HL Deb 08 January 2004 vol 657 c59WA
Lord Morris of Manchester

asked Her Majesty's Government:

Where legal liability lies in cases where unlicensed use of vaccines is held to have damaged the health of the vaccinated person or to have constituted a significant health hazard. [HL452]

Lord Warner

A doctor, to fulfil special needs, who orders or prescribes an unlicensed vaccine for use by his individual patients, or who orders or prescribes the use of a licensed vaccine outside the conditions of its marketing authorisation, does so on his/her direct personal responsibility. He/she may be liable if it were shown that the use of the product on the particular patient was negligent. In addition, the manufacturer may be liable if they are negligent in the manufacture of the product or the product was defective.

The question of where legal liability lies where unlicensed use of vaccines is held to have damaged the health of the vaccinated person, or to have constituted a significant health hazard, will depend on the individual circumstances of the case and can ultimately be determined only by the courts.