FrancophonIA/Publications_Medical_Domain_UE huggingface dataset:
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).
Slovenian: 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.
Slovenian: 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.
Slovenian: 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.
Slovenian: 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.
Slovenian: 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.
Slovenian: 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.
Slovenian: 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.
Slovenian: 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.
Slovenian: 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.
Slovenian: 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.
Slovenian: 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.
Slovenian: 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.
Slovenian: 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.
Slovenian: 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.
Slovenian: 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.
Slovenian: 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).
Slovenian: 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.
Slovenian: 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.
Slovenian: 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.
Slovenian: 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.
Slovenian: 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).
Slovenian: 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.
Slovenian: 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.
Slovenian: 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.
Slovenian: 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.
Slovenian: 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).
Slovenian: 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.
Slovenian: 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.
Slovenian: 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.
Slovenian: 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.
Slovenian: 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.
Slovenian: 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.
Slovenian: 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.
Slovenian: 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.
Slovenian: 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.
Slovenian: 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.
Slovenian: 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.
Slovenian: 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.
Slovenian: Druga merila za ustreznost, o katerih bi želelo razmisliti več držav, se nanašajo na preteklo malignost, tvegano vedenje darovalca in ravni hemoglobina.
English: Inactivation techniques are mainly used for plasma although pathogen inactivation of platelets is likely to be more common going forward.
Slovenian: Tehnike inaktivacije se večinoma uporabljajo za krvno plazmo, čeprav bo v prihodnosti inaktivacija patogenov pri trombocitih verjetneje pogostejša.
English: Donor screening for eligibility.
Slovenian: Presejalni test darovalcev glede ustreznosti.
English: About two thirds of the countries mention that blood establishments also apply more sensitive nucleic acid testing (NAT), along with serological testing, although several countries also raised questions regarding the cost-benefit ratio of this relatively costly testing technique.
Slovenian: Približno dve tretjini držav navaja, da transfuzijske ustanove poleg serološkega testiranja uporabljajo tudi občutljivejše testiranje z nukleinsko kislino (NAT), čeprav je nekaj držav odprlo vprašanja glede stroškovne učinkovitosti te razmeroma drage tehnike testiranja.
English: Support for the Implementation of the Blood Directives
Slovenian: Podpora pri izvajanju direktiv o krvi
English: All Member States reported that the same rules on traceability apply to blood establishments and hospital blood banks, allowing tracing of blood and blood components from donor to recipient and vice versa.
Slovenian: Vse države članice poročajo, da se ista pravila o sledljivosti uporabljajo za transfuzijske ustanove in transfuzijske banke v bolnišnicah, kar omogoča sledenje krvi in komponent krvi od darovalca do prejemnika in obratno.
English: Plasma and plasma derivatives can have a longer shelf-life and as fractionation plants exist only in twelve Member States, both plasma (the starting material) and plasma derivatives (the end product) are frequently exchanged across borders, within the EU and with third (non-EU) countries.
Slovenian: Krvna plazma in derivati krvne plazme imajo lahko daljši rok uporabe, in ker obrati za frakcioniranje obstajajo samo v 12 državah članicah, se krvna plazma (vhodni material) in derivati krvne plazme (končni izdelek) pogosto prenašajo prek meja znotraj EU in s tretjimi državami (ki niso v EU).
English: Men having sex with men (MSM) is the most commonly reported sexual risk exclusion criterion due to the higher incidence of infections such as HIV within this population.
Slovenian: Spolni odnosi med moškimi je najpogosteje navedeno merilo za izključitev zaradi spolnega tveganja, ker je v tej populaciji večja pojavnost okužb, kot je HIV.
English: It is common practice to provide refreshments to donors (27 countries) and to give them small tokens such as pin badges, pens, towels, t-shirts and mugs (24 countries).
Slovenian: Običajna praksa je, da darovalci dobijo okrepčila (27 držav) in majhna darila, kot so značke, pisala, brisače, majice in skodelice (24 držav).
English: In the Eurobarometer survey on Blood and Cell and Tissue Donation, only 12% of EU citizens reported that they thought compensation additional to the costs related to donation was acceptable, when donating blood or plasma.
Slovenian: V anketi Eurobarometra o darovanju krvi, celic in tkiv je samo 12 % državljanov EU navedlo, da je nadomestilo poleg stroškov v zvezi z darovanjem sprejemljivo pri darovanju krvi ali krvne plazme.
English: Nonetheless, the voluntary reporting of SAR in donors has increased, suggesting the Member States' increasing interest in the protection of living donors.
Slovenian: Vendar se je prostovoljno poročanje o hudih neželenih reakcijah pri darovalcih kljub temu povečalo, kar kaže na povečan interes držav članic za zaščito živih darovalcev.
English: Twenty one Member States have dedicated vigilance officer(s) in place.
Slovenian: Enaindvajset držav članic ima imenovane posebne uradnike za vigilanco.
English: In half of the countries, the blood establishments either determine, or are involved in determining, the value of the compensations and incentives, while in one-third of the countries the national blood competent authorities are involved.
Slovenian: V polovici držav transfuzijske ustanove določijo vrednost nadomestil in spodbud ali pa so vključene v njihovo določanje, medtem ko so v eni tretjini držav v to vključeni nacionalni pristojni organi za kri.
English: This overarching Report is a summary, drawing from the replies to questionnaires that the Commission sent to Member States in 2012 (verification of the completeness of transposition), 2013 (implementation survey), and 2014 (implementation of the VUD principle) and follows up on the Report in 2006 and the Commission Communication in 2010, as well as on the two Reports on the application of the principle of VUD for blood and blood components issued in 2006 and 2011.
Slovenian: To krovno poročilo je povzetek, ki 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 poročilu iz leta 2006 in sporočilu Komisije iz leta 2010 ter poročiloma o uporabi načela PBD za kri in komponente krvi, izdanima leta 2006 oziroma leta 2011.
English: No additional testing was reported for plasma collection, compared with collection of whole blood donations.
Slovenian: V zvezi z zbiranjem krvne plazme ni bilo sporočeno nobeno dodatno testiranje v primerjavi z zbiranjem polne krvi.
English: Since the survey was conducted, changes in national policies have been reported by some countries during the bi-annual meetings of Competent Authorities; the trend is to move from permanent to temporary (usually 12 months) deferral for MSM.
Slovenian: Od izvedbe ankete so nekatere države na dveletnih srečanjih pristojnih organov poročale o spremembah nacionalnih politik; trend je prehajanje s trajnega odklona na začasni (običajno 12-mesečni) odklon zaradi spolnih odnosov med moškimi.
English: The VUD survey shows that Member States overall comply with Article 20 of Directive 2002/98/EC requiring them to take the necessary measures to encourage VUD.
Slovenian: Anketa o PBD je pokazala, da države članice na splošno ravnajo v skladu s členom 20 Direktive 2002/98/ES, ki zahteva, da sprejmejo potrebne ukrepe za spodbujanje prostovoljnega in brezplačnega darovanja.
English: There is diversity between Member States in organisation (e.g. desk-based versus on-site), and outcome (i.e. classification and follow-up of deficiencies) of inspections.
Slovenian: Med državami članicami obstajajo razlike glede organizacije (npr. dokumentacijski pregled v primerjavi s pregledom na kraju samem) in rezultatov (tj. razvrščanje in nadaljnje spremljanje pomanjkljivosti) inšpekcijskih pregledov.
English: Seven countries do not recover all plasma from whole blood donations for plasma fractionation into derivatives.
Slovenian: Sedem držav ne dobi nazaj vse krvne plazme v primeru darovanja polne krvi za frakcioniranje krvne plazme v derivate.
English: In conclusion, this Report reveals an overall adequate level of application of the current quality and safety requirements of the EU blood legislation.
Slovenian: To poročilo kaže, da se obstoječe zahteve glede kakovosti in varnosti iz zakonodaje EU o krvi na splošno ustrezno uporabljajo.
English: The reported picture seems not to be complete, with some inconsistencies between the information provided by countries whose citizens travel to donate and those who have donors coming from another Member State to donate.
Slovenian: Videti je, da sporočena slika ni popolna, saj obstajajo nedoslednosti med informacijami iz držav, katerih državljani dajejo kri v tujini, in tistih, v katere prispejo darovalci iz druge države članice, da bi dali kri.
English: In order to manage demand and supply of blood and blood components, almost all countries have policies in place that combine annual forecasting with weekly monitoring.
Slovenian: Skoraj vse države imajo za upravljanje povpraševanja in ponudbe krvi in komponent krvi vzpostavljene politike, ki združujejo letno napovedovanje s tedenskim spremljanjem.
English: Whole blood and blood components such as platelets and red blood cells have a limited shelf-life and are rarely exchanged between Member States, with the exception of rare emergency or humanitarian situations.
Slovenian: Polna kri in komponente krvi, kot so trombociti in eritrociti, imajo omejen rok uporabe in si jih države članice redko izmenjujejo, razen v redkih nujnih primerih ali v primeru humanitarne pomoči.
English: Safety and quality of the blood supply is an important issue for EU citizens, with 56% of respondents to the Eurobarometer survey on Blood and Cell and Tissue Donation citing the risk of contracting a disease as a major concern when accepting donated substances.
Slovenian: Varnost in kakovost dobave krvi je pomembno vprašanje za državljane EU, pri čemer je 56 % tistih, ki so ogovorili na anketo Eurobarometra o darovanju krvi, celic in tkiv, tveganje prenosa bolezni navedlo kot glavno skrb pri sprejetju darovanih snovi.
English: Where appropriate, data gathered through other channels and supporting the findings of the two surveys (e.g. exchanges with the national blood competent authorities during the bi-annual meetings with the Commission, mandatory annual reporting to the Commission of serious adverse reactions and events (SARE), alerts launched in the Rapid Alerts for Blood (RAB) platform, a study mapping the economic landscape of the sector and more recently a Eurobarometer survey as well as outputs of EU-funded projects were also taken into account.
Slovenian: Kadar je bilo to ustrezno, so bili upoštevani tudi podatki, zbrani po drugih poteh in v podporo ugotovitvam obeh anket (npr. izmenjava informacij s pristojnimi nacionalnimi organi za kri na dveletnih srečanjih s Komisijo, obvezno letno poročanje Komisiji o hudih neželenih reakcijah in dogodkih, opozorila, poslana prek platforme za hitro obveščanje o krvi (RAB), študija o ekonomskem okolju v sektorju in novejša anketa Eurobarometra ter rezultati projektov, ki jih je financirala EU).
English: While not mandatory, two-thirds of countries have put in place donor self-exclusion systems.
Slovenian: Dve tretjini držav sta vzpostavili sisteme za samoizključitev darovalca, čeprav tak sistem ni obvezen.
English: Fig. 6: Main causes leading to deferrals/country
Slovenian: Slika 6: Glavni vzroki za odklon po državah
English: A common reason for these recalls is information received from the donor regarding his/her health situation and made available after the donation event.
Slovenian: Pogost vzrok za odpoklic so informacije, ki jih darovalec predloži v zvezi s svojim zdravstvenim stanjem in ki so dane na voljo po darovanju.
English: In addition, thematic/focused inspections, inspections following SARE and desk-based assessments are organised.
Slovenian: Poleg tega so organizirani tematski/usmerjeni inšpekcijski pregledi, inšpekcijski pregledi po hudih neželenih reakcijah in dogodkih ter dokumentacijska ocenjevanja.
English: In this context, it is challenging for MS to apply a requirement for the exclusive importation of plasma sourced from voluntary and unpaid donors.
Slovenian: V teh okoliščinah države članice težko uporabijo zahtevo po izključnem uvozu krvne plazme, ki jo darovalci dajo prostovoljno in brezplačno.
English: However blood competent authorities in one third of the countries do not believe that all blood establishments are reporting SARE.
Slovenian: Vendar pristojni organi za kri v eni tretjini držav ne verjamejo, da vse transfuzijske ustanove poročajo o hudih neželenih reakcijah in dogodkih.
English: Implementation of the EU blood legislation
Slovenian: Izvajanje zakonodaje EU o krvi
English: These two areas are often cause for general alerts in the blood sector, as demonstrated since the launch of the Commission managed Rapid Alert System for Blood (RAB), where a number of alerts relating to emerging disease risks with relevance to blood donor selection or testing and to medical device defects that were important in blood collection or processing were shared among the national blood competent authorities.
Slovenian: Ti dve področji sta pogosto vzrok za splošni preplah v sektorju krvi, kot se je pokazalo od uvedbe sistema za hitro obveščanje o krvi (RAB), ki ga upravlja Komisija in v okviru katerega so si nacionalni pristojni organi za kri izmenjali več opozoril v zvezi s nevarnostmi nastajajočih bolezni, pomembnih pri izbiri krvodajalcev ali njihovem testiranju, ter v zvezi z okvarami medicinskih pripomočkov, pomembnih pri zbiranju ali predelavi krvi.
English: Five countries reported having donations by donors from abroad, while six countries reported having citizens that travel to donate abroad.
Slovenian: Pet držav je poročalo, da so pri njih kri dali darovalci iz tujine, šest pa jih je poročalo o državljanih, ki dajejo kri v tujini.
English: Notification of serious adverse reactions and events (SARE).
Slovenian: Obveščanje o hudih neželenih reakcijah in dogodkih.
English: All Member States except Hungary reported having a SARE notification system in place, in the majority of them based on the practical guidance developed in co-operation with the Member States for the compilation of the online annual SARE report.
Slovenian: Vse države članice, razen Madžarske, so poročale, da imajo vzpostavljen sistem za obveščanje o hudih neželenih reakcijah in dogodkih, večinoma na podlagi praktičnih navodil, oblikovanih v sodelovanju z državami članicami, za pripravo spletnega letnega poročila o hudih neželenih reakcijah in dogodkih.
English: Transposition of EU Blood legislation
Slovenian: Prenos zakonodaje EU o krvi
English: The difference in purchasing power between Member States might be one factor which explains the diverging views on what is or is not an incentive to donate.
Slovenian: Eden od dejavnikov, ki pojasnjuje različna mnenja o tem, kaj je in kaj ni spodbuda za darovanje, je lahko razlika v kupni moči med državami članicami.
English: Levels of inspector empowerment and training were regularly commented upon in the replies to the implementation survey.
Slovenian: V odgovorih na anketo o izvajanju so bile redno navedene pripombe o stopnjah pooblastitve in usposabljanja inšpektorjev.
English: [8: http://ec.europa.eu/health/blood_tissues_organs/docs/20150408_cc_report_en.pdf;http://ec.europa.eu/health/blood_tissues_organs/docs/20150408_key_findings_cc_en.pdfhttp://ec.europa.eu/health/blood_tissues_organs/eurobarometers/eb822_en.htm]
Slovenian: [8: http://ec.europa.eu/health/blood_tissues_organs/docs/20150408_cc_report_en.pdf;http://ec.europa.eu/health/blood_tissues_organs/docs/20150408_key_findings_cc_en.pdf;http://ec.europa.eu/health/blood_tissues_organs/eurobarometers/eb822_en.htm.]
English: [1: Detailed Member State replies (as well as replies from Norway and Liechtenstein) can be accessed at: http://ec.europa.eu/health/blood_tissues_organs/key_documents/][2: In a number of cases clarification requests were sent to Member States for verification.
Slovenian: [1: Podrobni odgovori držav članic (ter odgovori Norveške in Lihtenštajna) so na voljo na: http://ec.europa.eu/health/blood_tissues_organs/key_documents/.
English: In addition to providing regular updates during the bi-annual meeting of the blood expert sub-group on the epidemiological situation relevant to the blood sector, the development of risk assessments (e.g. for HTLV, malaria, dengue and chikungunya) and preparedness plans (e.g. for WNV outbreaks) provide a valuable contribution to policy and decision making in this sector at both national and EU level.
Slovenian: Razvoj ocenjevanja tveganja (npr. za HTLV, malarijo, dengo in čikungunjo) in načrtov pripravljenosti (npr. za izbruhe virusa zahodnega Nila) je, poleg tega da je zagotovil redno obveščanje o epidemioloških razmerah v zvezi s sektorjem krvi na dveletnih srečanjih strokovne podskupine za kri, dragoceno prispeval k oblikovanju politik in sprejemanju odločitev v tem sektorju na nacionalni ravni in ravni EU.
English: Fig. 3: Percentage of reporting blood establishments/country
Slovenian: Slika 3: Delež transfuzijskih ustanov poročevalk po državah
English: ][3: http://ec.europa.eu/health/blood_tissues_organs/docs/blood_reportdonation_en.pdf][4: http://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:52010DC0003][5: http://ec.europa.eu/health/ph_threats/human_substance/documents/blood_com_0217_en.pdf][6: http://ec.europa.eu/health/blood_tissues_organs/docs/blood_reportdonation_en.pdf]
Slovenian: ][3: http://ec.europa.eu/health/blood_tissues_organs/docs/blood_reportdonation_sl.pdf][4: http://eur-lex.europa.eu/legal-content/SL/ALL/?uri=CELEX:52010DC0003.
English: Clarification of the operational rules on reporting SARE at EU level would be perceived as helpful by Member State haemovigilance experts.
Slovenian: Strokovnjaki držav članic za hemovigilanco bi razjasnitev operativnih pravil o poročanju hudih neželenih reakcij in dogodkov šteli za koristno.
English: The Commission is closely following this case.
Slovenian: Komisija to pozorno spremlja.
English: In any event, the number of penalties imposed is very low.
Slovenian: Vsekakor je število naloženih kazni zelo majhno.
English: These are of particular importance given the numerous technological developments in the field in recent years.
Slovenian: Te so zlasti pomembne glede na obsežen tehnološki razvoj na tem področju v zadnjih letih.
English: Obligations of Member State competent authorities
Slovenian: Obveznosti pristojnih organov držav članic
English: [11: Case C-29/14, judgment pronounced on 11 June 2015.
Slovenian: [11: Zadeva C-29/14, sodba razglašena 11. junija 2015.
English: It was also suggested that the full list of these more stringent requirements could be made available by the Commission.
Slovenian: Predlagano je bilo tudi, da bi lahko Komisija dala na voljo celoten seznam teh strožjih zahtev.
English: Concerning joint inspections by authorities from more than one Member State, a small number have been organised in recent years.
Slovenian: Kar zadeva skupne inšpekcijske preglede organov iz več kot ene države članice, jih je bilo v zadnjih letih organiziranih manjše število.
English: Quality management, responsible person and personnel.
Slovenian: Upravljanje kakovosti, odgovorna oseba in osebje.
English: The gaps and difficulties identified suggest that a further in-depth evaluation might be useful.
Slovenian: Ugotovljene vrzeli in težave kažejo, da bi lahko bila koristna nadaljnja podrobnejša ocena.
English: No problems were reported regarding the implementation of the provisions related to data protection.
Slovenian: V zvezi z izvajanjem določb o varstvu podatkov ni bilo sporočenih nobenih težav.
English: Significant progress has been made in many areas, also through the active support by Commission funded projects and other initiatives.
Slovenian: Na številnih področjih je napredek znaten, tudi zaradi dejavne podpore projektov, ki jih financira Komisija, in drugih pobud.
English: Other practices include compensation for the inconveniences related to the donation.
Slovenian: Druge prakse vključujejo nadomestilo za neprijetnosti v zvezi z darovanjem.
English: The application of selection criteria should be transparent and subject to continuous evaluation in order to minimize safety risks.
Slovenian: Uporaba meril za izbor bi morala biti pregledna in predmet stalnega vrednotenja, da se čim bolj zmanjšajo varnostna tveganja.
English: Designation of competent authority or authorities responsible for the implementation of Directive 2004/23/EC
Slovenian: Imenovanje pristojnega organa ali organov, odgovornih za izvajanje Direktive 2004/23/ES
English: Another important issue highlighted by some Member States was the need to foster harmonisation of the inspection practices in the Member States.
Slovenian: Še eno pomembno vprašanje, na katero so opozorile nekatere države članice, je bila potreba po spodbujanju usklajevanja inšpekcijskih praks v državah članicah.
English: Penalties.
Slovenian: Kazni.
English: More generally speaking, it was difficult to assess how divisions of tasks impacts oversight of the sector, especially as some of the national competent authorities did not provide precise/complete information.
Slovenian: Splošneje je bilo težko oceniti, kako razdelitev nalog vpliva na nadzor nad sektorjem, zlasti ker nekateri nacionalni pristojni organi niso predložili natančnih/popolnih informacij.
English: In some Member States the sector is fully controlled by public organisations, whilst in others private operators make a significant contribution (Fig. 5).
Slovenian: V nekaterih državah članicah sektor v celoti obvladujejo javne organizacije, v drugih pa znatno prispevajo zasebni subjekti (slika 5).
English: Donor testing.
Slovenian: Testiranje darovalcev.
English: Consent, data protection and confidentiality.
Slovenian: Soglasje, varstvo podatkov in zaupnost.
English: The survey confirmed that this core responsibility of competent authorities is well implemented across the Union.
Slovenian: Anketa je potrdila, da se ta ključna odgovornost pristojnih organov dobro izvaja po vsej Uniji.
English: As a consequence, pursuant to Article 258 TFEU, the Commission has brought action against one Member State to the Court of Justice, and launched an infringement proceeding against another Member State, which is ongoing.
Slovenian: Zato je Komisija v skladu s členom 258 PDEU zoper eno državo članico vložila tožbo na Sodišču, zoper drugo pa sprožila postopek za ugotavljanje kršitev, ki še poteka.
English: However, the ways in which Member States have implemented the principle of VUD are difficult to assess in a comprehensive manner.
Slovenian: Vendar je načine, na katere države članice izvajajo načelo PBD, težko celovito oceniti.
English: The penalties foreseen in national legislation, their criteria for implementation and their effective implementation can differ significantly between Member States.
Slovenian: Kazni, predvidene v nacionalni zakonodaji, merila za njihovo izvajanje in učinkovitost njihovega izvajanja se lahko znatno razlikujejo med državami članicami.
English: It has to be highlighted that, irrespective of the organisational set up in each country, it is important that authorities have appropriate resources at their disposal in order to ensure their independence from economic operators, in the sector and from other influences.
Slovenian: Poudariti je treba, da je ne glede na organizacijsko strukturo v posamezni državi pomembno, da imajo organi na voljo ustrezne vire za zagotovitev svoje neodvisnosti od gospodarskih subjektov v sektorju in od drugih vplivov.
English: The high number of procurement organisations shows that this activity is well developed across the Union.
Slovenian: Veliko število organizacij za pridobivanje kaže, da je ta dejavnost dobro razvita po vsej Uniji.
English: However, Member States interpretation of what is considered compensation and incentive vary.
Slovenian: Vendar se razlage držav članic, kaj se šteje za nadomestilo in spodbudo, razlikujejo.
English: Even though only trained personnel are allowed to provide appropriate information to donors, this information has been standardised at national level in a small number of countries.
Slovenian: Čeprav lahko samo usposobljeno osebje darovalcem zagotovi ustrezne informacije, so bile te informacije na nacionalni ravni standardizirane le v majhnem številu držav.
English: There is no harmonisation in defining or applying such penalties, therefore it is difficult to evaluate whether similar measures are applied by all the Member States in case of a specific breach of the legislation in this area.
Slovenian: Opredelitev in uporaba takih kazni nista usklajeni, zato je težko oceniti, ali vse države članice uporabljajo podobne ukrepe v primeru specifične kršitve zakonodaje na tem področju.
English: The differences in purchasing power between Member States might also explain why a measure is considered a "compensation" in one country and an "incentive" in another.
Slovenian: Tudi razlike v kupni moči med državami članicami lahko pojasnijo, zakaj se nek ukrep v eni državi šteje za „nadomestilo", v drugi pa za „spodbudo".
English: The importance of inspections was highlighted again in the context of compliance with the requirements in the Directive 2006/86/EC, as the most frequent approach to verify their implementation.
Slovenian: Pomen inšpekcijskih pregledov je bil znova poudarjen v okviru izpolnjevanja zahtev Direktive 2006/86/ES kot najpogostejši pristop k preverjanju izvajanja.
English: It should be highlighted that several Member States indicated that there is no national legal requirement for organising national follow-up registries for living donors.
Slovenian: Poudariti je treba, da je več držav članic navedlo, da ni nacionalne zakonske zahteve po organizaciji nacionalnih registrov za nadaljnje spremljanje za žive darovalce.
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.
Slovenian: Poudariti je treba, da je PBD dejavnik, ki ni zgolj etičen, temveč lahko prispeva tudi k višjim varnostnim standardom v zvezi s tkivi in celicami ter s tem k varstvu zdravja ljudi.
English: Although the principle of VUD is mandatory in the large majority of the Member States, its concrete application varies across the Union.
Slovenian: Čeprav je načelo PBD obvezno v veliki večini držav članic, se njegova dejanska uporaba po Uniji razlikuje.
English: However, some difficulties in interpretation, implementation and enforcement of the legislation have been identified, which in some cases could be explained by the scientific and technological advances since its adoption.
Slovenian: Vendar je bilo ugotovljenih nekaj težav pri razlagi, izvajanju in izvrševanju zakonodaje, ki jih je mogoče v nekaterih primerih pojasniti z znanstvenim in tehnološkim napredkom od njenega sprejetja.
English: Concerning donor anonymity, most countries rely on the EU and national data protection legislation, but also on coding.
Slovenian: V zvezi z anonimnostjo darovalca se večina držav opira na zakonodajo EU in nacionalno zakonodajo o varstvu podatkov, pa tudi na kodiranje.
English: The Commission will consider the need for an evaluation in order to assess the relevance, effectiveness, efficiency, coherence and the EU added value of Directive 2004/23/EC and its implementing Directives.
Slovenian: Komisija bo razmislila o potrebi po ocenjevanju za ovrednotenje ustreznosti, učinkovitosti, uspešnosti, skladnosti in dodane vrednosti EU Direktive 2004/23/ES in njenih izvedbenih direktiv.
English: Their outcome was in general satisfying and in particular allowed bringing expertise where this might be missing within the own Member State.
Slovenian: Njihovi rezultati so bili na splošno zadovoljivi in omogočali so zlasti uporabo strokovnega znanja, ki morda ne bi bilo na voljo v eni sami državi članici.
English: The large majority of the responding countries (28) reported that the principle of VUD is mandatory at national level.
Slovenian: Velika večina držav, ki so se odzvale (28), je poročala, da je načelo PBD obvezno na nacionalni ravni.
English: A majority also supported European legislation to ensure the safety and quality of blood, tissues and cells.
Slovenian: Večina je tudi podprla evropsko zakonodajo za zagotavljanje varnosti in kakovosti krvi, tkiv in celic.
English: Wherever accreditation and inspections are undertaken by different authorities, a good communication and coordination between respective authorities needs to be ensured.
Slovenian: Kadar akreditacijo in inšpekcijske preglede izvajajo različni organi, je treba zagotoviti dobro komunikacijo in usklajevanje med zadevnimi organi.
English: These consist mainly in providing administrative support for the funeral and ensuring full or partial coverage of the cost of the funeral/burial/cremation.
Slovenian: Večinoma zagotavljajo upravno podporo glede pogrebnih storitev in zagotavljajo celotno ali delno kritje stroškov pogreba/pokopa/upepelitve.
English: At the end of 2011, 2047 tissue establishments were authorised in the EU, showing an almost 20% increase compared to the 2008 data (Fig. 4).
Slovenian: Konec leta 2011 je bilo v EU odobrenih 2 047 ustanov za tkiva in celice, kar je bilo skoraj 20-odstotno povečanje v primerjavi s podatki za leto 2008 (slika 4).
English: If donor payment were allowed, some individuals could find the monetary remuneration so important that they might hide relevant medical and/or behavioural information.
Slovenian: Če bi bilo plačevanje darovalcem dovoljeno, bi bila lahko za nekatere denarna nagrada tako pomembna, da bi lahko prikrili pomembne zdravstvene in/ali vedenjske informacije.
English: The European Commission has been supporting the implementation of the legislation by the Member States by encouraging the active participation of national Competent Authorities in a series of actions, from bi-annual expert group meetings to EU-funded projects.
Slovenian: Evropska komisija podpira izvajanje zakonodaje s strani držav članic, tako da spodbuja dejavno sodelovanje nacionalnih pristojnih organov v več dejavnostih, od dveletnih srečanj strokovne skupine do projektov, ki jih financira EU.
English: Another Member State and one EEA country have not yet defined national provisions on the application of the VUD principle.
Slovenian: Druga država članica in ena država EGP še nista opredelili nacionalnih določb o uporabi načela PBD.
English: This may also explain why some Member States have not put in place a coherent policy to ensure national sufficiency at least for some type of tissues or cells.
Slovenian: S tem je mogoče tudi pojasniti, zakaj nekatere države članice niso vzpostavile usklajene politike za zagotavljanje nacionalne zadostnosti vsaj za nekatere vrste tkiv ali celic.
English: Several Member States suggested that a common list of diagnostic tests (panel) for some genetic diseases may be valuable for increasing safety in the EU ART sector.
Slovenian: Več držav članic je predlagalo, da bi skupni seznam diagnostičnih testov (panel) za nekatere genske bolezni lahko bil koristen za povečanje varnosti v sektorju OBMP UE.
English: Therefore information provided by the donor or his/her family contributes to an accurate assessment of all risks associated to the application of donated tissues or cells.
Slovenian: Zato informacije, ki jih predloži darovalec ali njegova družina, prispevajo k točni oceni vseh tveganj v zvezi z uporabo darovanih tkiv ali celic.
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.
Slovenian: Komisija mora na podlagi teh nacionalnih poročil poročati Evropskemu parlamentu in Svetu ter ju obvestiti o morebitnih nadaljnjih potrebnih ukrepih v zvezi s PBD, ki jih namerava sprejeti na ravni Unije.
English: The overall aim of the annual reporting, to identify the most frequent causes of SARE and provide appropriate corrective measures, has not yet been fully achieved.
Slovenian: Splošni cilj letnega poročanja, tj. določiti najpogostejše vzroke za hude neželene reakcije in dogodke ter zagotoviti ustrezne korektivne ukrepe, še ni bil v celoti dosežen.