natgillin/translations-raw huggingface dataset:
(d) na zahtevo pristojnega organa predložiti kopijo sporazuma s tretjimi stranmi.
(d) provide copies of agreements with third parties at the request of the Competent Authority.
((Tako določa direktiva o človeških tkivih in celicah, glej člen 24 Direktive 2004/23/ES. ) )
((These arrangements were foreseen in the Tissues and Cells Directive, see Article 24 of Directive 2004/23/EC.) )
Verjetno obstajajo dejavnosti, ki jih organizacije za pridobivanje organov in transplantacijski centri morajo izvajati, in ki bi želeli, da jih zdaj ali v prihodnje izvajajo tretje strani, denimo upravljanje sistemov informacijske tehnologije.
There are likely to be activities which procurement organisations or transplant centres need to carry out that they would like to be carried out by third parties either now or in the future, for example the running of IT systems.
Ta člen bi zagotovil, da te tretje strani izpolnjujejo standarde varnosti in kakovosti iz te direktive.
This Article would ensure that these third parties comply with the quality and safety standards set out in this Directive.
Države članice zagotovijo, da je darovanje človeških organov umrlih in živih darovalcev prostovoljno in brezplačno.
Member States shall ensure that donations of human organs from deceased and living donors are voluntary and unpaid.
Države članice zagotovijo, da je darovanje človeških organov umrlih in živih darovalcev nesebično, prostovoljno in brezplačno.
Member States shall ensure that donations of human organs from deceased and living donors are altruistic, voluntary and unpaid.
Darovanje organov je darilo, ki temelji na solidarnosti in sočutju do sočloveka.
Organ donation is a gift based on solidarity and compassion for a fellow human being.
Če ni zahteve po tem, da mora biti darovanje nesebično, to pomeni podcenjevanje darila in dostojanstva umrlega ali živega darovalca.
Not to require an organ donation to be altruistic means to belittle the gift and the dignity of the deceased or living donor.
Evropski parlament je to posebno zahtevo priznal že v svoji resoluciji z dne 22. aprila 2008 (resolucija o darovanju in presajanju organov ( A6-0090/2008 ), odstavek 22), Komisija pa jo je povzela v členu 23 obrazložitvenega memoranduma.
The European Parliament acknowledged this specific requirement already in its resolution of 22 April 2008 (Resolution on organ donation and transplantation ( A6-0090/2008 ), § 22) and the Commission took it up in § 23 of its Explanatory Memorandum.
Člen 13 – odstavek 1 a (novo)
Article 13– paragraph 1 a (new)
Načelo brezplačnega darovanja živim darovalcem ne preprečuje, da prejmejo nadomestilo, če je omejeno izključno na povračilo za stroške in nevšečnosti, povezane z darovanjem.
The principle of non-payment shall not prevent living donor s from receiving compensation, provided it is strictly limited to making good the expenses and inconveniences related to the donation.
Za take primere države članice določijo pogoje, pod katerimi se dovoli plačilo nadomestila, preprečijo pa vsakršne finančne spodbude za morebitne darovalce.
For such cases , Member State shall define the conditions under which compensation may be granted, while avoiding any financial incentives or benefit for a potential donor.
Komisija v tesnem sodelovanju z državami članicami, Evropskim parlamentom in zainteresiranimi stranmi razišče možnost razvoja sistema, v katerem bodo želje državljanov, ki soglašajo z darovanjem organov po smrti, upoštevane v kar največjem številu držav članic.
The Commission, in close cooperation with Member States, the European Parliament and relevant stakeholders, shall examine the possibility of developing a system whereby the wishes expressed by citizens consenting to the donation of organs after they are deceased are taken into account in as many Member States as possible.
Ker ljudje živimo, potujemo in delamo v številnih državah Evropske unije, tudi umiramo v državah, v katerih nismo državljani ali rezidenti.
As people live, travel and work in several countries of the European Union, they also die in other countries than the one of which they are citizens or residents.
Člen 13 – odstavek 3 b (novo)
Article 13 – paragraph 3 b (new)
Države članice zagotovijo sisteme in registre, ki so prosto dostopni za namene beleženja želja bodočih darovalcev, ter da pristojni organi dajo prednost željam darovalca pred vsako morebitno nasprotno željo zakonca, sorodnika prve sorodstvene stopnje ali druge osebe.
Member States shall ensure that systems and registers are in place which are easily accessible for the purposes of recording the wishes of future donors , and that the competent authorities give priority to the wishes expressed by a donor over any possible contrary wishes of a spouse, first-degree relative or other person .
Države članice je treba pozvati, da bodo zagotovile sisteme za sporočanje, če kdo želi postati darovalec, ter da mora biti tako izražena želja obravnavana prednostno.
Member States should be urged to ensure that there are systems in place to communicate a wish to become a donor and that this expressed wish should be respected as a priority.
Člen 13 – odstavek 3 c (novo)
Article 13 – paragraph 3 c (new)
Države članice zagotovijo, da so organi prejemnikom dodeljeni v skladu s preglednimi, nediskriminatornimi in znanstvenimi merili.
Member States shall ensure that organs are allocated to recipients according to transparent, non-discriminatory and scientific criteria.
To pravilo o dodelitvi organov je neposreden rezultat uporabe načel enakosti in pravičnosti pri dodeljevanju virov zdravstvenega varstva.
This rule regarding the allocation of organs is the direct result of the application of the principles of equality and of justice in healthcare resource allocation.
Člen 13 – odstavek 3 d (novo)
Article 13 – paragraph 3 d (new)
Države članice zagotovijo, da so organi umrli osebi odvzeti samo, če je njena smrt potrjena v skladu z nacionalno zakonodajo.
Member States shall ensure that organs are not removed from a deceased person unless that person has been certified dead in accordance with national law.
Zahtevanje mrliškega lista za umrlega darovalca, preden se dovoli odvzem organa, izhaja iz načela nedotakljivosti človeškega življenja in fizične integritete, kot je določeno v členu 16 dodatnega protokola h konvenciji o človekovih pravicah in biomedicini o presajanju organov in tkiv človeškega izvora.
Demanding a death certificate regarding a deceased donor before allowing the organ removal is a requirement deriving from the principle of inviolability of human life and physical integrity as laid down in Article 16 of the Additional Protocol to the Convention on Human Rights and Biomedicine, on Transplantation of Organs and Tissues of Human Origin.
Člen 13 – odstavek 3 e (novo)
Article 13 – paragraph 3 e (new)
Države članice okrepijo svoje sodelovanje znotraj Interpola in Europola, da bi učinkoviteje reševale problem trgovine z organi.
Member States shall intensify their cooperation within Interpol and Europol in order to address the problem of trafficking in organs more effectively.
Člen 13 – odstavek 3 f (novo)
Article 13 – paragraph 3 f (new)
Države članice za zmanjšanje tveganja trgovine z organi v Uniji zmanjšajo povpraševanje, učinkoviteje spodbujajo darovanje organov, ohranjajo strogo zakonodajo glede živečih darovalcev, ki niso sorodniki, zagotovijo preglednost nacionalnih registrov in čakalnih list, določijo pravno odgovornost medicinske stroke v zvezi z odkrivanjem nepravilnosti in izmenjujejo informacije.
Member States shall, in order to minimise the risk of organ trafficking in the Union, reduce demand, promote organ donation more effectively, maintain strict legislation with regard to live unrelated donors, guarantee transparency of national registers and waiting lists, establish the legal responsibility of the medical professional for tracking irregularities, and share information.
Pridobivanje se lahko izvaja šele, ko so izpolnjene vse zahteve glede obveznega soglasja ali odobritve , ki veljajo v zadevni državi članici.
Procurement shall only be carried out only after compliance with all mandatory consent or authorisation requirements in force in the Member State concerned.
Pridobivanje se lahko izvaja šele, ko so izpolnjene vse zahteve glede obveznega soglasja in zahteve v zvezi z nenasprotovanjem darovanju organa , ki veljajo v zadevni državi članici.
Procurement shall only be carried out only after compliance with all mandatory consent requirements and all requirements relating to the absence of any objection to organ donation in force in the Member State concerned.
Glej predlog spremembe k členu 4(2) o nacionalnih programih kakovosti.
See the amendment to Article 4(2) concerning national quality programmes.
Da bi izpolnile vse zahteve glede kakovosti in varnosti iz te direktive, si države članice prizadevajo, da od živih darovalcev pridobijo vse potrebne podatke in da jim nudijo vse informacije, ki jih potrebujejo za razumevanje posledic darovanja.
In order to meet the quality and safety requirements laid down in this Directive, Member States shall endeavour to obtain all necessary information from living donors and to provide them with the information they need to understand the consequences of donation.
Pri umrlih darovalcih si države članice prizadevajo, da te podatke pridobijo od sorodnikov ali druge osebe, ki daje dovoljenje za darovanje.
In the case of deceased donation, Member States shall endeavour to obtain such information from relatives or other persons authori s ing donation.
Države članice tudi poskrbijo, da so vse strani, od katerih se zahtevajo podatki, seznanjenje s pomembnostjo hitrega posredovanja teh podatkov.
Member States shall make all parties , from whom information is requested , aware of the importance of swift ly transmitting such information.
Soglasje o tem, da je treba darovalcem (ali sorodnikom) dati informacije o postopku darovanja in presaditve.
Agree on the concept of the need of providing information to donors (or relatives) on the process of donation and transplantation.
Vendar bi se bilo treba, da se ta koncept ohrani v okviru pristojnosti EU, podeljenih s členom 168 PDEU, osredotočiti na tveganje za prejemnika zaradi kakovosti in varnosti organov.
However, in order to keep this concept under the competencies of the EU conferred by article 168 of the TFEU, it is suggested to focus on the risks for recipients as a result of the quality and safety of the organs.
Glede na to, da je to posredno povezano s pridobivanjem popolnih, objektivnih in zanesljivih podatkov o predhodnem zdravstvenem stanju s strani medicinske ekipe, bi bilo treba to določbo vključiti v člen 7, ki je povezan z določanjem značilnosti darovalcev in organov.
As this is implicitly linked to obtaining a complete, objective and reliable clinical history by the medical team, it is also suggested to include this provision under article 7, related to the characterisation of donors and organs.
Še vedno delamo na končnem besedilu in preučujemo najprimernejše mesto v direktivi za to določbo.
We are still working on the final wording and studying the most appropriate place to locate this provision in this Directive
Na darovanje organov živih darovalcev je treba gledati kot na dopolnilo darovanju organov po smrti in se ga lahko izvaja, če ni ustreznega organa umrle osebe.
Living donation should be seen as complementary to post-mortem donation and may be carried out where there is no suitable organ available from a deceased person.
Darovanje organov živih darovalcev poteka pretežno med družinskimi člani in bližnjimi sorodniki in/ali v prid prejemnika, s katerim je darovalec v tesnem osebnem razmerju, ali če je mogoče dokazati, da darovalec ne daruje zaradi finančnih koristi, da bi preprečili komercializacijo.
Living donations are predominantly carried out among family members and close relatives and/ or for the benefit of a recipient with whom the donor has a close personal relationship, or where it can be proven that the donor is not acting for the purpose of financial gain in order to prevent commercialisation.
Zlasti kadar ne gre za tesno razmerje, se v nacionalni zakonodaji držav članic sprejmejo ustrezne določbe, ki zagotovijo največje možno varstvo živih darovalcev.
Particularly, in the absence of such a close relationship, adequate provisions in national law of the Member States shall be made, thus assuring the highest possible protection of living donors.
Države članice zagotovijo, da žive darovalce izbirajo kvalificirani in usposobljeni strokovnjaki na podlagi njihovega zdravja in zdravstvene anamneze, vključno s psihološko oceno, če se zdi potrebna.
Member States shall ensure that living donors are selected on the basis of their health and medical history, including a psychological evaluation if deemed necessary, by qualified and trained professionals.
Takšne ocene lahko prispevajo k izločanju oseb, katerih darovanje bi lahko ogrozilo zdravje drugih, na primer s prenosom bolezni, ali njihovo lastno zdravje.
Such assessments may provide for the exclusion of persons whose donation could present a health risk to others, such as the possibility of transmitting diseases, or a serious risk to themselves.
Države članice zagotovijo, da imajo živi darovalci zavarovanje pravnega varstva.
Member States shall also ensure that living donors are legally insured.
Zavarovanje pravnega varstva je pomembno za zaščito živih darovalcev.
Legal insurance cover is important to protect living donors.
Pri darovanju organov iz človekoljubnih razlogov so živi darovalci izpostavljeni precejšnjemu zdravstvenemu tveganju, ki bi ga s takim ukrepom lahko zmanjšali.
In altruistically donating organs, living donors face a significant health risk which such a measure will help to mitigate.
Države članice zagotovijo, da se organa ne sme odvzeti osebi, ki po nacionalni zakonodaji ni sposobna dati privolitve.
Member States shall ensure that no organ removal may be carried out on a person who under national law does not have the capacity to consent to it .
Osebe, ki niso sposobne dati privolitve za zdravstveni postopek, še posebej potrebujejo zaščito.
Persons not having the capacity to consent to a medical procedure are in an especially dire need of protection.
To so lahko mladoletniki, vendar tudi odrasle osebe, ki nimajo pravne sposobnosti.
This may concern minors, but also adult persons lacking legal capacity.
Ta predlog spremembe odraža člen 14(1) dodatnega protokola h konvenciji o človekovih pravicah in biomedicini o presajanju organov in tkiv človeškega izvora, hkrati pa državam članicam prepušča odločitev, pod katerimi pogoji oseba je ali ni sposobna privoliti v zdravstveni postopek.
While reflecting Article 14 § 1 of the Additional Protocol to the Convention on Human Rights and Biomedicine, on Transplantation of Organs and Tissues of Human Origin, this amendment leaves it to the Member States to determine under which conditions a person is or is not capable to consent to a medical procedure.
Člen 15 – odstavek 3 b (novo)
Article 15 – paragraph 3 b (new)
Države članice zagotovijo nadaljnje spremljanje živih darovalcev v skladu z nacionalnimi določbami, da bi identificirali, zabeležili in nadzirali vsak dogodek, ki bi lahko vplival na kakovost in varnost darovanega organa in s tem na varnost prejemnika, kot tudi kakršne koli hude neželene reakcije v živem darovalcu, ki so lahko posledica darovanja.
Member States shall ensure follow-up in relation to living donors in accordance with national provisions, in order to identify, report, and manage any event potentially relating to the quality and safety of the donated organ, and hence of the safety of the recipient, as well as any serious adverse reaction in the living donor that may result from the donation.
Glej predlog spremembe 33a.
See amendment 33a
Države članice zagotovijo, da se temeljna pravica do varovanja osebnih podatkov v celoti in učinkovito spoštuje pri vseh dejavnostih presajanja organov v skladu z določbami Skupnosti o varovanju osebnih podatkov, kot je Direktiva 95/46/ES in zlasti člen 8(3), člena 16 in 17 ter člen 28(2) navedene direktive.
Member States shall ensure that the fundamental right to protection of personal data is fully and effectively protected in all organ transplantation activities, in conformity with Community provisions on the protection of personal data, such as Directive 95/46/EC, and in particular Articles 8 (3), 16, 17 and 28 (2) of that Directive.
Države članice zagotovijo, da se temeljna pravica do varovanja osebnih podatkov v celoti in učinkovito spoštuje pri vseh dejavnostih darovanja in presajanja organov v skladu z določbami Skupnosti o varovanju osebnih podatkov, kot je Direktiva 95/46/ES in zlasti člen 8(3), člena 16 in 17 ter člen 28(2) navedene direktive.
Member States shall ensure that the fundamental right to protection of personal data is fully and effectively protected in all organ donation and transplantation activities, in conformity with Community provisions on the protection of personal data, such as Directive 95/46/EC, and in particular Articles 8 (3), 16, 17 and 28 (2) of that Directive.
Varovanje osebnih podatkov zadeva tudi darovalce.
Protection of personal data also implies donors.
Države članice sprejmejo potrebne ukrepe za zagotovitev, da so vsi darovalci in prejemniki, katerih podatki se obdelujejo v sklopu te direktive, določljivi le za osebe, ki lahko dokažejo, da morajo poznati njihovo identiteto.
Member States shall take the necessary measures to ensure that donors and recipients whose data are being processed under this Directive are identifiable only by persons who can demonstrate a need to know their identities.
Člen 16 – odstavek 1 b (novo)
Article 16 - paragraph 1 b (new)
Države članice sprejmejo potrebne ukrepe za zagotovitev zaupnosti, celovitosti, odgovornosti in razpoložljivosti podatkov darovalcev in prejemnikov ter odgovornosti v zvezi z njimi.
Member States shall take the necessary measures to ensure the confidentiality, integrity, accountability and availability of the personal data of donors and recipients.
Izredno pomembno je izvajanje politike za varnost informacij, ki temelji na strogih in učinkovitih zaščitnih ukrepih pristojnih nacionalnih služb, zlasti da bi se izpolnjevale zahteve glede zaupnosti podatkov darovalcev in prejemnikov, ki so določene v predlogu, in da bi zavarovali celovitost in razpoložljivost podatkov ter odgovornost v zvezi z njimi.
It is of utmost importance to implement an information security policy based on strict and sound security measures at the relevant national services, especially in order to meet the confidentiality requirements for the donors and recipients set out in the proposal, as well as to safeguard integrity, accountability and availability of these data.
Zagotavljanje anonimnosti darovalcev in prejemnikov
Anonymisation of donors and recipients
Države članice sprejmejo potrebne ukrepe za zagotovitev, da se vsi osebni podatki darovalcev in prejemnikov, katerih obdelavo zajema ta direktiva, spremenijo v anonimne, tako da niti darovalcev niti prejemnikov ni več možno identificirati.
Member States shall take all necessary measures to ensure that all personal data of donors and recipients processed within the scope of this Directive are rendered anonymous so that neither donors nor recipients remain identifiable.
Člen 17 bi lahko črtali in ga glede na vsebino (zagotavljanje zaupnosti) vključili kot novi odstavek v člen 16, ki se nanaša na varovanje osebnih podatkov, zaupnost in varnost obdelave.
Article 17 as such could be deleted, incorporating its content (in terms of confidentiality needs) in a new paragraph of Article 16 on the Protection of personal data, confidentiality and security of processing.
Člen 18 – naslov
Article 18 – title
Imenovanje in naloge pristojnih organov
Designation and tasks of competent authorities
Imenovanje in naloge pristojnih organov , organizacij in institucij
Designation and tasks of the competent authorities , organisations and institutions
Obstoječe organizacijske strukture za darovanje, dodeljevanje in presajanje organov v državah članicah so tesno povezane z organizacijo nacionalnega zdravstvenega sistema na splošno.
The existing organisational structures for organ donation, allocation and transplantation in the Member States are closely connected to the organisation of the national health care system in general.
Uvodna izjava 19 navaja, da v državah članicah lahko skupek lokalnih, regionalnih, nacionalnih in/ali mednarodnih organov sodeluje in tako uskladi darovanje, dodeljevanje in/ali presajanje, če obstoječi okvir zagotavlja določanje odgovornosti, sodelovanje in učinkovitost.
Recital 19 states that within Members States, a combination of local, regional, national and/or international bodies may work together to co-ordinate donation, allocation and/or transplantation, provided that the framework in place ensures accountability, co-operation and efficiency.
Glej tudi predlog spremembe 38.
See also Amendment 38.
Pristojni organi sprejmejo zlasti naslednje ukrepe:
The competent authorities shall, in particular, take the following measures:
Pristojni organi ali institucije sprejmejo zlasti naslednje ukrepe:
The competent authorities or institutions shall, in particular, take the following measures:
Države članice lahko prenesejo na pristojni organ ali mu dovolijo, da prenese del nalog ali vse naloge, dodeljene v skladu s to direktivo, drugemu organu, ki je v skladu z nacionalnimi določbami.
Member State s may delegate, or may allow a Competent Authority to delegate, part or all of the tasks assigned to it under this Directive to another body which is deemed suitable under national provisions.
Ta organ lahko pristojnemu organu tudi pomaga pri izvajanju njegovih funkcij.
Such a body may also assist a Competent Authority in carrying out its functions.
Strinjanje s potrebo po uvedbi koncepta možnosti prenosa nalog.
Agree with the need of introducing the concept of the possibility of delegation.
To besedilo je prožnejše.
This wording is more flexible.
Ta odstavek je treba postaviti pred potrebne ukrepe (18.2).
This paragraph should be placed before the measures to take (18.2)
Člen 18 – odstavek 2 – točka (b)
Article 18 – paragraph 2 – point b
(b) zagotavljanje rednega nadzora in revizije organizacij za pridobivanje in transplantacijskih centrov, da se preveri izpolnjevanje zahtev te direktive;
(b) ensure that procurement organisations and transplantations centres are controlled and audited on a regular basis to ascertain compliance with the requirements of this Directive;
b) zagotavljanje rednega javnega nadzora in revizije organizacij za pridobivanje in transplantacijskih centrov, da se preveri izpolnjevanje zahtev te direktive;
b) ensure that procurement organisations and transplantations centres are subject to public controls and audited on a regular basis to ascertain compliance with the requirements of this Directive;
Ker je postopek presaditve organov občutljiv in nepridobiten in ker so pacienti, ki čakajo na presaditev, v ranljivem položaju, je treba za vsako fazo postopka določiti stroge postopke javnega nadzora.
Owing to the sensitive and non-profit making aspect of the organ transplant procedure and the weak position of patients waiting for a transplant, provision must be made for stringent public control procedures for each phase of the procedure.
Člen 18 – odstavek 2 – točka (d)
Article 18 – paragraph 2 - point d
(d) vzpostavitev sistema za poročanje in sistema za odpoklic organov iz člena 11(1) in (2);
(d) put in place a reporting system and a system for the recall of organs as provided for in Article 11(1) and (2);
(d) vzpostavitev sistema za poročanje in upravljanje ter sistema za hude neželene dogodke in/ali reakcije iz člena 11(1) in (2);
(d) put in place a reporting and management system and a system for serious adverse events and/or reactions as provided for in Article 11(1) and (2);
Člen 18 – odstavek 2 – točka (e)
Article 18 – paragraph 2 – point e
(e) izdajanje ustreznih smernic zdravstvenim ustanovam, strokovnjakom in drugim zainteresiranim stranem, ki so vključeni v katero koli stopnjo postopka od darovanja do presaditve ali odstranitve;
(e) issue appropriate guidance to health care establishments, professionals and other parties involved in all stages of the chain from donation to transplantation or disposal;