FrancophonIA/Publications_Medical_Domain_UE huggingface dataset:
English: A majority of countries report having policies to also optimise the clinical use of plasma derivatives, with a small number of countries having national prioritisation strategies to ensure supply to those patient groups who are highly dependent on treatment with these products.
Danish: De fleste lande indberettede, at de har politikker til at optimere den kliniske anvendelse af plasmaderivater, og et lille antal lande har nationale prioriteringsstrategier for at sikre forsyningerne til de patientgrupper, som er stærkt afhængige af behandling med disse lægemidler.
English: About two thirds of the countries mention that blood establishments also apply more sensitive nucleic acid testing (NAT), along with serological testing, although several countries also raised questions regarding the cost-benefit ratio of this relatively costly testing technique.
Danish: Ca. to tredjedele af landene nævnte, at blodcentrene også anvender mere følsomme nukleinsyretest sammen med serologiske test, selv om en række lande også har rejst spørgsmål om cost-benefit-forholdet for denne relativt dyre testteknik.
English: 3.2 Obligations of blood competent authorities
Danish: 3.2 Forpligtelserne for de kompetente myndigheder med ansvar for blod
English: Ten countries reported facilitating donations by donors from abroad by providing donor questionnaires in different languages.
Danish: Ti lande indberettede, at de lettede donationer fra donorer fra udlandet ved at have donorspørgeskemaer på forskellige sprog.
English: Men having sex with men (MSM) is the most commonly reported sexual risk exclusion criterion due to the higher incidence of infections such as HIV within this population.
Danish: Mænd, som dyrker sex med mænd, er det hyppigst rapporterede udelukkelseskriterium baseret på seksuel risikoadfærd som følge af den højere forekomst af infektioner såsom HIV i denne population.
English: Nonetheless, the voluntary reporting of SAR in donors has increased, suggesting the Member States' increasing interest in the protection of living donors.
Danish: Ikke desto mindre er den frivillige indberetning af alvorlige bivirkninger hos donorer steget, hvilket tyder på, at medlemsstaterne har en øget interesse i at beskytte levende donorer.
English: Therefore, information provided by the donor contributes to an accurate assessment of all risks associated to the transfusion of blood and blood components and the clinical application of plasma derivatives.
Danish: Derfor bidrager oplysninger fra donoren til en nøjagtig vurdering af alle risici i forbindelse med transfusion af blod og blodkomponenter og den kliniske anvendelse af plasmaderivater.
English: To engage these local stakeholders, countries mention the use of audits and programmes such as the implementation of patient blood management (PBM) (for which there is currently a tendered study on-going under the Union's Third Health Programme).
Danish: For at engagere disse lokale aktører nævner landene brugen af kontroller og programmer såsom gennemførelsen af forvaltning af patienters blod (som i øjeblikket er ved at blive undersøgt gennem en undersøgelse, som der er indgået kontrakt om under EU's tredje sundhedsprogram).
English: Voluntary and unpaid donation (VUD)
Danish: Frivillig og vederlagsfri donation
English: Rules for export of plasma for fractionation are usually less restrictive, although practice was reported of plasma export for contract fractionation of derivatives which are subsequently to be used for patients only in the country of collection.
Danish: Reglerne for eksport af plasma til fraktionering er normalt mindre restriktive, om end der blev indberettet eksport af plasma til fraktionering af derivater, der efterfølgende kun skal anvendes for patienter i det indsamlende land.
English: Support for the Implementation of the Blood Directives
Danish: Støtte til gennemførelsen af bloddirektiverne
English: A common reason for these recalls is information received from the donor regarding his/her health situation and made available after the donation event.
Danish: En almindelig årsag til sådanne tilbagekaldelser er oplysninger fra donoren om dennes sundhedstilstand, som er kommet frem, efter donationen har fundet sted.
English: In the Eurobarometer survey on Blood and Cell and Tissue Donation, only 12% of EU citizens reported that they thought compensation additional to the costs related to donation was acceptable, when donating blood or plasma.
Danish: I Eurobarometer-undersøgelsen om donation af blod, celler og væv indberettede kun 12 % af EU-borgerne, at de mente, at kompensation ud over omkostningerne i forbindelse med donationen var acceptabelt, når man donerer blod eller plasma.
English: These include standards for verifying equivalent safety and quality standards, which in half of the Member States go beyond the requirements of the EU blood legislation, e.g. adding requirements for the use of the more sensitive nucleic acid testing (NAT) now available as a routine test for hepatitis and HIV screening.
Danish: Disse omfatter standarder for kontrol af tilsvarende kvalitets- og sikkerhedsstandarder, der i halvdelen af medlemsstaterne går videre end kravene i EU's lovgivning om blod, f.eks. ved at tilføje krav om brug af den mere følsomme nukleinsyretest, der nu er tilgængelig som en rutinemæssig screeningstest for hepatitis og HIV.
English: Also the inspection approaches vary significantly towards mobile and satellite sites, hospital blood banks, plasma collection centres and potential third country players.
Danish: Inspektionsmetoderne varierer også betydeligt for mobile og underordnede steder, hospitalsblodbanker, plasmatapningscentre og potentielle tredjelandsaktører.
English: In this context, it is challenging for MS to apply a requirement for the exclusive importation of plasma sourced from voluntary and unpaid donors.
Danish: I den forbindelse er det en udfordring for medlemsstaterne at kræve, at den indførte plasma udelukkende stammer fra frivillige og ubetalte donorer.
English: No additional testing was reported for plasma collection, compared with collection of whole blood donations.
Danish: Der blev ikke indberettet nogen yderligere test for plasmatapning, sammenlignet med tapning af fuldblodsdonationer.
English: Safety and quality of blood depends on the implementation of a combination of three pillars: donor screening for deferral criteria, donor testing and, where possible, pathogen inactivation techniques.
Danish: Sikkerheden ved og kvaliteten af blod afhænger af gennemførelsen af en kombination af tre søjler: donorscreening for udelukkelseskriterier, donortest og, hvor det er muligt, patogeninaktiveringsteknikker.
English: Although the definition of serious adverse reaction (SAR) in Directive 2002/98/EC, Article 3, gives equal importance to SAR in donors and in recipients, the current requirements refer only to reporting of SAR in recipients.
Danish: Selv om definitionen af alvorlige bivirkninger i artikel 3 i direktiv 2002/98/EF lægger lige stor vægt på alvorlige bivirkninger hos donorer og hos recipienter, henviser de nuværende krav kun til indberetning af alvorlige bivirkninger hos recipienter.
English: Some countries foresee compensation for loss of earnings in some circumstances, e.g. one Member State foresees this for plasma apheresis donations.
Danish: Nogle lande foreskriver kompensation for tabt arbejdsfortjeneste under visse omstændigheder, f.eks. foreskriver en medlemsstat det for plasmaferesedonationer.
English: Inactivation techniques are mainly used for plasma although pathogen inactivation of platelets is likely to be more common going forward.
Danish: Inaktiveringsteknikker anvendes hovedsagelig i forbindelse med plasma, selv om patogeninaktivering af trombocytter sandsynligvis vil blive mere udbredt fremover.
English: The full analysis of the Member States' replies to the 2013 implementation survey and the 2014 survey on the implementation of the VUD principle is included in the two Staff Working Documents accompanying this Report.
Danish: En fuldstændig analyse af medlemsstaternes svar i forbindelse med 2013-gennemførelsesundersøgelsen og undersøgelsen fra 2014 om gennemførelse af princippet om frivillig og vederlagsfri donation er indeholdt i de to arbejdsdokumenter fra Kommissionens tjenestegrene, som ledsager denne rapport.
English: Fig. 3: Percentage of reporting blood establishments/country
Danish: Fig. 3: Procentdel af indberettende blodcentre pr. land
English: Most countries have additional supportive measures in place, primarily focused on promoting VUD or defining compensation and incentives (see below).
Danish: De fleste lande har yderligere understøttende foranstaltninger, der primært fokuserer på at fremme frivillig og vederlagsfri donation eller på at fastsætte kompensation og incitamenter (se nedenfor).
English: Whole blood and blood components such as platelets and red blood cells have a limited shelf-life and are rarely exchanged between Member States, with the exception of rare emergency or humanitarian situations.
Danish: Import og eksport Fuldblod og blodkomponenter såsom trombocytter og røde blodlegemer har begrænset holdbarhed og udveksles sjældent mellem medlemsstaterne, bortset fra sjældne krisesituationer eller humanitære situationer.
English: Other eligibility criteria that several countries would wish to reflect on relate to the history of malignancy, donor risk behaviour and haemoglobin levels.
Danish: Andre udvælgelseskriterier, som flere lande ønsker at overveje, vedrører udviklingen af ondartethed, donorernes risikoadfærd og hæmoglobinniveauer.
English: There is diversity between Member States in organisation (e.g. desk-based versus on-site), and outcome (i.e. classification and follow-up of deficiencies) of inspections.
Danish: Der er store forskelle medlemsstaterne imellem med hensyn til organisation (f.eks. administrativ kontrol over for kontrol på stedet) og resultater (dvs. klassificering og opfølgning af mangler) af inspektioner.
English: Seven countries do not recover all plasma from whole blood donations for plasma fractionation into derivatives.
Danish: Syv lande inddriver ikke al plasma fra fuldblodsdonationer til plasmaderivater gennem fraktionering.
English: To facilitate good regulatory communication between Member States, as well as to comply with the annual reporting requirements to the Commission, a well-informed national coordinating contact point is essential, even where competent authority responsibilities are shared among multiple organisations or regions.
Danish: Det er afgørende med en velinformeret national koordinerende kontaktperson for at fremme god kommunikation om reguleringsmæssige emner mellem medlemsstaterne, således at kravene om årlig rapportering til Kommissionen også kan opfyldes, selv når de kompetente myndigheders ansvar er delt mellem flere organisationer eller regioner.
English: Five countries reported having donations by donors from abroad, while six countries reported having citizens that travel to donate abroad.
Danish: Grænseoverskridende donorer Fem lande indberettede, at de fik donationer fra donorer fra udlandet, mens seks lande indberettede, at de har borgere, der rejser til udlandet for at donere.
English: The VUD survey addressed questions on the balance between supply and demand, and the measures taken to achieve sufficiency.
Danish: Undersøgelsen om frivillig og vederlagsfri donation undersøgte spørgsmål om balancen mellem udbud og efterspørgsel, og de foranstaltninger, der træffes for at opnå tilstrækkelighed.
English: All Member States, Liechtenstein and Norway also provided answers to the survey on the implementation of the principle of VUD.
Danish: Alle medlemsstaterne, Liechtenstein og Norge besvarede også undersøgelsen om gennemførelsen af princippet om frivillig og vederlagsfri donation.
English: This overarching Report is a summary, drawing from the replies to questionnaires that the Commission sent to Member States in 2012 (verification of the completeness of transposition), 2013 (implementation survey), and 2014 (implementation of the VUD principle) and follows up on the Report in 2006 and the Commission Communication in 2010, as well as on the two Reports on the application of the principle of VUD for blood and blood components issued in 2006 and 2011.
Danish: Denne overordnede rapport er en oversigt, der trækker på svarene til de spørgeskemaer, som Kommissionen sendte til medlemsstaterne i 2012 (kontrol af gennemførelsens fuldstændighed), 2013 (gennemførelsesundersøgelsen), og 2014 (gennemførelse af princippet om frivillig og vederlagsfri donation), og følger op på rapporten fra 2006 og Kommissionens meddelelse fra 2010 samt de to rapporter offentliggjort i 2006 og 2011 om anvendelsen af princippet om frivillig og vederlagsfri donation i forbindelse med blod og blodkomponenter.
English: Fig. 6: Main causes leading to deferrals/country
Danish: Fig. 6: De vigtigste årsager, der leder til udelukkelse, pr. land
English: The authorities interact effectively with the RAB system, although many mention a need to improve communication of the information from RAB to the local blood establishments, which needs to be accomplished at national level.
Danish: Myndighederne indgår i et effektivt samspil med det hurtige varslingssystem vedrørende blod, selv om mange nævner et behov for at forbedre kommunikationen af oplysninger fra det hurtige varslingssystem vedrørende blod til de lokale blodcentre, hvilket skal gennemføres på nationalt niveau.
English: These two areas are often cause for general alerts in the blood sector, as demonstrated since the launch of the Commission managed Rapid Alert System for Blood (RAB), where a number of alerts relating to emerging disease risks with relevance to blood donor selection or testing and to medical device defects that were important in blood collection or processing were shared among the national blood competent authorities.
Danish: Disse to områder er ofte årsag til generelle advarsler i blodsektoren, som det er blevet set siden lanceringen af det af Kommissionen forvaltede hurtige varslingssystem vedrørende blod, hvor en række advarsler vedrørende nye sygdomsrisici med relevans for udvælgelse eller testning af bloddonorer og for defekter i medicinsk udstyr, som er vigtigt for tapning af blod eller forarbejdning, blev sendt rundt mellem de nationale kompetente myndigheder med ansvar for blod.
English: The main causes leading to deferrals of candidate donors reported by Member States were low haemoglobin levels (putting at risk the health of the donor) as well as risk of transmission of infectious diseases, (sexual) risk behaviours, travel, medication and other medical reasons (putting the health of the recipient at risk).
Danish: Screening for at udvælge donorer De vigtigste årsager som medlemsstaterne har indberettet til at udelukke potentielle donorer var lave hæmoglobinniveauer (hvilket truer donors helbred) samt risikoen for overførsel af smitsomme sygdomme, (seksuel) risikoadfærd, rejser, medicinering og andre medicinske grunde (der truer recipientens helbred).
English: No problems were reported regarding the implementation of the provisions related to data protection.
Danish: Beskyttelse af personoplysninger og tavshedspligt Der blev ikke rapporteret om problemer vedrørende gennemførelsen af bestemmelserne om databeskyttelse.
English: The ways in which EU Member States have implemented the principle of VUD are difficult to assess in a comprehensive manner.
Danish: De måder, hvorpå EU's medlemsstater har gennemført princippet om frivillig og vederlagsfri donation, er vanskelige at vurdere på en sammenhængende måde.
English: Safety and quality of the blood supply is an important issue for EU citizens, with 56% of respondents to the Eurobarometer survey on Blood and Cell and Tissue Donation citing the risk of contracting a disease as a major concern when accepting donated substances.
Danish: Sikringen af blodforsyninger af høj kvalitet er et vigtigt anliggende for EU's borgere, idet 56 % af respondenterne i Eurobarometer-undersøgelsen om donation af blod, celler og væv nævnte risikoen for at pådrage sig en sygdom som et stort problem i forbindelse med modtagelse af donerede stoffer.
English: Where appropriate, data gathered through other channels and supporting the findings of the two surveys (e.g. exchanges with the national blood competent authorities during the bi-annual meetings with the Commission, mandatory annual reporting to the Commission of serious adverse reactions and events (SARE), alerts launched in the Rapid Alerts for Blood (RAB) platform, a study mapping the economic landscape of the sector and more recently a Eurobarometer survey as well as outputs of EU-funded projects were also taken into account.
Danish: Hvis relevant blev også oplysninger indsamlet via andre kanaler, der støtter konklusionerne fra de to undersøgelser (f.eks. udvekslinger med de nationale kompetente myndigheder med ansvar for blod under de halvårlige møder med Kommissionen, obligatorisk årlig indrapportering til Kommissionen om alvorlige bivirkninger og uønskede hændelser (SARE), advarsler gennem platformen for det hurtige varslingssystem vedrørende blod, en undersøgelse, der kortlægger sektorens økonomiske situation og på det seneste en Eurobarometer-undersøgelse samt resultater af EU-finansierede projekter) taget i betragtning.
English: EU legislation defines the minimum serological testing for human immunodeficiency virus (HIV) 1/2, hepatitis B and hepatitis C to be carried out for every whole blood and apheresis donation.
Danish: Test- og inaktiveringsteknologier Der er i EU-lovgivningen defineret mindstekrav til serologisk undersøgelse for human immundefekt virus (HIV) 1/2, hepatitis B og hepatitis C, som skal foretages ved hver donation af fuldblod eller aferese.
English: All Member States except Hungary reported having a SARE notification system in place, in the majority of them based on the practical guidance developed in co-operation with the Member States for the compilation of the online annual SARE report.
Danish: Indberetning af alvorlige bivirkninger og alvorlige uønskede hændelser (SARE) Alle medlemsstaterne, undtagen Ungarn, indberettede, at de havde et SARE-underretningssystem, der i de fleste medlemsstater var baseret på de praktiske vejledninger, der er udarbejdet i samarbejde med medlemsstaterne vedrørende udarbejdelse af den årlige, online SARE-rapport.
English: Implementation of the EU blood legislation
Danish: Gennemførelse af EU's lovgivning om blod
English: The VUD survey shows that Member States overall comply with Article 20 of Directive 2002/98/EC requiring them to take the necessary measures to encourage VUD.
Danish: Undersøgelsen om frivillig og vederlagsfri donation viser, at medlemsstaterne generelt overholder artikel 20 i direktiv 2002/98/EF, der forpligter dem til at træffe de nødvendige foranstaltninger for at tilskynde frivillig og vederlagsfri donation.
English: The practical application of the VUD principle varies across the Union.
Danish: Den praktiske anvendelse af princippet om frivillig og vederlagsfri donation varierer i EU.
English: Clarification of the operational rules on reporting SARE at EU level would be perceived as helpful by Member State haemovigilance experts.
Danish: En præcisering af de operationelle regler om indberetning af alvorlige bivirkninger og alvorlige uønskede hændelser på EU-plan vil blive opfattet som nyttigt af medlemsstaternes blodovervågningseksperter.
English: Twenty one Member States have dedicated vigilance officer(s) in place.
Danish: Enogtyve medlemsstater har særlige overvågningsansvarlige.
English: However blood competent authorities in one third of the countries do not believe that all blood establishments are reporting SARE.
Danish: Kompetente myndigheder i en tredjedel af landene mente dog ikke, at alle blodcentre indberetter alvorlige bivirkninger og alvorlige uønskede hændelser.
English: Most countries organise root cause analyses to understand the reasons behind SARE, however there is a generally reported interest in developing this approach further, in particular to address the challenge of involving local professionals and hospitals in these analyses.
Danish: Der er imidlertid indberettet en generel interesse i at udvikle denne tilgang yderligere, navnlig med henblik på at tage fat på udfordringen om at inddrage lokale fagfolk og hospitaler i disse analyser.
English: Almost all countries report that a donor identification system was implemented in their country, in the majority of countries at national level.
Danish: Sporbarhed Næsten alle lande indberettede, at der er indført et donoridentifikationssystem i deres land.
English: [1: Detailed Member State replies (as well as replies from Norway and Liechtenstein) can be accessed at: http://ec.europa.eu/health/blood_tissues_organs/key_documents/][2: In a number of cases clarification requests were sent to Member States for verification.
Danish: [1: Detaljerede svar fra medlemsstaterne (samt svarene fra Norge og Liechtenstein) kan ses på: http://ec.europa.eu/health/blood_tissues_organs/key_documents/.
English: In addition to providing regular updates during the bi-annual meeting of the blood expert sub-group on the epidemiological situation relevant to the blood sector, the development of risk assessments (e.g. for HTLV, malaria, dengue and chikungunya) and preparedness plans (e.g. for WNV outbreaks) provide a valuable contribution to policy and decision making in this sector at both national and EU level.
Danish: Udviklingen af risikovurderinger (f.eks. vedrørende HTLV, malaria, denguefeber og chikungunya) og beredskabsplaner (f.eks. for udbrud af vestnilvirus) yder ud over regelmæssige opdateringer på det halvårlige møde i ekspertundergruppen for den epidemiologiske situation, der er relevant for blodsektoren, et værdifuldt bidrag til udarbejdelse af politikker og beslutningstagning i denne sektor på både nationalt plan og EU-plan.
English: Levels of inspector empowerment and training were regularly commented upon in the replies to the implementation survey.
Danish: Der blev i gennemførelsesundersøgelsen regelmæssigt kommenteret på de forskellige niveauer af selvstændiggørelse og uddannelse af inspektører.
English: National rules for export often limit or place conditions on export of blood and blood components, e.g. only in situations of emergency, which is seen by many countries as part of their national policy to ensure self-sufficiency (see below).
Danish: Nationale regler for eksport begrænser ofte eller opstiller ofte betingelser for eksport af blod og blodkomponenter, f.eks. ved kun at tillade det i akutte situationer.
English: The implementation survey confirmed that this core responsibility of national competent authorities is well developed across the Union.
Danish: Akkreditering, udpegning og godkendelse af eller udstedelse af licens til blodcentre Gennemførelsesundersøgelsen bekræftede, at dette centrale ansvarsområde for de nationale kompetente myndigheder er veludviklet i hele Unionen.
English: Since the survey was conducted, changes in national policies have been reported by some countries during the bi-annual meetings of Competent Authorities; the trend is to move from permanent to temporary (usually 12 months) deferral for MSM.
Danish: Siden undersøgelsen blev foretaget, har nogle lande indberettet ændringer i nationale politikker under de halvårlige møder mellem de kompetente myndigheder.
English: The Commission is closely following this case.
Danish: Kommissionen følger denne sag nøje.
English: In any event, the number of penalties imposed is very low.
Danish: Under alle omstændigheder er antallet af pålagte sanktioner meget lavt.
English: These are of particular importance given the numerous technological developments in the field in recent years.
Danish: Dette er særlig af betydning i betragtning af de mange teknologiske udviklinger på dette område i de seneste år.
English: Obligations of Member State competent authorities
Danish: Forpligtelser for medlemsstaternes kompetente myndigheder
English: Significant progress has been made in many areas, also through the active support by Commission funded projects and other initiatives.
Danish: Der er gjort betydelige fremskridt på mange områder, også gennem aktiv støtte af kommissionsfinansierede projekter og andre initiativer.
English: The application of selection criteria should be transparent and subject to continuous evaluation in order to minimize safety risks.
Danish: Anvendelsen af udvælgelseskriterier bør være gennemsigtig og underkastet løbende evaluering for at minimere sikkerhedsrisici.
English: [11: Case C-29/14, judgment pronounced on 11 June 2015.
Danish: [11: Sag C-29/14, dom af 11. juni 2015.
English: It was also suggested that the full list of these more stringent requirements could be made available by the Commission.
Danish: Det blev også foreslået, at Kommissionen kan offentliggøre den fulde liste over disse strengere krav.
English: No problems were reported regarding the implementation of the provisions related to data protection.
Danish: Der blev ikke rapporteret om problemer vedrørende gennemførelsen af bestemmelserne om databeskyttelse.
English: Concerning joint inspections by authorities from more than one Member State, a small number have been organised in recent years.
Danish: For så vidt angår fælles inspektioner med deltagelse af myndigheder fra mere end en medlemsstat, er der blevet afholdt et lille antal af disse i de seneste år.
English: Legend: ART = assisted reproductive technologies
Danish: Forklaring: ART = assisteret reproduktionsteknologi
English: Another important issue highlighted by some Member States was the need to foster harmonisation of the inspection practices in the Member States.
Danish: Et andet vigtigt spørgsmål, der blev fremhævet af nogle medlemsstater, var behovet for at fremme harmoniseringen af inspektionspraksis i medlemsstaterne.
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 hyperlinksene indeholder de oprindelige svar fra medlemsstaterne, mens rapporten afspejler medlemsstaternes ajourførte oplysninger.
English: In some Member States the sector is fully controlled by public organisations, whilst in others private operators make a significant contribution (Fig. 5).
Danish: I nogle medlemsstater er sektoren fuldstændigt kontrolleret af offentlige organisationer, mens private operatører i andre yder et væsentligt bidrag (fig. 5).
English: The gaps and difficulties identified suggest that a further in-depth evaluation might be useful.
Danish: De konstaterede mangler og problemer viser, at en mere indgående evaluering kunne være nyttig.
English: Donor selection and evaluation
Danish: Udvælgelse og evaluering af donorer
English: In 2015 the MS concerned has adopted new legislation for the ART sector and is in process of implementing it.]
Danish: I 2015 vedtog den pågældende medlemsstat ny lovgivning for ART-sektoren, og den er i færd med at gennemføre denne lovgivning.]
English: Other practices include compensation for the inconveniences related to the donation.
Danish: Andre praksisser omfatter kompensation for ulemper i forbindelse med donationen.
English: As a consequence, pursuant to Article 258 TFEU, the Commission has brought action against one Member State to the Court of Justice, and launched an infringement proceeding against another Member State, which is ongoing.
Danish: Som følge heraf har Kommissionen i henhold til artikel 258 i TEUF anlagt sag mod en medlemsstat ved Domstolen, og den har iværksat en traktatbrudsprocedure mod en medlemsstat, som endnu ikke er afsluttet.
English: The overall aim of the annual reporting, to identify the most frequent causes of SARE and provide appropriate corrective measures, has not yet been fully achieved.
Danish: Det overordnede mål med den årlige rapportering, nemlig at identificere de hyppigste årsager til SARE og at yde passende afhjælpende foranstaltninger, er endnu ikke opfyldt fuldt ud.
English: The implementation survey was answered by all Member States except Greece, and also by two EEA countries, Liechtenstein and Norway.
Danish: Gennemførelsesundersøgelsen blev besvaret af alle medlemsstater med undtagelse af Grækenland, og også af to EØS-lande, Liechtenstein og Norge.
English: Their outcome was in general satisfying and in particular allowed bringing expertise where this might be missing within the own Member State.
Danish: Resultaterne heraf var generelt tilfredsstillende, og det gjorde det navnlig muligt at bringe ekspertise ind, hvor en sådan kunne mangle i medlemsstaten.
English: Reproductive cells (ART sector).
Danish: Kønsceller (ART-sektoren).
English: If donor payment were allowed, some individuals could find the monetary remuneration so important that they might hide relevant medical and/or behavioural information.
Danish: Hvis betaling af donorer var tilladt, kunne nogle personer finde den monetære aflønning så vigtig, at de skjulte relevante medicinske og/eller adfærdsmæssige oplysninger.
English: It should be highlighted that several Member States indicated that there is no national legal requirement for organising national follow-up registries for living donors.
Danish: Det bør fremhæves, at flere medlemsstater anførte, at der ikke findes noget nationalt retligt krav om at organisere nationale opfølgningsregistre vedrørende levende donorer.
English: Designation of competent authority or authorities responsible for the implementation of Directive 2004/23/EC
Danish: Udpegning af kompetente myndigheder med ansvar for gennemførelsen af direktiv 2004/23/EF
English: At the end of 2011, 2047 tissue establishments were authorised in the EU, showing an almost 20% increase compared to the 2008 data (Fig. 4).
Danish: Ved udgangen af 2011 var der 2047 godkendte vævscentre i EU, hvilket er en stigning på næsten 20 % sammenlignet med oplysningerne for 2008 (fig. 4).
English: The penalties foreseen in national legislation, their criteria for implementation and their effective implementation can differ significantly between Member States.
Danish: Sanktioner Sanktionerne fastsat i national lovgivning, kriterierne for gennemførelse og deres effektive gennemførelse kan variere betydeligt mellem medlemsstaterne.
English: It has to be highlighted that, irrespective of the organisational set up in each country, it is important that authorities have appropriate resources at their disposal in order to ensure their independence from economic operators, in the sector and from other influences.
Danish: Det skal understreges, at det uanset den organisatoriske opbygning i hvert land er vigtigt, at myndighederne har passende ressourcer til deres rådighed med henblik på at sikre deres uafhængighed af økonomiske operatører i sektoren og af andre påvirkninger.
English: However, Member States interpretation of what is considered compensation and incentive vary.
Danish: Medlemsstaternes fortolkning af, hvad der betragtes som kompensation og incitamenter, varierer imidlertid.
English: (Total POs = 4825; 2011 data)
Danish: (PO'er i alt = 4825; data fra 2011)
English: Even though only trained personnel are allowed to provide appropriate information to donors, this information has been standardised at national level in a small number of countries.
Danish: Selv om kun uddannet personale får lov til at udarbejde passende oplysninger til donorer, så er disse oplysninger blevet standardiseret på nationalt plan i et lille antal lande.
English: A majority also supported European legislation to ensure the safety and quality of blood, tissues and cells.
Danish: Et flertal støttede også europæisk lovgivning til sikring af sikkerheden og kvaliteten af blod, væv og celler.
English: There is no harmonisation in defining or applying such penalties, therefore it is difficult to evaluate whether similar measures are applied by all the Member States in case of a specific breach of the legislation in this area.
Danish: Der er ingen harmonisering vedrørende fastlæggelsen eller anvendelsen af sådanne sanktioner, og det er derfor vanskeligt at vurdere, hvorvidt lignende foranstaltninger anvendes af alle medlemsstater i tilfælde af en specifik tilsidesættelse af lovgivningen på dette område.
English: The differences in purchasing power between Member States might also explain why a measure is considered a "compensation" in one country and an "incentive" in another.
Danish: Forskellene i de enkelte medlemsstaters købekraft kan også forklare, hvorfor en foranstaltning anses for at være "kompensation" i ét land og "incitament" i et andet.
English: More generally speaking, it was difficult to assess how divisions of tasks impacts oversight of the sector, especially as some of the national competent authorities did not provide precise/complete information.
Danish: Mere generelt er det vanskeligt at vurdere, dels hvordan opgavefordelingen påvirker tilsynet med sektoren, især da nogle af de nationale kompetente myndigheder ikke forelagde nøjagtige/fuldstændige oplysninger.
English: In terms of inspection outcomes, mostly minor shortcomings were recorded with few suspensions and revocations of authorisations (Fig. 6).
Danish: Med hensyn til resultaterne af inspektionerne blev der for det meste registreret mindre mangler med få suspenderinger og tilbagekaldelser af tilladelser (fig. 6).
English: These consist mainly in providing administrative support for the funeral and ensuring full or partial coverage of the cost of the funeral/burial/cremation.
Danish: Denne består hovedsagelig af administrativ støtte til begravelsen og sikring af fuldstændig eller delvis dækning af omkostningerne til begravelsen/jordfæstelsen/kremeringen.
English: Wherever accreditation and inspections are undertaken by different authorities, a good communication and coordination between respective authorities needs to be ensured.
Danish: Når akkreditering og inspektioner gennemføres af forskellige myndigheder, er det nødvendigt at sikre en god kommunikation og koordinering mellem de forskellige myndigheder.
English: However, the tissue establishment reports are not always publicly available, mainly due to different interpretations of this provision by the Member States authorities.
Danish: Vævscenterrapporterne er imidlertid ikke altid offentligt tilgængelige, hvilket først og fremmest skyldes, at medlemsstaternes myndigheder har forskellige fortolkninger af denne bestemmelse.
English: This may suggest a role for the EU in supporting Member States to develop national sufficiency policies although the exact impact of such policies on cross-border exchanges and the supply of starting materials for medicinal product manufacture would need to be carefully analysed.
Danish: Dette kan betyde, at EU har en rolle med hensyn til at hjælpe medlemsstaterne med at udvikle nationale tilstrækkelighedspolitikker, selv om den præcise indvirkning af sådanne politikker på grænseoverskridende udvekslinger og udbuddet af udgangsmateriale til fremstilling af lægemidler ville skulle analyseres nøje.
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 2004/23/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 2004/23/EF og dets gennemførelsesdirektiver.
English: However, some difficulties in interpretation, implementation and enforcement of the legislation have been identified, which in some cases could be explained by the scientific and technological advances since its adoption.
Danish: Imidlertid er der blevet konstateret nogle problemer med fortolkning, gennemførelse og håndhævelse af lovgivningen, hvilket i nogle tilfælde kan forklares ved den videnskabelige og teknologiske udvikling siden vedtagelsen.
English: Several Member States suggested that a common list of diagnostic tests (panel) for some genetic diseases may be valuable for increasing safety in the EU ART sector.
Danish: Flere medlemsstater foreslog, at en fælles liste over diagnostiske test (paneltest) for visse genetiske sygdomme kan være værdifuld for at øge sikkerheden i EU's ART-sektor.
English: It should be noted that, although much has been achieved and reporting improves every year, challenges related to under-reporting by organisations responsible for human application and the lack of accurate data remain.
Danish: Det skal bemærkes, at selv om der er opnået meget, og indberetningerne forbedres hvert år, så er der fortsat udfordringer i forbindelse med underrapportering af organisationer med ansvar for anvendelse på mennesker og mangel på præcise data..
English: Developing more detailed requirements for these activities as part of GTP was supported by several national competent authorities for tissues and cells.
Danish: Udarbejdelsen af mere detaljerede krav til disse aktiviteter som et led i GTP blev støttet af flere nationale kompetente myndigheder for væv og celler.
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 human tissue and cells for clinical application.
Danish: Siden 2003 er en række projekter blevet finansieret under de flerårige programmer for Unionens indsats inden for sundhedsområdet vedrørende humane væv og celler til klinisk anvendelse.
English: All Member States replied to the transposition questionnaire.
Danish: Alle medlemsstaterne besvarede spørgeskemaet om gennemførelse i praksis.
English: Reimbursement of costs linked to travel and medication based on actual costs/receipts are among the most commonly used type of compensation for living donors.
Danish: Godtgørelse af udgifter til rejser og medicin baseret på faktiske omkostninger og kvitteringer er blandt de mest anvendte former for kompensation til levende donorer.
English: As regards the risk of transmission of communicable diseases thorough tissues and cells, the collaboration with ECDC proved extremely valuable.
Danish: For så vidt angår risikoen for spredning af overførbare sygdomme gennem væv og celler, har samarbejdet med ECDC vist sig yderst værdifuldt.
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 group meetings to EU-funded projects.
Danish: Europa-Kommissionen har støttet gennemførelsen af lovgivningen i medlemsstaterne ved at fremme aktiv deltagelse af nationale kompetente myndigheder i en række aktioner, fra halvårlige møder med ekspertgrupper til EU-finansierede projekter.
English: Projects such as EUSTITE, EuroGTP, SOHO V&S, and the on-going joint actions ARTHIQS and VISTART have provided a strong support to Member States in their efforts to implement the requirements of the EU tissue and cell legislation.
Danish: Projekter, såsom EUSTITE, EuroGTP, SOHO V&S og de igangværende fælles aktioner ARTHIQS og VISTART har ydet medlemsstaterne en stærk støtte i deres indsats for at gennemføre kravene i EU's lovgivning om væv og celler.
English: All reporting Member States have appointed competent authorities for tissues and cells.
Danish: Alle indberettende medlemsstater har udpeget kompetente myndigheder for væv og celler.
English: It was underlined that Member States introducing more stringent safety and quality requirements should inform the other Member States and EEA countries, as well as the Commission, regarding these measures, in a transparent manner.
Danish: Det blev understreget, at medlemsstater, der indfører strengere krav til sikkerhed og kvalitet, på en gennemsigtig måde bør underrette de øvrige medlemsstater og EØS-landene samt Kommissionen om disse foranstaltninger.
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 on the cross-border movement of tissues and cells.
Danish: Disse forskelle fremmer en vellykket integrering af kravene i national lovgivning, men i nogle tilfælde kan de begrænse den gensidige accept af godkendelser med konsekvenser for den grænseoverskridende bevægelighed for væv og celler.
English: An important issue is how and by whom the decision concerning the value and form of compensations for tissue and cell donors is taken.
Danish: Et vigtigt spørgsmål er, hvordan og af hvem afgørelsen træffes om værdien og formen for kompensation for vævs- og celledonorer.
English: Therefore information provided by the donor or his/her family contributes to an accurate assessment of all risks associated to the application of donated tissues or cells.
Danish: Derfor bidrager oplysninger fra donoren eller dennes familie til en nøjagtig vurdering af alle risici forbundet med anvendelsen af donerede væv eller celler.
English: The Commission is also required to provide the European Parliament and the Council with an overview report on the implementation of the requirements of the Directive, in particular as regards inspections and monitoring.
Danish: Kommissionen skal desuden give Europa-Parlamentet og Rådet en oversigtsrapport om gennemførelsen af kravene i direktivet, navnlig kravene vedrørende inspektion og kontrol.
English: It is also interesting to highlight the split between private and public ownership of tissue establishments.
Danish: Det er også interessant at se på opdelingen mellem offentlige og privatejede vævscentre.
English: Overall, the implementation of the EU tissues and cells legislation by the Member States is considered adequate and the legislation has resulted in the establishment of a network of competent authorities that oversee the sector through authorisation, inspection, and vigilance.
Danish: Overordnet set anses medlemsstaternes gennemførelse af EU's lovgivning om væv og celler for at være tilstrækkelig, og lovgivningen har ført til oprettelse af et netværk af kompetente myndigheder, der fører tilsyn med sektoren gennem godkendelser, inspektion og overvågning.
English: This may suggest that tissue establishments are striving to comply with the EU quality and safety requirements, but it may also indicate under-enforcement, e.g. in countries which have never reported any shortcomings.
Danish: Dette kan tyde på, at vævscentrene stræber efter at opfylde EU's kvalitets- og sikkerhedskrav, men det kan også betyde, at håndhævelsen ikke er tilstrækkelig, f.eks. i lande, der aldrig har meddelt nogle mangler.
English: Only in a small number of Member States is the value of the compensation provided to tissue and cell donors connected to national economic indicators (e.g. monthly income, purchasing capacity).
Danish: Kun i få medlemsstater er værdien af den kompensation, der ydes til vævs- og celledonorer, knyttet til nationale økonomiske indikatorer (f.eks. månedlig indkomst, købekraft).
English: In spite of this, both the Commission and national competent authorities for tissues and cells acknowledge that there is still a high degree of under-reporting requiring careful consideration when analysing the data.
Danish: Til trods herfor anerkender både Kommissionen og de nationale kompetente myndigheder for væv og celler, at der stadig er en høj grad af underrapportering, der kræver omhyggelige overvejelser, når data analyseres.
English: This may also explain why some Member States have not put in place a coherent policy to ensure national sufficiency at least for some type of tissues or cells.
Danish: Dette kan også forklare, hvorfor nogle medlemsstater ikke har indført en sammenhængende politik til sikring af den nationale forsyning, i hvert fald for nogle typer væv eller celler.
English: Additional tests required by Member States are usually justified for local reasons, like e.g. the increased prevalence of a certain infectious disease.
Danish: Supplerende test, der kræves af medlemsstaterne, er normalt begrundet i lokale forhold, som f.eks. den øgede forekomst af visse smitsomme sygdomme.
English: Several of the selection criteria, as well as the tasks of the responsible persons in Member States with more stringent requirements, have been subject to discussion during the bi-annual national competent authority meetings.
Danish: Flere af udvælgelseskriterierne samt de opgaver, der påhviler de ansvarlige personer i medlemsstater med strengere krav, er blevet drøftet under de halvårlige møder mellem de nationale kompetente myndigheder.
English: Only 17 Member States reported having guiding principles regarding the possibility to compensate tissue and cell donors, but in many cases these principles were just a description of the practices allowed at national level.
Danish: Kun 17 medlemsstater har oplyst, at de har vejledende principper vedrørende muligheden for at kompensere vævs- og celledonorer, men i mange tilfælde var disse principper blot en beskrivelse af fremgangsmåder tilladt på nationalt plan.
English: Outcome of tissue establishment inspections performed in 2011
Danish: Figur 6 Resultatet af inspektioner af vævscentre udført i 2011
English: Some mixed models have emerged where, for example, the private sector may take the role of a third party for processing or storage, with all donation, promotion and distribution activities remaining in public hands.
Danish: Der er opstået nogle blandede modeller, hvor f.eks. den private sektor kan påtage sig rollen som tredjepart med henblik på forarbejdning eller oplagring, mens alle aktiviteter i forbindelse med donation, markedsføring og distribution forbliver på offentlige hænder.
English: It has to be underlined that countries which reported difficulties in implementing the donation identification system were either developing a central allocation system for identifiers or were waiting for the adoption of the implementing legislation introducing a Single European Code for tissues and cells.
Danish: Det skal understreges, at lande, der rapporterede om vanskeligheder ved indførelsen af donationsidentifikationssystemet enten var ved at udvikle en central tildelingsordning for identifikatorer eller afventede vedtagelsen af den gennemførelseslovgivning, der vil indføre en fælles europæisk kode for væv og celler.
English: The regular meetings of the national competent authorities as part of the Competent Authorities on Substances of Human Origin Expert Group (CASoHO E01718) developed into a well-appreciated platform for discussions, allowing for sharing best practices and clarification of common difficulties encountered at national and EU level.
Danish: De regelmæssige møder mellem nationale kompetente myndigheder som en del af ekspertgruppen for kompetente myndigheder inden for stoffer af menneskelig oprindelse (CASoHO E01718) udviklede sig til en vellidt platform for drøftelser, der giver mulighed for at udveksle bedste praksis og tydeliggøre fælles problemer på nationalt plan og EU-plan.
English: The main reasons for shortages were the lack of donors, followed by insufficient procurement capacity at national level and technical reasons (e.g. practical difficulties in finding a compatible match for patients in need of an HSC transplantation).
Danish: De vigtigste årsager til manglerne var manglen på donorer, efterfulgt af utilstrækkelig udtagningskapacitet på nationalt plan og tekniske årsager (f.eks. praktiske vanskeligheder ved at finde en forenelig match for patienter, der har behov for en HSC-transplantation).
English: There is a need to find the most appropriate solutions to ensure both the respect of the Article 12 of Directive 2004/23/EC and an adequate supply of tissues and cells to the patients in need across the Union.
Danish: Der er behov for at finde de mest hensigtsmæssige løsninger for at sikre både overholdelse af artikel 12 i direktiv 2004/23/EF og en tilstrækkelig forsyning af væv og celler til patienter i hele Unionen, der har behov herfor.
English: Nevertheless, it has to be noted that it is difficult to draw firm conclusions regarding the volume of imports and exports of human tissues and cells due the lack of mandatory reporting of such information at national level and absence of a harmonised framework for data collection in the Member States.
Danish: Det skal imidlertid bemærkes, at det er vanskeligt at drage klare konklusioner om omfanget af import og eksport af humane væv og celler som følge af manglen på obligatorisk anmeldelse af disse oplysninger på nationalt plan og manglen på en harmoniseret ramme for dataindsamling i medlemsstaterne.