FrancophonIA/Publications_Medical_Domain_UE huggingface dataset:
English: Looking at flows of patients travelling for healthcare after receiving prior authorisation, the greatest flow was from France to Spain.
Slovenian: Kar zadeva pretoke pacientov, ki po izdani predhodni odobritvi potujejo zaradi zdravstvenega varstva, je bil največji pretok iz Francije v Španijo.
English: Delegated powers
Slovenian: Prenos pooblastil
English: An additional call took place in 2018 allowing more Member States to participate in the eHDSI.
Slovenian: Leta 2018 je bil izveden dodatni razpis, s katerim se je še več državam članicam omogočilo sodelovanje v infrastrukturi za digitalne storitve e-zdravja.
English: Based on responses provided by Member States approximately €65,000,000 was spent across all EU countries collectively on care with and without PA in 2016.
Slovenian: Glede na odgovore držav članic je bilo leta 2016 za oskrbo s predhodno odobritvijo in brez nje v vseh državah EU skupaj porabljenih približno 65 000 000 EUR.
English: [45: Based on Article 11(2)(a), (c) and (d) of the Directive.
Slovenian: [45: Na podlagi člena 11(2)(a), (c) in (d) Direktive.
English: However, Article 4(4) requires Member States to ensure that healthcare providers apply the same scale of fees to patients from other Member States as they do for domestic patients in a comparable medical situation.
Slovenian: Pri tem pa morajo v skladu s členom 4(4) zagotoviti, da izvajalci zdravstvenega varstva pacientom iz drugih držav članic zaračunajo enake cene kot domačim pacientom s primerljivim zdravstvenim stanjem.
English: Data was received in 2015 from 23 Member States and Norway; in 2016, from all 28 Member States plus Norway and Iceland; and in 2017 from 26 Member States.
Slovenian: Leta 2015 je podatke predložilo 23 držav članic in Norveška, leta 2016 jih je predložilo vseh 28 držav članic ter Norveška in Islandija, leta 2017 pa 26 držav članic.
English: The Directive (Article 8(2)) introduces the possibility for Member States to make reimbursement of costs for healthcare received in another Member State subject to prior authorisation.
Slovenian: Z Direktivo (člen 8(2)) se za države članice uvaja možnost, da za povračilo stroškov zdravstvenega varstva, prejetega v drugi državi članici, zahtevajo predhodno odobritev.
English: However, the fact that there has been a slow but steady increase in the number of citizens travelling to receive care suggests that the increase of information available on NCP websites has reduced the number of requests patients made to NCPs.
Slovenian: Vendar dejstvo, da se število državljanov, ki potujejo zaradi oskrbe, počasi, a vztrajno povečuje, kaže, da se je s povečanjem količine razpoložljivih informacij na spletiščih nacionalnih kontaktnih točk zmanjšalo število poizvedb pacientov pri nacionalnih kontaktnih točkah.
English: ][46: Commission Implementing Directive 2012/52/EU of 20 December 2012 laying down measures to facilitate the recognition of medical prescriptions issued in another Member State (OJ L 356, 22.12.2012, p.
Slovenian: ][46: Izvedbena direktiva Komisije 2012/52/EU z dne 20. decembra 2012 o določitvi ukrepov za olajšanje priznavanja zdravniških receptov, predpisanih v drugi državi članici (UL L 356, 22.12.2012, str.
English: ][6: Article 7(6) and Article 9.
Slovenian: ][6: Člen 7(6) in člen 9.
English: Patient mobility with prior authorisation
Slovenian: Mobilnost pacientov s predhodno odobritvijo
English: ][8: Article 4(2)(c), (e)-(f), 4(3), 4(4), 5(b)-(d), 7(1), 9(4)-(5).
Slovenian: ][8: Člen 4(2)(c), (e) in (f), člen 4(3), člen 4(4), člen 5(b), (c) in (d), člen 7(1), člen 9(4) in (5).
English: For the years 2015 and 2017, when France was not able to provide data on patient mobility with PA, Luxembourg to Germany and Ireland to UK were amongst the most common cases of patient mobility.
Slovenian: V letih 2015 in 2017, ko Francija ni mogla predložiti podatkov o mobilnosti pacientov s predhodno odobritvijo, so bili najpogostejši primeri mobilnosti pacientov mobilnost iz Luksemburga v Nemčijo in iz Irske v Združeno kraljestvo.
English: The flow maps, as well as the raw data, show clearly that most patients travel from France to other countries, with patient mobility from France to Spain and France to Germany being the most prevalent.
Slovenian: Diagrami pretoka tako kot neobdelani podatki jasno kažejo, da največ pacientov potuje iz Francije v druge države, pri čemer prevladuje mobilnost pacientov iz Francije v Španijo in iz Francije v Nemčijo.
English: Patient mobility not subject to prior authorisation
Slovenian: Mobilnost pacientov, za katero se ne zahteva predhodna odobritev
English: The aggregated data reported by Member States on the number of requests for PA in 2015, 2016 and 2017 show that such requests remain generally low.
Slovenian: Zbirni podatki, ki so jih države članice sporočile o številu zahtevkov za predhodno odobritev v letih 2015, 2016 in 2017, kažejo, da jih je na splošno še vedno malo.
English: [28: IF SBH (International Federation for Spina Bifida and Hydrocephalus) and EDF (European Disability Forum), "Impact of Cross-border Healthcare on Persons with Disabilities and Chronic Conditions", 2017 ][29: https://ec.europa.eu/health/sites/health/files/cross_border_care/docs/2015_operation_report_dir201124eu_en.pdf]
Slovenian: [28: IF SBH (Mednarodna zveza za spino bifido in hidrocefalijo) in EDF (Evropski invalidski forum), „Impact of Cross-border Healthcare on Persons with Disabilities and Chronic Conditions" (Učinek čezmejnega zdravstvenega varstva na invalide in osebe s kroničnimi obolenji), 2017.
English: [27: https://ec.europa.eu/health/cross_border_care/key_documents_en]
Slovenian: [27: https://ec.europa.eu/health/cross_border_care/key_documents_sl.]
English: Regarding the voluntary cooperation structure (eHealth, HTA, ERNs), the Directive provides the basis for the Commission and Member States to enhance cross-border cooperation and on how broader technological and societal challenges might be met. A number of developments regarding these new perspectives are already underway.
Slovenian: Kar zadeva strukturo prostovoljnega sodelovanja (e-zdravje, ocenjevanje zdravstvene tehnologije, evropske referenčne mreže), je Direktiva podlaga, na kateri Komisija in države članice krepijo čezmejno sodelovanje in morebitne načine spopadanja s širšimi tehnološkimi in družbenimi izzivi.
English: Compliance check
Slovenian: Preverjanje skladnosti
English: [1: Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients' rights in cross-border healthcare (OJ L 88, 4.4.2011, p.
Slovenian: [1: Direktiva 2011/24/EU Evropskega parlamenta in Sveta z dne 9. marca 2011 o uveljavljanju pravic pacientov pri čezmejnem zdravstvenem varstvu (UL L 88, 4.4.2011, str.
English: Financial Implications of Patient Mobility
Slovenian: Finančne posledice mobilnosti pacientov
English: [32: https://ec.europa.eu/health/sites/health/files/technology_assessment/docs/2018_mapping_npc_en.pdf][33: Mapping of HTA national organisations programmes and processes in EU and Norway, 2017, Contract nr. 17010402/2016/734820, ISBN: 978-92-79-77080-7]
Slovenian: ][33: Vzporejanje nacionalnih organizacij, programov in postopkov za ocenjevanje zdravstvene tehnologije v EU in na Norveškem, 2017, pogodba št. 17010402/2016/734820, ISBN: 978-92-79-77080-7.]
English: ][31: https://ec.europa.eu/health/cross_border_care/events/ev_20161024_en]
Slovenian: ][31: https://ec.europa.eu/health/cross_border_care/events/ev_20161024_sl.]
English: [34: https://ec.europa.eu/health/technology_assessment/policy/network_en][35: Commission Implementing Decision 2013/329/EU of 26 June 2013 providing the rules for the establishment,management and transparent functioning of the network of national authorities or bodies responsible for healthtechnology assessment (OJ L 175, 27.6.2013, p.
Slovenian: ][35: Izvedbeni sklep Komisije 2013/329/EU z dne 26. junija 2013 o pravilih za vzpostavitev,upravljanje in pregledno delovanje mreže nacionalnih organov ali teles, pristojnih za ocenjevanjezdravstvene tehnologije (UL L 175, 27.6.2013, str.
English: [47: Article 10(3) of the Directive.
Slovenian: [47: Člen 10(3) Direktive.
English: [41: Regulation (EU) No 1316/2013 of the European Parliament and of the Council of 11 December 2013 establishing the Connecting Europe Facility, amending Regulation (EU) No 913/2010 and repealing Regulations (EC) No 680/2007 and (EC) No 67/2010, OJ L 348, 20.12.2013, p.
Slovenian: [41: Uredba (EU) št. 1316/2013 Evropskega parlamenta in Sveta z dne 11. decembra 2013 o vzpostavitvi Instrumenta za povezovanje Evrope, spremembi Uredbe (EU) št. 913/2010 in razveljavitvi uredb (ES) št. 680/2007 in (ES) št. 67/2010 (UL L 348, 20.12.2013, str.
English: ][9: Article 4(2)(d).]
Slovenian: ][9: Člen 4(2)(d).]
English: Completeness check
Slovenian: Preverjanje popolnosti
English: ][2: Regulations (EC) No 883/2004 of the European Parliament and of the Council of 29 April 2004 on the coordination of social security systems (OJ L 166, 30.4.2004, p. 1) and 987/2009 laying down the procedure for implementing Regulation (EC) No 883/2004 (OJ L 284, 30.10.2009, p.1).]
Slovenian: ][2: Uredba (ES) št. 883/2004 Evropskega parlamenta in Sveta z dne 29. aprila 2004 o koordinaciji sistemov socialne varnosti (UL L 166, 30.4.2004, str. 1) in Uredba (ES) št. 987/2009 o določitvi podrobnih pravil za izvajanje Uredbe (ES) št. 883/2004 (UL L 284, 30.10.2009, str.
English: In 2017 a total of 74,589 enquiries were received across 22 Member States and Norway, reflecting a very similar use of NCPs to that reported for 2016 when a total of 69,723 enquires were counted across 28 Member States and Norway and in 2015 when a total of 59,558 requests were received in 19 Member States.
Slovenian: Leta 2017 je bilo v 22 državah članicah in na Norveškem prejetih skupno 74 589 poizvedb, kar kaže na zelo podobno uporabo nacionalnih kontaktnih točk, kot je bila sporočena za leto 2016, ko je bilo v 28 državah članicah in na Norveškem skupno podanih 69 723 poizvedb, ter za leto 2015, ko je bilo v 19 državah članicah prejetih 59 558 zahtevkov.
English: [49: "Study on Cross-Border Cooperation: Capitalising on existing initiatives for cooperation in cross-border regions", Gesundheit Österreich Forschungs und Planungs GmbH, SOGETI, Maastricht University, 2017][50: See the General Secretariat of the Benelux Union studies, e.g. "Barriers and Opportunities in the Benelux", February 2018.]
Slovenian: [49: „Study on Cross-Border Cooperation: Capitalising on existing initiatives for cooperation in cross-border regions" (Študija o čezmejnem sodelovanju: izkoriščanje obstoječih pobud za sodelovanje v čezmejnih regijah), Gesundheit Österreich Forschungs und Planungs GmbH, SOGETI, Univerza v Maastrichtu, 2017.
English: [52: Article 12(5), read together with Article 12(4)(a).
Slovenian: [52: Člen 12(5) v povezavi s členom 12(4)(a).
English: [11: Recital 38 of the Directive.]
Slovenian: [11: Uvodna izjava 38 Direktive.]
English: Two significant trends emerge from the data on the direction of patient flows, whether it is mobility with or without PA.
Slovenian: Iz podatkov o cilju pretoka pacientov, in to ne glede na to, ali gre za mobilnost s predhodno odobritvijo ali brez nje, izhajata dva pomembna trenda.
English: Firstly, the HTA Network which connects national authorities or bodies responsible for HTA.
Slovenian: Prvi je mreža za ocenjevanje zdravstvenih tehnologij, ki povezuje nacionalne organe ali telesa, pristojne za ocenjevanje zdravstvene tehnologije.
English: [3: Commission Report on the operation of Directive 2011/24/EU on the application of patients' rights in cross-border healthcare, COM(2015) 421 final, 04.09.2015.]
Slovenian: [3: Poročilo Komisije o izvajanju Direktive 2011/24/EU o uveljavljanju pravic pacientov pri čezmejnem zdravstvenem varstvu (COM(2015) 421 final z dne 4. septembra 2015).]
English: Flow Map 2 in Annex B represents the aggregated flows across 2015, 2016 and 2017 for treatment without prior authorisation.
Slovenian: V diagramu pretoka 2 v Prilogi B so prikazani zbirni pretoki v letih 2015, 2016 in 2017 v zvezi z zdravljenjem brez predhodne odobritve.
English: It requires the Commission to prepare a report in respect of the delegated powers.
Slovenian: Komisija mora v skladu s tem členom pripraviti poročilo o pooblastilu.
English: In 2015 the total number of requests granted was 180,704 across 19 Member States plus Norway; in 2016 the number of requests granted over 22 Member States amounted to 209,568; and in 2017 the total number of requests granted was 194,292 across 20 Member States.
Slovenian: Leta 2015 so bili skupno odobreni 180 704 zahtevki v 19 državah članicah in na Norveškem, leta 2016 je bilo odobrenih zahtevkov v 22 državah članicah 209 568, leta 2017 pa v 20 državah članicah 194 292.
English: Flow Map 1 in Annex B represents the aggregated flows across 2015, 2016 and 2017 for treatment requiring prior authorisation.
Slovenian: V diagramu pretoka 1 v Prilogi B so prikazani zbirni pretoki v letih 2015, 2016 in 2017 v zvezi z zdravljenjem, za katero se zahteva predhodna odobritev.
English: ][15: See e.g. Case C-205/99 Analir and Others [2001] ECR I 1271, paragraphs 35-38; case C-157/99 Smits and Peerbooms, paragraphs 80- 90.
Slovenian: ][15: Glej na primer zadevo C-205/99, Analir in drugi, Recueil 2001, str. I-1271, točke od 35 do 38; zadevo C-157/99, Smits in Peerbooms, točke od 80 do 90.
English: First, the Commission has made a legislative proposal on health technology assessment (see Chapter 4.1).
Slovenian: Komisija je na primer pripravila zakonodajni predlog o ocenjevanju zdravstvene tehnologije (glej poglavje 4.1) ter v sporočilu o digitalni preobrazbi zdravstvenega varstva in oskrbe predlagala nadaljnje ukrepe v zvezi z e-zdravjem (glej poglavje 4.2).
English: A great majority of the issues of compliance examined with Member States at issue have led to a common agreement.
Slovenian: Soglasje je bilo doseženo v zvezi z veliko večino vprašanj glede skladnosti, proučenih z zadevnimi državami članicami.
English: Figure 3: Requests for information made to NCPs
Slovenian: Slika 3: Zahtevki za informacije, ki so jih prejele nacionalne kontaktne točke
English: [17: Article 8(1) of the Directive.]
Slovenian: [17: Člen 8(1) Direktive.]
English: [14: See e.g. Case C205/99 Analir and Others [2001] ECR I1271, paragraph 38; case C-157/99 Smits and Peerbooms, paragraph 90.
Slovenian: [14: Glej na primer zadevo C-205/99, Analir in drugi, Recueil 2001, str. I-1271, točka 38; zadevo C-157/99, Smits in Peerbooms, točka 90.
English: Twenty-one infringement procedures were started for non-communication of national transposal measures.
Slovenian: Ker države članice niso sporočile nacionalnih ukrepov za prenos, je bilo začetih 21 postopkov za ugotavljanje kršitev.
English: Three Member States, with varying conditions and extent, use the former lower reimbursement level as the reference point for reimbursement of the costs of cross-border healthcare under the Directive.
Slovenian: Prejšnjo nižjo stopnjo povračila kot referenčno točko za povračilo stroškov čezmejnega zdravstvenega varstva na podlagi Direktive z različnimi pogoji in v različnem obsegu uporabljajo tri države članice.
English: [18: Article 7(4) of the Directive.]
Slovenian: [18: Člen 7(4) Direktive.]
English: [38: https://ec.europa.eu/health/technology_assessment/eu_cooperation_en][39: Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on health technology assessment and amending Directive 2011/24/EU, COM(2018)51 final, 31.01.2018. https://ec.europa.eu/health/technology_assessment/eu_cooperation_en]
Slovenian: ][39: Predlog uredbe Evropskega parlamenta in Sveta o ocenjevanju zdravstvene tehnologije in spremembi Direktive 2011/24/EU (COM(2018) 51 final z dne 31. januarja 2018).
English: ][7: Article 4(2) (a)-(b), 5(b), 6(3).
Slovenian: ][7: Člen 4(2)(a) in (b), člen 5(b) in člen 6(3).
English: Data on patient mobility
Slovenian: Podatki o mobilnosti pacientov
English: Direction of Patient Mobility
Slovenian: Cilj mobilnosti pacientov
English: ][42: https://ec.europa.eu/health/sites/health/files/ehealth/docs/ev_20161121_co10_en.pdf][43: https://ec.europa.eu/health//sites/health/files/ehealth/docs/eprescription_guidelines_en.pdf]
Slovenian: ][42: https://ec.europa.eu/health/sites/health/files/ehealth/docs/ev_20161121_co10_en.pdf.
English: This can lead to certain discrepancies.
Slovenian: Zaradi tega lahko nastanejo določena razhajanja.
English: In such cases this report contains the updated information.
Slovenian: V takih primerih to poročilo vsebuje posodobljene informacije.
English: Traceability.
Slovenian: Sledljivost.
English: In the latter case, an infringement proceeding pursuant to Article 258 TFEU is ongoing.
Slovenian: V tem zadnjem primeru še poteka postopek za ugotavljanje kršitev v skladu s členom 258 PDEU.
English: Import and export.
Slovenian: Uvoz in izvoz.
English: Some Member States would welcome an exchange of best practices in this respect.
Slovenian: Nekatere države članice bi pozdravile izmenjavo dobrih praks v zvezi s tem.
English: Cross-border movement of donors.
Slovenian: Čezmejno gibanje darovalcev.
English: According to reports from Member States, no such penalties have so far been imposed.
Slovenian: Po poročanju držav članic take kazni do zdaj še niso bile uporabljene.
English: Time off work varies from less than half a day to up to two days.
Slovenian: Dopust lahko traja od manj kot pol dneva do dveh dni.
English: Shortages, surpluses and self-sufficiency.
Slovenian: Pomanjkanje, presežek in samozadostnost.
English: At the end of 2011, 1363 blood establishments were authorised in the EU.
Slovenian: Konec leta 2011 je bilo v EU odobrenih 1 363 transfuzijskih ustanov.
English: Member States can add tests for specific components or epidemiological situations.
Slovenian: Države članice lahko dodajo teste za specifične komponente ali epidemiološke razmere.
English: Designation of competent authority or authorities
Slovenian: Imenovanje pristojnega organa ali organov
English: Data protection and confidentiality.
Slovenian: Varstvo podatkov in zaupnost.
English: In all Member States these tests are performed by authorised laboratories.
Slovenian: V vseh državah članicah te teste opravljajo pooblaščeni laboratoriji.
English: Public, national suppliers are predominant in a minority of EU countries.
Slovenian: Javni, nacionalni dobavitelji prevladujejo v manjšini držav EU.
English: The gaps and difficulties identified may suggest that a further in-depth evaluation might be useful.
Slovenian: Ugotovljene vrzeli in težave lahko kažejo, da bi lahko bila koristna nadaljnja podrobnejša ocena.
English: The Commission will follow-up with Member States to address situations where the legislation might not have been fully or correctly implemented.
Slovenian: Komisija bo nadalje spremljala države članice, da bi rešila primere, v katerih se zakonodaja morda ne izvaja v celoti ali ustrezno.
English: Combining the implementation of all three pillars, where possible, is probably the most effective way to minimise risks.
Slovenian: Združevanje izvajanja vseh treh stebrov, kadar je to mogoče, je verjetno najučinkovitejši način za zmanjšanje tveganj na najnižjo mogočo raven.
English: No problems were reported regarding the implementation of the provisions related to data protection.
Slovenian: V zvezi z izvajanjem določb o varstvu podatkov niso bile sporočene nobene težave.
English: The Commission is required to transmit these national reports to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions.
Slovenian: Komisija mora ta nacionalna poročila poslati Evropskemu parlamentu, Svetu, Ekonomsko-socialnemu odboru in Odboru regij.
English: Views vary on whether such cross-border donations are desirable.
Slovenian: Mnenja o tem, ali so taka čezmejna darovanja zaželena, se razlikujejo.
English: Significant progress has been made in many areas, often through the active support of Commission funded projects and other initiatives.
Slovenian: Na številnih področjih je napredek znaten, pogosto zaradi dejavne podpore projektov, ki jih financira Komisija, in drugih pobud.
English: [7: Links to be added once published]
Slovenian: [7: Povezave bodo dodane, ko bosta objavljena.]
English: There are a small number of international companies that supply the majority of countries.
Slovenian: Majhno število mednarodnih družb dobavlja večini držav.
English: Several Member States expressed interest in applying instead a risk-based prioritisation planning for inspections.
Slovenian: Več držav članic je izrazilo zanimanje, da se namesto tega uporabi prednostno načrtovanje inšpekcijskih pregledov na podlagi tveganja.
English: Some Member States called for more common procedures for authorisation across the Union.
Slovenian: Nekatere države članice so pozvale k enotnejšim postopkom odobritve po vsej Uniji.
English: In 2012, 22 countries reported having performed 760 on-site inspections.
Slovenian: Leta 2012 je 22 držav poročalo, da je bilo opravljenih 760 inšpekcijskih pregledov na kraju samem.
English: All Member States replied to the transposition questionnaire.
Slovenian: Vse države članice so odgovorile na vprašalnik o prenosu.
English: Irrespective of the organisational set-up, it is important that authorities have appropriate resources at their disposal to enable them to carry out the required duties, as well as to ensure their independence from economic operators in the sector and from other influences.
Slovenian: Ne glede na organizacijsko strukturo je pomembno, da imajo organi na voljo ustrezne vire, ki jim omogočajo opravljanje zahtevanih nalog ter zagotavljajo njihovo neodvisnost od gospodarskih subjektov v sektorju in od drugih vplivov.
English: Voluntary and unpaid donation (VUD)
Slovenian: Prostovoljno in brezplačno darovanje (PBD)
English: One national competent authority has taken the lead on developing such an initiative within the network of national competent authorities.
Slovenian: Eden od nacionalnih pristojnih organov je prevzel vodilno vlogo pri razvoju take pobude znotraj mreže nacionalnih pristojnih organov.
English: All Member States have appointed competent authorities for blood.
Slovenian: Vse države članice so imenovale pristojne organe za kri.
English: In some Member States, donors receive a fixed payment that is not directly related to actual costs incurred.
Slovenian: V nekaterih državah članicah darovalci prejmejo fiksno plačilo, ki ni neposredno povezano z dejanskimi stroški.
English: VUD is a factor which is not only ethical in nature, but which might also contribute to higher safety standards and, therefore, be important for the protection of human health.
Slovenian: PBD je dejavnik, ki ni zgolj etičen, temveč lahko prispeva tudi k višjim varnostnim standardom ter je zato lahko pomemben za varstvo zdravja ljudi.
English: These authorisations also cover 731 mobile sites, 534 satellite sites and 253 plasma collection centres.
Slovenian: Te odobritve vključujejo tudi 731 mobilnih enot, 534 satelitskih enot in 253 centrov za zbiranje krvne plazme.
English: 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 2002/98/EC and its implementing Directives.
Slovenian: Komisija bo razmislila o potrebi po ocenjevanju za ovrednotenje ustreznosti, učinkovitosti, uspešnosti, skladnosti in dodane vrednosti EU Direktive 2002/98/ES in njenih izvedbenih direktiv.
English: Inspections and control measures.
Slovenian: Inšpekcijski pregledi in kontrolni ukrepi.
English: Fig. 4: Countries reporting regular shortages
Slovenian: Slika 4: Države, ki poročajo o rednem pomanjkanju
English: Testing and inactivation technologies.
Slovenian: Testiranje in tehnologije inaktivacije.
English: However, some difficulties in interpretation, implementation and enforcement of the legislation were identified, in some cases due to technological and scientific advances since its adoption.
Slovenian: Vendar je bilo ugotovljenih nekaj težav pri razlagi, izvajanju in izvrševanju zakonodaje, v nekaterih primerih zaradi tehnološkega in znanstvenega napredka od njenega sprejetja.
English: In almost every country, donation promotion activities are the main actions taken to increase supply.
Slovenian: V skoraj vseh državah so dejavnosti spodbujanja darovanja glavni ukrepi za povečanje dobave.
English: Quality and safety of blood and blood components
Slovenian: Kakovost in varnost krvi in komponent krvi
English: Less than half of the countries reported having national guiding principles to define what form of compensation or other practice is allowed and under which circumstances.
Slovenian: Manj kot polovica držav je poročala, da imajo nacionalna vodilna načela za opredelitev, katera oblika nadomestila ali druga praksa je dovoljena in v kakšnih okoliščinah.
English: This topic is intrinsically linked with the promotion and success of the principle of VUD, as highlighted in recital 23 of Directive 2002/98/EC.
Slovenian: Ta tema je neločljivo povezana s spodbujanjem in uspehom načela PBD, kot je poudarjeno v uvodni izjavi 23 Direktive 2002/98/ES.
English: The implementation survey confirmed that this core responsibility of national competent authorities is well developed across the Union.
Slovenian: Anketa o izvajanju je potrdila, da je ta ključna odgovornost nacionalnih pristojnih organov dobro razvita po vsej Uniji.
English: There are differences between Member States in relation to the duration and terms of renewal of the individual authorisations.
Slovenian: Med državami članicami obstajajo razlike glede trajanja in pogojev obnove posameznih odobritev.
English: The UK and Ireland apply this policy as part of their risk mitigation strategy for transmission of variant Creutzfeldt Jacob disease.
Slovenian: Združeno kraljestvo in Irska to politiko uporabljata kot del strategije za blažitev tveganj prenosa različice Creutzfeldt-Jacobove bolezni.
English: In order to address shortages, countries can put in place policies to increase supply and to optimise usage.
Slovenian: Za reševanje težav s pomanjkanjem lahko države vzpostavijo politike za povečanje dobave in optimizacijo uporabe.
English: The ways in which EU Member States have implemented the principle of VUD are difficult to assess in a comprehensive manner.
Slovenian: Načine, kako države članice EU izvajajo načelo PBD, je težko celovito oceniti.
English: Reimbursement of travel costs can cover the actual costs or be a standard lump sum.
Slovenian: Povračilo potnih stroškov lahko krije dejanske stroške ali pa je izplačano v obliki standardnega pavšalnega zneska.
English: Almost all countries report that a donor identification system was implemented in their country, in the majority of countries at national level.
Slovenian: Skoraj vse države poročajo, da je bil v njihovi državi vzpostavljen sistem identifikacije darovalcev, v večini držav na nacionalni ravni.
English: A verification of the completeness of transposition into national legislation of the EU blood legislation, carried out by the Commission, demonstrated that it is fully transposed in all but one Member State.
Slovenian: Preverjanje popolnosti prenosa zakonodaje EU o krvi v nacionalno zakonodajo, ki ga je izvedla Komisija, je pokazalo, da je v celoti prenesena v vseh državah članicah, razen v eni.
English: There appears to be a good interconnectivity with other health-related vigilance systems, in particular on medical devices and communicable diseases.
Slovenian: Videti je, da obstaja dobra medsebojna povezanost z drugimi sistemi vigilance v zvezi z zdravjem, zlasti glede medicinskih pripomočkov in nalezljivih bolezni.
English: Accreditation, designation, authorisation or licensing of blood establishments.
Slovenian: Akreditacija, imenovanje, odobritev ali izdajanje dovoljenj transfuzijskim ustanovam.
English: Other challenges to the principle of (self-) sufficiency are outlined below.
Slovenian: Spodaj so prikazane še druge težave v zvezi z načelom (samo)zadostnosti.
English: Wherever different oversight activities (authorisation, inspection, haemovigilance) are undertaken by different authorities, good communication and coordination between respective authorities needs to be ensured.
Slovenian: Kadar različne nadzorne dejavnosti (odobritev, inšpekcija, hemovigilanca) izvajajo različni organi, je treba zagotoviti dobro komunikacijo in usklajevanje med zadevnimi organi.
English: Since 2003, a number of projects have been funded under the multi-annual programmes for Union action in the field of health addressing the area of blood and blood components.
Slovenian: Od leta 2003 je bilo financiranih več projektov v okviru večletnih programov za ukrepanje Unije na področju zdravja, ki so se nanašali na kri in komponente krvi.
English: The debate on possible compensation and incentives for donors plays an important role in supply management (see below).
Slovenian: Razprava o morebitnem nadomestilu in spodbudah za darovalce ima pomembno vlogo pri upravljanju dobave (glej spodaj).
English: The VUD survey addressed questions on the balance between supply and demand, and the measures taken to achieve sufficiency.
Slovenian: Anketa o PBD se je nanašala na vprašanja ravnotežja med ponudbo in povpraševanjem ter ukrepe, sprejete za zagotovitev zadostnosti.
English: Finally, the Commission developed, in close cooperation with the Member States, a Rapid Alert Platform for Blood (RAB) which facilitates web-based communications between Member States in case of alerts with relevance in two or more Member States.
Slovenian: Nazadnje, Komisija je v tesnem sodelovanju z državami članicami razvila platformo za hitro obveščanje o krvi (RAB), ki olajšuje spletno komuniciranje med državami članicami v primeru opozoril, ki se nanašajo na dve ali več držav članic.
English: Member States also highlight the need for good validation of testing technologies, and also pathogen inactivation technologies, in order to achieve an effective level of safety and quality.
Slovenian: Države članice poudarjajo tudi potrebo po dobri validaciji tehnologij testiranja in tehnologij inaktivacije patogenov za dosego učinkovite stopnje varnosti in kakovosti.
English: They reported conducting additional tests for syphilis, malaria, hepatitis A, hepatitis E and Parvovirus B19.
Slovenian: Poročale so o izvajanju dodatnih testov za sifilis, malarijo, hepatitis A, hepatitis E in parvovirus B19.
English: While most cross-border donations seem to be individual initiatives, Hungary and Slovakia reported organised transport for their citizens to travel to Austria for plasma donation.
Slovenian: Medtem ko je za večino čezmejnih darovanj videti, da gre za individualno pobudo, sta Madžarska in Slovaška poročali o organiziranem prevozu državljanov, ki potujejo v Avstrijo darovat krvno plazmo.
English: In a system allowing donor payment, some individuals may find the monetary remuneration so important that they might not disclose relevant medical and/or behavioural information.
Slovenian: V sistemu, ki bi dovoljeval plačevanje darovalcem, bi lahko bila denarna nagrada za nekatere tako pomembna, da ne bi razkrili bistvenih zdravstvenih in/ali vedenjskih informacij.
English: Article 26 of Directive 2002/98/EC requires Member States to submit to the European Commission, before 31 December 2003 and every three years thereafter, a report on the activities carried out in relation to the provisions of the Directive, including an account of the measures taken in relation to inspection and control.
Slovenian: V skladu s členom 26 Direktive 2002/98/ES morajo države članice pred 31. decembrom 2003 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 pregledom in kontrolo.
English: On the basis of these national reports, the Commission is required to inform the European Parliament and the Council of any necessary further measures in relation to VUD it intends to take at Union level.
Slovenian: Komisija mora na podlagi teh nacionalnih poročil Evropski parlament in Svet obvestiti o morebitnih nadaljnjih potrebnih ukrepih v zvezi s PBD, ki jih namerava sprejeti na ravni Unije.
English: 3.2 Obligations of blood competent authorities
Slovenian: 3.2 Obveznosti pristojnih organov za kri
English: 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 meetings to EU-funded projects.
Slovenian: Evropska komisija podpira izvajanje zakonodaje s strani držav članic s spodbujanjem dejavnega sodelovanja nacionalnih pristojnih organov v več dejavnostih, od dveletnih strokovnih srečanj do projektov, ki jih financira EU.
English: Many countries reported financially supporting blood establishments and local players in the organisation of such promotion activities (although the financial support in many of these countries also relates to collection, processing, storage and distribution activities).
Slovenian: Številne države so poročale, da finančno podpirajo transfuzijske ustanove in lokalne akterje pri organizaciji takih dejavnosti spodbujanja (čeprav se finančna podpora v številnih od teh držav nanaša tudi na dejavnosti zbiranja, predelave, shranjevanja in razdeljevanja).
English: While two of these latter six countries also report regular shortages in national supply, the information provided was not sufficient to establish a causal link between these shortages and the cross-border movement of donors.
Slovenian: Čeprav sta dve od teh zadnjih šestih držav poročali tudi o rednem pomanjkanju v nacionalni dobavi, poslane informacije niso bile zadostne, da bi lahko sklepali o vzročni povezavi med tem pomanjkanjem in čezmejnim gibanjem darovalcev.
English: The maximum reported values of compensation and incentives are around EUR 25-30 per donation while the reported values of refreshments and small tokens are between EUR 1 and EUR 10 per donation.
Slovenian: Najvišja sporočena vrednost nadomestil in spodbud je približno 25 EUR-30 EUR na darovanje, medtem ko je sporočena vrednost okrepčil in majhnih daril med 1 EUR in 10 EUR na darovanje.
English: Several Member States mentioned the limited role of authorities at federal/national level and pointed to the important tasks attributed to/carried out by regional competent authorities.
Slovenian: Več držav članic je omenilo omejeno vlogo organov na zvezni/nacionalni ravni in opozorilo na pomembne naloge, ki so dodeljene regionalnim pristojnim organom/jih regionalni pristojni organi izvajajo.
English: While all countries report having recall procedures in place, only 14 reported recalls (1867 in total).
Slovenian: Medtem ko vse države poročajo, da imajo vzpostavljene postopke za odpoklic, jih je o odpoklicih poročalo samo 14 (skupaj 1 867 primerov).
English: The Commission is also required to provide them with an overview report on the implementation of the requirements of the Directive, in particular as regards inspections and control.
Slovenian: Predložiti jim mora tudi pregledno poročilo o izvajanju zahtev Direktive, zlasti glede inšpekcijske in kontrolnih ukrepov.
English: As the legislation in question does not provide a basis for full harmonisation and as Directives allow the Member States a certain degree of discretion as to how to ensure their implementation, there are accordingly many differences between Member States in the approaches they have taken to implementation.
Slovenian: Ker zadevna zakonodaja ne daje podlage za popolno uskladitev in ker direktive državam članicam dopuščajo določeno stopnjo proste presoje glede tega, kako zagotoviti njihovo izvajanje, med državami članicami obstajajo številne razlike v pristopih k izvajanju.
English: 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 point is essential, even where competent authority responsibilities are shared among multiple organisations or regions.
Slovenian: Za dobro regulativno komunikacijo med državami članicami in izpolnjevanje zahtev po letnem poročanju Komisiji je bistvena dobro obveščena nacionalna usklajevalna kontaktna točka, tudi če so odgovornosti pristojnih organov razdeljene na več organizacij ali regij.
English: Every change in deferral, testing or pathogen inactivation policy has a possible impact not only on safety and quality, but also on the economics and on the volume of donations and supply.
Slovenian: Vsaka sprememba politike glede odklona, testiranja ali inaktivacije patogenov lahko vpliva tako na varnost in kakovost kot tudi na ekonomičnost ter količino darovanj in dobave.
English: It is important to note that the hyperlinks contain the original replies of Member States, whilst the report reflects the updated information provided by Member States.
Slovenian: Opozoriti je treba, da povezave vsebujejo prvotne odgovore držav članic, medtem ko so v poročilu upoštevane posodobljene informacije, ki so jih poslale države članice.
English: These policies involve players at multiple levels, national competent authorities as well as local clinicians.
Slovenian: Te politike vključujejo akterje na več ravneh, nacionalne pristojne organe in lokalne klinične zdravnike.
English: These actions brought improvements in areas of common interest such as quality management and inspection and donor selection and included training courses for Member States Competent Authorities and their inspectors.
Slovenian: Ti ukrepi so prinesli izboljšanja na področjih, ki so v splošnem interesu, kot so upravljanje kakovosti, inšpekcija in izbira darovalcev, ter so vključevali usposabljanja za pristojne organe držav članic in njihove inšpektorje.
English: The service contract aims to develop best practices, which could allow for a significant reduction of blood demand for many treatments.
Slovenian: Namen naročila storitev je razviti dobre prakse, ki bi lahko omogočile znatno zmanjšanje potrebe po krvi pri številnih zdravljenjih.
English: From an EU perspective, the relevant question is whether blood collected from these donors might have a different safety and quality profile (see below).
Slovenian: Z vidika EU je pomembno vprašanje, ali ima lahko kri, zbrana od teh darovalcev, drugačne lastnosti glede varnosti in kakovost (glej spodaj).
English: These shortages often occur in summer/holiday seasons when the number of donors is reduced and the risk of epidemiological outbreaks, such as West Nile Virus, can temporarily reduce the number of eligible donors.
Slovenian: Do takega pomanjkanja pogosto pride poleti / med počitnicami, ko je število darovalcev manjše in lahko nevarnost epidemioloških izbruhov, kot je izbruh virusa zahodnega Nila, začasno zmanjša število ustreznih darovalcev.
English: In almost all countries, the inspections of blood establishments overlap with inspections in other areas.
Slovenian: Skoraj v vseh državah se inšpekcijski pregledi transfuzijskih ustanov prekrivajo z inšpekcijskimi pregledi na drugih področjih.
English: A limited number of countries report surpluses for some blood components which indicates the potential for cross-border agreements.
Slovenian: Omejeno število držav poroča o presežku nekaterih komponent krvi, kar kaže na možnost čezmejnih sporazumov.
English: Policies towards them vary, from prohibition to seeing replacement donations as an opportunity to contribute to national self-sufficiency by converting them into regular donors.
Slovenian: Politike v odnosu do njih so različne, od prepovedi do razumevanja nadomestnega darovanja kot priložnosti za prispevanje k nacionalni samozadostnosti, tako da postanejo redni darovalci.
English: The value of international projects, at EU level and organised by the Council of Europe, are clearly appreciated by most of the national competent authorities as a means to help maintain an adequate level of training and know-how within the group of inspectors and to help ensure a uniform level of compliance verification throughout the EU.
Slovenian: Večina nacionalnih pristojnih organov očitno ceni mednarodne projekte, tiste na ravni EU in tiste, ki jih organizira Svet Evrope, kot pomoč pri vzdrževanju ustrezne ravni usposabljanja in strokovnega znanja v skupini inšpektorjev ter pomoč pri zagotavljanju enotne ravni preverjanja skladnosti po vsej EU.
English: Overall, the implementation of the EU blood legislation by Member States is considered adequate and the legislation has resulted in the establishment of a network of competent authorities that oversee the field through authorisation, inspection, and vigilance.
Slovenian: Na splošno se izvajanje zakonodaje EU o krvi šteje za ustrezno, zaradi zakonodaje pa je bila vzpostavljena mreža pristojnih organov, ki to področje nadzorujejo z odobritvami, inšpekcijo in vigilanco.
English: In contrast, 47-48% considered that receiving refreshments, free blood testing or a free physical check-up were acceptable.
Slovenian: Nasprotno jih je 47 %-48 % menilo, da je sprejemljivo prejetje okrepčil, brezplačno testiranje krvi ali brezplačen zdravniški pregled.
English: The practical application of the VUD principle varies across the Union.
Slovenian: Praktična uporaba načela PBD se po Uniji razlikuje.
English: Although the large majority of the responding countries (26) reported that the principle of VUD is mandatory at national level, their legislations often refer to an "encouragement" or to a "strong recommendation".
Slovenian: Čeprav je velika večina držav, ki so se odzvale (26), poročala, da je načelo PBD obvezno na nacionalni ravni, njihove zakonodaje pogosto govorijo o „spodbujanju" ali „močno priporočljivem" ravnanju.
English: Most countries have additional supportive measures in place, primarily focused on promoting VUD or defining compensation and incentives (see below).
Slovenian: Večina držav je sprejela dodatne podporne ukrepe, ki so osredotočeni predvsem na spodbujanje PBD ali opredelitev nadomestil in spodbud (glej spodaj).
English: Overall, Member States expressed interest in an increased level of donor protection and in an overview of additional national eligibility criteria in order to increase transparency and mutual trust in exchanges.
Slovenian: Na splošno so države članice izrazile zanimanje za povečano stopnjo zaščite darovalcev in pregled dodatnih nacionalnih meril za ustreznost, da bi izboljšale preglednost in medsebojno zaupanje pri izmenjavah.
English: The 2013 implementation survey was answered by all Member States and also by two EEA countries, Liechtenstein and Norway.
Slovenian: Na anketo o izvajanju iz leta 2013 so odgovorile vse države članice in dve državi EGP, in sicer Lihtenštajn in Norveška.
English: Fig. 2: Overlapping inspection schemes
Slovenian: Slika 2: Prekrivajoči se inšpekcijski programi
English: Countries identify an increase of the maximum donor age as the most promising initiative to improve the supply of blood and blood components.
Slovenian: Države ugotavljajo, da je povečanje najvišje dovoljene starosti darovalca najobetavnejša pobuda za izboljšanje dobave krvi in komponent krvi.
English: Countries also see value in further centralisation of laboratory test results at EU level to facilitate benchmarking against average EU rates of positivity.
Slovenian: Državam se zdi koristna tudi nadaljnja centralizacija rezultatov laboratorijskih testov na ravni EU za lažjo primerjavo s povprečnimi stopnjami pozitivnosti v EU.
English: The global growth of utilisation of plasma derivatives, particularly intravenous immunoglobulin (IVIG), requires a growing number of donations.
Slovenian: Zaradi splošne rasti uporabe derivatov krvne plazme, zlasti intravenskih imunoglobulinov (IVIG), je potrebno vse večje število darovalcev.
English: Projects such as EUBIS, CATIE, DOMAINE, Optimal Blood Use, EU-Q-Blood-SOP and the on-going joint action VISTART provide strong support to Member States in their efforts to implement the requirements of the blood directives.
Slovenian: Projekti, kot so EUBIS, CATIE, DOMAINE, Optimal Blood Use, EU-Q-Blood-SOP in trenutni skupni ukrep VISTART, so državam članicam v veliko oporo pri prizadevanjih za izvajanje zahtev direktiv o krvi.
English: Ten countries reported facilitating donations by donors from abroad by providing donor questionnaires in different languages.
Slovenian: Deset držav je poročalo o tem, da so olajšale darovanje za darovalce iz tujine z zagotovitvijo vprašalnikov za darovalce v različnih jezikih.
English: These differences facilitate successful integration of the requirements into national legislation but in some cases they may limit the mutual acceptance of authorisations with consequences for potential cross-border movement of blood and blood components.
Slovenian: Te razlike omogočajo uspešno vključitev zahtev v nacionalno zakonodajo, vendar lahko v nekaterih primerih omejijo vzajemno priznavanje odobritev, kar pomeni posledice za morebitni čezmejni prenos krvi in komponent krvi.
English: Fig. 5: Policy setting to ensure effective use of blood, blood components and plasma derivatives
Slovenian: Slika 5: Oblikovanje politike za zagotovitev učinkovite uporabe krvi, komponent krvi in derivatov krvne plazme
English: Eight countries reported regular shortages of one or more blood components in the survey.
Slovenian: V anketi je osem držav poročalo o rednem pomanjkanju ene ali več komponent krvi.
English: Many countries are largely supplied with plasma derivatives by just one supplier, either public or private.
Slovenian: Številne države večinoma dobivajo derivate krvne plazme od enega samega dobavitelja, javnega ali zasebnega.
English: However, Member States' perceptions of what is considered compensation and incentive vary.
Slovenian: Vendar se razlage držav članic, kaj se šteje za nadomestilo in spodbudo, razlikujejo.
English: There is considerable heterogeneity across the EU, with certain practices perceived as compensation in one country and as incentives in another.
Slovenian: V EU obstaja precejšnja raznolikost, pri čemer se nekatere prakse v eni državi štejejo za nadomestilo, v drugi pa za spodbudo.
English: However, the Report also points to some gaps and difficulties in relation to the application and enforcement of the existing provisions (e.g. definitions, provisions for donor safety, inspections framework), some due to different approaches taken by the Member States and others due to technological advances and changing risks observed since the legislation was adopted.
Slovenian: Vendar poročilo kaže tudi na nekatere vrzeli in težave v zvezi z uporabo in izvrševanjem obstoječih določb (npr. opredelitve, določbe o varnosti darovalcev, okvir inšpekcijskih pregledov), pri čemer so nekatere posledica različnih pristopov držav članic, druge pa tehnološkega napredka in sprememb v tveganjih, ugotovljenih od sprejetja zakonodaje.
English: Sixteen reported discouraging such donations by requiring a local ID document or a proof or local residence.
Slovenian: Šestnajst jih je poročalo o odvračanju od takega darovanja z zahtevo po lokalnem osebnem dokumentu ali dokazilu o lokalnem prebivališču.
English: In addition, and in accordance with Article 20(2) of the Directive 2002/98/EC, Member States have to submit to the Commission reports on the application of the principle of voluntary and unpaid donation (VUD) every three years.
Slovenian: Poleg tega morajo države članice v skladu s členom 20(2) Direktive 2002/98/ES Komisiji vsaka tri leta predložiti poročila o uporabi načela prostovoljnega in brezplačnega darovanja (PBD).
English: Most common are awareness building campaigns for specific donor groups, such as students, or events such as the World Blood Donor Day (WHO, 14 June) or Thalassemia day (8 May in Greece and Cyprus).
Slovenian: Najpogostejše so kampanje ozaveščanja za posebne skupine darovalcev, kot so študenti, ali dogodki, kot sta svetovni dan krvodajalcev (SZO, 14. junij) ali dan talasemije (8. maj v Grčiji in na Cipru).
English: Fig. 1: Additional fields of competence for national blood competent authorities
Slovenian: Slika 1: Dodatna področja pristojnosti za nacionalne pristojne organe za kri