I move amendment No. 2:
In page 4, between lines 30 and 31, to insert the following:
"(3) Where a person proposes to arrange for the conducting of a clinical trial or to conduct a clinical trial, and
(a) there is in force in respect of the substance or preparation concerned a product authorisation granted under the Medical Preparations (Licensing, Advertisement and Sale) Regulations, 1984, and
(b) the purpose of the clinical trial is to determine the effect of a new use for the substance or preparation concerned.
then the provisions of section 3 to 6 and sections 8 to 11 shall not apply where—
(i) the National Drugs Advisory Board have been notified in writing of the proposal and have, not later than 6 weeks after being so notified, made a recommendation to the Minister on the proposal, and
(i) the Minister has granted permission for the proposed trial to be undertaken, and
(iii) in respect of the substance or preparation concerned, the conditions relating to dosage form contained in the product authorisation so granted are complied with when the clinical trial is being conducted and the dosage administered in each case does not exceed that specified in the said authorisation.".
While discussing the provisions of section 2 of the Bill during Committee Stage, the Minister gave an undertaking to Deputy Flaherty to look again at section 2 with a view to safeguarding the interests of participants in trials while at the same time ensuring against unduly impeding legitimate trials on products which have been authorised.
The trials in question are carried out to determine new uses for products which have a product authorisation and which are in extensive use in medical practice. These types of trials are generally undertaken by hospital consultants and are of considerable benefit in determining new and beneficial uses for widely used products, determined on the basis of experience in using the product clinically, In considering how best to develop an appropriate mechanism for clinical trials under section 2 of the Bill, I find it necessary to restrict any deviation from the full requirements of the Bill to certain trials for new uses only.
It is proposed, therefore, to exempt, subject to certain conditions, from the requirements set out in sections 3 to 6 and 8 to 11 of the Bill, trials involving a preparation which has a product authorisation where the purpose of the trial is to determine a new use for the preparation.
The amendment governing the exemption include the following stipulations: where the National Drugs Advisory Board have been notified in writing of the proposal and have not later than six weeks after being so notified, made a recommendation to the Minister on the proposal; the Minister has granted permission for the proposed trial to be undertaken; and in respect of the substance or preparation concerned, the conditions relating to dosage form contained in the product authorisation so granted are complied with when the clinical trial is being conducted and the dosage administered in each case does not exceed that specified in the said authorisation.
When assessing the application for the trial, the National Drugs Advisory Board would have to be satisfied with the arrangements made by the applicant. These would include an independent committee to vet the trial. I feel that this amendment will go a long way towards meeting the legitimate demands of individual researchers conducting clinical trials while, at the same time, protecting those participants in such trials.