natgillin/translations-raw huggingface dataset:
Vi er nemlig af den mening, at ikke blot markeds føringen bør reguleres, men også arbejdstagernes sikkerhed og generelt også befolkningens ved fremstillingen af bioteknologiske produkter.
V. a directive amending Directive 65/65/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products
For langt vigtigere anser vi ændringen af direktiv nr. 65/66, for så vidt beskyttelsen af den åndelige ejendomsret angår.
I would only say one thing, Mr Parodi's amendments have been withdrawn, insofar as they refer to the directive, when we are talking about numerus clausus, and insofar as they appear to refer to the Commission.
Udvalget om økonomi, valutaspørgsmål og industripolitik lægger vægt på, at Kommissionen intensiverer sine arbejder inden for OECD for at diskutere reelle patentløbetider med de andre OECD-lande. overalt hvor de bliver berørt af statslige godkendelseskriterier, der hyppigt kræver mange
In this respect Amendment No 7 was intended to refer to the Committee on Legal Affairs and Citizens' Rights and the Committee on Legal Affairs and Citizens' Rights will take up the question of numerus clausus, which is a very complicated one, and will deal with it fully and bring it back to Parliament later.
I dag er den reelle patentløbetid i medicinalindustrien, men ikke blot dér, dalet til gennesnitlig 10 år.
Mr Parodi (PPE), rapporteur. — (IT) Mr President, ladies and gentlemen, the proposals from the Commission contained in document COM 84/437 of 25. 9.
Vittinghoff (S). — (DE) Hr. formand, mine damer og herrer, den socialistiske gruppe vil støtte betænkningen, dog med forbehold af nogle ændringsforslag.
Mrs Veil (L). — (FR) Mr President, since we are sit ting late it will perhaps be in order for me, following the statement by Mr Turner, to put a question on the same subject to the Commissioner: does the Commission intend to make proposals about the numerus clausus} Because this is a very important point, which is directly related to this training and the problems of freedom of movement.
Vi støtter også de med Kommissionsforslaget for bundne mål: nye impulser for innovationsforskningen i Europa, etablering af et europæisk lægemiddel marked som et led i realiseringen det indre marked, indskrænkning af dyreforsøg så vidt det overhovedet er muligt, og indretning af tilfredsstillende laboratoriebetingelser, ikke mindst og især af hensyn til de dér beskæftigede arbejdstagere.
The fact that there is a numerus clausus in some countries and not in others raises a real problem in regard to freedom of movement. I should therefore like to know what the Commission's intentions are in this respect.
Vi er også af den mening, at beskyttelsen af opfindernes rettigheder bør tilgodeses. Samtidig bør det også blive muligt at lade efterfølgende anmeldere foretage videreanvendelse. fordi risikoen for fornyede dyre-
This document, which contains four proposals for directives and one recommendation concerns, as we know, medicinal products derived from bio-technology in particular, and high technology medicinal products in general.
Her er der i princippet tre forskellige modeller: en tiårig udnyttelsesspærring, således som Kommission en foreslår, nogle grupper foreslår her 15 år eller mere.
Since, at present, in the field of advanced technology there is cutthroat competition between the most industrially advanced countries — that is to say, those of the Community, the United States and Japan —
Desuden er der muligheden for en godkendelscsspærring, og for det tredje muligheden for en bindende licensordning.
Lord Cockfield, Vice-President of the Commission. — Mr President, we do not at the moment intend to make specific proposals on this point, but of course I do note what Mrs Veil has said.
Vittinghoff forsøg, testrækker og også humanforsøg på den måde formindskes eller helt kan undgås.
Parodi guarantee to the maximum the safety and efficacy of the medicinal product.
Hvad vi vil forhindre, er også en yderligere prisstigning på medikamenterne i Det europæiske Fællesskab på grund af markedsudvidelsen og forbedrede konkurrencebetingelser, der egentlig skulle bevirke det omvendte. Her bør Kommissionen være særlig agtpågivende og finde ordninger, der i det mindste ikke kan give medicinalindustrien carte blanche.
In conclusion, against a background of completely different sets of legislation, and faced with the call for guarantees for the protection of the citizen's health, I think this is a great step forward in the promotion of health protection, without any fanciful ideas, but in· accordance with the real circumstances in the countries of the Community.
Ikke mindst i Forbundsrepublikken er medicinalindustriens indtjening så høj. at omkostningsspørgsmålet ikke ubetinget burde spille hovedrollen. De eksisterende kæmpeprofitter kunne bruges til at nedsætte priserne i EF i alles interesse.
Mr Gautier (S), draftsman ofthe opinion ofthe Com mittee on Economic and Monetary Affairs and Industrial Policy. — (DE) Mr President, ladies and gentlemen, the Committee on Economic and Monetary Affairs and Industrial Policy assumes that, under the legislation on medicinal products in the European Com munity, the principle of the mutual recognition of marketing authorizations for such products will be in force by 1990 at the latest, as provided for in various Community directives.
Jeg vil afslutningsvis sige, at punkt 7 i forslaget til beslutning absolut må vedtages, idet det er til fordel for direktivet om højteknologiske lægemidler. Det er derfor nødvendigt at omgøre den negative afstemning, der fandt sted i udvalget om miljø- og sund hedsanliggender og forbrugerbeskyttelse.
This would achieve the objective of enabling medicinal products derived from biotechnology or, at all events, advanced technology, to be marketed in the entire Community market, so placing European firms on a level footing with American or Japanese firms, which, from the outset, can count on a very wide market.
Vi går også ind for — og vi anmoder i den forbindelse om alles støtte ved afstemningen og også om Kom missionens støtte ved gennemførelsen af vores beslutninger — at der ved godkendelsen af lægemidler an vendes de strengeste bestemmelser, der overhovedet findes i Fællesskabet for tiden, og det for hele EF.
This would make it possible to recover more quickly the very heavy costs of researching new medicinal products which, as my report shows, lie between 50 and 100 million ECU, allowing a time span of up to ten years for research and approval.
Lægemiddelpolitikken er er yderst indviklet sag.
We are, however, faced with a special problem today.
Der produceres for mange lægemidler, for mange forskellige, og der ordineres for mange. Priserne på lægemidler i de forskellige medlemsstater for det samme middel varierer ud i det absurde.
All the Member States are confronted with the situation that biotechnological and blood plasma products are subject to different authorization criteria, making mutual recognition of authorizations rather more difficult. ficult.
For visse lægemidler betales der i visse lande 100% for meget. Nødvendigheden af mange lægemidler er ikke bevist.
For the achievement of these objectives, the Commission's proposals are contained in four directives and one recommendation.
Scrivener (L). — (FR) Hr. formand, dette forslag fra Kommissionen sigter i det væsentlige på at sikre en bedre forskningskapacitet i den farmaceutiske industri, men også på at åbne perspektiver for de europæiske firmaer af samme art som dem, deres japan ske og amerikanske konkurrenter kender til.
The Committee on Economic and Monetary Affairs and Industrial Policy therefore very much welcomes the Commission's proposals for directives, which pro vide for uniform criteria for the authorization of medicinal products produced by biotechnological pro cesses.
Godkendelsespolitikken i de forskellige medlemssta ter er meget forskellig.
The purpose of these measures is as follows.
Hundrede lægemidler, der er tilladt i visse lande, accepteres ikke i andre, og under disse omstændigheder er vi efter vor mening langt fra en gensidig anerkendelse.
The first of them proposes, with regard to approvals, the possibility of prior agreement between the competent authorities of Member States meeting in a committee on medicinal products, so as to reduce to a minimum any possible subsequent objections and authorize, as quickly as possible, the sale of such products through out the Community.
Selv om de foranstaltninger, som Kommissionen fo reslår, tager sigte på at fremme en hurtigere adgang til et europæisk enhedsmarked, er det ikke desto mindre sådan, at den foreslåede ordning for markedsføring af højteknologiske lægemidler er og bliver tvetydig, det må man erkende.
It also provides for the technical regulations to be quickly updated to meet the needs of scientific progress, in accordance with directive 83/ 189/CEE.
Vi er ikke imod et vesteuropæisk marked for læge midler.
We attach far more importance to the amendment of Directive No 65/65 where it concerns the protection of intellectual property.
Den farmaceutiske industri ønsker det, og det vil vi slet ikke blokere, men så må den vælge: enten en EF-godkendelsespolitik eller en godkendelsespolitik, der så også er virkelig harmoniseret og går ud fra de samme kriterier, og det er langtfra tilfældet. For målet med vore ændringsforslag er at gøre Parlamentets udtalelse utvetydig klar: først harmonisere og så ét marked.
The Committee on Economic and Monetary Affairs and Industrial Policy believes the Commission should step up its activities within the OECD with a view to discussing with the other OECD countries the real terms of patents wherever they are adversely affected by national authorization criteria, which often take many years to establish.
Vel minder man i Kommissionens begrundelse om princippet om gensidig anerkendelse — og den tanke kan vi naturligvis kun tilslutte os — men alligevel kan man beklage, at der ikke udtrykkeligt tales om det i direktivet.
The second directive modifies directive 75/318/CEE concerning proprietary medical products for human use, and the third modifies directive 81/852/CEE concerning veterinary medicinal products.
Det drejer sig dog om et vigtigt skridt henimod den frie bevægelighed, som vi går stærkt ind for.
Both of these directives lay down regulations for analytical, pharmacotoxicological and clinical standards and protocols, and the proposed alternations keep the pro cedures abreast of scientific progress.
For det andet, hr. formand, dyreforsøgene. Netop under disse vilkår foretages der alt for mange dyre forsøg.
Today the real term of a patent in the pharmaceutical industry, and in other industries too, has dropped to an average of ten years.
Der må findes et middel til på forhånd også at vurdere nødvendigheden af nye lægemidler, før man tester det 27. lægemiddel til samme formål.
As it is obviously not making much progress in the OECD, the Commission is now proposing an interim solution, which would in fact result in an extension of the term of patents.
Formålet med ændringsforslag nr. 20 er at fjerne bestemmelsen om, at dokumentationen i 15 år giver eneret for den for markedsføringen ansvarlige. Jeg mener, at dokumentationen er det firmas ejendom, som har udarbejdet den, og denne ejendomsret
The fourth measure comprises a recommendation con cerning pharmacotoxicological and clinical tests, and consists of a numer of explanatory rules designed to
Van der Lek første af de fem forslag, og dernæst de indvendinger det har fremført vedrørende det femte forslag.
Gautier the Commission proposes. Some groups are suggesting it should be 15 years or more.
går ind for et bedre samarbejde med universiteter og andre forskningsinstitutter.
We also believe that the rights of inventors must be protected.
Når det gælder folkesundhed, må koncurrencen ikke have det sidste ord, og derfor er vi også imod den længere beskyttelse af den åndelige ejendomsret. Det er ikke måden at tjene folkesundheden på.
But continued use by second applicants must also be made possible, because the risk of renewed tests on animals and even humans can then be reduced or even avoided.
Med hensyn til det første forslag anser Kommission en gennemførelsen af de nye procedurer for at være vigtig, ikke blot fordi de vil gøre det lettere at virke liggøre det interne marked, men også fordi det vil forbedre beskyttelsen af patienterne.
What we also want to prevent, however, is a further increase in the prices of medicinal products in the European Community by expanding the market, by improving conditions of competition, which may in fact result in prices falling.
Dette er natur ligvis af stor betydning.
The Commission should take a particular interest in this aspect and propose arrangements which at least cannot be seen by the pharmaceutical industry as giving them carte blanche.
Jeg må også sige, at jeg i høj grad påskønner den generelle støtte til de forslag, Kommissionen har fremsat.
I would point out that the ban on exploitation pro posed by the Commission has a number of disadvantages.
Lad mig tage de enkelte ændringsforslag til det første forslag.
Firstly, it would be legally unenforceable for a variety of reasons, which I cannot explain because time is too short.
Kommissionens synspunkter er følgende: Ændringsforslag nr. 4 går ud på, at vi bør nævne beskyttelse af folkesundheden i betragtningerne.
Secondly, it would to all intents and purposes eliminate competition in the pharmaceuticals market, and we want more competition in this of all sectors.
Det te er allerede medtaget som første betragtning i det første direktiv om lægemidler, så det er unødvendigt at gentage det her.
Thirdly, it might result in more experiments on animals if the ban on exploitation continued for an excessively long period, as some groups — and the committee responsible — are advocating.
Som jeg allerede har sagt, er dette afgørende for udviklingen af ny teknologi.
The enormous profits being made could be used to reduce prices in the Community in everyone's interest.
Det er vigtigt, at den europæiske lægemiddelindustri tilskyndes til at spille en aktiv rolle på dette nye forskningsområde. Kommissionen er meget opmærksom på behovet for at fastsætte bestemmelser, som vil kunne fremme udviklingen af de pågældende nye teknologier.
We also advocate — and we ask everyone to support this when we come to the vote, and the Commission too, when it implements our decisions — the application throughout the Community of the strictest stan dards that exist in the Community at present when medicinal products are authorized.
Ændringsforslag nr. 6 tager sigte på, at gøre samordning i Fællesskabet obligatorisk for alle nye lægemidler.
The Committee on Economic and Monetary Affairs and Industrial Policy feels that either a maximum, ten-year ban on exploitation or, even better, a compulsory licensing arrangement should be introduced.
I Kommissionens oprindelige forslag er den obligatoriske samrådsprocedure begrænset til kun at om fatte lægemidler henhørende under gruppe A. dvs. lægemidler fremstillet ved bioteknologiske metoder. Grunden hertil er, at ekspertisen på dette område er meget begrænset i flere af medlemsstaterne.
On the expiry of the term of the original patent, the holder would then be required to make his application documents available to a second applicant in return for a share of the latter's turnover.
Vi mener derfor, at procedurerne bør være obligatoriske på det te nye område, hvor medlemsstaterne meget vel kan operere med forskellige normer.
On the question of second applicants we take the view, unlike the report, that ten years of patent protection, as the Commission has proposed, is enough.
Men vi mener ikke, det er muligt i øjeblikket at medtage produkter, henhørende under gruppe B, dvs. alle andre nye læge midler, i samordningsprocessen.
Like Mr Gautier, we believe there are other ways of settling the question of second applicants, and we are in favour of a licensing arrangement rather than a ban on exploitation.
Begrundelsen er, at dette ville kræve et fuldstændigt registreringssystem, hvilket to forhold taler imod.
All in all, we approve of the report, but we call on Members, even those not present, to support our amendments.
Med henblik på fremtiden er det nu vor pligt at bygge videre på de ændringer, der blev indført ved Rådets forordning nr. 83(570), som trådte i kraft i november sidste år, således at vi kan sikre, at medicinalvarer kan bevæge sig frit i Fællesskabet, og at dette mål nås inden slutningen af indeværende årti.
My committee attaches considerable importance to the harmonization not only of the authorization of medicinal products derived from biotechnology but also of the rules on safety during the manufacture of biotechnological products.
På nuværende tidspunkt er medlemsstaterne de hovedansvarlige for godkendelsen af lægemidler.
We know that work is being done on this in the OECD, and we also know that the Americans are at the moment blocking the approval of the OECD recommendation on this subject.
De gør det under hen syntagen til patienterne og industrien.
But we expect the Commission to submit the OECD's draft recommendation to the European Parliament in the form of a Community directive.
Kommissionen så imidlertid gerne en større samordning af de nationale beslutninger, der træfles på dette område.
Mrs Scrivener (L). — (FR) Mr President, this propo sal from the Commission is essential if the research capacity of the pharmaceutical industry is to be improved, and also if European firms are to enjoy prospects comparable with those of their Japanese and American competitors.
For så vidt angår ændringsforslag nr. 7, er vi ikke helt klar over hensigten med det.
We take the view that there should be rules not only on marketing but also on the safety of workers and of the public generally during the manufacture of bio technological products.
Men det vil under ingen omstændigheder kunne forbedre det oprindelige for slag.
We therefore call on the Com mission to combine the two steps that need to be taken, the introduction of rules governing marketing and rules governing safety.
Det er meningen, at de skal tages op til revision i 1988/89, hvor Kom missionen vil gennemgå de eksisterende fællesskabs bestemmelser vedrørende lægemidler og fremsætte omfattende forslag til fjernelse af de resterende han delshindringer på dette område.
While the measures proposed by the Commission are aimed at promoting quicker access to a unified European market, it has to be admitted that the system suggested for the marketing of high technology medicinal products is ambiguous.
Jeg er glad for, at Parlamentet generelt er enig i Kom missionens holding. Jeg skal nu kommentere de ind vendinger, der er fremført af udvalget vedrørende de
I say this because, although the principle of mutual recognition is mentioned in the Commission's explanatory statement, and of course this has our entire approval, there is no express reference to it in the directive, and this is to be regretted, since mutual recognition is an important objective in view of the contribution that it can make towards establishing freedom of movement, to which we are committed.
Jeg skal nu komme ind på ændringsforslagene til det femte forslag.
Mr Vittinghoff (S). — (DE) Mr President, ladies and gentlemen, the Socialist Group will vote for the report provided that a number of amendments are adopted.
Brandsikring gore forsogsfritagelscn meningsløs, og Kommissionen kan derfor ikke tilslutte sig dette ændringsforslag.
On this subject too there is much to be said. Research costs money of course, and new medicines can be a blessing to mankind.
Formanden. — Næste punkt på dagsordenen er anden betænkning (dok.
We advocate better cooperation with universities and other research bodies.
A2-156/85) af Tongue for udvalget om miljø- og sundhedsanliggender og forbrugerbeskyttelse over forslag fra Kommissionen til Rådet (KOM(83) 751 endel. à dok.
In matters of public health, competition must not be allowed to have the last word, and we are thus against· such further protection of intellectual property.
11360/83) til henstilling om brandsikring af eksisterende hoteller.
That is not in the best interests of public health.
Med hensyn til ændringsforslag nr. 3 og 20 mener vi ikke. det ville være hensigtsmæssigt at medtage disse i det foreliggende forslag.
Amendment No 20 calls for deletion of the 15-year period during which the file is the exclusive property of the person responsible for the marketing of the product.
De rejser nye vigtige, principielle sporgsmål vedrørende intellektuel ejendomsret samt fortrolighed.
I think, in fact, that the file is the pro perty of the firm which prepared it, which cannot therefore be deprived of this right until after a certain time has elapsed.
Tongue (S), ordfører. — (EN) Hr. formand, jeg vil gerne takke alle her for deres tilstedeværelse.
Lord Cockfield, Vice-President of the Commission. — Mr President, may I start by expressing my great appreciation to Mr Parodi for his very clear exposition of the problems involved in what is a very difficult and complex field.
Antallet af tilstedeværende medlemmer i aften synes at være omvendt proportionalt med betydningen af de be tænkninger, der skal drøftes.
I can only add that I much appreciate the general support which has been forthcoming for the proposals which the Commission has put forward.
Kommissionen undersøger disse spørgsmål i samarbejde med OECD og WIPO, Verdensorganisationen for intellektuel Ejendomsret.
I would say, in conclusion, that paragraph 7 of the motion for a resolution absolutely must be adopted, since it is favourable to the directive on high technology medicinal products.
På baggrund af disse drøftelser vil Kommissionen træffe beslutning om. hvilke foranstaltninger der skal gennemføres.
It is therefore essential to re verse the negative vote recorded by the Committee on the Environment, Public Health and Consumer Pro tection.
Men måske skulle jeg gøre det klart med det samme, at jeg vil være meget villig til at overveje at udvide den periode på 10 år. der er foreslået i direktivet, til 15 år.
The Liberal Group will of course be voting in favour of the Parodi report, but on this one condition.
Dette er et vanskeligt teknisk område, fordi vi ikke kun har at gøre med patenter.
Mr Van der Lek (ARC). — (NL) Mr President, the point at issue in this debate is public health and not competition among the various industries.
Ofte er de pågældende produkter ikke patenterbare, eller de anvendte frem stillingsmetoder er det ikke.
Policy on medicinal products is an extremely complicated matter.
Derfor bevæger vi os på et vanskeligt område.
Too much medicines are produced, too many different ones, and too many are prescribed.
Alligevel kan forsikre det ærede medlem om. at vi meget velvilligt vil overveje det forslag, han har stillet om, at perioden ændres fra 10 til 15 år.
The range of prices for one and the same medicinal product in the various Member States is absurdly huge.
Vi i udvalget beklager den forsinkede behandling af denne betænkning og udsættelsen hvilket ikke er vor skyld.
May I start, however, by explaining precisely what the background to the present proposals is.
Der er tre grunde til at bringe betænkningen tilbage i nøjagtig den samme form som før, og udvalget har enstemmigt besluttet, at det ikke ønsker at ændre den.
Biotechnology and other technological developments in pharmacy hold out the prospect of major developments in the prevention, diagnosis and treatment of important and intractable diseases such as cancers and parasitic and viral infections.
For det første føler vi nu, at Kommission en kan acceptere størstedelen af vore ændringsforslag.
This will be achieved through better medicines, especially vaccines and uncontaminated blood and hormonal products.
For det andet lover lord Cockfield i sit dokument om det interne marked ved slutningen af indeværende år eller i begyndelsen af 1987 at forelægge et direktiv om brandsikring af alle offentlige forsamlingsteder.
It is important that the European pharmaceutical industry is encouraged to play an active part in this new area of research.