The conference was organized by the Nordic Committee on Bioethics in collaboration with Centre for Legal Studies in Welfare and Market at the University of Copenhagen.Below you can see the conference program - see slides from each talk by clicking on the titles. Abstracts for each talk can be found here. The conference was filmed - you can find the playlist here.
Clinical innovation involves development of new techinques, methods,
treatments and diagnostics for detecting,
and curing diseases. By nature novel clinical methods and treatments are
unproven when first developed. Through the centuries, medicine has advanced by trials and errors of physicians and researchers
experimenting with treatments and methods. The failure of certain methods are
inseperable from success of others, because a priori it is hard to know
what works and what does not. The scientific method is the preferred approach to
develop cures and treatments, but many current medical practices were not
developed by strict scientific testing or trials. Healthcare professionals may
try unproven methods, for instance as a last resort in attempt to safe a life.
Such unproven methods for clinics and health care, occur at the intersect of
and standard health-care and raise number of bioethical issues. Those include
the following issues. Do patients have sufficient and equal access to the
experimental methods? Are patients protected from harm when unproven methods
are tested? Who should make decisions about when to experiment with a
treatment? How can society and the health care system best simultaneously
promote clinical innovation and protect patients?
Session 1 - How are clinical
innovations/unproven methods developed and introduced?
"Ethics and Policy Surrounding Patient Access to Experimental Therapy", Professor Jonathan Kimmelman, Director of Biomedical Ethics Unit, McGill Uiversity, Canada
“Experimental oncolytic immunotherapy for individualized treatment of cancer patiets incurable with routine approaches ”, Professor Akseli Hemminki , University of Helsinki, Finland
“ Developing a cancer vaccine, and challenges in performing clinical trials of experimental therapies” ,
Professor Steinar Aamdal, University of Oslo, Norway
“We can do better - a patient perspective”, Anne Sofie Boldsen Salicath, MD, Patient group representative, Denmark
Session 2 - What is the legal and
regulatory environment concerning clinical innovations in medicine?
"The room for clinical innovation under Swedish law ", Senior Lecturer Lena Wahlberg, Lund University, Sweden
“The regulatory challenges in regards to clinical innovation”, Professor Mette Hartlev, University of Copenhagen, Denmark
"Regulating Risk in Surgical Innovation? A UK perspective", Dr. Jonathan Ives, University of Bristol, UK
Session 3 - What
ethical principles should guide work on emerging treatments and experimentation
"Novel medical treatments, innovation, hope and headlines", Catherine Joynson, Assistant Director, Nuffield Council on Bioethics, UK
"Harms and benefits in clinical innovation", Dr. Gardar Arnason, University of Tübingen, Germany
"Ethical principles in unproven methods – is there a need for regulations?", Professor Ingemar Engström, Örebro University/NCBio, Sweden