1. Scope and Definitions
The IRPMA Code covers interactions with healthcare professionals, medical institutions and patient organizations, and the promotion of pharmaceutical products. Member companies should of course, comply with these local laws, regulations and/or codes.
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 methods of communications, 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.
- “patient organization” means typically a not-for-profit institution that primarily represent the interests and needs of patients, their families and/or caregivers.
- “medical institution” means typically an organization that is comprised of healthcare professionals and/or that provides healthcare or conducts healthcare research.
- “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.
2. Basis of Interactions
2.1 Basis of Interactions
Member companies’ relationships with healthcare professionals and other stakeholders are intended to benefit patients and to enhance the practice of medicine. Interactions should be focused on informing healthcare professionals about pharmaceutical product, providing scientific and educational information and supporting medical research and education.
2.2 Transparency of Promotion
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. Promotion should not be disguised.
3. Pre-Approval Communications and Off-Label Use
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.
This provision is not intended to prevent 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 of information to stockholders and others concerning any pharmaceutical product, as may be required or desirable under law, rule or regulation.
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.
Respecting the requirement that promotion should be consistent with the label and approved uses locally, healthcare professionals in developing countries should have access to similar data to those being communicated in developed countries.
4.2 Accurate and Not Misleading
Promotional information should be clear, legible, accurate, balanced, fair, 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.
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 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.
6. Electronic Materials, including Audiovisuals
The same requirements shall apply to electronic promotional materials as apply to printed materials. Specifically, in the case of pharmaceutical product related websites:
- 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 and Meetings
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 provide scientific or educational information and/or to inform healthcare professionals about products.
7.1.2 Events Involving Foreign Travel
No company may organize or sponsor an Event for healthcare professionals (including sponsoring individuals to attend such an Event as described in Article 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:
- Host country regulations should permit such an arrangement;
- 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 as described in Article 7.5.2) 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.
7.1.4 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 must avoid using renowned or extravagant venues. The additional requirements set forth in Article 7 of this Code also apply accordingly.
7.1.5 Limits of Hospitality
Refreshments and/or meals incidental to the main purpose of the Event can only be provided:
- exclusively to participants of the Event; and
- if they are moderate and reasonable as judged by local standards.
No entertainment or other leisure or social activities should be provided or paid for by member companies.
As a general rule, the hospitality provided should not exceed what healthcare professional recipients would normally be prepared to pay for themselves.
Member companies may sponsor healthcare professionals to attend Events provided such sponsorship is in accordance with the following requirements:
- The Event complies with the requirements in this Code as described in 7.1;
- 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, purchase, supply, administer or promote any pharmaceutical product.
Companies should not pay any costs associated with individuals accompanying invited healthcare professionals.
7.4 Fees for Services
Healthcare professionals may be engaged as consultants and advisors for services such as speaking at and/or chairing meetings and events, involvement in medical/scientific studies, clinical trials or training services, participation at advisory board meetings, and participation in market research where such participation involves remuneration. The arrangements which cover these genuine consultancies or other services must, to the extent relevant to the particular arrangement, fulfill all the following criteria:
- a written contract or agreement must be agreed in advance of the commencement of the services which specifies the nature of the services to be provided and the basis for payment of those services;
- a legitimate need for the services must be clearly identified and documented in advance;
- the criteria for selecting consultants must be directly related to the identified need and the consultants must have the expertise necessary to provide the service;
- the number of consultants retained must not be greater than the number reasonably necessary to achieve the identified need;
- the hiring of the consultant to provide the relevant service must not be an inducement to prescribe, recommend, purchase, supply, and/or administer any medicine; and
- the compensation for the services must be reasonable and reflect the fair market value of the services provided.
7.5 Gifts and Other Items
7.5.1 Prohibition of Cash & Personal Gifts
Payments in cash or cash equivalents (such as gift certificate) must not be offered to healthcare professionals. Gifts for the personal benefit of healthcare professionals (such as sporting or entertainment tickets, electronic items, etc.) must not be provided or offered.
7.5.2 Promotional Aids
Promotional aids of minimal value and quantity may be provided or offered to healthcare professionals if relevant to the practice of the healthcare professional.
7.5.3 Items of Medical Utility
In accordance with local laws and regulations, items of medical utility may be offered or provided if such items are of modest value, do not offset routine business practices and are beneficial to enhancing the provision of medical services and for patient care.
In accordance with local laws and regulations, free samples of a pharmaceutical product may be supplied to healthcare professionals authorized to prescribe that product in order to enhance patient care. Samples should be marked as such so that they cannot 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. Companies should not collect clinical data and should not make any payment to physicians.
9. Clinical Research and Transparency
Companies are committed to the transparency of clinical trials which they sponsor. It is recognized that there are important public health benefits associated with making clinical trial information more publicly available to healthcare practitioners, patients, and others. Such disclosure, however, must maintain protections for individual privacy, intellectual property and contract rights, as well as conform to legislation and current national practices in patent law.
Companies disclose clinical trial information as set out in the Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases (2009) and the Joint Position on the Publication of Clinical Trial Results in the Scientific Literature (2010) issued by the IFPMA, the European Federation of Pharmaceutical Industries and Associations (EFPIA), the Japanese Pharmaceutical Manufacturers Association (JPMA) and the Pharmaceutical Research and Manufacturers of America (PhRMA).
9.2 Distinct from Promotion
All human subject research must have a legitimate scientific purpose. Human subject research, including clinical trials and observational studies, must not be disguised promotion.
10. Support for Continuing Medical Education
Continuing medical education (CME) helps ensure that healthcare professionals obtain the latest and most accurate information and insights on therapeutic areas and related interventions that are critical to the improvement of patient care and overall enhancement of the healthcare system. The primary purpose of an educational meeting must be the enhancement of medical knowledge and therefore financial support from companies is appropriate.
When companies provide content to CME activities and programs, such material must be fair, balanced and objective, and designed to allow the expression of diverse theories and recognized opinions. Content must consist of medical, scientific or other information that can contribute to enhancing patient care.
Companies must follow Article 7 of the IRPMA Code where applicable.
11. Interactions with Patient Organizations
The pharmaceutical industry has many common interests with patient organizations. All interactions with patient organizations must be ethical. The independence of patient organizations must be respected.
11.2 Declaration of Involvement
When working with patient organizations, companies must ensure that the involvement of the company and the nature of that involvement is clear from the outset. No company may require that it be the sole funder of the patient organization or any of its programs.
11.3 Written Documentation
Companies that provide financial support or in-kind contribution to patient organizations must have in place written documentation setting out the nature of support, including the purpose of any activity and its funding.
Companies may provide financial support for patient organization meetings provided that the primary purpose of the meeting is professional, educational, and scientific in nature, or otherwise supports the mission of the patient organization. When companies hold meetings for patient organizations, companies must ensure that the venue and location is appropriate and conducive to informational communication. In addition, any meals or refreshments provided by a company must be modest as judged by local standards.
12. Company Procedures and Responsibilities
Companies should establish and maintain appropriate procedures to ensure compliance with relevant codes and applicable law and to review and monitor all of their activities and materials in that regard.
Companies should also ensure that relevant employees receive training appropriate to their role.
12.3 Responsibilities for Approving Promotional Communications
A designated company employee, with sufficient knowledge and appropriate qualifications should be responsible for approving all promotional communications. In the alternative, a senior company employee(s) could be made responsible provided that he or she receives scientific advice on such communications from adequately qualified scientific personnel.
13. Infringement, Complaints, and Enforcement
Genuine complaints relating to infringements of the IRPMA Code are encouraged.
13.2 Measures to Ensure and Enforce Compliance
IRPMA strongly encourages member companies to adopt procedures to assure adherence to this code.
Code of Practice