natgillin/translations-raw huggingface dataset:
PISMO ODBORA ZA KMETIJSTVO IN RAZVOJ PODEŽELJA
LETTER OF THE COMMITTEE ON AGRICULTURE AND RURAL DEVELOPMENT
gospod Giuseppe Gargani
Mr Giuseppe Gargani
predsednik Odbora
Chairman of the Committee on
za pravne zadeve
Legal Affairs
gospod József Szájer
Mr József Szájer
Zadeva: Predlog uredbe Evropskega parlamenta in Sveta o prilagoditvi nekaterih aktov, za katere se uporablja postopek iz člena 251 Pogodbe, sklepu Sveta 1999/468/ES, kakor je bil spremenjen s sklepom 2006/512/ES, glede regulativnega postopka s pregledom (OMNIBUS I) (KOM(2007)741).
Subject: Proposal for a Regulation of the European Parliament and of the Council adapting a number of instruments subject to the procedure referred to in Article 251 of the Treaty to Council Decision 1999/468/EC, as amended by Decision 2006/512/EC, with regard to the regulatory procedure with scrutiny (OMNIBUS I) (COM(2007) 741)
Spoštovani gospod Gargani, spoštovani gospod Szájer
Dear Mr Gargani, dear Mr Szaijer,
Odbor za kmetijstvo in razvoj podeželja je pregledal omenjene predloge, tj. člen 5.5 (Uredba (ES) št. 138/2004 Evropskega parlamenta in Sveta o ekonomskih računih za kmetijstvo v Skupnosti) .
The Committee on Agriculture and Rural Development has scrutinized the above-mentioned proposal, i.e. Annex 5.5 (Regulation (EC) No 138/2004 of the European Parliament and of the Council of 5 December 2003 on the economic accounts for agriculture in the Community).
Odbor ne nasprotuje predlagani prilagoditvi, saj se vsi postopki komitologije spremenijo v regulativni postopek s pregledom.
The Committee has no objections to the proposed realignment, as all comitology-procedures are changed to regulatory procedure with scrutiny (RPS).
predsednik pripravljavec mnenja
Chairman Draftsman
– ob upoštevanju predloga Komisije Svetu ( KOM(2007)0753 ),
– having regard to the Commission proposal to the Council ( COM(2007)0753 ),
– ob upoštevanju člena 83 Pogodbe ES, v skladu s katerim se je Svet posvetoval s Parlamentom ( C6‑0475/2007 ),
– having regard to Article 83 of the EC Treaty, pursuant to which the Council consulted Parliament ( C6‑0475/2007 ),
– ob upoštevanju poročila Odbora za pravne zadeve ( A6‑0089/2008 ),
– having regard to the report of the Committee on Legal Affairs ( A6‑0089/2008 ),
POSVETOVALNA SKUPINA
CONSULTATIVE WORKING PARTY
PRAVNIH SLUŽB
OF THE LEGAL SERVICES
V skladu z Medinstitucionalnim sporazumom z dne 20. decembra 1994 o pospešenem delovnem postopku za uradno kodifikacijo zakonodajnih besedil, še posebej z njegovo 4. točko, se je posvetovalna skupina, ki jo sestavljajo predstavniki pravnih služb Evropskega parlamenta, Sveta in Komisije, srečala 4. decembra 2007, da bi med drugim preučila omenjeni predlog, ki ga je predstavila Komisija.
Having regard to the Interinstitutional Agreement of 20 December 1994 on an accelerated working method for official codification of legislative texts, and in particular to point 4 thereof, the Consultative Working Party, consisting of the respective legal services of the European Parliament, the Council and the Commission, met on 4 December 2007 for the purpose of examining, among others, the aforementioned proposal submitted by the Commission.
Posvetovalna delovna skupina je na srečanju preučila
In the course of examining
Posvetovalna delovna skupina je imela na voljo 19 uradnih jezikovnih različic, svoje delo pa je opravila na podlagi francoske različice, saj je bila francoščina izvorni jezik delovnega dokumenta. predlog uredbe Sveta, ki kodificira Uredbo Sveta (EGS) št. 479/92 z dne 25. februarja 1992 o uporabi člena 85(3) Pogodbe za nekatere skupine sporazumov, sklepov in usklajenih ravnanj med prevozniki v linijskem prevozu po morju (konzorciji), in soglasno prišla do naslednjih ugotovitev:
The Consultative Working Party had at its disposal 19 language versions of the proposal and worked on the basis of the French version, being the original-language version of the working document. the proposal for a Council regulation codifying Council Regulation (EEC) No 479/92 of 25 February 1992 on the application of Article 85(3) of the Treaty to certain categories of agreements, decisions and concerted practices between liner shipping companies (consortia), the Working Party established the following points by common accord:
Legalizacija teh sporazumov je ukrep, ki lahko ugodno prispeva k izboljšanju konkurenčnosti ladijskega prevoza v Skupnosti".
The legalisation of these agreements is a measure which can make a positive contribution to improving the competitiveness of shipping in the Community’.
Seveda pa bi bilo treba preštevilčiti sedanje uvodne izjave 5 do 8.
Consequently, the recitals currently numbered 5 to 8 should be renumbered.
o darovanju in presajanju organov: politični ukrepi na ravni EU
on organ donation and transplantation: Policy actions at EU level
MNENJE Odbora za pravne zadeve ...........................................................................18
OPINION of the Committee on Legal Affairs ......................................................17
MNENJE Odbora za državljanske svoboščine, pravosodje in notranje zadeve 21
OPINION of the Committee on Civil Liberties, Justice and Home Affairs 20
– ob upoštevanju člena 152(4)(a) Pogodbe o ES,
– having regard to Article 152(4)(a) of the EC Treaty,
– ob upoštevanju sporočila Komisije o darovanju in presajanju organov: politični ukrepi na ravni EU (KOM (2007)0275) in delovnega dokumenta služb Komisije, ki je priložen sporočilu: Ocena učinka SEC(2007)0705 ,
– having regard to the Commission Communication on Organ Donation and Transplantation: Policy Actions at EU level (COM (2007)0275) and the Commission Staff Working Document accompanying the Communication: Impact Assessment ( SEC(2007)0705 ),
– ob upoštevanju Direktive 2004/23/ES Evropskega parlamenta in Sveta o določitvi standardov kakovosti in varnosti, darovanja, pridobivanja, testiranja, predelave, konzerviranja, shranjevanja in razdeljevanja človeških tkiv in celic
– having regard to Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells
– ob upoštevanju Direktive Evropskega parlamenta in Sveta 95/46/ES z dne 24. oktobra 1995 o varstvu posameznikov pri obdelavi osebnih podatkov in o prostem pretoku takih podatkov
– having regard to Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data
UL L 281, 23.11.1995, str.
OJ L 281,23.11.1995, p.
– ob upoštevanju Direktive 2002/58/ES evropskega parlamenta in Sveta z dne 12. julija 2002 o obdelavi osebnih podatkov in varstvu zasebnosti na področju elektronskih komunikacij
- having regard to Directive 2002/58/EC of the European Parliament and of the Council of 12 July 2002 concerning the processing of personal data and the protection of privacy in the electronic communications sector
– ob upoštevanju Direktive 2001/20/ES Evropskega parlamenta in Sveta z dne 4. aprila 2001 o približevanju zakonov in drugih predpisov držav članic v zvezi z izvajanjem dobre klinične prakse pri kliničnem preskušanju zdravil za ljudi
- having regard to Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use
– ob upoštevanju vodilnih načel Svetovne zdravstvene organizacije o presajanju človeških organov,
– having regard to the World Health Organisation's Guiding Principles on Human Organ Transplantation,
– ob upoštevanju Konvencije Sveta Evrope o človekovih pravicah v zvezi z biomedicino in njenega dodatnega protokola o presaditvi človeških organov in tkiv,
– having regard to the Council of Europe Convention on Human Rights and Biomedicine, and its additional protocol concerning Transplantation of Organs and Tissues of Human Origin,
– ob upoštevanju poročila Sveta Evrope o napotkih za zagotavljanje varnosti in kakovosti organov, tkiv in celic
– having regard to the Council of Europe report "Guide to the safety and quality assurance for organs, tissues and cells"
Druga izdaja, 2004. ,
Second edition, 2004. ,
– ob upoštevanju dokumenta s prvega srečanja nacionalnih strokovnjakov o darovanju in presajanju organov na ravni Skupnosti, SANCO C6 EFZ/gsc D (2007) 360346, 13. september 2007,
– having regard to a document from the first national expert meeting on organ donation and transplantation at Community Level, SANCO C6 EFZ/gsc D (2007) 360346, 13 September 2007,
– ob upoštevanju poročila Odbora za okolje, javno zdravje in varnost hrane ter mnenj Odbora za pravne zadeve in Odbora za državljanske svoboščine, pravosodje in notranje zadeve ( A6-0090/2008 ),
– having regard to the report of the Committee on the Environment, Public Health and Food Safety and the opinions of the Committee on Legal Affairs and the Committee on Civil Liberties, Justice and Home Affairs ( A6‑0090/2008 ),
A. ker potrebe po presajanju organov v Evropi neprestano naraščajo in so že večje od števila darovanih organov; ker je na čakalnih listah v Evropi več kot 60.000 bolnikov, ki potrebujejo presaditev organov, in ker veliko število bolnikov zaradi kroničnega pomanjkanja organov umre; ker se čakalni seznami kljub porastu števila darovalcev niso skrajšali,
A. whereas the need for organ transplantation in Europe has increased steadily and more rapidly than the number of organs donated, whereas there are more than 60 000 patients in need of transplants on waiting lists across Europe and whereas a significant number of patients die as a result of the chronic shortage of organs, whereas the increase in the number of donors does not lead to a reduction of the waiting lists,
B. ker se trgovina z organi, komercializacija in presaditveni turizem naglo razraščajo, kar je v neskladju s spoštovanjem človekovega dostojanstva; ker obstaja povezava med pomanjkanjem organov ter trgovino z njimi; ker je potrebnih več podatkov o trgovini z organi,
B. whereas organ trafficking, commercialism and transplant tourism are rapidly developing, which is inconsistent with respect for human dignity; whereas there is a link between organ shortage and organ trafficking, whereas more data on organ trafficking are needed,
C. ker se pri izvajanju nezakonitih komercialnih presaditev organov varnostna vprašanja pogosto ne upoštevajo, kar lahko ogrozi življenje darovalca in prejemnika,
C. whereas safety issues are often ignored when illegal commercial organ transplantation is practised, which may put the life of the donor and the recipient at risk,
D. ker štiri države članice še niso ratificirale konvencije Združenih narodov proti mednarodnemu organiziranemu kriminalu, pet držav članic ni ratificiralo protokola o preprečevanju, zatiranju in kaznovanju trgovine z ljudmi, predvsem ženskami in otroki, ki dopolnjuje omenjeno konvencijo (Palermski protokol), devet držav članic pa ni ratificiralo izbirnega protokola h konvenciji Združenih narodov o otrokovih pravicah glede prodaje otrok, otroške prostitucije in otroške pornografije,
D. whereas four Member States have still not ratified the United Nations Convention against Transnational Organized Crime, five Member States have not ratified its supplementary Protocol to Prevent, Suppress and Punish Trafficking in Persons, Especially Women and Children ("the Palermo Protocol") and nine Member States have not ratified the UN Optional Protocol to the Convention on the Rights of the Child on the sale of children, child prostitution and child pornography,
E. ker postaja trgovina z organi in tkivi, kljub sedanjim razmeroma nizkim ocenam v primerjavi z drugimi oblikami nezakonite trgovine, vse večji svetovni problem, ki se pojavlja znotraj nacionalnih meja in sega čeznje, in ker jo usmerja povpraševanje (v Evropi je po ocenah 150–250 primerov letno),
E. whereas although current estimates put organ trafficking at a relatively low level among all forms of trafficking, trafficking in organs and tissues is becoming an increasing global problem which occurs within and across national borders and is demand-driven (estimation of 150-250 cases/year in Europe),
F. ker je trgovina z organi in tkivi oblika trgovine z ljudmi, ki pomeni resne kršitve temeljnih človekovih pravic, zlasti človekovega dostojanstva in telesne integritete, in ker lahko zmanjša zaupanje državljanov v zakoniti sistem za presajanje organov, kar lahko vodi v nadaljnje pomanjkanje prostovoljno darovanih organov in tkiv,
F. whereas trafficking in organs and tissues is a form of trafficking in human beings, which entails serious violations of fundamental human rights, and in particular of human dignity and physical integrity and can undermine citizens' confidence in the legitimate transplantation system, which may lead to further shortage of supply of voluntarily donated organs and tissues,
G. ker so kakovost, varnost, učinkovitost in preglednost bistvene, če želi družba izkoristiti možnosti, ki jih lahko presajanje ponudi kot vrsta zdravljenja,
G. whereas quality, safety, efficacy and transparency are essential if society is to reap the benefits transplantation can offer as a therapy,
H. ker je presajanje organov edini način zdravljenja, ki je na voljo ob dokončni odpovedi organov, kot so jetra, pljuča in srce, in ker je tako zdravljenje pri dokončni ledvični odpovedi stroškovno najučinkovitejše; ker je mogoče s presaditvijo organa rešiti življenje in izboljšati njegovo kakovost,
H. whereas organ transplantation is the only available treatment for end-stage failure of organs such as the liver, lung and heart and the most cost-effective treatment for end-stage kidney failure; whereas organ transplantation provides the possibility of saving lives and of offering a better quality of life,
I. ker obstajajo med državami članicami in v državah samih velike razlike v številu presaditev, virih organov (živi ali umrli darovalci) ter celo neskladja v zahtevah glede kakovosti in minimalnih varnostnih zahtevah pri darovanju in presajanju organov, hkrati pa se organizacijski pristop k presajanju od države do države razlikuje, kar je v EU privedlo do neenotnih standardov,
I. whereas there are important differences between and within Member States with respect to rates of transplant, to the source (living or deceased donor) of organs, and even discrepancies in quality and minimum safety requirements for organ donation and transplantation, while the organisational approach to transplantation varies from country to country leading to uneven standards across the EU,
J. ker se pravni sistemi v državah članicah razlikujejo (privolitev, zavrnitev) in izkušnje različnih držav članic kažejo, da je vpliv pravnega sistema na število darovalcev precej omejen,
J. whereas Member States have different legal frameworks (opt-in, opt-out) and experiences in different Member States show that the impact of the legal system on the number of donors is rather limited,
K. ker lahko presaditev pogosto nadomesti le intenzivna nega, ki je za bolnika neprijetna in obremeni zdravstveni sistem ter družino in negovalce bolnikov,
K. whereas the alternative to transplantation is often intensive care, which is unpleasant for the patient and places a burden on healthcare systems and the family and carers of patients,
L. ker sta darovanje in presajanje organov občutljivi in zapleteni vprašanji, ki ne vključujeta le medicinskih, ampak tudi pravne in etične vidike ter za svoj razvoj potrebujeta sodelovanje celotne civilne družbe,
L. whereas organ donation and transplantation are sensitive and complex issues that encompass not only medical but also legal and ethical aspects, which require the full participation of civil society for their development,
M. ker obstaja pri uporabi organov za zdravljenje tveganje prenosa nalezljivih in drugih bolezni,
M. whereas the use of organs in therapy contains a risk of transmission of infectious and other diseases,
O. ker obstoječe izkušnje (npr. španski model, belgijski projekt GIFT ter projekta DOPKI in Alliance-O) kažejo, da so rezultati dobri in jih je treba upoštevati,
O. whereas existing experience (e.g. Spanish model, Belgian GIFT project, DOPKI, Alliance-O) shows positive results and should be taken into account,
1. pozdravlja sporočilo Komisije o darovanju in presajanju organov: politični ukrepi na ravni EU, v katerem je predlagan integriran tristebrni pristop, ki je zelo cenjen;
Welcomes the Commission Communication "Organ Donation and Transplantation: Policy Actions at EU level" which proposes a very much appreciated integrated three-pillar approach;
PRAVNI INSTRUMENT
LEGAL INSTRUMENT
3. poudarja, da mora novi zakonodajni dokument dopolniti in okrepiti prizadevanje držav članic za doseganje dejavne in učinkovite metode usklajevanja, ne da bi se pri tem preprečevala uvedba ali ohranitev strožjih ukrepov;
Points out that the new legislative document should complement and reinforce efforts made by Member States to achieve an active and efficient method of coordination without preventing the introduction or maintenance of more stringent measures;
SODELOVANJE MED DRŽAVAMI ČLANICAMI
COOPERATION BETWEEN MEMBER STATES
7. poudarja, da je darovanje organov darilo in da je zato pri iskanju rešitve za resno pomanjkanje organov izjemno pomembno spoštovati in varovati svobodo pri odločanju o tem, ali bo nekdo daroval organe ali ne;
Points out that organ donation is a gift; therefore stresses that, while finding an answer to the severe organ shortage in Europe is extremely important, the free choice to donate or not to donate an organ needs to be respected and protected as well;
9. zato trdno verjame, da imajo države članice EU veliko možnosti za delitev strokovnega znanja in izkušenj, na osnovi katerih se lahko poveča število darovalcev ter izenači dostop do presajanja v vsej EU; zato pričakuje akcijski načrt Komisije za okrepljeno sodelovanje med državami članicami, da se
Strongly believes, therefore, that there is significant potential for sharing expertise between EU Member States which can increase donor rates and equalise access to transplantation across the EU; hence, looks forward to the Commission's Action Plan for strengthened cooperation between Member States in order to:
· poveča razpoložljivost organov,
· increase organ availability,
· izboljšata učinkovitost in dostopnost sistemov za presajanje organov,
· enhance the efficiency and accessibility of transplantation systems,
· poveča javna ozaveščenost,
· increase public awareness,
· zagotovita kakovost in varnost;
· guarantee quality and safety;
11. poudarja, da so države članice same odgovorne za svoj pravni model; ugotavlja, da v EU obstajata dva modela, ki imata različne oblike; meni, da ni treba prilagajati ali usklajevati pravnih sistemov; poziva države članice, naj v svoji zakonodaji uvedejo možnost določitve nacionalnega predstavnika, ki lahko odloča o darovanju po nekogaršnji smrti;
Points out that Member States are responsible for their own legal model; notes that in the EU two models exist, each with different variants; considers it unnecessary to adapt or harmonise legal systems; invites Member States to introduce into their legislation the possibility to appoint a legal representative who can decide on donation after one's death;
· ozaveščajo, izobražujejo in usposabljajo medicinsko in paramedicinsko osebje,
· sensitizing, educating and training medical and paramedical staff,
· finančno podpirajo bolnišnice pri imenovanju internih koordinatorjev presaditev (zdravniki na oddelkih intenzivne nege, ki jim pomaga medicinska ekipa); njihova naloga bi bila aktivna določitev možnih darovalcev in stik z njihovimi družinami,
· supporting hospitals financially to appoint "in-house transplant coordinators" (doctors working inside the intensive care units who are supported by a medical team); their task would be to actively identify potential donors and approach their families,
· izvajajo programe za izboljšanje kakovosti v vseh bolnišnicah ali skupinah bolnišnic v Evropi, kjer se pokažejo možnosti za darovanje organov;
· implementing quality improvement programmes in every hospital or cluster of hospitals across Europe where there is proven evidence of potential for organ donation;
14. meni, da so mogoče presaditve organov, ki niso optimalni; v takih primerih bi morala imeti skupina za presajanje po posvetu z bolnikom in/ali njegovo družino možnost na osnovi analize tveganj in koristi odločati o uporabi organov za posamezne bolnike;
Considers that transplants can be carried out using a sub-optimal organ; it would then be for the transplant team, acting in consultation with the patient and/or his or her family, to make decisions about the use of organs for individual patients on the basis of a risk-benefit analysis;
18. se zaveda, da biotehnologija že ponuja rešitve za tveganje zavrnitve presajenih organov, na primer z zdravljenjem, ki zmanjšuje stopnjo zavrnitve, kar bo hkrati prispevalo k večji razpoložljivosti organov, saj bodo zdravniki zavračanje lahko zdravili ali celo preprečevali; meni, da to podpira uporabo organov razširjenega kroga darovalcev, saj se zmanjšuje tveganje, ki je povezano s programi za te kroge;
Recognises that biotechnology is already offering solutions to the risk of rejection of transplanted organs, for example through treatments that reduce rates of rejection, which will in turn support the availability of more organs, by allowing doctors to treat or even prevent rejection; argues that this would help support the “expanded” donor pool, by reducing the risk associated with expanded organ programmes;
24. odločno poziva države članice, naj sprejmejo ali ohranjajo stroge zakonske določbe o presajanju organov živih darovalcev, ki niso sorodniki, da bo sistem pregleden in bo izključeval možnosti za nezakonito prodajo organov ali prisilo darovalcev; tako se organi živih darovalcev, ki niso sorodniki, lahko darujejo v skladu z zahtevami nacionalnega prava in po odobritvi ustrezne neodvisne ustanove;
Urges the Member States to adopt or maintain strict legal provisions in connection with transplantation from unrelated living donors, in order to make the system transparent and exclude the possibility of illicit organ selling or coercion of donors; thus, donations by unrelated living donors could only be made under the conditions defined in national law and following authorisation by a suitable independent body;
27. meni, da bo biotehnologija, če bo zagotovljena sledljivost, raziskovalcem v prihodnosti omogočila, da pridobivajo organe iz obstoječih tkiv in celic bolnikov ali darovalcev tkiv; poziva Komisijo, naj spodbuja takšne raziskave, ki jih pogosto izvajajo novonastala evropska mala in srednje velika biotehnološka podjetja, v kulturnih in etičnih okvirih, ki veljajo v državah članicah, ter v skladu z Listino o temeljnih pravicah in konvencijo o biomedicini Sveta Evrope;
Considers that, in the future, provided that traceability is guaranteed, biotechnology may offer the possibility for researchers to grow organs from existing tissues and cells, either from the patients themselves or from other tissue donors; asks the Commission to promote such research, which is often carried out by Europe’s emerging SME biotech companies within the cultural and ethical frameworks laid down in the Member States and in the Charter on Fundamental Rights and the Convention on biomedicine of the Council of Europe;
UČINKOVITOST IN DOSTOPNOST SISTEMOV ZA PRESAJANJE ORGANOV
EFFICIENCY AND ACCESSIBILITY OF TRANSPLANTATION SYSTEMS