{"$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":"2026-04-23T06:17:40.275+02:00","jsonDocumentationUrl":"https://www.lobbyregister.bundestag.de/informationen-und-hilfe/open-data-1049716","registerNumber":"R001428","registerEntryDetails":{"registerEntryId":69000,"legislation":"GL2024","version":12,"detailsPageUrl":"https://www.lobbyregister.bundestag.de/suche/R001428/69000","pdfUrl":"https://www.lobbyregister.bundestag.de/media/e7/97/651549/Lobbyregister-Registereintraege-Detailansicht-R001428-2025-12-08_17-46-20.pdf","validFromDate":"2025-12-08T17:46:20.000+01:00","fiscalYearUpdate":{"updateMissing":false,"lastFiscalYearUpdate":"2025-06-27T12:11:49.000+02:00"}},"accountDetails":{"activeLobbyist":true,"activeDateRanges":[{"fromDate":"2024-06-25T15:14:45.000+02:00"}],"firstPublicationDate":"2022-02-24T18:22:59.000+01:00","lastUpdateDate":"2025-12-08T17:46:20.000+01:00","registerEntryVersions":[{"registerEntryId":69000,"jsonDetailUrl":"https://www.lobbyregister.bundestag.de/sucheJson/R001428/69000","version":12,"legislation":"GL2024","validFromDate":"2025-12-08T17:46:20.000+01:00","versionActiveLobbyist":true},{"registerEntryId":57269,"jsonDetailUrl":"https://www.lobbyregister.bundestag.de/sucheJson/R001428/57269","version":11,"legislation":"GL2024","validFromDate":"2025-06-27T12:11:49.000+02:00","validUntilDate":"2025-12-08T17:46:20.000+01:00","versionActiveLobbyist":true},{"registerEntryId":48003,"jsonDetailUrl":"https://www.lobbyregister.bundestag.de/sucheJson/R001428/48003","version":10,"legislation":"GL2024","validFromDate":"2024-12-13T11:46:34.000+01:00","validUntilDate":"2025-06-27T12:11:49.000+02:00","versionActiveLobbyist":true},{"registerEntryId":37733,"jsonDetailUrl":"https://www.lobbyregister.bundestag.de/sucheJson/R001428/37733","version":9,"legislation":"GL2024","validFromDate":"2024-06-25T15:14:45.000+02:00","validUntilDate":"2024-12-13T11:46:34.000+01:00","versionActiveLobbyist":true}],"accountHasCodexViolations":false},"lobbyistIdentity":{"identity":"ORGANIZATION","name":"Fresenius SE & Co. 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KGaA"},"contactDetails":{"phoneNumber":"+4961726080","emails":[{"email":"pr-fre@fresenius.com"}],"websites":[{"website":"https://fresenius.de/"}]},"address":{"type":"NATIONAL","street":"Else-Kröner-Str.","streetNumber":"1","zipCode":"61352","city":"Bad Homburg v.d.H.","country":{"code":"DE","de":"Deutschland","en":"Germany"}},"capitalCityRepresentationPresent":true,"capitalCityRepresentation":{"address":{"type":"NATIONAL","nationalAdditional1":"Berlin","nationalAdditional2":"Berlin","street":"Neustädtische Kirchstraße","streetNumber":"6","zipCode":"10117","city":"Berlin"},"contactDetails":{"phoneNumber":"+491732681747","email":"markus.beck@fresenius.com"}},"legalRepresentatives":[{"lastName":"Sen","firstName":"Michael","function":"Vorsitzender des Vorstands","recentGovernmentFunctionPresent":false,"entrustedPerson":false,"contactDetails":{}},{"lastName":"Antonelli","firstName":"Pierluigi","function":"Mitglied des Vorstands","recentGovernmentFunctionPresent":false,"entrustedPerson":false,"contactDetails":{}},{"lastName":"Hennicken","firstName":"Sara","function":"Mitglied des Vorstands","recentGovernmentFunctionPresent":false,"entrustedPerson":false,"contactDetails":{}},{"lastName":"Möller","firstName":"Robert","function":"Mitglied des Vorstands","recentGovernmentFunctionPresent":false,"entrustedPerson":false,"contactDetails":{}},{"academicDegreeBefore":"Dr.","lastName":"Moser","firstName":"Michael","function":"Mitglied des Vorstands","recentGovernmentFunctionPresent":false,"entrustedPerson":false,"contactDetails":{}}],"entrustedPersonsPresent":true,"entrustedPersons":[{"lastName":"Weith","firstName":"Joachim","recentGovernmentFunctionPresent":false},{"lastName":"Beck","firstName":"Markus","recentGovernmentFunctionPresent":false},{"lastName":"Hellmuth","firstName":"Nicolas","recentGovernmentFunctionPresent":true,"recentGovernmentFunction":{"ended":true,"endDate":"2024-09","type":{"code":"FEDERAL_ADMINISTRATION","de":"Bundesverwaltung","en":"Federal administration"},"federalAdministration":{"supremeFederalAuthority":"Bundesministerium der Justiz (BMJ) oder dessen Geschäftsbereich","supremeFederalAuthorityShort":"BMJ","supremeFederalAuthorityElectionPeriod":20,"function":"Pers. Referent des Parlamentarischen Staatssekretärs"}}}],"membersPresent":false,"membershipsPresent":true,"memberships":[{"membership":"Afrika-Verein der deutschen Wirtschaft e.V."},{"membership":"American Chamber of Commerce in Germany (AmCham)"},{"membership":"Asien-Pazifik-Ausschuss der deutschen Wirtschaft"},{"membership":"Bundesverband der Medizintechnologie (BVMed) e.V."},{"membership":"German Health Alliance (GHA)"},{"membership":"Initiative Gesundheitsindustrie Hessen (IGH)"},{"membership":"MedTech Europe"},{"membership":"Nah- und Mittelostverein (NUMOV) e.V."},{"membership":"Ost-Ausschuss der deutschen Wirtschaft"},{"membership":"Deutscher Investor Relations Verband (DIRK)"},{"membership":"Deutsches Aktieninstitut "},{"membership":"Verband der Chemischen Industrie e.V. (VCI)"},{"membership":"Pharma Deutschland"},{"membership":"Wirtschaftsvereinigung der Grünen e.V."},{"membership":"Förderkreis der Deutschen Industrie e.V. "},{"membership":"Stiftung Marktwirtschaft e. V."},{"membership":"Förderverein der Deutschen Akademie der Technikwissenschaft e.V."},{"membership":"econsense Forum Nachhaltige Entwicklung der Deutschen Wirtschaft e. V."},{"membership":"Wirtschaftsforum der SPD e.V."}]},"activitiesAndInterests":{"activity":{"code":"ACT_ORGANIZATION_V2","de":"Sonstiges Unternehmen","en":"Other company"},"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"},{"code":"CONTRACTS_OPERATED_BY_THIRD_PARTY","de":"Die Interessenvertretung wird in eigenem Interesse durch die Beauftragung Dritter wahrgenommen","en":"Contracts are awarded to third parties to represent own interests of the company"}],"fieldsOfInterest":[{"code":"FOI_ECONOMY_SERVICES","de":"Handel und Dienstleistungen","en":"Trade and services"},{"code":"FOI_ECONOMY_INDUSTRIAL","de":"Industriepolitik","en":"Industrial policy"},{"code":"FOI_HEALTH_MEDICINE","de":"Arzneimittel","en":"Medicine"},{"code":"FOI_HEALTH_CARE","de":"Pflege","en":"Health care"},{"code":"FOI_HEALTH_OTHER","de":"Sonstiges im Bereich \"Gesundheit\"","en":"Other in the field of \"Health\""},{"code":"FOI_AF_FOOD_INDUSTRY","de":"Lebens- und Genussmittelindustrie","en":"Food and luxury food industry"},{"code":"FOI_SCIENCE_RESEARCH_TECHNOLOGY","de":"Wissenschaft, Forschung und Technologie","en":"Science, research and technology"},{"code":"FOI_PUBLIC_FINANCE","de":"Öffentliche Finanzen, Steuern und Abgaben","en":"Public finances, taxes and duties"},{"code":"FOI_WORK_RIGHT","de":"Arbeitsrecht/Arbeitsbedingungen","en":"Work right"},{"code":"FOI_SS_HEALTH","de":"Krankenversicherung","en":"Health insurance"},{"code":"FOI_EU_LAWS","de":"EU-Gesetzgebung","en":"EU legislation"},{"code":"FOI_HEALTH_SUPPLY","de":"Gesundheitsversorgung","en":"Health supply"},{"code":"FOI_HEALTH_PROMOTION","de":"Gesundheitsförderung","en":"Health promotion"},{"code":"FOI_FOREIGN_TRADE","de":"Außenwirtschaft","en":"Foreign trade"}],"activityDescription":"Im Geschäftsjahr 2024 erwirtschaftete Fresenius mit über 176.000 Mitarbeiterinnen und Mitarbeitern einen Jahresumsatz von 21,5 Milliarden Euro. Fresenius bietet Lösungen für die gesellschaftlichen Herausforderungen, die durch eine wachsende und alternde Bevölkerung und dem daraus folgenden Bedarf nach erschwinglicher und hochwertiger Gesundheitsversorgung entstehen. Zu Fresenius gehören die operativen Unternehmensbereiche Fresenius Kabi und Fresenius Helios sowie die Unternehmensbeteiligung an Fresenius Medical Care. \r\n\r\nDie Interessenvertretung von Fresenius SE & Co KGaA und ihrer operativen Unternehmensbereiche wird durch direkte Gespräche und Treffen mit politischen Entscheidungsträgern, schriftliche Stellungnahmen sowie Teilnahme an Anhörungen und Konsultationen ausgeübt. Dazu gehören auch der Aufbau von Netzwerken und Koalitionen mit anderen Organisationen sowie die Organisation und Teilnahme an Veranstaltungen. Zusätzlich werden durch den Austausch mit Experten und die Förderung von Forschung fundierte Argumente entwickelt.\r\n\r\nDie Ziele der Interessenvertretung umfassen die Verbesserung der gesetzlichen und wirtschaftlichen Rahmenbedingungen für Unternehmen, die Förderung der (industriellen) Gesundheitswirtschaft, die Sicherstellung der Finanzierbarkeit des Gesundheitssystems sowie die Gewährleistung einer hochqualitativen Gesundheitsversorgung. Weiterhin zielt die Interessenvertretung auf die Verbesserung der Arbeitsbedingungen der Beschäftigten, die Förderung des wirtschaftlichen Wachstums und die Einbringung praxisnaher Perspektiven in politische Diskussionen, um umsetzbare Lösungen zu entwickeln."},"employeesInvolvedInLobbying":{"relatedFiscalYearFinished":true,"relatedFiscalYearStart":"2024-01-01","relatedFiscalYearEnd":"2024-12-31","employeeFTE":1.0},"financialExpenses":{"relatedFiscalYearFinished":true,"relatedFiscalYearStart":"2024-01-01","relatedFiscalYearEnd":"2024-12-31","financialExpensesEuro":{"from":150001,"to":160000}},"mainFundingSources":{"relatedFiscalYearFinished":true,"relatedFiscalYearStart":"2024-01-01","relatedFiscalYearEnd":"2024-12-31","mainFundingSources":[{"code":"MFS_ECONOMIC_ACTIVITY","de":"Wirtschaftliche Tätigkeit","en":"Economic activity"}]},"publicAllowances":{"publicAllowancesPresent":true,"relatedFiscalYearFinished":true,"relatedFiscalYearStart":"2024-01-01","relatedFiscalYearEnd":"2024-12-31","publicAllowances":[{"name":"Bundesamt für Wirtschaft und Ausfuhrkontrolle","type":{"code":"GERMAN_PUBLIC_SECTOR_FEDERAL","de":"Deutsche Öffentliche Hand – Bund","en":"German Public Sector – Federal"},"location":"Berlin, Deutschland","publicAllowanceEuro":{"from":40001,"to":50000},"description":"Programm „Energie- und Ressourceneffizienz der Wirtschaft“; Modul 3: MSR, Sensorik und Energiemanagement-Software"}]},"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":0,"to":0},"individualContributorsPresent":false,"individualContributors":[]},"annualReports":{"annualReportLastFiscalYearExists":true,"lastFiscalYearStart":"2024-01-01","lastFiscalYearEnd":"2024-12-31","annualReportPdfUrl":"https://www.lobbyregister.bundestag.de/media/87/8d/651548/Fresenius_Geschaeftsbericht_2024_0.pdf"},"regulatoryProjects":{"regulatoryProjectsPresent":true,"regulatoryProjectsCount":7,"regulatoryProjects":[{"regulatoryProjectNumber":"RV0005542","title":"Beibehaltung der MVZ-Trägervielfalt","printedMattersPresent":true,"printedMatters":[{"title":"Entwurf eines Gesetzes zur Stärkung der Gesundheitsversorgung in der Kommune (Gesundheitsversorgungsstärkungsgesetz - GVSG)","printingNumber":"20/11853","issuer":"BT","documentUrl":"https://dserver.bundestag.de/btd/20/118/2011853.pdf","projectUrl":"https://dip.bundestag.de/vorgang/gesetz-zur-st%C3%A4rkung-der-gesundheitsversorgung-in-der-kommune-gesundheitsversorgungsst%C3%A4rkungsgesetz-gvsg/312308","leadingMinistries":[{"title":"Bundesministerium für Gesundheit","shortTitle":"BMG","electionPeriod":20,"url":"https://www.bundesgesundheitsministerium.de/"}]}],"draftBillPresent":false,"description":"Beibehaltung von § 95 SGB V in Hinblick auf die Gründung von MVZ","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"}]},{"regulatoryProjectNumber":"RV0005543","title":"Sicherstellung der TI-Anbindung für Hilfsmittelleistungserbringer","printedMattersPresent":false,"printedMatters":[],"draftBillPresent":false,"description":"Frühzeitige Anbindung an die TI-Struktur zur Nutzung der KIM und der damit verbundenen Schaffung der notwendigen gesetzlichen Anpassungen zur Ausgabe von eHBA und SMC-B für (Mitarbeitende der) Hilfsmittelleistungserbringer sowie der sonstigen Leistungserbringer von Medizinprodukten nach § 31 SGB V. ","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_SS_HEALTH","de":"Krankenversicherung","en":"Health insurance"},{"code":"FOI_HEALTH_SUPPLY","de":"Gesundheitsversorgung","en":"Health supply"}]},{"regulatoryProjectNumber":"RV0005544","title":"Sicherstellung einer patientenorientierten Notfallversorgung","printedMattersPresent":false,"printedMatters":[],"draftBillPresent":true,"draftBill":{"customTitle":"Entwurf eines Gesetzes zur Reform der Notfallversorgung","customDate":"2024-06-03","leadingMinistries":[{"title":"Bundesministerium für Gesundheit","shortTitle":"BMG","electionPeriod":20,"url":"https://www.bundesgesundheitsministerium.de/"}]},"description":"Ziel einer Reform der Notfallversorgung sollte es sein, teure Doppelstrukturen zu vermeiden und funktionierende Strukturen zu stärken, um eine wirtschaftliche und hochqualitative Patientenversorgung 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_SS_HEALTH","de":"Krankenversicherung","en":"Health insurance"},{"code":"FOI_HEALTH_SUPPLY","de":"Gesundheitsversorgung","en":"Health supply"}]},{"regulatoryProjectNumber":"RV0005545","title":"Einführung eines Anspruchs auf Therapieberatung und Management","printedMattersPresent":false,"printedMatters":[],"draftBillPresent":false,"description":"Es sollte ein Leistungsanspruch auf Therapieberatung und -management (z. B. § 37d SGB V) in Ausgestaltung des Anspruchs auf ein Versorgungsmanagement (§ 11 SGB V) in das SGB V eingeführt 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_SS_HEALTH","de":"Krankenversicherung","en":"Health insurance"},{"code":"FOI_HEALTH_SUPPLY","de":"Gesundheitsversorgung","en":"Health supply"}]},{"regulatoryProjectNumber":"RV0017398","title":"Schaffung einer Krankenhausstruktur mit Fokus auf Patientenorientierung, Ergebnisqualität und Wirtschaftlichkeit","printedMattersPresent":false,"printedMatters":[],"draftBillPresent":false,"description":"Helios unterstützt die Grundzüge der Krankenhausreform. Eine Zentralisierung komplexer Behandlungsfälle bei einer weiteren Spezialisierung der Krankenhäuser ist sowohl aus Sicht der medizinischen Qualität als auch aus ökonomischen Erwägungen sinnvoll. Zentrenbildung, Konzentration und Spezialisierung von Krankenhausleistungen werden bereits seit Jahren von Fresenius Helios umgesetzt und erfolgreich praktiziert. Wenn alle Krankenhäuser alles machen, sind die Ergebnisqualität niedrig und die Kosten hoch. Die Einführung von Leistungsgruppen und deren Verknüpfung mit der Vergütung ist ein Schritt in die richtige Richtung.","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"},{"title":"Gesetz über die Entgelte für voll- und teilstationäre Krankenhausleistungen","shortTitle":"KHEntgG","url":"https://www.gesetze-im-internet.de/khentgg"}],"fieldsOfInterest":[{"code":"FOI_HEALTH_SUPPLY","de":"Gesundheitsversorgung","en":"Health supply"}]},{"regulatoryProjectNumber":"RV0017399","title":"Schneller Marktzugang von kostengünstigen Arzneimitteln (EU-Pharmapaket)","printedMattersPresent":false,"printedMatters":[],"draftBillPresent":false,"description":"Fresenius befürwortet eine klare, harmonisierte und praxisgerechte Ausgestaltung der Bolar-Klausel. Nur so kann die Wettbewerbsfähigkeit des europäischen Pharmastandorts gestärkt und der Zugang der Patientinnen und Patienten zu bezahlbaren Arzneimitteln gesichert werden.","affectedLawsPresent":false,"affectedLaws":[],"fieldsOfInterest":[{"code":"FOI_HEALTH_MEDICINE","de":"Arzneimittel","en":"Medicine"},{"code":"FOI_EU_LAWS","de":"EU-Gesetzgebung","en":"EU legislation"}]},{"regulatoryProjectNumber":"RV0017400","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_HEALTH_MEDICINE","de":"Arzneimittel","en":"Medicine"},{"code":"FOI_EU_LAWS","de":"EU-Gesetzgebung","en":"EU legislation"}]}]},"statements":{"statementsPresent":true,"statementsCount":1,"statements":[{"regulatoryProjectNumber":"RV0017399","regulatoryProjectTitle":"Schneller Marktzugang von kostengünstigen Arzneimitteln (EU-Pharmapaket)","pdfUrl":"https://www.lobbyregister.bundestag.de/media/6a/77/556819/Stellungnahme-Gutachten-SG2506050023.pdf","pdfPageCount":25,"text":{"copyrightAcknowledgement":"Die grundlegenden Stellungnahmen und Gutachten können urheberrechtlich geschützte Werke enthalten. Eine Nutzung ist nur im urheberrechtlich zulässigen Rahmen erlaubt.","text":"Die Bolar-Klausel ist ein entscheidendes Instrument, um sicherzustellen, dass Generika und Biosimilars am Tag 1 nach Ablauf des geistigen Eigentumsschutzes auf den Markt gebracht werden können.\r\n\r\n \r\n\r\nUm dieses Ziel zu erreichen, halten wir folgende Punkte für essenziell:\r\n\r\n \r\n\r\nHarmonisierung und Klarstellung der Bolar-Klausel\r\nEine funktionierende Bolar-Klausel muss ausdrücklich die Durchführung aller regulatorischen und administrativen Tätigkeiten erlauben, die erforderlich sind, um Generika und Biosimilars am Tag 1 nach Ablauf des IP-Schutzes auf den Markt zu bringen. Dazu zählen insbesondere:\r\nEinreichung und Bearbeitung von Zulassungsanträgen,\r\nPreis- und Erstattungsverfahren (P&R),\r\ndie Teilnahme an öffentlichen Ausschreibungen.\r\nEin unabhängiges Gutachten aus dem Jahr 2024 zeigt, dass 91 % der Onkologieprodukte zwischen 1995 und 2020 ihre F&E-Investitionen innerhalb von acht Jahren amortisiert haben. Vor diesem Hintergrund sind künstliche Verzögerungen des Marktzugangs über die bereits gewährten 15 Jahre effektiven Monopols hinaus weder wirtschaftlich noch ethisch vertretbar – sie schaden Patientinnen und Patienten, belasten die Gesundheitssysteme und schwächen die Wettbewerbsfähigkeit der europäischen Industrie.\r\n\r\n \r\n\r\nBerücksichtigung bewährter nationaler Praktiken\r\nDas Beispiel Dänemarks zeigt, dass Ausschreibungen bereits bis zu ein Jahr vor Ablauf des Patentschutzes gestartet werden können, ohne gegen bestehende Schutzrechte zu verstoßen. Eine solche Praxis sollte unionsweit ermöglicht werden.\r\n \r\n\r\nVermeidung künstlicher Marktzugangsverzögerungen\r\nDer Fall Sugammadex in Finnland verdeutlicht, wie unklare Ausschreibungsregeln zu erheblichen Verzögerungen führen können – mit negativen Folgen für Patientenversorgung und Wettbewerb.\r\n \r\n\r\nSiehe hierzu auch Anlage 1.\r\n\r\n \r\n\r\nKlarstellung, dass das „Anbieten zum Verkauf“ keine kommerzielle Handlung im Sinne des IP-Rechts darstellt\r\nDie zentrale Frage darf nicht lauten, ob das „Anbieten zum Verkauf“ eine kommerzielle oder vor-kommerzielle Handlung darstellt. Entscheidend ist: Ohne Teilnahme an Ausschreibungen ist ein Markteintritt am Tag 1 faktisch unmöglich.\r\n\r\nWenn die EU das Ziel verfolgt, den Zugang zu Generika und Biosimilars unmittelbar nach Ablauf des IP zu ermöglichen, dann müssen alle dafür notwendigen vorbereitenden Maßnahmen – einschließlich der Teilnahme an Krankenhausausschreibungen – unter die Bolar-Klausel fallen.\r\n\r\n \r\n\r\nEinige Mitgliedstaaten vertreten die Auffassung, dass die Teilnahme an Ausschreibungen vor Ablauf des IP eine potenzielle Patentverletzung darstellen könnte. Diese Auslegung widerspricht nicht nur dem Zweck der Bolar-Klausel, sondern führt zu einer faktischen Verlängerung des Patentschutzes, die weder rechtlich vorgesehen noch wirtschaftlich gerechtfertigt ist.\r\n\r\n \r\n\r\nUm dieses Ziel zu erreichen und einen Kompromiss zu erzielen unterstützen wir die folgende Formulierung für Artikel 85 („Exemption to the protection of intellectual property rights“) der Richtlinie:\r\n\r\n \r\n\r\n(ad) submitting an application on hospital procurement tenders are submitted, in compliance with Union and national law, to the extent that it does not entail the actual sale or offering for sale of the marketing effective placing on the market of the patented medicinal product concerned during the protection period provided by patent rights or supplementary protection certificate.\r\n\r\n \r\n\r\nWeitere Informationen zur Formulierung für Artikel 85 in Anlage 2\r\n\r\n \r\n\r\nBerücksichtigung bestehender Rechtsprechung\r\nDie Rechtsprechung in England und Wales (z. B. Gerber v. Lectra) erlaubt die Teilnahme an Ausschreibungen vor Ablauf des Patents, sofern die Lieferung danach erfolgt. Diese Auslegung steht im Einklang mit dem Ziel der EU, Innovation zu schützen und gleichzeitig Wettbewerb nach Ablauf der Schutzfristen zu ermöglichen.\r\n \r\n\r\nAblehnung zusätzlicher Benachrichtigungspflichten\r\nDer Versuch, eine Benachrichtigungspflicht in die Bolar-Klausel aufzunehmen, würde eine unzulässige Patentverknüpfung darstellen und den Zugang zu Arzneimitteln verzögern – entgegen dem Ziel der Reform.Rue d’Arlon 50 - 1000 Brussels - Belgium\r\nT: +32 (0)2 736 84 11- F: +32 (0)2 736 74 38\r\nwww.medicinesforeurope.com 1\r\nMay 2025\r\nNeed the explicit inclusion of “hospital tender bids” within the Bolar\r\nExemption for European harmonisation\r\nDenmark allows hospital tender for supply after the patent expiry under Bolar clause\r\nThe tender process in Denmark is often started up to one year in advance the IP protection expires, of course\r\nthe patent must have expired before the actual delivery into the market.\r\nAMGROS (National tender organisation in DK) provides an overview of medicines and extensions of indication\r\nthat are expected to be marketed in Denmark within the next two to three years.\r\nThis enables Amgros to better prepare for upcoming price negotiations with suppliers and organize tendering\r\nprocedures. For generics as well as biosimilars the results are very positive in Denmark since they normally can\r\nenter the hospital markets on Day One after patent expiry.\r\nCompatibility with the World Trade Organisation’s TRIPS Agreement\r\nUnder Article 30 of the TRIPS agreement, “Members may provide limited exceptions to the exclusive rights\r\nconferred by a patent, provided that such exceptions do not unreasonably conflict with a normal exploitation of\r\nthe patent and do not unreasonably prejudice the legitimate interests of the patent owner, taking account of the\r\nlegitimate interests of third parties.”\r\nThe inclusion in the Bolar of the possibility to participate in tender bids when the supply is foreseen after the\r\nprotection expires does not unreasonably conflict with a normal exploitation of the patent and does not\r\nunreasonably prejudice the legitimate interests of the patent owner, taking account of the legitimate interests\r\nof third parties.\r\nA generic participation in a tender would not impact the patent owner’s powers associated with patent rights\r\nsuch as for instance exclusion of competitors or financial revenues through licensing. He would keep its\r\nexclusivity on the market and related powers until the protection expires. Participation in a tender bid is merely\r\nan administrative act and does not constitute a launch of the generic on the market.\r\nMoreover, such participation would not unreasonably prejudice the legitimate interests of the patent owner,\r\ntaking account of the legitimate interests of third parties.1\r\nParticipation in a tender does not cause an\r\nunreasonable loss of income nor is it against relevant public policies or social norms, rather the contrary: it would\r\nbe justified by the legitimate interests related to public health and timely access to medicines, allowing\r\nimmediate competition right after IP expiry as indeed supposed to occur in the current system This is the\r\ninherent purpose of the Bolar exemption.\r\nIn practice, originators can today delay generic entry beyond the term intended by the legislator (i.e., the\r\nregulatory or IP exclusivity), a strategy aided by the current EU pharmaceutical legal framework. If administrative\r\nacts such as P&R procedures delay generic or biosimilar entry, they inevitably prolong market exclusivity beyond\r\n1\r\nLegitimate interests are defined as a normative claim calling for protection of interests that are “justifiable” in the sense\r\nthat they are supported by relevant public policies or other social norms. Applied to the circumstances of that dispute, the\r\nPanel considered that: ‘[i]n our view, prejudice to the legitimate interests of right holders reaches an unreasonable level if\r\nan exception or limitation causes or has the potential to cause an unreasonable loss of income to the copyright owner’ –\r\nsee Canada Patents case (cite needed).\r\npatients • quality • value • sustainability • partnership 2\r\nthe intention of the legislation and the basic principles inherent in the IP and competition systems, distorting\r\ncompetition and generating unjustifiable losses of savings for healthcare systems.\r\nFor this reason, the European Commission states in the 2009 Pharmaceutical Sector Inquiry Report that \"when\r\nloss of exclusivity approaches, tenders should be timed in such a way that generic companies can effectively\r\nparticipate.\" (p. 499)\r\nSome examples of undue delay\r\n- 2 years delay: the table below shows an ongoing case of unjustified generic delay by 2 years\r\n- 4 years delay in Romania: Eg. in 2019, in Romania, biosimilar medicines were unlawfully blocked from\r\nparticipating in a tender for Trastuzumab and Rituximab, with additional costs for the healthcare system\r\nof $100million. As a result, the Romanian Competition authority fined the originator company 9,47\r\nmillion EUR.\r\nThe UK Case Law\r\nIn England and Wales, the case law has developed to allow generic companies to participate in tenders before\r\npatent expiry as long as the launch onto the market is foreseen after patent expiry. In Gerber v. Lectra, ([1995]\r\nRPC 383) the High Court (Lord Justice Robin Jacob) decided that the offer for sale of a patented product during\r\nthe period of validity of the patent for a supply after the expiry of the patent does not constitute an infringement\r\nof the patent.\r\nSuch an approach is in line with the rationale of the system to protect innovation with long exclusivities and,\r\nonce the exclusivities expire, ensure immediate competition. Any tender delays and subsequent artificial\r\nextension of the monopoly beyond IP expiry is contrary to the EU system and anticompetitive.\r\nArticle 85\r\nExemption to the protection of intellectual property rights\r\n1. The protection provided by pPatent rights, or supplementary protection certificates of\r\nmedicinal products under the [Regulation (EC) No 469/2009 - OP please replace reference\r\nby new instrument when adopted] shall not be regarded as infringed when the necessary\r\nstudies, trials and other activities are conducted a reference medicinal product is used for\r\nthe purposes of:\r\n(a) studies, trials and other activities conducted to generate data necessary for an application,\r\nwhich are necessary for:\r\n(i) obtaining a marketing authorisation of medicinal products, in particular of generic,\r\nbiosimilar, hybrid or bio-hybrid medicinal products and for subsequent variations;\r\n(aa)(ii) conducting health technology assessment as defined in Regulation\r\n(EU) 2021/2282;\r\n(ab)(iii) obtaining pricing and reimbursement approval;\r\n(ac) complying with subsequent practical requirements associated with activities referred\r\nto in points (i)-(iii).\r\n** Tenders **\r\nCouncil proposal\r\n(ad) submitting an application on procurement tenders are submitted, in compliance with\r\nUnion and national law, to the extent that it does not entail the sale or offering for sale of\r\nthe marketing of the patented medicinal product concerned during the protection period\r\nprovided by patent rights or supplementary protection certificate.\r\nAlternative wording\r\nto include tenders under the Bolar clause to ensure clarity of the legal text and avoid litigation\r\nat national level and deliver on Day1 launch for hospital medicinal products. A reference to\r\n“hospital” may be a good way to address some of the pricing issues raised in the past. And the\r\nreference below to “actual” sale or “effective placing on the market” confirms that good faith\r\nof intending to effectively launch only after IP expiry.\r\n(ad) submitting an application on hospital procurement tenders are submitted, in compliance\r\nwith Union and national law, to the extent that it does not entail the actual sale or offering\r\nfor sale of the marketing effective placing on the market of the patented medicinal product\r\nconcerned during the protection period provided by patent rights or supplementary\r\nprotection certificate.\r\n(b) Tthe activities conducted exclusively for the purposes set out the first subparagraph in\r\npoint (a), may cover, where relevant, the submission of the application for a marketing\r\nauthorisation and the offer, manufacture, sale, supply, storage, import, use and purchase of\r\npatented medicinal products or processes, including by third party suppliers and service\r\nproviders.\r\n2. Decisions adopted concerning the activities referred to in paragraph 1 shall not be\r\nconsidered as infringing intellectual property rights, within the meaning of that\r\nparagraph.\r\n3. This exception provided for in this Article shall not cover the placing on the market of the\r\nmedicinal products resulting from such activities.\r\nJUSTIFICATION\r\nThe quesfions should not be whether offering for sale is a commercial or pre-commercial act\r\nor not.\r\nThe core problem is that without parficipafing to a hospital tender, there is no way a generic\r\nor any producer can effecfively launch on Day 1 after IP expiry. Therefore, if we accept the\r\nprinciple that the day after IP expiry generics should enter the market, then we need to be\r\nclear that whatever is needed for that to happen has to be covered by Bolar. If, on the contrary,\r\none (originators) wants to sfick to the interpretafion of some MSs saying that parficipafing to\r\na tender may be potenfially considered a commercial act (remember that in UK the \"offering\r\nfor sale\" is allowed before IP expiry) then the whole purpose of the Bolar is frustrated and\r\noriginators confinue to keep an arfificial, undue and illegal (because not foreseen by EU law)\r\nextension of the protecfion. If, by allowing generic medicines to parficipate to a hospital\r\ntender for supply after IP expiry, prices of originators in some MSs are lowered earlier that the\r\ngeneric entry, the generic industry construcfively commit to support nafional discussions to\r\nmake sure that this does not happen. Referring to «HOSPITAL tenders» may be a good way\r\nto address some of the pricing issues raised in the past.\r\nThe UK Case Law\r\nIn England and Wales, the case law has developed to allow generic companies to parficipate\r\nin tenders before patent expiry as long as the launch onto the market is foreseen after patent\r\nexpirty. In Gerber v. Lectra, ([1995] RPC 383) the High Court (Lord Jusfice Robin Jacob) decided\r\nthat the offer for sale of a patented product during the period of validity of the patent for a\r\nsupply after the expiry of the patent does not consfitute an infringement of the patent.\r\nSuch an approach is in line with the rafionale of the system to protect innovafion with long\r\nexclusivifies and, once the exclusivifies expire, ensure immediate compefifion. Any tender\r\ndelays and subsequent arfificial extension of the monopoly beyond IP expiry is contrary to the\r\nEU system and anficompefifive.\r\nHungarian Presidency Proposed\r\ntext\r\nEFPIA amendments EFPIA rationale Medicines for Europe comments\r\nArticle 85\r\nExemption to the protection of\r\nintellectual property rights\r\n1. The protection provided by\r\npatent rights, or supplementary\r\nprotection certificates of medicinal\r\nproducts\r\nshall not be regarded as infringed\r\nwhen the necessary studies, trials\r\nand other activities are for the\r\npurposes of:\r\n1. Subject to the conditions\r\nunder Article 85a, The\r\nprotection provided by patent\r\nrights, or supplementary protection\r\ncertificates of medicinal products\r\nunder the [Regulation (EC) No\r\n469/2009 - OP please replace\r\nreference by new instrument\r\nwhen adopted] shall not be\r\nregarded as infringed when the\r\nnecessary studies, trials and other\r\nactivities are conducted\r\nexclusively for the purposes of:\r\nAs per international law, any\r\nlimitation to individual acquired\r\nrights should be clearly defined\r\nand only implemented if there is\r\nno other means to pursue a\r\npublic interest. Its interpretation\r\nshould be construed narrowly to\r\nprotect the effectiveness of the\r\nrights. As such, the extension of\r\nthe Bolar exemption shall be\r\nlimited to strictly necessary\r\nactivities.\r\n(For the reference to article 85a,\r\nsee below at article 85a)\r\nIn agreement with the EFPIA\r\nrationale, the Bolar should\r\nclearly define what is exempted\r\n(the current uncertainties have\r\nled to different MSs approaches)\r\nand should include the strictly\r\nnecessary activities to allow\r\nimmediate day1 launch after\r\npatent expiry, as intended by\r\nthis reform.\r\n(a) studies, trials and other\r\nactivities conducted to generate\r\ndata for an application, which are\r\nnecessary for:\r\n(a) obtaining a marketing\r\nauthorisation of medicinal\r\nproducts, in particular of generic,\r\nbiosimilar, hybrid or bio-hybrid\r\nmedicinal products and for\r\nsubsequent variations;\r\n(a) obtaining a marketing\r\nauthorisation for a of medicinal\r\nproducts, in particular of generic,\r\nbiosimilar, hybrid or bio-hybrid\r\nmedicinal products and for\r\nsubsequent variations;\r\nThere is no reason to restrict the\r\nBolar exemption to certain\r\nbeneficiaries rather than others\r\n(i.e. generics/hybrid vs.\r\ninnovators\r\nproducts). A harmonized\r\napproach with respect to the\r\nbeneficiaries of the exemption\r\nwas the primary reason to review\r\nand clarify the scope of the\r\nexemption and one of the only\r\nones which was subject to an\r\nimpact assessment.\r\nA clearly defined Bolar exemption\r\nthat can facilitate efficient\r\nregulatory approval is important.\r\nThe suggested change provides for\r\na broader scope which has already\r\nbeen implemented in many\r\nmember states and should not\r\nbe controversial.\r\nAgree with the EFPIA rationale\r\n(aa) conducting health\r\ntechnology assessment as defined\r\nin Regulation (EU) 2021/2282;\r\n(aa) conducting health\r\ntechnology assessment as defined\r\nin Regulation (EU) 2021/2282;\r\nBoth the Commission proposal\r\nand the amendments proposed\r\nby the Hungarian Presidency on\r\nexpanding the Bolar scope have\r\nthe objective of facilitating \"Day\r\nOne\" generic launch. \"Day One\r\nlaunch\" is not something EFPIA\r\nis opposed to, as long as launches\r\nare after expiration of all\r\nlegitimate acquired rights (i.e.\r\nnot, in fact, before \"Day One\",\r\nWe welcome the generosity of\r\nEFPIA in agreeing that generics/\r\nbiosimilars should be able to\r\nlaunch after expiration of patents\r\n(not before – which no one has\r\never requested), but EFPIA has\r\nfailed to show real or systemic\r\nexamples of launches before\r\nexpiry, since, out of half a million\r\n(!) approved products in Europe,\r\nthey always refer to two very old\r\ncases where the court blocked\r\nwhich EFPIA has various examples\r\nof as alluded to below).\r\nThat said, even the Commission's\r\nown impact assessment has not\r\nsufficiently proven that there were\r\nissues with launches of generic\r\nafter expiry of protection.\r\nEFPIA sees no reason to extend the\r\nBolar exemption. However, if HTA is\r\nto be retained in a compromise it\r\nmust be clarified that the\r\nexemption is limited to generating\r\ndata for the purposes of a potential\r\nHTA process but shall not extend to\r\nactually conducting HTA activities -\r\nthese are clear commercial\r\nactivities, and in the absence of\r\npatent linkage, would severely\r\nundermine the ability for an\r\ninnovator to defend its patent\r\nrights by seeking to obtain\r\npreliminary injunctions, contrary to\r\nthe requirements of the Intellectual\r\nProperty Rights Enforcement\r\nDirective. It should also be\r\naccompanied by adequate\r\nsafeguards to basic legitimate\r\ninterests of IP rights holders, as\r\nproposed in new Article 85a, and\r\nparticularly a notification\r\nmechanism.\r\nNo impact assessment has been\r\nconducted on the effect of an\r\nthe early launch and damages\r\nwere paid (the court systems\r\nworked well) and two cases\r\nwhere there was real genuine\r\ndoubt on the validity of the SPC:\r\n1) Darunavir (2017), for which\r\nCJEU Advocate General\r\nconcluded it was “likely invalid”\r\nand Dutch, Spanish & Swedish\r\nCourts considered it invalid! The\r\ncase was ultimately settled.\r\n2) Bortezomib (2017), whose SPC\r\nwas invalidated in Canada\r\ninvalidated (as not inventive) and\r\ngeneric company also got\r\ncompensation for losses, and in\r\nEurope generics were NOT\r\nlaunched, but just included in\r\nP&R database in The\r\nNetherlands.\r\nIt is strange that EFPIA mentions\r\nthere is not enough evidence\r\nthat generics are delayed after\r\npatent expiry, because the 2022\r\nIQVIA report done for EFPIA\r\nstates the generics launch delay\r\nin EU4: “the average is now 5.2\r\nmonths” (p.20)\r\nOn the doubts around timely\r\npreliminary relief, there is today\r\nno doubts because patent\r\nexpansion of Bolar on getting\r\ntimely preliminary relief to\r\nprevent an unlawful patent\r\ninfringing launch.\r\nThere are numerous examples\r\nshowing that IP- infringing\r\nlaunches are a reality. It is at\r\npresent already difficult to obtain\r\ntimely preliminary injunctions in\r\nsome countries. The expansion of\r\nthe scope of the Bolar exemption\r\nmakes IP enforcement very\r\ndifficult as any act that would\r\nusually lead to action by the\r\ncourts, such as manufacturing,\r\nselling, participating in tenders,\r\netc., could be claimed to be\r\ncarried out under the exemption.\r\nAdditionally, this would result in\r\nlegal uncertainty for both the\r\ngeneric/biosimilar manufacturer\r\nand the right holder, as courts\r\nwould need to establish new case\r\nlaw and redefine what constitutes\r\nan actionable imminent\r\ninfringement threat.\r\nholders perfectly know what\r\ncompany is launching where,\r\nsince no marketing authorization\r\nor P&R decision is secret.\r\nMoreover, in countries where\r\nP&R decisions are allowed\r\nbefore patent expiry (eg.\r\nDenmark, Czeck Republic,\r\nSlovakia, Spain, Sweden,\r\nBelgium, etc.), generic medicines\r\nenter the market on day-1 after\r\nprotections expire and there is\r\nNO illicit earlier launch, showing\r\nthat there is NO need for any\r\nunnecessary safeguard that\r\nwould only be a further tool to\r\ndelay generic entry and go\r\nclearly against the Bolar’s\r\nobjectives.\r\nThe legal uncertainty results\r\nfrom the current Bolar. Multiple\r\nstudies1 (including Commission\r\nstudies) show that the long-\r\nstanding lack of harmonisation\r\nand clarification of the Bolar has\r\nbeen causing:\r\n(1) disinvestments in Active\r\nPharmaceutical\r\nIngredients (API)\r\ndevelopment in Europe\r\nand\r\n1\r\nLinks to independent studies, European Parliament reports, etc. can be found in this position paper.\r\n(2) patent linkage practices,\r\nconsidered\r\nanticompetitive by the\r\nEuropean Commission2 as\r\nthey unduly delay generic\r\nand biosimilar\r\ncompetition.\r\nThis is well documented by\r\nnational competition authorities\r\nand courts,3\r\nand confirmed by\r\nthe fact that the Commission\r\nalready tried to block these\r\nabuses in 2012 and ban patent\r\nlinkage. These misuses of the\r\npatent and regulatory system\r\ncreate severe delays for patient\r\naccess to medicines and massive\r\ncosts for healthcare budgets, as\r\nshown in the multiple examples\r\nhere.\r\n(ab) obtaining pricing and\r\nreimbursement approval;\r\n(ab) obtaining pricing and\r\nreimbursement approval;\r\nBoth the Commission proposal\r\nand the amendments proposed\r\nby the Hungarian Presidency on\r\nexpanding the Bolar scope have\r\nthe objective of facilitating \"Day\r\nOne\" generic launch. \"Day One\r\nlaunch\" is not something EFPIA\r\nis opposed to, as long as\r\nlaunches are after expiration of\r\nall legitimate acquired rights\r\nIt is essential, instead, to clarify\r\nthat the exemption allows to\r\nobtain a pricing and\r\nreimbursement decision or\r\nsubmit a hospital tender bid for\r\nsupply after patent expiry. This is\r\nthe only way to effectively allow\r\nday-one launch, which otherwise\r\nwould be impossible.\r\n2\r\nEuropean Commission’s Sector Inquiry Report, 2009\r\n3\r\nSee the decisions in the 2025 IGBA Report “Gaming the System” and in this position paper.\r\n(i.e. not, in fact, before \"Day\r\nOne\", which EFPIA has various\r\nexamples of as alluded to\r\nbelow).\r\nThat said, even the\r\nCommission's own impact\r\nassessment has not sufficiently\r\nproven that there were issues\r\nwith launches of generic after\r\nexpiry of protection.\r\nEFPIA sees no reason to extend\r\nthe Bolar exemption to P&R.\r\nHowever, if P&R is to be retained\r\nin a compromise it must be\r\nclarified that the exemption is\r\nlimited to generating data for\r\nthe purposes of a pricing and\r\nreimbursement submission but\r\nshall not extend to actually\r\nobtaining pricing and\r\nreimbursement approval - these\r\nare clear commercial activities,\r\nand in the absence of patent\r\nlinkage, would severely\r\nundermine the ability for an\r\ninnovator to defend its patent\r\nrights, contrary to the\r\nrequirements of the Intellectual\r\nProperty Rights Enforcement\r\nDirective.\r\nMost countries use internal\r\nreference pricing systems,\r\nadjusting the innovative price\r\nonce a generic price is registered.\r\nThe impact assessment on the\r\neffects of P&R on timely relief\r\nalready exists, and is provided by\r\nthose Member States where\r\nP&R decisions are allowed\r\nbefore patent expiry (eg.\r\nDenmark, Czeck Republic,\r\nSlovakia, Spain, Sweden,\r\nBelgium, etc.), where generic\r\nmedicines enter the market on\r\nday-1 after protections expire\r\nand there is NO illicit earlier\r\nlaunch, showing that there is NO\r\nneed for any unnecessary\r\nsafeguard that would only be a\r\nfurther tool to delay generic\r\nentry and go clearly against the\r\nBolar’s objectives.\r\nObtaining a price or a\r\nreimbursement status can NEVER\r\nbe considered “early generic\r\ncompetition”, even it has an\r\neffect on the originator price,\r\nsimply because the generic is not\r\nable to launch until patent expiry.\r\nIf an effect on the originator price\r\nexists, this is something that\r\nshould be dealt with at national\r\nlevel (and Medicines for Europe is\r\nglad to cooperate to support\r\nthat), otherwise, if the generic\r\ncompany can only obtain P&R\r\nafter IP expiry, its launch would\r\nIf a generic company was to\r\nobtain a pricing and\r\nreimbursement approval and that\r\nprice were to become known to\r\nthe payer, this would de facto\r\ncreate early generic competition\r\neven if before the generic is\r\nactually commercialized. The\r\neffects of such early competition\r\nmay have a snowball effect on\r\nprices in other countries who use\r\nInternational Reference Pricing,\r\nthereby creating significant\r\ncumulative price erosion.\r\nEven if the innovator price is not\r\nautomatically decreased per\r\nnational pricing rules, the price\r\npublication or reimbursement\r\nacceptance even before the\r\ngeneric is actually\r\ncommercialized and becomes\r\navailable to patients, can, in\r\nsome systems, trigger a co-pay\r\nfor the patient. This would\r\narrive without warning at the\r\npoint of prescription, effectively\r\nlevying an unexpected tax on\r\npatients and undermining\r\naffordability.\r\nClearly national pricing laws\r\ncould and would need to be\r\namended to accommodate this\r\nEU instrument. This is a federal\r\nnever be possible on day1 (on\r\nwhich EFPIA seems to agree),\r\ncompetition would be\r\nillegitimately delayed and the\r\nMember State would pay a\r\nhigher price well beyond the\r\npatent expiry.\r\nNB: The Commission, by including\r\nP&R in the Bolar, intends to\r\nremove ‘patent linkage’, i.e. to\r\navoid that regulatory and\r\nadministrative decisions (public\r\ndecisions) be based on the status\r\nof patents (private rights issues to\r\nbe dealt with in Court between\r\nprivate entities). Patent linkage in\r\nEurope is declared “unlawful”\r\nand anticompetitive – see AM\r\nbelow.\r\nBy introducing any amendment\r\nNOT allowing to start P&R\r\nprocedures or to obtain P&R\r\ndecisions or introducing a\r\nnotification system, the Directive\r\nwould formally introduce a\r\npatent linkage, which is exactly\r\nwhat the new Bolar is trying to\r\neliminate and that the\r\nPharmaceutical Sector Inquiry\r\nReport of 2009, conducted by DG\r\nEU diction of amendments of\r\nlaws on\r\nDrug pricing (a clear national\r\ncompetence) via the backdoor.\r\nNo impact assessment has been\r\nconducted on the effect of an\r\nexpansion of Bolar on getting\r\ntimely preliminary relief to\r\nPREVENT an unlawful patent\r\ninfringing launch.\r\nThere are numerous examples\r\nshowing that IP- infringing\r\nlaunches are a reality. It is at\r\npresent already difficult to\r\nobtain timely preliminary\r\ninjunctions in some countries.\r\nThe expansion of the scope of\r\nthe Bolar exemption makes IP\r\nenforcement very difficult as\r\nany act that would usually lead\r\nto action by the courts, such as\r\nmanufacturing, selling,\r\nparticipating in tenders, etc.,\r\ncould be claimed to be carried\r\nout under the exemption.\r\nAdditionally, this would result in\r\nlegal uncertainty for both the\r\ngeneric/biosimilar\r\nmanufacturer and the right\r\nholder, as courts would need to\r\nCOMPETITION, declared\r\nunlawful4 .\r\nEFPIA has failed to show real or\r\nsystemic examples of launches\r\nbefore expiry, since, out of half a\r\nmillion (!) approved products in\r\nEurope, they always refer to two\r\nvery old cases where the court\r\nblocked the early launch and\r\ndamages were paid (the court\r\nsystems worked well) and two\r\ncases where there was real\r\ngenuine doubt on the validity of\r\nthe SPC: 1) Darunavir (2017), for\r\nwhich CJEU Advocate General\r\nconcluded it was “likely invalid”\r\nand Dutch, Spanish & Swedish\r\nCourts considered it invalid! The\r\ncase was ultimately settled.\r\n2) Bortezomib (2017), whose SPC\r\nwas invalidated in Canada\r\ninvalidated (as not inventive) and\r\ngeneric company also got\r\ncompensation for losses, and in\r\nEurope generics were NOT\r\nlaunched, but just included in\r\nP&R database in The\r\nNetherlands.\r\nThe legal uncertainty results\r\nfrom the current Bolar. Multiple\r\n4\r\nhttps://ec.europa.eu/competition/sectors/pharmaceuticals/inquiry/staff_working_paper_part1.pdf\r\nestablish new case law and\r\nredefine what constitutes an\r\nactionable imminent\r\ninfringement threat.\r\nAny changes to the current\r\nsystem should also be\r\naccompanied by adequate\r\nsafeguards to basic legitimate\r\ninterests of IP rights holders, as\r\nproposed in new Article 85a,\r\nand particularly a notification\r\nmechanism.\r\nstudies5 (including Commission\r\nstudies) show that the long-\r\nstanding lack of harmonisation\r\nand clarification of the Bolar has\r\nbeen causing:\r\n(3) disinvestments in Active\r\nPharmaceutical\r\nIngredients (API)\r\ndevelopment in Europe\r\nand\r\n(4) patent linkage practices,\r\nconsidered\r\nanticompetitive by the\r\nEuropean Commission6 as\r\nthey unduly delay generic\r\nand biosimilar\r\ncompetition.\r\nThis is well documented by\r\nnational competition authorities\r\nand courts,7\r\nand confirmed by\r\nthe fact that the Commission\r\nalready tried to block these\r\nabuses in 2012 and ban patent\r\nlinkage. These misuses of the\r\npatent and regulatory system\r\ncreate severe delays for patient\r\naccess to medicines and massive\r\ncosts for healthcare budgets, as\r\nshown in the multiple examples\r\nhere.\r\n5\r\nLinks to independent studies, European Parliament reports, etc. can be found in this position paper.\r\n6\r\nEuropean Commission’s Sector Inquiry Report, 2009\r\n7\r\nSee the decisions in the 2025 IGBA Report “Gaming the System” and in this position paper.\r\nOn the competence on national\r\npricing: national pricing would\r\nalways remain a national\r\ncompetence. Including P&R in\r\nBolar would not impose any\r\ndecision on national authorities.\r\nThey will continue to decide on\r\ntheir own whether to agree on a\r\nprice and/or what price. This\r\nwould only allow them to take\r\nP&R decisions freely, without\r\nthe fear of being sued or\r\nthreatened to be sued by patent\r\nholders.\r\n(ac) complying with subsequent\r\npractical requirements associated\r\nwith activities referred to in\r\npoints (i)-(iii).\r\n(ac) complying with subsequent\r\npractical requirements associated\r\nwith activities referred to in\r\npoints (i)-(iii).\r\nThis is not necessary in light of\r\nthe reference to \"other\r\nactivities\" in paragraph 1, as\r\ndefined in subparagraph (b). As\r\nany exception, the Bolar\r\nexemption should be\r\ninterpreted narrowly and name\r\nspecific activities clearly - this\r\nparagraph is vague and\r\ntherefore inconsistent with this\r\nprinciple.\r\nA reference to “subsequent\r\npractical requirements” exists in\r\nthe Bolar of today. By removing\r\nit, it would reduce its scope from\r\nthe one of today.\r\nThe text in the Council proposal\r\njust clarifies that all preparatory\r\nactivities are covered by Bolar\r\nwithout leaving any uncertainty.\r\nRemoving uncertainty seems to\r\nbe a shared priority.\r\n(ad) submitting an application on\r\nprocurement tenders are\r\nsubmitted, in compliance with\r\nUnion and national law, to the\r\nextent that it does not entail the\r\nsale or offering for sale of the\r\nmarketing of the patented\r\nmedicinal product during the\r\n(ad) submitting an application on\r\nprocurement tenders are\r\nsubmitted, in compliance with\r\nUnion and national law, to the\r\nextent that it does not entail the\r\nsale or offering for sale of the\r\nmarketing of the patented\r\nmedicinal product during the\r\nThe submission of a procurement\r\nbid constitutes commercial use\r\nunder the WTO Agreement on\r\nTrade- Related Aspects of\r\nIntellectual Property Rights\r\n(TRIPS): participation in a tender\r\nis a quintessentially commercial\r\nactivity reserved to the\r\nThe submission of a hospital\r\nprocurement tender bids is a\r\nnecessary part of the process for\r\nsecuring market access for\r\ngenerics and biosimilars after\r\npatent or SPC expiration.\r\nPreventing generics or biosimilars\r\nfrom participating in\r\nprotection period provided by\r\npatent rights or supplementary\r\nprotection certificate.\r\nprotection period provided by\r\npatent rights or supplementary\r\nprotection certificate.\r\npatent/SPC holder. This results in\r\ncommercial damage to\r\ninnovators undermining the value\r\nof patent rights, while also\r\npresenting legal challenges.\r\nExpanding the exemption from\r\nprotection of intellectual\r\nproperty rights (\"Bolar\r\nexemption\") to submission or\r\nacceptance of procurement bids -\r\nas part of the Proposal for a\r\nDirective on the Union code\r\nrelating to medicinal products for\r\nhuman use - raises significant\r\ncause for concern.\r\nAllowing generic or biosimilar MA\r\napplicants using a product\r\nprotected by a patent or SPC to\r\nengage, in the context of\r\nprocurement procedures, in\r\ncommercial activities such as an\r\noffer for sale (tender) and\r\npotentially actual sales - which\r\nwould otherwise be reserved to\r\nthe patent/SPC holder during the\r\npatent or SPC term - will not be\r\ncompliant with EU principles of\r\nproportionality and necessity and\r\ncould cause considerable\r\ncommercial damage.\r\nFurthermore, allowing generic\r\nand biosimilar manufacturers to\r\nparticipate in tenders would only\r\nencourage launches before IP\r\nprocurement tenders, even\r\nbefore they are commercially\r\nlaunched, will unnecessarily\r\ndelay their entry into the market\r\nand limit competition.\r\nSeveral studies exist that\r\ndemonstrate that including\r\nhospital tenders into the Bolar\r\nwould not infringe any\r\ninternational law or EU law.\r\nprotection (launches at risk).\r\nApart from the irreparable\r\ncommercial damage, this could\r\nalso result in legal uncertainty for\r\nthose manufacturers themselves\r\nand in supply disruptions, should\r\nan infringement case be initiated\r\nand ruled in favour of the rights\r\nholder,\r\nFrom a legal perspective, any\r\nproposal permitting the\r\nsubmission and acceptance of\r\nprocurement bids is:\r\ninconsistent with the EU's\r\nobligations under Article 28.1 of\r\nTRIPS, because it does not satisfy\r\nall the cumulative conditions\r\nrequired under Article 30 of\r\nTRIPS;\r\n(ii) inconsistent with the EU's\r\nobligations under Article 27.1 of\r\nTRIPS, because it unjustifiably\r\nimposes differentially\r\ndisadvantageous treatment to\r\npatent/SPC holders in the field of\r\nmedicinal products compared to\r\ninventions in all other fields of\r\ntechnology;\r\n(iii) inconsistent with the EU's\r\nobligations under Article 1.1 of\r\nTRIPS because it limits the\r\nprotection of patent and SPC\r\nrights without complying with the\r\nrelevant requirements in Articles\r\n27.1 and 28.1 of TRIPS.\r\n(b) The activities conducted\r\nexclusively for the purposes set\r\nout in first subaragraph, may\r\ncover, where relevant, the\r\nsubmission of the application for\r\na marketing authorisation and\r\nthe offer, manufacture, sale,\r\nsupply, storage, import, use and\r\npurchase of patented medicinal\r\nproducts or processes, including\r\nby third party suppliers and\r\nservice providers.\r\n(b) The necessary activities\r\nconducted exclusively for the\r\npurposes set out in first\r\nsubaragraph, may cover, where\r\nrelevant, the submission of the\r\napplication for a marketing\r\nauthorisation and the offer,\r\nmanufacture, sale, supply,\r\nstorage, import, use and\r\npurchase of patented medicinal\r\nproducts or processes, including\r\nby third party suppliers and\r\nservice providers.\r\nA clearly defined Bolar exemption\r\nthat can facilitate efficient\r\nregulatory approval is important.\r\nTo achieve harmonisation across\r\nthe EU, the exemption shall\r\napply to activities directed to\r\ngenerating data for the purpose\r\nof obtaining any kind of\r\nmarketing authorisation. The\r\nexemption shall include strictly\r\nnecessary activities to that\r\npurpose, including where\r\nconducted by third parties on a\r\nreactive basis. It should however\r\nbe tightly framed, to prevent\r\nabuses and avoid IP- infringing\r\nlaunches, which have been a\r\nreality, as explained above.\r\nIt is important to refer to all the\r\nactivities allowed, not just to MA\r\napplication, otherwise any other\r\nactivity done with the API would\r\nbe an infringement, which is not\r\nthe intention of the legislation.\r\n‘Export’ is also fundamental or\r\notherwise EU API developers\r\nwould be disadvantages vis-à-vis\r\nnon-EU developers.\r\n(In the first lines of the EFPIA\r\nrationale they refer to multiple IP-\r\ninfringing cases mentioned\r\nbelow. Here they refer to cases\r\nmentioned above, but at the end\r\nthere is no case mentioned…)\r\n2. Decisions adopted concerning\r\nthe activities referred to in\r\nparagraph 1 shall not be\r\nconsidered as infringing\r\nintellectual property rights,\r\nwithin the meaning of that\r\nparagraph.\r\n2. Provided conditions under Article\r\n85a have been respected, decisions\r\nadopted concerning the activities\r\nreferred to in paragraph 1 shall\r\nnot be considered as infringing\r\nintellectual property rights,\r\nwithin the meaning of that\r\nparagraph.\r\nSee justification for the\r\nsafeguards proposed in the\r\nsuggested new Art. 85a.\r\nReference to the new proposed\r\nArticle 85a would create a new\r\ntype of patent linkage, which is\r\nwhat the EU wants to eliminate\r\nhere because anticompetitive\r\nand “unlawful”.\r\n3. This exception provided for in\r\nthis Article shall not cover the\r\nplacing on the market of the\r\nmedicinal products resulting from\r\nsuch activities.\r\n3. This exception provided for in\r\nthis Article shall cover the\r\nsubmission and decision on an\r\n·application for marketing\r\nauthorisation. It shall not cover\r\nduring the period of protection by\r\nIt is advised to remove similar\r\nprovision from (b) above, and\r\nrather express it clearly here.\r\nThe scope of the exemption\r\nshould be clearly and narrowly\r\nconstrued. Stockpiling for\r\nA Bolar that covers only\r\nmarketing authorization already\r\nexists and in some MSs (eg.\r\nDenmark, Czeck Republic,\r\nSlovakia, Spain, Sweden, Belgium,\r\netc.) P&R procedures are possible\r\nintellectual property rights, the\r\nplacing on the market of the\r\nmedicinal products, stockpiling for\r\nthe purpose of placing the\r\nmedicinal products on the\r\nmarket, offering to place the\r\nmedicinal products on the\r\nmarket, or indicating commercial\r\navailability of the medicinal\r\nproducts via listing or otherwise,\r\nresulting from such activities,\r\nunless provided for and subject\r\nto the conditions in Regulation\r\n(EU) 2019/933.\r\npurposes of placing the product\r\non the market should be clearly\r\nexcluded as it constitutes an\r\ninfringing act as established in\r\nthe EU vs Canada WTO case\r\narbitration outcome (DS 114,\r\n2000). Similarly, to ensure an\r\neffective IP enforcement system,\r\noffering to place the product on\r\nthe market or signalling\r\ncommercial availability during the\r\npatent/SPC protection term\r\nshould continue to be considered\r\nas signals of an imminent\r\ninfringement that should be\r\nactionable in court.\r\nalready. By limiting the text in\r\nthis way, these MSs would see\r\nhuge delays of competition after\r\npatent expiry, which today they\r\ndo not see. Stockpiling is not in\r\nthe scope of the Bolar, but of the\r\nSPC manufacturing waiver (where\r\nby the way the notification\r\nsystem hugely limits the use and\r\nis being misused by SPC holders\r\nin all ways: see the 2024 Industry\r\nReport).\r\nA clarification of the part on\r\n“placing on the market” is\r\nnecessary to avoid legal\r\nuncertainty. We propose the\r\nfollowing text: “This exception\r\nshall not cover the placing on the\r\nmarket in a Member State of the\r\nmedicinal products\r\nmanufactured for the purposes\r\nmentioned above, while the\r\nrelevant patent rights or\r\nsupplementary protection\r\ncertificates are in force in that\r\nMember Stateresulting from\r\nsuch activities.”\r\nNew Article 85a\r\n1. To benefit from the exemption\r\nin Article 85, the holder or\r\napplicant for a marketing\r\nauthorisation in accordance with\r\nArticles 9, 10, 11, 12 of [revised\r\nAppropriate measures should be\r\nput in place to safeguard the\r\neffectiveness of patents/SPC\r\nrights enforcement. The following\r\nnotification system is proposed:\r\nA notification system is an\r\nunnecessary, unjustified,\r\nanticompetitive mechanism that\r\nwould further allow patent\r\nholders to misuse the system to\r\ndelay generic and biosimilar\r\nDirective 2001/83] shall notify\r\ntheir intention to avail\r\nthemselves of the exemption in\r\nwriting, through appropriate and\r\ndocumented mean,1 the MAH of\r\nthe reference medicinal product,\r\nno later than eighteen months\r\nbefore the submission of an\r\napplication for pricing and\r\nreimbursement for the\r\nauthorised product.\r\n1a. The notification shall include\r\nall the following information:\r\n(i) the name and address of the\r\nholder or applicant for a\r\nmarketing authorisation in\r\naccordance with Articles 9, 10,\r\n11, 12 ;\r\n(ii) confirmation of submission\r\nor grant of the application for\r\nthe marketing authorization,\r\nincluding sufficient information\r\nregarding the indication and\r\nformulation of the product for\r\nthe rights owner to make an\r\nassessment of potential patent\r\ninfringement;\r\n(iii) a list of the activities to be\r\nperformed;\r\n(iv) the Member State(s) and\r\naddresses where the activities\r\nare taking place;\r\no Any generic manufacturer\r\nwould notify the innovator of its\r\nintention to perform allowed\r\nactivities under the expanded\r\nBolar exemption, mentioning\r\namongst others, what their\r\nearliest commercial launch date\r\nis.\r\no To guarantee the effectiveness\r\nof the notification in supporting\r\npatent/SPC enforcement, it must\r\nbe sufficiently timely to enable at\r\nleast trial proceedings to be\r\nconcluded before actual launch,\r\ni.e., at least one and preferably\r\ntwo years before actual launch.\r\nWe suggest using the application\r\nfor pricing & reimbursement as\r\nthe reference point, where\r\napplicable. The notification\r\nshould be at least 18 months\r\nprior to launch.\r\no Right holders need enough\r\ntime to resolve patent disputes\r\nbefore they are exposed to\r\nirrecoverable damages if\r\ninfringing generic products are\r\nlaunched before patent/SPC\r\nexpiry. This means not just relying\r\non preliminary injunctions but\r\nactually be able to resolve the\r\ndispute.\r\nmedicines entry, as very widely\r\nrecognised. This is well\r\ndocumented by national\r\ncompetition authorities and\r\ncourts,8\r\nand confirmed by the\r\nfact that the Commission already\r\ntried to block these abuses in\r\n2012 and ban patent linkage.\r\nThese misuses of the patent and\r\nregulatory system create severe\r\ndelays for patient access to\r\nmedicines and massive costs for\r\nhealthcare budgets, as shown in\r\nthe multiple examples here.\r\nThe only other example of a\r\nnotification mechanism, ie. the\r\nSPC manufacturing waiver, is\r\nregularly misused as a basis for\r\ncresting legal hurdles for generic\r\nmarket entry (see the 2024\r\nIndustry Report).\r\nOn the contrary, this legislation is\r\ntrying to remove patent linkage,\r\nwhose prohibition is foreseen in\r\nRecital 65.\r\nPatent linkage occurs when\r\ngeneric & biosimilars’ Marketing\r\nAuthorisations/P&R\r\ndecisions/hospital tender bids are\r\n8\r\nSee the decisions in the 2025 IGBA Report “Gaming the System” and in this position paper.\r\n(v) the country where the\r\napplicant has submitted\r\napplications for HTA or pricing &\r\nreimbursement under paragraph\r\n1 point (a), (ii) or (iii);\r\n(vi) the reference of all relevant\r\npatent(s) and/or SPC;\r\n(vii) the earliest commercial\r\nlaunch date in the Member State\r\nor States concerned.\r\n1b. Such notification shall\r\nconstitute an indication and\r\nthreat of imminent launch and IP\r\nrights infringement, absent any\r\nbinding commitment and\r\nmeasures taken to the contrary\r\nby the applicant for pricing &\r\nreimbursement approval, as per\r\nfollowing subparagraphs c to d.\r\n1c. The applicant shall commit to\r\nrespect the earliest launch date\r\nnotified pursuant to Article 85a,\r\nparagraph 1(a)(vii), before which\r\nno product can be supplied or\r\nmade commercially available in\r\nany way or form. In accordance\r\nwith paragraph 2 below, no price\r\nor reimbursement for that\r\nproduct can be effective or listed\r\nbefore that date, and the\r\nbeneficiary of the exemption\r\nshall therefore take necessary\r\nmeasures to that effect.\r\no Even the Unitary Patent Court\r\n(UPC) takes 1 year (and the\r\nduration of appeal process\r\nremains unknown at this stage).\r\nNational courts will (mostly) take\r\nlonger and some courts very\r\nmuch longer (Italy).\r\nPreliminary injunctions alone can\r\ntake 24-36 hours to obtain in\r\nsome countries and more than\r\nyear in countries like Portugal\r\n(many countries in the middle\r\nsuch as Denmark 4-6 months,\r\nwith alone 1 week of court\r\nhearings).\r\no Such a notification would be\r\nconsidered a reason for the\r\ninnovator to take action in Court\r\nin case there are disagreements\r\non the lawfulness of generic\r\nentry. A right holder should be\r\nable to avail themselves of the\r\nnotification to initiate court\r\nproceedings to obtain\r\npreliminary injunctions. A Court\r\ncould clarify in a transparent and\r\nbinding manner when exclusivity\r\nexpires before any commercial\r\ndamage is done to either party.\r\nThis transparency and clarity\r\ncreated early on for all parties\r\nwould increase legal certainty for\r\nboth innovators and generics, but\r\nalso for healthcare systems.\r\nblocked due to existing patents\r\ncovering the reference\r\nproduct. The EC considers it\r\n“unlawful” and anti-\r\ncompetitive in its Pharmaceutical\r\nSector Inquiry Report of 2009\r\n(p.315), as it delays\r\ngeneric/biosimilar medicines\r\nsystematically. The EU already\r\nattempted to ban patent linkage\r\nin the 2012 EC Proposal for\r\nRevised Transparency Directive .\r\nThe European Parliament\r\nResolutions on Access to\r\nMedicines in 2017 & on the\r\nPharmaceutical Strategy in\r\n2021 urged the Commission to\r\nend patent linkage to ensure\r\nimmediate market entry for\r\ngeneric/biosimilar\r\ncompetitors. A June 2021 study\r\nof the European\r\nParliament confirms the issue,\r\nand the European Parliament\r\nReport on the IP Action\r\nPlan urges to ban patent\r\nlinkage and to address Bolar.\r\nTherefore, this article should ban\r\npatent linkage, instead of\r\nintroducing it.\r\nVery importantly, while the EU is\r\nnegotiating the pharmaceutical\r\n1d. The applicant shall exercise\r\ndue diligence to identify relevant\r\nIP rights which would otherwise\r\nbe infringed and take all\r\nnecessary measures so that their\r\nuse of the exemption does not\r\nunreasonably conflict with the\r\nnormal exploitation of the IP\r\nrights or prejudice the legitimate\r\ninterests of the IP rights owner.\r\nWhere applicable, IPR holders\r\nare entitled to ask courts to\r\nassess whether such due\r\ndiligence has been exercised and\r\nwhether necessary measures\r\nhave been taken by beneficiaries\r\nof this exemption to prevent\r\ntheir activities from\r\nunreasonably conflicting with\r\nthe normal exploitation of the IP\r\nrights or prejudice the legitimate\r\ninterests of the IP rights owner.\r\n1e. The burden shall be on the\r\nbeneficiary of the exemption to\r\ndemonstrate that sufficient and\r\nreasonable efforts have been\r\ntaken to prevent infringement or\r\nother activities unreasonably\r\nconflicting with the normal\r\nexploitation of the IP rights, or\r\nalternatively, that timely efforts\r\nlegislation reform, the United\r\nStates are very active to\r\n(1) lower medicines prices9\r\nand\r\n(2) block anticompetitive\r\npractices10 that delay\r\ngeneric and biosimilar\r\ncompetition.\r\nBy introducing a mechanism that\r\nis widely recognised as\r\nanticompetitive, the EU would\r\ngo exactly in the opposite\r\ndirection against its own\r\ninterests.\r\nThis is a dangerous attempt to\r\nintroduce notifications and a\r\npatent linkage system (similar to\r\nthe one in the US) into the Bolar\r\nin order to create systemic\r\nlitigation and blocking phantom\r\n‘early launch’ of generic and\r\nbiosimilar medicines. This is\r\nexactly what the US is\r\ninvestigating to block\r\nanticompetitive practices.\r\nNot only did the originators fail\r\nto justify the need for such\r\nanticompetitive proposal,11\r\nbut a\r\n2023 Yale University Study\r\nshows that\r\n9\r\n15 April 2025 Executive Order: https://www.whitehouse.gov/presidential-actions/2025/04/lowering-drug-prices-by-once-again-putting-americans-first/\r\n10\r\n9 April 2025 Executive Order: https://www.whitehouse.gov/presidential-actions/2025/04/reducing-anti-competitive-regulatory-barriers/\r\n11\r\nThis proposal had been already made in the Parliament without success.\r\nhave been made to bring court\r\nproceedings sufficiently in\r\nadvance to resolve potential IP\r\nrights disputes.\r\n2. Competent national\r\nauthorities, including those\r\ncompetent for the inclusion of\r\nproducts within the public\r\nhealth insurance system, shall\r\nset up mechanisms to allow\r\ncompletion of pricing\r\n&reimbursement procedures\r\nwhile ensuring the product, or\r\nits price, are not effective,\r\navailable or publicly listed as\r\navailable before the earliest\r\ncommercial launch date as\r\nnotified to the MAH of the\r\nreference product, unless the\r\napplicant and the MAH of the\r\nreference medicinal product or\r\nthe owners of the relevant IP\r\nrights agree otherwise.\r\n3. The European Commission\r\nshall create a Working Group\r\nincluding representatives of\r\nMember States, national IP\r\nCourts, UPC, pricing &\r\nreimbursement authorities,\r\npharmaceutical industry, to\r\nexplore best practices and\r\nbalanced mechanisms that can\r\n“91% of drugs that obtain patent\r\nterm extensions continue their\r\nmonopolies well past the\r\nexpiration of those extensions,\r\nmost often by relying on\r\nsecondary patents … costing the\r\nsystem a conservatively\r\nestimated $53.6 billion”.\r\nA US-like notification and patent\r\nlinkage system would have\r\nequivalent effects in Europe and\r\nthis is exactly why patent linkage\r\nis anticompetitive and\r\n“unlawful” in Europe. And this is\r\nwhy the Parliament calls for\r\nbanning it and the Commission\r\nhas been trying to eliminate this\r\npractice for the past 15 years.\r\nThe EU and its Member States\r\nshould defend the\r\nharmonization and clarification\r\nof the Bolar exemption in the\r\ninterest of timely competition\r\nand patient access, security of\r\nsupply, sustainable healthcare\r\nsystems and the competitiveness\r\nof the EU manufacturing\r\nindustry.\r\nfacilitate timely entry while\r\npreserving the effectiveness and\r\nintegrity of IP rights. The\r\nEuropean Commission should\r\nreview and issue a report on the\r\nuse of this exemption, the\r\nimpact on generic and biosimilar\r\nentry as well as on the\r\nenforcement of IP rights within 3\r\nyears of its entry into force.\r\nNOTE\r\nThe costs of proposals to introduce anti-competitive\r\npatent linkage in the Bolar Exemption\r\n16.04.2025\r\nMedicines for Europe is aware that the originator industry is proposing not only to extend the EU\r\npharmaceutical regulatory protections (which are already the longest in the world), but also to block the\r\nharmonisation and clarification of the Bolar Exemption (Article 85 of the proposed Directive on Human Use\r\nMedicines).\r\nNot only will this NOT stop originator pharmaceutical companies from transferring their R&D to the US, as\r\nseveral have already announced, but will also continue to allow the current misuses of the patent system to\r\ndelay competition and affect patient access and public health budgets, which already struggle to finance the\r\nreimbursement of expensive drugs.\r\nThe note provides some important facts and new data for consideration to keep supporting the Hungarian\r\ncompromise that the Council reached in December 2024. This includes the possibility to conduct\r\nadministrative and regulatory activities (listed in the paragraph 1.a) required for a generic and biosimilar\r\nmedicine are possible under the Bolar clause (obtaining a market authorisation, obtaining P&R decisions and\r\ntenders). Any change to this text would make the bolar clause unworkable.\r\nBolar Exemption: essential for competition and competitiveness of the EU manufacturing industry\r\nThe Bolar exemption was enacted to allow the development and approvals of generics and biosimilars for\r\nimmediate competition at IP expiry. Multiple studies1 (including Commission studies) show that the long-\r\nstanding lack of harmonisation of the Bolar has been causing:\r\n(1) disinvestments in Active Pharmaceutical Ingredients (API) development in Europe and\r\n(2) patent linkage practices, considered anticompetitive by the European Commission2 as they unduly\r\ndelay generic and biosimilar competition.\r\nThis is well documented by national competition authorities and courts,3\r\nand confirmed by the fact\r\nthat the Commission already tried to block these abuses in 2012 and ban patent linkage. These misuses\r\nof the patent and regulatory system create severe delays for patient access to medicines and massive\r\ncosts for healthcare budgets, as shown in the multiple examples here.\r\nThe Hungarian Bolar blocks anticompetitive practices that cost billions to EU healthcare systems\r\nClarifying and harmonising the Bolar exemption has the stated objective to effectively allow immediate\r\ncompetition after patent expiry by allowing all regulatory/pricing and reimbursement activities during the\r\nprotection. By blocking or watering down the proposed Bolar exemption and the related amendments applied\r\nby Parliament and Council, the EU and Member States would provide a free ride to continue delaying\r\ncompetition and blocking the needed savings for healthcare systems.\r\nAs shown in the Table below, the value of the products for which delaying strategies are applied is enormous\r\nand even a few days of artificial delays have a very direct impact on healthcare sustainability:\r\n1\r\nLinks to independent studies, European Parliament reports, etc. can be found in this position paper.\r\n2\r\nEuropean Commission’s Sector Inquiry Report, 2009\r\n3\r\nSee the decisions in the 2025 IGBA Report “Gaming the System” and in this position paper.\r\nThe global daily revenue losses at patent expiry\r\nA 2024 independent study shows that, between 1995 and 2020, 91% of oncology products recouped R&D\r\ninvestments in 8 years. Any artificial delays of generic and biosimilar medicines beyond the 15 years of\r\neffective monopoly enjoyed in the EU is unjustifiable and detrimental for patients, competition, healthcare\r\nbudgets and the competitiveness of the EU manufacturing industry.\r\nShould the EU lag behind internationally and undermine Member States healthcare sustainability\r\nto protect artificial monopoly extensions?\r\nWhile the EU is negotiating the pharmaceutical legislation reform, the United States are very active to\r\n(1) lower medicines prices4 and\r\n(2) block anticompetitive practices5 that delay generic and biosimilar competition.\r\nWithout the needed Bolar reform, the EU would go exactly in the opposite direction against its own interests.\r\nNew attempt to introduce unlawful patent linkage in Bolar that would cost the EU billions\r\nAttempts are being made to introduce notifications and a patent linkage system (similar to the one in the US)\r\ninto the Bolar in order to create systemic litigation and blocking phantom ‘early launch’ of generic and\r\nbiosimilar medicines. This is exactly what the US is investigating to block anticompetitive practices.\r\nNot only did the originators fail to justify the need for such anticompetitive proposal,6\r\nbut a 2023 Yale\r\nUniversity Study shows that\r\n“91% of drugs that obtain patent term extensions continue their monopolies well past the\r\nexpiration of those extensions, most often by relying on secondary patents … costing the system\r\na conservatively estimated $53.6 billion”.\r\nA US-like notification and patent linkage system would have equivalent effects in Europe and this is exactly\r\nwhy patent linkage is anticompetitive and “unlawful” in Europe.\r\nThe EU and its Member States should defend the harmonization and clarification of the Bolar exemption in\r\nthe interest of timely competition and patient access, security of supply, sustainable healthcare systems and\r\nthe competitiveness of the EU manufacturing industry.\r\n4\r\n15 April 2025 Executive Order: https://www.whitehouse.gov/presidential-actions/2025/04/lowering-drug-prices-by-once-again-\r\nputting-americans-first/\r\n5\r\n9 April 2025 Executive Order: https://www.whitehouse.gov/presidential-actions/2025/04/reducing-anti-competitive-regulatory-\r\nbarriers/\r\n6\r\nThis proposal had been already made in the Parliament without success.\r\n"},"recipientGroups":[{"recipients":{"parliament":[],"federalGovernment":[{"department":{"title":"Bundesministerium für Gesundheit (BMG)","shortTitle":"BMG","url":"https://www.bundesgesundheitsministerium.de/","electionPeriod":20}}]},"sendingDate":"2025-05-28"}]}]},"contracts":{"contractsPresent":false,"contractsCount":0,"contracts":[]},"codeOfConduct":{"ownCodeOfConduct":false}}