natgillin/translations-raw huggingface dataset:
De farmaceutiske virksomheder mener, at det er uretfærdigt, at de skal dække sådanne omkostninger.
Some months ago the House passed amendments to Statutes, as mentioned by Mr Tappin.
De advarer om, at hvis gebyrerne sættes for højt eller på et niveau, der undergraver rentabiliteten, vil de skære ned på forskning og udvikling. De er tydeligvis, som alle andre, opsat på at beskytte deres kapitalinteresser.
I am assured by the Council that those amendments are not blocked in the Council, but are merely behind schedule.
Denne nye linje skal gøre det muligt at inkorporere yder ligere aktiviteter i agenturernes arbejdsprogram, så længe dette ikke indebærer øgede personale- eller kapitaludgifter, der overstiger grænserne for eksisterende budgetter.
What conclusions can we draw? Over the three years in which I have been standing rapporteur for the agencies for the Committee on Budgets, I have been fortunate to have the very positive support of people like Edward Kellett-Bowman - my colleague across the way - Mr Mingasson, and the agency directors.
Medlemmerne er muligvis klar over, at Den Europæiske Union netop har truffet en række afgørelser om ønskelig heden ved at opretholde arbejdet med lægemidler uden indtægtsgrundlag, teknisk samarbejde forud for tiltrædelse, aftaler med tredjelande om gensidig anerkendelse osv. Det er i alles interesse, at dette vigtige unionsforehavende udføres effektivt.
We want to make sure that, although they operate at a dis tance from the central places of work, they are still part of Community bodies, still accountable to the democratically elected Members of Parliament, controlled but not overwhelmed either by lots of different groups which have dropped in to check up on them and their work, or by the bureaucratic demands of people trying to assess what is going on from a distance. We wanted to strike a balance.
For at sikre at London og alle andre agenturer fremover opretholder deres støtte til princippet,.har vi fastlagt og udarbejdet en adfærdskodeks.
Many of the agencies are still in their start-up phases. Many were frozen in mid-growth by the standstill budgets of the past two years.
Den omhandler f.eks. aftaler om rapportering og gennemsigtighed som f.eks. for det første at bede agenturer om at rapportere eventuelle ændringer i deres budgetter til budgetmyndigheden og for det andet at rapportere deres stillingsfortegnelser og arbejdsprogrammer til overvejelse i udarbejdelsen af deres budgetter.
Some may never achieve the format originally set out in their establishment plan, and there are still ideas for more agencies in the pipeline.
Det er i alles interesse, herunder medlemsstaternes, at reducere omkostningerne ved lægemidler, da staten i sidste ende yder tilskud til en stor del af omkostningerne gennem folkesundhedsprogrammer og lægebehandling.
The fourth point is that the European Court of Auditors' initial report on this agency for the past year gives them a clean sheet.
Det er ligeledes tydeligt, at den fremtidige finansiering af agenturet vil afhænge af de strukturelle mekanismer, vi opretter for at garantere den stabilitet, det behøver for at fungere ordentligt.
This certificate has eluded the Commission and all other bodies over the years since the Maastricht Treaty brought it into being but I see this agency as being a candidate for taking the blue ribbon very soon.
Jeg må understrege, at størstedelen af agenturerne har støttet kodeksen fuldt ud, og den er desuden blevet udformet i samråd med de involverede parter.
Mr Tappin has produced a good report. I encourage the House to support the amendments and his report.
Disse principper, gælder alle agenturer, ikke kun i London.
The automated financial systems, which not just London but almost all the agencies will have up and running in the near future, will help.
Vi er ligeledes, i store træk, nået til en aftale om harmoni seringen af bestemmelser vedrørende stiftelse.
The next agency budgets will take place in the new par liamentary term.
Selvom dette er blevet godkendt i Parlamentet, ligger det stadig hos Rådet og afventer enighed.
By then all the mechanisms and structures should be in place to make arguments about budget levels much more informed.
Dér har det været alt for længe, og vi burde presse hårdt på i Rådet via budgetproceduren for at få dem til at tage sig af dette hurtigst muligt. ligt.
The budgetary authority should be able to make its assess ments on the basis of real evidence of need and perform ance, surely the best basis for judgement.
Vi har også medtaget et afsnit i det almindelige budget, der skal dække agenturernes bygninger.
To conclude, I commend my recommendations specifically on the fee structure for the EMEA but, in general, for those which will impact on this and other agencies' abilities to produce the work we require of them in the most efficient and effective way.
Det synes latter ligt, at EU har aktiver eller passiver i medlemsstaterne, som vi ikke har nogen oplysninger om.
I hope the House will support my amendments and the amendments of the Committee on Budgets and the Committee on the Envi ronment, Public Health and Consumer Protection.
For det første kræver Parlamentet, at der indføres en me kanisme til automatisk'op- eller nedjustering af agenturer nes budgetter til kompensation for virkningen ved valutakurssvingninger eller ændringer i de institutionelle juste ringskoefficienter.
Valverde López (PPE), draftsman of the opinion of the Committee on the Environment, Public Health and Consumer Protection. - (ES) Mr President, I would firstly like to add my congratulations to those for the rapporteur, Mr Tappin, as he has drawn up an excellent report.
Hvilke slutninger kan vi drage? I løbet af de tre år, hvor jeg har været ordfører for agenturerne for Budgetudvalget, har jeg været så heldig at få megen positiv tilslutning fra mennesker som Edward Kellett-Bowman - min kollega på den anden side af gangen - hr. Mingasson og di rektørerne for agenturerne.
Kellett-Bowman (PPE), draftsman of the opinion of the Committee on Budgetary Control. - Mr President, I want to congratulate Mr Tappin.
Vi har forsøgt at afmystificere satellitagenturerne: at få dem ned på jorden.
Clearly he has become an ac knowledged expert on the workings of the decentralised bodies and agencies.
Vi ønsker at sikre, at de stadig er en del af fællesskabsorganerne, selvom de opererer et stykke væk fra de centrale arbejds pladser, stadig er ansvarlige over for de demokratisk valgte parlamentsmedlemmer, kontrolleret men ikke
The conclusions of the Budgetary Control Committee are brief, and read as follows: 'The Committee on Budgetary Control welcomes the proposal of the Commission whereby the EMEA charges its customers fees that are more commensurate with the costs it incurs, and also
EMEA har lidt store tab som følge af det britiske punds stærke stilling.
It was necessary for fee levels to be updated - as provided for in the regulations establishing the Agency - and I therefore believe that it is appropriate for this Parliament to support the change in these fee levels.
Det handler ikke om, hvorvidt de taber el ler tjener penge, men om at et aftalt budget bør være et budget, der efterleves.
But perhaps we must also remember that these fees are not taxes and should only be paid for services rendered. That is the ba-
Mange veterinærprodukter kommer i sidste ende ind i det humane system, og jeg spekulerer på, om de ikke burde på løbe større udgifter, men det er ikke sket.
Gradin, Member of the Commission. -1 am very pleased that it has been possible to have this item on the agenda of the plenary session so quickly.
Som hr. Tappin nævnte, godkendte Parlamentet for nogle måneder siden nogle ændringsforslag til statutter.
I would therefore like to thank all those who invested a considerable amount of work on this draft proposal.
oversvømmet hverken af mange forskellige grupper, der er kommet forbi for at efterse deres arbejde, eller af de bureaukratiske krav fra mennesker, der på afstand forsøger at vurdere, hvad der foregår.
The current level and structure of fees payable by the pharmaceutical industry to the European Agency for the evaluation of medical products was set out in the 1995 Council regulation.
Vi ønskede at finde en balance. Mange agenturer er stadig i startfasen.
In accordance with Article 10 of this regulation the Commission submitted a report on its im plementation.
Mange blev frosset fast midtvejs af de sidste to års stillestående bud getter.
In the light ofthat exercise we proposed the definitive regulation in January 1998.
Det fjerde punkt er, at Den Europæiske Revisionsrets før ste beretning for sidste år om dette agentur visker tavlen ren.
However, Mr President, whilst I support an increase in fees, I would like to highlight the pressing need to main tain the Agency's independence.
Hr. Tappin har udarbejdet en god betænkning. Jeg opfordrer Parlamentet til at støtte ændringsforslagene og hans betænkning.
In preparing this report the Commission has sought to en sure two aims: first, not to place undue burden on applicants; second, not to endanger the achievement of the EMEA's primary task which is to provide scientific ad vice of the highest possible quality in relation to the au thorisation and supervision of medical products.
De automatiske finansieringssystemer, som ikke blot London men næsten alle agenturerne får op at køre inden for nær fremtid, vil hjælpe.
The European Union and its pharmaceutical industry -the largest in the world - need a strong Agency that has the necessary scientific resources.
De næste agenturbudgetter finder sted i den nye parlamentariske periode.
It is just one example of how important this body is.
Da bør alle mekanismer og strukturer være på plads for at gøre argumenter vedrørende budget niveauer langt mere velunderrettede.
It can only grow in importance, bearing in mind that it has only been operational for three years.
Afslutningsvis anbefaler jeg mine henstillinger, særligt om gebyrstrukturen til EMEA, men generelt til dem der vil have indflydelse på dette og andre agenturers evner til at foretage det arbejde, vi kræver af dem, så effektivt som muligt.
Particular attention was given to the fact that fees should normally be lower than the total of fees charged by 15 Member States.
Og agenturerne er et fantastisk arbejdsredskab i Kommissionen.
So I think that most of the EMEA's revenue should come from fees, but that some of it should continue to come from the EU budget.
Derfor er de tre udvalg, som har udarbejdet betænkninger, i det store hele enige om denne støtte til agenturet på grund af dets fremragende arbejde.
It would give us a better idea in future of what proportion of the Agency's work is taken up by the public health re sponsibilities laid on it by the institutions.
Kellett-Bowman (PPE), ordfører for udtalelsen fra Bud getkontroludvalget. - (EN) Hr. formand Jeg vil gerne lykønske hr. Tappin.
I am pleased to announce that the Commission will take up several of the amendments proposed by the European Parliament.
Budgetkontroludvalgets konklusioner er korte og lyder som følgende: »Budgetkontroludvalget glæder sig over Kommissionens forslag, hvorved EMEA kan pålægge sine kunder gebyrer, der er mere forenelige med de om kostninger, det har, og vil også benytte denne lejlighed til at lykønske agenturet med de driftsmæssige fremskridt, der er gjort.«
It will take on board the following is sues: the suggestion that future amendments to the fees regulation will be based on a complete evaluation of all costs of the Agency - Amendment No 16; clarification that the fee for evaluation covers all strengths and pharmaceutical forms of a product - Amendments Nos 10 and 11 ; increase of the additional arbitration fee for veterinary medical products - Amendment No 12; increase of the fees for changes to a maximum residue limit óf a veterinary medical product - Amendment No 13; the introduction of a flexible fee for scientific advice; Amendment No 14.
At vi må beskæftige os med ajourføring af gebyrerne er en nødvendighed - og det var fastlagt i dets grundforordning - og derfor mener jeg, at det er godt, at Parlamentet samtykker i ændringen af disse gebyrer.
The rapporteur also says that the Agency made a loss of 20 % due to currency fluctuations and the effect of the corrective coefficient or weighting.
Men det bør måske også huskes, at gebyrerne ikke er afgifter, og at de kun skal betales for ydede tjenester.
How does the Commission deal with this question of currency move ments and the weighting in the Agency's case?
Jeg vil gerne trække fire punkter frem. For det første er agenturet et glimrende eksempel på subsidaritet. Læge middelfabrikanter i Europa kan opnå registrering et sted, som fungerer i alle medlemsstater.
Unfortunately we will not be able to take on board all amendments.
Dette er langt mere ef fektivt og absolut billigere.
Lastly, we think it is important, and this must be clear, to guarantee the payment of a certain sum from our budget.
Problemet med gebyrer blev vel fremført af hr. Tappin.
As rapporteur on the budget for the Environment Com mittee I argued in favour of an extra ECU 2 million over and above the present figure of twelve million.
Agenturet presses af den måde, vi griber det an på.
The Com mittee on Budgets decided last week to give one million more, or half of what we had asked for.
Jeg undrer mig dog over en ting -hvorfor der skal være et meget lavere gebyr for veterinær
But as you see, we in the Environment Committee are doing our best to safe guard the budget for this Agency.
For det andet, hr. formand, vil jeg, samtidig med at jeg støtter gebyrforhøjelserne, understrege nødvendigheden af at bevare agenturets uafhængighed.
Article 10 of the 1995 regulation already gives a precise and specific legal basis which has to be respected. In other cases we think that the suggested amendments might bring about a possible risk for public health.
Bidraget fra EU-budgettet skal sikres - det vil sige bevares, samtidig med at nedskæringer undgås - for agenturet arbejder for medi-
For example, by encouraging an inflation in different presentations of one medical product.
Valverde López cinalindustrien i Europa, men varetager samtidig millioner af menneskers interesser, herunder patienter, ansatte inden for sundhedssektoren og forbrugere.
The proposal to make the first fixation of a maximum residue limit for several animal species more expensive can not be accepted.
Husk på, at agenturets uafhængighed altid er blevet støttet af Parlamentet. mentet.
This would be contrary to the Commission's policy to encourage and stimulate applications for fixations of new MRLs.
I udarbejdelsen af denne rapport har Kommissionen søgt at opnå to mål.
Other issues will be laid down in horizontal legal texts and not in the fees regulation.
Eisma (ELDR). - (NL) Hr. formand, for ikke så længe si den har vi ved markedsføringen af Viagra-pillen set, hvor nyttig Det Europæiske Agentur for Lægemiddelvurdering er, for Kommissionen har på grundlag af dette agenturs udtalelse besluttet at lade Viagra-pillen markedsføre. Det er kun et eksempel på, hvor vigtig denne institution er.
Eisma (ELDR). - (NL) Mr President, I asked the Com missioner how she proposed to deal with the question of currency movements and the effect of the corrective coefficient.
Denne institutions betydning vil i fremtiden kun tiltage, når man tænker på, at dette agentur kun har virket tre år.
What is the Commission going to do about it?
Den foreslåede gebyrforhøjelse demonstreres tydeligt og støttes af en omkostningsundersøgelse, udarbejdet af de nationale myndigheder og EMEA.
In view of the above, how probable and how serious does the Commission consider the adverse consequences of the growing crisis in Russia for the coun try's energy management and nuclear safety to be?
Opmærksomheden blev særligt rettet mod, at gebyrerne normalt skulle være lavere end de gebyrer, de 15 medlemsstater opkræver.
What will the Commission do to help the Russian au thorities to avert and eliminate any safety hazards arising from the above energy problems?
Jeg er helt enig med ordføreren, fordi dette agentur til dels er pålagt gennemførelsen af den interne markedspolitik og sikringen af sundheden.
Gradin, Member of the Commission. - Mr President, I am representing Mr Bangemann and I will ask him to give you a written answer.
Derfor mener jeg, at størstedelen af EMEA's indtægter skal komme fra godtgørelserne, men en bestemt del skal stadigvæk komme fra EU.
I give the floor to Mr Liikanen to answer Mrs Matikainen-Kallstròm's question.
Det er kun, og ordføreren har meget rigtigt peget på dette, lidt utilfredsstillende, at der endnu ikke er foretaget en til bundsgående undersøgelse af udgifterne ved behandlingen af ansøgningerne.
Tappin (PSE). - Mr President, I think that as Mr Kellett-Bowman might well attest, in the budget arrangements for 1999 we put in a series of amendments to ensure that the Commission actually tops up on the third or fourth pay ments every year the losses made by any agency through exchange rate fluctuations or the weighting arrangements.
Jeg beklager dette sammen med ordføreren.
If the budget goes through the first reading in early De cember, that will actually be operational.
På den måde ved vi også bedre, hvilken del af agenturets kapacitet der i fremtiden omfatter de sund hedsmæssige opgaver, som pålægges af institutionerne.
Similarly, if agencies win out, they will lose their grant the next year, so there will not be a win-win but rather a win-lose situation.
Jeg håber, at vi herom hurtigt kan imødese resultater.
I hope that clarifies the position.
Vi skal derfor snarest fremsætte et ændret forslag.
(The sitting was suspended until 5.30p.m.)
Vi er desværre ikke i stand til at acceptere samtlige ændringsforslag.
Liikanen, Member of the Commission. - (FI) Mr President, there is nothing to indicate that the present situation in Russia is having a negative impact on the energy sector and nuclear safety.
Af flere grunde. Visse kan ikke accepteres af juridiske grunde.
There have been signs that the govern ment intends to pay employees in the industries concerned the salaries that have remained outstanding.
Det er f.eks. ikke muligt at ændre retsgrundlaget for forordningen.
In this way there could be a positive effect on the present difficult situation.
Artikel 10 i forordningen af 1995 opstiller allerede et præcist og specifikt retsgrundlag, som skal respekteres.
The Commission is monitoring the situation and makes a daily assessment of developments, mainly through its delegation in Moscow.
I an dre tilfælde mener vi, at ændringsforslagene kan medføre en risiko for folkesundheden, f.eks. ved at tilskynde til in flation i forskellige præsentationer af et givent lægemiddel. del.
At the same time the implementation of the TACIS programme which is currently under way, particularly in the energy sector, will enable us to acquire the information that we need.
Til sidst mener vi, at det er vigtigt, at der sikres et bidrag fra vores budget, det er indlysende.
In this way, the situation with regard to nuclear power plants can be monitored continuously.
Som budgetordfører for Miljøudvalget har jeg slået til lyd for ECU to millioner ekstra i forhold til det nuværende beløb på 12 millioner.
It is with this programme very much in mind that the Commission and the Russian authorities are developing fresh strategies.
I sidste uge blev det i Budgetudvalget besluttet at yde én million mere, altså halvdelen af det, vi anmodede om.
Since the start of the programme around ECU 300 million has been mà*de available to improve nuclear safety in Russia.
Men som De kan se, gør Udvalget om Miljøog Sund hedsanliggender og Forbrugerbeskyttelse alt, hvad vi kan for at sikre dette agenturs budget.
It is hoped that the strategy will be fully in place before Viktor Kliman, Jacques Santer and Boris Yeltsin meet in Vienna on 27 October.
Forslaget om at gøre den første fastsættelse af en maksimalgrænseværdi for flere dyrearter dyrere kan ikke accepteres.
President. - The next item is questions to the Commission (B4-0483/98).
Gradin, medlem af Kommissionen. - (EN) Det glæder mig, at det har været muligt at få dette emne på dagsordenen for plenarmødet så hurtigt.
Matikainen-Kallström (PPE). - (FI) Mr President, I wish to thank the Commissioner for his reply.
Jeg vil derfor gerne takke alle, der lagde så stort arbejde i dette forslag.
I would still like to have it clarified what guarantees the Russian au thorities have given to the employees that their salaries will be paid, since it is an absolute requirement for the employees concerned to stay on in these plants, as well as for the safety of the plants to be ensured.
Andre emner fastlægges i tværgående juridiske tekster og ikke i forordningen om gebyrer. Dette inkluderer f.eks. anførelsen af euroen og budgetmæssige detaljer.
President. - Mr Liikanen has just arrived and is probably running on Finnish time, which is not exactly the same as our own.
Endnu en gang tak for jeres frugtbare samarbejde vedrørende dette emne.
Subject: The. impact of the crisis in Russia on the country's energy production and nuclear safety
Eisma (ELDR). - (NL) Hr. formand Jeg har spurgt kom missæren, hvad hendes løsning er på valutakurssvingnin-
The deepening economic, social and political crisis in Russia has given rise to fears that the coming winter
I overensstemmelse med artikel 10 i denne forordning forelagde Kommissionen en rapport om dens gennemførelse.
Obviously, our problem is that Russia's economic difficulties cannot be overcome with the support of the international community alone.
Gradin, medlem af Kommissionen. - (EN) Hr. formand, jeg repræsenterer hr. Bangemann, og jeg skal bede ham svare Dem skriftligt.
Does the Commission believe that the Spanish nation ality requirement for Spanish airline captains constitutes an infringement of Article 48 of the EC Treaty?
Hvor virkningsfulde og alvorlige mener Kommissionen, at de negative konsekvenser af den tiltagende russiske krise vil være for landets energiforsyning og nukleare sikkerhed?
herself that must solve these structural problems, which include paying the outstanding salaries.
Hvilke foranstaltninger agter Kommissionen at træffe for at hjælpe de russiske myndigheder med at forebygge og løse eventuelle sikkerhedsproblemer i forbindelse med de ovennævnte energispørgsmål?
I shall pass the question on to the Commissioner responsible. If we learn any more, we shall glad to forward the information to the honourable Member.
Hr. Liikanen, jeg beder Dem besvare fru Matikainen-Kallströms spørgsmål.
If so, does the Commission intend to force the Spanish Government to rectify the situation?
Hvis budgettet går igennem ved førstebehandlingen i starten af december, træder det faktisk i kraft.
I give the floor to Mr Liikanen to answer Mr Aparicio Sanchez's question.
Formanden. - Forhandlingen er afsluttet.
President. - Thank you very much, Mr Liikanen.
Afstemningen finder sted i morgen kl. 11.30.
The first is from Mr Rübig, who has the floor for one minute.
(Mødet udsat til kl. 17.30)
You have the floor, Mr Riibig.
Liikanen, medlem af Kommissionen. - (FI) Hr. formand, der er ingen tegn på, at den nuværende situation i Rusland har en negativ virkning på energiområdet og den nukleare sikkerhed.
Liikanen, Member of the Commission. - (FI) Mr President, only posts having judicial powers or involving the public interests of the State are reserved for citizens of the country in question.
Vi har fået nogle tegn på, at regeringen agter at betale de ubetalte lønninger til medarbejderne i den om talte branche.
These would include such jobs as po lice officer, judge or state minister, together with certain top executive posts in the public administration.
Dette kan have en positiv virkning på den aktuelle, svære situation.
The crew of a commercial airliner clearly does not fall within this category.
Ligeledes muliggør den aktuelle gennemførelse af Tacis-programmet også kommunikationen specielt på kernekraftområdet.
On this basis, it could be said in a general way that the captain of an air craft wields judicial power, or at least may wield it if called upon to do so.
Situationen i kernekraftværkerne kan dermed observeres kon stant.
This is the practice adopted by most Member States and that approved by the Commission.