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QPPV indemnification

The role of the QPPV is defined in EU regulations and the in the Good Vigilance Guidelines (GVP).

The person that takes on the role as EU QPPV also take on a great personal responsibility as the EU QPPV is responsible for all safety related activities globally for the marketing authorisation holder (MAH) towards EMA and the EU.

Normally this functions well and the QPPV can maintain oversight with all essential activities of the MAH. However there is a risk that the MAH might not provide all relevant information; like omit to inform about important restrictions in other countries, provide old and outdated information etc. This can potentially expose the EU QPPV to legal actions from the EMA if they think this can have subjected the public to additional risks. Such legal action can be long drawn – over years and be very expensive for the QPPV even if the QPPV ultimately is found to have done everything right.

It is important that the any person that takes on that responsibility makes sure to have a clear indemnification from the MAH they work for to cover any legal costs related to the conduct of the QPPV role for the company.

Such indemnification should cover any situation where the QPPV has been acting in good faith and have been performing the duties as it would normally be expected in the profession. If there is clear misconduct on the QPPV side the QPPV must have a separate insurance covering such professional errors/mistakes.

The wording of the indemnification is important and should be reviewed by a lawyer with expertise in the field, however there are templates available that can assist in completing a QPPV indemnification contract available. Such a separate indemnification is usually used when EU QPPV services are provided by a full time employee of the MAH.

It is also possible to include an indemnification clause into a consulting contract for the EU QPPV if the service is provided as an external consultant. Templates are also available for such EQ QPPV consulting contracts but these should also always be adapted and reviewed by a lawyer with specific expertise.

 

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