Qualified Persons (QPs) are liable with their personal assets for their own mistakes and for those committed by their staff members. But is the risk to be personally liable really that big?
Discussions of how dramatic the situation and its related dangers are can be heard everywhere. However, most likely no QP involved in the discussion knows a person who has actually experienced a corresponding liability scenario and thus ended up in personal financial ruin.
A systematic consideration basically reveals three areas to be analysed that include grounds of liability of the QP:
Possibilities for Insurance:
The QP enjoys a very far-reaching insurance protection, which also might include acts of gross negligence. As part of the pharmaceutical company's business insurances, the QP's insurance should also covers personal liability. This should be discussed before starting to work for the company.
The employer is also entitled to indemnity from the employee (QP), but only on the condition that there has been medium (constituting shared liability) or gross negligence on the part of the employee. But in these cases the QP's financial risk might remain to be manageable.
Apart from the above-mentioned scenarios, some risks do remain. However, it is certainly reasonable to mitigate these risks to a large extent in the labour contract, through declarations by the employer or by an insurance.
Source: Heinz Lomen, asmit GmbH, "Personal Liability of the Qualified Person under § 14 AMG", to be published in the upcoming GMP Journal.
So does this mean that the QP's liability potential is mostly overestimated? And how could a far-reaching insurance coverage, even in case of gross negligence reduce the liability risk for the QP to a minimum? This will be discussed in detail by Heinz Lomen (Lawyer and Insurance Broker, asmit GmbH) with the delegates of the 2010 QP Forum in Barcelona.
On behalf of the European QP Association