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	England and Wales Court of Appeal (Criminal Division) Decisions
You are here: BAILII >> Databases >> England and Wales Court of Appeal (Criminal Division) Decisions >> Lee, R v [2010] EWCA Crim 1404 (24 June 2010) URL: http://www.bailii.org/ew/cases/EWCA/Crim/2010/1404.html Cite as: [2011] WLR 418, [2011] 1 WLR 418, (2010) 116 BMLR 147, [2010] EWCA Crim 1404, [2010] 2 Cr App R 26, [2010] 2 Cr App Rep 26

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IN THE HIGH COURT OF JUSTICE
COURT OF APPEAL (CRIMINAL DIVISION)
ON APPEAL FROM THE CENTRAL CRIMINAL COURT, LONDON
THE RECORDER OF LONDON, HHJ BEAUMONT QC
T20090037

		Royal Courts of Justice Strand, London, WC2A 2LL
		24/06/2010

Lord Justice Aikens :

1. On 26 May 2010 we heard the appeal against conviction and sentence in this case which raises novel questions on the construction of the Medicines Act 1968: ("the Act"). In both cases the single judge had granted leave and the necessary extension of time. At the end of the hearing, we announced that we would allow the appeal. However, we also decided to exercise our jurisdiction under section 3A(1) of the Criminal Appeal Act 1968 to substitute a verdict of guilty of another offence in the terms which we set out below. In respect of that substituted verdict we imposed a sentence of a fine of £300 to be paid within 28 days or 14 days imprisonment in default. We said that we would hand down our reasons at a later date. These are our reasons.

The verdict and sentence below.

2. On 2 April 2009 the appellant had pleaded guilty on re-arraignment before The Recorder of London, HHJ Beaumont QC, to a charge of supplying a medicinal product with a misleading label on the package, contrary to sections 85(5)(b) and 91(1) of the Medicines Act 1968. That was count one on the Indictment. The Recorder sentenced the appellant to 3 months imprisonment suspended for 18 months with a requirement of supervision for 12 months.
3. There was a second count on the indictment, alleging that the appellant had supplied a medicinal product which was not of the nature demanded by the purchaser contrary to section 64(1) and section 67(1) of the Act. That charge was ordered to remain on the file on the usual terms.

The Facts giving rise to the charges.

4. There is no dispute about the facts, apart perhaps from one point. We will take the basic facts from the Defence Statement used before the Recorder.
5. The appellant had qualified as a pharmacist in 2000. In 2007 she remained a member of the Pharmaceutical Society of Great Britain. On Thursday, 30 August 2007 she was working as a "locum" pharmacist at Tesco Pharmacy, Dedworth Road, Windsor ("the Pharmacy"). The Pharmacy is a registered pharmacy within the meaning of section 69 of the Medicines Act 1968.
6. Mrs Carmel Sheller was a lady then aged 72. At the time, Mrs Sheller suffered from wheezing, inflammation and infection in one lung. Mrs Sheller's general practitioner had prescribed some medication for her. This prescription was to be dispensed at the Pharmacy.
7. The appellant had worked as a locum pharmacist in a variety of pharmacies until she started work at the Pharmacy in March 2007. She worked there two or three days a week as a locum pharmacist. As such, she was self employed and was not an employee of Tesco Pharmacy. The Pharmacy also employed a variety of other staff.
8. 30 August 2007 was a fairly busy day in which the Pharmacy probably dispensed about 300 items. The appellant worked from 9am until 7pm without a break, save for the time taken to eat lunch in the corner of the dispensary between dealings with prescriptions. That was in keeping with her usual pattern of work.
9. In the early afternoon of 30 August 2007 a prescription was presented for Mrs Sheller. Two types of medicine were prescribed. The first was amoxicillin in capsules. Amoxicillin is an antibiotic. The second was prednisolone in tablet form; that is a steroid.
10. In the Pharmacy, the typical procedure is that one member of staff will enter the details of the prescription on a computer, in order to produce a dispensing label. Another member of staff will then assemble the tablets themselves and will apply the dispensing label to the boxes of medication. A pharmacist will then check the whole dispensed items and initial the dispensing label. A member of staff will hand the assembled medications to the patient or a representative of the patient.
11. The dispensing labels for Mrs Sheller's prescription were produced at 2.41pm. It is not known which assistant prepared the labels. Nor is it known which assistant assembled the medication or handed the medication to Mrs Sheller. However, the dispensing label on each of the two medicines was initialled by the appellant to indicate that she had checked the items.
12. Mrs Sheller's amoxicillin was dispensed accurately.
13. The dispensing label for the prednisolone was properly produced. However, in error this label was applied to a box of propranolol tablets. Propranolol is used for a variety of complaints, including angina, heart arrhythmias and high blood pressure. The fact that box contained propranolol tablets and not prednisolone tablets was not spotted by the appellant.
14. Mrs Sheller took some propranolol tablets. As a result she collapsed and she had to be admitted to hospital. Mrs Sheller recovered from the effects of taking the propranolol tablets in error. However, she later died in hospital from other, natural, causes.
15. The propranolol tablets were a licensed medication made by Alpharma. That product has a Product Licence number 0142/0140. That product is not on the general sales list ("GSL"), a concept to which we refer in more detail below.

The proceedings before the Recorder of London.

16. On 2 April 2009, the case was ready for trial. Before a jury was empanelled to hear the matter, the Recorder heard argument on points of law. He did so pursuant to section 40(1)(b) of the Criminal Procedure and Investigations Act 1996, on the basis that these were questions of law that related to a trial. The judge was asked to rule on six questions of law, which were all questions of construction of various provisions of the Medicines Act 1968. Only one of those questions is relevant to this appeal. That is whether, for the purposes of section 85(5)(b) of the Act, on the facts of this case, a pharmacist in the position of the appellant dispensing medication "supplies a medicinal product" for the purposes of that section. The Recorder held that, for the purposes of that section and also for the purposes of section 64(1) of the Act, that the jury could find that the appellant did supply the medicinal product in question. There is no challenge to that conclusion.
17. Once the Recorder had determined the various points of law, the appellant decided to change her plea of not guilty to count 1 of the Indictment, (that is the charge under section 85(5) and 91(1) of the Medicines Act), to one of guilty. The Recorder then sentenced the appellant in the terms we have indicated. The Recorder ordered Count 2 to lay on the file on the usual terms.

Leave to appeal.

18. Despite the fact that the appellant had pleaded guilty to count 1, the single judge granted leave to appeal. In doing so, he said that the issue concerning the proper scope and application of section 85(5) of the Medicines Act 1968 was sufficiently arguable and important to merit consideration by the Court of Appeal. Before us, Mr John Price QC, appearing for the Crown, accepted that the appeal raised a question of construction of section 85(5) of the Act and that if the appellant's argument as to the proper construction of that section was upheld, then the appellant's conviction must be unsafe. He therefore conceded that if that were the position, the appeal must be allowed despite the guilty plea. On the facts of this case, we regard that as a proper concession to make.

The relevant provisions of the Medicines Act 1968.

19. The relevant parts of sections 64, 67, 85(5), 91, 106, 121 and 132 (1) (definition of "business") of the Medicines Act 1968 provide as follows:

"……

64.— Protection of purchasers of medicinal products.

(1) No person shall, to the prejudice of the purchaser, sell any medicinal product which is not of the nature or quality demanded by the purchaser.

(2) For the purposes of this section the sale of a medicinal product shall not be taken to be otherwise than to the prejudice of the purchaser by reason only that the purchaser buys the product for the purpose of analysis or examination.

(3) Subsection (1) of this section shall not be taken to be contravened by reason only that a medicinal product contains some extraneous matter, if it is proved that the presence of that matter was an inevitable consequence of the process of manufacture of the product.

(4) Subsection (1) of this section shall not be taken to be contravened by reason only that a substance has been added to, or abstracted from, the medicinal product, if it is proved that—

(a) the addition or abstraction was not carried out fraudulently, and did not injuriously affect the composition of the product, and

(b) the product was sold having attached to it, or to a container or package in which it was sold, a conspicuous notice of adequate size and legibly printed, specifying the substance added or abstracted.

(5) Where a medicinal product is sold or supplied in pursuance of a prescription given by a practitioner, the preceding provisions of this section shall have effect as if—

(a) in those provisions any reference to sale included a reference to supply and (except as provided by the following paragraph) any reference to the purchaser included a reference to the person (if any) for whom the product was prescribed by the practitioner, and

(b) in subsection (1) of this section, for the words " " demanded by the purchaser" " , there were substituted the words " " specified in the prescription" " .

…….

67.— Offences under Part III.

(1) The following provisions of this section shall have effect subject to sections 121 and 122 of this Act.

(1A) Any person who gives a prescription or directions or administers a medicinal product in contravention of a condition imposed by an order under section 58 of this Act by virtue of subsection (4A) of that section shall be guilty of an offence.

(1B) Any person who–

(a) is an appropriate practitioner by virtue of provision made under section 58(1) of this Act; and

(b) gives a prescription or directions in respect of a medicinal product of a description or class in relation to which he is not an appropriate practitioner,

shall be guilty of an offence.;

(2) Any person who contravenes any of the following provisions of this Part of this Act, that is to say, sections 52, 58, 63 , 64 and 65, or who contravenes any regulations made under section 60 or section 61 or any order made under section 62 of this Act, shall be guilty of an offence.

(3) Where a medicinal product is sold, supplied or imported in contravention of an order made under section 62 of this Act, any person who, otherwise than for the purpose of performing or exercising a duty or power imposed or conferred by or under this Act or any other enactment, is in possession of the medicinal product, knowing or having reasonable cause to suspect that it was sold, supplied or imported in contravention of the order, shall be guilty of an offence. [

(3A) A person who has in his possession a medicinal product to which paragraph (a) of section 58(2) applies, with the intention of supplying it otherwise than in accordance with the requirements of that paragraph, is guilty of an offence.

(4) Any person guilty of an offence under [subsection (1A), (1B), (2), (3) or (3A)]³ of this section shall be liable—

(a) on summary conviction, to a fine not exceeding [the prescribed sum]⁴; (b) on conviction on indictment, to a fine or to imprisonment for a term not exceeding two years or to both.

(5) Any person who contravenes section 53 or section 54(1) or an order made under section 54(2) of this Act shall be guilty of an offence and liable on summary conviction to a fine not exceeding [level 3 on the standard scale.

(6) Any regulations made under section 66 of this Act may provide that any person who contravenes the regulations shall be guilty of an offence and liable on summary conviction to a fine not exceeding [level 5 on the standard scale]⁶ or such lesser sum as may be specified in the regulations.

…….

85.— Labelling and marking of containers and packages.

…….

(5) Without prejudice to the preceding provisions of this section, no person shall, in the course of a business carried on by him, sell or supply, or have in his possession for the purpose of sale or supply, a medicinal product of any description in a container or package which is labelled or marked in such a way that the container or package—

(a) falsely describes the product, or

(b) is likely to mislead as to the nature or quality of the product or as to the uses or effects of medicinal products of that description.

[Emphasis added]

…..

91.— Offences under Part V, and supplementary provisions.

(1) Subject to sections 121 and 122 of this Act, any person who contravenes the provisions of [section 85(5) or section 86(3) or (4)]¹ of this Act shall be guilty of an offence and liable—

(a) on summary conviction, to a fine not exceeding [the prescribed sum];

(b) on conviction on indictment, to a fine or to imprisonment for a term not exceeding two years or to both.

(2) Any regulations made under this Part of this Act may provide that any person who contravenes the regulations, or who contravenes the provisions of section 85(3), section 86(2) or section 87(2) of this Act [...], shall be guilty of an offence and—

(a) shall be liable on summary conviction to a fine not exceeding [level 5 on the standard scale] or such lesser sum as may be specified in the regulations, and

(b) if the regulations so provide, shall be liable on conviction on indictment to a fine or to imprisonment for a term not exceeding two years or to both.

(3) Without prejudice to the application of section 129(5) of this Act, any power to make regulations conferred by sections 85 to 87 of this Act may be exercised so as to impose requirements either in relation to medicinal products generally or in relation to medicinal products of a particular description, or falling within a particular class, specified in the regulations [...].

(4) In this Part of this Act "requirements" includes restrictions.

……

106.— Extension of references to carrying on business.

(1) The Ministers may by order direct that such provisions of this Act as may be specified in the order, in so far as they relate to things done by a person in the course of a business carried on by him, shall have effect, subject to such exceptions and modifications as may be specified in the order, as if in those provisions any reference to a business included a reference to an activity (other than a business) of a description specified in the order.

(2) Without prejudice to the preceding subsection, the Ministers may by order direct that such provisions of this Act as may be specified in the order, in so far as they relate to things done by a person in the course of a business carried on by him, shall have effect, subject to such exceptions and modifications as may be specified in the order, as if, in such circumstances as may be so specified, a business carried on by a person's employer were a business carried on by that person.

……

121.- (1) Where a contravention by any person of any provision to which this section applies constitutes an offence this Act, and is due to an act or default of another person, then, whether proceedings are taken against the first-mentioned person or not, that other person may be charged with and convicted of that offence, and shall be liable on conviction to the same punishment as might have been imposed on the first-mentioned person if he had been convicted of the offence.

(2) Where a person who is charged with an offence under this Act in respect of a contravention of a provision to which this section applies proves to the satisfaction of the court-

(a) that he exercised all due diligence to secure that the provision in question would not be contravened, and

(b) that the contravention was due to the act or default of another person,

the first-mentioned person shall, subject to the next following subsection, be acquitted of the offence.

(3) A person shall not, without the leave of the court, be entitled to rely on the defence provided by subsection (2) of this section unless, not later than seven clear days before the date of the hearing, he has served on the prosecutor a notice in writing giving such information identifying, or assisting in the identification of, the other person in question as was then in his possession.

(4) This section applies to the following provisions, that is to say, sections 63 to 65, 85 to 90, and 93 to 96, and the provisions of any regulations made under any of those sections.

……

132.— General interpretation provisions.

(1) In this Act, except in so far as the context otherwise requires, the following expressions have the meanings hereby assigned to them respectively, that is to say:—

……

" business" includes a professional practice and includes any activity carried on by a body of persons, whether corporate or unincorporate;…"

20. It is important to note that the appellant was charged with an offence based upon a breach of section 85(5)(b) only. There was no allegation that the label on the package supplied to Mrs Sheller "falsely" described the product, as contemplated by section 85(5)(a). That might involve issues of the state of mind of the appellant at the time and that was not the subject of any admission or, of course, conclusion of the jury. We say no more about that.

The Issue raised on this appeal.

21. It is clear that, between them, sections 85(5)(b) and 91(1) of the Medicines Act create an offence. It was accepted by Mr Orlando Pownall QC, appearing for the appellant, that, for the purposes of section 85(5)(b) and on the facts of this case as set out in the Defence Statement, this appellant was a person who supplied a medicinal product in a package which was labelled in such a way that the package was likely to mislead as to the nature or quality of the product or as to its uses or effects.
22. Mr Pownall also accepted, as we understood it, that section 85(5)(b) and 91(1) together create an offence of strict liability in the sense that the Crown does not have to prove any mens rea in relation to the selling or supplying of the medicinal product or in relation to the misleading nature of the labelling or marking. It is enough for the Crown to prove that the person sells or supplies or possesses the medicinal products in a container or package that is, in fact, labelled or marked in such a way that it will, objectively speaking, be likely to mislead as to the nature or quality of the product or as to the uses or effects of the medicinal products of the description given on the labelling or marking.
23. Therefore the issue of construction that arises is this: for the purposes of section 85(5), was the appellant, as a self-employed locum pharmacist engaged by Tesco Pharmacy on 30 August 2007, capable of being a person, who "in the course of a business carried on by her", sold or supplied or had in her possession for the purposes of sale or supply medicinal products in a package that was likely to mislead as to the nature or quality of the product in the package.

The rival constructions of section 85(5)

24. The rival arguments on the construction of section 85(5) are these: for the appellant, Mr Pownall submits that the appellant cannot come within the ambit of section 85(5)(b) because she was "not acting in the course of a business carried on by her" when the propranolol tablets were supplied to Mrs Sheller in error. He submits that there can only be one "person" carrying on the business at any one time. That "person" was Tesco Stores in this case. Mr Pownall accepts that pharmacy transactions were being carried out on Tesco Store's behalf by the appellant and others. But the appellant had been engaged as a self-employed locum pharmacist and she did not carry on the business herself.
25. Mr Price submits that it is important to recall the purpose of the Medicines Act which was enacted in the wake of the Thalidomide scandal in the mid – 1960s. The Act's object is, amongst other things, to control those who have the ability to supply medicines so as to protect the consumer. He submits that section 85(5) is concerned with the accuracy of the labelling and marking of medicinal products sold or supplied or held for sale or supply to the public.
26. Mr Price submits that the short answer to the proper construction of the words "…in the course of a business carried out by him…" is provided by the definition section of the Act, section 132(1), which sets out a definition of "business". This is stated to include "… a professional practice and includes any activity carried on by a body of persons, whether corporate or unincorporated". Therefore, Mr Price submits, the appellant is included in section 85(5)(b) by virtue of her professional status as a pharmacist; she was carrying on her professional practice as a pharmacist on 30 August 2007. Moreover, he submits that it is clear from the fact that section 132(1) stipulates that a business includes any activity carried on by a "body of persons" that it can also be carried on by one person, such as a sole practitioner.

Analysis of the relevant provisions of the Medicines Act 1968

27. The Medicines Act 1968 is divided into various Parts. Part III, in which section 64 is to be found, is headed "further Provisions relating to dealings with medicinal products". Section 51 provides that ministers can, by order, specify descriptions or classes of medicinal products that can safely be sold or supplied other than by, or under the supervision of, a pharmacist. Such medicinal products will be on a so-called "general sale list": see section 51(2).
28. Section 52(1) stipulates that from an appointed day:

"no person shall, in the course of a business carried on by him, sell by retail, offer or expose for sale by retail, or supply in circumstances corresponding to retail sale, any medicinal product which is not a medicinal product on a general sale list unless, (a) that person is, in respect of that business, a person lawfully conducting a retail pharmacy business; (b) the product is sold, offered or exposed for sale, or supplied, on premises which are a registered pharmacy; and (c) that person, or if the transaction is carried out on his behalf by another person, then that other person, is, or acts under the supervision of a pharmacist".

[Emphasis added].

29. So the general scheme of sections 51 and 52 is that no person shall, "in the course of a business carried on by him" sell by retail offer or expose for sale by retail and so forth, any medicinal product which is not on the general sale list, unless that person is, "in respect of that business", first, lawfully conducting a retail pharmacy business; secondly, on premises which are registered as a pharmacy; and thirdly, a pharmacist, or the transaction is supervised by a pharmacist. Section 67 of the Act makes it an offence to contravene section 52. A person charged with contravening sections 52 and 67 can utilise the defences set out in section 121 of the Act: see above.
30. Therefore section 52 focuses on what is required of the "person" who is carrying on a business involving the sale by retail and so forth of medicinal products which are not on the "general sales list". It is noteworthy that section 52(1)(c) provides for the case where a transaction (ie. the sale by retail of medicinal products and so forth) is carried out on behalf of the "person" who is carrying on the business. In such a case the person carrying out the transaction itself must do so under the supervision of a pharmacist. This therefore distinguishes between the person who is carrying on the business which involves the sale by retail etc of medicinal products and the person who carries out the actual transaction itself.
31. Section 64(1) and 67 of Part III make it an offence if a person, to the prejudice of the purchaser, sells any medicinal product which is not of the nature or quality demanded by the purchaser. The effect of section 64(5) together with section 67 is to make it an offence when the same thing occurs in relation to medicinal products supplied in pursuance to a prescription.
32. The important point to note about section 64 is that the prohibition is directed at the actual person who sells or supplies the medicinal products. There is no wording that relates the sale to the person who does so "in the course of a business carried on by him".
33. It must be accepted, of course, that "person" in the Act must, where appropriate, include both natural persons and legal persons such as companies and other bodies corporate or incorporate. That is clear from both the Interpretation Act 1978 (Schedule 1) and also the provisions of sections 69 to 71 of the Medicines Act itself.
34. Sections 69 to 71 set out the conditions that must be fulfilled by either an individual, a partnership or a body corporate before such "person" can be said lawfully to be conducting a "retail pharmacy business". Section 71 stipulates what a body corporate, such as Tesco, has to do in order lawfully to be carrying on a retail pharmacy business with regard to keeping, preparing and dispensing medicinal products on a retail basis, other than those on the general sale list. Fundamentally, the business has to be carried on under the personal control of a pharmacist. The name and certificate of registration of the pharmacist under whose personal control the business is carried on at the relevant premises has to be displayed: see section 71(1)(a). We understand that the appellant's name was not displayed at the Pharmacy on 30 August 2007, although Mr Pownall conceded that it should have been.
35. Section 85 comes in Part V of the Act, headed "Containers, Packages, and Identification of Medicinal Products". Section 85 itself is intended to regulate the labelling and marking of medicinal products to ensure that the medicinal products in containers or packages are correctly described and also that accurate information in relation to the products is given to the user of the medicinal products. It applies to medicinal products which can be and those which cannot be on the "general sales list" as defined in sections 51 and 52. It is noteworthy that section 85 has two other prohibitions in addition to that in section 85(5). Thus section 85(3) stipulates: "No person shall, in the course of a business carried on by him, sell or supply, or have in his possession for the purposes of sale or supply, any medicinal product in such circumstances as to contravene any requirements imposed by regulations under…" section 85. Section 85(4) prohibits a person, "in the course of a business carried on by him", from selling or supplying a medicinal product to which requirements imposed by regulations apply, otherwise than in a container. In both those cases and in the case of section 85(5) the prohibition is directed at the person who, "in the course of a business carried on by him…", sells or supplies (and so forth) any medicinal products.
36. The same formula that is used in section 85(5) is used in relation to prohibitions concerning leaflets as set out in section 86(3) and prohibitions on the sale or supply of medicated animal feedstuffs, as set out in section 90(2). Failure to abide by those prohibitions are all made offences by section 91.
37. Part VIII is headed "Miscellaneous and Supplementary Provisions". It contains section 106, which we have set out above and which we regard as important for the purposes of construing section 85(5) of the Act. Section 106(1) states that ministers can, by order, direct that provisions in the Act, in so far as they relate to things done by a person "…in the course of a business carried on by him", shall have effect as if in those provisions any reference to a business included any reference to an activity other than a business, as described in the order. This appears designed to enable ministers to identify other activities which a person might carry on (other than a "business"), in the course of which that person might be able to sell or supply medicinal products, but which activities, if not included in an order, might not fall within the scope of the prohibitions set out in such sections as 52, 85 and 86 of the Act.
38. Section 106(2) is, in our view, of the greatest importance to the correct construction of section 85(5) for the purposes of this case. So we repeat its provisions here:

"106.— Extension of references to carrying on business.

…….

(2) Without prejudice to the preceding subsection, the Ministers may by order direct that such provisions of this Act as may be specified in the order, in so far as they relate to things done by a person in the course of a business carried on by him, shall have effect, subject to such exceptions and modifications as may be specified in the order, as if, in such circumstances as may be so specified, a business carried on by a person's employer were a business carried on by that person.".

39. This subsection therefore envisages a situation where there is an employer who is "carrying on a business" and that business is being conducted on his behalf by someone engaged by "a person's employer". The subsection enables ministers to identify circumstances (by reference to provisions in the Act) in which references to things done by a person "in the course of a business done by him" shall have effect as if the business carried on by a person's employer were a business carried on by "that person". In other words, the minister can, by order, state that, in the circumstances identified, the business carried on by the employer is also carried on by the employee. For these purposes, "business" must include a professional practice. So where an employer is carrying on a professional practice, the Minister can, by order, stipulate that in circumstances as prescribed, the employee will also be carrying on that professional practice.
40. Mr Price accepted in argument that "employer" is not confined to someone who employs others under contracts of service. He accepted that "employer" would also cover those who engage persons for services under terms which made them either "workers" or self-employed for the purposes of UK employment legislation. Mr Price and Mr Pownall informed us that no orders have been made by Ministers under either section 106(1) or (2).

Discussion on the construction of section 85(5).

41. The words in section 85(5) "…in the course of a business carried on by him…" have to be given some sensible meaning. The section cannot be read as if those words did not exist and as if the section referred simply to a person who sells or supplies or has in his possession for the purpose of sale or supply, a medicinal product in a container or package which is likely to mislead and so forth. So the question is: what is the purpose of having those words in that section and in so many others to which we have referred already in this judgment? In our view, the key is provided by section 52, which lays down the basic prohibition on a person selling or exposing for sale or offering for sale medicinal goods which are not on the general sale list, "in the course of a business carried on by him" unless certain conditions are fulfilled. That section is aimed at persons who carry on business and it sets out what the person must do in respect of that business if they want to sell medicinal goods not on the general sale list. In other words, it is concentrating on the person who is carrying on the business that involves the sale or supply of medicinal products. So it invites the question: who was carrying on the business, in the course of which there is to be a sale or supply (and so forth) of medicinal products not on the general sales list?
42. Looking again at section 85(5), it seems to us that the section is aimed at ensuring that the person "carrying on the business" will label and mark medicinal products correctly. So we think that we have to ask: was the appellant selling or supplying the mislabelled drugs "in the course of a business carried on by her"? The short answer to that is that she was not, because the business was not being carried on by her, but by Tesco Pharmacy. But that answer must be subject to the argument raised by Mr Price concerning the definition of "business" in section 132(1) of the Act.
43. He submits that because "business" in section 132(1) is defined as including a professional practice and includes any activity carried on by a body of persons whether corporate or unincorporated, that must mean that the appellant was carrying on a business on 30 August 2007, because she was carrying on her professional practice as a pharmacist on that date. We do not accept that submission. The extension of the meaning of the word "business" is to prevent a professional person who carries on the business of a pharmacy from saying: "I do not carry on a business; I am a professional. I carry on a professional practice as a pharmacist as a member of the Pharmaceutical Society of Great Britain. Therefore this sale was not made by me in the course of a business carried on by me". Mr Price's argument does not answer the question: whose business (or professional practice) was being carried on at the relevant time, in the course of which the medicines were supplied? Was it the appellant's or was it Tesco's business?
44. We think that our construction of section 85(5) is reinforced by the provisions of section 106(2) of the Act. The subsection, (like section 52(1)(c)), clearly draws a distinction between that which is done by the person engaged by the employer and the business carried on by the employer of that person. In our view section 106(2) contemplates that without an order under this section being made, the business being carried on when there is an employer and someone engaged by the employer, is the business of the employer and is not the person engaged by the employer. It is only if an order is made under this section that the business carried on by the person engaged by the "employer" will have effect as if it were the business of the employer, but carried on by the person engaged by him. It must follow from that, in the absence of any order under section 106(2), the proper construction of section 85(5) is that the person who is carrying on the business for the purposes of that section is the employer, not the "employee".
45. We think that analysis fits in with other sections in the Act. First, it leaves the person who actually does the selling or prescribing, liable to be prosecuted for an offence under section 64(1) and 67 if that person sells, or supplies pursuant to a prescription, any medicinal product which is not of the nature or quality demanded by the purchaser or specified in the prescription. As we will discuss more fully in a moment, in our view that covers the present case exactly. Secondly, if we are correct that section 85(5) and 91 are aimed at "the person" who is carrying on the business and those sections create a strict liability offence, then if the person who carries on the business is not personally at fault and has exercised all due diligence under the Act, that person could have a defence to a charge under section 85(5) of the Act, under section 121(2) of the Act.
46. It follows that, on the facts of this case, the appellant was not capable of being the person carrying on a business for the purposes of section 85(5)(b). Therefore all the ingredients of the actus reus of the offence created by that section and section 91 are not fulfilled. So the conviction on count 2 must be quashed.

Consequences: substitution of verdict under section 3A of the Criminal Appeal Act 1968?

47. That leads on to the Crown's submission that this court should exercise its powers under section 3A of the Criminal Appeal Act 1968, which was added by the Criminal Justice Act 2003 sections 316(1) and (3). Section 3A of the 1968 Act provides:

"Power to substitute conviction of alternative offence after guilty plea

3A. – (1) This subsection applies on an appeal against conviction where –

(a) an appellant has been convicted of an offence to which he pleaded guilty.

(b) if he had not so pleaded, he could on the indictment pleaded, or been found guilty, of some other offence; and

(c) it appears to the Court of Appeal that the plea of guilty indicates an admission by the appellant of facts which prove him guilty of the other offence.

(2) The Court of Appeal may, instead of allowing or dismissing the appeal, substitute for the appellant's plea of guilty a plea of guilty of the other offence and pass sentence in substitution for the sentence passed at the trial as may be authorised by law for the other offence , not being a sentence of greater severity."

48. Mr Price invites us to substitute a conviction under section 64(1) of the Act. Section 3A(1)(a) is obviously satisfied because the appellant pleaded guilty to the offence under section 85(5)(b) of the Act contained in count 1 of the Indictment. Mr Price submits that section 3A(1)(b) is satisfied because the offence under sections 64 and 69 was contained in a count on the Indictment (count 2) and that remains on the court file, subject to any orders of this court and the Crown Court. Mr Price submits that section 3A(1)(c) is also satisfied because, on the admissions made in the Defence Statement, the appellant is guilty of the offence that is covered by section 64(1) as modified by section 64(5) for the purposes of prescription given by a practitioner, ie a doctor. That is because, as Mr Pownall accepts, the appellant supplied a medicinal product not of the nature or quality specified in the prescription.
49. In R v R and others [2007] 1 Cr App R 10, [2006] EWCA Crim 1974, Hughes LJ, giving the judgment of the court, said (at paragraph 48) that section 3A of the 1968 Act imposed a two stage test. The court considering substitution had to ask: (1) could the jury have convicted on the trial indictment of the substitute offence; and if it could, then (2) does the plea of guilty (to the offence to which the original plea was made), indicate an admission of facts proving the defendant guilty of the substitute offence?
50. It seems to us that these two tests are satisfied on the facts we have set out above. The appellant pleaded guilty to the section 85(5)(b) offence, set out in count 1 of the Indictment. The section 64 offence was on the trial indictment as count 2. The plea to the section 85(5)(b) offence was made on the basis of the Defence Statement. That admitted that the appellant "supplied" the medicinal product, ie. propranolol, which is a beta-blocker, which was not of the nature or quality specified in the prescription, which was the drug prednisolone, which is of a different quality or nature, being a steroid.
51. Mr Pownall did not dispute that this court had jurisdiction to make the substitution of conviction pursuant to section 3A of the 1968 Act, but he submitted that we should exercise our discretion against doing so. Having considered the various possible courses open to this court in the light of our conclusion that the conviction on count 1 must be quashed and the various factors mentioned by Mr Pownall, we decided that we should exercise the jurisdiction given to the court under section 3A. Accordingly, we substitute a conviction on count 2 for that we have quashed on count 1.

Sentence.

52. We must now consider the question of sentence. We accept Mr Pownall's submission that the sentence that had been imposed in respect of count 1 was manifestly excessive. We accept that what occurred was an error; it was, at worst, an isolated act of negligence by the appellant. It was a dreadful error which caused Mrs Sheller to collapse. But, as all accept, the error did not, either as a matter of law or fact, cause her death. She died of other, natural, causes.
53. The error has had a profound effect on the family of Mrs Sheller and the effect will not be easily forgotten; nor should it be. But we also accept that the error has had a very great effect on the appellant, who is a young woman of otherwise impeccable character and who has a family which has supported her throughout these proceedings. She has felt compelled to resign her membership of the Pharmaceutical Society of Great Britain. She says she will never again practice as a pharmacist. At present she works as a cleaner in her Church and she earns £3000 a year doing this job. We have seen the very many letters which speak of her good character and her many good works.
54. The offence committed under section 64(1) in the circumstances of this case does not pass the custody threshold. There is, in our view, no place for a community order. The proper penalty is a fine. We set that at £300. We do so on the basis that if this case had been pursued under section 64 then it would have been most likely to go before a Magistrates' court. (It was the prosecution's decision to pursue the matter in the Crown Court in this case). In the Magistrates' Court the maximum fine would have been £400. We discounted that to £300 to take account of the guilty plea. The fine must be paid within 28 days and there is a sentence of 14 days imprisonment in default.