Rechtliche Grundlagen der 26 und 27 Projekte. Modul 3

Transkript

1 der 26 und 27 Projekte Modul 3

2 It s all in the contracts but doctor s don t read contracts (Prof. Kulenthran Arumugam, University Hospital Kuala Lumpur)

3 Was ist ein Vertrag? zwei- oder mehrseit. Rechtsgeschäft Voraussetzungen: - Geschäftsfähigkeit - Wille rechtliche Wirkungen auszulösen - übereinstimmende Willenserklärungen - inhaltliche Bestimmtheit - Fehlen von Irrtum und Zwang Vertragsfreiheit Beispiele

4 Arten von Verträgen Auftragsforschungsvertrag (klin-., nichtklin. Prüfvertrag, AWB, Registervertrag) MTA CDA Letter of Intent

5 Was muss ein klin. Prüfvertrag mind. beinhalten? Vertragspartner: Auftraggeber (Sponsor) Auftragnehmer Medizinische Universität Wien, OE, Spitalgasse 23, 1090 Wien Beispiel 1

6 Beispiel 1 Vertragspartner Falsch: This Clinical Study Agreement ( Agreement ) is by and between EDWARDS LIFESCIENCES LLC ( EDWARDS ), having an office at One Edwards Way, Irvine, California, 92614, a Delaware limited liability company, and General Hospital Vienna, Währinger Gürtel 18-20, A-1090 Vienna, Austria, represented by Dr. XY, Department of Surgery Richtig: This Clinical Study Agreement ( Agreement ) is by and between EDWARDS LIFESCIENCES LLC ( EDWARDS ), having an office at One Edwards Way, Irvine, California, 92614, a Delaware limited liability company, and Medizinische Universität Wien, Universitätsklinik für Chirurgie, Spitalgasse 23, A-1090 Wien, Austria, represented by O. Univ. Prof. Dr. Ferdinand Mühlbacher according to 27 UG 2002

7 Pflichten des Auftraggebers (Sponsors), der MUW und des Prüfarztes ( 2a Abs (16) AMG: Sponsor ist jede physische oder juristische Person, die die Verantwortung für die Planung, die Einleitung, die Betreuung und die Finanzierung einer klinischen Prüfung übernimmt) ( 2a Abs (11) AMG: Prüfer ist ein zur selbstständigen Berufsausübung in Österreich berechtigter Arzt oder Zahnarzt, der für die Durchführung der klinischen Prüfung in einem Prüfzentrum verantwortlich ist. Wird eine Prüfung in einem Prüfzentrum von einem Team vorgenommen, so ist der Prüfer der verantwortliche Leiter des Teams)

8 Dateneigentum bzw Datenverwendung Daten gehören Auftraggeber (bei voll finanzierter Auftragsforschung und Sponsorship des Auftraggebers) jedenfalls: Datennutzung durch MUW für Lehre und non commercial research

9 Publikationsrechte Richtlinien der MUW zur Publikation aus 2006 MUW muss immer publizieren dürfen Recht zum Review und/oder Kommentieren keine inhaltliche Einflussnahme Fristen verhandelbar Deklaration von Helsinki Beispiel 2

10 Beispiel 2 Publication Falsch: Publication (abstracts and manuscripts) or presentation of the overall clinical study results requires the prior written approval of Sponsor. Richtig: Institution and Investigator shall have the right to publish and present the results of the Study and shall exercise all resasonable efforts to do so in a timely manner provided to the following: Investigator or Institution shall submit to Sponsor any and all drafts of publications at least 30 days prior to the submission to any third party for Sponsor s review. In addition, if Sponsor requests in writing, Institution and Investigator shall withhold any publication or presentation for an additional 60 days. Sponsor reserves the right to remove all Confidential Information - except Study Results - from any publication or presentation; however, Sponsor will not otherwise exercise editorial control over the proposed publication or presenation.

11 Regelungen über Intellectual Property Rights Was aus Projekt entspringt, gehört Auftraggeber (AG) - bei voller Finanzierung und Verantwortung des AGs Urheberrechte: Werknutzungsrechte an Auftraggeber übertragen

12 Regelungen über Patente Definition Diensterfindung (PatentG u UG 2002) Üblich: bei voll finanzierter und in Verantwortung des AGs durchgeführter Auftragsforschung verpflichtet sich MUW, Rechte an AG zu übertragen; Dienstnehmer ex lege verpflichtet, Erfindungen an Rektorat zu melden; Nur wenn AG Erfindung nicht will, gehört sie MUW und nur wenn MUW sie nicht verwerten will, gehört sie Dienstnehmer Dienstnehmererfindervergütung

13 Geheimhaltungsregelungen Gegenseitigkeit

14 Schad- und Klagloshaltung (Indemnification) muss verschuldensunabhängig sein Beispiel 3

15 Falsch: Indemnification Baxter agrees to indemnify and hold MUW harmless for any injury occurring to property or any individuals as a result of the performance of the SPONSORED RESEARCH, provided that such injury has occurred because of the negligence of BAXTER. Richtig: Indemnification SPONSOR shall defend, indemnify and hold harmless the PRINCIPAL INVESTIGATOR, INSTITUTION, its trustees, officers, employees and agents ( Indemnitees ) from any and all liabilities, claims, actions or suits, proceedings, costs and expenses (including reasonable legal costs) in respect of loss of damage to property, and for personal injury or death arising out of the administration or use of the Medicinal Product or Study Device or Materials - including Study related procedures - during the course of the Study; provided that: -The Study is conducted in accordance with the Protocol and this Agreement; -Such loss does not arise out of the gross negligence or willful misconduct of any Indemnitee or of a breach of the obligations of the PRINCIPAL INVESTIGATOR and/or the INSTITUTION under this Agreement; Beispiel 3 Indemnification -SPONSOR is notified as soon as possible after the receipt of any complaint or injury relating to the loss by the Indemnitee; and -SPONSOR shall have control over the defense and settlement of the complaint or claim(s). SPONSOR shall provide diligent defense against and/or settlement of any claims brought or actions filed for the loss, that is subject to the indemnification obligations hereunder, whether such claims or actions are rightfully or wrongfully brought or filed. SPONSOR shall have the right to settle claims at SPONSOR s sole expense; provided, however, that SPONSOR shall not admit to any wrongdoing or fault on behalf of the Indemnitees without the prior written consent of such Indemnitees, which consent shall not be unreasonably withheld, conditioned or delayed. The Indemnitee shall fully cooperate with SPONSOR and its legal representatives in the investigation and defense of any claim or suit covered under this Agreement. If the claim or action is asserted, Indemnitee shall have the right to select and obtain its own legal counsel, as long as Indemnitee pays for all costs and expenses incurred by it for such separate counsel.

16 Regelung über Projektvergütung Vergütung ausschließlich auf MUW Konto keine außervertraglichen Vereinbarungen (zb separate Prüfarzthonorare)

17 Vertragsdauer Dauer des Projektes Kündigung AG jederzeit Kündigung aus wicht. Grund immer (österr. Recht) daher: MUW auch separates Kündigungsrecht ( medical reasons )

18 Rechtswahl österr. Recht Gerichtsstand Wien

19 Unterschriftenzeilen jedenfalls: OE-Leiter für die MUW (gem. 27 UG 2002) Abteilungsleiter (wenn gewollt) Prüfarzt wenn Vertragspartei (jedenfalls), sonst üblich zur Kenntnis

20 Anlagen des Vertrages: Protokoll Projektvergütungsplan (falls nicht im Vertrag) Vollmachten Indemnification (falls nicht im Vertrag) Financial disclosure forms

21 Vor Projektbeginn muss vorliegen: - Vertrag (von Rechtsabteilung begutachtet) - positive Projektmeldung - gültiges Ethikkommissionsvotum (MUW- GSP) - Nichtuntersagung durch Behörde (AMG/MPG; AGES) - Meldung ärztliche Direktion

22 Exkurs Versicherungen - Personenschadenversicherung (verschuldensunabhängig) und - Arzthaftpflicht- und Rechtschutzversicherung Versicherungsnehmer: Sponsor lt. AMG/MPG MUW Rahmenversicherung

23 Publication Policy der MUW Medical University of Vienna Standard for clinical-trial agreements with industry in regard of publication-rights The Medical University of Vienna (MUV) welcomes and encourages collaborative research with industry, including clinical trial agreements. MUV is aware of an ongoing public debate on standards pertaining to clinical-trial agreements and contractual provisions that restrict institution s or investigators` control over trials. Against this background, and in order to establish best practice at the university, MUV has adopted the following institutional policy, which MUV considers to be in the long-term interest of all stakeholders: MUV will not approve contractual provisions giving industry sponsors the authority to revise manuscripts or decide whether the results should be published. MUV acknowledges the legitimate needs of sponsors of clinical trials for timely information and for protection of intellectual property rights. Therefore, MUV will accept provisions permitting the sponsor to review manuscripts for a limited time before publication. MUV`s maximum acceptable time will be days (please refer to sample texts below). For further information concerning this policy please contact the office of the Vice-Rector for Research: vr_forschung@meduniwien.ac.at, +43/1/40160/10122 or the legal office of MUV: rechtsabteilung@meduniwien.ac.at, +43/1/40160/21403

24 Examples: A) the following provisions would not be approvable as part of a contractual agreement between MUV or MUVstaff and industry sponsors: Publications related to the trial and results there from are subject to prior agreement of the sponsor. or: The Principal Investigator and/or the Institution shall not publish, present or use any data or results arising out of the performance of this Study for their own instruction, research or publication without the prior express written consent of Sponsor. B) the following provisions would be approvable by MUV: for mono-center trials: The Institution and the Investigator shall have the right to publish the results of the Study in accordance with this section. Prior to submission for publication or presentation, the Institution and/or the Investigator shall provide sponsor [maximum 60] days to review any poster presentation, abstract or any other written or oral material which describes or discloses the results of the study. At the expiration of such [maximum 60] day period, Institution and/or Investigator may proceed with the presentation or submission with the publication; provided, however, that, in the event that sponsor has notified Institution and/or Investigator that sponsor reasonably believes that prior to such publication or presentation it must take action to protect its intellectual property interests, such as the filing of a patent application claiming an invention or a trademark registration application, Institution and/or Investigator shall either (a) delay such publication or presentation for an additional sixty (60) days or until the forgoing actions have been taken, whichever shall occur first; or (b) if Institution and/or Investigator are unwilling to delay the publication or presentation, Institution and/or Investigator shall remove from the publication or presentation the information which sponsor has specified it reasonably believes would jeopardize it's intellectual property rigths." or:

25 All results and other information obtained in the context of the Clinical Trial shall be treated as strictly confidential until their publication. In order not to jeopardise applications for intellectual property rights by Sponsor, and to ensure protection of Sponsor s Confidential Information, publications of any kind including, without being limited to, abstracts, posters, oral or written contributions on congresses or clinical seminars, shall be provided to Sponsor [maximum 60] days in advance of any disclosure. Sponsor shall have the right to review the intended communication. In case a patent application is or will be prepared, the approval for publication may be delayed for the period necessary for the patent application, maximum 60 days. for multi-center trials: The sponsor encourages the publication of study data in reputable scientific journals and at seminars or conferences. MUV shall have the right, consistent with academic standards, to publish the results of the study, subject to the following conditions: MUV acknowledges that the study is part of a multi-center investigation and that a joint publication is anticipated to be authored by all participating investigators. Accordingly, MUV agrees not to independently publish the results of the study before the publication of the multi-center investigator paper. Notwithstanding the foregoing, in the event that (i) the multi-center investigation has been terminated prior to completion and no joint publication is to be made, or (ii) no publication of the study results has been made within 12 month of study database lock and no proposed publication is under discussion by the publication committee, MUV may publish its own study results, provided that MUV furnishes the sponsor with a copy of the proposed publication for the sponsor s review and comment at least [maximum 60 days] prior to submission to a publisher or disclosure to any third party. Within this [maximum 60] day period, the sponsor may request in writing that MUV delay such publication for a maximum of an additional 60 days in order to protect the potential patentability of any invention described therein.

26 Kontakt Rechtsabteilung der Medizinischen Universität Wien Bauteil 88, Spitalgasse 23, 1090 Wien Leiter: Stv.: Dr. Markus Grimm, MBA Dr. Daniela Leitner, MAS Tel.: 40160/21400 Fax: 40160/