A CRO company has gone bankrupt. The company has a biobank registered in Sweden. What are the rules?

According to the Swedish Biobank Act, the principal of the biobank, in this case the CRO company, may decide to close the biobank. The principal is responsible for ensuring that the decision to close is reported to the Swedish Health and Social Care Inspectorate. The notification must include information about what has happened to samples in the biobank.

If samples are still available or needed, the biobank cannot be closed down outright. The biobank or sample collections in the biobank must first be transferred to another principal. In order for a principal to transfer a biobank to another principal, a permit from the Swedish Health and Social Care Inspectorate is required. The request must include the reasons for the transfer and information on who will take over the biobank.