The Pharmaceutical Journal
Vol 279 No 7467 p224
1 September 2007

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Plans laid for trials of emergency care medicines to treat children

Research into emergency care for children will no longer require prior authorisation if legislative amendments proposed by the Medicines and Healthcare products Regulatory Agency are adopted.

The MHRA says that the current system prevents trials of emergency-care medicines for children taking place in the UK because prior consent cannot usually be obtained.

Its proposed amendments, which have opened for consultation, suggest that, in certain emergencies, there should be an exception to the general rule that informed consent must be obtained from a child’s parent or legal representative before participation in trials of medicines.

An ethics committee would have to approve the detailed circumstances in which the exception would be used and consent would have to be obtained as soon as reasonably practicable after participation starts. The MHRA envisages that, in practice, the change would mirror an amendment made last year in relation to incapacitated adults.

The change is one of three suggested changes to the Medicines for Human Use (Clinical Trials) Regulations 2004. The other two relate to delegating some of the Gene Therapy Advisory Committee’s functions and amending the regulations for appointing members to UK ethics committees. The proposals are available online.

The deadline for comments is 7 December 2007.