natgillin/translations-raw huggingface dataset:
Zato mora podelitev prisilnih licenc po tej uredbi pridobitelju licence naložiti jasne pogoje glede aktov, ki jih zajema licenca, opredelitve farmacevtskih izdelkov, proizvedenih po licenci, in držav, v katere se bodo ti izdelki izvozili;
The issuing of compulsory licences under this Regulation must therefore impose clear conditions upon the licensee as regards the acts covered by the licence, the identification of the pharmaceutical products manufactured under the licence and the countries to which these products will be exported.
(9) Da bi se izognili pospeševanju prevelike proizvodnje in možnemu preusmerjanju izdelkov, bi morali pristojni organi upoštevati obstoječe prisilne licence za enake izdelke in države, kot tudi vzporedne zahtevke, ki jih je navedel vlagatelj.
(9) To avoid facilitating overproduction and possible diversion of products, competent authorities should take into account existing compulsory licences for the same products and countries, as well as parallel applications indicated by the applicant.
Treba vzpostaviti potrebna omrežja za izmenjavo podatkov, kjer le-ta še niso zagotovljena.
Where they do not already exist, the data exchange networks necessary for this purpose should be created.
10(a) Skupnost se zaveda, da ukrepi iz te direktive niso zadostni, da bi zagotovili ustrezen dostop do generičnih zdravil v državah v razvoju in da mora nujno sprejeti dodatne ukrepe z namenom:
(10a) The Community recognises that the measures provided for in this Regulation are not sufficient to guarantee adequate access to generic medicines in developing countries and that it must take additional measures as a matter of urgency with a view to:
- vzpodbujanja proizvodnje zdravil in razvoja v Evropski uniji za boj proti glavnim epidemijam, ki prizadenejo države v razvoju in
- encouraging within the European Union the production of medicines and research to combat the major epidemics affecting developing countries; and
- vzpodbujanje prenosa tehnologije, raziskav, krepitev zmogljivosti, regijskih oskrbovalnih sistemov in pomoč pri registraciji, da bi olajšali in povečali proizvodnjo farmacevtskih izdelkov s strani samihdržav v razvoju.
- encouraging the transfer of technology, research, capacity strengthening, regional supply systems and help with registration, in order to facilitate and increase the production of pharmaceutical products by the developing countries themselves.
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 .
Države članice podelijo prisilno licenco vsakemu, ki odda zahtevek v skladu s členom 5 in ob upoštevanju pogojev, določenih v členih 5 do 8.
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.
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 države uvoznice .
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 importing countries .
Izraz „se soočajo s težavami v javnem zdravju“ uvaja dodatno merilo upravičenosti, katerega Sklep STO ne zahteva in ki ni obrazložen v drugih delih osnutka Uredbe.
The phrase ‘affected by public health problems’ imposes an additional criterion of eligibility, which is neither required by the WTO Decision nor clarified in other parts of the draft Regulation.
To ne more biti neodvisno merilo.
This should not be an independent criterion.
Medtem ko se je o Sklepu STO pogajalo v smislu STO in v korist njenih članic, zakonodaja STO članic ne omejuje, da razširijo izvajanje Sklepa na nečlanice STO.
While the WTO Decision was negotiated in the context of WTO and to benefit its members, WTO law does not restrict WTO members in extending the implementation of the Decision to non-WTO members.
Ob upoštevanju, da se težavami pomanjkanja zdravil po dostopni ceni ne srečujejo le članice STO, je treba obseg uredbe razširiti, da vključi tudi države v razvoju in najmanj razvitih držav.
Given that problems of lack of affordable medicines are not limited to WTO member, the scope of the regulation should be extended to include also developing countries and least-developed countries.
Člen 2, odstavek (3)
Article 2, paragraph (3)
(3) „ članica STO uvoznica“ pomeni ime članice STO, v katero se bo izvažal farmacevtski izdelek.
(3) “importing WTO member ” means the name of the WTO member to which the pharmaceutical product is to be exported;
(3) „ država uvoznica“ pomeni ime članice STO, države v razvoju ali najmanj razvite države, v katero se bo izvažal farmacevtski izdelek.
(3) “importing country ” means the name of the WTO member , of the developing country or of the least-developed country to which the pharmaceutical product is to be exported;
Ob upoštevanju, da se s težavami pomanjkanja zdravil po dostopni ceni ne srečujejo le države članice STO, ni mogoče zagotoviti vzajemnih ugodnosti trgovinske in razvojne politike, če je obseg omejen na članice STO.
Given that problems of lack of affordable medicines are not limited to WTO member countries, the mutual beneficiality of trade and development policy can not be ensured if the scope is limited to WTO members.
Zato je treba obseg uredbe razširiti, da vključi tudi države v razvoju in najmanj razvitih držav.
Therefore, the scope of the regulation should be extended to include also developing countries and least-developed countries.
Upravičene članice STO uvoznice so naslednje:
The following are eligible importing WTO members :
Upravičene države uvoznice so naslednje:
The following are eligible importing countries :
(a) katera koli najmanj razvita država članica STO
(a) any least-developed country member of WTO
(a) katera koli najmanj razvita država ,
(a) any least-developed country
(b) katera koli druga članica STO, ki je Svet za TRIPs obvestila o svojem namenu uporabe sistema kot uvoznica, vključno s tem, ali bo sistem uporabljala v celoti ali na omejen način.
(b) any other member of WTO that has made a notification to the Council for TRIPs of its intention to use the system as an importer, including whether it will use the system in whole or in a limited way.
(b) katera koli druga članica STO, ki je Svet za TRIP obvestila o svojem namenu uporabe sistema kot uvoznica, vključno s tem, ali bo sistem uporabljala v celoti ali na omejen način.
(b) any other member of WTO that has made a notification to the Council for TRIPs of its intention to use the system as an importer, including whether it will use the system in whole or in a limited way.
(c) katera koli država v razvoju, ki ni članica STO in je Komisijo obvestila o namenu, da uporabi sistem kot uvoznica, če bo sistem uporabljala v celoti ali omejeno.
(c) any developing country that is not a member of WTO and has made a notification to the Commission of its intention to use the system as an importer, including whether it will use the system in whole or in a limited way.
Vendar katera koli članica STO, ki je Svetovni trgovinski organizaciji podala izjavo, da ne bo uporabljala sistema kot članica STO uvoznica, ni upravičena članica STO uvoznica.
However, any WTO member that has made a declaration to the WTO that it will not use the system as an importing WTO member is not an eligible importing WTO member .
Vendar katera koli članica STO, ki je Svetovni trgovinski organizaciji dala izjavo, da ne bo uporabljala sistema kot članica STO uvoznica, ni upravičena država uvoznica.
However, any WTO member that has made a declaration to the WTO that it will not use the system as an importing WTO member is not an eligible importing country .
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.
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 concerned.
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 državah uvoznicah.
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 countries concerned.
Ob upoštevanju, da se s težavami pomanjkanja zdravil po dostopni ceni ne srečujejo le države članice STO, ni mogoče zagotoviti vzajemnih ugodnosti trgovinske in razvojne politike, če je obseg omejen le članice STO.
Given that problems of lack of affordable medicines are not limited to WTO member countries, the mutual beneficiality of trade and development policy can not be ensured if the scope is limited to WTO members.
Člen 5, odstavek 3, točka a
Article 5, paragraph 3, point (a)
(a) ime in kontaktne podatke vlagatelja ter posrednika ali zastopnika, ki ga je vlagatelj imenoval, da deluje v njegovem imenu pred pristojnim organom;
(a) the name and contact details of the applicant and of any agent or representative the applicant has appointed to act for him before the competent authority;
(a) ime in kontaktne podatke vlagatelja, imetnika pravic ter posrednika ali zastopnika, ki ga je vlagatelj imenoval, da pred pristojnim organom deluje v njegovem imenu;
(a) the name and contact details of the applicant and rights holder and of any agent or representative the applicant has appointed to act for him before the competent authority;
Člen 5, odstavek 3, točka b
Article 5, paragraph 3, point (b)
(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,
Člen 5, odstavek 3, točka (c)
Article 5, paragraph 3, point (c)
(c) opredelitev patenta (patentov) in/ali dodatnega (dodatnih) varstvenega (varstvenih) certifikata (certifikatov), v zvezi s katerimi se zahteva prisilna licenca;
(c) identification of the patent(s) and/or supplementary protection certificate(s) in respect of which a compulsory licence is sought;
Člen 5, odstavek 3, točka d
Article 5, paragraph 3, point (d)
(d) (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) količino 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) ;
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) državo ali države uvoznice;
e) the importing country or countries ;
Člen 5, odstavek 3, točka (f)
Article 5, paragraph 3, point (f)
(f) dokazila o prejšnjih pogajanjih z imetnikom pravice v skladu s členom 7;
(f) evidence of prior negotiation with the right holder pursuant to Article 7;
(f) po potrebi, dokazila o prejšnjih pogajanjih z imetnikom pravice v skladu s členom 7;
(f) where applicable, evidence of prior negotiation with the right holder pursuant to Article 7;
Sklep STO predvideva nekatere okoliščine, v katerih se prejšnja pogajanja lahko opustijo.
The WTO decision provides for certain circumstances in which prior negotiation can be waived.
Možnost uporabe hitrih postopkov je posebno pomembna glede na tveganje, da lastniki patentov ne sodelujejo pri pogajanjih z dobrimi nameni.
The possibility of applying fast-track procedures is of particular importance given the risk of patentees not engaging in negotiations in good faith
Člen 5, odstavek 3, točka g
Article 5, paragraph 3, point (g)
(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 :
(g) evidence of a specific request from :
(i) pooblaščenih zastopnikov članice ali članic STO uvoznic;
( i ) authorised representatives of the importing country or countries;
(ii) nevladne organizacije, ki uradno zastopa eno ali več držav uvoznic;
(ii) a non-governmental organisation acting with the formal approval of one or more importing countries;
(iii) organov ZN ali drugih mednarodnih zdravstvenih organizacij, ki uradno zastopajo eno ali več držav uvoznic;
(iii) UN bodies or other international health organisations acting with the formal approval of one or more importing countries;
in navedbo zahtevane količine izdelka.
and indicating the quantity of product required.
Pristojni organ lahko predpiše dodatne formalne ali upravne zahteve za učinkovito obravnavo zahtevka.
The competent authority may prescribe additional formal or administrative requirements for efficient processing of the application.
Osnutek Uredbe dovoljuje, da pristojni organ „predpiše dodatne formalne in upravne zahteve za učinkovito obravnavo“.
The draft Regulation allows the competent authority to ‘prescribe additional formal or administrative requirements for efficient processing’.
Nejasno je, katere so lahko te zahteve in zakaj imajo pristojni organi takšna pooblastila, če je namen osnutka Uredbe vzpostaviti enotni sistem v celotni EU.
It is unclear what these requirements may be and why national authorities should be given such power if the purpose of the draft Regulation is to establish a uniform system throughout the EU.
Člen 5, odstavek 4a (novo)
Article 5, paragraph 4 a (new)
Pred podelitvijo prisilne licence pristojni organ imetniku pravice omogoči, da poda pripombe na zahtevek in pristojnemu organu posreduje glede zahtevka pomembne podatke.
Before the grant of the compulsory licence, the competent authority shall give the right holder an opportunity to comment upon the application and to provide the competent authority with any relevant information regarding the application.
This could be particularly important if the rights holders interests have not been respected in the importing country .
This could be particularly important if the rights holders interests have not been respected in the importing country.
Člen 6, odstavek 1, uvodni del
Article 6, paragraph 1, introductory part
Pristojni organ preveri, ali je vsaka članica STO uvoznica, navedena v zahtevku, v skladu s Sklepom z dne 30. avgusta 2003 Generalnega Sveta STO o izvajanju člena 6 Deklaracije iz Dohe o Sporazumu TRIPs in javnem zdravju, v nadaljnjem besedilu „Sklep“, glede vsakega izdelka, ki ga zajema zahtevek, Svetovni trgovinski organizaciji poslala uradno obvestilo, ki:
The competent authority shall verify that each importing WTO member cited in the application has made a notification to the WTO pursuant to the Decision of 30 August 2003 of the General Council of the WTO on the implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, hereinafter “the Decision” in respect of each of the products covered by the application that:
Pristojni organ preveri:
The competent authority shall verify that
– ali je vsaka članica STO uvoznica, navedena v zahtevku, v skladu s Sklepom z dne 30. avgusta 2003 Generalnega Sveta STO o izvajanju člena 6 Deklaracije iz Dohe o Sporazumu TRIPs in javnem zdravju, v nadaljnjem besedilu „Sklep“, Svetovni trgovinski organizaciji poslala uradno obvestilo, oziroma :
- each importing WTO member cited in the application has made a notification to the WTO pursuant to the Decision of 30 August 2003 of the General Council of the WTO on the implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, hereinafter “the Decision”, or
– ali je vsaka država v razvoju ali najmanj razvita država, navedena v zahtevku, ki ni članica STO,obvestila Komisijo v skladu s to uredbo,
- that each developing country or least-developed country cited in the application which is not a WTO member has made a notification to the Commission according to this Regulation
glede vsakega izdelka, ki ga zajema zahtevek in ki:
in respect of each of the products covered by the application that:
Ob upoštevanju, da se s težavami pomanjkanja zdravil po dostopni ceni ne srečujejo le države članice STO, ni mogoče zagotoviti vzajemnih ugodnosti trgovinske in razvojne politike, če je obseg omejen le na članice STO.
Given that problems of lack of affordable medicines are not limited to WTO member countries, the mutual beneficiality of trade and development policy can not be ensured if the scope is limited to WTO members.
(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 država uvoznica najmanj razvita država in ko je to potrebno , potrjuje, da je država ugotovila, da nima zadostnih ali nobenih proizvodnih zmogljivosti v farmacevtskem sektorju za posamičen ali več izdelkov, opredeljenih v Prilogi k Sklepu STO z dne 30. avguste 2003 ;
b) unless the importing country is a least-developed country, confirms where necessary that the country has established that it had insufficient or no manufacturing capacities in the pharmaceutical sector in relation to a particular product or products in one of the ways set out in the Annex to the WTO decision of 30 August 2003 ;
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 TRIPs 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) potrjuje, da je v primerih, ko je farmacevtski izdelek patentiran na ozemlju države uvoznice, navedena država uvoznica podelila ali namerava podeliti prisilno licenco za uvoz zadevnega izdelka v skladu s členom 31 Sporazuma TRIPs in določbami Sklepa.
(c) confirms that where a pharmaceutical product is patented in the territory of the importing country , that importing country 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.
To velja brez poseganja v prožnost, ki jo imajo najmanj razvite države na podlagi Sklepa Sveta za TRIP z dne 27. junija 2002.
This is without prejudice to the flexibility that least-developed countries have under the Decision of the Council for TRIPS of 27 June 2002.
Ob upoštevanju, da se s težavami pomanjkanja zdravil po dostopni ceni ne srečujejo le članice STO, je treba obseg uredbe razširiti, da vključi tudi države v razvoju in najmanj razvitih držav.
Given that problems of lack of affordable medicines are not limited to WTO member, the scope of the regulation should be extended to include also developing countries and least-developed countries.
Glede na Sklep Sveta za TRIP z dne 27. junija 2002 „bodo najmanj razvite države v zvezi s farmacevtskimi izdelki izključene iz izvajanja ali uveljavljanja oddelkov 5 in 7 dela II Sporazuma TRIP ali iz uveljavljanja pravic, ki so predvidene v teh oddelkih od 1. januarja 2016“.
According to the Decision of the Council for TRIPS of 27 June 2002, "least-developed country members will not be obliged, with respect to pharmaceutical products, to implement or apply Sections 5 and 7 of Part II of the TRIPS Agreement or to enforce rights provided for under these Sections until 1 January 2016".
Pristojni organ preveri, da količina izdelka, navedena v zahtevku, ne presega tiste, ki jo je (so jih) Svetovni trgovinski organizaciji sporočila (sporočile) članica STO uvoznica (članice STO uvoznice) in da je ob upoštevanju drugih prisilnih licenc, odrejenih v Skupnosti, skupna količina izdelka , ki so lahko proizvedeni za katero koli članico STO uvoznico, občutno ne presega količine, ki jo je Svetovni trgovinski organizaciji sporočila navedena članica.
The competent authority shall verify that the quantity of product cited in the application does not exceed that notified to the WTO by the importing WTO member(s), and that, taking into account other compulsory licences ordered in the Community, the total amount of product authorised to be produced for any importing WTO member does not significantly exceed the amount notified to the WTO by that member.
Pristojni organ preveri, da količina izdelka, navedena v zahtevku, ne presega tiste, ki jo je (so jih) Svetovni trgovinski organizaciji sporočila (sporočile) članica STO uvoznica (članice STO uvoznice) ali jo je Komisiji sporočila država uvoznica v razvoju ali najmanj razvita država uvoznica, ki ni članica STO, in da ob upoštevanju drugih prisilnih licenc, odrejenih v Skupnosti, skupna količina izdelkov , ki so lahko proizvedeni za katero koli članico uvoznico, občutno ne presega količine, ki jo je Svetovni trgovinski organizaciji sporočila navedena članica STO ali jo je Komisiji sporočila država v razvoju ali najmanj razvita država, ki ni članica STO .
The competent authority shall verify that the quantity of product cited in the application does not exceed that notified to the WTO by the importing WTO member(s) or to the Commission by an importing developing country or least-developed country which is not a WTO member , and that, taking into account other compulsory licences ordered in the Community, the total amount of product authorised to be produced for any importing country does not significantly exceed the amount notified to the WTO by that WTO member or to the Commission by that developing country or least-developed country which is not a WTO member .