natgillin/translations-raw huggingface dataset:
They have all been closed on the grounds of subsequent transposition by the Member States.
Vsi so bili zaključeni zaradi poznejšega prenosa v zadevnih državah članicah.
[23: Under the Directive reimbursement is usually at the rate that would have been made in the country of insurance, while under the Regulations it is at the rate of cost in the country of treatment.]
[23: Stroški se na podlagi Direktive običajno povrnejo po stopnji, kakršna bi bila v državi zavarovanja, na podlagi zadevnih uredb pa po stopnji stroškov v državi zdravljenja.]
c) Administrative procedures regarding cross-border healthcare
(c) Upravni postopki v zvezi s čezmejnim zdravstvenim varstvom
The current Joint Action, EUnetHTA 3, launched in June 2016, runs until 2020 and includes more than 80 partners, relevant HTA bodies that carry out assessments and not-for-profit organisations contributing to HTA in Europe.
Trenutni skupni ukrep, tj. tretji skupni ukrep mreže EUnetHTA, ki se je začel izvajati junija 2016, se bo izvajal do leta 2020, vključuje pa več kot 80 partnerjev, ustrezne organe za ocenjevanje zdravstvene tehnologije, ki izvajajo ocenjevanja, in neprofitne organizacije, ki prispevajo k ocenjevanju zdravstvene tehnologije v Evropi.
The Commission considers that it has exercised its delegated powers within the remit conferred to it by the Directive.
Komisija meni, da je pooblastila izvedla v okviru pristojnosti, ki so bile nanjo prenesene z Direktivo.
Information on complaint procedures and settlement of disputes was also scarce, as well as information on the time period required to process reimbursements and prior authorisation requests.
Prav tako je bilo malo informacij o pritožbenih postopkih in reševanju sporov, pa tudi o času, potrebnem za obdelavo povračil in zahtevkov za predhodno odobritev.
In the case of the Regulation (EC) No 883/2004, unplanned cross-border healthcare is mostly reimbursed between Member States on receipt of a request from the Member State of treatment.
V primeru Uredbe (ES) št. 883/2004 se stroški nenačrtovanega čezmejnega zdravstvenega varstva med državami članicami večinoma povrnejo ob prejemu zahtevka države članice zdravljenja.
The European Reference Networks (ERNs) are virtual, voluntary cross-border networks, bringing together healthcare providers across Europe.
Evropske referenčne mreže so virtualne, prostovoljne čezmejne mreže, ki povezujejo izvajalce zdravstvenega varstva iz vse Evrope.
After the transposition deadline, the Commission launched 26 infringement procedures for late or incomplete notification of transposition measures.
Komisija je po roku za prenos začela 26 postopkov za ugotavljanje kršitev zaradi pozne ali nepopolne priglasitve ukrepov za prenos.
Even if a Member State does not apply such mechanism of prior notification, Article 9(5) requires Member States to reimburse patients without undue delay.
Tudi če država članica ne uporablja takega mehanizma predhodnega obveščanja, morajo države članice v skladu s členom 9(5) stroške pacientom povrniti brez nepotrebnega odlašanja.
By June 2018 165 panels had been opened, the number growing daily, with the first patients directly benefiting.
Do junija 2018 je bilo sklicanih 165 panelnih razprav, pri čemer se njihovo število dnevno povečuje, prvi pacienti pa že imajo od njih neposredno korist.
Where authorisation was not required, the greatest flow was from France to Germany.
V primerih, kjer se odobritev ni zahtevala, je bil največji pretok iz Francije v Nemčijo.
Cross-border patient mobility within the EU shows a slight increasing trend over the last three years.
Čezmejna mobilnost pacientov v EU se je v zadnjih treh letih nekoliko povečala.
The latter should be seen as an opportunity to improve access to care for patients, to capitalise on economies of scale and to use resources efficiently.
Slednje bi bilo treba obravnavati kot priložnost za izboljšanje dostopa pacientov do oskrbe, izkoriščanje ekonomije obsega in učinkovito porabo sredstev.
These reports cover healthcare with or without prior authorisation, requests for information about healthcare, healthcare provided, reimbursements made and reasons for which healthcare was reimbursed, or not.
Ta poročila zajemajo zdravstveno varstvo s predhodno odobritvijo ali brez nje, zahtevke za informacije o zdravstvenem varstvu, zagotovljeno zdravstveno varstvo, povračila stroškov in razloge, zaradi katerih so bili stroški zdravstvenega varstva povrnjeni ali ne.
[19: Article 4(2)(d) of the Directive requires the existence of a system of professional liability insurance or an equivalent or essentially comparable guarantee or similar arrangement.]
[19: V skladu s členom 4(2)(d) Direktive mora biti vzpostavljen sistem zavarovanja poklicne odgovornosti ali enakovreden sistem ali v bistvu primerljivo jamstvo ali podobna ureditev.]
Most of the Member States reported having in place a national HTA system for medicinal products (26 Member States and Norway) and/or medical devices (20 Member States and Norway).
Večina držav članic je poročala, da ima vzpostavljen nacionalni sistem ocenjevanja zdravstvene tehnologije za zdravila (26 držav članic in Norveška) in/ali medicinske pripomočke (20 držav članic in Norveška).
This may partly be due to the gradual improvements in the information of citizens regarding the Directive and a better awareness on patient rights as a possible consequence.
To je lahko delno posledica postopnega izboljšanja obveščenosti državljanov o Direktivi in posledične boljše ozaveščenosti o pravicah pacientov, ki je lahko ena od posledic.
Recognition of prescriptions
Priznavanje receptov
The Commission adopted Implementing Directive 2012/52/EU to give effect to the principle of mutual recognition of medical prescriptions.
Komisija je sprejela Izvedbeno direktivo 2012/52/EU, da bi uveljavila načelo vzajemnega priznavanja zdravniških receptov.
"There is still very little experience about cross-border healthcare among patient communities.
„Skupnosti pacientov imajo še vedno zelo malo izkušenj s čezmejnim zdravstvenim varstvom."
a) Systems of reimbursement of costs for cross-border healthcare
(a) Sistemi povračila stroškov za čezmejno zdravstveno varstvo
[10: See, for example, case C-372/04 Watts, paragraph 100.]
[10: Glej na primer zadevo C-372/04, Watts, točka 100.]
Since the last report, the Members States within the ERN Board have approved 24 thematic Networks which were launched in March 2017 in Vilnius at the third ERN Conference.
Države članice v Odboru držav članic za evropske referenčne mreže so od prejšnjega poročila odobrile 24 tematskih mrež, ki so se začele izvajati marca 2017 v Vilni na tretji konferenci evropski referenčnih mrež.
On 25 April 2018 the Commission adopted a Communication, which inter alia seeks to ensure appropriate governance of the eHDSI and its financial basis and to improve the interoperability of patient data and access by the citizen.
Komisija je 25. aprila 2018 sprejela sporočilo, s katerim si med drugim prizadeva zagotoviti ustrezno upravljanje infrastrukture digitalnih storitev e-zdravja in njene finančne osnove ter izboljšati interoperabilnost podatkov o pacientih in dostop državljanov.
If there is no comparable price for domestic patients, Article 4(4) places an obligation on providers to charge a price calculated according to objective, non-discriminatory criteria.
Če ni primerljive cene za domače paciente, se s členom 4(4) določa obveznost za izvajalce, da zaračunajo ceno v skladu z objektivnimi, nediskriminatornimi merili.
Another Member State required a certificate from the foreign National Contact Point attesting that the healthcare to be provided within its territory would be compliant with the necessary safety and quality standards in place.
Druga država članica je zahtevala potrdilo tuje nacionalne kontaktne točke, da bo zdravstveno varstvo, ki bo zagotovljeno na njenem ozemlju, v skladu s potrebnimi vzpostavljenimi standardi varnosti in kakovosti.
A recent study of the Commission on the information provided to patients shows that in-depth information on patients' rights is generally lacking on NCP websites, including insight into what to do in the case of undue delay.
Iz nedavne študije Komisije o informacijah, zagotovljenih pacientom, je razvidno, da na spletiščih nacionalnih kontaktnih točk na splošno ni dovolj poglobljenih informacij o pravicah pacientov, vključno z vpogledom v to, kaj storiti v primeru neupravičene zamude.
National experts have been trained in explaining the two routes, firstly via the Conference of October 2016 on awareness of rights under the Directive and secondly via the NCP Capacity Building Workshop on 8 March 2018 which were both organised by the Commission.
Nacionalni strokovnjaki so usposobljeni za razlago obeh možnosti, in sicer so se najprej oktobra 2016 udeležili konference o ozaveščenosti o pravicah iz Direktive, nato pa 8. marca 2018 še delavnice za krepitev zmogljivosti nacionalnih kontaktnih točk, ki ju je obe organizirala Komisija.
The good results of this resource-intensive work have led to fewer administrative burdens on citizens accessing cross-border healthcare, more compressed prior-authorisation systems and lighter procedures for exercising the basic patient rights enshrined in the Directive.
Dobri rezultati tega intenzivnega dela, ki je zahtevalo veliko sredstev, so privedli do manjše upravne obremenitve za državljane, ki dostopajo do čezmejnega zdravstvenega varstva, bolj zgoščenih sistemov predhodnih odobritev in lažjih postopkov za uveljavljanje temeljnih pravic pacientov iz Direktive.
Based on the reported data for planned cross-border care under the Regulations, in 2015, Member States issued around 55,000 authorisations for planned treatment abroad.
Na podlagi sporočenih podatkov za načrtovano čezmejno oskrbo na podlagi zadevnih uredb so leta 2015 države članice odobrile približno 55 000 zahtevkov za načrtovano zdravljenje v tujini.
However, as explained in recital 46 to the Directive, in certain cases, the benefits should be provided under the Regulations, unless otherwise requested by the patient.
Vendar bi morale biti storitve, kot je pojasnjeno v uvodni izjavi 46 Direktive, v nekaterih primerih izvedene na podlagi uredb, razen če pacient ne zahteva drugače.
One Member State introduced an excessive minimum threshold (of 15 Euros) for reimbursement that roughly equalled average reimbursement tariffs for outpatient healthcare in that Member State.
Ena država članica je za povračilo stroškov uvedla previsok najnižji prag (15 EUR), ki je bil približno enakovreden povprečnim tarifam za povračilo stroškov ambulantne zdravstvene oskrbe v navedeni državi članici.
In response to the calls from the Council and the European Parliament to ensure sustainability of EU cooperation on HTA beyond 2020, the Commission launched an extensive reflection process, including stakeholder consultations and impact assessment in line with the Commission's Better Regulation Agenda.
Komisija je na pobudo Sveta in Evropskega parlamenta, naj zagotovi vzdržnost sodelovanja EU na področju ocenjevanja zdravstvene tehnologije po letu 2020, začela obsežen razmislek, vključno s posvetovanji z zainteresiranimi stranmi in oceno učinka v skladu z agendo Komisije za boljše pravno urejanje.
Figure 2: Requests for Reimbursement without prior authorisation
Slika 2: Zahtevki za povračilo brez predhodne odobritve
A key principle of ERNs is to let the knowledge travel rather than the patient.
Ključno načelo evropskih referenčnih mrež je omogočiti, da namesto pacienta potuje znanje.
Today EU cooperation on HTA has two main components.
Sedanje sodelovanje na ravni EU na področju ocenjevanja zdravstvene tehnologije ima dva glavna sestavna dela.
Under the mutual recognition of prescriptions between Member States, Article 11(5) empowers the Commission to adopt, by means of delegated acts, measures to exclude specific categories of medicinal products or medical devices from the recognition of prescriptions, where necessary, to safeguard public health.
Komisija je s členom 11(5) v okviru vzajemnega priznavanja receptov med državami članicami pooblaščena, da z delegiranimi akti sprejme ukrepe za izključitev posebnih kategorij zdravil ali medicinskih pripomočkov iz obsega priznavanja receptov, kadar je to potrebno zaradi varovanja javnega zdravja.
It also notes that Member States may, under certain circumstances, adopt measures regarding access to treatment; however, such measures must be justified, proportionate and necessary; they must also be announced publicly in advance.
V členu 4(3) je navedeno tudi, da v nekaterih okoliščinah države članice lahko sprejmejo ukrepe glede dostopa do zdravljenja, vendar morajo biti taki ukrepi utemeljeni, sorazmerni in nujni, morajo pa biti tudi vnaprej javno najavljeni.
By using the toolbox disseminated during the Workshop, all NCPs should now be able to explain the distinction between the two legal routes via their websites and to proactively bring them up in contact with patients.
Z uporabo zbirke orodij, razširjene med delavnico, bi morale biti zdaj vse nacionalne kontaktne točke na svojih spletiščih zmožne pojasniti razlike med obema zakonitima možnostma in jih proaktivno omeniti v stiku s pacienti.
Article 4(3) requires Member States to observe the principle of non-discrimination with regard to patients from other Member States.
Države članice morajo v skladu s členom 4(3) upoštevati načelo nediskriminacije, kar zadeva paciente iz drugih držav članic.
This would suggest that, on the whole, patients prefer to receive healthcare near their home if possible, and that if they do elect to travel, they prefer to travel to a neighbouring country.
To bi na splošno pomenilo, da je pacientom ljubša zdravstvena oskrba blizu doma, če je to mogoče, če pa se že odločijo za potovanje, najraje potujejo v sosednjo državo.
Member States therefore can build a comparable cost-based price for the actual cost of the health service, which should be based on objective and non-discriminatory methodology that does not financially discriminate between "domestic" covered under local public schemes and "cross-border" patients for a given intervention.
Države članice lahko zato primerljivo ceno na podlagi stroškov oblikujejo na podlagi dejanskih stroškov zdravstvene storitve, ki bi morala temeljiti na objektivni in nediskriminatorni metodologiji, s katero se pri zadevnem posegu finančno ne razlikuje med „domačimi" pacienti, vključenimi v lokalne javne sheme, in „čezmejnimi" pacienti.
The eHealth Network is a voluntary network composed of national authorities responsible for eHealth that works towards interoperable applications and enhanced continuity of and access to care.
Mreža e-zdravje je prostovoljna mreža, ki jo sestavljajo nacionalni organi, pristojni za e-zdravje, prizadeva pa si za interoperabilne aplikacije ter povečano kontinuiteto oskrbe in dostopa do nje.
Although the Commission has received no specific notifications under Article 7(9), certain transposition measures could be questioned as limiting the level of reimbursement for cross-border healthcare.
Čeprav Komisija ni prejela posebnih uradnih obvestil na podlagi člena 7(9), bi se lahko glede nekaterih ukrepov za prenos posumilo, da omejujejo raven povračila stroškov čezmejnega zdravstvenega varstva.
Taking into account the variation in the number of Member States providing feedback on the number of requests received, and noting the limited variation in the spread of requests (in all three years the total number of requests was dominated by Poland and Lithuania which together accounted for more than 50% of all requests for information across all Member States), there has been little change in the level of enquiry about access to cross-border healthcare made by citizens.
Ob upoštevanju razlik v številu držav članic, ki so zagotovile povratne informacije o številu prejetih zahtevkov, in majhnih razlik pri porazdelitvi zahtevkov (v vseh treh letih je bilo skupno število zahtevkov največje na Poljskem in v Litvi, kjer je bilo skupaj podanih več kot 50 % vseh zahtevkov za informacije v vseh državah članicah), se stopnja poizvedovanja državljanov o dostopu do čezmejnega zdravstvenega varstva ni veliko spremenila.
As the figures have been moderate and stable over the years, impact on national health budgets arising from patients wishing to access cross-border healthcare appears marginal.
Ker so bili podatki v preteklih letih zmerni in stabilni, se zdi, da je učinek pacientov, ki želijo dostopati do čezmejnega zdravstvenega varstva, na nacionalne zdravstvene proračune zanemarljiv.
The Commission identified four priority areas for the compliance assessment which had the greatest potential to act as barriers to patients if left unaddressed: systems of reimbursement, use of prior authorisation, administrative requirements and charging of incoming patients.
Komisija je opredelila štiri prednostna področja za ocenjevanje skladnosti, pri katerih je bila največja možnost, da bodo v primeru neukrepanja ovirala paciente: sistemi povračila stroškov, uporaba predhodne odobritve, upravne zahteve in zaračunavanje stroškov prihajajočim pacientom.
This is identical to "conformity checks" in the terminology used in the Commission Communication "EU Law: Better results through better application" C/2016/8600, OJ C 18, 19.1.2017 final, p. 10-20.
Pomeni enako kot „preverjanje skladnosti" iz terminologije, ki se uporablja v sporočilu Komisije „Pravo EU: z boljšo uporabo do boljših rezultatov" (C/2016/8600, UL C 18, 19.1.2017, str. 10).
Information to patients
Informacije za paciente
Again, a clear pattern emerges showing that France has the greatest number of travelling patients, with the three most common countries for healthcare provision being Spain, Portugal and Belgium in all three years.
Ponovno se pojavi jasen vzorec, ki kaže, da ima Francija največje število potujočih pacientov, pri čemer so vsa tri leta tri najpogostejše države za zagotavljanje zdravstvenega varstva Španija, Portugalska in Belgija.
As indicated in recital 44 to the Directive and according to the constant case-law of the Court of Justice, Member States may make reimbursement of the costs of cross-border healthcare subject to prior authorisation when it is both necessary and reasonable; such a scheme must also be based on objective and non-discriminatory criteria.
Kot je navedeno v uvodni izjavi 44 Direktive in v skladu s stalno sodno prakso Sodišča lahko države članice za povračilo stroškov čezmejnega zdravstvenega varstva zahtevajo predhodno odobritev, kadar je to nujno in sorazmerno; taka shema mora temeljiti tudi na objektivnih in nediskriminatornih merilih.
[30: 14 out of 37 NCP staff admitted in 2017 to facing difficulties communicating the Directive's relationship with the Regulations to the patient.
[30: Leta 2017 je 14 od 37 članov osebja nacionalnih kontaktnih točk priznalo, da imajo težave, ko pacientom pojasnjujejo razmerje med Direktivo in zadevnima uredbama.
Noting that the OECD Health at a Glance report for 2017 estimates that in EU countries the average spent on healthcare is 10% of GDP; and that Eurostat reported EU GDP in 2017 at €15.3 trillion; the expenditure across the EU on cross-border healthcare incurred under the Directive may therefore be estimated at 0.004% of the EU-wide annual healthcare budget.
Ob upoštevanju, da je v poročilu OECD z naslovom Health at a Glance (Pregled zdravstva) za leto 2017 ocenjeno, da se za zdravstveno varstvo v državah EU povprečno porabi 10 % BDP, in da je Eurostat za leto 2017 poročal o BDP EU v višini 15,3 bilijona EUR, se lahko tako izdatki po vsej EU za čezmejno zdravstveno varstvo, nastali na podlagi Direktive, ocenijo na 0,004 % letnega proračuna za zdravstveno varstvo na ravni EU.
The findings show that, while information provision through NCP websites was well taken care of for several categories, there remains a need to further improve the websites.
Ugotovitve kažejo, da je bilo za zagotavljanje informacij prek spletišč nacionalnih kontaktnih točk dobro poskrbljeno pri več kategorijah, vendar je treba spletišča še dodatno izboljšati.
Their clinical operation started in November 2017, when the dedicated IT platform, the Clinical Patient Management System, became operational, allowing for the first virtual panels on patient cases to take place.
Klinično delovanje evropskih referenčnih mrež se je začelo novembra 2017, ko je začela delovati namenska informacijska platforma, sistem za klinično obravnavo pacientov, kar je omogočilo izvedbo prvih virtualnih panelnih razprav o primerih pacientov.
The Directive calls on NCPs to provide patients and health professionals with information on accessibility of hospitals for persons with disabilities (Article 4(2)(a)).
Z Direktivo so nacionalne kontaktne točke pozvane, naj pacientom in zdravstvenim delavcem zagotovijo informacije o dostopnosti bolnišnic invalidnim osebam (člen 4(2)(a)).
[20: See footnote 2.]
[20: Glej sprotno opombo 2.]
The proposal sets out a support framework and procedures for cooperation on HTA at Union level and common rules for clinical assessments of health technologies.
Predlog določa okvir podpore in postopke za sodelovanje pri ocenjevanju zdravstvene tehnologije na ravni Unije ter skupna pravila za klinične ocene zdravstvene tehnologije.
Article 7(9) permits Member States to limit application of the rules on reimbursement of cross-border healthcare for overriding reasons of general interest.
Člen 7(9) državam članicam omogoča, da omejijo uporabo pravil o povračilu stroškov čezmejnega zdravstvenega varstva zaradi prevladujočih razlogov v splošnem interesu.
ERNs are not directly accessible by individual patients; instead, healthcare providers refer patients to the relevant Network, with their consent and in accordance with the national health systems rules.
Do evropskih referenčnih mrež posamezniki nimajo neposrednega dostopa; namesto tega izvajalci zdravstvenega varstva paciente z njihovim soglasjem in v skladu s pravili nacionalnega zdravstvenega sistema napotijo na ustrezno mrežo.
][16: Articles 8(2)(b) and (c) also allow Member States to require prior authorisation when the healthcare involves treatments presenting a particular risk for the patient or the population, or when it is provided by a healthcare provider that could give rise to serious and specific concerns relating to the quality or safety of the care.]
][16: Člen 8(2)(b) in (c) državam članicam omogoča tudi, da zahtevajo predhodno odobritev, kadar zdravstveno varstvo vključuje oblike zdravljenja, ki pomenijo posebno tveganje za pacienta ali prebivalce, ali kadar ga opravi izvajalec zdravstvenega varstva, ki bi lahko pomenil resne in konkretne pomisleke glede kakovosti ali varnosti oskrbe.]
The Network laid the foundations for the eHealth Digital Service Infrastructure (eHDSI), an IT system funded by the Connecting Europe Facility and the Member States, and adopted guidelines on Patient Summaries (November 2013) and on ePrescriptions (November 2014) .
Mreža je postavila temelje za infrastrukturo za digitalne storitve e-zdravja (eHDSI), informacijski sistem, ki ga financirajo Instrument za povezovanje Evrope in države članice, ter sprejela smernice o povzetkih podatkov o pacientih (november 2013) in e-receptih (november 2014).
[12: Directive 2011/24/EU was due to be transposed by the EFTA countries Iceland, Liechtenstein and Norway no later than 1 August 2015.
[12: Države Efte Islandija, Lihtenštajn in Norveška so morale Direktivo 2011/24/EU prenesti najpozneje do 1. avgusta 2015.
Cooperation on HTA post 2020 in line with the proposal is expected to help to make innovative health technologies available to Europe's patients, make better use of available resources and improve business predictability.
S sodelovanjem na področju ocenjevanja zdravstvene tehnologije po letu 2020 v skladu s predlogom naj bi se prispevalo k zagotovitvi razpoložljivosti inovativnih zdravstvenih tehnologij za paciente v Evropi, izboljšali pa naj bi se tudi uporaba razpoložljivih sredstev in predvidljivost poslovanja.