natgillin/translations-raw huggingface dataset:
Očitno je tudi, da je treba za zdravljenje redkih bolezni urediti mobilnost bolnikov , saj posamezne države članice nimajo na voljo vsega strokovnega znanja in izkušenj.
It is also obvious that to combat rare diseases, one need to regulate mobility of patients because there is not all the expertise in each Member State.
Dokler ne bo na voljo strokovnega znanja in izkušenj ter centrov, kjer bodo poskrbeli za bolnike, bo treba to kompenzirati z mobilnostjo le-teh.
Therefore as long as there are no expertise and centres which can take care of the patients, this should be corrected by their mobility.
Državam članicam je treba prepustiti v razmislek vprašanje, kako to financirati.
Here the issue of funding should be left for consideration to the Member States.
Naslednji pomembni vidik je mobilnost strokovnih delavcev in sicer
Mobility of professionals is another very important aspect, i.e.:
a.) mobilnost strokovnjakov v Evropski uniji, s katero bi pomagali ustanavljati nove centre v drugih državah članicah,
a.) mobility of experts across the European Union in order to help the creation of new centres in other Member States
b.) mobilnost strokovnih delavcev, s pomočjo katere bi v obstoječih centrih po Evropski uniji pridobivali strokovno znanje in izkušnje.
b.) mobility of professionals in order to acquire expertise on certain rare diseases in existing centres across the European Union.
Ta ukrep terja uvajanje usposabljanja in klinične prakse, da bi na področju teh bolezni usposobili več strokovnjakov.
This action requires the creation of training courses and clinical practice in order to train more experts on these diseases.
Namen teh centrov torej ne bi bil le zdravljenje redkih bolezni, ampak ustvarjanje okolja, potrebnega za prenos znanja.
Therefore the mission of these centres will not only be to combat rare diseases but to create the necessary environment for transmission of knowledge.
In končno, glede na to, da je veliko redkih bolezni dednih, so za povečanje diagnostičnih sposobnosti s pomočjo genskega testiranja nujno potrebne raziskave in ino vacije.
Finally because many of the rare diseases are of hereditary nature, research and innovation is absolutely essential in order to enhance the diagnostic ability through genetic tests .
V nekaterih primerih bi lahko z uporabo genskih testov v predimplantacijskih postopkih preprečili pojav teh bolezni v zarodkih in s tem izkoreninili nekatere od teh bolezni.
There are cases for which genetic tests exist and can be applied to pre-implantation procedures in order to avoid these diseases in embryos and consequently eradicate some of these diseases.
To bi moralo potekati v okviru usklajenega delovanja s pomočjo genskega svetovanja in podatkovnih mrež.
This should be done in concerted action with genetic counselling and networks of information.
Takšno prakso v nekaterih državah članicah že uporabljajo pri nekaterih boleznih, zato bi jo bilo treba preučiti in upoštevati, saj bi izvajanje takšnih ukrepov pripomoglo k dokončnemu izkoreninjenju nekaterih od teh bolezni.
This is in practice in some Member States for certain diseases, and it should be considered and taken into account as the application of these actions will eradicate in the end some of these diseases.
V povprečju za redko boleznijo zboli ena oseba na 2000 prebivalcev.
The average is one in 2000.
Danes jih poznamo več kot 7000, v medicinskih objavah pa sta vsak teden opisani dve novi.
Over 7000 rare diseases are known to exist today, and two new pathologies are described every week in medical publications.
80 % redkih bolezni je genetske, 65 % pa pediatrične narave.
Eighty per cent of rare diseases are genetic in origin, and 65% are paediatric.
Zato morajo biti redke bolezni v Evropi prednostna naloga, da se bodo bolj upoštevale potrebe več milijonov državljanov, ki so žrtve napačnega diagnosticiranja ter zaradi tega ne prejemajo ustreznega zdravljenja.
It is therefore essential that rare diseases be made a priority at European level, in order to deal properly with the needs of several million citizens suffering from misdiagnosis and thus receiving no treatment to cure their diseases.
Za razliko od drugih tematik na področju javnega zdravja in raziskav tu ne gre za to, da bi nadoknadili zamujeno zaradi zanemarjenja redkih bolezni, temveč je treba vzpostaviti orodja ali trajno ureditev, da se bodo posebnosti teh bolezni odslej vedno ustrezno upoštevale.
Unlike other public health or research issues, what is at stake here is not merely making up for lost time with regard to a neglected problem, but devising tools or permanent arrangements which will enable the specific features of these diseases to be taken into due account for all time to come.
Te bolezni zaradi svoje redkosti predstavljajo izzive z znanstvenega, pa tudi ekonomskega in organizacijskega vidika, s katerimi se ni mogoče spoprijeti z običajnimi ukrepi.
Their rarity spawns specific challenges in scientific, economic and organisational terms, and these challenges cannot be tackled with the tools that are generally applied.
Zato je na tem področju potreben splošen, dosleden in trajnosten pristop, ki ga je mogoče doseči le, če ga bodo hkrati izvajali vsi zainteresirani akterji, namreč politiki, institucije, združenja pacientov, zdravstveni delavci, združenja bolnikov, negovalci, raziskovalci ter zdravstvena industrija.
What is called for is a global, consistent and sustainable approach, which can only be achieved by simultaneously mobilising all those concerned: politicians, institutions, patients' associations, health professionals, sufferers' associations, carers, researchers and industry.
Ker bolnikov ni veliko, zdravljenje zanje ni zagotovljeno na lokalni ali regionalni ravni, same bolezni pa so preveč številne, da bi se o njih izobraževali zdravstveni delavci, zaradi česar je tudi strokovno znanje redko.
The tiny numbers involved mean that sufferers cannot be dealt with at local or regional level, while the illnesses are far too numerous to be taught to health professionals; the result is that expert knowledge is as rare as the diseases.
Ker se nobena država članica Evropske unije ne more sama boriti proti redkim boleznim, je treba dostop do informacij, diagnostiko, nego in raziskave urediti v obliki skladne in usklajene mreže metodologij ter skupnih pristopov na nacionalni in evropski ravni, ki bi jo uporabljali vsi zainteresirani akterji.
Since no EU Member State is capable of combating rare diseases on its own, access to information, diagnostics, carers and research needs to be organised into coherent and coordinated networks - usable by all those involved - of methodologies and shared approaches at national and European level.
Zato je vseevropski pristop nujen za organiziran boj proti redkim boleznim ter za združenje virov in sredstev, pa tudi za njihov razvoj.
The Europe-wide approach is therefore essential when it comes to organising the fight against rare diseases and to mutualising and implementing resources and wherewithal.
Evropski parlament in Svet ministrov sta 16. decembra 1999 sprejela Uredbo (ES) št. 141/2000 o zdravilih sirotah, ki spodbuja farmacevtsko in biotehnološko industrijo k razvoju in trženju zdravil sirot (davčne spodbude, pomoč pri protokolu, podelitev certifikata o desetletnem obdobju tržne ekskluzivnosti itd.).
On 16 December 1999, the European Parliament and the Council of Ministers adopted Regulation (EC) No 141/2000 on orphan medicinal products, which urges the pharmaceutical and biotechnology industry to develop and market orphan medicinal products (tax incentives, protocol assistance, 10 years' exclusivity, etc.).
Evropska agencija za zdravila (EMEA) je ustanovila odbor za zdravila sirote (COMP), zadolžen za pregled vlog za določitev in pomoč Komisiji pri razpravah o teh zdravilih.
A Committee for orphan medicinal products (COMP) was set up within the European Agency for the Evaluation of Medicinal Products (EMEA), with the remit of examining applications for designation and assisting the Commission in discussions concerning orphan medicinal products.
Oktobra 2008 je bil status zdravila sirote podeljen za 569 zdravil v Evropi, med katerimi jih je že 54 pridobilo dovoljenje za promet v Skupnosti, kar zadeva skoraj 3 milijone evropskih pacientov.
In October 2008, 569 medicinal products had been granted 'orphan' designation in Europe, whereof 54 have already received Community marketing authorisation; almost 3 million patients are concerned.
S sprejetjem evropske uredbe o zdravilih sirotah je bil vzpostavljen ugoden okvir za podjetja, ki razvijajo zdravila sirote, saj zagotavlja davčne spodbude, desetletno obdobje tržne ekskluzivnosti itd., poleg tega pa tudi močno spodbuja razvijanje zdravil sirot.
The adoption of the European Regulation on orphan medicinal products created a favourable framework for companies involved in developing these products, in the shape of the aforementioned tax incentives, commercial exclusivity, etc., and has proved a boost to work on developing orphan medicinal products.
Odbor za industrijo, raziskave in energetiko poziva Odbor za industrijo, raziskave in energetiko kot pristojni odbor, da v svoje poročilo vključi naslednje predloge sprememb:
The Committee on Industry, Research and Energy calls on the Committee on the Environment, Public Health and Food Safety, as the committee responsible, to incorporate the following amendments in its report:
(5) Redke bolezni zaradi svoje nizke prevalence in specifičnosti 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 and their specificity, 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.
Priporočila državam članicam – odstavek 1 – točka 1
Recommendations to Member States – paragraph 1 – point 1
Priporočila 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, obsežnim in ustrezno 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 identified funding, management structures and regular reports;
Priporočila državam članicam – odstavek 1 – točka 5 a (novo)
Recommendations to Member States – paragraph 1 – point 5 a (new)
(5a) v nacionalnih načrtih predvidijo izjemne ukrepe za zagotavljanje zdravil brez dovoljenja za trženje, ko se pojavi resnična potreba za javno zdravje.
(5a) provide for exceptional measures within the national plans when it comes to making available medicinal products which have no marketing authorisation, when there is a real public health need.
Če v državi članici ni drugih možnosti ustreznega in razpoložljivega zdravljenja, ocena iz poročila o koristih/tveganjih pa je predvidoma pozitivna, se bolnikom z redkimi boleznimi omogoči dostop do teh zdravil.
In the absence of appropriate and available therapeutic alternatives in a Member State , and when the risk/benefit balance is presumed to be positive, patients affected by rare diseases shall have access to the medicinal products in question.
Priporočila državam članicam – odstavek 2 – točka 4
Recommendations to Member States – paragraph 2 – point 4
(4) na ravni Skupnosti ter nacionalni in regionalni ravni podpirajo posebne informacijske mreže, registre in zbirke podatkov o boleznih , zlasti s finančnimi sredstvi .
(4) support , in particular by financial means, at European, national or regional level specific disease information networks, registries and databases.
Priporočila državam članicam – odstavek 3 – točka 3 a (novo)
Recommendations to Member States – paragraph 3 – point 3 a (new)
(3a) vzpostavijo ustrezen mehanizem dolgoročnega financiranja, na primer prek javno-zasebnih partnerstev, za podpiranje raziskav na nacionalni in evropski ravni, da se zagotovi njihova trajnost;
(3a) put in place adequate, long-term funding, by means , for example, of public/private partnerships, to support research at national and European level, so as to guarantee its viability;
Priporočila državam članicam – odstavek 3 – točka 3 b (novo)
Recommendations to Member States – paragraph 3 – point 3 b (new)
(3b) 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;
(3b) 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;
Priporočila državam članicam – odstavek 4 – točka 3
Recommendations to Member States – paragraph 4 – point 3
(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, 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, 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;
Priporočila 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 ter bolnike vključijo v dejavnosti, upravljanje in ocenjevanje 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 and involving the patients in the activities, management and evaluation of the centres .
Priporočila državam članicam – odstavek 5 – točka 1 – točka c
Recommendations to Member States – paragraph 5 – point 1 – point 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 State 's 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) porazdelitve priprave poročil o oceni klinične dodane vrednosti zdravil sirot na ravni EU med države članice 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) sharing Member States' assessment reports on the clinical added value of orphan drugs at EU level within the European Medicines Agency, which brings together European expertise in this field , in order to minimise delays for access to orphan drugs for rare disease patients;
Evropska agencija za zdravila je najustreznejša platforma za zmanjšanje čakalnih rokov in centraliziranje poročil o oceni.
The EMEA is the most appropriate platform for reducing the waiting times and centralising the evaluation reports.
Priporočila državam članicam – odstavek 6 – točka 2 a (novo)
Recommendations to Member States – paragraph 6 – point 2 a (new)
(2a) 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;
(2a) 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;
(-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:
o odločitvah Odbora za peticije v letu 2008
on the deliberations of the Committee on Petitions during the year 2008
PRILOGA: Peticije, ki jih je Parlament prejel leta 2008...............................................................16
ANNEX: Petitions received by Parliament in 2008......................................................................18
– ob upoštevanju izidov misij za ugotavljanje dejstev leta 2008 v Romuniji, Bolgariji in Franciji ter ustreznih poročil in priporočil, ki jih je odbor sprejel,
– having regard to the results of its fact-finding missions in 2008 to Romania, Bulgaria, and France and the corresponding reports and recommendations approved by the Committee,
– ob upoštevanju poročila Odbora za peticije ( A6‑0232/2009 ),
– having regard to the report of the Committee on Petitions ( A6-0232/2009 ),
A. ker priznava pomembnost postopka za obravnavanje peticij in njegove posebne značilnosti, ki omogočajo pristojnemu odboru, da poišče rešitve in pojasnila za državljane EU, ki na Parlament naslovijo peticijo,
A. recognising the importance of the petitions process and its specific attributes, which enable the responsible committee to seek solutions and explanations for EU citizens who petition Parliament,
B. ker vedno več državljanov EU na Parlament naslovi peticijo, Odbor za peticije pa si prizadeva še pospešiti svoje postopke, da bi državljanom, ki ga prosijo za pomoč, zagotovil čim boljše storitve,
B. having regard to the growing number of EU citizens who petition Parliament, together with the efforts by the Committee on Petitions to further expedite its procedures in order to provide a better service for citizens seeking its assistance,
C. ker morajo organi Parlamenta izpolniti še kar nekaj priporočil iz letnega poročila 2007, kot je zahtevek za nujno izboljšanje upravnih virov Odbora za peticije, tudi jezikovnega in pravnega strokovnega znanja, da bi povečali zmogljivosti Parlamenta za izvajanje neodvisnih preiskav o vloženih peticijah, in na primer tesnejše sodelovanje z omrežjem SOLVIT na področju peticij in pritožb glede notranjega trga, ali ustanovitev skupnega portala EU za evropske državljane,
C. whereas several of the recommendations adopted in the 2007 Annual Report are yet to be implemented by Parliament's authorities, such as the request for an urgent improvement of the administrative resources, including linguistic and legal expertise, of its Committee on Petitions in order to increase Parliament's capacity to conduct independent investigations of petitions addressed to it, and, for instance, closer cooperation with SOLVIT in the field of petitions and complaints regarding the internal market, and the establishment of a common EU portal for European citizens,
D. ker upošteva, da državljani kljub znatnemu napredku pri razvoju struktur in politik Unije v tem obdobju neposredno občutijo številne pomanjkljivosti pri uporabi politik in programov Unije, saj neposredno vplivajo nanje in so pogosto tudi tema vloženih peticij,
D. mindful of the fact that, in spite of considerable progress in the development of the structures and policies of the Union during this period, citizens remain directly aware of many shortcomings in the application of the policies and programmes of the Union as they affect them directly, and whereas these are frequently the subject of petitions received,
E. ker bo institut državljanske pobude iz lizbonske pogodbe omogočil še večje sodelovanje javnosti pri dejavnostih in delu Evropske unije,
E. whereas the institution of the 'Citizens' Initiative' under the Treaty of Lisbon will result in even greater public participation in the activities and work of the European Union,
F. ker ima zaradi tega Parlament odgovornost, da v interesu državljanov in prebivalcev EU zagotovi boljšo uporabo prava Skupnosti v posameznih državah članicah ter z njimi sodeluje za izpolnitev tega cilja,
F. whereas, consequently, Parliament has a responsibility to ensure better application of Community law by the individual Member States in the interests of EU citizens and residents, and thus to work in cooperation with Member States to achieve this objective,
G. ker so mnoge države članice kljub temu še vedno zadržane glede dejavnega sodelovanja s pristojnim odborom (predvsem se ne udeležujejo se njegovih sej), to pa kaže, da ni lojalnega sodelovanja z institucijo,
G. whereas, however, many Member States remain reluctant to cooperate actively with the responsible committee, in particular by failing to attend meetings of the committee, and whereas this denotes a lack of loyal cooperation with the institution,
H. ker neuspešnost posamezne države članice, da bi dejavno in pravočasno sodelovala pri delu pristojnega odbora za pravilno izvajanje prava Skupnosti, vzbuja dvome o tem, da si želi in namerava pravilno izvajati politike in cilje EU, in zato izpostavlja organe ukrepom v obliki sankcij in kazni, ki jih omogočajo Pogodbe, ter kritiki javnosti,
H. whereas failure to cooperate actively and in a timely manner with the work of the responsible committee in the interest of the correct application of Community law raises doubts about the desire and intent of the Member State concerned to correctly apply EU policies and objectives and therefore exposes the authorities to measures in the form of sanctions and penalties which are available under the terms of the Treaties as well as to public criticism,
I. ker pa priznava, da mnoge države članice dobro sodelujejo s Parlamentom in si prizadevajo odgovoriti na skrbi državljanov, ki jih ti izražajo z vlaganjem peticij,
I. recognising, however, that many Member States demonstrate a good level of cooperation and work with Parliament in an effort to respond to the concerns of citizens as expressed through the petitions process,
J. ker priznava ustvarjalni prispevek služb Komisije k postopku obravnavanja peticij, saj na zahtevo pristojnega odbora redno zagotavljajo predhodne ocene številnih prejetih peticij,
J. recognising the constructive contribution made to the petitions process by the services of the Commission, which regularly provide, at the request of the responsible committee, preliminary assessments of many petitions received,
K. ker bi se dalo to sodelovanje še izboljšati, predvsem glede postopkov iz členov 226 in 228 Pogodbe ES v ustrezno utemeljenih postopkih,
K. whereas such cooperation could and should be further enhanced, notably as regards procedures pursuant to Articles 226 and 228 of the EC Treaty in duly justified cases,