natgillin/translations-raw huggingface dataset:
Če vlagatelj zahtevka za prisilno licenco izvede študije in poskuse, potrebne za znanstveno mnenje ali podobne postopke, predpisane z nacionalno zakonodajo, kot je navedeno v odstavku 2 tega člena, to ne pomeni kršitve patentnih pravic (ali dodatnega varstvenega certifikata v skladu z Uredbo Sveta (EGS) št. 1768/92 z dne 18. junija 1992 o uvedbi dodatnega varstvenega certifikata za zdravila 1 ).
Where the applicant for a compulsory license conducts studies and trials necessary to obtain a scientific opinion or other similar procedure provided for under national law as referred to in paragraph 2 of this Article, this shall not constitute an infringement of the rights conferred by a patent (or supplementary protection certificate granted pursuant to Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products 1 ).
1 UL L 182, 2.7.1992, str.
1 OJ L 182, 2.7.1992, p.
Člen 16 a
Article 16 a
Patent ne zajema proizvodnje, skladiščenja in uporabe, tudi za klinične poskuse ali prodaje patentirane inovacije, če se te dejavnosti opravljajo izključno za namene podelitve prisilne licence v smislu te uredbe.
The effect of a patent does not extend to the production, storage, use, including use for clinical trials, or sale of a patented innovation where these actions are carried out solely for the purpose of the granting of a compulsory licence within the meaning of this Regulation.
To ne posega v člen 16.
This shall be without prejudice to Article 16.
Z dodano tako imenovano „določbo Bolar“ se študije in poskusi, potrebni za odobritev dovoljenja v skladu z zakonodajo o farmacevtskih izdelkih, ter zahteve, ki iz tega izhajajo, ne štejejo kot kršitev patenta.
The insertion of a ‘ Bolar provision’ means that the studies and trials necessary for a pharmaceutical product to be authorised and the consequent practical requirements are not to be seen as an infringement of the patent.
Zaradi odsotnosti takšne ureditve raziskovalno delo v zvezi z novimi generičnimi izdelki poteka zunaj Evrope v državah, v katerih je takšna ureditev zagotovljena.
The absence of such a provision results in work on developing new generic products being done outside Europe , in countries which have such a provision.
Zato se v Skupnosti ukinja delovna mesta.
The consequence is that jobs are lost within the Community.
Ker je mednarodno gledano razvoj generičnih izdelkov med patentnim varstvom dovoljen, se patentno varstvo imetnikov pravice dejansko ne krči.
Given that the development of generic products during the period covered by patent protection is allowed internationally in any case, the patent protection enjoyed by the right holder will not be abridged in practice.
Dodano besedilo je v skladu z Direktivo EU 2004/27/ES, ki prav tako predvideva vpeljavo „določbe Bolar“.
The insertion is in line with EU Directive 2004/27/EC, which also envisages the introduction of a ‘ Bolar provision’ .
Komisija tri leta po začetku veljavnosti te uredbe Evropskemu parlamentu, Svetu in Ekonomsko-socialnemu odboru predstavi poročilo o izvajanju te uredbe in njenem prispevanju k uveljavljanju sistema, vzpostavljenega s Sklepom.
Three years after the entry into force of this Regulation, the Commission shall present a report to the European Parliament, the Council, and the European Economic and Social Committee on the operation of this Regulation and the contribution it has made to the implementation of the system established by the Decision.
Komisija tri leta po začetku veljavnosti te uredbe in zatem vsaka tri leta Evropskemu parlamentu, Svetu in Ekonomsko-socialnemu odboru predstavi poročilo o izvajanju te uredbe in njenem prispevanju k uveljavljanju sistema, vzpostavljenega s Sklepom.
Three years after the entry into force of this Regulation, and every three years thereafter, the Commission shall present a report to the European Parliament, the Council, and the European Economic and Social Committee on the operation of this Regulation and the contribution it has made to the implementation of the system established by the Decision.
Če je potrebno, poda predloge sprememb k tej uredbi.
Where necessary, it shall present proposals for amendments to this Regulation.
S spremembo Sporazuma TRIPS Komisija Evropskemu parlamentu in Svetu poda tudi morebitne predloge za ponovni pregled uredbe.
The Commission shall also present to the European Parliament and the Council any necessary proposals for revising this Regulation when the TRIPS Agreement has been amended.
o predlogu Uredbe Evropskega parlamenta in Sveta o prisilnem licenciranju patentov v zvezi s proizvodnjo farmacevtskih izdelkov za izvoz v države s težavami v javnem zdravju
on the proposal for a regulation of the European Parliament and of the Council on compulsory licensing of patents relating to the manufacture of pharmaceutical products for export to countries with public health problems
The Doha WTO Ministerial in 2001 produced a landmark agreement, The Doha Declaration on TRIPS and Public Health, which clearly defined the primacy of public health in relation to intellectual property rights.
The Doha WTO Ministerial in 2001 produced a landmark agreement, the Doha Declaration on TRIPS and Public Health, which clearly defined the primacy of public health in relation to intellectual property rights.
The draft EC regulation is intended to establish the conditions under which compulsory licenses for export can be granted.
The draft EC regulation is intended to establish the conditions under which compulsory licences for export can be granted.
Regrettably, the regulation consistently applies conditions which are not featured in the WTO Decision and which could potentially discourage suppliers.
Regrettably, the regulation consistently applies conditions which are not featured in the WTO decision and which could potentially discourage suppliers.
Serious consideration should now be given to the need for some relaxation of what is an over zealous interpretation of the WTO Decision.
Serious consideration should now be given to the need for some relaxation of what is an over zealous interpretation of the WTO decision.
The draft regulation also includes a requirement which does not feature in the WTO Decision.
The draft regulation also includes a requirement which does not feature in the WTO decision.
It should also be noted that the WTO Decision allows for such an annual review.
It should also be noted that the WTO decision allows for such an annual review.
Indeed, any future amendment of TRIPS in order to incorporate the WTO Decision would, it seems, require an immediate review of the EC regulation and its operation should be monitored at regular intervals.
Indeed, any future amendment of TRIPS in order to incorporate the WTO decision would, it seems, require an immediate review of the EC regulation and its operation should be monitored at regular intervals.
These elements are clear objectives of the WTO Decision.
These elements are clear objectives of the WTO decision.
Odbor za razvoj poziva Odbor za mednarodno trgovino, kot pristojni odbor, da vključi v poročilo naslednje predloge sprememb:
The Committee on Development calls on the Committee on International Trade, as the committee responsible, to incorporate the following amendments in its report:
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 .
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 countries.
Predlagana uredba bi iz določb izključila nečlanice STO, vključno s 40 najmanj razvitimi državami.
The proposed regulation would exclude non-WTO members from the provisions, including 40 LDCs.
Če dosegamo cilj iz Dohe o spodbujanju dostopa do zdravil za vse, mora biti v to vključenih teh 40 najrevnejših držav.
If we are achieving the Doha objective of promoting access to medicines for all, this must include these 40 poorest countries.
Sklep STO v ničemer ne preprečuje takšne razširitve, kot je razvidno iz zakonodaje, predstavljene na Norveškem, v Kanadi in na Nizozemskem.
Nothing in the WTO decision prevents such an extension as is demonstrated by the legislation presented in Norway, Canada and the Netherlands.
Člen 2, točka 3
Article 2, paragraph 3
(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 or developing country or least developed country to which the pharmaceutical product is to be exported;
Najmanj razvite države, ki niso članice STO, morajo imeti možnost, da uporabljajo sistem.
Non-WTO-member LDCs should be able to make use of the system.
Člen 4, odstavek 1, uvodni del
Article 4, paragraph 1, introductory part
(a) katera koli najmanj razvita država ali država v razvoju
(a) any least-developed or developing country
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 država , ki je Svetovni trgovinski organizaciji podala izjavo, da ne bo uporabljala sistema kot država uvoznica, ni upravičena država uvoznica.
However, any country that has made a declaration to the WTO that it will not use the systems as an importing country is not an eligible importing country .
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 to the applicant from :
i) pooblaščenih zastopnikov države uvoznice ali držav uvoznic;
i ) authorised representatives of the importing country or countries;
ii) nevladne organizacije, ki deluje z uradno odobritvijo ene ali več držav uvoznic;
ii) a non-governmental organisation acting with the formal approval of one or more importing countries;
iii) organizacij iz sistema ZN ali drugih mednarodnih zdravstvenih organizacij, ki delujejo z uradno odobritvijo ene države uvoznice ali več držav uvoznic;
iii) organisations from the UN system or other international health organisations acting with the formal approval of one or more importing countries;
vlagatelju z navedbo zahtevane količine izdelka.
and indicating quantity of product required.
Države morajo imeti možnost, da skupaj vložijo zahtevek, sistem pa mora nevladnim organizacijam, organizacijam Združenih narodov ali drugim mednarodnim zdravstvenim organizacijam zagotoviti, da zastopajo eno ali več držav uvoznic pri iskanju proizvajalca in da uvažajo farmacevtske izdelke v države uvoznice.
Countries should be able to file an application together and the system should offer the possibility to NGOs, organisations of the United Nations or other international health organisations to act for one or more importing countries in the search for a producer and to import the pharmaceutical products in the importing countries.
Ta zahteva ni vsebovana v Sklepu STO in prinaša nepotrebne dodatne zaplete.
This requirement is absent from the WTO Decision and adds unnecessary complication
Pristojni organ preveri, ali je vsaka država , 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 country 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:
(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, potrjuje, da je država uvoznica ugotovila, da nima proizvodnih zmogljivosti v farmacevtskem sektorju v zvezi z določenim izdelkom ali izdelki , 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 za ta izdelek ali izdelke ;
(b) unless the importing country is a least-developed country, confirms that the importing country has established that it either has no manufacturing capacities in the pharmaceutical sector in relation to a particular product or products 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 for that product or products ;
Splošna izjava o neobstoječi ali nezadostni proizvodni zmogljivosti je strožji standard, kot tisti, ki ga vzpostavlja Sklep STO.
A general declaration of no or insufficient manufacturing capacity is a more stringent standard than the one established in the WTO decision.
(c) potrjuje, da je v primerih, ko je farmacevtski izdelek patentiran na ozemlju države uvoznice, navedena država 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 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.
Izjema za najmanj razvite države.
Exemption for least developing countries
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 predvidena količina izdelka, navedena v zahtevku, ne presega tiste, ki jo je Svetovni trgovinski organizaciji sporočila država uvoznica ali države uvoznice in da je ob upoštevanju drugih prisilnih licenc, odrejenih v Skupnosti, skupna količina izdelka, ki so lahko proizvedeni za katero koli državo uvoznico, občutno ne presega količine, ki jo je Svetovni trgovinski organizaciji sporočila navedena država .
The competent authority shall verify that the expected quantity of product cited in the application does not exceed that notified to the WTO by the importing country or countries , 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 country .
Vlagatelj pristojnemu organu predloži dokazila, da si je prizadeval za pridobitev pooblastila od imetnika pravice pod razumnimi komercialnimi pogoji in da v razumnem časovnem obdobju takšno prizadevanje ni bilo uspešno.
The applicant shall provide evidence to satisfy the competent authority that he has made efforts to obtain authorisation from the right holder on reasonable commercial terms and conditions and that such efforts have not been successful within a reasonable period of time .
Vlagatelj pristojnemu organu predloži dokazila, da si je prizadeval za pridobitev pooblastila od imetnika pravice pod razumnimi komercialnimi pogoji in da v 30 dneh takšno prizadevanje ni bilo uspešno.
The applicant shall provide evidence to satisfy the competent authority that he has made efforts to obtain authorisation from the right holder on reasonable commercial terms and conditions and that such efforts have not been successful within 30 days .
Pri določitvi razumnega časovnega obdobja se upošteva, ali je članica STO uvoznica razglasila izredno stanje na nacionalni ravni ali druge okoliščine skrajne nuje.
The determination of a reasonable period of time shall take into account whether the importing WTO member has declared a situation of national emergency or other circumstances of extreme urgency.
Prejšnja pogajanja niso potrebna v primeru izrednega stanja na nacionalni ravni, drugih okoliščin skrajne nuje, javne nekomercialne uporabe ali protikonkurenčnih praks.
Prior negotiations shall not be required in situations of national emergency, other circumstances of extreme urgency, public non-commercial use or anti-competitive practices.
Količina patentiranega (patentiranih) izdelka (izdelkov), proizvedenega (proizvedenih) po licenci, ne presega količine, ki je potrebna za izpolnitev potreb države ali držav uvoznic, navedenih v zahtevku.
The amount of patented product(s) manufactured under the licence shall not exceed what is necessary to meet the needs of the importing country or countries cited in the application.
Kakršna koli dodatna količina istega patentiranega (patentiranih) izdelka (izdelkov), proizvedenega (proizvedenih) po licenci se ponovno sporoči pristojnemu organu in STO.
Any additional amount of the same patented product(s) manufactured under the licence shall be subject to renewed notification to the competent authority and the WTO .
Predlagana uredba bi iz določb izključila nečlanice STO, vključno s 40 najmanj razvitimi državami.
The proposed regulation would exclude non-WTO members from the provisions, including 40 LDCs .
Sklep STO v ničemer ne preprečuje takšne razširitve, kot je razvidno iz zakonodaje, predstavljene na Norveškem, v Kanadi in na Nizozemskem.
Nothing in the WTO decision prevents such an extension as is demonstrated by the legislation presented in Norway , Canada and the Netherlands .
Noben izdelek, narejen po prisilni licenci se ne ponudi za prodajo ali da na trg v kateri koli drugi državi razen v članici (članicah) STO , ki je ( so ) navedena ( navedene ) v zahtevku.
No product made under the compulsory licence shall be offered for sale or put on the market in any country other than the WTO member(s) cited in the application.
Licenca je strogo omejena na vsa dejanja, potrebna za uvoz, proizvodnjo in prodajo zadevnega farmacevtskega izdelka državi ali državam , navedenim v zahtevku.
The licence shall be strictly limited to all acts necessary to import, produce and sell the relevant pharmaceutical product to the country or countries cited in the application.
Noben izdelek, narejen po prisilni licenci , se ne ponudi za prodajo ali da na trg v kateri koli drugi državi , razen v državi ali državah , ki so navedene v zahtevku.
No product made under the compulsory licence shall be offered for sale or put on the market in any country other than the country or countries cited in the application.
Besedilo predlagane zakonodaje je dvoumno in bi lahko preprečilo uvoz farmacevtskih učinkovin in tako resno ogrozilo sistem.
The wording of the proposed legislation is ambiguous and could prevent the importation of active pharmaceutical ingredients, thereby threatening to seriously undermine the system.
Izjemoma lahko upravičena država uvožene izdelke ponovno izvozi v druge članice regionalnega trgovinskega sporazuma, katerega članica je tudi država uvoznica, če najmanj polovico tedanjih članic sestavljajo države, ki so uvrščene na seznam najmanj razvitih držav Združenih narodov.
By way of exception, imported products may be re-exported by an eligible country to other members of a regional trade agreement of which the importing country is also a member, provided that at least half of the then current membership is made up of countries then on the United Nations list of least developed countries.
Jasno je, da to ne vpliva na ozemeljsko naravo zadevnih patentnih pravic.
It is understood that this will not prejudice the territorial nature of the patent rights in question.
Ta člen je predviden po Sklepu STO – da se spodbuja ekonomija obsega.
This article is provided for under the WTO decision - in order to promote economies of scale.
Člen 8, odstavek 5
Article 8, paragraph 5, introductory part
(a) količine, dobavljene po licenci, in članice STO , katerim jih dobavlja.
(a) the quantities being supplied under the licence and the WTO members to which they are supplied.
(a) količine, dobavljene po licenci, in država , kateri jih dobavlja;
(a) the quantities being supplied under the licence and the country to which they are supplied;
Če je (so) izdelek (izdelki), ki ga (jih) pokriva prisilna licenca, patentiran (patentirani) v državi uvoznici, navedeni v zahtevku, se izdelek (izdelki) lahko izvozi (izvozijo) le, če so te države podelile prisilno licenco za uvoz in prodajo izdelkov.
If the product(s) covered by the compulsory licence are patented in the importing country cited in the application, the product(s) shall only be exported if those countries have issued a compulsory licence for the import and sale of the products.
Pridobitelj licence zagotovi dokazilo o izvozu izdelka z deklaracijo o izvozu, ki jo je overil zadevni pristojni organ, in dokazilo o uvozu ali dajanju na trg, ki ga je overil organ članice STO uvoznice, in hraniti takšno evidenco vsaj tri leta.
The licensee shall be required to provide proof of exportation of the product, through a declaration of exportation certified by the customs authority concerned, and proof of importation or putting on the market certified by an authority of the importing WTO member , and shall retain such records for at least three years.
Pridobitelj licence zagotovi dokazilo o izvozu izdelka z deklaracijo o izvozu, ki jo je overil zadevni pristojni organ, in dokazilo o uvozu ali dajanju na trg, ki ga je overil organ države uvoznice, in hraniti takšno evidenco vsaj tri leta.
The licensee shall be required to provide proof of exportation of the product, through a declaration of exportation certified by the customs authority concerned, and proof of importation or putting on the market certified by an authority of the importing country , and shall retain such records for at least three years.