qanastek/ELRC-Medical-V2 huggingface dataset:
English: [4: OJ C 373, 20.12.2013, p.
Translation (en-sl): [4: UL C 373, 20.12.2013, str.
English: [2: OJ L 347, 20.12.2013, p.
Translation (en-sl): [2: UL L 347, 20.12.2013, str.
English: [1: COM(2020) 145, 27.3.2020.]
Translation (en-sl): [1: COM(2020) 145 z dne 27. marca 2020.]
English: [7: COM(2020) 145, 27.3.2020.]
Translation (en-sl): [7: COM(2020) 145 z dne 27. marca 2020.]
English: A number of points should be noted:
Translation (en-sl): Treba je opozoriti na nekatere točke:
English: The study is not a formal evaluation.
Translation (en-sl): Ta študija ni uradno vrednotenje.
English: Some do not mention safety and quality at all.
Translation (en-sl): Nekatere sploh ne omenijo varnosti in kakovosti.
English: This could deliver tangible benefits to health systems across the EU.
Translation (en-sl): Ta bi lahko zagotovil oprijemljive koristi za zdravstvene sisteme po vsej EU.
English: The Commission has therefore not yet used the delegated power.
Translation (en-sl): Zato Komisija še ni uporabila pooblastila.
English: The analysis was carried out between 6 October 2014 and 6 November 2014.
Translation (en-sl): Analiza se je izvedla med 6. oktobrom 2014 in 6. novembrom 2014.
English: Member States have asked the Commission to propose measures to ensure long-term sustainability.​[16]​
Translation (en-sl): Države članice so prosile Komisijo, naj predlaga ukrepe za zagotavljanje dolgoročne trajnosti​[16]​.
English: 4.2 European Reference Networks
Translation (en-sl): 4.2 Evropske referenčne mreže
English: To realise this potential, ongoing support and commitment from all sides will be needed.
Translation (en-sl): Za uresničitev tega potenciala bo potrebna stalna podpora in zavezanost vseh strani.
English: The conclusion of this meeting (and of the support study carried out) was that no exclusion was needed at that time.
Translation (en-sl): Sklep tega srečanja (in izvedene podporne študije) je bil, da takrat ni bila potrebna nobena izključitev.
English: Methodology
Translation (en-sl): Metodologija
English: However, in practice, prior authorisation systems are based almost entirely on Article 8(2)(a), on which this report will therefore focus.
Translation (en-sl): V praksi pa sistemi predhodne odobritve skoraj v celoti temeljijo na členu 8(2)(a), na katerega se bo torej osredotočilo to poročilo.
English: Limitations
Translation (en-sl): Omejitve
English: It entered into force on 27 May 2014.
Translation (en-sl): Veljati je začel 27. maja 2014.
English: A questionnaire was sent to all Member States in January 2015.
Translation (en-sl): Januarja 2015 je bil državam članicam poslan vprašalnik.
English: That report set out in detail the data which would be needed to assess whether this had, in fact, happened.
Translation (en-sl): V navedenem poročilu so bili podrobno opisani podatki, ki bi bili potrebni za oceno, ali se je to dejansko zgodilo.
English: Data from Member States on the operation of the Directive
Translation (en-sl): Podatki od držav članic o izvajanju Direktive
English: There are a number of reasons why this may be the case.
Translation (en-sl): Vzrokov za to je lahko več.
English: Such arrangements would need to facilitate joint work, and consequently enable Member States and other stakeholders to benefit fully from it.
Translation (en-sl): Take ureditve bi morale lajšati skupno delo in posledično omogočiti državam članicam in drugim deležnikom, da jo v celoti izkoristijo.
English: ^6 The UK has no National Contact Point covering the whole UK, so it was necessary to examine the separate contact points.
Translation (en-sl): ^6 Združeno kraljestvo nima nacionalne kontaktne točke, ki bi krila celotno Združeno kraljestvo, zato je bilo treba proučiti ločene kontaktne točke.
English: These infringements relate only to the completeness of transposition measures.
Translation (en-sl): Te kršitve so povezane zgolj s celovitostjo ukrepov za prenos.
English: This evaluation is likely to mean that it is desirable to adjust the content of the current Delegated Act in the future.
Translation (en-sl): Ocenjevanje verjetno pomeni, da je zaželeno, da se v prihodnje prilagodi vsebina sedanjega delegiranega akta.
English: - Patient organisation
Translation (en-sl): - Organizacija pacientov
English: This subject of which information patients need, and how it should be provided, is likely to be on the agenda for some time to come.
Translation (en-sl): Vprašanje, katere informacije potrebujejo pacienti in kako jih je treba zagotoviti, pa bo verjetno še nekaj časa na dnevnem redu.
English: Use of prior authorisation (number of Member States)
Translation (en-sl): Uporaba predhodne odobritve (število držav članic)
English: It is currently working on guidelines on effective methods for enabling the use of medical information for public health and research.
Translation (en-sl): Trenutno pripravlja smernice za učinkovite metode, s katerimi se bo omogočila uporaba zdravstvenih informacij za javno zdravje in raziskave.
English: This list includes, among other elements and with limited exceptions, the "common name" of the product (which, in practice, means the International Non-proprietary Name for a large majority of products).
Translation (en-sl): Ta seznam zajema, med drugimi elementi in z omejenimi izjemami, „skupno ime" proizvoda (kar v praksi pomeni mednarodno nelastniško ime za veliko večino proizvodov).
English: A note on the evaluative study is attached in Annex B of this report.
Translation (en-sl): Opomba v zvezi z evalvacijsko študijo je v Prilogi B k temu poročilu.
English: Secondly, as also indicated by the Eurobarometer, the number of citizens who are aware of their general rights to reimbursement is extremely low.
Translation (en-sl): Drugič, kar je prav tako razvidno iz raziskave Eurobarometra, število državljanov, ki se zavedajo svojih splošnih pravic do povračila stroškov, je izjemno nizko.
English: The next stage for the Commission is to assess whether Member States have transposed the Directive correctly.
Translation (en-sl): Komisija bo v naslednji fazi ocenila, ali so države članice Direktivo prenesle pravilno.
English: Those will need to be addressed in future exercises, as they affect the comparability of the data.
Translation (en-sl): Te bo treba obravnavati pri prihodnjih zbiranjih podatkov, saj vplivajo na primerljivost podatkov.
English: Geographical areas which might benefit from such collaboration also need to be identified.
Translation (en-sl): Treba je opredeliti tudi geografska območja, ki bi jim tako sodelovanje lahko koristilo.
English: The delegated powers shall be automatically extended for periods of an identical duration, unless the European Parliament or the Council revokes them in accordance with Article 18.
Translation (en-sl): Prenos pooblastila se samodejno podaljša za enako obdobje, razen če Evropski parlament ali Svet pooblastilo prekliče v skladu s členom 18.
English: Some Member States - particularly those with insurance-based systems - have experienced difficulties in collecting information from the component parts of their system.
Translation (en-sl): Nekatere države članice, zlasti tiste s sistemi, ki temeljijo na zavarovanju, so imele težave pri zbiranju informacij od sestavnih delov njihovega sistema.
English: This requirement will therefore need to be analysed under the conditions of Article 7(7).
Translation (en-sl): To zahtevo bo torej treba proučiti glede na pogoje iz člena 7(7).
English: It is also worth noting that some of the demand that does exist may be catered for under local bilateral arrangements, which exist in some Member States.
Translation (en-sl): Treba je tudi omeniti, da se za določeno obstoječe povpraševanje morda uporabljajo lokalni dvostranski dogovori, ki obstajajo v nekaterih državah članicah.
English: The chapter of the Directive on cooperation between health systems has created a new framework for Member States' cooperation.
Translation (en-sl): Poglavje Direktive o sodelovanju med zdravstvenimi sistemi je oblikovalo nov okvir za sodelovanje držav članic.
English: 2.2 Reimbursement and administration
Translation (en-sl): 2.2 Povračilo stroškov in administracija
English: It has contributed to a number of important discussions going on in many Member States regarding healthcare reform.
Translation (en-sl): Prispevala je k več pomembnim razpravam v zvezi z reformo zdravstvenega varstva v mnogih državah članicah.
English: As things stand, that data is unavailable and the Commission is, therefore, unable to make any further analysis at this time.
Translation (en-sl): Trenutno podatki niso na voljo in Komisija torej za zdaj ne more tega nadalje proučiti.
English: This is not surprising, given EU citizens' seemingly low awareness of their rights and the existence of the NCPs.
Translation (en-sl): To ni presenetljivo glede na navidezno nizko ozaveščenost državljanov EU o njihovih pravicah in obstoju nacionalnih kontaktnih točk.
English: ^18 Reimbursement practices may vary considerably from Member State to Member State.
Translation (en-sl): ^18 Prakse povračila stroškov se lahko med državami članicami zelo razlikujejo.
English: Information requests received by National Contact Points
Translation (en-sl): Zahtevki za informacije, ki so jih prejele nacionalne kontaktne točke
English: The next step is to identify those EU activities and best practices which will help implement real cross-border collaboration which delivers added value.
Translation (en-sl): Naslednji korak je, da se opredelijo tiste dejavnosti in dobre prakse EU, ki bodo pomagale izvajati dejansko čezmejno sodelovanje, ki zagotavlja dodano vrednost.
English: Chapter 3: National Contact Points and Information to patients
Translation (en-sl): Poglavje 3: Nacionalne kontaktne točke in informacije za paciente
English: The majority of these measures were addressed in Implementing Directive 2012/52/EU​[8]​.
Translation (en-sl): Večina teh ukrepov je bilo obravnavanih v Izvedbeni direktivi 2012/52/EU​[8]​.
English: It requires the Commission to prepare a report in respect of the delegated powers not later than six months before the end of the five-year period.
Translation (en-sl): Določa, da mora Komisija pripraviti poročilo o pooblastilu najpozneje šest mesecev pred koncem petletnega obdobja.
English: A recent Eurobarometer survey​[7]​ indicated that fewer than two out of ten citizens feel that they are informed about their cross-border healthcare rights:
Translation (en-sl): Nedavna raziskava Eurobarometra​[7]​ je pokazala, da manj kot dva od desetih državljanov menita, da sta obveščena o svojih pravicah glede čezmejnega zdravstvenega varstva.
English: Complaints, infringements and transposition measures were not part of its remit.
Translation (en-sl): Ukrepi za pritožbe, kršitve in prenos niso sodili v njeno področje uporabe.
English: These ‘focus countries' are a representative sample, based on a host of criteria detailed in the report.
Translation (en-sl): Te „države v žarišču" so reprezentativni vzorec, ki temelji na več merilih, podrobno opisanih v poročilu.
English: However, the impact of the Directive should be considered more widely than simply cross-border healthcare.
Translation (en-sl): Vpliv Direktive pa je treba obravnavati širše kot pa zgolj v okviru čezmejnega zdravstvenega varstva.
English: PA for everything, with exception of one specialist consultation per year per patient 1
Translation (en-sl): Predhodna odobritev za vse, z izjemo enega specialističnega posveta na leto na pacienta 1
English: ^3 Regulations (EC) No 883/2004 and No 987/2009 on the coordination of social security systems.
Translation (en-sl): ^3 Uredbi (ES) št. 883/2004 in št. 987/2009 o koordinaciji sistemov socialne varnosti.
English: Its overall objective is to report on implementation to date on the basis of the sources at hand and to identify gaps and potential for improvement, as called for by Article 20(1) of the Directive.
Translation (en-sl): Njen splošni cilj je poročati o dosedanjem izvajanju na podlagi razpoložljivih virov ter opredeliti pomanjkljivosti in možnosti za izboljšave, kot to določa člen 20(1) Direktive.
English: The data is not, therefore, easily comparable between Member States: examples in this Annex are given by way of illustration only.
Translation (en-sl): Podatki torej niso zlahka primerljivi med državami članicami: primeri v tej prilogi služijo samo za ponazoritev.
English: Regarding Article 12(5), the Commission worked closely with the Member States on the content of the delegated act before adopting it on 10 March 2014 (see reference under 4.2, above).
Translation (en-sl): V zvezi s členom 12(5) je Komisija tesno sodelovala z državami članicami o vsebini delegiranega akta, preden ga je 10. marca 2014 sprejela (glej referenco pod točko 4.2).
English: In March 2014 the legal framework for the establishment and evaluation of Networks (delegated​[9]​ and implementing decisions​[10]​) was adopted, with unanimous support of the Member States.
Translation (en-sl): Marca 2014 je bil sprejet pravni okvir za ustanavljanje in vrednotenje mrež (delegirani​[9]​ in izvedbeni sklep​[10]​) s soglasno podporo držav članic.
English: The eHealth Network aims to support cooperation between national authorities.
Translation (en-sl): Cilj mreže e-zdravja je podpirati sodelovanje med nacionalnimi organi.
English: Given the recent adoption of the Directive and the scarcity of readily available data on patient mobility, a formal evaluation of the Directive would have been premature.
Translation (en-sl): Glede na nedavno sprejetje Direktive in pomanjkanje razpoložljivih podatkov o mobilnosti pacientov bi bilo uradno vrednotenje Direktive prezgodnje.
English: This Directive established a list of common elements to be included in cross-border prescriptions.
Translation (en-sl): V tej direktivi je opredeljen seznam skupnih elementov, ki jih je treba vključiti v čezmejne recepte.
English: It meets twice a year, and is supported on scientific and technical issues by a joint action under the Health Programme, called EUnetHTA.
Translation (en-sl): Srečuje se dvakrat letno, na področju znanstvenih in tehničnih vprašanj pa je podprta s skupnim ukrepom v okviru programa za zdravje, ki se imenuje EUnetHTA.
English: As outlined in recital 43 of the Directive, the criteria attached to the grant of prior authorisation have to be duly justified.
Translation (en-sl): Kot je opisano v uvodni izjavi 43 Direktive, morajo biti merila, povezana s predhodno odobritvijo, ustrezno utemeljena.
English: The Directive requires Member States to provide information on their quality and safety systems.
Translation (en-sl): Direktiva določa, da morajo države članice zagotoviti informacije o svojih sistemih kakovosti in varnosti.
English: It is questionable whether this is in line with the principle of free movement of patients and with the criteria set out in Articles 7(9) and 7(11).
Translation (en-sl): Vprašljivo je, ali je to v skladu z načelom prostega pretoka pacientov in z merili, ki so opredeljena v členu 7(9) in (11).
English: An evaluative study does, however, deliver a meaningful, albeit qualitative contribution to the baseline assessment and to future evaluation efforts, in line with the ‘evaluate first' principle.
Translation (en-sl): Kljub temu pa evalvacijska študija zagotavlja pomemben, čeprav kakovosten prispevek k osnovni oceni in prihodnjim prizadevanjem za vrednotenje v skladu z načelom „najprej ovrednoti".
English: Although exclusions from the principle of mutual recognition of prescriptions are not currently needed, such a need may arise in the future, and would need to be dealt with swiftly via a delegated act in order to safeguard public health.
Translation (en-sl): Čeprav izključitve iz načela vzajemnega priznavanja receptov niso trenutno potrebne, se lahko to zgodi v prihodnosti, takrat pa bi se morale obravnavati hitro z delegiranim aktom, da se zavaruje javno zdravje.
English: Some 50 % of stakeholders contacted agreed to be interviewed over the four-week period.
Translation (en-sl): Približno 50 % deležnikov, s katerimi se je navezal stik, se je strinjalo z razgovorom v štiritedenskem obdobju.
English: France, Luxembourg, and possibly Finland and Denmark appear to be exceptions to this general observation.
Translation (en-sl): Videti je, da so Francija, Luksemburg ter morda Finska in Danska izjema od te splošne ugotovitve.
English: The evaluative study on the Cross-border Healthcare Directive
Translation (en-sl): Evalvacijska študija o direktivi o čezmejnem zdravstvenem varstvu
English: For example, if a Member State decides to reimburse someone under the Regulations on the grounds that this is more beneficial to the patient, then the procedure for establishing the reimbursement amount can take several months.
Translation (en-sl): Če se na primer država članica odloči, da bo nekomu povrnila stroške v okviru uredb, ker je to bolj koristno za pacienta, lahko postopek za ugotavljanje zneska za povračilo stroškov traja več mesecev.
English: They stressed the desirability of facilitating ‘comparability and reliability of information provided to patients on quality and safety, across institutions and across Member States'.
Translation (en-sl): Poudarile so, da je zaželeno olajševanje „primerljivosti in zanesljivosti informacij o kakovosti in varnosti, ki se zagotovijo pacientom v vseh institucijah in državah članicah".
English: Chapter 5: Conclusions
Translation (en-sl): Poglavje 5: Sklepne ugotovitve
English: 4.5 Cross-border collaboration
Translation (en-sl): 4.5 Čezmejno sodelovanje
English: Via a series of conferences organised on behalf of the Commission by the European Patients' Forum, patient organisations have reported their concern that patients are faced with ‘a labyrinth of confusing, sometimes insufficient and sometimes too detailed information' with regard to cross-border healthcare.
Translation (en-sl): V sklopu več konferenc, ki jih je v imenu Komisije organiziral Evropski forum pacientov, so organizacije pacientov izrazile svojo skrb, da se pacienti soočajo z „labirintom nejasnih in včasih pomanjkljivih ali preveč podrobnih informacij" v zvezi s čezmejnim zdravstvenim varstvom.
English: Firstly, a number of Member States were late implementing the Directive, which will impact on the numbers able to use it during 2014.
Translation (en-sl): Prvič, nekatere države članice so začele pozno izvajati Direktivo, kar bo vplivalo na številke, ki so se lahko uporabile za leto 2014.
English: Article 20(1) of the Directive requires the Commission to ‘draw up a report on the operation of this Directive and submit it to the European Parliament and to the Council' by 25 October 2015, and every three years thereafter.
Translation (en-sl): Člen 20(1) Direktive določa, da Komisija „pripravi poročilo o izvajanju te direktive ter ga predloži Evropskemu parlamentu in Svetu" do 25. oktobra 2015, nato pa vsaka tri leta.
English: Even where citizens are aware of their rights, there are a number of Member States where it is difficult for patients to find out more about how to use these rights in practice.
Translation (en-sl): Tudi ko se državljani zavedajo svojih pravic, pacienti v več državah članicah težko izvejo več o tem, kako te pravice uveljaviti v praksi.
English: A total of 109 223 such requests were recorded in 2014.
Translation (en-sl): Leta 2014 je bilo skupno zabeleženih 109 223 takih zahtevkov.
English: ^16 Council conclusions on ‘innovation for the benefit of patients' Employment, Social policy, Health and Consumer affairs Council meeting Brussels, 1 December 2014
Translation (en-sl): ^16 Sklepi Sveta o inovacijah v korist pacientov, seja Sveta za zaposlovanje, socialno politiko, zdravje in varstvo potrošnikov, 1. decembra 2014
English: Successful cross-border collaboration requires significant buy-in from local-level actors, with the support of national authorities.
Translation (en-sl): Uspešno čezmejno sodelovanje zahteva precejšnjo podporo lokalnih akterjev in podporo nacionalnih organov.
English: This seems to be due to low numbers of claims rather than large numbers of refusals: the available data suggests that roughly 85 % of reimbursement claims are granted.
Translation (en-sl): Vzrok za to je verjetno nizko število zahtevkov, ne pa visoko število zavrnitev: iz razpoložljivih podatkov je razvidno, da je odobrenih približno 85 % zahtevkov za povračilo stroškov.
English: Similarly, the pressures faced by health services are leading to increased interest in making better use of resources via cross-border collaboration.
Translation (en-sl): In podobno se zaradi pritiskov, s katerimi se srečujejo zdravstvene storitve, krepi zanimanje za boljšo uporabo virov na podlagi čezmejnega sodelovanja.
English: These much larger figures are probably due to website visits being recorded as information requests in these three Member States.
Translation (en-sl): Vzrok za te veliko večje številke je verjetno to, da so bili v teh treh državah članicah obiski spletišča zabeleženi kot zahtevki za informacije.
English: According to the principle of mutual recognition of qualifications, however, Member States should recognise decisions about clinical need and appropriateness provided by an equivalent professional in another Member State.
Translation (en-sl): V skladu z načelom vzajemnega priznavanja kvalifikacij pa bi morale države članice priznavati odločitve o klinični potrebi in ustreznosti, ki jih sprejme enakovredni strokovnjak v drugi državi članici.
English: Chapter 4: Cross-border cooperation
Translation (en-sl): Poglavje 4: Čezmejno sodelovanje
English: Germany did provide a data return but was unable to provide data on the use of prior authorisation.
Translation (en-sl): Nemčija je sicer zagotovila podatke, ni pa mogla zagotoviti podatkov o uporabi predhodne odobritve.
English: For the future, the HTA Network will continue its strategic role, but strong and efficient scientific cooperation will be essential.
Translation (en-sl): Mreža za ocenjevanje zdravstvene tehnologije bo v prihodnje še naprej izvajala svojo strateško vlogo, bistvenega pomena pa bo močno in učinkovito znanstveno sodelovanje.
English: This study considers the effects of Directive 2011/24/EU.
Translation (en-sl): V tej študiji so obravnavani učinki Direktive 2011/24/EU.
English: The report under Article 20(3) of Directive 2011/24/EU which the Commission adopted in early 2014,​[5]​ noted that the coming into operation of the Directive could affect the use of the Social Security Regulations.
Translation (en-sl): V poročilu v skladu s členom 20(3) Direktive 2011/24/EU, ki ga je Komisija sprejela na začetku leta 2014​[5]​, je bilo navedeno, da bi začetek izvajanja Direktive lahko vplival na uporabo uredb o socialni varnosti.
English: Some Member States have different National Contact Points (NCPs) for ‘incoming' and ‘outgoing' patients.
Translation (en-sl): Nekatere države članice imajo različne nacionalne kontaktne točke za „prihajajoče" in „odhajajoče" paciente.
English: Member States transposed Directive 2011/24/EU at different times and in many cases the data provided only cover part of 2014.
Translation (en-sl): Države članice so prenesle Direktivo 2011/24/EU na različne datume in v mnogih primerih se zagotovljeni podatki nanašajo samo na del leta 2014.
English: The application of the Directive to ‘telemedicine' (i.e. health services provided remotely) has led to a certain lack of clarity.
Translation (en-sl): Uporaba Direktive na področju „telemedicine" (tj. zdravstvene storitve, ki se zagotavljajo na daljavo) je povzročila določene nejasnosti.
English: These findings are in line with the data reported by Member States on information requests (contained in Annex A)
Translation (en-sl): Te ugotovitve so v skladu s podatki, ki so jih o zahtevkih za informacije sporočile države članice (v Prilogi A).
English: Chapter 2: Patient mobility
Translation (en-sl): Poglavje 2: Mobilnost pacientov
English: In the two pending cases, the Member States concerned have committed to addressing the outstanding issues.
Translation (en-sl): V dveh nerešenih primerih sta se zadevni državi članici zavezali, da bosta obravnavali nerešena vprašanja.