UK Offence Report

False or misleading information

regulation 50(2) of The Medicines for Human Use (Clinical Trials) Regulations 2004

This offence was read from the text as made, and no revised version was available, so a later revocation could not be ruled out. Check the current text at legislation.gov.uk.

What the provision says

2 Any person who— a is conducting a clinical trial authorised in accordance with these Regulations; b is a sponsor of such a clinical trial; c while acting under arrangements made with a sponsor of such a clinical trial, performs the functions of that sponsor; or d holds a manufacturing authorisation, and who, for the purposes of these Regulations, provides to the licensing authority or an ethics committee any relevant 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 This is the text as originally made; later amendments are not shown here.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
making a false or misleading statement
Fault element
Strict liability
Burden of proof
Legal burden on the defendant

The prosecution must prove that the conduct happened. This is a strict liability offence as drafted: the provision uses no word of intention, knowledge, recklessness or negligence, so there is no need to show that a person meant to do it, knew about it, or was careless.

Intention, knowledge and carelessness are irrelevant to guilt. They may still matter a great deal to sentence.

The provision gives a defence the defendant must prove, on the balance of probabilities. A legal burden of that kind can be read down to a merely evidential one under section 3 of the Human Rights Act 1998 where placing it on the defendant would be disproportionate (R v Lambert [2001] UKHL 37; Sheldrake v DPP [2004] UKHL 43).

Classifier’s reasoning: no word of intention, knowledge, recklessness or negligence in the offence or its provision.

The defence, as drafted

on does not commit an offence under these Regulations if he took all reasonable precautions and exercised all due diligence to avoid the commission of that offence. 2 Where evidence is adduced which is sufficient to raise an issue with respect to that defence, the court or jury shall assume that the defence is satisfied unless the prosecution proves beyond reasonable doubt that it

What would breach regulation 50(2)?

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. On these words an offence is committed where a person provides to the licensing authority or an ethics committee any relevant information which is false or misleading in a material particular.
  2. Entering a figure on a form or return that is known to be wrong under the Medicines for Human Use (Clinical Trials) Regulations 2004.
  3. Leaving out something the form asks for, where the omission is what makes the answer misleading.
  4. Producing a document to an official that has been altered since it was issued.

Penalty

Mode of trial
Either way — magistrates’ court or Crown Court
Maximum fine
£5,000
Maximum prison (summary)
3 months
Maximum prison (on indictment)
2 years

expressed as the statutory maximum (the prescribed sum): the same words mean £5,000 in England and Wales and £10,000 in Scotland.

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

The Ministry of Justice records offences under this instrument against offence code 9182 — 09182 - Triable either way offences under Medicines for Human Use (Clinical Trials) Regulations 2004. That code may cover several provisions of the instrument, so a count against it is not a count of prosecutions under this provision alone.

No published per-offence figure was found for this provision. Offences created by statutory instrument very largely do not have their own code in the MoJ’s Outcomes by Offence data tool. Absence of a figure is not evidence that the offence is unused.

Status and lifecycle

Current status
Status not determined
Made
31 March 2004
In force from
1 May 2004
Extent
Not stated

How this was established: read from the text as made; no revised version available, so later revocation could not be ruled out.

What the instrument is for

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

These Regulations implement Directive 2001/20/EC on the approximation of laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (“the Directive”). The Regulations provide that the licensing authority established in accordance with the Medicines Act 1968 for the purpose of Part II of that Act (licences and certificates relating to medicinal products) shall exercise the functions of the competent authority under the Directive and certain functions falling to be performed by Member States under that Directive (regulation 4), unless those functions are conferred on any other person or body (for example, enforcement functions are conferred on the Secretary of State for Health, the National Assembly for Wales, the Scottish Ministers and the Department for Health, Social Services and Public Safety in Northern Ireland). Regulations 5 to 10, and Schedule 2, make provision for ethics committees in the United Kingdom, which are to be responsible, amongst other things, for giving opinions on the ethics of clinical trials involving medicinal products. Regulation 5 provides for the United Kingdom Ethics Committees Authority, which is to be responsible for establishing, recognising, and monitoring ethics committees. Regulations 11 to 27, and Schedules 3 to 5, make provision for clinical trial authorisations by the licensing authority and for ethics committee opinions. In particular: regulation 12 provides that a clinical trial may be conducted only if it has been authorised by the licensing authority and an ethics committee has given a favourable opinion; regulation restricts the supply of medicinal products for the purposes of clinical trials; regulations 14 to 16 and Schedules 3 and 4 make provision for applications for ethics committee opinions; and regulations 17 to 21 and Schedule 3 deal with requests to the licensing authority for authorisation. Regulations 22 to 25 make provision for amendments to clinical trial authorisations; and regulation 26 and Schedule 5 make provision for the reference to the appropriate committee or the Medicines Commission of decisions to refuse authorisations, amendments etc. Regulation 27 makes provision for the conclusion of a trial. Regulations 28 to 31, and Schedules 1 and 5, make provision for: the conduct of a clinical trial, including the requirement to adhere to the principles of Good Clinical Practice; urgent safety measures to protect trial subjects from immediate hazards; and the suspension and termination of a trial. Schedule 5 includes provisions for referral to the appropriate committee or the Medicines Commission where a trial is suspended or terminated by the licensing authority. Regulations 32 to 35 make provision for pharmacovigilance; i.e. the recording and reporting of adverse events and reactions to medicinal products being used in a clinical trial. Regulations 36 to 45, and Schedules 6 to 8, make provision for the manufacture and importation of medicinal products to be used in clinical trials. In particular they make provision for: authorisations for manufacture, assembly and importation (regulations 36 and 37); the applications for, consideration of and grant or refusal of such authorisations (regulations 38 to 40 and Schedules 6 to 8); the application and effect of authorisations (regulations 41 and 42); the qualified persons responsible for checking the quality of products being manufactured, assembled or imported (regulation 43); and the variation, suspension and revocation of authorisations (regulations 44 and 45 and Schedule 8). Regulation 46 concerns the labelling of such medicinal products. Regulations 47 to 52, and Schedule 9, make provision for enforcement and related matters, including powers of inspection, infringement notices, offences and penalties for breaches of the Regulations. Regulations 53 to 56, and Schedules 10 to 12, contain miscellaneous provisions for the construction of references in authorisations to pharmacopoeias and other publications, for the consequential amendment and revocation of legislation, and for transitional arrangements. A full regulatory impact assessment of the effect that this instrument will have on the costs of business is available from the Medicines and Healthcare products Regulatory Agency, Room 10-202, Market Towers, 1 Nine Elms Lane, London SW8 5NQ. A copy of that assessment, and a Transposition Note in relation to the implementation of Directive 2001/20/EC, have been placed in the libraries of both Houses of Parliament.

Read the full note and every offence in this instrument

What Parliament said

Mentions of this instrument in Hansard. Parliamentary material is reused under the Open Parliament Licence v3.0.

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