Policy responses and statements
- Name of organisation:
- Medicines and Healthcare Products Regulatory Agency (MHRA)
- Name of policy document:
- MLX 340: Amendments to the Medicines for Human Use (Clinical Trials) Regulations
- Deadline for response:
- 7 December 2007
Background: Consultation MLX 340 sought views on amendments to the Medicines for Human Use (Clinical Trials) Regulations 2004. The amended Regulations would:
allow trials of emergency care medicines in children without initial consent clarify which trials require ethical review by the Gene Therapy Advisory Committee provide greater flexibility in the operation of ethics committees and their appointing authority.
The three sets of amendments are linked only insofar as they are amendments to the same set of UK regulations. They are not inter-dependent, but rather have been drawn together with a view to undertaking a single consultation and implementing a single statutory instrument.
COMMENTS ON
MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (MHRA)
MLX 340: AMENDMENTS TO THE MEDICINES FOR HUMAN USE (CLINICAL TRIALS) REGULATIONS 2004
The Royal College of Physicians of Edinburgh is pleased to respond to the Medicines and Healthcare Products Regulatory Agency on consultation MLX 340. Our comments are as follows.
Emergency Care Research in Children
The College recognises the importance of children having access to licensed drugs that may benefit them, including in emergency situations. Extrapolation from adult data is often inappropriate, and frequently drugs are used that have not been subject to trials in children in whom there may be differences in pharmacodynamics, side-effects and outcomes.
The College therefore broadly supports these amendments, which will make it easier for research data relating to children to be gathered. Appropriate safeguards are in place to ensure that the studies are ethically approved and consent is obtained as soon as is feasible, with withdrawal from any study if consent is withheld.
Perhaps one situation merits consideration. Suppose a minor at age 14 years is in need of emergency treatment. The minor is alert and able to communicate clearly. No parent or legal representative is available. Surely the views of that child must be taken into account before being entered in a trial? These circumstances may not be common but presumably will occur from time to time. Remember the House of Lords’ view in the Gillick case. It may be prudent for the modification to cover this situation.
Scope of GTAC Review
Again, broadly, the College supports this recommendation. It would be helpful to clarify who makes the decision as to which applications will not be assessed by GTAC. Will it be the secretariat according to strict criteria, or will it be the GTAC or the chair who will scrutinise the applications and make the decision?
Membership and Operation of UK Ethics Committees
Amendments which will simplify and speed up the process of handling applications to Research Ethics Committees are to be welcomed, provided there is no loss of protection to potential volunteers. These proposals appear to meet that criterion. They should facilitate starting trials more quickly without compromising safety and preventing anyone without appropriate expertise from joining the committee.
Two small points merit consideration. First, who would ensure that any conditions (paragraph 28) accompanying a favourable Research Ethics Committee decision were met? Second, does paragraph 34 refer to membership of ethics committees in EU countries, or any country?
Copies of this response are available from:
Lesley Lockhart,
Royal College of Physicians of Edinburgh,
9 Queen Street,
Edinburgh,
EH2 1JQ.
Tel: 0131 225 7324 ext 608
Fax: 0131 220 3939
[6 December 2007] |
