February 10, 2016

Clinical drug trials – issues for insurers

The recent adverse events during a clinical trial in France raise interesting questions and issues to consider for insurers in this area

As was widely reported in the media, one man died and four others were hospitalised with neurological symptoms in France in January 2016. They had all been healthy volunteers participating in a phase one clinical trial into a drug, BIA 10-2474, designed to inhibit a particular enzyme. Phase one of a clinical trial is when a drug is tested on human volunteers for the first time. 

The trial had been approved in advance by the French regulators (including the French equivalent of the MRHA, the ANSM). As a result of the adverse events, various investigations have been launched in France. Preliminary findings were released last week.  To date, the cause of the adverse reactions to the drug could not be determined.

It would be inappropriate to speculate as to what happened in France given the ongoing investigations. However, comparisons have inevitably been drawn in the media to the last major clinical trial incident in the UK, that of TGN1412 at Northwick Park Hospital in 2006.  This was also a Phase 1 trial and resulted in six volunteers being hospitalised, several of them with multiple organ dysfunction.

Further to the TGN1412 incident, the company who developed the drug, TeGenero Immuno Therapeutics, went bankrupt later the same year. In the French incident, there are numerous ongoing regulatory investigations all of which require considerable time and resources from the companies involved to fully co-operate with the authorities. This is a separate issue to any claims that may or may not follow. We would suggest that definitions and exclusions in insurance policies are key to preventing unintended financial outlay.

The drug involved in the French trial was manufactured and developed in Portugal but the clinical trial research organisation was based in France. The trial received approval from the French regulatory authorities and the volunteers were also based in France. Jurisdiction and applicable law provisions are therefore highly relevant. 

The volunteers in the French study were admitted to the University Hospital of Rennes from the clinical research organisation's trial site. This underlines the importance of proximity to emergency services and proximity to acute hospital care and insurers should ensure they are satisfied with emergency transfer protocols.

As a result of the French incident, another pharmaceutical company has voluntarily suspended an ongoing Phase 2 clinical trial into another new drug due to that drug also acting as an inhibitor to the same enzyme the French trial was interested in. The contractual and insurance implications of such a suspension might not have been considered when drafting the relevant documentation. 

The high profile nature of the French incident could also cause recruitment issues for clinical trials in the future yet scrupulously high standards need to be maintained when consenting volunteers and carrying out screenings into volunteers' medical histories. Again, documentation needs to be carefully considered to ensure risks are adequately defined and assigned appropriately.

Fortunately, high profile adverse events during clinical trials are rare. Clinical trials are crucially important to furthering medical advances yet the consequences of what happens when things go wrong can be wider than first anticipated.