natgillin/translations-raw huggingface dataset:
(2) Akcijski program Skupnosti glede redkih bolezni, vključno z genetskimi boleznimi, je bil sprejet za obdobje od 1. januarja 1999 do 31. decembra 2003.
(2) A Community Action Programme on Rare Diseases, including genetic diseases, was adopted for the period 1 January 1999 to 31 December 2003.
Glede na opredelitev prevalence v tem programu so redke bolezni opredeljene kot bolezni, ki ne prizadenejo več kot 5 na 10 000 oseb v Evropski uniji.
This programme defined the prevalence for a rare disease as affecting no more than 5 per 10 000 persons in the European Union.
Glede na opredelitev prevalence v tem programu so redke bolezni opredeljene kot bolezni, ki ne prizadenejo več kot 5 na 10 000 oseb v Evropski uniji , to število pa je treba vrednotiti na statistični podlagi, ki mora biti predmet strokovne presoje .
This programme defined the prevalence for a rare disease as affecting no more than 5 per 10 000 persons in the European Union , a number to be judged on a statistical basis subject to a scientific review .
Da bi se izognili dilemam, ki nastanejo pri boleznih z incidenco 5,1 ali 5,2 na 10 000 oseb, je potrebna večja prožnost.
More flexibility is required to avoid dilemmas arising from diseases with incidence 5,1 or 5,2 etc. per 10 000 persons.
(2a) Da bi ugotavljali potrebo po morebitnih dopolnitvah, mora strokovni odbor na podlagi statistične incidence natančno razvrščati in redno pregledovati redke bolezni.
(2a) Based on this statistical incidence, rare diseases should be meticulously catalogued and reviewed regularly by a scientific committee to determine the need for possible additions.
Nujno je treba sestaviti katalog redkih bolezni v Evropski uniji.
It is an absolute necessity to compile the catalogue of rare diseases in the European Union.
(4) Po ocenah danes obstaja med 5 000 in 8 000 različnih redkih bolezni, ki prizadenejo med 6 % in 8 % prebivalstva v času njihovega življenja.
(4) It is estimated that between 5 000 and 8 000 distinct rare diseases exist today, affecting between 6% and 8% of the population in the course of their lives.
Z drugimi besedami to pomeni med 27 in 36 milijoni ljudi v Evropski uniji.
In other words, between 27 and 36 million people in the European Union.
Večina trpi za bolj redko pojavljajočimi se boleznimi, ki prizadenejo 1 na 100 000 oseb ali manj.
Most of them suffer from less frequently-occurring diseases affecting one in 100 000 people or less.
Z drugimi besedami , klub temu, da je značilnost redkih bolezni nizka prevalenca posamezne izmed njih, je skupno število prizadetih ljudi precej visoko, saj se giblje med 27 in 36 milijoni ljudi v Evropski uniji.
In other words, although rare diseases are characteri s ed by low prevalence for each one of them, the total number of people affected is quite high, ranging between 27 and 36 million people in the European Union.
(5) Redke bolezni zaradi svoje nizke prevalence in specifičnosti zahtevajo globalen pristop, ki temelji na prizadevanjih na posameznih področjih ter skupnih prizadevanjih za preprečitev znatne obolevnosti ali prezgodnje umrljivosti, ki se ji je mogoče izogniti, in za izboljšanje kakovosti življenja ter socialno-ekonomskih možnosti prizadetih oseb.
(5) Because of their low prevalence and their specificity, rare diseases call for a global approach based on special and combined efforts to prevent significant morbidity or avoidable premature mortality, and to improve quality of life and socio-economic potential of affected persons.
(5) Redke bolezni zaradi svoje nizke prevalence in specifičnosti ter visokega končnega števila primerov zahtevajo globalen pristop, ki temelji na prizadevanjih na posameznih področjih ter skupnih prizadevanjih, vključno s partnerstvi s tretjimi državami, kot so ZDA, za preprečitev znatne obolevnosti ali prezgodnje umrljivosti, ki se ji je mogoče izogniti, in za izboljšanje kakovosti življenja ter socialno-ekonomskih možnosti prizadetih oseb v razvitih državah in državah v razvoju .
(5) Because of their low prevalence , their specificity and the high total number of cases , rare diseases call for a global approach based on special and combined efforts , including in partnership with third countries such as the United States, to prevent significant morbidity or avoidable premature mortality, and to improve quality of life and socio-economic potential of affected persons in developed and developing countries.
Specifičnost redkih bolezni, kot so omejeno število bolnikov in pomanjkanje ustreznega strokovnega znanja in izkušenj, pomeni, da sodelovanje z državami zunaj EU lahko prinaša koristi ne le EU, temveč tudi izmenjavi izkušenj z revnejšimi državami in državami v razvoju.
The specificities of rare diseases - limited number of patients and scarcity of relevant knowledge and expertise - means that cooperation with countries outside the EU can bring benefits, not just to the EU but also in knowledge sharing with poorer and developing countries.
(8) Za izboljšanje usklajevanja in povezovanja nacionalnih, regionalnih in lokalnih pobud, ki se nanašajo na redke bolezni, je treba vse ustrezne nacionalne ukrepe na področju redkih bolezni vključiti v nacionalne načrte za redke bolezni.
(8) In order to improve the coordination and coherence of national, regional and local initiatives addressing rare diseases, all relevant national actions in the field of rare diseases should be integrated into national plans for rare diseases.
(8) Za izboljšanje usklajevanja in povezovanja nacionalnih, regionalnih in lokalnih pobud ter sodelovanja med izobraževalnimi centri , ki se nanašajo na redke bolezni, je treba vse ustrezne nacionalne ukrepe na področju redkih bolezni vključiti v nacionalne načrte za redke bolezni.
(8) In order to improve the coordination and coherence of national, regional and local initiatives and cooperation between research centres addressing rare diseases, all relevant national actions in the field of rare diseases should be integrated into national plans for rare diseases.
(13) Dodana vrednost Skupnosti evropskih referenčnih mrež je še posebej visoka za redke bolezni zaradi redkosti pojavljanja takšnih stanj, kar pomeni omejeno število bolnikov in pomanjkanje strokovnega znanja in izkušenj v posamezni državi.
(13) The Community added-value of European reference networks is particularly high for rare diseases by reason of the rarity of these conditions, which implies both limited number of patients and scarcity of expertise within a single country.
Zbiranje strokovnega znanja in izkušenj na evropski ravni je zato izjemnega pomena za zagotavljanje enakega dostopa do visokokakovostne oskrbe bolnikom z redko boleznijo.
Gathering expertise at European level is therefore paramount to ensure equal access to high quality care to rare disease patients.
Zbiranje strokovnega znanja in izkušenj na evropski ravni je zato izjemnega pomena za zagotavljanje enakega dostopa do točne informacije, ustrezne in pravočasne diagnoze in visokokakovostne oskrbe bolnikom z redko boleznijo.
Gathering expertise at European level is therefore paramount to ensure equal access to accurate information, appropriate and timely diagnosis and to high quality care to rare disease patients.
(14a) Farmacevtski forum je 12. oktobra 2008 sprejel končno poročilo, v katerem predlaga smernice, da bi lahko države članice, zainteresirane strani in Komisija okrepile svoja prizadevanja za zagotovitev lažjega in hitrejšega dostopa do zdravil sirot v Evropski uniji.
(14a) On 12 October 2008 the Pharmaceutical Forum adopted its final report, which proposes guidelines to enable Member States, stakeholders and the Commission to step up their efforts to guarantee easier and swifter access to orphan medicinal products within the European Union.
Države članice so se ob upoštevanju sklepov farmacevtskega foruma politično zavzele, da bodo odpravile težave pri dostopanju do zdravil sirot prek postopka odobritve Skupnosti.
Following the conclusions of the Pharmaceutical Forum, the Member States have given a political undertaking to eliminate bottlenecks in respect of access to orphan medicinal products via the Community approval procedure.
V predlogu priporočila morajo biti konkretno opredeljene smernice iz končnega poročila farmacevtskega foruma.
The guidelines set out in the Pharmaceutical Forum's final report need to be given specific mention in the proposal for a recommendation.
(20) Zato morajo biti bolniki in njihovi predstavniki vključeni na vsaki stopnji postopka oblikovanja politike in odločanja.
(20) Patients and patients’ representatives should therefore be involved at all steps of the policy and decision-making processes.
Njihove dejavnosti je treba aktivno spodbujati in podpirati, tudi finančno, v vsaki državi članici.
Their activities should be actively promoted and supported, including financially, in each Member State.
Njihove dejavnosti je treba aktivno spodbujati in podpirati, tudi finančno, v vsaki državi članici , kot tudi na ravni Evropske unije prek vseevropskih mrež pomoči bolnikom s posebnimi redkimi boleznimi .
Their activities should be actively promoted and supported, including financially, in each Member State , but also at EU level in terms of pan-EU patient support networks for specific rare diseases .
Ker so te bolezni redke, mnogo organizacij bolnikov delujejo v vseevropskih mrežah za komuniciranje in vzajemno podporo v EU 27.
Because of the rarity of these diseases, many patient organisations are working in pan-European networks to communicate and support each other across the EU 27.
Priporočilo državam članicam – odstavek 1 – uvodni del
Recommendations to Member States – Paragraph 1 – introductory part
1. vzpostavijo nacionalne načrte za redke bolezni, da bolnikom z redkimi boleznimi zagotovijo univerzalen dostop do visokokakovostne oskrbe, vključno z diagnostiko, zdravljenjem in zdravili sirotami po njihovem celotnem ozemlju, po načelu enakosti in solidarnosti po vsej EU in zlasti, da:
Establish national plans for rare diseases in order to ensure to patients with rare diseases universal access to high quality care, including diagnostics, treatments and orphan drugs throughout their national territory on the basis of equity and solidarity throughout the EU, and in particular:
Treba je poudariti, da se mora mnogo bolnikov z redkimi boleznimi naučiti živeti mnogo let s svojo boeznijo.
It is important to note that many sufferers of rare diseases will be forced to live with their ailment for many years.
Zato morajo biti dejavnosti in raziskave na področju redkih bolezni usmerjene tudi v vključevanje bolnikov z redkimi boleznimi v družbo v skladu s členom 25 konvencije Združenih narodov o ljudeh s posebnimi potrebami.
For this reason, research and other activities in this area should also seek to ensure the social integration of those suffering from rare diseases in accordance with Article 26 of the UN Convention on the Rights of Persons with Disabilities.
Priporočilo državam članicam – odstavek 1 – točka 1
Recommendations to Member States – paragraph 1 – point 1
(1) do konca leta 2011 oblikujejo in sprejmejo celovito strategijo, katere cilj je usmerjanje in oblikovanje vseh ustreznih ukrepov na področju redkih bolezni v obliki nacionalnega načrta za redke bolezni;
(1) elaborate and adopt a comprehensive and integrated strategy, by the end of 2011 , aimed at guiding and structuring all relevant actions in the field of rare diseases in the form of a national plan for rare diseases;
(1) do konca leta 2010 oblikujejo in sprejmejo celovito strategijo, katere cilj je usmerjanje in oblikovanje vseh ustreznih ukrepov na področju redkih bolezni v obliki nacionalnega načrta za redke bolezni;
(1) elaborate and adopt a comprehensive and integrated strategy, by the end of 2010 , aimed at guiding and structuring all relevant actions in the field of rare diseases in the form of a national plan for rare diseases;
Pomembno je, da države članice do konca leta 2010 oblikujejo in sprejmejo celovito strategijo, katere cilj je usmerjanje in oblikovanje vseh ustreznih ukrepov na področju redkih bolezni v obliki nacionalnega načrta za redke bolezni.
It is important for Member States to elaborate and adopt by the end of 2010 a comprehensive and integrated strategy aimed at guiding and structuring all relevant actions in the field of rare diseases in the form of a national plan for rare diseases;
Priporočilo državam članicam – odstavek 1 – točka 3
Recommendations to Member States – Paragraph 1 – point 3
(3) v okviru nacionalnega načrta za redke bolezni določijo omejeno število prednostnih ukrepov s konkretnimi cilji, jasno določenimi roki, strukturami za upravljanje in rednim poročanjem;
(3) define a limited number of priority actions within the national plan for rare diseases, with concrete objectives, clear deadlines, management structures and regular reports;
(3) v okviru nacionalnega načrta za redke bolezni določijo omejeno število prednostnih ukrepov s konkretnimi cilji, jasno določenimi roki, obsežnim in jasno določenim financiranjem, strukturami za upravljanje in rednim poročanjem;
(3) define a limited number of priority actions within the national plan for rare diseases, with concrete objectives, clear deadlines , substantial and clearly designated funding , management structures and regular reports;
Odstavek 1 – točka 3 a (novo)
Paragraph 1 – point 3 a (new)
(3a) izjavijo, ali imajo specializirane centre, in sestavijo katalog strokovnjakov;
(3a) Declare whether they have any speciali s ed centres and compile a catalogue of experts;
Priporočilo državam članicam – odstavek 1 – točka 5
Recommendations to Member States – Paragraph 1 – point 5
(5) v nacionalne načrte vključijo določbe, oblikovane za zagotavljanje enakega dostopa do visokokakovostne oskrbe, vključno z diagnostiko, zdravljenjem in zdravili sirotami , za vse bolnike z redkimi boleznimi po vsem ozemlju njihove države, da bi tako končno na podlagi pravičnosti in solidarnosti dosegli pravičen dostop do kakovostne oskrbe po vsej Evropski uniji;
(5) include in the national plans provisions designed to ensure equitable access to high quality care, including diagnostics, treatments and orphan drugs, to all rare disease patients throughout their national territory with a view to ensuring equitable access to quality care on the basis of equity and solidarity throughout the European Union.
(5) v nacionalne načrte vključijo določbe, oblikovane za zagotavljanje enakega dostopa do visokokakovostne oskrbe, vključno z diagnostiko, primarnimi preventivnimi ukrepi, zdravljenjem in zdravili sirotami ter rehabilitacijo in navajanje na življenje z boleznijo v korist vseh bolnikov z redkimi boleznimi po vsem ozemlju njihove države, da bi tako na podlagi pravičnosti in solidarnosti dosegli pravičen dostop do kakovostne oskrbe po vsej Evropski uniji , v skladu z načeli iz dokumenta z naslovom „Izboljšanje dostopa do zdravil sirot za vse obolele državljane EU“, ki ga je sprejel farmacevtski forum na visoki ravni .
(5) include in the national plans provisions designed to ensure equitable access to high quality care, including diagnostics, primary preventive measures, treatments and orphan drugs, together with rehabilitation and habilitation for those living with the disease for the benefit of all rare disease patients throughout their national territory with a view to ensuring equitable access to quality care on the basis of equity and solidarity throughout the European Union following the principles agreed in the High Level Pharmaceutical Forum paper entitled "Improving a ccess to o rphan m edicines for all a ffected EU citizens" .
Treba je poudariti, da se mora mnogo bolnikov z redkimi boleznimi naučiti živeti mnogo let s svojo boleznijo.
It is important to note that many sufferers of rare diseases will be forced to live with their ailment for many years.
Zato morajo biti dejavnosti in raziskave na področju redkih bolezni usmerjene tudi v vključevanje bolnikov z redkimi boleznimi v družbo, v skladu s členom 25 konvencije Združenih narodov o ljudeh s posebnimi potrebami.
For this reason, research and other activities in this area should also seek to ensure the social integration of those suffering from rare diseases in accordance with Article 26 of the UN Convention on the Rights of Persons with Disabilities.
Priporočilo državam članicam – odstavek 1 – točka 5 a (novo)
Recommendations to Member States – Paragraph 1 – point 5 a (new)
(5a) spodbujajo prizadevanja za preprečevanje dednih redkih bolezni, kar bo na koncu privedlo do njihovega izkoreninjenja
(5a) encourage efforts to avoid rare diseases which are hereditary, and which will lead finally to the eradication of those rare diseases, through:
(a) z genetskim svetovanjem staršem, ki so prenašalci bolezni; in
(a) genetic counselling of carrier parents; and
(b) z izborom zdravih zarodkov pred vsaditvijo – po potrebi, če ni v nasprotju z obstoječo nacionalno zakonodajo in vedno na prostovoljni podlagi.
(b) where appropriate and not contrary to existing national laws and always on a voluntary basis, through pre-implantation selection of healthy embryos.
Priporočilo državam članicam – odstavek 1 – točka 5 b (novo)
Recommendations to Member States – paragraph 1 – point 5 b (new)
(5b) v nacionalnih načrtih o dajanju na voljo medicinskih proizvodov brez dovoljenja za trženje zagotovijo izjemne ukrepe, po katerih se bolnikom z redkimi boleznimi omogoči dostop do teh zdravil, ko obstaja realna javna potreba po tem, in če v državi članici ni drugih možnosti ustreznega in razpoložljivega zdravljenja, ocena iz poročila o koristih/tveganjih pa je predvidoma pozitivna.
(5b) provide for exceptional measures within the national plans in relation to making available medicinal products which have no marketing authorisation, when there is a real public health need ;and, in the absence of appropriate and available therapeutic alternatives in a Member State, and when the risk/benefit balance is presumed to be positive, ensure that patients affected by rare diseases have access to the medicinal products in question.
V nacionalnih načrtih je treba predvideti tudi možnost za zagotovitev in povračilo stroškov začasnega dostopa do zdravljenj ali zdravil, ki so v postopku pridobitve dovoljenja za trženje ali tega dovoljenja niso prejela, v zelo posebnih primerih, ko bi lahko koristila bolnikom z redkimi boleznimi.
The national plans also need to provide for the possibility of providing and reimbursing temporary access to treatments or medicinal products which are in the process of securing marketing authorisation, or which do not have such authorisation, in extremely specific cases where the use of these products could be beneficial to patients suffering from a rare disease.
To omogoča postopek za odobritev začasne uporabe.
This possibility exists via the compassionate use ('Autorisation Temporaire d'Utilisation' - ATU) procedure.
Priporočilo državam članicam – odstavek 1 – točka 5 c (novo)
Recommendations to Member States – Paragraph 1 – point 5 c (new)
(5c) ustanovijo večstranske svetovalne skupine na nacionalni ravni, v katere bodo vključene vse zainteresirane strani in ki bodo vodile vlade pri zasnovi in izvajanju nacionalnih akcijskih načrtov za redke bolezni.
(5c) establish at the national level multi- stakeholder advisory groups comprising all interested stakeholders to guide governments in the setting up and implementation of national action plans for rare diseases.
Zagotoviti morajo, da so vlade dobro informirane in da sklepi, sprejeti na nacionalni ravni, odražajo mnenje in potrebe družbe.
These should ensure that governments are well- info rmed and that the decisions taken at national level reflect the views and needs of society.
Da bi se čim bolj zmanjšalo tveganje izgube strokovnosti pri posebnih vprašanjih zaradi sprememb v vladi in upravi, je treba ustanoviti stalne odbore, v katerih bodo zastopane vse zainteresirane in strokovne strani, kot so zdravniki, plačniki, znanstveniki in industrija.
In order to minimise the risk of loosing expertise on such a matter of specific nature due to changes in government and administration, there should be standing committees comprising all interested and experienced parties i.e. patients , treating physicians, payers, academia and industry.
Vsi ti udeleženci bi morali usmerjati akterje, ki sprejemajo politične odločitve in oblikujejo politiko vzpostavljanja in izvajanja nacionalnih akcijskih načrtov.
These parties should offer guidance for the political decision takers and policy makers in the set up and implementation of national action plans.
Priporočilo državam članicam – odstavek 1 – točka 5 d (novo)
Recommendations to Member States – Paragraph 1 – point 5 d (new)
(5d) spodbujajo nacionalno financiranje zdravljenja redkih bolezni.
(5d) encourage treatments for rare diseases to be funded at national level.
Če država članica ne želi ali ne more ustanoviti centrov odličnosti, je treba uporabiti ta nacionalni sklad za zagotavljanje pacientom, da lahko potujejo v tak center v drugi državi.
Where Member States may not wish or may not be able to have Centres of Excellence, this central national fund should be used to ensure that patients can travel to a Centre in another country.
Vendar je tudi bistveno, da se ta proračun letno pregleduje in prilagaja na osnovi znanj o pacientih, ki potrebujejo zdravljenje v tem letu, in o morebitnih zdravljenjih, ki jih je treba dodati.
However, it is also vital that this separate budget is annually reviewed and adapted on the basis of the knowledge about patients needing treatment in that given year, and about eventual new therapies to be added.
To je treba narediti ob udeležbi večstranskih svetovalnih odborov.
This should be done with the input of the multi-stakeholder advisory committees.
Bolnice in zdravstvene centre bi treba spodbujati, da postavljajo diagnoze in začnejo z zdravljenjem bolnikov z redkimi boleznimi.
Treating centres or hospitals should be encouraged in diagnosing and treating patients with rare disease .
Če morajo računati le na svoja sredstva za kritje stroškov, mogoče ne bodo mogli nositi tega finančnega bremena.
If they have to pay from their own budgets, they might not be able to bare the financial burden.
Da bi se bolnikom omogočil dostop do ustreznega zdravljenja je treba zagotoviti financiranje na nacionalni ravni.
Funding at national level can give the opportunity to the patients to have access to the appropriate medical care.
Priporočilo državam članicam – odstavek 2 – točka 1
Recommendations to Member States – Paragraph 2 – point 1
(1) v Evropski uniji uporabljajo skupno opredelitev redkih bolezni kot bolezni, ki prizadenejo največ 5 na 10 000 oseb;
(1) implement a European Union common definition of rare diseases as those diseases affecting no more than 5 per 10 000 persons;
(1) v Evropski uniji uporabljajo skupno opredelitev redkih bolezni kot bolezni, ki prizadenejo največ 5 na 10 000 oseb , kot število, ki velja za celotno Evropsko unijo, pri čemer je zelo pomembno poznati natančno razširjenost bolezni za vsako državo članico posebej ;
(1) implement a European Union common definition of rare diseases as those diseases affecting no more than 5 per 10 000 persons , as a number for the whole European Union, but it is very important to know the exact distribution for each Member State ;
Priporočilo državam članicam – odstavek 2 – točka 4
Recommendations to Member States – Paragraph 2 – point 4
(4) na nacionalni in regionalni ravni podpirajo posebne informacijske mreže, registre in zbirke podatkov o boleznih.
(4) support at national or regional level specific disease information networks, registries and databases.
(4) na evropski, nacionalni in regionalni ravni zlasti finančno podpirajo posebne informacijske mreže, registre in zbirke podatkov o boleznih , ki vključujejo sproti posodobljene informacije, ki so za javnost dostopne na internetu .
(4) support , in particular by financial means, at European , national or regional level specific disease information networks, registries and databases , including regularly-updated information, which is accessible to the public, on the internet .
Priporočilo državam članicam – odstavek 3 – točka 3
Recommendations to Member States – Paragraph 3 – point 3