natgillin/translations-raw huggingface dataset:
Ker imata izboljšano sodelovanje in čezmejna izmenjava med državami članicami izjemen potencial za povečanje števila presaditev, je treba sprejeti skupne standarde kakovosti in varnosti.
Since enhanced cooperation and cross border exchange between Member States has an impressive potential to increase number of transplantations, it requires the adoption of common quality and safety standards.
Da bi bilo mogoče zagotoviti visoko raven varstva zdravja v Evropski uniji, predlagana direktiva določa skupne zavezujoče standarde kakovosti in varnosti človeških organov, namenjenih za presaditev.
In order to ensure high level of health protection throughout the European Union, the proposed Directive establishes common binding standards of quality and safety of human organs intended for transplantation.
Po sprejetju direktive o kakovosti in varnosti človeške krvi in sestavin krvi (2003), čemur je sledila direktiva o kakovosti in varnosti človeških tkiv in celic (2004), je namen te direktive vključiti še človeške organe, da se zaokroži zakonodaja, ki jo določa člen 152 Pogodbe ES.
After adoption of the directive on quality and safety of human blood and blood components (2003), followed by the directive on quality and safety of human tissues and cells (2004), this directive seeks to encompass human organs to complete the legislation based on the Article 152 of the EC Treaty.
Potreba po skupnem ukrepanju na evropski ravni je bila jasno določena v resoluciji o darovanju in presajanju organov, ki jo je Evropski parlament z veliko večino sprejel aprila 2008.
A need for common action at European level was clearly acknowledged in the Resolution on organ donation and transplantation adopted in the European Parliament by huge majority in April 2008.
Predlagana direktiva določa pravila za zagotavljanje visokih standardov kakovosti in varnosti za organe človeškega izvora, namenjene za presajanje v človeško telo, v postopku darovanja, pridobivanja, testiranja, določanja značilnosti, konzerviranja, prevoza in presajanja.
Proposed Directive lays down rules to ensure high standards of quality and safety for organs of human origin intended for transplantation to the human body - in the process of donation, procurement, testing, characterization, preservation, transport and transplantation.
Uvaja nacionalne programe kakovosti, ki določajo pravila in prakse postopka presajanja v državah članicah.
It introduces national quality programmes specifying rules and practice of the transplantation process in Member States.
Poleg tega podrobneje določa postopek pridobivanja in vključene osebe, tudi sistem poročanja.
It further elaborates more on process of the procurement and involved subjects including reporting system.
Posebna pozornost je namenjena sledljivosti in varstvu darovalca in prejemnika.
Special attention is paid to the traceability and protection of donor and recipient.
Glede izvajanja so podane določbe o navedbi in nalogah pristojnih nacionalnih organov, evropskih organizacij za izmenjavo organov ter o izmenjavi organov s tretjimi državami.
With regard to the implementation, there are provisions on designation and tasks of competent national authorities, European organ exchange organizations and exchange of organs with third countries.
Poročevalec pozdravlja ta predlog in močno podpira tri njegove glavne cilje: zagotavljanje kakovosti in varnosti bolnikov na ravni EU, zagotavljanje varstva darovalcev ter poenostavitev sodelovanja med državami članicami.
The rapporteur welcomes this proposal and highly appreciates its three principal aims: ensuring quality and safety for patients at EU level, ensuring protection of donors and facilitating cooperation between Member States.
V splošnem je v Evropski uniji prisotno široko družbeno soglasje glede darovanja organov za namen presajanja.
Generally, in the European Union there is broad societal consensus on organ donation for the purpose of transplantation.
Vendar so zaradi različnega kulturnega, tradicionalnega ali organizacijskega sistema prisotne razlike med državami članicami glede pristopa k temu vprašanju.
However, due to different cultural, traditional or organizational system background, there are differences between Member States in approach to this issue.
Ob ohranjanju ali prizadevanju za izboljšanje usklajenosti ukrepov kakovosti in varnosti poročevalec poudarja, da direktiva ne sme pomeniti dodatnega upravnega bremena za države članice in da mora omogočiti dovolj prožnosti brez ogrožanja veljavnih dobrih praks.
While maintaining or striving for harmonization of the quality and safety measures, rapporteur stresses that the directive must not create an additional administrative burden for Member States and must leave enough flexibility without jeopardizing current good practices.
Poročevalec se strinja z mnenjem Komisije, da programi presajanja organov načeloma temeljijo na načelu prostovoljnega in neplačanega darovanja, saj je to načelo vključevala že prejšnja zakonodaja o snoveh človeškega izvora.
The rapporteur agrees with Commission’s view, that as matter of principle, organ transplantation programmes are based on the principle of voluntary and unpaid donation since this principle was anchored already in the previous legislation on substances of human origin.
Darovanje organa mora biti vedno brezplačno darilo in zato zaščiteno pred morebitno komercializacijo.
Organ donation must be always a free gift and protected from any linkage to possible commercialization.
Poleg tega temeljita sistema darovanja in presajanja na nesebičnosti.
Moreover, donation and transplantation systems are based on altruism.
Za povečanje kakovosti postopka presajanja priporoča poročevalec nekaj sprememb v zvezi s človekovim dostojanstvom.
To foster the quality of transplantation process, rapporteur proposes some amendments related to the human dignity.
Kar zadeva vprašanje soglasja, je treba spoštovati in varovati svobodno izbiro darovanja ali nedarovanja, zato sodi ta prilagoditev v področje urejanja držav članic.
Coming to the issue of consent, the freedom of choice as whether or not to donate an organ needs to be respected and protected as well, therefore its adjustment falls in the competence of Member States.
Uvedbo nadomestila za žive darovalce je treba razumeti strogo v smislu povračila stroškov, neposredno povezanih z darovanjem, npr. potnih stroškov, in ne v smislu finančnih spodbud za morebitne darovalce.
Introducing the compensation to the living donors should be seen strictly as making good the expenses directly related to the donation such as for example travelling fees, avoiding any financial incentives for potential donors.
Poleg tega je oseba, ki je imela nepotrebno škodo zaradi posega, upravičena do pravičnega nadomestila.
Moreover, the person who has suffered undue damage resulting from an intervention is entitled to fair compensation.
Sledljivost organa od darovalca do prejemnika in obratno predstavlja enega glavnih pomislekov glede varnosti, zato je treba koncept anonimnosti zamenjati z zaupnostjo, da se preprečijo morebitna protislovja.
Traceability of organ from the donor to the recipient and vice versa represents one of the major safety concerns, for that reason concept of anonymity needs to be replaced by confidentiality in order to avoid any contradiction in terms.
Poročevalec je podprl vključitev pojma ukrepov za dobro zaščito podatkov o darovalcu in prejemniku v predlog.
Rapporteur supported inclusion of the notion of sound data protection measures of donor and recipient into the proposal.
Širjenje najboljših praks, modelov in znanj v Evropski uniji se je že izkazalo za uporabno pri povečanju števila darovalcev organov.
Sharing of best practices, models and expertise across the European Union has already proved useful in increasing organ donor rates.
Sodelovanje je treba okrepiti, da se določijo uspešni elementi različnih sistemov presajanja, in te elemente spodbujati na evropski ravni, kar vodi do izboljšav pri zagotavljanju visoke kakovosti in varnosti darovanja ter presajanja organov.
Cooperation should be fostered in order to identify successful elements of different transplantation systems and promote them on the European level, thus leading to the improvements in provision of high quality and safety of organ donation and transplantation.
Končno poročevalec predlaga ustrezno število sprememb, ki odražajo pomisleke glede opredelitve darovalca, pristojnih organov, obdobja po presaditvi, in določnejše besedilo nekaterih členov, da bi tako izboljšal besedilo.
Finally, the rapporteur proposes proportionate number of amendments reflecting concerns with regard to the definition of donor, competent authorities, post transplantation period and more precise wording in certain articles to improve the text.
Poročevalec se je odločil, da bo vključil tudi skoraj vse predloge odbora JURI.
Rapporteur decided as well to include almost all proposals by JURI committee.
Osnutek poročila ne vsebuje predlogov sprememb členov 25 in 26 predloga, da bi jih bilo mogoče uskladiti s sistemom izvedbenih aktov, kot jih uvaja lizbonska pogodba.
The draft report does not contain amendments to Article 25 and 26 of the proposal in order to align them to the system of implementing acts as introduced by the Treaty of Lisbon.
Po statistiki iz leta 2007 čaka v Evropi na presaditev organov skoraj 56.000 bolnikov.
According to statistics from 2007 almost 56 000 patients in Europe are on waiting lists to receive organ transplants.
Stopnja smrtnosti med čakanjem na presaditev jeter, pljuč ali srca se giblje med 15 in 30 odstotki.
Mortality rates while waiting for a transplant of a liver, lung or heart vary between 15 and 30 percent.
V Evropi med čakanjem na organe vsak dan umre okoli deset oseb.
Every day nearly 10 people in Europe die while waiting for organs.
Na način, kako so se različne države članice spoprijele z vprašanjem darovanja organov, so vplivali tradicije, verska in etična prepričanja ter pogledi na konec življenja.
Traditions, religious- and ethical beliefs and views on the end of life have had an impact on the way that different Member States have approached the issue of organ donation.
Glede na to so v različnih državah članicah prisotni bistveno različni sistemi darovanja organov in presaditev.
Accordingly the various Member States have largely different systems regarding organ donation as well as transplantation.
Obstajajo tudi velike razlike v številu darovalcev na prebivalca in v številu organov, ki prečkajo državne meje držav članic.
There are also large differences in the number of donors per capita as well as the number of organs that cross borders between Member States.
Pri večini bolnikov, zlasti otrocih ali zelo občutljivih osebah, je potrebna velika skupina darovalcev, znotraj katere je mogoče najti ustrezno ujemanje.
Most patients, specially children or people, who are very sensitive, require large pools of donors to find a suitable match.
Posledica tega je, da v majhnih sistemih osebe, ki so pripravljene darovati organe po smrti, ostanejo prezrte, saj v sistemu ni ustreznih bolnikov, ki bi lahko prejeli njihove organe.
This has the implication that in small systems, people who are willing to donate organs after they are deceased may be overlooked as there are no suitable patients within the system to receive their organs.
Komisija je zato predlagala niz uredb o standardih kakovosti in varnosti človeških organov, ki so namenjeni za presaditve.
The Commission has thus proposed a set of regulations regarding standards of quality and safety of human organs intended for transplants.
Namen predloga je z izvajanjem teh skupnih standardov omogočiti lažjo izmenjavo organov med državami članicami in s tem ustvariti večjo bazo razpoložljivih organov, ki bi lahko koristili bolnikom po vsej Evropi.
The aim of the proposal is to facilitate, through the application of these common standards, the exchange of organs between Member States, thus creating a larger pool of organs that could benefit patients all over Europe.
Stališče Odbora za pravne zadeve
Position of the Legal Affairs Committee
Odbor za pravne zadeve podpira splošno področje uporabe in cilje predlaganih uredb.
The Committee on Legal Affairs is supportive of the general scope and aims of the proposed regulations.
Jasno je, da morajo države članice Evropske unije še bolj okrepiti svoje sodelovanje na področju presajanja organov, pri čemer bo predlagana direktiva najverjetneje imela pomembno vlogo.
The Member States of the European Union clearly need to further increase their cooperation in the field of organ transplants and the proposed directive will hopefully be important in this respect.
Okrepljeno sodelovanje mora temeljiti na medsebojnem zaupanju držav članic v sisteme drugih držav članic.
Increased cooperation has to build upon the mutual trust of Member States towards the systems of other Member States.
To zaupanje pa temelji na visokih standardih kakovosti in varnosti ter na upoštevanju teh uredb v vseh državah članicah.
This trust in turn is based on the existence of high standards of quality and safety and the observance of these regulations by all Member States.
Odbor je trdno prepričan, da moramo biti pri skupnih prizadevanjih za kar najučinkovitejšo pomoč tisočem bolnikov, ki bodo le z boljšim sodelovanjem v Evropi prišli do ustreznega organa, izrazito spoštljivi do različnih stališč in etičnih prepričanj posameznih držav članic.
The Committee strongly believes that we need to by very respectful of the various positions and ethical views of each Member State while working together to assist, in the best way possible the thousands of patients in need of increased cooperation in Europe to find a suitable organ.
V zvezi s tem so vloženi številni predlogi za spremembo besedila Komisije.
In this context a number of amendments are proposed to the Commission's text.
Najpomembnejše je zelo občutljivo vprašanje soglasja morebitnih darovalcev po njihovi smrti.
The most important issue concerns the very delicate issue of consent of prospective donors after they are deceased.
Komisija v svojem predlogu navaja, da se v različnih državah članicah uporabljajo številni različni sistemi.
The Commission, in its proposal, notes that there are many different systems in place in the various Member States.
Ob upoštevanju tega dejstva, občutljivosti vprašanja in neobstoja pravne osnove za ukrepanje Skupnosti Komisija predlaga ohranitev nacionalne zakonodaje.
With reference to this fact, the sensitivity of the issue and the lack of legal base for Community action, the Commission proposes that national legislation be kept in place.
Odbor za pravne zadeve se strinja s tem splošnim pristopom Komisije k temu vprašanju, vendar predlaga njegovo dopolnitev z besedilom, ki bi države članice pozval, naj državljanom zagotovijo pravico, da izrazijo svoje strinjanje z darovanjem organov po svoji smrti, in zagotovijo upoštevanje teh želja.
The Legal Affairs Committee agrees with this general approach of the Commission on this issue but suggests that it be complemented with a text urging Member States to offer the right of the individual citizen to express their consent to donate organs after they are deceased and for these wishes to be taken into account.
Ker imajo državljani Evrope pravico do potovanja, bivanja in dela v vseh državah Evropske unije, bodo tudi umirali v državah, v katerih niso rezidenti ali državljani.
As the citizens of Europe make use of the freedom to travel, live and work in all countries of the European Union they will also die in countries where they are not residents or citizens.
Odbor zato, glede na to, da je odločitve posameznikov treba upoštevati, nadalje meni, da morajo osebe, ki izrazijo soglasje za darovanje svojih organov po smrti, imeti možnost, da so obravnavane kot darovalci v vseh državah članicah, ne glede na to, kje prebivajo.
The Committee thus also believes, in the sprit of respecting individual choice that people who have chosen to communicate their consent to donate their organs after they are deceased should have the possibility to be tried as donors in all Member States, irrespective of where they are residing.
Da bi bilo takšen sistem mogoče izvajati, je potrebno nadaljnje sodelovanje vseh strani.
In order to implement such a system there is a need for further cooperation between all concerned parties.
Odbor želi tudi predlagati ukrepe za nadaljnjo okrepitev pravice do anonimnosti darovalcev in prejemnikov ob sočasnem zagotavljanju varne možnosti sledenja organov do darovalcev in prejemnikov za strogo zdravstvene namene.
The Committee on Legal Affairs would also like to propose measures to further strengthen the rights of anonymity of donors and recipients while guaranteeing a safe possibility to trace back organs to donors and recipients for strictly medical purposes.
Namen treh predlogov sprememb je zmanjšati tveganje za trgovino z organi in za druge neetične in nezakonite dejavnosti.
Three amendments aim at minimising the risk of organ trafficking and other unethical and illegal activities.
Končno odbor predlaga številne manjše predloge sprememb za izboljšanje besedila na različne načine.
Finally the Committee proposes a number of minor amendments to improve the text in various ways.
(14) Osebje, ki neposredno sodeluje pri darovanju, pridobivanju, testiranju, konzerviranju, prevozu in presajanju človeških organov, mora biti ustrezno kvalificirano in usposobljeno.
(14) Personnel directly involved in the donation, procurement, testing, preservation, transport and transplantation of human organs should be suitable qualified and trained.
(14) Osebje, ki neposredno sodeluje pri darovanju, pridobivanju, testiranju, določanju značilnosti, konzerviranju, prevozu in presajanju človeških organov, mora biti ustrezno kvalificirano in usposobljeno.
(14) Personnel directly involved in the donation, procurement, testing, characterisation, preservation, transport and transplantation of human organs should be suitable qualified and trained.
Seznam postopkov iz člena 2(1) vključuje tudi „določanje značilnosti“.
The listing of procedures provided in Article 2(1) also includes "characterisation".
(16a) Boj proti trgovini s človeškimi organi ne bi smel ostati samo v pristojnosti Evropske unije.
(16a) Combating organ trafficking should not remain the responsibility of the European Union alone.
Tudi države članice bi morale sprejeti temu namenjene ukrepe, vključno z zmanjšanjem povpraševanja, učinkovitejšim spodbujanjem darovanja organov, ohranitvijo stroge zakonodaje glede živečih darovalcev, zagotovitvijo preglednosti nacionalnih registrov in čakalnih list, določitvijo pravne odgovornosti medicinskega osebja v zvezi z odkrivanjem nepravilnosti in z izmenjavo informacij.
Member States should also take measures to that end, including reducing demand, promoting organ donation more effectively, maintaining strict legislation with regard to live donors, guaranteeing transparency of national registers and waiting lists, establishing the legal responsibility of the medical profession for tracking irregularities, and sharing information.
Člen 4 – odstavek 2 – točka e a (novo)
Article 4 – paragraph 2 – point e a (new)
(ea) standardnih operativnih postopkov za odkrivanje in omejitev tveganja za neetične ali nezakonite dejavnosti, zlasti za odločitve o pridobivanju in presajanju organov.
(ea) standard operating procedures for tracing and limiting the risks of unethical or illegal activities, particularly concerning decisions for organ procurement and transplantation .
Člen 10 – odstavek 3 – točka b a (novo)
Article 10 – paragraph 3 – point b a (new)
(a) nepooblaščeno dostopanje do podatkov ali sistemov, ki omogočajo identifikacijo darovalca ali prejemnika;
(a) the unauthorised accessing of data or systems permitting the identification of donors or recipients;
(b) vsako uporabo sistemov ali podatkov, ki omogočajo identifikacijo darovalca ali prejemnika, da bi jih izsledili za namene, ki niso potrebni iz zdravstvenih razlogov.
(b) any use which is made of systems or data permitting the identification of donors or recipients with a view to tracing donors or recipients otherwise than for necessary medical purposes.
Kazni so potrebne, da bi ljudi odvrnili od tega, da bi sisteme uporabljali za nepooblaščene raziskave.
Penalties are needed to deter people from attempting to use the systems for unauthorized searches.
Države članice zagotovijo sistem za poročanje, raziskovanje, registracijo ter pošiljanje ustreznih in potrebnih informacij o hudih neželenih dogodkih in reakcijah, ki lahko vplivajo na kakovost in varnost človeških organov ter se jih lahko pripiše pridobivanju, testiranju , konzerviranju in prevozu organov, kakor tudi o ugotavljanju kakršnih koli hudih neželenih reakcij med presaditvijo ali po njej, ki bi lahko bile povezane s temi dejavnostmi.
Member States shall ensure that there is a reporting system in place to report, investigate, register and transmit relevant and necessary information concerning serious adverse events and reactions that may influence the quality and safety of human organs and which may be attributed to the procurement, testing, preservation and transport of organs, as well as any serious adverse reaction observed during or after transplantation which may be connected to those activities.
Seznam postopkov iz člena 2(1) vključuje tudi „konzerviranje“, upoštevanje vprašanj, povezanih s konzerviranjem, kot vzroka za resne neželene dogodke, pa je bržkone potencialno koristno.
The listing of procedures provided in Article 2(1) also includes "preservation" and it seems potentially beneficial to take issues relating to preservation into account as a cause for serious adverse events.
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 v prvem kolenu 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 prednostno obravnavana.
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.
Komisija v tesnem sodelovanju z državami članicami, Evropskim parlamentom in zadevnimi 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 expressed wishes of citizens consenting to the donation of organs after they are deceased are taken into account in as many Member States as possible.
Države članice okrepijo svoje sodelovanje v okviru Interpola in Europola, da bi učinkoviteje reševale problem trgovine z organi.
Member States shall intensify their cooperation under the auspices of Interpol and Europol in order to address the problem of trafficking in organs more effectively.
Države članice za zmanjšanje tveganja trgovine z organi v Evropski 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 medicinskega osebja v zvezi z odkrivanjem nepravilnosti in izmenjujejo informacije.
Member States shall, in order to minimise the risk of organ trafficking in the European 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 profession for tracking irregularities, and share information.