{"$schema":"https://www.lobbyregister.bundestag.de/json-schemas/R2.22/Lobbyregister-Registereintrag-schema-R2.22.json","source":"Deutscher Bundestag, Lobbyregister für die Interessenvertretung gegenüber dem Deutschen Bundestag und der Bundesregierung","sourceUrl":"https://www.lobbyregister.bundestag.de","sourceDate":"2026-04-14T10:06:27.281+02:00","jsonDocumentationUrl":"https://www.lobbyregister.bundestag.de/informationen-und-hilfe/open-data-1049716","registerNumber":"R000211","registerEntryDetails":{"registerEntryId":71458,"legislation":"GL2024","version":18,"detailsPageUrl":"https://www.lobbyregister.bundestag.de/suche/R000211/71458","pdfUrl":"https://www.lobbyregister.bundestag.de/media/e8/b4/696655/Lobbyregister-Registereintraege-Detailansicht-R000211-2026-02-19_12-06-41.pdf","validFromDate":"2026-02-19T12:06:41.000+01:00","fiscalYearUpdate":{"updateMissing":false,"lastFiscalYearUpdate":"2025-06-24T11:04:41.000+02:00"}},"accountDetails":{"activeLobbyist":true,"activeDateRanges":[{"fromDate":"2024-09-10T16:02:13.000+02:00"}],"firstPublicationDate":"2022-01-28T13:26:01.000+01:00","lastUpdateDate":"2026-02-19T12:06:41.000+01:00","registerEntryVersions":[{"registerEntryId":71458,"jsonDetailUrl":"https://www.lobbyregister.bundestag.de/sucheJson/R000211/71458","version":18,"legislation":"GL2024","validFromDate":"2026-02-19T12:06:41.000+01:00","versionActiveLobbyist":true},{"registerEntryId":66501,"jsonDetailUrl":"https://www.lobbyregister.bundestag.de/sucheJson/R000211/66501","version":17,"legislation":"GL2024","validFromDate":"2025-10-09T16:31:17.000+02:00","validUntilDate":"2026-02-19T12:06:41.000+01:00","versionActiveLobbyist":true},{"registerEntryId":63004,"jsonDetailUrl":"https://www.lobbyregister.bundestag.de/sucheJson/R000211/63004","version":16,"legislation":"GL2024","validFromDate":"2025-07-30T11:15:18.000+02:00","validUntilDate":"2025-10-09T16:31:17.000+02:00","versionActiveLobbyist":true},{"registerEntryId":58914,"jsonDetailUrl":"https://www.lobbyregister.bundestag.de/sucheJson/R000211/58914","version":15,"legislation":"GL2024","validFromDate":"2025-06-24T11:04:41.000+02:00","validUntilDate":"2025-07-30T11:15:18.000+02:00","versionActiveLobbyist":true},{"registerEntryId":50802,"jsonDetailUrl":"https://www.lobbyregister.bundestag.de/sucheJson/R000211/50802","version":14,"legislation":"GL2024","validFromDate":"2025-02-20T14:52:42.000+01:00","validUntilDate":"2025-06-24T11:04:41.000+02:00","versionActiveLobbyist":true},{"registerEntryId":43863,"jsonDetailUrl":"https://www.lobbyregister.bundestag.de/sucheJson/R000211/43863","version":13,"legislation":"GL2024","validFromDate":"2025-01-22T14:30:19.000+01:00","validUntilDate":"2025-02-20T14:52:42.000+01:00","versionActiveLobbyist":true},{"registerEntryId":43862,"jsonDetailUrl":"https://www.lobbyregister.bundestag.de/sucheJson/R000211/43862","version":12,"legislation":"GL2024","validFromDate":"2024-09-10T16:02:13.000+02:00","validUntilDate":"2025-01-22T14:30:19.000+01:00","versionActiveLobbyist":true}],"accountHasCodexViolations":false},"lobbyistIdentity":{"identity":"ORGANIZATION","name":"Pro Generika e.V.","legalFormType":{"code":"JURISTIC_PERSON","de":"Juristische Person","en":"Legal person"},"legalForm":{"code":"LF_EV","de":"Eingetragener Verein (e. 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Vorsitzender ","recentGovernmentFunctionPresent":false,"entrustedPerson":true,"contactDetails":{}}],"entrustedPersonsPresent":true,"entrustedPersons":[{"lastName":"Burkhardt","firstName":"Andreas","recentGovernmentFunctionPresent":false},{"lastName":"Mestrovic","firstName":"Josip","recentGovernmentFunctionPresent":false},{"lastName":"Bretthauer","firstName":"Bork","recentGovernmentFunctionPresent":false},{"lastName":"Steinbach","firstName":"Anna","recentGovernmentFunctionPresent":false},{"academicDegreeAfter":"M.A. ","lastName":"Strobel","firstName":"Franziska","recentGovernmentFunctionPresent":false},{"lastName":"Freifrau von Schorlemer-Lieser-Thomsen","firstName":"Gloria","recentGovernmentFunctionPresent":false},{"lastName":"Weigold","firstName":"Thomas","recentGovernmentFunctionPresent":false},{"academicDegreeAfter":"MBA","lastName":"Wittkemper","firstName":"Frank","recentGovernmentFunctionPresent":false},{"lastName":"Locher","firstName":"Fabian","recentGovernmentFunctionPresent":false},{"lastName":"Röhrer","firstName":"Walter","recentGovernmentFunctionPresent":false},{"academicDegreeBefore":"Dr. ","lastName":"Kirsch","firstName":"Christopher","recentGovernmentFunctionPresent":false},{"lastName":"Holub","firstName":"Katarzyna","recentGovernmentFunctionPresent":false}],"membersPresent":true,"membersCount":{"naturalPersons":0,"organizations":20,"totalCount":20,"dateCount":"2025-06-23"},"membershipsPresent":true,"memberships":[{"membership":"Medicines for Europe"},{"membership":"Bundesverband Managed Care e.V."}]},"activitiesAndInterests":{"activity":{"code":"ACT_TRADE_ASSOC","de":"Wirtschaftsverband oder Gewerbeverband/-verein","en":"Trade association"},"typesOfExercisingLobbyWork":[{"code":"SELF_OPERATED_OWN_INTEREST","de":"Die Interessenvertretung wird in eigenem Interesse selbst wahrgenommen","en":"Interest representation is self-performed in its own interest"}],"fieldsOfInterest":[{"code":"FOI_HEALTH_MEDICINE","de":"Arzneimittel","en":"Medicine"},{"code":"FOI_ECONOMY_INDUSTRIAL","de":"Industriepolitik","en":"Industrial policy"},{"code":"FOI_ENVIRONMENT_POLLUTION","de":"Immissionsschutz","en":"Immission control"},{"code":"FOI_HEALTH_SUPPLY","de":"Gesundheitsversorgung","en":"Health supply"},{"code":"FOI_EU_OTHER","de":"Sonstiges im Bereich \"Europapolitik und Europäische Union\"","en":"Other in the field of \"European politics and the EU\""},{"code":"FOI_LAW_OTHER","de":"Sonstiges im Bereich \"Recht\"","en":"Other in the field of \"Law\""},{"code":"FOI_IS_CYBER","de":"Cybersicherheit","en":"Cyber security"},{"code":"FOI_IS_OTHER","de":"Sonstiges im Bereich \"Innere Sicherheit\"","en":"Other in the field of \"Internal security\""},{"code":"FOI_EU_LAWS","de":"EU-Gesetzgebung","en":"EU legislation"}],"activityDescription":"Der Verband Pro Generika ist ein Wirtschaftsverband, der gemäß Satzung die gemeinsamen Interessen der Generika- und Biosimilarhersteller in Deutschland fördert und vertritt. Der Verband konstituiert sich aus Unternehmen, die Generika- und Biosimilars herstellen und vertreiben. Die Generika- und Biosimilar-Unternehmen stellen 80 % der Tagestherapiedosen von rezeptpflichtigen Arzneimittel für die Versorgung in Deutschland zur Verfügung. \r\n\r\nPro Generika  setzt sich mit seiner Interessensvertretung insbesondere für ein Erstattungssystem im Rahmen des SGB V ein, dass eine sichere und nachhaltige Arzneimittelversorgung mit Generika und Biosimilars unterstützt und die Vielfalt der Anbieter erhält, durch die sich bereits Preiswettbewerb ergibt. Dabei geht es u.a. um Festbeträge, Rabattverträge, Preismoratorium, Herstellerabschläge, Informationspflichten, Lagerhaltung und weitere Regelungen. Daneben geht es um weitere Rahmenbedingungen der Industrie, u.a. Umweltbelange und Aspekte des Geistigen Eigentums.\r\n\r\nHierfür betreibt der Verband Lobbyarbeit. Mithilfe von Positionspapieren, Stellungnahmen und weiteren Hinweisen zur Arbeit des Gesetzgebers informieren wir Abgeordnete, die Bundes- und Landesregierungen, Bundes- und Landesministerien und Bundesoberbehörden zu den Belangen der Industrie. Zwei bis dreimal jährlich finden öffentliche Veranstaltungen statt, bei denen aktuelle Fragestellungen der Branche diskutiert werden. Dazu laden wir neben weiteren Stakeholdern auch Abgeordnete und Vertreter der Ministerien und BOB ein. \r\n\r\n\r\n"},"employeesInvolvedInLobbying":{"relatedFiscalYearFinished":true,"relatedFiscalYearStart":"2024-01-01","relatedFiscalYearEnd":"2024-12-31","employeeFTE":5.0},"financialExpenses":{"relatedFiscalYearFinished":true,"relatedFiscalYearStart":"2024-01-01","relatedFiscalYearEnd":"2024-12-31","financialExpensesEuro":{"from":2130001,"to":2140000}},"mainFundingSources":{"relatedFiscalYearFinished":true,"relatedFiscalYearStart":"2024-01-01","relatedFiscalYearEnd":"2024-12-31","mainFundingSources":[{"code":"MFS_MEMBERSHIP_FEES","de":"Mitgliedsbeiträge","en":"Membership fees"},{"code":"MFS_OTHERS","de":"Sonstiges","en":"Others"}]},"publicAllowances":{"publicAllowancesPresent":false,"relatedFiscalYearFinished":true,"relatedFiscalYearStart":"2024-01-01","relatedFiscalYearEnd":"2024-12-31"},"donators":{"relatedFiscalYearFinished":true,"relatedFiscalYearStart":"2024-01-01","relatedFiscalYearEnd":"2024-12-31","totalDonationsEuro":{"from":0,"to":0}},"membershipFees":{"relatedFiscalYearFinished":true,"relatedFiscalYearStart":"2024-01-01","relatedFiscalYearEnd":"2024-12-31","totalMembershipFees":{"from":2140001,"to":2150000},"individualContributorsPresent":false,"individualContributors":[]},"annualReports":{"annualReportLastFiscalYearExists":true,"lastFiscalYearStart":"2024-01-01","lastFiscalYearEnd":"2024-12-31","annualReportPdfUrl":"https://www.lobbyregister.bundestag.de/media/1c/c4/696651/Pro-Generika-Jahresrechnung-2024-Lobbyregister_kurz.pdf"},"regulatoryProjects":{"regulatoryProjectsPresent":true,"regulatoryProjectsCount":14,"regulatoryProjects":[{"regulatoryProjectNumber":"RV0003642","title":"Arzneimittel-Lieferengpassbekämpfungs- und Versorgungsverbesserungsgesetz (ALBVVG) ","printedMattersPresent":true,"printedMatters":[{"title":"Arzneimittelversorgung sicherstellen - Versorgungssicherheit gewährleisten","printingNumber":"20/9319","issuer":"BT","documentUrl":"https://dserver.bundestag.de/btd/20/093/2009319.pdf","projectUrl":"https://dip.bundestag.de/vorgang/arzneimittelversorgung-sicherstellen-versorgungssicherheit-gew%C3%A4hrleisten/305965","leadingMinistries":[]}],"draftBillPresent":false,"description":"Ziel war es Veränderungen der Erstattungsregeln zu erreichen, um eine sicherere Arzneimittelversorgung zu gewährleisten. ","affectedLawsPresent":true,"affectedLaws":[{"title":"Sozialgesetzbuch (SGB) Fünftes Buch (V) - Gesetzliche Krankenversicherung - (Artikel 1 des Gesetzes v. 20. Dezember 1988, BGBl. I S. 2477)","shortTitle":"SGB 5","url":"https://www.gesetze-im-internet.de/sgb_5"}],"fieldsOfInterest":[{"code":"FOI_HEALTH_SUPPLY","de":"Gesundheitsversorgung","en":"Health supply"},{"code":"FOI_HEALTH_MEDICINE","de":"Arzneimittel","en":"Medicine"}]},{"regulatoryProjectNumber":"RV0003643","title":"System der Erweiterten Herstellerverantwortung zur Finanzierung 4. Klärstufe","printedMattersPresent":false,"printedMatters":[],"draftBillPresent":false,"description":"Die jetzt von der UWWTD / KARL vorgesehene Finanzierung der 4. Klärstufe führt in einen Zielkonflikt mit der Gewährleistung einer sicheren Arzneimittel-Grundversorgung. Dieser Zielkonflikt muss gelöst werden. Wir weisen darauf hin, dass die anfallenden Klärwerks-Beiträge für die Hersteller nicht kalkulierbar sind und die Generika-Preise im derzeitigen Generikapreis-Regulierungssystem nicht erhöht werden können. Dies wird zu einer nicht absehbaren Anzahl von Marktrücknahmen führen.","affectedLawsPresent":false,"affectedLaws":[],"fieldsOfInterest":[{"code":"FOI_EU_LAWS","de":"EU-Gesetzgebung","en":"EU legislation"},{"code":"FOI_ENVIRONMENT_POLLUTION","de":"Immissionsschutz","en":"Immission control"}]},{"regulatoryProjectNumber":"RV0003644","title":"Einführung eines pre-grant opposition mechanisms bei einheitlichen SPC","printedMattersPresent":false,"printedMatters":[],"draftBillPresent":false,"description":"Wir setzen uns dafür ein, dass im Rahmen der europäischen Diskussion ein pre-grant opposition mechanism für das einheitliche SPC eingeführt wird. Dadurch wäre es möglich, bereits vor einer Patenterteilung die Validität des Patentes überprüfen zu lassen. Hierdurch ließen sich unnötige Rechtsstreitigkeiten vermeiden, so dass die Einführung von Generika nicht durch juristische Auseinandersetzungen unnötig verzögert wird. ","affectedLawsPresent":false,"affectedLaws":[],"fieldsOfInterest":[{"code":"FOI_EU_LAWS","de":"EU-Gesetzgebung","en":"EU legislation"},{"code":"FOI_HEALTH_MEDICINE","de":"Arzneimittel","en":"Medicine"}]},{"regulatoryProjectNumber":"RV0003645","title":"Der Erstattungsbetrag des Originals gilt auch fürs Generikum. Hersteller brauchen ihn vorab. Wir fordern ein Auskunftsrecht für Planungssicherheit.","printedMattersPresent":true,"printedMatters":[{"title":"Entwurf eines Medizinforschungsgesetzes","printingNumber":"155/24","issuer":"BR","documentUrl":"https://dserver.bundestag.de/brd/2024/0155-24.pdf","projectUrl":"https://dip.bundestag.de/vorgang/medizinforschungsgesetz/310586","leadingMinistries":[{"title":"Bundesministerium für Gesundheit","shortTitle":"BMG","electionPeriod":20,"url":"https://www.bundesgesundheitsministerium.de/"},{"title":"Bundesministerium für Umwelt, Naturschutz, nukleare Sicherheit und Verbraucherschutz","shortTitle":"BMUV","electionPeriod":20,"url":"https://www.bmuv.de/"}]}],"draftBillPresent":false,"description":"Da der vertrauliche Erstattungsbetrag des Originals auch für das folgende Generikum als Preisobergrenze fort gilt, muss der generische Hersteller den Erstattungsbetrag mit einem gewissen Vorlauf kennen, um seinen Markteintritt kalkulieren zu können. Wir haben uns für ein Auskunftsrecht eingesetzt.","affectedLawsPresent":false,"affectedLaws":[],"fieldsOfInterest":[{"code":"FOI_HEALTH_SUPPLY","de":"Gesundheitsversorgung","en":"Health supply"},{"code":"FOI_HEALTH_MEDICINE","de":"Arzneimittel","en":"Medicine"}]},{"regulatoryProjectNumber":"RV0003646","title":"Position der europäischen Generika- und Biosimilarindustrie zum EU-Vergaberecht","printedMattersPresent":false,"printedMatters":[],"draftBillPresent":false,"description":"Der größte Teil (rund 75%) aller rezeptpflichtigen Generika wird in der Apotheke unter Rabattvertrag abgegeben. Einziges Kriterium für die Vergabe ist in den allermeisten Fällen ausschließlich der Preis  (einige Ausnahmen sind mit dem ALBVVG eingeführt worden und in einigen Fällen wurde die Ausschreibungspraxis geändert). In den europäischen Regelungen sind keine anderen Vorgaben für die Ausschreibung von Arzneimitteln vorgesehen. Wir setzten uns ein für die Berücksichtigung weiterer Vergabekriterien über das Kriterium des \"billigsten Preises\" für ein Generikum hinaus.","affectedLawsPresent":false,"affectedLaws":[],"fieldsOfInterest":[{"code":"FOI_EU_LAWS","de":"EU-Gesetzgebung","en":"EU legislation"},{"code":"FOI_LAW_OTHER","de":"Sonstiges im Bereich \"Recht\"","en":"Other in the field of \"Law\""}]},{"regulatoryProjectNumber":"RV0006118","title":"Wir fordern, Lagerpflicht auf kritische Arzneimittel zu fokussieren (3 Monate als Bulk) und Doppelregulierung bei Biosimilars abzubauen.","printedMattersPresent":false,"printedMatters":[],"draftBillPresent":true,"draftBill":{"title":"Gesetz für eine Apothekenhonorar- und Apothekenstrukturreform (Apotheken-Reformgesetz) (20. WP)","publicationDate":"2024-06-14","leadingMinistries":[{"title":"Bundesministerium für Gesundheit","shortTitle":"BMG","electionPeriod":20,"url":"https://www.bundesgesundheitsministerium.de/","draftBillDocumentUrl":"https://www.bundesgesundheitsministerium.de/fileadmin/Dateien/3_Downloads/Gesetze_und_Verordnungen/GuV/A/ApoRG-Apotheken-Reformgesetz_RefE.pdf","draftBillProjectUrl":"https://www.bundesgesundheitsministerium.de/service/gesetze-und-verordnungen/detail/aporg.html"}]},"description":"Wir setzen uns dafür ein, dass eine Fokussierung und Flexibilisierung der sechsmonatige Lagerhaltung für Rabattarzneimittel (§ 130a Abs. 8 SGB V) auf versorgungskritische Arzneimittel, wobei 3 Monate in Form von Bulk gelagert werden können, und der Abbau der Doppelregulierung bei Biosimilars durch Hilfstaxe und 8c-Verträge in den Referentenentwurf aufgenommen werden.","affectedLawsPresent":true,"affectedLaws":[{"title":"Sozialgesetzbuch (SGB) Fünftes Buch (V) - Gesetzliche Krankenversicherung - (Artikel 1 des Gesetzes v. 20. Dezember 1988, BGBl. I S. 2477)","shortTitle":"SGB 5","url":"https://www.gesetze-im-internet.de/sgb_5"}],"fieldsOfInterest":[{"code":"FOI_HEALTH_MEDICINE","de":"Arzneimittel","en":"Medicine"},{"code":"FOI_HEALTH_SUPPLY","de":"Gesundheitsversorgung","en":"Health supply"}]},{"regulatoryProjectNumber":"RV0007583","title":"Gleichstellung der elektronischen Packungsbeilage","printedMattersPresent":false,"printedMatters":[],"draftBillPresent":false,"description":"Die digitale Transformation der Gebrauchsinformation soll vorangetrieben werden. Eine entsprechende Öffnung sieht der Entwurf der Pharmaceutical Legislation auf EU-Ebene bereits vor. Diese sollte in einer pragmatischen und anwenderfreundlichen Art und Weise und ohne eine Doppelbelastung der generischen Industrie umgesetzt werden. Dafür sollen deren praktische Vorteile bei der Bewältigung von Lieferengpässen, dem Ersatz gedruckter GI in der Klinik und der Information von Patienten und Fachkreisen im praktischen Einsatz zu zeigen.","affectedLawsPresent":true,"affectedLaws":[{"title":"Gesetz über den Verkehr mit Arzneimitteln","shortTitle":"AMG 1976","url":"https://www.gesetze-im-internet.de/amg_1976"}],"fieldsOfInterest":[{"code":"FOI_EU_LAWS","de":"EU-Gesetzgebung","en":"EU legislation"},{"code":"FOI_HEALTH_MEDICINE","de":"Arzneimittel","en":"Medicine"}]},{"regulatoryProjectNumber":"RV0011979","title":"Possible Restriction of PFAS: impact on critical medicines supply","printedMattersPresent":false,"printedMatters":[],"draftBillPresent":false,"description":"In der EU wird ein weitgehendes Verbot von PFAS-Substanzen diskutiert. Diese umfangreiche Substanzgruppe ist in vielen Arzneimitteln enthalten und in noch größerem Umfang in Produktionsanlagen oder Verpackungen. Da eine Änderung von Wirkstoffen im Wesentlichen ausgeschlossen und eine Änderung von Produktion oder Verpackung im pharmazeutischen Bereich ein höchst aufwendiger Prozess ist, würde ein umfangreiches Verbot die anderweitigen Bemühungen um eine stabile Arzneimittelversorgung konterkarieren und voraussichtlich zu akuten Engpässen und zu einer Produktionsverlagerung noch weiter in Drittstaaten führen. Insofern ist bei den anstehenden EU-Verhandlungen aus unserer Sicht ein sehr weitgehendes Übergangsregime dringend geboten. (Schreiben Europ. Dachverband Medicines for Europe).","affectedLawsPresent":false,"affectedLaws":[],"fieldsOfInterest":[{"code":"FOI_EU_LAWS","de":"EU-Gesetzgebung","en":"EU legislation"}]},{"regulatoryProjectNumber":"RV0014766","title":"Gemeinsame / Kassenartenübergreifende Ausschreibungen von Krankenkassen","printedMattersPresent":false,"printedMatters":[],"draftBillPresent":false,"description":"In der Politik gibt es, z. B. bei Bündnis 90 / Die Grünen bzw. in der SPD, Stimmen und Positionen, wonach Rabattvertragsausschreibungen durch die Krankenkassen nochmals stärker Krankenkassenarten-übergreifend (Vorschlag Bündnis 90 / Die Grünen) oder gemäß einem SPD-Vorschlag auch EU-Länder übergreifend erfolgen sollen. Offenbar verspricht man sich davon eine Senkung des administrativen Aufwands bzw. auch eine größere Planungssicherheit durch höhere Versorgungsvolumen für die Hersteller. Dieser an sich positiv gedachte Ansatz geht jedoch mit ernsthaften Folgen für die\r\nVersorgungssicherheit einher.\r\nFakten zum Ausschreibungsmarkt: Bereits heute sind die Ausschreibungen der Krankenkassen in Deutschland sehr stark gebündelt und zentralisiert","affectedLawsPresent":false,"affectedLaws":[],"fieldsOfInterest":[{"code":"FOI_HEALTH_MEDICINE","de":"Arzneimittel","en":"Medicine"}]},{"regulatoryProjectNumber":"RV0018726","title":"Gefahrenbewertung von Ethanol (Alkohol) nach EU-Biozidprodukteverordnung (EU) Nr. 528/2012 (BPR-Verfahren) ","printedMattersPresent":false,"printedMatters":[],"draftBillPresent":false,"description":"Gefahrenbewertung von Ethanol (Alkohol) nach EU-Biozidprodukteverordnung (EU) Nr. 528/2012 (BPR-Verfahren) und dem nachgelagerten Verfahren zur harmonisierten Einstufung und Kenn-zeichnung (CLH-Verfahren) unter der “Classification, Labelling and Packaging”-Verordnung (EG) Nr. 1272/2008.\r\n\r\nEthanol (Alkohol) soll in diesem Verfahren in eine höhere Gefahrenklasse eingestuft werden, was unabsehbare Folgen hätte für die Handdesinfektion, Abläufe in Arztpraxen/Krankenhäusern und auch für die pharmazeutische Produktion. \r\nWir fordern, die unsachgemäße Neueinstufung von Ethanol als CMR-Stoff zu verhindern und die laufenden Verfahren auf EU-Ebene zum jetzigen Zeitpunkt endgültig zu beenden.","affectedLawsPresent":false,"affectedLaws":[],"fieldsOfInterest":[{"code":"FOI_EU_LAWS","de":"EU-Gesetzgebung","en":"EU legislation"},{"code":"FOI_HEALTH_MEDICINE","de":"Arzneimittel","en":"Medicine"}]},{"regulatoryProjectNumber":"RV0018727","title":"Stellungnahme zum Referentenentwurf des NIS-2-Umsetzungs- und Cybersicherheitsstärkungsgesetzes ","printedMattersPresent":false,"printedMatters":[],"draftBillPresent":true,"draftBill":{"customTitle":"Entwurf eines Gesetzes zur Umsetzung der NIS-2-Richtlinie und zur Re-gelung wesentlicher Grundzüge des Informationssicherheitsmanage-ments in der Bundesverwaltung","customDate":"2025-06-23","leadingMinistries":[{"title":"Bundesministerium des Innern","shortTitle":"BMI","electionPeriod":21,"url":"https://www.bmi.bund.de/DE/startseite/startseite-node.html"}]},"description":"Wir sehen deutlichen Änderungsbedarf in der praktischen Umsetzung des geplanten Gesetzes – insbesondere mit Blick auf:\r\n- eine klarere Ausgestaltung von Informationspflichten und Zugangsrechten in § 6,\r\n- realitätsnahe und verhältnismäßige Vorgaben für Schulungsmaßnahmen in § 30,\r\n- eine differenzierte Betrachtung der Lieferkettensicherheit mit Ausnahmen für und  praxisnaher Unterstützung kleiner Unternehmen,\r\n- eine rechtsklare, verhältnismäßige Eingrenzung der Geschäftsführungsverantwortung\r\n\r\nWir appellieren daher an den Gesetzgeber, die betroffenen Branchen – insbesondere den Bereich der Arzneimittelherstellung – stärker in die Ausgestaltung der Verordnungen und Umsetzungsrichtlinien einzubeziehen.\r\n","affectedLawsPresent":false,"affectedLaws":[],"fieldsOfInterest":[{"code":"FOI_IS_OTHER","de":"Sonstiges im Bereich \"Innere Sicherheit\"","en":"Other in the field of \"Internal security\""},{"code":"FOI_IS_CYBER","de":"Cybersicherheit","en":"Cyber security"}]},{"regulatoryProjectNumber":"RV0020204","title":"Critical Medicines Act","printedMattersPresent":false,"printedMatters":[],"draftBillPresent":false,"description":"Unser Ziel ist es, dass der CMA verbindliche und definierte MEAT-Kriterien bei Arzneimittelausschreibungen der Krankenkassen vorsieht. ","affectedLawsPresent":false,"affectedLaws":[],"fieldsOfInterest":[{"code":"FOI_EU_LAWS","de":"EU-Gesetzgebung","en":"EU legislation"}]},{"regulatoryProjectNumber":"RV0022620","title":"Gesetzliche Verankerung von Open-House-Verträgen als Regelform der Krankenkassenausschreibungen bei Biosimilars","printedMattersPresent":false,"printedMatters":[],"draftBillPresent":false,"description":"Wir setzen uns für die gesetzliche Verankerung von Open-House-Verträgen als Regelform der Krankenkassenausschreibungen für Biosimilars ein. Damit würden alle politische Anforderungen an eine Regelung für Krankenkassenausschreibungen erfüllt werden: höhere Einsparungen für die Krankenkassen, Gewährleistung der Versorgungssicherheit und Erhalt des Biotechnologiestandortes Deutschland. Ohne gesetzliche Festlegung droht eine Entwicklung analog zum Generikamarkt mit zunehmender Anbieterreduktion und steigender Lieferengpassanfälligkeit. Aufgrund der komplexen und investitionsintensiven biotechnologischen Herstellung sind stabile und planbare Marktbedingungen im Biosimilarbereich besonders wichtig.","affectedLawsPresent":true,"affectedLaws":[{"title":"Gesetz über das Apothekenwesen","shortTitle":"ApoG","url":"https://www.gesetze-im-internet.de/apog"}],"fieldsOfInterest":[{"code":"FOI_HEALTH_SUPPLY","de":"Gesundheitsversorgung","en":"Health supply"}]},{"regulatoryProjectNumber":"RV0022621","title":"Aufrechterhaltung der Versorgungssicherheit mit Arzneimitteln im Krisen- und Verteidigungsfall","printedMattersPresent":false,"printedMatters":[],"draftBillPresent":false,"description":"Wir setzen uns für eine ressortübergreifende Strategie zur Sicherstellung der Versorgung mit generischen Arzneimitteln im Krisen- und Verteidigungsfall ein. Das bestehende Rabatt- und Ausschreibungssystem hat im Generikabereich zu Marktverengung, Standortverlusten in Europa und steigender Abhängigkeit von Drittstaaten geführt. Es zielt nur auf maximale kurzfristige Effizienz - zulasten von Resilienz und europäischer Produktion. Trotz des Zieles im Koalitionsvertrag, die Versorgungsresilienz zu stärken, verliert Deutschland messbar an Produktionskapazitäten für lebenswichtige Arzneimittel. Vor dem Hintergrund der veränderten geopolitischen Lage sollte die Resilienz der Arzneimittelversorgung gestärkt und eine weitere Ausweitung rein preisorientierter Ausschreibungsmodelle vermieden werden.","affectedLawsPresent":false,"affectedLaws":[],"fieldsOfInterest":[{"code":"FOI_HEALTH_SUPPLY","de":"Gesundheitsversorgung","en":"Health supply"}]}]},"statements":{"statementsPresent":true,"statementsCount":4,"statements":[{"regulatoryProjectNumber":"RV0003643","regulatoryProjectTitle":"System der Erweiterten Herstellerverantwortung zur Finanzierung 4. Klärstufe","pdfUrl":"https://www.lobbyregister.bundestag.de/media/3d/df/627438/Stellungnahme-Gutachten-SG2510090017.pdf","pdfPageCount":6,"text":{"copyrightAcknowledgement":"Die grundlegenden Stellungnahmen und Gutachten können urheberrechtlich geschützte Werke enthalten. Eine Nutzung ist nur im urheberrechtlich zulässigen Rahmen erlaubt.","text":"Vorgesehene Finanzierung der 4. Reinigungsstufe führt zum Zielkonflikt von Umweltpolitik und Gesundheitspolitik – und birgt in jetzigen Form Disruptionspotenzial für die generische Grundversorgung mit Arzneimitteln\r\n\r\nHintergrund\r\nDie Kommunale Abwasserrichtlinie (KARL / Urban Wastewater Treatment Directive, UWWTD) wurde im November 2024 in Brüssel verabschiedet und ist seit 1. Januar 2025 in Kraft. Sie regelt die Säuberung kommunalen Abwassers. Der für die  Grundversorgung mit Generika (patentfreie Arzneimittel) bedrohliche Punkt ist die Finanzierung des verpflichtenden Ausbaus von rund 500-600 Klärwerken in Deutschland mit einer 4. Reinigungsstufe. Mit einer solchen (z.B. mit Ozonierung oder Aktivkohle) können sogenannte Mikroschadstoffe besser entfernt werden. Dazu zählen viele Substanzen wie z.B. Farben und Lacke, Reinigungsmittel, aber eben auch Kosmetika und die Rückstände von Arzneimitteln aus Patientenausscheidungen.\r\nFür die Finanzierung setzt die UWWTD auf das Prinzip der Erweiterten Herstellerverantwortung (EPR): Verursacher sollen die Beseitigung der durch den Gebrauch ihrer Produkte eingebrachten Stoffe (bei Medikamenten sind das die Ausscheidungen der Patientinnen und Patienten) bezahlen. Auf Basis eines – wissenschaftlich anfechtbaren – Impact Assessments hat die EU-Kommission festgelegt, dass mindestens 80 % der Kosten von der pharmazeutischen und der kosmetischen Industrie zu tragen sind, da laut Assessment 92 % der Stofflast auf diese beiden Gruppen entfallen. \r\n\r\nAktueller Stand\r\n•\tUmsetzung in deutsches Recht: bis 31. Juli 2027\r\n•\tStart EPR-Finanzierung: ab 1. Januar 2029\r\n•\tZiele des Klärwerkausbaus: bis 31. Dezember 2045 sukzessive alle großen Anlagen (ab 150.000 EW) sowie alle kleineren Anlagen, soweit in sensiblen Gebieten (10.000–150.000 EW); insgesamt 500–600 Anlagen\r\nDie EU-Kommission hat die Kosten für Deutschland für den Bau und den Betrieb der Kläranlagen auf rund 250 Mio. Euro jährlich geschätzt, der VKU hingegen auf        rund 1 Mrd. Euro jährlich und Hochrechnungen, die von den Kosten bereits gebauter Anlagen auf zukünftige Kosten schließen, kommen noch auf weit höhere Beträge.\r\nDas BMUKN/UBA hat ein Ressortforschungsgutachten in Auftrag gegeben, das die rechtliche und fachliche Umsetzung prüfen soll. Ergebnisse werden Ende 2026 erwartet, also circa 6 Monate vor der Umsetzungsfrist in nationales Recht.\r\n\r\nDer Zielkonflikt\r\nDer Bedarf, das Wasser mit einer 4. Reinigungsstufe zu säubern, ist unstrittig. Es besteht jedoch ein ungelöster Zielkonflikt zwischen Versorgungssicherheit mit Generika und der geplanten EPR-Finanzierung der 4. Reinigungsstufe. Dieser ergibt sich aus der Tatsache, dass die Produktion vieler Generika für die Hersteller jetzt schon kaum mehr wirtschaftlich ist und eine Verteuerung der Produktionskosten – aufgrund vielfältig regulierter Preise – zur Unwirtschaftlichkeit zahlreicher Produkte führen wird.\r\nRisikotreiber von Versorgungsengpässen\r\n•\tIm Generika-Bereich lassen die eng verzahnten Preisregeln keine Weitergabe zusätzlicher Kosten an die GKV zu. Denn die Gesundheitspolitik hat über rund 30 Jahre ein Netz dichter Regulierungsinstrumente mit dem Ziel gewoben, Preise und Kosten von Generika immer weiter zu senken. Preissteigerungen sind dadurch de facto unmöglich.\r\n•\tDem Netto-Umsatz mit rezeptpflichtigen Generika im ambulanten Bereich von 2,4 Mrd. € stehen allein für Deutschland mindestens 1 Mrd. € jährliche Zusatzkosten für die 4. Klärstufe  (VKU-Schätzung) gegenüber – ein eklatantes Missverhältnis, selbst wenn die Last nicht vollständig auf Generika entfällt.\r\n•\tDie durchschnittliche generische Tagestherapiedosis (DDD) setzt rund 6 Cent um – und das quer über die 80 % Marktanteil, den Generika bei den zulasten der GKV abgegebenen Arzneimitteln haben. Aus 6 Cent lässt sich keine zusätzliche Abgabe für die 4. Stufe finanzieren.\r\n•\tPreiserhöhungen für Generika sind systemisch ausgeschlossen. Für Unternehmen steigt mithin der Effizienzdruck bei dünnen Margen massiv an. Mit einer Abgabe belastete Wirkstoffe müssen vom Markt genommen werden; die verbleibenden Anbieter tragen dann höhere Anteile, bis auch sie wegen Unwirtschaftlichkeit aussteigen (vgl. anhängendes Metforminbeispiel)\r\n•\tAuch dann bleiben die Kosten der 4. Klärstufe bestehen und müssten auf weitere Wirkstoffe verteilt werden, bei denen sich der Prozess wiederholt – ein Dominoeffekt.\r\nSämtliche Bemühungen um eine sichere Arzneimittelversorgung auf deutscher und EU-Ebene werden damit vollständig konterkariert und die Versorgungsprobleme verschärft.\r\n\r\nKeine Lenkungswirkung bei Arzneimitteln\r\nDie EPR soll Hersteller zu weniger umweltschädlichen Produkten bewegen. Bei Arzneimitteln greift das nicht: Sie haben per se und wunschgemäß chemische und damit u.U. auch ökotoxikologische Wirkungen, z.B. viele Krebsmittel oder eben auch das Diabetesmittel Metformin.  Jede molekulare Veränderung an einem generischen Arzneimittel, damit es umweltverträglicher ist, erzeugt ein neues, innovatives – und damit auch deutlich teureres – Arzneimittel und ist nicht einfach eine „ökologischere“ Variante. Generische Hersteller bringen keine innovativen Arzneimittel auf den Markt. Damit verpufft die intendierte Lenkungswirkung, die EPR wird faktisch zu einer Finanzierungsquelle ohne Steuerungseffekt. Darüber hinaus braucht die Marktzulassung von innovativen Arzneimitteln rund 10 Jahre.\r\n\r\nErweiterung auf weitere Stoffgruppen?\r\nDie Einbeziehung weiterer Industrien in die EPR wäre zwar geboten – schließlich ist das Assessment der Kommission, dass Pharma und Kosmetik 92% der Schadstofflast ausmachen, laut Gutachten der Umweltberatung Ramboll nachweislich falsch – doch würde diese Maßnahme das Problem nicht ausreichend entschärfen. Denn: auch kleinere Belastungen im rezeptpflichtigen generischen Bereich werden zu massiven Verzerrungen in der Versorgung führen, wie sich daraus ersehen lässt, dass Hersteller z.B. für eine Pille Metformin derzeit 2 Cent erhalten. \r\nAußerdem vergrößert eine Erweiterung der Finanzierung nur die an sich schon riesige Bürokratie für das Einsammeln von mind. 1 Mrd. Euro und das Verteilen an 500-600 kommunale Wasserbetriebe, das eine sogenannte Producer Responsibility Organisation leisten soll.\r\n\r\nNächste Schritte\r\nDie EU-Kommission überarbeitet derzeit ihr ursprüngliches Impact Assessment zur EPR-Finanzierung – Umfang und Tiefe sind unklar. Ohne „Clock-Stop“ läuft die nationale Umsetzungsfrist weiter und schafft Fakten mit den skizzierten Folgen. Bis der Zielkonflikt gelöst ist, sollte die Umsetzung der UWWTD daher dringend ausgesetzt werden. Mögliche Lösungen:\r\n•\tFinanzierung über Abwassergebühren wie herkömmlich bei der 1.–3. Reinigungsstufe, oder\r\n•\tein pragmatisches Modell nach Schweizer Vorbild.\r\nZiel muss sein, sauberes Wasser und stabile Arzneimittelversorgung gleichermaßen zu sichern – statt das eine zulasten des anderen zu erzwingen.\r\n\r\nBeispiel Metformin – Warum die neue EU-Abwasserrichtlinie Millionen Diabetes-Patient:innen betrifft\r\n\r\nWarum ist Metformin durch die UWWTD gefährdet?\r\n•\tMetformin ist extrem preisgünstig: Hersteller erhalten im Schnitt nur 5,12 € pro 3-Monats-Packung (N3), was zu rund 21 Euro Jahrestherapiekosten führt (auf Basis Abgabepreis des pharmazeutischen Unternehmers) \r\n•\tDie Abwasserbeiträge für Metformin würden laut Berechnungen von IQVIA bis zu 445 % der aktuellen Ausgaben ergeben.\r\n•\tDiese Mehrkosten können nicht auf den Preis aufgeschlagen werden, da Arzneimittelpreise in Deutschland gesetzlich festgelegt sind (Festbeträge).\r\n•\tKonsequenz: Die Hersteller machen Verlust und müssen Metformin vom Markt nehmen\r\n\r\nDominoeffekt droht\r\n•\tSteigt der erste Hersteller aus, müssen die verbleibenden Anbieter (97% der Metformin-Monopräparate werden derzeit von 5 Herstellern[1] hergestellt) die Kostenlast, die auf Metformin entfällt, allein schultern – was sie wirtschaftlich ebenfalls nicht verkraften.\r\n•\tDer Rückzug weiterer Hersteller wird unausweichlich – am Ende steht ein Versorgungsausfall bei Metformin.\r\n•\tDanach müssen die Kosten der 4. Klärstufe, die auf Metformin entfielen, auf andere generische Substanzen verteilt werden und der oben beschriebene Mechanismus geht weiter.\r\n\r\nWas bedeutet das für Patient:innen?\r\nRund 2,9 Millionen Menschen in Deutschland sind derzeit auf Metformin als Mono- oder Kombinationspräparat angewiesen . Es ist laut S3-Leitlinie das Mittel der ersten Wahl bei Typ-2-Diabetes und steht auf der WHO-Liste der essenziellen Arzneimittel[2] sowie der BfArM-Liste für versorgungsrelevante Wirkstoffe[3].\r\nOhne Metformin müssten Patient:innen auf Alternativen umsteigen. Das sind etwa die im Allgenmeinen deutlich teureren Gliflozine, Glutide[4], DPP-4-Hemmer, Sulfonylharnstoffe oder Insulin.\r\n•\tSpritzen statt Tabletten: Viele Ersatzstoffe wie Insulin oder GLP-1-Analoga müssen injiziert werden – ein erheblicher Einschnitt in den Alltag.\r\n•\tGeringere Therapietreue: Die Notwendigkeit, sich selbst zu spritzen, führt bei vielen Patient:innen zu Ablehnung oder Fehlanwendung.\r\n•\tTeilweise mehr Nebenwirkungen:\r\no\tUnterzuckerungen (v. a. bei Sulfonylharnstoffen)\r\no\tGewichtszunahme (Insuline und Sulfonylharnstoffen)\r\no\tMagen-Darm-Beschwerden\r\no\tHöheres Risiko für Komplikationen wie Genitalinfektionen \r\n\r\nKostenexplosion für das Gesundheitssystem und Gefährdung der Patientensicherheit\r\n•\tMillionen gut eingestellte Patienten müssten umgestellt werden: das kann in der Übergangsphase Patientensicherheit gefährden\r\n•\tDie Mehrkosten für die oben aufgeführten alternativen Therapien liegen bei rund 1,1 bis 1,5 Milliarden Euro pro Jahr (verglichen mit rund 350 Mio. Euro auf Basis Apothekenabgabepreis für Metformin als Monopräparat). \r\n•\tFür die gesetzlichen Krankenkassen bedeutet das massive Mehrausgaben, ohne medizinischen Zusatznutzen.\r\n\r\n\r\n\r\n\r\nFazit\r\nWas mit einem unterstützenswerten Ziel – der Reinigung des Abwassers – begann, endet im schlimmsten Fall in einer Versorgungskrise: Wenn die Politik nicht handelt, können Millionen Diabetes-Patienten ihr bewährtes Medikament verlieren. Die Folgen sind medizinisch gravierend, sozial belastend und ökonomisch fatal. Deshalb braucht es eine faire Finanzierung über die Abwassergebühren.\r\n\r\n\r\n[1]  >82% von nur 3 Herstellern, Berechnungen nach IGES Institut\r\n[2] https://www.who.int/publications/i/item/WHO-MHP-HPS-EML-2023.02, abgerufen am 26.3.2025\r\n[3] § 52b Absatz 3c Arzneimittelgesetz\r\n[4] z. B. kostet Semaglutid in der 2,4 mg Erhaltungsdosis pro Tag über 10 €, Quelle: Lauer Taxe\r\n\r\n\r\nSeptember 2025\r\n"},"recipientGroups":[{"recipients":{"parliament":[{"code":"RG_BT_MEMBERS_OF_PARLIAMENT","de":"Mitglieder des Bundestages","en":"Members of parliament"}],"federalGovernment":[]},"sendingDate":"2025-10-08"}]},{"regulatoryProjectNumber":"RV0003645","regulatoryProjectTitle":"Der Erstattungsbetrag des Originals gilt auch fürs Generikum. Hersteller brauchen ihn vorab. Wir fordern ein Auskunftsrecht für Planungssicherheit.","pdfUrl":"https://www.lobbyregister.bundestag.de/media/65/56/301844/Stellungnahme-Gutachten-SG2406200045.pdf","pdfPageCount":2,"text":{"copyrightAcknowledgement":"Die grundlegenden Stellungnahmen und Gutachten können urheberrechtlich geschützte Werke enthalten. Eine Nutzung ist nur im urheberrechtlich zulässigen Rahmen erlaubt.","text":"Pro Generika e.V.\r\nÄnderungsvorschlag zur Verankerung des\r\nAuskunftsanspruchs der generischen Hersteller auf Mitteilung des vertraulichen Erstattungsbetrages\r\nzum Entwurf des MedizinforschungsG (BT-Drucksache 20/11561)\r\nProblem:\r\nDie neue Regelung zur Vertraulichkeit des Erstattungsbetrages betrifft auch die Interes-senssphäre der Generikaanbieter: Gemäß § 130b Absatz 8a SGB V gilt der nach § 130b ver-einbarte oder festgesetzte Erstattungsbetrag des Originalproduktes nach Ablauf der Schutzfristen fort und stellt den höchstens zulässigen Abgabepreis des Generikums dar. Mit diesem Preis muss der generische Hersteller sein Produkt und dessen Markteintritt kalkulie-ren. Um mit ihm kalkulieren zu können, muß der generische Hersteller den Preis kennen, was dann nicht der Fall ist, wenn die Vertraulichkeit des Erstattungsbetrages vereinbart wurde. Im Hinblick auf den nicht nach § 131 Absatz 4 Satz 3 veröffentlichen Erstattungsbe-trag ist daher ein Auskunftsrecht zu schaffen, weil diese Information für den Generikaan-bieter bei der Entwicklung und Zulassung eines Generikums von entscheidender Bedeutung ist. Das Gesetz soll eine Rechtsgrundlage für ein solches Auskunftsrecht schaffen.\r\nVorschlag:\r\nArtikel 6 - Änderung des Fünften Buches Sozialgesetzbuch\r\nNr. 5. § 130b wird wie folgt geändert (gelb unterlegt):\r\n…\r\ne)\r\nNach Absatz 4 werden die folgenden Absätze 4a bis 4c eingefügt:\r\n„(4a) …\r\n.\r\n(4b) Der Spitzenverband Bund der Krankenkassen erteilt auf Anfrage Auskunft über den Erstattungsbetrag für ein Arzneimittel, für das eine Vereinbarung oder Festsetzung gemäß Absatz 1c gilt, und den gemäß § 78 Absatz 3a Satz 5 des Arz-neimittelgesetzes auszugleichenden Betrag gegenüber\r\n1. Krankenhäusern, den für diese zuständigen Aufsichtsbehörden und dem Insti-\r\ntut für das Entgeltsystem im Krankenhaus,\r\n2. jeder juristischen Person, die den Erwerb des Arzneimittels gegenüber dem\r\nSpitzenverband Bund der Krankenkassen nachweist,\r\n3. Arzneimittelimporteuren.\r\n4. Zweitanbieter zu Arzneimitteln mit neuen Wirkstoffen\r\n2\r\nDer Spitzenverband Bund der Krankenkassen kann Dritte mit der Erfüllung seiner\r\nVerpflichtung nach Satz 1 beauftragen. Er legt eine pauschalierte Vergütung für\r\nden ihm tatsächlich entstehenden Aufwand je Auskunft nach Satz 1 fest. Der pharmazeutische\r\nUnternehmer, zu dessen Arzneimittel die Auskunft nach Satz 1 erteilt\r\nwird, hat die Vergütung nach Satz 3 an den Spitzenverband Bund der Krankenkassen zu\r\nleisten.\r\nBegründung:\r\nDie neue Regelung betrifft auch die Interessenssphäre der Generikaanbieter. Diese müssen\r\nim Rahmen des § 130b Absatz 8a wissen, zu welchem höchstens zulässigen Abgabepreis\r\ndas Generikum nach Ablauf der Schutzfristen ausgeboten werden darf, und müssen auf\r\ndieser Grundlage ihr Produkt und ihren Markteintritt kalkulieren. Im Hinblick auf den nicht\r\nnach § 131 Absatz 4 Satz 3 veröffentlichten Erstattungsbetrag ist daher ein Auskunftsrecht\r\nzu schaffen, weil diese Information für den Generikaanbieter bei der Entwicklung und Zulassung\r\neines Generikums von entscheidender Bedeutung ist.\r\nBerlin, 19.06.2024"},"recipientGroups":[{"recipients":{"parliament":[{"code":"RG_BT_MEMBERS_OF_PARLIAMENT","de":"Mitglieder des Bundestages","en":"Members of parliament"}],"federalGovernment":[{"department":{"title":"Bundeskanzleramt (BKAmt)","shortTitle":"BKAmt","url":"https://www.bundeskanzler.de/bk-de","electionPeriod":20}},{"department":{"title":"Bundesministerium für Gesundheit (BMG)","shortTitle":"BMG","url":"https://www.bundesgesundheitsministerium.de/","electionPeriod":20}},{"department":{"title":"Bundesministerium für Wirtschaft und Klimaschutz (BMWK) (20. WP)","shortTitle":"BMWK (20. WP)","url":"https://www.bmwk.de/Navigation/DE/Home/home.html","electionPeriod":20}}]},"sendingDate":"2024-06-19"}]},{"regulatoryProjectNumber":"RV0011979","regulatoryProjectTitle":"Possible Restriction of PFAS: impact on critical medicines supply","pdfUrl":"https://www.lobbyregister.bundestag.de/media/67/a4/351753/Stellungnahme-Gutachten-SG2409100019.pdf","pdfPageCount":18,"text":{"copyrightAcknowledgement":"Die grundlegenden Stellungnahmen und Gutachten können urheberrechtlich geschützte Werke enthalten. Eine Nutzung ist nur im urheberrechtlich zulässigen Rahmen erlaubt.","text":"1\r\nSubject: Possible Restriction of PFAS – impact on critical medicines supply\r\nSep 3rd, 2024\r\n\r\nDear Sir and Madam,\r\nToday, we are approaching you on behalf of Medicines for Europe, the European organisation representing the off-patent pharmaceutical industry.\r\nOn 13 January 2023, the competent authorities from Germany, the Netherlands, Denmark, Sweden and Norway submitted a restriction dossier1 for PFAS (per- and polyfluoroalkyl substances)2 falling in the scope of the OECD definition3, under the REACH Regulation (Regulation (EC) No 1907/20064). The proposed restriction is intended to ban the manufacturing, placing on the market, and use of at least 10,000 known PFAS as such or in mixtures and articles above certain concentration limits.\r\nAcknowledging the concerns about PFAS, the generic pharmaceutical industry is working to reduce the use of PFAS in the manufacturing, packaging, and delivery processes of medicines and in processes that may release PFAS into the environment. The ban of more than 10,000 PFAS substances would, however, irreversibly affect the healthcare industry and undermine manufacturing in Europe. This could lead to supply shortages, and a discontinuation of life-saving technologies, medicines and services across the EU where viable alternatives have not yet been developed or approved from a regulatory perspective.\r\nTherefore, any decision to restrict the use of PFAS in medicinal products should only be made after a careful analysis of whether, how, and in what time periods, PFAS can be replaced in these products without putting their availability and thereby patient safety at risk. It should also be assessed whether the specific use has the potential to release a significant amount of PFAS into the environment.\r\nIn view of the large number and variety of pharmaceuticals concerned and the complexity of their manufacturing and regulatory approval processes, such a thorough analysis requires sufficient time.\r\nAs the industry is collaborating with authorities to identify and implement the most effective solutions, finding proper alternatives to PFAS is a complex journey requiring extensive research and thorough studies, over several years. Therefore, and to ensure the continued manufacturing of life-saving medicines, there must be a general derogation period from the proposed PFAS restriction for the manufacturing of pharmaceutical products, long enough to switch to adequate alternatives regarding patient safety. Our\r\n1 Annex XV Proposal submitted by Germany, the Netherlands, Denmark, Sweden and Norway\r\n2 Per- and polyfluoroalkyl substances (PFAS) are a large group of manufactured substances that do not occur naturally in the environment and are extremely resistant to degradation\r\n3 OECD, Reconciling Terminology of the Universe of Per- and Polyfluoroalkyl Substances: Recommendations and PracticalGuidance, 9 July 2021\r\n4 Regulation (EC) No 1907/2006 of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction ofChemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC\r\n2\r\nappeal considers the balance between healthcare needs and environmental concerns.\r\nFor a further outline we have compiled two examples regarding pharmaceuticals which underline our concerns:\r\n1) According to a Dutch case study5, a potential ban on PFAS could affect medicinal products that constitute 64% of all medicines used in the Netherlands. These include some of the most important drugs currently in use. It would also jeopardize the production of all pharmaceutical substances in Europe and would be in conflict with the EU’s strategy of reducing dependency on nations outside of the EU in the event of shortages or pandemics.\r\n2) In addition, there is a case study on a sterile cancer medicine, used in hospitals for slowing or stopping the growth of a cancer, which needs to be administrated by injection or infusion. It is therefore accompanied by a primary packaging, consisting of a pharmaceutical-grade glass vial and a fluoropolymer-coated rubber stopper, similar to polytetrafluorethylene (PTFE-like). The stopper protects the medicine and ensures its compatibility and stability. The tested alternatives, e.g. simple non-coated stoppers, do not provide the same functions as the coated rubber stopper, and suffer from higher extractability and leachability of the compounds, leading to negative consequences on the quality of the products and patient safety. Because of the importance of the primary packaging, several years would be required to find the most suitable alternative (including testing, product stability studies, compatibility studies, extractable and leachable studies), before asking the EMA or the national competent authorities to approve the variations brought to the marketing authorisation.\r\nFor more detailed information, please find enclosed our position paper on the restriction proposal. We also submitted our position to the Public Consultation led by the European Chemicals Agency (ECHA) on the restriction proposal last year.\r\nYours sincerely,\r\nLoreleï Lemetayer. Regulatory Policy Officer\r\nRue d'Arlon 50 - 1000 Brussels - Belgium email: lorelei@medicinesforeurope.com www.medicinesforeurope.com\r\n5 Joint study by AESGP, EFCG, EFPIA, Medicines for Europe and Vaccines Europe, Human Health Medicinal Products Sector Survey - Impact of Proposed PFAS Restriction on Patient Access to Medicines & EU Strategic Autonomy\r\nNPS-TPE-NP-00777\r\nCase study 1 – medical device – metered dose inhaler\r\nDescribing the medicine and the indication\r\nThe selected medicine is a respiratory product that contains an active ingredient that causes relaxation of airway smooth muscle. It is used for symptomatic treatment of asthma, including short-term relief in case of asthma attacks, and for prevention of exercise or allergen-induced bronchospasm both in children and adults. The active ingredient is delivered using a pressurized metered-dose inhaler (MDI). (1)\r\nMDIs are pocket-size hand-held drug delivery devices utilizing the energy of compressed propellant(s) for aerosol generation. They have the drug in solution or suspension in the propellant(s), or a mixture of propellant(s) and co-solvent(s). MDIs deliver small metered drug doses either directly, or via add-on devices to the patients. (2)\r\nWhere per- and polyfluoroalkyl substances (PFAS) are used and why they are needed\r\nPropellants, or propellent mixtures, represent the bulk of the MDIs’ formulation. It provides the force to create the aerosol cloud that delivers the medication to the lungs and acts as the medium in which the active ingredient is suspended or dissolved. Furthermore, inactive ingredients known as excipients may be included in the formulation to enhance overall product efficacy. These excipients include volatile and non-volatile co-solvents that dissolve the drug, surfactants that stabilize suspensions, bulking agents that increase the product's volume, and lubricants that ensure the smooth operation of the valve. (2)\r\nAny medical propellant must be non-toxic. This is to be demonstrated by non-clinical safety assessments that include acute toxicity, repeat dose toxicity, genetic toxicity, carcinogenicity, safety pharmacology (such as cardiovascular functional assessments), and reproductive and developmental toxicity. For the device, biocompatibility testing is required. Furthermore, the formulation of the inhaler (which includes the active ingredient, propellant and other co-formulants) has to ensure uniformity of the delivered dose, suitable aerodynamic particle size distribution and plume characterization; extractable and leachable testing has to be also conducted. (3)\r\nFollowing the international agreement in 1987 (Montreal Protocol on Substances that Deplete the Ozone Layer), the pharmaceutical industry has formed two consortia to find a suitable replacement for the \"first generation” propellants belonging to the group of chlorofluorocarbon (CFC) compounds. Two candidates - - HFC-134a and HFC-227ea – were tested and approved for use in MDIs in 1994 and 1995. (2) Both of these, representing the “second generation” of medical propellants, are currently used in the majority of MDIs. It is important to note that both of them are PFAS, therefore in the scope of the ongoing review of the restriction proposal under REACH Regulation (Registration, Evaluation, Authorisation and Restriction of Chemicals). (4). At the same time, these two propellants are already subject to policies and regulations (the 2023 revision of the F-gases Regulation EU No 517/2014 and the Kigali Amendment to the Montreal Protocol) aimed at phasing them out over the next several years in light of their carbon footprint and impacts on the climate.\r\nLastly, the drug-delivery device itself may also contain fluoropolymers. The drug formulation is contained under pressure in an aluminium container with or without an inner coating. The coating may serve as a protective barrier, preventing the drug from breaking down due to contact with the canister wall, reducing drug sticking or particle accumulation on the canister walls, and ensuring the canister material's resilience against corrosion in acidic formulations. These unwanted occurrences ultimately lead to diminished\r\nNPS-TPE-NP-00777\r\nstability and/or inconsistent dose delivery. Fluoropolymers, such as polytetrafluoroethylene (PTFE; brand name Teflon) or polyfluoroalkoxyalkylene (PFA) are used for this coating. (2)\r\nWhat are the options for alternatives and the timelines and requirements for implementing them\r\nIn light of the abovementioned policies aiming to reduce the emissions of, among others, the current propellants (HFC-134a and HFC-227ea) the pharmaceutical industry is searching for suitable alternatives. The two potential “third generation” propellants (HFO-1234ze – PFAS - and HFC-152a – non-PFAS) are currently being tested and are not available for patient use. As described above, MDIs are complex devices and the new medical propellants must meet a specific range of technical performance characteristics as well as favourable non-clinical safety characteristics a new propellant cannot simply be “dropped in”. Furthermore, the global regulatory health authorities are still in the process of determining the specific clinical study requirements for switching from the “second generation” to “third generation” propellants in MDIs. Notably, the European Medicines Agency (EMA) has released its draft guidance on the expectations it has for companies transitioning to new propellants. Overall, the generation of a robust evidence package and the subsequent regulatory approval of MDI using alternative propellants may take between 6 and 10 years. (3)\r\nIt must be noted, that dry powder inhalers (DPI) represent an already existing technical alternative to MDIs. DPIs, as the name suggests, contain a powdered formulation of the medicine that is drawn in by the force of the patient’s breath and does not require propellent to function. Therefore, they do not share the same impact on the climate. DPIs have their own set of advantages, including their breath-actuated mechanism, demanding less coordination from the user compared to MDIs. However, this advantage also represents a limitation as DPIs require sufficient inspiratory flow to de-aggregate the powder, which cannot be always achieved by asthmatic patients, particularly younger children and frail older people. (5) It is crucial to asthma care to select the right inhaler for the individual patient. When choosing the most appropriate inhaler, the preferred medication, available devices, patient skills, environmental impact and cost should be taken into consideration. (6)\r\nDisposal of the PFAS chemicals and materials\r\nAs the PFAS material is part of the primary packaging of the medicine, it is the patient's responsibility to dispose of it safely. Many EU Member States have medicines disposal programs, where patients can return unused medicines and their packaging via community pharmacies. Patient education about this is also supported by the MedsDisposal Campaign (7), which was developed as a collaborative project between healthcare professionals and the pharmaceutical industry. In the case of MDIs, the take-back programs are going even further and community pharmacists are instructing the patients to return the empty MDIs to the pharmacy. In all cases, the waste collected through these schemes is disposed of and incinerated by firms specializing in handling dangerous waste.\r\nConclusion and impact\r\nAs described, MDIs are highly complex medical devices and changes to any of its parts are not a trivial matter. It is important to consider that the comprehensive research and development activities outlined above will require the assessment of a diverse range of individual pMDIs, encompassing different dosages and strengths. The IPAC/IPAC-RS survey demonstrates that multiple companies manufacture numerous pMDIs in the European Union (at least 349 million units, and as many as 250 unique pMDI types). This reformulation effort will involve significant financial commitments, reaching billions of euros. (3)\r\nNPS-TPE-NP-00777\r\nFurthermore, switching patients to new medicines (such as DPI) must be handled carefully and driven by clinical factors. For a patient with stable asthma or COPD, introducing a new device may lead to potential destabilization of the disease, which can cause patient harm and unnecessary emergency room visits. At the same time, switching inhaler may not be an option for many patients. For example, DPIs are not appropriate for younger children, and the need for a particular medication may restrict device choice. Of course, considering the environmental impact when selecting an inhaler at treatment initiation or when stepping up or down treatment is reasonable as long as the patient’s needs, preferences, ability to use the inhaler and response to treatment are considered. (8)\r\nGiven the ongoing efforts to phase down the currently used propellants (“second generation”; HFC-134a and HFC-227ea) and substitute them with the new generation of propellants (“third generation”; HFO-1234ze and HFC-152a), it is important to ensure that this transition will be done rationally. The “second generation” propellants need to be given a sufficiently long transition period to prevent any immediate negative impact on the patients and the security of supply, such as shortages of both MDIs (due to the supply disruption of the propellant) and DPIs (due to increased demand as a consequence of MDIs shortage). The “third generation” is an important solution to deliver lower climate burden respiratory care in future. As such, the propellant in the scope of the PFAS restriction proposal (HFO-1234ze) should be permanently derogated, as it is important to preserve the choice from multiple suitable propellants.\r\nIt must be noted that this case study is mainly focused on the use of fluorinated gases as propellants in inhalers. The selected medicine, as well as DPIs, would be also impacted by the PFAS restriction, due to the use of PFAS materials in the manufacturing process itself, such as in tubing, collecting vessels, some filters as well as machinery. More details about this issue can be found in Case Study 2 – manufacturing of biologic medicines and Case Study 5 – manufacturing of final dosage forms. It can be expected that without a sufficient derogation of medicines manufacturing from the PFAS restriction, the medicines supply chain will become even more vulnerable, leading to a decrease in medicines availability to the patients and a higher occurrence of medicine shortages.\r\nReferences:\r\n1.\r\nAnderson, S. D., Atkins, P. J., Bäckman, P., Cipolla, D., Clark, A., Daviskas, E., Disse, B., Entcheva-Dimitrov, P., Fuller, R. W., Gonda, I., Lundbäck, H., Olsson, B., & Weers, J. G. (2022). Inhaled Medicines: past, present, and future. Pharmacological Reviews, 74(1), 48–118. https://doi.org/10.1124/pharmrev.120.000108\r\n2.\r\nDe Boer, A. H., & Thalberg, K. (2021). De Boer, A. H., & Thalberg, K. (2021). Chapter 4: Metered Dose Inhalers (MDIs). Chapter 4: Metered Dose Inhalers (MDIs). In Inhaled Medicines (pp. 65–97). https://doi.org/10.1016/C2017-0-02102-X\r\n3.\r\nInternational Pharmaceutical Aerosol Consortium [IPAC] & International Pharmaceutical Aerosol Consortium on Regulation & Science [IPAC-RS]. (2023, September 20). Supplemental Joint IPAC/IPAC-RS Comments on “PFAS REACH Annex XV Restriction (Public Consultation).”\r\n4.\r\nEuropean Chemicals Agency [ECHA]. (2023, February 7). ECHA publishes PFAS restriction proposal. https://echa.europa.eu/-/echa-publishes-pfas-restriction-proposal\r\n5.\r\nAtkins P. J. (2005). Dry powder inhalers: an overview. Respiratory care, 50(10), 1304–1312.\r\n6.\r\nVenkatesan P. 2023 GINA report for asthma. Lancet Respir Med. 2023 Jul;11(7):589. doi: 10.1016/S2213-2600(23)00230-8. Epub 2023 Jun 8. PMID: 37302397.\r\n7.\r\nHome - Meds disposal. (2022, October 10). Meds Disposal. https://medsdisposal.eu/\r\nNPS-TPE-NP-00777\r\n8.\r\nUsmani, O., & Levy, M. L. (2023). Usmani, O., & Levy, M. L. (2023). Effective respiratory management of asthma and COPD and the environmental impacts of inhalers. Npj Primary Care Respiratory Medicine, 33(1). https://doi.org/10.1038/s41533-023-00346-7\r\nNPS-TPE-NP-00778\r\nCase study 2 – manufacturing of biologic medicines\r\nDescribing the medicine and the indication\r\nThe medicine selected for this case study is biological medicine. It works in the same way as the natural hormone by stimulating the bone marrow to produce red blood cells. It is used for the treatment of anaemia (low red blood cell count) in patients with chronic renal failure or cancer patients.\r\nThe medicine is a sterile liquid, administered to the patient either subcutaneously or intravenously. (1) The primary packaging consists of a pre-filled syringe.\r\nWhere per- and polyfluoroalkyl substances (PFAS) are used and why is it needed\r\nBiologic medicines are typically administered to patients parenterally. The manufacturing requires low bioburden (low number of microorganisms on a surface or within a liquid) and sterile manufacturing techniques specific requirements for such medicines following the EU Guidelines for Good Manufacturing Practice (GMP) for Human and Veterinary Use Annex 1. (2) Furthermore, the manufacture of biological medicinal products requires tailored considerations arising from the nature of the products and the processes employed. The distinct steps of production, quality control, and administration demand particular precautionary measures as described in Annex 2 of the above-mentioned guidelines. (3)\r\nTo achieve the required level of equipment cleanliness, potent acids, bases, elevated temperatures, and pressures are crucial for “clean-in-place” and “steam-in-place” procedures of the production vessels as well as in the production of “water for injections” (water of extra high quality without significant contamination). To safeguard the integrity of facilities that distribute critical utilities to the main production site, rigorous monitoring and maintenance are essential. Polytetrafluoroethylene (PTFE; brand name Teflon) is widely employed in seals, gaskets, hoses, and diaphragm valves due to its resistance to corrosion and favourable mechanical properties, ensuring a safe working environment. (4)\r\nPTFE and other fluoropolymers are also used in single-use systems like bags and connectors, which are essential for enabling “next-generation” continuous bioprocessing. This method significantly reduces the manufacturing environmental footprint, minimizing energy and freshwater utilization. (4)\r\nTo guarantee the sterility and safety of the finished product, various liquids used in the manufacturing process undergo filtration at multiple points. These filters often include polyvinylidene fluoride (PVDF), another fluoropolymer. Biologics are susceptible to product quality issues like adsorption, aggregation, and degradation when non-fluoropolymer-containing filters are used, elevating the risk of leachables that endanger patient safety. (4)\r\nFinally, perfluoroalkoxyalken (PFA) is employed for production flasks. This material was chosen due to its extensive range of beneficial properties, including compatibility with a wide temperature range, compatibility with various cleaning and sterilization processes (autoclaving, depyrogenation, or gamma irradiation), a low leachable and extractable profile, exceptional chemical resistance, and a smooth interior surface.\r\nIn general, a notable benefit of fluoropolymers is their remarkably low coefficients of friction. This feature translates into a non-adhesion property, preventing biological materials from sticking to processing surfaces. By this characteristic, fluoropolymers inherently resist bioburden and endotoxins, making them\r\nNPS-TPE-NP-00778\r\nreadily cleanable when required. Moreover, the low coefficient of friction facilitates complete liquid drainage from fluoropolymer-based systems, as liquids effortlessly roll off container surfaces. (4)\r\nWhat are the options for alternative timelines and requirements, such as revalidation of the processes, for implementing them\r\nWhile there is no single replacement for PTFE in pharmaceutical manufacturing, some alternative sealing materials exist, including ceramic seals, which exhibit exceptional inertness but may release fibres into the medicinal product, and graphite seals, which are not suitable for pharmaceutical applications due to the risk of carbon debris in the finished product. Additionally, materials like tantalum or gold can be used for connections between equipment components, but their high cost (many orders of magnitude higher than PTFE) makes them impractical for widespread adoption. (4)\r\nPVDF filter membranes have become ubiquitous in filtration units within bioprocessing due to extensive testing and established reliability. Each filter within the industry has unique properties, including surface area, pore size, and “Material of Construction” (MOC). These MOC properties are not readily interchangeable, making it necessary to re-conduct filtration studies when changing MOCs while maintaining equivalent surface area and pore size. PVDF filters stand out for their superior oxidant resistance and mechanical strength compared to PES (polyether sulfone) filters, which are sometimes considered PVDF filter substitutes. (4)\r\nIn any case, alternative materials must be discussed with the machine manufacturers and various on-site departments, to ensure compliance with Good Manufacturing Practice (5) such as process validation, site engineering, packaging, quality compliance and assurance, technical compliance as well as compliance with rules for equipment for potentially explosive atmospheres (ATEX)(6). Furthermore, the change management process will require process optimization work, equipment re-qualification and validation, and regulatory approval by all global health authorities.\r\nFor example, the estimated change over time to successfully replace a filtration unit in a single manufacturing process could take 2 years. Each product depending on that filter may require re-registration in each target country where it is registered, which takes between an additional 3 and 5 years. These timescales consider a single change, however, multiple changes within a company would create production capacity constraints. (4)\r\nDisposal of the PFAS chemicals and materials\r\nThe waste management adheres to the rules as laid down by both European (e.g. Directive 2008/98/EC on waste) and local rules in the country of manufacturing. Based on Teva’s internal operating procedures, all of the waste produced by the plant producing the medicine in this case study is separated waste into approximately 75 different types of waste streams with four overarching categories. Two of these categories, which contain manufacturing and laboratory waste are transported to waste-to-energy plants. These plants have multi-stage exhaust gas cleaning systems and undergo voluntary environmental monitoring, which can be used to prove that the plant has no measurable negative impact on the environment.\r\nConclusion and impact\r\nIn case no alternatives will be identified or an insufficient derogation period to find and implement suitable alternative solutions will not be provided, it is expected that the European production of the affected\r\nNPS-TPE-NP-00778\r\nbiologic medicines will cease or relocate to non-EEA countries. (7) However, the transfer of manufacturing operations to non-EEA facilities to ensure the continued supply of many medicinal products may not be possible. It is incorrect to assume that there is readily available and suitable manufacturing capacity outside of the EEA. During this relocation period, the global supply capacity would be significantly diminished. (4)\r\nIt must be noted that this case study specifically focused on the use of fluoropolymers in the biological medicines manufacturing process. This case study can be further expanded by the impact described in Case Study 3 – the use of fluorinated raw materials. The selected medicine would be also impacted by the PFAS restriction, due to the use of PFAS materials in the primary packaging – the pre-filled syringe contains a fluoropolymer-coated rubber plunger. More details about this issue can be found in Case Study 4 – fluoropolymers in primary packaging. In general, it is expected that without a sufficient derogation of medicines manufacturing from the PFAS restriction, the medicines supply chain will become even more vulnerable, leading to a decrease in medicines availability to patients and a higher occurrence of medicine shortages.\r\nReferences:\r\n1.\r\nNg, T. M. H., Marx, G. E., Littlewood, T., & Macdougall, I. C. (2003). Recombinant erythropoietin in clinical practice. Postgraduate Medical Journal, 79(933), 367–376. https://doi.org/10.1136/pmj.79.933.367\r\n2.\r\nEuropean Commission. (2022). Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use: Annex 1. https://health.ec.europa.eu/system/files/2022-08/20220825_gmp-an1_en_0.pdf\r\n3.\r\nEuropean Commission. (2018). Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use: Annex 2. https://health.ec.europa.eu/system/files/2019-02/2018_annex2_en_0.pdf\r\n4.\r\nInternational Society for Pharmaceutical Engineering [ISPE] & European Federation of Pharmaceutical Industries and Associations [EFPIA]. (2023). EFPIA response to the ECHA consultation on the Annex XV restriction report on Per- and polyfluoroalkyl substances (PFAS) - Restriction on the manufacture, placing on the market and use of PFAS: Annex 3: Use of Fluoropolymers and Fluoro-Elastomers in Medicinal Product Manufacturing Facilities. https://www.efpia.eu/media/jc1lcupo/annex-3_industrial-use-of-fluoropolymers-in-pharma-manufacturing_final.pdf\r\n5.\r\nEuropean Commission. (2014b). Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use: Part 1, Chapter 5: Production. https://health.ec.europa.eu/system/files/2016-11/chapter_5_0.pdf\r\n6.\r\nEuropean Commission. (2014). Directive 2014/34/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres (recast). https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0034\r\n7.\r\nEuropean Federation of Pharmaceutical Industries and Associations [EFPIA], Medicines for Europe, European Fine Chemicals Group [EFCG], Association of the European Self-Care Industry [AESGP], & Vaccines Europe. (2023). EFPIA response to the ECHA consultation on the Annex XV restriction report on Per- and polyfluoroalkyl substances (PFAS) - Restriction on the manufacture, placing on the market and use of PFAS: Human Health Medicinal Products Sector Survey - Impact of Proposed PFAS Restriction on Patient Access to Medicines & EU Strategic Autonomy. https://www.efpia.eu/media/b1rcqvlt/annex-2-patient-impact-survey_human-health-associations.pdf\r\nNPS-TPE-NP-00828\r\nCase study 3 – Use of raw fluorinated material in the medicine synthesis\r\nDescribing the medicine and the indication\r\nThe active substance is a long-acting modified glycoprotein produced by biotechnology in bacteria called Escherichia coli. It is used in adults and children aged 2 years and older as an adjuvant therapy for the management of side effects of cytotoxic chemotherapy. The medicine is a sterile liquid, administered to the patient subcutaneously in the hospital environment. The primary packaging consists of either a pre-filled syringe or a vial. (1)\r\nWhere PFAS material is used and why is it needed\r\nTrifluoroacetic acid (TFA) raw material is used in critical process steps\r\nRecombinant DNA technology is a powerful method that allows to preparation of large quantities of therapeutically important peptide and protein products. After genetic engineering and fermentation technology produce the initial protein product, it has to undergo thorough purification and processing before being formulated into its final dosage form. The purification process needs to efficiently separate the desired protein product from the complex fermentation matrix. Moreover, the purification process must be capable of reducing the levels of highly similar but not desired byproducts. For manufacturing at scale, reversed-phase high-performance liquid chromatography (RP-HPLC) has been the industrial standard for many years. (2)\r\nThe protein solution is applied to an RP-HPLC column and fractions are eluted using a mobile phase composed of acetonitrile which is acidified by the addition of a very small amount of TFA (in the range of 0.05-0.1%) gradient in water. Since its introduction almost 40 years ago, TFA has become the staple mobile phase additive in RP-HPLC of peptides and proteins throughout all branches of the industry. TFA is used to fine-tune the elution parameters and acts as the protein structure stabilization agent. TFA is used in preference to other acids because of its volatility and UV transparency. (3)\r\nThe resulting purity of the main component in this process step ensures the required purity, quality and consistent content for further manufacturing process steps.\r\nTFA is used in Quality Control release/stability testing for both Drug Substance and Drug Product\r\nTo assure the desired product quality, as part of a comprehensive quality control package multiple RP-HPLC-based methods are used on a routine basis (for release and stability testing). TFA properties and use rationale, presented above apply to the analytical scale as well.\r\nWhat are the options for alternatives (if any) and timelines and requirements, such as revalidation of the processes, (and costs if you know them) for implementing them\r\nExchange to alternative raw materials would require process re-development, re-validation and re-submission. (4,5) The implementation of this scenario would result in a new development of the production technology. Components of the development are 1) process development, 2) process implementation at production scale and validation, 3) impurities clearance study, 4) product extended characterization, 5) stability studies, 6) evaluation of the impact on patient safety and efficacy, 7) variation submission for Regulatory Authorities and approval. For any alternative to the currently registered TFA used in the approved medicinal product, various guidelines have to be considered.\r\nThe timeline below is based on Teva's internal estimates and applies only in case equivalently performing substitute material is possible and available. There are three major phases of the implementation process:\r\nNPS-TPE-NP-00828\r\n•\r\nNew technology needs to be developed on a laboratory scale – estimated 3 years\r\n•\r\nIn case of success, new technology needs to be implemented at production scale and validation. Then impurities profiling studies and product stability studies need to be performed – estimated 3 years.\r\n•\r\nPreparation and filing of a major variation (Type II) (6) for regulatory submission and approval in EU and global markets – estimated 3 years for all markets.\r\nIn the best-case scenario, new process development and introduction would take about 9 years and also would require significant financial investments (Teva's internal estimate is several million dollars). Also, this best-case scenario would be applicable only on condition, that approval from the regulatory authorities would be granted.\r\nAt the same time, a re-development, re-validation and re-submission of analytical methods would be required and may impact currently approved specifications (7).\r\n•\r\nRe-development of at least 4 analytical methods will be required in case of a TFA non-use scenario. Estimated method development and method validation financial investment would reach hundreds of thousands of dollars. Estimated timelines for methods development and validation - 2 years.\r\n•\r\nPreparation and filing of a major variation (Type II) (6) for regulatory submission and approval in EU and global markets – estimated 3 years for all markets.\r\nDisposal of the PFAS chemicals and materials\r\nAll of the waste management adheres to the rules as laid down by both European (e.g. Directive 2008/98/EC on waste (8)) as well as the local rules in the country of manufacturing.\r\nThe waste from the manufacturing-scale and analytical chromatography is collected into a closed waste collection system and given to a specialized waste disposal company, that incinerates all of the waste. The waste disposal company also takes care of the single-use systems (e.g. bags) used in the process which had contact with TFA-containing substances.\r\nReusable materials that came into contact with TFA, such as mobile tanks or the glassware used in laboratory and manufacturing are washed and the wastewater is drained into an equilibration tank. Here the wastewater is treated for neutral pH and temperature before being released into the communal wastewater system.\r\nConclusion and impact\r\nDue to the nature of the product-related impurities and their similarity to the desired molecule, it is possible that a process employing an alternative material might not be able to generate the currently approved impurity profile, which would result in a different impurity profile. This could subsequently lead to discontinuation of the product or the need to conduct new clinical studies. Moreover, the final medicine is an originator product, which means there will be no biosimilars available in the foreseeable future. If the product is discontinued, there is no direct replacement for it.\r\nIt must be noted that this case study specifically focused on the use of fluoropolymers in the medicines manufacturing process. The selected medicine would be also impacted by the PFAS restriction, due to the use of PFAS materials in the primary packaging – the pre-filled syringe contains a fluoropolymer-coated\r\nNPS-TPE-NP-00828\r\nrubber plunger and the vial contains a fluoropolymer-coated rubber stopper. More details about this issue can be found in Case Study 4 – fluoropolymers in primary packaging. In general, it is expected that without a sufficient derogation of medicines manufacturing from the PFAS restriction, the medicines supply chain will become even more vulnerable, leading to a decrease in medicines availability to patients and a higher occurrence of medicine shortages.\r\nReferences:\r\n1.\r\nTeva B.V.. Lipegfilgrastim [Summary of product characteristics]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/lonquex-epar-product-information_en.pdf. Revised April 2023. Accessed March 08, 2024.\r\n2.\r\nKroeff, E. P., Owens, R. A., Campbell, E. L., Johnson, R. D., & Marks, H. I. (1989). Production scale purification of biosynthetic human insulin by reversed-phase high-performance liquid chromatography. Journal of Chromatography A, 461, 45–61. https://doi.org/10.1016/s0021-9673(00)94274-2\r\n3.\r\nChen, Y., Mehok, A. R., Mant, C. T., & Hodges, R. S. (2004). Optimum concentration of trifluoroacetic acid for reversed-phase liquid chromatography of peptides revisited. Journal of Chromatography A, 1043(1), 9–18. https://doi.org/10.1016/j.chroma.2004.03.070\r\n4.\r\nEuropean Medicines Agency [EMA]. (2005). ICH Q5E Biotechnological/biological products subject to changes in their manufacturing process: Comparability of Biotechnological/biological Products - Scientific Guideline (CPMP/ICH/5721/03). Retrieved March 21, 2024, from https://www.ema.europa.eu/en/documents/scientific-guideline/ich-q-5-e-comparability-biotechnologicalbiological-products-step-5_en.pdf\r\n5.\r\nEuropean Medicines Agency [EMA]. (2012). ICH Guideline Q11 on Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) (EMA/CHMP/ICH/425213/2011). Retrieved March 21, 2024, from https://www.ema.europa.eu/en/documents/scientific-guideline/ich-guideline-q11-development-and-manufacture-drug-substances-chemical-entities-and-biotechnologicalbiological-entities_en.pdf\r\n6.\r\nEuropean Commission. (2018). Guidelines on the details of the various categories of variations, on the operation of the procedures laid down in Chapters II, IIa, III and IV of Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products and on the documentation to be submitted pursuant to those procedures: 2013/C 223/01. https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:52013XC0802(04)\r\n7.\r\nEuropean Medicines Agency [EMA]. (2023). ICH Q2(R2) Guideline on Validation of Analytical Procedures. In European Medicines Agency (EMA/CHMP/ICH/82072/2006; pp. 2–33). Retrieved March 21, 2024, from https://www.ema.europa.eu/en/documents/scientific-guideline/ich-q2r2-guideline-validation-analytical-procedures-step-5-revision-1_en.pdf\r\n8.\r\nDirective 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste and repealing certain Directives. (2008). Official Journal of the European Union, L312/12. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32008L0098\r\nNPS-TPE-NP-00780\r\nCase study 4 – fluoropolymers in medicines packaging\r\nDescribing the medicine and the indication\r\nThe selected medicine is an oncology product that contains an active ingredient which slows or stops the growth of cancer cells. It is used to treat a type of cancer of the white blood cells called B-cell chronic lymphocytic leukaemia (B-CLL). (1)\r\nThe selected medicine is a sterile solution, administered to the patient in hospital settings intravenously as an injection or most often as an infusion. (2) The primary packaging consists of a pharmaceutical-grade glass vial and a fluoropolymer-coated rubber stopper.\r\nWhere per- and polyfluoroalkyl substances (PFAS) are used and why are they needed\r\nAs mentioned above the primary packaging contains a stopper made of special rubber, coated in fluoropolymer similar to polytetrafluorethylene (PTFE-like). Generally, the PTFE-like coated stoppers are inert and help protect the product ensuring good stability and compatibility of the product. Moreover, the coating prevents the leaching of unwanted compounds into the medicine, whose presence may have negative consequences for the patients. (3). At the same time, the coating provides additional comfort to the point of non-stickiness during steam sterilization and drying.\r\nWhat are the options for alternatives and the timelines and requirements for implementing them\r\nAt the moment, there are no like-for-like alternatives to the coated rubber stoppers. (3) Some existing alternative materials could be considered for use in the pharmaceutical industry - either non-coated or siliconized rubber stoppers. However, neither of the alternatives offers the same characteristics as coated stoppers and additionally suffers from specific issues.\r\nSimple non-coated stoppers are in most cases not suitable for use in pharmaceuticals. The reason is that non-coated stoppers suffer from higher extractability of the compounds from the stopper material in the presence of a solvent and high leachability of the compounds from the stopper material in the presence of the medicine compared to the coated stopper. The presence of these compounds may have negative consequences on the quality of the product and patient safety. (3)\r\nSiliconisation of non-coated stoppers is done to counteract their natural slight stickiness, which leads to an increase in the complexity of the medicine filling lines. The siliconization process prevents the rubber closures from sticking together and simplifies the processing. However, it also comes with its downsides. The silicon oils used in the siliconization can leave residues on the surface of the stopper and create droplets in the liquid that can be both visible and invisible to the naked eye. (5)\r\nAll the materials in medicine’s primary packaging are carefully selected based on the medicine's characteristics in line with current pharmaceutical scientific standards laid down in guidelines issued by global and regional Regulatory Authorities. Any changes to the primary medicines packaging have to be accompanied by rigorous testing, including product stability study, compatibility studies, container closer integrity, extractable and leachable studies, etc. before any change can be made. (6) This has to be done per product and the changes in the primary packaging stated in the dossier have to be submitted as a variation to the marketing authorisation for each market. (7) Based on Teva’s internal estimations, on average, it may take around 40 months from the identification of the alternative to the distribution of the first batch with changed stopper to patients.\r\nNPS-TPE-NP-00780\r\nDisposal of the PFAS materials\r\nAs the PFAS material is part of the primary packaging of the medicine, it is the patient's responsibility to dispose of it safely. Many EU Member States have medicines disposal programs, where patients can return unused medicines and their packaging via community pharmacies. Patient education about this is also supported by the MedsDisposal Campaign (8), which was developed as a collaborative project between healthcare professionals and the pharmaceutical industry. In all cases, the waste collected through these schemes is disposed of and incerinated by firms specializing in handling dangerous waste.\r\nConclusion and impact\r\nThe packaging of sterile medicines is highly specific and challenging due to the requirements of the products to ensure that the medicine is free of any possible contamination and thus safe for administration to the patient. (9)\r\nDue to the complexity of changing the primary packaging of a drug product, it can take several years to switch from PTFE-coated stoppers to an alternative material if available. This is because all of the necessary testing, including product stability studies, compatibility studies, and extractable and leachable studies, must be completed before the change can be made. (6)\r\nIt must be noted that this case study specifically focused on the use of fluoropolymers in medicine primary packaging. The selected medicine would be also impacted by the PFAS restriction, due to the use of PFAS materials in the manufacturing process itself, such as in tubings, collecting vessels, some filters as well as the machinery. More details about this issue can be found in Case Study 2 – manufacturing of biologic medicines and Case Study 5 – manufacturing of final dosage forms. It is expected that without a sufficient derogation of medicines manufacturing from the PFAS restriction, the medicines supply chain will become even more vulnerable, leading to a decrease in medicines availability to the patients and a higher occurrence of medicine shortages.\r\nReferences:\r\n1.\r\nVan den Neste E, Cardoen S, Offner F, Bontemps F. Old and new insights into the mechanisms of action of two nucleoside analogs active in lymphoid malignancies: fludarabine and cladribine (review). Int J Oncol. 2005 Oct;27(4):1113-24.\r\n2.\r\nAdkins JC, Peters DH, Markham A. Fludarabine. An update of its pharmacology and use in the treatment of haematological malignancies. Drugs. 1997 Jun;53(6):1005-37.\r\n3.\r\nBoven, K., Stryker, S., Knight, J., Thomas, A. G., Van Regenmortel, M., Kemeny, D. M., Power, D., Rossert, J., & Casadevall, N. (2005). The increased incidence of pure red cell aplasia with an Eprex formulation in uncoated rubber stopper syringes. Kidney International, 67(6), 2346–2353. https://doi.org/10.1111/j.1523-1755.2005.00340.x\r\n4.\r\nInternational Society for Pharmaceutical Engineering [ISPE] & European Federation of Pharmaceutical Industries and Associations [EFPIA]. (2023). EFPIA response to the ECHA consultation on the Annex XV restriction report on Per- and polyfluoroalkyl substances (PFAS) - Restriction on the manufacture, placing on the market and use of PFAS: Annex 3: Use of Fluoropolymers and Fluoro-Elastomers in Medicinal Product Manufacturing Facilities. https://www.efpia.eu/media/jc1lcupo/annex-3_industrial-use-of-fluoropolymers-in-pharma-manufacturing_final.pdf\r\nNPS-TPE-NP-00780\r\n5.\r\nPetersen, C. (2012). Containers made of cyclic olefins as a new option for the primary packaging of parenterals. Die Pharmazeutische Industrie, 74(1), 156-162.\r\n6.\r\nEuropean Medicines Agency [EMA]. (2005). Guideline on Plastic Immediate Packaging Materials. https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-plastic-immediate-packaging-materials_en.pdf\r\n7.\r\nEuropean Commission. (2018). Guidelines on the details of the various categories of variations, on the operation of the procedures laid down in Chapters II, IIa, III and IV of Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products and on the documentation to be submitted pursuant to those procedures: 2013/C 223/01. https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:52013XC0802(04)\r\n8.\r\nHome - Meds disposal. (2022, October 10). Meds Disposal. https://medsdisposal.eu/\r\n9.\r\nEuropean Commission. (2022). Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use: Annex 1. https://health.ec.europa.eu/system/files/2022-08/20220825_gmp-an1_en_0.pdf\r\nNPS-TPE-NP-00781\r\nCase study 5 – manufacturing of final dosage forms\r\nDescribing the medicine and the indication\r\nThis medicine is an antibiotic used for the treatment of a range of adult and paediatric infections, including those of upper and lower respiratory tract (e.g. pneumonia, bronchitis, sinusitis), skin and soft tissue infections, and some sexually transmitted diseases (STDs). (1) It is available on prescription in various dosage forms such as film-coated tablets, hard capsules, powder for oral suspension, as well as for intravenous administration. (2)\r\nWhere per- and polyfluoroalkyl substances (PFAS) are used and why are they needed\r\nEach dosage form requires a specific manufacturing process with a variety of steps and machinery involved. The operation of pharmaceutical manufacturing facilities is governed by EU Guidelines for Good Manufacturing Practice (GMP) for Human and Veterinary Use (3) Fluoropolymers are indispensable in various components, including tubing, piping, process and utility equipment, and single-use systems, contributing significantly to the smooth running of these facilities. Fluoropolymer materials have become ubiquitous in pharmaceutical manufacturing, owing to their exceptional water repellency, which translates into superior corrosion resistance. They also possess non-stick and friction-reducing properties. Further, their inertness is widely recognized by regulatory bodies, making them highly sought-after for the production of medicinal products. (4)\r\nIn the case of the powder for oral suspension dosage form (which is reconstituted into syrup by a pharmacist), a fluoropolymer called polytetrafluoroethylene (PTFE; brand name Teflon) is used in the primary packaging filling, specifically in three places. First is the mechanical seal rings on the shafts for dosing augers and piping connections, where durability and non-reactivity are the desirable properties. Second, is the dosing nozzles and dosing centring nozzles, which play a role in dosing the powdered product into the primary packaging. Here the non-stickiness and resistance to static electricity prevent a build-up of the dry powder in the nozzles while safeguarding the properties of the powder.\r\nFor machines in the production of oral solid dosage forms (such as tablets), PTFE is used in different steps of the manufacturing of seals and gaskets. During mixing on the mechanical shafts on dosing augers and piping connections and the automatic valves, due to the materials' durability and non-reactivity. In a granulation machine, a PTFE ring is used on the chopper knife (which prepares the dry material into the desired particle size) due to its self-lubricating and low friction properties – the chopper knife moves from hundreds to thousands of rotations per minute. In milling machines (which are further adjusting the particle size) PTFE is used as a seal for one of the parts. The non-stickiness of PTFE is used during the compression of the powder into the tablet in the compression machine’s roller seal. Lastly, the purified water necessary for the compounding PTFE is used as the material for the valve membranes.\r\nLastly, in the sterile production of the powder for solution for infusions, PTFE is used as valves, membranes and gaskets on the compounding vessel.\r\nFor all products in the manufacturing facility, PTFE is used in valve membranes for all clean utility piping, notably water for injections (extremely pure water), clean steam (sterile steam used for sterilizing or cleaning items in the production) and purified water.\r\nNPS-TPE-NP-00781\r\nWhat are the options for alternatives and the timelines and requirements for implementing them\r\nThere is no universal alternative to the use of PTFE in pharmaceutical manufacturing. Some sealing materials could be seen as alternatives to the use of PTFE, such as ceramic seals (very inert, but contain fibres that can be released into the medicinal product), or graphite seals (not suitable for pharmaceutical manufacturing due to the risk of carbon debris in the final medicinal product). Other materials, such as tantalum or gold can be used in connections between equipment parts but are extremely expensive (many orders of magnitude more expensive than PFAS). (4)\r\nIn any case, alternative materials must be discussed with the machine manufacturers and various on-site departments, to ensure compliance with Good Manufacturing Practice (3) such as process validation, site engineering, packaging, quality compliance and assurance, technical compliance as well as compliance with rules for equipment for potentially explosive atmospheres (ATEX)(5). Significant investments will have to be made to make the changes to the machines. However, the exact timelines and costs can only be evaluated after initial feedback from the machine supplier. According to Teva’s internal estimations, it is expected that changes to the manufacturing processes would range from 24 to 60 months per PFAS material use case in the best-case scenarios.\r\nDisposal of the PFAS chemicals and materials\r\nAll of the waste produced by the plant is separated waste into different types of waste streams. In general, if PFAS-containing materials are in contact with hazardous substances those materials are disposed of according to the procedure for hazardous materials, which is incineration in specialized facilities. If PFAS-containing materials are not in contact with hazardous materials those are disposed of conventionally according to the national law.\r\nConclusion and impact\r\nIn case no alternatives will be identified or a sufficient derogation period to find and implement suitable alternative solutions will not be provided, it is expected that the European production of the affected medicines will cease or relocate to non-EEA countries. However, the transfer of manufacturing operations to non-EEA facilities to ensure the continued supply of many medicinal products may not be possible. It is incorrect to assume that there is readily available and suitable manufacturing capacity outside of the EEA. (4) Furthermore, the required investments into transitioning to non-PFAS materials will lead to an increased cost of manufacturing which might render the manufacturing of some medicines, especially low-priced ones, unsustainable.\r\nIt must be noted that this case study specifically focused on the use of fluoropolymers in the manufacturing of the final dosage forms of the selected medicine. Medicines in general may also be impacted by the PFAS restriction, due to the use of PFAS materials in the primary packaging or the drug delivery device. It is expected that without a sufficient derogation of medicines manufacturing from the PFAS restriction, the medicines supply chain will become even more vulnerable, leading to a decrease in medicines availability to the patients and a higher occurrence of medicine shortages.\r\nReferences:\r\n1.\r\nHoepelman IM, Schneider MM. Azithromycin: the first of the tissue-selective azalides. Int J Antimicrob Agents. 1995 May;5(3):145-67. doi: 10.1016/0924-8579(95)00009-w.\r\nNPS-TPE-NP-00781\r\n2.\r\nDrew RH, Gallis HA. Azithromycin--spectrum of activity, pharmacokinetics, and clinical applications. Pharmacotherapy. 1992;12(3):161-73.\r\n3.\r\nEuropean Commission. (2014b). Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use: Part 1, Chapter 5: Production. https://health.ec.europa.eu/system/files/2016-11/chapter_5_0.pdf\r\n4.\r\nInternational Society for Pharmaceutical Engineering [ISPE] & European Federation of Pharmaceutical Industries and Associations [EFPIA]. (2023). EFPIA response to the ECHA consultation on the Annex XV restriction report on Per- and polyfluoroalkyl substances (PFAS) - Restriction on the manufacture, placing on the market and use of PFAS: Annex 3: Use of Fluoropolymers and Fluoro-Elastomers in Medicinal Product Manufacturing Facilities. https://www.efpia.eu/media/jc1lcupo/annex-3_industrial-use-of-fluoropolymers-in-pharma-manufacturing_final.pdf\r\n5.\r\nEuropean Commission. (2014). Directive 2014/34/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres (recast). https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0034"},"recipientGroups":[{"recipients":{"parliament":[],"federalGovernment":[{"department":{"title":"Bundesministerium für Gesundheit (BMG)","shortTitle":"BMG","url":"https://www.bundesgesundheitsministerium.de/","electionPeriod":20}},{"department":{"title":"Bundesministerium für Umwelt, Naturschutz, nukleare Sicherheit und Verbraucherschutz (BMUV) (20. WP)","shortTitle":"BMUV (20. WP)","url":"https://www.bmuv.de/","electionPeriod":20}},{"department":{"title":"Bundesministerium für Wirtschaft und Klimaschutz (BMWK) (20. WP)","shortTitle":"BMWK (20. WP)","url":"https://www.bmwk.de/Navigation/DE/Home/home.html","electionPeriod":20}}]},"sendingDate":"2024-09-03"}]},{"regulatoryProjectNumber":"RV0014766","regulatoryProjectTitle":"Gemeinsame / Kassenartenübergreifende Ausschreibungen von Krankenkassen","pdfUrl":"https://www.lobbyregister.bundestag.de/media/5e/d3/483443/Stellungnahme-Gutachten-SG2502200013.pdf","pdfPageCount":2,"text":{"copyrightAcknowledgement":"Die grundlegenden Stellungnahmen und Gutachten können urheberrechtlich geschützte Werke enthalten. Eine Nutzung ist nur im urheberrechtlich zulässigen Rahmen erlaubt.","text":"Pro Generika zu einer möglichen Stärkung gemeinsamer / kassenartenübergreifenden\r\nAusschreibungen von Krankenkassen\r\nHintergrund\r\n- In der Politik gibt es, z. B. bei Bündnis 90 / Die Grünen bzw. in der SPD, Stimmen und\r\nPositionen, wonach Rabattvertragsausschreibungen durch die Krankenkassen nochmals\r\nstärker Krankenkassenarten-übergreifend (Vorschlag Bündnis 90 / Die Grünen) oder\r\ngemäß einem SPD-Vorschlag auch EU-Länder übergreifend erfolgen sollen. Offenbar\r\nverspricht man sich davon eine Senkung des administrativen Aufwands bzw. auch eine\r\ngrößere Planungssicherheit durch höhere Versorgungsvolumen für die Hersteller.\r\n- Dieser an sich positiv gedachte Ansatz geht jedoch mit ernsthaften Folgen für die\r\nVersorgungssicherheit einher.\r\nFakten zum Ausschreibungsmarkt\r\n- Bereits heute sind die Ausschreibungen der Krankenkassen in Deutschland sehr stark\r\ngebündelt und zentralisiert\r\no AOKen: hier schreibt die AOK-Baden-Württemberg Generikarabattverträge für\r\nalle anderen AOKen aus. Sie repräsentieren rund 35% der GKV-Versicherten\r\no Ersatzkassen: auch hier schreibt im Normalfall eine Ersatzkasse (TK, Barmer & Co)\r\nfür die anderen Ersatzkassen mit aus. Gemeinsam repräsentieren sie dabei rund\r\n40 % der GKV-Versicherten\r\no Betriebskrankenkassen: diese haben zwei Servicegesellschaften (GWQ bzw.\r\nSpektrum K), die ebenfalls stellvertretend für eine hohe Anzahl an\r\nBetriebskrankenkassen Rabattverträge schließen\r\n- Der „Markt“ der ausschreibenden Krankenkassen ist mithin bereits sehr hoch konzentriert\r\n- Damit ist der Druck auf Generikapreise und die von den Unternehmen zu bietenden\r\nRabatten ebenfalls bereits extrem hoch\r\no In der Folge sind Rabattgebote von bis zu 99 % öffentlich bekannt. Das zeigt die\r\nfehlende Nachhaltigkeit des bestehenden Systems auf. Und das führt bereits zu\r\nzahlreichen Engpässen in der Versorgung.\r\nDa ein relevanter Anteil dieser Ausschreibungen auch immer noch mit nur einem\r\nZuschlag vergeben wird, ist auch auf Unternehmensseite eine sehr hohe\r\nMarktkonzentration heute evident: große Versorgungsanteile verteilen sich auf\r\nnur ein bzw. bis zu drei Unternehmen.\r\nAuswirkungen einer nochmaligen Stärkung der Nachfragemacht in Ausschreibungen\r\nWürde die Nachfrageseite durch eine Stärkung zentralisierter oder EU-Länder übergreifender\r\nAusschreibungen / Rabattverträge der Krankenkassen noch weiter gestärkt, sind kritische Folgen\r\nfür die Versorgungssicherheit unabwendbar:\r\n- Der gesamte Rabattvertragsmarkt würde nochmals massiv zentralisiert. Es würde zu noch\r\ngrößeren Marktmonopolen auf Seite der Krankenkassen (Nachfrageseite) führen\r\n- In ökonomischer Hinsicht ist ein noch massiverer Druck auf Preise und Rabatte die Folge\r\n- Vor allem auf Seite der Hersteller gäbe es eine nochmals wesentlich stärkere\r\nVerknappung der an der Versorgung teilnehmenden Unternehmen. Denn erhält ein\r\nUnternehmen keinen Zuschlag zum Rabattvertrag, muss es seine Produktion wegen dann\r\nfehlender Absatzchancen anpassen, also herunterfahren.\r\n- Das mittlerweile nahezu parteiübergreifend formulierte Ziel, mehr Diversifizierung bei\r\nGenerikaunternehmen und Lieferketten zu erreichen, würde ins Gegenteil verkehrt\r\n- Denn am Ende im Vergleich würden noch weniger Unternehmen noch größere\r\nVersorgungsanteile übernehmen müssen\r\n- Dass lässt das Risiko von Engpässen in dem Maße steigen, wie Unternehmen, die de facto\r\ndann den ganzen Markt versorgen müssten, in Lieferschwierigkeiten gerieten\r\n- Auch die Anforderungen an die jeweilige Bevorratung für den Gesamtmarkt durch die\r\nnoch an der Versorgung teilnehmenden Unternehmen würde nochmals drastisch steigen\r\nVor diesem Hintergrund lehnt Pro Generika eine weitere Stärkung gemeinsamer,\r\nkassenübergreifenden oder auch EU-Länder übergreifender Rabattvertragsausschreibungen\r\nentschieden ab. Sie tragen nicht zu einer Wettbewerbs- und Standortstärkung bei, sondern\r\nkonterkarieren diese politischen Ziele.\r\n"},"recipientGroups":[{"recipients":{"parliament":[{"code":"RG_BT_MEMBERS_OF_PARLIAMENT","de":"Mitglieder des Bundestages","en":"Members of parliament"}],"federalGovernment":[{"department":{"title":"Bundesministerium für Gesundheit (BMG)","shortTitle":"BMG","url":"https://www.bundesgesundheitsministerium.de/","electionPeriod":20}}]},"sendingDate":"2025-02-10"}]}]},"contracts":{"contractsPresent":false,"contractsCount":0,"contracts":[]},"codeOfConduct":{"ownCodeOfConduct":true,"codeOfConductPdfUrl":"https://www.lobbyregister.bundestag.de/media/99/c5/696652/Pro-Generika-Verhaltenskodex-final_6-9-2016.pdf"}}