UK Offence Report

Obstruction etc. of inspectors

regulation 12(1) of The Good Laboratory Practice Regulations 1997

The provision has been revoked and no saving provision preserving liability for earlier conduct was found.

What the provision says

1 Subject to paragraph (2)—

a any person who—

i intentionally obstructs an inspector, or

ii without reasonable cause fails to comply with any requirement made of him by an inspector, in circumstances where the inspector is acting in pursuance of any of his functions under these Regulations; or

b any person who, in purported compliance with any such requirement as is mentioned in sub-paragraph (a)(ii), intentionally or recklessly furnishes information which is false or misleading in

a material particular, shall be guilty of an offence.

Text as made, from legislation.gov.uk. © Crown copyright, reused under the Open Government Licence v3.0. This is the text as originally made; later amendments are not shown here.

Who it binds, and what has to be proved

Binds
a person
Conduct
obstructing an official exercising a power
Fault element
Requires proof of a state of mind
Burden of proof
No statutory defence — prosecution proves everything

The prosecution must prove both that the conduct happened and that it was done with the state of mind the provision names (intentionally, recklessly).

The provision states no defence, so the prosecution bears the burden on every element of the offence.

Classifier’s reasoning: mens rea word in the offence-creating words: intentionally, recklessly.

What would breach regulation 12(1)?

These are illustrations, not law. They are generated from the provision’s own words to show the shape of the offence. Whether any particular conduct is caught depends on the full text, on any amendment since, and on the facts.

  1. Refusing to let an inspector onto premises they are entitled to enter under the Good Laboratory Practice Regulations 1997.
  2. Sending an official away, or telling staff to say nothing, where the power being exercised does not depend on anyone's consent.
  3. Physically blocking an examination, or removing something an officer has said they intend to inspect.

Penalty

Mode of trial
Not determined
Maximum fine
Not determined
Maximum prison (summary)
Not determined

no penalty is stated in this instrument; it may be in the enabling Act, or in a general penalties provision this pass did not connect to the offence.

No penalty was determined from this instrument. It may be in the enabling Act, or in a general penalties provision this pass did not connect to the offence. Absence of a figure here is not evidence that the offence carries no penalty.

Sentencing

Offences of this kind are usually sentenced under the guidelines below. This is a mapping by subject, not a finding about this provision, and the links go to a search of the Sentencing Council’s own site.

Prosecution figures

No published per-offence figure was found for this provision, and it could not be matched to a Ministry of Justice offence code. Offences created by statutory instrument very largely do not have one. Absence of a figure is not evidence that the offence is unused.

Status and lifecycle

Current status
Revoked
Revoked by
The Good Laboratory Practice Regulations 1999
Revoked on
14 December 1999
Made
6 March 1997
In force from
1 April 1997
Extent
Not stated

How this was established: the instrument was revoked by a later instrument found in this corpus.

What the instrument is for

(This note is not part of the Regulations) — the explanatory note published with the instrument, © Crown copyright.

These Regulations contain the legislative measures necessary for the implementation of Council Directive 87/18/EEC on the harmonization of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances (OJ No. L15, 17.1.87, p. 29), Council Directive 88/320/EEC on the inspection and verification of Good Laboratory Practice (GLP) and Commission Directive 90/18/EEC adapting to technical progress the Annex to Council Directive 88/320/EEC on the inspection and verification of good laboratory practice. Regulation 2 is an interpretation provision. Amongst other definitions, there is a definition of the principles of good laboratory practice, a concept which is defined with reference to the principles set out in the Schedule 1 to the Regulations and the operating procedures set out in Schedule 2 to the Regulations. Regulation 3 sets out certain functions of the Secretary of State, including enforcing compliance with the Regulations. Regulation 4 contains a requirement that safety studies covered by the Regulations must only be conducted at laboratories which are part of the United Kingdom good laboratory practice compliance programme. Regulation 5 deals with prospective membership of the programme by laboratory operators in respect of particular laboratory premises, and regulation 6 deals with full membership of the programme. Regulation 7 contains a requirement that safety studies covered by the Regulations shall be conducted in accordance with the principles of good laboratory practice. Where there are serious deviations from the principles, there is a procedure for serving warning notices on laboratory operators requiring them to ensure that the serious deviation will not recur. Breach of such a notice is an offence, although there is an appeals procedure, contained in regulation 8, if an operator of a laboratory is aggrieved by a decision to serve a warning notice on him. Regulation 9 deals with the powers of inspectors who are discharging the enforcement functions of the Secretary of State. The conditions under which inspectors are to be appointed are governed by regulation 10. Regulation 11 contains rules relating to the disclosure of commercially sensitive or other confidential information which may come to light as a result of enforcement action taken under the Regulations. Impeding the work of an inspector who is acting in pursuance of any of his functions under the Regulations is made an offence under regulation 12. Regulation 13 relates to offences committed with the consent or connivance, or attributable to, bodies corporate or Scottish partnerships, and regulation 14 is a general defence of due diligence in relation to any of the offences contained in the Regulations. Regulation 15 is a penalties provision, and regulation 16 gives the Secretary of State powers to charge fees to cover the cost of carrying out inspections and study audits. Regulations 17 to 19 contain a set of consequential amendments to other Regulations. An assessment of the cost to business of complying with these Regulations has been prepared and copies may be obtained from the Good Laboratory Practice Monitoring Authority, Room 1801, Market Towers, 1 Nine Elms Lane, London SW8 5NQ. A copy has also been placed in the library of each of the Houses of Parliament.

Read the full note and every offence in this instrument

Other offences in the same instrument

How this was identified as an offence

Everything above rests on the judgement that this provision creates a criminal offence, rather than mentioning one. That judgement is made by rule, from the words of the provision, and this is the rule that made it — with a confidence of 0.92.

Basis
the provision says a person is “guilty of an offence”
Confidence
0.92 of 1.00

A provision that states a penalty for an offence created elsewhere can read very like one that creates an offence, and the rules can mistake the one for the other. If the text quoted above sets a penalty for something made an offence by another provision, treat the classification on this page with that in mind, and read the instrument.

Check the source