code of standards of advertising practice for the consumer healthcare industry, revision 5.1

Revision 5.1 Code of Standards of

Advertising Practice for theConsumer Healthcare Industry

First Edition 1967First Revision 1977Second Revision 1981Third Revision 1986Fourth Revision 1999Fifth Revision 2008Revision 5.1 2010

© Irish Pharmaceutical Healthcare AssociationFranklin House, 140 Pembroke Road, Dublin 4.Tel: (01) 6603350 Fax: (01) 6686672 E-mail: [email protected] Website: www.ipha.ie

Directors: Neil Boyle, Gerry Burke, Gerald Farrell, David Gallagher,Francis Lynch, Fergal McGarry, John McLaughlin, Elizabeth Reynolds,Mark Rodgers.

Registered in Ireland No. 254776 Registered Office: Franklin House, 140 Pembroke Road, Dublin 4.

The Irish Pharmaceutical HealthcareAssociation (IPHA) represents theinternational research-basedpharmaceutical industry in Ireland. Its member companies include bothmanufacturers of prescriptionmedicines and non-prescription orconsumer health care medicines.

IPHA

Code of Standards of Advertising Practice for the Consumer Healthcare Industry

1

IntroductionThis Code has been prepared by the Irish Pharmaceutical Healthcare

Association (IPHA) with a view to securing the universal acceptance

and adoption of high standards of advertising of medicinal products

which may be purchased by individuals without the presentation of a

prescription. The Code also incorporates guidelines on the promotion

of non-prescription medicines published by the Irish Medicines Board.

Acceptance and observance of the provisions of the Code are a

condition of membership of the Irish Pharmaceutical Healthcare

Association. Non-member companies are also invited to accept and

observe the Code.

Companies observing the Code also acknowledge that its provisions

are to be applied in the spirit, as well as in the letter.

Since January 1st 1993, the advertising of medicinal products for

human use in the European Union Member States has been governed

by Council Directive 92/28/EEC. The Code of Standards of Advertising

Practice fits into the general framework established by Article 97

Paragraph 5 of Directive 2001/83/EC as amended by 2004/27/EC, which

2


recognises the role of voluntary control of advertising of medicinal

products by self regulatory bodies and recourse to such bodies.

This edition of the Code of Standards of Advertising Practice

incorporates changes arising from the Medicinal Products (Control of

Advertising) Regulations 2007 (S.I. 541 of 2007) for the purposes of

providing practical guidance in implementing the Regulations.

The Minister for Health and Children, as provided for under

Regulation 26 of the Medicinal Products (Control of Advertising)

Regulations 2007, hereby endorses the parts of the IPHA Code of

Standard of Advertising for the Consumer Healthcare Industry, 5th

Revision, that are directly derived (verbatim) from the Medicinal

Products (Control of Advertising) Regulations 2007.

This Code has been provided to help in implementing the

requirements of the Regulations. It is designed to be used in

conjunction with the Regulations and is, by no means, a substitute for

the Regulations.

3

4

Philosophy of Voluntary Codes 5

1. Fundamental Principles and Legal Obligations 6

2. Interpretation and Scope 6

3. General Provisions 8

4. Contents of Advertisements 9

5. Responsibility of Advertisers 13

6. Competitions, Public Schemes and Samples 14

7. Review of Advertisements and Controls 15

8. Resolution and Hearing of Complaints 16

APPENDICES

I Relevant Legislation 18

II Guideline on the Use of a Cautionary Warning in Advertisements for Consumer Healthcare Medicines 19

III Advertisements to the Public - Checklist of Requirements 20

Contents


5

This is a voluntary Code and is not intended to be read or construed

as a document giving rise to legal rights or obligations: nor does it

envisage that rules of legal procedure should apply in the operation

of its provisions. The essence of this Code is the unequivocal

acceptance of its principles and procedures by agreement. A decision

in favour of or against advertising by a company by the Code

Committee does not exclude the need for compliance with any laws

in relation to the advertising of medicinal products and in particular

does not exclude the application of the Medicinal Products (Control

of Advertising) Regulations 2007 (S.I. No.541 of 2007).

Philosophy of Voluntary Codes

1. Fundamental Principles and LegalObligations

1.1 In compiling this Code, reference has been made and regard hadto the law governing the advertising of all medicinal productsand to Codes of Practice adopted by other organisations.

1.2 A non-definitive list of legislation relevant to the advertising ofConsumer Healthcare Medicines is contained in Appendix I.

1.3 All companies trading in the Republic of Ireland are bound by thelaws of the Republic of Ireland.

2. Interpretation and Scope

2.1 In this Code, the term “medicinal product” means a medicinalproduct as defined in Council Directive 2001/83/EC as amended by2004/27/EC and which is intended for human use.

2.2 In this Code, "advertising" includes any form of advertising,whether in a publication, or by the display of any notice, or bymeans of any letter (whether circular or addressed to a particularperson via mail (including post, telephone, email, and otherelectronic means of communication), press release or otherdocument, or by words inscribed on any article, or by theexhibition of a photograph or cinematograph, or by way ofsound recording, sound broadcasting or television or in any otherway including the use of audio-visual materials such as films,video recordings, data storage services and the like. It alsoincludes any form of door to door information, canvassingactivity or inducement designed to promote the supply, sale orconsumption of consumer healthcare medicinal products or anyinformation supplied to and available on the Internet.

2.3 Any illustration contained in an advertisement shall be regardedas an integral part of the advertisement.

6


7

2.4 The expression "product authorisation" means a licence grantedor renewed by the Irish Medicines Board in accordance with theMedicinal Products (Control of Placing on the Market)Regulations 2007 (S.I. 540 of 2007) or an authorisation granted orrenewed by the European Commission in accordance withRegulation 726/2004/EC of 31 March 2004 laying downCommunity procedures for the authorisation and supervision ofmedicinal products.

2.5 The expression "Consumer Healthcare Medicine" means anymedicinal product which is intended for use as human medicationor for general health care and which may be purchased byindividuals without the presentation of a prescription issued by aregistered medical practitioner.

2.6 This Code has no application to advertisements for prescriptiononly medicinal products, treatments or appliances addressed to orsent directly to registered medical or dental practitioners,pharmacists, nurses or other healthcare professionals or publishedin the respective journals of these professions or in any of therelevant trade journals.

2.7 The Code does not cover:

- The labelling of medicinal products and theaccompanying package leaflets, where such labelling andpackaging are in compliance with the Medicinal Products(Control of Placing on the Market) Regulations 2007 (S.I.540 of 2007) and the Medical Preparations (Labelling andPackage Leaflet) Regulations 1993 (S.I. 71 of 1993) asamended.1

- Correspondence, which may be accompanied by materialof a non-promotional nature, needed to answer a specificquestion about a particular medicinal product;

- Factual, informative announcements and referencematerial relating, for example, to pack changes, adverse-

1 This legislation will be revoked on 30th October 2010.

reaction warnings as part of general drug precautions,trade catalogues and price lists, provided they include noproduct claims;

- Books, journals, periodicals and other publications thatare imported into the State and which containadvertising which is not intended for or directed atpersons resident in the State;

- Information relating to human health or diseases,provided there is no reference, even indirect, tomedicinal products;

- Traditional herbal medicinal products or homeopathicmedicinal products.

3. General Provisions

3.1 A medicinal product should not be promoted prior to thegranting of the product authorisation permitting its sale orsupply.

3.2 The promotion of a medicinal product must be consistent withthe terms of the relevant product authorisation.

3.3 The holder of the authorisation in respect of a medicinal productshall establish within their undertaking a Scientific Service incharge of information about the medicinal product. Eachadvertisement shall be subject to the prior approval by theScientific Service in charge of information about medicinalproducts established under Article 24 of the Medicinal Products(Control of Advertising) Regulations 2007 (S.I. 541 of 2007).

3.4 The advertisement must not mislead and should encourage therational use of the medicinal product by presenting it objectivelyand without exaggerating its properties.

8


3.5 Products which should not be promoted to the public include:

1. Analgesics for the relief of pain containing codeine,dextromethorphan or related drugs

2. Cough mixtures containing any of the above as anantitussive

3. Anti-diarrhoeals (except as permitted by the marketingauthorisation)

3.6 Special Categories

Products containing antihistamines and/or sympathomimetics canbe advertised to the public, provided that:

(a) they are only for use in the management of thesymptoms of head colds, flu, stuffy nose, coughs, hayfever or travel sickness;

(b) there is no reference to use in children in theadvertisement;

(c) there is a recommendation that the consumer seeksfurther advice from their doctor or pharmacist;

(d) there is an overprint (in the case of visual promotion) oran audible statement (in the case of radio, etc.) whichrecommends that the consumer read the instructionscarefully

3.7 In addition to compliance with legal obligations, this Code shallbe observed and enforced in the spirit as well as in the letter.

4. Contents of Advertisements

4.1 All advertisements must be accurate and truthful.

4.2 All advertisements must be easily intelligible to the consumer.

9

4.3 All advertisements must comply with the requirements of theMedicinal Products (Control of Advertising) Regulations 2007 (S.I.541 of 2007) as follows:

(i) Format of the advertisement

The advertisement must be set out in such a way that it isclear that the message conveyed is an advertisement andthat the product is clearly identified as a medicinalproduct.

(ii) The full advertisement shall contain the followingminimum information:

(a) The name of the medicinal product, as well as thecommon name if the product contains only one activeingredient;

(b) An express and legible invitation to read carefully theinstructions on the leaflet contained within thepackage or on the label, as the case may be.

(iii) The advertisement shall not contain any material which:

(a) gives the impression that a medical consultation orsurgical operation is unnecessary, in particular byoffering a diagnosis or by suggesting treatment bymail;

(b) suggests that the effects of taking the medicine areguaranteed, are unaccompanied by adverse reactionsor are better than, or equivalent to, those of anothertreatment or medicinal product;

(c) suggests that the health of the subject can beenhanced by taking the medicinal product;

(d) suggests that the health of the subject could beaffected by not taking the medicine; this prohibitionshall not apply to vaccination campaigns providedthat such campaigns have been approved by theMinister;

10


(e) is directed exclusively or principally at children;

(f) might result in harm to children or which exploits theircredulity;

(g) leads the public to assume that the medicinal producthas some special property or quality which is in factunknown or unrecognised;

(h) claims that the product, medicine or treatmentadvertised will promote sexual virility or be effective intreating sexual weakness (unless it is authorised for suchindication) or habits associated with sexual excess orindulgence or any ailment, illness or disease associatedwith those habits;

(i) refers to a recommendation by scientists, healthprofessionals or persons who are neither of theforegoing but who, because of their celebrity status,could encourage the consumption of medicinal products;

(j) suggests that the medicinal product is a foodstuff,cosmetic or other consumer product;

(k) suggests that the safety or efficacy of the medicinalproduct is due to the fact that it is natural;

(l) could, by giving a description or detailed representationof a case history, lead to erroneous self-diagnosis;

(m)refers, in improper, alarming or misleading terms, toclaims of recovery;

(n) uses in improper, alarming or misleading terms, pictorialrepresentations of changes in the human body caused bydisease or injury, or of the action of a medicinal producton the human body or parts thereof;

11

4.4 Reminder Advertisements

In the case of an advertisement to the general public which isintended only as a reminder (i.e. which does not contain anyclaim), the advertisement shall consist solely of:

(a) the name of the product or its international non-proprietary name or the trademark and;

(b) advice to read carefully the instructions on the leafletcontained within the package or on the label, as the casemay be;

4.5 An advertisement must not:

i. bring disrepute upon the Consumer Healthcare Industry,undermine confidence in advertising or prejudice publicconfidence in medicinal products;

ii. offer any Consumer Healthcare Medicine or treatment fora serious disease or condition which requires medicaltreatment by a healthcare professional;

iii. refer to chronic conditions or contain any offer to make adiagnosis or prescribe treatment by correspondence;

iv. denigrate or attack unfairly any other products, goods orservices;

v. rest on claims that a product does not contain a giveningredient which is in common use in competitorproducts in any way which may give the impression thatthe ingredient is generally unsafe or harmful;

vi. contain any exaggerated claim, direct or implied, or claimor imply the cure of any illness as distinct from the reliefof symptoms of any ailment, disease or illness;

vii. use words such as "magic", "miracle", "mystical" or12


"secret active ingredient" in connection with the claimsmade for the product or treatment;

viii. in any way induce or tend to induce fear;

ix. persuade or tend to persuade towards the unnecessaryuse of a product;

x. be such as to deliberately use visual or aural intimationsintended to influence consumers in ways of which theyare not consciously aware;

xi. contain any reference to a doctor other than a personwho is registered in the Register of Medical Practitionersin Ireland or is a person entitled to be so registered or tohospital tests unless such reference can be substantiatedby independent evidence and can be properly used inthat manner;

xii. contain the words "college", "clinic", "institute","laboratory" or similar terms unless an establishmentcorresponding to the description used does and can beshown to exist;

xiii. use testimonials in an advertisement except where theyare limited to the genuine views of the user and anofficial or a certified copy is available with a signed anddated release of the person giving it.

Testimonials shall not be used in an advertisement formore than three years after the date on which they werewritten by the users and shall not contain anythingcontrary to the provisions of the Code

5. Responsibility of Advertisers

5.1 An advertiser will be held responsible for the contents and formof any advertisement which may appear with his authority inconnection with his products.

13

5.2 Advertisers shall inform their contracted third parties (includingadvertising and public relation agents etc…) commissioned toengage in promotional activities of the requirements under theCode of Standards of Advertising Practice for the ConsumerHealthcare Industry and provide them with training on the Codeand copies of the Code if necessary.

5.3 Advertisers shall keep available for supply on request a sample ofall advertising emanating from his or her undertaking togetherwith information indicating the audience to whom it isaddressed, methods of dissemination and date of firstdissemination as well as substantiating material relative to anyclaims made in any advertisement. Such material shall beavailable to the Code Committee constituted under Section 7below.

6. Competitions, Public Schemes andSamples

A Company shall not:

(i) Promote to the general public or be associated in anyway with any prize competition, or other activity, which isintended to encourage the unnecessary use of aConsumer Healthcare Medicine;

(ii) Promote or be in any way associated with any otherschemes which are intended to encourage the sale of aConsumer Healthcare Medicine if in the opinion of theCode Committee, they are likely to introduce any hazardto the consumer or to lower the tone of the Industry;

(iii) Offer to refund money to dissatisfied users;

(iv) Offer or supply any samples of medicinal products to thegeneral public.

14


The provisions of this Section shall not be construed in a mannerinconsistent with a person's statutory or other legal rightsrelating to the sale of goods and supply of services.

7. Review of Advertisements and Controls

7.1 Where a company subscribes to this Code, any complaints fromwhatever source relating to an advertisement in respect of aConsumer Healthcare Medicine shall be referred to the CodeCommittee for consideration.

7.2 The Code Committee shall be constituted as follows:

1. An independent legally qualified Chairman at theinvitation of the IPHA Consumer Healthcare Division.

2. A nominee of the Director of Consumer Affairs.

3. Two nominees of the IPHA Consumer Healthcare Division,one with medical/ pharmaceutical expertise.

4. One nominee from the non-IPHA member signatories tothe Code.

5. A nominee of the Institute of Advertising Practitioners inIreland.

6. A nominee of the Pharmaceutical Society of Ireland.

7. A nominee of the Advertising Standards Authority forIreland.

7.3 A complaint shall not be considered by the Code Committeeunless it has been submitted in writing with supportingdocumentation.

7.4 Proceedings before the Code Committee shall be informal.

15

7.5 The Code Committee shall determine its own rules of conductand procedure and may appoint a recording secretary. It will bedeemed properly constituted with a quorum of three.

8. Resolution and Hearing of Complaints

8.1 The expeditious resolution of complaints by the Code Committeeand the adoption of its findings in any case is accepted by allparties involved in a complaint as a fundamental principle underthe provisions of this Code.

8.2 In relation to any complaint affecting advertising, the CodeCommittee will take whatever steps are necessary. Affectedparties shall comply with any steps requested by the CodeCommittee to enable it to deliver its decision by not later thanthree weeks from the date of receipt of the full submission inresponse to the complaint.

8.3 The Chairman has an absolute discretion in the following matters:

- the setting and observance of time limits in order toensure the expeditious resolution of any complaints;

- the time permitted to be taken to correct or withdrawany advertisement that the Code Committee finds inbreach of the Code.

8.4 The Code Committee may, with absolute discretion, require thewithdrawal of any advertisement, where it is of the opinion thatthe continued use of any material is not in the interests ofconsumer safety.

8.5 For difficult cases and/or persistent breaches of the Code, theCommittee shall have the authority to refer such cases to theMinister for Health & Children for appropriate action under theMedicinal Products (Control of Advertising) Regulations 2007 (S.I.541 of 2007).

16


8.6 The Code Committee shall publish its findings on complaints withreasons to the parties involved in the complaint.

8.7 Where the Code Committee finds against an advertisement andthe advertiser refuses to accept or comply with the finding, theCode Committee shall, without prejudice to subsequentprovisions of this Code, advise the Advertising StandardsAuthority for Ireland of its findings and recommend that thesubscribers to that Authority should not accept the advertisementwhich has been found to be in conflict with the Code.

8.8 If the Code Committee takes the steps referred to in Section 8.7,it shall as soon as practicable advise the Minister for Health &Children that those steps were taken.

17

APPENDIX I

Relevant Legislation

Directive 2001/83/EC of 6th November 2001 on the Community Coderelating to medicinal products for human use (as amended byDirective 2004/27/EC).

Medicinal Products (Control of Advertising) Regulations 2007 (S.I. 541of 2007).

Medical Preparations (Labelling and Package Leaflets) Regulations1993 (S.I. 71 of 1993) as amended (effective until the 30th October2010, then revoked by the Medicinal Products (Control of Placing onthe Market) Regulations 2007 (S.I. 540 of 2007)).

Medicinal Products (Prescription and Control of Supply) Regulations2003-2007.

Medicinal Products (Control of Placing on the Market) Regulations2007 (S.I. 540 of 2007).

Consumer Information Act, 1978 (1 of 1978).

European Communities (Misleading Advertising) Regulations 1988(S.I. 134 of 1988).

This is not intended to be a definitive list and is provided forinformation purposes only.

Copies of the above legislation may be obtained from theGovernment Publications Sale Office, Molesworth Street, Dublin 2.Tel: +353 (0)1 6476879 or for postal orders +353 (0)1 6476995. http://www.opw.ie/services/gov_sup/fr_gov.htm

18


APPENDIX II

Guideline on the Use of a Cautionary Warning in Advertisements forConsumer Healthcare Medicines

(Reference: Clauses 4.3 (ii)(b) and 4.4 (b) of this Code)

An express and legible invitation to read carefully the instructions onthe leaflet contained within the package or the label must beincluded. In addition, the invitation must be clear and must not beobscured or disguised in any way by the content, design or format ofthe advertisement.

Any colour may by used so long as the colour does not interfere withlegibility.

In the case of a television advertisement the warning must appear onthe screen for a minimum of four seconds regardless of the length ofthe commercial or television slide.

19

20

Please tick

Please tick

Please tick

APPENDIX III

Advertisements to the Public – Checklist ofRequirements

This checklist is intended to help companies ensure compliance withthis Code when producing promotional material but it is not intendedas a substitute for the Code.

List of documents to provide for IPHA review

(a) A copy of the advertisement

(b) Part 1 & 2 of the Marketing Authorisation and a copy ofcover letter from the Irish Medicines Board accompanyingthe Marketing Authorisation

(c) Information necessary to substantiate any claims made inthe advertisement, where applicable (claims contained inthe SPC, package leaflet or label do not require furthersubstantiation)

Checklist of Requirements for Code Compliance

1. Format of advertisement

The advertisement must be set out in such a way that it is clearthat the message conveyed is an advertisement and that theproduct is a medicinal product.

2. A full advertisement must contain:

(a) the name of the medicinal product and;

(b) the common name of the medicinal product if theproduct contains only one active ingredient;

(c) an express and legible invitation to read carefully theinstructions on the leaflet contained within the packageor on the label, as the case may be.


21

Please tick

Please tick

3. A reminder advertisement (i.e. which does not contain anyclaims) must contain:

(a) the name of the product or its international non-proprietary name or the trademark

(b) advice to read carefully the instructions on the leafletcontained within the package or on the label, as the case may be

4. The advertisement shall not contain any material which:

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

(b) suggests that the effects of taking the medicine:

(i) are guaranteed

(ii) are unaccompanied by adverse reactions

(iii) are better than, or equivalent to, those of anothertreatment or medicinal product

(c) suggests that the health of the subject can be enhancedby taking the medicinal product

(d) suggests that the health of the subject could be affectedby not taking the medicinal product (with the exceptionof government approved vaccination campaigns)

(e) is directed exclusively or principally at children

(f) might result in harm to children or which exploits theircredulity

(g) leads the public to assume that the medicinal producthas some special property or quality which is in factunknown or unrecognised

Please tick(h) claims that the product, medicine or treatment advertised

will promote sexual virility or be effective in treatingsexual weakness (unless it is authorised for suchindication) or habits associated with sexual excess orindulgence or any ailment, illness or disease associatedwith those habits

(i) refers to a recommendation by scientists, healthprofessionals or persons who are neither of the foregoingbut who, because of their celebrity status, couldencourage the consumption of medicinal products

(j) suggests that the medicinal product is:

(i) a foodstuff

(ii) a cosmetic

(iii) another consumer product

(k) suggests that the safety or efficacy of the medicinalproduct is due to the fact that it is natural

(l) could, by giving a description or detailed representationof a case history, lead to erroneous self-diagnosis

(m) refers, in improper, alarming or misleading terms, toclaims of recovery

(n) uses improper, alarming or misleading terms, pictorialrepresentations of changes in the human body caused bydisease or injury or the action of a medicinal product onthe human body or parts thereof

22

Please tick


5. The advertisement must not:

(i) bring disrepute upon the Consumer Healthcare Industry,undermine confidence in advertising or prejudice publicconfidence in medicinal products

(ii) offer any Consumer Healthcare Medicine or treatment fora serious disease or condition which requires medicaltreatment by a healthcare professional

(iii) refer to chronic conditions or contain any offer to make adiagnosis or prescribe treatment by correspondence

(iv) denigrate or attack unfairly any other products, goods orservices

(v) rest on claims that a product does not contain a giveningredient which is in common use in competitorproducts in any way which may give the impression thatthe ingredient is generally unsafe or harmful

(vi) contain any exaggerated claim, direct or implied, or claimor imply the cure of any illness as distinct from the reliefof symptoms of any ailment, disease or illness

(vii) use words such as “magic”, “miracle”, “mystical or“secret active ingredient” in connection with the claimsmade for the product or treatment

(viii) in any way induce or tend to induce fear

(ix) persuade or tend to persuade towards the unnecessaryuse of a product

(x) be such as to deliberately use visual or aural intimationsintended to influence consumers in ways of which theyare not consciously aware

23

24

Please tick

Please tick

(xi) contain any reference to a doctor other than a personwho is registered in the Register of Medical Practitionersin Ireland or is a person entitled to be so registered or tohospital tests unless such reference can be substantiatedby independent evidence and can be properly used inthat manner

(xii) contain the words “college”, “clinic”, “institute”,“laboratory” or similar terms unless an establishmentcorresponding to the description used does and can beshown to exist

(xiii) use testimonials in an advertisement except where theyare limited to the genuine views of the user and anofficial or a certified copy is available with a signed anddated release of the person giving it.

Testimonials shall not be used in an advertisement formore than three years after the date on which they werewritten by the users and shall not contain anythingcontrary to the provisions of the Code.

6. Cautionary Warning

(a) The warning message must be clearly legible and readilyunderstood

(b) The advertisement contains an express and legibleinvitation to read carefully the instructions on the leafletcontained within the package or the label must beincluded, which is clear and must not be obscured ordisguised in any way by the content, design or format ofthe advertisement.

(c) The colour of the warning must not interfere with itslegibility

(d) In the case of a television advertisement the warningmust appear on the screen for a minimum of fourseconds regardless of the length of the commercial.

Franklin House140 Pembroke RoadDublin 4Ireland Tel: (353 1) 660 3350 Fax: (353 1) 668 6672 E-mail: [email protected]

www.ipha.iewww.medicines.iewww.feelbetter.ie

code of standards of advertising practice for the consumer healthcare industry, revision 5.1

Documents

iphacode of standards

which2code of standards

irish medicines board

substitute forthe regulations

pembroke road

general provisions

nonmember companies

general framework