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RECHTLICHE GRUNDLAGEN
DER ARZNEIMITTEL-
REGULIERUNG
Dr. Katharina Kern
Helmholtz-Zentrum für Umweltforschung
Department Umwelt- und Planungsrecht
Statusseminar Arzneistoffe in der Umwelt
7. und 8. September 2011, Dresden

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SEITE 2
Gliederung
Arzneimittel in der Umwelt
Umweltrisiko in der Vormarktkontrolle
Umweltrisiko in der Nachmarktkontrolle
Defizite des Humanarzneimittelrechts
Defizite des Tierarzneimittelrechts
Handlungsoptionen
Fazit

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SEITE 3
AM in der Umwelt: Einsatzmengen
ca. 9.000 Präparate mit 3.000 Wirkstoffen*
900 Tonnen TAM-Wirkstoffe**
(allein 700 Tonnen Antibiotika)
35.000 Tonnen HAM-Wirkstoffe***
(100 Tonnen Carbamazepin, Diclofenac, Metoprolol
350 Tonnen Ibuprofen
1000 Tonnen Acetylsäure und Paracetamol)
keine systematische Erfassung der
Verbrauchsdaten
* Arzneimittelverzeichnis Rote Liste,
** Schneidereit (2004), Koschorreck (2005)
*** Huschek/Krengel (2005)

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SEITE 4
AM in der Umwelt: Eintragswege
> 100 Arzneistoffe im OFG, GW, z.T. TW
Konzentrationen im Bereich von PSM, Frachten z.T. darüber

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SEITE 5
Umweltrisiko in der Vormarktkontrolle –
Allgemeine Mechanismen
Pharmaunternehmen
Antrag /
Zulassung
(AM-Dossier)
BfARM
BVL
PEI
EMA
(KOM)
UBA
(Einver-
nehmen)
CVMP
CHMP
Zulassungs-
behörde
(Gesamt-
bewertung)
Umwelt-
bewertung
(national)
(dezentral)
(zentral)
gegens.
Anerkenng
.
andere
Streit
MS

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SEITE 6
Rechtsquellen: RL 2001/83/EG (HAM),
RL 2001/82/EG (TAM),
AMG
Umweltrisikobewertung durch Antragsteller
Beurteilung, ob schädliche Auswirkungen für Umwelt
infolge bestimmungsgemäßer Anwendung des Mittels
wirkstoffbezogen inkl. bedeutender Metabolite
Konkretisierung der Testverfahren & Prüfschemata in
Leitlinien der EMA
TAM: seit 1998,
(CVMP/VICH/592/98-PHASE I - 2001, CVMP/VICH/790/03-PHASE II - 2005)
HAM: seit 2006 (EMEA/CHMP/SWP/4447/00)
Umweltrisiko in der Vormarktkontrolle

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SEITE 7
Umweltrisiko in der Vormarktkontrolle
Umweltkonzentration des Arzneistoffes (PEC)
Umweltrisiko =
Nicht-Effekt-Konzentration des Arzneistoffes
(PNEC)
≥ 1 : Annahme eines Umweltrisikos
weitere Tests
Absenkung mit Risikominderungsmaßnahmen

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SEITE 8
Umweltrisikobewertung für:
neue AM,
Generika & bibliographischen Zulassungen
(mit Ausnahmen)
keine
Umweltrisikobewertung für
AM ohne signifikantes Umweltrisiko
(Impfstoffe, pflanzl. AM, Vitamine, Elektrolyte, etc.)
alte Arzneimittel
Umweltrisiko in der Vormarktkontrolle

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SEITE 9
Umweltrisiko in der Vormarktkontrolle:
Auswirkungen auf Zulassung
HAM
TAM
Umweltrisiko in
NRA
nein
ja
(seit 2005)
Versagung aus
Umweltgründen
möglich
nein
ja
(Umweltrisiko als
gleichberechtigter Belang)
Umweltschützende
Auflagen
begrenzt
(Entsorgung,
Aufklärung)
unbegrenzt
(Verschreibungspflicht aus
Umweltgründen )
Zulassung: vollständige (inkl. umweltrelevante) Unterlagen
positive Nutzen-Risiko-Abwägung (NRA)

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SEITE 10
Umweltrisiko in der Nachmarktkontrolle -
Allgemeine Mechanismen
Pharmaunternehmen
BfARM
BVL
PEI
EMA
(Pharma-Daten-
bank)
EMA
(KOM)
Patient
Arzt
Apotheker
Länderbehörden
Landwirt
Landes-
behörden
BfARM
BVL
PEI
UBA
MELDUNG
REAKTION

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SEITE 11
Humanarzneimittel
keine Erfassung der Umweltrisiken über Nach-
marktkontrolle
keine gezielte Suche nach Umweltrisiken
keinen Einfluss auf erteilte Zulassung
Umweltrisiko in der Nachmarktkontrolle

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SEITE 12
Tierarzneimittel
Nachmarktkontrolle dient Sammlung von
Umweltrisiken
pharmazeutischer Unternehmer: Meldung bekannter
Umweltrisiken, keine eigenständigen Prüfpflichten
behördl. Anordnungsbefugnis zu Nachmarktkontrollstudien
(Umweltrisikobewertungsdaten, Monitoring)
Umweltrisiko in der Nachmarktkontrolle
Neubeurteilung
Nutzen-Risiko-
Verhältnis
Verändertes
Umweltrisiko nach
Zulassung
Keine Zulassungsverlängerung
Aufhebung/Änderung …
gilt auch für alte Arzneimittel

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SEITE 13
Verpflichtung zur Einrichtung von Sammelsystemen
für unbenutzte / abgelaufene Arzneimittel
in Mitgliedstaaten
Umweltrisiko in der Nachmarktkontrolle

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SEITE 14
Defizite des Humanarzneimittelrechts
keine Verweigerung der Zulassung aus Umwelt-
gründen möglich, keine effektiven RMM
keine Erfassung der Umweltrisiken über Nach-
marktkontrolle
keine Umweltrisikobewertung von alten HAM
(Zulassung vor 2006)
Wissenslücken
unzureichende Sammelsysteme

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SEITE 15
Defizite des Tierarzneimittelrechts
Vollzug ineffektiv und nicht kontrollierbar
fehlende rechtliche Instrumente
fehlende Ausführungsorgane
Behörde / Zulassung
Keine Kontrolle
Hinweise
Tierarzt / Landwirt
Auflagen
Hersteller

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SEITE 16
Defizite des Tierarzneimittelrechts
Eigenart der Umweltrisiken bedingt Probleme
bei der Nachmarktkontrolle:
übliche Berichtsmethoden ungeeignet
Nachweis der kausalen Kette schwierig
gleiche Wirkstoffe bei HAM & TAM vs.
unterschiedliche Behördenzuständigkeiten
und Konsequenzen
keine Umweltrisikobewertung von alten TAM
(Zulassung vor 1998)

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SEITE 17
Handlungsoptionen: Felder und Akteure
Pharmaindustrie
Politik
Behörden
Recht
Verbraucher
Ärzte
Apotheker
verbesserte
Produktkontrolle
Anwendung
Aufklärung
Entsorgung
Wasserrecht
Technische
Optionen
ZIEL
Entwicklung umweltfreundlicherer Arzneimittel
Reduzierung des Eintrages in die Umwelt

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SEITE 18
Zulassungskriterium Umweltverträg-
lichkeit bei Humanarzneimitteln
Innovationsdruck zur
Entwicklung umweltfreundlicher
Arzneimittel
Programm für Altarzneimittel (TAM & HAM)
hohes Umweltgefährdungspotential
Umweltrisikobewertung von prioritären Stoffen
auf europäischer Ebene
Handlungsfeld: verbesserte Produktkontrolle

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SEITE 19
klare gesetzliche Befolgungsregeln
Vor-Ort-Kontrollen von Land-
wirten und Tierärzten
Monitoringprogramme
artgerechte Tierhaltung und gute
landwirtschaftliche Praxis
Handlungsfeld: Anwendung
Kontrolle

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SEITE 20
gezielte Aufklärung von Verbrauchern, Ärzten, Apothekern,
pharmazeutischen Entwicklern, Politikern,…
Umweltkennzeichen und Entsorgungshinweise
auf Verpackung und Beipackzettel
in beruflichen Nachschlagewerken
Einführung eines verpflichtenden Rücknahme- und
Entsorgungssystems über Apotheken, Beispiel: Batterien
Handlungsfeld: Aufklärung und Entsorgung

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SEITE 21
Fazit
Umweltrisikobewertung
neuer TAM (1998), HAM (2006) + Generika
ohne AltAM
Umweltverhalten unbekannt
Altstoffprogramm
Vorreiterrolle Tierarzneimittelrecht
(trotz geringerer Einträge)
(Zulassung, Auflagen, Nachmarktkontrolle)
HAMR: Sammlung & Verwaltung von Umweltdaten neuer AM,
keine effektiven RMM
TAMR: anspruchsvolle Präventivkontrolle,
Probleme Vollzug
(Bindungswirkung, Kontrolle, Nachmarktkontrolle)
kein ausreichender Schutz
vor Arzneistoffen im akt. Recht

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Vielen Dank für Ihre Aufmerksamkeit !