natgillin/translations-raw huggingface dataset:
Poskusi, da se poslancem Evropskega parlamenta prepreči, da izražajo mnenje o zadevah, za katere obstajata legitimni javni interes in zaskrbljenost, ter da kritizirajo svoje politične nasprotnike tako, da se proti njim sproži sodne postopke, so v demokratični družbi nesprejemljivi in kršijo člen 8 Protokola, katerega namen je varovati svobodo izražanja poslancev pri izvrševanju njihovih dolžnosti v interesu Parlamenta kot institucije Evropske unije.
To seek to prevent Members of Parliament from expressing their opinions on matters of legitimate public interest and concern and from criticising their political opponents by bringing legal proceedings is unacceptable in a democratic society and in breach of Article 8 of the Protocol, which is intended to protect Members' freedom of expression in the performance of their duties in the interests of Parliament as an institution of the European Union.
Na osnovi zgornjih preudarkov in v skladu s členom 6(3) Poslovnika ter po preučitvi razlogov za in proti zaščiti poslančeve imunitete, Odbor za pravne zadeve priporoča, da Evropski parlament zaščiti poslansko imuniteto Luigija de Magistrisa.
On the basis of the above considerations and pursuant to Article 6(3) of the Rules of Procedure, after considering the reasons for and against defending the Member’s immunity, the Committee on Legal Affairs recommends that the European Parliament should defend the parliamentary immunity of Luigi De Magistris.
Marielle Gallo, Klaus-Heiner Lehne, Antonio Masip Hidalgo, Bernhard Rapkay, Francesco Enrico Speroni, Dimiter Stojanov (Dimitar Stoyanov), Alexandra Thein, Diana Wallis, Zbigniew Ziobro, Tadeusz Zwiefka
Marielle Gallo, Klaus-Heiner Lehne, Antonio Masip Hidalgo, Bernhard Rapkay, Francesco Enrico Speroni, Dimitar Stoyanov, Alexandra Thein, Diana Wallis, Zbigniew Ziobro, Tadeusz Zwiefka
o razrešnici glede izvrševanja proračuna Evropske agencije za zdravila za proračunsko leto 2009
on discharge in respect of the implementation of the budget of the European Medicines Agency for the financial year 2009
– ob upoštevanju letnih računovodskih izkazov Evropske agencije za zdravila za proračunsko leto 2009,
– having regard to the final annual accounts of the European Medicines Agency for the financial year 2009,
– ob upoštevanju poročila Računskega sodišča o letnih računovodskih izkazih Evropske agencije za zdravila za proračunsko leto 2009, skupaj z odgovori agencije
– having regard to the Court of Auditors’ report on the annual accounts of the European Medicines Agency for the financial year 2009, together with the Agency’s replies
– ob upoštevanju priporočila Sveta z dne 15. februarja 2011 (05892/2011 – C7-0052/2011 ),
– having regard to the Council's recommendation of 15 February 2011 (05892/2011 – C7‑0052/2011 ),
– ob upoštevanju poročila Odbora za proračunski nadzor in mnenja Odbora za okolje, javno zdravje in varnost hrane ( A7-0153/2011 ),
– having regard to the report of the Committee on Budgetary Control and the opinion of the Committee on the Environment, Public Health and Food Safety ( A7-0153/2011 ),
o zaključku poslovnih knjig Evropske agencije za zdravila za proračunsko leto 2009
on the closure of the accounts of the European Medicines Agency for the financial year 2009
s pripombami, ki so del sklepa o razrešnici glede izvrševanja proračuna Evropske agencije za zdravila za proračunsko leto 2009
with observations forming an integral part of its Decision on discharge in respect of the implementation of the budget of the European Medicines Agency for the financial year 2009
– ob upoštevanju letnega zaključnega računa Evropske agencije za zdravila za proračunsko leto 2009,
– having regard to the final annual accounts of the European Medicines Agency (EMEA) for the financial year 2009,
– ob upoštevanju letnega notranjega revizijskega poročila o Evropski agenciji za zdravila za leto 2009, ki ga je pripravila služba za notranjo revizijo;
– having regard to the Internal Audit Service's Annual Internal Audit Report on the European Medicines Agency for 2009;
A. ker je Računsko sodišče v svojem poročilu o letnih računovodskih izkazih agencije za proračunsko leto 2009 izdalo mnenje s pridržkom glede zakonitosti in pravilnosti z njimi povezanih transakcij,
A. whereas the Court of Auditors, in its report on the annual accounts of the Agency for the financial year 2009, qualified its opinion on the legality and regularity of the underlying transactions,
B. ker je Parlament 5. maja 2010 izvršnemu direktorju Evropske agencije za zdravila podelil razrešnico glede izvrševanja proračuna agencije za proračunsko leto 2008
B. whereas on 5 May 2010 Parliament granted the Executive Director of the European Medicines Agency discharge in respect of the implementation of the Agency’s budget for the financial year 2008
164. in v resoluciji, ki spremlja sklep Parlamenta o razrešnici, med drugim:
164. , and in its resolution accompanying the discharge decision, inter alia:
- izrazil zaskrbljenost zaradi ugotovitve Računskega sodišča, da je znesek prenesenih proračunskih sredstev dosegel 36 milijonov EUR (19,7 % proračuna), znesek razveljavljenih proračunskih sredstev pa 9,7 milijona EUR (tj.
- was concerned by the Court of Auditors' findings that the budget appropriations carried over and cancelled have amounted to EUR 36 000 000 (19,7 % of the budget) and EUR 9 700 000 (5,3 % of the budget) respectively,
C. ker je proračun agencije za leto 2009 znašal 194.000.000 EUR, kar je za 6,28 % več kot v proračunskem letu 2008,
C. whereas the budget of the Agency for the year 2009 was EUR 194 000 000 which is an increase of 6,28 % from the financial year 2008,
D. ker se proračun agencije financira iz proračuna Unij, ki predstavlja 18,52 % skupnih prejemkov v letu 2009, predvsem pa s taksami, ki jih plačujejo farmacevtske družbe, in ker se je posledično splošni prispevek Unije med letom 2008 in 2009 zmanjšal za 9,2 %;
D. whereas the Agency’s budget is financed both from the Union budget, which accounted for 18,52 % of total revenue in 2009, and, to a greater extent, from fees paid by pharmaceutical companies, and whereas the Union’s general contribution consequently decreased by 9,2 % between 2008 and 2009;
i. vodenje postopkov javnih naročil,
i. the management of procurement procedures,
ii. pomanjkanje upoštevanja postopkov in pogosto pomanjkanje izvedbenih postopkov za ugotavljanje in upravljanje navzkrižja interesov uslužbencev in strokovnjakov agencije,
ii. the lack of respect to, and frequent lack of, implementing procedures regarding the identification and management of conflicts of interest for its staff and experts,
iii. merila za zaposlovanje uslužbencev;
iii. the criteria used for recruiting staff;
i. ponavljajočih se napak pri vodenju postopkov javnih naročil, kot so bile tiste, najdene v letu 2009, ki so predstavljale precejšen delež celotnega proračuna agencije in bi lahko ogrozile zakonitost in pravilnost transakcij, povezanih z računovodskimi izkazi agencije,
i. persistent errors in the management of procurement procedures, such as the ones found in 2009 corresponding to a significant amount of the Agency's total budget, which could compromise the legality and regularity of the transactions underlying the Agency's accounts,
ii. morebitnih tveganj glede neodvisnosti strokovnjakov in uslužbencev, ki sodelujejo pri vrednotenju medicinskih proizvodov, kar bi lahko imelo ne samo hude posledice za ugled agencije, če bi bile ocene proizvodov uradno postavljene pod vprašaj, ampak tudi negativen vpliv na javno zdravje,
ii. potential risks to the independence of experts/staff involved in the evaluation of medicinal products, which could have not only detrimental consequences to the Agency's reputation should the evaluation of products be formally questioned, but also might have negative effects on public health,
iii. morebitnih pomanjkljivosti pri zaposlovanju uslužbencev in strokovnjakov, kar bi lahko privedlo ne samo do izločitve sposobnih kandidatov in/ali zaposlovanja manj sposobnih kandidatov, ampak ima lahko tudi negativne vplive na kakovost znanstvenega ocenjevanja agencije ter posledično na javno zdravje;
iii. potential deficiencies in staff/experts' recruitment which could not only lead to disqualification of competent candidates and/or recruitment of less qualified candidates but also might have adverse effects on the quality of the Agency’s scientific assessment work and, consequently, on public health;
4. še posebej poudarja, da je agencija v več postopkih javnih naročil za obsežne okvirne pogodbe za informacijsko tehnologijo v ocenjeni vrednosti 30.000.000 EUR leta 2009 naredila več napak pri začetku postopkov, kot so:
Acknowledges, in particular, that in a number of procedures for the procurement of large IT framework contracts of an estimated value of EUR 30 000 000 the Agency made several errors in 2009 at the moment of opening the procedure such as:
i. aritmetične napake pri vrednotenju meril za dodelitev naročila,
i. arithmetical errors in the evaluation of the award criteria,
ii. neustrezna dokumentacija o vrednotenju člana izbirne komisije,
ii. inappropriate documentation of the evaluation by a member of the evaluation committee,
iii. nezadostni dokazi, da je bila metoda vrednotenja izbirnih meril uporabljena dosledno, zato je dopuščala različne interpretacije,
iii. a lack of evidence that the evaluation method of the selection criteria had been applied consistently which was thus open to interpretation,
5. ugotavlja tudi, da je v drugih dveh postopkih javnih naročil s pogajanji v zneskih 5.300.000 EUR in 4.000.000 EUR z enim samim dobaviteljem prišlo do več napak pri začetku postopka, na primer:
Acknowledges, also, that in two other negotiated procurements of EUR 5 300 000 and EUR 4 000 000 with a single supplier, several errors were again made at the moment of opening the procedure such as:
i. uradno povabilo za javni razpis ni bilo objavljeno,
i. no formal invitation to tender being issued,
ii. podrobne tehnične specifikacije niso bile pripravljene vnaprej,
ii. no detailed technical specifications being prepared in advance,
iii. tehnične specifikacije pred začetkom pogajanj niso jasno opredeljevale vseh proizvodov, ki so predmet naročila,
iii. technical specifications not clearly defining all the products to be purchased before the negotiation started,
iv. izbirna komisija ni bila imenovana,
iv. no evaluation committee being appointed,
v. poročilo o vrednotenju ni bilo pripravljeno,
v. no evaluation report being prepared;
9. poziva agencijo, naj zagotovi, da se rezultati postopkov javnih naročil preverijo pred oddajo naročil; pričakuje, da se glede na ugotovitve Računskega sodišča vedno pripravijo podrobne tehnične specifikacije;
Calls on the Agency to ensure that the results of procurement procedures are verified before contracts are awarded; expects that detailed technical specifications shall always be prepared, in view of the Court of Auditors’ findings;
10. je zaskrbljen, ker je Računsko sodišče poročalo o prenosu proračunskih sredstev v znesku 19.500.000 EUR (38 % vseh obveznosti agencije) in da je bilo približno 14.800.000 EUR prenesenega zneska namenjenih dejavnostim, ki ob koncu leta še niso bile izvedene (oziroma v nekaterih primerih blagu, ki še ni bilo dobavljeno); poudarja, da je to stanje dokaz zamud pri izvajanju dejavnosti, ki se financirajo iz naslova II proračuna agencije, in priča, da agencija ne spoštuje proračunskega načela enoletnosti;
Is concerned that the Court of Auditors has reported a carryover of EUR 19 500 000 (38 % of the Agency's commitments) and that approximately EUR 14 800 000 of this carryover was for activities as yet not implemented (or, in some cases, goods not received) at the year-end; stresses that this situation indicates delays in the implementation of activities financed from Title II of the Agency’s budget and that the Agency is not in accordance with the budgetary principle of annuality;
Prihodki od pristojbin
Revenue from fees
14. od agencije ugotavlja, da je revizijski svetovalni odbor agencije revidiral politiko vodenja zakladnice, jo sprejel in uradno potrdil; poziva agencijo, da Parlamentu pred 30. junijem 2011 posreduje pregled izvajanja revidirane politike vodenja zakladnice;
Notes from the Agency that the treasury policy has been revised, adopted and formally approved by the Agency’s Audit Advisory Committee; calls on the Agency to provide Parliament with an overview of the implementation of the revised treasury policy before 30 June 2011;
Upravljanje navzkrižij interesov
Management of conflicts of interest
18. ni pripravljen sprejeti dejstva, da agencija ne spoštuje natančno kodeksa o ravnanju pri določanju načel in smernic o neodvisnosti in zaupnosti, ki veljajo za člane sveta in odbora, strokovnjake in zaposlene v agenciji; od agencije pričakuje, da pred določanjem projektnih vodij za izdelke podrobno oceni, ali bi lahko interesi, ki so jih razkrili uslužbenci, vplivali na njihovo nepristranskost in neodvisnost; poleg tega poziva agencijo, naj dokumentira in oceni svoje kontrole ter vodi evidenco sklepov o dodeljevanju projektov, ki morajo biti na voljo na njeni spletni strani;
Considers it unacceptable that the Agency is not complying effectively with its Code of Conduct by setting out principles and guidance on independence and confidentiality applicable to the Management Board and committees’ members, experts and Agency’s staff; expects the Agency to assess thoroughly, before the allocation of project team leaders to products, whether the interests declared by staff members might influence their impartiality and independence; urges, in addition, the Agency to document and assess its controls and file the relevant allocation decisions which must be made available on its website;
14 a. nemudoma poziva agencijo, da organu za podeljevanje razrešnice posreduje elemente, ki jih je vzpostavila za zagotavljanje neodvisnosti strokovnjakov vse od svoje ustanovitve;
Urges the Agency to inform the discharge authority of the steps it has taken to ensure the independence of its experts since its inception;
14 b. se sprašuje o tem, da pomanjkljivosti glede ocenjevanja neodvisnosti strokovnjakov niso navedene v poročilih Računskega sodišča glede letnih računovodskih izkazov agencije od leta 2006 dalje;
Wonders why the Court of Auditors’ reports since 2006 on the Agency’s annual accounts make no mention of any deficiencies with regard to the assessment of experts’ independence;
Primer Mediator
The Mediator case
Postopki za znanstveno vrednotenje zdravil za ljudi
Procedures supporting the provision of scientific evaluation for human medicines
Vloga agencije in pristojnih nacionalnih organov
Role of the Agency and national competent authorities
28. pozdravlja prizadevanja agencije, da bi ponudila obsežnejše znanstveno svetovanje v zgodnjih fazah razvoja novih zdravil, kakor tudi ukrepe za pospešitev ocenjevanja zdravil, ki so bistvenega pomena za javno zdravje, ter za pospešitev razvoja in izvajanja telematskih programov;
Welcomes the efforts of the Agency to provide more scientific advice at the early stages of the development of new medicines as well as the introduction of measures to accelerate the assessment of medicines that are of critical importance to public health and to accelerate the development and implementation of telematics' programmes;
Upravljanje človeških virov
Human resources management
33. ni pripravljen sprejeti dejstva, da izjava o zanesljivosti izvršnega direktorja z dne 13. maja 2010 ne vsebuje nobenega pridržka, in posledično ne spoštuje obveze iz kodeksa o ravnanju, ki ga je sprejela agencija, glede izjav o zanesljivosti službe za notranjo revizijo in Računskega sodišča;
Considers it unacceptable that the Executive Director’s statement of assurance, dated 13 May 2010, does not mention any reservations, and is consequently inconsistent with the undertaking given in the Code of Conduct adopted by the Agency in the light of the statements of assurance from the IAS and the Court of Auditors;
i. število in vrsto notranjih revizij, ki jih je opravila služba za notranjo revizijo;
i. the number and types of internal audits conducted by the IAS,
ii. vsa priporočila (tudi tista, ki bi jih agencija utegnila zavrniti) in
ii. all the recommendations made (including any that may have been rejected by the Agency), and
iii. vse ukrepe, sprejete na podlagi teh priporočil,
iii. all the measures taken on the basis of those recommendations,
se sprašuje, če so bile te obveze izpolnjene v prejšnjih proračunskih letih in zahteva, da agencija do 30. junija 2011 organu za podeljevanje razrešnice posreduje poročila službe za notranjo revizijo od leta 2007 dalje;
wonders whether these requirements were fulfilled in previous years, and asks the Agency to forward the IAS reports since 2007 to the discharge authority by 30 June 2011;
36. ugotavlja, da je izmed 32 priporočil službe za notranjo revizijo eno „kritično“, namreč o izvedbenih postopkih za strokovnjake, 12 pa jih je „zelo pomembnih“ ter se nanašajo predvsem na kadrovsko vodenje, upravljanje navzkrižja interesov zaposlenih in druge postopke znanstvenega vrednotenja zdravil za ljudi v agenciji; zato poziva agencijo, naj organ za podeljevanje razrešnice nemudoma obvesti o natančni vsebini teh priporočil; poziva agencijo, naj nemudoma izvede priporočila službe za notranjo revizijo in organu za podeljevanje razrešnice posreduje celovit pregled sprejetih in izvedenih ukrepov, da se do 30. junija 2011 ta priporočila obravnavajo; poleg tega od Računskega sodišča zahteva, naj spremlja učinkovitost sprejetih ukrepov in o tem obvešča organ za podeljevanje razrešnice;
Acknowledges that, out of the 32 recommendations of the IAS, one is "critical" on the implementing procedures involving experts and twelve are "very important" mainly on human resources management, on management of staff's conflicts of interest and on other procedures supporting the provision of scientific evaluation for human medicines in the Agency; calls, therefore, on the Agency to inform the discharge authority about the precise content of these recommendations without delay; urges the Agency to rapidly implement the IAS recommendations and to provide the discharge authority with a complete overview of measures taken and implemented to properly address these recommendations by 30 June 2011; asks, in addition, the Court of Auditors to monitor and inform the discharge authority of the efficiency of the measures taken;
Ukrepi, ki jih mora agencija sprejeti do 30. junija 2011
Actions to be taken by the Agency by 30 June 2011
23 a. poziva agencijo, naj do 30. junija 2011 organ za podeljevanje razrešnice obvesti o sprejetih ukrepih in izboljšavah v zvezi z vsemi temi vprašanji;
Calls on the Agency, therefore, to inform the discharge authority by 30 June 2011 of the measures taken and the improvements made in respect of all these areas of concern;
o razrešnici za izvrševanje proračuna Evropske agencije za zdravila za proračunsko leto 2009
on discharge in respect of the implementation of the budget of the European Medicines Agency for the financial year 2009
3. meni, da je agencija vir pomembnih znanstvenih mnenj, znanstvenih priporočil, najboljše prakse za ocenjevanje in nadzor zdravil v Uniji; pozdravlja prispevke Komisije in držav članic za uskladitev regulativnih standardov na mednarodni ravni;
Considers the Agency a source of important scientific advice, science-based recommendations, best practice for medicines' evaluation, and for supervision in the Union; welcomes the contributions of the Commission and the Member States towards the harmonisation of regulatory standards at international level;
1). ; spodbuja agencijo, naj nadaljuje z ukrepi za zagotavljanje spodbud za raziskave, razvoj in dajanje na trg zdravil, ki so opredeljena kot zdravila sirote;
1. ; encourages the Agency to continue its action to provide incentives for the research, development and placing on the market of designated orphan medicinal products;
8. ugotavlja, da je bilo usklajevanje lastnih prihodkov agencije med finančnimi in znanstvenimi službami deloma nezadovoljivo; poziva agencijo, naj si še naprej prizadeva za izboljšanje usklajevanja med službami;
Notes that the Agency’s own revenue coordination between financial and scientific departments was in some cases inadequate; calls on the Agency to continue its efforts to improve coordination between those departments;
János Áder, Kriton Arsenis, Pilar Ayuso, Paolo Bartolozzi, Sandrine Bélier, Sergio Berlato, Martin Callanan, Nessa Childers, Chris Davies, Bairbre de Brún, Bas Eickhout, Edite Estrela, Karl-Heinz Florenz, Elisabetta Gardini, Cristina Gutiérrez-Cortines, Satu Hassi, Jolanta Emilia Hibner, Dan Jørgensen, Karin Kadenbach, Christa Klaß, Holger Krahmer, Jo Leinen, Corinne Lepage, Linda McAvan, Radvilė Morkūnaitė-Mikulėnienė, Miroslav Ouzký, Vladko Todorov Panajotov (Vladko Todorov Panayotov), Gilles Pargneaux, Antonija Prvanova (Antonyia Parvanova), Andres Perello Rodriguez, Sirpa Pietikäinen, Mario Pirillo, Pavel Poc, Vittorio Prodi, Frédérique Ries, Anna Rosbach, Oreste Rossi, Dagmar Roth-Behrendt, Daciana Octavia Sârbu, Carl Schlyter, Horst Schnellhardt, Richard Seeber, Teodoros Skilakakis (Theodoros Skylakakis), Bogusław Sonik, Salvatore Tatarella, Åsa Westlund, Glenis Willmott, Sabine Wils, Marina Yannakoudakis
János Áder, Kriton Arsenis, Pilar Ayuso, Paolo Bartolozzi, Sandrine Bélier, Sergio Berlato, Martin Callanan, Nessa Childers, Chris Davies, Bairbre de Brún, Bas Eickhout, Edite Estrela, Karl-Heinz Florenz, Elisabetta Gardini, Cristina Gutiérrez-Cortines, Satu Hassi, Jolanta Emilia Hibner, Dan Jørgensen, Karin Kadenbach, Christa Klaß, Holger Krahmer, Jo Leinen, Corinne Lepage, Linda McAvan, Radvilė Morkūnaitė-Mikulėnienė, Miroslav Ouzký, Vladko Todorov Panayotov, Gilles Pargneaux, Antonyia Parvanova, Andres Perello Rodriguez, Sirpa Pietikäinen, Mario Pirillo, Pavel Poc, Vittorio Prodi, Frédérique Ries, Anna Rosbach, Oreste Rossi, Dagmar Roth-Behrendt, Daciana Octavia Sârbu, Carl Schlyter, Horst Schnellhardt, Richard Seeber, Theodoros Skylakakis, Bogusław Sonik, Salvatore Tatarella, Åsa Westlund, Glenis Willmott, Sabine Wils, Marina Yannakoudakis
– ob upoštevanju zahteve Bruna Gollnischa za zaščito njegove imunitete v zvezi s kazenskim postopkom pred francoskim sodiščem, ki je bila vložena 10. junija 2010 in razglašena na plenarnem zasedanju 14. junija 2010,
– having regard to the request by Bruno Gollnisch for defence of his immunity in connection with criminal proceedings pending before a French court, as submitted on 10 June 2010 and announced in plenary sitting on 14 June 2010,
– po zaslišanju Bruna Gollnischa dne 26. januarja 2011 v skladu s členom 7(3) poslovnika,
– having heard Bruno Gollnisch on 26 January 2011, in accordance with Rule 7(3) of its Rules of Procedure,
– ob upoštevanju člena 9 Protokola o privilegijih in imunitetah Evropske unije z dne 8. aprila 1965 in člena 6(2) Akta o volitvah poslancev Evropskega parlamenta s splošnimi neposrednimi volitvami z dne 20. septembra 1976,
– having regard to Article 9 of the Protocol on the Privileges and Immunities of the European Union of 8 April 1965, and to Article 6(2) of the Act of 20 September 1976 concerning the election of the members of the European Parliament by direct universal suffrage,
Zadeva 101/63 Wagner proti Fohrmannu in Krierju [1964] ECR 195, zadeva 149/85 Wybot proti Faure in drugim [1986] ECR 2391, zadeva T-345/05 Mote proti Parlamentu [2008] ECR II-2849, združeni zadevi C-200/07 in C-201/07 Marra proti De Gregorio in Clemente [2008] ECR I-7929 in zadeva T-42/06 Gollnisch proti Parlamentu . ,
Case 101/63 Wagner v Fohrmann and Krier [1964] ECR 195, Case 149/85 Wybot v Faure and Others [1986] ECR 2391, Case T-345/05 Mote v Parliament [2008] ECR II-2849, Joined Cases C-200/07 and C-201/07 Marra v De Gregorio and Clemente [2008] ECR I-7929, and Case T-42/06 Gollnisch v Parliament . ,
– ob upoštevanju 26. člena ustave Francoske republike,
– having regard to Article 26 of the Constitution of the French Republic,
– ob upoštevanju poročila Odbora za pravne zadeve ( A7-0154/2011 ),
– having regard to the report of the Committee on Legal Affairs ( A7-0154/2011 ),