Molecular Systems Engineering (MSE) incarnates a novel approach to clinical innovation that considerably expands the toolbox of molecular sciences and healthcare both theoretically and technically. The prospects of this emerging field to bring about scientific and clinical innovation crucially depend on proactively addressing potential ethical and regulatory bottlenecks.
Such issues include three major domains, that is: issues associated with society’s appraisal of the novel bio-technological characteristics of engineered molecular systems; the ethical and legal aspects linked to the clinical translation of MSE into healthcare applications; and the development of appropriate regulatory standards for the assessment of MSE applications by regulatory agencies.
To address those issues, this project brings new empirical research and analytical competences on ethics and regulatory issues of MSE technologies. Thanks to considerable experience and reputation in the field of bioethics and health policy, the ETH Zürich’s Health Ethics and Policy lab led by the PIs Effy Vayena, and Alessandro Blasimme will ensure dedicated research on all of the above issues.
Normative and empirical research on the ethics of MSE will result in specific ethical guidelines to guide the long-term development of the field in the future. As far as regulatory aspects are concerned, relevant national and international stakeholders – including regulators – will be engaged and a regulatory roadmap for MSE will be developed.