The Medicines for Human Use (Clinical Trials) Amendment (No.2) Regulations 2006

EXPLANATORY NOTE

(This note is not part of the Regulations)

These Regulations amend the Medicines for Human Use (Clinical Trials) Regulations 2004 (the Clinical Trials Regulations) which implement Directive 2001/20/EC on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use(1).

Regulation 28(1) of, and Schedule 1 to, the Clinical Trials Regulations implement, among other provisions, article 5(a) of that Directive, which requires that an incapacitated adult cannot be included in a clinical trial of a medicine without the consent of his legal representative.

Regulation 2 amends Schedule 1 to creates an exception to the general rule that an incapacitated adults cannot be included in a clinical trial unless the conditions in paragraphs 1 to 5 of Part 5 of Schedule 1 have been met; in particular that the adult’s legal representative (as defined) has given informed consent. The exception applies only when the following conditions are met: (i) treatment is required urgently; (ii) the nature of the trial also requires urgent action; (iii) it is not reasonably practicable to meet the conditions in paragraphs 1 to 5 of Part 5 (obtaining consent etc); and (iv) an ethics committee has given approval to the procedure under which the action is taken.

Regulation 3 amends the Adults with Incapacity (Scotland) Act 2000 consequentially.

A full regulatory impact assessment of the effect that this instrument will have on the costs of business is available from the Medicines and Healthcare products Regulatory Agency, Market Towers, 1 Nine Elms Lane, London, SW8 5NQ and copies have been placed in the library of both Houses of Parliament.

(1)

OJ No. L121, 1.5.2001, p.34.