code of marketing practice for the pharmaceutical industry, edition 7.4

Code of Marketing Practice forthe Pharmaceutical Industry

Edition 7.4

IPHA Code of Marketing Practice for the Pharmaceutical IndustryEdition 7.4 – January 2011

© Irish Pharmaceutical Healthcare Association Ltd.Franklin 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, Elizabeth Reynolds, Mark Rodgers,Craig Skelton.

Registered in Ireland No. 254776 Registered Office Franklin House 140Pembroke 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 Marketing Practice for the Pharmaceutical Industry

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Introduction

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The Code has been prepared by the Irish Pharmaceutical HealthcareAssociation (IPHA) with a view to securing the universal acceptance andadoption of high standards of conduct in the marketing of medicinalproducts to healthcare professionals, whether intended for use undermedical supervision or otherwise.

The advertising of medicinal products for human use in European UnionMember States is governed by Council Directive 2001/83/EC of 6November 2001 as amended by Council Directive 2004/27/EC of 24 March2004. This Code of Practice fits into the general framework establishedby Article 97 Paragraph 5 of Directive 2001/83/EC as amended, whichrecognises the role of voluntary control of advertising of medicinalproducts by self-regulatory bodies and recourse to such bodies.

The Code emphasises the importance of providing healthcareprofessionals with accurate, fair and objective information aboutmedicinal products so that rational decisions can be made as to their use.Moreover, the Code accepts the principle that such information must bepresented in a form and by ways and means which conform not only tolegal requirements but also to professional standards of ethics and goodtaste.

Acceptance and observance of the provisions of the Code and itsannexes are a condition of membership of the Irish PharmaceuticalHealthcare Association. Companies observing the Code alsoacknowledge that its provisions are to be applied in spirit, as well as inthe letter.


The provisions of the Code fully reflect the standards of the 2007edition of the “EFPIA Code on the Promotion of Prescription-onlyMedicines to, and Interactions with, Healthcare Professionals” whichis published by the European Federation of Pharmaceutical Industriesand Associations (EFPIA). IPHA is a member of EFPIA. Compliance withthe European Code is a requirement of all member associations ofEFPIA.

This Edition of the Code of Marketing Practice incorporates changesarising from the Medicinal Products (Control of Advertising)Regulations 2007 (S.I. 541 of 2007) for the purposes of providingpractical guidance in implementing the Regulations.

The Minister for Health and Children, as provided for underRegulation 26 of the Medicinal Products (Control of Advertising)Regulations 2007, hereby endorses the parts of the IPHA Code ofMarketing Practice for the Pharmaceutical Industry, 7th Edition, thatare directly derived (verbatim) from the Medicinal Products (Controlof Advertising) Regulations 2007.

This Code has been provided to help in implementing therequirements of the Regulations. It is designed to be used inconjunction with the Regulations and is, by no means, a substitute forthe Regulations.

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1. Scope & Definition of Terms 6

2. Methods of Promotion 8

3. Product Authorisation 8

4. Nature and Availability of Information 9

5. Claims & Comparisons 10

6. Disparaging References 10

7. Textual and Audio-Visual Promotional Material 11

8. References to the Irish Medicines Board & 13Related Organisations

9. References to the Primary Care 14Reimbursement Service

10. Distribution of Promotional Material 14

11. Reprints, Abstracts & Quotations 15

12. Pharmaceutical Company Employees 16(Direct and Contracted)

13. Samples 18

14. Gifts 20

Contents


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15. Grants & Other Forms of Support 21

16. Hospitality, Sponsorship & Meetings 22

17. Use of Consultants 27

18. Market Research Post, Marketing Surveillance & 29Related Activities

19. Non-Interventional Studies 30

20. Relations with the General Public & Lay 32Communication Media

21. Company Procedures for Code Compliance 33

ANNEXES

Annex I: Administration of the Code & 34Complaints Procedure

Annex II: Guideline on Nursing Services Provided by 54Pharmaceutical Companies

Annex III: Guideline for Pharmaceutical Companies 57on Working with Patient Associations

Provisions of the Code

1. Scope & Definition of Terms

1.1 The term “promotion” means those marketing and informationalactivities coming under the control or authority of the company,the purpose of which is to induce the prescribing, supply, sale orconsumption of the company’s products.

Promotion includes, for example, the activities of medicalrepresentatives; various aspects of sales promotion such as journaland direct mail advertising, the use of mail (including post,telephone, email, and other electronic means of communication),the use of the internet, the use of audio-visual materials such asfilms, video recordings, data storage services and the like,informational systems and exhibitions; press releases and theprovision of samples, gifts or hospitality.

1.2 The term “healthcare professional” means a person of any of thefollowing classes:

(i) Registered medical practitioners(ii) Registered dentists(iii) Registered pharmacists(iv) Registered nurses

1.3 The term “medicinal product” has the same meaning as theexpression “medical preparation” and means:

(i) Any substance or combination of substances presented ashaving properties for treating or preventing disease inhuman beings.

(ii) Any substance or combination of substances which maybe used in or administered to human beings either with aview to restoring, correcting or modifying physiologicalfunctions by exerting a pharmacological, immunologicalor metabolic action, or to making a medical diagnosis.

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1.4 The term “product authorisation” refers to a productauthorisation granted or renewed by the Irish Medicines Board inrespect of a medicinal product and also a marketingauthorisation for a medicinal product granted or renewed by theEuropean Commission under the centralised procedure.

1.5 The Code is not intended to inhibit the exchange of medical andscientific information during the development of a product.

1.6 The Code does not cover:

- the labelling of medicinal products and theaccompanying package leaflets, which are subject to theprovisions of the Medicinal Products (Control of Placingon the Market) Regulations 2007 (S.I. 540 of 2007) asamended;

- correspondence, possibly accompanied by material of anon-promotional nature, needed to answer a specificquestion about a particular medicinal product;

- factual, informative announcements and referencematerial relating, for example, to pack changes, adverse-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 at,persons resident in the State;

- information relating to human health or diseasesprovided there is no reference, even indirect, tomedicinal products.

2. Methods of Promotion

2.1 Methods of promotion must never be such as to bring discreditupon or reduce confidence in the pharmaceutical industry.

3. Product Authorisation

3.1 A medicinal product must not be promoted prior to receipt of theproduct authorisation authorising its sale or supply.

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

3.3 Promotional material which appears on exhibition stands or isdistributed to participants at international congresses or symposiaheld in Ireland may refer to a medicinal product or indication fora medicinal product which is not the subject of an authorisationin Ireland (but which is so authorised in at least one MemberState of the European Economic Area [EEA]) provided that thefollowing conditions are observed:

(i) The meeting must be a truly international, scientificevent with a significant proportion of the speakers anddelegates from other countries;

(ii) To ensure that the promotional material does notpromote the prescription, supply, sale or consumption ofthe medicinal product in Ireland, a clearly visible andlegible statement must be included to the effect that themedicinal product is not authorised in Ireland or that it isauthorised for different indications in this country;

(iii) Promotional material which refers to the prescribinginformation (indications, warnings etc.) authorised inother countries must include an explanatory statementindicating that licensing conditions differ internationally.

Promotional material for medicinal products which are notauthorised in any EEA country at the time of the congress or

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symposium, may not be displayed or distributed to participants.Scientific papers on such products may, however, be provided inaccordance with Clause 1.5 of the Code.

4. Nature and Availability of Information

4.1 Upon reasonable request, a company must promptly providehealthcare professionals with accurate and relevant informationabout the medicinal products which it markets.

4.2 Information about medicinal products must be up-to-date,verifiable and accurately reflect current knowledge or responsibleopinion.

4.3 Information about medicinal products must be accurate,balanced, fair, objective, and must not mislead either directly orby implication.

4.4 Information must be capable of substantiation. Suchsubstantiation need not be provided however in relation to thevalidity of indications approved in the product authorisation.

4.5 Substantiation that is requested pursuant to Clause 4.4 must beprovided without delay at the request of members of the medicaland pharmacy professions including the members of thoseprofessions employed in the pharmaceutical industry.

4.6 When promotional material refers to published studies, clearreferences must be given.

4.7 In accordance with an agreement reached between the IrishPharmaceutical Healthcare Association and the Department ofHealth & Children, the summaries of product characteristics (SPCs)relating to individual medicinal products are included in the IPHAMedicines Compendium which is made available free of charge tohealthcare professionals in Ireland. The contents of the SPCs inthat Compendium are determined by the relevant productauthorisations.

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5. Claims & Comparisons

5.1 Claims for the usefulness of a medicinal product must be basedon an up-to-date evaluation of all the evidence and must reflectthis evidence accurately and clearly. Such claims must have priormedical review and approval.

5.2 Exaggerated claims must not be made and all-embracing claimsand superlatives avoided. Claims must not imply that a medicinalproduct, or an active ingredient, has some special merit, qualityor property unless this can be substantiated.

5.3 The word “safe” must not be used without qualification and itmust not be stated categorically that a medicine has no side-effects, toxic hazards or risk of addiction (see also Clause 7.2).

5.4 The word “new” must not be used to describe any medicinalproduct which has been generally available, or therapeuticindication which has been generally promoted, in Ireland formore than 12 months.

5.5 Comparisons of medicinal products must be factual, fair andcapable of substantiation. In presenting a comparison, care mustbe taken to ensure that it does not mislead by distortion, byundue emphasis, omission or in any other way.

5.6 Brand names of products of other companies must not be used incomparison unless the prior consent of the companies concernedhas been obtained.

6. Disparaging References

6.1 Other companies, their products, services or promotions must notbe disparaged either directly or by implication.

6.2 The clinical and/or scientific opinions of members of healthcareprofessionals must not be disparaged either directly or byimplication.

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7. Textual and Audio-Visual PromotionalMaterial

7.1 All promotional material issued by a product authorisation holder orwith his authority, must be consistent with the requirements of thisCode.

7.2 Where the purpose of promotional material is to provide personsqualified to prescribe or supply with sufficient information uponwhich to reach a decision for prescribing or for use, then thefollowing minimum information, which must be compatible withthe SPC, must be given clearly and legibly and must be an integralpart of the advertisement:

(i) The relevant product authorisation number and the name andaddress of the holder of the authorisation or the businessname and address of the part of the business responsible forplacing the medicinal product on the market;

(ii) The name of the product, and a list of the activeingredients, using the common name, placed immediatelyadjacent to the most prominent display of the name of theproduct;

(iii) One or more of the indications for the use of the productcompatible with the terms of the marketing authorisation;

(iv) Recommended dosage, method of use and, where notobvious, method of administration;

(v) The classification for the sale or supply of the product;

(vi) Adverse reactions, warnings and precautions for use andrelevant contraindications of the product;

(vii) A statement that additional information is available onrequest;

(viii) The date on which the above particulars were generated orlast updated. 11

7.3 Where the purpose of the promotional material is to remindpersons qualified to prescribe or supply of the availability and ofthe indication(s) of a medicinal product (i.e. a “reminderadvertisement”), the following information, which must becompatible with the SPC, must be included:

(i) The name of the medicinal product, or the internationalnon-proprietary name, where such exists, or thetrademark;

(ii) A statement which clearly indicates that furtherinformation is available on request or in the SPC;

(iii) The name and address of the holder of the productauthorisation or the business name and address of thepart of the business responsible for placing medicinalproduct on the market;

(iv) The classification for sale or supply of the product.

All promotional material not falling within the category of“reminder advertisements” must comply with Clause 7.2.

7.4 Promotional material such as mailings and journal advertisementsmust not be designed to disguise their real nature. Where apharmaceutical company pays for or otherwise secures orarranges the publication of promotional material in journals, suchpromotional material must not resemble editorial matter.

7.5 All promotional material appearing in journals, the publication ofwhich is paid for or secured or arranged by a company andreferring by brand name to any product of that company, mustcomply with Clause 7.2 or 7.3 of this Code as appropriate,irrespective of the editorial control of the material published.

7.6 Promotional material must conform, both in text and illustration,to canons of good taste and must be expressed so as to recognisethe professional standing of the recipients and not be likely tocause offence.

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7.7 The names or photographs of healthcare professionals must notbe used in promotional material without their permission nor inany way that is contrary to the ethical code of the appropriateprofession.

7.8 Promotional material must not imitate the devices, copy, slogansor general layout adopted by other companies in a way that islikely to mislead or confuse.

7.9 Where appropriate (for example, in technical and otherinformative material), the date of printing or of the last review ofpromotional material must be stated.

7.10 Extremes of format, size or cost of promotional material must beavoided.

7.11 Postcards, other exposed mailings, envelopes or wrappers mustnot carry matter which might be regarded as advertising to thelay public or which could be considered unsuitable for publicview.

7.12 Audio-visual material must be accompanied by all appropriateprinted material so that all relevant requirements of the Code arecomplied with.

8. References to the Irish Medicines Board& Related Organisations

8.1 Unless specific requirements with regard to distribution or usehave been imposed, companies must not include in anyannouncement or promotional material, a statement that themarketing of the product has been approved or recommendedby the Irish Medicines Board or related organisations such as theEuropean Medicines Agency (EMA), the European Community,the European Commission or the Committee for MedicinalProducts for Human Use (CHMP).

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9. References to the Primary CareReimbursement Service

9.1 References to the Primary Care Reimbursement Service (PCRS) (orthe GMS as it was previously known) in advertising must beconfined to including the relevant code number, the print sizeand typeface of which must be the same as that of the productauthorisation number.

9.2 Where reference is made to the prescribing of a product underthe PCRS, the phrase “freely prescribable” or similar phrasessuggesting a lack of restriction or restraint must not be used.

9.3 Where a product has been added or restored to the PCRS list,announcements, advertisements and other communications tothis effect may include in the body of prescribing information, astatement that the product is “PCRS reimbursable” (or similar)provided that the print size of such statements is no larger thanthe rest of the text. Such a statement may be carried for nolonger than twelve months from the date of the adding orrestoring of the product to the PCRS list.

9.4 Reproductions of official documents, such as prescription forms,must not be used for promotional purposes unless the agreementof the appropriate Government department has been received.

10. Distribution of Promotional Material

10.1 Promotional material must only be sent or distributed to thosecategories of persons whose need for, or interest in, the particularinformation can be reasonably assumed.

Promotional material must be tailored to the audience to whomit is directed. For example, promotional material devised forgeneral practitioners might not be appropriate for hospitaldoctors.

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10.2 Any information designed to encourage the use of medicinalproducts in clinics, industrial concerns, clubs or schools must beaddressed to the medical adviser or medical officer or to medicalauxiliary staff.

10.3 Restraint must be exercised on the frequency of distribution andon the volume of promotional material distributed.

The style of mailings is relevant to their acceptability tohealthcare professionals and criticism of their frequency is mostlikely to arise where their informational content is limited orwhere they appear to be elaborate and expensive.

10.4 Mailing lists must be kept up-to-date. Requests from healthcareprofessionals to be removed from promotional mailing lists mustbe complied with promptly and no name should be restoredexcept at the healthcare professional’s request or with his/herpermission.

10.5 The use of faxes, e-mails, automated calling systems, textmessages and other electronic data communications forpromotion is prohibited except with the prior permission, orupon the request, of the recipient.

11. Reprints, Abstracts & Quotations

(Such use is, of course, subject to the Law of Copyright)

11.1 All reprints of articles included in mailings must comply with theprovisions of Clause 7.2 or 7.3 as appropriate and may besupplied to individual healthcare professionals.

11.2 It is permissible to include in promotional material, reasonablybrief abstracts of, or quotations from, articles, or accuratelyreproduced tables or other illustrative matter taken from thescientific literature and to include in such material references toauthors’ names in a bibliography of published works. In no casehowever, should authors’ names be used in a prominent mannerin promotional material.

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11.3 Quotations from medical literature, or from personalcommunications received from healthcare professionals, mustaccurately reflect the meaning of the author and the significanceof the study.

12. Pharmaceutical Company Employees(Direct and Contracted)

12.1 The term “medical representative” means sales representatives,including personnel retained by way of contract with thirdparties, and any other company representatives who call onhealthcare professionals, pharmacies, hospitals or otherhealthcare facilities in connection with the promotion ofmedicinal products.

12.2. Medical representatives must be provided with thorough trainingby the company which employs them and possess sufficientscientific knowledge to present information on the company’sproducts in an accurate, complete and responsible manner. Thecontribution of the Medical Representatives Institute of Ireland inthis respect (for example by the inclusion of the Code ofMarketing Practice in its examination syllabus) is acknowledged.

12.3 During each visit medical representatives must give the personsvisited or have available for them, the most up-to-date version ofthe SPC for each medicinal product they promote.

Where the SPCs are included in the IPHA Medicines Compendiumthat has been delivered to to the class of health care professionalvisited within the previous twelve months, or published in itsonline version www.medicines.ie, and this fact is drawn to theattention of the persons visited, this requirement is deemed to besatisfied, except when the medicinal product being promoted isbeing placed on the market in Ireland for the first time.

In the case of a medicinal product that has been placed on themarket in the State for the first time during the period of twelvemonths after the date of the most recent publication of the IPHAMedicines Compendium a medical representative shall, during16


each visit where they promote that product, give, or have availablefor them, a copy of the most up to date version of the SPC.

12.4 All company employees must transmit to the Scientific Servicesestablished in their companies forthwith any information onadverse reactions reported to them by the persons they visit.

12.5 Medical representatives must at all times maintain a highstandard of ethical conduct in the discharge of their duties. Theymust comply with all relevant requirements of the Code.

12.6 Medical representatives must not employ any inducement orsubterfuge to gain an interview. They must not pay, under anyguise, for access to a healthcare professional.

This clause does not preclude the occasional provision of lightrefreshments/modest meals at a meeting organised by a medicalrepresentative. Such hospitality may only be provided tohealthcare professionals and occur in a manner and venueconducive to information exchange and/or scientific education.Payments to healthcare professionals to cover the cost of suchmeals are not allowed.

12.7 Medical representatives must ensure that the frequency, timingand duration of calls on healthcare professionals, or on hospitals,together with the manner in which they are made, areacceptable to the healthcare professionals and hospitals asappropriate and are not such as to cause inconvenience. Thewishes of an individual healthcare professional, or thearrangements in force at any particular establishment, must beobserved by representatives.

Medical representatives must always endeavour to treathealthcare professionals’ time with respect and if for any reasonan appointment cannot be kept by the representative, thelongest possible notice must be given.

12.8 Medical representatives must take adequate precautions toensure the security of medicinal products in their possession.

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12.9 Medical representatives must not use the telephone or similarelectronic means to promote medicinal products to the medicalprofession unless prior arrangement has been made withindividual healthcare professional.

12.10 Companies are responsible for the activities of all their employeesand must ensure that employees who are concerned in any waywith the drafting or approval of promotional material (includingemployees of third parties contracted on behalf of the company)are fully conversant and compliant with the requirements of theCode.

Other third parties working for or on behalf of pharmaceuticalcompanies, (including advertising companies executives, businessconsultants and market research companies), and those that donot act on behalf of companies (such as joint ventures andlicensees) commissioned to engage in activities covered by theCode should also have a good working knowledge of the Code.

12.11 The provision of nursing services by a pharmaceutical companymust be undertaken in accordance with the guideline on theprovision of nursing services by pharmaceutical companiespublished in Annex II.

13. Samples

13.1 Free samples of medicinal products shall not be supplied to anyperson who is not qualified to prescribe such product.

The supply of a sample means the supply of a medicinal productmade otherwise than in connection with a clinical trial notified orauthorised under the European Communities (Clinical Trials onMedicinal Products for Human Use) Regulations, 2004 (S.I. 190 of2004) as amended or the Control of Clinical Trials Act, 1987 (No.28 of 1987).

13.2 Where samples of products are distributed by a medicalrepresentative, the sample must be handed directly to a personqualified to prescribe such product or to a person authorised toreceive the sample on their behalf.18


13.3 The following conditions shall be observed in the provision ofsamples to a person qualified to prescribe such product:

(i) Such samples are provided on an exceptional basis only(see (ii) to (vii) below) and for the purpose of acquiringexperience in dealing with such a product;

(ii) Such samples in respect of a medicinal product shall notexceed four in number per year; and sampling shall notextend beyond the two years after the product is firstlaunched1.

(iii) Any supply of such samples must be in response to asigned and dated request from the recipient;

(iv) An adequate system of control and accountability mustbe maintained in respect of the supply of such samples;

(v) Each sample shall be no larger than the smallestpresentation on the market;

(vi) Each sample shall be marked “free medical sample – notfor sale” or bear another legend of analogous meaning;

(vii) Each sample shall be accompanied by a copy of the mostup-to-date version of the SPC relating to that product inaccordance with the requirements set out in Clause 12.3.

13.5 A person shall not supply a sample of a medicinal product whichis a controlled drug under Section 2 of the Misuse of Drugs Act,1977 (No. 12 of 1977) or which is an anti-depressant, hypnotic,sedative or tranquilliser.

13.6 Samples sent by post must be packed so as to be reasonablysecure against the package being opened by children.

13.7 Distribution of samples in hospitals must also comply withindividual hospital regulations, if any.

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1 Effective from 01 Jan 2011 for products placed on the market after that date. Forproducts already on the market prior to 01.01.11 the requirements become effectivefrom 01.04.11

14. Gifts

14.1 Subject to any regulations for the time being in force relating toprices, margins and discounts, no gifts, pecuniary advantages orbenefits in kind may be supplied, offered or promised to personsqualified to prescribe or supply by a pharmaceutical companyunless they are inexpensive and relevant to the practice ofmedicine or pharmacy.

14.2 Except where they carry all the information stipulated in Clause7.2 above, gifts or other promotional aid of the type mentionedin Clause 14.1 may bear no more than the name of the companyand the name of the medicinal product, or its international non-proprietary name, where this exists, or the trademark.

14.3 Gifts for the personal benefit of healthcare professionals (such astickets to entertainment events) should not be offered orprovided.

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15. Grants & Other Forms of Support

15.1 Clause 14.1 shall not preclude a pharmaceutical company fromproviding support in the form of educational, research oremployment grants, donation or sponsorship of equipment forthe betterment of patients, provided that the followingconditions are complied with:

(i) The company must be in receipt of a written requestfrom a healthcare professional or institution (forexample, a practice, medical centre, clinic or hospital) forthe specific type of support provided, as the case may be.Sufficient information must be obtained to establish thatthere is a genuine need for such support;

(ii) Educational, equipment, employment or research grantsmust be paid directly to an institution rather than to anindividual healthcare professional;

(iii) Any such support provided by a company must berelevant to the practice of medicine or pharmacy andmust be given to an institution rather than to anindividual healthcare professional and intended solely foruse in the institution;

(iv) Any such support must not be linked in any way withproduct promotion. No commitment must be sought orgiven in relation to the prescribing, supply or use of thecompany’s products;

(v) Any such support must be reasonable, modest and inproportion to the scale and scope of the recipientinstitution and must be likely to appear so toindependent third parties.

Companies are encouraged to make available, publicly,information about such donations, grants or sponsorship.

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16. Hospitality, Sponsorship & Meetings

16.1 The pharmaceutical industry has a special obligation to ensurethat healthcare professionals are kept constantly in touch withcontinuing developments in the pharmaceutical field. With this inmind, the practice has arisen of meetings and events beingorganised between the industry and the professions for thefurther exchange of ideas and information. In addition, thecustom has grown of the industry supporting independentmeetings of healthcare professionals intended to update andexpand the continuing education of the professions themselves.

Many of these meetings could not take place without the supportand assistance of the pharmaceutical industry. Companies maylegitimately provide assistance that is directly related to the bonafide continuing education of the healthcare professionals andwhich genuinely facilitates attendance of the healthcareprofessional for the duration of the educational aspect of theevent. Such support and assistance must however, always be suchas to leave healthcare professionals’ independence of judgementmanifestly unimpaired.

16.2 Where appropriate and depending on the time, location andlength of the meeting, support to healthcare professionals maycover actual travel expenses, meals, refreshments,accommodation and registration fees.

16.3 It should be the programme that attracts delegates and not theassociated venue or hospitality.

Companies must not organise meetings to coincide with sporting,entertainment or other leisure events or activities. Venues thatare renowned for their entertainment or leisure facilities or areextravagant must not be used.

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16.4 Any hospitality offered to healthcare professionals must:

(i) Be reasonable in level and be likely to appear toindependent third parties, to be reasonable;

(ii) Be secondary and strictly limited to the main purpose ofthe event at which it is offered;

(iii) Not exceed the level that recipients would normally beprepared to pay for themselves;

(iv) Not be extended to spouses or other accompanyingpersons, unless they are healthcare professionals whoqualify as participants in their own right. Travel expensesmay not be paid for spouses or other accompanyingpersons, unless they are healthcare professionals whoqualify as participants in their own right;

(v) Not include sponsoring, securing, organising directly orindirectly any entertainment, sporting or leisure events.

16.5 Funding of healthcare professionals to compensate them for thetime spent in attending the event is not permitted.

16.6 All promotional, scientific or professional meetings, congresses,conferences, symposia, and other similar events (including, forexample, advisory board meetings, visits to research ormanufacturing facilities, and planning, training or investigatormeetings for clinical trials and non-interventional studies) (each,an “event”) organised or sponsored by or on behalf of acompany must be held at an appropriate venue that is conduciveto the main purpose of the event. The provisions of 16.3 apply.

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16.7 A pharmaceutical company may not organise or sponsor an eventor a participant at an event that takes place outside Ireland (an“international event”) unless there is a valid reason to do so. Theprovisions of 16.3 and 16.5 must be applied together with thefollowing additional principles:

(i) Most of the invitees are from outside Ireland and, giventhe countries of origin of most of the invitees, it makesgreater logistical sense to hold the event in anothercountry or;

(ii) Given the location of the relevant resource or expertisethat is the object or subject matter of the event, it makesgreater logistical sense to hold the event in anothercountry;

(iii) As with meetings held in Ireland, consideration must begiven to the educational programme, overall cost,facilities offered by the venue, nature of the audienceand the hospitality to be provided, which must besecondary to the meeting and not out of proportion tothe occasion;

(iv) Any hospitality offered to healthcare professionals atinternational meetings must:

(a) Be reasonable in level and be likely to appear toindependent third parties, to be reasonable;

(b) Be secondary and strictly limited to the main purposeof the event at which it is offered;

(c) Not exceed the level that recipients would normallybe prepared to pay for themselves;

(d) Not be extended to spouses or other accompanyingpersons, unless they are healthcare professionals whoqualify as participants in their own right;

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(e) Not include sponsoring, securing, organising directlyor indirectly any entertainment, sporting or leisureevents or activities;

(f) Actual travel expenses of healthcare professionalsmay be covered, but the payment of travel expensesfor spouses and accompanying persons is notpermitted;

(g) It should be the programme that attracts delegatesand not the associated venue or hospitality;

(h) To avoid any confusion as to the primary purpose ofthe event, international events should not coincidewith a major event of a sporting or social nature in alocality.

16.8 The following additional requirements shall apply in relation tothe sponsorship of meetings convened by the health professions:

(i) Smaller meetings

The sponsorship of local clinical meetings, initiated by anorganising body of the healthcare professions, is frequentlysought from pharmaceutical companies. In such instances,companies must respond only to formal written requests forsupport from the organising committee. Any request for supportshould indicate the exact anticipated items of expenditure forwhich the support is sought.

Support must not extend beyond:- cost of room hire- cost of equipment hire- actual travel expenses of speaker(s)- honorarium to speaker(s) if appropriate- modest meals and/or light refreshments

Promotional input from companies at an appropriate stage of themeeting must be with the agreement of the Chairman orthrough a printed acknowledgement on the programme (if any).

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In any series of such meetings, as for example during the winterseason, no one company should undertake the sponsorship ofsuch a series of meetings to the exclusion of other available andwilling sponsors. No payment must be made by a company inorder to be included on a shortlist of possible sponsors.

(ii) Larger meetings

For larger meetings initiated by the healthcare professions, suchas annual association meetings, support usually involves therental of a stand or space for the purposes of exhibiting thecompany’s product range. This form of exhibition bypharmaceutical companies is acceptable.

As far as possible, for reasons of security, medicinal products mustnot be brought to such meetings. In no circumstances shouldmedicinal products be handed over to visitors to the stand orexhibition.

Other support for such meetings must not extend beyond acontribution to the general expenses of the meeting. Anacknowledgement of this support, by way of a list of sponsors onthe programme (if any) and/or by way of a similar list displayedon a notice board, is acceptable.

Sponsorship of major annual or bi-annual meetings of anydiscipline within the health professions should not be undertakenby any one company to the exclusion of other available andwilling sponsors. No payment must be made by a company inorder to be included on a shortlist of possible sponsors.

16.9 Corporate Hospitality

Aside from meetings and events as referred to in the precedingparagraphs, it is recognised that, on occasion, pharmaceuticalcompanies may provide what may be considered as “corporatehospitality”.

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Corporate hospitality involving sporting, entertainment or socialevents or activities must not be extended to healthcareprofessionals.

However, on an occasional basis, corporate hospitality involvingevents organised by not for profit organisations and/or a bonafide registered charity may be extended to healthcareprofessionals provided that the clear and transparent objective ofthe event or activity itself, is to raise funds for charitable orbenevolent purposes. Such events must not involve or be in anyway associated with major sporting or social events.

The following principles shall apply to corporate hospitality:

(i) There must be no element of product promotion at theevent, either direct or implied;

(ii) Companies should appreciate the need for moderation.Corporate hospitality must never be such that, on areasonable view, it might give rise to the inference thatthe scale and costs of such hospitality could adverselyaffect the cost of medicines to the patient or taxpayer;

(iii) Corporate hospitality should be reasonable in level andlikely to appear to independent third parties to bereasonable. It should not exceed the level that recipientswould normally be prepared to pay for themselves.

17. Use of Consultants

Healthcare professionals can be used as consultants and advisors,whether in groups or individually, for:- Services (e.g chairing or speaking at meetings, being

involved in medical/scientific studies or in clinical trials) - Training- Participating in advisory board meetings - Participating in market research where such participation

involves remuneration and/or travel 27

With the exception of one-off phone interviews or mail/e-mail/internet questionnaires, the arrangements that cover thesegenuine consultancy or other services must fulfil all of thefollowing criteria:

(i) A legitimate need must be clearly identified before therequest for such services, and the arrangements with theprospective consultants, are made;

(ii) A written contract or agreement, including detailsregarding the nature of the services to be provided andthe basis for payment of those services, must be signed inadvance of the commencement of the services;

(iii) Criteria directly related to the identified need must drivethe selection and evaluation of consultants;

(iv) No greater number of healthcare professionals can beretained than is reasonably necessary to fulfil theidentified need;

(v) Records concerning the services provided by consultantsmust be maintained by the contracting company;

(vi) The hiring of the healthcare professional to provide therelevant services must not be an inducement to prescribe,purchase, supply or sell a particular medicinal product;

(vii) The compensation for the services must be reasonableand reflect the fair market value of the services provided.In this regard, token consultancy arrangements must notbe used to justify compensating healthcare professionals.

Consultants who have entered contractual arrangements withcompanies or are employed on a part-time basis while stillpractising their profession, should be strongly encouraged todeclare their arrangements with the company, whenever theywrite or speak in public about a matter that is the subject of theagreement or any other issue relating to that company.

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If a healthcare professional attends an event (an internationalevent or otherwise) in a consultant or advisory capacity theprovisions of Clause 16 covering hospitality shall apply.

18. Market Research, Post MarketingSurveillance & Related Activities

18.1 Methods used for market research must never be such as to bringdiscredit upon or reduce confidence in the pharmaceuticalindustry. The following provisions set out in this clause applywhether the research is carried out directly by the company or byan organisation acting on its behalf.

18.2 Access to respondents must not be gained by subterfuge. Anyincentives given must be kept to a minimum and becommensurate with the work involved.

18.3 Questions intended to solicit disparaging references to competingproducts or companies must be avoided.

18.4 Market research must not be used as a form of disguised salespromotion.

18.5 Post-marketing surveillance studies, pharmacoeconomic studies,non-interventional trials, clinical audit programmes and the like(including those that are retrospective in nature) commissioned,undertaken or provided by companies must never bepromotional in nature and must be conducted primarily with ascientific or educational purpose. This clause does not precludethe use of the data generated from such studies to support claimsin promotion.

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19. Non-Interventional Studies

19. 1 A “non-interventional study” is defined as:

(i) A study of one or more medicinal products which have amarketing authorisation where the products areprescribed in the usual manner in accordance with theterms of that authorisation and where;

(ii) The assignment of the patient to a particular therapeuticstrategy is not decided in advance by a trial protocol butfalls within current practice and where;

(iii) The prescription of the medicine is clearly separated fromthe decision to include the patient in the study andwhere;

(iv) No diagnostic or monitoring procedures are applied tothe patients included in the study, other than those whichare ordinarily applied in the course of the particulartherapeutic strategy in question and whereepidemiological methods shall be used for the analysis ofdata arising from the study.

19.2 Non-interventional studies that are prospective in nature andthat involve the collection of patient data specifically for thestudy from or on behalf of individual, or groups of, healthcareprofessionals must comply with all of the following criteria:

(i) The study must be conducted with a scientific purpose;

(ii) There must be a written study plan;

(iii) The healthcare professionals and/or the site at which thestudy will take place, on the one hand, and the companysponsoring the study, on the other hand, must signwritten contracts which specify the nature of the servicesto be provided and the basis for payment of thoseservices;

(iv) Any remuneration provided must be reasonable andreflect the fair market value of the work performed;

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(v) If applicable, the study protocol must be submitted to theEthics Committee for review;

(vi) Laws, rules and regulations on personal data privacy(including the collection and use of personal data) mustbe respected;

(vii) The study must not constitute an inducement toprescribe, purchase, supply or sell a particular medicinalproduct;

(viii) The company’s Scientific Service must approve the studyprotocol and supervise the conduct of non-interventionalstudies;

(ix) The study results must be analysed by or on behalf of thecontracting company and summaries thereof must bemade available within a reasonable period of time to thecompany’s Scientific Service. This Scientific Service shallmaintain records of such reports for a reasonable periodof time. The company should send the summary report toall healthcare professionals that participated in the studyand should make the summary report available toindustry self-regulatory bodies and/or committees thatare in charge of supervising or enforcing applicableCodes upon their request. If the study shows results thatare important for the assessment of benefit-risk, thesummary report should be immediately forwarded to therelevant competent authority;

(x) Medical Sales Representatives may only be involved in anadministrative capacity and such involvement must beunder the sole supervision of the company’s ScientificService that will also ensure that the representatives areadequately trained. Such involvement must not be linkedto the promotion of any medicinal product.

To the extent applicable, companies are encouraged to complywith the above requirements for all other types of studies,including epidemiological studies and registries and other studiesthat are retrospective in nature. 31

20. Relations with the General Public & LayCommunication Media

20.1 Subject to the provisions of the Medicinal Products (Control ofAdvertising) Regulations 2007 (S.I. 541 of 2007), medicines maynot be advertised or promoted to the general public if they areprescription-only medicines. This prohibition includes non-prescription medicines which by virtue of any applicablelegislation or regulation, may not be advertised to the public.

20.2 Requests from individual members of the public for informationor advice on personal medical matters must always be refusedand the enquirer recommended to consult their own healthcareprofessional.

20.3 Information about a scientific discovery of a medicinal productshould normally be supplied only where it is desirable ornecessary to do so in the public interest or where the object is tokeep the public informed of scientific and medical progress.However, there may be circumstances where disclosure to thepublic as shareholders or as persons with some other special orvalid interest may be required or be desirable.

20.4 Information must be presented in a balanced way to avoid therisk of raising unfounded hopes in the public mind from theresults of treatment. Statements must not be made or designedfor the purpose of encouraging members of the public to asktheir doctor to prescribe a medicinal product.

20.5 Information about a new medicinal product must not be releasedto the general public by the company until the medical professionhas been informed of its availability, except in so far as thecircumstances in Clause 20.3 may apply.

20.6 Patient associations play a key role in representing, meeting theinformation needs of and offering support to people living withill-health. To assist pharmaceutical companies in their interactionswith patient associations, a “Guideline for PharmaceuticalCompanies on Working with Patient Associations” is published inAnnex III. The requirements of these guidelines have the sameweight as the rest of the Code.

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21. Company Procedures for CodeCompliance

21.1 Every company must establish a Scientific Service in charge ofinformation about its medicinal products and, the approval andsupervision of non-interventional studies.

21.2 This Scientific Service must include a medical doctor or, whereappropriate, a pharmacist or other suitably qualified person whowill be responsible for:

(i) Approving any promotional material before release. Suchperson must certify that he or she has examined the finalversion of all promotional material and that, in his or herbelief, it is in accordance with the requirements of theCode and any applicable advertising laws andregulations, is consistent with the relevant SPC and is afair and truthful presentation of the facts about themedicinal product being promoted;

(ii) Overseeing any non-interventional study. Such personmust certify that he or she has examined the protocolrelating to the non-interventional study and that in his orher belief it is in accordance with the requirements of theCode.

21.3 Each company must appoint at least one senior employee whoshall be responsible for supervising the company and itssubsidiaries to ensure that the standards of this Code are met.

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Annex IAdministration of the Code & Complaints Procedure

1. Introduction

The IPHA Code of Marketing Practice is a self-regulatory Code. Allmembers of IPHA, as a condition of their membership of theAssociation, are signatories to the Code. Several non-IPHAmember companies are also signatories to the Code. Where aperson or body is concerned that the promotional activities ofany signatory to the Code may be in breach of the Code, acomplaint may be submitted to IPHA for consideration. The Codeof Marketing Practice is administered by the Code Council (seeSection 3 of this Annex) and complaints are heard in the firstinstance by the Code Council. Decisions of the Code Council maybe appealed to the Appeals Board (see Section 5 of this Annex).Alleged breaches of the Code by a Code signatory which come toIPHA’s attention other than by way of a formal written complaintare defined as “referrals” and dealt with in accordance with theprocedure set out in Section 7 of this Annex.

2. Inter-company Resolution

For inter-company complaints, it is recommended that everyreasonable effort should be made to resolve differences betweencompanies directly. Only after such efforts have been exhausted,should the matter be referred to the Code Council for resolution.

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3. Code of Marketing Practice Panel, CodeCouncil & Appeals Board

3.1 Composition of Panel

The Code Council is drawn from the Code of Marketing PracticePanel [the “Panel”] which is made up of the following:

• A minimum of 18 persons drawn from IPHA membercompanies;

• One person drawn from non-IPHA signatories to theCode [“the non-IPHA member”];

• Four persons who are financially and otherwiseindependent of the pharmaceutical industry;

• Two independent Chairmen.

In the event of an appeal, the Appeals Board will be drawn fromthe Panel. The members of the Appeals Board will not haveparticipated in the Code Council for that particular complaint.

In the event that no non-IPHA signatory nominations have beenreceived at the time of hearing a complaint, the CodeCouncil/Appeals Board shall be constituted without a non-IPHAmember. The same principle will apply if no independent personnominees are in place at the time of the hearing of a complaint.

3.2 Selection of the Panel

IPHA members:Nomination papers are sent by the IPHA Executive to all membercompanies when a position(s) on the panel becomes available.The nominations are considered by the IPHA PrescriptionMedicines Division Strategy Board [the “Strategy Board”] whichselects the appropriate person(s) to serve on the Panel. Ifinsufficient nominations are received, the Strategy Board may fillany remaining vacancies as it deems appropriate.

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Non-IPHA members:The IPHA Executive invites nominations from all non-memberCode signatories. The selection of the non-IPHA member is madeby the Strategy Board.

Independent members:The selection of the independent members is made by theStrategy Board.

3.3 Composition of the Panel

Most areas of management in the industry (e.g. general,regulatory, marketing, medical, sales management) areconsidered to provide appropriate or relevant skills/expertise withregard to membership of the Panel. A mix of skills and expertiseacross the Panel is desirable and will be taken into account by theStrategy Board in the selection process.

3.4 Term of Office

Selection to the Panel will be for a three-year term. All membersare eligible for re-selection.

3.5 Chairmen

Two independent Chairmen, one for the Code Council [the “CodeCouncil Chairman”] and one for the Appeals Board [the “AppealsBoard Chairman”], will be appointed by the IPHA Board ofDirectors. These appointments will be reviewed every three years.

The Chairmen have general authority to obtain assistance in anyfield and have a casting vote only, except as provided for inSection 7.3 of this Annex, which stipulates that in referral casesthe Code Council Chairman shall not have any vote.

3.6 Consultation

The Code Council Chairman and the Appeals Board Chairmanshall have the right to consult external experts. The Code Council

36


and Appeals Board are encouraged to avail of this facility, shouldthe need arise.

Individual members of the Code Council and the Appeals Boardare encouraged to inform themselves by researching orconsulting externally on issues in a general sense, whilstmaintaining confidentiality.

3.7 Conflict of Interest

If a Panel member is employed by a company directly involved ina complaint, referral or appeal, either as Complainant orRespondent, such member cannot participate in the Code Councilor Appeals Board established to consider that complaint, referralor appeal.

It is recognised that, on occasion, members of the Code Council orAppeals Board while not employed directly by a companyinvolved in a complaint, referral or appeal, may have somedegree of conflict of interest (e.g. direct competitor, sametherapeutic area etc.). However, it may not be feasible orpracticable to require such a member to stand down forconsideration of a given complaint, referral or appeal. A memberof the Code Council or Appeals Board should declare his or herinterest to enable the relevant Chairman to make an appropriatedecision. Confidentiality must be maintained.

3.8 Substitution

No substitution or replacement is allowed on the Code Council orAppeals Board or during the hearing of a particular complaint,referral or appeal.

3.9 Autonomy

Panel members must have autonomy vis-à-vis theircompany/employer in the context of their participation in theCode Council and/or the Appeals Board.

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3.10 Confidentiality

Absolute confidentiality must be maintained by Panel members.

As a rule, parties to proceedings before the Code Council shallmaintain confidentiality concerning any dealings with the CodeCouncil until such time as the Code Council reaches a finaldecision. Parties in exceptional circumstances may discuss issuesbefore the Code Council with third parties but only to the extentthat they can show to the satisfaction of the Code Council thatthis was absolutely necessary because of the intimateinvolvement of the third party with the matter to be consideredby the Code Council and only to the extent that such discussionwas factual, fair and balanced.

3.11 Accountability

The Code Council and Appeals Board are accountable to the IPHABoard of Directors for their satisfactory performance.

The Code Council and the Appeals Board are responsible for theirown conclusions and deliberations.

3.12 Procedures for Meetings

The Code Council and Appeals Board settle their own rules ofconduct and procedure. Proceedings before the Code Counciland the Appeals Board are informal. The Appeals Board hasrecourse to all methods and operational procedures that apply tothe Code Council.

4. Code Complaints Procedure

4.1 Who can make a complaint?

Complaints may be made by a pharmaceutical company,healthcare professional or any other body or person, with theexception of the IPHA Board of Directors, the Strategy Boards andany other IPHA committee or any member of the IPHA Executive.

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4.2 What constitutes a valid complaint?

Complaint made by Code Signatory:

When the Complainant is a Code signatory, the followingrequirements must be satisfied for a complaint to be consideredvalid:

(i) The complaint must be in writing;(ii) It must specify those clauses of the Code which are

alleged to have been breached;(iii) Ten bound copies of the complaint must be supplied

(further copies will be requested in the event of anappeal).

The Complainant must also provide in writing:

• an unqualified undertaking that the company will complywith every reasonable request of the Code of MarketingPractice Council or Appeals Board, if relevant;

• confirmation that the company will accept the finaldecision of the Council, or Appeals Board, if relevant,(although it may reserve the right to have recourse tolaw, should it consider that route necessary)

Failure by the Complainant to provide the required writtenundertaking of compliance and confirmation of acceptance ofthe Decision of the Code Council or Appeals Board, if relevant,will result in the Complaint not being processed further.

Other Complainants:

In the case of all other Complainants e.g. members of the public,healthcare professionals (other than those working directly for oron behalf of a pharmaceutical company) the complaint must besubmitted in writing. Anonymous complaints will not beaccepted. The Complainant’s identity will be disclosed to theRespondent, only in exceptional circumstances, where it may benecessary for the Respondent to know the identity of theComplainant so that the matter can be fully investigated, andonly with permission from the Complainant. 39

The Code Council will examine the complaint in detail anddetermine which clauses of the Code have been breached.

4.3 Establishment of Code Council

On receipt of a complaint in the IPHA offices, the IPHA Executivewill establish a Code Council (having due regard to conflicts ofinterest and other relevant matters) from amongst the membersof the Code Panel, to consider the complaint.

A quorum of four (three IPHA members plus the Code CouncilChairman) is required to hear a complaint and arrive at a finaldecision.

One of the independent persons and the non-IPHA member willalso be invited to participate in the Code Council. Papersregarding the case will only be circulated to those persons whohave confirmed that they will be in a position to attend themeeting.

4.4 Code Council Procedure and Timelines

The Code Council will endeavour to consider and deal withcomplaints in accordance with the following procedure andtimelines:

The “clock” starts when a valid complaint arrives at the IPHAoffices.

- A copy of the complaint is sent to the company alleged tohave breached the Code (i.e. the Respondent) who isrequested to:

• Provide a written response within 10 working days;• Provide an unqualified undertaking that the company

will comply with every reasonable request of the Codeof Marketing Practice Council or Appeals Board, if relevant;

• Confirm that the company will accept the final decision of the Council, or Appeals Board, if relevant (although it may reserve the right to have recourse to law should it consider that route necessary).

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• Supply ten bound copies of the response (further copies will be requested in the event of an appeal);

Failure by the Respondent to provide the required writtenundertaking of compliance and confirmation of acceptance ofthe Decision of the Code Council or Appeals Board, if relevant,will result in the matter being referred to the IPHA Board ofDirectors.

- Following receipt of the complaint and response, andprior to the first meeting of the Code Council, the CodeCouncil Chairman shall have the discretion to ask eitherparty to supply any additional information considerednecessary to establish the full facts of the alleged breachso as to enable the Code Council to reach a decision onthe matters complained of;

- Upon receipt of the Respondent’s response, the IPHAExecutive will issue a copy of the complaint and theresponse to each member of the Code Council;

- A meeting of the Code Council will be arranged within 30working days of the date of receipt of the complaint (i.e.whether or not the Respondent has replied). If theRespondent has provided a Response but not therequired written undertaking of compliance andconfirmation of acceptance of the Decision of the CodeCouncil or Appeals Board, if relevant, the clock will stopuntil the IPHA Board of Directors has considered thematter and advised how the complaint is to be dealtwith;

- It is desirable but not always possible to reach a decisionat that meeting. From time to time, subsequent meetingsmay be required;

- The Complainant and Respondent shall be kept informedof progress with the complaint. The names of themembers of the Code Council hearing the complaint mayonly be made available to either party subsequent to thecompletion of a case and only then on request; 41

- Where the Code Council, having considered a complaintor referral, has found that the Code has been breached, itshall have the authority to consider whether the gravityof the breach upheld is such that Clause 2.1 of the Codehas also been breached;

- The Code Council will issue a final decision within 10working days of its last meeting. The Complainant will beprovided with a copy of the response to the complaint atthe same time;

- The Respondent will have 10 working days from the dateon which the decision is issued to either lodge an appealor to confirm in writing its intention to comply with anyrecommendations/sanctions imposed. Failure by thecompany concerned to do so will result in the matterbeing referred to the IPHA Board of Directors;

The above time frame for the Code complaints procedure can beshortened or lengthened at the discretion of the Code CouncilChairman, depending on the complexity of the issues presentedand having regard to the availability of the Chairman of the CodeCouncil and members of the Code Panel.

Any request for an extension of the 10-day timeline forsubmitting an appeal will be a matter for consideration by theCode Council Chairman.

4.5 Withdrawal of complaints

The Complainant may withdraw the complaint at any time upuntil the response has been received by IPHA. If a complaint iswithdrawn before it has been sent to the Respondent, theRespondent will not be informed about the complaint.

Where the Code Council Chairman is of the view that the allegedbreach is serious, he or she may choose to continue theinvestigation of the matter in the manner outlined under thereferral system (see Section 7 of this Annex) regardless of thewithdrawal of the complaint.

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5. Appeals Board Procedure & Timelines

5.1 What constitutes a valid Appeal?

The following requirements must be satisfied for an Appeal to beconsidered valid: (i) The Appeal must be in writing;(ii) It must specify which aspects of the Code Council’s

Decision are being appealed and also the grounds for theAppeal which must be one or more of the following:

(a) the finding(s) is(are) wrong (b) the sanction(s) is(are) excessive(c) finding(s) is(are) flawed because of a serious

procedural or other irregularity;(iii) It may refer to documentation already submitted to the

Code Council and include any further material, includingnew evidence;

(v) In the case of an Appeal lodged by a Code signatory,twelve bound copies of the Appeal and twelve boundcopies of the original Code Council submission must besupplied.

5.2 Who can lodge an Appeal?

Only the Respondent to a Complaint may lodge an Appeal to theAppeals Board in respect of the Decision of the Code Council onthe Complaint.

5.3 Establishment of Appeals Board

On receipt, in the IPHA offices, of a written Appeal from theRespondent in respect of a Decision of the Code Council, the IPHAExecutive will establish an Appeals Board from amongst themembers of the Panel having due regard to conflicts of interestand other relevant matters. Panel members who have considereda Complaint at Code Council level are not eligible to consider thesame Complaint at Appeals Board level.

A quorum of six (five IPHA members plus the Appeals BoardChairman) is required to hear an Appeal and arrive at a finalDecision. One of the independent persons and the non-IPHA 43

member, if they have not participated in the Code Councilhearing, will also be invited to participate in the Appeals Board.

5.4 Material Supplied to Members of Appeals Board

Appeals shall be conducted as follows:

(i) In the case of an Appeal on the ground described inSection 5.1(ii) (a), the role of the Appeals Board is toreach a Decision based on the rehearing of those aspectsof the Complaint under Appeal, conducted and heard asthough at first instance, taking into account the originalsubmissions to the Code Council and any additionalevidence submitted by either party in the Appeal that theAppeals Board deems to be relevant.

(ii) In the case of an Appeal on either of the groundsdescribed in Section 5.1 (ii) (b) and (c), the role of theAppeals Board is to reach a Decision taking into accountthe grounds of the Appeal, the original submissions tothe Code Council, the Code Council Decision and anyadditional evidence submitted by either party in theAppeal that the Appeals Board deems to be relevant. TheAppeals Board will not rehear the original Complaint.

A copy of the Appeal and Response thereto and the originalwritten Decision of the Code Council will be sent to each memberof the Appeals Board. The Appeals Board will also be sent theoriginal documentation supplied by the Complainant andRespondent to the Code Council, i.e. the Complaint and theResponse thereto.

5.5 Appeals Board Procedures & Timelines

The Appeals Board will endeavour to consider and deal withComplaints in accordance with the following procedure andtimelines:- The “clock” starts when a valid Appeal arrives at the IPHA

offices;

- A copy of the Appeal is sent to the other party involvedin the Complaint, who is requested to provide a written

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Response, within 10 working days. If the other party is aCode signatory, it must supply twelve bound copies of theResponse and twelve bound copies of the original CodeCouncil submission;

- Upon receipt of the Response to the Appeal, theExecutive issues the documentation referred to at Section5.4 above to each member of the Appeals Board, i.e.Appeal, Response to Appeal, Code Council Decision, aswell as the original Complaint and Response to theComplaint, both of which will be included in the Appealsdocument provided by both parties;

- A meeting of the Appeals Board is arranged within 30working days of the date of receipt of the Appeal (i.e.whether or not the other party has replied);

- It is desirable but not always possible to reach a Decisionat the first meeting of the Appeals Board. From time totime, additional meetings may be required;

- The two parties involved in the Appeal shall be keptinformed of progress with the Complaint;

- The Appeals Board may limit its deliberations to selectedrelevant additional evidence, at its discretion;

- The names of the members of the Appeals Board hearingthe Appeal may only be made available to either partysubsequent to the completion of a case and only then onrequest;

- The Appeals Board issues a final Decision within 10working days of its last meeting. The party who made theAppeal is also provided with a copy of the Response tothe Appeal at the same time;

- Where a breach of the Code is confirmed by the AppealsBoard, the company concerned has 10 working days toconfirm in writing its intention to comply with therecommendations/sanctions imposed and to providedetails of any actions taken in that regard. Failure by thecompany concerned to do so will result in the matter

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being referred to the IPHA Board of Directors;

- The above time frame can be shortened or lengthened atthe discretion of the Appeals Board Chairman dependingon the complexity of the issues presented and havingregard to the availability of the Chairman of the AppealsBoard and members of the Code Panel.

5.6 Decision of the Appeals Board

The Decision of the Appeals Board is final and binding.

5.7 Personal Representation during Appeals

Each party involved in an Appeal has the right to make an oralpresentation to the Appeals Board. The following conditions willapply to all such personal representations:

(i) The IPHA Executive must be notified in writing if the relevantparty intends to exercise this right at least five working daysbefore the date of the first meeting of the Appeals Board;

(ii) Details of the company representatives who will be in attendancemust also be provided in writing. External advisors (includingbarristers or representatives from firms of solicitors) are notpermitted to attend on behalf of either party. Additionally, theAppeals Board Chairman has the right to limit the number ofrepresentatives;

(iii) A summary of each party’s representations to the Appeals Boardshall be submitted as soon as possible after the request for suchrepresentations and in any event, no later than five working daysbefore the Appeals hearing. Each party to the Appeal will receivethe summary of the other’s representations in advance of thehearing;

(iv) Each party’s presentation shall be limited in duration (generally toa maximum of 20 minutes followed by 10 minutes for questionsfrom the Appeals Board);

(v) No new material or data may be introduced during the oralpresentation that was not previously included in the writtendocumentation provided to the Appeals Board

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5.8 Withdrawal of Appeals

The Appellant may withdraw the Appeal at any time up until theResponse has been received by IPHA. If an Appeal is withdrawnbefore it has been sent to the Respondent, the Respondent willnot be informed about the Appeal.

6. Requirement for Complaints to HaveSubstance

All complaints submitted for consideration must have substance.In the event of doubt about whether a complaint has substance,the Code Council Chairman will be asked to adjudicate.

6.1 Complaints concerning promotional activities other than printedmatterThe difficulty in particular of establishing evidence for the CodeCouncil to consider in relation to complaints concerningpromotional activities such as meetings, hospitality, samples etc. isrecognised. The following requirements will therefore apply tosuch complaints:

(i) Any complaint in relation to such activity must havesubstance;

(ii) The complaint must be in writing and should containenough detail about the activity alleged to be in breachof the Code, as to justify the Code Council’sconsideration;

(iii) Any available material evidence must be included e.g.invitation or correspondence from the Respondent’scompany. The absence of such material evidence will notpreclude the Code Council’s consideration of thecomplaint.

If the Code Council considers that such a complaint justifiesinvestigation, it will have the right to ask the Respondent’scompany to demonstrate that it was in compliance with theCode. These provisions shall also apply in the case of appealsconcerning promotional activities other than printed matter.

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7. Referrals (i.e. alleged breaches of Codewhere there is no formal writtencomplaint)

Alleged breaches of the Code by a Code signatory which come toIPHA’s attention other than by way of a formal written complaintare defined as “referrals” and dealt with in accordance with thefollowing procedure:

7.1 Establishing if referral is appropriate and has substance

Where the Code Council Chairman receives information, fromwhatever source, from which it appears that a Code signatorymay have contravened the Code, the Code signatory concernedshall be requested to comment on the matter(s) of complaint.

The Code Council Chairman shall decide, having taken intoconsideration any information received, if the referral hassubstance and in particular if there is enough detail about thealleged activity as to justify the Code Council’s investigation. Ifthe Code Council Chairman decides that the matter does notwarrant investigation by the Code Council, that decision will befinal and the complainant shall be so advised.

7.2 Use of the referral mechanism by a Code signatory

Code signatories shall normally use the complaints mechanism toseek redress for alleged breaches of the Code. Where they usethe referral mechanism they must provide the Code CouncilChairman with a satisfactory explanation as to why it was notpossible to utilise the normal complaints mechanism. The CodeCouncil Chairman shall then decide whether it is appropriate forthe matter to be dealt with in this way or whether the Codesignatory, should it wish to progress the matter further, should berequired to use the complaints procedure outlined in Section 4 ofthis Annex.

Where the Chairman decides it is appropriate for the matter tobe dealt with by way of the referral mechanism, the Codesignatory will be identified to the Code Council and the48


Respondent as the source of the referral.

7.3 Role of Code Council

The Code Council will be responsible for investigating the allegedbreach and, in particular, for identifying any clauses of the Codewhich may have been breached. The referral will be handledusing the standard procedures and timelines that apply to Codecomplaints, except that in such cases the Code Council Chairmanshall not have a vote. The Code Council will have the samepowers to apply sanctions as in the case of a complaint.

7.4 Procedure for Consideration of Referrals by Code Council

The following procedure shall apply to the Code Council’sinvestigation of a referral:

- In order to expedite matters, the Code Council Chairmanmay write to the company that is alleged to havebreached the Code before the first meeting of the CodeCouncil seeking preliminary information for the CodeCouncil to consider at its first meeting;

- In any case, the company will be required to provide thestandard undertakings that apply to complaints, i.e. anunqualified undertaking that it will comply with everyreasonable request of the Code Council and confirmationthat it will accept the final decision of the Council (orAppeals Board if relevant);

- After its first meeting, the Code Council will issue a letterto the company setting out the alleged breaches of theCode and it will be required to submit a written response.The Code Council has the authority to seek any furtheradditional information considered necessary from thecompany which is alleged to have breached the Code;

- All information requested by the Code Council Chairmanand Code Council must be provided within 10 workingdays, with extensions only possible at the discretion ofthe Code Council Chairman; 49

- The company shall have a right of appeal to the AppealsBoard in relation to the decision of the Code Council,including any sanctions applied. The procedures outlinedin Section 5 of this Annex will apply to such appeals;

- In the case of a referral where the Code is found to havebeen breached, details of the case shall be reported inthe usual manner in the Code of Marketing PracticePublication of Findings Report, with referrals beingreported separately to complaints;

- “Self-referrals” from Code signatories will not beaccepted in any circumstances, i.e. it shall not be open toCode signatories to seek the views of the Code Council onany of their own activities.

8. Sanctions

Where the Code Council, having considered a complaint orreferral, has found that the Code has been breached it shall,without prejudice to the right of any affected party to have thematter resolved through the judicial process, have the authorityto:

(i) Require the company concerned to cease the practicefound to be breach of the Code and take all necessarysteps to avoid a similar breach in the future;

(ii) Reprimand the company for the breach of the Code;

(iii) Order the recovery of material found to have been inbreach of the Code;

(iv) Order the correction of inaccurate information by way ofdirect contact with relevant healthcare professionals orby publication, in the medical and/or pharmaceuticalpress, of a corrective notice in terms approved by theCode Council/Appeals Board;

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(v) Order the immediate publication of the decision in wholeor in part and specify how and to whom the decision is tobe sent. This is additional to inclusion of details of thedecision in the annual Code of Marketing PracticePublication of Findings (see Section 11 of this Annex);

(vi) In the case of difficult and/or persistent breaches of theCode, refer the matter to the Minister for Health andChildren;

(vii) Recommend to the IPHA Board of Directors suspension orexpulsion from IPHA of the offending party.

This list is not exhaustive and other sanctions may be applied bythe Code Council/Appeals Board as appropriate.

In the event that the decision of the Code Council is appealed,the Appeals Board shall assume responsibility for the applicationof any or all or the above sanctions. In addition, the AppealsBoard may uphold the decision of the Code Council but vary thesanctions applied. As soon as a decision of the Code Councilbecomes the subject of an appeal, the decision and any sanctionsimposed by the Code Council is deemed to be suspended.

9. Abuse of Code

Abuse of the Code procedure shall in itself be a breach of theCode.

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10. Recourse to Legal System

A company’s right to have recourse to the legal system is notaffected by participation in and compliance with the Code ofMarketing Practice and the Code Council’s and the AppealsBoard’s decisions. However, it is envisaged that the transparencyof procedures in this Code will ensure that the necessity for suchaction will not arise.

A Complainant/Respondent must advise the Code Council and theAppeals Board in the unlikely event of recourse to the legalsystem before or during a complaint. The Code Council or theAppeals Board, as appropriate, will have the right to takewhatever action it sees fit under the circumstances.

11. Code of Marketing Practice Publicationof Findings

The Code of Marketing Practice Publication of Findings ispublished at least once a year by IPHA.

A copy of the Publication of Findings shall be sent to:

- All members of IPHA- All non-IPHA member Code signatories- The Minister for Health & Children/ Department of Health

& Children- The Irish Medicines Board

The Publication of Findings will include details of the number ofcomplaints and referrals heard by the Code Council and AppealsBoard each year. A summary of each complaint upheld in wholeor part will be provided, including the names of companies foundto have breached the Code.

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An extract of the Publication of Findings summarising cases(where matters will be made anonymous) that have value asprecedents and are of international interest can be madeavailable for teaching purposes. Cases resulting in the finding of abreach as well as those where no breach is found to haveoccurred may each have such value and/or interest.

12. Administration Fees

IPHA reserves the right to set fees for the operation of the IPHACode Council and Appeals Board at any time in the future.

13. Procedures for Amending Provisions ofthe Code

It is important that the Code and its associated guidelines shouldaccurately reflect the highest standards and for this reason it iskept under constant review and amended from time to timewhere necessary, to clarify it and bring it up to date.

IPHA’s Code of Marketing Practice Review Team will be convenedas necessary to consider proposals to amend provisions of theCode and make appropriate recommendations. The CodeCouncil, the Appeals Board, the general membership of IPHA,non-IPHA member signatories to the Code and any other externalinterested parties may refer items for discussion by the ReviewTeam.

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Annex IIGuideline on Nursing Services Provided by Pharmaceutical Companies

In recent years, pharmaceutical companies, with the agreement ofindividual medical practitioners, have provided the services ofspecially trained nurses to educate patients about the medicines theytake and help them achieve compliance with their treatment regimeswith a view to enhancing the care of patients in the practice.

Although working in the medical practice, these nurses are eitherdirectly in the employ of the pharmaceutical companies or indeed,may be contracted from a third party agency by the companies.Owing to the special nature of such employment conditions, it isconsidered important to set out guidance for sponsoringpharmaceutical companies, the nurses and the medical professionalswho benefit from these services. The purpose of the guidance istwofold: it seeks to ensure standards of best practice in the operationof these services; it also seeks to enhance the understanding of therole and authority of such nurses in the provision of these services.

1. The provision of nursing services must be done in such away as to avoid any inference that they might beconsidered to be an inducement designed to promote theprescription, supply, sale or consumption of a medicine.

2. The decision as to what medicine a particular patient isprescribed rests with the medical practitioner alone. Thenurse has no authority to prescribe medicines or tochange a prescription authorised by the practitioner.

3. Nurses may provide direct advice to a patient about amedication upon receipt by the patient of a prescription.Such advice must be consistent with the terms of theproduct authorisation.

4. Companies should only offer the services of nurses in adoctor’s clinic by prior arrangement. 54


5. Nurses must operate to detailed written instructionsprovided by the company. These instructions shouldclearly set out the role of the nurse. Nurses must bemindful of their professional nursing role and of theneed to maintain registration with An Bord Altranais.Attention is also drawn to the Board’s Code ofProfessional Conduct, which states that registration statusshould not be used in the promotion of commercialproducts. In this context, therefore it is important toavoid confusing the nurse’s role with that of a medicalrepresentative.

6. The medical professional in the practice/clinic, which isreceiving the nursing service, must be provided with awritten protocol to avoid any misunderstanding as towhat he/she has agreed.

7. The remuneration of nurses must not be linked to sales inany particular territory or place or to sales of a specificproduct or products. In particular, it may not include abonus scheme linked to such sales. Bonus schemes linkedto a company’s overall national performance or to thelevel of service provided may be considered.

8. Any printed patient-oriented material provided by thenurse to the patient must be non-promotional. It is notacceptable for such materials to promote theprescription, supply, sale or consumption of thecompany’s products. All printed materials must identifythe pharmaceutical company involved.

9. Patient confidentiality is crucially important; thereforethe nature of any details, taken and retained by thenurse, should be agreed with the healthcare professionaland patient. Any information retained must be done soin accordance with current data protection legislation.

10. Companies must ensure that nurses are adequatelytrained for the role that they will undertake. In particular,they must be familiar with the products of the companyin relation to which the services are provided. They mustalso be cognizant of this guideline.

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11. Like all other pharmaceutical industry employeesinvolved in the provision of information they must befully conversant and compliant with the provisions of theCode of Marketing Practice.

12. Like all other pharmaceutical industry employees, theyshould transmit to their companies forthwith anyinformation on adverse reactions to the company’sproducts, reported to them.

13. Companies are fully responsible for the activities of thenurses (including those contracted from a third party)within the scope of their employ/contract.

14. The patient may at all times reserve the right to declinethe support offered by nurses and such decisions must berespected.

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Annex IIIGuideline for Pharmaceutical Companies on Working with Patient Associations

1. Introduction

Patient associations play a key role in representing, meeting theinformation needs of and offering support to people living withill-health. Increasingly, patient associations (including patient andhealthcare advocacy groups which are not disease specific) andpharmaceutical companies are realising that they do sharecommon interests and can benefit from working togethertowards achieving early diagnosis and appropriate treatment ofan illness, improved compliance with treatment and better healthoutcomes. This type of collaboration is to be welcomed andencouraged.

The purpose of this document is to provide guidance topharmaceutical companies on how to ensure their relationshipwith patient associations is positive, constructive, mutuallybeneficial and ethical.

2. General Principles

The following general principles shall apply to the relationshipbetween a pharmaceutical company and a patient association:

- The independence of the patient association, in terms oftheir policies and their activities, must be guaranteed;

- The relationship between the patient association and thecompany shall be based on mutual respect and trust;

- In all matters where there is joint co-operation, theremust be full transparency. In particular, public disclosureof direct and indirect support provided by pharmaceuticalcompanies to patient organisations is required; 57

- The pharmaceutical company shall not request, and thepatient association shall not undertake, the promotionof the company’s products either directly or indirectly;

- The company and the patient association shall, onrequest, provide each other with annual reports, and anyother information deemed appropriate by both parties soas to provide further background to the campaign,project, funding request, etc.

3. Funding of Patient Associations

Despite the importance of patient associations and the growingnumber of people who depend on their services, these groups arecharities and must therefore raise money from a wide variety ofsources such as legacies, foundations, Government and largecorporations. It is also appropriate for pharmaceutical companiesto provide funding for patient associations and many companiesdo so.

There are a number of ways in which it is acceptable for apharmaceutical company to provide funding for a patientassociation, for example:

- Pharmaceutical companies may donate money withoutreference to the specific purpose for which it is to beused. This is sometimes referred to as a contribution tocore funding;

- Funding may be provided for a patient associationpublication, meeting, project or piece of research inwhich the pharmaceutical company has little or noinvolvement;

- A company may facilitate patient association meetings byproviding or sponsoring speakers or providing a venue ormaking a contribution towards travel expenses fordelegates;

- A company may undertake projects of joint interest witha patient association.

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The following principles shall apply in relation to such funding:

- Pharmaceutical companies working with patient associationsshould recognise the limits of their involvement (which should beset out in writing in all cases) and the independence of thepatient association. In particular, pharmaceutical companies mustnot seek to influence the text of patient organisation materialsthey sponsor in a manner favourable to their own commercialinterests. This does not preclude companies from correctingfactual inaccuracies;

- Both parties should be transparent about funding arrangements,ensuring that partnership programmes and fundingarrangements are not only proper, but also seen to be so. Eachcompany must make publicly available a list of patientorganisations to which it provides financial support and/orsignificant indirect/non-financial support. This should include ashort description of the nature of the support. Companies mustensure that their sponsorship is always clearly acknowledged andapparent from the outset;

- No one company should fund a patient association to theexclusion of other available and willing sponsors. However apatient association’s independence must be recognised insofar aswhom they wish to work with exclusively. It would be reasonablefor a willing sponsor to receive an explanation as to why theyhave not been included as a sponsor by the patient association;

- Where a patient association receives a significant part of itsfunding from one or more pharmaceutical companies, the controlof the association must be independent of the pharmaceuticalcompanies involved;

- The public use of a patient organisation’s logo and/or proprietarymaterial by a pharmaceutical company requires writtenpermission from that organisation. In seeking such permission,the specific purpose and the way the logo and/or proprietarymaterial will be used must be clearly stated.

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Any hospitality provided by a pharmaceutical company to patientassociations and their members should be reasonable andsecondary to the main purpose of the event at which it is offeredand linked directly to the event in question, whether the event isorganised by the patient association or the company. The sameprinciples regarding hospitality apply if a company has providedsponsorship for hospitality at an event and has a significant say inhow it is to be spent, although the patient association shouldalways retain overall control of the event. Venues that arerenowned for their entertainment or leisure facilities or areextravagant must not be used.

4. Provision of Information byPharmaceutical Companies

Many pharmaceutical companies are engaged in comprehensiveinformational activities in conjunction with patient associationsfocused on providing support material to patients who have beenprescribed or use their products and in the publication ofinformation about specific diseases. These activities play animportant role in educating patients about their conditions andhelping them to achieve good compliance with, and the bestoutcomes, from their medicines.

4.1 Prescription-only medicines

The advertising and promotion of prescription-only medicines tothe public is prohibited by Irish and EU legislation, which isreflected in the IPHA Code of Marketing Practice. Thisprohibition extends to patient associations as well aspharmaceutical companies. Any informational activities by acompany should not be undertaken in such a way as to give riseto the inference that their purpose is to encourage members ofthe public to ask their doctors to prescribe a specific medication.In particular:

- As a general rule, the brand name of a prescription-onlymedicine (including logos incorporating brand names)should not appear in any leaflet, brochure or other60


material, including a website, produced by a patientassociation that is sponsored in whole or in part by apharmaceutical company. This does not preclude a non-promotional reference to a named product in a patientassociation newsletter or website, provided that thesponsoring company has no editorial input and thereference to the product by the patient association is notin any way linked with the sponsorship provided;

- No references by brand name to a prescription-onlymedicine should be included;

- On any material displayed by a pharmaceutical companyat a patient association event or at an event organisedfor patients/the public by a company;

- The brand name of a prescription-only medicine may onlyappear in informational material produced by apharmaceutical company that is to be given to patientsafter the medicine is prescribed, to assist them in using itcorrectly;

- Speakers provided by a pharmaceutical company for apatient association event must avoid any references tothe company’s products that could be regarded aspromotion.

4.2 Disease awareness campaigns

In recent years, a number of companies have been associatedwith public advertising campaigns designed to raise awareness ofspecific diseases and encourage sufferers or at risk people to seekadvice on treatment. Many of these campaigns have been rununder the umbrella of patient associations and have been fundedwholly or in part by the industry. These campaigns are particularlyuseful for conditions or symptoms that might otherwise gountreated, including asymptomatic diseases like diabetes andhypertension, and embarrassing conditions like impotence andincontinence.

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A disease awareness campaign should not in any way promote abrand of medicine, either directly by naming a product orindirectly, for example:

- If there are non-prescription as well as prescription-onlymedicines available to treat a particular condition,advising patients to visit their doctor for treatment couldbe regarded as promoting the use of a prescription-onlymedicine. To avoid any such inference, considerationshould be given to advising patients to talk to theirdoctor or pharmacist;

- In the case of a disease awareness campaign sponsoredby a company which markets the only available medicinefor that disease/condition, particular care is required toensure that the campaign could not be regarded aspromoting that product. Statements such as “Your doctorcan prescribe a medicine to help you” should be avoided.

It is recommended that a company makes the medical professionand the relevant patient associations (where appropriate) awareof its plans to run a disease awareness campaign before it islaunched to the public.

4.3 Information about new scientific discoveries

A pharmaceutical company may only provide information abouta new scientific discovery of a prescription-only medicine to apatient association if the following conditions are satisfied:

- The information must be presented in a non-promotionalway. Statements must not be made or designed for thepurpose of encouraging members of the public to asktheir doctors to prescribe a particular product;

- The information must be presented in a balanced way toavoid the risk of raising unfounded hopes in the publicmind arising from the results of treatment.

A pharmaceutical company can only incorporate a supportivestatement about a new scientific discovery from a patient62


association in a press release, with the written approval of thepatient association.

4.4 OTC medicines

Unlike prescription-only medicines, most non-prescription orover-the-counter (OTC) medicines can be advertised to the public.The advertising and promotion of these medicines must complywith the IPHA Code of Standards of Advertising Practice for theConsumer Healthcare Industry. In particular:

- Any reference to an OTC medicine (including its brandname and/or product specific logo) in promotionalmaterial produced by or paid for by a company (e.g.brochure, leaflet, website, company stand), is regarded asan advertisement. This includes advertisements in patientassociation newsletters, brochures, websites, etc.;

- Promotional material referring to OTC products by brandname/logo, including material prepared by a patientassociation but paid for by the manufacturer, must not bedesigned to disguise its real nature. In particular, suchmaterial must not resemble editorial matter;

- References to a company’s product by active ingredientonly in material prepared by a patient association are notregarded as advertising provided that the material isdrafted independently of the company and any otherrelevant active ingredients are mentioned. Such materialmay carry advertising for OTC products, including thosereferred to by active ingredient in the editorial.

4.5 Requests for information from patient associations

Pharmaceutical companies should always refuse requests frompatient associations and their members for advice on personalmedical matters (e.g. is this medicine suitable for me?). In suchcases, they should be advised to contact their own healthcareprofessional. The intention of this is to ensure that companies donot intervene in the patient/healthcare professional relationship.

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It is however permissible to answer general questions aboutmedicines, for example, whether they are suitable for diabetics orcoeliacs, whether the medicine should be taken before or aftermeals, etc.

Summaries of Product Characteristics (SPCs), Package Leaflet (PL)and European public assessment reports (EPARs) may also beprovided to patients but must not be presented in a promotionalway.

5. Provision of Samples

Free samples of medicinal products (i.e. both prescription-onlyand OTC medicines) may not be supplied to members of thepublic under Irish and EU legislation. Pharmaceutical companiesshould not offer nor should patient associations or their membersseek free samples. Packs containing medicinal products shouldnot be displayed on company stands at patient association events.

6. Summary

Co-operation between pharmaceutical companies and patientassociations makes a valuable contribution to the nation’sunderstanding of many conditions and improved complianceamongst the population being treated for these conditions.Adherence to this guideline will ensure that this collaboration isundertaken in a positive and ethical manner.

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 marketing practice for the pharmaceutical industry, edition 7.4

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