§ The Parliamentary Under-Secretary of State for Health (Miss Melanie Johnson)The draft regulations to transpose the clinical trials directive into domestic law are currently being discussed with stakeholders. The process of developing these regulations fully, at which point they can be laid before Parliament, should therefore be completed some time after Parliament reconvenes in October. I will aim to give a further update at around that time. Member States are required to implement the directive fully by 1 May 2004.