(ii) IRPMA and its members are committed to educational and promotional efforts that benefit patients and promotional programs and collaborations that enhance the practice of medicine. IRPMA also seeks to preserve the independence of the decisions taken by healthcare professionals in prescribing medicines to patients. The pharmaceutical industry has an obligation and responsibility to provide accurate information and education about its products to healthcare professionals in order to establish a clear understanding of the appropriate use of prescription medicines. Industry relationships with healthcare professionals must support, and be consistent with, the professional responsibilities healthcare professionals have towards their patients. Pharmaceutical companies must maintain high ethical standards when conducting promotional activities and comply with applicable legal, regulatory and professional requirements. Through the promotion of this Code, IRPMA seeks to ensure that ethical promotional practices are established worldwide.

(iii) The IRPMA Code of Marketing Practices (the “IRPMA Code”) based on the IFPMA Code of Pharmaceutical Marketing Practices 2007 version sets forth standards for the ethical promotion of pharmaceutical products to healthcare professionals, and for member companies’ interactions with them. Effective January 1st, 2007, this Code replaces the IRPMA Code of Marketing Practices (Update 2003). Member companies of IRPMA must incorporate this Code into existing internal codes no later than January 1st, 2007.

(iv) The IRPMA Code contains provisions relating to scope, applicability and guiding principles (Articles 1-2), the content of promotional material (Articles 3-6); interactions with healthcare professionals (Articles 7-8); company procedures and responsibilities (Article 9); and operation and enforcement (Article 10).

(v) The IRPMA Code is consistent with local laws and regulations.

(vi) IRPMA member companies are accountable for addressing and correcting infringements under relevant codes. They should also ensure that internal structures and procedures (including adequate training of employees) are created to ensure responsible and ethical promotional activities. Companies not in membership with IRPMA may elect to be subject to the IRPMA Code and its complaints handling processes.

(vii) The IRPMA is open to receive genuine complaints from any source on any aspect of the IRPMA Code, in accordance with its operating procedures. Where it is determined that there has been a breach of the IRPMA Code, the objective is to correct the matter as rapidly as possible.

(viii) The IRPMA is a non-profit, non-governmental organization comprising European, American, Japanese, and Taiwanese research-based pharmaceutical companies. Member companies and distributors, commissioned agents or representatives acting on behalf of any IRPMA member company, are committed to the ethical standards set out in this Code.

1. Objective and Scope:

1.1 Objective: The IRPMA Code sets out standards for the ethical promotion of pharmaceutical products to healthcare professionals to ensure that member companies’ interactions with healthcare professionals are appropriate and perceived as such.

1.2 Scope: For the purposes of the IRPMA Code:

• “pharmaceutical product” means all pharmaceutical or biological products (irrespective of patent status and/or whether they are branded or not) which are intended to be used on the prescription of, or under the supervision of, a healthcare professional, and which are 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.


• “promotion” means any activity undertaken, organized or sponsored by a member company which is directed at healthcare professionals to promote the prescription, recommendation, supply, administration or consumption of its pharmaceutical product(s) through all media, including the internet.


• “healthcare professional” means any member of the medical, dental, pharmacy or nursing professions or any other person who in the course of his or her professional activities may prescribe, recommend, purchase, supply, or administer a pharmaceutical product.


• “member company” means all corporate members and individual members of IRPMA and distributors, commissioned agents or representatives acting on behalf of any IRPMA member company.

1.3 Exclusions: This Code does not seek to regulate the following activities:

• Promotion of self-medication products that are provided “over the counter” without prescription.


• Pricing or other trade terms for the supply of pharmaceutical products.


• The engagement of a healthcare professional to provide genuine consultancy or other genuine services to a member company.


• The conduct of clinical trials.


• The provision of non-promotional information by member companies.

2. General Principles:

2.1 Basis of Interaction: Member companies’ relationships with healthcare professionals are intended to benefit patients and to enhance the practice of medicine. Interactions should be focused on informing healthcare professionals about products, providing scientific and educational information and supporting medical research and education.

2.2 Independence of Healthcare Professionals: No financial benefit or benefit-in-kind (including grants, scholarships, subsidies, support, consulting contracts or educational or practice related items) may be provided or offered to a healthcare professional in exchange for prescribing, recommending, purchasing, supplying or administering products or for a commitment to continue to do so. Nothing may be offered or provided in a manner or on conditions that would have an inappropriate influence on a healthcare professional’s prescribing practices.

2.3 Appropriate Use: Promotion should encourage the appropriate use of pharmaceutical products by presenting them objectively and without exaggerating their properties.

2.4 Local Regulations: In all cases, all relevant laws, local regulations and industry codes must be observed and companies have a responsibility to check local requirements, in advance of preparing promotional material or events in any specific country.

2.5 Transparency of Promotion: Promotion should not be disguised. Clinical assessments, post-marketing surveillance and experience programmes and post-authorization studies must not be disguised promotion. Such assessments, programmes and studies must be conducted with a primarily scientific or educational purpose. Material relating to pharmaceutical products and their uses, whether promotional in nature or not, which is sponsored by a company should clearly indicate by whom it has been sponsored.

4. Standards of Promotional Information

4.1 Consistency of Product information: It is understood that national laws and regulations usually dictate the format and content of the product information communicated on labeling, packaging, leaflets, data sheets and in all promotional material. Promotion should not be inconsistent with locally approved product information.

4.2 Accurate and Not Misleading: Promotional information should be clear, legible, accurate, balanced, fair, objective and sufficiently complete to enable the recipient to form his or her own opinion of the therapeutic value of the pharmaceutical product concerned. Promotional information should be based on an up-to-date evaluation of all relevant evidence and reflect that evidence clearly. It should not mislead by distortion, exaggeration, undue emphasis, omission or in any other way. Every effort should be made to avoid ambiguity. Absolute or all-embracing claims should be used with caution and only with adequate qualification and substantiation. Descriptions such as ‘safe’ and ‘no side effects’ should generally be avoided and should always be adequately qualified..

4.3 Substantiation: Promotion should be capable of substantiation either by reference to the approved labeling or by scientific evidence. Such evidence should be made available on request to healthcare professionals. Companies should deal objectively with requests for information made in good faith and should provide data which are appropriate to the source of the inquiry.

5. Printed Promotional Material:
Where local regulations or codes are in force which define requirements, those take precedence.

5.1 All Printed Promotional Material, including Advertisements:
All printed promotional materials other than those covered in 5.2 below must be legible and include:

• the name of the product (normally the brand name);
• the active ingredients, using approved names where they exist;
• the name and address of the pharmaceutical company or its agent responsible for marketing the product;
• date of production of the advertisement;
• “abbreviated prescribing information” which should include an approved indication or indications for use together with the dosage and method of use; and a succinct statement of the contraindications precautions and side effects.

5.2 Reminder Advertisements: A “reminder” advertisement is defined as a short advertisement containing no more than the name of the product and a simple statement of indications to designate the therapeutic category of the product. For “reminder” advertisements, “abbreviated prescribing information” referred to in 5.1 above may be omitted.

• the identity of the pharmaceutical company and of the intended audience should be readily apparent;
• the content should be appropriate for the intended audience;
• the presentation (content, links, etc.) should be appropriate and apparent to the intended audience; and
• country-specific information should comply with local laws and regulations.

7. Interactions with Healthcare Professionals

7.1 Events

7.1.1 Scientific and Educational Objectives: The purpose and focus of all symposia, congresses and other promotional, scientific or professional meetings (an “Event”) for healthcare professionals organized or sponsored by a company should be to inform healthcare professionals about products and/or to provide scientific or educational information.

7.1.2 Events Involving Foreign Travel: No company may organize or sponsor an Event for healthcare professionals (including sponsoring individuals to attend such Event as described in 7.2) that takes place outside of their home country unless it is appropriate and justified to do so from the logistical or security point of view. International scientific congresses and symposia that derive participants from many countries are therefore justified and permitted.

7.1.3 Promotional Information at Events: Promotional information which appears on exhibition stands or is distributed to participants at international scientific congresses and symposia may refer to pharmaceutical products which are not registered in the country where the Event takes place, or which are registered under different conditions, provided that the following conditions are observed:

• The meeting should be a truly international, scientific Event with a significant proportion of the speakers and attendees from countries other than the country where the Event takes place;
• Promotional material (excluding promotional aids) for a pharmaceutical product not registered in the country of the Event should be accompanied by a suitable statement indicating the countries in which the product is registered and make clear that such product is not available locally;
• Promotional material which refers to the prescribing information (indications, warnings etc.,) authorized in a country or countries other than that in which the Event takes place but where the product is also registered, should be accompanied by an explanatory statement indicating that registration conditions differ internationally; and
• An explanatory statement should identify the countries in which the product is registered and make it clear that it is not available locally.

7.2 Sponsorship: Member companies may sponsor healthcare professionals to attend Events provided such sponsorship is in accordance with the following requirements:

• The Event complies with the hospitality requirements in this Code as described in 7.5;
• Sponsorship to healthcare professionals is limited to the payment of travel, meals, accommodation and registration fees;
• No payments are made to compensate healthcare professionals for time spent in attending the Event; and
• Any sponsorship provided to individual healthcare professionals must not be conditional upon an obligation to prescribe, recommend or promote any pharmaceutical product.

7.3 Guests: Companies should not pay any costs associated with individuals accompanying invited healthcare professionals.

7.4 Payments for Speakers and Presenters: Payments of reasonable fees and reimbursement of out-of-pocket expenses, including travel and accommodation, may be provided to healthcare professionals who are providing genuine services as speakers or presenters on the basis of a written contract with the company at the Event.

7.5 Hospitality

7.5.1 Appropriate Venue: All Events should be held in an appropriate venue that is conducive to the scientific or educational objectives and the purpose of the Event or meeting. Companies should avoid using renowned or extravagant venues. The additional requirements set forth in Article 7 of this Code also apply accordingly.

7.5.2 Limits of Hospitality: Hospitality should be limited to refreshments and/or meals incidental to the main purpose of the Event and should only be provided: l to participants of the Event and not their guests; and l if it is moderate and reasonable as judged by local standards.

7.5.3 As a general rule, the hospitality provided should not exceed what healthcare professional recipients would normally be prepared to pay for themselves.

7.5.4 Entertainment: No stand-alone entertainment or other leisure or social activities should be provided or paid for by member companies. At Events, entertainment of modest nature which is secondary to refreshments and/or meals is allowed.

7.6 Gifts and Items of Medical Utility

7.6.1 Cash: Payments in cash or cash equivalents (such as gift certificate) must not be offered to healthcare professionals.

7.6.2 Personal Gifts: Gifts for the personal benefit of healthcare professionals (including, but not limited to, music CDs, DVDs, sporting or entertainment tickets, electronic items) must not be provided or offered.

7.6.3 Promotional Aids: Promotional aids or reminder items may be provided or offered to healthcare professionals and appropriate administrative staff, provided the gift is of minimal value and relevant to the practice of the healthcare professional.

7.6.4 Items of Medical Utility: Items of medical utility may be offered or provided free of charge provided that such items are of modest value and are beneficial to the provision of medical services and for patient care.

7.6.5 Cultural Courtesy Gifts: In some countries, if allowed under local law and in accordance with local practice, an inexpensive gift not related to the practice of medicine may be given on an infrequent basis to healthcare professional in acknowledgment of significant national, cultural or religious holidays.

8. Samples

8.1 Samples Permitted: In accordance with local laws and regulations, free samples of a pharmaceutical product may be supplied to healthcare professionals in order to enhance patient care. Samples should not be resold or otherwise misused.

8.2 Control and Accountability: Companies should have adequate systems of control and accountability for samples provided to healthcare professionals including how to look after such samples whilst they are in possession of medical representatives.

9. Company Procedures and Responsibilities

Companies should establish and maintain appropriate procedures to ensure full compliance with relevant codes and applicable law and to review and monitor all of their promotional activities and materials. A designated company employee, with sufficient knowledge and appropriate scientific or healthcare qualifications should be responsible for approving all promotional communications. Also, a senior company employee could be made responsible, provided that scientific advice is taken.

10. Infringement, Complaints, and Enforcement

10.1 Complaints: Genuine complaints relating to infringements of the IRPMA Code are encouraged.

10.2 Measures to Ensure and Enforce Compliance: IRPMA strongly encourages member companies to adopt procedures to assure adherence to this code.