Risk-benefit decisions in product licence applications

Abstract

Professor Bass has presented some very interesting case reports, and I shall now discuss some of the principles involved. There are many people in this audience who have served either on the Medicines Commission or the Section 4 Committees, and everyone involved has had three words impressed upon their minds: quality, safety and efficacy. These are the three guidelines for giving product licences by the licensing authority, who looks at risk with respect to safety and quality and at risk-benefit with respect to efficacy. We all realize that the licensing authority has to make decisions, both on risk-benefit ratios and on whether a product should be marketed, with very limited knowledge. We, therefore, understand how difficult the task is for the CSM and the other committees, when they have limited knowledge; not very many patients and animal data which may or may not be relevant. One of the other problems which the licensing authority has is that medicine, in this country, is effectively an individual business, in that the doctor is treating one patient and trying to assess risk-benefit for him. The licensing authority has to look at group results and, therefore, sometimes tends to forget risk and benefits which may be applicable to an individual, so that benefits to a minority group can become lost.