natgillin/translations-raw huggingface dataset:
To je odveč, ker je na tem mestu poglavitna izključna uporaba tako proizvedenih zdravil na trgu izbranih najmanj razvitih držav, poleg tega pa to ni v skladu z ureditvijo iz Uredbe 726/2004 (ES), katere člen 58 je ponovno naveden v odstavku 2.
This is not only superfluous given that medicines produced in this way are exclusively intended for the market of selected LDCs, which is at the core of the regulation, but also conflicts with the rules laid down in Regulation (EC) No 726/2004, Article 58 of which is echoed in paragraph 2.
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 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.
Komisija tri leta po začetku veljavnosti te uredbe, in potem 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 thereafter every three years, 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, predstavi predloge za spremembe te uredbe.
Where necessary, it shall present proposals for amendments to this Regulation.
Komisija predstavi Evropskemu parlamentu in Svetu tudi vsak predlog revizije te uredbe, ko se Sporazum o TRIP spremeni.
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.
Vsaki objavi poročila o izvajanju, če je to potrebno, mora biti priložen predlog sprememb zakonodaje Skupnosti, da bi upoštevali ugotovljene vrzeli.
Publication of reports on implementation must be accompanied, where necessary, by proposals for amendments to Community provisions in order to address gaps found.
Poleg tega mora Komisija predlagati vsako potrebno spremembo te uredbe ob upoštevanju sprememb Sporazuma o TRIP.
Furthermore, the Commission must propose any amendments to this Regulation necessary in order to take account of amendments to the TRIPS Agreement.
Treba je zagotoviti usklajenost besedil.
Consistency between the texts should be ensured.
Predlog Uredbe Evropskega parlamenta in Sveta o prisilnem licenciranju patentov v zvezi s proizvodnjo farmacevtskih izdelkov za izvoz v države s težavami v javnem zdravju
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
Adamos Adamou, Georgs Andrejevs, Irena Belohorská, Johannes Blokland, John Bowis, Hiltrud Breyer, Martin Callanan, Dorette Corbey, Avril Doyle, Mojca Drčar Murko, Jillian Evans, Anne Ferreira, Karl-Heinz Florenz, Françoise Grossetête, Cristina Gutiérrez-Cortines, Satu Hassi, Gyula Hegyi, Caroline Jackson, Dan Jørgensen, Christa Klaß, Holger Krahmer, Urszula Krupa, Aldis Kušķis, Peter Liese, Linda McAvan, Marios Matsakis, Riitta Myller, Péter Olajos, Dimitrios Papadimoulis, Vittorio Prodi, Guido Sacconi, Karin Scheele, Carl Schlyter, Horst Schnellhardt, Richard Seeber, Jonas Sjöstedt, María Sornosa Martínez, Antonios Trakatellis, Thomas Ulmer, Anja Weisgerber in Åsa Westlund.
Adamos Adamou, Georgs Andrejevs, Irena Belohorská, Johannes Blokland, John Bowis, Hiltrud Breyer, Martin Callanan, Dorette Corbey, Avril Doyle, Mojca Drčar Murko, Jillian Evans, Anne Ferreira, Karl-Heinz Florenz, Françoise Grossetête, Cristina Gutiérrez-Cortines, Satu Hassi, Gyula Hegyi, Caroline Jackson, Dan Jørgensen, Christa Klaß, Holger Krahmer, Urszula Krupa, Aldis Kušķis, Peter Liese, Linda McAvan, Marios Matsakis, Riitta Myller, Péter Olajos, Dimitrios Papadimoulis, Vittorio Prodi, Guido Sacconi, Karin Scheele, Carl Schlyter, Horst Schnellhardt, Richard Seeber, Jonas Sjöstedt, María Sornosa Martínez, Antonios Trakatellis, Thomas Ulmer, Anja Weisgerber and Åsa Westlund.
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 European Parliament and Council regulation on compulsory licensing of patents relating to the manufacture of pharmaceutical products for export to countries with public health problems
Predlog uredbe, ki ga je predložila Komisija, je namenjen temu, da podeli proizvajalcem generičnih zdravil prisilno licenco za proizvodnjo in trženje patentiranih izdelkov, namenjenih izvozu v države z nezadostnimi ali brez proizvodnih zmogljivosti.
The aim of the regulation proposed by the Commission is to enable manufacturers of generic pharmaceutical products to produce and sell patented pharmaceutical products intended for export to countries in need of such products which either have no manufacturing capacity, or are not self-sufficient, in the relevant sector.
Cilj tega predloga je uveljaviti Sklep Generalnega sveta STO z dne 30. avgusta 2003 o izvajanju odstavka 6 Deklaracije o Sporazumu o TRIP in javnem zdravju na ravni Skupnosti.
The regulation aims to implement at Community level the WTO General Council decision of 30 August 2003 on the implementation of paragraph 6 of the Declaration on the TRIPs agreement and public health.
Z opustitvijo obveznosti članic STO iz člena 31(f) Sporazuma STO o trgovinskih vidikih pravic intelektualne lastnine (Sporazum TRIP) dovoljuje ta sklep članicam STO, da za proizvodnjo in prodajo patentiranih farmacevtskih izdelkov, namenjenih za izvoz v tretje države z nezadostnimi proizvodnimi zmogljivostmi ali brez njih v farmacevtskem sektorju, podelijo prisilne licence.
By waiving WTO members’ obligations under Article 31(f) of the WTO agreement on Trade Related Aspects of Intellectual Property Rights (the TRIPS agreement), this decision allows WTO members to grant compulsory licences for the production and sale of patented pharmaceutical products intended for export to third countries with insufficient or no manufacturing capacity in the pharmaceutical sector.
Evropska unija, ki je eden od najbolj dejavnih udeležencev na mednarodni ravni, ima zato namen zagotoviti najbolj zapostavljenim državljanom dostop do zdravil po znižani ceni.
The European Union, therefore, proposes to take a stand as one of the international players with the greatest commitment to ensuring that the citizens of the most disadvantaged countries have access to pharmaceutical products at lower prices.
Ob upoštevanju navedenih ciljev mora vaš pripravljavec mnenja izraziti prepričanje v predlog uredbe, ki ga je predstavila Komisija.
In view of the objectives set forth by the Commission, your rapporteur can only warmly welcome this proposal for a regulation.
Vseeno je treba poudariti, da so ukrepi iz preučenega akta oblika posredovanja, ki ponovno zmanjšuje zaščito pravic intelektualne lastnine, ki so jih, ob upoštevanju Sporazuma TRIP, običajno deležne.
However, it should be remembered that the measures contained in the proposal in question constitute, objectively speaking, a reduction in the protection usually accorded to intellectual property rights through the TRIPS agreement.
Zato se vseeno, čeprav nas vse druži skrb za medčloveško solidarnost, na kateri temelji predlog, zdi primerno, da se imetnikom prisilne licence odobri možnost posega v postopek za prisilno licenciranje patentov v zvezi s proizvodnjo farmacevtskih izdelkov za izvoz v države STO s težavami v javnem zdravju.
Consequently, while fully supporting the principle of solidarity with the disadvantaged which underlies the proposal, it is perfectly reasonable to allow patent holders the opportunity to be involved in the procedure laid down for the granting of compulsory licences for the manufacture and sale of pharmaceuticals intended for export to WTO countries with public health problems.
Razen tega so predlogi sprememb predvideni tudi za zagotovitev zaščite zakonitih gospodarskih, industrijskih in tržnih interesov imetnika farmacevtskega patenta.
The amendments tabled by your rapporteur aim, therefore, to protect the legitimate economic, industrial and commercial interests of pharmaceutical patent holders.
Zato je treba pridobiti pravico, da se pristojnemu državnemu organu predložijo pripombe, ki morajo, ob pomoči sprožitve sistema predlogov, dovoliti sprejem končne odločitve, da čim bolj omeji oškodovanje pravic intelektualne lastnine.
This would be achieved by giving them the right to submit comments to the competent national authority in order to ensure, by providing for both parties to have a say in the proceedings, that the decision taken minimises any loss of rights in relation to intellectual property.
Predvideti je treba tudi udeležbo imetnika pravice v fazah, ki so namenjene ugotavljanju kršitve prepovedi o ponovnem uvozu farmacevtskih izdelkov s prisilnim licenciranjem patentov na evropski trg.
Provision is made also for the right holder to be involved in any proceedings to ascertain whether there has been an infringement of the ban on re-importing into the European market pharmaceutical products manufactured under a compulsory licence.
Končno se je treba izogniti, da proizvajalci generičnih zdravil, ki so imetniki prisilne licence, ne izkoriščajo neupravičene prednosti na ravni konkurence.
Finally, your rapporteur has sought to avoid giving manufacturers of generic pharmaceuticals under compulsory licences an unfair competitive advantage.
Dejansko omogoča člen 16 predloga uredbe dva postopka, ki državam uvoznicam zagotavljata nadzorovanje kakovosti izvoženih farmacevtskih izdelkov: dovoljenje za promet na evropskem trgu (člen 6 Direktive 2001/83/ES) in postopek znanstvenega mnenja (člen 58 Uredbe (ES) št. 726/2004).
Article 16 of the proposal refers to two possible procedures which may be used to enable importing countries to control the quality of the pharmaceuticals exported: a marketing authorisation for the European market (under Article 6 of Directive 2001/83/EC) or the scientific opinion procedure (under Article 58 of Regulation (EC) No 726/2004).
V obeh primerih je mogoče odstopanje od splošne ureditve varstva podatkov in zapadlosti.
In both cases, provision is made for derogations from the usual data protection and caducity rules.
Zato ima imetnik pravice, če mu je bilo izdano dovoljenje za promet, dostop do trga EU pod pogoji, ki mu drugače ne bi bili dovoljeni.
However, in the case of marketing authorisation, this procedure would allow the authorised person to enter the EU market on conditions in which he would not otherwise be allowed to do so.
Razen tega bi lahko dovoljenje, čeprav je bilo izdano le za namen izvoza, vplivalo na pravno varnost in neumestno dajalo prednost proizvajalcu generičnih zdravil, ki bi lahko – ob izteku obdobja varstva podatkov o patentiranih zdravilih – pridobil dovoljenje za prodajo na trgu EU prej, kot bi bilo to običajno predvidljivo.
Even on the understanding that such authorisation was granted only for export purposes, it would have the effect of reducing legal certainty and creating an unfair advantage for manufacturers of generic pharmaceuticals who, at the end of the period laid down for the protection of data relating to the patented product, could obtain marketing authorisation for the EU market before they could otherwise expect to do so.
Rešitev, ki se ponuja, je odprava postopka izdaje dovoljenja za promet, takoj ko postopek znanstvenega mnenja zagotovi nadzorovanje kakovosti farmacevtskih izdelkov za izvoz.
The solution proposed by your rapporteur, therefore, is to drop the marketing authorisation procedure, given that the scientific opinion procedure guarantees the possibility of controlling the quality of pharmaceutical products intended for export.
Odbor za pravne zadeve poziva Odbor za mednarodno trgovino, ki je edini pristojen, da v poročilo vključi naslednje predloge sprememb:
The Committee on Legal Affairs calls on the Committee on International Trade, as the committee responsible, to incorporate the following amendments in its report:
Predlogi Parlamenta
Amendments by Parliament
Naslov spletne strani mora biti sporočen pristojnemu organu in imetniku pravice .
The website address shall be communicated to the competent authority and to the right holder .
Pomembno je, da ima druga zainteresirana stran, in sicer imetnik pravice, dostop do tovrstnih podatkov.
The other party concerned, i.e. the right holder, should have access to this information.
V roku enega meseca po oddaji zahteve pri pristojnem državnem organu obvesti vlagatelj zahteve po prisilni licenci o tem imetnika pravice.
Within a month of applying to the competent national authority for a compulsory licence, the applicant shall notify the right holder of that application.
Vlagatelj mora o prejemu obvestila obvestiti pristojni državni organ.
The notification shall be communicated to the competent authority by the applicant.
Če obvestilo še ni bilo poslano, se postopek izdaje prisilne licence prekine.
If the applicant fails to notify the right holder, the procedure for granting the compulsory licence shall be suspended.
Imetnik pravice lahko poseže v postopek izdaje prisilne licence tako, da:
The right holder may intervene in the procedure for granting the compulsory licence in order to:
a) predloži pripombe v zvezi z obstojem dokazov in okoliščin iz člena 7;
(a) submit his own comments concerning the existence of the evidence and the factual circumstances referred to in Article 7;
b) predloži stališče v zvezi z roki in pogoji za izdajo prisilne licence;
(b) state his opinion on the terms and conditions governing the grant of the compulsory licence;
c) predloži pripombe v zvezi z upoštevanjem pogojev iz člena 8(2), (3), (6), in (9);
(c) submit his own comments concerning compliance with the conditions laid down in Article 8 (2),(3),(6) and (9);
d) oblikuje predloge in pripombe v zvezi s predpisi iz člena 8(4) o etiketiranju, označevanju in pakiranju izdelkov s prisilno licenco.
(d) submit proposals and comments concerning the requirements laid down in Article 8(4) on the labelling, marking and packaging of products manufactured under a compulsory licence.
Izdajanje prisilne licence znatno omejuje pravice intelektualne lastnine.
Granting a compulsory licence involves a significant curtailment of intellectual property rights.
Zato je treba uvesti postopek predlogov, ki imetniku pravice ponuja možnost, da poseže v postopek, ki ga obravnava pristojni državni organ.
For that reason, it is essential to have a system that allows both sides to be heard and enables the right holder to participate in the procedure brought before the competent national authority.
Tako bo lahko s predložitvijo pripomb v zvezi z roki in pogoji, ki veljajo za izdajanje prisilne licence, branil svoje pravne interese.
This will enable him to protect his legitimate rights by submitting his own observations on the terms and conditions for the grant of the compulsory licence.
(e) trajanje licence in pogoji za njeno izdajo,
(e) the duration of the licence and the conditions for the issue thereof ;
Kadar zahtevek za prisilno licenco zadeva zdravilo, odobreno v skladu s členom 6 Direktive 2001/83/ES, se določbe člena 24 (4) in (5) ter člena 14(4) in (5) Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta 1 ne uporabljajo.
Where the application for a compulsory licence concerns a medicinal product authorised in accordance with Article 6 of Directive 2001/83/EC, the provisions of Article 24(4) and (5) and of Article 14(4) and (5) of Regulation (EC) No 726/2004 of the European Parliament and the Council
Če odpravimo sklicevanje na dovoljenje za promet, ostanejo le odstopanja, ki dovoljujejo sprožitev postopka pridobitve znanstvenega mnenja iz člena 58 Uredbe (ES) št. 726/2004, ki popolnoma ustreza namenu, da se zagotovi kakovost izdelkov
By removing the reference to market authorisation, derogations would only be possible in connection with the scientific opinion procedure referred to in Article 58 of Regulation 726/2004/EC, which fully meets the purpose of ensuring the quality of products.
Predlog uredbe Evropskega parlamenta in Sveta o prisilnem licenciranju patentov v zvezi s proizvodnjo farmacevtskih izdelkov za izvoz v države s težavami v javnem zdravju
Proposal for a European Parliament and Council regulation on compulsory licensing of patents relating to the manufacture of pharmaceutical products for export to countries with public health problems
Predlog uredbe Evropskega parlamenta in Sveta o prisilnem licenciranju patentov v zvezi s proizvodnjo farmacevtskih izdelkov za izvoz v države s težavami v javnem zdravju
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
Členi 251(2) , 95 ES in 133 ES
Articles 251(2) , 95 EC and 133 EC
o vključevanju priseljencev v Evropi s pomočjo večjezičnih šol in izobraževanja
on integrating immigrants in Europe through schools and multilingual education
– ob upoštevanju Direktive Sveta 77/486/EGS z dne 25. julija 1977 o izobraževanju otrok delavcev migrantov
– having regard to Council Directive 77/486/EEC of 25 July 1977 on the education of the children of migrant workers
UL L 199, 6.8.1977, str.
OJ L 199, 6.8.1977, p.
– ob upoštevanju resolucije ministrov za šolstvo Evropske unije z dne 16. decembra 1997, ki države članice poziva k spodbujanju zgodnjega poučevanja jezikov in evropskega sodelovanja med šolami, ki ponujajo tovrstni pouk
– having regard to the resolution adopted on 16 December 1997 by the Union Ministers of Education, which calls on the Member States to encourage the early teaching of languages and Europe-wide cooperation among schools offering teaching of this type
UL C 1, 3.1.1998, str.
OJ C 1, 3.1.1998, p.
– ob upoštevanju Resolucije Sveta z dne 25. novembra 2003 o preoblikovanju šole v odprto učno okolje z namenom, da bi preprečili zgodnje zapuščanje šole in nezadovoljstvo med mladimi ter spodbudili njihovo socialno vključevanje
– having regard to the Council resolution of 25 November 2003 on ‘making school an open learning environment to prevent and combat early school leaving and disaffection among young people and to encourage their social inclusion’
UL C 295, 5.12.2003, str.
OJ C 295, 5.12.2003, p.
– ob upoštevanju poziva Evropskega sveta iz Barcelone marca 2002 k spodbujanju poučevanja vsaj dveh tujih jezikov od najzgodnejših let naprej,
– having regard to the call by the Barcelona European Council (March 2002) for at least two foreign languages to be taught from the earliest possible age,
– ob upoštevanju Sporočila Komisije Svetu, Evropskemu parlamentu, Ekonomsko-socialnemu odboru in Odboru regij o priseljevanju, vključevanje in zaposlovanju ( KOM(2003)0336 ),
– having regard to the communication from the Commission to the Council, the European Parliament, the European Economic and Social Committee and the Committee of the Regions on immigration, integration and employment ( COM(2003)0336 ),
– ob upoštevanju sporočila Komisije z dne 24. julija 2003 z naslovom "Pospeševanje učenja jezikov in jezikovne raznolikosti - akcijski načrt 2004-2006" ( KOM(2003)0449 ),
– having regard to the Commission communication of 24 July 2003 entitled ‘Promoting Language Learning and Linguistic Diversity: An Action Plan 2004 – 2006’ ( COM(2003)0449 ),
– ob upoštevanju sklepov Evropskega centra za spremljanje rasizma in ksenofobije, v katerih je predlagana okrepitev javnih sredstev za zmanjšanje pomanjkljivosti, ki jih imajo učenci iz skupnosti priseljencev ali manjšin,
– having regard to the conclusions in which the European Monitoring Centre on Racism and Xenophobia recommends that greater public support be provided in order to reduce the disadvantages suffered by pupils from migrant or minority communities,
– ob upoštevanju sklepov simpozija "Razvoj izobraževanja v Evropi - večjezičnost odpira nove perspektive", ki ga je 10. in 11. marca 2005 organiziralo luksemburško predsedstvo EU,
– having regard to the conclusions of the symposium on ‘The changing European classroom – the potential of plurilingual education’, held on 10 and 11 March 2005 under the auspices of the Luxembourg EU Presidency,
– ob upoštevanju sklepov Sveta ministrov za šolstvo z dne 25. maja 2005,
– having regard to the conclusions issued following the Education Council of 25 May 2005,
– ob upoštevanju poročila Odbora za kulturo in izobraževanje ( A6-0243/2005 ),
– having regard to the report of the Committee on Culture and Education ( A6‑0243/2005 ),
A. ker so se znatno povečali migracijski tokovi, odkar je bila leta 1977 sprejeta direktiva, s katero so priseljenci znotraj Skupnosti dobili pravico do učenja jezika države gostiteljice ter učenja jezika in spoznavanja kulture države izvora,
A. whereas migration has increased significantly since 1977, the year of adoption of the directive establishing the right of immigrants from within the Community to be taught the language of their host country and the language and culture of their country of origin,
B. ker so premiki priseljencev ustvarili nove izzive v zvezi z identiteto in uvrstili politiko vključevanja med prednostne naloge EU, držav članic ter regionalnih in lokalnih oblasti,
B. whereas migration has created new challenges in terms of identity and made integration policies one of the priorities for the EU, the Member States, and regional and local authorities,
C. ker je Evropa v različnih zgodovinskih dobah doživela obdobja preganjanj manjšin in ker ta stran v zgodovini, za katero si vsi želimo, da se ne bi nikoli več odprla, poudarja potrebo po politikah proti diskriminaciji na območju Unije,
C. whereas Europe has, at different times, seen periods in which minorities have been persecuted and whereas this chapter of European history, which, it is to be hoped, has been closed for good, highlights the importance of policies to combat discrimination in the Union area,
D. ker cela vrsta odločitev evropskih institucij poskuša izenačiti pravice do izobraževanja otrok in mladostnikov, živečih v EU, ne glede na njihov kraj rojstva, izvor njihovih staršev in starih staršev ali pravni položaj v katerem se nahajajo,
D. whereas the body of decisions taken by the European institutions seeks to establish equal rights as regards education for children and teenagers living in the EU, no matter where they were born, where their parents and grandparents came from, or what particular laws might apply to them,
E. ker sklepi Evropskega sveta z dne 23. in 24. marca 2000 (do leta 2010 prepoloviti število mladih med 18 in 24 letom, ki so končali zgolj nižje srednje izobraževanje) predpostavljajo splošen dostop do izobraževanja za otroke priseljencev in pripravljenost šol za spodbujanje njihovega vključevanja brez vsake diskriminacije,
E. whereas the European Council decisions of 23-24 March 2000 (whereby the number of 18- to 24-year-olds educated only up to lower secondary level is to be halved by 2010) imply that education needs to be made generally accessible to the sons and daughters of immigrants and schools have to be ready to promote their integration without any form of discrimination,
F. ker so težave z učenjem učencev, pri katerih se družinsko življenje odvija v drugem jeziku kot tistem, ki ga uporabljajo v šoli, pogosto povezane z oteženimi materialnimi, socialnimi in psihološkimi pogoji za normalen šolski uspeh,
F. whereas as well as finding it difficult to learn when their families communicate in a language other than the one used at school, the pupils concerned are often affected by material, social, and psychological circumstances that militate against normal school achievement,