FrancophonIA/Publications_Medical_Domain_UE huggingface dataset:
English: During the transposition period, there were some arguments raised by Member States that existing public tariffs do not represent a comparable price because important elements, for example from general taxation (e.g. capital investment costs), are not represented in the public tariff which is not fully cost-recovering.
Slovenian: Med obdobjem prenosa so države članice navedle nekaj argumentov, da veljavne javne tarife ne predstavljajo primerljive cene, ker v javni tarifi, s katero se stroški ne povrnejo v celoti, niso zajeti pomembni elementi, na primer iz splošne obdavčitve (npr. stroški kapitalskih naložb).
English: In addition, a written confirmation is required from the healthcare provider on its availability to grant the requested healthcare in the period indicated by the applicant for prior authorisation.
Slovenian: Poleg tega se od izvajalca zdravstvenega varstva zahteva pisno potrdilo o njegovi razpoložljivosti za zagotovitev zahtevanega zdravstvenega varstva v obdobju, ki ga je navedel prosilec za predhodno odobritev.
English: Furthermore, Member States are required to notify the Commission of any decision to introduce limitations under Article 7(9).
Slovenian: Poleg tega morajo države članice Komisijo uradno obvestiti o vsaki odločitvi za uvedbo omejitev na podlagi člena 7(9).
English: Their aim is to help diagnose and treat patients suffering from rare, complex and low prevalence diseases that require highly specialised healthcare and a concentration of knowledge and resources.
Slovenian: Njihov cilj je pomagati pri diagnosticiranju in zdravljenju pacientov z redkimi, zapletenimi in malo razširjenimi boleznimi, ki zahtevajo visoko specializirano zdravstveno varstvo ter koncentracijo znanja in virov.
English: These are of course highly schematic figures, but when read in conjunction with the figures of the cost of cross-border healthcare under the Regulations (which amount to approximately 0.1%), it is clear that the vast majority of healthcare budgets is spent domestically.
Slovenian: To so seveda zelo shematične številke, vendar je v povezavi s podatki o stroških čezmejnega zdravstvenega varstva na podlagi uredb (ki znašajo približno 0,1 %) jasno, da se velika večina proračunov za zdravstveno varstvo porabi doma.
English: It may also be partly due to the collaboration between the Commission and the Member States regarding its proper implementation and the interaction between the Directive and social security coordination Regulations, not least via the work done with NCPs and through the own-initiative investigations of the Commission (see Chapter 1).
Slovenian: Morda je delno tudi posledica sodelovanja med Komisijo in državami članicami glede njenega pravilnega izvajanja ter interakcije med Direktivo in uredbama o koordinaciji sistemov socialne varnosti, tudi zaradi dela, opravljenega z nacionalnimi kontaktnimi točkami, in preiskav Komisije na lastno pobudo (glej poglavje 1).
English: The virtual panels are convened to review a patient's diagnosis and treatment and are attended by medical specialists from different centres of expertise across the EU.
Slovenian: Virtualne panelne razprave se skličejo zaradi pregleda diagnoze in zdravljenja pacienta, udeležijo pa se jih zdravniki specialisti iz različnih strokovnih centrov po vsej EU.
English: Information should be made available by electronic means and in formats accessible for persons with disabilities (Article 6(5)) and additional costs for persons with disabilities may be taken into account (Article 7(4)).
Slovenian: Informacije bi morale biti dane na voljo prek elektronskih medijev v obliki, dostopni invalidnim osebam (člen 6(5)), upoštevajo pa se lahko dodatni stroški za invalidne osebe (člen 7(4)).
English: Last but not least, the launch of the ERNs clearly marked a major change for the delivery of quality and accessible cross-border healthcare to EU citizens (see Chapter 4.3).
Slovenian: Nenazadnje začetek izvajanja evropskih referenčnih mrež jasno pomeni veliko spremembo pri zagotavljanju kakovostnega in dostopnega čezmejnega zdravstvenega varstva za državljane EU (glej poglavje 4.3).
English: The Directive applies to cross-border healthcare without prejudice to the framework provided by the social security coordination Regulations.
Slovenian: Direktiva se uporablja za čezmejno zdravstveno varstvo, ne da bi se pri tem posegalo v okvir, ki ga določata uredbi o koordinaciji sistemov socialne varnosti.
English: As a result of a systematic assessment of all notified measures, the Commission opened 11 own-initiative investigations gathering information for proper compliance assessment and others are in the pipeline.
Slovenian: Komisija je na podlagi sistematične ocene vseh priglašenih ukrepov začela 11 preiskav na lastno pobudo, v okviru katerih se zbirajo informacije za ustrezno ocenjevanje skladnosti, pripravljajo pa se še druge.
English: According to a survey of NCPs, a number of Member States continue to express concern about communicating the complexities of the current legal situation.
Slovenian: V skladu z raziskavo o nacionalnih kontaktnih točkah več držav članic še naprej izraža zaskrbljenost glede poročanja o kompleksnosti trenutnega pravnega položaja.
English: Moreover, the Directive promotes cross-border cooperation in healthcare between Member States for the benefit of EU citizens, regarding prescriptions, digital health (eHealth), rare diseases and health technology assessments (HTAs).
Slovenian: Poleg tega se z Direktivo spodbuja čezmejno sodelovanje na področju zdravstvenega varstva med državami članicami v korist državljanov EU, kar zadeva recepte, digitalno zdravstvo (e-zdravje), redke bolezni in ocenjevanje zdravstvene tehnologije.
English: The large number of national laws involved is partly due to the fact that the Directive regulated a number of issues which are under different regional/administrative levels and in separate pieces of legislation in Member States, such as reimbursement mechanisms, information channels (National Contact Points, healthcare providers), patients' rights and entitlements, professional liability.
Slovenian: Veliko število zadevnih nacionalnih zakonov je delno posledica dejstva, da so se z Direktivo uredila številna vprašanja, ki v državah članicah spadajo na različne regionalne/upravne ravni in so zajeta v nepovezanih delih zakonodaje, kot so mehanizmi povračila stroškov, informacijski kanali (nacionalne kontaktne točke, izvajalci zdravstvenega varstva), pravice in upravičenja pacientov ter poklicna odgovornost.
English: Certain Member States introduced systems of prior notification whereby the patient receives a written confirmation of the amount to be reimbursed on the basis of an estimate, as provided for under Article 9(5) of the Directive.
Slovenian: Nekatere države članice so uvedle sisteme predhodnega obveščanja, na podlagi katerega pacient prejme pisno potrdilo o znesku povračila stroškov na podlagi ocene, v skladu s členom 9(5) Direktive.
English: They have all been closed on the grounds of subsequent transposition by the Member States.
Slovenian: Vsi so bili zaključeni zaradi poznejšega prenosa v zadevnih državah članicah.
English: [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.]
Slovenian: [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.]
English: c) Administrative procedures regarding cross-border healthcare
Slovenian: (c) Upravni postopki v zvezi s čezmejnim zdravstvenim varstvom
English: 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.
Slovenian: 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.
English: The Commission considers that it has exercised its delegated powers within the remit conferred to it by the Directive.
Slovenian: Komisija meni, da je pooblastila izvedla v okviru pristojnosti, ki so bile nanjo prenesene z Direktivo.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: V primeru Uredbe (ES) št. 883/2004 se stroški nenačrtovanega čezmejnega zdravstvenega varstva med državami članicami večinoma povrnejo ob prejemu zahtevka države članice zdravljenja.
English: The European Reference Networks (ERNs) are virtual, voluntary cross-border networks, bringing together healthcare providers across Europe.
Slovenian: Evropske referenčne mreže so virtualne, prostovoljne čezmejne mreže, ki povezujejo izvajalce zdravstvenega varstva iz vse Evrope.
English: After the transposition deadline, the Commission launched 26 infringement procedures for late or incomplete notification of transposition measures.
Slovenian: Komisija je po roku za prenos začela 26 postopkov za ugotavljanje kršitev zaradi pozne ali nepopolne priglasitve ukrepov za prenos.
English: 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.
Slovenian: 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.
English: By June 2018 165 panels had been opened, the number growing daily, with the first patients directly benefiting.
Slovenian: 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.
English: Where authorisation was not required, the greatest flow was from France to Germany.
Slovenian: V primerih, kjer se odobritev ni zahtevala, je bil največji pretok iz Francije v Nemčijo.
English: Cross-border patient mobility within the EU shows a slight increasing trend over the last three years.
Slovenian: Čezmejna mobilnost pacientov v EU se je v zadnjih treh letih nekoliko povečala.
English: 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.
Slovenian: Slednje bi bilo treba obravnavati kot priložnost za izboljšanje dostopa pacientov do oskrbe, izkoriščanje ekonomije obsega in učinkovito porabo sredstev.
English: 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.
Slovenian: 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.
English: [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.]
Slovenian: [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.]
English: 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).
Slovenian: 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).
English: 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.
Slovenian: To je lahko delno posledica postopnega izboljšanja obveščenosti državljanov o Direktivi in posledične boljše ozaveščenosti o pravicah pacientov, ki je lahko ena od posledic.
English: Recognition of prescriptions
Slovenian: Priznavanje receptov
English: The Commission adopted Implementing Directive 2012/52/EU to give effect to the principle of mutual recognition of medical prescriptions.
Slovenian: Komisija je sprejela Izvedbeno direktivo 2012/52/EU, da bi uveljavila načelo vzajemnega priznavanja zdravniških receptov.
English: "There is still very little experience about cross-border healthcare among patient communities.
Slovenian: „Skupnosti pacientov imajo še vedno zelo malo izkušenj s čezmejnim zdravstvenim varstvom."
English: a) Systems of reimbursement of costs for cross-border healthcare
Slovenian: (a) Sistemi povračila stroškov za čezmejno zdravstveno varstvo
English: [10: See, for example, case C-372/04 Watts, paragraph 100.]
Slovenian: [10: Glej na primer zadevo C-372/04, Watts, točka 100.]
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Figure 2: Requests for Reimbursement without prior authorisation
Slovenian: Slika 2: Zahtevki za povračilo brez predhodne odobritve
English: A key principle of ERNs is to let the knowledge travel rather than the patient.
Slovenian: Ključno načelo evropskih referenčnih mrež je omogočiti, da namesto pacienta potuje znanje.
English: Today EU cooperation on HTA has two main components.
Slovenian: Sedanje sodelovanje na ravni EU na področju ocenjevanja zdravstvene tehnologije ima dva glavna sestavna dela.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Article 4(3) requires Member States to observe the principle of non-discrimination with regard to patients from other Member States.
Slovenian: Države članice morajo v skladu s členom 4(3) upoštevati načelo nediskriminacije, kar zadeva paciente iz drugih držav članic.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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).
English: Information to patients
Slovenian: Informacije za paciente
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: [30: 14 out of 37 NCP staff admitted in 2017 to facing difficulties communicating the Directive's relationship with the Regulations to the patient.
Slovenian: [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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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)).
Slovenian: Z Direktivo so nacionalne kontaktne točke pozvane, naj pacientom in zdravstvenim delavcem zagotovijo informacije o dostopnosti bolnišnic invalidnim osebam (člen 4(2)(a)).
English: [20: See footnote 2.]
Slovenian: [20: Glej sprotno opombo 2.]
English: 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.
Slovenian: Predlog določa okvir podpore in postopke za sodelovanje pri ocenjevanju zdravstvene tehnologije na ravni Unije ter skupna pravila za klinične ocene zdravstvene tehnologije.
English: Article 7(9) permits Member States to limit application of the rules on reimbursement of cross-border healthcare for overriding reasons of general interest.
Slovenian: Člen 7(9) državam članicam omogoča, da omejijo uporabo pravil o povračilu stroškov čezmejnega zdravstvenega varstva zaradi prevladujočih razlogov v splošnem interesu.
English: 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.
Slovenian: 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.
English: ][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.]
Slovenian: ][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.]
English: 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) .
Slovenian: 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).
English: [12: Directive 2011/24/EU was due to be transposed by the EFTA countries Iceland, Liechtenstein and Norway no later than 1 August 2015.
Slovenian: [12: Države Efte Islandija, Lihtenštajn in Norveška so morale Direktivo 2011/24/EU prenesti najpozneje do 1. avgusta 2015.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Member States may define the fees for the delivery of healthcare in their territory.
Slovenian: Države članice lahko določijo cene za izvajanje zdravstvenega varstva na svojem ozemlju.
English: 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.
Slovenian: 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.
English: [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.]
Slovenian: [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).]
English: b) Prior authorisation
Slovenian: (b) Predhodna odobritev
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: A little less than half of the NCP websites provide information on both pieces of legislation.
Slovenian: Informacije o obeh zakonodajnih aktih zagotavlja malo manj kot polovica spletišč nacionalnih kontaktnih točk.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Under the Directive, they are reimbursed for treatment abroad as if the treatment was provided in their home countries (Member State of affiliation).
Slovenian: Na podlagi Direktive se jim stroški zdravljenja v tujini povrnejo, kot če bi bilo zdravljenje zagotovljeno v njihovih domačih državah (državi članici zdravstvenega zavarovanja).
English: 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.
Slovenian: 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.
English: [51: See more details in the Commission report on the operation of the Directive published on 4 September 2015 (COM(2015) 421 final).]
Slovenian: [51: Za več podrobnosti glej Poročilo Komisije o izvajanju Direktive, objavljeno 4. septembra 2015 (COM(2015) 421 final).]
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: The present report gives a high-level overview of the data received in 2015, 2016 and 2017.
Slovenian: To poročilo vsebuje splošni pregled podatkov, prejetih v letih 2015, 2016 in 2017.
English: 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.
Slovenian: 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.
English: Figure 1: Prior Authorisation Requests and Authorisations
Slovenian: Slika 1: Zahtevki za predhodno odobritev in odobritve
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: [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]
Slovenian: ][25: http://ec.europa.eu/eurostat/tgm/refreshTableAction.do;jsessionid=9ea7d07e30dd3bf0a52b9a8a474c872db039e243c026.e34OaN8Pc3mMc40Lc3aMaNyTa3eQe0?tab=table&plugin=1&pcode=tec00001&language=en.]
English: ][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.
Slovenian: ][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.
English: 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.
Slovenian: 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.
English: [21: It should be noted that France was able to report data on healthcare subject to PA only in 2016.
Slovenian: [21: Opozoriti je treba, da je lahko Francija podatke o zdravstvenem varstvu, za katero se zahteva predhodna odobritev, sporočila le leta 2016.
English: The proposal seeks to build on the on-going project based cooperation on HTA and to address certain shortcomings identified in the reflection process.
Slovenian: Namen predloga je nadgraditi trenutno projektno sodelovanje na področju ocenjevanja zdravstvene tehnologije in odpraviti nekatere pomanjkljivosti, ugotovljene v okviru razmisleka.
English: 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.
Slovenian: 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.
English: Article 8(7) of the Directive requires Member States to ‘make publicly available which healthcare is subject to prior authorisation'.
Slovenian: Države članice morajo v skladu s členom 8(7) Direktive „javno objavi[ti], za katero zdravstveno varstvo je potrebna predhodna odobritev".
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: [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]
Slovenian: [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.]
English: Some Member States require patients to provide a certified translation of their medical documentation in order to obtain their reimbursement.
Slovenian: Nekatere države članice zahtevajo, da morajo pacienti za povračilo stroškov zagotoviti sodno overjeni prevod zdravstvene dokumentacije.