Accident in clinical trials and compensation for victims
On January 15th 2016, we learned through the press that a dramatic event had just occurred during the phase 1 clinical trial performed in France. This is the first accident of this severity since the trial of a German biotechnology company in March 2006 during also a phase 1 trial in England. At the time of writing the responsibilities of different participants (promoter, CRO, CMO…) are not known and investigations are ongoing; but, regardless of the responsible, the victims and their dependents will ask to be compensated and insurance mechanisms come into play. After reviewing the facts we will discuss about the insurance arrangements required by French regulations in terms of clinical trials victims compensation.
I would like to thank Frédéric Nouaille, our broker, insurance expert, who was kind enough to write this article for our website to allow you to better grasp this theme.
The tragedy of January 15th 2016, recall the facts
This Friday, January 15th, the entire world press echoed an accident when performing a Phase 1 trial in France.
Who are the actors?
– The trial promoter with headquarters based in Coronado, Portugal.
– The CRO (also phase center 1) based in Rennes, France.
– Participants in the trial were “healthy volunteers”: 116 in total, some of which were administered a placebo.
What is the protocol?
This is phase 1 protocol on healthy volunteers, in double-blind, randomized, versus placebo. The aim of this study is to investigate the safety of use, tolerability and pharmacokinetic and pharmacodynamic profiles of the molecule in single ascending dose, multiple ascending doses and interactions with food.
For more information, the protocol can be downloaded from the website of the French health authority (ANSM) http://ansm.sante.fr/S-informer/Actualite/Essai-clinique-BIA-102474-101-du-laboratoire-BIAL-Publication-du-protocole-clinique-Point-d-Information
What is the tested molecule?
It is an inhibitor of FAAH (Fatty Acid Amide Hydrolase). This new chemical class has seen many pharmaceutical companies file patents in recent years; some have already passed safety tests successfully.
While 84 volunteers had received the drug at different doses according to the protocol procedure, a group of 8 new volunteers was included to test a new dose (50 mg); a placebo was administered to two of them. Among the six who received the molecule under study, one saw his first symptoms appear on January 10 and ended up in brain-dead on 11. The others were also hospitalized the following day, victims of serious adverse effects (some potentially irreversible).
The volunteer who was brain-dead unfortunately died and several investigations are underway to determine the potential liabilities and the mistakes to avoid in the future.
Compensation for victims in clinical trials in France
Since a 1988 law, promoters conducting clinical trials in France are obliged to take out insurance ad hoc liability which complies with all provisions of the Code of Public Health, this regardless of the type of test (drug Phase 1, Phase 2, …, medical device, nutraceuticals …). These various provisions of the Code of Public Health make that insurance contracts, covering a trial in France, are almost word for word the same and; above all, allow an easy and quality compensation to victims or their dependents. Here are some of these provisions:
- The insurance is a “strict liability” (Article L1121-10 CSP): this means that unlike many other types of litigation, if a healthy volunteer or a patient suffers harm as a result of his participation in the test, it is not up to him to prove the fault of the promoter (or his subcontractors) but it will be to the promoter to prove the absence of fault that he wishes to be exempt from liability.
- The promoter is considered as the insured in the insurance contract but it is also the case with all other participants in the clinical trial (CRO, investigators, CMO…) (Art R1121-5 CSP): for damage suffered by a participant this allows him to have a single insurer who will potentially make compensation. This is more efficient than having several parties and their insurers who in turn point the finger at another for the accident.
- Minimum guarantee amounts are required (Art R1121-7 CSP): the guarantee amounts set out in the insurance contract cannot be less than € 1,000,000 per victim and € 6,000,000 per clinical trial protocol. These are relatively large amounts compared to what is practiced in many other countries.
- The exclusions in the insurance contract are limited (Art R1121-6 CSP).
- The insurance covers claims well after the end of the trial (Article L1121-10 CSP): any claim arising in a period between the start of the trial and 10 years after the end of that trial will be taking over by the insurer. This allows protecting properly the victims who have significant side effects revealing several years after their participation in the trial.
- If the promoter and other participants prove that they have committed any fault, they cannot be held responsible but the victims will still be compensated (Article L1142-3 CSP): this will be possible through the ONIAM (National Office of Medical Accidents Compensations). The ONIAM is a public institution that was created in 2002 whose mission is to organize the compensation scheme – friendly, fast and free – of medical accident victims.
Thanks to these provisions, France is one of the most protective countries of victims clinical trials accident.
i4CT Insurance for Clinical Trials
Brokerage in clinical trial insurances
Frédéric Nouaille is an insurance broker specializing in healthcare companies: from the biotechnology company to health facilities. Through his two companies (i4CT and A & RS), he manages all the insurance needs of organizations both French and foreign.
Visit our new website online since 09 Feb 2016: www.pharmaspecific.fr
Update July 6, 2020: “To date, the Rennes accident of January 15, 2016 still does not appear to have been tried. ”
To be modified in the guarantees section:
“Minimum guarantee amounts are compulsory (article R1121-6 of the CSP)”
“The exclusions in the insurance contract are limited (art R1121-5 CSP)”