Risks and clinical trials: between uncertainties and (bio) technological development

Long considered a conjectural science, an uncertain art inspiring fears, suspicion and criticisms, medical and pharmaceutical research has been marked by significant advances in recent years. Certain recent technological developments, such as the advent of the 3D printer, could push the limits still further while at the same time changing the concept of risk.

The Huriet-Sérusclat law of 1988, relative to the protection of persons lending themselves to biomedical research, is the first text to have regulated experimentation on human beings. In parallel, the bioethics laws, adopted and revised in 1994, 2004 and 2011 respectively, outlined the contours of medical and research activities that use elements of the human body. However, in spite of the legislator’s will to regulate the medical research and technological developments of recent years, a medical act without risk remains to this day an illusion.

An accident in France arouses professionals’ concerns

In January 2016, an accident that happened in the context of a clinical trial conducted by a laboratory caused the death of one person and hospitalisation of five others. The experts in charge of pinpointing the scientific cause of the accident paid particular attention to the effects of the molecule that initially used for pain-relief effects. The study conducted by the laboratory concerned phase 1, allowing assessment of human tolerance to the molecule and had obtained the necessary authorisation from the French National Agency for the Safety of Medicines. This unprecedented accident aroused the concern of professionals in the clinical research sector in France.

Effectively, the Huriet-Sérusclat law imposes an obligation on the Sponsor to take out a third-party liability insurance policy to cover the adverse effects of research on clinical trial patients (article L. 1121-10 of the French Public Health Code).

Thus, certain professionals have begun to invoke and indeed fear an increase in insurance contract premiums. This analysis must nevertheless be qualified.

The French National Agency for the Safety of Medicines authorised 899 and 821 clinical trials in 2013 and 2014 respectively. To date, the exceptionally serious accident that happened in the town of Rennes remains an isolated case on French territory. Although other cases of accidents have been recorded, particularly in the United Kingdom in 2006 and several years previously in the United States, the number of accidents remains extremely low with regard to the number of clinical trials conducted each year throughout the world.

It also appears that the legal and scientific regulation of medical research conducted in France is widely recognised by the professionals in this sector of activity.
Finally, in spite of the inherent risk, clinical trials still remain essential to medical and pharmaceutical developments, even if technological advances, such as the advent of 3D printers, could quickly reduce this dependence.

The 3D printer: medical promises and insurance consequences

Manufacturing of custom made medical devices or prostheses, diagnostic tools, bone, cartilage, tissue and, ultimately, human organs; bio-printing is considered a real revolution in the health field. This new technology will allow not only custom made designs according to the specific characteristics of each person but also it could, by definition, limit the risks inherent in clinical trials.
The latter would no longer be conducted on animals and humans but directly on tissues fabricated by 3D printers, which would make it possible to increase considerably the number of molecules tested and also the discovery of new medicinal products. In a world in which we are constantly seeking to extend life expectancy limits, the potential of these new techniques can not be neglected.

Legally, these upheavals should quickly raise questions from an ethical point of view, whether it involve liabilities incurred by the different intervening parties or again the definition of products designed by 3D printers. When the bioethics laws are next updated, the legislator should progressively pay attention to this development. We can also ask ourselves about the reliability of clinical trials conducted on these new “devices,” which can not completely replace and reproduce the functions and reactions of the human organism. Although the benefit of bio-printing in the health field and particularly in the clinical research sector can not be ignored, the risk/benefit factor will not be definitively dismissed.

From an insurance point of view, the recent French accident may effectively be considered a serious but extremely rare event and should therefore not have an impact on insurance premiums.
On the other hand, policies aiming to cover risks related to clinical trials should experience major upsets with the progressive introduction of new technologies in the health sector, since the scope of the concept of bio-technological risk is much wider and more unclear than the concept of risk currently adopted in the Insurance sector.

 

Stéphanie Dumoulin
Casualty liability loss adjuster, GM Consultant Group

Morgan Petit
Environment and Life Sciences risks loss adjuster, GM Consultant Group