natgillin/translations-raw huggingface dataset:
Pred kratim opravljena študija je pokazala, da se 61 % francoskih zdravnikov ne namerava cepiti.
A recent study shows that 61% of French doctors do not intend to have themselves vaccinated.
To ponovno kaže, da bi morala imeti Evropska unija, če bi bilo to nujno, učinkovito politiko farmakovigilance, da bi pomirila in zaščitila svoje državljane.
This context further highlights (if it were necessary to do so) the need for the European Union to have an effective pharmacovigilance policy, to reassure and protect its citizens.
Na žalost lahko v zadnjih letih naštejemo kar nekaj primerov zdravil, ki so imela nezanemarljive stranske učinke, čeprav so bila dana na trg po opravljenem standardnem postopku:
We are unfortunately able to point to several cases of medicinal products in recent years which, despite having been placed on the market upon completion of a traditional procedure, have produced substantial side-effects:
– refekoksib (Vioxx®, Ceox®, Ceeoxx®): protivnetno zdravilo, ki ni učinkovitejše od ibuprofena, povzročilo pa je na tisoče smrtnih primerov zaradi srčnega napada; odobreno je bilo leta 1999, leta 2004 pa umaknjeno s trga;
- rofecoxib (Vioxx®, Ceox®, Ceeoxx®): an anti-inflammatory which is no more effective than ibuprofene and which triggered thousands of fatal heart attacks; authorised in 1999 and withdrawn from the market in 2004;
– paroksetin: antidepresiv (Deroxat®, Seroxat®), ki je povečal tveganje za samomor;
- paroxetine: an anti-depressant (Deroxat®, Seroxat®) which increased the risk of suicide;
– rimonabant (Acomplia®): zdravilo proti debelosti, ki je bilo dano v promet kljub pomanjkljivi oceni, z evropskega trga pa umaknjeno leto in pol zatem.
- rimonabant (Acomplia®): an anti-obesity medicine which was put on the market without adequate assessment and withdrawn from the European market a year and a half later.
Več kazenskih postopkov je pokazalo, da se farmacevtske družbe nagibajo k temu, da čim dlje skrivajo informacije o neželenih učinkih svojih zdravil, ki bi lahko slabo vplivale na prodajo.
Several court cases have shown that pharmaceutical companies have a tendency to conceal information about adverse reactions to their medicinal products, which might damage sales, for as long as possible.
V vseh teh primerih smo lahko videli, da sta počasnost postopka odločanja in prikrivanje informacij o neželenih učinkih škodila pacientom.
In each of these cases we were able to see that the length of the decision-making process and the withholding of information about adverse reactions were harmful to patients.
Človeški davek teh stranskih učinkov je nesprejemljiv, finančni stroški pa ogromni, poleg tega jih krije družba kot celota, saj se nanašajo na 5 % hospitalizacij in 5 % smrti v bolnišnici.
The human cost of such side-effects is unacceptable; as for the financial costs, these are massive, and it is society as a whole which bears them, because they account for 5% of hospital admissions and 5% of the causes of hospital deaths.
Od ocene prek nadzora in informacij o zdravilu do tega, da je dano v promet
From assessment, via supervision and information relating to medicinal products, to placing them on the market
Preden se zdravilo lahko trži po pridobitvi dovoljenja promet z zdravilom, je potrebna njegova ocena.
Before medicinal products are granted marketing authorisation they have to be assessed.
Nekaj časa je omejeno na vzorec izbranih pacientov.
This is done over a limited period using a sample of selected patients.
Naloga farmakovigilance je, da nas zatem podrobno seznani z neželenimi učinki, zato da se omeji škoda v populaciji.
Pharmacovigilance's role is subsequently to extend our knowledge of adverse reactions, so as to limit the harm caused to the public.
Pripravljavka mnenja se boji, da bo uredba oslabila sistem farmakovigilance, namesto da bi ga okrepila, in sicer iz naslednjih razlogov:
Your rapporteur fears that the regulation will weaken the pharmacovigilance system, instead of strengthening it, for the reasons given below.
Načrti za obvladovanje tveganja in druge študije po pridobitvi dovoljenja lahko vodijo v manj stroge ocene pred izdajo dovoljenja za promet z zdravilom.
The risk management plans and other post-authorisation studies may be used as a backstop in order to reduce assessment before marketing authorisations are granted.
To bi moralo ostati izjema.
This must remain an exception.
Če bi odpravili obveznosti javnega financiranja, bi obstajala nevarnost, da bi sistem farmakovigilance omejili na funkcijo izvajalca storitev za farmacevtske družbe.
The ending of the requirement for funding to be public threatens to reduce the pharmacovigilance system to the status of service provider to pharmaceutical firms.
Namesto tega pripravljavka mnenja predlaga, da bi okrepili neodvisne nacionalne in regionalne sisteme farmakovigilance.
The rapporteur proposes, instead, to strengthen the independent national and regional pharmacovigilance systems.
Večanje monopola družb nad zbiranjem, analizo in razlago informacij jih spravlja v nevzdržen položaj zaradi konflikta interesov.
Companies' increased control over the collection, analysis and interpretation of the data places them in an untenable situation regarding conflicts of interest.
Družbam mora biti omogočeno sodelovanje pri študijah neželenih učinkov, vendar pod nadzorom javnih organov, nikakor pa ne smejo imeti monopola.
Firms should be able to take part in the study of adverse reactions, but under the control of the authorities, and in no circumstances in a monopoly position.
Organizacija redčenja podatkov, ki so neposredno shranjeni v podatkovno megazbirko Eudravigilance, brez postopka, s katerim bi zagotovili kakovost njene vsebine.
The organisation of dilution of the data, which are stored directly in Eudravigilance, a mega-database, without any procedure to ensure that the quality of the content of Eudravigilance is safeguarded.
Pripravljavka mnenja predlaga, da bi podatke v zbirko Eudravigilance vnašali izključno pristojni organi držav članic na področju farmakovigilance (ne pa neposredno pacienti niti farmacevtska podjetja, ker bi se tako povečala količina nepomembnih vnosov, zaradi česar bi bilo nemogoče pridobiti ustrezne podatke).
Your rapporteur proposes that input to Eudravigilance be restricted to the Member States' relevant pharmacovigilance authorities (no direct input by patients, or by pharmaceutical firms, which might create too much background noise and thus making the relevant data unusable).
Zelo omejen dostop javnosti in neodvisnih strokovnjakov do zbirke Eudravigilance.
The very limited access to the Eudravigilance database for the public and independent experts.
Preglednost podatkov farmakovigilance je nujna za povrnitev zaupanja državljanov v pristojne organe na področju zdravstva.
Transparency with regard to pharmacovigilance data is essential in order to restore public confidence in the health authorities.
Kar nekaj predlogov je zaenkrat še preveč skromnih in bi jih bilo treba okrepiti:
Several proposals are still too cautious and should be strengthened.
Formalna ustanovitev evropskega svetovalnega odbora za oceno tveganja na področju farmakovigilance (PRAAC), ki dejansko ne bi imel večje pristojnosti ali avtonomije, kot jo ima sedaj delovna skupina za farmakovigilanco, ne prinaša bistvene dodane vrednosti.
The formal establishment of a European risk management advisory committee (PRAAC), without any more genuine authority or autonomy than the current Pharmacovigilance Working Party, does not contribute any significant added value.
Nepreglednost podatkov farmakovigilance ostaja pravilo: na primer ni dostopa do posodobljenih poročil o varnosti za paciente z izgovorim, da gre za varovanje poslovne skrivnosti.
Lack of transparency where pharmacovigilance data is concerned remains the rule: for instance, there is no access to PSURs, on the pretext of commercial confidentiality.
Ta in vsa druga poročila o ocenah je treba nemudoma objaviti.
PSURs and all assessment reports should be published immediately.
Če povzamemo:
To conclude:
· treba je okrepiti merila, ki bodo omogočila izdajanje zanesljivejših dovoljenj za promet z zdravilom , iz česar bo razvidno tudi, da bodo morala nova zdravila prinesti dejanski napredek v zdravljenju; pospešitev postopka ne bi smela biti splošno pravilo;
· Strengthen the criteria to enable marketing authorisation to be granted on surer grounds , entailing the requirement for new medicinal products to bring genuine therapeutic advances; no widespread use of the fast-track procedure
· zagotoviti bi bilo treba kakovost podatkov o farmakovigilanci;
· Ensure the quality of pharmacovigilance data
· zagotoviti bi bilo treba sredstva za učinkovito javno farmakovigilanco ;
· Provide the resources to ensure effective public pharmacovigilance
· okrepiti bi bilo treba preglednost.
· Increase transparency
Potrošniki imajo pravico do več informacij o farmakovigilanci ter o razmerju med koristmi in tveganjem, ki so povezani z njihovimi zdravili.
Consumers have the right to have more information regarding pharmacovigilance concerns and about the risk-benefit balance of their medicines.
Namesto tega mora podatkovna zbirka Eudravigilance sočasno obvestiti zadevne države članice o poročilih, ki jih vložijo imetniki dovoljenj za promet.
Instead, the Eudravigilance database should simultaneously notify the relevant Member States of reports submitted by market authorisation holders.
Države članice morajo za zagotavljanje visokokakovostnih informacij podpreti razvoj strokovnega znanja nacionalnih in regionalnih centrov farmakovigilance.
In order to ensure the high quality of information, Member States should support the development of the expertise of national and regional pharmacovigilance centres.
(7) Da se zagotovi razpoložljivost potrebnega strokovnega znanja in izkušenj ter sredstev za ocene farmakovigilance na ravni Skupnosti, je primerno ustanoviti nov znanstveni odbor v okviru Agencije, in sicer Svetovalni odbor za oceno tveganja na področju farmakovigilance.
(7) In order to ensure the availability of the necessary expertise and resources for pharmacovigilance assessments at Community level, it is appropriate to create a new scientific committee within the Agency, the Pharmacovigilance Risk Assessment Advisory Committee.
Odbor morajo sestavljati neodvisni znanstveni strokovnjaki, usposobljeni za področje varnosti zdravil, vključno z odkrivanjem, ocenjevanjem, zmanjševanjem in sporočanjem tveganj, ter za pripravo varnostnih študij po pridobitvi dovoljenja za promet in presojo farmakovigilance.
That committee should be composed of independent scientific experts with competence in the safety of medicines including the detection, assessment, minimisation and communication of risk, and the design of post-authorisation safety studies and pharmacovigilance audit.
Znanstveni strokovnjaki, ki delujejo v odboru, morajo biti neodvisni od imetnikov dovoljenj in Agencije, zlasti ko se izvajajo varnostne študije na zdravilih.
The scientific experts serving on the committee should be independent both in relation to authorisation holders and in relation to the Agency itself, especially when safety studies are being conducted on medicines.
Priporočljivo je zagotoviti popolno neodvisnost strokovnjakov, saj bodo pristojni za odobritev dovoljenj le stežka umaknili s trga zdravila, ki so jih pred tem že odobrili.
It is desirable to ensure that the experts will be completely independent, given that those who grant authorisation will hardly be inclined to withdraw medicines from the market once they have approved them.
(11) Da se zavaruje javno zdravje, mora imeti Agencija zadostna sredstva za financiranje dejavnosti, povezanih s farmakovigilanco.
(11) In order to protect public health, there should be adequate funding of activities related to pharmacovigilance by the Agency.
Predvideti je treba, da se omogočijo zadostna sredstva za financiranje dejavnosti farmakovigilance z zbiranjem pristojbin, ki se zaračunajo imetnikom dovoljenj za promet.
Provision should be made to allow adequate funding for pharmacovigilance activities through the collection of fees charged to marketing authorisation holders.
Da se zagotovi neodvisnost Agencije, mora biti upravljanje zbranih sredstev pod stalnim nadzorom uprave.
The management of those collected funds should be under a permanent control of the Management Board in order to guarantee the independence of the Agency.
(11) Da se zavaruje javno zdravje, mora imeti Agencija zadostna sredstva za financiranje dejavnosti, povezanih s farmakovigilanco.
(11) In order to protect public health, there should be adequate funding of activities relating to pharmacovigilance by the Agency.
(15) Tri leta po umestitvi na trg na novo odobrenega zdravila ali kadar je za zdravilo izdano dovoljenje za promet pod pogojem, da je treba opraviti študijo varnosti po pridobitvi dovoljenja za promet, oziroma pod pogoji ali na podlagi omejitev v zvezi z varno in učinkovito uporabo zdravila, je treba zdravilo intenzivno spremljati na trgu.
(15) For three years following the placing on the market of a newly authorised medicinal product or where a medicinal product is authorised subject to the requirement to conduct a post-authorisation safety study or subject to conditions or restrictions with regard to the safe and effective use of the medicinal product, the medicinal product should be intensively monitored on the market.
Posebna opozorila za vsa na novo odobrena zdravila in zdravila, ki se intenzivno spremljajo, bodo tako zdravstvenim strokovnjakom kot bolnikom v pomoč pri prepoznavanju na novo odobrenih zdravil, ki so na trgu manj kot tri leta, in bodo povečala njihovo ozaveščenost glede poročanja o neželenih učinkih, ki bi se lahko pojavili.
Special warnings for all new authorised products as well as intensively monitored medicines will help both the health professionals and the patients to identify new authorised medicines on the market for a period of less than three years and would increase their awareness of the need to report any adverse reaction that might appear.
(20a) Ta uredba se mora uporabljati brez poseganja v Direktivo 95/46/ES Evropskega parlamenta in Sveta z dne 24. oktobra 1995 o varstvu posameznikov pri obdelavi osebnih podatkov in o prostem pretoku takih podatkov 1 in v Uredbo (ES) št. 45/2001 Evropskega parlamenta in Sveta z dne 18. decembra 2000 o varstvu posameznikov pri obdelavi osebnih podatkov v institucijah in organih Skupnosti in o prostem pretoku takih podatkov 2 .
(20a) This Regulation should apply without prejudice to Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data 1 and Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data 2 .
Da bi odkrili, ocenili, razumeli in preprečili neželene reakcije, prepoznali in sprejeli ukrepe za zmanjšanje tveganj in povečanje koristi zdravil za namene varovanja javnega zdravja, bi bilo treba omogočiti, da se osebni podatki v sistemu Eudravigilance obdelajo v skladu z zakonodajo EU o varstvu podatkov.
In order to detect, assess, understand and prevent adverse reactions, and to identify and take action to reduce risks and increase benefits from medicinal products for the purpose of safeguarding public health, it should be possible to process personal data within the Eudravigilance system while complying with EU data protection legislation.
Predlog zajema zelo občutljive osebne podatke, ki bi morali biti v celoti zaščiteni.
The proposal covers highly sensitive personal information which should be fully protected.
Glej tudi mnenje evropskega nadzornika za varstvo podatkov iz aprila 2009.
See also the opinion of the European Data Protection Supervisor of April 2009.
Člen 5 – odstavek 2 – zadnji stavek
Article 5 – paragraph 2 – last sentence
„Pri izpolnjevanju nalog v zvezi s farmakovigilanco mu pomaga Svetovalni odbor za oceno tveganja na področju farmakovigilance iz člena 56(1)(aa).“
For the fulfilment of its pharmacovigilance tasks, it shall be assisted by the Pharmacovigilance Risk Assessment Advisory Committee referred to in Article 56(1)(aa).
Pri izpolnjevanju nalog v zvezi s farmakovigilanco mu pomaga odbor za farmakovigilanco iz člena 56(1)(aa).
For the fulfilment of its pharmacovigilance tasks, it shall be assisted by the Pharmacovigilance Committee referred to in Article 56(1)(aa).
Spremembo je treba narediti po vsem besedilu.
Horizontal change required throughout the proposal.
S predlogom se ustanovi Evropski svetovalni odbor za oceno tveganja na področju farmakovigilance, ki so mu zaupane pomembne naloge glede farmakovigilance, ima pa le svetovalno vlogo in nobenih pristojnosti.
The proposal establishes a European Pharmacovigilance Risk Assessment Advisory Committee and entrusts it with important pharmacovigilance tasks but with a mere advisory role and no authority.
Njegovo vlogo je treba okrepiti, to pa se mora odražati tudi v njegovem imenu.
The committee's role should be strengthened and that is to be reflected in its title.
Člen 10 a – odstavek 3
Article 10 a – paragraph 3
Kadar Komisija potrdi zahtevo, se dovoljenje za promet spremeni tako, da se zahteva vključi kot pogoj za izdajo dovoljenja za promet, sistem obvladovanja tveganja pa se ustrezno dopolni z novimi podatki.“
Where the Commission confirms the requirement, the marketing authorisation shall be varied to include the requirement as a condition of the marketing authorisation and the risk management system shall be updated accordingly.
Ne glede na to, ali je bila zahteva odobrena ali zavrnjena, mora Komisija natančno obrazložiti odločitev, ki se tudi ustrezno zabeleži.
Irrespective of whether the requirement is confirmed or withdrawn, the Commission shall justify its decision in detail, and the decision shall be duly recorded.
V izjemnih okoliščinah in po posvetu s predlagateljem se dovoljenje za promet lahko izda ob upoštevanju zahteve, da predlagatelj izpolnjuje določene pogoje , zlasti take, ki zadevajo varnost zdravila, obveščanje pristojnih organov o kakršnem koli pripetljaju v zvezi z uporabo zdravila in predvidene ukrepe.
In exceptional circumstances and following consultation with the applicant, the authorisation may be granted subject to a requirement for the applicant to meet certain conditions , in particular concerning the safety of the medicinal product, notification to the competent authorities of any incident relating to its use, and action to be taken.
To dovoljenje za promet se lahko izda samo , kadar lahko predlagatelj dokaže, da ne more predložiti celovitih podatkov o učinkovitosti in varnosti zdravila pod normalnimi pogoji uporabe zaradi objektivnih, preverljivih razlogov, in mora temeljiti na razlogih, določenih v Prilogi I k Direktivi 2001/83/ES.
This authorisation may be granted only when the applicant can show that he is unable to provide comprehensive data on the efficacy and safety of the medicinal product under normal conditions of use, for objective, verifiable reasons and must be based on one of the grounds set out in Annex I to Directive 2001/83/EC.
Podaljšanje dovoljenja za promet je povezano z vsakoletno ponovno oceno teh pogojev.
Continuation of the authorisation shall be linked to the annual reassessment of these conditions.
V izjemnih okoliščinah in po posvetu s predlagateljem se dovoljenje za promet lahko izda ob upoštevanju zahteve, da predlagatelj uvede posebne postopke , zlasti take, ki zadevajo varnost zdravila, obveščanje pristojnih organov o kakršnem koli pripetljaju v zvezi z uporabo zdravila in predvidene ukrepe.
In exceptional circumstances and following consultation with the applicant, the authorisation may be granted subject to a requirement for the applicant to introduce specific procedures , in particular concerning the safety of the medicinal product, notification to the competent authorities of any incident relating to its use, and action to be taken.
To dovoljenje za promet se lahko izda samo zaradi objektivnih, preverljivih razlogov in mora temeljiti na razlogih, določenih v prilogi I Direktive 2001/83/ES.
This authorisation may be granted only for objective, verifiable reasons and must be based on one of the grounds set out in Annex I to Directive 2001/83/EC.
Ubeseditev veljavne zakonodaje zagotavlja strožja merila in boljšo zaščito potrošnikov pred tveganjem prehitre izdaje dovoljenja za promet.
The wording of the existing legislation ensures stricter criteria and better consumer protection against the risk of a premature marketing authorisation.
Agencija sproti dopolnjuje ta seznam.
The Agency shall keep the list up to date.
Zdravila, vključena v seznam zdravil, morajo biti kot taka jasno opredeljena na embalaži, da se bolnikom in zdravstvenim strokovnjakom poleg seznama zagotovi še drug vir informacij.
Medicinal products included on the list must be clearly identified as such on the package in order to provide patients and healthcare professionals with a source of information separate from the list.
Države članice morajo podpreti razvoj strokovnega znanja nacionalnih in regionalnih centrov farmakovigilance.
Member States should support the development of the expertise of national and regional pharmacovigilance centres.
Člen 24 – odstavek 2 – pododstavek 2 a (novo)
Article 24 – paragraph 2 – subparagraph 2 a (new)
Agencija sodeluje z organizacijami zdravstvenih delavcev, bolnikov in potrošnikov, da se določi „ustrezna raven dostopa“.
The Agency shall work together with organisations representing healthcare professionals, patients and consumers to define ‘the appropriate level of access’.
Agencija v sodelovanju z državami članicami razvije standardne spletne oblike , prek katerih lahko zdravstveni delavci in bolniki poročajo o domnevnih neželenih učinkih .
The Agency, in collaboration with the Member States, shall develop standard web-based structured forms for the reporting of suspected adverse reactions by health-care professionals and patients.
Agencija v sodelovanju z državami članicami in zadevnimi interesnimi skupinami razvije standardno vsebino, oblike in postopke , prek katerih lahko zdravstveni delavci in bolniki poročajo o domnevnih neželenih učinkih , in sledljivost bioloških zdravil, ki se predpisujejo, razdeljujejo ali prodajajo v EU .
The Agency, in collaboration with the Member States and relevant stakeholders , shall develop standard content, formats and procedures for the reporting of suspected adverse reactions by health-care professionals and patients and the traceability of biological medicinal products prescribed, dispensed, or sold on EU territory .
Obrazci, namenjeni bolnikom, morajo biti sestavljeni v skladu s tehničnimi merili, da bo njihova struktura jasna, jezik pa preprost in dostopen splošni javnosti.
Forms intended for patients must be designed according to technical criteria conforming to the principles of clear structure and simplified language accessible to the general public.
Dostopni morajo biti na spletu in v lekarnah.
They must be accessible on the internet and in pharmacies.
Obrazci morajo vključevati zahtevane informacije, da lahko lekarne ali neposredno bolniki poročajo oblastem po pošti, faksu ali elektronski poti.
The forms must include the information required to enable reports to be submitted to the authorities by pharmacies or directly by patients, by post, by fax, or electronically.
Predlagani predlog spremembe bi od Agencije zahteval, da razvije uporabniku prijazno standardno vsebino, obliko in postopke, ki jih bodo zdravstveni delavci in bolniki uporabljali pri poročanju o neželenih učinkih.
The proposed amendment would require the Agency to develop user-friendly standard content, format and procedures for use by healthcare professionals and patients in reporting adverse events.