natgillin/translations-raw huggingface dataset:
P. 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,
P. 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,
Q. 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,
Q. 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,,
R. ker je potrebna preglednost glede izpolnjevanja teh pogojev,
R. whereas there needs to be transparency about the fulfilment of these conditions,
S. ker je bilo sedaj prikazano razmerje koristi in tveganj tega cepiva na osnovi testiranja tolerance in imunogenosti, opravljenega na podlagi njegove dejanske rabe;
S. whereas the vaccines’ benefit-risk ratio has now been demonstrated in tolerance and immunogenicity studies based on actual use,
T. ker so potrebne študije o cepivih in protivirusnih zdravilih, neodvisne od farmacevtskih družb, da bi dosegli ravnotežje med zasebno in javno financiranimi študijami;
T. 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,
U. 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,
U. 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,
V. 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,
V. 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,
W. 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,
W. 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,
X. 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,
X. 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,
Y. 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,
Y. 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,
4. 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;
6. 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;
9. 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;
17. 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;
A) različnih cepivih in protivirusnih zdravilih, in sicer za oboje:
A) on different vaccines and anti-viral treatments, respectively:
(i) število kupljenih odmerkov,
(i) the number of doses purchased,
(ii) skupni znesek, plačan za nakup,
(ii) the total expenditure for the purchase,
(iii) število dejansko porabljenih odmerkov,
(iii) the number of doses actually used,
(iv) število odmerkov, danih na zalogo, poslanih nazaj proizvajalcu in poplačanih ali prodanih drugim državam članicam oziroma tretjim državam,
(iv) the number of doses placed in storage, sent back to the manufacturer and reimbursed, or sold to other Member States or third countries,
B) boleznih in stranskih učinkih cepiv ter protivirusnih zdravil, in sicer za oboje:
B) on the disease and side effects of vaccines and anti-viral treatment, respectively:
(i) število okužb z H1N1,
(i) the number of H1N1 infections,
(ii) število smrtnih žrtev zaradi okužbe z H1N1,
(ii) the number of deaths due to H1N1 infections,
(iii) število in vrsta poročil o stranskih učinkih cepiv ali protivirusnih zdravil proti H1N1,
(iii) the number and nature of adverse effects reported due to vaccinations or and anti-viral treatment against H1N1,
24. poziva Komisijo, naj s podporo Evropskega centra za preprečevanje in nadzor bolezni in Evropske agencije za zdravila do ...** pripravi zbirno poročilo o podatkih iz odstavka 23 za vsako državo članico posebej in ga objavi kot pomemben prispevek k pregledu sedanjih načrtov pripravljenosti na pandemijo gripe;
Calls on the Commission, with the support of ECDC and EMA, to make a summary report about the information referred to in paragraph 23, broken down by Member State, before ...** and to make it publicly available as an important contribution to the review of the current pandemic influenza preparedness plans;
26. priznava, da navzkrižje interesov pri nekaterih strokovnjakih, ki nudijo svetovanje evropskim organom javnega zdravstva, zbuja sum zlorabe vpliva in škodi splošni verodostojnosti teh organov in njihovih priporočil; meni, da se je treba izogniti vsakršnemu navzkrižju interesov;
Recognises that conflicts of interest among experts who advise European public health authorities lead to suspicions of undue influence and harm the overall credibility of these public health authorities and their recommendations; considers that all conflicts of interest must be avoided;
„Za razliko od virusa ptičje gripe, virus H1N1 zaenkrat povzroča le lažja obolenja z malo smrtnimi primeri, razen pri izbruhu bolezni v Mehiki.
“Unlike the avian virus, H1N1 presently causes mainly mild illness, with few deaths, outside the outbreak in Mexico .
Upajmo, da se bo ta vzorec nadaljeval.“
We hope this pattern continues.”
Margaret Chan, generalna direktorica Svetovne zdravstvene organizacije (WHO), 18. maja 2009
Margaret Chan, Director‑General of the World Health Organisation, 18 May 2009
Zaradi gripe A (H1N1) je po podatkih, ki jih je konec aprila 2010 objavil Evropski center za preprečevanje in nadzor bolezni, leta 2009 v Evropi umrlo 2900 oseb.
According to the figures provided by the European Centre for Disease Prevention and Control (ECDC) at the end of April 2010, influenza A(H1N1) 2009 caused 2 900 deaths in Europe.
Ta številka je nižja od uradnih ocen Komisije glede števila umrlih samo zaradi sezonske gripe, ki je približno 40.000 oseb v običajnem letu in približno 220.000 oseb v posebno hudi sezoni.
These figures are low in comparison to the official mortality estimates for seasonal influenza, which the Commission put at 40 000 deaths in a moderate year and 220 000 in a particularly severe season.
To število je tudi veliko nižje od najbolj optimističnih napovedi zdravstvenih ustanov držav članic Evropske unije.
They are also significantly less than the most optimistic forecasts suggested by the health services of the EU Member States.
Države članice in evropske institucije so to najvišjo stopnjo pripravljenosti sprejele, kar je v nekaterih državah članicah sprožilo plaz zelo dragih ukrepov (na primer stroški Velike Britanije so po ocenah znašali 1300 milijonov EUR, v Franciji pa 990 milijonov EUR – stroški, povezani s sezonsko gripo, so znašali 87 milijonov EUR), ki so bili nesorazmerni z dejansko (in znano) nevarnostjo gripe H1N1.
Member States and European institutions accepted this maximum‑level alert, triggering in some Member States a raft of measures that were very costly (e.g. the costs are put at EUR 1 300 million in Great Britain and EUR 990 million in France - compared to EUR 87 million against seasonal influenza), and in those cases disproportionate to the actual – and known – severity of H1N1 influenza.
Večina v odboru je dejala, da je bilo nemogoče predvideti, kako se bo virus razvil.
A majority in the committee stated that it was unforeseeable to predict how the virus would develop.
Poročevalec je opozoril na primer Poljske, kjer vlada ni pristopila k cepljenju proti virusu H1N1 in je bilo število smrtnih žrtev primerljivo s številom v državah, ki so se odločile za državne kampanje cepljenja.
The rapporteur pointed to the case of Poland, where the government did not proceed to vaccination against H1N1, and where nevertheless the death rate was comparable to those countries which decided to go for national vaccination campaigns.
Svetovna zdravstvena organizacija bi morala nujno pregledati svojo opredelitev in vanjo vključiti resnost bolezni na stopnjah pandemije, s čimer bi omogočila ustreznejši odziv.
The WHO should urgently revise its definition to include the severity of a disease into its definitions on the stages of a pandemic to allow for more appropriate responses.
Evropska unija potrebuje tesnejše sodelovanje
The European Union needs closer cooperation
Odbor meni, da je pri odzivu na pandemije potrebno boljše sodelovanje.
The committee considered that better cooperation is needed in the response to pandemics.
Podpira uvedbo postopka, ki bi državam članicam omogočil prostovoljen skupni nakup.
It also supported the introduction of a procedure that would enable the Member States to make group purchases on a voluntary basis.
Meni, da morajo proizvajalci nositi vso odgovornost za odobrene indikacije svojih zdravil in da morajo države članice to dosledno izvajati v vseh pogodbah o javnih naročilih cepiv.
The committee made it clear that manufacturers have to bear full liability for the authorised indications of their products and that this should be fully applied by Member States in all contracts for the procurement of vaccines.
Evropska unija mora biti bolj neodvisna
The European Union needs greater independence
Poročevalec meni, da analiza odziva na gripo H1N1 v Evropi kaže na temeljno težavo: pomanjkanje neodvisnih ocen nacionalnih in/ali evropskih zdravstvenih organov in zaradi tega nezmožnost optimalnega in pravočasnega prilagajanja javnozdravstvenih ukrepov pravim kliničnim in epidemiološkim podatkom, ki so bili na voljo.
According to the rapporteur, the analysis of the management of H1N1 influenza in Europe highlights an underlying problem: a lack of independent evaluation by our national and/or European health authorities, and a resulting failure to adapt the public health measures, as best as possible and in real time, to the actual clinical and epidemiological statistics available.
Strategije, ki so jih sprejele Evropska unija in države članice temeljijo na pripravah iz leta 2005 ali 2007 v sodelovanju s Svetovno zdravstveno organizacijo.
The strategies adopted in the European Union and the Member States derived from preparedness plans drafted in 2005 or 2007, in conjunction with the WHO.
V večini držav članic je bila politika nakupa cepiv vnaprej določena na podlagi pogodb o nakupu, sklenjenih s farmacevtskimi podjetji leta 2007.
In the majority of the Member States, the policies on the purchasing of vaccines had already been laid down in advance purchase agreements signed back in 2007 with pharmaceutical companies.
Za pandemična cepiva, ki so se vbrizgala milijonom ljudi v Evropi, so veljali postopki za pospešeno dodeljevanje dovoljenj, ki so temeljili na starih študijah in formulah cepiv za virus H5N1 iz let 2005/2007.
The stock ‘pandemic’ vaccines given to millions of people in Europe were the subject of an accelerated authorisation procedures, based in fact on studies and vaccine formulae produced at the time of the H5N1 virus, which also dated from the years 2005/2007.
Nekdanja direktorica Evropskega centra za preprečevanje in nadzor bolezni Zsuzsanna Jakab je na vprašanja o znanstveni dokumentaciji o pandemičnih cepivih 29. septembra 2009 v pismu poročevalcu odgovorila, da res še nobeno cepivo ni bilo odobreno na podlagi tako malo podatkov, vendar je po pričakovanjih mogoče narediti ekstrapolacijo na podlagi prejšnjih izkušenj z enakimi adjuvanti ,vendar z drugačnimi sevi gripe .
When asked about the safety of the adjuvants in the ‘pandemic’ vaccines, Zsuzsanna Jakab, former head of the ECDC, responded on 29 September 2009 in a letter to the rapporteur that ‘ it is true that no vaccine has ever been authorized on so little data, but it is expected that extrapolation can be done from the previous experience with the same adjuvants but with different flu strains ’.
Evropski center za preprečevanje in nadzor bolezni je agencija EU, katere naloga je ocenjevanje nalezljivih bolezni.
With ECDC, the EU has a dedicated agency with regard to the assessment of communicable diseases.
Ta agencija bi morala pri ocenjevanju in razglasitvi stopnje nevarnosti okužbe delovati neodvisno, za opravljanje vseh nalog pa mora imeti na voljo ustrezna sredstva.
ECDC should full apply its competences as an independent agency to assess and communicate the severity of infection risk and be given adequate means for all its tasks.
Za boljše ocenjevanje cepiv v primeru pandemije so potrebne različne izboljšave postopka za pospešeno dodeljevanje dovoljenj.
Various improvements to the accelerated authorisation procedure are needed to allow for a better assessment of vaccines in case of a pandemic.
Financiranje in predhodne izbire lahko vplivajo na uspeh ali neuspeh študije.
Financing and upstream choices can play a decisive role in deciding whether a trial is successful or not.
Zato je treba neodvisno od farmacevtskih družb opraviti študije o cepivih in protivirusnih zdravilih, pa tudi spremljanje obsega cepljenja.
That is why there is a need for studies on vaccines and antiviral medications that are independent of the pharmaceutical companies, including as regards monitoring of the vaccination coverage.
Evropska unija potrebuje več preglednosti
The European Union needs greater transparency
Analiza odziva Evropske unije na krizo v zvezi z gripo H1N1 postavi v ospredje še eno ključno težavo: ocenjevanje priporočenih zdravil proti gripi in njihova uporaba.
The analysis of the EU’s management of the H1N1 crisis also highlights another vital issue: that of the evaluation of the medicinal products recommended against influenza, and the way they are being used.
Odbor meni, da 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.
The committee agreed that vaccination strategies should rely on three conditions to be successful: that the vaccine is efficacious, that it has a positive risk-benefit balance and that it is targeted to the risk groups.
Komisija bi morala na podlagi podatkov iz držav članic pripraviti poročilo o številu kupljenih in porabljenih odmerkov cepiv v posameznih državah članicah ter o boleznih in stranskih učinkih cepiv in protivirusnih zdravil.
A report providing clarity on the number of vaccines purchased and used in the various Member States and on the disease and its side effects of vaccines and anti-viral treatments should be made by the Commission based on information by Member States.
Hkrati bi bilo treba na podlagi omenjenih meril oceniti strategije cepljenja proti gripi, ki jih priporoča EU in jih izvajajo države članice.
At the same time, an assessment of the influenza vaccination strategies recommended in the EU and applied in Member States against these criteria should be done.
Navzkrižje interesov neposredno zbuja sum zlorabe vpliva.
Conflicts of interest immediately lead to suspicions of undue influence.
Izogniti se je treba vsakršnemu navzkrižju interesov.
All conflicts of interests need to be avoided.
Nenazadnje poročevalec meni, da bi morale biti objavljene izjave o interesu vseh strokovnjakov, ki nudijo svetovanje evropskim organom javnega zdravstva.
According to the rapporteur, at the very least, declarations of interest of all experts that advise the European public health authorities have to be published.
János Áder, Elena Oana Antonescu, Kriton Arsenis, Pilar Ayuso, Paolo Bartolozzi, Sandrine Bélier, Sergio Berlato, Martin Callanan, Nessa Childers, Chris Davies, Bairbre de Brún, Anne Delvaux, Bas Eickhout, Edite Estrela, Jill Evans, Elisabetta Gardini, Gerben-Jan Gerbrandy, Julie Girling, Nick Griffin, Françoise Grossetête, Cristina Gutiérrez-Cortines, Satu Hassi, Jolanta Emilia Hibner, Dan Jørgensen, Karin Kadenbach, Christa Klaß, Holger Krahmer, Jo Leinen, Corinne Lepage, Linda McAvan, Radvilė Morkūnaitė-Mikulėnienė, Vladkko Todorov Panajotov (Vladko Todorov Panayotov), Gilles Pargneaux, Antonija Prvanova (Antonyia Parvanova), Andres Perello Rodriguez, Sirpa Pietikäinen, Mario Pirillo, Pavel Poc, Vittorio Prodi, Anna Rosbach, Oreste Rossi, Dagmar Roth-Behrendt, Horst Schnellhardt, Richard Seeber, Teodoros Skilakakis (Theodoros Skylakakis), Bogusław Sonik, Catherine Soullie, Salvatore Tatarella, Sabine Wils, Marina Yannakoudakis
János Áder, Elena Oana Antonescu, Kriton Arsenis, Pilar Ayuso, Paolo Bartolozzi, Sandrine Bélier, Sergio Berlato, Martin Callanan, Nessa Childers, Chris Davies, Bairbre de Brún, Anne Delvaux, Bas Eickhout, Edite Estrela, Jill Evans, Elisabetta Gardini, Gerben-Jan Gerbrandy, Julie Girling, Nick Griffin, Françoise Grossetête, Cristina Gutiérrez-Cortines, Satu Hassi, Jolanta Emilia Hibner, Dan Jørgensen, Karin Kadenbach, Christa Klaß, Holger Krahmer, Jo Leinen, Corinne Lepage, Linda McAvan, Radvilė Morkūnaitė-Mikulėnienė, Vladko Todorov Panayotov, Gilles Pargneaux, Antonyia Parvanova, Andres Perello Rodriguez, Sirpa Pietikäinen, Mario Pirillo, Pavel Poc, Vittorio Prodi, Anna Rosbach, Oreste Rossi, Dagmar Roth-Behrendt, Horst Schnellhardt, Richard Seeber, Theodoros Skylakakis, Bogusław Sonik, Catherine Soullie, Salvatore Tatarella, Sabine Wils, Marina Yannakoudakis
o inovativnem financiranju na svetovni in evropski ravni
on innovative financing at global and European level
Nirj Deva , Odbor za razvoj
Nirj Deva , Committee on Development
(*) Pridruženi odbor – člen 50 poslovnika
(*) Associated committee, Rule 50 of the Rules of Procedure
MNENJE Odbora za razvoj ...........................................................................................21
OPINION of the Committee on Development(*) ..................................................21
– ob upoštevanju sklepov Evropskega sveta z dne 17. junija 2010 in z dne 11. decembra 2009,
– having regard to the conclusions of the European Council of 17 June 2010 and the conclusions of the European Council of 11 December 2009,
– ob upoštevanju zapisnika zasedanja Sveta EU v sestavi finančnih ministrov (ECOFIN) z dne 19. oktobra in poročila Evropskemu svetu, ki je v njem naveden,
– having regard to the minutes of the ECOFIN meeting of 19 October 2010 and to the report to the European Council quoted therein,
– ob upoštevanju programa belgijskega predsedovanja, zlasti predlogov o inovativnem financiranju,
– having regard to the Belgian Presidency's programme, in particular the proposals on innovative financing,
– ob upoštevanju svoje resolucije z dne 10. marca 2010 o davkih na finančne transakcije – izvajanje v praksi
– having regard to its resolution of 10 March 2010 on financial transaction taxes – making them work
Sprejeta besedila, P7_TA(2010)0056 . ,
Texts adopted, P7_TA (2010)0056. ,
– ob upoštevanju svoje resolucije z dne 20. oktobra 2010 o finančni, gospodarski in socialni krizi
– having regard to its resolution of 20 October 2010 on the Financial, Economic and Social Crisis
Sprejeta besedila, P7_TA(2010)0376 . ;
Texts adopted, P7_TA(2010)0376 . ,
– ob upoštevanju svoje resolucije z dne 22. septembra 2010 o evropskih nadzornih organih
– having regard to its resolution of 22 September 2010 on European Supervisory Authorities
Sprejeta besedila, P7_TA(2010)0336 . , zlasti svojih resolucij z dne 22. septembra 2010 o Evropskem organu za zavarovanja in poklicne pokojnine
Texts adopted, P7_TA-(2010)0336. and, specifically, its resolutions of 22 September 2010 on the European Insurance and Occupational Pensions Authority
Sprejeta besedila, P7_TA(2010)0334 . , o Evropskem bančnem organu
Texts adopted, P7_TA-(2010)0334. , of 22 September 2010 on the European Banking Authority
Sprejeta besedila, P7_TA(2010)0337 . , Evropskem organu za vrednostne papirje in trge
Texts adopted, P7_TA-(2010)0337. , of 22 September 2010 on the European Securities and Markets Authority
Sprejeta besedila, P7_TA(2010)0335 . ,
Texts adopted, P7_TA-(2010)0335. ,
– ob upoštevanju delovnega dokumenta Komisije o inovativnem financiranju na svetovni in evropski ravni ( SEC(2010)0409 ) in sporočila Komisije o obdavčitvi finančnega sektorja ( KOM(2010)0549 /5) ter priloženega delovnega dokumenta Komisije ( SEC(2010)1166 ),
– having regard to the Commission staff working document on innovative financing at a global and European level ( SEC(2010)0409 ) and the Commission Communication on the taxation of the financial sector ( COM(2010)0549 /5), along with the accompanying staff working document ( SEC(2010)1166 ),