qanastek/ELRC-Medical-V2 huggingface dataset:
English: However, the tissue establishment reports are not always publicly available, mainly due to different interpretations of this provision by the Member States authorities.
Translation (en-sl): Vendar poročila ustanov za tkiva in celice niso povsod na voljo javnosti, predvsem zato, ker si organi držav članic to določbo različno razlagajo.
English: Mandatory SOPs are also required during the authorisation/accreditation/designation or licensing process in most of the responding countries.
Translation (en-sl): Obvezni standardni operativni postopki se zahtevajo tudi pri odobritvi/akreditaciji/imenovanju ali izdaji dovoljenj v večini držav, ki so se odzvale.
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.
Translation (en-sl): V nekaterih državah članicah so organi za tkiva in celice odgovorni tudi za nadzor nad drugimi sektorji (npr. organi, kri in/ali zdravila) (sliki 1 in 2), kar je lahko koristno z vidika učinkovitosti.
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.
Translation (en-sl): Nekateri nacionalni pristojni organi so menili, da bi bilo koristno okrepiti upoštevanje podatkov o farmakovigilanci v zvezi z zdravili, ki se uporabljajo v okviru darovanja tkiv in celic.
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.
Translation (en-sl): Vendar je treba opozoriti, da je težko oblikovati trdne sklepe glede količine uvoza in izvoza človeških tkiv in celic, ker na nacionalni ravni ni obveznega poročanja o teh informacijah in ker v državah članicah ni usklajenega okvira za zbiranje podatkov.
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.
Translation (en-sl): Kar zadeva hranjenje podatkov vsaj 30 let, skoraj vse države članice in države EGP izpolnjujejo zahteve iz člena 9 Direktive 2006/86/ES ter zahtevajo, da se za navedeno obdobje hranijo evidence na papirju in v elektronski obliki.
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.
Translation (en-sl): Vendar je znaten delež anketirancev (48 %) menil, da se prejetje okrepčil, brezplačno testiranje ali brezplačen zdravniški pregled zdijo primerni ob darovanju človeških tkiv in celic.
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.
Translation (en-sl): Opozoriti je treba, da je nedavna anketa Eurobarometra o darovanju krvi, celic in tkiv pokazala, da se samo 13 % državljanom EU zdi sprejemljivo, da bi poleg povračila stroškov v zvezi z darovanjem prejeli denarne zneske.
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.
Translation (en-sl): Nekatere države so uvedle strožje zahteve glede testiranja, kot je testiranje z nukleinsko kislino (NAT) na hepatitis B (HBV), hepatitis C (HCV) in/ali virus človeške imunske pomanjkljivosti (HIV) za nereproduktivna in/ali reproduktivna tkiva in celice, medtem ko se v večini držav članic in držav EGP uporaba te vrste testiranja ne zahteva na podlagi analize stroškov in koristi in/ali glede na epidemiološki okvir.
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.
Translation (en-sl): Poleg tega je anketa pokazala, da 19 držav (17 držav članic in dve državi EGP) ni vzpostavilo nacionalnih politik za spodbujanje nacionalne samozadostnosti/zadostnosti za tkiva in celice ter da na nacionalni ravni ne zbirajo vedno podatkov o čezmejnem prenosu tkiv in celic.
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.
Translation (en-sl): Plačevanje pavšalnih zneskov darovalcem reproduktivnih celic, kot je praksa v nekaterih državah, lahko olajša upravno breme, vendar odpira tudi vprašanja, kadar vrednost določijo samo ustanove za tkiva in celice ali kadar je vrednost precej visoka glede na povprečni nacionalni mesečni dohodek.
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.
Translation (en-sl): Čeprav je mogoče tak promet pojasniti z globalizacijo zdravstvenih proizvodov in storitev, so enotni standardi kakovosti in varnosti iz zakonodaje EU o tkivih in celicah oblikovali okvir za lažji transnacionalni promet znotraj Unije.
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.
Translation (en-sl): Poleg tega je večina držav članic navedla, da bi morale nove zahteve glede kodiranja, zdaj določene v Direktivi (EU) 2015/565 o spremembi Direktive 2006/86/ES, prispevati k usklajenemu izvajanju enotnega evropskega kodnega sistema za tkiva in celice ter dejavno podpirati njegov razvoj.
English: Reproductive cells (ART sector).
Translation (en-sl): Reproduktivne celice (sektor OBMP).
English: The data reported show that the EU and EEA countries comply with the minimal testing requirements stipulated in the Directive 2006/17/EC.
Translation (en-sl): Posredovani podatki kažejo, da države EU in EGP izpolnjujejo minimalne zahteve glede testiranja iz Direktive 2006/17/ES.
English: Outcome of tissue establishment inspections performed in 2011
Translation (en-sl): Slika 6 Rezultati inšpekcijskih pregledov ustanov za tkiva in celice, opravljenih leta 2011
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.
Translation (en-sl): Čeprav pristojni organi to prakso štejejo za nadomestilo, jo lahko družinski člani/sorodniki pokojnih darovalcev razumejo kot spodbudo, zlasti kadar ni izrecnega soglasja pokojne osebe ali kadar sorodniki zaradi finančnih omejitev težko krijejo stroške pogreba/pokopa/upepelitve.
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.
Translation (en-sl): Redna srečanja nacionalnih pristojnih organov v okviru strokovne skupine pristojnih organov za snovi človeškega izvora (CASoHO E01718) so se razvila v cenjeno platformo za razprave, ki omogoča izmenjavo dobrih praks ter pojasnjevanje pogostih težav, ki nastajajo na nacionalni ravni in ravni EU.
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.
Translation (en-sl): Nazadnje, Komisija je v tesnem sodelovanju z državami članicami razvila platformo za hitro obveščanje o tkivih in celicah (RATC), ki olajšuje spletno komuniciranje med državami članicami v primeru opozoril v zvezi s človeškimi tkivi in celicami, ki se prenašajo čez meje.
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.
Translation (en-sl): Čeprav se obstoječe zahteve iz Direktive 2006/86/ES nanašajo samo na poročanje o hudih neželenih reakcijah pri prejemnikih tkiv in celic, se prostovoljno poročanje o hudih neželenih reakcijah pri darovalcih v zadnjih letih postopno izboljšuje, kar kaže na povečan interes držav članic za zaščito živih darovalcev.
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.
Translation (en-sl): Poleg tega nekatere države ne razlikujejo med razdelitvijo znotraj Unije ter uvozom v tretje države in izvozom iz njih, kar se lahko šteje za bistveno oviro ne samo za zbiranje podatkov in analizo, temveč tudi za optimalni promet s tkivi in celicami za paciente po vsej EU.
English: Total inspections = 443; data reported by 21 Member States
Translation (en-sl): Skupno število inšpekcijskih pregledov = 443; podatke je poslalo 21 držav članic
English: The current survey showed that in addition to the requirements in the Directive 2006/17/EC, the more stringent selection criteria required by Member States are usually justified for local reasons, such as the increased prevalence of a certain disease.
Translation (en-sl): Anketa je pokazala, da so poleg zahtev iz Direktive 2006/17/ES strožja merila za izbor, ki jih zahtevajo države članice, običajno utemeljena zaradi lokalnih dejavnikov, kot je večja prevalenca določene bolezni.
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.
Translation (en-sl): Samo 15 držav članic je poročalo o vzpostavitvi dodatnih ukrepov, kot so preučitev / inšpekcijski pregled / odobritev gradiva za oglaševanje, usposabljanje strokovnjakov za odkrivanje nezakonitih in goljufivih dejavnosti ter preverjanje, da se načelo PBD spoštuje tudi pri uvoženih tkivih in celicah.
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.
Translation (en-sl): Poudariti je treba, da sta varnost in kakovost zelo pomembna za državljane EU, pri čemer je 56 % tistih, ki so odgovorili na anketo Eurobarometra o darovanju krvi, celic in tkiv18, tveganje prenosa bolezni navedlo kot glavno skrb pri sprejetju darovanih snovi.
English: All Member States, and also Liechtenstein and Norway provided answers to the survey on the implementation of the VUD principle.
Translation (en-sl): Vse države članice ter Lihtenštajn in Norveška so predložili odgovore na anketo o izvajanju načela PBD.
English: The analysis of the replies concerning inspections of tissue establishments indicates, overall, an adequate implementation of the EU requirements.
Translation (en-sl): Analiza odgovorov v zvezi z inšpekcijskimi pregledi ustanov za tkiva in celice kaže, da je izvajanje zahtev EU na splošno ustrezno.
English: As demonstrated by the Member State replies, there are important cross-border movements of human tissues and cells within the EU and EEA countries (Fig. 8).
Translation (en-sl): Kot dokazujejo odgovori držav članic, znotraj EU in držav EGP obstaja znatni čezmejni promet s človeškimi tkivi in celicami (slika 8).
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.
Translation (en-sl): Kljub temu Komisija in nacionalni pristojni organi za tkiva in celice priznavajo, da je nezadostno poročanje še vedno precej prisotno, kar je treba pazljivo upoštevati pri analizi podatkov.
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.
Translation (en-sl): Različna merila pa lahko predstavljajo tudi ovire za izmenjavo tkiv in celic med državami članicami za zdravstvene delavce, ki zaprosijo za tkiva ali celice iz druge države članice.
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.
Translation (en-sl): To poročilo temelji na odgovorih na vprašalnike, ki jih je Komisija poslala državam članicam leta 2012 (preverjanje popolnosti prenosa), leta 2013 (anketa o izvajanju) in leta 2014 (izvajanje načela PBD), ter sledi sporočilu Komisije, objavljenemu januarja 2010 ter poročiloma o uporabi načela PBD za tkiva in celice, izdanima leta 2006 oziroma leta 2011.
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.
Translation (en-sl): O vrednosti večine praks v zvezi z darovanjem tkiv in celic so bile poslane omejene informacije, verjetno zato, ker se stroški znatno razlikujejo glede na okoliščine darovanja (npr. potreba po predhodnem testiranju/zdravljenju, trajanje hospitalizacije, učinki na splošno zdravje in sposobnost za delo) ali pa so odvisni od klinike, na kateri se darovanje izvede.
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.
Translation (en-sl): Ti ukrepi so omogočili razvoj smernic in priročnikov na področjih, ki so v splošnem interesu, kot so inšpekcijski pregledi in vigilanca, vključevali so usposabljanja za pristojne organe držav članic in njihove inšpektorje ter združili strokovnjake iz sektorja shranjevanja tkiv za razvoj podrobnih tehničnih navodil v skladu z zakonskimi zahtevami EU.
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.
Translation (en-sl): V zvezi s tem je več nacionalnih pristojnih organov pozvalo, da se na ravni EU potrdijo smernice za dobro prakso v zvezi s tkivi, podobne pristopu s smernicami za dobro proizvodno prakso v farmacevtskem sektorju, in da se nadalje zagotavlja podpore za usposabljanje inšpektorjev na ravni EU.
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.
Translation (en-sl): Poleg tega morajo države članice v skladu s členom 12(1) Direktive 2004/23/ES Komisiji vsaka tri leta predložiti poročilo o uporabi načela prostovoljnega in brezplačnega darovanja (PBD).
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.
Translation (en-sl): Pri preverjanju skladnosti ustanov za tkiva in celice z zahtevami EU glede vrednotenja in izbiranja darovalcev so inšpekcijski pregledi najpomembnejši način preverjanja, ki ga uporabljajo pristojni organi držav članic.
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).
Translation (en-sl): Zato imajo lahko enake pomanjkljivosti različne posledice za ustanove, v katerih so bili opravljeni inšpekcijski pregledi, glede na njihovo geografsko lokacijo (npr. kazni v primerjavi s preklicem ali začasnim odvzemom dovoljenja za enako pomanjkljivost).
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.
Translation (en-sl): V zvezi s tem je 18 držav članic in držav EGP poročalo, da imajo register za nadaljnje spremljanje ali podatkovno zbirko o darovalcih krvotvornih matičnih celic, vendar se lahko vrsta nadaljnjih pregledov, njihova pogostost in odgovorne zdravstvene ustanove/delavci razlikujejo po posameznih državah.
English: Regarding practices vis-à-vis deceased donors of tissues and cells, only three Member States reported that they provide compensation to donor relatives.
Translation (en-sl): V zvezi s praksami glede pokojnih darovalcev tkiv in celic so samo tri države članice poročale, da dajejo nadomestilo sorodnikom darovalca.
English: Total inspections = 549; data reported by 22 Member States
Translation (en-sl): Skupno število inšpekcijskih pregledov = 549; podatke je poslalo 22 držav članic
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.
Translation (en-sl): To lahko pojasni znatno raznolikost praks v zvezi z darovalci tkiv in celic po EU, pri čemer nekatere države določene prakse štejejo za nadomestilo, druge pa za spodbudo ali druge prakse.
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.
Translation (en-sl): V zvezi s tem bo potrebnega več usposabljanja zdravstvenih delavcev in uradnikov za vigilanco v ustanovah za tkiva in celice ter pristojnih organih za ustrezno določitev in analizo „temeljnih vzrokov" za te hude neželene reakcije in dogodke, kar bi moralo privesti do prepoznavanja in odprave sistemskih napak.
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.
Translation (en-sl): Poleg tega, da se s tem poročilom izpolnjujejo zakonske obveznosti v skladu s členom 12(1) in členom 26 Direktive 2004/23/ES, je v njem prikazano, kako Direktiva 2004/23/ES ter izvedbeni direktivi 2006/17/ES in 2006/86/ES (v nadaljnjem besedilu skupaj: zakonodaja EU o tkivih in celicah) delujejo v praksi glede na znaten znanstveni in organizacijski razvoj (internacionalizacija, komercializacija) v sektorju tkiv in celic v zadnjem desetletju.
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).
Translation (en-sl): Več organov je poudarilo, da v takih primerih obstaja znatno tveganje izgube sledljivosti, vključno z neustreznim poročanjem o stopnji nosečnosti in hudih neželenih reakcijah po medicinski uporabi (npr. otroci, rojeni z genskimi boleznimi, o katerih razdeljevalna ustanova za tkiva in celice ni obveščena).
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.
Translation (en-sl): Nove zakonske določbe za uporabo enotne evropske kode morajo izpolniti tudi zahtevo iz člena 10(3) Direktive 2004/23/ES z vzpostavitvijo EU-kompendija ustanov za tkiva in celice, vključno z vsemi ustanovami za tkiva in celice s svojimi koordinatami in statusom glede akreditacije/imenovanja/odobritve ali izdaje dovoljenja.
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.
Translation (en-sl): Kot predlagajo nekatere države članice, bi lahko postopek, ki bi določal višje (minimalne) standarde za odobritev postopkov priprave tkiv in celic v ustanovah za tkiva in celice (iz člena 4 Direktive 2006/86/ES), spodbudil medsebojno zaupanje in sprejemanje med državami članicami ter s tem okrepil čezmejni prenos tkiv in celic po vsej EU.