PARALLEL TEXTS
A parere dell’avvocato generale Yves Bot, i prodotti a base di erbe aromatiche e di cannabinoidi sintetici commercializzati esclusivamente a fini ricreativi non costituiscono medicinali
Inglese tratto da:
http://europa.eu/rapid/press-release_CJE-14-84_en.htm
Italiano tratto da:
http://europa.eu/rapid/press-release_CJE-14-84_it.htm
Data documento: 12-06-2014
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According to Advocate General Bot, products consisting of aromatic herbs and synthetically produced cannabinoids and which are sold exclusively for recreational purposes are not medicinal products
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A parere dell’avvocato generale Yves Bot, i prodotti a base di erbe aromatiche e di cannabinoidi sintetici commercializzati esclusivamente a fini ricreativi non costituiscono medicinali
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In order to be classified as a medicinal product, a substance or combination of substances must be intended to prevent or treat an illness
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Per poter essere qualificata come medicinale, una sostanza o un’associazione di sostanze dev’essere destinata alla prevenzione o alla cura di una patologia
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An EU directive defines the concept of ‘medicinal product by function’ as ‘any substance or combination of substances which may be used in or administered to human beings … with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action’.
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Una direttiva dell’Unione definisce la nozione di «medicinale per funzione» nel senso di «ogni sostanza o associazione di sostanze che possa essere utilizzata sull’uomo o somministrata sull’uomo allo scopo di ripristinare, correggere o modificare funzioni fisiologiche, esercitando un’azione farmacologica, immunologica o metabolica (…)».
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Between 2010 and 2012, D and G sold mixtures of aromatic herbs containing various synthetically produced cannabinoids.
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I signori D e G commercializzavano tra il 2010 e il 2012 miscele di erbe aromatiche contenenti vari cannabinoidi di sintesi.
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The latter consist of psychoactive substances intended to reproduce the effects of cannabis when they are smoked.
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Si tratta di sostanze psicoattive che, se fumate, tendono a riprodurre gli effetti della cannabis.
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At the time, the German Law on combatting narcotics did not allow prosecution for the sale of those substances.
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All’epoca dei fatti, la normativa tedesca sulla lotta agli stupefacenti non consentiva di ricomprendere la commercializzazione di tali sostanze.
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The German authorities therefore sentenced D and G to custodial sanctions on the basis of the Law relating to medicines, concluding that they had marketed a ‘dubious medicinal product’.
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Le autorità tedesche hanno condannato quindi i signori D e G a pene detentive in base alla normativa sui medicinali, per aver immesso sul mercato un «medicinale sospetto».
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The case having been brought before it, the Bundesgerichtshof (Federal Court of Justice, Germany) asks whether, in spite of the risks to human health, the combination of substances at issue may be classified as a ‘medicinal product’, in so far as, although it does, as the directive provides, modify human physiological functions by exerting a pharmacological action, it does not produce any therapeutic benefit for humans.
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Investito della controversia, il Bundesgerichtshof (Corte federale di giustizia, Germania) si chiede se la detta associazione di sostanze, nonostante i rischi che presenta per la salute umana, possa essere qualificata come «medicinale», considerato che, sebbene determini effettivamente, come previsto dalla direttiva, una modificazione delle funzioni fisiologiche nell’uomo esercitando un’azione farmacologica , non procura alcun beneficio terapeutico.
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In his Opinion today, Advocate General Yves Bot considers that the concept of ‘medicinal product’ referred to in the directive is not capable of covering a combination of substances such as that at issue.
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Nelle conclusioni odierne, l’avvocato generale Yves Bot ritiene che la nozione di «medicinale» contemplata dalla direttiva, non possa ricomprendere un’associazione di sostanze come quella oggetto della causa.
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Such a combination of substances is, admittedly, capable of modifying human physiological functions, but its use for purely recreational purposes is intended neither to prevent nor treat an illness.
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Un’associazione di sostanze di tal genere è, certamente, idonea a modificare funzioni fisiologiche nell’uomo, ma la sua somministrazione a fini puramente ricreativi non è destinata né a prevenire, né a curare alcuna patologia.
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First of all, the Advocate General points out that the issue is not to prevent the medical use of narcotics, which remains essential for pain relief, but to restrict the marketing of psychoactive substances consumed by humans for exclusively recreational purposes, the consumer seeking, in this instance, psychic effects associated with the consumption of cannabis.
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L’avvocato generale Bot ricorda, in limine, che non si tratta di ostacolare l’impiego medico di stupefacenti, che permane indispensabile ai fini dell’attenuazione del dolore, bensì di limitare l’immissione in commercio di sostanze psicoattive consumate a fini puramente ricreativi, ove, nella specie, il consumatore ricerca gli effetti psichici associati al consumo di cannabis.
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In support of his arguments, Mr Bot relies first of all on the definition of the concept of ‘medicinal product by presentation’ covered by the directive, since that concept makes reference to the product’s ‘properties for treating or preventing disease in human beings’.
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A sostegno del proprio ragionamento, l’avvocato generale Bot si fonda anzitutto sulla definizione della nozione di «medicinale per presentazione» contemplata dalla direttiva, che fa riferimento alle «proprietà [del prodotto] curative o profilattiche delle malattie umane».
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Mr Bot considers next that the criterion relating to the ‘modification of physiological functions’ cannot be interpreted independently of its context or of the intended medical use of the substance or combination of substances at issue.
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L’avvocato generale Bot ritiene, inoltre, che il criterio relativo alla «modificazione delle funzioni fisiologiche» non possa essere interpretato a prescindere dal contesto in cui si colloca né dall’applicazione medica cui la sostanza o l’associazione di sostanze di cui trattasi è destinata.
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The directive uses not only the verb ‘to modify’, but also the verbs ‘to restore’ and ‘to correct’, those verbs referring to an improvement of human organic function or the restoration of human physiological functions, which implies the existence of a medical or therapeutic benefit.
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Infatti, la direttiva utilizza non solo il verbo «modificare», bensì parimenti i verbi «ripristinare» e «correggere», i quali fanno riferimento al miglioramento delle funzioni organiche dell’uomo o al recupero delle sue funzioni fisiologiche, il che implica l’esistenza di un beneficio medico o terapeutico.
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Advocate General Bot notes, moreover, the Court’s settled case-law according to which the use of a medicinal product must ‘be intended to prevent or treat disease’.
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L’avvocato generale Bot ricorda inoltre la costante giurisprudenza della Corte secondo cui la somministrazione di un medicinale deve «avere una funzione di profilassi o di cura».
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In addition, the Advocate General considers that the directive, based on the protection of public health and the free movement of goods within the EU, precludes the marketing of substances presenting risks for human health similar to those presented by narcotics the use of which has no medical application.
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L’avvocato generale Bot ritiene peraltro che la direttiva, fondata sulla protezione della salute pubblica e sulla libera circolazione delle merci in seno all’Unione, non ammetta l’introduzione sul mercato di sostanze i cui rischi per la salute umana siano analoghi a quelli che presentano gli stupefacenti e la cui somministrazione venga effettuata al di fuori di qualsiasi applicazione medica.
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By regulating the marketing authorisation, manufacture, importation, labelling and the distribution of medicines, the directive seeks to allow the marketing and free movement of safe and effective products, the composition of which has been analysed, the indications, contra-indications, risks and adverse reactions of which have been assessed and the posology, the pharmaceutical form and the method of administration have been determined.
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Infatti, disciplinando l’autorizzazione di immissione sul mercato nonché la fabbricazione, l’importazione, l’etichettatura o, ancora, la distribuzione dei medicinali, la direttiva è volta a consentire l’immissione sul mercato e la libera circolazione di un prodotto sicuro ed efficace, di cui sia stata analizzata la composizione, di cui siano stati valutati le indicazioni, le controindicazioni, i rischi e gli effetti collaterali e di cui siano state stabilite la posologia, la forma farmaceutica e la modalità di somministrazione.
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Those rules are therefore not applicable to a combination of substances intended, in reality, to be excluded from the market because it lacks any medical benefit and presents risks to human health.
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Tale disciplina non è, quindi, destinata ad applicarsi ad un’associazione di sostanze che si vuole, in realtà, escludere dal mercato, essendo priva di qualsiasi beneficio medico e presentando rischi per la salute umana.
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Furthermore, Mr Bot considers that the sale for purely recreational purposes of new psychoactive substances is clearly outside the legal economic sphere of the internal market.
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L’avvocato generale Bot ritiene, peraltro, che la commercializzazione, a fini esclusivamente ricreativi, di nuove sostanze psicoattive si collochi chiaramente al di fuori della sfera economica legale del mercato interno.
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He notes in that regard that, in accordance with the Court’s case-law, ‘narcotic drugs that are not distributed through channels strictly controlled by the competent authorities to be used for medical and scientific purposes are, because of their very nature, subject to a prohibition on their being imported and offered for sale in all the Member States’.
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A tal riguardo ricorda che, conformemente alla giurisprudenza della Corte «gli stupefacenti non presenti nel circuito rigorosamente sorvegliato dalle competenti autorità in vista dell’uso per scopi medici o scientifici rientrano, per loro stessa natura, in un divieto di importazione e di commercializzazione in tutti gli Stati membri».
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Although it is understandable that, confronted with a legal vacuum, Germany sought to apply legislation relating to medicinal products in order to be better able to control and prevent the marketing of those new substances, Advocate General Bot concludes that such an aim is not however capable of warranting a broad interpretation, indeed a distortion, of the concept of ‘medicinal product’.
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Se è comprensibile che, a fronte di una lacuna normativa, la Germania sia stata indotta ad applicare la normativa relativa ai medicinali, al fine di meglio controllare e reprimere l’immissione sul mercato di queste nuove sostanze, l’avvocato generale Bot conclude che tale obiettivo non può tuttavia giustificare un’interpretazione estensiva, se non addirittura una distorsione, della nozione di «medicinale».
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He considers, consequently, that only enforcement measures based on the control of narcotics are suitable in order to respond to the appearance of psychoactive substances on the market.
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Egli ritiene, conseguentemente, che solamente provvedimenti repressivi basati sul controllo degli stupefacenti possano far fronte alla comparsa sul mercato di sostanze psicoattive.
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In that regard and in the interests of clarity, he recommends that the legal basis of texts currently being drafted be clearly linked with the area of freedom, security and justice.
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A tal proposito e a fini di chiarezza, suggerisce che il fondamento normativo della legislazione, attualmente in fase di progetto, venga chiaramente ricondotta allo spazio di libertà, di sicurezza e di giustizia.
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NOTE:
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IMPORTANTE:
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The Advocate General’s Opinion is not binding on the Court of Justice.
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Le conclusioni dell'avvocato generale non vincolano la Corte di giustizia.
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It is the role of the Advocates General to propose to the Court, in complete independence, a legal solution to the cases for which they are responsible.
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Il compito dell'avvocato generale consiste nel proporre alla Corte, in piena indipendenza, una soluzione giuridica nella causa per la quale è stato designato.
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The Judges of the Court are now beginning their deliberations in this case.
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I giudici della Corte cominciano adesso a deliberare in questa causa.
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Judgment will be given at a later date.
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La sentenza sarà pronunciata in una data successiva.
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NOTE:
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IMPORTANTE:
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A reference for a preliminary ruling allows the courts and tribunals of the Member States, in disputes which have been brought before them, to refer questions to the Court of Justice about the interpretation of European Union law or the validity of a European Union act.
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Il rinvio pregiudiziale consente ai giudici degli Stati membri, nell'ambito di una controversia della quale sono investiti, di interpellare la Corte in merito all’interpretazione del diritto dell’Unione o alla validità di un atto dell’Unione.
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The Court of Justice does not decide the dispute itself.
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La Corte non risolve la controversia nazionale.
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It is for the national court or tribunal to dispose of the case in accordance with the Court’s decision, which is similarly binding on other national courts or tribunals before which a similar issue is raised. |
Spetta al giudice nazionale risolvere la causa conformemente alla decisione della Corte. Tale decisione vincola egualmente gli altri giudici nazionali ai quali venga sottoposto un problema simile. |
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According to Advocate General Bot, products consisting of aromatic herbs and
synthetically produced cannabinoids and which are sold exclusively for
recreational purposes are not medicinal products
In order to be classified as a medicinal product, a substance or combination
of substances must be intended to prevent or treat an illness
An EU directive defines the concept of ‘medicinal product by function’ as
‘any substance or combination of substances which may be used in or administered
to human beings … with a view to restoring, correcting or modifying
physiological functions by exerting a pharmacological, immunological or
metabolic action’.
Between 2010 and 2012, D and G sold mixtures of aromatic herbs containing
various synthetically produced cannabinoids.
The latter consist of psychoactive substances intended to reproduce the
effects of cannabis when they are smoked.
At the time, the German Law on combatting narcotics did not allow prosecution
for the sale of those substances.
The German authorities therefore sentenced D and G to custodial sanctions on
the basis of the Law relating to medicines, concluding that they had marketed a
‘dubious medicinal product’.
The case having been brought before it, the Bundesgerichtshof (Federal Court
of Justice, Germany) asks whether, in spite of the risks to human health, the
combination of substances at issue may be classified as a ‘medicinal product’,
in so far as, although it does, as the directive provides, modify human
physiological functions by exerting a pharmacological action, it does not
produce any therapeutic benefit for humans.
In his Opinion today, Advocate General Yves Bot considers that the concept of
‘medicinal product’ referred to in the directive is not capable of covering a
combination of substances such as that at issue.
Such a combination of substances is, admittedly, capable of modifying human
physiological functions, but its use for purely recreational purposes is
intended neither to prevent nor treat an illness.
First of all, the Advocate General points out that the issue is not to
prevent the medical use of narcotics, which remains essential for pain relief,
but to restrict the marketing of psychoactive substances consumed by humans for
exclusively recreational purposes, the consumer seeking, in this instance,
psychic effects associated with the consumption of cannabis.
In support of his arguments, Mr Bot relies first of all on the definition of
the concept of ‘medicinal product by presentation’ covered by the directive,
since that concept makes reference to the product’s ‘properties for treating or
preventing disease in human beings’.
Mr Bot considers next that the criterion relating to the ‘modification of
physiological functions’ cannot be interpreted independently of its context or
of the intended medical use of the substance or combination of substances at
issue.
The directive uses not only the verb ‘to modify’, but also the verbs ‘to
restore’ and ‘to correct’, those verbs referring to an improvement of human
organic function or the restoration of human physiological functions, which
implies the existence of a medical or therapeutic benefit.
Advocate General Bot notes, moreover, the Court’s settled case-law according
to which the use of a medicinal product must ‘be intended to prevent or treat
disease’.
In addition, the Advocate General considers that the directive, based on the
protection of public health and the free movement of goods within the EU,
precludes the marketing of substances presenting risks for human health similar
to those presented by narcotics the use of which has no medical application.
By regulating the marketing authorisation, manufacture, importation,
labelling and the distribution of medicines, the directive seeks to allow the
marketing and free movement of safe and effective products, the composition of
which has been analysed, the indications, contra-indications, risks and adverse
reactions of which have been assessed and the posology, the pharmaceutical form
and the method of administration have been determined.
Those rules are therefore not applicable to a combination of substances
intended, in reality, to be excluded from the market because it lacks any
medical benefit and presents risks to human health.
Furthermore, Mr Bot considers that the sale for purely recreational purposes
of new psychoactive substances is clearly outside the legal economic sphere of
the internal market.
He notes in that regard that, in accordance with the Court’s case-law,
‘narcotic drugs that are not distributed through channels strictly controlled by
the competent authorities to be used for medical and scientific purposes are,
because of their very nature, subject to a prohibition on their being imported
and offered for sale in all the Member States’.
Although it is understandable that, confronted with a legal vacuum, Germany
sought to apply legislation relating to medicinal products in order to be better
able to control and prevent the marketing of those new substances, Advocate
General Bot concludes that such an aim is not however capable of warranting a
broad interpretation, indeed a distortion, of the concept of ‘medicinal
product’.
He considers, consequently, that only enforcement measures based on the
control of narcotics are suitable in order to respond to the appearance of
psychoactive substances on the market.
In that regard and in the interests of clarity, he recommends that the legal
basis of texts currently being drafted be clearly linked with the area of
freedom, security and justice.
NOTE:
The Advocate General’s Opinion is not binding on the Court of Justice.
It is the role of the Advocates General to propose to the Court, in complete
independence, a legal solution to the cases for which they are responsible.
The Judges of the Court are now beginning their deliberations in this case.
Judgment will be given at a later date.
NOTE:
A reference for a preliminary ruling allows the courts and tribunals of the
Member States, in disputes which have been brought before them, to refer
questions to the Court of Justice about the interpretation of European Union law
or the validity of a European Union act.
The Court of Justice does not decide the dispute itself.
It is for the national court or tribunal to dispose of the case in accordance
with the Court’s decision, which is similarly binding on other national courts
or tribunals before which a similar issue is raised.
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