UK Offence Report

Amendment of Schedule 3

paragraph 3(2) of SCHEDULE 5 of The Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations 2010 (revoked)

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 relevant person who fails— a to establish a traceability system in accordance with the requirements set out in Article 15(1) of the ATMP Regulation; b where the product contains human cells or tissues, to ensure that the traceability system is complementary to and compatible with, the requirements laid down in Articles 8 and 14 of Directive 2004/23/EC as regards human cells and tissues other than blood cells, and Articles 14 and 24 of Directive 2002/98/EC as regards blood cells; or c to keep the data to which the traceability system relates in accordance with the requirements set out in Article 15(4) of the ATMP Regulation, 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 This is the text as originally made; later amendments are not shown here.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
failing to do something the instrument requires
Fault element
Strict liability
Burden of proof
No statutory defence — prosecution proves everything

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

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

What would breach paragraph 3(2) of SCHEDULE 5?

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. Not doing what the provision requires under the Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations 2010, by the time it requires it to be done.
  2. Doing it, but not in the manner or to the standard the instrument specifies.

Penalty

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

no penalty is stated here: this instrument amends another one, and the penalty for the offence is in the instrument being amended.

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
21 July 2010
In force from
19 August 2010
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 provide for the enforcement of Regulation (EC) No.1394/2007 of the European Parliament and of the Council on advanced therapy medicinal products (“ATMPs”). Regulation 2 disapplies section 7 of the Medicines Act 1968 (which is concerned with product licences for medicinal products which are not subject to the European Union law governing medicines) in relation to exempt ATMPs. Regulation 3 gives effect to— a Schedule 1 which sets out requirements which have effect as provisions of manufacturers’ licences insofar as they relate to exempt ATMPs; b Schedule 2 which sets out requirements which may be incorporated in manufacturers’ licences insofar as they relate to exempt ATMPs; c Schedule 3 which sets out requirements which have effect as provisions of wholesale dealers’ licences insofar as they relate to exempt ATMPs; and d Schedule 4 which sets out requirements which may be incorporated in wholesale dealers’ licences insofar as they relate to exempt ATMPs. Regulation 4 makes it an offence to treat a patient with an ATMP if there is not a system of patient and product traceability. It is a defence to that offence if the person is assured in writing that there is such a system in relation to the treatment. A person commits an offence if they provide such a written assurance when there is not a system in place in relation to such treatment. Regulation 5 makes provision as to data relating to starting and raw materials of exempt ATMPs including substances coming into contact with the cells or tissues that exempt ATMPs may contain. It subjects a holder of a manufacturing licence in respect of an exempt ATMP to liability for a criminal offence if that person does not keep data required as part of a traceability system for 30 years or, in the event of that person’s bankruptcy or liquidation, transfer it to the licensing authority. Regulation 6 amends the Medicines (Standard Provisions for Licences and Certificates) Regulations 1971 so that they do not apply in relation to exempt ATMPs. Regulation 7 amends the Medicines (Applications for Manufacturer’s and Wholesale Dealer’s Licences) Regulations 1971 so that an applicant for a manufacturer’s licence which relates to exempt ATMPs must provide an outline of the arrangements for maintaining records to allow product traceability containing sufficient detail to enable linking a product to the patient who received it and vice versa. Regulation 8 and Schedule 5 amend the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 to enable enforcement of the provisions of Regulation (EC) No 1394/2007 (other than in relation to exempt ATMPs). They also give effect to the decision of the European Court of Justice in C-143/06 Ludwigs-Apotheke München Internationale Apotheke v Juers Pharma Import-Export GmbH by permitting price lists to be issued that do not make representations in respect of a product supplied in response to a bona fide unsolicited order, formulated in accordance with the specification of a doctor, dentist or supplementary prescriber and for use by that person’s individual patients on that person’s direct personal responsibility, in order to fulfil the special needs of those patients. They also make an amendment to take into account an amendment to Directive 2001/83 of the European Parliament and of the Council by Commission Directive 2009/120/EC. Regulation 9 amends the Medicines for Human Use (Clinical Trials) Regulations so that the procedures for giving an ethics committee opinion and for authorising clinical trials apply to trials involving tissue engineered products in the same way that they apply to trials involving gene therapy and somatic cell therapy. It also corrects an error in Schedule 2 to those Regulations. Regulation 10 amends the Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005 so that they do not apply to ATMPs. It also gives effect to the decision of the European Court of Justice in C-143/06 by permitting holders of wholesale dealer’s licences or manufacturer’s licences to issue price lists that do not make representations in respect of a product to which paragraph 1 of Schedule 1 to the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994. These Regulations (other than the amendment resulting from Commission Directive 2009/120) have been notified to the European Commission and other Member States of the European Union in accordance with Directive 98/34/EC of the European Parliament and of the Council laying down a procedure for the provision of information in the field of technical standards and regulations and rules on Information Society services, as amended by Article 1(4) of the European Parliament and Council Directive 98/48/EC and Council Directive 2006/96/EC of 20 November 2006. An Impact Assessment has been prepared in respect of these Regulations which is available from the Medicines and Healthcare products Regulatory Agency, Market Towers, 1 Nine Elms Lane, London SW8 5NQ.

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