natgillin/translations-raw huggingface dataset:
Vernier (RDE). — (FR) Hr. formand, kære kolleger, også jeg vil udtale mig anerkendende, meget anerkendende, om de udmærkede tekster, Kommis sionen har udarbejdet.
We are not in favour of over-regulation, that is quite clear; but that a minimum of regulation is required here has been rightly stressed by all the rapporteurs.
Det er det, ændringsforslag nr. 39 handler om.
The individual must be placed in a position in which he is able to decide rationally for himself.
Hvad angår Valverde-betænkningen, glæder jeg mig især over, at Kommissionens tekst opererer med en procedure for hurtig sagsbehandling, og at vort Sundhedsudvalg har vedtaget ændringsforslag med det formål at sikre overholdelse af tidsfristerne.
That is why we are in favour of advertising in the field of self-medication, but not for advertising which gives the impression that there are no problems associated with the application and use of medicinal products in selfmedication.
Endelig, vedrørende Ceci-betænkningen om udleveringsbestemmelser for humanmedicinske lægemidler, har jeg stillet adskillige ændringsforslag, især nr. 28 og 30, som kræver, at lægemidler, når de sælges uden for apoteker, i det mindste sælges af fagfolk,
We are at first reading; we shall have further opportunities for discussion. If we manage to reach second reading during this year and if we then manageto find a location for the agency — that, of course, will be the most acute problem, but the more such issues of location remain undecided, Mr President, the greater the incentive to one day take a decision on them, with everybody getting their share — we shall have
Vernier og at de desuden opbevares under betryggende forhold.
BANGEMANN established an important section of the internal market in good time, before the end of 1992.
finder derimod, at det bedre kunne løse problemet, hvis reklamebudskabet blev begrænset til bestemte områder.
I think we shall be anxious, before holding our final vote on the legislative resolution, to know the position of the Commission.
Dette er et problem, som vedrører de såkaldte etiske lægemidler, butikslægemidler og de homøopatiske lægemidler — det sidste er et andet problem, som undersøges af Parlamentet.
In other words, if you are interested, you could approach a rapporteur in order to get the list ; but since you have a personal interest in the matter, I shall make an exception, and I shall also give you this list, right away.
Alavanos (CG). — (GR) Hr. formand, det spørgsmål, vi behandler, har ikke kun en økonomisk dimension.
PRESIDENT. — I take it that the rapporteur would like to have a list right away.
Det har direkte relation til beskyttelsen af forbrugerne, og det er velkendt, at der hersker overordentlig mange problemer. Et typisk problem er det, der kom frem for nylig i mit land, hvor det viste sig, at der var vaccine, som var for gammel, i omløb, vaccine, som anvendes til børn.
Let me say now that, on the basis of the results of the survey we have set in hand, we shall also begin the necessary harmonization of the national social security systems.
Dette sidste ville derefter blive offentliggjort ad andre kanaler, hvilket ville efterlade borgeren uden reel information om egenskaberne ved det produkt, han agter at købe, især når det drejer sig om problemet selvbehandling.
JACKSON, Caroline. — (ED) Mr President, on a point of organization : to avoid us having to chase the rapporteurs around the building, would it be possible for the Vice-President to give your office the list so that we can consult it there ?
Vi er derfor imod denne konkrete del af bestemmelsen.
The vote will take place at 5 p.m. tomorrow.
Parodi (PPE). — (IT) Hr. formand, kære kolleger, også jeg vil gerne takke Kommissionen. Som ord fører vedrørende dette emne i 1985 konstaterer jeg med glæde, hvorledes projektet skrider frem.
CECI (GUE), rapporteur. — (IT) Mr President, I am very perplexed, because the fact that the Commission is accepting 157 out of the 500 amendments in no way enables us to understand what value it means to attach to the very substantial work done by the Committee on the Environment, Public Health and Consumer Protection.
Det er særlig vigtigt, at vi i Europa skaber en europæisk og ikke en tysk eller fransk medicinalindustri.
PRESIDENT. — The next item is the debate on the Report (Doc.
Muscardini (NI). — (IT) Hr. formand, kære kolleger, vi fra Italiens Sociale Bevægelse har altid været meget opmærksomme på de problemer, som kunne opstå især hos borgerne og forbrugerne ved en ukorrekt brug af reklame.
I. widening the scope of Directives 65/65/EEC and 75/319/EEC on the approximation of the laws of the Member States on medicinal products and laying down additional provisions on home opathic medicinal products (COM(90) 72 final — Doc. C3-112/90 — SYN 251) ;
Jeg vil i den forbindelse gerne fremhæve det påtrængende i at ændre procedurerne for vurdering af lægemidler og deres markedsføring.
The Commission has an enormous responsibility vis-à-vis Parliament: it acts in fact as a filter for Parliament, in relation to the Council.
Jeg er enig med hr. Valverde. Også jeg mener, som jeg allerede udtrykte i 1985, at den eneste vej at følge er den gensidige anerkendelse, som også er den rigtige vej til at gennemføre det indre marked.
CHANTERIE (PPE), rapporteur. — (NL) Mr President, in 1987 the European Commission conducted a survey of European consumer attitudes to alternative medicine.
Mulighederne for et frit farmaceutisk marked eksisterer faktisk ikke i dag. Mens Traktaten, som ligger til grund for Det Europæiske Fælles skab, taler om princippet om den frie konkurrence, er det farmaceutiske marked faktisk et monopol-
It was found that a large section of the population are increasingly turning to alternative medicine.
Parodi marked, selv om det er af en særlig type, idet der er monopol ikke på udbuddet, men på efterspørgslen.
CHANTERIE be most popular in Belgium, where 66 to 75% of the population had used it at some time.
Men selv om disse principper er gyldige i alle lande, så modificerer sundhedssystemet de samme lægemidlers bevægelighed.
Then came herbal medicine, massage and paranormal methods. Homeopathic medicines account for a small, but not unimportant share of the market in medicinal products.
De Donnea (LDR). — (FR) Hr. formand, når jeg læser Schleicher-betænkningen om reklame for læge midler, må jeg med beklagelse konstatere, at visse af vore kolleger tror, det kan nytte gennem ændringsforslag at vedtage bestemmelser, som jeg finder overflødige, alt for restriktive eller urealistiske.
Thirdly, the marketing of medicines will be conditional on authorization or licensing. The directive largely harmonizes the manner in which the Member States will grant authorizations or licences.
Jeg har derfor genfremsat 17 ændringsforslag, som alle rede var blevet vedtaget af Udvalget om Økonomi, Valutaspørgsmål og Industripolitik.
A very important distinction is made between, on the one hand, homeopathic medicines which can be regarded as entirely safe and are marketed without any specifictherapeutic indication, and all other homeopathicmedicines on the other hand.
De tager især udgangspunkt i følgende principper.
For the former category of products authorization is fully harmonized, for the other category it is regulated in exactly the same way as for allopathic medicines.
For det første bør reklame, hvis formål er at informere forbrugerne, fortsat være mulig.
I also tabled Amendment 19 regarding the marketing and presentation of homeopathic medicines and their strength or degree of dilution.
Under alle omstændigheder bør information af videnskabelig, teknisk eller uddannelsesmæssig karakter udelukkes fra dette direktivs anvendelsesfelt.
On this point particularly I think we must find a solution together with the Commission, because I think it is rather too simplistic to set a single limit for all homeopathic medicines.
Man må erindre, at i alle landene er 80% af det farmaceutiske marked dækket af det sociale system.
In some Member States it has long been accepted, in others it is tolerated in others it is scorned.
Ellers går dampen af den farmaceutiske industri, af den frie bevægelighed for lægemidler, og vi vil ikke få held til at beskytte personers frie bevægelighed, som den grundlæggende Traktat ønsker.
France too has a strong tradition of homeopathic medicine with special licensing procedures and monographs on homeopathic preparations and substances which are included in the pharmacopoeia.
For det andet skal informationer til brug for patienter være tydelige og let forståelige.
Homeopathic medicines are also named, albeit on a smaller scale, in the laws on medicines in Belgium, Denmark, the Netherlands, the United Kingdom and Ireland.
Det tjener derfor ikke noget formål at gøre betingelserne unødigt fyldige.
These countries and other Member States too are waiting for a Community initiative before revising their own legislation.
Avgerinos (S). — (GR) Hr. formand, de forslag, vi behandler, er overordentlig vigtige, og ordførerne har gjort et prisværdigt stykke arbejde.
The patient or consumer should thus be more readily able to obtain homeopathic medicines and at the same time have guarantees of their quality and safety.
Forslagene lever op til behovet for at forbedre anvendelsen af og regulere handelen med humanmedicinske læge midler.
The directives now before us contain stipulations as to the manufacture, supervision, import and export, labelling and marketing of homeopathic medicines.
For det fjerde bør man tilskynde en sektor, som altid har udvist stor ansvarlighed til at regulere sig selv.
This directive on homeopathic medicines is just a beginning, there is more to be done, not least the adoption of a European pharmacopoeia.
Dette er især indholdet af ændringsforslagene nr. 109 og 110.
That is a matter of urgency ; the Member States are waiting for one.
I mange medlems lande distribueres stadig mange lægemidler, som ikke opfylder direktivernes krav, og i de 15 år, der er gået, har medicinalfirmaerne ikke kunnet dokumentere disse lægemidlers virkning, og alligevel distribueres de stadig.
Thirdly, as regards reimbursement, in some countries such as Germany, France and the Netherlands the cost of medicines is reimbursed by the health insurance schemes.
Også i dag godkendes lægemidler, som ikke opfylder direktivernes krav, og vi vil ikke få ensartede forhold på EF-markedet, hvis direktiverne ikke overholdes lige strengt i alle landene.
In principle I am in favour of this, because it is the result of having a free choice of medical treatments. Those who opt for a homeopathic medicine must not be duped and discriminated against.
Uden at der har været foretaget nogen som helst vurdering af behovet og af de allerede eksisterende redskaber, og uden at kende det mindste til, hvordan den vil fungere, har man allerede fremsat et budget for den.
The granting of licences to manufacture homeopathic medicines, to import them from outside the Community or export them from the Community, will be governed by the same Community rules as apply to traditional allopathic medicines.
Hvis dette fortsætter, vil sygesikringerne blive sprængt.
Mr President, these are a few elements which I consider important in this debate.
Der må absolut være en form for EF-kontrol.
We achieved a very large degree of consensus in the committee.
Og for øjeblikket findes der ingen priskontrol, hverken i Tyskland eller Storbritan-
I hope that will be reflected here in the debate and subsequently in our vote.
Det kan man da vist kalde at spænde ploven for okserne, og efter min mening bør dette ændringsfor slag forkastes.
The proper practices for goods manufacturing must be observed. Plant and premises will be subject to checks by the pharmaceuticals inspectorate.
Med hensyn til korrekt anvendelse af lægemidler er der et påtrængende behov for at få udsendt en EF-recept, også selv om den blot skal tjene som vejledning for de forskellige nationale recepter.
In the past homeopathic medicines could in principle be offered for sale by anyone, but this will now no longer be possible.
Endelig er det nødvendigt at intensivere arbejdet med at informere lægerne, så der kan ske en streng overvågning af firmaernes reklame, idet der stadig forekommer vildledende reklame.
ERNST DE LA GRAETE (V). — (FR) Mr President, I am going to join in the consensus, since I can say on behalf of my committee that the report presented by Mr Chanterie on the free movement of homeopathic medicinal products is a good report; for it has taken up a series of amendments tabled by the Committee on Economic Affairs, even including some that the committee did not adopt.
Der er tale om en gråzone, hvor veterinærmedicinske lægemidler får samme virkning som ydelsesfremmende lægemidler inden for husdyrbruget.
The proposals require that the label and packaging of homeopathic medicines should clearly be marked with the words homeopathic medicine.
På dette punkt er direktivet ikke klart nok, og det er nødvendigt, at vi skaber klarhed med et ændringsforslag.
They also stipulate which other data must and may be given.
Og endelig fru Schleichers betænkning om reklame for lægemidler.
their medicine must be guaranteed throughout the Community.
Dette fører mig frem til at insistere på nødvendigheden af at opretholde et informationssystem på højt niveau for læger og til at minde om nødvendigheden af videnskabelige kongresser, for udsat de udelukkende er videnskabelige og henvender sig til eksperter, der er internationalt aner kendte.
That is why, in our opinion, it is essential to delete paragraph 2 of Article 9, which could hinder freedom of choice of therapy and free movement of therapeutic medicinal products within the Community.
Vi har allerede stemt i så henseende i relation til direktivet for BST.
I hope that that will be one of the amendments that you will take on board.
Hvad angår det at stille prøver på nye lægemidler til rådighed for lægerne, så er det indlysende nødvendigt, at lægen kan danne sig en personlig mening om det lægemiddel, han skal ordinere, og at han selv vurderer, hvilke betingelser, der er de bedste for tildeling af medicin til de syge.
We consider that freedom of choice with regard to therapy is important because homeopathy and other alternative medicines in fact offer many advantages. The first, which should convince us of the importance of that freedom, is the number of users within the European Community.
Det er bydende nødvendigt, at man overholder princippet om proportionalitet mellem forseelsens omfang og sanktionen, og at eventuelle suspensioner fra AMM ikke iværksættes ud fra irreelle eller uberettigede motiver.
This Mr Chanterie has done in his report, since, inter alia, he has amended the provisions concerning proof of therapeutic effect, which may now be established by methods in accordance with those alternative medicines. cines.
Pompidou (RDE). — (FR) Hr. formand, kære kolleger, lægemidler er ikke en forbrugsvare som alle andre.
That brings me to Art 9(2) which Mrs de la Graete has already mentioned. It certainly does have an effect, and we Germans are best able to judge that.
For de forskellige medlemsstater udgør de en større økonomisk indsats, såvel ved deres værdi ved eksport ud af EF som i form af de udgifter, de medfører til sygdomsbekæmpelse, men de virker direkte ind på mennesket.
There is a great need for practitioners in fields other than orthodox medicine; consumers have a great need for homeopathic, allopathic and anthroposophic medicines, and we must therefore make such products available to them.
Et sygt menneske bør kunne have tillid til, at et lægemiddel virker og ikke er giftigt, dvs. at det er fremstillet under strengt videnskabelige forhold og afprøvet og distribueret under ulastelige etiske vilkår.
That also means, however, that we must not make the requirements so high that we at the same time preclude them.
Endelig vil jeg fremhæve kvaliteten i det arbejde, Kommissionen har udført på et område, der er så følsomt som dette.
Lastly, I think it is very important to go beyond free movement of medicinal products.
Med forbehold for overholdelsen af principper, som hviler på strengt videnskabeligt, men ikke desto mindre humant, eksperimentelt grundlag, kan vi støtte direktiverne om lægemidler, som ændret af Parlamentet, med henblik på en større effektivitet i den medicinske behandling og dermed til gavn for de syges velbefindende.
Europe is not only a single market, it is also a means of safeguarding the health and safety of all our citizens; and to do that we need a European pharmacopoeia, we need regulation of the legitimate practice of alternative medicines, we need harmonization of arrangements to refund the cost of alternative medicinal products, and we need to promote high-quality teaching.
Det er derfor påtrængende nødvendigt for EF at virkeliggøre et indre marked for lægemidler gennem harmonisering af registreringsprocedurerne.
There should not be any dangerous medicinal products on the market, but we must not make the same requirements of anthroposophic as of allopathic medicinal products.
Denne harmonisering må dog ikke forsinke markedsføringen, hvad der ville være uheldigt for udviklingen i den kommende forskning og for den fart, hvormed behandlingen kan forbedres.
If we avoid doing that and genuinely guarantee freedom of therapy, then this will be a good directive which we shall be able to transpose into national law in the Com munity, and consumers will have the option of choosing the weakest or for them most easily tolerated remedy, or indeed that which they fear the least.
Der bør derfor oprettes et lægemiddelagentur, som skal forkorte de alt for centraliserede procedurer og fremme gensidige anerkendelser.
For all these reasons, Mr President, the Committee on Economic and Monetary Affairs and Industrial Policy recommends you to vote in favour of Mr Chanterie's report.
Udtalelserne fra dette kommende agentur bør være strengt videnskabelige, dvs. baseret alene på kriterier som kvalitet, sikkerhed og effektivitet.
We hope that the Commission will move further in the direction favoured by Parliament, towards the recognition of alternative medicines.
Chanterie (PPE). — (NL) Hr. formand, 3 000 virksomheder, 400 000 arbejdstagere, en årlig omsætning på 40 mia. ECU — ingen kan benægte den økonomiske betydning af den europæiske farmaceutiske industri.
ROTH-BEHRENDT (S). — (DE) Mr President, ladies and gentlemen, I would add to the praise given to the Commission in relation to the earlier reports.
Det behøver derfor ikke vække nogen forundring, at Kommissionen i sit program med henblik på virkeliggørelsen af det indre marked lægger temmelig stor vægt på denne sektor.
It has taken a great deal of trouble, and we have sought to acknowledge that in our treatment of the Chanterie report.
Hensigten med dens forslag er at ophæve de hindringer, som står i vejen for den frie handel med lægemidler. ler.
I hope that his report will attain as great a majority in Parliament as it did in the Committee on the Environment, Public Health and Consumer Protection.
For at give dette agentur mulighed for at virke efter hensigten, er det vigtigt, at man ikke i starten overbebyrder det med ekstraopgaver, såsom at kontrollere reklamen eller databankerne.
The Commission did fail to consider something in the directive, namely guaranteeing the choice of therapy throughout the European Community, including allopathic, homeopathic and also anthroposophic medicines.
Under disse forudsætninger vil vores gruppe støtte hr. Valverde Lopez' betænkning, som ændret af Parlamentet.
That is absent from the directive and must therefore be remedied as a matter of urgency.
Inden for forbrugsvarerne udgør lægemidlerne en ganske særlig kategori.
GREEN (S). — Mr President, I rise in support of Mr Chanterie's report.
Forbrugerne bruger i reglen ikke lægemidler, fordi de føler behov for det eller har lyst til det, de bruger dem ikke af fri vilje, men fordi de er patienter, fordi de vil helbredes.
This report represents a careful, sensitive and intelligent way forward, which takes account of the different feelings of Community citizens as to which remedies, medicines and approaches they want to'use for the good health of their own bodies.
Patienterne afgør ofte ikke selv, om de skal bruge dem. De er afhængige af sagkyndiges vurdering.
The essential point that we have stressed in the Committee on the Environment, Public Health and Consumer Protection is that of safety.
Nøjagtig af denne grund undslipper lægemidler markedskontrolmekanismerne; i modsætning til almindelige for brugsvarer kan vurderingen af lægemidler ikke over lades forbrugerne.
If Community citizens have been using remedies and treatments for many years, if these treatments have been approved through the process of registration and if there is no evidence of any risk to health or wellbeing then, frankly, I can see no reason why such remedies or treatments should not be allowed access to our markets.
Engrosforhandlingen har i udstrakt grad haft fordel af Parlamentets ændringsforslag, hvis mål er at bevare lægemidlets kvalitet igennem hele forløbet: Distribution, produktion og forbrug, og ikke mindst under oplagringen, som hr. Vernier understregede.
If we are to be serious about what has just been said by Mr Chanterie and Mrs Ernst de la Graete, that is to say that there must be freedom of therapy for consumers in the Community, the directive must embrace not only allopathic and homeopathic but also anthroposophic
Vi henleder Kommissionens opmærksomhed på disse to aspekter!
We are not displeased with it. There is room for impovement on one or two points, though.
Man leger ikke med borgernes helbred, navnlig ikke i et Europa, der ønsker at gå i spidsen.
The rapporteur, Mr Chanterie, has proposed a number of amendments to that end in his excellent report, and 1 wholeheartedly support them.
at kontrol med lægemidler først og fremmest skal ske forinden.
I hope that this Parliament, the Commission and the Council will support the approach taken in Mr Chanterie's excellent report.
Tilladelsen til at markedsføre et læge middel må med andre ord først gives efter en grundig undersøgelse af virkningen, fabrikationskvaliteten, udleveringsform og sikkerhed.
VALVERDE LÓPEZ (PPE). — (ES).Mr President, I asked to speak again in this debate on homceopathic products to make certain brief but basic points to safeguard the consistency and rationality of Par liament's decisions.
Denne undersøgelse skal foretages uafhængigt af økonomiske og politiske overbevisninger, idet den udelukkende skal hvile på objektive, videnskabelige oplysninger.
Despite stubborn and sometimes fierce resistance on the part of some areas of more traditional medicine, millions of people in the Community benefit from homeopathy and homeopathic medicines.
Til trods for den store omhu, hvormed den skal foretages, er enhver registrering desuden i virkeligheden af foreløbig karakter.
That freedom of choice must not be restricted by the fact that the cost of some medicines is reimbursed by health insurance whilst that of others is not, but this naturally means that these medicines have to meet specific requirements.
Schleicher (PPE), ordfører. — (DE) Hr. formand, mine damer og herrer, jeg vil gerne igen komme ind på nogle punkter, som jeg gerne vil gøre rede for ud fra min gruppes synspunkt.
The Environment Committee's amendment to Article 7, paragraph 1, quite rightly speaks of listing permitted quantities of an active ingredient in an annex to the directive.
Som ordfører ville jeg komme ud i visse vanskeligheder, idet der i udvalget er blevet vedtaget en lang række ændringsforslag ved flertalsafgørelse, som jeg ud fra min bedømmelse af tingenes tilstand ser anderledes.
In this connection I warmly endorse the amendment tabled by Mrs Veil from my own group to this same section, to the effect that the appropriate authority in each Member State should compile a list of permitted concentrations as a transitional measure and pending preparation of a European list.
Hr. de Donnea, jeg kan forstå, at De på vegne af Udvalget om Øko nomi, Valutaspørgsmål og Industripolitik har frem sat Deres ændringsforslag.
It is to be hoped that this will bring a swift end to discrimination against homeopathic medicines in the Community.
Flertallet vil afgøre, om de vedtages eller ej.
I don't therefore, agree with Mr Valverde.