The risks here are very different from the risks of growing, processing and distributing cannabis products. They include bodily injury to trial participants and financial loss to sponsors, partners, investors or clients caused by professional errors.

The problem – why standard business insurance is not enough

Standard liability and property policies are not designed for clinical trials or high end professional services. They do not:

  1. Reflect informed consent processes and trial documentation.
  2. Address jurisdiction specific requirements for clinical trials.
  3. Clarify which party bears which responsibility in a complex trial structure.
  4. Deal properly with bodily injury in a research context.

At the same time, general liability policies and basic professional indemnity covers are not equipped to handle the combination of human subject risk, complex contracts and long tail exposure that characterise cannabis related life sciences work.

The solution – combined clinical trials and professional liability cover

For cannabis related life sciences businesses, two main lines of cover are usually needed.

Clinical trials insurance

This cover responds to claims by trial participants who allege bodily injury caused by their participation in the trial. It is structured based on:

  1. A specific trial protocol.
  2. The territories where the trial takes place.
  3. The duration of the trial and the nature of the intervention.

The policy funds defence and compensation, within agreed limits, when a claim is made.

Professional liability insurance

This cover protects against financial loss caused to clients or partners by the company’s professional services. In the cannabis R&D context, this may include:

  1. Errors in data analysis.
  2. Misleading or inaccurate research reports.
  3. Incorrect regulatory advice.
  4. Poorly designed trial protocols that fail to meet professional standards.

Example scenarios

  1. Injury to a trial participant – A participant in a medical cannabis trial suffers an unexpected serious side effect. They sue the sponsor, alleging inadequate warning or negligence. Clinical trials cover responds to defence costs and compensation, subject to the policy terms.
  2. Misleading research report – A company provides research services to a pharmaceutical partner. Due to a mistake in data handling, the report overstates the effectiveness of a formulation. The partner invests in a direction that later proves unviable and sues for financial loss. Professional liability cover responds.
  3. Regulatory consulting error – A regulatory consultant advises a cannabis company on the design and submission of a trial application. Because of a mistake, the application is rejected and the project is delayed. The company sues the consultant for the additional costs. Professional liability insurance responds.
  4. Failure of a digital trial tool – A start up provides a digital platform to support a cannabis clinical trial. A system error leads to loss of part of the monitoring data. The sponsor incurs extra costs and sues for negligence. Professional liability cover may apply.