Im März 2019 meldete die Novartis Pharma GmbH, dass sie sich mit der GWQ ServicePlus (Gesellschaft für Wirtschaftlichkeit und Qualität bei Krankenkassen) auf ein Erstattungsverfahren zur Finanzierung der CART -Zelltherapie mit Tisagenlecleucel geeinigt habe (Madlberger 2019). Das neue Erstattungsverfahren sieht eine am individuellen Therapieergebnis orientierte Erstattung vor. Die Jahrestherapiekosten/Patient mit Tisagenlecleucel betragen 320.000,00 C (Gemeinsamer Bundesausschuss 2019). Die Novartis Pharma GmbH erstatte allerdings einen Teil der Kosten, wenn die oder der damit behandelte Patientin oder Patient einen bestimmten Zeitraum nicht überlebt (Madlberger 2019). Bei der CART -Zellentherapie handelt es sich um eine zelluläre Immuntherapie, die bei Patienten mit refraktärer oder rezidivierter akuter lymphatischer B-Zell-Leukämie (ALL) und bei Patienten mit rezidiviertem oder refraktärem diffusen großzelligen B-Zell-Lymphom (DLBCL) eingesetzt wird (Madlberger 2019; Bach et al. 2017; European Medicines Agency 2018). Hierfür werden körpereigene T-Lymphozyten gewonnen und ex vivo genetisch modifiziert, um nach Reinfusion in vivo das Immunsystem gegen die Leukämie-oder Lymphomzellen zu richten (Bach et al.
The possibilities of structuring clinical trial agreement are far reaching. Especially regarding the question, who the contract partner will be, an initial, also liability-related, positioning is possible; by either including or not including the respective examining physician in the agreement. The agreement has in large parts a clarifying function regarding the contractual obligations of both parties, as the AMG, the ICH-GCP guideline and various european regulations and directives stipulate a wide range of requirements for the performance of clinical trials. Inclusion in the agreement allows for a clear division of responsibilities and liability in the event of non-compliance with the requirements. It is also necessary that the sponsor is obligated to carry out quality assurance measures and the modalities of their implementation, including the remuneration of the time spent for this purpose. A central question is also, who is entitled to the results of the clinical trial or to inventions based on them, whereby the ArbnErfG also must be taken into account. Whether there are at least rights of use for non-commercial purposes for the other party, should also be regulated. Also relevant is the agreement of confidentiality agreements and the answer to the question, when and to which extent publications on the results of the tests in question are permissible, in order to ensure an appropriate balance of the parties' interests. In terms of data protection law, special attention must be paid to the question which party is the controller within the meaning of the GDPR - depending on the answer to this question, complicated and extensive regulations must be made. In addition to the regulation of the remuneration and its payment modalities, regulations regarding the liability, at least within the legal ramifications are possible and necessary. Conclusively – as always - general cancellation rights and other possibilities of terminating the agreement can be added. The preceding explanations show how complex and comprehensive the aspects to be taken into account are. Numerous possibilities have been highlighted above, in order to provide an overview and to simplify the drafting, in hope that the contribution may aid as an orientation.
The exchange of information and materials within the framework of research projects can be managed in different ways. In most cases a so-called “Material Transfer Agreement” (MTA) is necessary. What looks like a simple ascertainment of rights and duties of the contracting parties, is clearly more fraught with risks than it looks at first sight. An individual arrangement and initial negotiation are necessary to prevent legal risks and not to burden the cooperation between the contracting parties and scientists with legal conflicts and uncertainties. Of course, confidential clauses shouldn’t be missing. While the precise regulations of the scope of work serves the concretion of the subject matter of the contract, clauses for the protection of property and IP rights regulate the handling with the research and possible publications regarding the use of the provided materials and their specific ownerships. The following will deal with the areas of application, the requirements and the regulatory content of this important type of contract.
<p>The article aims to give an overview of the contractual situation in Germany, which arise in clinical studies. The goal of the authors is to show any potential sponsor of a clinical study, who is interested in cooperation with German partners such as universities or other study sites, what kind of agreements may be expected and to give a brief overview about necessary themes included within the contractual negotiations. The different contractual settings are considered from the perspective each different type of agreement. The authors have chosen amongst all possible types the ones which are the most common in a clinical study, such as CDA, MTA, grant agreement, clinical study agreement, CRO-service agreement etc. The authors show the complexity of the contractual setting of a clinical study and emphasize to pay close attention to the contractual settings. Even though the content of the agreement is mostly universal in nature, in some cases, Germany has some very special rules (e.g. regarding employees’ inventions), which any potential sponsor should keep in mind.</p>
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