natgillin/translations-raw huggingface dataset:
It is also important that the activities conducted under the EDCTP2 Programme should be coherent with the Union’s development policy actions.
Znanstveni odbor za zdravje, ki je bil ustanovljen z Obzorjem 2020 kot v znanost usmerjena platforma zainteresiranih strani, pripravlja znanstvene prispevke, zagotavlja celovito, znanstveno usmerjeno analizo ovir in priložnosti za raziskave in inovacije, povezanih z družbenim izzivom Obzorja 2020 v zvezi z zdravjem, demografskimi spremembami in blaginjo, prispeva k opredelitvi z njim povezanih prednostnih nalog na področju raziskav in inovacij ter spodbuja sodelovanje znanstvene skupnosti iz vse Unije.
In this context, synergies between EDCTP2 and the European Development Fund should be sought.
Ob dejavnem sodelovanju zainteresiranih strani prispeva h krepitvi zmogljivosti ter spodbujanju izmenjave znanja in tesnejšega sodelovanja na tem področju po vsej Evropi.
Within the objective of cooperation with international development assistance initiatives, EDCTP2 funded activities should take into account the recommendations proposed by the relevant World Health Organisation (WHO) initiatives where appropriate, including the consultative Expert Working Group on Research and Development (‘CEWG’).
Zato bi moral program EDCTP2 po potrebi z Znanstvenim odborom za zdravje sodelovati in izmenjevati informacije.
The Scientific Panel for Health was set up by Horizon 2020 as a science-led stakeholder platform, in order to elaborate scientific input, to provide a coherent scientific focused analysis of research and innovation bottlenecks and opportunities related to the Horizon 2020 societal challenge on health, demographic change and well-being, to contribute to the definition of its research and innovation priorities and to encourage Union-wide scientific participation.
Ker ciljev tega sklepa – in sicer prispevati k zmanjšanju socialnega in gospodarskega bremena bolezni, povezanih z revščino, v državah v razvoju, zlasti v podsaharski Afriki, s pospešitvijo kliničnega razvoja učinkovitih, varnih, dostopnih, ustreznih in cenovno dostopnih zdravstvenih ukrepov proti boleznim, povezanim z revščino – države članice ne morejo zadovoljivo doseči zaradi pomanjkanja potrebne kritične mase, ki jo je treba doseči v človeškem in finančnem smislu, temveč se zaradi obsega ukrepa lažje dosežejo na ravni Unije, lahko Unija sprejme ukrepe v skladu z načelom subsidiarnosti iz člena 5 Pogodbe o Evropski uniji.
Through active cooperation with stakeholders, it helps to build capabilities and to foster knowledge-sharing and stronger collaboration across the Union in that field.
V skladu z načelom sorazmernosti iz navedenega člena ta sklep ne presega tistega, kar je potrebno za doseganje navedenih ciljev –
EDCTP2 should, therefore, collaborate and exchange information with the Scientific Panel for Health, where appropriate.
SPREJELA NASLEDNJI SKLEP:
Since the objectives of this Decision, namely to contribute to the reduction of the social and economic burden of poverty-related diseases in developing countries, and in particular in sub-Saharan Africa, by accelerating the clinical development of effective, safe, accessible, suitable and affordable medical interventions for poverty-related diseases, cannot be sufficiently achieved by the Member States due to the lack of necessary critical mass to be achieved, both in human and financial terms, and can therefore, by reason of the scale of the action, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union.
Člen 1
In accordance with the principle of proportionality, as set out in that Article, this Decision does not go beyond what is necessary for those objectives,
Sodelovanje v drugem programu Partnerstvo evropskih držav in držav v razvoju na področju kliničnega preskušanja
HAVE ADOPTED THIS DECISION:
Unija sodeluje v drugem programu Partnerstvo evropskih držav in držav v razvoju na področju kliničnega preskušanja (v nadaljnjem besedilu: program EDCTP2), ki ga skupaj izvajajo Avstrija, Danska, Finska, Francija, Grčija, Irska, Italija, Luksemburg, Nizozemska, Norveška, Portugalska, Španija, Švedska Švica in Združeno kraljestvo (v nadaljnjem besedilu: sodelujoče države), v skladu s pogoji iz tega sklepa.
Article 1
V programu EDCTP2 lahko sodeluje katera koli država članica poleg tistih iz odstavka 1 ali katera koli druga država, pridružena Obzorju 2020, če izpolnjuje pogoj iz točke (e) člena 3(1) tega sklepa.
Participation in the second European and Developing Countries Clinical Trials Partnership Programme
Če izpolnjuje pogoj iz točke (e) člena 3(1), se za namene tega sklepa obravnava kot sodelujoča država.
The Union shall participate in the second European and Developing Countries Clinical Trials Partnership Programme (the ‘EDCTP2 Programme’), jointly undertaken by Austria, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, the Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom (the ‘Participating States’) in accordance with the conditions laid down in this Decision.
Člen 2
Any Member State other than those listed in paragraph 1 and any other country associated to Horizon 2020 may participate in the EDCTP2 Programme, provided it fulfils the condition set out in point (e) of Article 3(1) of this Decision.
Finančni prispevek Unije
If it fulfils the condition set out in point (e) of Article 3(1), it shall be regarded as a Participating State for the purposes of this Decision.
Finančni prispevek Unije, vključno z odobritvami Efte, za program EDCTP2 znaša do 683000000 EUR, in sicer do enakega zneska kot prispevki sodelujočih držav.
Article 2
Finančni prispevek Unije se plača iz odobritev splošnega proračuna Unije, dodeljenih zadevnim delom posebnega programa za izvajanje Obzorja 2020, vzpostavljenega s Sklepom 2013/743/EU, in zlasti iz sredstev v okviru posebnega cilja „zdravje, demografske spremembe in blaginja“ v skladu s točko (c)(vi) člena 58(1) ter členoma 60 in 61 Uredbe (EU, Euratom) št. 966/2012.
Union’s financial contribution
Izvedbena struktura programa EDCTP2 (v nadaljnjem besedilu: EDCTP2-IS) lahko za kritje svojih upravnih stroškov porabi do 6 % finančnega prispevka Unije iz odstavka 1.
The Union’s financial contribution, including EFTA appropriations, to the EDCTP2 Programme shall be up to EUR 683000000 to equal the contributions of Participating States.
Člen 3
The Union’s financial contribution shall be paid from the appropriations in the general budget of the Union allocated to the relevant parts of the Specific Programme implementing Horizon 2020, established by Decision 2013/743/EU, and in particular from the appropriations under the specific objective ‘Health, demographic change and wellbeing’ in accordance with point (c)(vi) of Article 58(1) and Articles 60 and 61 of Regulation (EU, Euratom) No 966/2012.
Pogoji za finančni prispevek Unije
Up to 6 % of the Union’s financial contribution referred to in paragraph 1 may be used by the implementing structure of EDCTP2 (the ‘EDCTP2-IS’) to cover its administrative costs.
Finančni prispevek Unije je pogojen z naslednjim:
Article 3
sodelujoče države morajo dokazati, da je program EDCTP2 vzpostavljen v skladu s prilogami I, II in III;
Conditions for the Union’s financial contribution
sodelujoče države ali organizacije, ki so jih določile sodelujoče države, morajo določiti EDCTP2-IS, subjekt s pravno osebnostjo, kot strukturo, odgovorno za izvajanje programa EDCTP2 ter za prejemanje, dodeljevanje in spremljanje prispevka sodelujočih držav ter finančnega prispevka Unije;
The Union’s financial contribution shall be conditional upon the following:
EDCTP2-IS mora dokazati, da je zmožna izvajati program EDCTP2, tudi prejemati, dodeljevati in spremljati prispevek Unije v okviru posrednega upravljanja proračuna Unije v skladu s členi 58, 60 in 61 Uredbe (EU, Euratom) št. 966/2012;
the demonstration by the Participating States that the EDCTP2 Programme is set up in accordance with Annexes I, II and III;
vsaka sodelujoča država se mora zavezati, da bo prispevala k financiranju programa EDCTP2.
the demonstration by the EDCTP2-IS of its capacity to implement the EDCTP2 Programme, including receiving, allocating and monitoring the Union’s contribution in the framework of indirect management of the Union budget in accordance with Articles 58, 60 and 61 of Regulation (EU, Euratom) No 966/2012;
EDCTP2-IS mora uresničevati cilje iz Priloge I in izvajati dejavnosti iz Priloge II k temu sklepu, zlasti dejavnosti in posredne ukrepe, ki jih financira, v skladu z Uredbo (EU) št. 1290/2013 iz člena 6 tega sklepa;
the establishment of a governance model for the EDCTP2 Programme in accordance with Annex III;
vzdrževati je treba ustrezen in učinkovit model upravljanja za program EDCTP2 v skladu s Prilogo III;
the commitment by each Participating State to contribute to the financing of the EDCTP2 Programme.
izpolniti je treba zaveze iz točke (e) odstavka 1.
During the implementation of the EDCTP2 Programme, the Union’s financial contribution shall be conditional upon the following:
Člen 4
the maintenance of an appropriate and efficient governance model for the EDCTP2 Programme in accordance with Annex III;
Dejavnosti programa EDCTP2 izpolnjujejo cilje, opisane v Prilogi I, in so v skladu s Prilogo II.
the compliance by the EDCTP2-IS with the reporting requirements set out in Article 60(5) of Regulation (EU, Euratom) No 966/2012;
Med njimi so lahko dejavnosti iz nacionalnih programov sodelujočih držav, vključno s tistimi, ki jih izvajajo javne ali zasebne nepridobitne raziskovalne organizacije, in nove dejavnosti, vključno z razpisi za zbiranje predlogov, ki jih upravlja EDCTP2-IS.
the fulfilment of the commitments referred to in point (e) of paragraph 1.
Dejavnosti so vključene v delovni načrt programa EDCTP2, ki ga vsako leto sprejme EDCTP2-IS (v nadaljnjem besedilu: letni delovni načrt programa EDCTP2), na podlagi pozitivnega rezultata njihovega zunanjega ocenjevanja z mednarodnim medsebojnim strokovnim pregledom glede na cilje programa EDCTP2.
Article 4
V letnem delovnem načrtu programa EDCTP2 je podrobno navedena proračunska vrednost vsake dejavnosti ter predvideno dodeljevanje finančnih sredstev, ki jih upravlja EDCTP2-IS, tudi finančnega prispevka Unije.
Activities of the EDCTP2 Programme
V letnem delovnem načrtu programa EDCTP2 se razlikuje med dejavnostmi, ki jih financira ali sofinancira Unija, in tistimi, ki jih financirajo sodelujoče države ali so financirane iz drugih virov.
The activities of the EDCTP2 Programme shall meet the objectives described in Annex I and shall comply with Annex II.
EDCTP2-IS izvaja letni delovni načrt programa EDCTP2.
Activities may include national programme activities of Participating States, including activities undertaken by public or private not-for-profit research organisations, and new activities, including calls for proposals managed by the EDCTP2-IS.
EDCTP2-IS spremlja izvajanje vseh dejavnosti, ki so vključene v delovni načrt ali izbrane na podlagi razpisov za zbiranje predlogov, ki jih upravlja EDCTP2-IS, in o tem poroča Komisiji.
Activities shall be included in the work plan of the EDCTP2 Programme adopted annually by the EDCTP2-IS (‘the EDCTP2 annual work plan’), following the positive outcome of their external evaluation by international peer review with regard to the objectives of the EDCTP2 Programme.
Dejavnosti, vključene v letni delovni načrt programa EDCTP2, ki jih ne financira EDCTP2-IS, se izvajajo v skladu s skupnimi načeli, o katerih se dogovorijo sodelujoče države in Komisija ob upoštevanju načel iz tega sklepa, naslova VI Uredbe (EU, Euratom) št. 966/2012 in Uredbe (EU) št. 1290/2013, zlasti načeli enakega obravnavanja, preglednosti, ocenjevanja z neodvisnimi medsebojnimi strokovnimi pregledi in neodvisne izbire.
The EDCTP2 annual work plan shall detail the budgeted value of each activity and shall provide for the allocation of the funding managed by the EDCTP2-IS, including the Union’s financial contribution.
Sodelujoče države in Komisija se poleg tega dogovorijo o zahtevah za poročanje EDCTP2-IS, tudi glede kazalnikov, vključenih v vsako od teh dejavnosti.
The EDCTP2 annual work plan shall differentiate between the activities funded or co-funded by the Union and those funded by Participating States or other revenues.
Vsaka dejavnost, ki jo financira EDCTP2-IS v skladu z letnim delovnim načrtom programa EDCTP2 ali na podlagi razpisov za zbiranje predlogov, ki jih upravlja EDCTP2-IS, se šteje za posredni ukrep v smislu Uredbe (EU) št. 1290/2013 in se izvaja v skladu s členom 6 tega sklepa.
The EDCTP2-IS shall implement the EDCTP2 annual work plan.
Vsako sporočilo ali objava na področju dejavnosti programa EDCTP2, ki jih v tesnem sodelovanju s programom EDCTP2 izvajajo EDCTP2-IS, sodelujoča država ali sodelujoči v dejavnosti, se označi ali dodatno označi kot „[ime dejavnosti] je del programa EDCTP2, ki ga podpira Evropska unija“.
The EDCTP2-IS shall monitor and report to the Commission on the implementation of all the activities included therein or selected following calls for proposals managed by the EDCTP2-IS.
Člen 5
Activities included in the EDCTP2 annual work plan that are not funded by the EDCTP2-IS shall be implemented in compliance with common principles to be agreed by the Participating States and the Commission, taking into account the principles set out in this Decision, in Title VI of Regulation (EU, Euratom) No 966/2012 and in Regulation (EU) No 1290/2013, in particular the principles of equal treatment, transparency, independent peer review evaluation and selection.
Prispevki sodelujočih držav
The Participating States and the Commission shall also agree on the reporting requirements to the EDCTP2-IS, including with regard to indicators inserted into each of those activities.
Prispevke sodelujočih držav sestavljajo:
Any activity funded by the EDCTP2-IS in accordance with the EDCTP2 annual work plan, or following calls for proposals managed by the EDCTP2-IS, shall be considered to be an indirect action within the meaning of Regulation (EU) No 1290/2013, and shall be implemented in accordance with Article 6 of this Decision.
finančni prispevki za EDCTP2-IS in
Any communication or publication in the area of the activities of the EDCTP2 Programme, and performed in close collaboration with EDCTP2, whether undertaken by the EDCTP2-IS, a Participating State, or participants to an activity, shall be labelled or co-labelled as ‘[name of the activity] is part of the EDCTP2 programme supported by the European Union’.
prispevki v naravi, ki jih sestavljajo stroški, ki jih imajo sodelujoče države pri izvajanju dejavnosti, vključenih v letni delovni načrt programa EDCTP2 in v njem jasno opredeljenih, ali ki so nastali v povezavi z upravnim proračunom EDCTP2-IS.
Article 5
Za ocenjevanje prispevkov iz točke (b) odstavka 1 se stroški določijo v skladu z običajnimi računovodskimi praksami in računovodskimi standardi zadevne sodelujoče države in veljavnimi mednarodnimi računovodskimi standardi/mednarodnimi standardi računovodskega poročanja.
Contributions from Participating States
Člen 6
financial contributions to the EDCTP2-IS;
Za posredne ukrepe, ki jih EDCTP-IS izbere in financira na podlagi letnega delovnega načrta programa EDCTP2 ali razpisov za zbiranje predlogov, ki jih upravlja EDCTP2-IS, se uporablja Uredba (EU) št. 1290/2013.
in-kind contributions consisting of the costs incurred by the Participating States in implementing activities included and clearly identified in the EDCTP2 annual work plan, or in relation to the administrative budget of the EDCTP2-IS.
V skladu z navedeno uredbo se EDCTP2-IS šteje za organ financiranja, ki zagotavlja finančno podporo za posredne ukrepe v skladu s Prilogo II k temu sklepu.
For the purpose of evaluating the contributions referred to in point (b) of paragraph 1, the costs shall be determined in accordance with the usual accounting practices and accounting standards of the Participating State concerned and to the applicable International Accounting Standards/International Financial Reporting Standards.
Z odstopanjem od točke (b) člena 9(1) Uredbe (EU) št. 1290/2013 so med sodelujočimi najmanj dva pravna subjekta s sedežem v dveh različnih sodelujočih državah in tretji pravni subjekt s sedežem v državi podsaharske Afrike, navedeni v letnem delovnem načrtu programa EDCTP2.
Article 6
Z odstopanjem od točke (c) člena 10(1) Uredbe (EU) št. 1290/2013 je do financiranja upravičen vsak pravni subjekt, ki ima sedež v državi podsaharske Afrike, navedeni v letnem delovnem načrtu programa EDCTP2.
Rules for participation and dissemination
Če je takšna dejavnost vključena v letni delovni načrt programa EDCTP2, lahko EDCTP2-IS objavi skupne razpise s tretjimi državami ali njihovimi znanstvenimi ali tehnološkimi organizacijami in agencijami, z mednarodnimi organizacijami ali drugimi tretjimi osebami, zlasti nevladnimi organizacijami, v skladu s pravili, oblikovanimi na podlagi člena 12 Uredbe (EU) št. 1290/2013.
Regulation (EU) No 1290/2013 shall apply to indirect actions selected and funded by the EDCTP2-IS on the basis of the EDCTP2 annual work plan or following calls for proposals managed by the EDCTP2-IS.
Člen 7
In accordance with that Regulation, the EDCTP2-IS shall be considered to be a funding body and shall provide financial support to indirect actions in accordance with Annex II to this Decision.
Sporazumi med Unijo in EDCTP2-IS
By way of derogation from point (b) of Article 9(1) of Regulation (EU) No 1290/2013, the minimum number of participants shall be two legal entities established in two different Participating States and a third legal entity in a sub-Saharan African country listed in the EDCTP2 annual work plan.
Če je predhodna ocena EDCTP2-IS v skladu s členom 61(1) Uredbe (EU, Euratom) št. 966/2012 pozitivna, Komisija v imenu Unije z EDCTP2-IS sklene sporazum o prenosu pooblastil in letne sporazume o prenosu sredstev.
By way of derogation from point (c) of Article 10(1) of Regulation (EU) No 1290/2013, any legal entity established in a sub-Saharan country listed in the EDCTP2 annual work plan shall be eligible for funding.
Sporazum o prenosu pooblastil iz odstavka 1 se sklene v skladu s členom 58(3) ter členoma 60 in 61 Uredbe (EU, Euratom) št. 966/2012 ter členom 40 Delegirane uredbe (EU) št. 1268/2012.
Where such an activity is included in the EDCTP2 annual work plan, the EDCTP2-IS may launch joint calls with third countries or their scientific and technological organisations and agencies, with international organisations or with other third parties, in particular non-governmental organisations, in accordance with the rules developed based on Article 12 of Regulation (EU) No 1290/2013.
V njem je med drugim določeno naslednje:
Article 7
zahteve za prispevek EDCTP2-IS v zvezi s kazalniki uspešnosti iz Priloge II k Sklepu 2013/743/EU;
Agreements between the Union and the EDCTP2-IS
zahteve za prispevek EDCTP2-IS v zvezi s spremljanjem iz Priloge III k Sklepu.
Subject to a positive ex-ante assessment of the EDCTP2-IS in accordance with Article 61(1) of Regulation (EU, Euratom) No 966/2012, the Commission, on behalf of the Union, shall conclude a delegation agreement and annual transfer of funds agreements with the EDCTP2-IS.
2013/743/EU;
The delegation agreement referred to in paragraph 1 shall be concluded in accordance with Article 58(3) and Articles 60 and 61 of Regulation (EU, Euratom) No 966/2012 and Article 40 of Delegated Regulation (EU) No 1268/2012.
posebni kazalniki uspešnosti za delovanje EDCTP2-IS;
It shall also set out, inter alia, the following:
zahteve za EDCTP2-IS v zvezi s posredovanjem informacij o upravnih stroških in podrobnih zneskih za izvajanje programa EDCTP2;
the requirements for the EDCTP2-IS contribution regarding the performance indicators set out in Annex II to Decision 2013/743/EU;
ureditev posredovanja potrebnih podatkov, da lahko Komisija izpolni svoje obveznosti glede razširjanja in poročanja;
the requirements for the EDCTP2-IS contribution in relation to the monitoring referred to in Annex III to Decision 2013/743/EU;
določbe o objavi razpisov za zbiranje predlogov v okviru programa EDCTP2, zlasti na enotnem portalu za sodelujoče, pa tudi z drugimi sredstvi elektronskega razširjanja iz Obzorja 2020, ki jih upravlja Komisija.
the specific performance indicators related to the functioning of the EDCTP2-IS;
Člen 8
the arrangements regarding the provision of data necessary to ensure that the Commission is able to meet its dissemination and reporting obligations;
Če se program EDCTP2 ne izvaja ali se izvaja neustrezno, delno ali z zamudo, lahko Komisija ukine, sorazmerno zniža ali začasno ustavi finančni prispevek Unije v skladu z dejanskim izvajanjem programa EDCTP2.
the arrangements for the approval or rejection by the Commission of the draft EDCTP2 annual work plan, before it is adopted by the EDCTP2-IS;
Če sodelujoče države ne prispevajo k financiranju programa EDCTP2 ali prispevajo delno ali z zamudo, lahko Komisija ukine, sorazmerno zniža ali začasno ustavi finančni prispevek Unije, pri čemer upošteva znesek financiranja, ki so ga sodelujoče države namenile izvajanju programa EDCTP2.
provisions for the publication of calls for proposals by EDCTP2, in particular on the single portal for participants as well as through other Horizon 2020 electronic means of dissemination managed by the Commission.
Člen 9
Article 8
Naknadne revizije
Termination, reduction or suspension of the Union’s financial contribution
Naknadne revizije odhodkov za posredne ukrepe opravi EDCTP2-IS v skladu s členom 29 Uredbe (EU) št. 1291/2013.
If the EDCTP2 Programme is not implemented or is implemented inadequately, partially or late, the Commission may terminate, proportionately reduce or suspend the Union’s financial contribution in line with the actual implementation of the EDCTP2 Programme.
Komisija se lahko odloči, da bo revizije iz odstavka 1 izvedla sama.
If the Participating States do not contribute, contribute partially or late to the financing of the EDCTP2 Programme, the Commission may terminate, proportionately reduce or suspend the Union’s financial contribution, taking into account the amount of funding allocated by the Participating States to implement the EDCTP2 Programme.
V takih primerih to stori v skladu z veljavnimi pravili, zlasti z določbami uredb (EU, Euratom) št. 966/2012, (EU) št. 1290/2013 in (EU) št. 1291/2013.
Ex-post audits
Zaščita finančnih interesov Unije
Ex-post audits of expenditure on indirect actions shall be carried out by the EDCTP2-IS in accordance with Article 29 of Regulation (EU) No 1291/2013.
Komisija sprejme ustrezne ukrepe, s katerimi zagotovi, da so pri izvajanju ukrepov, ki se financirajo na podlagi tega sklepa, finančni interesi Unije zaščiteni z izvajanjem preventivnih ukrepov proti goljufijam, korupciji in drugim protipravnim ravnanjem ter z učinkovitimi pregledi, ob odkritju nepravilnosti pa z izterjavo napačno izplačanih zneskov ter po potrebi z učinkovitimi, sorazmernimi in odvračilnimi upravnimi in denarnimi kaznimi.
The Commission may decide to carry out itself the audits referred to in paragraph 1.
EDCTP2-IS odobri osebju Komisije in drugim osebam, ki jih ta pooblasti, ter Računskemu sodišču dostop do svojih objektov in prostorov ter vseh informacij, tudi tistih v elektronski obliki, ki so potrebni za izvedbo revizij.
In such cases, it shall do so in accordance with the applicable rules, in particular the provisions of Regulations (EU, Euratom) No 966/2012, (EU) No 1290/2013 and (EU) No 1291/2013.
3.
Article 10
Evropski urad za boj proti goljufijam (OLAF) lahko v skladu z določbami in postopki iz Uredbe Sveta (Euratom, ES) št. 2185/96 [11] ter Uredbe (EU, Euratom) št. 883/2013 Evropskega parlamenta in Sveta [12] opravi preiskave, vključno s pregledi in inšpekcijami na kraju samem, da bi ugotovil, ali je v zvezi s sporazumom ali odločbo o dodelitvi nepovratnih sredstev ali pogodbo, ki se financira v skladu s tem sklepom, prišlo do goljufije, korupcije ali drugih protipravnih ravnanj, ki škodijo finančnim interesom Unije.