natgillin/translations-raw huggingface dataset:
In 2015, some 2 million such requests were issued by Member States, while reimbursements for cross-border treatments under the Directive not requiring PA amounted to just over 180,000 in 2015.
Leta 2015 so države članice izdale približno 2 milijona takih zahtevkov, povračil stroškov čezmejnih zdravljenj na podlagi Direktive, za katera se ne zahteva predhodna odobritev, pa je bilo leta 2015 nekaj več kot 180 000.
Among more than 400 initiatives analysed in the mapping exercise, the large majority took place between countries with similar welfare state traditions and concerned knowledge sharing and management and shared treatment and diagnosis of patients.
Velika večina od več kot 400 pobud, ki so bile analizirane pri vzporejanju, je potekala med državami s podobnimi tradicijami socialne države, nanašale pa so se na izmenjavo in upravljanje znanja ter skupno obravnavo in diagnosticiranje pacientov.
Besides exchanging information on relevant policy developments in the area of HTA, in the past three years the HTA Network developed important policy papers such as the 'Added Value of the European Cooperation in the Joint HTA of Medical Devices' in October 2015 and a 'Reflection Paper on Synergies between Regulatory and HTA issues' in November 2016.
Mreža za ocenjevanje zdravstvene tehnologije je poleg izmenjave informacij o zadevnem razvoju politike na področju ocenjevanja zdravstvene tehnologije v zadnjih treh letih pripravila pomembne dokumente o politiki, kot sta „Added Value of the European Cooperation in the Joint HTA of Medical Devices" (Dodana vrednost evropskega sodelovanja pri skupnem ocenjevanju zdravstvene tehnologije za medicinske pripomočke) iz oktobra 2015 in „Reflection Paper on Synergies between Regulatory and HTA issues" (Dokument o razmisleku o sinergijah med regulativnimi vprašanji in vprašanji na področju ocenjevanja zdravstvene tehnologije) iz novembra 2016.
Member States may define the fees for the delivery of healthcare in their territory.
Države članice lahko določijo cene za izvajanje zdravstvenega varstva na svojem ozemlju.
This refers to Member States granting reimbursement of cross-border healthcare on the basis of lower levels of reimbursement, applicable to healthcare received from private or non-contracted healthcare providers within their own territory, compared to the level of reimbursement within the system of public healthcare or contracted healthcare providers.
To se nanaša na države članice, ki odobrijo povračilo stroškov čezmejnega zdravstvenega varstva na podlagi nižjih ravni povračil, ki se uporabljajo za zdravstveno varstvo pri zasebnih ali nepogodbenih izvajalcih zdravstvenega varstva na njihovem ozemlju, v primerjavi z ravnjo povračila v javnem sistemu zdravstvenega varstva ali pri pogodbenih izvajalcih zdravstvenega varstva.
[44: Communication on enabling the digital transformation of health and care in the Digital Single Market; empowering citizens and building a healthier society, COM(2018) 233 final, 25.4.2018.]
[44: Sporočilo o omogočanju digitalne preobrazbe zdravstva in oskrbe na enotnem digitalnem trgu; krepitev vloge državljanov in oblikovanje bolj zdrave družbe (COM(2018) 233 final z dne 25. aprila 2018).]
b) Prior authorisation
(b) Predhodna odobritev
According to Article 7(4) of the Directive, the costs of cross-border healthcare shall be reimbursed or paid up to the level of costs that would have been assumed by the Member State of affiliation, had this healthcare been provided in its territory, without exceeding the actual cost of the healthcare received.
V skladu s členom 7(4) Direktive se stroški čezmejnega zdravstvenega varstva povrnejo ali neposredno plačajo do višine stroškov, ki bi jih prevzela država članica zdravstvenega zavarovanja, če bi bilo to zdravstveno varstvo zagotovljeno na njenem ozemlju, ne da bi bili preseženi dejanski stroški prejetega zdravstvenega varstva.
Article 7(11) requires such limitations to be necessary and proportionate, and not to constitute a means of arbitrary discrimination or an unjustified obstacle to free movement.
V skladu s členom 7(11) morajo biti take omejitve potrebne in sorazmerne ter ne bi smele predstavljati sredstva za samovoljno diskriminacijo ali neutemeljene ovire za prosti pretok.
Any system of prior authorisation shall be restricted to what is necessary and proportionate to the objective to be achieved, and may not constitute a means of arbitrary discrimination or an unjustified obstacle to the free movement of patients.
Vsak sistem predhodne odobritve je omejen na to, kar je potrebno in sorazmerno z zadanim ciljem, in ne sme predstavljati sredstva za samovoljno diskriminacijo ali neutemeljene ovire za prost pretok pacientov.
This is reflected as well in Article 8(2)(a) of the Directive, which allows Member States to use a system of prior authorisation in particular for healthcare that is subject to planning requirements if it involves overnight hospital accommodation or if it requires use of highly specialised and cost-intensive medical infrastructure or medical equipment.
To je izraženo tudi v členu 8(2)(a) Direktive, ki državam članicam omogoča, da sistem predhodne odobritve uporabijo zlasti za zdravstveno varstvo, ki je predmet potreb za načrtovanje, vključuje prenočitev v bolnišnici ali zahteva uporabo visoko specializirane in drage medicinske infrastrukture ali medicinske opreme.
A little less than half of the NCP websites provide information on both pieces of legislation.
Informacije o obeh zakonodajnih aktih zagotavlja malo manj kot polovica spletišč nacionalnih kontaktnih točk.
The main difference between the Directive and the Regulations as regards the reimbursement rights is that under the Regulations, patients are entitled to healthcare abroad as if they were insured under the social security system of the Member State of treatment.
Kar zadeva pravice do povračila stroškov, je glavna razlika med Direktivo in zadevnima uredbama, da so na podlagi uredb pacienti upravičeni do zdravstvenega varstva v tujini, kot če bi bili zavarovani v okviru sistema socialne varnosti države članice zdravljenja.
Such choice may be driven by a desire to return ‘home' to a country of birth for healthcare, or to bring a relative closer to a place where a family member can care for them or it may be driven by a desire to find expertise not available in their home country.
Razlogi za tako izbiro so morda želja po vrnitvi „domov" v državo rojstva, da bi bil pacient tam deležen zdravstvenega varstva, premestitev sorodnika bližje kraju, kjer lahko zanj skrbi družinski član, ali strokovno znanje, ki ni na voljo v domači državi.
This would suggest that while 50% of patient mobility may be driven by issues of proximity, and possibly also collaborations between clinicians in border regions, a very significant part may also reflect patients' desires to receive healthcare in a place of their choice.
To bi pomenilo, da 50 % mobilnosti pacientov spodbudita bližina ter morda celo sodelovanje med zdravniki v obmejnih regijah, zelo pomemben del mobilnosti pa morda kaže tudi željo pacientov, da so deležni zdravstvenega varstva v kraju po lastni izbiri.
Under the Directive, they are reimbursed for treatment abroad as if the treatment was provided in their home countries (Member State of affiliation).
Na podlagi Direktive se jim stroški zdravljenja v tujini povrnejo, kot če bi bilo zdravljenje zagotovljeno v njihovih domačih državah (državi članici zdravstvenega zavarovanja).
Article 9(1) of the Directive requires Member States to ensure that administrative procedures for cross-border reimbursement are based on objective, non-discriminatory criteria which are necessary and proportionate to the objective to be achieved.
Države članice morajo v skladu s členom 9(1) Direktive zagotoviti, da upravni postopki za čezmejno povračilo stroškov temeljijo na objektivnih, nediskriminatornih merilih, ki so nujna in sorazmerna za zadani cilj.
[51: See more details in the Commission report on the operation of the Directive published on 4 September 2015 (COM(2015) 421 final).]
[51: Za več podrobnosti glej Poročilo Komisije o izvajanju Direktive, objavljeno 4. septembra 2015 (COM(2015) 421 final).]
Adjusting for the number of countries reporting data, this shows that EU citizens' use of the rights granted under the Directive had no significant growth or reduction over the three years of the reporting period.
Ob prilagoditvi zaradi števila držav, ki so sporočile podatke, je iz navedenega razvidno, da se v treh letih obdobja poročanja število državljanov EU, ki so uveljavljali pravice iz Direktive, ni bistveno povečalo ali zmanjšalo.
If this number is compared to the reported number of PA for cross-border care under the Directive in 2016 (the latter being the most comparable year), it may be estimated that cross-border with PA under the Directive amounts to approximately 6% of the authorised treatments in another Member State.
Če se to število primerja s sporočenim številom predhodnih odobritev za čezmejno oskrbo na podlagi Direktive leta 2016 (ki je najbolj primerljivo leto), je mogoče oceniti, da čezmejno zdravstveno varstvo s predhodno odobritvijo na podlagi Direktive zajema približno 6 % odobrenih zdravljenj v drugi državi članici.
The present report gives a high-level overview of the data received in 2015, 2016 and 2017.
To poročilo vsebuje splošni pregled podatkov, prejetih v letih 2015, 2016 in 2017.
Moreover, it was also difficult for some Member States to implement the principle which extends patients' choice to healthcare providers located in another Member State, irrespective of whether or not they are contracted by the statutory health system in that Member State.
Poleg tega so nekatere države članice tudi težko izvajale načelo, s katerim se izbira, ki jo imajo pacienti, razširja na izvajalce zdravstvenega varstva v drugi državi članici, in sicer ne glede na to, ali imajo v navedeni državi članici sklenjeno pogodbo z obveznim zdravstvenim sistemom.
Figure 1: Prior Authorisation Requests and Authorisations
Slika 1: Zahtevki za predhodno odobritev in odobritve
The concern of the Commission in this respect is that systems of prior authorisation should not suffer from the lack of legal certainty and transparency about which treatments are subject to and fit the criteria of prior authorisation.
Komisija ima v zvezi s tem pomislek, da na sisteme predhodne odobritve ne bi smeli vplivati slaba pravna varnost in nepreglednost glede tega, za katere oblike zdravljenja veljajo merila za predhodno odobritev in katere oblike zdravljenja jih izpolnjujejo.
The National Contact Points (NCPs) have an essential role to play in relation to this, providing information to citizens upon demand and, more generally, in raising awareness on patient rights and responding to information needs.
Pri tem imajo bistveno vlogo nacionalne kontaktne točke, saj državljanom na zahtevo zagotavljajo informacije, splošneje pa so pomembne tudi pri ozaveščanju o pravicah pacientov in odzivanju na potrebe po informacijah.
While about half the patient mobility is accounted for by movements from France to its neighbouring countries, the other half of the flow is made up by small numbers of patients travelling throughout the EU to receive care - both to neighbouring countries and to countries further away.
Premiki iz Francije v njene sosednje države predstavljajo približno polovico mobilnosti pacientov, drugo polovico pretoka pa sestavlja majhno število pacientov, ki zaradi oskrbe potujejo po vsej EU, in sicer v sosednje in bolj oddaljene države.
[24: https://www.oecd-ilibrary.org/social-issues-migration-health/health-at-a-glance-2017/health-expenditure-in-relation-to-gdp_health_glance-2017-45-en][25: http://ec.europa.eu/eurostat/tgm/refreshTableAction.do;jsessionid=9ea7d07e30dd3bf0a52b9a8a474c872db039e243c026.e34OaN8Pc3mMc40Lc3aMaNyTa3eQe0?tab=table&plugin=1&pcode=tec00001&language=en]
][25: http://ec.europa.eu/eurostat/tgm/refreshTableAction.do;jsessionid=9ea7d07e30dd3bf0a52b9a8a474c872db039e243c026.e34OaN8Pc3mMc40Lc3aMaNyTa3eQe0?tab=table&plugin=1&pcode=tec00001&language=en.]
][53: Commission Delegated Decision 2014/286/EU of 10 March 2014 setting out criteria and conditions that European Reference Networks and healthcare providers wishing to join a European Reference Network must fulfil (OJ L 147, 17.5.2014, p.
][53: Delegirani sklep Komisije 2014/286/EU z dne 10. marca 2014 o določitvi meril in pogojev, ki jih morajo izpolnjevati evropske referenčne mreže in izvajalci zdravstvenega varstva, ki se želijo pridružiti evropski referenčni mreži (UL L 147, 17.5.2014, str.
After patients travelling from France, the next most frequent cases of patient mobility were patients travelling from Denmark to Germany; followed by Poland to Czech Republic and Norway to Spain.
Za pacienti, ki potujejo iz Francije, so bili naslednji najpogostejši primeri mobilnosti pacientov pacienti, ki so potovali iz Danske v Nemčijo, sledili so jim pacienti, ki so potovali iz Poljske na Češko in iz Norveške v Španijo.
[21: It should be noted that France was able to report data on healthcare subject to PA only in 2016.
[21: Opozoriti je treba, da je lahko Francija podatke o zdravstvenem varstvu, za katero se zahteva predhodna odobritev, sporočila le leta 2016.
The proposal seeks to build on the on-going project based cooperation on HTA and to address certain shortcomings identified in the reflection process.
Namen predloga je nadgraditi trenutno projektno sodelovanje na področju ocenjevanja zdravstvene tehnologije in odpraviti nekatere pomanjkljivosti, ugotovljene v okviru razmisleka.
Under the eHDSI Infrastructure, the first wave of voluntary cross-border exchanges of patient summaries and ePrescriptions is set to begin by a few pioneering countries by the end of 2018; with around 20 Member States expected to participate by 2020.
V okviru infrastrukture za digitalne storitve e-zdravja je nekaj prvih držav pripravljenih, da bodo do konca leta 2018 začele prvi sklop prostovoljnih čezmejnih izmenjav povzetkov podatkov o pacientih in e-receptov, do leta 2020 pa naj bi sodelovalo približno 20 držav članic.
Article 8(7) of the Directive requires Member States to ‘make publicly available which healthcare is subject to prior authorisation'.
Države članice morajo v skladu s členom 8(7) Direktive „javno objavi[ti], za katero zdravstveno varstvo je potrebna predhodna odobritev".
Nevertheless, a steady increase has occurred since 2015, with more than twice as many requests for PA being made and authorised in 2017 as in 2015 across the Member States.
Kljub temu se njihovo število od leta 2015 nenehno povečuje, pri čemer je bilo leta 2017 na ravni vseh držav članic vloženih in odobrenih več kot dvakrat toliko zahtevkov za predhodno odobritev kot leta 2015.
Accordingly, Figure 2 should be interpreted knowing that in 2016 France accounted for 3510 of the 5162 requests for PA and 2579 of the 3644 authorisations for PA.
V skladu s tem bi bilo treba sliko 2 razlagati ob upoštevanju, da je leta 2016 Francija prejela 3 510 od 5 162 zahtevkov za predhodno odobritev in da je bilo njenih 2 579 od 3 644 odobrenih zahtevkov.
[40: 2011/890/EU: Commission Implementing Decision of 22 December 2011 providing the rules for the establishment, the management and the functioning of the network of national responsible authorities on eHealth]
[40: 2011/890/EU: Izvedbeni sklep Komisije z dne 22. decembra 2011 o pravilih za vzpostavitev, upravljanje in delovanje mreže nacionalnih organov, pristojnih za e-zdravje.]
Some Member States require patients to provide a certified translation of their medical documentation in order to obtain their reimbursement.
Nekatere države članice zahtevajo, da morajo pacienti za povračilo stroškov zagotoviti sodno overjeni prevod zdravstvene dokumentacije.
Looking at flows of patients travelling for healthcare after receiving prior authorisation, the greatest flow was from France to Spain.
Kar zadeva pretoke pacientov, ki po izdani predhodni odobritvi potujejo zaradi zdravstvenega varstva, je bil največji pretok iz Francije v Španijo.
Delegated powers
Prenos pooblastil
An additional call took place in 2018 allowing more Member States to participate in the eHDSI.
Leta 2018 je bil izveden dodatni razpis, s katerim se je še več državam članicam omogočilo sodelovanje v infrastrukturi za digitalne storitve e-zdravja.
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.
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.
[45: Based on Article 11(2)(a), (c) and (d) of the Directive.
[45: Na podlagi člena 11(2)(a), (c) in (d) Direktive.
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.
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.
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.
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.
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.
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.
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.
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.
][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.
][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.
][6: Article 7(6) and Article 9.
][6: Člen 7(6) in člen 9.
Patient mobility with prior authorisation
Mobilnost pacientov s predhodno odobritvijo
][8: Article 4(2)(c), (e)-(f), 4(3), 4(4), 5(b)-(d), 7(1), 9(4)-(5).
][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).
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.
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.
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.
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.
Patient mobility not subject to prior authorisation
Mobilnost pacientov, za katero se ne zahteva predhodna odobritev
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.
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.
[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]
[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.
[27: https://ec.europa.eu/health/cross_border_care/key_documents_en]
[27: https://ec.europa.eu/health/cross_border_care/key_documents_sl.]
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.
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.
Compliance check
Preverjanje skladnosti
[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.
[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.
Financial Implications of Patient Mobility
Finančne posledice mobilnosti pacientov
[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]
][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.]
][31: https://ec.europa.eu/health/cross_border_care/events/ev_20161024_en]
][31: https://ec.europa.eu/health/cross_border_care/events/ev_20161024_sl.]
[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.
][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.
[47: Article 10(3) of the Directive.
[47: Člen 10(3) Direktive.
[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.
[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.
][9: Article 4(2)(d).]
][9: Člen 4(2)(d).]
Completeness check
Preverjanje popolnosti