§ Mr. Ashleyasked the Secretary of State for Social Services whether there has been any action based on the recommendations of the Committee on Review of Medicines, reported in its annual report for 1976, that on the data sheets which companies are legally required to provide for doctors there should be separate and distinct entries for contra-indications, precautions, and warnings and adverse effects; with what companies and organisations this recommendation has been discussed; and what was their view.
§ Mr. MoyleExisting regulations made under the Medicines Act require that a data sheet shall include particulars of contra-indications, warnings, precautions, and any action to be taken in the event of an overdose. They do not however specify the format of this information. There is nothing, however, to prevent the entries being separated as proposed by the Committee. The Committee incudes462W in its specific recommendation for particular drug susbtances separate statements as to contra-indications, as to precautions and as to warnings and adverse effects. As licences are reviewed steps will be taken to ensure that data sheets are brought into line.
Under the new arrangements for the control of advertising agreed with the industry last year, data sheets will require the specific approval of the licensing authority. It is now necessary to revise the data sheet regulations and the Medicines Commission has been asked to consider this matter. In the light of its advice, consultations about new regulations will take place in the usual manner.
The recommendations of the Committee on Review of Medicines on data sheets have been known to interested parties for over a year and I am unaware of any general objections to its views, although, as indicated in the Committee's report, some companies felt that the separation of contra-indications would unnecessarily inhibit doctors in their prescribing decisions.