natgillin/translations-raw huggingface dataset:
Protection of the financial interests of the Union
Pogodbe ter sporazumi in odločbe o dodelitvi nepovratnih sredstev, ki izhajajo iz izvajanja tega sklepa, vsebujejo določbe, ki izrecno pooblaščajo Komisijo, EDCTP2-IS, Računsko sodišče in OLAF, da v skladu s svojimi pristojnostmi opravljajo takšne revizije in preiskave.
The Commission shall take appropriate measures ensuring that, when actions financed under this Decision are implemented, the financial interests of the Union are protected by the application of preventive measures against fraud, corruption and any other illegal activities, by effective checks and, if irregularities are detected, by the recovery of the amounts wrongly paid and, where appropriate, by effective, proportionate and dissuasive administrative and financial penalties.
Sodelujoče države pri izvajanju programa EDCTP2 sprejmejo zakonodajne, regulativne, upravne in druge ukrepe, potrebne za zaščito finančnih interesov Unije, zlasti za zagotovitev popolne izterjave vseh zneskov, dolgovanih Uniji, v skladu z Uredbo (EU, Euratom) št. 966/2012 in Delegirano uredbo (EU) št. 1268/2012.
The EDCTP2-IS shall grant Commission staff and other persons authorised by it, as well as the Court of Auditors, access to its sites and premises and to all the information, including information in electronic format, needed in order to conduct their audits.
Člen 11
The European Anti-Fraud Office (OLAF) may carry out investigations, including on-the-spot checks and inspections, in accordance with the provisions and procedures laid down in Council Regulation (Euratom, EC) No 2185/96 [11] and Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council [12] with a view to establishing whether there has been fraud, corruption or any other illegal activity affecting the financial interests of the Union in connection with a grant agreement or grant decision or a contract funded in accordance with this Decision.
Sporočanje informacij
Contracts, grant agreements and grant decisions resulting from the implementation of this Decision shall contain provisions expressly empowering the Commission, the EDCTP2-IS, the Court of Auditors and OLAF to conduct such audits and investigations, in accordance with their competences.
EDCTP2-IS Komisiji na zahtevo pošlje vse informacije, potrebne za pripravo poročil iz člena 12.
In implementing the EDCTP2 Programme, the Participating States shall take the legislative, regulatory, administrative and other measures necessary to protect the Union’s financial interests, in particular, to ensure full recovery of any amounts due to the Union in accordance with Regulation (EU, Euratom) No 966/2012 and Delegated Regulation (EU) No 1268/2012.
Sodelujoče države prek EDCTP2-IS Komisiji predložijo vse informacije, ki jih zahteva Evropski parlament, Svet ali Računsko sodišče v zvezi s finančnim upravljanjem programa EDCTP2.
Article 11
Komisija vključi informacije iz odstavka 2 tega člena v poročila iz člena 12.
Communication of information
Člen 12
On request, the EDCTP2-IS shall send any information necessary for preparation of the reports referred to in Article 12 to the Commission.
Ocenjevanje
The Participating States shall submit to the Commission, through the EDCTP2-IS, any information that is requested by the European Parliament, the Council or the Court of Auditors concerning the financial management of the EDCTP2 Programme.
Komisija do 30. junija 2017 s pomočjo neodvisnih strokovnjakov izvede vmesno ocenjevanje programa EDCTP2.
The Commission shall include the information referred to in paragraph 2 of this Article in the reports referred to in Article 12.
O tem ocenjevanju pripravi poročilo, ki vključuje zaključke ocenjevanja in pripombe Komisije.
Article 12
Navedeno poročilo do 31. decembra 2017 pošlje Evropskemu parlamentu in Svetu.
Evaluation
Rezultat vmesnega ocenjevanja programa EDCTP2 se upošteva pri vmesni oceni Obzorja 2020.
By 30 June 2017 the Commission shall carry out, with the assistance of independent experts, an interim evaluation of the EDCTP2 Programme.
Komisija ob koncu sodelovanja Unije v programu EDCTP2, najpozneje pa 31. decembra 2023, opravi še eno vmesno ocenjevanje programa EDCTP2.
The Commission shall prepare a report on that evaluation which includes conclusions of the evaluation and observations by the Commission.
O tem ocenjevanju pripravi poročilo, ki vključuje rezultate ocenjevanja.
The Commission shall send that report to the European Parliament and to the Council by 31 December 2017.
To poročilo pošlje Evropskemu parlamentu in Svetu.
The result of the interim evaluation of EDCTP2 Programme shall be taken into account in the interim evaluation of Horizon 2020.
Komisija do 31. decembra 2026 opravi končno ocenjevanje programa EDCTP2.
At the end of the Union participation in EDCTP2 but not later than 31 December 2023, the Commission shall conduct another interim evaluation of the EDCTP2 Programme.
Rezultate tega ocenjevanja pošlje Evropskemu parlamentu in Svetu.
The Commission shall prepare a report on that evaluation which is to include the results of that evaluation.
Člen 13
The Commission shall send that report to the European Parliament and to the Council.
Začetek veljavnosti
The Commission shall conduct a final evaluation of the EDCTP2 Programme by 31 December 2026.
Ta sklep začne veljati dvajseti dan po objavi v Uradnem listu Evropske unije.
The Commission shall send the results of that evaluation to the European Parliament and to the Council.
Člen 14
Article 13
Naslovniki
Entry into force
Ta sklep je naslovljen na države članice.
This Decision shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
V Bruslju, 15. maja 2014
Article 14
Za Evropski parlament
Addressees
Predsednik
Done at Brussels, 15 May 2014.
Mnenje z dne 10. decembra 2013 (še ni objavljeno v Uradnem listu).
For the European Parliament
Stališče Evropskega parlamenta z dne 15. aprila 2014 (še ni objavljeno v Uradnem listu) in odločitev Sveta z dne 6. maja 2014.
The President
Uredba (EU) št. 1291/2013 Evropskega parlamenta in Sveta z dne 11. decembra 2013 o vzpostavitvi okvirnega programa za raziskave in inovacije (2014–2020) - Obzorje 2020 in razveljavitvi Sklepa št. 1982/2006/ES (UL L 347, 20.12.2013, str.
Opinion of 10 December 2013 (not yet published in the Official Journal).
Sklep št. 1209/2003/ES Evropskega parlamenta in Sveta z dne 16. junija 2003 o sodelovanju Skupnosti v programu raziskav in razvoja s ciljem razviti nove klinične posege za boj proti HIV/aids-u, malariji in tuberkulozi z dolgoročnim partnerstvom med Evropo in državami v razvoju, ki ga izvaja več držav članic (UL L 169, 8.7.2003, str.
Regulation (EU) No 1291/2013 of the European Parliament and of the Council of 11 December 2013 establishing Horizon 2020 — the Framework Programme for Research and Innovation (2014-2020) and repealing Decision No 1982/2006/EC (OJ L 347, 20.12.2013, p.
Sklep št. 1513/2002/ES Evropskega parlamenta in sveta z dne 27. junija 2002 o šestem okvirnem programu Evropske skupnosti na področju raziskav, tehnološkega razvoja in predstavitvenih dejavnosti, ki prispeva k oblikovanju Evropskega raziskovalnega prostora in k inovacijam (2002-2006) (UL L 232, 29.8.2002, str.
Decision No 1209/2003/EC of the European Parliament and of the Council of 16 June 2003 on Community participation in a research and development programme aimed at developing new clinical interventions to combat HIV/AIDS, malaria and tuberculosis through a long-term partnership between Europe and developing countries, undertaken by several Member States (OJ L 169, 8.7.2003, p.
Sklep št. 1982/2006/ES Evropskega parlamenta in Sveta z dne 18. decembra 2006 o Sedmem okvirnem programu Evropske skupnosti za raziskave, tehnološki razvoj in predstavitvene dejavnosti (2007–2013) (UL L 412, 30.12.2006, str.
Decision No 1513/2002/EC of the European Parliament and of the Council of 27 June 2002 concerning the sixth framework programme of the European Community for research, technological development and demonstration activities, contributing to the creation of the European Research Area and to innovation (2002 to 2006) (OJ L 232, 29.8.2002, p.
Sklep Sveta 2013/743/EU z dne 3. decembra 2013 o vzpostavitvi posebnega programa za izvajanje okvirnega programa za raziskave in inovacije (2014–2020) – Obzorje 2020 in razveljavitvi odločb 2006/971/ES, 2006/972/ES, 2006/973/ES, 2006/974/ES in 2006/975/ES (UL L 347, 20.12.2013, str.
Decision No 1982/2006/EC of the European Parliament and of the Council of 18 December 2006 concerning the Seventh Framework Programme of the European Community for research, technological development and demonstration activities (2007-2013) (OJ L 412, 30.12.2006, p.
Uredba (EU, Euratom) št. 966/2012 Evropskega Parlamenta in Sveta z dne 25. oktobra 2012 o finančnih pravilih, ki se uporabljajo za splošni proračun Unije, in razveljavitvi Uredbe Sveta (ES, Euratom) št. 1605/2002 (UL L 298, 26.10.2012, str.
Council Decision 2013/743/EU of 3 December 2013 establishing the specific programme implementing Horizon 2020 — the Framework Programme for Research and Innovation (2014-2020) and repealing Decisions 2006/971/EC, 2006/972/EC, 2006/973/EC, 2006/974/EC and 2006/975/EC (OJ L 347, 20.12.2013, p.
Delegirana uredba Komisije (EU) št. 1268/2012 z dne 29. oktobra 2012 o pravilih uporabe Uredbe (EU, Euratom) št. 966/2012 (UL L 362, 31.12.2012, str.
Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council of 25 October 2012 on the financial rules applicable to the general budget of the Union repealing Council Regulation (EC, Euratom) No 1605/2002 (OJ L 298, 26.10.2012, p.
Uredba (EU) št. 1290/2013 Evropskega parlamenta in Sveta z dne 11. decembra 2013 o pravilih za sodelovanje v okvirnem programu za raziskave in inovacije (2014–2020) - Obzorje 2020 ter za razširjanje njegovih rezultatov in o razveljavitvi Uredbe (ES) št. 1906/2006 (UL L 347, 20.12.2013, str.
Commission Delegated Regulation (EU) No 1268/2012 of 29 October 2012 on the rules of application of Regulation (EU, Euratom) No 966/2012 (OJ L 362, 31.12.2012, p.
Uredba Sveta (Euratom, ES) št. 2185/96 z dne 11. novembra 1996 o pregledih in inšpekcijah na kraju samem, ki jih opravlja Komisija za zaščito finančnih interesov Evropskih skupnosti pred goljufijami in drugimi nepravilnostmi (UL L 292, 15.11.1996, str.
2).
CILJI PROGRAMA EDCTP2
Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council of 11 September 2013 concerning investigations conducted by the European Anti-Fraud Office (OLAF) and repealing Regulation (EC) No 1073/1999 of the European Parliament and of the Council and Council Regulation (Euratom) No 1074/1999 (OJ L 248, 18.9.2013, p.
Program EDCTP2 prispeva k naslednjim ciljem:
1).
Splošni cilj
ANNEX I
Program EDCTP2 prispeva k zmanjšanju socialnega in gospodarskega bremena bolezni, povezanih z revščino, v državah v razvoju, zlasti v podsaharski Afriki, in sicer tako, da v partnerstvu s podsaharsko Afriko pospešuje klinični razvoj učinkovitih, varnih, dostopnih, ustreznih in cenovno dostopnih zdravstvenih ukrepov [1] proti boleznim, povezanim z revščino.2.
OBJECTIVES OF THE EDCTP2 PROGRAMME
Posebni cilji Kot prispevek k splošnemu cilju se s programom EDCTP2 dosežejo naslednji posebni cilji:
EDCTP2 shall contribute to the following objectives:
tesnejše sodelovanje z državami podsaharske Afrike, zlasti pri krepitvi njihove zmogljivosti za izvajanje kliničnih preskusov ob upoštevanju temeljnih etičnih načel ter zadevne nacionalne zakonodaje, zakonodaje Unije in mednarodne zakonodaje, vključno z Listino Evropske unije o temeljnih pravicah, Evropsko konvencijo o varstvu človekovih pravic in njenimi dodatnimi protokoli, Helsinško deklaracijo Svetovne zdravniške organizacije iz leta 2008 in standardi dobre klinične prakse, ki jih je sprejela Mednarodna konferenca o usklajevanju tehničnih zahtev za registracijo farmacevtskih izdelkov za uporabo v humani medicini (ICH);
General Objective
boljše usklajevanje, povezovanje in, kadar je to ustrezno, združevanje zadevnih nacionalnih programov za izboljšanje stroškovne učinkovitosti evropskih javnih naložb.
EDCTP2 shall contribute to the reduction of the social and economic burden of poverty-related diseases in developing countries, in particular in sub-Saharan Africa, by accelerating the clinical development of effective, safe, accessible, suitable and affordable medical interventions [1] for poverty-related diseases, in partnership with sub-Saharan Africa.(2) Specific Objectives
Poleg tega bi bilo treba raziskovalne prednostne naloge določiti na ciljno usmerjen način, da bi tako pospešili doseganje rezultatov ter prispevali k nadzoru in izkoreninjenju bolezni, povezanih z revščino, vključno z zapostavljenimi boleznimi;
In order to contribute to the general objective, EDCTP2 shall achieve the following specific objectives:
širše mednarodno sodelovanje z drugimi javnimi in zasebnimi partnerji, da se zagotovita čim večji učinek vseh raziskav in upoštevanje sinergij ter da se pritegnejo viri in naložbe;
an increased number of new or improved medical interventions for HIV/AIDS, tuberculosis, malaria and other poverty-related diseases, including neglected ones, and by the end of the programme to have delivered at least one new medical intervention;
večji učinek zaradi učinkovitega sodelovanja z zadevnimi pobudami Unije, vključno z njeno razvojno pomočjo.
to have issued approximately 30 guidelines for improved or extended use of existing medical interventions;
Operativni kazalniki in cilji
and to have progressed the clinical development of approximately 20 candidate medical interventions;
Za dosego posebnih ciljev iz točke 2 se v času programa EDCTP2 spremljajo naslednji kazalniki:
strengthened cooperation with sub-Saharan African countries, in particular on building their capacity for conducting clinical trials in compliance with fundamental ethical principles and relevant national, Union and international legislation, including the Charter of Fundamental Rights of the European Union, the European Convention on Human Rights and its Supplementary Protocols, the World Medical Association’s Declaration of Helsinki of 2008 and the standards on good clinical practice adopted by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH);
Podpora kliničnemu preskušanju v zvezi z novimi ali izboljšanimi zdravstvenimi ukrepi proti boleznim, povezanim z revščino, vključno z zapostavljenimi boleznimi, s partnerstvi med evropskimi državami in državami v razvoju, zlasti podsaharsko Afriko:
better coordination, alignment and, where appropriate, integration of relevant national programmes to increase the cost-effectiveness of European public investments.
kazalnik:
Moreover, the research priorities should be established in an objective-orientated manner in order to accelerate results and contribute to the control and eradication of poverty-related diseases, including neglected ones;
povečanje števila podprtih kliničnih preskusov na vsaj 150 v primerjavi z 88 v okviru programa EDCTP1, ki bi privedli do novih proizvodov, procesov, metodologij, diagnostik, načinov zdravljenja ali preventive;
extended international cooperation with other public and private partners to ensure that the impact of all research is maximised and that synergies can be taken into consideration and achieve leveraging of resources and investments;
ohranitev ali povečanje deleža kliničnih preskusov pod afriškim vodstvom, ki jih financira EDCTP2-IS;
an increased impact due to effective cooperation with relevant Union initiatives, including its development assistance.
prizadevanje za povečanje števila objavljenih strokovno pregledanih znanstvenih člankov na trikratnik števila tovrstnih člankov, objavljenih v okviru programa EDCTP1.
Operational Indicators and Objectives
Podpora dejavnostim krepitve raziskovalnih zmogljivosti v podsaharski Afriki z omogočanjem izvajanja kliničnih preskusov in pomočjo za zmanjšanje bega možganov:
In order to reach the specific objectives set out in point 2, the following indicators shall be monitored during the course of the EDCTP2 programme:
prizadevanje za ohranitev ali povečanje sodelovanja držav podsaharske Afrike v programu EDCTP2;
Support clinical trials on new or improved medical interventions for poverty-related diseases, including neglected ones, through partnerships between European and developing countries, in particular sub-Saharan Africa:
povečanje števila štipendij za raziskovalce iz podsaharske Afrike in za magistrske/doktorske študente s 400 v okviru programa EDCTP1, pri čemer se jih odločno spodbuja k nadaljevanju raziskovalne poklicne poti v podsaharski Afriki po koncu štipendiranja in jih pri tem podpira;
Indicator:
povečanje števila dejavnosti za krepitev zmogljivosti, podprtih za izvajanje kliničnih preskusov v podsaharski Afriki, s 74 v okviru programa EDCTP1.
increase the number of supported clinical trials to at least 150, compared to 88 under EDCTP1, that lead to new products, processes, methodologies, diagnostics, treatments or preventions.
Oblikovanje raziskovalnega načrta za program EDCTP2 na podlagi skupnih meril za določanje prednostnih nalog in skupno ocenjevanje ob priznavanju, da se lahko prispevki nacionalnih programov in programa EDCTP razlikujejo:
sustain or increase the proportion of clinical trials funded by the EDCTP2-IS with African leadership.
cilj:
aim to increase the number of peer-reviewed scientific articles published to three times that of EDCTP1.
vsaj 50 % javnih naložb sodelujočih držav se združi, poveže ali uskladi v okviru programa EDCTP2.
Support research capacity-building activities in sub-Saharan Africa enabling clinical trials to be conducted and help to reduce the brain drain:
Zagotavljanje učinkovitosti izvajanja programa EDCTP2:
aim to sustain or increase the participation of sub-Saharan African countries in the EDCTP2 Programme.
upravni stroški znašajo manj kot 5 % proračuna EDCTP2-IS.
increase the number of fellowships to sub-Saharan African researchers and MSc/PhD students from 400 under EDCTP1, strongly encouraging and supporting them to continue their research career in sub-Sahara Africa following their fellowship.
Vzpostavitev sodelovanja in uvedba skupnih ukrepov z drugimi javnimi in zasebnimi financerji;
increase the number of capacity-building activities supported for conducting clinical trials in sub-Saharan Africa from 74 under EDCTP1.
povečanje prispevkov iz držav v razvoju s 14000000 EUR v okviru programa EDCTP1 na vsaj 30000000 EUR;
Develop a research agenda for EDCTP2 based on common criteria for priority setting and common evaluation, whilst recognising that contributions from national programmes and EDCTP may differ.
pridobitev dodatnih javnih ali zasebnih prispevkov v višini vsaj 500000000 EUR, v primerjavi z 71000000 EUR, pridobljenimi v okviru programa EDCTP1.
Target:
Vzpostavitev sodelovanja in uvedba skupnih ukrepov s pobudami Unije ter nacionalnimi in mednarodnimi pobudami za razvojno pomoč, po potrebi vključno z ustreznimi pobudami SZO, da se zagotovi dopolnjevanje in poveča učinek rezultatov dejavnosti, financiranih v okviru programa EDCTP.
at least 50 % of the public investment by Participating States are integrated, aligned or coordinated through the EDCTP2 Programme.
Za namene tega sklepa so „zdravstveni ukrepi“ ukrepi, namenjeni izboljšanju ali ohranjanju zdravja ali spremembi poteka bolezni, zlasti preprečevanje in zdravljenje z uporabo medicinskih proizvodov, kot so zdravila, mikrobicidi ali cepiva, vključno z načinom njihovega dajanja, spremljanje zdravljenja in preprečevanje pri prizadetem prebivalstvu ter medicinska diagnostika za odkrivanje in spremljanje razvoja bolezni/zdravstvenega stanja.
Ensure efficiency of the implementation of the EDCTP2 Programme:
PRILOGA II
increase the contributions received from developing countries to at least EUR 30000000 compared to EUR 14000000 under EDCTP1.
Program EDCTP2 vključuje naslednje dejavnosti:
obtain additional contributions, either public or private, of at least EUR 500000000, compared to EUR 71000000 under EDCTP1.
spodbujanje mrežnega povezovanja, usklajevanja, povezovanja, sodelovanja in združevanja nacionalnih raziskovalnih programov in dejavnosti na področju bolezni, povezanih z revščino, vključno z zapostavljenimi boleznimi, na znanstveni, upravljavski in finančni ravni;
Establish cooperation and launch joint actions with Union, national and international development assistance initiatives, including where appropriate, relevant WHO initiatives, in order to ensure complementarity and increase the impact of the results of EDCTP-funded activities.
podpiranje raziskav s kliničnim preskušanjem in sorodnih dejavnosti na področju bolezni, povezanih z revščino, zlasti HIV/aidsa, malarije, tuberkuloze in drugih bolezni, povezanih z revščino, vključno z zapostavljenimi boleznimi;
For the purpose of this decision, ‘medical interventions’ encompass measures whose purpose is to improve or sustain health or alter the course of a disease, in particular prevention and treatment based on medicinal products such as drugs, microbicides or vaccines, including their delivery modality, follow up of treatment and prevention in the affected population as well as medical diagnostics to detect and monitor disease/health evolution.
vzpostavitev sodelovanja in uvedba skupnih ukrepov z drugimi javnimi in zasebnimi financerji;
ANNEX II
zagotavljanje ozaveščanja, podpiranja in priznavanja programa EDCTP2 in njegovih dejavnosti z zavzemanjem zanj in obveščanjem tako na ravni Unije in držav v razvoju kot na svetovni ravni.
ACTIVITIES AND IMPLEMENTATION OF THE EDCTP2 PROGRAMME
Opredelitev in izvajanje programa
Activities
Program EDCTP2 izvaja EDCTP2-IS na podlagi letnega delovnega načrta in večletnega strateškega delovnega načrta, ki ga pripravi EDCTP2-IS ob posvetovanju z zadevnimi deležniki, sprejme pa ga generalna skupščina EDCTP2-IS na podlagi mednarodnega medsebojnega strokovnega pregleda in po predhodni odobritvi Komisije.
The EDCTP2 Programme shall include the following activities:
V letnem delovnem načrtu so opredeljene teme in dejavnosti, ki se bodo izvajale, vključno z razpisi za zbiranje predlogov, ki jih bo EDCTP-IS objavila za izbiro in financiranje posrednih ukrepov, ter proračuni in financiranje teh tem in dejavnosti v okviru programa EDCTP2.
promoting networking, coordination, alignment, collaboration and integration of national research programmes and activities on poverty-related diseases, including neglected ones, at scientific, management and financial level;
Po potrebi lahko program EDCTP2 izmenjuje informacije z drugimi javnimi ali zasebnimi pobudami, tudi tistimi v sklopu Obzorja 2020.
supporting clinical trial research and related activities on poverty-related diseases, in particular HIV/AIDS, malaria, tuberculosis and other poverty-related diseases, including neglected ones;
V letnem delovnem načrtu se razlikuje med dejavnostmi, ki jih financira ali sofinancira Unija, in tistimi, ki jih financirajo sodelujoče države ali se financirajo iz drugih virov.
fostering capacity development for clinical trials and related research in developing countries, in particular in Sub-Saharan Africa, through grants for:
V večletnem strateškem delovnem načrtu je določen skupni strateški raziskovalni program, ki se pripravi in posodobi vsako leto.
career development of junior and senior fellows, promoting mobility, staff exchange grants, research training networks, strengthening ethics and regulatory bodies, mentoring and partnerships at individual or institutional or regional level;
EDCTP2-IS spremlja izvajanje dejavnosti, vključenih v delovni načrt, med drugim tudi posredne ukrepe, izbrane na podlagi razpisov za zbiranje predlogov, ki jih upravlja.
establishing cooperation and launching joint actions with other public and private funders;
Zanje dodeljuje in upravlja finančna sredstva v skladu s tem sklepom ter skrbi za učinkovito izvajanje dejavnosti, izbranih in opredeljenih v predhodnih delovnih načrtih.