HC Deb 29 January 1973 vol 849 cc320-1W
Mr. Pavitt

asked the Secretary of State for Social Services (1) if he will annul the temporary provisions for drug manufacturers who cannot produce data sheets by 1st March, in view of the danger to patients for whom drugs may be prescribed on inadequate information;

(2) why he has diversified the form of Medicines Act data sheets to a combination of loose sheets, compendia produced by individual manufacturers, and multiple manufacturer's compendia; and if he will reconsider his regulations with a view to securing easy access by prescribers on a single system.

Sir K. Joseph

The Medicines Commission took the view that it would be desirable that, as far as possible, data sheets should take the form of entries in a compendium; they felt that it would be more satisfactory for medical practitioners to receive a single book containing entries relating to all the products involved rather than to receive separate sets of data sheets for each company involved. There seems no acceptable way of making an absolute requirement that all promoters of medicinal products should participate in a particular publication, but on the commission's advice the regulations were drafted in such a way as to allow alternative presentations while encouraging maximum participation in a joint compendium, and it seems likely that the great majority of products promoted to doctors will appear in a compendium being prepared by the Association of the British Pharmaceutical Industry. I have no power to defer the date from which the data sheet requirements become general (1st March 1973), and as it would not have been possible for a compendium to be prepared by that date, the regulations make provision for the use of a simplified form of sheet to be used for an interim period by those companies who have arranged to participate in a joint compendium. I have no reason to believe that the use of these simplified data sheets could lead to any danger to patients.