qanastek/ELRC-Medical-V2 huggingface dataset:
English: Overall, Member States expressed interest in an increased level of donor protection and in an overview of additional national eligibility criteria in order to increase transparency and mutual trust in exchanges.
Translation (en-sl): Na splošno so države članice izrazile zanimanje za povečano stopnjo zaščite darovalcev in pregled dodatnih nacionalnih meril za ustreznost, da bi izboljšale preglednost in medsebojno zaupanje pri izmenjavah.
English: The 2013 implementation survey was answered by all Member States and also by two EEA countries, Liechtenstein and Norway.
Translation (en-sl): Na anketo o izvajanju iz leta 2013 so odgovorile vse države članice in dve državi EGP, in sicer Lihtenštajn in Norveška.
English: Fig. 2: Overlapping inspection schemes
Translation (en-sl): Slika 2: Prekrivajoči se inšpekcijski programi
English: Countries identify an increase of the maximum donor age as the most promising initiative to improve the supply of blood and blood components.
Translation (en-sl): Države ugotavljajo, da je povečanje najvišje dovoljene starosti darovalca najobetavnejša pobuda za izboljšanje dobave krvi in komponent krvi.
English: Countries also see value in further centralisation of laboratory test results at EU level to facilitate benchmarking against average EU rates of positivity.
Translation (en-sl): Državam se zdi koristna tudi nadaljnja centralizacija rezultatov laboratorijskih testov na ravni EU za lažjo primerjavo s povprečnimi stopnjami pozitivnosti v EU.
English: The global growth of utilisation of plasma derivatives, particularly intravenous immunoglobulin (IVIG), requires a growing number of donations.
Translation (en-sl): Zaradi splošne rasti uporabe derivatov krvne plazme, zlasti intravenskih imunoglobulinov (IVIG), je potrebno vse večje število darovalcev.
English: Projects such as EUBIS, CATIE, DOMAINE, Optimal Blood Use, EU-Q-Blood-SOP and the on-going joint action VISTART provide strong support to Member States in their efforts to implement the requirements of the blood directives.
Translation (en-sl): Projekti, kot so EUBIS, CATIE, DOMAINE, Optimal Blood Use, EU-Q-Blood-SOP in trenutni skupni ukrep VISTART, so državam članicam v veliko oporo pri prizadevanjih za izvajanje zahtev direktiv o krvi.
English: Ten countries reported facilitating donations by donors from abroad by providing donor questionnaires in different languages.
Translation (en-sl): Deset držav je poročalo o tem, da so olajšale darovanje za darovalce iz tujine z zagotovitvijo vprašalnikov za darovalce v različnih jezikih.
English: These differences facilitate successful integration of the requirements into national legislation but in some cases they may limit the mutual acceptance of authorisations with consequences for potential cross-border movement of blood and blood components.
Translation (en-sl): Te razlike omogočajo uspešno vključitev zahtev v nacionalno zakonodajo, vendar lahko v nekaterih primerih omejijo vzajemno priznavanje odobritev, kar pomeni posledice za morebitni čezmejni prenos krvi in komponent krvi.
English: Fig. 5: Policy setting to ensure effective use of blood, blood components and plasma derivatives
Translation (en-sl): Slika 5: Oblikovanje politike za zagotovitev učinkovite uporabe krvi, komponent krvi in derivatov krvne plazme
English: Eight countries reported regular shortages of one or more blood components in the survey.
Translation (en-sl): V anketi je osem držav poročalo o rednem pomanjkanju ene ali več komponent krvi.
English: Many countries are largely supplied with plasma derivatives by just one supplier, either public or private.
Translation (en-sl): Številne države večinoma dobivajo derivate krvne plazme od enega samega dobavitelja, javnega ali zasebnega.
English: However, Member States' perceptions of what is considered compensation and incentive vary.
Translation (en-sl): Vendar se razlage držav članic, kaj se šteje za nadomestilo in spodbudo, razlikujejo.
English: There is considerable heterogeneity across the EU, with certain practices perceived as compensation in one country and as incentives in another.
Translation (en-sl): V EU obstaja precejšnja raznolikost, pri čemer se nekatere prakse v eni državi štejejo za nadomestilo, v drugi pa za spodbudo.
English: However, the Report also points to some gaps and difficulties in relation to the application and enforcement of the existing provisions (e.g. definitions, provisions for donor safety, inspections framework), some due to different approaches taken by the Member States and others due to technological advances and changing risks observed since the legislation was adopted.
Translation (en-sl): Vendar poročilo kaže tudi na nekatere vrzeli in težave v zvezi z uporabo in izvrševanjem obstoječih določb (npr. opredelitve, določbe o varnosti darovalcev, okvir inšpekcijskih pregledov), pri čemer so nekatere posledica različnih pristopov držav članic, druge pa tehnološkega napredka in sprememb v tveganjih, ugotovljenih od sprejetja zakonodaje.
English: Sixteen reported discouraging such donations by requiring a local ID document or a proof or local residence.
Translation (en-sl): Šestnajst jih je poročalo o odvračanju od takega darovanja z zahtevo po lokalnem osebnem dokumentu ali dokazilu o lokalnem prebivališču.
English: In addition, and in accordance with Article 20(2) of the Directive 2002/98/EC, Member States have to submit to the Commission reports on the application of the principle of voluntary and unpaid donation (VUD) every three years.
Translation (en-sl): Poleg tega morajo države članice v skladu s členom 20(2) Direktive 2002/98/ES Komisiji vsaka tri leta predložiti poročila o uporabi načela prostovoljnega in brezplačnega darovanja (PBD).
English: Most common are awareness building campaigns for specific donor groups, such as students, or events such as the World Blood Donor Day (WHO, 14 June) or Thalassemia day (8 May in Greece and Cyprus).
Translation (en-sl): Najpogostejše so kampanje ozaveščanja za posebne skupine darovalcev, kot so študenti, ali dogodki, kot sta svetovni dan krvodajalcev (SZO, 14. junij) ali dan talasemije (8. maj v Grčiji in na Cipru).
English: Fig. 1: Additional fields of competence for national blood competent authorities
Translation (en-sl): Slika 1: Dodatna področja pristojnosti za nacionalne pristojne organe za kri
English: In half of the countries one authority is responsible for the entire oversight of the blood sector, whereas in others the tasks are divided amongst two or three authorities (based on duties, e.g. accreditation/authorisation versus inspections/vigilance, or based on the allocation of tasks between federal and regional levels).
Translation (en-sl): V polovici držav je en organ odgovoren za celoten nadzor nad sektorjem krvi, v drugih pa so naloge razdeljene med dva ali tri organe (glede na naloge, npr. akreditacija/odobritev v primerjavi z inšpekcijskim pregledom/vigilanco, ali glede na razdelitev nalog med zvezno in regionalno ravnjo).
English: While many countries report having data on imported volumes, it is difficult to draw conclusions in the absence of a harmonised data collection system on import and export volumes.
Translation (en-sl): Čeprav številne države poročajo, da imajo podatke o količini uvoza, je iz njih težko sklepati, ker ni usklajenega sistema zbiranja podatkov o količinah uvoza in izvoza.
English: In contrast to blood components for transfusion, the demand for plasma derivatives is steadily increasing (around 6% per year) which also generates import flows from third countries into the EU.
Translation (en-sl): Povpraševanje po derivatih krvne plazme v nasprotju s komponentami krvi za transfuzijo stalno narašča (za približno 6 % letno), kar tudi ustvarja uvozne tokove iz tretjih držav v EU.
English: The ageing EU population could exacerbate supply challenges, leading both to increased demand and reduced numbers of eligible donors.
Translation (en-sl): Zaradi staranja prebivalstva EU se lahko izzivi glede dobave povečajo, saj to pomeni povečano povpraševanje in zmanjšano število ustreznih darovalcev.
English: Seventeen Member States reported having penalties in place, addressing different situations such as making financial gain or collection of donations without consent.
Translation (en-sl): Sedemnajst držav članic je poročalo, da so pri njih uvedene kazni za različne primere, kot je pridobivanje finančne koristi ali zbiranje darovanj brez soglasja.
English: All Member States, Liechtenstein and Norway also provided answers to the survey on the implementation of the principle of VUD.
Translation (en-sl): Vse države članice ter Lihtenštajn in Norveška so predložili tudi odgovore na anketo o izvajanju načela PBD.
English: As regards the risk of transmission of communicable diseases thorough blood and blood components, the collaboration with ECDC proved extremely valuable.
Translation (en-sl): Kar zadeva tveganje prenosa nalezljivih bolezni prek krvi in komponent krvi, se je sodelovanje z Evropskim centrom za preprečevanje in obvladovanje bolezni (ECDC) izkazalo za izredno dragoceno.
English: Many countries reported in 2013 on the feasibility/appropriateness of deferring donors on the grounds of sexual risk behaviour and about two-thirds of the countries have national guidance in place.
Translation (en-sl): Leta 2013 so številne države poročale o izvedljivosti/ustreznosti odklona darovalcev zaradi tveganega (spolnega) vedenja, približno dve tretjini držav pa ima glede tega sprejeta nacionalna navodila.
English: Sixteen countries report having pathogen inactivation technologies in place.
Translation (en-sl): Šestnajst držav poroča, da imajo vzpostavljene tehnologije inaktivacije patogenov.
English: Other Member States reported to be negotiating agreements for fractionation, while one reported having difficulties finding a partner to carry out fractionation.
Translation (en-sl): Druge države članice so poročale, da se pogajajo o sporazumih o frakcioniranju, medtem ko je ena poročala, da ima težave pri iskanju partnerja za izvajanje frakcioniranja.
English: In the vast majority of Member States, the authorities for blood are also responsible for the oversight of other sectors (e.g. organs, tissues, cells and/or medicinal products), which can be beneficial for achieving greater efficiency and coherence.
Translation (en-sl): V veliki večini držav članic so organi za kri odgovorni tudi za nadzor nad drugimi sektorji (npr. organi, tkiva, celice in/ali zdravila), kar je lahko koristno z vidika učinkovitosti in skladnosti.
English: Additionally, the distinction between import/export from/to third countries and distribution from/to other EU Member States is not consistently applied.
Translation (en-sl): Poleg tega ni doslednega razlikovanja med uvozom v tretje države oz. izvozom iz njih ter razdeljevanjem iz drugih držav članic EU in vanje.
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.
Translation (en-sl): Zato informacije, ki jih predloži darovalec, prispevajo k točni oceni vseh tveganj v zvezi s transfuzijo krvi in komponent krvi ter klinično uporabo derivatov krvne plazme.
English: For the purpose of the survey, "compensation" was defined as "reparation strictly limited to making good the expenses and inconveniences related to the donation" and "incentive" was defined as "inducement or stimulus for donation with a view to seeking financial gain or comparable advantage", but even with these (non-binding) definitions Member States reached divergent classifications.
Translation (en-sl): Za namene ankete je bilo „nadomestilo" opredeljeno kot „odškodnina, strogo omejena na povračilo stroškov in kompenzacijo za neprijetnosti v zvezi z darovanjem", „spodbuda" pa kot „stimulacija ali motivacija za darovanje za pridobitev finančne koristi ali podobne ugodnosti", vendar so države članice kljub tem (nezavezujočim) opredelitvam uporabile različne razvrstitve.
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.
Translation (en-sl): Večina držav poroča, da imajo tudi politike za optimiziranje klinične uporabe derivatov krvne plazme, majhno število držav pa ima nacionalne strategije za prednostno razvrščanje za zagotovitev dobave tistim skupinam pacientov, ki so močno odvisni od zdravljenja s temi pripravki.
English: The majority of Member States have rules to authorise and control import of blood and blood components for transfusion, while only about half have such rules for plasma for fractionation.
Translation (en-sl): Večina držav članic ima pravila za odobritev in kontrolo uvoza krvi in komponent krvi za transfuzijo, medtem ko jih ima taka pravila za krvno plazmo za frakcioniranje samo približno polovica.
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).
Translation (en-sl): Nacionalna pravila o izvozu pogosto omejujejo izvoz krvi in komponent krvi ali zanj postavljajo pogoje, na primer samo v nujnih primerih, kar številne države razumejo kot del svoje nacionalne politike za zagotavljanje samozadostnosti (glej spodaj).
English: Besides complying with the legal obligations, the current report sets out how Directive 2002/98/EC and its implementing Directives 2004/33/EC, 2005/61/EC and 2005/62/EC (henceforth commonly referred to as the EU blood legislation) function in practice, against a backdrop of significant scientific and organisational developments (internationalisation, commercialisation) that have taken place in the European blood and blood components sector over the past decade.
Translation (en-sl): Poleg tega, da se s tem poročilom izpolnjujejo zakonske obveznosti, je v njem prikazano, kako Direktiva 2002/98/ES ter izvedbene direktive 2004/33/ES, 2005/61/ES in 2005/62/ES (v nadaljnjem besedilu skupaj: zakonodaja EU o krvi) delujejo v praksi glede na znaten znanstveni in organizacijski razvoj (internacionalizacija, komercializacija) v sektorju krvi in komponent krvi v zadnjem desetletju.
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.
Translation (en-sl): Varnost in kakovost krvi sta odvisni od izvajanja kombinacije treh stebrov: presejalni test darovalcev glede na merila za odklon, testiranje darovalcev in, kadar je to mogoče, tehnike inaktivacije patogenov.
English: Also the inspection approaches vary significantly towards mobile and satellite sites, hospital blood banks, plasma collection centres and potential third country players.
Translation (en-sl): Pristopi k inšpekcijskim pregledom se znatno razlikujejo tudi pri mobilnih in satelitskih enotah, transfuzijskih bankah v bolnišnicah, centrih za zbiranje krvne plazme in morebitnih akterjih iz tretjih držav.
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.
Translation (en-sl): Čeprav opredelitev hude neželene reakcije iz člena 3 Direktive 2002/98/ES daje enak pomen hudim neželenim reakcijam pri darovalcih in prejemnikih, se sedanje zahteve nanašajo samo na poročanje o hudih neželenih reakcijah pri prejemnikih.
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).
Translation (en-sl): Glavni vzroki za odklon kandidatov za darovalce, o katerih so poročale države članice, so bili nizka raven hemoglobina (ki ogroža zdravje darovalca) ter nevarnost prenosa nalezljivih bolezni, tvegano (spolno) vedenje, potovanje, jemanje zdravil in drugi zdravstveni razlogi (ki ogrožajo zdravje prejemnika).
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.
Translation (en-sl): Organi učinkovito sodelujejo prek sistema RAB, čeprav številni navajajo, da je treba izboljšati pošiljanje informacij lokalnim transfuzijskim ustanovam od RAB, kar je treba doseči na nacionalni ravni.
English: Whilst overall Member States seem to correctly implement the provisions concerning inspections, a number of Member States reported difficulties related to staffing, which makes compliance with the required 2-year inspection interval challenging.
Translation (en-sl): Medtem ko je videti, da države članice na splošno ustrezno izvajajo določbe glede inšpekcijskih pregledov, je več držav članic poročalo o kadrovskih težavah, zaradi česar je težko izpolniti zahteve v zvezi z dveletnimi inšpekcijskimi pregledi.
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.
Translation (en-sl): Večina držav organizira analize izvornega vzroka, da bi razumele razloge za hude neželene reakcije in dogodke, vendar na splošno poročajo o interesu za nadaljnji razvoj tega pristopa, zlasti za spopadanje z izzivom, da bi v take analize vključili lokalne strokovnjake in bolnišnice.
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.
Translation (en-sl): Pravila o izvozu krvne plazme za frakcioniranje so običajno manj omejevalna, čeprav se poroča o praksi izvoza krvne plazme za pogodbeno frakcioniranje derivatov, ki se nato uporabijo samo za paciente v državi zbiranja.
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).
Translation (en-sl): Države za vključitev teh lokalnih deležnikov navajajo uporabo revizij in programov, kot je izvajanje upravljanja krvi pacientov (glede katerega trenutno v okviru tretjega progama zdravja Unije poteka študija, ki se izvaja na podlagi javnega razpisa).
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.
Translation (en-sl): Zakonodaja EU opredeljuje minimalno serološko testiranje na virus človeške imunske pomanjkljivosti (HIV) 1/2, hepatitis B in hepatitis C, ki ga je treba opraviti pri vsakem darovanju polne krvi in darovanju z uporabo afereze.
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.
Translation (en-sl): Celotna analiza odgovorov držav članic na anketo o izvajanju iz leta 2013 in anketo o izvajanju načela PBD iz leta 2014 je vključena v dva delovna dokumenta služb Komisije, priložena temu poročilu.
English: In around half of the Member States, donors have their travel costs reimbursed and get time off work in the public and private sector.
Translation (en-sl): V približno polovici držav članic so darovalcem povrnjeni potni stroški, v javnem in zasebnem sektorju pa jim je odobren tudi dopust.
English: The regular meetings of the expert sub-group on blood and blood components (which is part of the Competent Authorities on Substances of Human Origin Expert Group - CASoHO E01718) allow for sharing best practices and clarification of common difficulties encountered at national and EU level.
Translation (en-sl): Redna srečanja strokovne podskupine za kri in komponente krvi (ki je del strokovne skupine pristojnih organov za snovi človeškega izvora - CASoHO E01718) omogočajo izmenjavo dobrih praks in pojasnjevanje pogostih težav, do katerih pride na nacionalni ravni in ravni EU.
English: The EU is significantly reliant on importation of plasma for the manufacture of plasma derived medicinal products, mainly from the United States.
Translation (en-sl): EU je precej odvisna od uvoza krvne plazme za izdelavo zdravil iz krvne plazme, predvsem iz ZDA.
English: The role of common assessments by ECDC and the Commission was recognised in this context, e.g. when developing a preparedness plan to help blood establishments address the seasonal outbreaks of West Nile Virus in some southern EU countries.
Translation (en-sl): V tem okviru je bila priznana vloga skupnih ocenjevanj Evropskega centra za preprečevanje in obvladovanje bolezni (ECDC) in Komisije, na primer pri razvoju načrta pripravljenosti na pomoč transfuzijskim ustanovam pri spopadanju z izbruhi virusa zahodnega Nila v nekaterih južnih državah EU.
English: Replacement donors, i.e. donors that are encouraged to make donations to replace those being used for a relative or friend, are reported as important for maintaining supply in five countries.
Translation (en-sl): Po poročanju so nadomestni darovalci, tj. darovalci, ki jih spodbujajo k darovanju za nadomestitev krvi, ki se je uporabila za sorodnika ali prijatelja, pomembni za vzdrževanje dobave v petih državah.
English: In their responses to the implementation survey, several countries suggested making syphilis testing mandatory at EU level, while some suggest making NAT testing for HIV and hepatitis mandatory, despite the reservations mentioned by other countries.
Translation (en-sl): Več držav je v svojih odgovorih na anketo o izvajanju predlagalo obvezno testiranje na sifilis na ravni EU, nekatere pa predlagajo obvezno testiranje na HIV in hepatitis z NAT, in to kljub zadržkom, ki jih navajajo druge države.
English: Some countries foresee compensation for loss of earnings in some circumstances, e.g. one Member State foresees this for plasma apheresis donations.
Translation (en-sl): Nekatere države predvidevajo nadomestilo za izgubo dohodka v določenih okoliščinah, ena od držav članic pa to na primer predvideva za darovanje krvne plazme z aferezo.
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.
Translation (en-sl): Ta vključujejo standarde za preverjanje enakovrednih standardov glede varnosti in kakovosti, ki v polovici držav članic presegajo zahteve zakonodaje EU o krvi, na primer dodatne zahteve za uporabo občutljivejšega testiranja z nukleinsko kislino (NAT), ki je zdaj na voljo kot redni presejalni test za hepatitis in HIV.
English: Additional screening and testing may reduce, but cannot completely eliminate, the possibility of a transmission from donor to recipient.
Translation (en-sl): Dodatni presejalni test in testiranje lahko zmanjšata možnost prenosa z darovalca na prejemnika, vendar je ne moreta povsem izločiti.
English: Other eligibility criteria that several countries would wish to reflect on relate to the history of malignancy, donor risk behaviour and haemoglobin levels.
Translation (en-sl): Druga merila za ustreznost, o katerih bi želelo razmisliti več držav, se nanašajo na preteklo malignost, tvegano vedenje darovalca in ravni hemoglobina.