Vol. 430 No. 2
87 Mr. E. Kenny asked the Minister for Health if he intends to introduce a more formalised scheme to monitor the distribution of free drugs samples to members of the medical profession; and if he will make a statement on the matter.
The Deputy may be aware that the EC Directive on the advertising of medical products for human consumption allows member states to control the provision of drug samples to members of the medical profession.
The Medical Preparations (Advertising) Regulations, 1993, give effect to the provisions of this directive. These regulations provide in the first instance that free samples shall not be provided to any person other than a registered medical practitioner or a registered dentist.
The regulations further provide that the provision of samples to such persons must conform with a number of specific conditions: the supply of samples must be in response to a signed and dated request from the recipient; no more than six samples of any medical preparation can be provided in a year; the sample cannot exceed the smallest presentation of the product on the market; the sample must be marked ‘free medical sample — not for resale'; the company involved must maintain an adequate system of control and accountability in respect of the supply of samples.
The regulations provide that the Minister may take action under section 65 of the Health Act in pursuance of the regulations. The regulations further provide that the Minister may approve of a code of practice for the purpose of providing practical guidance with respect to the requirements or prohibitions of the provisions of the regulations. My Department is currently finalising discussions with the Federation of Irish Chemical Industries in this regard.
