FrancophonIA/Publications_Medical_Domain_UE huggingface dataset:
English: This may suggest a role for the EU in supporting Member States to develop national sufficiency policies although the exact impact of such policies on cross-border exchanges and the supply of starting materials for medicinal product manufacture would need to be carefully analysed.
Slovenian: To lahko kaže na vlogo EU pri podpori državam članicam za razvoj politik nacionalne zadostnosti, čeprav je treba natančno analizirati točen vpliv takih politik na čezmejne izmenjave in dobavo vhodnih snovi za proizvodnjo zdravil.
English: Most Member States allow compensation to be offered to living donors (22 countries for living donors of non-reproductive tissues and cells; 17 countries for donors of reproductive cells).
Slovenian: Večina držav članic dovoljuje, da se živim darovalcem ponudi nadomestilo (22 držav živim darovalcem nereproduktivnih tkiv in celic; 17 držav darovalcem reproduktivnih celic).
English: Only in a small number of Member States is the value of the compensation provided to tissue and cell donors connected to national economic indicators (e.g. monthly income, purchasing capacity).
Slovenian: Samo v majhnem številu držav članic je vrednost nadomestila za darovalce tkiv in celic povezana z nacionalnimi gospodarskimi kazalniki (npr. mesečni dohodek, kupna moč).
English: Diverse practices related to the implementation of the requirements of Article 4 of Directive 2006/86/EC were reported.
Slovenian: Sporočene so bile različne prakse v zvezi z izvajanjem zahtev iz člena 4 Direktive 2006/86/ES.
English: The implementation survey was answered by all Member States except Greece, and also by two EEA countries, Liechtenstein and Norway.
Slovenian: Na anketo o izvajanju so odgovorile vse države članice, razen Grčije, in dve državi EGP, in sicer Lihtenštajn in Norveška.
English: It was underlined that Member States introducing more stringent safety and quality requirements should inform the other Member States and EEA countries, as well as the Commission, regarding these measures, in a transparent manner.
Slovenian: Poudarjeno je bilo, da bi morale države članice, ki uvedejo strožje zahteve glede varnosti in kakovosti, na pregleden način obvestiti druge države članice in države EGP ter Komisijo o takih ukrepih.
English: Since 2003, a number of projects have been funded under the multi-annual programmes for Union action in the field of health addressing the area of human tissue and cells for clinical application.
Slovenian: Od leta 2003 je bilo financiranih več projektov v okviru večletnih programov za ukrepanje Unije na področju zdravja, ki so se nanašali na človeško tkivo in celice za klinično uporabo.
English: It has to be underlined that countries which reported difficulties in implementing the donation identification system were either developing a central allocation system for identifiers or were waiting for the adoption of the implementing legislation introducing a Single European Code for tissues and cells.
Slovenian: Poudariti je treba, da so države, ki so poročale o težavah pri vzpostavljanju sistema za identifikacijo darovanj, razvijale centralni sistem dodeljevanja za identifikatorje ali čakale na sprejetje izvedbene zakonodaje o uvedbi enotne evropske kode za tkiva in celice.
English: The Commission is also required to provide the European Parliament and the Council with an overview report on the implementation of the requirements of the Directive, in particular as regards inspections and monitoring.
Slovenian: Evropskemu parlamentu in Svetu mora predložiti tudi pregledno poročilo o izvajanju zahtev Direktive, zlasti glede inšpekcijske in kontrolnih ukrepov.
English: On the basis of the information collected, the Commission will follow up with the Member States in order to promote, where desirable, a common understanding of Article 12 in the Directive 2004/23/EC.
Slovenian: Komisija bo na podlagi zbranih informacij spremljala države članice za spodbujanje, kadar je to zaželeno, enotnega razumevanja člena 12 Direktive 2004/23/ES.
English: Reimbursement of costs linked to travel and medication based on actual costs/receipts are among the most commonly used type of compensation for living donors.
Slovenian: Povračila stroškov v zvezi s potovanjem in zdravili na podlagi dejanskih stroškov/potrdil so med najpogostejšimi vrstami nadomestil za žive darovalce.
English: It is also interesting to highlight the split between private and public ownership of tissue establishments.
Slovenian: Zanimivo je tudi opozoriti na vrzel med zasebnim in javnim lastništvom ustanov za tkiva in celice.
English: Article 26 of Directive 2004/23/EC requires Member States to submit to the European Commission, before 7 April 2009 and every three years thereafter, a report on the activities carried out in relation to the provisions of the Directive, including an account of the measures taken in relation to inspection and control.
Slovenian: V skladu s členom 26 Direktive 2004/23/ES morajo države članice pred 7. aprilom 2009 in nato vsaka tri leta Evropski komisiji predložiti poročilo o dejavnostih, ki se izvajajo v zvezi z določbami navedene direktive, skupaj s poročilom o ukrepih, sprejetih v zvezi z inšpekcijskim nadzorom in kontrolo.
English: These differences facilitate successful integration of the requirements into national legislation but in some cases they may limit the mutual acceptance of authorisations with consequences on the cross-border movement of tissues and cells.
Slovenian: Te razlike omogočajo uspešno vključitev zahtev v nacionalno zakonodajo, vendar lahko v nekaterih primerih omejijo vzajemno priznavanje odobritev, kar pomeni posledice za čezmejni prenos tkiv in celic.
English: Donor selection and evaluation
Slovenian: Izbiranje in vrednotenje darovalcev
English: Additional tests required by Member States are usually justified for local reasons, like e.g. the increased prevalence of a certain infectious disease.
Slovenian: Dodatni testi, ki jih zahtevajo države članice, so običajno utemeljeni zaradi lokalnih dejavnikov, kot je večja prevalenca neke nalezljive bolezni.
English: To facilitate good regulatory communication between Member States, as well as to comply with the annual reporting requirements to the Commission, a well-informed national coordinating contact is essential, even where responsibilities of national competent authorities are shared among multiple organisations or regions.
Slovenian: Za dobro ureditveno komunikacijo med državami članicami in izpolnjevanje zahtev po letnem poročanju Komisiji je bistvena dobro obveščena nacionalna usklajevalna kontaktna točka, tudi če so odgovornosti pristojnih nacionalnih organov razdeljene na več organizacij ali regij.
English: Overall, the implementation of the EU tissues and cells legislation by the Member States is considered adequate and the legislation has resulted in the establishment of a network of competent authorities that oversee the sector through authorisation, inspection, and vigilance.
Slovenian: Na splošno se izvajanje zakonodaje EU o tkivih in celicah šteje za ustrezno, zaradi zakonodaje pa je bila vzpostavljena mreža pristojnih organov, ki sektor nadzorujejo z odobritvami, inšpekcijo in vigilanco.
English: This may suggest that tissue establishments are striving to comply with the EU quality and safety requirements, but it may also indicate under-enforcement, e.g. in countries which have never reported any shortcomings.
Slovenian: To lahko pomeni, da si ustanove za tkiva in celice prizadevajo izpolniti zahteve EU glede kakovosti in varnosti, vendar lahko pomeni tudi nezadostno izvrševanje zakonodaje, na primer v državah, ki nikoli niso poročale o pomanjkljivostih.
English: In this context, the new requirements on the application of the Single European Code for tissues and cells laid down in Directive (EU) 2015/565 may be considered an additional tool for ensuring that donor data are not disclosed to the recipient14.
Slovenian: V tem okviru se lahko nove zahteve glede uporabe enotne evropske kode za tkiva in celice iz Direktive (EU) 2015/565 štejejo za dodatno orodje za zagotavljanje, da se podatki o darovalcu ne razkrijejo prejemniku14.
English: In 2015 the MS concerned has adopted new legislation for the ART sector and is in process of implementing it.]
Slovenian: Leta 2015 je zadevna država članica sprejela novo zakonodajo za sektor oploditve z biomedicinsko pomočjo (OBMP) in jo zdaj izvaja.]
English: Projects such as EUSTITE, EuroGTP, SOHO V&S, and the on-going joint actions ARTHIQS and VISTART have provided a strong support to Member States in their efforts to implement the requirements of the EU tissue and cell legislation.
Slovenian: Projekti, kot so EUSTITE, EuroGTP, SOHO V&S in trenutna skupna ukrepa ARTHIQS in VISTART, so bili v veliko oporo državam članicam pri prizadevanjih za izvajanje zahtev zakonodaje EU o tkivih in celicah.
English: As the EU legislation in the tissue and cell does not provide a basis for full harmonisation and as Directives allow the Member States a certain degree of discretion as to how to ensure their implementation, there are accordingly many differences between Member States in the approaches they have taken to implementation.
Slovenian: Ker zakonodaja EU o tkivih in celicah ne daje podlage za popolno uskladitev in ker direktive državam članicam dopuščajo določeno stopnjo proste presoje glede tega, kako zagotoviti njihovo izvajanje, med državami članicami obstajajo številne razlike v pristopih k izvajanju.
English: However, one Member State who reported that the VUD principle is mandatory indicated that payment of gamete donors is allowed at national level.
Slovenian: Vendar je ena država, ki je poročala, da je načelo PBD obvezno, navedla, da je plačilo darovalcem gamet dovoljeno na nacionalni ravni.
English: All reporting Member States have appointed competent authorities for tissues and cells.
Slovenian: Vse države članice poročevalke so imenovale pristojne organe za tkiva in celice.
English: Only 17 Member States reported having guiding principles regarding the possibility to compensate tissue and cell donors, but in many cases these principles were just a description of the practices allowed at national level.
Slovenian: Samo 17 držav članic je poročalo, da imajo vzpostavljena vodilna načela glede možnosti nadomestila za darovalce tkiv in celic, vendar so v številnih primerih ta načela samo opis praks, ki so dovoljene na nacionalni ravni.
English: (Total POs = 4825; 2011 data)
Slovenian: (skupno število organizacij za pridobivanje = 4 825; podatki za leto 2011)
English: Some mixed models have emerged where, for example, the private sector may take the role of a third party for processing or storage, with all donation, promotion and distribution activities remaining in public hands.
Slovenian: Nastalo je nekaj mešanih modelov, pri katerih lahko ima zasebni sektor na primer vlogo tretje strani za predelavo ali hranjenje, dejavnosti darovanja, promocije in razdeljevanja pa ostajajo v javnih rokah.
English: In this respect, it should be highlighted that the new Directive (EU) 2015/566 provides for the harmonisation of the minimum requirements in terms of contents of written agreements between importing tissue establishments and their third country suppliers.
Slovenian: V zvezi s tem je treba poudariti, da nova Direktiva (EU) 2015/566 določa uskladitev minimalnih zahtev glede vsebine pisnih sporazumov med ustanovami uvoznicami za tkiva in celice in njihovimi dobavitelji iz tretjih držav.
English: One concern raised during national tissue and cell competent authorities meetings was direct distribution of gametes (i.e. sperm) to individuals for self-application without the involvement of a health professional.
Slovenian: Ena od skrbi, ki so jih nacionalni pristojni organi za tkiva in celice izrazili na srečanjih, je bilo neposredno razdeljevanje gamet (tj. sperme) posameznicam za samouporabo brez sodelovanja zdravstvenih delavcev.
English: Overall, the survey showed that regardless of the consent system, all responding countries have put measures in place for verifying donor consent.
Slovenian: Na splošno je anketa pokazala, da so vse države, ki so se odzvale, ne glede na sistem soglasij sprejele ukrepe za preverjanje soglasja darovalca.
English: It is noted that an additional support on training of tissue establishment personnel was given through EU-funded projects such as European Quality System for Tissue Banking (EQSTB) and European Good Tissue Practices (EuroGTPs).
Slovenian: Opozoriti je treba, da je bila dodatna podpora usposabljanju osebja ustanov za tkiva in celice zagotovljena s projekti, ki jih financira EU, kot sta evropski sistem kakovosti za shranjevanje tkiv (European Quality System for Tissue Banking, EQSTB) in evropske dobre prakse v zvezi s tkivi (European Good Tissue Practices, EuroGTPs).
English: A verification of the completeness of transposition into national legislation has been carried out by the Commission and demonstrated that the EU tissues and cells legislation is fully transposed into national legislation in all but two Member (which have failed to fully transpose the requirements of the Directives for reproductive cells).
Slovenian: Preverjanje popolnosti prenosa v nacionalno zakonodajo, ki ga je izvedla Komisija, je pokazalo, da je zakonodaja EU o tkivih in celicah v celoti prenesena v nacionalno zakonodajo v vseh državah članicah, razen v dveh (ki nista v celoti prenesli zahtev direktiv glede reproduktivnih celic).
English: There is a need to find the most appropriate solutions to ensure both the respect of the Article 12 of Directive 2004/23/EC and an adequate supply of tissues and cells to the patients in need across the Union.
Slovenian: Poiskati je treba najustreznejše rešitve za zagotovitev skladnosti s členom 12 Direktive 2004/23/ES ter zadostno preskrbo tkiv in celic pacientom, ki jih potrebujejo, po vsej Uniji.
English: However, the report points to some gaps and difficulties in relation to the application and enforcement of the existing provisions (e.g. definitions, requirements on the safety aspects regarding living donors, inspections framework), some of them owing to the different approaches taken by the Member States when transposing and implementing the current EU legislation and others due to the scientific and technologic developments since the adoption of the Directives.
Slovenian: Vendar poročilo kaže na nekatere vrzeli in težave v zvezi z uporabo in izvrševanjem obstoječih določb (npr. opredelitve, zahteve glede varnostnih vidikov v zvezi z živimi darovalci, okvir inšpekcijskih pregledov), pri čemer so nekatere posledica različnih pristopov držav članic pri prenosu in izvajanju sedanje zakonodaje EU, druge pa znanstvenega in tehnološkega razvoja od sprejetja direktiv.
English: The data provided, even though incomplete and sometimes not precisely defined, confirm that increasing volumes of human tissues and cells are imported from or exported to third countries (Fig. 7).
Slovenian: Poslani podatki, čeprav nepopolni in ponekod nenatančno opredeljeni, potrjujejo, da se iz tretjih držav uvažajo in vanje izvažajo vse večje količine človeških tkiv in celic (slika 7).
English: As regards the risk of transmission of communicable diseases thorough tissues and cells, the collaboration with ECDC proved extremely valuable.
Slovenian: Kar zadeva tveganje prenosa nalezljivih bolezni prek tkiv in celic, se je sodelovanje z Evropskim centrom za preprečevanje in obvladovanje bolezni (ECDC) izkazalo za izredno dragoceno.
English: However, the tissue establishment reports are not always publicly available, mainly due to different interpretations of this provision by the Member States authorities.
Slovenian: 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.
Slovenian: 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.
Slovenian: 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.
Slovenian: 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.
Slovenian: 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.
Slovenian: 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.
Slovenian: 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.
Slovenian: 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.
Slovenian: 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.
Slovenian: 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.
Slovenian: 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.
Slovenian: 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.
Slovenian: 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).
Slovenian: 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.
Slovenian: 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
Slovenian: 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.
Slovenian: 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.
Slovenian: 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.
Slovenian: 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.
Slovenian: 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.
Slovenian: 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
Slovenian: 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.
Slovenian: 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.
Slovenian: 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.
Slovenian: 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.
Slovenian: 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.
Slovenian: 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).
Slovenian: 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.
Slovenian: 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.
Slovenian: 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.
Slovenian: 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.
Slovenian: 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.
Slovenian: 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.
Slovenian: 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.
Slovenian: 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.
Slovenian: 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).
Slovenian: 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.
Slovenian: 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.
Slovenian: 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
Slovenian: 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.
Slovenian: 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.
Slovenian: 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.
Slovenian: 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).
Slovenian: 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.
Slovenian: 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.
Slovenian: 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.
English: The competent authorities allowing such practices were requested to evaluate if and/or how traceability and reporting requirements are ensured by the tissue establishments distributing gametes to individuals and to take the necessary measures in case such practices do not fulfil the safety and quality requirements laid down in the EU tissue and cell legislation.
Slovenian: Od pristojnih organov, ki take prakse dovoljujejo, se je zahtevalo, naj ocenijo, če in/ali kako ustanove za tkiva in celice, ki razdeljujejo gamete posameznicam, zagotavljajo izpolnjevanje zahtev glede sledljivosti in poročanja, ter sprejmejo potrebne ukrepe, če take prakse ne izpolnjujejo zahtev glede varnosti in kakovosti iz zakonodaje EU o tkivih in celicah.
English: Even though most respondents confirmed respecting the required 2-year interval between inspections, some Member States suggested that prioritising inspections based on factors like the size of establishment, range of activity, experience of inspectors and compliance history may prove valuable especially in a period when financial constraints have a considerable influence on the staffing of departments in charge of inspections.
Slovenian: Čeprav je večina anketirancev potrdila, da upoštevajo zahtevano dveletno obdobje med inšpekcijskimi pregledi, je nekaj držav članic predlagalo, da je lahko koristno določiti prednostni vrstni red inšpekcijskih pregledov glede na dejavnike, kot so velikost ustanove, razpon dejavnosti, izkušnje inšpektorjev in izpolnjevanje zakonskih obveznosti v preteklosti, zlasti v obdobju, ko finančne omejitve znatno vplivajo na kadrovske zmogljivosti oddelkov, odgovornih za inšpekcijske preglede.
English: As underlined by several national competent authorities, a more harmonised procedure for the accreditation, designation, authorisation or licensing of tissue establishments would foster mutual trust and acceptance between Member States which are essential for ensuring a prompt supply of tissues and cells to the patients in need for the cases in which tissues and cells are distributed from another Member State than the one where the patient is treated.
Slovenian: Kot je poudarilo več nacionalnih pristojnih organov, bi bolj usklajen postopek akreditacije, imenovanja, odobritve ali izdaje dovoljenja ustanovam za tkiva in celice spodbudil vzajemno zaupanje in sprejemanje med državami članicami, ki sta bistvena za zagotavljanje hitre dostave tkiv in celic pacientom, ki jih potrebujejo, kadar tkiva in celice prihajajo iz druge države članice, ki ni tista, v kateri se pacient zdravi.
English: The fact that third parties may be involved in all steps of the chain from donation and procurement to distribution in most Member States highlights the importance that needs to be given to the written agreements established by tissue establishments and their verification by the national competent authorities.
Slovenian: Dejstvo, da so lahko v večini držav članic v vse stopnje v verigi od darovanja in pridobivanja do razdeljevanja vključene tretje osebe, poudarja pomen, ki ga je treba dati pisnim sporazumom z ustanovami za tkiva in celice ter njihovemu preverjanju s strani nacionalnih pristojnih organov.
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 delovna dokumenta služb Komisije, priložena temu poročilu.
English: However, it has to be noted that, as for import and export, data collected by the Member States probably serve different purposes and use various methodologies, so it is very difficult to draw a clear conclusion on the importance of EU distribution compared to import/export from/to third countries and therefore to evaluate tissue and cell sufficiency at EU level.
Slovenian: Vendar je treba opozoriti, da se podatki, ki so jih države članice zbrale v zvezi z uvozom in izvozom, verjetno uporabljajo za različne namene in da se zanje uporabljajo različne metodologije, zato je zelo težko oblikovati jasen sklep glede pomena razdeljevanja v EU v primerjavi z uvozom v tretje države in izvozom iz njih ter ovrednotiti zadostnost glede tkiv in celic na ravni EU.
English: Accreditation, designation, authorisation or licensing of tissue establishments.
Slovenian: Akreditacija, imenovanje, odobritev ali izdajanje dovoljenj ustanovam za tkiva in celice.
English: Concerning the number of competent authorities, in some Member States only one authority is responsible for the oversight of the tissue and cell sector, whereas in other countries the tasks are divided amongst two or three authorities (based either on type of tissues and cells or on duties e.g. accreditation/authorisation v. inspections/vigilance or the allocation of tasks between federal and regional levels).
Slovenian: Kar zadeva število pristojnih organov, je v nekaterih državah članicah samo en organ odgovoren za nadzor nad sektorjem tkiv in celic, v drugih pa so naloge razdeljene med dva ali tri organe (glede na vrsto tkiv in celic ali glede na naloge, npr. akreditacija/odobritev v primerjavi z inšpekcijskimi pregledi/vigilanco, ali glede na razdelitev nalog med zvezno in regionalno ravnjo).
English: In relation to the supply-demand balance, 17 Member States and one EEA country reported experiencing regular shortages of tissues and cells on a national level, mostly for bone marrow and haematopoietic stem cells, corneas and bone.
Slovenian: V zvezi z ravnotežjem med ponudbo in povpraševanjem je 17 držav članic in ena država EGP poročalo o rednem pomanjkanju tkiv in celic na nacionalni ravni, večinoma za kostni mozeg in krvotvorne matične celice, roženice in kosti.
English: Development of follow-up registries as an additional tool for ensuring safety of living donors was also addressed in the survey.
Slovenian: Anketa se je nanašala tudi na razvoj registrov za nadaljnje spremljanje kot dodatnega orodja za zagotavljanje varnosti živih darovalcev.
English: In most of the Member States compliance with the requirements for tissue and cell procurement set by Directive 2006/17/EC is verified by the competent authorities when performing inspections, but also by auditing procurement organisations and centres of human application.
Slovenian: V večini držav članic skladnost z zahtevami glede pridobivanja tkiv in celic iz Direktive 2006/17/ES pristojni organi preverjajo pri opravljanju inšpekcijskih pregledov, pa tudi pri revizijskih pregledih organizacij za pridobivanje in centrov za zdravljenje ljudi.
English: The main reasons for shortages were the lack of donors, followed by insufficient procurement capacity at national level and technical reasons (e.g. practical difficulties in finding a compatible match for patients in need of an HSC transplantation).
Slovenian: Glavni razlogi za pomanjkanje so pomanjkanje darovalcev ter nezadostna zmogljivost pridobivanja na nacionalni ravni in tehnični razlogi (npr. praktične težave pri iskanju ustreznega darovalca za paciente, ki potrebujejo presaditev krvotvornih matičnih celic).
English: Best practices to ensure tissue and cell sufficiency/self-sufficiency or measures to reduce shortages might be addressed as well as best practices on verification of the implementation of the VUD principle by the competent authorities.
Slovenian: Obravnavajo se lahko dobre prakse za zagotavljanje zadostnosti/samozadostnosti glede tkiv in celic ali ukrepi za zmanjšanje pomanjkanja ter dobre prakse preverjanja, kako pristojni organi izvajajo načelo PBD.
English: The survey showed that a donor identification system was implemented by most Member States, with a unique code for each donation being assigned, predominantly at the level of the tissue establishment.
Slovenian: Anketa je pokazala, da je večina držav članic vzpostavila sistem identifikacije darovalcev z določitvijo edinstvene kode za vsako darovanje, predvsem na ravni ustanove za tkiva in celice.
English: Nevertheless, it has to be underlined that a small number of countries rely only on the medical records of the donor and/or the autopsy report without interviewing the donor's family or his/her treating physician/general practitioner.
Slovenian: Kljub temu pa je treba poudariti, da se le majhno število držav zanaša samo na zdravstveno kartoteko darovalca in/ali obdukcijski izvid, ne da bi bil opravljen razgovor z družino darovalca ali zdravnikom, ki ga zdravi, oziroma izbranim splošnim zdravnikom.
English: Only six Member States have national registries of oocyte and sperm donors.
Slovenian: Samo šest držav članic ima nacionalne registre darovalcev jajčnih celic in sperme.
English: Even though most of the Member States reported using the Operational Manual for Competent Authorities on inspection of tissue and cell procurement and tissue establishments, there is no common agreement on the classification of shortcomings identified during inspections (e.g. classification of minor, major and critical deficiencies).
Slovenian: Čeprav je večina držav članic poročala, da uporabljajo Operativni priročnik za pristojne organe o inšpekcijskih pregledih pridobivanja tkiv in celic ter ustanov za tkiva in celice, niso soglasne glede razvrščanja pomanjkljivosti, ugotovljenih pri inšpekcijskih pregledih (npr. razvrščanje manjših, velikih in kritičnih pomanjkljivosti).
English: Good practices developed by the EU-funded initiatives were also included by the Council of Europe in a dedicated Guide to the Quality and Safety of Tissues and Cells.
Slovenian: Dobre prakse, razvite v okviru pobud, ki jih financira EU, je Svet Evrope vključil tudi v namenski vodnik za kakovost in varnost tkiv in celic (Guide to the Quality and Safety of Tissues and Cells).