natgillin/translations-raw huggingface dataset:
ki ima škodljive posledice za pacienta
while undergoing medical treatment
Škodljiva posledica pomeni
Harm implies
trajno ali začasno
permanent or temporary
poškodbo telesne strukture ali funkcije in/ali kakršen koli škodljiv učinek, ki je njena posledica.
impairment of structure or function of the body and/or any deleterious effect which arises from that.
Priloga 1 – opredelitve – "Zdravstveni zavod'– stolpec 2
Annex 1 – Definitions − "Healthcare institution" – column 2
Javni, nejavni ali dobrodelni zdravstveni
A public, non-public or charitable healthcare
ali prostovoljci
or volunteers
v zdravstvu zagotavljajo sekundarno ali terciarno oskrbo.
provide secondary or tertiary care.
Priloga 1 – opredelitve – "Varnost pacientov" – stolpec 2
Annex 1 – Definitions – "Patient safety" − column 2
Priloga 1 – opredelitve – "Delavci za povezavo s skupino za obvladovanje okužb" – stolpec 2
Annex 1 – Definitions – "Infection control link staff" − column 2
Zdravstveni delavci, zaposleni v
Health professionals working in
bolnišničnih oddelkih
clinical wards/departments
, ki so zadolženi za povezavo med svojim
who act as a liaison between their
in skupino za preprečevanje in obvladovanje okužb.
and the Infection Prevention and Control Team.
in pošiljajo povratne informacije skupini za preprečevanje in obvladovanje okužb.
and give feedback to the Infection Prevention and Control Team.
ustreznih sektorjih
the corresponding sectors
področjem dela
work sector
Priloga 2 – Poglavje 1 – točka 1 – točka b a (novo)
Annex 2 – Chapter I – point 1 – point b a (new)
Priloga 2 – Poglavje 1 – točka 4 – točka c a (novo)
Annex 2 – Chapter I – point 4 – point c a (new)
(aa) tudi na področju uporabe nanotehnologij in nanomaterialov v medicini.
Encouraging research, for example into medical applications of nanotechnologies and nanomaterials.
Priloga 2 – Poglavje 2 – točka 1 – točka a – alinea 2
Annex 2 – Chapter 2 – point 1 – point a – indent 2
skupaj s potrebnimi kampanjami za cepljenje osebja
, including the necessary staff vaccination campaigns
Zakonodajna resolucija Evropskega parlamenta z dne 23. aprila 2009 o predlogu priporočila Sveta o evropskem ukrepanju na področju redkih bolezni ( KOM(2008)0726 – C6-0455/2008 – 2008/0218(CNS) )
European Parliament legislative resolution of 23 April 2009 on the proposal for a Council recommendation on a European action in the field of rare diseases ( COM(2008)0726 – C6-0455/2008 – 2008/0218(CNS) )
ob upoštevanju predloga Komisije Svetu ( KOM(2008)0726 ),
having regard to the Commission proposal to the Council ( COM(2008)0726 ),
ob upoštevanju drugega pododstavka člena 152(4) Pogodbe ES, v skladu s katerim se je Svet posvetoval s Parlamentom ( C6-0455/2008 ),
having regard to Article 152(4), second subparagraph of the EC Treaty, pursuant to which the Council consulted Parliament ( C6-0455/2008 ),
ob upoštevanju poročila Odbora za okolje, javno zdravje in varnost hrane in mnenja Odbora za industrijo, raziskave in energetiko ( A6-0231/2009 ),
having regard to the report of the Committee on the Environment, Public Health and Food Safety and the opinion of the Committee on Industry, Research and Energy ( A6-0231/2009 ),
Redke bolezni ogrožajo zdravje evropskih državljanov, če so smrtno nevarne ali kronično izčrpavajoče bolezni z nizko stopnjo prevalence in visoko ravnijo zapletenosti.
Rare diseases are a threat to the health of European citizens insofar as they are life-threatening or chronically debilitating diseases with a low prevalence and a high level of complexity.
Redke bolezni ogrožajo zdravje evropskih državljanov, če so smrtno nevarne ali kronično izčrpavajoče bolezni z nizko stopnjo prevalence in visoko ravnijo zapletenosti
Rare diseases are a threat to the health of European citizens insofar as they are life-threatening or chronically debilitating diseases with a low prevalence and a high level of complexity
, ker pa obstaja tako veliko različnih vrst redkih bolezni, je skupno število prizadetih oseb precej veliko
, but since there are so many different types of rare disease, the total number of people affected is quite high
Akcijski program Skupnosti glede redkih bolezni, vključno z genetskimi boleznimi, je bil sprejet za obdobje od 1. januarja 1999 do 31. decembra 2003.
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
, to število pa je treba vrednotiti na statistični podlagi, ki mora biti predmet strokovne presoje
, a number to be judged on a statistical basis subject to a scientific review
Da bi ugotavljali potrebo po morebitnih dopolnitvah, mora strokovni odbor na podlagi statistične incidence natančno razvrščati in redno pregledovati redke bolezni.
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.
Po ocenah danes obstaja med 5 000 in 8 000 različnih redkih bolezni, ki prizadenejo med 6 % in 8 % prebivalstva v času njihovega življenja.
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
In other words,
, klub temu, da je značilnost redkih bolezni nizka prevalenca posamezne izmed njih, je skupno število prizadetih ljudi precej visoko, saj se giblje
although rare diseases are characterised by low prevalence for each one of them, the total number of people affected is quite high, ranging
med 27 in 36 milijoni ljudi v Evropski uniji.
between 27 and 36 million people in the European Union.
ter visokega končnega števila primerov
and the high total number of cases
zahtevajo globalen pristop, ki temelji na prizadevanjih na posameznih področjih ter skupnih prizadevanjih
, rare diseases call for a global approach based on special and combined efforts
, vključno s partnerstvi s tretjimi državami, kot so ZDA,
, including in partnership with third countries such as the United States,
za preprečitev znatne obolevnosti ali prezgodnje umrljivosti, ki se ji je mogoče izogniti, in za izboljšanje kakovosti življenja ter socialno-ekonomskih možnosti prizadetih oseb
to prevent significant morbidity or avoidable premature mortality, and to improve quality of life and socio-economic potential of affected persons
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.
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.
Za izboljšanje usklajevanja in povezovanja nacionalnih, regionalnih in lokalnih pobud
In order to improve the coordination and coherence of national, regional and local initiatives
ter sodelovanja med izobraževalnimi centri
and cooperation between research centres
, ki se nanašajo na redke bolezni, je treba vse ustrezne nacionalne ukrepe na področju redkih bolezni vključiti v nacionalne načrte za redke bolezni.
addressing rare diseases, all relevant national actions in the field of rare diseases should be integrated into national plans for rare diseases.
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.
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
Gathering expertise at European level is therefore paramount to ensure equal access
točne informacije, ustrezne in pravočasne diagnoze in
to accurate information, appropriate and timely diagnosis and
visokokakovostne oskrbe bolnikom z redko boleznijo.
to high quality care to rare disease patients.
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.
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.
Zato morajo biti bolniki in njihovi predstavniki vključeni na vsaki stopnji postopka oblikovanja politike in odločanja.
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
, kot tudi na ravni Evropske unije prek vseevropskih mrež pomoči bolnikom s posebnimi redkimi boleznimi
, but also at EU level in terms of pan-EU patient support networks for specific rare diseases
kot tudi rehabilitacijo in navajanjem na življenje z boleznijo,
, as well as rehabilitation and habilitation for those living with the disease
po njihovem celotnem ozemlju, po načelu enakosti in solidarnosti po vsej EU in zlasti, da:
throughout their national territory on the basis of equity and solidarity throughout the EU, and in particular:
(1) do konca leta
(1) elaborate and adopt a comprehensive and integrated strategy, by the end of
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;
, 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,
(3) define a limited number of priority actions within the national plan for rare diseases, with concrete objectives, clear deadlines
obsežnim in jasno določenim financiranjem,
, substantial and clearly designated funding
strukturami za upravljanje in rednim poročanjem;
, management structures and regular reports;
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
(5) include in the national plans provisions designed to ensure equitable access to high quality care, including diagnostics, treatments and orphan drugs,
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;
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,
(5) include in the national plans provisions designed to ensure equitable access to high quality care, including diagnostics,
primarnimi preventivnimi ukrepi,
primary preventive measures,
zdravljenjem in zdravili sirotami
treatments and orphan drugs,
kot tudi rehabilitacijo in navajanje na življenje z boleznijo v korist vseh bolnikov
as well as rehabilitation and habilitation for those living with the disease for the benefit of
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
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
, 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
following the principles agreed in the High Level Pharmaceutical Forum paper entitled "Improving access to orphan medicines for all affected EU citizens"
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:
(5a) encourage efforts to avoid rare diseases which are hereditary, through:
(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.
Priporočilo državam članicam – odstavek 1 – točka 5 c (novo)
Recommendations to Member States – paragraph 1 – point 5 c (new)
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-informed and that the decisions taken at national level reflect the views and needs of society.
Priporočilo državam članicam – odstavek 1 – točka 5 d (novo)
Recommendations to Member States – paragraph 1 – point 5 d (new)
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 funding 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 možnih 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 possible new therapies to be added.
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
, kot število, ki velja za celotno Evropsko unijo, pri čemer je zelo pomembno poznati natančno razširjenost bolezni za vsako državo članico posebej
, 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
podpirajo posebne informacijske mreže, registre in zbirke podatkov o boleznih
national or regional level specific disease information networks, registries and databases
, ki vključujejo sproti posodobljene informacije, ki so za javnost dostopne na internetu
, 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
(3) spodbujajo udeležbo nacionalnih raziskovalcev in laboratorijev pri raziskovalnih projektih za redke bolezni, ki so financirani na ravni Skupnosti
(3) foster participation of national researchers and laboratories in research projects on rare diseases funded at Community level
, ter izkoristijo možnosti, ki jih nudi Uredba (ES) št. 141/2000 o zdravilih sirotah
and make use of the possibilities offered by Regulation (EC) No 141/2000 on orphan medicinal products
Priporočilo državam članicam – odstavek 3 – točka 4
Recommendations to Member States – paragraph 3 – point 4
(4) v nacionalne načrte za redke bolezni vključijo določbe, katerih cilj je spodbujanje raziskav, vključno z raziskavami v okviru javnega zdravja, in socialnimi raziskavami na področju redkih bolezni, zlasti z namenom, da se oblikujejo orodja, kot so transverzalne infrastrukture, ter projekti, ki so specifični za posamezne bolezni
(4) include in the national plan for rare diseases provisions aimed at fostering research, including public health and social research, in the field of rare diseases, especially with a view to the development of tools such as transversal infrastructures as well as disease-specific projects,
, programi za rehabilitacijo ter programi za navajanje na življenje z redko boleznijo, kot tudi raziskave o diagnostičnih testih in orodjih
and rehabilitation and habilitation programmes for the duration of a rare disease as well as research on diagnostic tests and tools
Priporočilo državam članicam – odstavek 3 – točka 4 a (novo)
Recommendations to Member States – paragraph 3 – point 4 a (new)
(4a) zagotovijo ustrezen mehanizem dolgoročnega financiranja, na primer prek javno-zasebnih partnerstev, za podpiranje raziskav na nacionalni in evropski ravni, da se zagotovi njihova trajnost;
(4a) provide adequate and long-term funding, for example through public-private partnerships, so as to support research efforts at national and European level and guarantee the sustainability thereof.
Priporočilo državam članicam – odstavek 4 – točka 1
Recommendations to Member States - Paragraph 4 – point 1
(1) do konca leta 2011 določijo nacionalne in regionalne strokovne centre po vsem nacionalnem ozemlju in tam, kjer strokovnih centrov ni, spodbujajo njihovo ustanovitev z vključitvijo določb o ustanovitvi nacionalnih in regionalnih strokovnih centrov v nacionalni načrt za redke bolezni;
(1) identify national or regional centres of expertise throughout their national territory by the end of 2011, and foster the creation of centres of expertise where they do not exist notably by including in their national plan for rare diseases provisions on the creation of national or regional centres of expertise;
pomagajo sestaviti kataloge redkih bolezni in strokovnjakov za redke bolezni;
help compile catalogues of rare diseases and rare diseases experts;
z redkimi boleznimi
suffering from rare diseases
z vzpostavitvijo sodelovanja z ustreznimi strokovnjaki v državi ali po potrebi iz tujine; kadar je to potrebno za zagotovitev univerzalnega dostopa do posebne zdravstvene oskrbe, podpirajo čezmejno zdravstveno varstvo, vključno z mobilnostjo bolnikov
through the establishment of cooperation with relevant experts within the country or from abroad when necessary; cross-border healthcare, including mobility of patients
in strokovnega znanja prek prenosa podatkov
and expertise through data-mobility support
, zdravstvenih delavcev in izvajalcev storitev ter zagotavljanje storitev prek informacijskih in komunikacijskih tehnologij;
, health professionals and providers and provision of services through information and communication technologies should be supported where it is necessary to ensure universal access to the specific healthcare needed;
Priporočilo državam članicam – odstavek 4 – točka 5
Recommendations to Member States – paragraph 4 – point 5
(5) zagotovijo, da nacionalni in regionalni strokovni centri upoštevajo standarde, ki so jih opredelile evropske referenčne mreže za redke bolezni, ter pri tem upoštevajo potrebe in pričakovanja bolnikov in strokovnjakov
(5) ensure that national or regional centres of expertise adhere to the standards defined by the European reference networks for rare diseases taking into due account the needs and expectations of patients and professionals
ter bolnike vključijo dejavnosti teh centrov
, by involving patients in the activities of these centres
Priporočilo državam članicam – odstavek 4 – točka 5 a (novo)
Recommendations to Member States - paragraph 4 – point 5 a (new)
(5a) spodbujajo strokovne centre in specializirane bolnišnice, da, če je mogoče s pomočjo financiranja ali sofinanciranja Evropske unije, uvedejo posebno usposabljanje strokovnih delavcev za nekatere redke bolezni in jim omogočijo pridobitev ustreznega strokovnega znanja in izkušenj.
(5a) encourage, possibly with European Union funding or co-funding, centres and hospitals of expertise to create specific training for professionals in certain rare diseases and allow them to acquire relevant expertise.
Priporočilo državam članicam – odstavek 5 – točka 1 – podtočka b
Recommendations to Member States – paragraph 5 – point 1 –point b
, vključno z genetskimi testi, kot je presejalni test heterozigotnosti in diagnoza z biopsijo polarnega telesa, ki zagotavljajo poskuse na visoki kakovostni ravni in ustrezno genetsko svetovanje, ob upoštevanju različnih etičnih stališč držav članic
, including genetic tests like heterozygote testing and polar body diagnosis, ensuring high- quality testing and appropriate genetic counselling while respecting ethical diversity in the Member States
Priporočilo državam članicam – odstavek 5 – točka 1 – podtočka c
Recommendations to Member States – paragraph 5 – point 1 – point c
, da skrajšajo roki dostopa do zdravil sirot za bolnike z redkimi boleznimi;
added value of orphan drugs at EU level, in order to minimise delays for access to orphan drugs for rare disease patients;
o oceni klinične dodane vrednosti zdravil sirot na ravni EU
added value of orphan drugs at EU level
v okviru Evropske agencije za zdravila (EMEA), ki združuje evropsko znanje na tem področju
within the European Medicines Agency (EMEA) where the relevant European knowledge and expertise is gathered
, da se skrajšajo roki dostopa do zdravil sirot za bolnike z redkimi boleznimi;
, in order to minimise delays for access to orphan drugs for rare disease patients;
Priporočilo državam članicam – odstavek 5 – točka 1 – podtočka c a (novo)
Recommendations to Member States – paragraph 5 – point 1 –point c a (new)
(ca) strukturne podpore za naložbe v zbirko podatkov Orphanet, da bi se zagotovil lahek dostop do informacij o redkih boleznih;
(ca) structural support for investment in the Orphanet database to ensure ease of access to information concerning rare diseases.
Priporočilo državam članicam – odstavek 6
Recommendations to Member States – paragraph 6
Povečanje odgovornosti
Empowerment of
organizacij bolnikov
patient organisations
(1) sprejmejo ukrepe za zagotovitev ustreznih posvetovanj z bolniki in predstavniki bolnikov na vseh stopnjah oblikovanja politike in odločanja na področju redkih bolezni, vključno z vzpostavitvijo in upravljanjem strokovnih centrov in evropskih referenčnih mrež ter oblikovanjem nacionalnih načrtov;
(1) take action to ensure that patients and patients" representatives are duly consulted at all steps of the policy and decision-making processes in the field of rare diseases, including for the establishment and management of centres of expertise and of European reference networks and for the elaboration of national plans;
(1) sprejmejo ukrepe za zagotovitev ustreznih posvetovanj z bolniki in
(1) take action to ensure that patients and