natgillin/translations-raw huggingface dataset:
Obstaja veliko virov neodvisnih in z dokazi podprtih informacij o možnostih zdravljenja, ki so na razpolago v Evropski uniji.
There are many sources of independent and evidence-based information on treatment choices available within the European Union.
Ti viri upoštevajo kulturne posebnosti in okolje za prebivalstvo, tudi zdravstvene dejavnike.
These resources take into account cultural specificities and contexts for the population, including health determinants.
Razvijajo jih zdravstveni organi, agencije za zdravila, zdravstveni organi za oceno, ponudniki zdravstvenih storitev, zdravstveni delavci, potrošniške organizacije in neodvisne organizacije bolnikov.
They are developed by health authorities, medical products agencies, healthcare assessment bodies, healthcare providers, healthcare professionals, consumer organisations, and independent patients’ organisations.
Te vire informacij je treba dejavno promovirati v širši javnosti.
These information sources should be actively promoted to the general public.
Člen 57 – odstavek 2
Article 57 – paragraph 2
(2b) V členu 57 se odstavek 2 nadomesti z:
(2 b ) In Article 57, paragraph 2 shall be replaced by the following:
Baza podatkov, predvidena v odstavku 1(1), vključuje povzetke glavnih značilnosti zdravil, navodila za uporabo zdravila za bolnika ali uporabnika in podatke, prikazane na ovojnini.
The database provided for in paragraph 1(l) shall include the summaries of product characteristics, the patient or user package leaflet and the information shown on the labelling.
Baza podatkov se razvija v stopnjah: Baza podatkov se razvija v stopnjah: prednost dobijo zdravila, odobrena po tej uredbi, in tista, ki so odobrena po poglavju 4 naslova III Direktive 2001/83/ES in Direktive 2001/82/ES.
The database shall be developed in stages, priority being given to medicinal products authorised under this Regulation and those authorised under Chapter 4 of Title III of Directive 2001/83/EC and of Directive 2001/82/EC respectively.
Baza podatkov se bo širila, da bo vključevala vsa zdravila, dana v promet znotraj Skupnosti.
The database shall subsequently be extended to include any medicinal product placed on the market within the Community.
Uporaba te baze podatkov med evropskimi državljani se dejavno spodbuja.
This database shall be actively promoted to European citizens.
Glede na primernost baza podatkov vključuje sklice na podatke o kliničnih preskušanjih, ki se trenutno izvajajo ali pa so že zaključeni in jih hranijo v bazi podatkov o kliničnih preskušanjih, predvideni v členu 11 Direktive 2001/20/ES.
Where appropriate, the database shall also include references to data on clinical trials currently being carried out or already completed, contained in the clinical trials database provided for in Article 11 of Directive 2001/20/EC.
Komisija v dogovoru z državami članicami izda smernice o področjih podatkov, ki jih je mogoče vključiti in so lahko dostopni javnosti.
The Commission shall, in consultation with the Member States, issue guidelines on data fields which could be included and which may be accessible to the public.
Informacije, ki jih posredujejo imetniki dovoljenja za dajanje v promet in jih odobrijo nacionalni organi, morajo ti organi poslati agenciji, ta pa jih mora vključiti v svojo bazo podatkov, dostopno javnosti.
The information submitted by marketing authorisation holders and approved by the national authorities shall be sent to the Agency by those authorities and included in its database available to the public.
Baza podatkov bi morala biti za javnost glavni vir objektivnih informacij.
The database should be publicly accessible as a prime source of objective information.
Države članice, Komisija in sama agencija bi morale storiti vse, da bi zagotovile njeno učinkovito uporabo.
With this aim in mind, the Member States, the Commission and the Agency itself should make every effort to ensure that proper use is made of this database.
Poročevalec pozdravlja predlog Komisije v zvezi z informacijami za bolnike o zdravilih na recept ( KOM(2008)0662 –0663).
The Rapporteur welcomes the proposal by the Commission on information to patients on prescription-only medicines ( COM(2008)0662 -0663).
Parlament in organizacije bolnikov so že dolgo pozivali k pripravi takšnega predloga, da bi bili bolniki bolje obveščeni o zdravilih, ki so jim predpisana in jih jemljejo.
The Parliament and patient organizations have been asking for such a proposal for a long time, in order to enable patients to better informed on the medicines they are prescribed and taking.
Cilj predloga zato ne more biti le uskladitev evropske zakonodaje, temveč tudi izboljšanje zdravja prek večje zdravstvene opismenjenosti.
Therefore the objective of the proposal can not only be harmonisation of European legislation but also to improve health through improved health literacy.
Farmacevtska industrija ima pomembno vlogo pri spodbujanju zdravstvene opismenjenosti in dobrega zdravja, vendar mora biti njena vloga jasno opredeljena in njeno sodelovanje strogo pravno urejeno, da bi preprečili prekomerno porabo farmacevtskih izdelkov zaradi težnje po dobičku.
The pharmaceutical industry has an important role to play in promoting health literacy and good health, but their role must be clearly defined and their involvement strictly regulated, in order to avoid commercially driven overconsumption of pharmaceuticals.
Sedanji pravni okvir in stanje v Evropi glede dostopa bolnikov do informacij o zdravilih na recept kažeta veliko težav.
There are many problems with the current legal framework and the situation within Europe when it comes to patients' access to information on prescription-only medicine.
Ker si države članice direktivo različno razlagajo, bolniki v različnih delih Evrope nimajo enakega dostopa do visokokakovostnih informacij o farmacevtskih izdelkih.
The differences in interpretations of the Directive by the Member States give patients in different parts of Europe different access to high quality information on pharmaceuticals.
V nekaterih državah članicah nimajo enostavnega dostopa celo do najosnovnejših informacij o farmacevtskih izdelkih, ki so jim predpisani.
In some Member States patients lack easy access to even the most basic information about the pharmaceuticals they are prescribed.
To je nesprejemljivo in povzroča zdravstvene neenakosti v Uniji.
This is unacceptable and creates health inequalities within the Union.
Sedanja uredba ni prilagojena tehničnemu razvoju ter možnostim in izzivom interneta.
Today's regulation is not adjusted to technical development and the possibilities and challenges created by Internet.
Bolniki v Evropi lahko že v nekaj sekundah neomejeno dostopajo do nenadzorovanih in pogosto nepravilnih informacij o farmacevtskih izdelkih.
Patients in Europe already have infinite access to uncontrolled and often incorrect information about prescribed-only pharmaceuticals in a few seconds.
Dejstvo, da sodišča po Evropi direktivo različno razlagajo, kaže na določeno pravno nejasnost, zaradi katere je težko opredeliti, kako naj bi se direktiva izvajala in za koga naj bi se uporabljala.
The current and different interpretation of the Directive by courts throughout Europe shows that there is a certain legal unclarity that creates uncertainty about how the Directive should be implemented and to whom it is applicable.
To se kaže tudi v različnem izvajanju direktive v posameznih državah članicah.
This is also shown through the differences in the way different Member States have implemented the Directive.
Zato je bistveno, da se zagotovijo jasnejše določbe in posodobijo določbe glede informacij o farmacevtskih izdelkih na recept ter da se čim prej uvedejo nova pravila.
Altogether it is therefore necessary to update the provisions regarding information about prescribed pharmaceuticals, and that new rules come into place soon.
Poročevalec ima več pomislekov glede predloga Komisije.
The Rapporteur, however, raises several concerns about the Commission's proposal.
V tej obrazložitvi so poudarjene najpomembnejše spremembe, ki so predlagane v osnutkih poročil.
This explanatory statement highlights the most important changes put forward in the draft reports.
§ Predlog Komisije se osredotoča na pravico farmacevtskih podjetij do širjenja informacij, ne pa na pravico bolnikov do dostopa do kakovostnih informacij.
§ The Commission's proposal focuses on the pharmaceutical companies' right to disseminate information rather then the patients' right to access quality information.
Poročevalec zato predlaga, da se spremeni osredotočenost predloga in pooblasti farmacevtska podjetja, da bolnikom zagotovijo nekatere informacije, s čimer bi pravice bolnikov do obveščenosti umestili v središče zakonodaje.
The Rapporteur therefore proposes to shift the focus of the proposal and to mandate pharmaceutical companies to provide certain information to the patients and thus, to put the "patients' right to know" into the centre of the legislation .
Poročevalec želi, da bi farmacevtska industrija morala dati na razpolago evropskim bolnikom nekatere osnovne informacije o farmacevtskih izdelkih na recept, na primer povzetek karakteristik in navodila za uporabo zdravila, ter jim zagotoviti lahek dostop do njih.
The Rapporteur wishes to oblige pharmaceutical industry to make certain fundamental information on prescription-only pharmaceuticals available and easy accessible to European patients, e.g. summary of product specifications and package leaflets.
§ Dajanje informacij na razpolago bi moralo temeljiti na „načelu povpraševanja“, t.j. informacije bi morale biti na razpolago tistim bolnikom, ki jih sami iščejo.
§ The making available of information should be based on the "pull principle" , i.e. information should be made available to those patients who are searching for information themselves.
Zato bi bilo treba kanale, po katerih se informacije dajejo na razpolago, skrbneje izbrati.
Thus the channels through which information is made available should be more carefully selected .
Medtem ko ima internet vedno večjo vlogo, se njegova razširjenost in dostop do njega med državami članicami precej razlikujeta, da ne omenjamo razlik v internetni opismenjenosti.
While the role of internet is increasing, internet penetration and access varies considerably from one Member State to the other, not to mention the differences in internet literacy.
Zato bi morale biti informacije na razpolago prek bolj tradicionalnih kanalov, na primer dopisovanja.
For that reason information should be made available through more "traditional" channels as well e.g. correspondence.
§ Kar zadeva uporabo tiskanih medijev kot kanalov informacij, ima poročevalec pomisleke.
§ Concerning, though, the use of printed media as information channel the Rapporteur has reservations.
Informacije v časopisih in revijah so dostopne vsem, ne samo tistim, ki jih iščejo, kar pomeni, da bolniki niso zaščiteni pred nezaželenimi informacijami.
Information in newspapers or magazines is available to everyone not only to those who are seeking for information themselves, i.e. patients are not protected from unsolicited information.
Poročevalec zato predlaga, da se črta možnost, da farmacevtska podjetja dajo na razpolago informacije v časopise, revije in podobne publikacije.
The Rapporteur therefore proposes to delete the possibility to make information available by the pharmaceutical companies in newspapers, magazines and similar publications.
§ Poročevalec želi tudi bolj pojasniti razliko med oglasom in informacijo.
§ The Rapporteur also wishes to make a clearer distinction between advertisement and information .
Čeprav člen 86 direktive opredeljuje oglaševanje in člen 88(1) prepoveduje oglase za zdravila na recept, bi bilo treba zaradi jasnosti poudariti, da ne sme biti na razpolago nobenega promocijskega gradiva za zdravila na recept.
Though Article 86 of the Directive sets the definition of advertising, and Article 88 (1) prohibits the advertisement of prescription-only medicines, for the sake of clarity it should underlined that no promotional material on prescription-only medicines could be made available.
§ Da bi se izognili zmedi, je treba poudariti, da bodo določbe direktive veljale za farmacevtska podjetja in v nobenem primeru ne bodo vplivale na pravico tiska ali bolnikov ter njihovih organizacij, da izrazijo stališče o nekaterih zdravilih in zdravljenjih, če delujejo neodvisno od farmacevtskih podjetij, ne delujejo v njihovem imenu ali v njihovem interesu ali po njihovih navodilih.
§ In order to avoid confusion, it has to be emphasised that the provisions of the Directive would apply to the pharmaceutical companies only and would not affect, under any circumstances, the right of either the press or patients and their organisations to express their views on certain medicines and treatment, as long as they are acting independently and not on behalf of, in the interest of, or upon instructions by the pharmaceutical companies .
Gre za pravno urejanje panoge, ne pa za širše urejanje, ki bi vplivalo na svobodo govora in svobodo tiska itd.
This is a regulation on the industry, and not a broader regulation that affects freedom of speech or the freedom of the press etc.
§ Da bi upoštevali mnenje bolnikov, morajo organizacije bolnikov dejavno sodelovati pri izvajanju direktive in uredbe.
§ In order to make patients' voice heard, patients' organisation should be actively involved into the implementation of the Directive and the Regulation .
Poročevalec pozdravlja zamisel iz osnutka o smernicah in kodeksu ravnanja v zvezi z informacijami, ki bi bile na razpolago bolnikom, in želi, da bi Komisija pri njunem oblikovanju sodelovala z organizacijami bolnikov.
The Rapporteur welcomes the idea to have guidelines and a code of conduct drafted concerning the information which is made available to the patients, and wants the Commission to cooperate with patients' organisations when drafting those guidelines and code of conduct.
§ Treba je poudariti pomembnost odnosa med zdravnikom in bolnikom.
§ There is a need to emphasise the important relationship between doctor and patient.
Najpomembnejši vir informacij o zdravilih na recept je zdravnik, ki jih predpiše, in tako bi moralo tudi ostati.
The most important source of information about prescription-only medicines is, and should remain, the prescribing doctor.
Ta odnos ima temeljno vrednost, drugi informacijski kanali pa ga lahko le dopolnijo.
This relationship has a fundamental value and can only be supplemented by other channels of information.
§ Kar zadeva obseg informacij, poročevalec odobrava javno objavo različice poročila o oceni, ki je javno dostopna.
§ With regard to the scope of information the Rapporteur welcomes that the publicly accessible version of the assessment report is made public.
Meni pa, da se lahko da na razpolago tudi farmacevtske in predklinične preizkuse ter klinična preskušanja zadevnih zdravil.
He is, however, of the opinion that the pharmaceutical and pre-clinical tests and the clinical trials of the given medicines could also be made available.
Glede na poslovno občutljivost tovrstnih informacij farmacevtskih podjetij ne bi bilo mogoče pooblastiti za njihovo objavo, ker pa so lahko dragocene za bolnike in njihove organizacije, ne bi smelo biti prepovedano dajati jih na razpolago.
Given the commercial sensitivity of such information, pharmaceutical companies could not be mandated to publish this information, but as this information can be of value to patients and their organisation making available of the information should not be prohibited.
Ob umestitvi predloga v kontekst poročevalec poudarja, da so informacije za bolnike o zdravilih na recept del širše strategije „zagotavljanja informacij bolnikom“ in zdravstvene opismenjenosti.
Putting the proposals into context, the Rapporteur underlines that information to patients on prescription-only medicines should be part of a wider "information to patients strategy" and a broader strategy of health literacy .
Bolniki in vsi zainteresirani bi morali biti sposobni poiskati natančne in nepristranske informacije o zdravem življenjskem slogu, preprečevanju bolezni in posebnih boleznih ter različnih možnostih zdravljenja.
Patients and everyone interested should be able to find accurate and unbiased information on healthy lifestyle, the prevention of illness and specific diseases, and various treatment options.
Seveda pa to presega obseg sedanjega predloga in poročila.
This, however, goes beyond the scope of the current proposal and report.
Poročevalec zato pričakuje, da bo Komisija v bližnji prihodnosti kot del take širše „strategije zagotavljanja informacij bolnikom“ predstavila nov predlog ter dopolnila pričujočega.
The Rapporteur though expects the Commission to present a new proposal in a near future as a part of such wider "information to patients strategy" and to complement this one.
o predlogu Uredbe Evropskega parlamenta in Sveta o spremembi Uredbe (ES) št. 726/2004 o postopkih Skupnosti za pridobitev dovoljenja za promet in nadzor zdravil za humano in veterinarsko uporabo ter o ustanovitvi Evropske agencije za zdravila v zvezi z informacijami za širšo javnost o zdravilih na recept za uporabo v humani medicini
on the proposal for a regulation of the European Parliament and of the Council amending, as regards information to the general public on medicinal products for human use subject to medical prescription, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency
Namen predlogov je torej zlasti ustvariti jasen okvir za zagotavljanje informacij o zdravilih na recept, da se spodbudi učinkovita uporaba tovrstnih zdravil.
Following this line, the proposals aim specifically to provide for a clear framework for provision of information about prescription-only medicines to the general public with a view to enhancing the rational use of these medicines.
Ta predlog zagotavlja prepoved javnega oglaševanja zdravil na recept.
The proposals ensure that the prohibition of direct-to-consumer advertising of prescription-only medicines continues to apply.
Ta cilj se doseže tako, da:
These aims are to be achieved by:
• se informacije zagotavljajo prek kanalov, kjer so upoštevane potrebe in zmožnosti različnih bolnikov;
• Allowing information to be provided through channels addressing needs and capabilities of different types of patients;
• se imetnikom dovoljenj za dajanje zdravil v promet omogoči, da pripravijo razumljive, objektivne in nepromocijske informacije o koristih in tveganjih njihovih zdravil;
• Allowing marketing authorisation holders to provide in an understandable way objective and non-promotional information about the benefits and the risks of their medicines;
• z zagotavljanjem vzpostavitve nadzornih in izvršilnih ukrepov za zagotovitev, da ponudniki informacij izpolnjujejo merila kakovosti, ter da se hkrati prepreči nepotrebna birokracija.
• Ensuring that monitoring and enforcement measures are in place to ensure that information providers comply with the quality criteria, while avoiding unnecessary bureaucracy.
Razčlemba posameznih ciljev.
As to the individual aims:
Komisija je ugotovila, da se pacienti vedno bolj zanimajo za svoje zdravje in da želijo biti pri tem bolj vključeni.
The Commission has recognised that patients are increasingly interested in their health and wish to be involved more actively in health-related processes.
Ustrezno zdravljenje je torej mogoče le, če so pacienti seznanjeni z zdravili, ki jih jemljejo, kar omogoča ozaveščeno izbiro in učinkovito uporabo zdravil.
Optimum treatment is therefore only possible if patients have access to information about the medicinal products that they are taking so that informed choices can be made and the rational use of these medicines is enhanced.
Pripravljavec mnenja soglaša s Komisijo, da lahko ukrepi Skupnosti na področju informacij za paciente pozitivno vplivajo na javno zdravje.
The author of the report agrees with the Commission that Community action on patient information can have a positive impact in terms of promoting public health.
Poleg tega želi poudariti, da lahko informacije o zdravilih na recept, pri katerih so upoštevane potrebe in pričakovanja pacientov, izboljšajo preventivni vidik.
He also wishes to stress that information about prescription-only medicines that takes account of patients’ needs and expectations can promote the prevention aspect.
Dejstvo je, da zaenkrat razpoložljive informacije o zdravilih na recept v EU niso zadostne niti ne pravočasne.
Nonetheless, it is a fact that the information currently available in the EU about prescription-only medicines is neither adequate nor timely.
Dostop do informacij je odvisen od tega, kako dobro zna posamezni državljan uporabljati internet in katere jezike govori.
Access to information depends on how proficiently the citizen can use the Internet and which language he or she speaks.
Poleg tega je zagotavljanje informacij v posameznih državah zelo različno urejeno in obravnavano, saj ni enotnih pogojev glede njihove vsebine.
Furthermore, due to the lack of harmonised conditions on the content of information, the provision of this information is subject to a wide variety of rules and approaches in the individual Member States, resulting in inequality of access to information about medicinal products.
Ukrepi na tem področju so zdaj posebnega pomena, saj tehnični napredek državljanom omogoča, da na internetu poiščejo informacije, in nehote tudi oglase, z vsega sveta, tako da so izpostavljeni zavajajočim in pomanjkljivim informacijam.
Action in this area is particularly important at the present time as technological advances make it possible for citizens to obtain information via the Internet, but also expose them subconsciously to advertising from all over the world, and hence to misleading and flawed information.
Zato pripravljavec mnenja meni, da je treba to nujno spremeniti in jim zagotoviti informacije, ki bodo skladne s predpisi EU, zanesljive in brez oglasnih vsebin.
For that reason, the author sees an urgent need to rectify this situation so as to provide citizens with objective and non-promotional information that complies with EU rules.
S certificiranimi informacijami si mora EU prizadevati zagotoviti informacijsko protiutež zavajajočim oglasom, ki krožijo na internetu.
Through the provision of certified information, the EU must take action to provide an informative counterweight to the misleading advertising in circulation in the Internet.
Posebno pozornost je treba nameniti navodilom za uporabo, ki so priložena zdravilom.
Attention must focus primarily on the package leaflet.
Informacije v navodilih za uporabo je treba preoblikovati tako, da bodo razumljive vsem državljanom.
The information contained in the package leaflet must be redesigned so that it can be understood by every citizen.
To je še toliko bolj pomembno, saj je sedanja oblika navodil za uporabo nezadovoljiva, tako da lahko pri bolnikih vzbudi strah in se lahko odločijo za prekinitev zdravljenja.
This is especially important because the package leaflet is inadequate in its current form, in that it can awaken patients’ fears and cause them to discontinue treatment.
Bistvo predloga Komisije je preoblikovati navodilo za uporabo.
The Commission proposal is therefore directed primarily at the redesigning of the package leaflet.
Pripravljavec mnenja želi ponovno izrecno poudariti, da je v EU treba ohraniti prepoved javnega oglaševanja zdravil na recept.
The author of the report wishes to emphasise, once again, that the ban on direct-to-consumer advertising of prescription-only medicine in the EU should be maintained.
Vztraja tudi, da so pristojni organi v posameznih državah in zdravstveni delavci še vedno pomemben vir informacij o zdravilih za splošno javnost, vendar priznava, da so pomemben vir informacij o zdravilih brez oglasnih elementov tudi imetniki dovoljenj za promet s posameznimi zdravili.
He also points out that the national competent authorities and health professionals are still important sources of information on medicinal products for the general public, but he recognises that marketing authorisation holders also constitute a valuable source of non-promotional information about medicinal products.