§ Mr. Ian Lloyd
asked the Secretary of State for Social Services what steps he has taken since 2nd February 1978 to ensure that proper sampling procedures for the control of the quality and safety of medicines sold in retail outlets, as provided in Section 108 of the Medicines Act 1968, shall be continued in view of the local food and drug authorities responsibility for these procedures on that date; and what he estimates to be the cost of these changes.74W
§ Mr. Moyle,
pursuant to his reply [Official Report, 25th May 1978; Vol. 950, c. 712], gave the following information:
The main provisions for ensuring quality and safety of medicines now take the form of licensing requirements under Part II of the Medicines Act 1968. The responsibility for enforcement of these requirements is assigned to the Health and Agriculture Ministers by Section 108 and, in discharging this responsibility, samples are taken at manufacturing and wholesale levels by inspectors of my Department for analysis. Section 108 also provides, however, for certain other provisions to be enforced by local authorities or by the Pharmaceutical Society concurrently with the Ministers. Regulations under Section 108(4) and (7) have placed certain responsibilities on food and drugs authorities. Other matters are dealt with in Section 108(2); this provides for Ministers to give directions or make arrangements whereby food and drugs authorities or the Society shall have powers or duties of enforcement in respect of specified sections of the Act. In such circumstances expenses incurred by the authority are recoverable from the Minister concerned (Section 128(4)).
Until 31st January 1978, local authorities were under a duty to enforce Sections 1(2) and 2 of the Food and Drugs Act 1955 in relation to drugs and, in the course of executing such functions, authorities operated sampling procedures. This work was carried out at their expense and I have no comprehensive information as to the expenditure involved. These provisions ceased to apply to drugs—medical products—on 1st February this year; however there are corresponding provisions relating to medicinal products in Sections 63 and 64 of the Medicines Act and these are among the provisions specified in Section 108(2). In view of the sampling of medicines that is currently undertaken by my Department under the licensing system and the different financial implications, further consideration is necessary before any decision is reached as to new arrangements.
It is envisaged that there will be discussions with the Pharmaceutical Society and the relevant associations of local authorities in due course. At this stage I cannot offer any estimate of the costs 75W involved but, in view of the factors mentioned above, the total cost of sampling medicines at the retail level may be less than hitherto.