Date: 19.6.1986
PHARMACEUTICAL SOCIETY OF GREAT
(RESPONDENTS)
BRITAIN AND STORKWAIN LTD.
(APPELLANTS)
(On Appeal from the Divisional Court of the Queen's Bench Division)
LORD BRIDGE OF HARWICH
My Lords,
For the reasons given in the speech of my noble and learned friend Lord Goff of Chieveley, with which I agree, I would dismiss this appeal.
LORD BRANDON OF OAKBROOK
My Lords,
I have had the advantage of reading in draft the speech prepared by my noble and learned friend, Lord Goff of Chieveley. I agree with it, and for the reasons which he gives I would dismiss the appeal.
LORD TEMPLEMAN
My Lords,
For the reasons given by my noble and learned friend, Lord Goff of Chieveley, I would dismiss the appeal.
LORD ACKNER
My Lords,
I have had the advantage of reading in draft the speech prepared by my noble and learned friend, Lord Goff of Chieveley, and for the reasons he gives I would dismiss the appeal.
LORD GOFF OF CHIEVELEY
My Lords,
This appeal is concerned with a question of construction of section 58 of the Medicines Act 1968. Section 58(2)(a) of the Act provides:
"(2) Subject to the following provisions of this section —
(a) no person shall sell by retail, or supply in circumstances corresponding to retail sale, a medicinal product of a description, or falling within a class, specified in an order under this section except in accordance with a prescription given by an appropriate practitioner; ..."
By section 67(2) of the Act of 1968, it is provided that any person who contravenes, inter alia, section 58 shall be guilty of an offence. The question which has arisen for decision in the present case is whether, in accordance with the well-recognised presumption, there are to be read into section 58(2)(a) words appropriate to require mens rea, on the principle stated in Reg. v. Tolson (1889) 23 QBD 168, and Sweet v. Parsley [1970] AC 132.
The matter has arisen in the following way. On 2 February 1984, informations were preferred by the prosecutor, the Pharmaceutical Society of Great Britain, against the defendants, Storkwain Ltd., alleging that the defendants had on 14 December 1982 unlawfully sold by retail certain medicines. It was alleged that they unlawfully sold by retail, to a person purporting to be Linda Largey, 200 Physeptone tablets and 50 Ritalin tablets; and that they unlawfully sold by retail, to a person purporting to be Thomas Patterson, 50 ampoules of Physeptone and 30 Valium tablets. All these medicines are substances controlled under article 3(1)(b) of the Medicines (Prescription only) Order 1980 (S.I. 1980, No. 1921); and the informations alleged in each case that the sale was not in accordance with a prescription issued by an appropriate practitioner, contrary to section 58(2) and section 67(2) of the Act of 1968. Before the magistrate, the evidence (which was all agreed) was to the effect that the medicines were supplied under documents which purported to be prescriptions signed by a doctor, Dr. Irani, of Queensdale Road, London; but that subsequent inquiries revealed that the prescriptions were both forgeries. It was submitted on behalf of the defendants that the presumption of mens rea applied to the prohibition in section 58(2)(a) of the Act of 1981; and that, the medicines having been supplied by the defendants on the basis of prescriptions which they believed in good faith and on reasonable grounds to be valid prescriptions, the informations should be dismissed. The magistrate accepted that submission and accordingly dismissed the informations; but he stated a case for the opinion of the High Court, the question for the opinion of the court being whether or not mens rea was required in the case of a prosecution under sections 58(2) and 67(2) of the Medicines Act 1968. On 2 May 1985, a Divisional Court (Farquharson and Tudor Price JJ.) answered the question in the negative, and accordingly allowed the appeal of the prosecutor and directed that the case should be remitted to the magistrate with a direction to convict. The Divisional Court certified the following point of law as being of general public importance:
"Whether the prosecution has to prove mens rea where an information is brought under section 58(2)(a) of the Medicines Act 1968, where the allegation is that the supply of prescription only drugs was made by the [defendants] in accordance with a forged prescription and without fault on their part."
From that decision, the defendants now appeal with leave of Your Lordships' House, the Divisional Court having refused leave.
In order to consider this question, it is first necessary to set out the provisions of the Act of 1968 which are of immediate relevance. Under Part III of the Act of 1968, medicinal products (as defined by the Act) are segregated into three categories. These are: (1) the general sale list, which comprises medicines which can be sold otherwise than under the supervision of a pharmacist; (2) pharmacy only medicines, which can be supplied only under the supervision of the pharmacist; (3) prescription only medicines, which can only be supplied in accordance with a prescription given by an appropriate practitioner. Section 51 makes provision for the general sale list. Section 53 provides for the conditions under which medicinal products on the general sale list may be sold, and, "Subject to any exemption conferred by or under this Part of this Act," prohibits, inter alia, retail sales elsewhere than at a registered pharmacy unless those conditions are fulfilled. Section 52 provides for pharmacy only products, in that, it prohibits, inter alia, retail sales of any medicinal product not on a general sale list, unless certain conditions are complied with, including a requirement that the transaction is carried out by a person who is, or who acts under the supervision of, a pharmacist. Sections 55, 56 and 57 provide for exemptions from sections 52 and 53. The exemptions in section 55 are for doctors, dentists, veterinary surgeons and veterinary practitioners; those in section 56 are in respect of herbal remedies; and section 57 confers power on the appropriate ministers to extend or modify the exemptions relating to sections 52 and 53. Prescription only products are legislated for in section 58. Since this is the most relevant section for the purposes of the present appeal, I shall set it out in full:
"(1) The appropriate ministers may by order specify descriptions or classes of medicinal products for the purposes of this section; and, in relation to any description or class so specified, the order shall state which of the following, that is to say — (a)doctors, (b) dentists, and (c) veterinary surgeons and veterinary practitioners, are to be appropriate practitioners for the purposes of this section. (2) Subject to the following provisions of this section — (a) no person shall sell by retail, or supply in circumstances corresponding to retail sale, a medicinal product of a description, or falling within a class, specified in an order under this section except in accordance with a prescription given by an appropriate practitioner; and (b) no person shall administer (otherwise than to himself) any such medicinal product unless he is an appropriate practitioner or a person acting in accordance with the directions of an appropriate practitioner. (3) Subsection (2)(a) of this section shall not apply — (a) to the sale or supply of a medicinal product to a patient of his by a doctor or dentist who is an appropriate practitioner, or (b) to the sale or supply of a medicinal product, for administration to an animal or herd under his care, by a veterinary surgeon or veterinary practitioner who is an appropriate practitioner. (4) Without prejudice to the last preceding subsection, any order made by the appropriate ministers for the purposes of this section may provide — (a) that paragraph (a) or paragraph (b) of subsection (2) of this section, or both those paragraphs, shall have effect subject to such exemptions as may be specified in the order; (b) that, for the purpose of paragraph (a) of that subsection, a medicinal product shall not be taken to be sold or supplied in accordance with a prescription given by an appropriate practitioner unless such conditions as are prescribed by the order are fulfilled. (5) Any exemption conferred by an order in accordance with subsection (4)(a) of this section may be conferred subject to such conditions or limitations as may be specified in the order. (6) Before making an order under this section the appropriate ministers shall consult the appropriate committee, or, if for the time being there is not such committee, shall consult the commission."
I should record that, pursuant to powers conferred by, inter alia, section 58(1) and (4) of the Act of 1968, the appropriate ministers have made regulations relating to prescription only products. The relevant statutory instrument in force at the time of the alleged offence is the Order to which I have already referred, the Medicines (Prescription only) Order 1980 (S.I. 1980 No. 1921). I shall refer to certain provisions of that Order in due course.
Finally, I shall set out in full section 121 of the Act of 1968 which provides:
"(1) Where a contravention by any person of any provision to which this section applies constitutes an offence under 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."
For the defendants, Mr. Fisher submitted that there must, in accordance with the well-recognised presumption, be read into section 58(2)(a) words appropriate to require mens rea in accordance with Reg. v. Tolson, 23 Q.B.D. 168; in other words, to adopt the language of Lord Diplock in Sweet v. Parsley [1970] AC 132, 163, the subsection must be read subject to the implication that a necessary element in the prohibition (and hence in the offence created by the subsection together with section 67(2) of the Act of 1968) is the absence of belief, held honestly and upon reasonable grounds, in the existence of facts which, if true, would make the act innocent. He further submitted, with reference to the speech of Lord Reid in Sweet v. Parsley, at p. 149, that the offence created by section 58(2)(a) and section 67(2) of the Act of 1968 was not to be classified as merely an offence of a quasi-criminal character in which the presumption of mens rea might more readily be rebutted, because in his submission the offence was one which would result in a stigma attaching to a person who was convicted of it, especially as Parliament had regarded it as sufficiently serious to provide that it should be triable on indictment, and that the maximum penalty should be two years' imprisonment. He also submitted that, if Parliament had considered that a pharmacist who dispensed under a forged prescription in good faith and without fault should be convicted of the offence, it would surely have made express provision to that effect; and that the imposition of so strict a liability could not be justified on the basis that it would tend towards greater efficiency on the part of pharmacists in detecting forged prescriptions. Finally, he referred Your Lordships to the Misuse of Drugs Act 1971. Under section 4(1) and (3) of that Act, it is an offence to supply a controlled drug to another; but it is provided in section 28 that (subject to an immaterial exception) it shall be a defence for the accused to prove that he neither knew of nor suspected nor had reason to suspect the existence of some fact alleged by the prosecution which it is necessary for the prosecution to prove if he is to be convicted of the offence charged. Mr. Fisher submitted that it would be anomalous if such a defence were available in the case of the more serious offence of supplying a controlled drug to another, but that the presumption of mens rea should be held inapplicable in the case of the offence created by section 58(2)(a) and 67(2) of the Act of 1968.
I am unable to accept Mr. Fisher's submission, for the simple reason that it is, in my opinion, clear from the Act of 1968 that Parliament must have intended that the presumption of mens rea should be inapplicable to section 58(2)(a). First of all, it appears from the Act of 1968 that, where Parliament wished to recognise that mens rea should be an ingredient of an offence created by the Act, it has expressly so provided. Thus, taking first of all offences created under provisions of Part II of the Act of 1968, express requirements of mens rea are to be found both in section 45(2) and in section 46(1)(2) and (3) of the Act. More particularly, in relation to offences created by Part III and Parts V and VI of the Act of 1968, section 121 makes detailed provision for a requirement of mens rea in respect of certain specified sections of the Act, including sections 63 to 65 (which are contained in Part III), but significantly not section 58, nor indeed sections 52 and 53. I have already set out the full text of section 121 and need not repeat it. It is very difficult to avoid the conclusion that, by omitting section 58 from those sections to which section 121 is expressly made applicable, Parliament intended that there should be no implication of a requirement of mens rea in section 58(2)(a). This view is fortified by subsections (4) and (5) of section 58 itself. Subsection (4)(a) provides that any order made by the appropriate ministers for the purposes of section 58 may provide that section 58(2)(a) or (b), or both, shall have effect subject to such exemptions as may be specified in the order. From this subsection alone it follows that the ministers, if they think it right, can provide for exemption where there is no mens rea on the part of the accused. Subsection (5) provides that any exemption conferred by an order in accordance with subsection (4)(a) may be conferred subject to such conditions or limitations as may be specified in the order. From this it follows that if the ministers, acting under subsection (4), were to confer an exemption relating to sales where the vendor lacked the requisite mens rea, they may nevertheless circumscribe their exemption with conditions and limitations which render the exemption far narrower than the implication for which Mr. Fisher contends should be read into the statute itself. I find this to be very difficult to reconcile with the proposed implication.
It comes as no surprise to me, therefore, to discover that the relevant order in force at that time, the Medicines (Prescriptions only) Order 1980, is drawn entirely in conformity with the construction of the statute which I favour. It is unnecessary, in the present case, to consider whether the relevant articles of the Order may be taken into account in construing section 58 of the Act of 1968; it is enough, for present purposes, that I am able to draw support from the fact that the ministers, in making the Order, plainly did not read section 58 as subject to the implication proposed by Mr. Fisher. So, for example, article 11 of the Order (which is headed "Exemption in cases involving another's default") reads as follows:
"The restrictions imposed by section 58(2)(a) (restrictions on sale and supply) shall not apply to the sale or supply of a prescription only medicine by a person who, having exercised all due diligence, believes on reasonable grounds that the product sold or supplied is not a prescription only medicine, where it is due to the act or default of another person that the product is a product to which section 58(2)(a) applies."
This provision which, by including the words "having exercised due diligence," provides for a narrower exemption than that which Mr. Fisher has submitted should be read by implication into the statute, in the limited circumstances specified in the concluding words of the paragraph, is plainly inconsistent with the existence of any such implication. Likewise, article 13(1) provides that, for the purposes of section 58(2)(a), a prescription only medicine shall not be taken to be sold or supplied in accordance with a prescription given by a practitioner unless certain specified conditions are fulfilled. Those conditions, which are very detailed, are set out in article 13(2); and they all presuppose the existence of a valid prescription. Furthermore, article 13(3) provides:
"The restrictions imposed by section 58(2)(a) (restrictions on sale and supply) shall not apply to a sale or supply of a prescription only medicine which is not in accordance with a prescription given by an appropriate practitioner by reason only that a condition specified in paragraph (2) is not fulfilled, where the person selling or supplying the prescription only medicine, having exercised all due diligence, believes on reasonable grounds that that condition is fulfilled in relation to that sale or supply."
So here again we find a provision which creates an exemption in narrower terms than that which Mr. Fisher submits is to be found, by implication, in section 58(2)(a) itself. It follows that article 13, like article 11, of the Order is inconsistent with the existence of any such implication.
For these reasons, which are substantially the same as those which are set out in the judgments of Farquharson and Tudor Price JJ. in the Divisional Court [1985] 3 All E.R. 4, I am unable to accept the submissions advanced on behalf of the defendants. I gratefully adopt as my own the following passage from the judgment of Farquharson J., at p.10:
"... It is perfectly obvious that pharmacists are in a position to put illicit drugs and perhaps other medicines on the market. Happily this rarely happens but it does from time to time. It can therefore be readily understood that Parliament would find it necessary to impose a heavier liability on those who are in such a position, and make them more strictly accountable for any breaches of the Act."
I would therefore answer the certified question in the negative, and dismiss the appeal with costs.
Pharmaceutical Society of Great Britain (Respondents)
v.
Storkwain Limited (Appellants)
(On Appeal from a Divisional Court of the Queen's Bench Division)
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JUDGMENT
____________________________________________
Die Jovis 19° Junii 1986
Upon Report from the Appellate Committee to whom was referred the Cause Pharmaceutical Society of Great Britain against Storkwain Limited, That the Committee had heard Counsel on Monday the 28th day of April 1986 upon the Petition and Appeal of Storkwain Limited, of 149 Edgware Road, London W2 praying that the matter of the Order set forth in the Schedule thereto, namely an Order of a Divisional Court of the Queen's Bench Division of Her Majesty's High Court of Justice, might be reviewed before Her Majesty the Queen in Her Court of Parliament and that the said Order might be reversed, varied or altered or that the Petitioners might have such other relief in the premises as to Her Majesty the Queen in Her Court of Parliament might seem meet; and Counsel having been heard on behalf of the Pharmaceutical Society of Great Britain (on behalf of Her Majesty) the Respondents to the said appeal; and due consideration had this day of what was offered on either side in this Cause;
It is Ordered and Adjudged, by the Lords Spiritual and Temporal in the Court of Parliament of Her Majesty the Queen assembled, That the said Order of a Divisional Court of the Queen's Bench Division of Her Majesty's High Court of Justice of the 2nd May 1985 complained of in the said Appeal be, and the same is hereby, Affirmed; that the Certified Question be answered in the negative; and that the said Petition and Appeal be, and the same is hereby, dismissed this House; And it is further Ordered, That the Appellants do pay or cause to be paid to the said Respondents the Costs incurred by them in respect of the said Appeal, the amount thereof to be certified by the Clerk of the Parliaments if not agreed between the parties.
Cler; Parliamentor: