natgillin/translations-raw huggingface dataset:
ker se faza svetovne pandemije razglasi na podlagi določb mednarodnega zdravstvenega pravilnika in v posvetovanju z drugimi organizacijami, institucijami in prizadetimi državami članicami,
whereas the phases of a global pandemic are determined in accordance with the provisions of the IHR and in consultation with other organisations and institutions and with the Member States affected,
ker merila o opredelitvi pandemije, ki jih je Svetovna zdravstvena organizacija leta 2009 ponovno pregledala, temeljijo zgolj na širjenju virusa in ne upoštevajo resnosti obolenja, ki ga ta povzroča,
whereas the criteria for defining a ‘pandemic’, as revised by the WHO in 2009, are based solely on the spread of the virus while disregarding the severity of the illness caused by it,
ker bi morale države članice, Evropska komisija in zunanji organi, na primer Svetovna zdravstvena organizacija, pri sprejemanju odločitev v javnem zdravstvu, ki bi lahko vplivale na javno zdravje in socialno politiko v državah članicah, upoštevati virulenco izbruha gripe v prihodnosti, pa tudi širjenje virusa,
whereas Member States, the European Commission and external bodies such as the WHO should take into account the virulence of a future influenza outbreak as well as the propagation of the virus when making public health decisions which may affect public health and social policies in Member States,
ker je stopnja nepredvidljivosti glede resnosti pandemije in njenega poteka visoka ter vedno obstaja možnost, da bi se lahko v Evropi zaostrila, kot se je leta 1918 in 1968,
considering the high degree of unforeseeability regarding the pandemic's severity and how it was going to unfold, and the possibility that the pandemic might worsen in Europe, as it did in 1918 and 1968;
ker so se države članice na podlagi razglasitve pandemije Svetovne zdravstvene organizacije in priporočil, ki so temu sledila, v skladu z načelom previdnosti hitro odzvale glede na razpoložljiva sredstva, da bi vzpostavile zdravstvene akcijske načrte; ker so bile ob razglasitvi najvišje stopnje nevarnosti pandemije na področju javnega zdravja ponekod sprejete nesorazmerne odločitve;
whereas, on the basis of the WHO pandemic alert and subsequent recommendations, the Member States responded rapidly, in line with the precautionary principle, using what resources they had available to implement public health action plans; whereas the move to the highest level of alert, indicating the presence of a pandemic, gave rise in some cases to public health decisions that were disproportionate,
ker je Svetovna zdravstvena organizacija šele avgusta 2010 razglasila prenehanje stanja pripravljenosti na pandemijo gripe H1N1 (izjava generalnega direktorja Svetovne zdravstvene organizacije z dne 10. avgusta 2010 http://www.who.int/mediacentre/news/statements/2010/h1n1_vpc_20100810/en/print.html.
whereas the WHO called an end to the state of alert concerning H1N1 influenza only in August 2010 (statement by the WHO Director-General of 10 August 2010 http://www.who.int/mediacentre/news/statements/2010/h1n1_vpc_20100810/en/print.html
ker v skladu z načelom subsidiarnosti priprava na zdravstvena tveganja v Evropski uniji in odziv nanj spada v pristojnost držav članic; ker Lizbonska pogodba poziva države članice, naj okrepijo sodelovanje, izmenjavo informacij in primerov dobre prakse v okviru Svetovne zdravstvene organizacije in obstoječih struktur EU; ker okrepljeni ukrepi Komisije za usklajevanje skupaj s podporo Evropskega centra za preprečevanje in nadzor bolezni ter Agencije za vrednotenje zdravil v okviru mednarodnega zdravstvenega pravilnika izboljšujejo učinkovitost nacionalnih ukrepov,
whereas, in accordance with the principle of subsidiarity, the preparation for and reaction to health risks in the European Union fall within the competence of the Member States; whereas the Treaty of Lisbon exhorts the Member States to strengthen cooperation, sharing of information and good practices within the framework of the WHO and the existing structures of the EU; whereas stronger coordination measures by the Commission,with the support of the ECDC and the EMEA within the framework of the International Health Regulation, reinforce the effectiveness of national measures,
ker se je morala farmacevtska industrija odzvati na nenadne, nujne in eksponentno naraščajoče zahteve držav članic glede dobave cepiv; ker je morala industrija zelo hitro razviti novo učinkovito cepivo proti virusu,
whereas the pharmaceutical industry had to respond to a sudden, pressing and exponential demand for the supply of vaccines by the Member States; whereas the industry had to develop with very great urgency a new vaccine likely to be effective against the virus,
ker so bili stroški upravljanja te krize v državah članicah visoki in bi jih morda lahko zmanjšali, če bi države članice sodelovale med seboj pa tudi z Evropskim centrom za preprečevanje in nadzor bolezni,
whereas the costs arising from the management of this crisis in the Member States were significant and could perhaps have been reduced by better cooperation between the Member States and better coordination between the Member States and ECDC,
ker je bil nakup velikih količin cepiv in protivirusnih zdravil glavni del stroškov, ki so jih imele nekatere države članice v okviru odziva na krizo, nabavni postopki pa so zbudili resne pomisleke glede spoštovanja pravil o javnih naročilih in preglednosti v nekaterih državah članicah,
whereas the expenditure committed by certain Member States to the response plans drawn up relates mainly to the purchase of vast quantities of vaccines and antiviral treatments, and whereas purchasing procedures led to concerns regarding compliance with rules on public procurement and transparency in some Member States,
ker so bile znatne cenovne razlike med državami članicami, ki so imele predhodne dogovore za nakup cepiva, med drugim zaradi diferenciranih pogojev glede odgovornosti v vsakem dogovoru,
whereas there were significant price disparities among the Member States that had prior purchase agreements for vaccines, based, among other factors, on the differentiated liability conditions of each agreement.
ker so bile v posameznih državah članicah na sodišče vložene pritožbe zaradi korupcije in zarote državnih uradnikov po tem, ko so poleti 2009 ministrstva za zdravje sklenila pogodbe s proizvajalci cepiv proti gripi H1N1,
whereas lawsuits were taken in various Member States, alleging corruption and conspiracy on the part of civil servants in relation to contracts signed in summer 2009 between ministries of public health and manufacturers of H1N1 influenza vaccines,
ker po poročanjih Komisije dobavitelji cepiv ne želijo nositi vso odgovornost za cepiva, kar je morda prispevalo k manjšem zaupanju državljanov v varnost cepiv; ker je zaupanje v cepiva proti gripi H1N1 postalo vprašljivo tudi zaradi pomanjkljivega in neskladnega obveščanja javnosti o koristih in tveganjih cepljenja ter morebitnih tveganjih pandemije gripe,
whereas, according to the Commission the reluctance of vaccine suppliers to bear full product liability may have contributed to reducing citizens' trust in vaccine safety; whereas confidence in vaccines against H1N1 influenza was also undermined by incomplete and contradictory communication on the benefits and risks of vaccination and the potential risks of H1N1 influenza to the public,
ker različna priporočila EU in držav članic pri opredeljevanju prednostnih skupin za cepljenje pričajo o precejšnji negotovosti in različnih mnenjih glede ustreznega odziva na gripo H1N1,
whereas the differing recommendations made within the EU and the Member States on the subject of the priority groups targeted for vaccination illustrate the significant uncertainties and diverging views surrounding the appropriate response to H1N1 influenza,
ker načrtovanje pripravljenosti na pandemijo gripe v veliki meri temelji na strategijah cepljenja; ker bi morale strategije cepljenja sloneti na treh pogojih, če naj bi bile uspešne: učinkovitost cepiva, njegovo pozitivno razmerje med tveganji in koristmi in usmerjenost na ciljne skupine,
whereas pandemic influenza preparedness planning relies to a great extent on vaccination strategies; whereas vaccination strategies should rely on three conditions to be successful: efficacy of the vaccine, a positive benefit-risk balance for the vaccine, and targeting of risk groups,
ker je potrebna preglednost glede izpolnjevanja teh pogojev,
whereas there needs to be transparency about the fulfilment of these conditions,
ker je bilo sedaj prikazano razmerje koristi in tveganj tega cepiva na osnovi testiranja tolerance in imunogenosti, opravljenega na podlagi njegove dejanske rabe;
whereas the vaccines' benefit-risk ratio has now been demonstrated in tolerance and immunogenicity studies based on actual use,
ker so potrebne študije o cepivih in protivirusnih zdravilih, neodvisne od farmacevtskih družb, da bi dosegli ravnotežje med zasebno in javno financiranimi študijami;
whereas there is a need for studies on vaccines and antiviral medications that are independent from pharmaceutical companies so as to have a balance between private and publicly funded studies,
ker je treba v primeru pandemije gripe v prihodnosti narediti več, da bi izboljšali učinkovitost cepiv proti gripi, zlasti za skupine z visokim tveganjem, in proti mutiranim različicam,
whereas, in the event of a future influenza pandemic, more work needs to be done to improve the performance of influenza vaccines, especially for high risk groups and against drifted variants,
ker je bila EU zaradi zgodnje pridobitve cepiv in strategij sistematičnega cepljenja, zlasti med najranljivejšimi skupinami, najbolje pripravljena na svetu, vendar so se pojavile znatne razlike med pripravljenostjo držav članic EU, pomanjkanje pristnega sodelovanja pa je oslabilo skupno pripravljenost EU,
whereas, due to the early acquisition of vaccines and systematic vaccination strategies, especially among the most vulnerable groups, the EU was the best prepared region in the world; whereas, however, considerable differences emerged between the preparedness of EU Member States and the lack of genuine cooperation weakened the EU's overall preparedness,
ker so bili omejeno sodelovanje med državami članicami, zlasti pomanjkanje skupnih javnih naročil za zdravila, pomanjkanje skupnih zalog, solidarnosti in mehanizma posredovanja med državami članicami, ter neobstoj predhodnih sporazumov o dobavi v številnih državah članicah glavni dejavniki, ki so oslabili boljšo pripravljenost EU,
whereas the limited cooperation among Member States, especially the lack of joint public procurement of vaccines, the lack of joint stockpiles, the lack of a solidarity and brokerage mechanism between Member States, and the absence of prior purchase agreements in several Member States were the main factors undermining the EU's better preparedness,
ker kljub temu, da je Evropski varuh človekovih pravic vztrajno zahteval od Evropske agencije za zdravila, naj objavi dokumente o raziskovalnih protokolih, kliničnih poskusih in nezaželenih posledicah zdravil, ki jih je obravnavala, ti še vedno niso javno dostopni,
whereas despite the repeated requests made by the European Ombudsman to the European Medicines Agency (EMA), the documents held by the EMA relating to research protocols, clinical trials and the undesirable effects of medicinal products submitted to it for assessment are not always accessible to the public,
ker se je z obveščanjem in sporočanjem glede gripe H1N1 v letih 2009–2010 v EU pokazala bistvena vloga medijev pri posredovanju previdnostnih ukrepov in priporočil glede javnega zdravja, pa tudi pri poudarjanju izbranih vidikov izbruha in njegovih posledic, zaradi česar se lahko spremeni javno mnenje in odziv javnih oblasti,
whereas the information and communication concerning H1N1 influenza in 2009-2010 in the EU have demonstrated the crucial role played by the media in relaying public health precautions and recommendations, but also in emphasising selected aspects of the outbreak and its consequences, thus potentially altering public opinion perceptions and the public authorities' responses,
zahteva, naj se preventivni načrti EU in držav članic za prihodnje pandemije gripe ponovno preučijo na osnovi posodobljenih ustreznih podatkov, da bi bili bolj učinkoviti in skladni ter ustrezno neodvisni in prilagodljivi ter da bi se odzvali čim hitreje na vsak primer pravega tveganja;
Calls for the prevention plans established in the EU and its Member States for future influenza pandemics to be revised in order to gain in effectiveness and coherence and to make them sufficiently autonomous and flexible to be adapted as swiftly as possible and on a case-by-case basis to the actual risk, based on up-to date relevant information ;
poziva k razjasnitvi ter po potrebi ponovnem pregledu vlog, nalog, pristojnosti, omejitev, odnosov in odgovornosti ključnih akterjev in struktur za obvladovanje groženj zdravju na ravni EU – Evropske komisije, Evropskega centra za preprečevanje in nadzor bolezni, Evropske agencije za zdravila, držav članic, pa tudi neuradnih organov, kot je odbor za zdravstveno varnost, operacijski center za ukrepanje v izrednih zdravstvenih razmerah ali skupina „javno zdravje“, v katerih so visoki uradniki, ki lahko posežejo v postopek sprejemanja odločitev o ukrepanju v zdravstvenih krizah – in poziva k objavi teh podatkov;
Requests clarification, and if necessary review, of the roles, duties, remits, limits, relationships and responsibilities of the key actors and structures at EU level for the management of medical threats – the European Commission, the ECDC, the EMA and the Member States, as well as more informal entities such as the Health Security Committee, the HEOF and the ‘public health’ group, composed of senior officials able to intervene in the decision-making process regarding the management of a health crisis – and calls for that information to be made publicly available;
pozdravlja zavezo Komisije, da preuči možnost pregleda in dolgoročne okrepitve pravne podlage odbora za zdravstveno varnost;
Welcomes the fact that the Commission has committed itself to studying the possibility of a revision and a long-term reinforcement of the legal basis of the Health Security Committee;
meni, da je treba v okviru sodelovanja med državami članicami znotraj odbora za zdravstveno varnost posebno pozornost nameniti medsektorskim pripravam;
Requests that special attention be paid to preparation between sectors within the framework of co-operation between Member States on the Health Security Committee;
poudarja, da je treba okrepiti sodelovanje med državami članicami ter sodelovanje držav članic z Evropskim centrom za preprečevanje in nadzor bolezni, da bi zagotovili skladno obvladovanje tveganja pri odzivu na pandemijo v skladu z Mednarodnim zdravstvenim pravilnikom;
Emphasises the need to reinforce cooperation between Member States, and coordination of Member States with the ECDC, so as to ensure coherent risk management in response to a pandemic in compliance with the International Health Regulation;
poziva k nadaljevanju ter izboljšanju sodelovanja in usklajevanja med državami članicami, institucijami ter mednarodnimi in regionalnimi organizacijami, zlasti v zgodnji fazi izbruha virusa, da bi opredelili njegovo nevarnost in sprejeli ustrezne odločitve glede obvladovanja;
Calls for the continuation and improvement of cooperation and coordination among Member States, institutions and international and regional organisations, particularly in the early stages of a virus outbreak, in order to determine its severity and make appropriate management decisions;
meni, da je priporočljivo okrepiti mandat odbora za javno zdravje, čigar delovanje in vlogo bi bilo treba izboljšati, da bi bolje podpiral države članice pri doseganju skladnega pristopa k pripravljenosti ter odzivu na tveganja javnemu zdravju in izredne razmere mednarodne razsežnosti v skladu z mednarodnim zdravstvenim pravilnikom;
Considers it advisable to reinforce the mandate of the Committee of Public Health, the action and role of which should be improved to provide better support for the Member States in achieving a coherent approach to preparedness for and response to public health threats and emergencies of international concern as defined in the IHR;
poziva Svetovno zdravstveno organizacijo, naj preoblikuje opredelitev pandemije in pri tem poleg geografske razširjenosti upošteva tudi stopnjo nevarnosti virusa;
Urges the WHO to revise the definition of a pandemic, taking into consideration not only its geographical spread but also its severity;
poziva države članice, naj zdravstvene delavce bolj vključijo v vsako stopnjo priprave in uporabe strategij za preprečevanje pandemije in boj proti njej;
Calls on the Member States to involve health professionals more closely at every stage in the preparation and application of strategies for preventing and combating pandemics;
poziva Evropsko unijo, naj dodeli več sredstev za raziskave ter razvoj na področju preventivnih ukrepov v javnem zdravstvu ter obenem upošteva svoj cilj, da raziskavam in razvoju nameni 3 % evropskega BDP; natančneje, poziva k povečanju naložb v boljše ocenjevanje in napovedovanje učinka virusa gripe, tako v obdobju med pandemijami kot na začetku pandemije;
Urges the European Union to allocate more resources to research and development regarding preventive measures in the field of public health care while conforming to its stated objective of allocating 3% of European GDP to R&D; more specifically, calls for an increase in the investments dedicated to a better evaluation and anticipation of the impact of an influenza virus both between pandemics and at the beginning of a pandemic;
poziva k nenehnemu vlaganju v nacionalne epidemološke, serološke in virološke nadzorne centre;
Calls for continued investment in national epidemiological, serological and virological surveillance centres;
opozarja, da v skladu s sedanjo zakonodajo Unije o zdravilih odgovornost za kakovost, varnost in učinkovitost zdravila v zvezi z odobrenimi indikacijami nosi proizvajalec, ter poziva, naj države članice to pravilo dosledno upoštevajo v vseh pogodbah o javnih naročilih cepiv, saj gre za pomemben dejavnik za ohranjanje/ponovno pridobitev zaupanja državljanov v varnost cepiv;
Recalls that according to current Union legislation on medicinal products, liability for the quality, safety and efficacy concerning the authorised indications of a medicinal product rests with the manufacturer, and calls for full application of this rule by Member States in all contracts for the procurement of vaccines, as an important factor in maintaining/regaining citizens' trust in vaccine safety;;
v okviru skupnega in odgovornega upravljanja z dobavo cepiv poziva k razmisleku o možnosti olajšanja dostopa držav v razvoju do cepiv v primeru pandemije;
Requests, within the framework of the common and responsible management of the supply of vaccines, that consideration be given to the possibility of easing access for developing countries to vaccine products in the event of a pandemic;
meni, da mora Evropski center za preprečevanje in nadzor bolezni delovati kot neodvisna agencija, da bi ocenil in razglasil stopnjo nevarnosti okužbe, za opravljanje vseh nalog pa mora imeti na voljo ustrezna sredstva;
Takes the view that the European Centre for Disease Prevention and Control (ECDC) has to exercise its powers as an independent agency to assess and communicate the severity of infection risk and be given adequate means for all its tasks;
poziva Evropski center za preprečevanje in nadzor bolezni, naj s prispevkom Svetovne zdravstvene organizacije sodeluje pri pregledu primerov najboljše prakse v zvezi z nacionalnimi načrti pripravljenosti ter oblikuje priporočila glede primerov najboljše prakse na področjih, kot so tehnike kriznega upravljanja, strategije cepljenja in obveščanja;
Invites the ECDC, with input from the WHO, to contribute to reviewing best practice on national influenza preparedness plans, and to make recommendations on best practice in areas such as crisis management techniques, vaccination and communication strategies;
zahteva zagotovitev večje vigilance in popolne preglednosti pri ocenjevanju priporočenih zdravil v izrednih zdravstvenih razmerah in poročanju o teh zdravilih, zlasti v primeru prave pandemije;
Demands that increased vigilance and complete transparency be assured with regard to the evaluation of, and reporting on, medicinal products recommended in the event of health emergencies, and more particularly in genuine pandemic situations;
poudarja, da je treba neodvisno od farmacevtskih družb opraviti študije o cepivih in protivirusnih zdravilih, pa tudi o spremljanju obsega cepljenja;
Underscores the need for studies independent of the pharmaceutical companies on vaccines and antiviral medications, including with regard to the monitoring of vaccination coverage;
želi zagotoviti, da znanstveniki ne bodo imeli finančnega ali drugega interesa v farmacevtski industriji, ki bi lahko vplival na njihovo nepristranskost; poziva k oblikovanju evropskega kodeksa za opravljanje funkcije strokovnjaka na področju znanosti pri katerem koli evropskem organu, ki je zadolžen za varnost, napovedovanje in obvladovanje tveganj; zahteva, naj se vsak strokovnjak pred začetkom opravljanja svojih nalog zaveže etničnim načelom tega kodeksa;
Wishes to ensure that scientific experts have no financial or other interests in the pharmaceutical industry that could affect their impartiality; requests the development of a European code of conduct relating to the exercise of the function of a scientific expert in any European authority in charge of safety and of the management and anticipation of risks; requires that each expert subscribe to the ethical principles of this code of conduct before taking up his or her duties;
poziva, naj bodo strokovnjaki iz farmacevtskega sektorja vključeni v postopek posvetovanja, ne pa tudi v postopek odločanja;
Asks that experts who are involved in the pharmaceutical sector, while they may be consulted, should be excluded from decision-making;
poziva k oceni strategij cepljenja proti gripi, ki jih priporoča EU in izvajajo države članice, in sicer z vidika učinkovitosti cepiv, razmerja med koristmi in tveganji in različnih ciljnih skupin, za katere je cepljenje priporočljivo, da bi zagotovili varno in učinkovito uporabo;
Calls for an assessment of the influenza vaccination strategies recommended in the EU and applied in Member States, covering the efficacy of the vaccines, their risk-benefit balance and the different target groups recommended, with a view to safe and effective use;
poziva države članice, naj Komisiji do 8. septembra 2011 posredujejo podatke o:
Calls on Member States to report the following information to the Commission before 8 September 2011:
različnih cepivih in protivirusnih zdravilih, in sicer za oboje:
on different vaccines and anti-viral treatments, respectively:
število kupljenih odmerkov,
the number of doses purchased,
skupni znesek, plačan za nakup,
the total expenditure for the purchase,
število dejansko porabljenih odmerkov,
the number of doses actually used,
število odmerkov, danih na zalogo, poslanih nazaj proizvajalcu in poplačanih ali prodanih drugim državam članicam oziroma tretjim državam,
the number of doses placed in storage, sent back to the manufacturer and reimbursed, or sold to other Member States or third countries,
boleznih in stranskih učinkih cepiv ter protivirusnih zdravil, in sicer za oboje:
on the disease and side effects of vaccines and anti-viral treatment, respectively:
število okužb z H1N1,
the number of H1N1 infections,
število smrtnih žrtev zaradi okužbe z H1N1,
the number of deaths due to H1N1 infections,
število in vrsta poročil o stranskih učinkih cepiv ali protivirusnih zdravil proti H1N1,
the number and nature of adverse effects reported due to vaccinations or and anti- viral treatment against H1N1,