natgillin/translations-raw huggingface dataset:
The opinion of the expert panel was that EDCTP1 provided a unique platform for a genuine dialogue with African scientists, and that it has started to bridge the gap between North and South in building research capacities and in providing learning and working opportunities for young African researchers.
Skupina strokovnjakov je menila, da je program EDCTP1 edinstvena platforma za pristen dialog z afriškimi znanstveniki, s krepitvijo raziskovalnih zmogljivosti ter zagotavljanjem priložnosti za učenje in delo mladim afriškim raziskovalcem pa je začel zmanjševati razliko med severom in jugom.
Following that report, there are fundamental issues to be taken into consideration for a second European and Developing Countries Clinical Trials Partnership Programme (‘EDCTP2 Programme’):
Na podlagi tega poročila je treba pri drugem programu Partnerstvo evropskih držav in držav v razvoju na področju kliničnega preskušanja (v nadaljnjem besedilu: program EDCTP2) upoštevati naslednja temeljna vprašanja:
the current scope of EDCTP1 needs to be amended and extended;
sedanji obseg programa EDCTP1 je treba spremeniti in razširiti;
the capabilities in developing countries for the sound conduct and management of clinical trials should, where necessary, be further developed and strengthened, in particular the role and development of ethical review committees and the corresponding regulatory environment, the coordination, collaboration and, where appropriate, integration of European national programmes should be further improved;
kjer je to potrebno, bi bilo treba dodatno razviti in okrepiti zmogljivosti držav v razvoju za pravilno izvajanje in upravljanje kliničnega preskušanja, zlasti vlogo in razvoj odborov za etični pregled in ustrezno regulativno okolje, hkrati pa bi bilo treba še izboljšati usklajevanje, sodelovanje in, kjer je primerno, povezovanje evropskih nacionalnih programov;
collaboration with other major public and private partners, including the pharmaceutical industry, and public-private partnerships such as the Product Development Partnerships (‘PDPs’), civil society, non-governmental organisations and foundations, need to be strengthened and extended;
okrepiti in razširiti bi bilo treba sodelovanje z drugimi večjimi javnimi in zasebnimi partnerji, vključno s farmacevtsko industrijo, javno-zasebnimi partnerstvi, kot je partnerstvo za razvoj proizvodov, civilno družbo, nevladnimi organizacijami ali fundacijami;
there should be clear and transparent rules of governance;
obstajati bi morala jasna in pregledna pravila upravljanja;
synergies with European external policy actions should be developed specifically with Union development assistance;
razviti bi bilo treba sinergije z evropskimi ukrepi na področju zunanje politike, posebej z razvojno pomočjo Unije;
co-funding rules should be clarified and simplified;
pravila o sofinanciranju bi bilo treba razjasniti in poenostaviti;
and monitoring tools need to be strengthened.
okrepiti je treba orodja za spremljanje.
Pursuant to Council Decision 2013/743/EU [7], further support may be provided to the EDCTP2 Programme.
Na podlagi Sklepa Sveta 2013/743/EU [7] je mogoče zagotoviti dodatno podporo za program EDCTP2.
The Union is a major funder of research into poverty-related diseases and neglected infectious diseases.
Unija je pomembna vlagateljica v raziskave na področju bolezni, povezanih z revščino, in zapostavljenih nalezljivih bolezni.
The Commission and Member States contribute nearly one quarter (22 %) of the relevant global investment made by governments.
Komisija in države članice za to področje prispevajo približno četrtino (22 %) ustreznih državnih naložb na svetovni ravni.
The Union is also a major player in global health.
Poleg tega je Unija eden najpomembnejših akterjev na področju zdravja v svetu.
For example, the Commission and the Member States provide approximately half the financing of the Global Fund To Fight AIDS, Tuberculosis and Malaria.
Komisija in države članice na primer zagotavljajo približno polovico sredstev Globalnega sklada za boj proti aidsu, tuberkulozi in malariji.
EDCTP1 produced major achievements, and developed eight improved medical treatments, in particular for newborns, children and pregnant or breastfeeding women suffering from HIV/AIDS or malaria.
S programom EDCTP1 je bilo doseženega že veliko, pri čemer je bilo doslej razvitih osem izboljšanih postopkov zdravljenja, zlasti za novorojenčke, otroke in nosečnice oziroma doječe matere, ki imajo HIV/aids ali malarijo.
It has resulted in the launch of the first four African Regional Networks of Excellence promoting South-South cooperation on clinical research, and more than 400 African researchers have been trained.
Začele so delovati prve štiri afriške regionalne mreže odličnosti, ki spodbujajo sodelovanje jug-jug na področju kliničnih raziskav, usposabljalo pa se je več kot 400 afriških raziskovalcev.
It has also contributed to establishing the Pan-African Clinical Trials Registry and the African Vaccine Regulators Forum.
Program je prispeval tudi k vzpostavitvi vseafriškega registra kliničnih preskušanj in foruma afriških regulatorjev za cepiva.
Despite the considerable results and achievements of EDCTP1, poverty-related diseases still represent a major obstacle to the sustainable development of developing countries due to their social and economic burden, especially in sub-Saharan Africa.
Kljub pomembnim rezultatom in dosežkom programa EDCTP1 bolezni, povezane z revščino, zaradi svojega socialnega in gospodarskega bremena še vedno zelo ovirajo trajnostni razvoj držav v razvoju, zlasti v podsaharski Afriki.
Effective, safe, suitable and affordable medical treatments tailored to the specific circumstances of developing countries still do not exist for most poverty-related diseases, and investment in clinical research remains inadequate as conducting clinical trials is costly and the return on investment is limited due to market failure.
Za večino bolezni, povezanih z revščino, še vedno ni učinkovitega, varnega, ustreznega in cenovno dostopnega zdravljenja, prilagojenega posebnim okoliščinam držav v razvoju, naložbe v klinične raziskave so še vedno nezadostne, saj je izvajanje kliničnih preskusov drago, donosnost naložb pa je zaradi tržnih nepopolnosti omejena.
It should be underlined that only 10 % of global research funding is allocated to the diseases which account for 90 % of the world’s pathologies.
Poudariti bi bilo treba, da je samo 10 % svetovnih sredstev za raziskave namenjenih boleznim, ki povzročajo 90 % vseh bolezenskih stanj na svetu.
Moreover, European research activities and programmes are still often fragmented and are therefore either subcritical in scale or overlapping, whereas research capacity and investment in developing countries are inadequate.
Poleg tega so evropske raziskovalne dejavnosti in programi še vedno pogosto razdrobljeni in tako ne dosegajo kritične mase ali se prekrivajo, raziskovalne zmogljivosti in naložbe v državah v razvoju pa niso zadostne.
Supporting the fight against poverty-related diseases would also help to safeguard Europe’s citizens from those diseases as increasing global mobility (including tourism), migratory movements and shifts in the geographic distribution of those diseases mean that Europe may be facing new or returning challenges in connection with those diseases.
Podpora boju proti boleznim, povezanim z revščino, bi pripomogla tudi k zaščiti evropskih državljanov pred temi boleznimi, saj vse večja svetovna mobilnost (vključno s turizmom), migracijska gibanja in premiki pri geografski razširjenosti teh bolezni pomenijo, da se v Evropi lahko pojavijo nove bolezni ali pa se na to celino vrnejo stare.
On 15 June 2010, the European Parliament adopted a resolution on progress towards achieving the Millennium Development Goals (‘MDG’) in advance of the UN high-level meeting in September 2010, in which it asked the Commission, the Member States and developing countries to address MDG 5 (on improving maternal health), MDG 4 (on child mortality) and MDG 6 (on HIV/AIDS, malaria and tuberculosis) in a coherent and holistic way.
Evropski parlament je 15. junija 2010 sprejel resolucijo o napredku pri doseganju razvojnih ciljev tisočletja kot pripravo na srečanje ZN na visoki ravni septembra 2010, v kateri je pozval Komisijo, države članice in države v razvoju, naj skladno in celovito obravnavajo razvojne cilje tisočletja št. 5 (o izboljšanju zdravja mater), št. 4 (o umrljivosti otrok) in št. 6 (o HIV/aidsu, malariji in tuberkulozi).
The Union is committed to the 2012 Rio+20 conference conclusions on developing and achieving internationally-agreed Sustainable Development Goals (‘SDG’), following and including the MDG.
Unija je zavezana uresničitvi sklepov konference Rio+20 iz leta 2012 o oblikovanju in doseganju mednarodno sprejetih ciljev trajnostnega razvoja, med katere spadajo tudi razvojni cilji tisočletja, ki naj bi jih tako tudi izpolnjevali v tem okviru.
In 2000, the Union launched a high-level policy dialogue with Africa leading to the establishment of an Africa-EU Strategic Partnership, following which a Joint Africa-EU Strategy was adopted in 2007 and a high-level policy dialogue on Science, Technology and Innovation was established in 2011.
Unija je leta 2000 začela politični dialog na visoki ravni z Afriko, ki je privedel do vzpostavitve strateškega partnerstva Afriko-EU, na podlagi katerega je bila leta 2007 sprejeta skupna strategija Afrika-EU, leta 2011 pa je bil vzpostavljen politični dialog na visoki ravni o znanosti, tehnologiji in inovacijah.
On 31 March 2010, the Commission presented a communication on the Union’s role in global health, which called for a more coordinated approach among Member States and across relevant policies to identify and jointly address shared global priorities for health research.
Komisija je 31. marca 2010 predstavila sporočilo o vlogi Unije na področju zdravja v svetu, v katerem poziva k bolj usklajenemu pristopu med državami članicami in v zadevnih politikah, da bi določili in skupaj obravnavali skupne prednostne naloge za zdravstvene raziskave.
In that communication, the Commission also restated the need to promote equitable and universal coverage of quality health services, plus effective and fair financing of research that benefits the health of all people.
V njem je ponovno poudarila, da je treba spodbujati pravično porazdeljenost kakovostnih zdravstvenih storitev po vsem svetu ter učinkovito in pravično financiranje raziskav, ki bodo pripomogle k boljšemu zdravju vseh ljudi.
In the Council Conclusions of 10 May 2010 on the EU role in global health, the Council called on the Union to promote effective and fair financing of research that benefits the health of all and ensures that innovations and interventions lead to affordable and accessible solutions.
Leta 2010 je Svet v svojih sklepih z dne 10. maja 2010 o vlogi EU na področju svetovnega zdravja pozval Unijo, naj spodbuja učinkovito in pravično financiranje raziskav, ki bodo pripomogle k boljšemu zdravju vseh ljudi, in naj zagotovi, da bodo inovacije in ukrepi privedli do cenovno ugodnih in dostopnih rešitev.
In particular, models that dissociate the costs of Research and Development (‘R&D’) from the prices of medicines should be explored, including the opportunities for technology transfer to developing countries.
Raziskati bi bilo treba zlasti modele, kjer so stroški raziskav in razvoja ločeni od cene zdravil, med drugim tudi priložnosti za prenos tehnologije v države v razvoju.
In its Communication of 21 September 2011 on partnering in research and innovation, the Commission put partnerships across institutional, national and continental borders at the centre of the Union’s research policy.
Komisija je 21. septembra 2011 v svojem sporočilu o partnerstvu na področju raziskav in inovacij partnerstva prek institucionalnih, državnih in celinskih meja postavila v središče raziskovalne politike Unije.
In its Communication of 27 February 2013 entitled ‘A decent life for all: ending poverty and giving the world a sustainable future’, the Commission reaffirmed its commitment to doing its utmost to help achieve the MDG by 2015, and pointed out that EU-funded research under EDCTP1 had contributed to achieving the MDG.
Komisija je 27. februarja 2013 v svojem sporočilu z naslovom „Dostojno življenje za vse: izkoreninjenje revščine in zagotavljanje trajnostne prihodnosti sveta“ znova potrdila svojo zavezanost, da si bo z vsemi močmi prizadevala za uresničitev razvojnih ciljev tisočletja do leta 2015, in poudarila, da so raziskave, ki jih je financirala EU v okviru programa EDCTP1, prispevale k njihovemu uresničevanju.
In line with the objectives of Horizon 2020, any Member State and any country associated to Horizon 2020 should be entitled to participate in the EDCTP2 Programme.
V skladu s cilji Obzorja 2020 bi morale imeti pravico do sodelovanja v programu EDCTP2 vse države članice in vse države, pridružene Obzorju 2020.
Contribution to the exploration of open innovation models for needs-driven research, and available and affordable outcomes in alignment with other Union commitments in health R & D should be considered.
Razmisliti bi bilo treba o prispevku k preučevanju odprtih inovacijskih modelov za raziskave, ki jih narekujejo potrebe, ter razpoložljivi in cenovno dostopni rezultati, skladni z drugimi zavezami Unije na področju zdravstvenih raziskav in razvoja.
In order to take into account the duration of Horizon 2020, calls for proposals under the EDCTP2 Programme should be launched at the latest by 31 December 2020.
V okviru te zgornje meje bi moral biti prispevek Unije enak prispevkom držav iz tega sklepa, da bi tako dosegli močan učinek vzvoda in zagotovili večje združevanje programov teh držav.
In duly justified cases, calls for proposals may be launched by 31 December 2021.
Finančni prispevek Unije bi moral biti pogojen s formalnimi zavezami sodelujočih držav, da bodo prispevale k izvajanju programa EDCTP2, in izpolnitvijo teh zavez.
A ceiling should be established for the Union’s financial participation in EDCTP2 Programme for the duration of Horizon 2020.
Za skupno izvajanje programa EDCTP2 je potrebna izvedbena struktura.
Within the limits of that ceiling, the Union contribution should be equal to the contribution of the states referred to in this Decision in order to achieve a high leverage effect and ensure a stronger integration of those states’ programmes.
Sodelujoče države so se dogovorile o izvedbeni strukturi za program EDCTP2 in vzpostavile EDCTP2-Izvedbeno strukturo (v nadaljnjem besedilu: EDCTP2-IS).
The Union’s financial contribution should be subject to formal commitments from the Participating States to contribute to implementing the EDCTP2 Programme and to the fulfilment of those commitments.
EDCTP2-IS bi morala prejemati finančni prispevek Unije in zagotavljati učinkovito izvajanje programa EDCTP2.
The joint implementation of the EDCTP2 Programme requires an implementation structure.
Dejavnosti programa EDCTP2 bi morale biti skladne s cilji in prednostnimi nalogami na področju raziskav in inovacij iz Obzorja 2020 ter splošnimi načeli in pogoji iz člena 26 Uredbe (EU) št. 1291/2013.
The Participating States have agreed on the implementation structure for EDCTP2 Programme and have set up the EDCTP2-Implementation Structure (‘EDCTP2-IS’).
Razpisi za zbiranje predlogov v okviru EDCTP2-IS bi morali biti prav tako objavljeni na enotnem portalu za sodelujoče, pa tudi z drugimi sredstvi elektronskega razširjanja iz Obzorja 2020, ki jih upravlja Komisija.
The EDCTP2-IS should be the recipient of the Union’s financial contribution and should ensure the efficient implementation of the EDCTP2 Programme.
Finančni prispevek Unije bi bilo treba upravljati v skladu z načelom dobrega finančnega poslovodenja in zadevnimi pravili o posrednem upravljanju iz Uredbe (EU, Euratom) št. 966/2012 Evropskega Parlamenta in Sveta [8] in Delegirane uredbe Komisije (EU) št. 1268/2012 [9].
EDCTP2 activities should be in line with the objectives and research and innovation priorities of Horizon 2020 and with the general principles and conditions laid down in Article 26 of Regulation (EU) No 1291/2013.
Da se zaščitijo finančni interesi Unije, bi morala imeti Komisija pravico znižati, začasno ustaviti ali ukiniti finančni prispevek Unije, če se program EDCTP2 izvaja neustrezno, delno ali z zamudo ali če sodelujoče države ne prispevajo k financiranju programa EDCTP2 ali če prispevajo deloma ali z zamudo.
Calls for proposals by EDCTP2-IS should also be published on the single portal for participants, as well as through other Horizon 2020 electronic means of dissemination managed by the Commission.
Navedene pravice bi bilo treba določiti v sporazumu o prenosu pooblastil, sklenjenem med Unijo in EDCTP2-IS.
The Union’s financial contribution should be managed in compliance with the principle of sound financial management and in accordance with the relevant rules on indirect management laid down in Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council [8] and Commission Delegated Regulation (EU) No 1268/2012 [9].
Da bi se program EDCTP2 izvajal učinkovito, bi morala EDCTP2-IS zagotavljati finančno podporo zlasti v obliki nepovratnih sredstev za sodelujoče v ukrepih, izbranih na ravni EDCTP2-IS.
In order to protect the Union’s financial interests, the Commission should have the right to reduce, suspend or terminate the Union’s financial contribution if the EDCTP2 Programme is implemented inadequately, partially or late, or if the Participating States do not contribute, or contribute partially or late, to the financing of the EDCTP2 Programme.
Te ukrepe bi bilo treba izbrati na podlagi odprtih in konkurenčnih razpisov za zbiranje predlogov, za katere je odgovorna EDCTP2-IS.
Those rights should be provided for in the delegation agreement to be concluded between the Union and the EDCTP2-IS.
Sodelovanje v posrednih ukrepih v okviru programa EDCTP2 ureja Uredba (EU) št. 1290/2013 Evropskega parlamenta in Sveta [10].
In order to implement the EDCTP2 Programme efficiently, financial support should be provided by the EDCTP2-IS mainly in the form of grants to participants in actions selected at the level of the EDCTP2-IS.
Vendar je treba zaradi posebnih operativnih potreb programa EDCTP2 zagotoviti odstopanja od navedene uredbe v skladu z njenim členom 1(3).
The selection of those actions should be made following open and competitive calls for proposals under the responsibility of the EDCTP2-IS.
Potrebna so odstopanja od točke (b) člena 9(1), točke (c) člena 10(1) in člena 12 Uredbe (EU) št. 1290/2013, da se zahteva sodelovanje in omogoči financiranje afriških subjektov ter da se omogoči sodelovanje na podlagi skupnih razpisov programa EDCTP2 in drugih pravnih subjektov.
Participation in indirect actions under the EDCTP2 Programme is subject to Regulation (EU) No 1290/2013 of the European Parliament and of the Council [10].
Zaradi poenostavitve bi bilo treba za vse strani zmanjšati upravna bremena.
However, due to the specific operating needs of the EDCTP2 Programme, it is necessary to provide for derogations from that Regulation in accordance with Article 1(3) of that Regulation.
Izogibati bi se bilo treba dvojnim revizijam ter nesorazmernemu dokumentiranju in poročanju.
Derogations from point (b) of Article 9(1), point (c) of Article 10(1) and Article 12 of Regulation (EU) No 1290/2013 are necessary in order to require participation and allow funding of African entities, and allow cooperation through joint calls between the EDCTP2 Programme and any other legal entity.
Pri izvajanju revizij bi bilo treba, če je to primerno, upoštevati posebnosti nacionalnih programov.
For the purpose of simplification, administrative burdens should be reduced for all parties.
Revizije prejemnikov sredstev Unije, zagotovljenih v skladu s tem sklepom, bi morale zagotoviti zmanjšanje upravnega bremena v skladu z Obzorjem 2020.
Double audits and disproportionate documentation and reporting should be avoided.
Finančne interese Unije bi bilo treba v celotnem ciklusu odhodkov zaščititi s sorazmernimi ukrepi, med drugim s preprečevanjem, odkrivanjem in preiskovanjem nepravilnosti, povračilom izgubljenih, napačno izplačanih ali nepravilno porabljenih sredstev ter po potrebi upravnimi in denarnimi kaznimi v skladu z Uredbo (EU, Euratom) št. 966/2012.
When audits are conducted, the specificities of the national programmes should be taken into account, as appropriate.
Komisija bi morala opravljati vmesna ocenjevanja, s katerimi bi ocenila zlasti kakovost in učinkovitost programa EDCTP2 ter napredek pri doseganju zastavljenih ciljev, in končno ocenjevanje ter pripraviti poročila o teh ocenjevanjih.
Audits of recipients of Union funds provided in accordance with this Decision should ensure a reduction of the administrative burden, in compliance with Horizon 2020.
EDCTP2-IS in sodelujoče države bi morale na zahtevo Komisije predložiti vse informacije, ki jih mora ta vključiti v poročila o oceni programa EDCTP2.
The Union’s financial interests should be protected by means of proportionate measures throughout the expenditure life-cycle, including the prevention, detection and investigation of irregularities, the recovery of funds lost, wrongly paid or incorrectly used and, where appropriate, administrative and financial penalties in accordance with Regulation (EU, Euratom) No 966/2012.
Bistveno je, da se pri raziskovalnih dejavnostih, ki se izvajajo v okviru programa EDCTP2, v celoti upoštevajo Listina Evropske unije o temeljnih pravicah, Evropska konvencija o varstvu človekovih pravic in njeni dodatni protokoli, etična načela, vključena v Helsinško deklaracijo Svetovne zdravniške organizacije iz leta 2008, standardi dobre klinične prakse, ki jih je sprejela Mednarodna konferenca o usklajevanju tehničnih zahtev za registracijo farmacevtskih izdelkov za uporabo v humani medicini, zadevna zakonodaja Unije ter lokalne etične zahteve držav, v katerih se bodo izvajale raziskovalne dejavnosti.
The Commission should conduct interim evaluations, assessing in particular the quality and efficiency of the EDCTP2 Programme, the progress made towards the objectives set and a final evaluation, and should prepare reports on those evaluations.
Bistveno je, da bi morala biti privolitev na podlagi seznanjenosti za klinične preskuse, ki se izvajajo v državah v razvoju, resnično dana na podlagi ustrezne seznanjenosti in prostovoljno.
Upon request from the Commission, the EDCTP2-IS and the Participating States should submit any information the Commission needs to include in the reports on the evaluation of the EDCTP2 Programme.
Pomembno je tudi, da bi morale biti dejavnosti, ki se izvajajo v okviru programa EDCTP2, skladne z ukrepi Unije na področju razvojne politike.
It is essential that the research activities carried out under the EDCTP2 Programme are in full compliance with the Charter of Fundamental Rights of the European Union, the European Convention on Human Rights and its Supplementary Protocols, ethical principles included in the World Medical Association’s Declaration of Helsinki of 2008, the standards of good clinical practice adopted by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, relevant Union legislation and local ethics requirements of the countries where the research activities are to be conducted.
V tem pogledu bi si bilo treba prizadevati za iskanje sinergij med programom EDCTP2 in Evropskim razvojnim skladom.
It is essential that informed consent for clinical trials conducted in developing countries should always be obtained in a way that is truly informed and voluntary.
Znotraj cilja sodelovanja z mednarodnimi pobudami za razvojno pomoč bi bilo treba pri dejavnostih, ki se financirajo v okviru programa EDCTP2, upoštevati morebitna priporočila, ki jih predlagajo ustrezne pobude Svetovne zdravstvene organizacije (SZO), vključno s posvetovalno strokovno delovno skupino za raziskave in razvoj.