Offences relating to Commission Regulation 2016/161

Q: Is regulation 94A(1) of The Human Medicines (Amendment) Regulations 2019 a strict liability offence?

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 holder meant to do it, knew about it, or was careless.

regulation 94A(1) of The Human Medicines (Amendment) Regulations 2019

Status not determined
Strict liability
Drugs and medicines

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

1 The holder of
a marketing authorisation or parallel import licence, or
a parallel distributor, is guilty of an offence if the holder fails to comply with
a requirement or obligation contained in
a provision of Commission Regulation 2016/161 listed in paragraph (2).

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 This is the text as originally made; later amendments are not shown here.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 holder
Conduct: failing to comply with a notice or direction
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 holder 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 regulation 94A(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.

On these words an offence is committed where a holder fails to comply with a requirement or obligation contained in a provision of Commission Regulation 2016/161 listed in paragraph (2).
Being served with a notice under the Human Medicines (Amendment) Regulations 2019 and doing nothing by the date it specifies.
Doing part of what the notice requires, where it required all of it.
Disagreeing with the notice and ignoring it, rather than using whatever appeal the instrument provides.

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.

Drug offences: definitive guideline Magistrates' courts and the Crown Court in England and Wales
Covers importation, supply, production and possession of controlled drugs, with sentencing driven by drug class and the offender's role.
Reduction in sentence for a guilty plea: definitive guideline All courts in England and Wales · in force from 1 June 2017
The sliding scale of credit for pleading guilty, from one third at the first stage of proceedings downwards.
General guideline: overarching principles All courts in England and Wales · in force from 1 October 2019
The guideline a court uses when there is no offence-specific guideline, which is the position for the overwhelming majority of offences created by statutory instrument. It sets out how culpability and harm are assessed from first principles.
Totality: definitive guideline All courts in England and Wales
How to sentence more than one offence at once so that the total is just and proportionate - frequently in point here, because regulatory prosecutions commonly charge several breaches of the same instrument.

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: 14 January 2019
In force from: 9 February 2019
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

These Regulations amend the Human Medicines Regulations 2012 (“the 2012 Regulations”) in order to implement— points 8, 9, 11 and 12 of Article 1 of Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products (“Directive 2011/62/EU”); Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use (“the Delegated Regulation”). These regulations further amend the 2012 Regulations in order to widen the type of products containing naloxone hydrochloride that drug treatment services are able to supply for the purpose of saving life in an emergency and to introduce serious shortage protocols. Regulations 3 to 8, 10 and 12 to 15 amend the 2012 Regulations in order to ensure that the provisions of the Delegated Regulation are enforceable in the United Kingdom. Regulations 11, 17 and 19 amend the 2012 Regulations in order to transpose the changes made to Directive 2001/83 by points 8, 9, 11 and 12 of Article 1 of Directive 2011/62/EU. Regulation 9 amends the 2012 Regulations in order to provide for the sale or supply of prescription only medicines by retail pharmacy businesses under a severe shortage protocol issued by the Ministers. The Ministers will have powers to issue such protocols where, in their opinion, the United Kingdom or part of the United Kingdom is experiencing or may experience a severe shortage of particular prescription only medicines. The protocols will allow for substitution, in restricted circumstances, of a different quantity of a prescription only medicine, or a different prescription only medicine, to that ordered by the prescriber. Regulation 16 amends regulation 346 of the 2012 Regulations so that the new provisions are subject to review by the Secretary of State. Regulation 18 amends Schedule 17 of the 2012 Regulations in order to allow naloxone hydrochloride that is for non-parenteral administration to be supplied by drug treatment services for the purpose of saving life in an emergency. A transposition note and impact assessment of the impact of these Regulations on the private and public sector is published with the Explanatory Memorandum alongside the instrument on www.legislation.gov.uk. Copies may also be obtained from the Department of Health and Social Care, 2E14 Quarry House, Leeds, LS2 7UE.

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.

Human Medicines (Amendment) Regulations Commons · 18 March 2019 · Jonathan Ashworth (Leicester South) (Lab/Co-op)
I beg to move, That the Human Medicines (Amendment) Regulations 2019 (S.I., 2019, No. 62), dated 14 January 2019, a copy of which was laid before this House on 18 January, be revoked. This motion concerns the serious shortage protocol. I thank the business managers for allowing time for this debate, but it really should not have come about as a result of the Official Opposition tabling a prayer against the…
Interserve Commons · 18 March 2019 · Mr Deputy Speaker (Sir Lindsay Hoyle)
The hon. Gentleman has resolved the matter by putting it on the record. I know that through his good offices, and given his background, he will not let the issue drop today. I am sure that he will find other methods to ensure that he continues to support the employees whose jobs may be at risk. Business of the House (Today) Ordered, That, at this day’s sitting, proceedings on the Motion in the name of Jeremy Corbyn…
Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 Lords · 30 September 2019 · Baroness Thornton (Lab)
I thank the Minister and welcome him to the world of EU health statutory instruments and their amendments—whether it is just for today or for a longer period. I also thank him for his explanation. I really hope that the Government have managed to get it right this time—I am not quite sure whether I have visited this twice or three times in the last year or so. This statutory instrument comes into force immediately…
Community Pharmacies Commons · 2 October 2019 · Holly Lynch (Halifax) (Lab)
I beg to move, That this House has considered the role of community pharmacies. May I say what a pleasure it is, Sir David, to serve under your chairship this morning, and to have you join us for this important debate? Between the ages of 14 and 18 I worked in a local chemist shop two evenings a week and some Saturday mornings. There were the usual first job responsibilities: restocking shelves, cleaning, and…

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

This provision on legislation.gov.uk The authoritative text. Check it before relying on anything here.
The Human Medicines (Amendment) Regulations 2019 Every offence this instrument creates, and its explanatory note
Drugs and medicinesOther offences on the same subject
Offences created in 2019