natgillin/translations-raw huggingface dataset:
A selection of the data reported by Member States is presented here.
Izbor podatkov, ki so jih sporočile države članice, je predstavljen tukaj.
It draws on the situation on the ground and other valuable external sources (past studies, scientific literature, stakeholder input, etc.).
Izhaja iz dejanskih razmer in drugih koristnih zunanjih virov (pretekle študije, znanstvena literatura, prispevki deležnikov itd.).
For this report, the Commission asked Member States to participate in a data collection exercise.
Komisija je za namene tega poročila prosila države članice, da sodelujejo v zbiranju podatkov.
No prior authorisation 7
Ni predhodne odobritve 7
ANNEX A
PRILOGA A
Finally, the advance of technology means that ‘telemedicine' services (including online pharmacies) are likely to become more common and more significant in the immediate future.
Tehnološki napredek pa pomeni, da bodo v bližnji prihodnosti storitve „telemedicine" (vključno s spletnimi lekarnami) verjetno postale bolj razširjene in pomembne.
The field of medicinal products and medical devices is one where change may occur rapidly.
Na področju zdravil in medicinskih pripomočkov se lahko izjemno hitro pojavijo spremembe.
Two of these infringement cases were pending as of 1 July 2015, the others having been closed on the grounds of subsequent transposition by the Member States concerned.
Dva od teh primerov za ugotavljanje kršitev sta v teku od 1. julija 2015, drugi pa so bili zaključeni zaradi poznejšega prenosa zadevnih držav članic.
The Directive requires the Commission to encourage Member States to cooperate in cross-border healthcare provision in border regions.
Direktiva določa, da mora Komisija spodbujati države članice k sodelovanju pri zagotavljanju čezmejnega zdravstvenega varstva na obmejnih območjih.
However, Article 10 of the Directive obliges National Contact Points to assist each other in understanding invoices.
Člen 10 Direktive pa določa, da si morajo nacionalne kontaktne točke med seboj pomagati pri razumevanju računov.
This is not due to the Directive itself, but reflects broader technological and societal changes: people's expectations are radically different now than they were just a few years ago (and health services are unlikely to be immune from the impact of, for example, user-generated reviews).
Vzrok za to ni sama Direktiva, ampak širše tehnološke in družbene spremembe: pričakovanja ljudi so neprimerljivo drugačna zdaj, kot pa so bila pred samo nekaj leti (zdravstvene storitve pa na primer verjetno niso imune na vpliv kritik uporabnikov).
One relevant issue here is how the ‘basket of benefits', i.e. the healthcare to which the patient is entitled, is defined.
Pri tem se postavlja bistveno vprašanje, kako se opredeli „košarica storitev", tj. zdravstveno varstvo, do katerega je pacient upravičen.
Article 11 of the Directive gives effect to the principle of mutual recognition of medical prescriptions between Member States and empowers the Commission to adopt practical measures to assist such recognition.
Člen 11 Direktive uveljavlja načelo vzajemnega priznavanja zdravniških receptov med državami članicami in pooblašča Komisijo, da sprejme praktične ukrepe za pomoč pri takem priznavanju.
The report was to include, in particular, information on patient flows, financial dimensions of patient mobility, the implementation of Article 7(9) and Article 8, and on the functioning of the European reference networks and national contact points.
Poročilo naj bi vsebovalo zlasti informacije o pretokih pacientov, finančnih vidikih mobilnosti pacientov, izvajanju člena 7(9) in člena 8 ter delovanju evropskih referenčnih mrež in nacionalnih kontaktnih točk.
To take just one example, the European Reference Networks could seriously improve access to care for rare / low-prevalence and complex diseases where expertise is rare.
Če opišemo samo en primer, evropske referenčne mreže bi lahko znatno izboljšale dostop do oskrbe za redke bolezni/bolezni z nizko razširjenostjo in kompleksne bolezni, za katere je značilno, da primanjkuje strokovnega znanja.
This report sets out the current state of play of transposition, and covers the most important and relevant provisions, such as the use of prior authorisation, the level of patient mobility, reimbursement practices, information to patients and cooperation under the Directive.
V tem poročilu je opisano trenutno stanje prenosa ter zajete najbolj pomembne in bistvene določbe, kot so uporaba predhodne odobritve, raven mobilnosti pacientov, prakse povračila stroškov, informacije za paciente in sodelovanje v okviru Direktive.
Patient flows for healthcare abroad under the Directive are low.
Pretoki pacientov za zdravstveno varstvo v tujini v okviru Direktive so majhni.
However, given the points set out above, it is not possible to conclude now that use of cross-border healthcare accurately reflects potential demand.
Glede na že navedene točke zdaj ni mogoče zaključiti, da je iz uporabe čezmejnega zdravstvenega varstva natančno razvidno morebitno povpraševanje.
Although the Commission has received no specific notifications, some of the ways in which Member States have transposed the Directive could be considered as limiting reimbursement.
Čeprav Komisija ni prejela nobenih posebnih obvestil, so nekatere države članice prenesle Direktivo na tak način, ki bi se lahko obravnaval kot omejevanje povračila stroškov.
In addition to desk research and a literature review, a detailed website review and widely used participatory research methods were used.
Poleg pregleda dokumentacije in literature so se podrobno proučili tudi spletišče ter splošno razširjene participativne raziskovalne metode.
It also report on the use of delegated powers pursuant to Article 17(1) of the Directive, which requires the Commission to report on these by 24 October 2015.
Zajema tudi uporabo prenosa pooblastil v skladu s členom 17(1) Direktive, ki določa, da mora Komisija o teh poročati do 24. oktobra 2015.
Yet five of these twelve Member States explicitly insist that the referral must be from a professional in their country.
Kljub temu pa pet od teh dvanajstih držav članic izrecno zahteva, da mora napotitev zagotoviti strokovnjak iz njihove države.
Most obviously, the Directive contains a significant number of provisions relating to transparency for patients on their rights, and on the quality and safety of healthcare services.
In kar je najočitneje, Direktiva vključuje precejšnje število določb v zvezi s preglednostjo pravic za paciente ter kakovostjo in varnostjo storitev zdravstvenega varstva.
The work of the eHealth Network is supported by a number of activities carried out under the eHealth Action Plan 2012 - 2020: Innovative healthcare for the 21st century​[13]​.
Delo mreže e-zdravja je podprto z več dejavnostmi, ki se izvajajo v okviru akcijskega načrta za e-zdravje za obdobje 2012-2020: Inovativno zdravstveno varstvo za 21. stoletje​[13]​.
Other Member States also have regional contact points, but also one national NCP.
Druge države članice tudi imajo regionalne kontaktne točke in eno nacionalno kontaktno točko.
The number of requests for prior authorisation specifically under the Directive which were either authorised or refused in the remaining 17 Member States was 560, of which 360 were authorised.
Zahtevkov za predhodno odobritev, izključno v okviru Direktive, ki so bili odobreni ali zavrnjeni v preostalih 17 državah članicah je bilo 560, od tega jih je bilo 360 odobrenih.
So far, it is clear that there are significant differences between NCPs in the way they operate and the quality of the information they provide.
Za zdaj je jasno, da obstajajo precejšnje razlike med nacionalnimi kontaktnimi točkami ter načini njihovega delovanja in kakovostjo informacij, ki jih zagotavljajo.
Under the CEF Work plan 2015, EU funding has been allocated to implement the exchange of patient summaries, and ePrescriptions.
V okviru delovnega načrta instrumenta za povezovanje Evrope za leto 2015 so bila sredstva EU dodeljena izvedbi izmenjave povzetkov o pacientih in e-receptom.
Some Member States have difficulties dividing their cases between Directive 2011/24/EU and the Social Security Regulations (Regulations (EC) No 883/2004 and (EC) No 987/2009), particularly for claims for reimbursement of healthcare not subject to prior authorisation.
Nekatere države članice imajo težave pri ločevanju svojih primerov na Direktivo 2011/24/EU in uredbi o socialni varnosti (uredbi (ES) št. 883/2004 in (ES) št. 987/2009), zlasti za zahtevke za povračilo stroškov za zdravstveno varstvo, za katerega se ne uporablja predhodna odobritev.
‘Patients have high expectations …the prevailing sentiment is that the NCP must be a gateway to healthcare, not a gatekeeper blocking access.'
„Pacienti imajo visoka pričakovanja ... prevladujoče mnenje je, da mora biti nacionalna kontaktna točka okno v zdravstveno varstvo, ne pa nadzornik, ki preprečuje dostop."
^4 Note that the data for planned healthcare via the S2 forms covers only 22 Member States as data for the others was not available.
^4 Treba je opozoriti, da je v podatke za načrtovano zdravstveno varstvo v okviru obrazcev S2 zajetih samo 22 držav članic, saj podatki za druge države niso bili na voljo.
The agreed final cut-off date for the exercise was 30 April 2015.
Dogovorjeni končni presečni datum za zbiranje podatkov je bil 30. april 2015.
ANNEX B
PRILOGA B
The eHealth Network will review and, if necessary, update the guidelines in 2015-2016 in the light of the CEF experience.
Mreža e-zdravja bo proučila in po potrebi posodobila smernice za obdobje 2015-2016 glede na izkušnje v zvezi z instrumentom za povezovanje Evrope.
In these cases the data indicate 74 050 via website (see point above), 15 461 via telephone, 5 436 via email, and 2 179 via face-to-face contact.
V teh primerih je iz podatkov razvidno, da je bilo 74 050 zahtevkov poslanih prek spletišča (glej zgoraj navedeno točko), 15 461 prek telefona, 5 436 prek e-pošte in 2 179 prek osebnega stika.
It may therefore prove useful to consider whether and how the applicable rules (e.g. on applicable legislation; access to, and reimbursement for, treatment) need to be developed and clarified.
Torej bi bilo morda dobro proučiti, ali je treba razviti in pojasniti veljavna pravila (npr. o veljavni zakonodaji; dostopu do zdravljenja in povračilu stroškov zanj).
At least four Member States require patients to provide a sworn translation of invoices (one even requiring patients to get all documents certified by their consul in the country of treatment).
Vsaj štiri države članice zahtevajo, da morajo pacienti zagotoviti sodno overjen prevod računov (ena celo zahteva, da morajo pacienti overiti vse dokumente pri svojem konzulu v državi zdravljenja).
In 2013 there were 1.6 million claims for reimbursement for unplanned healthcare but only 30 172 applications for planned healthcare abroad under the Regulations (via the S2 form used in such cases).
Leta 2013 je bilo vloženih 1,6 milijona zahtevkov za povračilo stroškov za nenačrtovano zdravstveno varstvo, za načrtovano zdravstveno varstvo v tujini v okviru uredb (z obrazcem S2, ki se uporablja v takih primerih) pa samo 30 172.
6.1 Introduction
6.1 Uvod
^17 This data may include a limited number of claims for treatment which was supposed to be subject to prior authorisation but for which the claim was made retrospectively and ultimately reimbursed.
^17 Ti podatki lahko zajemajo omejeno število zahtevkov za zdravljenje, za katero naj bi veljala predhodna odobritev, vendar je bil zanj zahtevek vložen naknadno, stroški pa na koncu povrnjeni.
Regarding ERNs, the first Networks will be established in 2016, and will then need to be evaluated.
Kar zadeva evropske referenčne mreže, bodo prve mreže ustanovljene leta 2016, nato pa jih bo treba oceniti.
Whilst the initial work undertaken by the Commission so far has thrown up some suggestions for action at EU level (e.g. sharing of best practice from successful projects; development of checklists for those considering cross-border collaboration), it is clear that these would only work in support of national or local activities.
Začetno delo, ki ga je izvedla Komisija, je doslej zagotovilo nekaj predlogov za ukrepe na ravni EU (npr. izmenjava dobre prakse pri uspešnih projektih; oblikovanje kontrolnih seznamov za tiste, ki razmišljajo o čezmejnem sodelovanju), vendar bi ti nedvomno podpirali samo nacionalne ali lokalne dejavnosti.
Reimbursement for treatment not subject to prior authorisation​[17]​
Povračilo stroškov za zdravljenje, za katero predhodna odobritev ne velja​[17]​
It meets twice a year and is supported operationally by a joint action under the Health Programme established by Regulation (EU) No 282/2014​[12]​.
Srečuje se dvakrat letno, operativna podpora zanjo pa je zagotovljena na podlagi skupnega ukrepa v okviru programa za zdravje, ki je bil oblikovan z Uredbo (EU) št. 282/2014​[12]​.
Three Member States alone accounted for nearly 75 % of the requests recorded: Germany (36 602); Finland (25 207); and Austria (15 536).
Samo tri države članice so prejele skoraj 75 % zabeleženih zahtevkov: Nemčija (36 602), Finska (25 207) in Avstrija (15 536).
Of the latter, 29 115 were accepted​[4]​ - 17 358 in Luxembourg alone.
Od slednjih je bilo sprejetih 29 115​[4]​, od tega 17 358 samo v Luksemburgu.
It seems hard to argue, for example, that a treatment should be subject to prior authorisation when not a single person has applied for authorisation for that treatment that year (with a possible exception for extremely specialised or expensive treatments, of course, where even a very small number of reimbursement claims could have significant consequences).
Težko je na primer utemeljiti, da se mora za zdravljenje uporabljati predhodna odobritev, če v tistem letu niti ena oseba ni zaprosila za odobritev za tako zdravljenje (morebitna izjema so seveda izjemno specializirane ali drage oblike zdravljenja, pri katerih bi celo zelo majhno število zahtevkov za povračilo stroškov lahko imelo precejšnje posledice).
Article 17 of Directive 2011/24/EU confers on the Commission the delegated powers for a period of 5 years from 24 April 2011.
Člen 17 Direktive 2011/24/EU prenaša pooblastila na Komisijo za obdobje petih let od 24. aprila 2011.
4.1 Recognition of prescriptions
4.1 Priznavanje receptov
2.1 Prior authorisation: background
2.1 Predhodna odobritev: ozadje
Five Member States had fewer than 100 requests for information (Portugal, for example, recorded just 6).
Pet držav članic je imelo manj kot 100 zahtevkov za informacije (Portugalska jih je na primer zabeležila samo šest).
In these Member States there were a total of only 560 applications for authorisation (of which 360 were granted).
V teh državah članicah je bilo skupno samo 560 prijav za odobritev (od tega je bilo odobrenih 360).
They represented a range of health insurance providers, healthcare providers, patient ombudsmen, national and regional authorities, patient groups, audit bodies, trade unions and frontline healthcare prescriber organisations.
Predstavljali so nabor zdravstvenih zavarovalnic, izvajalcev zdravstvenega varstva, varuhov pacientovih pravic, nacionalnih in regionalnih organov, skupin pacientov, revizijskih organov, sindikatov in vodilnih pooblaščenih organizacij za predpisovanje zdravil.
It has also identified specific areas where greater cross-border collaboration could make a significant difference to patient outcomes, for example in access to critical care for myocardial infarctions.
Opredeljena so bila tudi posebna območja, na katerih bi okrepljeno čezmejno sodelovanje precej prispevalo k izidom za paciente, na primer pri dostopu do intenzivne nege za miokardne infarkte.
If a patient from a Member State where such consultations are not provided or funded has a consultation via telemedicine with a GP in a Member State where such consultations are so provided, it is not clear whether the Member State of affiliation may, in such a case, refuse reimbursement.
Če se pacient iz države članice, v kateri taka posvetovanja niso zagotovljena ali financirana, posvetuje v okviru telemedicine s splošnim zdravnikom v državi članici, kjer so taka posvetovanja zagotovljena, ni jasno, ali lahko država članica zdravstvenega zavarovanja v takem primeru zavrne povračilo stroškov.
Regarding Article 11(5), a meeting of Member State experts was convened on 14 February 2012 to discuss whether there was a need to exclude specific categories of medicinal products or medical devices from the recognition of prescriptions.
V zvezi s členom 11(5) je bilo 14. februarja 2012 sklicano srečanje strokovnjakov iz držav članic, da bi se obravnavalo, ali je treba izključiti posebne kategorije zdravil ali medicinskih pripomočkov iz obsega priznavanja receptov.
Two of these Member States reported that they had neither refused nor granted a single request, two reported only one each, and only two had more than 100 requests.
Dve od teh držav članic sta poročali, da nista niti zavrnili niti odobrili niti enega samega zahtevka, dve sta poročali o samo enem in le dve sta imeli več kot 100 zahtevkov.
All NCPs completed at least a part of the online survey.
Vse nacionalne kontaktne točke so izpolnile vsaj del spletne ankete.
A number of Member States continue to express concern about communicating the complexities of the current legal situation, where cross-border healthcare is covered by two distinct sets of EU legislation (the Directive and the Social Security Regulations), despite the stipulation in Article 2(m) of the Directive, whereby the former applies without prejudice to the Social Security Regulations (see also recitals 28-31 to the Directive).
Več držav članic še naprej izraža zaskrbljenost glede poročanja o kompleksnosti trenutnega pravnega položaja, saj je čezmejno zdravstveno varstvo zajeto v dva različna sklopa zakonodaje EU (Direktiva in uredbi o socialni varnosti), kljub določilu iz člena 2(m) Direktive, v skladu s katerim se prva uporablja brez poseganja v uredbi o socialni varnosti (glej tudi uvodne izjave 28-31 Direktive).
The first call for networks will take place in early 2016, with the first networks expected to be approved during that year.
Prvi razpisi za mreže se bodo začeli na začetku leta 2016 in v tem letu naj bi bile odobrene tudi prve mreže.
PA for detailed list of treatment only (categories not specified) 6
Predhodna odobritev samo za podrobni seznam zdravljenj (kategorije niso navedene) 6
Article 8(7) of the Directive requires Member States to ‘make publicly available which healthcare is subject to prior authorisation'.
Člen 8(7) Direktive določa, da morajo države članice „javno objavi[ti], za katero zdravstveno varstvo je potrebna predhodna odobritev".
Use of prior authorisation
Uporaba predhodne odobritve
Some Member States provide links to different legal documents; others give a general description of quality assurance strategies; a few provide detailed information (including links to hospital evaluation systems featuring typical safety parameters, e.g. mortality rate, number of cases treated with complications); others direct citizens to specific sources - websites or a named person.
Nekatere države članice zagotavljajo povezave do različnih pravnih dokumentov; druge na splošno opišejo strategije za zagotavljanje kakovosti; nekaj jih zagotovi podrobne informacije (vključno s povezavami do sistemov ocenjevanja bolnišnic z značilnimi parametri varnosti, npr. umrljivost, število primerov zdravljenja s komplikacijami); druge usmerjajo državljane v posebne vire, in sicer na spletne strani ali imenovano osebo.
For example, some Member States reimburse or provide consultations with general practitioners at a distance, whilst others do not.
Nekatere države članice na primer povrnejo stroške za posvetovanja s splošnimi zdravniki na daljavo ali taka posvetovanja zagotovijo, druge pa ne.
But the Directive does provide a ready-made space (and forum, in the shape of the network of NCPs, which meets regularly) for the Commission and Member States to share ideas on how this challenge might be met.
Ampak Direktiva zagotavlja vnaprej pripravljen prostor (in forum v obliki mreže nacionalnih kontaktnih točk, ki se redno srečuje) za izmenjavo idej med Komisijo in državami članicami o načinih reševanja tega izziva.
As of 1 July 2015, four infringement proceedings remained open, and all four Member States concerned had made firm commitments to address the outstanding issues.
Od 1. julija 2015 so odprti še štirje postopki za ugotavljanje kršitev, vse zadevne države članice pa so se trdno zavezale, da bodo obravnavale nerešena vprašanja.
The Commission is working with healthcare providers and authorities to raise awareness of the possibilities offered by ERNs, and to gather support for potential networks or members of networks.
Komisija sodeluje z izvajalci in organi zdravstvenega varstva, da bi okrepila ozaveščenost o možnostih, ki jih zagotavljajo evropske referenčne mreže, in pridobila podporo za morebitne mreže ali člane mrež.
In these 14 Member States, therefore, it is unclear for patients exactly which treatments are subject to prior authorisation, since the use of at least one of these criteria - and sometimes both - has not been elucidated by national authorities.
V teh 14 državah članicah torej pacienti ne vedo, za točno katere oblike zdravljenja velja predhodna odobritev, saj nacionalni organi niso pojasnili uporabe vsaj enega od teh meril, v nekaterih primerih pa celo obeh.
Interviews with 20 health insurers as part of an evaluative study​[2]​ on behalf of the Commission found that 15 of them thought that patients in their country do not know whether a treatment is subject to prior authorisation or not, and that patients therefore tended to request prior authorisations even when this was not necessary.
Na podlagi razgovorov z 20 zdravstvenimi zavarovalnicami v okviru evalvacijske študije​[2]​, ki je bil izvedena v imenu Komisije, je bilo ugotovljeno, da jih 15 meni, da pacienti v njihovi državi ne vedo, ali za zdravljenje velja predhodna odobritev ali ne, in da jo zato običajno zahtevajo, tudi če ni potrebna.
It may be that that the natural demand for cross-border healthcare is relatively low for a number of reasons: unwillingness of patients to travel (e.g. because of proximity to family or familiarity with home system); language barriers; price differentials between Member States; acceptable waiting times for treatment in the Member State of affiliation.
Morda je naravno povpraševanje po čezmejnem zdravstvenem varstvu sorazmerno nizko iz več razlogov: nepripravljenost pacientov, da bi potovali (npr. zaradi bližine družine ali poznavanja domačega sistema); jezikovne ovire; razlike v ceni med državami članicami; sprejemljive čakalne dobe za zdravljenje v državi članici zdravstvenega zavarovanja.
Of nine NCPs surveyed, three had fewer than 10 requests for information per month, four had between 10 and 100 requests, and only two had more than 100 requests per month.
Od devetih nacionalnih kontaktnih točk, ki so bile proučene, so tri imele manj kot 10 zahtevkov za informacije na mesec, štiri so imele med 10 in 100 zahtevki, samo dve pa sta imeli več kot 100 zahtevkov na mesec.
Two Member States (Poland and Greece) reported that they had neither authorised nor refused any requests for prior authorisation in 2014 and two (Croatia and Portugal) received just one each.
Dve državi članici (Poljska in Grčija) sta sporočili, da leta 2014 nista niti odobrili niti zavrnili nobenih zahtevkov za predhodno odobritev, dve (Hrvaška in Portugalska) pa sta vsaka prejeli samo po eno.