Institute for German, European and International Medical Law, Public Health Law and Bioethics

Der Ausbruch der Coronakrise verunsichert, aber Verträge sind in der Welt. Was hat Bestand, was bedarf der Anpassung? <b>Der Tagungsband</b> dokumentiert die Beiträge der Online-Tagung „Vertragsrecht in der Coronakrise“ in zitationsfähiger Form. Von grundlegenden dogmatischen Aspekten wie dem allgemeinen Leistungsstörungsrecht über das massenhaft relevante Verbraucher- sowie Mietrecht bis hin zu Spezialfragen in der Insolvenz beantworten Rechtsexperten die drängenden Fragen in der Pandemie, z.B. Wer trägt die Hotelkosten, wenn ein Pauschalreisender wegen Flugausfällen an der Rückreise gehindert ist? Können Arbeitnehmer auf erhöhte Schutzvorkehrungen im Betrieb pochen? Wer haftet, wenn eine Warenlieferung an der Landesgrenze durch überlange Kontrollen verspätet eintrifft oder zwischenzeitlich verdirbt? <b>Herausgeber und Autoren</b> Herausgegeben von PD Dr. Daniel Effer-Uhe und Dipl.-Psych. Alica Mohnert, Mag. iur., LL.M. (CUPL). Mit Beiträgen von Dr. Caspar Behme, Ludwig-Maximilians-Universität München; Dr. Jonas Brinkmann, Universität Bielefeld; Dr. Ann-Marie Kaulbach, Universität zu Köln; Stephan Klawitter, Humboldt-Universität zu Berlin; Jun.-Prof. Dr. Andreas Maurer, Universität Mannheim; PD Dr. Patrick Meier, Notarassessor, Julius-Maximilians-Universität Würzburg; Jun.-Prof. Dr. Jens Prütting, Rechtsanwalt, Bucerius Law School Hamburg; Prof. Dr. Thomas Riehm, Universität Passau; Prof. Dr. Jens M. Schmittmann, Rechtsanwalt, Mitglied des Senats für Anwaltssachen des Bundesgerichtshofs, FOM Hochschule Essen; Dipl.-Kfm. Dr. Bernd Scholl, Rechtsanwalt, Universität zu Köln.

BACKGROUND: Systems medicine has become a key word in biomedical research. Although it is often referred to as P4-(predictive, preventive, personalized and participatory)-medicine, it still lacks a clear definition and is open to interpretation. This conceptual lack of clarity complicates the scientific and public discourse on chances, risks and limits of Systems Medicine and may lead to unfounded hopes. Against this background, our goal was to develop a sufficiently precise and widely acceptable definition of Systems Medicine. METHODS: In a first step, PubMed was searched using the keyword "systems medicine". A data extraction tabloid was developed putting forward a means/ends-division. Full-texts of articles containing Systems Medicine in title or abstract were screened for definitions. Definitions were extracted; their semantic elements were assigned as either means or ends. To reduce complexity of the resulting list, summary categories were developed inductively. In a second step, we applied six criteria for adequate definitions (necessity, non-circularity, non-redundancy, consistency, non-vagueness, and coherence) to these categories to derive a so-called précising definition of Systems Medicine. RESULTS: We identified 185 articles containing the term Systems Medicine in title or abstract. 67 contained at least one definition of Systems Medicine. In 98 definitions, we found 114 means and 132 ends. From these we derived the précising definition: Systems Medicine is an approach seeking to improve medical research (i.e. the understanding of complex processes occurring in diseases, pathologies and health states as well as innovative approaches to drug discovery) and health care (i.e. prevention, prediction, diagnosis and treatment) through stratification by means of Systems Biology (i.e. data integration, modeling, experimentation and bioinformatics). Our study also revealed the visionary character of Systems Medicine. CONCLUSIONS: Our insights, on the one hand, allow for a realistic identification of actual ethical as well as legal issues arising in the context of Systems Medicine and, in consequence, for a realistic debate of questions concerning its matter and (future) handling. On the other hand, they help avoiding unfounded hopes and unrealistic expectations. This especially holds for goals like improving patient participation which are intensely debated in the context of Systems Medicine, however not implied in the concept.

BACKGROUND: As Next Generation Sequencing technologies are increasingly implemented in biomedical research and (translational) care, the number of study participants and patients who ask for release of their genomic raw data is set to increase. This raises the question whether research participants and patients have a legal and moral right to receive their genomic raw data and, if so, how this right should be implemented into practice. METHODS: In a first step we clarify some central concepts such as "raw data"; in a second step we sketch the international legal framework. The third step provides an extensive ethical analysis which comprehends two parts: an evaluation of whether there is a prima facie moral right to receive one's raw data, and a contextualization and discussion of the right in light of potentially conflicting interests and rights of the data subject herself and third parties; in a last fourth step we emphasize the main practical consequences of the ethical analyses and propose recommendations for the release of raw data. RESULTS: In several legislations like the new European General Data Protection Regulation, patients do in principle have the right to receive their raw data. However, the procedural implementation of this right and whether it involves genetic counselling is at the discretion of the Member States. Even more questions remain with respect to the research context. The ethical analysis suggests that patients and research subjects have a moral right to receive their genomic raw data and addresses aspects which are also of relevance for the legal discussion such as the costs of release of raw data and its impact on academic freedom. CONCLUSION: Taking into account the specific nature and implications of genomic raw data and the contexts of research and health care, several concerns and potentially conflicting interests of the data subjects themselves and involved researchers, physicians, biomedical institutions and relatives arise. Instead of using them to argue in favor of restrictions of the data subjects' legal and moral right to genomic raw data, the concerns should be addressed through provision of information and other measures. To this end, we propose relevant recommendations.

Die ultimative Arbeitshilfe für erfolgreiches und besseres Schreiben in Studium und Wissenschaft Wie gelingt es, ein wissenschaftliches Werk auf die erforderlichen Qualitätskriterien auszurichten und gleichzeitig leserfreundlich zu schreiben? Prägnant, anschaulich und mit vielen Beispielen zu Inhalt und Stil erklärt dieses Lehrbuch, wie man erfolgreich und verständlich schreibt: • Warum benötigt eine wissenschaftliche Arbeit ein präzise formuliertes Thema? Eine Forschungsfrage? Definitionen und Hypothesen? Einen Theorieteil? • Welche Literatur ist zu bevorzugen? Wie bewertet man deren Qualität? • Wie soll die Arbeit gegliedert werden? • Wie argumentiert man wissenschaftlich? • Wie wird man rechtzeitig fertig? • Wie meistert man „Schreibkrisen“? • Wie entwickelt man einen Schreibstil, der beim Lesen Spaß macht?

In medical practice in Germany and several other countries abbreviated orders linked to end-of-life decisions, such as DNR (do not resuscitate), are increasingly used. In order to investigate their legal status, this article gives an overview of the recently passed German law, which regulates the process of end-of-life decision-making and the use of living wills, giving primacy to patient autonomy. Concerning the risk of misinterpretation of acronyms, the article describes the impacts of such orders on patient autonomy and safety and suggests a clear systematic classification of the different DNR orders in order to investigate their legal status under the German law. Their general binding force is to be acknowledged, depending on its origination and the fulfilment of certain requirements.

Clinical trials in patients who cannot sign an informed consent are only possible under certain circumstances. The present paper explains the legal prerequisites and ethic rationales, which may allow including patients in such a trial without having signed informed consent. Translation of these prerequisites into practice needs the implementation of special inclusion procedures. These procedures will be explained using the example of the recombinant factor VIIa (rFVIIa) trials for intracerebral hemorrhage.

The Sustainable Constitution. Deliberations on Reform.

Die ultimative Arbeitshilfe für erfolgreiches und besseres Schreiben in Studium und Wissenschaft Wie gelingt es, ein wissenschaftliches Werk auf die erforderlichen Qualitätskriterien auszurichten und gleichzeitig leserfreundlich zu schreiben? Prägnant, anschaulich und mit vielen Beispielen zu Inhalt und Stil erklärt dieses Lehrbuch, wie man erfolgreich und verständlich schreibt: • Warum benötigt eine wissenschaftliche Arbeit ein präzise formuliertes Thema? Eine Forschungsfrage? Definitionen und Hypothesen? Einen Theorieteil? • Welche Literatur ist zu bevorzugen? Wie bewertet man deren Qualität? • Wie soll die Arbeit gegliedert werden? • Wie argumentiert man wissenschaftlich? • Wie wird man rechtzeitig fertig? • Wie meistert man „Schreibkrisen“? • Wie entwickelt man einen Schreibstil, der beim Lesen Spaß macht?

Die ultimative Arbeitshilfe für erfolgreiches und besseres Schreiben in Studium und Wissenschaft Wie gelingt es, ein wissenschaftliches Werk auf die erforderlichen Qualitätskriterien auszurichten und gleichzeitig leserfreundlich zu schreiben? Prägnant, anschaulich und mit vielen Beispielen zu Inhalt und Stil erklärt dieses Lehrbuch, wie man erfolgreich und verständlich schreibt: • Warum benötigt eine wissenschaftliche Arbeit ein präzise formuliertes Thema? Eine Forschungsfrage? Definitionen und Hypothesen? Einen Theorieteil? • Welche Literatur ist zu bevorzugen? Wie bewertet man deren Qualität? • Wie soll die Arbeit gegliedert werden? • Wie argumentiert man wissenschaftlich? • Wie wird man rechtzeitig fertig? • Wie meistert man „Schreibkrisen“? • Wie entwickelt man einen Schreibstil, der beim Lesen Spaß macht?

The Principle of Specific Performance.

Abstract Different complex physiological functions might be restored by means of distributed active implants. Wireless communication between the implants, on the one hand, and an external control unit, on the other hand, is necessary to synchronize electrical stimulation of neural and muscular tissue. Seventeen project partners from industries, universities, healthcare providers and research organizations closely cooperate in the framework of the BMBF Innovation Cluster “Interactive Implants (INTAKT)”. The goal of this cluster is to develop and evaluate networks of distributed implants. Challenges of the project include complex interaction between humans and technology, wireless power supply, long-term stability of implants as well as secure and safe signal transmission [1].

Bei der offiziellen Samenspende, beim Spender von der

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Abstract Over the last 15 years, there has been a steady increase in the development of orphan medicinal products ( omp s). This raises an important question: What impact does the eu marketing authorisation of an omp have on related research? This article establishes that the key orphan incentive, namely the 10‑year market exclusivity provision laid down in Article 8 of the eu Regulation on omp s (Regulation 141/2000), has a huge potential impact on related research. It is argued that this provision can make it too difficult for researchers/sponsors to attain marketing approval for closely related products. This article advances two proposals to address this problem. First, it argues for new principles for assessing similarity, so as to clarify and narrow the ambit of market exclusivity. Secondly, it argues for improved conditions for a demonstration of ‘clinical superiority’ for similar omp s.

Research with human embryonic stem cells (HESC) is very much disputed from an ethical point of view as it requires the destruction of the embryo to derive the stem cells. The legal situation in Europe is heterogeneous. This article gives an overview of the current debate on this topic by outlining the international regulations and the national legislation in the European Union. It is shown that the different legal positions are like an in vivo experiment for contrasting solutions. Furthermore, the legal situation in Germany is examined in more detail and with it the effectiveness and the constitutionality of the requirements.

Abstract Gruppennützige Forschung mit Kindern bedeutet im Ergebnis keineswegs per se eine Instrumentalisierung Wehrloser. Gruppennützige Forschung mit Kindern kann freilich nur dann zulässig sein, wenn sie wegen Alternativlosigkeit zwingend notwendig ist und dem Kind keine substanziellen Nachteile zufügt. Vor allem aber muss die Einwilligung des gesetzlichen Vertreters vorliegen, weil er derjenige ist, der von Rechts wegen dafür zu sorgen hat, dass Einwilligungsunfähigen die Teilnahme am Rechtsverkehr überhaupt erst ermöglicht wird. Zudem ist eine altersgerechte Aufklärung des Kindes erforderlich und darf sein natürlicher Wille nicht übergangen werden, muss ferner eine Verfahrenskontrolle durch eine unabhängige und interdisziplinär zusammengesetzte Ethikkommission vorgeschaltet und sollte “vor Ort” eine unabhängige Vertrauensperson als Ansprechpartner und Kontrollperson verfügbar sein. Nur durch dieses Zusammenwirken von Schutzmechanismen kann ein ausreichendes Schutzniveau sichergestellt werden, ohne die Gruppe der Kinder zugleich zu Forschungswaisen zu machen.

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Mit der am 11. Juli 2007 verabschiedeten, zum 11. Januar 2009 in Kraft tretenden sog "Rom II-Verordnung" werden weite Teile des bis dahin überwiegend auf autonome oder staatsvertragliche Wurzeln zurückgehenden Kollisionsrechts der außervertraglichen Schuldverhältnisse europaweit einheitlich neu geregelt. Die auf diese Weise erreichte Rechtsharmonisierung stellt nicht zuletzt mit Blick auf die inhaltliche Bandbreite der Regelungsgegenstände einen Meilenstein in der Vergemeinschaftung des internationalen Privatrechts dar. Der vorliegende Beitrag untersucht – erstmals seit Verabschiedung der Verordnung – die zu erwartenden Auswirkungen auf die geltende österreichische Rechtslage.

Abstract The use of intelligent implants and prostheses offers significant advances for optimizing medical treatment methods and is combined with an increasing technological modification of human body. This raises many exciting questions concerning law, ethics and social implications: Does the use of these techniques stay in line with our legal system and if yes, can the technical use be limited by governmental restrictions under certain conditions? Have moral values to be incorporated into technical artifacts? If machines are recreated from human beings, do they have to be provided with a legal subjectivity? Medical devices must be compatible with a high level of protection of health and safety. Therefore challenges, which are consequences of the indeterminate behaviour and the autonomous learning abilities of artificial intelligence, have to be faced. For avoidance of any hazards for legally protected rights medical product manufacturers have to assume legal duties, which affect construction, instruction and product development. For medical professionals there are also liabilities of maintenance measures and technical control that have to be accomplished. Associated with the use of intelligent medical devices is the processing of personal data on health. Health data have a high potential for misuse and discrimination and therefore they’re in need of special protection, particularly with regard to the development of “Big Data”, “Ubiquitous computing”, “Internet of Things” and constantly increasing cybercrime. If damages are suffered from the use of intelligent medical devices, difficulties in determining infringing acts, causality and culpability occur, especially because of the missing view into the technical progress of decision-making. It has to be explored, if the current liability law is able to assign responsibility adequately, otherwise there has to be found an appropriate concept for liability.

Networks of distributed interactive micro-implants could enhance the treatment of otoneurological conditions such as tinnitus or restore impaired complex physiological/ motor functions such as gastrointestinal motility or grasping. For this, an electrical stimulation of neural and muscular tissue is a key prerequisite. Challenges in the development of such interactive micro-implants are the complex human-machine interface, the wireless power supply, and the long-term stability of implants as well as secure and safe signal transmission. This paper addresses all these topics as well as the ethical, legal and social implications of smart implant networks in general. First achievements of the German innovation cluster INTAKT will be presented.