From the NAO
Procurement of Vaccines by the Department of Health
REPORT BY THE COMPTROLLER AND AUDITOR GENERAL HC 625 Session 2002-2003: 9 April 2003
18 All vaccines routinely administered in the UK are required to have a Marketing Authorisation (product licence) valid in the UK. All the vaccines we examined had this, with the exception of smallpox. All vaccines carry risks to the receipient when administered and could lead to the manufacturer being sued for damages. As the smallpox vaccine was unlicensed, the Department bore this risk by indemnifying PowderJect for up to £30 million against damages and notified the Committee of Public Accounts of this contingent liability on 26th March 2002.