FrancophonIA/Publications_Medical_Domain_UE huggingface dataset:
English: As a consequence, identical shortcomings may result in different outcomes for the inspected establishments depending on their geographical location (e.g. penalties vs. revocation or suspension of license for the same deficiency).
Danish: Som følge heraf kan identiske mangler føre til forskellige resultater for de inspicerede virksomheder afhængigt af deres geografiske placering (f.eks. sanktioner over for tilbagekaldelse eller suspension af licens for den samme mangel).
English: Even though this practice is considered as compensation by the competent authorities, it may be perceived as an incentive by the family/relatives of the deceased donors, especially in the absence of an expressed consent of the deceased person or when, due to financial constraints, the relatives have difficulty covering the costs of the funeral/burial/cremation.
Danish: Selv om de kompetente myndigheder anser denne praksis for at være kompensation, kan familier og pårørende til den afdøde donor opfatte det som et incitament, navnlig i mangel af et udtrykkeligt samtykke fra den afdøde person, eller når de pårørende på grund af finansielle begrænsninger har svært ved at dække omkostningerne til begravelsen/jordfæstelsen/kremeringen.
English: The importance of SARE reporting is confirmed by the interest of the Member States in collaborating with the Commission to improve the current reporting system (e.g. refining the SARE reporting templates for improving collection of data in the sector of assisted reproduction technology (ART)) and to expand communication with other countries and other sectors (e.g. fostering cooperation with relevant third countries with regard to SARE reporting).
Danish: Betydningen af SARE-rapporteringen bekræftes af medlemsstaternes interesse i at samarbejde med Kommissionen om at forbedre det eksisterende rapporteringssystem (f.eks. ved at finjustere SARE-indberetningsskemaerne for at forbedre indsamlingen af data i sektoren for assisteret reproduktionsteknologi (ART)) og i at udvide kommunikationen med andre lande og andre sektorer (f.eks. fremme af samarbejdet med relevante tredjelande for så vidt angår SARE indberetning).
English: In this regard, several national competent authorities have called for an EU-level endorsement of Good Tissue Practice guidelines (GTP), similar to Good Manufacturing Practice guidelines (GMP) approach in the pharmaceutical sector and for continuing to provide support for training of inspectors at the EU level.
Danish: I den forbindelse har en række nationale kompetente myndigheder efterlyst en godkendelse på europæisk plan af retningslinjer for gode praksisser for væv (GTP) på linje med tilgangen om retningslinjer for god fremstillingspraksis (GMP) i den farmaceutiske sektor og en fortsat ydelse af støtte til uddannelse af inspektører på EU-plan.
English: Finally the Commission developed - in close cooperation with Member States - a Rapid Alert Platform for Tissues and Cells (RATC) which facilitates web-based communications between Member States in case of alerts relating to human tissues or cells transferred across borders.
Danish: Endelig udviklede Kommissionen - i nært samarbejde med medlemsstaterne - en platform for hurtig varsling vedrørende væv og celler (RATC), som letter webbaseret kommunikation mellem medlemsstaterne i tilfælde af advarsler om humane væv eller celler, der overføres på tværs af grænserne.
English: Regarding practices vis-à-vis deceased donors of tissues and cells, only three Member States reported that they provide compensation to donor relatives.
Danish: For så vidt angår praksis over for døde donorer af væv og celler, har kun tre medlemsstater rapporteret, at de yder kompensation til donors pårørende.
English: Even though such movements may be explained by the globalisation of healthcare products and services, the common quality and safety standards laid down in the EU tissues and cells legislation have created the framework for facilitating trans-national movements within the Union.
Danish: Selv om sådanne overførsler kan forklares ved globaliseringen af sundhedsprodukter og -tjenester, så har de fælles kvalitets- og sikkerhedsstandarder, der er fastsat i EU's lovgivning om væv og celler, skabt rammerne for at lette grænseoverskridende overførsler inden for Unionen.
English: It is important to note that a recent Eurobarometer survey on blood and cell and tissue donation showed that only 13% of EU citizens considered acceptable to receive cash amounts in addition to the reimbursement of the costs related to the donation.
Danish: Det er vigtigt at bemærke, at en nylig Eurobarometerundersøgelse om donation af celler og væv og blod viste, at kun 13 % af EU's borgere finder det acceptabelt at modtage et kontant beløb ud over godtgørelse af udgifter i forbindelse med donationen.
English: In this context, the new requirements on the application of the Single European Code for tissues and cells laid down in Directive (EU) 2015/565 may be considered an additional tool for ensuring that donor data are not disclosed to the recipient14.
Danish: I denne forbindelse kan de nye krav om anvendelse af den fælles europæiske kode for væv og celler, der er fastlagt ved direktiv (EU) 2015/565 betragtes som et supplerende redskab til at sikre, at data om donoren ikke offentliggøres over for recipienten14.
English: Nevertheless, it has to be underlined that a small number of countries rely only on the medical records of the donor and/or the autopsy report without interviewing the donor's family or his/her treating physician/general practitioner.
Danish: Det skal ikke desto mindre understreges, at et lille antal lande kun benytter sig af donorens patientjournal og/eller obduktionsrapport uden at interviewe donorens familie eller hans/hendes behandlende læge og alment praktiserende læge.
English: On the basis of the information collected, the Commission will follow up with the Member States in order to promote, where desirable, a common understanding of Article 12 in the Directive 2004/23/EC.
Danish: På grundlag af de indsamlede oplysninger vil Kommissionen følge op med medlemsstaterne med henblik på at fremme en fælles forståelse af artikel 12 i direktiv 2004/23/EF, hvor det er ønskeligt.
English: On the other hand, ten Member States indicated that, especially for sperm donors, such registries are maintained by the tissue establishments.
Danish: På den anden side har ti medlemsstater anført, at især for sæddonorer vedligeholdes sådanne registre af vævscentrene.
English: Regarding data storage for at least 30 years, almost all Member States and EEA countries comply with the requirements of Article 9 of Directive 2006/86/EC, by requesting both paper and electronic records to be maintained for that period.
Danish: For så vidt angår lagring af data i mindst 30 år opfylder næsten alle medlemsstaterne og EØS-landene kravene i artikel 9 i direktiv 2006/86/EF ved at anmode om, at både papiroptegnelser og elektroniske optegnelser opbevares i så lang tid.
English: Total inspections = 443; data reported by 21 Member States
Danish: Inspektioner i alt = 443; data indberettet af 21 medlemsstater
English: This may explain the considerable heterogeneity across the EU in the practices vis-à-vis tissue and cell donors, with some practices being regarded as compensation in one country and incentives or other practices in others.
Danish: Dette kan forklare den store forskelligartethed i EU i praksis over for vævs- og celledonorer, hvor visse former for praksis betragtes som aflønning i ét land og incitamenter eller anden praksis i andre.
English: Article 26 of Directive 2004/23/EC requires Member States to submit to the European Commission, before 7 April 2009 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 2004/23/EF skal medlemsstaterne senest den 7. april 2009 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: It has to be highlighted that VUD is a factor which is not only ethical in nature, but which may contribute to higher safety standards for tissues and cells and therefore to the protection of human health.
Danish: Det skal understreges, at frivillig og vederlagsfri donation er en faktor, som ikke blot har etisk karakter, men som kan bidrage til høje sikkerhedsstandarder for væv og celler og derfor til beskyttelse af menneskers sundhed.
English: In this respect, it should be highlighted that the new Directive (EU) 2015/566 provides for the harmonisation of the minimum requirements in terms of contents of written agreements between importing tissue establishments and their third country suppliers.
Danish: I denne forbindelse skal det fremhæves, at der ved det nye direktiv (EU) 2015/566 fastsættes harmonisering af minimumskravene til indholdet af skriftlige aftaler mellem importerende vævscentre og disses tredjelandsleverandører.
English: Total inspections = 549; data reported by 22 Member States
Danish: Inspektioner i alt = 549; data indberettet af 22 medlemsstater
English: In this regard, 18 Member States and one EEA country reported to have a follow-up registry or database of haematopoietic stem cell donors, but the type of the follow-up examinations, their periodicity and the responsible healthcare facilities/professionals may vary from country to country.
Danish: I denne henseende har 18 medlemsstater og et EØS-land indberettet, at de har et opfølgningsregister eller en database over donorer af hæmatopoietiske stamceller, men arten af opfølgningsundersøgelserne, deres hyppighed og de ansvarlige sundhedsfaciliteter/fagfolk kan variere fra land til land.
English: Only six Member States have national registries of oocyte and sperm donors.
Danish: Kun seks medlemsstater har nationale registre over oocyt- og sæddonorer.
English: Giving lump sums to reproductive cell donors, as practised in some countries, may alleviate administrative burden, but it also raises questions when the value is determined solely by tissue establishments or when the value is significantly high in relation to average national monthly income.
Danish: Betaling af faste beløb til donorer af kønsceller, hvilket praktiseres i nogle lande, kan lette den administrative byrde, men det giver også anledning til spørgsmål, når værdien udelukkende bestemmes af vævscentre, eller når værdien er meget høj i forhold til den gennemsnitlige nationale månedlige indkomst.
English: Moreover, the inclusion in the EU Tissue Establishment Compendium will reinforce the credentials of the EU tissue establishments to their partners and customers around the world.
Danish: Optagelsen i EU-vævscenterkompendiet vil styrke EU's vævscentres omdømme over for deres partnere og kunder i hele verden.
English: However, a significant percentage of the respondents (48%) considered that receiving refreshments, free testing, or a free physical check-up seem suitable when donating human tissues and cells.
Danish: Imidlertid mente en væsentlig procentdel af de adspurgte (48 %), at det er passende, at man modtager forfriskninger, gratis testning eller en gratis lægeundersøgelse, når man donerer humane væv og celler.
English: Most Member States allow compensation to be offered to living donors (22 countries for living donors of non-reproductive tissues and cells; 17 countries for donors of reproductive cells).
Danish: De fleste medlemsstater tillader, at levende donorer tilbydes kompensation (22 lande for levende donorer af somatiske væv og celler; 17 lande, hvis der er tale om donorer af kønsceller).
English: The new legal provisions for the application of the Single European Code shall also satisfy the requirement in Article 10(3) of the Directive 2004/23/EC, by establishing the EU Tissue Establishment Compendium including all tissues establishments with their coordinates and the status of their accreditation/designation/authorised or licence.
Danish: De nye retlige bestemmelser for anvendelsen af den fælles europæiske kode skal også opfylde kravet i artikel 10, stk. 3, i direktiv 2004/23/EF, ved at oprette EU-vævscenterkompendiet, herunder alle vævscentrene med deres koordinater og status for akkreditering/udpegning/godkendelse eller licens.
English: In some Member States the authorities for tissues and cells are also responsible for the oversight of other sectors (e.g. organs, blood and/or medicinal products) (Fig.1 and 2), which can be beneficial from an efficiency point of view.
Danish: I nogle medlemsstater er myndighederne, der er ansvarlige for væv og celler, også ansvarlige for tilsyn med andre sektorer (f.eks. organer, blod og/eller lægemidler) (figur 1 og 2), hvilket ud fra et effektivitetssynspunkt kan være gavnligt.
English: An alert issued in RATC accompanied by recall of products from an EU tissue establishment revealed that the consent form and its verification may be very different from one Member State to another, depending also on the legal framework under which the EU tissue and cell legislation has been transposed.
Danish: En advarsel udstedt gennem RATC ledsaget af tilbagekaldelse af produkter fra et EU-vævscenter viste, at samtykkeerklæringen og kontrol heraf kan være meget forskellige fra den ene medlemsstat til den anden, afhængigt også af den retlige ramme, inden for hvilken EU-lovgivningen om væv og celler er blevet gennemført.
English: Such difficulties were also reported by operators manufacturing ATMP from human tissues and cells.
Danish: Disse problemer blev også indberettet af operatører, der fremstiller LTAT af humane væv og celler.
English: By updating the data in this Compendium, the tissues and cells competent authorities demonstrate full transparency and provide support to healthcare professionals searching for an authorised tissue or cell provider within the Union.
Danish: Ved at ajourføre data i dette kompendium udviser de kompetente myndigheder for væv og celler fuld gennemsigtighed og yder støtte til sundhedspersoner, der leder efter en godkendt udbyder af væv eller celler i Unionen.
English: On the basis of these national reports, the Commission is required to report to the European Parliament and the Council and to inform them 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 udarbejde en rapport til Europa-Parlamentet og Rådet og underrette dem om alle nødvendige yderligere foranstaltninger i forbindelse med frivillig og vederlagsfri donation, som Kommissionen agter at træffe på EU-plan.
English: In addition, some countries do not distinguish between distribution within the Union and import/export from/to third countries which may be considered an important hurdle, not only against data collection and analysis, but also against optimal circulation of tissues and cells for patient benefit across the EU.
Danish: Endvidere skelner nogle lande ikke mellem distribution inden for Unionen og import/eksport fra/til tredjelande, hvilket kan betragtes som en væsentlig hindring, ikke alene for indsamling og analyse af data, men også for en optimal formidling af væv og celler til fordel for patienter i hele EU.
English: In addition, the survey showed that nineteen countries (17 Member States and two EEA countries) did not put in place national policies for promoting national self-sufficiency/sufficiency for tissues and cells and do not always collect data on cross-border movement of tissues and cells at national level.
Danish: Undersøgelsen viste desuden, at 19 lande (17 medlemsstater og to EØS-lande) ikke har iværksat nationale politikker til fremme af national selvforsyning/tilstrækkelighed for væv og celler og ikke altid indsamler data på nationalt plan om grænseoverskridende transport af væv og celler.
English: Several authorities underlined that in such situations there is a significant risk of losing traceability, including inappropriate reporting of pregnancy rate and serious adverse reactions following medical application (e.g. children born with genetic diseases not reported back to the distributing tissue establishment).
Danish: Flere myndigheder understregede, at i sådanne situationer er der en betydelig risiko for at miste sporbarhed, herunder utilstrækkelige indberetninger af graviditetskvotienter og alvorlige bivirkninger efter en medicinsk anvendelse (f.eks. børn født med genetiske sygdomme, der ikke blev rapporteret tilbage til det distribuerende vævscenter).
English: Mandatory SOPs are also required during the authorisation/accreditation/designation or licensing process in most of the responding countries.
Danish: Obligatoriske operationelle standardprocedurer er også nødvendige under godkendelses-, akkrediterings-, udpegnings- eller licensprocessen i flertallet af de adspurgte lande.
English: Moreover, most of the Member States stated that the new coding requirements, now laid down in Directive (EU) 2015/565 amending Directive 2006/86/EC, should contribute to a harmonised implementation of the Single European Code for tissues and cells and actively supported their development.
Danish: Derudover gav de fleste af medlemsstaterne udtryk for, at de nye krav til kodning, der nu er fastsat i direktiv (EU) 2015/565 om ændring af direktiv 2006/86/EF, bør bidrage til en ensartet gennemførelse af den fælles europæiske kode for væv og celler og støttede aktivt deres udvikling.
English: Besides complying with the legal obligations pursuant to Article 12 (1) and Article 26 of Directive 2004/23/EC, the current report sets out how Directive 2004/23/EC and its implementing Directives 2006/17/EC and 2006/86/EC (hereafter commonly referred to as the EU tissue and cell legislation) function in practice, against a backdrop of significant scientific and organisational developments (internationalisation, commercialisation) that have taken place in the tissue and cell sector over the past decade.
Danish: Ud over at opfylde de juridiske forpligtelser i henhold til artikel 12, stk. 1, og artikel 26 i direktiv 2004/23/EF, beskriver den nuværende rapport, hvordan direktiv 2004/23/EF og de dertil hørende gennemførelsesdirektiver 2006/17/EF og 2006/86/EF (herefter ofte kaldet EU's lovgivning om væv og celler) fungerer i praksis i en situation, som er præget af en betydelig videnskabelig og organisatorisk udvikling (internationalisering og kommercialisering), der har fundet sted i sektoren for væv og celler i løbet af det seneste årti.
English: Even though the current requirements in Directive 2006/86/EC refer only to reporting of serious adverse reactions (SAR) in recipients of tissues and cells, the voluntary reporting of SAR in donors has gradually improved in the past years, suggesting the Member States' increasing interest in the protection of living donors.
Danish: Selv om de nuværende krav i direktiv 2006/86/EF kun henviser til indberetning af alvorlige bivirkninger i recipienter af væv og celler, er frivillig indberetning af alvorlige bivirkninger i donorer gradvist blevet bedre i de seneste år, hvilket viser medlemsstaternes stigende interesse i at beskytte levende donorer.
English: A verification of the completeness of transposition into national legislation has been carried out by the Commission and demonstrated that the EU tissues and cells legislation is fully transposed into national legislation in all but two Member (which have failed to fully transpose the requirements of the Directives for reproductive cells).
Danish: Kommissionen har gennemført en kontrol af fuldstændigheden af gennemførelse i national lovgivning, der viste, at EU's lovgivning om væv og celler er fuldt ud gennemført i national lovgivning i alle medlemsstater bortset fra to (der ikke fuldt ud har gennemført kravene i direktiverne om kønsceller).
English: Verification during inspections of standard operating procedures (SOP) prepared by the tissue establishments and inspecting patient and donor information provided by licensed fertility clinics were reported only by two Member States.
Danish: Verifikation under inspektioner af operative standardprocedurer (SOP), som er udarbejdet af vævscentrene, og inspektion af oplysninger om patienter og donorer indgivet af fertilitetsklinikker, der har licens, blev kun indberettet af to medlemsstater.
English: These actions allowed for the development of guidelines and manuals in areas of common interest such as inspections and vigilance, included training courses for Member States Competent Authorities and their inspectors and brought together professionals in the tissue banking sector for the development of detailed technical guidance in line with the EU legal requirements.
Danish: Disse aktioner gjorde det muligt at udarbejde retningslinjer og håndbøger på områder af fælles interesse som f.eks. inspektioner og overvågning, herunder uddannelseskurser for medlemsstaternes kompetente myndigheder og deres inspektører, og samlede fagfolk i sektoren for vævsbanker omkring udvikling af detaljerede tekniske retningslinjer i overensstemmelse med de retlige krav i EU.
English: However, the report points to some gaps and difficulties in relation to the application and enforcement of the existing provisions (e.g. definitions, requirements on the safety aspects regarding living donors, inspections framework), some of them owing to the different approaches taken by the Member States when transposing and implementing the current EU legislation and others due to the scientific and technologic developments since the adoption of the Directives.
Danish: Imidlertid peges der i rapporten på visse mangler og vanskeligheder i forbindelse med anvendelsen og håndhævelsen af de eksisterende bestemmelser (f.eks. definitioner, sikkerhedsmæssige krav vedrørende levende donorer og inspektionsrammer), nogle af dem på grund af de forskellige metoder medlemsstaterne anvender, når de gennemfører og indfører den nuværende EU-lovgivning, og andre mangler og vanskeligheder på grund af den videnskabelige og tekniske udvikling siden vedtagelsen af direktiverne.
English: Divergent criteria might however also create barriers for exchanging tissues and cells between Member States for healthcare professionals requesting tissues or cells from another Member State.
Danish: Divergerende kriterier kan dog også skabe hindringer for udvekslingen af væv og celler mellem medlemsstaterne for sundhedspersoner, der anmoder om væv eller celler fra en anden medlemsstat.
English: Limited information was provided on the value of most of the practices related to tissue and cell donation, probably because the costs vary considerably depending on the donation circumstances (e.g. need of prior testing/medical treatment, duration of hospitalisation, effects on the overall health and capacity to work) or depend on the clinic where the donation takes place.
Danish: Der var begrænsede oplysninger om værdien af de fleste praksisser i forbindelse med vævs- og celledonation, hvilket sandsynligvis skyldes, at omkostningerne varierer betydeligt afhængigt af omstændighederne omkring donation (f.eks. behov for forudgående testning/lægebehandling, varighed af hospitalsindlæggelse, indvirkning på den samlede sundhed og evnen til at arbejde) eller afhænger af den klinik, hvor donationen finder sted.
English: Although the principle of VUD is mandatory in the large majority of the Member States, its concrete application varies across the Union.
Danish: Selv om princippet om frivillig og vederlagsfri donation er obligatorisk i de fleste medlemsstater, varierer dets konkrete anvendelse i hele Unionen.
English: It has to be highlighted that safety and quality is a major concern for EU citizens, with 56% of respondents to the Eurobarometer survey on blood and cell and tissue donation18 citing the risk of contracting a disease as a major concern when accepting donated substances.
Danish: Det skal understreges, at sikkerhed og kvalitet er et vigtigt anliggende for EU's borgere, idet 56 % af respondenterne i Eurobarometerundersøgelsen om donation af blod, celler og væv18 nævnte, at risikoen for at udvikle en sygdom var en alvorlig bekymring ved modtagelsen af doneret materiale.
English: Even though most respondents confirmed respecting the required 2-year interval between inspections, some Member States suggested that prioritising inspections based on factors like the size of establishment, range of activity, experience of inspectors and compliance history may prove valuable especially in a period when financial constraints have a considerable influence on the staffing of departments in charge of inspections.
Danish: Selv om de fleste af de adspurgte bekræftede, at de overholdt de krævede 2 år mellem inspektioner, foreslog nogle medlemsstater, at det kan være nyttigt at prioritere inspektioner baseret på faktorer som centrets størrelse, vifte af aktiviteter, inspektørers erfaringer og hvor godt reglerne er blevet overholdt hidtil, navnlig i en tid hvor finansielle begrænsninger har en betydelig indflydelse på antallet af personale i de afdelinger, der har ansvaret for inspektionerne.
English: In addition, and in accordance with Article 12(1) of Directive 2004/23/EC, Member States also 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 12, stk. 1, i direktiv 2004/23/EF, skal medlemsstaterne hvert tredje år fremsende rapporter til Kommissionen om anvendelsen af princippet om frivillig og vederlagsfri donation.
English: The competent authorities allowing such practices were requested to evaluate if and/or how traceability and reporting requirements are ensured by the tissue establishments distributing gametes to individuals and to take the necessary measures in case such practices do not fulfil the safety and quality requirements laid down in the EU tissue and cell legislation.
Danish: De kompetente myndigheder, der tillader en sådan praksis, blev anmodet om at vurdere, om og/eller hvorledes sporbarheds- og rapporteringskrav er sikret af de vævscentre, der formidler kønsceller til enkeltpersoner, og træffe de nødvendige foranstaltninger, i tilfælde af at en sådan praksis ikke opfylder de krav til sikkerhed og kvalitet, der er fastsat i EU's lovgivning om væv og celler.
English: However, it has to be noted that, as for import and export, data collected by the Member States probably serve different purposes and use various methodologies, so it is very difficult to draw a clear conclusion on the importance of EU distribution compared to import/export from/to third countries and therefore to evaluate tissue and cell sufficiency at EU level.
Danish: Det skal dog bemærkes, at som for import og eksport tjener data indsamlet af medlemsstaterne sandsynligvis forskellige formål, og forskellige metoder er anvendt, og det er derfor meget vanskeligt at drage en klar konklusion om betydningen af distribution i EU sammenlignet med import/eksport fra/til tredjelande og dermed at vurdere tilstrækkeligheden af væv og celler på EU-plan.
English: Five Member States have both central oocyte and sperm donor registries.
Danish: Fem medlemsstater har både centrale oocyt og sæddonorregistre.
English: When verifying the compliance of tissues establishments with the EU donor evaluation and selection requirements, inspections are the most important verification method used by the Member State competent authorities.
Danish: I forbindelse med kontrollen af vævscentrenes overholdelse af kravene i forbindelse med EU-donorevaluering og -udvælgelse er inspektioner den vigtigste kontrolmetode, som de kompetente myndigheder i medlemsstaten anvender.
English: Several countries have introduced more stringent testing requirements such as nucleic acid testing (NAT) for hepatitis B (HBV), hepatitis C (HCV) and/or human immunodeficiency virus (HIV) for non-reproductive and/or reproductive tissue and cells, whereas in most Member States and EEA countries the use of this type of testing is not required on the basis of a cost-benefit analysis and/or the epidemiological context.
Danish: En række lande har indført strengere kontrolkrav såsom testning for nukleinsyre (NAT), hepatitis B (HBV) og hepatitis C (HCV) og/eller human immundefekt virus (HIV) i somatiske væv og celler og/eller kønsvæv og -celler, mens brugen af denne type test i de fleste medlemsstater og EØS-lande på grundlag af en cost-benefit-analyse og/eller den epidemiologisk kontekst ikke er nødvendig.
English: Legend: HSC = haematopietic stem cells
Danish: Forklaring: HSC = hæmatopoietiske stamceller
English: In conclusion, this Report reveals an overall adequate application of the current quality and safety requirements of the EU tissues and cells legislation in most of the responding EU Member States and EEA countries.
Danish: Denne rapport konkluderer, at der generelt er en tilfredsstillende anvendelse af de nuværende kvalitets- og sikkerhedskrav i EU's lovgivning om væv og celler i de fleste af de EU-medlemsstater og EØS-lande, der har svaret på undersøgelsen.
English: As underlined by several national competent authorities, a more harmonised procedure for the accreditation, designation, authorisation or licensing of tissue establishments would foster mutual trust and acceptance between Member States which are essential for ensuring a prompt supply of tissues and cells to the patients in need for the cases in which tissues and cells are distributed from another Member State than the one where the patient is treated.
Danish: Som det er blevet understreget af flere kompetente nationale myndigheder, vil en mere harmoniseret procedure for akkreditering, udpegning eller godkendelse af eller udstedelse af licens til vævscentre fremme gensidig tillid og anerkendelse medlemsstaterne imellem, hvilket er afgørende for at sikre en hurtig forsyning af væv og celler til patienter, som har behov for dem, i de tilfælde, hvor væv og celler distribueres fra en anden medlemsstat end den, hvor patienten behandles.
English: [18: For the purpose of the survey, in order to facilitate a consistency in replies, those terms were defined as follows: 'National self-sufficiency' was defined as fulfilling the needs of human tissue and cell products for medical application (e.g. transplantation, ART procedures) of the resident population by accessing resources from within the country's population.
Danish: [18: For at fremme ensartede svar blev disse termer som led i undersøgelsen defineret som følger: "National selvforsyning" blev defineret som opfyldelse af behovene for humane vævs- og celleprodukter til medicinsk anvendelse (f.eks. transplantation og ART-procedurer) på den fastboende befolkning ved anvendelse af ressourcerne i landets befolkning.
English: Another Member State and one EEA country have not yet defined national provisions on the application of the VUD principle.
Danish: En anden medlemsstat og ét EØS-land har endnu ikke fastsat nationale bestemmelser om anvendelsen af princippet om frivillig og vederlagsfri donation.
English: Concerning the number of competent authorities, in some Member States only one authority is responsible for the oversight of the tissue and cell sector, whereas in other countries the tasks are divided amongst two or three authorities (based either on type of tissues and cells or on duties e.g. accreditation/authorisation v. inspections/vigilance or the allocation of tasks between federal and regional levels).
Danish: For så vidt angår antallet af kompetente myndigheder er kun én myndighed ansvarlig for tilsynet med sektoren for væv og celler i nogle medlemsstater, mens opgaverne i andre lande er fordelt mellem to eller tre myndigheder (baseret enten på typen af væv og celler eller på opgaverne som f.eks. akkreditering/godkendelse over for inspektioner/overvågning eller opgavefordelingen mellem de føderale og regionale niveauer).
English: Development of follow-up registries as an additional tool for ensuring safety of living donors was also addressed in the survey.
Danish: Undersøgelsen behandlede også udvikling af opfølgende registre som et yderligere middel til at garantere de levende donorers sikkerhed.
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 is essential, even where responsibilities of national competent authorities 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 nationale myndigheders ansvar er delt mellem flere organisationer eller regioner.
English: Concerning donor anonymity, most countries rely on the EU and national data protection legislation, but also on coding.
Danish: De fleste lande er afhængige af EU's og national databeskyttelseslovgivning i forbindelse med donorers anonymitet, men også for kodning.
English: This report is based on 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 Commission communication published in January 2010 as well as the two reports on the application of the principle of VUD for tissues and cells issued in 2006 and 2011.
Danish: Denne rapport bygger på svar til spørgeskemaer, som Kommissionen sendte til medlemsstaterne i 2012 (kontrol af fuldstændigheden af gennemførelse), 2013 (gennemførelsesundersøgelse), og 2014 (gennemførelse af princippet om frivillig og vederlagsfri donation), og den følger op på meddelelsen fra Kommissionen, der blev offentliggjort i januar 2010, samt de to rapporter om anvendelsen af princippet om frivillig og vederlagsfri donation for væv og celler, der blev offentliggjort i 2006 og 2011.
English: Responses to the survey showed that this is also the case for procurement of tissues and cells for ATMP manufacturers, in line with Article 3 of the ATMP Regulation.
Danish: Besvarelserne fra rundspørgen viser, at dette også er tilfældet ved udtagning af væv og celler til brug for LTAT-fabrikanterne i overensstemmelse med artikel 3 i LTAT-forordningen.
English: One concern raised during national tissue and cell competent authorities meetings was direct distribution of gametes (i.e. sperm) to individuals for self-application without the involvement of a health professional.
Danish: En af de betænkeligheder, der blev rejst under møder med de nationale kompetente myndigheder med ansvar for væv og celler, var direkte distribution af kønsceller (f.eks. sæd) til enkeltstående personers egen anvendelse uden medvirken af en sundhedsprofessionel.
English: The large majority of the responding countries (28) reported that the principle of VUD is mandatory at national level.
Danish: Det store flertal af de adspurgte lande (28) har rapporteret, at princippet om frivillig og vederlagsfri donation er obligatorisk på nationalt plan.
English: Some national competent authorities considered that it would be useful to strengthen the consideration of pharmacovigilance data regarding medicinal products that are used in the context of donations of tissues and cells.
Danish: Nogle nationale kompetente myndigheder mente, at det ville være nyttigt at styrke behandlingen af oplysninger i forbindelse med overvågningen af lægemidler, der anvendes i forbindelse med donation af væv og celler.
English: Fig. 8.
Danish: Figur 8
English: In this regard, more training of both healthcare professionals and vigilance officers in tissue establishments and competent authorities will be needed for an appropriate identification and analysis of the "root causes" of these SARE, which should lead to the identification and correction of systematic errors.
Danish: I denne forbindelse vil der være behov for mere uddannelse til både sundhedspersonale og overvågningsansvarlige i vævscentre og kompetente myndigheder for at opnå en passende identifikation og analyse af de underliggende årsager til disse alvorlige bivirkninger og uønskede hændelser, hvilket bør føre til identifikation og korrektion af systematiske fejl.
English: However, one Member State who reported that the VUD principle is mandatory indicated that payment of gamete donors is allowed at national level.
Danish: Imidlertid har én medlemsstat, der indberettede, at princippet om frivillig og vederlagsfri donation er obligatorisk, anført, at betaling af donorer af kønsceller er tilladt på nationalt plan.
English: In relation to the supply-demand balance, 17 Member States and one EEA country reported experiencing regular shortages of tissues and cells on a national level, mostly for bone marrow and haematopoietic stem cells, corneas and bone.
Danish: For så vidt angår ligevægten mellem udbud og efterspørgsel, indberettede 17 medlemsstater og et EØS-land, at der regelmæssigt er mangel på væv og celler på nationalt plan, hovedsageligt for knoglemarv og hæmatopoietiske stamceller, hornhinder og knogler.
English: Concerning testing laboratories, the survey showed that in most of the reporting Member States accreditation/designation/authorisation or licensing of testing laboratories is the responsibility of authorities other than the tissue and cell competent authorities.
Danish: Vedrørende prøvningslaboratorier viste undersøgelsen, at i de fleste af de indberettende medlemsstater varetages akkreditering/udpegning/godkendelse af eller licens til prøvningslaboratorier af andre myndigheder end de kompetente myndigheder med ansvar for væv og celler.
English: Only 15 Member States reported putting in place additional measures like examination/inspection/approval of advertising materials, training of professionals to spot illegal and fraudulent activities, verification that the VUD principle is also respected for imported tissues and cells.
Danish: Kun 15 medlemsstater har rapporteret, at de har indført supplerende foranstaltninger, som f.eks. undersøgelse/inspektion/godkendelse af reklamemateriale eller uddannelse af fagfolk, til at opdage ulovlige og svigagtige aktiviteter, eller kontrol med, at princippet om frivillig og vederlagsfri donation også overholdes vedrørende importerede væv og celler.
English: 'National sufficiency was defined as fulfilling the needs of human tissue and cell products for medical application (e.g. transplantation, ART procedures) of the resident population by accessing resources from within the country and through regional/international cooperation.]
Danish: "National forsyningstilstrækkelighed" blev defineret som opfyldelse af behovene for humane vævs- og celleprodukter til medicinsk anvendelse (f.eks. transplantation og ART-procedurer) på den fastboende befolkning ved anvendelse af ressourcerne i landet og gennem regionalt/internationalt samarbejde.]
English: In addition to providing regular updates during the bi-annul meeting of the tissue and cell expert sub-group on the epidemiological situation relevant to the tissue and cell sector, the development of risk assessments (e.g. for HTLV, malaria, dengue and chikungunya) and preparedness plans (e.g. for WNV outbreaks) provided a valuable contribution to policy and decision making in this sector at both national and EU level.
Danish: Ud over at levere regelmæssige ajourføringer under de halvårlige møder i vævs- og celle-ekspertundergruppen om den epidemiologiske situation vedrørende vævs- og cellesektoren, så har udvikling af risikovurderinger (f.eks. vedrørende HTLV, malaria, denguefeber og chikungunya) og beredskabsplaner (f.eks. for VNV-udbrud) ydet et værdifuldt bidrag til udarbejdelse af politikker og beslutningstagning i denne sektor på både nationalt plan og EU-plan.
English: As suggested by some Member States, a procedure setting higher (minimum) standards for the authorisation of tissue and cell preparation processes at the tissue establishments (as referred to in Article 4 of Directive 2006/86/EC) may encourage mutual trust and acceptance between Member States and thus strengthen the cross-border movement of tissues and cells across EU.
Danish: Som foreslået af visse medlemsstater kan en procedure, der indførte højere (minimums)standarder for godkendelse af processer til forarbejdning af væv og celler på vævscentrene, jf. artikel 4 i direktiv 2006/86/EF, fremme den gensidige tillid og anerkendelse mellem medlemsstaterne og dermed styrke den grænseoverskridende bevægelighed for væv og celler i hele EU.
English: The data reported show that the EU and EEA countries comply with the minimal testing requirements stipulated in the Directive 2006/17/EC.
Danish: Testning af donorer De indberettede data viser, at EU- og EØS-lande opfylder de minimale krav til testning, der er fastsat i direktiv 2006/17/EF.
English: The survey showed that a donor identification system was implemented by most Member States, with a unique code for each donation being assigned, predominantly at the level of the tissue establishment.
Danish: Sporbarhed Undersøgelsen viste, at der var indført et donoridentifikationssystem i de fleste medlemsstater, med en entydig kode for hver donation, fortrinsvis i vævscentrene.
English: The analysis of the replies concerning inspections of tissue establishments indicates, overall, an adequate implementation of the EU requirements.
Danish: Inspektion og kontrolforanstaltninger Analysen af svarene vedrørende inspektion af vævscentre viser generelt en tilstrækkelig gennemførelse af EU-kravene.
English: Several of the testing requirements (e.g. no requirement for NAT testing, the 24 hours limit for blood sample collection from a deceased donor, testing of gamete donors at the time of donation) have been subject to debate at the bi-annual national competent authorities meetings and the various practices shared by the competent authorities showed the need for an evidence-based risk assessment of some practical situations which were not clearly defined/foreseen in Directive 2006/17/EC.
Danish: Flere af testkravene (f.eks. intet krav om NAT-test, fristen på 24 timer for indsamling af blodprøver fra en afdød donor, testning af kønscelledonorer på tidspunktet for donationen) har været genstand for debat på de halvårlige møder for de kompetente nationale myndigheder, og de forskellige praksisser, som de kompetente myndigheder har delt, viste, at der er behov for en evidensbaseret risikovurdering af nogle praktiske situationer, der ikke var klart defineret eller fastsat i direktiv 2006/17/EF.
English: Best practices to ensure tissue and cell sufficiency/self-sufficiency or measures to reduce shortages might be addressed as well as best practices on verification of the implementation of the VUD principle by the competent authorities.
Danish: Der kan tages fat i bedste praksis for at sikre en tilstrækkelig forsyning/selvforsyning af væv og celler eller foranstaltninger til at mindske mangler, samt bedste praksis for kontrol af de kompetente myndigheders gennemførelse af princippet om frivillig og vederlagsfri donation.
English: New processing methodologies, unthought-of of when the Directives were adopted, are now commonly applied: pre-cutting of corneas with the transplant of only the anterior or posterior segment to one patient, decellularisation of skin and heart valves in the tissue establishment to enhance cellularisation in vivo in the recipient, numerous new pathogen inactivation or sterilisation techniques including the use of radioprotectants to allow treatment with high doses of gamma irradiation, transplantation of highly selected cell populations to be used for the same essential function in the recipient as in the donor, have all increased the importance of robust preparation process authorisation.
Danish: Nye forarbejdningsmetoder, der endnu ikke var udtænkt, da direktiverne blev vedtaget, anvendes nu ofte: forskæring af hornhinder, hvor kun det forreste eller bagerste segment transplanteres til én patient, decellularisering af hud og hjerteklapper i det vævscenter, der skal øge celledannelse in vivo i recipienten, adskillige nye teknologier til patogeninaktivering eller sterilisering, herunder anvendelsen af radiobeskyttere for at muliggøre behandling med store doser gammabestråling, transplantation af stærkt udvalgte cellepopulationer, der skal anvendes til samme væsentlige funktion hos recipienten som hos donor, har alle øget vigtigheden af solide godkendelser af forberedelsesprocesser.
English: Provisions associated with procurement, but also with donation and testing, are regulated by the tissue and cell legislation and verified during tissue establishment inspection.
Danish: Bestemmelser vedrørende udtagning, men også donation og testning, er omfattet af lovgivningen om væv og celler, og de kontrolleres under inspektionerne af vævscentre.
English: The survey showed that all reporting Member States authorise the conditions of procurement by inspecting procurement organisations and/or by evaluating the procurement-related documentation made available by the tissue establishment working with procurement organisations.
Danish: Undersøgelsen viste, at alle rapporterende medlemsstater godkendte betingelserne for udtagning ved at inspicere udtagningsorganisationer og/eller ved at evaluere udtagningsrelateret dokumentation stillet til rådighed af det vævscenter, der arbejder med udtagningsorganisationerne.
English: In addition, in several Member States, only tissue establishments are authorised to procure tissues and cells, with some countries authorising tissue establishments just for procurement activities.
Danish: Desuden er det i flere medlemsstater kun vævscentre, der er godkendt til udtagning af væv og celler, mens nogle lande kun godkender vævscentre til at foretage udtagningsaktiviteter.
English: Even though most of the Member States reported using the Operational Manual for Competent Authorities on inspection of tissue and cell procurement and tissue establishments, there is no common agreement on the classification of shortcomings identified during inspections (e.g. classification of minor, major and critical deficiencies).
Danish: Selv om de fleste medlemsstater rapporterede, at de anvendte håndbogen for de kompetente myndigheder om inspektion af vævs- og celleudtagning og vævscentre, er der uenighed om klassificeringen af de mangler der afsløres under inspektionerne (f.eks. klassificering af mindre vigtige, vigtige og kritiske mangler).
English: The survey revealed a variety of approaches for the implementation of the procurement requirements laid down in Directive 2006/17/EC, especially when granting authorisation (e.g. prior on-site inspection vs. desk-based review of documentation, differing criteria for major changes requiring a notification of the competent authorities, differing duration of authorisation and conditions of renewal).
Danish: Undersøgelsen har afsløret en række forskellige tilgange til gennemførelse af udtagningskravene fastsat i direktiv 2006/17/EF, navnlig når godkendelser udstedes (f.eks. forudgående kontrolbesøg på stedet over for en administrativ gennemgang af dokumentationen, forskellige kriterier for større ændringer, som kræver underretning af de kompetente myndigheder, forskel i varigheden og betingelserne for fornyelse af godkendelser).
English: However, the ways in which Member States have implemented the principle of VUD are difficult to assess in a comprehensive manner.
Danish: De måder, hvorpå medlemsstaterne har gennemført princippet om frivillig og vederlagsfri donation, er imidlertid vanskelige at vurdere på en sammenhængende måde.
English: The fact that third parties may be involved in all steps of the chain from donation and procurement to distribution in most Member States highlights the importance that needs to be given to the written agreements established by tissue establishments and their verification by the national competent authorities.
Danish: Vævscentres forbindelser til tredjepart Den omstændighed, at tredjeparter kan være involveret i alle trin i kæden fra donation og udtagning til distribution i de fleste medlemsstater, viser den vigtighed, som de skriftlige aftaler, vævscentrene indgår, må tillægges, og hvor vigtigt det er, at disse kontrolleres af de kompetente nationale myndigheder.