1 Amendments of Theodoros SKYLAKAKIS related to 2012/0192(COD)
Amendment 159 #
Proposal for a regulation
Recital 47
Recital 47
(47) At present, such damage compensation is provided by way of insurance. This insurance may cover damages to be paid to the subject by the sponsor and investigator in the case of established liability. It may also compensate the subject directly without prior establishment of the liability of the sponsor or investigator. Experience shows that the insurance market is small and costs for insurance coverage are disproportionately high. Moreover, as liability regimes differ widely between Member States, it is difficult and burdensome for the sponsor of a multinational trial to obtain insurance in accordance with those national laws. Therefore, each Member State should establish a national indemnification mechanism which compensates subjects in accordance with the laws of that Member State.