Bioethics of clinical innovation and unproven methods 
Copenhagen, 9 April 2019, 9:00 - 17:00

Conference organized by the Nordic Committee on Bioethics in collaboration with Centre for Legal Studies in Welfare and Market at the University of Copenhagen.

Venue: Alf Ross auditorium (room 9A-3-01), Faculty of Law, University of Copenhagen, Karen Blixens Plads 16, 2300 Copenhagen S.

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Background: Clinical innovation involves development of new techinques, methods, treatments and diagnostics for detecting, alleviating 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 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 basic research 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?

This conference is arranged around three questions each addressed in separate sessions.

1. How are clinical innovations/unproven methods developed and introduced, with examples from the western and Nordic health-care systems?

2. What is the legal and regulatory environment concerning unproven methods in medicine?

3. What ethical principles should guide work on emerging treatments and experimentation in hospitals?

The conference is open to all interested, including medical doctors, clinical researchers, health committees in parliments, civil servants and hospital administrators.


Tentative programme:

09:00-09:10 Welcome / NCBio Chair Isabelle S. B. Ljøsne

Session 1 - How are clinical innovations/unproven methods developed and introduced? 

09:10-09:50 "Ethics and Policy Surrounding Patient Access to Experimental Therapy", Professor Jonathan Kimmelman, Director of Biomedical Ethics Unit, McGill

09:50-10:15 “Experimental oncolytic immunotherapy for individualized treatment of cancer patients incurable with routine approaches ”, Professor Akseli Hemminki, University of Helsinki

Coffee  

10:35-11:00 “ Developing a cancer vaccine, and challenges in performing clinical trials of experimental therapies”, Professor Steinar Aamdal, University of Oslo


11:00-11:30 Panel discussion

11:30-12:30 Lunch

Session 2 -  What is the legal and regulatory environment concerning clinical innovations in medicine?

12:30-12:55 "The room for clinical innovation under Swedish law ", Senior Lecturer Lena Wahlberg, Lund University

12:55-13:20 “The regulatory challenges in regards to clinical innovation”, Professor Mette Hartlev, University of Copenhagen

13:20-13:45 "Regulating Risk in Surgical Innovation? A UK perspective", Dr. Jonathan Ives, University of Bristol

Coffee

Session 3 -  What ethical principles should guide work on emerging treatments and experimentation in hospitals?

14:15-14:55 "Novel medical treatments, innovation, hope and headlines", Catherine Joynson, Nuffield Council on Bioethics

14:55 – 15:20 "Harms and benefits in clinical innovation", Dr. Gardar Arnason,  University of Tübingen

15:20 – 15:45 "Ethical principles in unproven methods – is there a need for regulations?", Professor Ingemar Engström, Örebro University/NCBio

15:45 – 16:20 Panel discussion

16:20 – 16:30 Closing remarks

16:30 - 18:00 Reception

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Please note that the conference is free of charge, but participants pay their own travel and accommodation costs.