UK Offence Report

Criminal offences

regulation 18(4) of The Blood Safety and Quality Regulations 2005

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

4 Any person who knowingly sells or supplies blood or any blood component which is not labelled in accordance with the requirements of regulation 8, 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 This is the text as originally made; later amendments are not shown here.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
selling or supplying something the instrument restricts
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 (knowingly).

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: knowingly.

What would breach regulation 18(4)?

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 knowingly sells or supplies blood or any blood component which is not labelled in accordance with the requirements of regulation 8.
  2. Selling the goods under the Blood Safety and Quality Regulations 2005 where the instrument prohibits the sale outright.
  3. Supplying without carrying out a check the instrument requires first, even where the sale would otherwise be lawful.
  4. Offering for sale counts as well as selling: displaying stock is enough where the provision reaches an offer.

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
Status not determined
Made
13 January 2005
In force from
8 February 2005
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 impose safety and quality requirements on human blood collection and storage. The requirements apply to blood transfusion services in England, Scotland, Wales and Northern Ireland. Many of the provisions of the Regulations also apply to hospital blood banks. The Regulations implement Directive 2002/98/EC of the European Parliament and Council of 27 January 2003 setting out the standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components (“the Directive”) – see OJ L 33, 8.2.2003, p30. They also implement Commission Directive 2004/33/EC – see, OJ L91, 30.3.2004, p25, which contains certain technical requirements relating to blood standards. Regulation 2 provides that the Secretary of State is to be the competent authority for the purposes of the Directive and outlines the scope of the Regulations. Regulation 3 prohibits the carrying on of certain activities relating to blood, unless they are a person authorised by the Secretary of State to act as a blood establishment or carried out by hospital blood banks or persons acting on behalf of an authorised blood establishment or a hospital blood bank. Regulation 4 sets out the procedures to be followed in respect of an application for authorisation and regulation 5 sets out the circumstances tin which the Secretary of State may suspend or revoke such authorisation. Regulations 6 to 8 impose requirements on blood establishments, including requirements relating to “responsible persons” at blood establishments (regulation 6) and the labelling of blood (regulation 8). Regulations 9 and 10 impose requirements on persons responsible for management of hospital blood banks, including requirements to provide information to the Secretary of State (regulation 10). Regulation 11 provides for the service of notices on hospital blood banks by the Secretary of State requiring them to undertake certain actions where they contravene the requirements of these regulations or where there are concerns as to safety. Regulation 12 makes provision for objections to suspensions and revocations of blood establishment authorisations and to notices served on blood establishments and hospital blood banks by the Secretary of State under regulations 5 and 11. Regulation 13 prohibits the import of blood or blood components which do not meet the standards of safety and quality equivalent to those specified in Part 5 of the Schedule to the Regulations. Regulation 14 imposes restrictions on the disclosure of information obtained under the Regulations. Regulations 15 to 21 provide for enforcement and related matters, including powers of inspection notices to provide information, offences and penalties for breaches of the Regulations. Regulation 22 provides for fees payable in relation to blood establishment authorisations and inspections of blood establishments and blood banks. Regulation 23 provides that in the event of a specific epidemiological situation such as a disease outbreak, which necessitates the adoption of deferral criteria additional to those specified in Part 3 of the Schedule, the Secretary of State is to notify the Commission and blood establishments, who are to adopt any additional deferral criteria specified by the Secretary of State. Regulation 24 makes transitional provision for blood establishments and hospital blood banks so that they may continue to operate under existing provisions until 8th November 2005. Regulation 25 makes consequential amendments. A Regulatory Impact Assessment and a Transposition Note have been prepared for these Regulations and a copy of each has been placed in the library of each House of Parliament. Copies of the Regulatory Impact Assessment and the Transposition Note are published on the Department of Health’s website (www.dh.gov.uk) and can be obtained from room 631B SKH, Department of Health, Skipton House, 80 London Road, London SE1 6LH.

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