natgillin/translations-raw huggingface dataset:
Europe's population has grown consistently over time.
Število prebivalcev v Evropi se nenehno povečuje.
Median age of EU-27 population, 2001-2070
Mediana starosti prebivalstva EU-27, 2001-2070
5.Conclusion and next steps
5.Zaključek in naslednji koraki
The same applies to the Member States of the European Economic Area (EEA).
Enako velja za države članice Evropskega gospodarskega prostora (EGP).
All regions of the world are affected.
Prizadete so vse regije sveta.
This makes the risk worth taking.
Zato je vredno tvegati.
The EU recognises this task as its responsibility.
EU priznava to nalogo kot svojo odgovornost.
Vaccine development usually takes more than 10 years.
Razvoj cepiva običajno traja več kot 10 let.
There is a very real risk that none of the supported candidates will be successful.
Obstaja zelo realno tveganje, da nobeden od podprtih kandidatov ne bo uspešen.
A truly European approach would avoid competition between Member States.
Resnično evropski pristop bi preprečil konkurenco med državami članicami.
The EU Member States are closely interlinked.
Države članice EU so med seboj tesno povezane.
The Commission will continue to support this global mobilisation and collaboration.
Komisija bo še naprej podpirala to globalno mobilizacijo in sodelovanje.
The spread of the virus has shown that no region is safe until the virus is under control everywhere.
Širjenje virusa je pokazalo, da nobena regija ni varna, dokler ni virus povsod pod nadzorom.
This will reduce the Commission's authorisation procedures from nine weeks to one.
S tem se bodo postopki Komisije za pridobitev dovoljenja zmanjšali z devet tednov na enega.
The EU will only be safe if the rest of the world is safe.
EU bo varna le, če bo varen ves svet.
When taking the financing decision, the following non-exhaustive criteria will be taken into account:
Pri sprejemanju sklepa o financiranju se bodo upoštevala naslednja neizčrpna merila:
It creates solidarity between all Member States, irrespective of the size of their population and their purchasing power.
Ustvaril bi solidarnost med vsemi državami članicami, ne glede na velikost njihovega prebivalstva in njihovo kupno moč.
3.4.Legislation on genetically modified organisms
3.4.Zakonodaja o gensko spremenjenih organizmih
The strategy rests on two pillars:
Strategija temelji na dveh stebrih:
This is not only a European challenge, it is also a global one.
To ni izziv samo za Evropo, ampak za cel svet.
These benefits will be increased if more countries were to join the common effort.
Te prednosti se bodo povečale, če se bo skupnim prizadevanjem pridružilo več držav.
These products may fall under the definition of genetically modified organisms (GMOs) and are thus covered by the relevant EU legislation.
Ti proizvodi lahko spadajo pod opredelitev gensko spremenjenih organizmov (GSO) in jih tako zajema ustrezna zakonodaja EU.
2.4.Additional support through loans from the European Investment Bank
2.4.Dodatna podpora v obliki posojil Evropske investicijske banke
A second step is underway in partnership with Global Citizen and other governmental and non-governmental partners.
Naslednji korak poteka v partnerstvu z organizacijo Global Citizen in drugimi vladnimi in nevladnimi partnerji.
The actions set out in this Communication contribute to this global response.
Ukrepi iz tega sporočila prispevajo k temu globalnemu odzivu.
Joint action at EU level is the surest, quickest and most efficient way of achieving that objective.
Skupno ukrepanje na ravni EU je najzanesljivejši, najhitrejši in najučinkovitejši način za doseganje tega cilja.
To this effect, it will deploy the regulatory, financial, advisory and other tools at its disposal.
V ta namen bo uporabila regulativna, finančna, svetovalna in druga orodja, ki so ji na voljo.
3.1.Early engagement with EMA and international cooperation
3.1.Zgodnje sodelovanje z EMA in mednarodno sodelovanje
The budgetary authorities, the European Parliament and the Council, have made EUR 2.7 billion available under the ESI.
Proračunska organa, tj. Evropski parlament in Svet, sta v okviru ESI dala na voljo 2,7 milijarde evrov.
3.3.Flexibility in relation to labelling and packaging requirements
3.3.Prožnost v zvezi z zahtevami glede označevanja in pakiranja
It will also enable us to combine the scientific and regulatory expertise of the Commission and the Member States.
Omogočil nam bo tudi združitev znanstvenega in regulativnega strokovnega znanja Komisije in držav članic.
The development and deployment of tests and treatments therefore remain important.
Zato so razvoj in uvajanje testov ter zdravljenja še naprej pomembni.
2.Support for vaccine development and production in the EU
2.Podpora za razvoj in proizvodnjo cepiva v EU
The Commission and EMA will encourage vaccine producers to consider this possibility.
Komisija in EMA bosta proizvajalce cepiv spodbudili k razmisleku o tej možnosti.
This is likely to cause significant delay, particularly for multi-centre clinical trials in several Member States.
To bo verjetno povzročilo znatno zamudo, zlasti pri multicentričnih kliničnih preskušanjih v več državah članicah.
A pan-EU approach will increase the EU's leverage when negotiating with industry.
Vseevropski pristop bo povečal vpliv EU v pogajanjih z industrijo.
Centralising vaccine procurement at EU level has the merit of speed and efficiency by comparison with 27 separate processes.
Centralizacija javnega naročanja cepiv na ravni EU ima tudi prednost hitrosti in učinkovitosti v primerjavi s 27 ločenimi postopki.
The output of such production sites will not be reserved for the EU.
Proizvodnja takih proizvodnih obratov ne bo namenjena samo za EU,
A common EU approach will always respect the principle of subsidiarity and Member States' competences in health policy: vaccination policies remain in the hands of Member States.
Skupni pristop EU bo vedno spoštoval načelo subsidiarnosti ter pristojnosti držav članic na področju zdravstvene politike: politike cepljenja ostajajo v rokah držav članic.
The Single Market, allowing the free movement of goods and people, has allowed economies to integrate closely and has increased the interdependence of all our economies and societies.
Enotni trg, ki omogoča prosti pretok blaga in ljudi, je omogočil tesno povezovanje gospodarstev ter povečal soodvisnost vseh naših gospodarstev in družb.
As the pandemic moves across borders, so its socio-economic impact on each of the Member States spreads to the others.
Ko se pandemija širi čez meje, se tudi njen socialno-ekonomski učinek na posamezno državo članico razširi na druge.
·Ensuring the quality, safety and efficacy of vaccines.
·zagotoviti kakovost, varnost in učinkovitost cepiv,
3.A flexible and robust regulatory process
3.Prožen in trden regulativni postopek
The aim of the negotiations is to conclude Advance Purchase Agreements with individual companies under the best possible conditions.
Cilj pogajanj je skleniti sporazume za vnaprejšnji nakup s posameznimi podjetji po najboljših možnih pogojih.
The strategy will seek synergies with other Union instruments to ensure full consistency and complementarity of Union actions.
Strategija si bo prizadevala za sinergije z drugimi instrumenti Unije, da se zagotovita popolna skladnost in dopolnjevanje ukrepov Unije.
2.1.An EU approach for efficiency and solidarity
2.1.Pristop EU za učinkovitost in solidarnost
This can greatly facilitate early availability of vaccines in low- and middle-income countries.
To lahko zelo olajša zgodnjo razpoložljivost cepiv v državah z nizkim in srednjim dohodkom.
2.3.Selection criteria for vaccine candidates
2.3.Merila za izbor kandidatov za cepivo
This immunisation framework draws on the expertise of Member States, the European Centre for Disease Prevention and Control (ECDC) and the World Health Organization (WHO).
Ta okvir za imunizacijo temelji na strokovnem znanju držav članic, Evropskega centra za preprečevanje in obvladovanje bolezni (ECDC) ter Svetovne zdravstvene organizacije (SZO).
The unprecedented circumstances in which the EU finds itself requires a bold response.
Okoliščine, v katerih se je znašla EU, so brez primere in zahtevajo drzen odziv.
Under normal circumstances, packaging and labelling of authorised medicinal products, including vaccines, should be provided in all EU languages.
V običajnih okoliščinah je treba pakiranje in označevanje odobrenih zdravil, vključno s cepivi, zagotoviti v vseh jezikih EU.
-Cost: amount of financing requested, the schedule and conditions of the related payments.
-stroški: znesek zaprošenih finančnih sredstev, časovni okvir in pogoji za povezana plačila,
3.2.Accelerated procedure for authorisation
3.2.Pospešeni postopek za odobritev
In order to clearly understand the scale of the vaccine needs in the EU, the Health Security Committee is advancing its work on an EU immunisation framework, as requested by the Health Council on 7 May.
Da bi jasno razumeli obseg potreb po cepivu v EU, Odbor za zdravstveno varnost pospešeno dela na okviru EU za imunizacijo, kar je 7. maja zahteval Svet za zdravje.
-Global solidarity: a commitment to making future doses of vaccines available for partner countries to end the global pandemic.
-globalna solidarnost: zaveza, da bodo odmerki cepiva v prihodnosti na voljo partnerskim državam, da bi končali svetovno pandemijo,
In the current crisis, teams around the world are working with the ambition of delivering a successful vaccine within a timeframe of 12 - 18 months.
V sedanji krizi si ekipe po celem svetu prizadevajo razviti uspešno cepivo v časovnem okviru od 12 do 18 mesecev.
The Commission proposes to enter into an Agreement with participating Member States to formalise their reciprocal commitments.
Komisija predlaga, da skupaj s sodelujočimi državami članicami sklene sporazum, s katerim bodo formalizirale svoje vzajemne obveznosti.
-Liability: what special liability coverage, if any, companies would require.
-odgovornost: katero posebno zavarovanje odgovornosti bi podjetja morebiti zahtevala,
·Securing timely access to vaccines for Member States and their population while leading the global solidarity effort.
·zagotoviti pravočasen dostop do cepiv za države članice in njihovo prebivalstvo ter imeti hkrati vodilno vlogo v globalnih solidarnostnih prizadevanjih,
The current proposal builds on the important groundwork undertaken by that Alliance.
Sedanji predlog temelji na pomembnem pripravljalnem delu v okviru tega zavezništva.
Significant levels of EU support have already been made available to vaccine producers.
Proizvajalcem cepiv so že na voljo znatne ravni podpore EU.
The COVID-19 pandemic is inflicting huge human and economic costs on the European Union and the world.
Pandemija COVID-19 povzroča ogromne človeške in gospodarske izgube v Evropski uniji in v svetu.
In this way, the Commission will ensure that the EU continues to play its part in resolving the COVID-19 crisis for the world.
Komisija bo tako zagotovila, da bo EU še naprej igrala svojo vlogo pri reševanju krize zaradi COVID-19 v svetu.
At the same time, EU citizens will want assurances that they will have access to any successful vaccine.
Državljani EU bodo hkrati hoteli imeti zagotovila, da bodo imeli dostop do morebitnega uspešnega cepiva.
The Commission invites the European Parliament and Council to adopt the proposal swiftly in order to enable clinical trials to take place in Europe as soon as possible.
Komisija poziva Evropski parlament in Svet, naj predlog hitro sprejmeta, da se čim prej omogoči izvajanje kliničnih preskušanj v Evropi.
These agreements will be negotiated with individual companies according to their specific needs and with the aim of supporting and securing an adequate supply of vaccines.
Ti sporazumi bodo sklenjeni po pogajanjih s posameznimi podjetji v skladu z njihovimi specifičnimi potrebami ter s ciljem, da se podprejo in zagotovijo ustrezne zaloge cepiv.
Against that background, it is essential that all 27 EU Member States have access to a vaccine as early as possible.
Glede na navedeno je nujno, da ima vseh 27 držav članic EU čim prej dostop do cepiva.
This process also offers vaccine producers a significantly simplified negotiation process with a single point of contact, thus reducing costs for all.
Ta postopek tudi proizvajalcem cepiv omogoča znatno poenostavljen pogajalski proces z enotno kontaktno točko, kar bi zmanjšalo stroške za vse.
This is because developing a safe and effective vaccine is a highly complex process.
To je zato, ker je razvoj varnega in učinkovitega cepiva zelo zapleten proces.
The scale of the crisis means that time pressure is unprecedented: every month gained in the deployment of a vaccine will save many lives, many jobs and many billions of euros.
Zaradi razsežnosti krize je časovni pritisk brez primere: z vsakim mesecem, ki ga bomo pridobili pri uvajanju cepiva, bomo rešili veliko življenj, delovnih mest in milijard evrov.
This allows the EIB to offer highly attractive conditions on financial products offered for vaccine development and related manufacturing activities.
To omogoča EIB, da ponudi zelo privlačne pogoje za finančne produkte, ki so na voljo za razvoj cepiv in s tem povezane proizvodne dejavnosti.
There is no guarantee that a safe and effective vaccine will be available soon.
Nimamo nobenega zagotovila, da bo varno in učinkovito cepivo kmalu na voljo.
For this reason, the assistance of the steering board on any liability issues will be essential.
Zato bo pri vseh vprašanjih v zvezi z odgovornostjo bistvenega pomena pomoč usmerjevalnega odbora.
The development of a vaccine within short deadlines creates a particular challenge for the authorisation process.
Razvoj cepiva v kratkih rokih pomeni poseben izziv za postopek za odobritev.
No Member State on its own has the capacity to secure the investment in developing and producing a sufficient number of vaccines.
Nobena država članica nima sama zmogljivosti, da bi zagotovila naložbe v razvoj in proizvodnjo zadostne količine cepiv.
This will facilitate and ultimately accelerate the development, assessment, authorisation and safety monitoring of vaccines.
To bo olajšalo in v končni fazi pospešilo razvoj, ocenjevanje, odobritev in spremljanje varnosti cepiv.
In order to scale this approach up to cover the whole EU, the Commission proposes to run a central procurement process, which creates a number of important advantages.
Da bi ta pristop razširili na celotno EU, Komisija predlaga izvedbo centralnega postopka javnega naročanja, kar bi imelo številne pomembne prednosti.
In addition, the Commission will reduce the time needed to complete the authorisation procedure, by shortening the period for consulting Member States, and allowing translation of the documents into the full set of languages after the authorisation, rather than before.
Poleg tega bo Komisija skrajšala čas, ki je potreben za dokončanje postopka za pridobitev dovoljenja, tako da bo skrajšala obdobje za posvetovanje z državami članicami in omogočila prevajanje dokumentov v vse jezike po pridobitvi dovoljenja namesto prej.
This means that the initial authorisation is based on less comprehensive data than would normally be the case (though nonetheless with a positive benefit-risk balance), and with obligations on the marketing authorisation holders for the data to be completed afterwards.
To pomeni, da prvotno dovoljenje temelji na manj celovitih podatkih, kot bi bili običajno (vendar kljub temu s pozitivnim razmerjem med tveganji in koristmi), imetniki dovoljenja za promet pa morajo podatke dopolniti naknadno.
Usually, the authorisation procedure starts when the applicant is in a position to present the relevant data package in the form of an application for marketing authorisation.
Postopek za odobritev se običajno začne, ko vložnik lahko predloži zadevni sveženj podatkov v obliki vloge za pridobitev dovoljenja za promet.
However, the value of earlier access to a vaccine is enormous, in terms of lives saved and economic damage avoided.
Vendar je vrednost hitrejšega dostopa do cepiva izjemna z vidika rešenih življenj in preprečene gospodarske škode.
Only very swift and unified action by the EU and its Member States will ensure sufficient and speedy supplies of a safe and effective vaccine.
Zgolj z zelo hitrim in enotnim ukrepanjem EU in njenih držav članic bomo zagotovili zadostno in hitro preskrbo z varnim in učinkovitim cepivom.
While the EU remains fully committed to international trade and to the development of global supply chains, it should also aim to attract production capacity for vaccines to its territory in order to mitigate disruptions to such supply chains.
Čeprav EU ostaja v celoti zavezana mednarodni trgovini in razvoju svetovnih dobavnih verig, bi si morala prizadevati tudi, da privabi proizvodne zmogljivosti za cepiva na svoje ozemlje, da bi se zmanjšale motnje v takih dobavnih verigah.
But an effective and safe vaccine against COVID-19 is generally considered the most likely lasting solution to the ongoing pandemic.
Vendar učinkovito in varno cepivo proti COVID-19 na splošno velja za najbolj verjetno trajno rešitev trenutne pandemije.
-Risk sharing: benefits offered in return for the financing provided in the two cases where there either (a) is a successful vaccine or (b) no vaccine (e.g. potential flexibilities in the use of manufacturing capacity).
-delitev tveganja: koristi, ponujene v zameno za finančna sredstva, ki se zagotovijo v dveh primerih, in sicer (a) kadar je cepivo uspešno ali (b) kadar cepiva ni (na primer morebitna prožnost pri uporabi proizvodnih zmogljivosti).
EMA also ensures close cooperation with relevant European and international organisations and third countries regulators, including with the World Health Organization on clinical trial protocols for vaccines.
EMA prav tako zagotavlja tesno sodelovanje z ustreznimi evropskimi in mednarodnimi organizacijami ter regulatorji iz tretjih držav, vključno s Svetovno zdravstveno organizacijo, v zvezi s protokoli kliničnega preskušanja za cepiva.
2.2.Advance Purchase Agreements via the Emergency Support Instrument
2.2.Sporazumi za vnaprejšnji nakup v okviru instrumenta za nujno pomoč
This proposed framework is therefore an insurance policy, which transfers some of the risk from industry to the public authorities in return for assuring Member States equitable and affordable access to a vaccine, should one become available.
Ta predlagani okvir je torej zavarovalna polica, pri kateri se nekatera tveganja prenesejo z industrije na javne organe v zameno za zagotovitev pravičnega in cenovno dostopnega dostopa do cepiva za države članice, če bi se to razvilo.
In addition, once a successful COVID-19 vaccine is available, hundreds of millions, or even billions, of doses will need to be produced in order to cover global needs, without compromising the production of other essential vaccines.
Ko bo uspešno cepivo proti COVID-19 na voljo, bo treba proizvesti na stotine milijonov ali celo milijard odmerkov, da bi pokrili globalne potrebe, ne da bi pri tem ogrozili proizvodnjo drugih osnovnih cepiv.
With sufficient scale and scope, such international mechanism could become the world's insurance policy against pandemics.
Tak mednarodni mehanizem bi z zadostnim obsegom in razponom lahko postal svetovna zavarovalna polica proti pandemijam.
They will be invited to contribute their expertise on potential vaccine candidates as well as provide additional financing (should financing under ESI be insufficient), and will be closely associated with the negotiations.
Pozvane bodo, da prispevajo svoje strokovno znanje o možnih kandidatih za cepivo in zagotovijo dodatna finančna sredstva (če bi bilo financiranje v okviru instrumenta ESI nezadostno), in bodo tesno vključene v pogajanja.
-Speed of delivery at scale: progress in clinical trials and the ability to deliver sufficient quantities of the vaccine in 2020 and 2021.
-hitrost dobave v ustreznem obsegu: napredek pri kliničnih preskušanjih in zmožnost zagotavljanja zadostnih količin cepiva v letih 2020 in 2021,
The contracts with companies may be concluded through a procurement process run by the Commission on behalf of all participating Member States.
Pogodbe s podjetji se lahko sklenejo prek postopka javnega naročanja, ki ga vodi Komisija v imenu vseh sodelujočih držav članic.
·Adapting the EU's regulatory framework to the current urgency and making use of existing regulatory flexibility to accelerate the development, authorisation and availability of vaccines while maintaining the standards for vaccine quality, safety and efficacy.
·prilagoditi regulativni okvir EU sedanjim izrednim razmeram in izkoristiti obstoječo regulativno prožnost za pospešitev razvoja, odobritve in razpoložljivosti cepiv ob ohranjanju standardov za kakovost, varnost in učinkovitost cepiv.
As stipulated in the ESI Regulation, the procurement procedure is carried out in conformity with the requirements of the Financial Regulation 3 , which contains rules which are equivalent to those of the Procurement Directives of the Union and therefore also to national procurement rules.
Kot je določeno v uredbi o ESI, se postopek javnega naročanja izvaja v skladu z zahtevami iz finančne uredbe 3 , ki vsebuje pravila, enakovredna pravilom iz direktiv Unije o javnem naročanju in torej enakovredna tudi nacionalnim pravilom o javnem naročanju.
Joint EU action within a global framework greatly enhances the potential for universal vaccination against COVID-19 and returning economic and social life to normality across the world.
Skupno ukrepanje EU znotraj svetovnega okvira močno povečuje možnosti za univerzalno cepljenje proti COVID-19 ter za vračanje gospodarskega in družbenega življenja v normalne vode po vsem svetu.
In particular, all EU Member States will be able to benefit from an option to purchase vaccines via a single procurement action.
Zlasti bodo vse države članice EU lahko izkoristile možnost nakupa cepiv prek enotnega javnega naročila.
However, requirements in relation to labelling and packaging may slow down the rapid deployment of the COVID-19 vaccines.
Vendar lahko zahteve glede označevanja in pakiranja upočasnijo hitro uvajanje cepiv proti COVID-19.
Though steps will be taken to mitigate the risk - for example, by investing in a portfolio of companies covering different technologies - the failure rate of vaccine development is high.
Čeprav bodo sprejeti ukrepi za zmanjšanje tveganja (na primer z vlaganjem v nabor podjetij, ki zajema različne tehnologije), je stopnja neuspeha pri razvoju cepiva visoka.
The EU regulatory system contains significant flexibility when it comes to authorisation procedures, which will facilitate access to a vaccine.
Regulativni sistem EU omogoča znatno prožnost pri postopkih za pridobitev dovoljenja, kar bo olajšalo dostop do cepiva.
While an initial list of candidates would need to be established quickly to start negotiations, the list will be updated as additional information becomes available, in particular from the clinical trials.
Začetni seznam kandidatov bi bilo sicer treba hitro oblikovati, da se pogajanja lahko začnejo, vendar se bo seznam posodabljal, ko bodo na voljo dodatne informacije, zlasti glede kliničnih preskušanj.
All participating Member States will be represented in a steering board, which will assist the Commission on all aspects of the APA contract before signature.
Vse sodelujoče države članice bodo zastopane v usmerjevalnem odboru, ki bo Komisiji v pomoč pred podpisom za vse vidike pogodbe v zvezi s sporazumom za vnaprejšnji nakup.
In return for the right to buy a specified number of vaccine doses in a given timeframe and at a given price, part of the upfront costs faced by vaccines producers will be financed from the ESI.
V zameno za pravico do nakupa določenega števila odmerkov cepiva v določenem časovnem okviru in po določeni ceni se bo del začetnih stroškov, s katerimi se soočajo proizvajalci cepiva, financiral iz ESI.
As the ultimate acquirers of the vaccines, Member States will participate in the process from the start.
Države članice bodo kot končni kupci cepiv sodelovale v postopku od samega začetka.