Joint Committee on Statutory Instruments Second Report


Memorandum by the Department of Health


  1. The Committee has requested a memorandum on the following point:

Given that the existing order was made on 23 July for a period of 3 months, explain why the consultation and other steps were not completed in time for this instrument to be laid so as to comply with the 21- day rule.

  2. The consultation which was undertaken prior to the making of S.I. 1999/2889 (the Temporary Order), as required by section 129(6) of the Medicines Act 1968 (c.67), concerned not only whether S.I. 1999/2109 (the Emergency Order) should be replaced, on its expiry, with an Order in the same terms, but also whether a further Order should be made under section 62, banning the sale and supply of various herbal substances which, while harmless in themselves, may be confused or tainted with Aristolochia. Consultees were asked to comment on whether the further Order should ban the sale or supply of those substances absolutely, or else ban them subject to an exception where due diligence could be shown by the trader.

  3. The consultation paper was issued on 27th July 1999, the day the Emergency Order was laid before Parliament. Since the consultation concerned complex matters, and it was thought that industry bodies would wish to consult their members, the Medicines Control Agency (MCA) of the Department of Health concluded that it was necessary to allow consultees until the end of September 1999 in order to comment. The MCA also took into account the fact that Cabinet Office Guidelines recommend that a consultation should be for a minimum period of eight weeks. It was considered necessary, in order to avoid confusion amongst consultees and duplication of effort, for the consultation to cover both the continuation of the Aristolochia ban, and the imposition of a ban on the sale and supply of the other herbal substances.

  4. It was imperative for the protection of public health, that there should be no gap between the expiry of the Emergency Order and the coming into force of the Temporary Order.

  5. Once the consultation period had ended, the MCA collated the comments and, on Friday 8th October, made a submission to Ministers recommending, in particular, that the ban on sale and supply of Aristolochia be continued on a temporary basis. Ministers approved this course of action on Monday 11th October, and the draft Temporary Order was submitted for signature, the final signature being obtained on Wednesday 20th October.

  6. The failure to comply with the 21—day rule in this case is obviously regretted, but it is submitted that it could not, unfortunately, have been avoided in this case bearing in mind that the Emergency Order could not have remained in force for longer than 3 months, and that it was in practice necessary to consult the industry on a complex range of options for possible further secondary legislation, before the Temporary Order could be made.

16th November 1999.

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