The new part is section 2 (a) (ii) which states that the principal purpose of that administration is to prevent disease in, or to save the life, restore the health, alleviate the condition or relieve the suffering of the patient.
Regarding the administration of drugs such as DDI to AIDS patients, or certain new drugs for leukaemia or terminal cancers, would that be considered exempt? Could the Minister give a practical example of something that was considered to be a clinical trial under the old Act which will now be considered normal clinical practice, not subject to the rigours of this legislation? It is important to clarify this matter. There must be a public assurance that unsafe drugs are not being used. Consultants have told me about the amount of paperwork they would have to go through in order to get approval for the use of a drug whose efficacy is fairly well known in other countries. In the context of new developments, this could be vital to individual patients. I should like an assurance that such administration of drugs would be considered as normal clinical practice and therefore exempt.