James Murray

The MHRA has introduced additional safeguards. As a result of its dialogue with the trial sponsors, the amended protocol published last week increases the level of safeguards. That means that if the regular monitoring, which will happen at least every three months—it can be more regular during the trial—shows any sign of increased risk of harm, that will lead to increased monitoring, clinical review and, when considered against objective criteria, automatic withdrawal from the trial. It is a question of monitoring this trial, possibly more closely than any trial before—the level of scrutiny is very great indeed—to ensure that at the first sign of any increased risk of harm, action will be taken. That is the assurance that I have sought in interrogating this matter carefully in recent days, and that is the basis on which I am talking to the right hon. Gentleman and others in the House today. We must come to a fair and settled conclusion on this matter to move forward as a country, and I believe that we should follow clinical advice and establish the clinical evidence gathered in a highly scrutinised trial with all the safeguards in place that I have described. Only that approach will give us the confidence about where we settle on this matter in the future. On that basis, the Government oppose this motion.