natgillin/translations-raw huggingface dataset:
(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;
(3) spodbujajo udeležbo nacionalnih raziskovalcev in laboratorijev pri raziskovalnih projektih za redke bolezni, ki so financirani na ravni Skupnosti , ter izkoristijo možnosti, ki jih nudi Uredba (ES) št. 141/2000 o zdravilih sirotah ;
(3) foster participation of national researchers and laboratories in research projects on rare diseases funded at Community level and make use of the possibilities offered by Regulation (EC) No 141/2000 on orphan medicinal products ;
Priporočilo državam članicam – odstavek 3 – točka 3 a (novo)
Recommendations to Member States – paragraph 3 – point 3 a (new)
(3a) spodbujajo izmenjavo znanja ter sodelovanje med raziskovalci, laboratoriji in raziskovalnimi projekti v Evropski uniji ter podobnimi ustanovami v tretjih državah, da bodo imele poleg EU splošne koristi tudi revnejše države in države v razvoju, ki so v slabšem položaju glede zagotavljanja sredstev za raziskave redkih bolezni;
(3a) foster knowledge-sharing and cooperation between researchers, laboratories and research projects in the European Union and similar institutions in third countries, to bring global benefits not only to the European Union but also to poorer and developing countries, which are less well placed to provide resources for research into rare diseases;
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 .
(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 , programi za rehabilitacijo ter programi za navajanje na življenje z redko boleznijo, kot tudi raziskave o diagnostičnih testih in orodjih ;
(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, 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;
Odstavek 4 – točka 1
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;
(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 ; pomagajo sestaviti kataloge redkih bolezni in strokovnjakov 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; help compile catalogues of rare diseases and rare diseases experts;
Priporočilo državam članicam – odstavek 4 – točka 3
Recommendations to Member States – paragraph 4 – point 3
(3) organizirajo poti zdravstvene oskrbe za bolnike 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, zdravstvenih delavcev in izvajalcev storitev ter zagotavljanje storitev prek informacijskih in komunikacijskih tehnologij;
(3) organise healthcare pathways for patients through the establishment of cooperation with relevant experts within the country or from abroad when necessary; cross-border healthcare, including mobility of patients, 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;
(3) organizirajo evropske poti zdravstvene oskrbe za bolnike z redkimi boleznimi 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 in strokovnega znanja prek prenosa podatkov , zdravstvenih delavcev in izvajalcev storitev ter zagotavljanje storitev prek informacijskih in komunikacijskih tehnologij;
(3) organise European healthcare pathways for those patients suffering from rare diseases through the establishment of cooperation with relevant experts within the country or from abroad when necessary; cross-border healthcare, including mobility of patients and expertise through data-mobility support , 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;
Organizirati je treba poti zdravstvene oskrbe za bolnike z redkimi boleznimi, in sicer prek sodelovanja z ustreznimi strokovnjaki v državi ali po potrebi iz tujine.
It is important to organise healthcare pathways for patients suffering from rare diseases through the establishment of cooperation with relevant experts within the country or from abroad when necessary.
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.
(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 ter bolnike vključijo dejavnosti teh centrov ;
(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 , by involving patients in the activitiesof these centres ;
Odstavek 4 – točka 5 a (novo)
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;
Za uspešen boj proti redkim boleznim je bistvenega pomena usposobiti več strokovnih delavcev na tem področju.
It is essential to train more professionals in the field of rare diseases in order to combat them efficiently.
Priporočilo državam članicam – odstavek 5 – točka 1 – podtočka b
Recommendations to Member States – Paragraph 5 – point 1 – subpoint b
(b) evropskih smernic za presejanje prebivalstva in diagnostične teste;
(b) European guidelines on population screening and diagnostic tests;
(b) evropskih smernic za presejanje prebivalstva in diagnostične teste , 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 ;
(b) European guidelines on population screening and diagnostic tests , 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 S tates ;
Priporočilo državam članicam – odstavek 5 – točka 1 – podtočka c
Recommendations to Member States – Paragraph 5 – point 1 – subpoint c
(c) porazdelitve priprave poročil o oceni terapevtske dodane vrednosti zdravil sirot na ravni EU med države članice , da skrajšajo roki dostopa do zdravil sirot za bolnike z redkimi boleznimi;
(c) sharing Member States' assessment reports on the therapeutic added value of orphan drugs at EU level, in order to minimise delays for access to orphan drugs for rare disease patients;
(c) priprave poročil držav članic o oceni klinične dodane vrednosti zdravil sirot na ravni EU v okviru Evropske agencije za zdravila, ki združuje evropsko znanje na tem področju , da se skrajšajo roki dostopa do zdravil sirot za bolnike z redkimi boleznimi;
(c) establishing Member States' assessment reports on the clinical added value of orphan drugs at EU level within the EMEA where the relevant European knowledge and expertise is gathered , 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 – subpoint 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 organizacij bolnikov
Empowerment of patient organisations
Povečanje odgovornosti neodvisnih organizacij bolnikov
Empowerment of independent 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 neodvisnimi 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 independent 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;
(2) podpirajo dejavnosti organizacij bolnikov, kot so ozaveščanje, vzpostavljanje zmogljivosti in usposabljanje, izmenjava informacij in dobrih praks, povezovanje v mreže, doseganje zelo izoliranih bolnikov;
(2) support the activities performed by patient organisations, such as awareness-raising, capacity-building and training, exchange of information and best practices, networking, outreach to very isolated patients;
(2) podpirajo dejavnosti neodvisnih organizacij bolnikov, kot so ozaveščanje, vzpostavljanje zmogljivosti in usposabljanje, izmenjava informacij in dobrih praks, povezovanje v mreže, doseganje zelo izoliranih bolnikov;
(2) support the activities performed by independent patient organisations, such as awareness-raising, capacity-building and training, exchange of information and best practices, networking, outreach to very isolated patients;
(2a) organizacijam pacientov zagotovijo sredstva, ki niso neposredno vezana na farmacevtske družbe;
(2a) ensure that funding for patient organisations which is not directly linked to single pharmaceutical companies is provided;
(2b) bolnikom omogočijo lažji dostop do informacij na evropski ravni o zdravilih, zdravljenju ali centrih za zdravljenje v državah članicah ali tretjih državah, ki nudijo medicinsko oskrbo, posebej prilagojeno njihovi bolezni;
(2b) facilitate patient access to info rmation existing at European level concerning medicines, treatments or treatment centres in the Member States or third countries providing medical care specifically suited to their illnesses;
(3) v nacionalne načrte za redke bolezni vključijo določbe o podpori organizacijam bolnikov in posvetovanju z njimi, kakor je navedeno v odstavkih (1) in (2);
(3) include in the national plans for rare diseases provisions on the support to and the consultation of patient organisations as referred to in paragraphs (1) and (2).
(3) v nacionalne načrte za redke bolezni vključijo določbe o podpori neodvisnim organizacijam bolnikov in posvetovanju z njimi, kakor je navedeno v odstavkih (1) in (2); zagotovijo, da sta v nacionalnih načrtih predvideni določitev nacionalnih ali regionalnih strokovnih centrov in sestava katalogov strokovnjakov za redke bolezni;
(3) include in the national plans for rare diseases provisions on the support to and the consultation of independent patient organisations as referred to in paragraphs (1) and (2) ; ensure that national plans provide for the identification of national or regional centres of expertise and for the compilation of catalogues of experts on rare diseases;
Bolnikom je treba omogočiti lažji dostop do informacij na evropski ravni o zdravilih, zdravljenju ali centrih za zdravljenje v državah članicah ali tretjih državah, ki nudijo medicinsko oskrbo, posebej prilagojeno njihovi bolezni.
It is important to facilitate patient access to information existing at European level concerning medicines, treatments or treatment centres in the Member States or third countries providing medical care specifically suited to their illnesses.
Priporočila Komisiji – odstavek -1 (novo)
Recommendations to the Commission – paragraph -1 (new)
(-1) trajnostno podpre Orphanet, evropsko spletno stran, na kateri bodo na enem mestu združene informacije o:
(-1) To support, in a sustainable way, "Orphanet", a European website and "one-stop shop" providing the following information:
(a) obstoju posebnih raziskav o redkih boleznih, njihovih rezultatih in dosegljivosti za bolnike,
(a) on the existence of specific research into rare diseases, the findings thereof and their availability to patients,
(b) zdravilih, ki so na voljo za posamezne redke bolezni,
(b) on available medicines for each rare disease,
(c) zdravljenju, ki ga posamezna država članica ponuja za posamezno redko bolezen,
(c) on the treatment existing in each Member State for each rare disease,
(d) specialističnih zdravstvenih centrih v državah članicah ali tretjih državah za posamezno redko bolezen.
(d) on existing specialist medical centres in Member States or third countries for each rare disease.
Priporočila Komisiji – odstavek 1
Recommendations to the Commission – Paragraph 1
1. najpozneje ob koncu petega leta po sprejetju tega priporočila na podlagi informacij, ki jih predložijo države članice, pripravi poročilo o izvajanju tega priporočila, naslovljeno na Svet, Evropski parlament, Evropski ekonomsko-socialni odbor in Odbor regij, da se proučita učinkovitost predlaganih ukrepov in potreba po nadaljnjem ukrepanju;
To produce an implementation report on this Recommendation addressed to the Council, the European Parliament, the European Economic and Social Committee and the Committee of the Regions on the basis of the information provided by the Member States, not later than in the end of the fifth year after the date of adoption of this Recommendation, to consider the extent to which the proposed measures are working effectively, and to consider the need for further action .
Splošni uvod in ocena
General introduction and appraisal
predloga priporočila Sveta
of the Proposal for a Council Recommendation
Priporočilo Sveta je dobrodošlo, saj je usklajeno delovanje na področju redkih bolezni na ravni Evropske unije in na nacionalni ravni nujno potrebno .
This Council Recommendation is welcome because a concerted action in the field of rare diseases at the European Union level and at the national level is an absolute necessity .
Razlog za to je, da je kljub zelo nizki incidenci posamezne redke bolezni v Evropski uniji prizadetih na milijone ljudi, saj je teh bolezni na tisoče.
This is because although the incidence for each rare disease is very low, millions of people are affected across the European Union because these diseases are measured in thousands.
Zaradi tega ni mogoče učinkovito promovirati nekaterih bistvenih vidikov, povezanih z redkimi boleznimi, na primer vzpostavitve strokovnih centrov, razvrstitve bolezni, potrebe po specializiranih raziskavah itd .
Thus cannot effectively promote certain essential aspects on rare diseases i.e. creation of networks of centres of expertise, cataloguing of diseases, special research required etc.
Besedilo vsebuje poziv Komisiji, naj pet let po sprejetju pripravi predlog o izvajanju: gre za dolgo obdobje, v katerem ni mogoče v praksi narediti ničesar, saj ni predvidenih nobenih sredstev.
The text asks for an implementation proposal from the Commission five years after the adoption, which is a long period during which nothing can be practically done as there is no funding provided.
Poročevalec zato predlaga, da se zaprosi Komisijo, naj ponudi predlog o izvajanju najkasneje do konca leta 2012, saj bodo do takrat že na voljo zahtevani podatki iz držav članic o strokovnih centrih in strokovnem znanju in izkušnjah glede redkih bolezni (2011).
Therefore as a Rapporteur, I propose that the Commission be asked to provide the implementation proposal at the latest by the end of 2012, since by this date the required data from Member States on expert centres and expertise on rare diseases will be at hand (2011).
V predlogu o izvajanju morata biti posebej omenjena financiranje in sofinanciranje na naslednjih področjih:
In this implementation specific mention should be made for funding/co funding etc. in the areas of:
a) zbiranje epidemioloških podatkov in sestava kataloga redkih bolezni, oboje je namreč potrebno, če želimo imeti jasno sliko stanja glede teh bolezni v Evropski uniji;
a.) the collection of epidemiological data and compiling a catalogue of rare diseases, as this is necessary in order to have a clear picture of the field of these diseases in the EU;
b) vzpostavitev ustreznih mrež;
b.) the formation of relevant networks;
c) ustanovitev strokovnih centrov v državah članicah, kjer takšnih centrov še ni;
c.) the creation of expert centres in Member States which lack such centres;
d) uvedba specializiranega usposabljanja v obstoječih centrih za strokovne delavce, da pridobijo strokovno znanje in izkušnje;
d.) the creation of special training courses in the existing centres for professionals to acquire expertise;
e) pritegnitev strokovnjakov in strokovnih delavcev, da se ustvarijo pogoji, potrebni za nadgradnjo obstoječega znanja;
e.) the mobilisation of experts and professionals in order to create the necessary conditions for advancing existing knowledge;
f) raziskave na področju orodja za diagnostiko in diagnostičnih testov za redke bolezni, zlasti za genske bolezni.
f.) research on diagnostic tools and tests on rare diseases and especially on genetic ones.
Pomembni vidiki, ki jih mora vsebovati
Important aspects to be mentioned
predlog Komisije o izvajanju
in the Commission's proposal for implementation
Iz priporočila Sveta izhaja, da področje redkih bolezni v Evropski uniji ni dobro opredeljeno , in sicer
As it is evident from the Council Recommendation, the field of rare diseases in the European Union is not well defined :
ne v obliki registra, v katerem bi bile po vrsti navedene redke bolezni,
-neither as a registry cataloguing the diseases one by one,
ne kar se tiče natančnosti statističnih podatkov.
- nor as far as the accuracy of the statistical data is concerned.
To je razvidno iz velike razlike pri številu bolnikov (27 do 36 milijonov ljudi) in pri številu redkih bolezni (5 000 do 10 000 redkih bolezni).
This is evident from the great spread in the number of patients (27 to 36 million people) and the number of rare diseases (5 000 to 10 000 rare diseases).
Pomembno je tudi omeniti, da se je treba te problematike lotiti prožno , saj je opredelitev redke bolezni kot bolezni, ki prizadene manj kot 5 oseb na 10.000 prebivalcev, preveč restriktivna , številke so namreč lahko malenkost višje in že se postavlja vprašanje, ali bolezen, katere razširjenost je na primer 5,1 na 10.000 prebivalcev, obravnavati kot redko bolezen.
It is also important to note that we should approach the subject with flexibility because a definition of rare disease as affecting less than 5 persons per 10 000 is too restrictive , as you may have numbers slightly above this ratio and be confronted with the dilemma of not considering as a rare disease one if the ratio is for example 5,1 .
Poleg tega je neka redka bolezen v različnih državah članicah lahko različno razširjena.
Also, a rare disease may have a different distribution from one Member State to another.
Zaradi visokega števila prizadetih oseb ob nizki incidenci za posamezno bolezen je v Evropski uniji nujno potrebno usklajeno delovanje.
Due to the great number of affected persons but the low incidence for each disease, a concerted action across the European Union level is of absolute necessity.
Zato menim, da bi bilo primerno, če bi v okviru končnega predloga za izvajanje poskusili popisati specializirane centre in bolnišnice za nekatere od teh bolezni, ter strokovno znanje in izkušnje , ki so na voljo v posameznih državah, ter vse skupaj združiti v mrežo .
For this reason, I believe that it is appropriate that the final implementation proposal should try to compile the specialized centres and hospitals for some of these diseases, as well as the expertise existing in each country and connect them in a network.