natgillin/translations-raw huggingface dataset:
– nakup blaga za zdravstveno nego, kot so medicinski pripomočki in zdravila, v državi članici, ki ni država zdravstvenega zavarovanja kupca; to lahko zajema (ne pa nujno) tudi fizični premik pacienta v drugo državo članico.
- The purchase of goods connected with health care, such as medical devices and medicines, in a Member State other than that where the purchaser has social security affiliation; this may be, but is not necessarily, accompanied by physical movement of the patient to the latter Member State.
Prvi del predloga spremembe je namenjen izboljšanju ubeseditve.
The first part of the amendment is intended to improve the formulation.
Drugi del se nanaša na nakup blaga za zdravstveno nego, ki je bilo med drugim predmet sodbe v primeru Decker, kar je treba vključiti v direktivo, ki je namenjena kodificiranju sodb v zadevah Kohll in Decker.
The second part refers to the purchase of goods connected with health care which were the subject, inter alia, of the Decker judgment, which should be incorporated into a directive intended to codify the Kohll and Decker judgments.
Glede na te skupne vrednote vendar velja, da se države članice iz etičnih razlogov različno odločajo glede dostopnosti nekaterih načinov zdravljenja in dejanskih pogojev za dostop.
In view of these common values it is nevertheless accepted that Member States take different decisions on ethical grounds as regards the availability of certain treatments and the concrete access conditions.
Ta direktiva ne posega v etično raznolikost.
This Directive is without prejudice to the ethical diversity.
Državam članicam ne nalaga, da na svojem ozemlju omogočijo dostopnost zdravljenja in storitev ali povračilo stroškov za ta zdravljenja (prejeta v drugi državi članici), ki niso dovoljena glede na nacionalno zakonodajo, predpise in kodekse ravnanja za zdravstvene poklice.
It does not impose on Member States to make treatments and services accessible their territory or to reimburse costs for those treatments (received in another Member State) which are not allowed according to national laws, regulations and codes of conduct of the medical professions.
Na drugih področjih, kot je testiranje DNK, je stanje bolj zapleteno, saj ga nobena država članica ne prepoveduje, imajo pa glede tega nekoliko različne pogoje, na primer v eni državi članici je obvezno svetovanje pred testiranjem, medtem ko v drugi to ni obvezno.
In other areas, like DNA-testing, the situation is more complicated because it is not banned in any Member State but the conditions are quite different, for example obligation to do counselling before testing is necessary in one Member State and not in the other.
Sodišče meni, da določbe Pogodbe o pravici opravljanja storitev vključuje pravico prejemnikov zdravstvenega varstva, vključno z osebami, ki potrebujejo zdravljenje, da navedeno oskrbo poiščejo v drugi državi članici.
The Court of Justice has held that the Treaty provisions on the freedom to provide services includes the freedom for the recipients of healthcare, including persons in need of medical treatment, to go to another Member Sate in order to receive it there .
Enako velja za prejemnike zdravstvenega varstva, ki iščejo zdravstveno varstvo v drugi državi članici na druge načine, na primer prek e-zdravstvenih storitev .
The same applies to recipients of healthcare seeking to receive healthcare provided in another Member State through other means, for example through e-health services .
Zakonodaja Skupnosti sicer ne posega v pristojnost držav članic, da organizirajo svoje sisteme zdravstvenega varstva in socialne varnosti, vendar morajo države članice to pristojnost uveljavljati v skladu z zakonodajo Skupnosti, zlasti z določbami Pogodbe o pravici opravljanja storitev.
Whilst Community law does not detract from the power of the Member States to organise their healthcare and social security systems, Member States must when exercising that power comply with Community law, in particular with the Treaty provisions on the freedom to provide services.
(18) Sodišče je v več sodbah priznalo pravico pacientov do povračila stroškov za zdravstveno varstvo ali nakup z njim povezanega blaga v drugi državi članici iz njihovega obveznega sistema socialne varnosti.
(18) The right to reimbursement of the costs of healthcare provided or goods purchased in connection with health care in another Member State from the statutory social security scheme to which patients are affiliated was recognised by the Court of Justice in several judgements.
Sodišče meni, da določbe Pogodbe o pravici opravljanja storitev in ponudbe blaga vključujejo pravico pacientov, da se odločijo prejemati zdravstveno varstvo in v ta namen nakupovati blago v zvezi z njim v drugi državi članici.
The Court of Justice has held that the Treaty provisions on the freedom to provide services and goods include the freedom for patients deliberately to receive health care services and deliberately to purchase goods connected with health care in another Member State .
Enako velja za prejemnike zdravstvenega varstva, ki iščejo zdravstveno varstvo v obliki telemedicine v drugi državi članici , ki ni država njihovega zdravstvenega zavarovanja .
The same applies to recipients of healthcare seeking to receive health care services by means of telemedicine from a Member State other than that where they have social security affiliation .
Zakonodaja Skupnosti sicer ne posega v pristojnost držav članic, da organizirajo svoje sisteme zdravstvenega varstva in socialne varnosti, vendar morajo države članice to pristojnost uveljavljati v skladu z zakonodajo Skupnosti, zlasti z določbami Pogodbe o pravici opravljanja storitev in ponudbe blaga .
Whilst Community law does not detract from the power of the Member States to organise their healthcare and social security systems, Member States must when exercising that power comply with Community law, in particular with the Treaty provisions on the freedom to provide services and goods .
Navedene določbe državam članicam prepovedujejo uvedbo ali ohranjanje neutemeljenih omejitev teh pravic .
Those provisions prohibit the Member States from introducing or maintaining unjustified restrictions on these freedoms.
Uvodna izjava se ne nanaša le na storitve, ampak tudi na nakup izdelkov v okviru čezmejnega zdravstvenega varstva.
This recital applies not only to services but also to the purchase of goods in the context of cross-border health care.
V predlogu spremembe je uvodna izjava tudi bolje oblikovana.
The amendment also formulates the recital better.
(21) Primerno je določiti, da pacienti, ki poiščejo zdravstveno varstvo v drugi državi članici v okoliščinah, ki niso predvidene za usklajevanje sistemov socialne varnosti, uvedenega z Uredbo (ES) št. 1408/71, prav tako imajo pravico do ugodnosti načela prostega pretoka storitev in blaga v skladu s Pogodbo in določbami te direktive.
(21) It is appropriate to require that patients who go for healthcare to another Member State in other circumstances than those envisaged for coordination of social security schemes established by Regulation (EC) No 1408/71 should also be able to benefit from the principles of free movement of services and goods in accordance with the Treaty and the provisions of this Directive.
Pacientom je treba zagotoviti prevzem stroškov za navedeno zdravstveno varstvo in to blago vsaj v višini zneska, zagotovljenega za enako ali podobno zdravstveno varstvo ali blago, ki je na voljo ali ga je mogoče kupiti v državi članici pacientovega zdravstvenega zavarovanja.
Patients should be guaranteed assumption of the costs of that healthcare and those goods at least at the level provided for the same or similar healthcare or goods had they been provided or purchased in the Member State of affiliation.
(25) Ta direktiva ne uvaja pravice do povračila stroškov zdravljenja ali stroškov nakupa blaga v drugi državi članici, če takšno zdravljenje ali takšno blago ni med storitvami, ki jih zagotavlja zakonodaja države članice pacientovega zdravstvenega zavarovanja.
(25) This Directive does not aim either to create entitlement for reimbursement of treatment or of the cost of purchasing goods in another Member State, if such a treatment or such goods are not among the benefits provided for by the legislation of the patient's Member State of affiliation.
(27) Ta direktiva pacientu prav tako zagotavlja pravico do kakršnega koli medicinskega izdelka ali medicinskega pripomočka , odobrenega za trženje v državi članici, kjer se zdravstveno varstvo izvaja v državi članici zdravljenja , tudi če medicinski izdelek ali medicinski pripomoček ni odobren za trženje v državi članici pacientovega zdravstvenega zavarovanja, saj je nepogrešljiv del tovrstnega posebnega učinkovitega zdravljenja pacienta v drugi državi članici.
(27) This Directive provides also for the right for a patient to receive any medicinal product or medical device authorised for marketing in the Member State where healthcare is provided in the Member State of treatment , even if the medicinal product or medical device is not authorised for marketing in the Member State of affiliation, as it is an indispensable part of obtaining this specific effective treatment for the patient in another Member State.
Zaradi pravne varnosti in praktičnih vidikov oskrbe z medicinskimi izdelki se ta direktiva ne sme oddaljiti od načela, opredeljenega v členu 6 direktive 2001/83/ES, v skladu s katerim se smejo na trg v določeni državi članici dajati le medicinski izdelki, ki so v tej državi članici odobreni.
For reasons of legal certainty and the practical consequences as regards the provision of medicinal products, this directive should not depart from the principle enshrined in Article 6 of Directive 2001/83/EC that only medicinal products authorised in the Member State concerned may be placed on the market .
(29) Vsakršno zdravstveno varstvo, ki se ne šteje za bolnišnično oskrbo v skladu z določbami te direktive, se obravnava kot nebolnišnična oskrba.
(29) Any healthcare which is not regarded as hospital care according to the provisions of this Directive should be considered as non-hospital care.
Glede na sodno prakso Sodišča v zvezi s prostim pretokom storitev je primerno, da se ne določi zahteva po predhodni odobritvi povračila stroškov prek obveznega sistema socialne varnosti države članice pacientovega zdravstvenega zavarovanja za nebolnišnično oskrbo v drugi državi članici.
In the light of the case-law of the Court of Justice on the free movement of services, it is appropriate not to set a requirement of prior authorisation for reimbursement by the statutory social security system of a Member State of affiliation for non-hospital care provided in another Member State.
V kolikor je povračilo stroškov za takšno oskrbo v mejah kritja, zagotovljenega v okviru sistema zdravstvenega zavarovanja države članice pacientovega zdravstvenega zavarovanja, ukinitev zahteve po predhodni odobritvi ne bo ogrozila finančnega ravnotežja sistemov socialne varnosti.
In so far as the reimbursement of such care remains within the limits of the cover guaranteed by the sickness insurance scheme of the Member State of affiliation, the absence of a prior authorisation requirement will not undermine the financial equilibrium of social security systems .
(29) Vsakršno zdravstveno varstvo, ki se ne šteje za bolnišnično oskrbo v skladu z določbami te direktive in zakonodajo države članice zdravstvenega zavarovanja , se obravnava kot nebolnišnična oskrba.
(29) Any healthcare which is not regarded as hospital care according to the provisions of this Directive and the legislation of the Member State of affiliation should be considered as non-hospital care.
Vzpostavitev sistema predhodne izjave za nebolnišnično oskrbo mora pacientu omogočiti, da prejme vse potrebne informacije pred odhodom.
Setting up a prior declaration system for non-hospital care should make it possible to ensure that patients have received all the necessary information before they depart.
Ta sistem pa ne sme vplivati na načelo avtomatične odobritve nebolnišnične oskrbe.
Such a system must not, however, call into question the principle of authorisation for non-hospital care being automatic.
Hkrati s sistemom predhodne odobritve, ki ga države članice zdravstvenega zavarovanja lahko vzpostavijo za bolnišnično in specialistično oskrbo, morajo imeti tudi sistem predhodne izjave.
In parallel with the system of prior authorisation which the Member States of affiliation can set up for hospital and specialised care, a system of prior declaration should also be put in place.
Država članica zdravstvenega zavarovanja ne more zavrniti prevzema stroškov po tem postopku, ki preprosto predvideva, da se pacientu zagotovi prejem vseh potrebnih informacij pred odhodom.
The Member State of affiliation cannot refuse to assume the costs in the context of this procedure, which simply aims to ensure that the patient has received all the necessary information before departure.
(32a) Predhodna odobritev se zavrne samo v okviru poštenega in preglednega postopka.
(32a) Prior authorisation should only be refused in the context of a fair and transparent procedure.
Pravila, ki jih države članice določijo za vlaganje zahtevka za odobritev in morebitne razloge za zavrnitev, je treba sporočiti vnaprej.
The rules laid down by the Member States for submitting an authorisation request and the possible reasons for refusal should be made known in advance.
Zavrnitev se omeji na tisto, kar je potrebno in mora biti sorazmerna s cilji vzpostavitve sistema predhodne odobritve.
Refusals should be limited to what is necessary, and should be proportionate to the objectives of setting up a prior authorisation system.
Kontaktna služba ne sme nuditi pravnega svetovanja o posameznih primerih.
The contact point should not provide legal advice in individual cases.
Zato so lahko kontaktne službe osnovane znotraj upravnih organov in pristojnih poklicnih organizacij, katerim je država članica zaupala to nalogo.
Consequently, the contact points may be based within the competent professional organisations entrusted with this task by the Member States, as well as in the administrative authorities.
Vključitev poklicnih organizacij v zdravstveno varstvo bi zmanjšala nevarnost nastanka dvojne strukture in s tem povezanih stroškov, saj so se te organizacije deloma že seznanile z nalogami zagotavljanja informacij.
Involving the relevant professional organisations would avoid the risk of duplication and the associated costs, since some of them are already familiar with these tasks of providing information.
Na ta način bi tudi zagotovili, da bi kontaktnim službam s svojim strokovnim znanjem pomagale ustrezne poklicne organizacije.
This would also make it possible to ensure that the contact points would benefit from the expertise of the professional organisations concerned.
Pravno svetovanje bi v posameznih primerih prekoračilo pristojnosti kontaktnih služb in sprožilo vprašanja glede odgovornosti.
Legal advice in individual cases would go beyond the remit of the contact points and raise questions in relation to liability.
(38a) Komisija bi morala okrepiti vzajemno pomoč med nacionalnimi organi, ki so pristojni za nadzorovanje kakovosti, prostovoljno certificiranje dejavnosti, kakovostno certificiranje in sodelovanje poklicnih združenj ter bi morale podpreti oblikovanje kodeksov ravnanja izvajalcev zdravstvenih storitev.
(38a) The Commission should reinforce reciprocal aid between national bodies responsible for monitoring quality, voluntary certification of activities, quality certifications and cooperation of professional associations and should support the development of codes of conduct of healthcare service providers.
(39) Kadar so medicinski izdelki odobreni znotraj pacientove države članice v skladu z Direktivo 2001/83/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v humani medicini ter so predpisani v drugi državi članici za posameznega, po imenu navedenega pacienta, mora biti za takšne zdravniške recepte načeloma možno, da so priznani in se uporabljajo v lekarnah v pacientovi državi članici.
(39) Where medicinal products are authorised within the patient's Member State in accordance with Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use and have been prescribed in another Member State for an individual named patient, it should be in principle possible for such prescriptions to be recognised medically or in pharmacies and used in the patient's own Member State.
Takšno priznavanje zdravniških receptov prav tako ne sme posegati v odločitev države članice pacientovega zdravstvenega zavarovanja v zvezi z vključitvijo takšnih medicinskih izdelkov v storitve, ki jih krije sistem socialne varnosti, v katerega je vključen pacient , in brez poseganja v veljavnost nacionalnih pravil glede cen in plačevanja.
Such recognition should also be without prejudice to the decision of the Member State of affiliation regarding the inclusion of such medicinal products within the benefits covered by the social security system of affiliation and without prejudice to the validity of national pricing and payment rules .
Pri priznavanju zdravniških receptov ne gre samo za zdravniško/medicinsko priznavanje, ampak za njihovo priznavanje pri prodaji medicinskih izdelkov v lekarnah.
The recognition of prescriptions is not only medical recognition, but recognition when medicinal products are sold by pharmacists.
(39a) Evropska komisija bi morala pripraviti študijo o izvedljivosti skupnega primerjalnega sistema EU glede kakovosti zdravstvenega varstva.
(39a) The European Commission should prepare a feasibility study on a common EU benchmark system on the quality of healthcare.
(40) Evropske referenčne mreže morajo zdravstveno varstvo zagotoviti vsem pacientom, za zdravstveno stanje katerih je potrebna posebno koncentracijo virov ali strokovnega znanja, da se zagotovi dosegljiva, visoko kakovostna in stroškovno učinkovita oskrba, ter ki bi prav tako lahko bile osrednje točke za medicinsko usposabljanje in raziskave, širjenje informacij in ocenjevanje.
(40) European reference networks should provide healthcare to all patients who have conditions requiring a particular concentration of resources or expertise, in order to provide affordable, high quality and cost-effective care and could also be focal points for medical training and research, information dissemination and evaluation.
Mehanizem za identifikacijo in razvoj evropskih referenčnih mrež mora biti vzpostavljen z namenom na evropski ravni organizirati enak dostop do visoko kakovostnega skupnega strokovnega znanja na določenem medicinskem področju za vse paciente in zdravstvene delavce.
The mechanism for identification and development of the European reference networks should be established with the aim to organise at European level equal access to high level shared expertise in a given medical field for all patients as well as for health professionals.
Precej sinergije bi bilo mogoče doseči z združitvijo institucionalnega okvira za referenčne mreže in osrednjih kontaktnih služb v državah članicah v skladu z uvodno izjavo 34.
Significant synergies could be achieved by combining the institutional framework for reference networks with the central contact points within Member States, pursuant to Recital 34.
Z združitvijo usklajevalne infrastrukture za čezmejne kontaktne službe zdravstvenega varstva in referenčne mreže v eno samo institucijo v vsaki državi članici bi pacienti imeli dvojno korist.
There is a dual gain to be achieved for patients by combining the co-ordinating infrastructure for both cross-border healthcare contact points and reference networks within a single institution within each Member State.
To lahko prav tako prispeva k notranjemu trgu z največjim možnim pospeševanjem in širjenjem obsega inovacij na področju medicine in zdravstvene tehnologije.
This may also contribute to the internal market by maximising the speed and scale of diffusion of innovations in medical science and health technologies.
Takšno sodelovanje zahteva trajnostne strukture, ki vključujejo vse pomembne zaintereeirane strani, vključno z zdravstvenimi delavci, predstavniki pacientov, raziskovalci in proizvajalci ter organi vseh držav članic, za nadgrajevanje obstoječih pilotnih projektov
Such cooperation requires sustained structures involving all the relevant stakeholders, including healthcare professionals, patients’ representatives, researchers and producers as well as authorities of all the Member States, building on existing pilot projects .
Poleg tega mora takšno sodelovanje temeljiti na razumnih načelih dobrega upravljanja, kot so preglednost, odprtost, vključenost, objektivnost in poštenost postopkov, ki ustrezajo potrebam, željam in pričakovanjem pacientov.
In addition, such cooperation must also be based on sound principles of good governance such as transparency, openness, inclusiveness, objectiveness and fairness of procedures, which are responsive to patients’ needs, preferences and expectations.
Komisija bi morala zagotoviti, da se v to mrežo lahko vključijo le organi za ocenjevanje zdravstvene tehnologije, ki spoštujejo ta načela.
The Commission should ensure that only Health Technology Assessment bodies which adhere to these principles can join the network.
Zdravstveni sistemi in postopek za ocenjevanje zdravstvene tehnologije bi morali biti odprti in vključujoči.
Health Systems and the process of Health Technology Assessment (HTA) should be open and inclusive.
Stališča, izkušnje in strokovno znanje pacientov bi moralo biti vključeno v postopek ocenjevanja, da bi lahko bolje ocenili prednosti, stroške in tveganja.
The views, experiences and expertise of patients should be integrated into the evaluation process to allow for a better evaluation of benefits, costs and risks.
Vključeni bi morali biti tudi zdravniki, zdravstveni delavci, raziskovalci in industrija.
Physicians, health professionals, researchers and industry should also be involved.
V postopku za ocenjevanje zdravstvene tehnologije je na stopnji odločanja treba upoštevati stališča zainteresiranih strani.
Stakeholders’ positions must be represented in the decision-making phase of the HTA process.
Predlog spremembe je povezan s predlogom spremembe člena 17.
This amendment goes with an amendment to Article 17.
Ta direktiva določa splošen okvir za dostop državljanov EU do varnega, visoko kakovostnega in učinkovitega zdravstvenega varstva pod enakimi pogoji in vzpostavlja mehanizme za sodelovanje na področju zdravstva med državami članicami, ob upoštevanju nacionalnih pristojnosti pri organizaciji in zagotavljanju zdravstvenega varstva, njen namen pa je izboljšati dostopnost, kakovost in učinkovitost zdravstvenih sistemov v državah članicah .
This Directive establishes a general framework for EU citizens' access to safe, high quality and efficient healthcare under equitable conditions, and establishes cooperation mechanisms between Member States in the field of health, respecting national responsibility for organising and providing healthcare and is intended to improve the accessibility, quality and efficiency of health systems in the Member States.
Določa tudi splošen okvir za večjo pravno gotovost za državljane glede povračila stroškov zdravstvenega varstva, ki se izvaja v drugi državi članici
And for enhanced legal certainty for citizens regarding the reimbursement of the cost of healthcare provided in another Member State.
Sedanji predlog, ki se osredotoča na mobilnost pacientov, bi lahko štel kot koristen za specifično skupino državljanov (premožnejši, dobro obveščeni in s poznavanjem jezikov), ki predstavljajo zgolj manjšino.
The current proposal, focused on patient mobility, might be deemed beneficial to citizens with a certain profile (well-off, well-informed and familiar with foreign languages), but these citizens are a minority.