Report: Bioethics of clinical innovation and unproven methods Copenhagen, 9 April 2019

For 30 years the Nordic Committee on Bioethics has promoted Nordic cooperation and exchange of information between scientists, parliamentarians, and public officials in bioethics. On April 9, 2019 the Nordic Committee on Bioethics organised the conference Bioethics of clinical innovation and unproven methods in collaboration with Centre for Legal Studies in Welfare and Market at the University of Copenhagen. How are clinical innovations and unproven methods developed and introduced in western Nordic health-care systems? What is the legal and regulatory environment concerning unproven methods in medicine? What ethical principles should guide work on emerging treatments and experimentation in hospitals? These three questions were addressed in separate sessions in a day of fruitful discussions.

Professor Jonathan Kimmelman, Director of Biomedical Ethics Unit at McGill, kicked off the conference with his talk, "Ethics and Policy Surrounding Patient Access to Experimental Therapy". He claimed that debates about patient access to experimental interventions are often framed as a zero sum gain between private preferences of patients and public interest, or between innovation and patient protection. He continued with his description of existing and proposed regulatory mechanisms for facilitating patients access to experimental interventions, before he offered several reasons to why the framings are inapt, and why oversight systems should restrict access to experimental interventions. See the complete talk

Professor Akseli Hemminki from the University of Helsinki took the stage after Kimmelman, and described the central findings from their Advanced Therapy Access Program (ATAP). 290 cancer patients were treated in an individual manner under the EU Advanced Therapy directive and its Hospital Exemption, and Hemminki stated that while robust single agent activity is seen only in a minority of patients with most oncolytic viruses currently in development, they are emerging as key ingredients of combination immunotherapy. See the Hemminki talk.

Professor Steinar Aamdal (University of Oslo) continued with his talk titled “Developing a cancer vaccine, and challenges in performing clinical trials of experimental therapies”, before dr. Anne Sofie Boldsen Salicath spoke from a patient perspective. She argued that we need to be more ambitious, bold and maybe just getting rid of the box, instead of trying to think outside it. See the complete talks of Boldsen Salicath and Aamdal.

During the second session, Senior Lecturer Lena Wahlberg from Lund University, gave an introduction to the Swedish regulatory framework pertaining to the use of unproven methods in medicine. Specifically, she addressed the room for clinical innovation in relation to the fundamental requirement that healthcare workers shall deliver care in accordance with “science and proven experience”. The Walhberg talk.

After Wahlberg, Professor Mette Hartlev from the University of Copenhagen talked about “The regulatory challenges in regards to clinical innovation”, before University of Bristol’s Dr. Jonathan Ives, took the stage. 

He focussed specifically on ethical and legal issues associated with regulating surgical innovation, presented several case studies, and concluded by proposing an eliminative approach to thinking about surgical innovation. See the full Hartlev and Ives talks.

Catherine Joynson from Nuffield Council on Bioethics in the UK, started the third session with her talk on "Novel medical treatments, innovation, hope and headlines". She claimed that there are several ways in which experimental treatments can be supplied and offered to patients within the UK legal and regulatory framework, and crowdfunding has emerged as a way to raise funds for costly medical treatments. Joynson also described how The Nuffield Council on Bioethics has identified some of the ethical issues that the use of experimental treatments can raise. See her talk.

Dr. Gardar Arnason (University of Tübingen) followed after Joynson and gave a talk on "Harms and benefits in clinical innovation", before the final speaker of the day took the stage, Professor Ingemar Engström from Örebro University and the Nordic Committee on Bioethics. 

Professor Engström presented two Swedish reports on ethical aspects on unproven methods (clinical innovation). Both reports concluded that it is ethically acceptable to provide unproven methods outside research projects under some strictly defined preconditions. In Sweden, this area is not satisfactorily legally regulated and Engström argued that a better regulation should be prioritised.

Follow the link for complete talks: Arnason and Engström

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See the full conference programme

Follow the link for complete abstracts and PowerPoint presentations

Text: NCBio/Tor Martin Nilsen