natgillin/translations-raw huggingface dataset:
Denne gruppe lægemidler anvendes inden for den antroposofiske medicin, som er en medicinsk bevægelse, der blev grundlagt i 1920’erne af en østrigsk filosof og viden-
The free movement of goods is a fundamental principle guaranteed by the Treaty, which is expressed in the prohibition, laid down in Article 28 EC, on quantitative restrictions on imports between Member States and all measures having an equivalent effect.
3 — Ifølge denne medicinske opfattelse anses sygdommen for at være et resultat af en uligevægt mellem menneskets fire elementer, nemlig det fysiske legeme, det æteriske legeme (livskræfterne), det astrale legeme (følelserne og sanseindtrykkene) og jeg’et eller det egotiske legeme (bevidstheden).
9 That prohibition of measures having an equivalent effect to quantitative restrictions is very broad since, according to caselaw, it applies to all legislation of the Member States that is capable of hindering, directly
4 — De antroposofiske lægemidler har en særlig form og en særlig tilberedningsmetode.
9 — Case C-147/04 De Groot en Slot Allium and Bejo Zaden [2006] ECR I-245, paragraph 70.
De er kun delvis beskrevet i en officiel farmakopé for homøopatiske lægemidler.
12 — See, to that effect, Case C-254/98 TK-Heimdienst [2000] ECR I-151, paragraph 24.
kodificering af de hidtil udstedte direktiv er med henblik på en indbyrdes tilnærmelse af de ved lov eller administrativt fastsatte bestemmelser om humanmedicinske lægemidler, idet direktivet har samlet disse bestemmelser i én retsakt.
foreign pharmacies to bear costs and overcome difficulties which are not encountered by operators that are already located in the vicinity of that hospital. It can therefore be deduced from this that the effect of the contested requirements is to hinder more seriously the marketing of medicinal products from other Member States.
Ifølge fællesskabslovgiver skal alle bestemmelser angående fremstilling, distribution og anvendelse af lægemidler have som hovedformål at beskytte den offentlige sundhed.
However, those requirements hinder the marketing of medicinal products from other Member States more than the marketing of domestic medicinal products, for the following reasons.
I dette forslag til afgørelse er jeg nået frem til den konklusion, at der ved direktiv 2001/83 er sket en fuldstændig harmonisering af de nationale procedurer for tilladelse af registrering af de humanmedicinske lægemidler, som er omfattet af direktivets materielle anvendelsesområde.
The Federal Republic of Germany raises a number of arguments against this position, which to my mind do not alter it.
På grundlag af konstateringen af, at forskellene mellem visse af de enkelte medlemsstaters bestemmelser vedrørende lægemidler virker hæmmende på handelen med disse produkter inden for Fællesskabet og således har en umiddelbar indvirkning på det indre markeds funktion, angives det endvidere i betragtningerne, at fællesskabslovgiver tilsigter at ophæve disse hindringer ved at foretage en tilnærmelse af de nationale bestemmelser 6.
As the Commission has shown, and as the Federal Republic of Germany has expressly acknowledged, the requirement that an external pharmacy should undertake, using its own resources, all aspects of supplying medicinal products can be met only by operators who are located in the vicinity of the hospital being supplied.
Direktiv 2001/83 udgør derfor »en vigtig etape i gennemførelsen af målsætningen
The contested requirements therefore oblige a pharmacist operating a pharmacy in another Member State who seeks to conclude a contract for the supply of medicinal products with a German hospital to relocate his dispensary and set it up in the vicinity of that hospital or to open another pharmacy in the area.
6 — Fjerde og femte betragtning til direktiv 2001/83.
Such measures, therefore, require
Ved direktiv 2001/83, som er udstedt på grundlag af artikel 95 EF, er der foretaget en
These arguments do not affect the existence of the barrier resulting from the contested requirements. In TK-Heimdienst,
[om] lægemidlers frie bevægelighed« 7.
OPINION OF MR BOT — CASE C-141/07
Denne type lægemidler omtales dog i direktivets 22. betragtning, hvori det udtales, at »[a]ntroposofiske lægemidler, der er beskrevet i en officiel farmakopé, og som fremstilles efter en homøopatisk fremstillingsmetode, kan for så vidt angår registrering og markedsføringstilladelse ligestilles med homøopatiske lægemidler«.
The Federal Republic of Germany also disputes the existence of a barrier to the marketing of medicinal products from other Member States, on the ground that the pharmacies of those States, as a rule, do not stock medicinal products covered by a marketing authorisation for Germany.
Ved denne forordning blev der indført en centraliseret ordning for markedsføringstilladelser inden for EU.
That argument does not seem to me to be acceptable either.
Forordningen blev ophævet og erstattet af Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004 af 31.3.2004 (EUT L 136, s. 1). Der skal anvendes den centraliserede procedure for de lægemidler, som er opregnet i denne forordnings bilag.
Certainly, at the present state of Community law no industrially produced medicinal product may be placed on the market of a Member State unless a marketing authorisation has been issued by the competent authorities of that State or by the European Medicines Agency (formerly the European Agency for the Evaluation of Medicinal Products).
Hvad angår de nationale markedsføringstilladelser for humanmedicinske lægemidler indeholder direktiv 2001/83 tre typer af procedurer .
In other words, the contested requirements, like the legislation at issue in TK-Heimdienst, constitute a restriction within the meaning of Article 28 EC because they have the effect of partitioning the market concerned, which is, by nature, contrary to the common market, that is to say, an internal market characterised in particular by the abolition, as between Member States, of obstacles to the free movement of goods. 15
Der kan idømmes straf for forhandling af farmaceutiske produkter, som ikke er registreret.
However, the fact that foreign pharmacies do not, as a rule, stock a sufficient quantity of such medicinal products does not remove the restriction in question.
For det andet fastsætter kapitel 2 i afsnit I IIi direktiv 2001/83, som vedrører »[s]ærlige bestemmelser for homøopatiske lægemidler«, en særlig, forenklet registreringsprocedure for homøopatiske lægemid-
That interpretation of the scope of Article 28 EC had already been given in Joined Cases C-1/90 and C-176/90 Aragonesa de Publicidad Exterior and Publivía [1991] ECR I-4151, paragraph 24.
10 — Jf. artikel 8, stk. 3, litra i), i direktiv 2001/83.
16 — Articles 2 and 6(1) of Directive 2001/83.
Reglerne om registreringer indeholdt i bekendtgørelse af 8. september 1977 om registrering af farmaceutiske specialiteter og præparater, som ændret i 2004 12.
It is settled caselaw that Article 28 EC applies to measures that are capable of hindering, directly or indirectly, actually or potentially, intraCommunity trade.
Endvidere er der fastsat særlige bestemmelser om registrering af homøopatiske farmaceutiske produkter i bekendtgørelse af 24. december 1991, som ændret i 2000 13.
17Clas-sification of a measure as a measure having an equivalent effect to a quantitative restriction on imports does not therefore require verification that a foreign undertaking has actually been prevented from exporting its products to the Member State concerned.
Det bestemmes i artikel 1, stk. 2, i bekendtgørelsen om homøopatiske produkter, at et produkt, der er fremstillet efter den antroposofiske metode, også anses for et homøopatisk farmaceutisk produkt ved anvendelsen af bekendtgørelsen, såfremt fremstillingsmetoden svarer til den generelle metode, der almindeligvis anvendes ved fremstillingen af homøopatiske farmaceutiske produkter.
It is sufficient that the contested measure is capable of hindering intraCommunity trade without it being necessary to prove that it has had an appreciable effect on trade within the Union. 18
Der gjaldt en overgangsordning for antroposofiske lægemidler, som indebar, at de var fritaget for registreringsforpligtelsen indtil den 1. juni 2002.
That view, it says, is in contradiction to the fact that in many Member States only an internal pharmacy is allowed to supply a hospital with medicinal products and to the caselaw whereby a State monopoly in the trade in medicinal products may be compatible with Community law.
Ifølge de nederlandske myndigheder gælder forbuddet i WoG’s artikel 3, stk. 4, fuldt ud for denne type lægemidler efter overgangsperiodens udløb.
In other words, the Member State is not left in an all or nothing situation where either medicinal products must be supplied by an internal pharmacy or they may be supplied from a source left to the discretion of each hospital.
De antroposofiske lægemidler, som er fremstillet efter en homøopatisk metode, kan
20 — Case 215/87 Schumacher [1989] ECR 617, paragraph 18, and Deutscher Apothekerverband, paragraph 104.
Spørgsmålet i tvisten er idet væsentlige, om WoG’s artikel 3, stk. 4, kan anvendes på
A Member State which provides that supplies of medicinal products for hospitals may also be obtained from an external pharmacy, and which imposes requirements in
2000, nr. 467, herefter »bekendtgørelsen om homøopatiske produkter«.
Lastly, this view does not conflict with the exercise by Member States of their reserved powers in public health matters and the provisions of Article 152 EC.
Parallelt med denne retssag anlagde de sagsøgte parter også sag mod Staat der Nederlanden ved Rechtbank te ’sGravenhage med begæring om iværksættelse af foreløbige forholdsregler, hvorunder de principalt nedlagde påstand om, at Staat der Nederlanden forbydes at anvende forbuddet i WoG’s artikel 3, stk. 4, indtil der er truffet afgørelse i hovedsagen.
The Commission, which has the task under Article 211 EC of ensuring that the provisions of the Treaty are applied, is therefore acting quite correctly if it brings proceedings against a Member State for failure to fulfil its obligations, where it considers that the legislation of that State concerning the
Under sagen om de foreløbige forholdsregler nedlagde de subsidiært påstand om, at Staat der Nederlanden, indtil der er afsagt dom i hovedsagen, tilpligtes at anerkende, at Weleda Nederland NV og Wala Nederland NV fremstiller, sælger, leverer, importerer og markedsfører antroposofiske lægemidler, som ikke er homøopatiske, samt at de apoteker, hvortil disse virksomheder leverer deres produkter, sælger og udleverer dem.
21 — See, in particular, with regard to direct taxation, Case C-196/04 Cadbury Schweppes and Cadbury Schweppes Overseas [2006] ECR I-7995, paragraph 40; with regard to criminal matters, Case 186/87 Cowan [1989] ECR 195, paragraph 19; and with regard to public security, Case C-285/98 Kreil [2000] ECR I-69, paragraphs 15 and 16.
De sagsøgte parter har ved Rechtbank te ’sGravenhage (retten i Haag) bestridt, at WoG’s artikel 3, stk. 4, kan anvendes på antroposofiske lægemidler.
That article determines the legislative powers of the Community in public health matters.
Det er nemlig vanskeligt at påvise disse lægemidlers terapeutiske virkning på grundlag af de objektive kriterier, der anvendes for traditionelle lægemidler.
As the Community only has the powers that have been conferred on it, the High Contracting Parties limited its powers in that field by providing in that article that
Heroverfor har de nederlandske myndigheder idet væsentlige indvendt, at der ved direktiv 2001/83 er foretaget en fuldstændig harmonisering af de procedurer, der gælder
It merely has the effect of circumscribing the exercise by that State of its reserved powers in public health matters by specifying the limits which stem from the freedoms of movement which all the Member States have undertaken to respect by entering into and then ratifying the Treaty. 22
Ved dom af 15. april 2003 tog Rechtbank te ’sGravenhage de sagsøgte parters subsidiære begæring om foreløbige forholdsregler til følge hvad angår lægemidler, som er ordineret af en læge.
Therefore, as the Commission contends, since the contested requirements constitute a restriction on the free movement of goods within the meaning of Article 28 EC they should be declared incompatible with Community law if that restriction is not justified on one of the grounds laid down in Article 30 EC or by an overriding reason of public interest. I shall now demonstrate why that restriction is justified.
I øvrigt stadfæstede Gerechtshof te ’sGravenhage dommen afsagt af førsteinstansen i Haag om foreløbige forholdsregler.
25 — Case C-254/05 Commission v Belgium [2007] ECR I-4269, paragraph 33 and caselaw cited.
A — Det første præjudicielle spørgsmål
26 — Deutscher Apothekerverband, paragraph 103.27 — Rosengren and Others, paragraph 43.
IV — De præjudicielle spørgsmål
OPINION OF MR BOT — CASE C-141/07 where appropriate, when medical treatment must be administered in an emergency.
Godkendelsen af antroposofiske lægemidler, som hverken er homøopatiske lægemidler eller traditionelle plantelægemidler, må derfor ske i overensstemmelse med den generelle procedure i direktivets afsnit III, afsnit 1.
Therefore, even though, as the Commission observes, it is the doctor who assumes responsibility in individual cases for the use of the medicinal products he has prescribed, it is still the case that the pharmacist has a competence of his own, namely to give information and advice.
Den italienske og nederlandske regering og Kommissionen for De Europæiske Fællesskaber har foreslået, at det første spørgsmål besvares bekræftende med den begrundelse, at der ved direktiv 2001/83 er foretaget en fuldstændig harmonisering af de nationale procedurer vedrørende markedsføringstilladelser til humanmedicinske lægemidler.
The Federal Republic of Germany is therefore entitled to make provision that in any hospital a pharmacist must assist in the distribution of medicinal products to hospital patients, within the context of providing advice on a regular basis to hospital staff and,
Artikel 95 EF udgør nemlig en generel retshjemmel, der uanset artikel 94 EF, og medmindre andet er bestemt i EF-traktaten, giver mulighed for at vedtage foranstaltninger med henblik på indbyrdes tilnærmelse af medlemsstaternes love og administrative bestemmelser, der vedrører det indre markeds oprettelse og funktion.
A Member State is entitled, in the exercise of its sovereign powers in the field of public health, to decide that such advice and supervision on the part of a pharmacist must also be assured for all hospital patients, irrespective of the type of hospital and its specialisations.
Dette resultater jeg nået frem til ved en undersøgelse af direktivets retsgrundlag, ordlyd, opbygning og formål 16.
Unlike the Commission, I consider that the situation is not comparable to that of distributing medicinal products to the public.
Jeg skal erindre om, at direktiv 2001/83 er udstedt på grundlag af artikel 95 EF.
The way in which this assurance is provided clearly varies according to the size of each hospital and its specialisations.
I modsætning til, hvad de sagsøgte parter har gjort gældende i deres skriftlige indlæg, mener jeg ikke, at det er umuligt på grundlag af denne traktatbestemmelse at foretage en fuldstændig harmonisering af de nationale procedurer for markedsføringstilladelser til humanmedicinske lægemidler og registrering heraf.
Consequently, in order for the pharmacist to carry out this duty to give advice and supervise the proper use of medicinal products in a hospital environment effectively, he must be able to familiarise himself with each patient’s situation. The pharmacist, as the Federal Republic of Germany contends, must form an integral part of the treatment team.
Når betingelserne er opfyldt for at anvende artikel 95 EF som hjemmel, kan fællesskabslovgiver ikke forhindres i at anvende denne hjemmel, selv om beskyttelsen af folkesundheden er afgørende for valget af hjemmel 18.
If an external pharmacist is to carry out this duty of providing advice and supervision, he must therefore be present at the hospital
Han fandt, at »[e]n fortolkning, der henhold er sig til direktivets formål, dets opbygning og ordlyd, såvel som dets retsgrundlag, giver dem ret, som mener, at [direktiv 2001/83] indfører et system uden andet spillerum for fornyelse end dét, som det udtrykkeligt tillader« (forslagets punkt 24).
However, in all situations I am of the view that the effective way of carrying out this duty of giving advice and supervising the proper use of medicinal products requires the pharmacist to go to the hospital in person on a regular basis and according to a schedule worked out for each hospital.
FORSLAG TIL AFGØRELSE FRA GENERALADVOKAT BOT — SAG C-84/06 der er udstedt tilladelse der til i henhold til forordning (EØF) nr. 2309/93« 19.
OPINION OF MR BOT — CASE C-141/07 in person on a regular basis and be available in an emergency.
Denne traktatbestemmelse angiver ganske vist ikke udtrykkeligt, hvilken grad af harmonisering der tilsigtes.
The Commission does not dispute that in order to select its medicinal products a hospital needs the help of a pharmacist with a detailed knowledge of what that hospital requires.
Artikel 95 EF’s funktion, som består i at begrænse eller ophæve forskellene mellem de nationale retsforskrifter, som kan udgøre en hindring for de grundlæggende friheder, skal dog give fællesskabslovgiver mulighed for at foretage en udtømmende harmonisering, såfremt lovgiver vælger denne hjemmel.
It is therefore the pharmacist whose job it is to provide advice on the use of medicinal products within the hospital who would appear to be the best person to be aware of precisely what the hospital’s needs are and to take part in the process of selecting medicinal products.
Det fremgår af en gennemgang af ordlyden af direktiv 2001/83, at fællesskabslovgiver har villet foretage en fuldstændig harmonisering af de nationale procedurer for markedsføringstilladelser til humanmedicinske lægemidler og registrering heraf.
Second, the Federal Republic of Germany is correct, in my view, in arguing that it is difficult to separate the selection of medicinal products from the provision of advice to hospital staff.
Den tilføjede, at »[p]rocedurerne for meddelelse af en sådan tilladelse og virkningerne heraf er detaljeret angivet i direktivets artikel 7-39« 21.
I base my view on two complementary reasons, the first functional and the second economic.
19 — Min fremhævelse. 20 — Præmis 57.
Moreover, a large number of medicinal products have identical or comparable properties.
21 — Præmis 57 (min fremhævelse). 22 — Præmis 60 (min fremhævelse).
Consequently, any hospital, for the sake of good management, must select the medicinal products needed for its areas of specialisation and avoid unnecessary ordering of a number of medicinal products having the same properties.
lægsseddel (afsnit V), klassificering (afsnit VI), engrosforhandling (afsnit VII) og reklame (afsnit VIII) 24.
COMMISSION v GERMANY best placed to carry out regular checks on the quality and storage of such products.
Et produkt, der opfylder betingelserne for at udgøre et »lægemiddel« ifølge fællesskabsbestemmelsernes definition heraf, og som ikke er omfattet af forordning nr. 726/2004, kan derfor få udstedt en markedsføringstilladelse i en medlemsstat »i overensstemmelse med bestemmelserne i direktiv 2001/83« og kun i overensstemmelse med de procedurer, der er fastsat i dette direktiv 23.
Similarly, the external pharmacist who would appear to be the best placed to supply a hospital with all the necessary medicin- al products and to keep in his dispens- ary adequate stocks to meet the hospital’s needs in all circumstances would appear to be the person who provides advice to the medical staff and takes part in the process of selecting medicinal products, since he is well acquainted with the needs of the hospital to be supplied.
Besvarelsen af spørgsmålet, om der ved direktiv 2001/83 er foretaget en fuldstændig harmonisering inden for hver af disse områder, forudsætter en undersøgelse af forholdet mellem bestemmelserne i hvert af afsnittene inden for dette direktiv 25.
As the Federal Republic of Germany states, there is a synergy between supplying medicinal products, advising hospital staff and checking stocks.
Opbygningen af direktiv 2001/83 taler også for, at der er foretaget en fuldstændig harmonisering .
Like the Federal Republic of Germany, I am of the view that those different functions are complementary and that, from the functional point of view, it is more rational to assign them to the same professional.
Opbygningen af direktiv 2001/83
It does not involve additional payment.
Som tidligere angivet fastsætter afsnit I IIi direktiv 2001/83 tre typer af procedurer for markedsføringstilladelser til humanmedicinske lægemidler i medlemsstaterne. Det er for det første den generelle procedure for markedsføringstilladelser (kapitel 1), for det andet den særlige, forenklede registreringsprocedure for homøopatiske lægemidler, der
This view also applies as regards the function of checking a hospital’s stocks of medicinal products.
24 — Det fremgår derimod ved en gennemlæsning af direktiv 2001/83, hvilke områder fællesskabslovgiver åbenbart ikke har villet harmonisere.
It is therefore the external pharmacy which has to have sufficient stocks of medicinal products to be able to meet the needs of that hospital in all circumstances.
Disse bestemmelser viser efter min opfattelse som helhed, at fællesskabslovgiver har ønsket at fastsætte en udtømmende ramme for godkendelse eller registrering af hvert enkelt lægemiddel i overensstemmelse med den procedure, som svarer til dettes kendetegn.
It has acknowledged in that regard that a Member State must be able to plan the number of hospitals, their geographical distribution, the way in which they are organised and the facilities with which they are equipped, and also the nature of the medical services which they are able to offer.
Forfølgelsen af disse to formål er i overensstemmelse med bestemmelsen i artikel 95, stk. 3, EF om, at den harmonisering, der foretages i medfør af denne traktatbestemmelse, skal bygge på et højt beskyttelsesniveau for sundheden.
In reality the hospital concerned would be forced to employ a pharmacist to carry out these tasks specially, which, because of the additional charges inherent in such recruitment, would offset to a great extent the advantage of using an external pharmacist.
Endelig kan den omstændighed, at der opretholdes eller indføres særlige procedurer i medlemsstaterne for særlige lægemidler, medvirke til at fremme forskellene mellem de kompetente nationale myndigheders vurdering af lægemidlernes kvalitet, sikkerhed og effektivitet. Sådanne forskelle vil i praksis kunne lamme den gensidige anerkendelse af markedsføringstilladelserne, hvilket ville være i strid med det formål, som fællesskabslovgiver forfølger med direktiv 2001/83,
Such wastage, in the view of the Court, would be all the more damaging because it is generally recognised that the hospital care sector generates considerable costs and must satisfy increasing needs, while the financial resources which may be made available for healthcare are not unlimited, whatever the mode of funding applied. 35
FORSLAG TIL AFGØRELSE FRA GENERALADVOKAT BOT — SAG C-84/06 om at fremme en sådan gensidig anerkendelse 26.
Of course, in principle, aims of a purely economic nature cannot justify a barrier to the fundamental principle of the free movement of goods.
udvikling i Fællesskabets bestemmelser på et område som det foreliggende, på grund af den videnskabelige udvikling og erfaringerne fra den praktiske gennemførelse af retsforskrifterne.
31However, in the field of public health the Court has accepted that derogations from that principle may be allowed where interests of an economic nature concern maintaining a balanced medical and hospital service open to all, 32in particular the maintenance of treatment capacity or medical competence on national territory. 33