natgillin/translations-raw huggingface dataset:
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.
Splošneje je bilo težko oceniti, kako razdelitev nalog vpliva na nadzor nad sektorjem, zlasti ker nekateri nacionalni pristojni organi niso predložili natančnih/popolnih informacij.
In some Member States the sector is fully controlled by public organisations, whilst in others private operators make a significant contribution (Fig. 5).
V nekaterih državah članicah sektor v celoti obvladujejo javne organizacije, v drugih pa znatno prispevajo zasebni subjekti (slika 5).
Donor testing.
Testiranje darovalcev.
Consent, data protection and confidentiality.
Soglasje, varstvo podatkov in zaupnost.
The survey confirmed that this core responsibility of competent authorities is well implemented across the Union.
Anketa je potrdila, da se ta ključna odgovornost pristojnih organov dobro izvaja po vsej Uniji.
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.
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.
However, the ways in which Member States have implemented the principle of VUD are difficult to assess in a comprehensive manner.
Vendar je načine, na katere države članice izvajajo načelo PBD, težko celovito oceniti.
The penalties foreseen in national legislation, their criteria for implementation and their effective implementation can differ significantly between Member States.
Kazni, predvidene v nacionalni zakonodaji, merila za njihovo izvajanje in učinkovitost njihovega izvajanja se lahko znatno razlikujejo med državami članicami.
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.
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.
The high number of procurement organisations shows that this activity is well developed across the Union.
Veliko število organizacij za pridobivanje kaže, da je ta dejavnost dobro razvita po vsej Uniji.
However, Member States interpretation of what is considered compensation and incentive vary.
Vendar se razlage držav članic, kaj se šteje za nadomestilo in spodbudo, razlikujejo.
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.
Čeprav lahko samo usposobljeno osebje darovalcem zagotovi ustrezne informacije, so bile te informacije na nacionalni ravni standardizirane le v majhnem številu držav.
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.
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.
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.
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".
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.
Pomen inšpekcijskih pregledov je bil znova poudarjen v okviru izpolnjevanja zahtev Direktive 2006/86/ES kot najpogostejši pristop k preverjanju izvajanja.
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.
Poudariti je treba, da je več držav članic navedlo, da ni nacionalne zakonske zahteve po organizaciji nacionalnih registrov za nadaljnje spremljanje za žive darovalce.
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.
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.
Although the principle of VUD is mandatory in the large majority of the Member States, its concrete application varies across the Union.
Čeprav je načelo PBD obvezno v veliki večini držav članic, se njegova dejanska uporaba po Uniji razlikuje.
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.
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.
Concerning donor anonymity, most countries rely on the EU and national data protection legislation, but also on coding.
V zvezi z anonimnostjo darovalca se večina držav opira na zakonodajo EU in nacionalno zakonodajo o varstvu podatkov, pa tudi na kodiranje.
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.
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.
Their outcome was in general satisfying and in particular allowed bringing expertise where this might be missing within the own Member State.
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.
The large majority of the responding countries (28) reported that the principle of VUD is mandatory at national level.
Velika večina držav, ki so se odzvale (28), je poročala, da je načelo PBD obvezno na nacionalni ravni.
A majority also supported European legislation to ensure the safety and quality of blood, tissues and cells.
Večina je tudi podprla evropsko zakonodajo za zagotavljanje varnosti in kakovosti krvi, tkiv in celic.
Wherever accreditation and inspections are undertaken by different authorities, a good communication and coordination between respective authorities needs to be ensured.
Kadar akreditacijo in inšpekcijske preglede izvajajo različni organi, je treba zagotoviti dobro komunikacijo in usklajevanje med zadevnimi organi.
These consist mainly in providing administrative support for the funeral and ensuring full or partial coverage of the cost of the funeral/burial/cremation.
Večinoma zagotavljajo upravno podporo glede pogrebnih storitev in zagotavljajo celotno ali delno kritje stroškov pogreba/pokopa/upepelitve.
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).
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).
If donor payment were allowed, some individuals could find the monetary remuneration so important that they might hide relevant medical and/or behavioural information.
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.
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.
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.
Another Member State and one EEA country have not yet defined national provisions on the application of the VUD principle.
Druga država članica in ena država EGP še nista opredelili nacionalnih določb o uporabi načela PBD.
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.
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.
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.
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.
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.
Zato informacije, ki jih predloži darovalec ali njegova družina, prispevajo k točni oceni vseh tveganj v zvezi z uporabo darovanih tkiv ali celic.
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.
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.
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.
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.
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.
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.
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).
Večina držav članic dovoljuje, da se živim darovalcem ponudi nadomestilo (22 držav živim darovalcem nereproduktivnih tkiv in celic; 17 držav darovalcem reproduktivnih celic).
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).
Samo v majhnem številu držav članic je vrednost nadomestila za darovalce tkiv in celic povezana z nacionalnimi gospodarskimi kazalniki (npr. mesečni dohodek, kupna moč).
Diverse practices related to the implementation of the requirements of Article 4 of Directive 2006/86/EC were reported.
Sporočene so bile različne prakse v zvezi z izvajanjem zahtev iz člena 4 Direktive 2006/86/ES.
The implementation survey was answered by all Member States except Greece, and also by two EEA countries, Liechtenstein and Norway.
Na anketo o izvajanju so odgovorile vse države članice, razen Grčije, in dve državi EGP, in sicer Lihtenštajn in Norveška.
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.
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.
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.
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.
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.
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.
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.
Evropskemu parlamentu in Svetu mora predložiti tudi pregledno poročilo o izvajanju zahtev Direktive, zlasti glede inšpekcijske in kontrolnih ukrepov.
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.
Komisija bo na podlagi zbranih informacij spremljala države članice za spodbujanje, kadar je to zaželeno, enotnega razumevanja člena 12 Direktive 2004/23/ES.
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.
Povračila stroškov v zvezi s potovanjem in zdravili na podlagi dejanskih stroškov/potrdil so med najpogostejšimi vrstami nadomestil za žive darovalce.
It is also interesting to highlight the split between private and public ownership of tissue establishments.
Zanimivo je tudi opozoriti na vrzel med zasebnim in javnim lastništvom ustanov za tkiva in celice.
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.
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.
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.
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.
Donor selection and evaluation
Izbiranje in vrednotenje darovalcev
Additional tests required by Member States are usually justified for local reasons, like e.g. the increased prevalence of a certain infectious disease.
Dodatni testi, ki jih zahtevajo države članice, so običajno utemeljeni zaradi lokalnih dejavnikov, kot je večja prevalenca neke nalezljive bolezni.
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.
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.
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.
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.
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.
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.
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.
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.
In 2015 the MS concerned has adopted new legislation for the ART sector and is in process of implementing it.]
Leta 2015 je zadevna država članica sprejela novo zakonodajo za sektor oploditve z biomedicinsko pomočjo (OBMP) in jo zdaj izvaja.]
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.
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.
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.
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.
However, one Member State who reported that the VUD principle is mandatory indicated that payment of gamete donors is allowed at national level.
Vendar je ena država, ki je poročala, da je načelo PBD obvezno, navedla, da je plačilo darovalcem gamet dovoljeno na nacionalni ravni.
All reporting Member States have appointed competent authorities for tissues and cells.
Vse države članice poročevalke so imenovale pristojne organe za tkiva in celice.
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.
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.
(Total POs = 4825; 2011 data)
(skupno število organizacij za pridobivanje = 4 825; podatki za leto 2011)
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.
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.
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.
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.
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.
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.
Overall, the survey showed that regardless of the consent system, all responding countries have put measures in place for verifying donor consent.
Na splošno je anketa pokazala, da so vse države, ki so se odzvale, ne glede na sistem soglasij sprejele ukrepe za preverjanje soglasja darovalca.
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).
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).
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).
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).
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.
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.