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IFPMA Code of Pharmaceutical Marketing Practices

The IFPMA Code was adopted by the International Federation of Pharmaceutical Manufacturers Associations in 1981 and the complaints procedure became operational in 1982. A major revision of the Code took place in 1994, recognising the many changes in the market environment which had occurred over the thirteen years of its operation and also taking account of the WHO Ethical Criteria on the marketing of medicinal products agreed by the World Health Assembly in May 1988. The 1994 Edition of the Code is published in three language versions (English, French and Spanish) and came into operation, 1 March 1995.

Most of the Member Associations of IFPMA now have well established codes of practice which apply to the way in which prescription medicines are advertised and promoted, nationally, by their member companies. The IFPMA Code, however, is binding on those companies wherever they market their products throughout the world. The IFPMA Code has therefore been established as an operational Code in its own right, with a procedure for dealing with complaints. IFPMA receives complaints of alleged Code violations and ensures that appropriate action is taken by relevant Member Associations and companies when breaches of the Code are determined. IFPMA applies the "sanction" of adverse publicity by publishing and giving wide circulation to Status Reports on complaints, which name the companies found in breach of the Code.

IFPMA Code of Pharmaceutical Marketing Practices

Revised 1994

Contents:
Introduction
History
Operation
Commitments of Industry
I. General Principles:
Scope of the Code
Standards of Promotion
Scientific Evidence
Safety Data
Disguised and Misleading Promotion
Pre-Registration Communications
Communications to the Public, Company Procedures
II. Medical Representatives
Training, Company Responsibility, Remuneration
III. Symposia, Congresses and Other Means of Verbal Communication:
Objectives
Sponsorship
IV. Hospitality and promotional Items:
Hospitality
Promotional Items
Educational Material
V. Printed Promotional Material:
General
All Advertisements
Full Advertisements
Reminder Advertisements
References
Frequency and Volume
VI Audio-Visual and Computer-Based Promotional Material
VII Samples
Addendum: Information for developing countries
Annex: Operating Procedures of the IFPMA Code,
A. The Procedure for Code Complaints
B. Use of the Complaints Procedure
C. Encouragement of Adherence to the Code

INTRODUCTION

The promotion of prescription medicines to healthcare professionals is a vital extension of the process of searching for and developing new and better means of preventing and treating illness. Promotion and the dissemination of educational information ensures that the full benefits of the years of work and enormous expenditure of skill and money will be made available promptly to the patients of the world. In all its activities the pharmaceutical industry believes that high standards should be defined and respected and is convinced that, so far as its marketing activities are concerned, self discipline is the process which best serves the public interest.

The voluntary adoption of the IFPMA Code of Pharmaceutical Marketing Practices in 1981 was in accordance with a key objective of the Federation as set out by its Founder Members in 1968 in the Statutes (Article 3) which state that one of the objects of the Federation is "to promote and support continuous development throughout the pharmaceutical industry of ethical principles and practices voluntarily agreed on" and "to coordinate the efforts of its members towards the realisation of the above objects".

When the Statutes of the Federation were revised in 1988 it became a requirement of membership of IFPMA that national associations should accept the conditions of the IFPMA Code, on behalf of their member companies.

This revision of the IFPMA Code of Pharmaceutical Marketing Practices is an important development from the original Code. The Federation recognises the value of the definition by the World Health Organization in 1988 of Ethical criteria for medicinal drug promotion. The present version of the IFPMA Code is consonant with these criteria, to the extent to that they are applicable to our constituents.

Like the original version of the IFPMA Code, this version is intended to define universally applicable baseline standards of marketing practices. A substantial proportion of the 51 member associations of IFPMA have their own Code of Practice. Some are based on the IFPMA Code, but elaborated to recognise national circumstances and conditions, while others are derived from versions which existed even before the IFPMA Code was first introduced. All, however, fully embody the principles set out in the IFPMA Code.

Companies within membership of IFPMA Member Associations are encouraged to formulate their own codes that may include more specific requirements and additional rules that must be observed by their own employees in conducting their own promotional activities. (Back to Index)

HISTORY

The original version of the IFPMA Code of Pharmaceutical Marketing Practices was approved by Member Associations in March 1981. A complaints procedure was announced the following year when a statement about the requirement to include the non-proprietary name in all advertisements was also included in the published document.

Following a decision by Council in 1983, detailed information on complaints received and their outcome has been published at intervals.

In 1988 a Revision of the Statutes embodied a previously enforced but informal requirement that acceptance of the terms of the Code on behalf of all member companies should be a condition of membership of the Federation. The implication of this development was that the adoption of any subsequent change in the Code and/or its operating procedure would be subject to the same procedural rules as a change in the Statutes of the Federation.

In 1989 the published version of the Code incorporated a number of explanatory notes to facilitate interpretation of the operation of the Code. At the same time the Code was published in three separate language versions (English, French and Spanish) instead of the previous single trilingual version.

The present Revised Code is the result of the deliberations of a specialised Task Force established by the Council of IFPMA and formal approval by the General Assembly of IFPMA at the meeting held in Malmö, Sweden on 31 August 1994. (Back to Index)

OPERATION OF THE CODE

(see also Annex)

In addition to setting out universal principles for ethical marketing conduct, the IFPMA Code is intended to provide an operational Code to be used in countries other than those in which a more demanding national Code operates. For the purpose of self discipline, there is a mechanism, described, in Annex 1, under which IFPMA deals with complaints of alleged breaches of the Code. Where it is determined that there has been a breach of the Code, the objective is to effect, as rapidly as possible, correction of the matter. Publicity is given to breaches of the Code and periodic reports are issued on the operation of the Code.

The Federation believes that being open to receive bona fide complaints from any source on any aspect of the Code provides for more effective operation of the Code than monitoring what would be a very small proportion of advertisements - themselves only a modest proportion of the industry's promotional activities.

An important feature of the Code is its universal applicability. It is a requirement that the terms of the Code should apply to any company belonging to at least one Member Association in all the countries of the world where that company does business. Companies entering into licensing and agency agreements are expected to require their licensees and agents to respect the provisions of the IFPMA Code. (Back to Index)

COMMITMENTS OF INDUSTRY

The international pharmaceutical industry is committed to the improvement of the health of mankind through research and development of new medicines and the production and marketing of pharmaceutical products of reliable quality, in accordance with internationally defined standards of good practice.

As part of its commitment to health, the industry has an obligation and responsibility to provide accurate information and education about its products to health care providers in order to establish a clear understanding of the appropriate use of prescription medicines.

Promotional activities (marketing practices) must be consistent with high ethical standards and information should be designed to help health care providers improve services to patients. Information must be provided with objectivity, truthfulness and in good taste and must conform to all relevant laws and regulations. Claims for therapeutic indications and conditions of use must be based on valid scientific evidence and include clear statements with respect to side effects, contra-indications, and precautions.

High standards of ethical behaviour shall apply equally to marketing of pharmaceutical products in all countries, regardless of the level of development of their economic and health care systems. (Back to Index)

THE CODE

I. GENERAL PRINCIPLES

1. Scope of the Code

The term 'pharmaceutical product' in the context of the Code means any pharmaceutical or biological product which is primarily intended to be used on the advice of, or under the supervision of a health care professional, and which is intended for use in the diagnosis, treatment or prevention of disease in humans, or to affect the structure or any function of the human body. The promotional activities within the scope of the Code include direct-to-consumer advertising, where this is permitted under local laws. Explanatory Note

In all matters of application, interpretation and enforcement of any section of the Code (or its Annexes), it is to be understood that compliance with national laws, regulations and regulatory decisions and requirements will take precedence. (Back to Index)

2. Standards of Promotion

Promotional material for pharmaceutical products should be accurate, fair and objective and presented in such a way as to conform not only to legal requirements but also to high ethical standards and to be in good taste. Claims should not be stronger than scientific evidence warrants, and every effort should be made to avoid ambiguity. (Back to Index)

3. Scientific Evidence

Information in promotional material should be based on an up-to-date evaluation of evidence that is scientifically valid and should not give an incorrect or misleading impression. Prescribing information should be supported by this information and be in accordance with the local product authorisation or, where this is not applicable, should be in accordance with an authorisation issued by a regulatory authority in an industrialised country. Scientific data to support the claims and recommendations for use should be made available, on request, to healthcare providers. Explanatory Notes

(Back to Index)

4. Safety Data

Particular care should be taken that essential information as to pharmaceutical products' safety, for example, contra-indications, precautions and side effects, is appropriately and consistently communicated, subject to the legal, regulatory and medical practices of each nation. The word "safe" should not be used without qualification.

Substantiated information on serious and unexpected adverse reactions associated with pharmaceutical products should be reported to the appropriate national health authority as a priority. Explanatory Note

(Back to Index)

5. Disguised and Misleading Promotion

Promotional material, such as mailings and medical journal advertisements, must not be such as to disguise its real nature.

Post-marketing and surveillance studies should be conducted on a scientific or educational basis. These studies should not be conducted simply as a means to promote a product and influence physicians, with little or no scientific or educational basis.

Explanatory note

(Back to Index)

6. Pre-Registration Communications

No pharmaceutical product shall be promoted for use in a specific country until the requisite approval for marketing for such use has been given in that country. However, this provision is not intended to abridge the right of the scientific community and the public to be fully informed concerning scientific and medical progress. It is not intended to restrict a full and proper exchange of scientific information concerning a pharmaceutical product, including appropriate dissemination of investigational findings in scientific or lay communications media and at scientific conferences. Nor should it restrict public disclosure to stockholders and others concerning any pharmaceutical product as may be required or desirable under law, rule or regulation.

(Back to Index)

7. Communications to the Public

Where it is permitted by law to communicate directly with patients regarding their prescription medicines, all such information should be accurate, fair and not misleading.

Where companies assist in the conduct of public/patient disease awareness programmes to meet growing demands of society for more information and enhance public understanding of disease prevention, signs and symptoms of medical conditions, illnesses, and available treatments, such activities should adhere to the highest standards of accuracy and support the role of the health care provider. Explanatory Note

(Back to Index)

8. Company Procedures

Promotional communications should have medical clearance or, when appropriate, clearance by the responsible person before their release. The responsible person must have appropriate scientific or healthcare qualifications.

Companies should establish and maintain appropriate procedures to ensure full compliance with appropriate national and international Codes and to review and monitor all of their promotional activities and materials. (Back to Index)

II. MEDICAL REPRESENTATIVES

1. Training and Responsibilities

Medical representatives must be adequately trained and possess sufficient medical and technical knowledge to present information on their company's products in an accurate, responsible and ethical manner. They must also feed back to their company, from contacts in the medical and allied professions, information which they receive on the use of products and particularly reports of side effects.

2. Company Responsibility

A company will assume responsibility, under the Code, for correcting breaches of the Code resulting from misconduct or misrepresentation of facts by any representative.

3. Remuneration

The system of remuneration of representatives should not be such as to adversely influence the proper prescribing of pharmaceutical products by the physician. Explanatory Note

(Back to Index)

III. SYMPOSIA, CONGRESSES AND OTHER MEANS OF VERBAL COMMUNICATION

1. Objectives

Symposia, congresses and the like are indispensable for the dissemination of knowledge and experience. Scientific objectives should be the principal focus in arranging such meetings and entertainment and other hospitality shall not be inconsistent with such objectives.

2. Sponsorship

When a pharmaceutical company or association sponsors a symposium, congress or other medical/health care or educational programme:

(Back to Index)

IV. HOSPITALITY AND PROMOTIONAL ITEMS

1. Hospitality

Inappropriate financial or material benefits, including inappropriate hospitality, should not be offered to healthcare professionals to influence them in the prescription of pharmaceutical products. Explanatory Note

2. Promotional Items

Promotional items of insignificant value, provided free of charge, are permissible as long as they are related to the health care provider's work and/or entail a benefit to patients.

3. Educational Material

Text- or reference-books/information, and other educational material may be given to health care providers if they serve a genuine educational function.

(Back to Index)

V. PRINTED PROMOTIONAL MATERIAL

1. General

Printed promotional material shall be presented in a legible manner. The scientific basis and presentation of the product information must be in conformity with the general principles set out in Section I of the Code and, where applicable, with the authorised product information. Explanatory Note

2. All Advertisements

All advertisements appearing in print must include:

Explanatory Note (Back to Index)

2.1 Full Advertisements

Full advertisements are those which include promotional claims for the use of the products. In addition to the requirements of paragraph V.2, full advertisements must also include prescribing information in the form of:

2.2 Reminder Advertisements

In the absence of local regulations, an abbreviated or "reminder" advertisement is defined as a short advertisement containing no more than a simple statement of indications to designate the therapeutic category of the product.

For reminder advertisements, the requirements of paragraph V.2 apply, but the prescribing information required under paragraph V.2.1 may be omitted, provided that there is:

Explanatory Note (Back to Index)

3. References

When promotional material relates to published studies, a clear reference to these should be given in the printed material. Quotations from medical literature or from personal communications must not change or distort the intended meaning of the author or clinical investigator or the significance of the underlying work or study.

4. Frequency and Volume

The frequency and volume of mailings of printed material to the healthcare professionals should be reasonable. Requests by physicians for their names to be removed from mailing lists for promotional material should be respected but full mailing lists should be maintained in order to permit provision of important information concerning adverse reactions, precautions, warnings, etc.

(Back to Index)

VI. AUDIO-VISUAL AND COMPUTER-BASED PROMOTIONAL MATERIAL

Promotional information provided using these media must fulfil the relevant requirements for printed material, as set out in Section V. Prescribing information may be omitted provided that complete product information is made available to the audience.

(Back to Index)

VII. SAMPLES

Samples, clearly identified as such, may be supplied to the prescribing professions to familiarise them with the products, to enable them to gain experience with the product in their practice, or upon request.

(Back to Index)

ADDENDUM:

Information for developing countries

Being mindful that many developing countries are not aware of the indications, contra-indications, side-effects, etc. of individual pharmaceutical products that have been accepted in the industrialised countries, IFPMA has offered help to supply, free of charge to Government Health Departments of developing countries, copies of up-to-date standard compendia such as The Physicians Desk Reference (USA), the ABPI Data Sheet Compendium (UK), the Rote Liste (Germany), the Japan Pharmaceutical Reference and the Dictionnaire Vidal (France).

(Back to Index)

ANNEX

OPERATING PROCEDURES OF THE IFPMA CODE

A. The procedure for Code complaints

1. Validation and Referral

When a complaint, alleging a breach of the IFPMA Code, is received by the IFPMA Secretariat, it is first validated to ensure that:

A single complaint may cover more than one 'case', i.e. the complaint may refer to several advertisements from different companies and/or for different products. Each 'case' is handled separately by IFPMA under the main complaint reference. The first action in each case is to identify:

A summary of each case in the complaint, with a copy of any supporting evidence (e.g. a copy of the advertisement alleged to be in breach of the code) is sent to the Member Association or Associations, as indicated above, with a copy to the senior management of the company, at its headquarters and at local level. Member Associations are asked to consult the company and report back, to IFPMA, the results of their investigation of the case.

Non-member companies

When a case refers to a company which does not belong (either locally, or through its parent company) to a Member Association of IFPMA, the case cannot be processed formally.

If IFPMA has a Member Association in the country where the alleged breach occurred, that association will be asked to take up the matter, informally, with the non-member company and draw its attention to the need to comply with the standards set out in the IFPMA Code.

In countries where there is no IFPMA Member Association information on the case will be referred to the local regulatory authority.

2. Time Limits

The letter to the Member Association(s), indicates the time within which a response must be made on the case(s) under investigation. This is normally 60 calendar days from receipt of the documentation.

In exceptional circumstances, an extension to the time limits may be allowed. An example would be if the Member Association in the country in which the alleged breach occurred intends to process the case through its national Code procedures, for which there is a defined timetable. In this event the complainant would be informed of the extended time frame.

3. Response

Where the company acknowledges that it has acted in breach of the Code, information is required on the action that has been taken or will be taken to remedy the matter.

Where the allegations are rejected, the reasons for rejection must be clearly stated and, where appropriate, supporting data (e.g. scientific evidence to support claims which have been questioned) should be provided.

The response(s) from the Member Association(s) is/are used in the preparation of the IFPMA decision on the case which is communicated to the complainant, with a copy to the company and respective Member Association(s).

4. Publication of the outcome

When a complaint is upheld and a breach of the Code is determined, information, identifying the company concerned, and the complainant, is immediately made public.

Likewise, information may be made public in cases where the company fails to respond within the agreed time limit.

Status Reports

Status Reports on the IFPMA Code, summarising all complaints received are also published periodically and given wide circulation to government health departments, WHO, the technical press and leading medical journals, and to Member Associations of IFPMA.

In these reports: :

(Back to Index)

B. USE OF THE COMPLAINT PROCEDURE

The IFPMA Code complaint procedure is open to any member of the healthcare professions, a company or the public, acting in good faith within the spirit and intentions of the Code.

1. Submission of Complaints

Complaints must be in writing and include:

Source of the complaint

The identity of the complainant, with a full mailing address (and fax number, if possible) for correspondence.

Company

For each case in the complaint, the identity of the company which is alleged to be in breach of the Code, and the name of any product or products which are specifically involved.

Reference material

For each case, a specific reference to the source of the advertisement/activity which is the subject of the complaint, of printed material or other evidence.

Date

The date of the alleged breach of the Code.

Summary

For each case, brief description of the complaint with a specific reference to the part of the Code under which the complaint is being made (section and paragraph number(s)).

All correspondence should be addressed to:

IFPMA
30 rue de St.-Jean
P.O. Box 9
1211 Geneva 18
Switzerland

Telefax: +41 (22) 340 13 80

2. Notes on the Evaluation Process

The IFPMA Code lays down certain specific requirements, for example, in relation to the minimum information to be included in printed promotional material, and others which require scientific judgment, for example, in relation to the need for claims and warnings, etc. to be based on up-to-date scientific information.

In all cases, even those where there appears a prima facie breach of the Code (for example, the absence of an approved name from printed promotional material), the case will be referred to the company and not dealt with directly by IFPMA. This is because a case, where a breach of the Code is determined, is not considered 'closed' until an undertaking has been received that the company has acknowledged the breach of the Code and has taken appropriate remedial action.

When a complaint calls into question the scientific basis for the claims made for a pharmaceutical product, it is the company's responsibility either to provide the appropriate data and information to justify the way in which it is promoted, or to acknowledge that the promotional material is in breach of the Code and take the necessary remedial steps.

In operating the Code, however, IFPMA does not set itself up to be a 'supranational' regulatory authority or to 'second guess' the decisions of national authorities and their advisers. It is the sovereign right of any country, in which pharmaceuticals are marketed, to decide which products should be available. If a product is duly registered with a regulatory authority, therefore, it is not for IFPMA to criticise the judgment of that authority. Similarly, as stated in the Code, national laws and regulations must always take precedence in matters concerning the evaluation of a complaint against the IFPMA Code.

(Back to Index)

C. ENCOURAGEMENT OF ADHERENCE TO THE CODE

The complaint procedure has been established to provide a mechanism for dealing with breaches of the Code after they have occurred. However, the IFPMA Code, and other self-regulatory codes, have an equally, if not more, important role in encouraging the implementation and monitoring of improved standards for marketing practices in order to prevent the errors which lead to breaches of the Code.

The IFPMA Code does not exist in isolation. It is supported by a global network of national association codes and company operating procedures, which function within a framework of national regulations, where these have been established.

In order to increase awareness of the role of self-regulation and the importance of compliance with the Code, the IFPMA Secretariat has been mandated to:

(Back to Index)

Explanatory Notes I.1

Promotion and advertisements for pharmaceutical products directed to the healthcare professions fall within the scope of the IFPMA Code but advertising direct to the general public of self-medication products is covered by other self-regulatory codes. However, direct-to-consumer advertising of pharmaceutical products, within the definition given, is covered in paragraph I.7 of the Code.

Advertising for distribution purposes (e.g. price lists and trade catalogues) is not within the scope of the Code.

The promotion of products for infant nutrition, in vitro diagnostic tests, and surgical and medical devices are also outside the scope of the Code.

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Explanatory Notes I.3

With regard to product information on labelling, packaging, leaflets, data sheets and in advertisements, it is understood that national laws and regulations dictate the format and content of the information communicated. Companies should, however, attempt to provide uniform information on indications, contraindications, warnings, precautions, side effects and dosage wherever possible, within the context of national requirements. Health professionals in developing countries should have access to similar data to those being communicated in industrialised countries.

Companies should deal objectively with requests for information made in good faith and should provide data which are appropriate to the source of the enquiry.

Companies should produce data to support claims whether or not the data are in the public domain but are not required to substantiate indications for use which are approved in a marketing authorisation. Normal considerations relating to confidentiality of information apply.

Data from in vitro and animal tests should be clearly marked as such and not be cited in such a way that it could give an incorrect or misleading impression.

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Explanatory Notes I.4

National requirements for reporting adverse reactions to pharmaceutical products must always take precedence.

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Explanatory Note I.5

Examples of disguised promotion include advertisements in journals which appear to be part of the editorial content.

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Explanatory Note I.7

Communications to the public covered in paragraph I.7 of the Code, may include the provision of patient package inserts and other leaflets and booklets, etc., made available to inform patients about products prescribed or recommended by health professionals.

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Explanatory Note II.1

The training given to medical representatives should be an on-going process and should include familiarity with appropriate national and international self-regulatory codes of practice.

Where national regulatory requirements include an approved scientific data sheet, medical representatives should have this available for prescribers and dispensers for each pharmaceutical product promoted.

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Explanatory Note II.3

The provision relating to remuneration is intended to ensure that no incentives are provided that would lead to unethical behaviour of representatives, and not whether a fixed salary or bonus system is used for compensation.

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Explanatory Note IV.1

Making hospitality or other benefits conditional upon past prescribing performance is also precluded.

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Explanatory Note V.1

Where local regulations or Codes are in force which define requirements for printed promotional material, these take precedence.

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Explanatory Note V.2

The approved name shown should be the International Non-proprietary Name (INN) when this exists and is not in conflict with local regulations or requirements.

The mailing address of the contact from whom further information may be obtained must appear, either in the advertisement itself or be readily accessible from the publication in which the advertisement appears.

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Explanatory Note V.2.2

Legal requirements with respect to the definition of abbreviated or "reminder" advertisements may differ from country to country.

The statement that further information is available on request should normally appear in the advertisement but the requirement will be deemed to have been met if a general notice to this effect, referring to all advertisements, is clearly printed on the same page of the publication.

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