On 16 March I informed the House of the Medicines and Healthcare products Regulatory Agency's (MHRA) suspension on 14 March 2006 of the phase 1 clinical trial for a drug in development known as TGN1412. As well as suspending the trial and alerting international regulatory authorities, the MHRA initiated an immediate investigation into the incident. On 5 April the MHRA announced its interim findings. This, and associated documents, are available on the MHRA website.

To date, the MHRA has found no evidence to suggest that there was any problem with the manufacture of the product. It does not appear to have been contaminated, or to have contained anything other than the correct ingredients. Neither did the MHRA find any problems with the administration of the clinical trial which is likely to have contributed to the incident. It was run according to the agreed protocol and the correct dose of the product was given to the patients.

There are still further tests which the MHRA is carrying out to confirm these findings. However, if those findings are confirmed, it would indicate that there was something particular about this product and its mode of operation in humans which led to the adverse reactions in this case, and which was not predicted in the pre-clinical research carried out on the drug, including animal tests.

The product in question is a very specific kind of human monoclonal antibody, and it is essential now to understand what this incident reveals about the underlying science, and how clinical trials involving these types of products should be managed and authorised in the future. The Secretary of State has therefore agreed to the establishment of an expert working group to address these questions. The Secretary of State has appointed Professor Gordon Duff to chair the expert group. It will start work as soon as possible and provide advice to Ministers. We have asked for an interim report in three months.

It is important to stress that clinical trials in general have an extremely high safety record. It is the unprecedented nature of this incident that makes it all the more important to learn the lessons from this incident and prevent a recurrence. At the same time, the progress of clinical trials for other types of product which are vital to patient care must not be impeded.

This clinical trial was conducted by a contract research organisation and not by, or within, the NHS. I would, however, like to pay special tribute to the staff of the Northwick Park Hospital, and particularly those in the Intensive Care Unit, for their exceptional work in dealing with the aftermath of the trial and saving all the participants lives.

I will provide a further report to the House when the expert group provides its interim report. In the meantime, until the expert group provides advice, the MHRA is adopting a precautionary approach to the authorisation of trials involving products of this kind, and will not authorise trials without having received expert advice on whether the effects seen in the TGN1412 case may be repeated in relation to those substances.