FrancophonIA/Publications_Medical_Domain_UE huggingface dataset:
English: ][2: Regulations (EC) No 883/2004 of the European Parliament and of the Council of 29 April 2004 on the coordination of social security systems (OJ L 166, 30.4.2004, p. 1) and 987/2009 laying down the procedure for implementing Regulation (EC) No 883/2004 (OJ L 284, 30.10.2009, p.1).]
Danish: ][2: Europa-Parlamentets og Rådets forordning (EF) nr. 883/2004 af 29. april 2004 om koordinering af de sociale sikringsordninger (EUT L 166 af 30.4.2004, s. 1) og 987/2009 om de nærmere regler til gennemførelse af forordning (EF) nr. 883/2004 (EUT L 284 af 30.10.2009, s.
English: Flow Map 2 in Annex B represents the aggregated flows across 2015, 2016 and 2017 for treatment without prior authorisation.
Danish: Kort 2 i bilag B viser aggregerede strømme i 2015, 2016 og 2017 for behandling uden forhåndstilladelse.
English: [27: https://ec.europa.eu/health/cross_border_care/key_documents_en]
Danish: [27: https://ec.europa.eu/health/cross_border_care/key_documents_da.]
English: Two significant trends emerge from the data on the direction of patient flows, whether it is mobility with or without PA.
Danish: Dataene om patientstrømme, uanset om det drejer sig om mobilitet med eller uden forhåndstilladelse, viser to tendenser.
English: Data on patient mobility
Danish: Data om patientmobilitet
English: ][31: https://ec.europa.eu/health/cross_border_care/events/ev_20161024_en]
Danish: ][31: https://ec.europa.eu/health/cross_border_care/events/ev_20161024_da.]
English: Direction of Patient Mobility
Danish: Retningen af patientmobiliteten
English: [38: https://ec.europa.eu/health/technology_assessment/eu_cooperation_en][39: Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on health technology assessment and amending Directive 2011/24/EU, COM(2018)51 final, 31.01.2018. https://ec.europa.eu/health/technology_assessment/eu_cooperation_en]
Danish: ][39: Forslag til EUROPA-PARLAMENTETS OG RÅDETS FORORDNING om medicinsk teknologivurdering og om ændring af direktiv 2011/24/EU, COM(2018) 51 final af 31.1.2018.
English: Figure 3: Requests for information made to NCPs
Danish: Figur 3: Anmodninger om oplysninger til nationale kontaktpunkter
English: This refers to Member States granting reimbursement of cross-border healthcare on the basis of lower levels of reimbursement, applicable to healthcare received from private or non-contracted healthcare providers within their own territory, compared to the level of reimbursement within the system of public healthcare or contracted healthcare providers.
Danish: Hermed menes medlemsstater, der yder godtgørelse af grænseoverskridende sundhedsydelser på grundlag af lavere godtgørelse, som gælder for sundhedsydelser modtaget fra private sundhedstjenesteydere eller sundhedstjenesteydere uden for kontrakt inden for deres eget område, sammenlignet med niveauet for godtgørelse inden for systemet af offentlige sundhedstjenesteydere eller sundhedstjenesteydere, som der er indgået kontrakt med. Tre medlemsstater anvender på forskellige betingelser og i forskelligt omfang førstnævnte lavere godtgørelsesniveau som referencepunkt for godtgørelse af udgifter til grænseoverskridende sundhedsydelser i henhold til direktivet.
English: In 2015 the total number of requests granted was 180,704 across 19 Member States plus Norway; in 2016 the number of requests granted over 22 Member States amounted to 209,568; and in 2017 the total number of requests granted was 194,292 across 20 Member States.
Danish: I 2016 var antallet af imødekomne anmodninger i 22 medlemsstater 209 568, og i 2017 var det samlede antal anmodninger, der blev imødekommet, 194 292 i 20 medlemsstater.
English: Flow Map 1 in Annex B represents the aggregated flows across 2015, 2016 and 2017 for treatment requiring prior authorisation.
Danish: Kort 1 i bilag B viser den samlede strøm i 2015, 2016 og 2017 for behandlinger, der kræver forhåndstilladelse.
English: ][7: Article 4(2) (a)-(b), 5(b), 6(3).
Danish: ][7: Artikel 4, stk. 2, litra a)-b), artikel 5, litra b), artikel 6, stk.
English: Data was received in 2015 from 23 Member States and Norway; in 2016, from all 28 Member States plus Norway and Iceland; and in 2017 from 26 Member States.
Danish: Nedennævnte data vedrører rapporter om mobilitet for tre år (2015-2017), men antallet af lande for hvert år er ikke ens. I 2015 blev der modtaget data fra 23 medlemsstater og Norge, i 2016 fra alle 28 medlemsstater plus Norge og Island og i 2017 fra 26 medlemsstater.
English: ][15: See e.g. Case C-205/99 Analir and Others [2001] ECR I 1271, paragraphs 35-38; case C-157/99 Smits and Peerbooms, paragraphs 80- 90.
Danish: 2001 I, s. 1271, præmis 35-38, sag C-157/99, Smits og Peerbooms, præmis 80-90.
English: [14: See e.g. Case C205/99 Analir and Others [2001] ECR I1271, paragraph 38; case C-157/99 Smits and Peerbooms, paragraph 90.
Danish: 2001 I, s. 1271, præmis 38, sag C-157/99, Smits og Peerbooms, præmis 90.
English: ][42: https://ec.europa.eu/health/sites/health/files/ehealth/docs/ev_20161121_co10_en.pdf][43: https://ec.europa.eu/health//sites/health/files/ehealth/docs/eprescription_guidelines_en.pdf]
Danish: ][42: https://ec.europa.eu/health/sites/health/files/ehealth/docs/ev_20161121_co10_en.pdf.
English: This can lead to certain discrepancies.
Danish: Dette kan føre til visse uoverensstemmelser.
English: According to reports from Member States, no such penalties have so far been imposed.
Danish: Ifølge rapporterne fra medlemsstaterne er der ikke hidtil blevet pålagt nogen sådanne sanktioner.
English: In such cases this report contains the updated information.
Danish: I sådanne tilfælde indeholder denne rapport de ajourførte oplysninger.
English: In the latter case, an infringement proceeding pursuant to Article 258 TFEU is ongoing.
Danish: I sidstnævnte tilfælde er en overtrædelsesprocedure i henhold til artikel 258 i TEUF i gang.
English: Time off work varies from less than half a day to up to two days.
Danish: Tiden, der gives til at være væk fra arbejdet, varierer fra mindre end en halv dag til op til to dage.
English: At the end of 2011, 1363 blood establishments were authorised in the EU.
Danish: Ved udgangen af 2011 var der 1363 godkendte blodcentre i EU.
English: Combining the implementation of all three pillars, where possible, is probably the most effective way to minimise risks.
Danish: En kombineret gennemførelse af alle tre søjler er, hvor det er muligt, den mest effektive måde til at minimere risici.
English: Views vary on whether such cross-border donations are desirable.
Danish: Der er forskellige synspunkter om, hvorvidt sådanne donationer på tværs af grænserne er ønskværdigt.
English: The Commission will follow-up with Member States to address situations where the legislation might not have been fully or correctly implemented.
Danish: Kommissionen vil følge op med medlemsstaterne med henblik på at afhjælpe situationer, hvor lovgivningen muligvis ikke er blevet fuldt ud eller korrekt gennemført.
English: The Commission is required to transmit these national reports to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions.
Danish: Kommissionen skal fremsende disse nationale rapporter til Europa-Parlamentet, Rådet, Det Europæiske Økonomiske og Sociale Udvalg og Regionsudvalget.
English: Member States can add tests for specific components or epidemiological situations.
Danish: Medlemsstaterne kan tilføje test af specifikke komponenter eller epidemiologiske situationer.
English: Some Member States called for more common procedures for authorisation across the Union.
Danish: Nogle medlemsstater efterlyste flere fælles procedurer for godkendelse i hele Unionen.
English: The gaps and difficulties identified may suggest that a further in-depth evaluation might be useful.
Danish: De konstaterede mangler og vanskeligheder kan være tegn på, at en yderligere dybdegående evaluering kan være nyttig.
English: Significant progress has been made in many areas, often through the active support of Commission funded projects and other initiatives.
Danish: Der er gjort betydelige fremskridt på mange områder, ofte gennem aktiv støtte fra projekter finansieret af Kommissionen og andre initiativer.
English: Public, national suppliers are predominant in a minority of EU countries.
Danish: Offentlige, nationale leverandører er fremherskende i et mindretal af landene i EU.
English: Some Member States would welcome an exchange of best practices in this respect.
Danish: Nogle medlemsstater ville i den forbindelse gerne have en udveksling af de bedste praksisser.
English: [7: Links to be added once published]
Danish: [7: Links indsættes, når de er offentliggjort.]
English: In all Member States these tests are performed by authorised laboratories.
Danish: Disse test udføres i alle medlemsstaterne af godkendte laboratorier.
English: There are a small number of international companies that supply the majority of countries.
Danish: Der er et lille antal internationale virksomheder, som leverer til hovedparten af landene.
English: One national competent authority has taken the lead on developing such an initiative within the network of national competent authorities.
Danish: En national kompetent myndighed er gået forrest for at udvikle et sådant initiativ inden for netværket af nationale kompetente myndigheder.
English: Reimbursement of travel costs can cover the actual costs or be a standard lump sum.
Danish: Godtgørelse af transportudgifter kan dække de faktiske omkostninger eller være et fast engangsbeløb.
English: The UK and Ireland apply this policy as part of their risk mitigation strategy for transmission of variant Creutzfeldt Jacob disease.
Danish: Det Forenede Kongerige og Irland anvender denne politik som led i deres risikobegrænsende strategi for overførsel af variant Creutzfeldt-Jacobs sygdom.
English: Shortages, surpluses and self-sufficiency.
Danish: Mangler, overskud og selvforsyning
English: The 2013 implementation survey was answered by all Member States and also by two EEA countries, Liechtenstein and Norway.
Danish: 2013-gennemførelsesundersøgelsen blev besvaret af alle medlemsstaterne og også af to EØS-lande, Liechtenstein og Norge.
English: The difference in purchasing power between Member States might be one factor which explains the diverging views on what is or is not an incentive to donate.
Danish: Forskellen i købekraft mellem medlemsstaterne kan være en af de faktorer, der forklarer de divergerende synspunkter om, hvad der er eller ikke er et incitament til at donere.
English: Several Member States expressed interest in applying instead a risk-based prioritisation planning for inspections.
Danish: En række medlemsstater udtrykte interesse for i stedet at anvende en risikobaseret prioritering til at planlægge inspektioner.
English: The Commission will consider the need for an evaluation in order to assess the relevance, effectiveness, efficiency, coherence and the EU added value of Directive 2002/98/EC and its implementing Directives.
Danish: Kommissionen vil overveje, om der er behov for en evaluering for at vurdere relevansen, effektiviteten, virkningsgraden, sammenhængen og merværdien for EU af direktiv 2002/98/EF og dets gennemførelsesdirektiver.
English: In some Member States, donors receive a fixed payment that is not directly related to actual costs incurred.
Danish: I nogle medlemsstater kan donorerne modtage en fast betaling, som ikke er direkte knyttet til de faktiske afholdte omkostninger.
English: There appears to be a good interconnectivity with other health-related vigilance systems, in particular on medical devices and communicable diseases.
Danish: Der lader til at være en god sammenkobling med andre sundhedsrelaterede overvågningssystemer, navnlig om medicinsk udstyr og overførbare sygdomme.
English: There are differences between Member States in relation to the duration and terms of renewal of the individual authorisations.
Danish: Der er forskelle mellem medlemsstaterne med hensyn til varigheden af og vilkårene for forlængelse af de individuelle godkendelser.
English: While most cross-border donations seem to be individual initiatives, Hungary and Slovakia reported organised transport for their citizens to travel to Austria for plasma donation.
Danish: Mens de fleste grænseoverskridende donationer synes at være enkeltstående initiativer, har Ungarn og Slovakiet indberettet, at der blev organiseret transport for deres borgere for at rejse til Østrig for at donere plasma.
English: However, some difficulties in interpretation, implementation and enforcement of the legislation were identified, in some cases due to technological and scientific advances since its adoption.
Danish: Imidlertid er der blevet konstateret nogle problemer med fortolkning, gennemførelse og håndhævelse af lovgivningen, i nogle tilfælde på grund af teknologiske og videnskabelige fremskridt siden dens vedtagelse.
English: In order to address shortages, countries can put in place policies to increase supply and to optimise usage.
Danish: For at afhjælpe mangler kan lande indføre politikker til at øge udbuddet og optimere brugen.
English: Quality and safety of blood and blood components
Danish: Kvalitet og sikkerhed i forbindelse med blod og blodkomponenter
English: Additional screening and testing may reduce, but cannot completely eliminate, the possibility of a transmission from donor to recipient.
Danish: Yderligere screening og testning kan reducere, men ikke fuldstændigt eliminere risikoen for en overførsel fra donor til recipient.
English: Additionally, the distinction between import/export from/to third countries and distribution from/to other EU Member States is not consistently applied.
Danish: Desuden sondres der ikke konsekvent mellem import/eksport fra/til tredjelande og distribution fra/til andre EU-medlemsstater.
English: From an EU perspective, the relevant question is whether blood collected from these donors might have a different safety and quality profile (see below).
Danish: Fra et EU-perspektiv er det relevante spørgsmål, om blod indsamlet fra disse donorer kan have en anden sikkerheds- og kvalitetsprofil (se nedenfor).
English: In a system allowing donor payment, some individuals may find the monetary remuneration so important that they might not disclose relevant medical and/or behavioural information.
Danish: I et system, der tillader betaling af donorer, kan nogle personer finde den monetære aflønning så vigtige, at de ikke videregiver relevante medicinske og/eller adfærdsrelaterede oplysninger.
English: Fig. 2: Overlapping inspection schemes
Danish: Fig. 2: Overlappende inspektionsordninger
English: The maximum reported values of compensation and incentives are around EUR 25-30 per donation while the reported values of refreshments and small tokens are between EUR 1 and EUR 10 per donation.
Danish: De maksimale indberettede værdier for kompensation og incitamenter er ca. 25-30 EUR pr. donation, mens de indberettede værdier af forfriskninger og små erkendtligheder ligger på mellem 1 og 10 EUR pr. donation.
English: It is important to note that the hyperlinks contain the original replies of Member States, whilst the report reflects the updated information provided by Member States.
Danish: Det er vigtigt at bemærke, at linksene indeholder de oprindelige svar fra medlemsstaterne, mens rapporten afspejler de ajourførte oplysninger fra medlemsstaterne.
English: These authorisations also cover 731 mobile sites, 534 satellite sites and 253 plasma collection centres.
Danish: Disse godkendelser omfatter også 731 mobile enheder, 534 tilknyttede underordnede steder og 253 plasmatapningscentre.
English: Irrespective of the organisational set-up, it is important that authorities have appropriate resources at their disposal to enable them to carry out the required duties, as well as to ensure their independence from economic operators in the sector and from other influences.
Danish: Det er, uafhængigt af den organisatoriske struktur, vigtigt, at myndighederne har tilstrækkelige ressourcer til rådighed, så de kan udføre de krævede opgaver samt sikre deres uafhængighed af sektorens økonomiske operatører og fra andre påvirkninger.
English: They reported conducting additional tests for syphilis, malaria, hepatitis A, hepatitis E and Parvovirus B19.
Danish: De indberettede, at de gennemførte yderligere test for syfilis, malaria, hepatitis A, hepatitis E og parvovirus B19.
English: All Member States have appointed competent authorities for blood.
Danish: Alle medlemsstater har udpeget kompetente myndigheder med ansvar for blod.
English: In almost every country, donation promotion activities are the main actions taken to increase supply.
Danish: I næsten alle lande er aktiviteter til fremme af donation de vigtigste tiltag til at øge udbuddet.
English: In contrast, 47-48% considered that receiving refreshments, free blood testing or a free physical check-up were acceptable.
Danish: Derimod anser 47-48 % det for acceptabelt at modtage forfriskninger, gratis blodprøver eller en gratis lægeundersøgelse.
English: The global growth of utilisation of plasma derivatives, particularly intravenous immunoglobulin (IVIG), requires a growing number of donations.
Danish: Den globale vækst i udnyttelse af plasmaderivater, navnlig intravenøst indgivet immunglobulin (IVIG), kræver et stigende antal donationer.
English: Fig. 4: Countries reporting regular shortages
Danish: Fig. 4: Lande, der indberetter regelmæssige mangler
English: In almost all countries, the inspections of blood establishments overlap with inspections in other areas.
Danish: I næsten alle lande overlapper inspektionerne i blodcentre inspektioner på andre områder.
English: In around half of the Member States, donors have their travel costs reimbursed and get time off work in the public and private sector.
Danish: I omkring halvdelen af medlemsstaterne får donorerne deres rejseudgifter refunderet og fri fra arbejde i den offentlige og private sektor.
English: In conclusion, this Report reveals an overall adequate level of application of the current quality and safety requirements of the EU blood legislation.
Danish: Sammenfattende viser denne rapport en generel tilstrækkelig anvendelse af de nuværende kvalitets- og sikkerhedskrav i EU's lovgivning.
English: Since 2003, a number of projects have been funded under the multi-annual programmes for Union action in the field of health addressing the area of blood and blood components.
Danish: Siden 2003 er en række projekter blevet finansieret under de flerårige programmer for Unionens indsats inden for sundhed med hensyn til blod og blodkomponenter.
English: In contrast to blood components for transfusion, the demand for plasma derivatives is steadily increasing (around 6% per year) which also generates import flows from third countries into the EU.
Danish: I modsætning til blodkomponenter til transfusion er efterspørgslen efter plasmaderivater støt stigende (med ca. 6 % om året), hvilket også skaber importstrømme fra tredjelande til EU.
English: The Commission is also required to provide them with an overview report on the implementation of the requirements of the Directive, in particular as regards inspections and control.
Danish: Kommissionen skal også sende dem en oversigtsrapport om gennemførelsen af kravene i direktivet, navnlig kravene vedrørende inspektion og kontrol.
English: Many countries are largely supplied with plasma derivatives by just one supplier, either public or private.
Danish: Mange lande forsynes hovedsagelig med plasmaderivater fra blot én leverandør, der enten er offentlig eller privat.
English: While all countries report having recall procedures in place, only 14 reported recalls (1867 in total).
Danish: Mens alle lande indberettede, at de har tilbagekaldelsesprocedurer, indberettede kun 14, at de har foretaget tilbagekaldelser (1867 i alt).
English: The debate on possible compensation and incentives for donors plays an important role in supply management (see below).
Danish: Debatten om eventuel kompensation eller incitamenter for donorer spiller en vigtig rolle i forvaltningen af udbuddet (se nedenfor).
English: The ageing EU population could exacerbate supply challenges, leading both to increased demand and reduced numbers of eligible donors.
Danish: EU's aldrende befolkning kan forværre forsyningsrelaterede udfordringer, hvilket både fører til øget efterspørgsel og et reduceret antal potentielle donorer.
English: As regards the risk of transmission of communicable diseases thorough blood and blood components, the collaboration with ECDC proved extremely valuable.
Danish: For så vidt angår risikoen for overførsel af overførbare sygdomme gennem blod og blodkomponenter, har samarbejdet med ECDC vist sig yderst værdifuldt.
English: The value of international projects, at EU level and organised by the Council of Europe, are clearly appreciated by most of the national competent authorities as a means to help maintain an adequate level of training and know-how within the group of inspectors and to help ensure a uniform level of compliance verification throughout the EU.
Danish: Værdien af internationale projekter på EU-plan og organiseret af Europarådet er særdeles værdsat af de fleste af de kompetente nationale myndigheder som et middel til at opretholde et tilstrækkeligt uddannelsesniveau og knowhow i gruppen af inspektører og for at bidrage til at sikre et ensartet niveau for kontrol af overholdelsen i hele EU.
English: These policies involve players at multiple levels, national competent authorities as well as local clinicians.
Danish: Disse politikker inddrager aktører på forskellige niveauer, nationale kompetente myndigheder såvel som lokale klinikere.
English: As the legislation in question does not provide a basis for full harmonisation and as Directives allow the Member States a certain degree of discretion as to how to ensure their implementation, there are accordingly many differences between Member States in the approaches they have taken to implementation.
Danish: Da den pågældende lovgivning ikke giver hjemmel til en fuldstændig harmonisering, og eftersom direktiver giver medlemsstaterne en vis skønsmargen med hensyn til, hvordan de vil sikre deres gennemførelse, er der som følge heraf mange forskelle mellem medlemsstaterne i de tilgange, som de har truffet vedrørende gennemførelse.
English: The European Commission has been supporting the implementation of the legislation by the Member States by encouraging the active participation of national Competent Authorities in a series of actions, from bi-annual expert meetings to EU-funded projects.
Danish: Europa-Kommissionen har støttet medlemsstaternes gennemførelse af lovgivningen ved at fremme aktiv deltagelse af nationale kompetente myndigheder i en række aktioner fra halvårlige ekspertmøder til EU-finansierede projekter.
English: Other challenges to the principle of (self-) sufficiency are outlined below.
Danish: Andre udfordringer for princippet om selvforsyning eller tilstrækkelighed er skitseret nedenfor.
English: Every change in deferral, testing or pathogen inactivation policy has a possible impact not only on safety and quality, but also on the economics and on the volume of donations and supply.
Danish: Alle ændringer i udelukkelses-, test- eller patogeninaktiveringspolitik har en mulig indvirkning, ikke kun på sikkerhed og kvalitet, men også på de økonomiske aspekter samt på mængden af donationer og forsyningsmængden.
English: Countries identify an increase of the maximum donor age as the most promising initiative to improve the supply of blood and blood components.
Danish: Landene har udpeget en forhøjelse af den højest tilladte donoralder som det mest lovende initiativ til at forbedre forsyningen af blod og blodkomponenter.
English: Less than half of the countries reported having national guiding principles to define what form of compensation or other practice is allowed and under which circumstances.
Danish: Under halvdelen af de indberettende lande har nationale retningslinjer for at definere, hvilken form for kompensation eller anden praksis der er tilladt og under hvilke omstændigheder.
English: Several Member States mentioned the limited role of authorities at federal/national level and pointed to the important tasks attributed to/carried out by regional competent authorities.
Danish: Flere medlemsstater nævnte en begrænset rolle for myndigheder på føderalt/nationalt plan og pegede på de vigtige opgaver, som de regionale kompetente myndigheder er tildelt eller foretager.
English: These actions brought improvements in areas of common interest such as quality management and inspection and donor selection and included training courses for Member States Competent Authorities and their inspectors.
Danish: Disse aktioner medførte forbedringer på områder af fælles interesse, såsom kvalitetsstyring og kontrol og udvælgelse af donorer og omfattede kurser for medlemsstaternes kompetente myndigheder og deres inspektører.
English: Overall, Member States expressed interest in an increased level of donor protection and in an overview of additional national eligibility criteria in order to increase transparency and mutual trust in exchanges.
Danish: Generelt har medlemsstaterne udtrykt interesse i en øget grad af donorbeskyttelse og en oversigt over yderligere nationale udvælgelseskriterier for at øge gennemsigtigheden og den gensidige tillid til udvekslinger.
English: Seventeen Member States reported having penalties in place, addressing different situations such as making financial gain or collection of donations without consent.
Danish: Sytten medlemsstater beretter, at de har straffe på plads, som omhandler forskellige situationer, som f.eks. opnåelse af finansiel gevinst eller indsamling af donationer uden samtykke.
English: There is considerable heterogeneity across the EU, with certain practices perceived as compensation in one country and as incentives in another.
Danish: Der er betydelige forskelle i EU, hvor visse praksisser opfattes som kompensation i ét land og som incitamenter i et andet.
English: In 2012, 22 countries reported having performed 760 on-site inspections.
Danish: Inspektion og kontrolforanstaltninger I 2012 indberettede 22 lande, at de har foretaget 760 inspektioner på stedet.
English: A limited number of countries report surpluses for some blood components which indicates the potential for cross-border agreements.
Danish: Et begrænset antal lande indberettede overskud for visse blodkomponenter, hvilket viser potentialet for grænseoverskridende aftaler.
English: Fig. 5: Policy setting to ensure effective use of blood, blood components and plasma derivatives
Danish: Fig. 5: Udarbejdelse af politikker til at sikre effektiv anvendelse af blod, blodkomponenter og plasmaderivater
English: A verification of the completeness of transposition into national legislation of the EU blood legislation, carried out by the Commission, demonstrated that it is fully transposed in all but one Member State.
Danish: En kontrol af fuldstændigheden af gennemførelsen af EU's lovgivning om blod i national lovgivning, som Kommissionen har foretaget, viste, at den er fuldt ud gennemført i alle medlemsstater undtagen en enkelt.
English: Projects such as EUBIS, CATIE, DOMAINE, Optimal Blood Use, EU-Q-Blood-SOP and the on-going joint action VISTART provide strong support to Member States in their efforts to implement the requirements of the blood directives.
Danish: Projekter som f.eks. EUBIS, CATIE, DOMAINE, optimal anvendelse af blod, EU-Q-Blood-SOP og den igangværende fælles aktion VISTART yder stærk støtte til medlemsstaterne i deres indsats for at gennemføre kravene i bloddirektiverne.
English: Overall, the implementation of the EU blood legislation by Member States is considered adequate and the legislation has resulted in the establishment of a network of competent authorities that oversee the field through authorisation, inspection, and vigilance.
Danish: Gennemførelsen af EU's lovgivning om blod i medlemsstaterne anses overordnet set for at være tilstrækkelig, og lovgivningen har ført til oprettelse af et netværk af kompetente myndigheder, der overvåger området gennem godkendelse, inspektion og overvågning.
English: Whilst overall Member States seem to correctly implement the provisions concerning inspections, a number of Member States reported difficulties related to staffing, which makes compliance with the required 2-year inspection interval challenging.
Danish: Mens medlemsstaterne generelt ser ud til på korrekt vis at gennemføre bestemmelserne om inspektioner, indberettede en række medlemsstater problemer vedrørende personale, der gør overholdelsen af de krævede 2-års intervaller mellem inspektioner til en udfordring.
English: Wherever different oversight activities (authorisation, inspection, haemovigilance) are undertaken by different authorities, good communication and coordination between respective authorities needs to be ensured.
Danish: Hvis forskellige tilsynsaktiviteter (godkendelse, inspektion og blodovervågning) foretages af forskellige myndigheder, må der sikres god kommunikation og koordinering mellem de forskellige myndigheder.
English: These shortages often occur in summer/holiday seasons when the number of donors is reduced and the risk of epidemiological outbreaks, such as West Nile Virus, can temporarily reduce the number of eligible donors.
Danish: Disse mangler opstår ofte om sommeren eller i ferieperioder, når antallet af donorer er mindsket, og risikoen for epidemiologiske udbrud, såsom vestnilvirus, midlertidigt kan mindske antallet af potentielle donorer.
English: The EU is significantly reliant on importation of plasma for the manufacture of plasma derived medicinal products, mainly from the United States.
Danish: EU er i høj grad afhængig af import af plasma til fremstilling af plasmabaserede lægemidler, primært fra USA.
English: These differences facilitate successful integration of the requirements into national legislation but in some cases they may limit the mutual acceptance of authorisations with consequences for potential cross-border movement of blood and blood components.
Danish: Disse forskelle kan fremme en vellykket integrering af kravene i national lovgivning, men i nogle tilfælde kan de begrænse den gensidige accept af godkendelser med konsekvenser for en potentiel grænseoverskridende transport af blod og blodkomponenter.
English: Most common are awareness building campaigns for specific donor groups, such as students, or events such as the World Blood Donor Day (WHO, 14 June) or Thalassemia day (8 May in Greece and Cyprus).
Danish: De mest almindelige er opmærksomhedsskabende kampagner for specifikke donorgrupper, såsom studerende, eller begivenheder som f.eks. den internationale bloddonordag (WHO, 14. juni) eller thalassæmidagen (den 8. maj i Grækenland og Cypern).
English: Article 26 of Directive 2002/98/EC requires Member States to submit to the European Commission, before 31 December 2003 and every three years thereafter, a report on the activities carried out in relation to the provisions of the Directive, including an account of the measures taken in relation to inspection and control.
Danish: I henhold til artikel 26 i direktiv 2002/98/EF skal medlemsstaterne senest den 31. december 2003 og derefter hvert tredje år forelægge Kommissionen en rapport om de aktiviteter, der er gennemført i medfør af dette direktiv, herunder en redegørelse for inspektions- og kontrolforanstaltninger.
English: In order to manage demand and supply of blood and blood components, almost all countries have policies in place that combine annual forecasting with weekly monitoring.
Danish: Med henblik på at styre efterspørgslen og udbuddet af blod og blodkomponenter har næsten alle medlemslande indført politikker, der kombinerer årlige prognoser med ugentlig overvågning.
English: While many countries report having data on imported volumes, it is difficult to draw conclusions in the absence of a harmonised data collection system on import and export volumes.
Danish: Mens mange lande indberetter, at de har oplysninger om importerede mængder, er det i fraværet af et harmoniseret dataindsamlingssystem vedrørende import- og eksportmængder vanskeligt at drage konklusioner.
English: Designation of competent authority or authorities
Danish: Udpegning af kompetente myndigheder
English: In addition, thematic/focused inspections, inspections following SARE and desk-based assessments are organised.
Danish: Desuden blev der organiseret tematiske/fokuserede inspektioner, inspektioner i henhold til SARE og administrative vurderinger.
English: While not mandatory, two-thirds of countries have put in place donor self-exclusion systems.
Danish: Selv om det ikke er obligatorisk, har to tredjedele af landene iværksat systemer, hvor donorerne kan udelukke sig selv.
English: Policies towards them vary, from prohibition to seeing replacement donations as an opportunity to contribute to national self-sufficiency by converting them into regular donors.
Danish: Politikker over for disse donorer varierer fra forbud til at betragte erstatningsdonationer som en lejlighed til at bidrage til den nationale selvforsyning ved at konvertere dem til rigtige donorer.
English: This topic is intrinsically linked with the promotion and success of the principle of VUD, as highlighted in recital 23 of Directive 2002/98/EC.
Danish: Dette emne er uløseligt forbundet med fremme af og succes vedrørende princippet om frivillig og vederlagsfri donation, som fremhævet i betragtning 23 i direktiv 2002/98/EF.
English: Plasma and plasma derivatives can have a longer shelf-life and as fractionation plants exist only in twelve Member States, both plasma (the starting material) and plasma derivatives (the end product) are frequently exchanged across borders, within the EU and with third (non-EU) countries.
Danish: Plasma og plasmaderivater kan have en længere holdbarhed, og eftersom der kun findes fraktioneringscentre i tolv medlemsstater, udveksles både plasma (udgangsmaterialet) og plasmaderivater (det endelige produkt) hyppigt på tværs af grænserne inden for EU og med tredjelande (ikke-EU-lande).
English: Sixteen reported discouraging such donations by requiring a local ID document or a proof or local residence.
Danish: Seksten rapporterede, at de søgte at hindre sådanne donationer ved at kræve et lokalt identitetsdokument eller et bevis på en lokal bopæl.
English: Member States also highlight the need for good validation of testing technologies, and also pathogen inactivation technologies, in order to achieve an effective level of safety and quality.
Danish: Medlemsstaterne har også fremhævet behovet for god validering af testteknologier og patogeninaktiveringsteknologier med henblik på at opnå et effektivt niveau for sikkerhed og kvalitet.
English: The reported picture seems not to be complete, with some inconsistencies between the information provided by countries whose citizens travel to donate and those who have donors coming from another Member State to donate.
Danish: Det indberettede billede synes ikke at være fuldstændigt, da der er visse uoverensstemmelser mellem oplysningerne fra lande, hvis borgere rejser ud for at donere, og dem, der har donorer, der kommer fra en anden medlemsstat for at donere.
English: Sixteen countries report having pathogen inactivation technologies in place.
Danish: Seksten lande angiver, at de har patogeninaktiveringteknologier.
English: However, Member States' perceptions of what is considered compensation and incentive vary.
Danish: Imidlertid varierer medlemsstaternes opfattelse af, hvad der betragtes som kompensation og incitament.
English: Many countries reported in 2013 on the feasibility/appropriateness of deferring donors on the grounds of sexual risk behaviour and about two-thirds of the countries have national guidance in place.
Danish: Mange lande berettede i 2013 om gennemførligheden og hensigtsmæssigheden af at udelukke donorer på grund af seksuel risikoadfærd, og omkring to tredjedele af landene har nationale retningslinjer.
English: Countries also see value in further centralisation of laboratory test results at EU level to facilitate benchmarking against average EU rates of positivity.
Danish: Landene ser også det nyttige i yderligere centralisering af laboratorietestresultaterne på EU-plan for at fremme benchmarking i forhold til EU's gennemsnitlige frekvenser af positive resultater.
English: Finally, the Commission developed, in close cooperation with the Member States, a Rapid Alert Platform for Blood (RAB) which facilitates web-based communications between Member States in case of alerts with relevance in two or more Member States.
Danish: Og sluttelig udviklede Kommissionen i tæt samarbejde med medlemsstaterne et hurtigt varslingssystem vedrørende blod, som letter webbaseret kommunikation mellem medlemsstaterne i tilfælde af advarsler med relevans i to eller flere medlemsstater.
English: Eight countries reported regular shortages of one or more blood components in the survey.
Danish: Otte lande har i undersøgelsen oplyst, at de regelmæssigt mangler en eller flere blodkomponenter.
English: While two of these latter six countries also report regular shortages in national supply, the information provided was not sufficient to establish a causal link between these shortages and the cross-border movement of donors.
Danish: Selv om to af disse seks lande også indberettede, at de har tilbagevendende mangelsituationer i den nationale forsyning, så var de fremlagte oplysninger ikke tilstrækkelige til at påvise en årsagsforbindelse mellem disse mangler og donorernes grænseoverskridende bevægelighed.
English: For the purpose of the survey, "compensation" was defined as "reparation strictly limited to making good the expenses and inconveniences related to the donation" and "incentive" was defined as "inducement or stimulus for donation with a view to seeking financial gain or comparable advantage", but even with these (non-binding) definitions Member States reached divergent classifications.
Danish: Som led i undersøgelsen var "kompensation" defineret som "erstatning, der er strengt begrænset til en godtgørelse for udgifter og ulemper i forbindelse med donationen", og "incitament" var defineret som "ansporing eller tilskyndelse til donation med henblik på at opnå økonomisk vinding eller tilsvarende fordel", men selv med disse (ikkebindende) definitioner nåede medlemsstaterne frem til forskellige klassifikationer.
English: In addition, and in accordance with Article 20(2) of the Directive 2002/98/EC, Member States have to submit to the Commission reports on the application of the principle of voluntary and unpaid donation (VUD) every three years.
Danish: Endvidere, og i overensstemmelse med artikel 20, stk. 2, i direktiv 2002/98/EF, skal medlemsstaterne forelægge rapporter om anvendelse af princippet om frivillig og vederlagsfri donation for Kommissionen hvert tredje år.
English: All Member States replied to the transposition questionnaire.
Danish: Alle medlemsstaterne besvarede spørgeskemaet om gennemførelsens fuldstændighed.
English: The regular meetings of the expert sub-group on blood and blood components (which is part of the Competent Authorities on Substances of Human Origin Expert Group - CASoHO E01718) allow for sharing best practices and clarification of common difficulties encountered at national and EU level.
Danish: De regelmæssige møder i ekspertundergruppen for blod og blodkomponenter (som er en del af ekspertgruppen for kompetente myndigheder inden for stoffer af menneskelig oprindelse - CASoHO E01718) giver mulighed for at udveksle bedste praksis og tydeliggøre fælles problemer på nationalt plan og EU-plan.
English: Many countries reported financially supporting blood establishments and local players in the organisation of such promotion activities (although the financial support in many of these countries also relates to collection, processing, storage and distribution activities).
Danish: Mange lande har indberettet, at de støtter blodcentre og lokale aktører økonomisk i tilrettelæggelsen af sådanne pr-aktiviteter (selv om den finansielle støtte i mange af disse lande også vedrører tapnings-, behandlings-, opbevarings- og distributionsaktiviteter).
English: The service contract aims to develop best practices, which could allow for a significant reduction of blood demand for many treatments.
Danish: Tjenesteydelseskontrakten sigter mod at udvikle bedste praksisser, som for mange behandlingers vedkommende vil give mulighed for en betydelig reduktion af efterspørgslen efter blod.
English: Fig. 1: Additional fields of competence for national blood competent authorities
Danish: Fig. 1: Yderligere kompetenceområder for nationale kompetente myndigheder med ansvar for blod
English: In half of the countries one authority is responsible for the entire oversight of the blood sector, whereas in others the tasks are divided amongst two or three authorities (based on duties, e.g. accreditation/authorisation versus inspections/vigilance, or based on the allocation of tasks between federal and regional levels).
Danish: I halvdelen af landene er der én myndighed med ansvar for hele tilsynet med blodsektoren, mens opgaverne i andre er fordelt mellem to eller tre myndigheder (baseret på opgaver, f.eks. akkreditering/godkendelse over for inspektion/overvågning, eller på grundlag af opgavefordelingen mellem føderale og regionale niveauer).
English: Replacement donors, i.e. donors that are encouraged to make donations to replace those being used for a relative or friend, are reported as important for maintaining supply in five countries.
Danish: Erstatningsdonorer, dvs. donorer, der opfordres til at give donationer til erstatning for dem, der anvendes i forbindelse med et familiemedlem eller en ven, indberettes af fem lande som værende vigtige for at opretholde forsyningen.
English: The role of common assessments by ECDC and the Commission was recognised in this context, e.g. when developing a preparedness plan to help blood establishments address the seasonal outbreaks of West Nile Virus in some southern EU countries.
Danish: Den rolle, som fælles vurderinger af Det Europæiske Center for Forebyggelse af og Kontrol med Sygdomme (ECDC) og Kommissionen spiller, blev anerkendt i denne forbindelse, f.eks. i forbindelse med udvikling af en beredskabsplan for at hjælpe blodcentre håndtere sæsonbetonede udbrud af vestnilvirus i visse sydlige EU-lande.
English: In the vast majority of Member States, the authorities for blood are also responsible for the oversight of other sectors (e.g. organs, tissues, cells and/or medicinal products), which can be beneficial for achieving greater efficiency and coherence.
Danish: I langt de fleste medlemsstater er myndigheder med ansvar for blod også ansvarlige for tilsynet med andre sektorer (f.eks. organer, væv, celler og/eller lægemidler), hvilket kan være til gavn ved at føre til større effektivitet og sammenhæng.
English: Other Member States reported to be negotiating agreements for fractionation, while one reported having difficulties finding a partner to carry out fractionation.
Danish: Andre medlemsstater rapporterede, at de forhandler aftaler om fraktionering, mens én indberettede, at de havde svært ved at finde en partner til at udføre fraktionering.
English: Although the large majority of the responding countries (26) reported that the principle of VUD is mandatory at national level, their legislations often refer to an "encouragement" or to a "strong recommendation".
Danish: Skønt det store flertal af de adspurgte lande (26) har rapporteret, at princippet om frivillig og vederlagsfri donation er obligatorisk på nationalt plan, henviser deres lovgivninger ofte til en "opfordring" eller en "kraftig anbefaling".
English: The majority of Member States have rules to authorise and control import of blood and blood components for transfusion, while only about half have such rules for plasma for fractionation.
Danish: De fleste medlemsstater har regler for godkendelse og kontrol af import af blod og blodkomponenter til transfusion, mens kun omkring halvdelen har sådanne regler for plasma beregnet til fraktionering.
English: On the basis of these national reports, the Commission is required to inform the European Parliament and the Council of any necessary further measures in relation to VUD it intends to take at Union level.
Danish: På grundlag af disse nationale rapporter skal Kommissionen underrette Europa-Parlamentet og Rådet om eventuelle yderligere nødvendige foranstaltninger i forbindelse med frivillig og vederlagsfri donation, som den agter at træffe på EU-plan.
English: However, the Report also points to some gaps and difficulties in relation to the application and enforcement of the existing provisions (e.g. definitions, provisions for donor safety, inspections framework), some due to different approaches taken by the Member States and others due to technological advances and changing risks observed since the legislation was adopted.
Danish: Dog kommer rapporten også ind på visse mangler og vanskeligheder i forbindelse med anvendelsen og håndhævelsen af de eksisterende bestemmelser (f.eks. definitioner, bestemmelser vedrørende donorers sikkerhed, rammer for inspektioner), nogle af disse som følge af forskellige tilgange, som medlemsstaterne anvender, og andre på grund af teknologiske fremskridt og ændrede risici, der er konstateret, siden vedtagelsen af lovgivningen.
English: In their responses to the implementation survey, several countries suggested making syphilis testing mandatory at EU level, while some suggest making NAT testing for HIV and hepatitis mandatory, despite the reservations mentioned by other countries.
Danish: I deres svar på gennemførelsesundersøgelsen har adskillige medlemsstater foreslået, at syfilistest gøres obligatorisk på EU-plan, mens nogle foreslår, at nukleinsyretest for HIV og hepatitis gøres obligatoriske, på trods af de forbehold, der nævnes af andre lande.
English: In half of the countries, the blood establishments either determine, or are involved in determining, the value of the compensations and incentives, while in one-third of the countries the national blood competent authorities are involved.
Danish: I halvdelen af landene fastsætter blodcentrene enten eller de er involveret i fastsættelsen af værdien af kompensationerne og incitamenterne, mens de nationale kompetente myndigheder med ansvar for blod er involveret i en tredjedel af landene.
English: All Member States reported that the same rules on traceability apply to blood establishments and hospital blood banks, allowing tracing of blood and blood components from donor to recipient and vice versa.
Danish: Alle medlemsstaterne indberettede, at de samme regler vedrørende sporbarhed gælder for blodcentre og hospitalsblodbanker, hvilket muliggør sporing af blod og blodkomponenter fra donor til recipient og vice versa.
English: Besides complying with the legal obligations, the current report sets out how Directive 2002/98/EC and its implementing Directives 2004/33/EC, 2005/61/EC and 2005/62/EC (henceforth commonly referred to as the EU blood legislation) function in practice, against a backdrop of significant scientific and organisational developments (internationalisation, commercialisation) that have taken place in the European blood and blood components sector over the past decade.
Danish: Ud over at opfylde de juridiske forpligtelser beskriver den herværende rapport, hvordan direktiv 2002/98/EF og dets gennemførelsesdirektiver 2004/33/EF, 2005/61/EF og 2005/62/EF (herefter kaldet "EU's lovgivning om blod") fungerer i praksis i en situation, som er præget af en betydelig videnskabelig og organisatorisk udvikling (internationalisering og kommercialisering), som i løbet af det seneste årti har fundet sted i den europæiske sektor for blod og blodkomponenter.
English: VUD is a factor which is not only ethical in nature, but which might also contribute to higher safety standards and, therefore, be important for the protection of human health.
Danish: Princippet om frivillig og vederlagsfri donation er ikke blot af etisk karakter, men kan også bidrage til højere sikkerhedsstandarder og derfor være vigtig for beskyttelsen af menneskers sundhed.
English: It is common practice to provide refreshments to donors (27 countries) and to give them small tokens such as pin badges, pens, towels, t-shirts and mugs (24 countries).
Danish: Det er almindelig praksis at give donorer forfriskninger (27 lande) og små erkendtligheder såsom pins, kuglepenne, håndklæder, T-shirts og krus (24 lande).