1 S.I.
2012/1426: Reported for defective drafting
Medical Devices (Amendment) Regulations 2012
(S.I. 2012/1426)
1.1 The Committee draws the special attention
to these Regulations on the ground that they are defectively drafted
in one respect.
1.2 These Regulations amend the Medical Devices Regulations
2002. The only changes made to those Regulations are updating
references to three European Directives and providing that references
in the 2002 Regulations to the Annexes of those Directives are
to be construed as references to those Annexes as amended from
time to time.
1.3 Regulation 3(1) requires the Secretary of State
from time to time to carry out a review of the provisions within
these Regulations and publish a report containing the conclusions
of the review. Regulation 3(2) requires the Secretary of State,
in doing so, to have regard to how [two Directives] are implemented
in other member States. Regulation 3(3)(a) requires the report
to set out "the objectives intended to be achieved by the
regulatory system established by the provision of these Regulations
that implement the Directives mentioned in paragraph (2)".
1.4 The provision appeared to the Committee to be
materially similar to one used in a previous case, in which the
Committee considered a review provision relating to a single food
additive, lycopene, that had been brought into the existing control
system for food additives. In its 27th Report of Session 2010-12,
the Committee had reported the Food Additives (England) (Amendment)
(No.2) Regulations 2011 (S.I. 2011/1456) in the following
terms:
These Regulations have effect
to adjust the application to lycopene of the regulatory system
established by S.I.2009/3238. Regulation 4 requires reviews; and
paragraph (3) of that regulation requires the report of a review
to set out and assess the objectives of "the regulatory system
established by these Regulations". The Committee queried
the terms of that paragraph in the light of the limited purpose
of the Regulations. In a memorandum printed at Appendix 2, the
Food Standards Agency states that the terms of paragraph (3) are
closely based on the text of the Guidance on Sunsetting Regulations
produced by the Better Regulation Executive and argues that those
terms are not inappropriate, given that the Regulations establish
an altered regulatory system for lycopene. The Committee considers
that including in regulation 4(3) some specific reference to the
regulatory system established by S.I.2009/3238 as, by virtue of
the Regulations, it applies in relation to lycopene would have
accurately indicated what a report of a review is required to
address: the Regulations do not establish a regulatory system
as such but vary the coverage of an already established regulatory
system. The Committee accordingly reports regulation 4(3)
for defective drafting.
1.5 The Committee therefore asked the Department
of Health why, in the light of that report, regulation 3(3)(a)
did not refer to "the regulatory system established by the
provisions of the Medical Devices Regulations 2002 (as amended
by these Regulations)". In a memorandum printed at Appendix
1, the Department accepts that, in the light of the Committee's
earlier report, the Committee's suggested wording should have
been used. The Department apologises for the error and will take
steps to ensure that all drafters and checkers are specifically
made aware of the point. It undertakes to make an appropriate
amendment at the earliest practicable opportunity. The Committee
accordingly reports regulation 3 for defective drafting, acknowledged
by the Department.
1.6 The Committee also asked the Department why,
in the light of the earlier report, section 3 of the Explanatory
Memorandum to these Regulations indicated that there were no matters
of special interest to the Committee. The Department's reply is
less than explicit, but the Committee can only infer that neither
the drafter nor the checker of this instrument was aware of the
Committee's earlier report.
1.7 The Committee expects Departments making statutory
instruments to be sufficiently familiar with its reports and those
of the Select Committee on Statutory Instruments that, where they
operate in a manner potentially conflicting with what either Committee
has stated to be its preferred approach, they are in a position
to explain clearly in section 3 of their Explanatory Memoranda
why they have chosen to do so.
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