Memorandum by the Department
1999 (S.I. 1999/2889)
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
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 21day 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.