natgillin/translations-raw huggingface dataset:
Pridobitelj licence je odgovoren za plačilo pravičnega nadomestila imetniku pravice, kot ga določi pristojni organ ob upoštevanju tržne vrednosti uporabe, ki je bila odobrena po licenci zadevni državi ali državam uvoznicam.
The licensee shall be responsible for the payment of adequate remuneration to the right holder as determined by the competent authority taking into account the economic value of the use that has been authorised under the licence to the importing country or countries concerned.
Člen 14, odstavek 1, točka (b)
Article 14, paragraph 1, point (b)
(b) če in ko okoliščine, ki so vodile do podelitve licence, ne obstajajo več in je malo verjetno, da bodo ponovno nastopile .
(b) if and when the circumstances which led to the grant of the licence cease to exist and are unlikely to recur.
(b) če in ko država uvoznica, države uvoznice ali predstavniki države uvoznice ali držav uvoznic, omenjenih v členu 5(3)(g)(i) do (iii) namerno kršijo pogoje licence.
(b) if and when the terms of the licence are deliberately breached by the importing country, the importing countries or representatives of the importing country or countries as mentioned in Article 5(3)(g)( i ) to (iii).
Odločitev o tem, ali so se okoliščine spremenile in da licenca ni več potrebna, mora sprejeti država uvoznica.
The decision whether the circumstances have changed and the licence is no longer necessary, must be made by the importing country.
Pristojni organ mora kljub temu imeti možnost, da ukrepa v primeru neustrezne uporabe licence.
The competent authority should however be able to act in case of improper use of the licence.
Člen 15, odstavek 1 a (novo)
Article 15, paragraph 1 a (new)
Pritožba proti odločbi o dodelitvi prisilne licence ne odloži veljavnosti licence.
An appeal against a decision to grant a compulsory licence shall not suspend operation of the licence.
Možnost, da se prepreči dobava zdravil za daljše obdobje, bo povzročila negotovost za morebitne dobavitelje in lahko še bolj zmanjša interes možnih dobaviteljev za delovanje v skladu s sistemom.
The possibility of blocking the supply of medicines for long periods of time will lead to uncertainty for prospective suppliers and may further reduce the interest of potential suppliers in operating under the system.
Komisija vzpostavi sklad, da se zagotovi neposredna podpora v obliki nepovratnih sredstev družbam in ustanovam za prenos tehnologije v države v razvoju, raziskave, krepitev zmogljivosti, regionalne oskrbovalne sisteme, pomoč za registracijo, da bi se olajšala in okrepila proizvodnja farmacevtskih izdelkov v teh državah.
The Commission shall establish a fund in order to provide direct support in the form of grants to companies and institutions for the transfer of technology to developing countries, research, capacity building, regional supply systems and registration assistance, with a view to facilitating and bolstering the production of pharmaceutical products by the countries themselves.
Osnutek uredbe ne predvideva instrumentov za spodbujanje prenosa tehnologije in usposabljanja na področju farmacevtskih izdelkov v državah v razvoju in najmanj razvitih državah, čeprav je to eden od ciljev sklepa STO.
The draft Regulation also lacks instruments to promote the transfer of technology and capacity building in pharmaceuticals in developing countries and LDCs, despite that this is one of the objectives of the WTO decision.
Čeprav gre za enega od ciljev sklepa STO, osnutek ne predvideva dejanskih mehanizmov za spodbujanje prenosa tehnologije in proizvodnje farmacevtskih izdelkov s strani držav v razvoju samih, da bi te države postale manj odvisne.
Although this is one of the objectives of the WTO decision, the proposal makes no provision for any practical means of promoting technology transfer and the production of pharmaceutical products by developing countries themselves, with a view to reducing their dependence.
Komisija natančno spremlja izvajanje te uredbe in vsako leto Evropskemu parlamentu, Svetu in Ekonomsko-socialnemu odboru predstavi poročilo o njenem prispevanju k uveljavljanju sistema, vzpostavljenega s Sklepom.
The Commission shall carefully monitor the operation of this Regulation and each year shall present a report to the European Parliament, the Council, and the European Economic and Social Committee on the contribution it has made to the implementation of the system established by the Decision.
Komisija izvede popoln pregled te uredbe neposredno po spremembi Sporazuma TRIPS in nato vsaka tri leta.
The Commission shall conduct a full review of this regulation immediately after the amendment of the TRIPS Agreement and thereafter every three years.
Stalno spremljanje in pregled uredbe sta pomembna, da se zagotovi dobro delovanje sistema, ki bo predmet pregleda.
Constant monitoring and review of the regulation are important in order to ensure the good functioning of the system, which will be subject to review.
Patenti za farmacevtske izdelke, namenjene državam s težavami v javnem zdravju
Licences for pharmaceutical products intended for countries with public health problems
Odbor zaprošen za mnenje Datum razglasitve na zasedanju
Committee asked for its opinion Date announced in plenary
Odbor za okolje, javno zdravje in varno hrano pozdravlja predlog Komisije za uredbo o prisilnem licenciranju patentov v zvezi s proizvodnjo farmacevtskih izdelkov za izvoz v države s težavami v javnem zdravju.
The Committee on the Environment, Public Health and Food Safety welcomes the Commission proposal for a regulation on compulsory licensing of patents relating to the manufacture of pharmaceutical products for export to countries with public health problems.
Resnih težav na področju javnega zdravja, s katerimi se borijo najmanj razvite države na svetu, z dodeljevanjem takšnih prisilnih licenc sicer ne bi mogli rešiti, lahko pa bi jih vsaj zajezili.
The serious public health problems facing the world's least developed countries cannot be solved by issuing such compulsory licences, but they can at least be contained.
Predlog Komisije je uravnotežen poskus uskladitve interesov držav v stiski na eni strani in interesov imetnikov patentov, ki jih je treba zaščititi, na drugi strani.
The Commission proposal represents a balanced attempt to reconcile the concerns of countries in need on the one side and the interests of patent holders which deserve to be protected on the other side.
S težavami na področju javnega zdravja pa se ne ukvarjajo samo države članice STO, saj je tudi manj razvitim državam sveta treba omogočiti dostop do dosegljivih farmacevtskih izdelkov.
Nevertheless, it is not only member countries of the WTO which face public health problems, and other little developed countries in the world must also be given access to affordable pharmaceutical products.
Pri tem pa se ne sme pozabiti, da je podelitev prisilne licence občuten poseg v lastninsko pravico imetnika patenta.
It must not be forgotten that the issuing of a compulsory licence represents a serious encroachment on the ownership rights of the patent holder.
Zato je treba imetnike licenc vključiti v nadzor poštene uporabe sistema prisilnega licenciranja, ki ga vzpostavlja Uredba.
For this reason, patent holders should be involved in monitoring the application of the compulsory licensing system set up by this regulation to ensure that it is used in good faith.
Treba je zagotoviti dostop do informacij, ki so za to potrebne.
Access to the necessary information must be guaranteed.
Odbor za okolje, javno zdravje in varno hrano poziva Odbor za mednarodno trgovino kot pristojni odbor, da vključi v svoje poročilo naslednje predloge sprememb:
The Committee on the Environment, Public Health and Food Safety calls on the Committee on International Trade, as the committee responsible, to incorporate the following amendments in its report:
Ne bi se smel uporabljati z osnovnim namenom doseganja drugih ciljev in predvsem ciljev, ki so povsem komercialne narave.
It should not be used with the primary purpose of addressing other objectives, and in particular objectives of a purely commercial nature.
(6) Sistem prisilnega licenciranja, vzpostavljen s to uredbo, je namenjen reševanju težav v javnem zdravju, zato se mora uporabljati v dobri veri.
(6) The compulsory licensing system set up by this Regulation is intended to address public health problems, and must therefore be used in good faith.
Nikakor se ne sme uporabljati z namenom doseganja drugih ciljev in predvsem ciljev, ki so povsem komercialne narave.
It must on no account be used with the purpose of addressing other objectives, and in particular objectives of a purely commercial nature.
Da bi se odzvali na te razmere, je treba izvajati ukrepe in dejavnosti čim hitreje, za izboljšanje tehnične sposobnosti teh držav.
In order to address this situation, measures and action should be implemented as soon as possible, with a view to improving the technical capacity of those countries .
(7) Izdelki, proizvedeni v skladu s to uredbo, smejo doseči samo tiste, ki izdelke potrebujejo, in ne smejo biti preusmerjeni od tistih, katerim so namenjeni.
(7) Products manufactured pursuant to this Regulation must reach only those who need them and should not be diverted from those for whom they were intended.
Treba je vzpostaviti potrebna omrežja za izmenjavo podatkov, če še niso zagotovljena.
The data exchange networks necessary for this purpose should be created, where they do not already exist.
Ta uredba uvaja postopek za podelitev prisilnih licenc v zvezi s patenti in dodatnimi varstvenimi certifikati za proizvodnjo in prodajo farmacevtskih izdelkov, kadar so takšni izdelki namenjeni za izvoz v upravičene članice STO, ki se soočajo s težavami v javnem zdravju.
This Regulation establishes a procedure for the grant of compulsory licences in relation to patents and supplementary protection certificates concerning the manufacture and sale of pharmaceutical products, when such products are intended for export to eligible WTO members affected by public health problems.
Ta uredba uvaja postopek za podelitev prisilnih licenc v zvezi s patenti in dodatnimi varstvenimi certifikati za proizvodnjo in prodajo farmacevtskih izdelkov, kadar so takšni izdelki namenjeni za izvoz v upravičene članice STO in druge države v stiski , ki se soočajo s težavami v javnem zdravju.
This Regulation establishes a procedure for the grant of compulsory licences in relation to patents and supplementary protection certificates concerning the manufacture and sale of pharmaceutical products, when such products are intended for export to eligible WTO members and other countries in need affected by public health problems.
Dopolnitev pojasnjuje, da je treba med upravičene države prištevati tudi države, ki niso članice STO .
The insertion makes it clear that countries which are not members of the WTO are also to be considered as eligible countries.
Države članice podelijo prisilno licenco vsakemu, ki odda zahtevek v skladu s členom 5 in ob upoštevanju pogojev, določenih v členih 5 do 8, razen če imetnik pravice lahko dokaže, da se bo prisilna licenca uporabljala z namenom doseganja drugih ciljev in predvsem ciljev, ki so povsem komercialne narave .
Member States shall grant a compulsory licence to any person making an application in accordance with Article 5 and subject to the conditions set out in Articles 5 – 8 , unless the right holder can prove that the compulsory licence is to be used with the purpose of addressing other objectives, and in particular objectives of a purely commercial nature .
Ta dopolnitev omogoča dajalcem licence, da prevzamejo obširno nadzorno funkcijo in vnaprej prepoznajo morebiten namen zlorabe s strani pridobitelja licence.
The text inserted offers licence issuers the possibility of taking on a comprehensive monitoring role and drawing attention at an early stage to a possible intention on the part of the licensee to misuse the licence.
(3a) „druga država v stiski“ pomeni vsako najmanj razvito državo v skladu z uradnim seznamom ZN najmanj razvitih držav.
(3a) "other country in need" means any of the least-developed countries in accordance with the official UN list of LDCs .
Dopolnitev opredeljuje tiste države, ki niso članice STO, ampak bi jih bilo treba kljub temu prištevati med upravičene države.
The insertion defines countries which are not members of the WTO but which should nevertheless be regarded as countries in need.
Upravičene so tudi druge države v stiski, ki niso članice STO, če:
Other countries in need which are not WTO members are also eligible provided that they:
(a) imajo pravico do uradne razvojne pomoči po Organizaciji za gospodarsko sodelovanje in razvoj ter
(a) are entitled to official development aid according to the Organisation for Economic Cooperation and Development and
(b) razglasijo nacionalno izredno stanje ali druge okoliščine izrednih razmer ter
(b) declare a national emergency or other circumstances of extreme urgency and
(c) natančno navedejo ime in količino določenega farmacevtskega izdelka, ki ga potrebujejo za premagovanje izrednega stanja.
(c) specify the exact name and quantity of a particular product which they require in order to overcome the emergency.
Dodatno besedilo razširja krog upravičenih držav v skladu z mednarodnimi določbami, ki veljajo na ravni ZN, tudi na tiste države v stiski, ki niso članice STO.
The text inserted expands the group of eligible countries to include countries in need which are not WTO members in line with the international conditions valid at UN level.
Te države bi morale biti, pod nekaterimi dodatnimi pogoji, prav tako upravičene.
These countries should also be eligible, under certain supplementary conditions.
Osebe, ki zaprosijo za prisilne licence pri pristojnih organih več kot ene države članice za enak izdelek, to v vseh svojih zahtevkih označijo skupaj s podatki o količinah in zadevnih članicah STO uvoznicah ali drugih državah v stiski .
If the person applying for a compulsory licence is submitting applications to competent authorities in more than one Member State for the same product, he shall indicate that in each application, together with details of the quantities and importing WTO members or other countries in need concerned.
Prilagoditev je redakcijska sprememba glede na razširjen krog upravičenih držav.
Adjustment to the wording to reflect the expanded group of eligible countries.
b) ime farmacevtskega izdelka ali farmacevtskih izdelkov, ki jih vlagatelj namerava proizvajati in prodajati za izvoz po prisilni licenci, vključno s katerimi koli dodatnimi podatki, ki so potrebni za zagotovitev točne opredelitve zadevnega proizvoda ali zadevnih proizvodov ;
(b) the name of the pharmaceutical product or products the applicant intends to manufacture and sell for export under the compulsory licence , including any additional information needed to ensure the precise identification of the product or products in question ;
b) ime farmacevtskega izdelka ali farmacevtskih izdelkov, ki jih vlagatelj namerava proizvajati in prodajati za izvoz po prisilni licenci;
(b) the name of the pharmaceutical product or products the applicant intends to manufacture and sell for export under the compulsory licence;
Ta določba v zvezi z elementi, ki jih je treba zagotoviti v okviru zahteve za prisilno licenco vlagatelja, ni potrebna glede na sklep Generalnega sveta STO z dne 30. avgusta 2003 (prim. točko (b) (ii) odstavka 2, sklepa Generalnega sveta STO).
The WTO General Council Decision of 30 August 2003 does not lay down such a provision concerning the information required to be supplied by the applicant in connection with an application for a compulsory licence (cf. paragraph 2(b)(ii) of the WTO General Council Decision).
Člen 5, odstavek 3, točka c
Article 5, paragraph 3, point (c)
Ta določba v zvezi z elementi, ki jih je treba zagotoviti v okviru zahteve za prisilno licenco vlagatelja, ni potrebna glede na sklep Generalnega sveta STO z dne 30. avgusta 2003.
The WTO General Council Decision of 30 August 2003 does not lay down such a provision concerning the information required to be supplied by the applicant in connection with an application for a compulsory licence.
Razen tega se lahko postopek opredelitve patentov ali dodatnih certifikatov izkaže kot dolg in drag zaradi sestave zadevnega zdravila na zahtevo prisilne licence.
Furthermore, this identification procedure for patents or supplementary protection certificates could prove long and costly in view of the composition of the medicine to which an application for a compulsory licence relates.
Na koncu je vlagatelj prisilne licence obvezan zagotoviti dokaz, ki ga je izposloval z lastnikom patentov ali dodatnega certifikata (dodatnih certifikatov), v skladu s členom 7 tega predloga Uredbe.
Finally, the applicant for a compulsory licence is under an obligation to provide evidence that he has negotiated with the holder of the patent(s) or supplementary protection certificate(s) in accordance with Article 7 of this proposal for a regulation.
Ta določba je očitno nepotrebna in bo verjetno ovirala možne vlagatelje, da si pomagajo s sistemom podelitve prisilne licence.
This provision is redundant, and is likely to have the effect of preventing potential applicants from making use of this compulsory licensing system.
To določbo je torej treba odpraviti.
It should therefore be deleted.
d) količino farmacevtskega izdelka, ki jih namerava vlagatelj proizvesti po prisilni licenci;
(d) the amount of pharmaceutical product which the applicant seeks to produce under the compulsory licence;
d) količine farmacevtskega izdelka, ki jih namerava vlagatelj proizvesti po prisilni licenci, v skladu s členom 8(2) ;
(d) the amount of pharmaceutical product which the applicant seeks to produce under the compulsory licence , in accordance with Article 8(2) ;
Prim. predlog spremembe člena 8(2).
Cf. the amendment to Article 8(2).
Člen 5, odstavek 3, točka e
Article 5, paragraph 3, point (e)
(e) članico ali članice STO uvoznice;
(e) the importing WTO member or members;
(e) članico ali članice STO uvoznice ali drugo državo v stiski ali druge države v stiski ;
(e) the importing WTO member or members or other country or countries in need ;
g) dokazila o posebni zahtevi pooblaščenih zastopnikov članice STO uvoznice vlagatelju z navedbo zahtevane količine izdelka.
(g) evidence of a specific request to the applicant from authorised representatives of the importing WTO member and indicating quantity of product required.
g) dokazila o posebni zahtevi članic(e) STO uvoznic(e) ali drugih držav uvoznic v stiski , z navedbo zahtevane količine izdelka.
(g) evidence of a specific request from the importing WTO member or members or other country or countries in need and indicating quantity of product required.
Nevladnim in celo mednarodnim organizacijam je treba omogočiti, da sodelujejo v tem sistemu.
Non‑governmental and even international organisations should be allowed to participate in this system.
Na eni strani je sestava preveč nerazločna in ni jasno, katere dodatne zahteve lahko zahtevajo pristojni organi države članice.
On the one hand, the wording is too vague, and it is unclear what additional requirements might be specified by the competent authority of a Member State.
Na drugi strani pa je takšna zahteva v nasprotju s ciljem tega predloga, da se uskladijo določbe med državami članicami Unije.
On the other hand, such a requirement is contrary to the objective of this proposal to harmonise EU Member States' provisions.
Ta odstavek je torej treba odpraviti .
This paragraph should therefore be deleted.
Pristojni organ obvesti imetnika pravice o zahtevku za prisilno licenco v roku 14 dni.
The competent authority shall inform the right holder of the application for a compulsory licence within a period of 14 days.
Dodano besedilo omogoča imetniku pravice, da že od samega začetka sodeluje v sistemu prisilnega licenciranja, in tako krepi položaj imetnika pravice.
The text inserted enables the right holder to participate in the compulsory licence system from the outset and thus strengthens the right holder's position.
Člen 6, odstavek 1, točka b
Article 6, paragraph 1, point (b)
b) razen če je članica STO uvoznica najmanj razvita država, potrjuje, da je članica STO uvoznica ugotovila, da nima proizvodnih zmogljivosti v farmacevtskem sektorju, ali pa je preverila svojo proizvodno zmogljivost v tem sektorju in ugotovila, da če se ne upošteva zmogljivosti, ki je v lasti ali pod nadzorom imetnika pravice, ta zmogljivost trenutno ne zadostuje za izpolnjevanje njenih potreb;
(b) unless the importing WTO member is a least-developed country, confirms that the importing WTO member has established that it either has no manufacturing capacities in the pharmaceutical sector or has examined its manufacturing capacity in that sector and found that, excluding any capacity owned or controlled by the right holder, it is currently insufficient for meeting its needs ;
b) razen če je članica STO uvoznica najmanj razvita država, potrjuje, če je potrebno, da je članica STO uvoznica ugotovila, da je imela nezadostne proizvodne zmogljivosti ali jih ni imela v farmacevtskem sektorju za zadevni proizvod (zadevne proizvode), na enega od načinov iz priloge sklepa.
(b) unless the importing WTO member is a least-developed country, confirms , if necessary, that the importing WTO member has established that it has insufficient or no manufacturing capacities in the pharmaceutical sector for the product(s) in question in one of the ways set out in the Annex to the Decision ;
Ta sestava povzema sestavo iz sklepa STO z dne 30. avgusta 2003.
This wording follows that contained in the WTO Decision of 30 August 2003.
Izraz mora biti enak, da se prepreči, da si nekateri mogoči vlagatelji ne bi mogli pomagati s sistemom prisilnega licenciranja.
The form of wording should be identical in order to prevent a situation in which certain potential applicants cannot make use of the compulsory licensing system.
Člen 6, odstavek 1, točka c
Article 6, paragraph 1, point (c)
c) potrjuje, da je v primerih, ko je farmacevtski izdelek patentiran na ozemlju članice STO uvoznice, navedena članica STO podelila ali namerava podeliti prisilno licenco za uvoz zadevnega izdelka v skladu s členom 31 Sporazuma TRIP in določbami Sklepa.
(c) confirms that where a pharmaceutical product is patented in the territory of the importing WTO member, that WTO member has granted or intends to grant a compulsory licence for import of the product concerned in accordance with Article 31 of the TRIPS Agreement and the provisions of the Decision.
c) razen če je članica STO uvoznica najmanj razvita država , potrjuje, da je v primerih, ko je farmacevtski izdelek patentiran na ozemlju članice STO uvoznice, navedena članica STO podelila ali namerava podeliti prisilno licenco za uvoz zadevnega izdelka v skladu s členom 31 Sporazuma TRIP in določbami Sklepa.
(c) confirms that where a pharmaceutical product is patented in the territory of the importing WTO member, other than a least ‑developed country, that WTO member has granted or intends to grant a compulsory licence for import of the product concerned in accordance with Article 31 of the TRIPS Agreement and the provisions of the Decision.
Za najmanj razvite države članice STO ne veljajo obveznosti, ki jih imajo države v razvoju, članice omenjene organizacije, v skladu s sklepom Sveta TRIP (ADPIC) z dne 27. junija 2002 (IP/C/25, 1. julij 2002).
Least‑developed countries that are WTO members are exempt from the obligations placed on developing countries that are members of that organisation, in accordance with the Decision of the Council for TRIPS of 27 June 2002 (IP/C/25, 1 July 2002).