S.I. No. 76/1993:

THE MEDICAL PREPARATIONS (ADVERTISING) REGULATIONS, 1993.

THE MEDICAL PREPARATIONS (ADVERTISING) REGULATIONS, 1993.

The Minister for Health, in exercise of the powers conferred on him by sections 5 and 65 of the Health Act, 1947 (No. 28 of 1947) as amended by section 39 of the Health Act, 1953 (No. 26 of 1953) and section 36 of the Misuse of Drugs Act, 1977 (No. 12 of 1977) hereby makes the following Regulations:--

1. These Regulations may be cited as The Medical Preparations (Advertising) Regulations 1993.

2. (1) In these Regulations--

"advertising" includes

(i) every form of advertising, whether in a publication, or by the display of any notice, or by means of any letter (whether circular or addressed to a particular person), press release or other document, or by words inscribed on any article, or by the exhibition of a photograph or cinematograph, or by way of sound recording, sound broadcasting or television or in any other way,

(ii) any form of door to door information, canvassing activity or inducement designed to promote the prescription, supply, sale or consumption of medical preparations and including in particular

( a ) the advertising of medical preparations to the general public,

( b ) the advertising of medical preparations to persons qualified to prescribe or supply them,

( c ) visits by medical sales representatives to persons qualified to prescribe medical preparations,

( d ) the supply of samples of medical preparations,

( e ) the provision of inducements to prescribe or supply medical preparations by the gift, offer or promise of any benefit or bonus, whether in money or in kind,

( f ) the sponsorship of promotional meetings attended by persons qualified to prescribe or supply medical preparations,

( g ) the sponsorship of scientific congresses attended by persons qualified to prescribe or supply medical preparations and in particular payment of their travelling and accommodation expenses in connection therewith,

and cognate words shall be construed accordingly;

"health professional" means a person of any of the following classes:

(i) registered medical practitioners or registered dentists

(ii) persons registered in any of the registers provided for in the Pharmacy Acts, 1875 to 1977;

"the Minister" means the Minister for Health;

"product authorisation" means a licence granted or renewed by the Minister under Article 6 of the Medical Preparations (Licensing, Advertisement and Sale) Regulations, 1984, ( S.I. No. 210 of 1984 ), as amended, for the sale or manufacture for sale of a medical preparation;

"summary of product characteristics" means the summary of product characteristics referred to in Article 6 (4) of the Medical Preparations (Licensing, Advertisement and Sale) Regulations, 1984, ( S.I. No. 210 of 1984 ) as amended.

(2) In these Regulations any reference to an article or Schedule shall be construed as a reference to an article contained in these Regulations or, as the case may be, to a Schedule thereto, any reference in an article to a sub-article shall be construed as a reference to a sub-article of that article and any reference in a Schedule to a paragraph shall be construed as a reference to a paragraph of that Schedule.

3. The provisions of these Regulations do not apply to--

(i) the labelling of medical preparations and the accompanying package leaflets,

(ii) correspondence of a non-promotional nature needed to answer a specific question about a particular medical preparation,

(iii) factual, informative announcements and reference material relating to pack changes, adverse-reaction warnings as part of general drug precautions, trade catalogues and price lists, provided they include no product claims and provided they relate to a medical preparation which is subject to a product authorisation.

4. A person shall not advertise a medical preparation in respect of which a product authorisation has not been granted and shall ensure that--

(i) all parts of his advertising of a medical preparation shall comply with the particulars listed in the summary of product characteristics in respect of that medical preparation and that,

(ii) the advertising by him of a medical preparation shall encourage the rational use of the medical preparation by presenting it objectively and without exaggerating its properties and shall not be misleading.

5. Subject to the provisions of Article 7 a person shall not advertise any medical preparation which

(i) by virtue of the Medical Preparations (Prescription and Control of Supply) Regulations 1993 ( S.I. No. 69 of 1993 ) may not be sold except in accordance with a prescription, or

(ii) is a controlled drug under Section 2 of the Misuse of Drugs Act 1977 (No. 12 of 1977).

6. (1) Subject to the provisions of Article 7 a person shall not publish or take any part in the publication of an advertisement referring to any medical preparation in a manner which might lead to the use of such preparation in the diagnosis, prevention or treatment in human beings of an ailment, infirmity, injury or defect set out in Schedule 1 or of any form of an ailment, infirmity, injury or defect set out in Schedule 1.

(2) A person taking part in the publication of an advertisement to which sub-article (1) applies shall be deemed not to have contravened that sub-article where the advertisement was published in such circumstances that he did not know and could not by the exercise of reasonable care have known that he was taking part in the publication thereof.

7. The provisions of Articles 5 and 6(1) shall not apply in relation to an advertisement which was published

(i) in such a manner and insofar as was reasonably necessary to bring it to the notice of the following persons:

( a ) health professionals

( b ) nurses within the meaning of the Nurses Act 1985 (No. 18 of 1985)

( c ) persons undergoing training with a view to becoming members of any of the classes specified at (a) and (b) above

( d ) persons who in the course of their business or profession provide training or instruction to persons undergoing training with a view to obtaining a qualification specified in (a) or (b) above

( e ) persons who in the course of their business or profession are engaged in the preparation or publication of advertisements addressed to persons referred to in (a) to (d) above.

( f ) members of either House of the Oireachtas, officials of a Government Department or of a health board, members and officials of the National Drugs Advisory Board or members of the governing body of a hospital or similar institution.

(ii) ( a ) in an imported book, periodical, newspaper or other publication and referred to a medical preparation which is not sold or intended for sale in the State or to persons resident in the State or

( b ) by a health board or by or with the consent of the Minister.

8. (1) A person who advertises a medical preparation to the general public shall ensure that such advertising conforms to the requirements set out in Schedule 2.

(2) In the case of an advertisement to the general public which is intended solely as a reminder, the person so advertising the medical preparation shall include

(i) in the case of an advertisement by way of sound recording, sound broadcasting or television

( a ) the name of the product and

( b ) advice to read carefully the information notice accompanying the medical preparation, and

(ii) in the case of a written advertisement

( a ) the number of the product authorisation and

( b ) the name and address of the holder of the product authorisation.

9. (1) Subject to the provisions of sub-article (2), any person advertising a medical preparation to a health professional shall include in such advertisement

(i) essential information compatible with the summary of product characteristics,

(ii) information as to whether or not the medical preparation is subject to medical prescription.

(2) In the case of an advertisement to a health professional which is intended solely as a reminder the person so advertising the medical preparation shall include

(i) the name of the medical preparation,

(ii) the number of the product authorisation in respect of the medical preparation,

(iii) the name and address of the product authorisation holder,

(iv) an indication that the information specified in sub-article (1) is available on request.

10. A person transmitting any documentation relating to a medical preparation as part of the promotion of that preparation to a health professional shall

(i) include as a minimum the particulars specified in article 9 (1),

(ii) ensure that all the information contained in the documentation referred to in this article is accurate, up-to-date, verifiable and sufficiently complete to enable the recipient to form his own opinion of the therapeutic value of the medical preparation concerned, and

(iii) ensure that quotations, tables and other illustrative matter taken from medical journals or other scientific works for use in the documentation referred to in this article is faithfully reproduced and the precise sources indicated.

11. (1) The employer of a medical sales representative shall ensure that such representative is given adequate training and has sufficient scientific knowledge to be able to provide information which is precise and as complete as possible about any medical preparation which he promotes.

(2) Where in his opinion the requirements in relation to the training and scientific knowledge referred to in sub-article 1 are not being observed, the Minister may specify the training and scientific knowledge so required.

(3) Subject to Article 14 (5), a medical sales representative, during each visit to a health professional, shall in respect of each medical preparation he presents, give to the person visited a summary of the product characteristics.

12. (1) A person promoting a medical preparation shall not supply, offer or promise to a health professional any gifts, pecuniary advantages, or benefits in kind, unless they are inexpensive and relevant to the practice of medicine or pharmacy.

(2) A person providing hospitality to a health professional in the course of sales promotion shall ensure that such hospitality is reasonable in level and secondary to the main purpose of the meeting and that it is not extended to other than health professionals.

(3) A health professional shall not solicit or accept any inducement prohibited under sub-article (1) or sub-article (2).

(4) The provisions of sub-articles (1) to (3) shall not prejudice the negotiation of prices, margins and discounts in the ordinary course of business provided such prices, margins and discounts are incorporated in the sales invoice as a consequence of such negotiation.

13. The provisions of sub-articles (1) and (2) of Article 12 shall not prevent hospitality being offered, directly or indirectly, at events for purely professional and scientific purposes; such hospitality must always be reasonable in level and remain subordinate to the main scientific objective of the meeting; it must not be extended to persons other than health professionals.

14. (1) A person shall not provide a free sample of a medical preparation to any person who is not a registered medical practitioner or a registered dentist.

(2) The following conditions shall be observed in the provision of a sample to a registered medical practitioner or a registered dentist:

(i) such samples in respect of a medical preparation concerned shall not exceed six in number per year,

(ii) any supply of such samples must be in response to a signed and dated request from the recipient,

(iii) an adequate system of control and accountability must be maintained in respect of the supply of such samples,

(iv) each such sample shall be no larger than the smallest presentation on the market provided such presentation does not exceed an amount which provides a single treatment in the ordinary course of medical practice,

(v) each sample shall be marked "free medical sample -- not for resale" or bear another legend of analogous meaning,

(vi) each sample shall be accompanied by a copy of the summary of product characteristics.

(3) A person shall not supply a sample of a medical preparation which is a controlled drug under Section 2 of the Misuse of Drugs Act, 1977 (No. 12 of 1977) or which is an antidepressant, hypnotic or tranquilliser.

(4) In this article "the supply of a sample" means the supply of a medical preparation made otherwise than in connection with a clinical trial notified or authorised under the Control of Clinical Trials Act, 1987 (No. 28 of 1987).

(5) It shall be sufficient compliance with Articles 11 (3), 14 (2) (vi), and 17 (4) (a) if the summary of product characteristics is included in a compendium or other such reference publication which has been delivered within the previous two years to the person visited or supplied with a sample and the presence of such summary in such publication has been drawn to the attention of the said person visited or provided with a sample.

15. (1) A person who--

( a ) has issued or displayed or caused to be issued or displayed, or

( b ) proposes to issue or display or cause to be issued or displayed any advertisement which in the opinion of the Minister is misleading, shall, if so directed by the Minister, ensure that such advertisement or proposed advertisement is withdrawn and he shall in the case of an advertisement which has been issued or displayed, if further directed by the Minister, publish a corrective statement in a form and by a means acceptable to the Minister.

(2) A person who has been convicted of an offence under Section 65 of the Health Act, 1947 in relation to these Regulations, where the Court was satisfied that an advertisement was misleading, shall if so directed by the Court withdraw the advertisement and if required by the Court publish a corrective statement in a form and by a means acceptable to the Court.

(3) Any direction as provided for in sub-article (1) shall state the reasons on which it is based.

16. (1) The Minister may approve of any code of practice or any part of any code of practice for the purpose of providing practical guidance with respect to the requirements or prohibitions of any of the provisions of these Regulations, and he may withdraw any such approval.

(2) Where the Minister approves or withdraws approval as provided for in sub-article (1), he shall publish a notice to that effect in Iris Oifigiúil.

17. The holder of a product authorisation in respect of a medical preparation shall

(1) establish within his undertaking a scientific service in charge of information about the medical preparation,

(2) keep available for inspection or supply on request by an officer of the Minister a copy of each advertisement for the medical preparation emanating from his undertaking together with a statement indicating the person or persons to whom it is addressed, the method of dissemination and the date of first dissemination,

(3) furnish to the Minister such further information relevant to the operation of the controls provided for in these Regulations as the Minister may request from time to time, and

(4) ensure that any medical sales representative employed by him

( a ) shall have available for the information of persons visited by such representative the summary of product characteristics, and

( b ) shall transmit to him any information about the use of the medical preparations advertised by such representative, with particular reference to any adverse reactions reported to that representative by the persons visited.

18. The enforcement and execution of the provisions of these Regulations may be carried out by

(i) officers of the Minister,

(ii) health boards and their officers,

(iii) insofar as persons involved in the retail sale of medical preparations are concerned, the Pharmaceutical Society of Ireland and its officers.

SCHEDULE 1

(Article 6 (1)

AIDS

Alopecia (including male pattern baldness)

Appendicitis

Arteriosclerosis

Blood Pressure

Choleocystitis

Depression

Diabetes and other metabolic diseases

Diphtheria

Epilepsy

Gallstones

Gastric or Peptic Ulcers

Heart and Vascular Diseases

HIV Infection

Impotency

Lupus

Malignant Diseases

Mastoiditis

Nephritis

Otitis Media

Pneumonia

Prostate Gland disorders

Scarlet Fever

Schizophrenia

Sinus Infection

Whooping Cough

Diseases notifiable under the Infectious Diseases Regulations 1981 (No. 390 of 1981), as amended.

SCHEDULE 2

(Article 8 (1))

Requirements in the advertising of a medical preparation to the general public

1. Format of the advertisement

The advertisement must be set out in such a way that it is clear that the message conveyed is an advertisement.

2. The advertisement shall contain:

( a ) A clear identification by name that the product being advertised is a medical preparation, as well as by the common name if the preparation contains only one active ingredient;

( b ) The information necessary for the correct use of the medical preparation;

( c ) A warning to read carefully the instructions on the package leaflet or on the outer packaging, as the case may be;

3. The advertisement shall not contain any material which:

( a ) gives the impression that a medical consultation or surgical operation is unnecessary, in particular by offering a diagnosis or by suggesting treatment by mail;

( b ) suggests that the effects of taking the medicine are guaranteed, are unaccompanied by side effects or are better than, or equivalent to, those of another treatment or medical preparation;

( c ) suggests that the health of the subject can be enhanced by taking the medicine;

( d ) suggests that the health of the subject could be affected by not taking the medicine; this prohibition shall not apply to vaccination campaigns;

( e ) is directed exclusively or principally at children;

( f ) refers to a recommendation by scientists, health professionals or persons who are neither of the foregoing but who, because of their celebrity, could encourage the consumption of medical preparations;

( g ) suggests that the medical preparation is a foodstuff, cosmetic or other consumer product;

( h ) suggests that the safety or efficacy of the medical preparation is due to the fact that it is natural;

( i ) could, by a description or detailed representation of a case history, lead to erroneous self diagnosis;

( j ) refers, in improper, alarming or misleading terms, to claims of recovery;

( k ) uses, in improper, alarming or misleading terms, pictorial representations of changes in the human body caused by disease or injury, or of the action of a medical preparation on the human body or parts thereof;

( l ) mentions that the medical preparation has been granted a marketing authorisation.

GIVEN under the Official Seal of the Minister for Health, this 16th

day of March, 1993.

BRENDAN HOWLIN,

Minister for Health.

EXPLANATORY NOTE.

These Regulations give effect to E.C. Council Directive 92/28 of 31 March 1992 on the advertising of medicinal products for human use (O.J. No. L 113, 30.4.92, p.13) and cover advertising both to health professionals and to the general public.