border care under the Regulations, in 2015, Member States issued around 55,000 authorisations for planned treatment abroad.
Danish: Baseret på de indberettede data for planlagte grænseoverskridende sundhedsydelser i henhold til forordningerne udstedte medlemsstaterne i 2015 ca. 55 000 tilladelser til planlagt behandling i udlandet.
English: Cooperation on HTA post 2020 in line with the proposal is expected to help to make innovative health technologies available to Europe's patients, make better use of available resources and improve business predictability.
Danish: Samarbejdet om MTV efter 2020 forventes i overensstemmelse med forslaget at bidrage til innovative medicinske teknologier, der tilbydes Europas patienter, gøre bedre brug af tilgængelige ressourcer og forbedre forudsigeligheden for erhvervslivet.
English: Twenty-one infringement procedures were started for non-communication of national transposal measures.
Danish: Der blev indledt 21 traktatbrudsprocedurer for manglende meddelelse af nationale gennemførelsesforanstaltninger.
English: Article 4(3) requires Member States to observe the principle of non-discrimination with regard to patients from other Member States.
Danish: I henhold til artikel 4, stk. 3, skal medlemsstaterne overholde princippet om ikke-forskelsbehandling med hensyn til patienter fra andre medlemsstater.
English: If there is no comparable price for domestic patients, Article 4(4) places an obligation on providers to charge a price calculated according to objective, non-discriminatory criteria.
Danish: Hvis der ikke findes nogen tilsvarende pris for indenlandske patienter, pålægger artikel 4, stk. 4, udbyderne en forpligtelse til at forlange en pris, der udregnes i henhold til objektive, ikke-diskriminerende kriterier.
English: The latter should be seen as an opportunity to improve access to care for patients, to capitalise on economies of scale and to use resources efficiently.
Danish: Dette bør betragtes som en mulighed for at forbedre patienters adgang til sundhedspleje, udnytte stordriftsfordele og anvende ressourcer effektivt.
English: Taking into account the variation in the number of Member States providing feedback on the number of requests received, and noting the limited variation in the spread of requests (in all three years the total number of requests was dominated by Poland and Lithuania which together accounted for more than 50% of all requests for information across all Member States), there has been little change in the level of enquiry about access to cross-border healthcare made by citizens.
Danish: Under hensyntagen til variationen i antallet af medlemsstater, der giver feedback om antallet af modtagne anmodninger, og i lyset af den begrænsede variation i spredningen af anmodninger (i alle tre år var det samlede antal anmodninger domineret af Polen og Litauen, der tilsammen tegnede sig for mere end 50 % af alle anmodninger om oplysninger i alle medlemsstater) er der kun sket få ændringer i niveauet af forespørgsler om adgang til grænseoverskridende sundhedsydelser fra borgere.
English: Even if a Member State does not apply such mechanism of prior notification, Article 9(5) requires Member States to reimburse patients without undue delay.
Danish: Selv om en medlemsstat ikke anvender en sådan ordning med forudgående underretning, skal medlemsstaterne i henhold til artikel 9, stk. 5, godtgøre patienterne uden unødig forsinkelse.
English: The good results of this resource-intensive work have led to fewer administrative burdens on citizens accessing cross-border healthcare, more compressed prior-authorisation systems and lighter procedures for exercising the basic patient rights enshrined in the Directive.
Danish: De gode resultater af dette ressourcekrævende arbejde har ført til en mindre administrativ byrde for borgere, der har adgang til grænseoverskridende sundhedsydelser, mere komprimerede ordninger med forhåndstilladelser og lettere procedurer for udøvelsen af grundlæggende patientrettigheder i henhold til direktivet.
English: Moreover, the Directive promotes cross-border cooperation in healthcare between Member States for the benefit of EU citizens, regarding prescriptions, digital health (eHealth), rare diseases and health technology assessments (HTAs).
Danish: Desuden fremmer direktivet grænseoverskridende samarbejde på sundhedsområdet mellem medlemsstaterne til gavn for EU-borgerne, hvad angår recepter, digital sundhed (e-sundhed), sjældne sygdomme og medicinsk teknologivurdering (MTV).
English: Second, in its Communication on the Digital Transformation of Health and Care, the Commission put forward further measures on eHealth (see Chapter 4.2).
Danish: For det andet fremsatte Kommissionen i sin meddelelse om den digitale omstilling af sundhed og pleje yderligere foranstaltninger om e-sundhed (se kapitel 4.2).
English: In terms of the financial dimensions of patient mobility, the year 2016 (for which the most complete data exist), may be taken as an example of the level of reimbursements made for care under the Directive.
Danish: Hvad angår de finansielle dimensioner af patientmobilitet, kan 2016 (som året med de mest fuldstændige data) ses som et eksempel på omfanget af godtgørelser for sundhedsydelser efter direktivet.
English: c) Administrative procedures regarding cross-border healthcare
Danish: c) Administrative procedurer i forbindelse med grænseoverskridende sundhedsydelser
English: This would suggest that, on the whole, patients prefer to receive healthcare near their home if possible, and that if they do elect to travel, they prefer to travel to a neighbouring country.
Danish: Dette tyder på, at de fleste patienter foretrækker at blive behandlet tæt ved deres hjem, hvis det er muligt, og at de, hvis de vælger at rejse, foretrækker at rejse til et naboland.
English: These are of course highly schematic figures, but when read in conjunction with the figures of the cost of cross-border healthcare under the Regulations (which amount to approximately 0.1%), it is clear that the vast majority of healthcare budgets is spent domestically.
Danish: Dette er selvfølgelig meget skematiske tal, men sammenholdt med udgifterne til grænseoverskridende sundhedsydelser i henhold til forordningerne (som udgør ca. 0,1 %) er det klart, at den altovervejende del af sundhedsbudgettet bruges på hjemmemarkedet.
English: While about half the patient mobility is accounted for by movements from France to its neighbouring countries, the other half of the flow is made up by small numbers of patients travelling throughout the EU to receive care - both to neighbouring countries and to countries further away.
Danish: Mens omkring halvdelen af patientmobiliteten udgøres af bevægelser fra Frankrig til nabolandene, består den anden halvdel af strømmene af et lille antal patienter, der rejser over hele EU for at modtage behandling - både til nabolandene og til lande, der ligger længere væk.
English: In addition, a written confirmation is required from the healthcare provider on its availability to grant the requested healthcare in the period indicated by the applicant for prior authorisation.
Danish: Desuden krævedes der en skriftlig bekræftelse fra sundhedstjenesteyderen om, at denne er parat til at yde den ønskede sundhedsydelse i den periode, som ansøgeren havde angivet med henblik på forhåndstilladelse.
English: Member States therefore can build a comparable cost-based price for the actual cost of the health service, which should be based on objective and non-discriminatory methodology that does not financially discriminate between "domestic" covered under local public schemes and "cross-border" patients for a given intervention.
Danish: Medlemsstaterne kan derfor skabe en sammenlignelig omkostningsbaseret pris for de faktiske udgifter til sundhedsydelsen, som bør være baseret på en objektiv og ikke-diskriminerende metode, der ikke i finansiel forstand forskelsbehandler "indenlandske" patienter, som er omfattet af lokale offentlige ordninger, og "grænseoverskridende" patienter for en given intervention.
English: This would suggest that while 50% of patient mobility may be driven by issues of proximity, and possibly also collaborations between clinicians in border regions, a very significant part may also reflect patients' desires to receive healthcare in a place of their choice.
Danish: Dette tyder på, at mens 50 % af patientmobiliteten kan være drevet af spørgsmål om nærhed og muligvis også samarbejde mellem klinikere i grænseregioner, afspejler en meget betydelig del også patienternes ønske om at gøre brug af sundhedsydelser et sted, de selv vælger.
English: Member States may define the fees for the delivery of healthcare in their territory.
Danish: Medlemsstaterne kan fastsætte gebyrer for levering af sundhedsydelser på deres område.
English: Article 20(1) of the Directive requires the Commission to 'draw up a report on the operation of this Directive and submit it to the European Parliament and to the Council' by 25 October 2015, and every three years thereafter.
Danish: I henhold til artikel 20, stk. 1, i direktivet skal Kommissionen senest den 25. oktober 2015 og derefter hvert tredje år udarbejde "en rapport om gennemførelsen af dette direktiv" og forelægge denne for Europa-Parlamentet og Rådet.
English: The findings show that, while information provision through NCP websites was well taken care of for several categories, there remains a need to further improve the websites.
Danish: Resultaterne viser, at mens der for flere kategorier blev taget fint hånd om oplysninger gennem de nationale kontaktpunkter, er der stadig behov for at forbedre webstederne yderligere.
English: In 2015, some 2 million such requests were issued by Member States, while reimbursements for cross-border treatments under the Directive not requiring PA amounted to just over 180,000 in 2015.
Danish: I 2015 blev der fremsat ca. 2 mio. sådanne anmodninger af medlemsstaterne, mens godtgørelser for grænseoverskridende behandlinger i henhold til direktivet, der ikke kræver forhåndstilladelse, beløb sig til lidt over 180 000 i 2015.
English: Recognition of prescriptions
Danish: Anerkendelse af recepter
English: The Network laid the foundations for the eHealth Digital Service Infrastructure (eHDSI), an IT system funded by the Connecting Europe Facility and the Member States, and adopted guidelines on Patient Summaries (November 2013) and on ePrescriptions (November 2014) .
Danish: Netværket skabte grundlaget for digitaltjenesteinfrastrukturen for e-sundhed (eHDSI), et IT-system, der finansieres via Connecting Europe-faciliteten og medlemsstaterne, og vedtog retningslinjer om patientjournaler (november 2013) og e-recepter (november 2014).
English: Figure 2: Requests for Reimbursement without prior authorisation
Danish: Figur 2: Anmodninger om godtgørelse uden forhåndstilladelse
English: The Directive applies to cross-border healthcare without prejudice to the framework provided by the social security coordination Regulations.
Danish: Direktivet finder anvendelse på grænseoverskridende sundhedsydelser med forbehold af de rammer, der er fastlagt i forordningerne om koordinering af sociale sikringsordninger.
English: Under the Directive, they are reimbursed for treatment abroad as if the treatment was provided in their home countries (Member State of affiliation).
Danish: I henhold til direktivet godtgøres de for behandling i udlandet, som hvis behandlingen havde fundet sted i hjemlandet (forsikringsmedlemsstaten).
English: [49: "Study on Cross-Border Cooperation: Capitalising on existing initiatives for cooperation in cross-border regions", Gesundheit Österreich Forschungs und Planungs GmbH, SOGETI, Maastricht University, 2017][50: See the General Secretariat of the Benelux Union studies, e.g. "Barriers and Opportunities in the Benelux", February 2018.]
Danish: [49: "Study on Cross-Border Cooperation: Capitalising on existing initiatives for cooperation in cross-border regions", Gesundheit Österreich Forschungs und Planungs GmbH, SOGETI, Maastricht University, 2017][50: Se generalsekretariatet for Beneluxunionens undersøgelser, f.eks. "Barriers and Opportunities in the Benelux", februar 2018.]
English: However, the fact that there has been a slow but steady increase in the number of citizens travelling to receive care suggests that the increase of information available on NCP websites has reduced the number of requests patients made to NCPs.
Danish: Men den omstændighed, at der har været en langsom, men støt stigning i antallet af borgere, der rejser for at modtage behandling, tyder på, at stigningen i tilgængelige oplysninger på de nationale kontaktpunkters websteder har reduceret antallet af anmodninger, som patienterne foretager til nationale kontaktpunkter.
English: Noting that the OECD Health at a Glance report for 2017 estimates that in EU countries the average spent on healthcare is 10% of GDP; and that Eurostat reported EU GDP in 2017 at €15.3 trillion; the expenditure across the EU on cross-border healthcare incurred under the Directive may therefore be estimated at 0.004% of the EU-wide annual healthcare budget.
Danish: Idet det bemærkes, at OECD i sin rapport "Health at a Glance" for 2017 vurderer, at EU-landene i gennemsnit brugte 10 % af BNP på sundhedsydelser, og at Eurostat rapporterede, at EU's BNP i 2017 var 15,3 bio. EUR, kan udgifterne i hele EU til grænseoverskridende sundhedsydelser i medfør af direktivet derfor anslås til 0,004 % af EU's årlige sundhedsbudget.
English: The Commission adopted Implementing Directive 2012/52/EU to give effect to the principle of mutual recognition of medical prescriptions.
Danish: Kommissionen vedtog gennemførelsesdirektiv 2012/52/EU om gennemførelse af princippet om gensidig anerkendelse af recepter.
English: The proposal sets out a support framework and procedures for cooperation on HTA at Union level and common rules for clinical assessments of health technologies.
Danish: I forslaget fastsættes en ramme og procedurer for samarbejdet om MTV på EU-niveau og fælles regler for kliniske vurderinger af medicinske teknologier.
English: Nevertheless, a steady increase has occurred since 2015, with more than twice as many requests for PA being made and authorised in 2017 as in 2015 across the Member States.
Danish: Ikke desto mindre er der set en støt stigning siden 2015 med mere end dobbelt så mange indgivne og godkendte anmodninger om forhåndstilladelser i 2017 som i 2015 på tværs af medlemsstaterne.
English: Under the mutual recognition of prescriptions between Member States, Article 11(5) empowers the Commission to adopt, by means of delegated acts, measures to exclude specific categories of medicinal products or medical devices from the recognition of prescriptions, where necessary, to safeguard public health.
Danish: Under proceduren for gensidig anerkendelse af recepter mellem medlemsstater tillægges Kommissionen i artikel 11, stk. 5, beføjelse til ved hjælp af delegerede retsakter at vedtage foranstaltninger, hvorefter særlige kategorier af lægemidler eller medicinsk udstyr kan udelukkes fra anerkendelse af recepter, hvis det er nødvendigt af hensyn til folkesundheden.
English: This is identical to "conformity checks" in the terminology used in the Commission Communication "EU Law: Better results through better application" C/2016/8600, OJ C 18, 19.1.2017 final, p. 10-20.
Danish: Dette svarer til "overensstemmelseskontrol" i den terminologi, der anvendes i Kommissionens meddelelse "EU-retten: Bedre resultater gennem bedre anvendelse" C/2016/8600, EUT C 18 af 19.1.2017, s. 10-20.
English: For the years 2015 and 2017, when France was not able to provide data on patient mobility with PA, Luxembourg to Germany and Ireland to UK were amongst the most common cases of patient mobility.
Danish: For årene 2015 og 2017, hvor Frankrig ikke kunne fremlægge data om patientmobilitet med forhåndstilladelse, var Luxembourg til Tyskland og Irland til Det Forenede Kongerige blandt de mest almindelige eksempler på patientmobilitet.
English: Their clinical operation started in November 2017, when the dedicated IT platform, the Clinical Patient Management System, became operational, allowing for the first virtual panels on patient cases to take place.
Danish: Rent klinisk blev de først idriftsat i november 2017, hvor den særlige IT-platform, det kliniske patientstyringssystem CPMS, blev sat i drift, så de første virtuelle paneler om patientsager kunne finde sted.
English: Article 7(11) requires such limitations to be necessary and proportionate, and not to constitute a means of arbitrary discrimination or an unjustified obstacle to free movement.
Danish: I artikel 7, stk. 11, kræves det, at sådanne begrænsninger skal være nødvendige og rimelige og ikke må udgøre et middel til vilkårlig forskelsbehandling eller en ubegrundet hindring for den frie bevægelighed.
English: eHealth
Danish: E-sundhed
English: Moreover, it was also difficult for some Member States to implement the principle which extends patients' choice to healthcare providers located in another Member State, irrespective of whether or not they are contracted by the statutory health system in that Member State.
Danish: Endvidere var det også vanskeligt for visse medlemsstater at gennemføre princippet om, at patienterne skal have mulighed for at vælge sundhedstjenesteydere, der er etableret i en anden medlemsstat, uanset om de har indgået kontrakt med det lovpligtige sundhedssystem i denne medlemsstat.
English: [44: Communication on enabling the digital transformation of health and care in the Digital Single Market; empowering citizens and building a healthier society, COM(2018) 233 final, 25.4.2018.]
Danish: [44: Meddelelse om at sætte gang i den digitale omstilling af sundhed og pleje i det digitale indre marked, give borgerne større indflydelse og opbygge et sundere samfund, COM(2018) 233 final af 25.4.2018.]
English: Besides exchanging information on relevant policy developments in the area of HTA, in the past three years the HTA Network developed important policy papers such as the 'Added Value of the European Cooperation in the Joint HTA of Medical Devices' in October 2015 and a 'Reflection Paper on Synergies between Regulatory and HTA issues' in November 2016.
Danish: Ud over at udveksle oplysninger om relevant politikudvikling inden for MTV har MTV-netværket i de seneste tre år udviklet vigtige politikdokumenter om f.eks. merværdien af det europæiske samarbejde i det fælles MTV ("Added Value of the European Cooperation in the Joint HTA of Medical Devices") i oktober 2015 og et oplæg om synergi mellem lovgivningmæssige og MTV-relaterede spørgsmål vedrørende lægemidler ("Reflection Paper on Synergies between Regulatory and HTA issues") i november 2016.
English: Again, a clear pattern emerges showing that France has the greatest number of travelling patients, with the three most common countries for healthcare provision being Spain, Portugal and Belgium in all three years.
Danish: Igen ses et klart mønster, hvor Frankrig har det største antal rejsende patienter, mens de tre mest almindelige lande, der udbyder sundhedsydelser, er Spanien, Portugal og Belgien i alle tre år.
English: The Directive calls on NCPs to provide patients and health professionals with information on accessibility of hospitals for persons with disabilities (Article 4(2)(a)).
Danish: Direktivet opfordrer de nationale kontaktpunkter til at give patienter og sundhedspersonale oplysninger om hospitalers tilgængelighed for handicappede (artikel 4, stk. 2, litra a)).
English: b) Prior authorisation
Danish: b) Forhåndstilladelse
English: The National Contact Points (NCPs) have an essential role to play in relation to this, providing information to citizens upon demand and, more generally, in raising awareness on patient rights and responding to information needs.
Danish: De nationale kontaktpunkter spiller en vigtig rolle i denne forbindelse ved på anmodning at give borgerne oplysninger og mere generelt ved at øge bevidstheden om patienters rettigheder og opfylde informationsbehovene.
English: [19: Article 4(2)(d) of the Directive requires the existence of a system of professional liability insurance or an equivalent or essentially comparable guarantee or similar arrangement.]
Danish: [19: Ifølge direktivets artikel 4, stk. 2, litra d), skal der findes ordninger for erhvervsansvarsforsikring eller en garanti eller en lignende ordning, som er ækvivalent eller i det væsentlige sammenlignelig med hensyn til formålet.]
English: [10: See, for example, case C-372/04 Watts, paragraph 100.]
Danish: [10: Se f.eks. sag C-372/04, Watts, præmis 100.]
English: [51: See more details in the Commission report on the operation of the Directive published on 4 September 2015 (COM(2015) 421 final).]
Danish: [51: Se flere oplysninger i Kommissionens rapport om gennemførelsen af direktivet, som blev offentliggjort den 4. september 2015 (COM (2015) 421 final).]
English: ][16: Articles 8(2)(b) and (c) also allow Member States to require prior authorisation when the healthcare involves treatments presenting a particular risk for the patient or the population, or when it is provided by a healthcare provider that could give rise to serious and specific concerns relating to the quality or safety of the care.]
Danish: ][16: Artikel 8, stk. 2, litra b) og c), giver også medlemsstaterne mulighed for at kræve forhåndstilladelse, hvis sundhedsydelsen indebærer behandlinger, der udgør en særlig risiko for patienten eller befolkningen, eller hvis den ydes af en sundhedstjenesteyder, der kan give anledning til alvorlig og konkret bekymring, for så vidt angår kvaliteten og sikkerheden af sundhedsydelsen.]
English: The Commission identified four priority areas for the compliance assessment which had the greatest potential to act as barriers to patients if left unaddressed: systems of reimbursement, use of prior authorisation, administrative requirements and charging of incoming patients.
Danish: Kommissionen identificerede de fire prioritetsområder for vurderingen af overholdelsen med størst risiko for at udgøre hindringer for patienterne, hvis der intet gøres: systemer til godtgørelse, brug af forhåndstilladelser, administrative krav samt gebyrer for patienter udefra.
English: The present report gives a high-level overview of the data received in 2015, 2016 and 2017.
Danish: Denne rapport giver en generel oversigt over de modtagne data i 2015, 2016 og 2017.
English: According to Article 7(4) of the Directive, the costs of cross-border healthcare shall be reimbursed or paid up to the level of costs that would have been assumed by the Member State of affiliation, had this healthcare been provided in its territory, without exceeding the actual cost of the healthcare received.
Danish: I henhold til direktivets artikel 7, stk. 4, skal udgifterne til grænseoverskridende sundhedsydelser godtgøres eller betales op til et beløb, der svarer til de udgifter, der ville være blevet godtgjort af forsikringsmedlemsstaten, hvis disse sundhedsydelser var blevet leveret på dens område, uden at beløbet dog kan overstige de faktiske udgifter til de modtagne sundhedsydelser.
English: Based on responses provided by Member States approximately €65,000,000 was spent across all EU countries collectively on care with and without PA in 2016.
Danish: På grundlag af svarene fra medlemsstaterne blev der brugt ca. 65 000 000 EUR i alle EU-lande tilsammen på sundhedsydelser med og uden forhåndstilladelse i 2016.
English: This is reflected as well in Article 8(2)(a) of the Directive, which allows Member States to use a system of prior authorisation in particular for healthcare that is subject to planning requirements if it involves overnight hospital accommodation or if it requires use of highly specialised and cost-intensive medical infrastructure or medical equipment.
Danish: Dette afspejles også i direktivets artikel 8, stk. 2, litra a), som giver medlemsstaterne mulighed for at anvende en forhåndstilladelsesordning navnlig for sundhedsydelser, der kræver planlægning, såfremt dette indebærer hospitalsindlæggelse med mindst én overnatning eller kræver brug af højt specialiseret og omkostningskrævende medicinsk infrastruktur eller udstyr.
English: Any system of prior authorisation shall be restricted to what is necessary and proportionate to the objective to be achieved, and may not constitute a means of arbitrary discrimination or an unjustified obstacle to the free movement of patients.
Danish: Enhver ordning med forhåndstilladelse skal begrænses til, hvad der er nødvendigt og rimeligt i forhold til målet, og må ikke udgøre et middel til vilkårlig forskelsbehandling eller en ubegrundet hindring for den frie bevægelighed for patienter.
English: [21: It should be noted that France was able to report data on healthcare subject to PA only in 2016.
Danish: [21: Det skal bemærkes, at Frankrig først kunne indberette data om sundhedsydelser betinget af en forhåndstilladelse i 2016.
English: After patients travelling from France, the next most frequent cases of patient mobility were patients travelling from Denmark to Germany; followed by Poland to Czech Republic and Norway to Spain.
Danish: Efter patienter, der rejser fra Frankrig, ses de næstmest hyppige tilfælde af patientmobilitet hos patienter, der rejser fra Danmark til Tyskland efterfulgt af Polen til Tjekkiet og Norge til Spanien.
English: Article 9(1) of the Directive requires Member States to ensure that administrative procedures for cross-border reimbursement are based on objective, non-discriminatory criteria which are necessary and proportionate to the objective to be achieved.
Danish: Direktivets artikel 9, stk. 1, pålægger medlemsstaterne at sikre, at de administrative procedurer i forbindelse med brug af grænseoverskridende godtgørelse er baseret på objektive, ikke-diskriminerende kriterier, som er nødvendige og står i et rimeligt forhold til målet.
English: Looking at flows of patients travelling for healthcare after receiving prior authorisation, the greatest flow was from France to Spain.
Danish: Ser man på strømmene af patienter, der rejser efter sundhedsydelser efter at have fået en forhåndstilladelse, var den største mellem Frankrig og Spanien.
English: Figure 1: Prior Authorisation Requests and Authorisations
Danish: Figur 1: Anmodninger om og godkendelser af forhåndstilladelser
English: The Directive (Article 8(2)) introduces the possibility for Member States to make reimbursement of costs for healthcare received in another Member State subject to prior authorisation.
Danish: Direktivet (artikel 8, stk. 2) giver medlemsstaterne mulighed for at gøre godtgørelse af udgifter til sundhedsydelser modtaget i en anden medlemsstat betinget af en forhåndstilladelse.
English: Information on complaint procedures and settlement of disputes was also scarce, as well as information on the time period required to process reimbursements and prior authorisation requests.
Danish: Der findes heller ikke mange oplysninger om klageprocedurer og bilæggelse af tvister eller oplysninger om, hvor lang tid der kræves for at behandle anmodninger om godtgørelser og forhåndstilladelser.
English: [24: https://www.oecd-ilibrary.org/social-issues-migration-health/health-at-a-glance-2017/health-expenditure-in-relation-to-gdp_health_glance-2017-45-en][25: http://ec.europa.eu/eurostat/tgm/refreshTableAction.do;jsessionid=9ea7d07e30dd3bf0a52b9a8a474c872db039e243c026.e34OaN8Pc3mMc40Lc3aMaNyTa3eQe0?tab=table&plugin=1&pcode=tec00001&language=en]
Danish: ][25: http://ec.europa.eu/eurostat/tgm/refreshTableAction.do;jsessionid=9ea7d07e30dd3bf0a52b9a8a474c872db039e243c026.e34OaN8Pc3mMc40Lc3aMaNyTa3eQe0?tab=table&plugin=1&pcode=tec00001&language=en.]
English: Furthermore, Member States are required to notify the Commission of any decision to introduce limitations under Article 7(9).
Danish: Endvidere er medlemsstaterne forpligtede til at underrette Kommissionen om alle afgørelser om at begrænse godtgørelse af de grunde, der er anført i artikel 7, stk. 9.
English: Patient mobility not subject to prior authorisation
Danish: Patientmobilitet, som ikke er underlagt krav om forhåndstilladelse
English: If this number is compared to the reported number of PA for cross-border care under the Directive in 2016 (the latter being the most comparable year), it may be estimated that cross-border with PA under the Directive amounts to approximately 6% of the authorised treatments in another Member State.
Danish: Sammenlignes dette tal med det indberettede antal forhåndstilladelser til grænseoverskridende behandling i henhold til direktivet i 2016 (idet sidstnævnte er det mest sammenlignelige år), kan det skønnes, at grænseoverskridende sundhedsydelser med forhåndstilladelse i henhold til direktivet udgør ca. 6 % af de godkendte behandlinger i en anden medlemsstat.
English: Accordingly, Figure 2 should be interpreted knowing that in 2016 France accounted for 3510 of the 5162 requests for PA and 2579 of the 3644 authorisations for PA.
Danish: Figur 2 skal derfor fortolkes i lyset af, at Frankrig i 2016 tegnede sig for 3 510 af de 5 162 anmodninger om forhåndstilladelser og 2 579 af de 3 644 godkendelser af forhåndstilladelser.
English: ][53: Commission Delegated Decision 2014/286/EU of 10 March 2014 setting out criteria and conditions that European Reference Networks and healthcare providers wishing to join a European Reference Network must fulfil (OJ L 147, 17.5.2014, p.
Danish: ][53: Kommissionens delegerede afgørelse 2014/286/EU af 10. marts 2014 om fastsættelse af kriterier og betingelser, som europæiske netværk af referencecentre og de sundhedstjenesteydere, der ønsker at blive medlemmer af et europæisk netværk af referencecentre, skal opfylde (EUT L 147 af 17.5.2014, s.
English: [40: 2011/890/EU: Commission Implementing Decision of 22 December 2011 providing the rules for the establishment, the management and the functioning of the network of national responsible authorities on eHealth]
Danish: [40: 2011/890/EU: Kommissionens gennemførelsesafgørelse af 22. december 2011 om foranstaltninger til etablering, forvaltning og drift af netværket af nationale myndigheder, der er ansvarlige for e-sundhed.]
English: [45: Based on Article 11(2)(a), (c) and (d) of the Directive.
Danish: [45: Baseret på direktivets artikel 11, stk. 2, litra a), c) og d).
English: Article 8(7) of the Directive requires Member States to ‘make publicly available which healthcare is subject to prior authorisation'.
Danish: I henhold til direktivets artikel 8, stk. 7, skal medlemsstaterne "offentliggør[e], hvilke sundhedsydelser der kræves forhåndstilladelse til".
English: However, Article 4(4) requires Member States to ensure that healthcare providers apply the same scale of fees to patients from other Member States as they do for domestic patients in a comparable medical situation.
Danish: Men i henhold til artikel 4, stk. 4, skal medlemsstaterne sikre, at sundhedstjenesteyderne anvender den samme prisskala for patienter fra andre medlemsstater som for patienter fra medlemsstaten i en tilsvarende helbredssituation.
English: ERNs are not directly accessible by individual patients; instead, healthcare providers refer patients to the relevant Network, with their consent and in accordance with the national health systems rules.
Danish: I stedet henviser sundhedstjenesteydere patienter til det relevante netværk med deres samtykke og i overensstemmelse med de nationale sundhedssystemers regler.
English: [11: Recital 38 of the Directive.]
Danish: [11: Betragtning 38 i direktivet.]
English: [32: https://ec.europa.eu/health/sites/health/files/technology_assessment/docs/2018_mapping_npc_en.pdf][33: Mapping of HTA national organisations programmes and processes in EU and Norway, 2017, Contract nr. 17010402/2016/734820, ISBN: 978-92-79-77080-7]
Danish: ][33: Mapping of HTA national organisations programmes and processes in EU and Norway, 2017, kontrakt nr. 17010402/2016/734820, ISBN: 978-92-79-77080-7.]
English: As indicated in recital 44 to the Directive and according to the constant case-law of the Court of Justice, Member States may make reimbursement of the costs of cross-border healthcare subject to prior authorisation when it is both necessary and reasonable; such a scheme must also be based on objective and non-discriminatory criteria.
Danish: Som anført i betragtning 44 i direktivet og i henhold til Domstolens faste retspraksis kan medlemsstaterne gøre godtgørelse af udgifter til grænseoverskridende sundhedsydelser betinget af en forhåndstilladelse, når det er både nødvendigt og rimeligt.
English: Article 7(9) permits Member States to limit application of the rules on reimbursement of cross-border healthcare for overriding reasons of general interest.
Danish: I henhold til artikel 7, stk. 9, kan medlemsstaterne begrænse anvendelsen af reglerne for godtgørelse af grænseoverskridende sundhedsydelser ud fra tvingende almene hensyn.
English: ][46: Commission Implementing Directive 2012/52/EU of 20 December 2012 laying down measures to facilitate the recognition of medical prescriptions issued in another Member State (OJ L 356, 22.12.2012, p.
Danish: ][46: Kommissionens gennemførelsesdirektiv 2012/52/EU af 20. december 2012 om foranstaltninger, der skal lette anerkendelsen af recepter udskrevet i en anden medlemsstat (EUT L 356 af 22.12.2012, s.
English: Regarding the voluntary cooperation structure (eHealth, HTA, ERNs), the Directive provides the basis for the Commission and Member States to enhance cross-border cooperation and on how broader technological and societal challenges might be met. A number of developments regarding these new perspectives are already underway.
Danish: Hvad angår den frivillige samarbejdsstruktur (e-sundhed, MTV, ERN'er), danner direktivet grundlag for, at Kommissionen og medlemsstaterne kan fremme det grænseoverskridende samarbejde, samt for, hvordan bredere teknologiske og samfundsmæssige udfordringer kan tackles.
English: The flow maps, as well as the raw data, show clearly that most patients travel from France to other countries, with patient mobility from France to Spain and France to Germany being the most prevalent.
Danish: Kortene viser ligesom rådataene tydeligt, at de fleste patienter rejser fra Frankrig til andre lande, idet patientmobiliteten fra Frankrig til Spanien og Frankrig til Tyskland er den mest udbredte.
English: Compliance check
Danish: Kontrol af overholdelsen
English: ][6: Article 7(6) and Article 9.
Danish: ][6: Artikel 7, stk. 6, og artikel 9.
English: ][9: Article 4(2)(d).]
Danish: ][9: Artikel 4, stk. 2, litra d).]
English: [41: Regulation (EU) No 1316/2013 of the European Parliament and of the Council of 11 December 2013 establishing the Connecting Europe Facility, amending Regulation (EU) No 913/2010 and repealing Regulations (EC) No 680/2007 and (EC) No 67/2010, OJ L 348, 20.12.2013, p.
Danish: [41: Europa-Parlamentets og Rådets forordning (EU) nr. 1316/2013 af 11. december 2013 om oprettelse af Connecting Europe-faciliteten, om ændring af forordning (EU) nr. 913/2010 og om ophævelse af forordning (EF) nr. 680/2007 og (EF) nr. 67/2010 (EUT L 348 af 20.12.2013, s.
English: [47: Article 10(3) of the Directive.
Danish: [47: Direktivets artikel 10, stk. 3.
English: [34: https://ec.europa.eu/health/technology_assessment/policy/network_en][35: Commission Implementing Decision 2013/329/EU of 26 June 2013 providing the rules for the establishment,management and transparent functioning of the network of national authorities or bodies responsible for healthtechnology assessment (OJ L 175, 27.6.2013, p.
Danish: ][35: Kommissionens gennemførelsesafgørelse 2013/329/EU af 26. juni 2013 om foranstaltninger til etablering,forvaltning og gennemsigtig drift af netværket af nationale myndigheder eller organer, der er ansvarlige for medicinskteknologivurdering (EUT L 175 af 27.6.2013, s.
English: [1: Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients' rights in cross-border healthcare (OJ L 88, 4.4.2011, p.
Danish: [1: Europa-Parlamentets og Rådets direktiv 2011/24/EU af 9. marts 2011 om patientrettigheder i forbindelse med grænseoverskridende sundhedsydelser (EUT L 88 af 4.4.2011, s.
English: [52: Article 12(5), read together with Article 12(4)(a).
Danish: [52: Artikel 12, stk. 5, sammenholdt med artikel 12, stk. 4, litra a).
English: Patient mobility with prior authorisation
Danish: Patientmobilitet med forhåndstilladelse
English: Financial Implications of Patient Mobility
Danish: Finansielle konsekvenser af patientmobilitet
English: State of play of transposition
Danish: Status over gennemførelsen
English: The aggregated data reported by Member States on the number of requests for PA in 2015, 2016 and 2017 show that such requests remain generally low.
Danish: De aggregerede data, som medlemsstaterne indberettede om antallet af anmodninger om forhåndstilladelser i 2015, 2016 og 2017, viser et generelt lavt antal anmodninger.
English: [3: Commission Report on the operation of Directive 2011/24/EU on the application of patients' rights in cross-border healthcare, COM(2015) 421 final, 04.09.2015.]
Danish: [3: Kommissionens rapport om gennemførelsen af direktiv 2011/24/EU om patientrettigheder i forbindelse med grænseoverskridende sundhedsydelser, COM(2015) 421 final af 4.9.2015.]
English: In 2017 a total of 74,589 enquiries were received across 22 Member States and Norway, reflecting a very similar use of NCPs to that reported for 2016 when a total of 69,723 enquires were counted across 28 Member States and Norway and in 2015 when a total of 59,558 requests were received in 19 Member States.
Danish: I 2017 blev der modtaget i alt 74 589 forespørgsler i 22 medlemsstater og Norge, hvilket afspejler en brug af de nationale kontaktpunkter, som i høj grad svarer til den, som blev indberettet for 2016, hvor i alt 69 723 forespørgsler var fordelt på 28 medlemsstater og Norge, og i 2015, hvor der blev modtaget i alt 59 558 forespørgsler i 19 medlemsstater.
English: [28: IF SBH (International Federation for Spina Bifida and Hydrocephalus) and EDF (European Disability Forum), "Impact of Cross-border Healthcare on Persons with Disabilities and Chronic Conditions", 2017 ][29: https://ec.europa.eu/health/sites/health/files/cross_border_care/docs/2015_operation_report_dir201124eu_en.pdf]
Danish: [28: IF SBH (International Federation for Spina Bifida and Hydrocephalus) og EDF (European Disability Forum), "Impact of Cross-border Healthcare on Persons with Disabilities and Chronic Conditions", 2017.
English: Completeness check
Danish: Fuldstændighedskontrol
English: Member States agreed that no exclusion is needed; therefore, the Commission has not used the delegated power.
Danish: Medlemsstaterne var enige om, at der ikke er behov for udelukkelse.
English: ][8: Article 4(2)(c), (e)-(f), 4(3), 4(4), 5(b)-(d), 7(1), 9(4)-(5).
Danish: ][8: Artikel 4, stk. 2, litra c), e)-f), artikel 4, stk. 3, artikel 4, stk. 4, artikel 5, litra b)-d), artikel 7, stk. 1, artikel 9, stk.