The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) announced an expansion of its Code of Practice to govern how companies interact with healthcare professionals, medical institutions and patient organizations. Representing the research-based pharmaceutical industry, IFPMA requires all member companies and member associations around the world to adopt and implement this new Code.
IFPMA represents the research-based pharmaceutical companies and associations across the globe. The research-based pharmaceutical industry’s 1.3 million employees research, develop and provide medicines and vaccines that improve the life of patients worldwide. Based in Geneva, IFPMA has official relations with the United Nations and contributes industry expertise to help the global health community find solutions that improve global health.
“Advancing medical knowledge and improving global public health depend on regular information sharing interactions between the medical community and pharmaceutical companies. These exchanges ensure patients benefit from the most up-to-date information regarding medicines,” says Eduardo Pisani, IFPMA Director General. “Ensuring that governments, healthcare providers and patients are confident that interactions with our members are conducted to the highest ethical and professional standards is our commitment.”
Beyond addressing interactions, the Code now also includes high-level guiding principles for practice, a requirement for member companies to train all employees, a clear distinction between gifts, promotional aids and items of medical utility, guidance for supporting continuing medical education, a provision on disclosure of clinical trials information, and guidance for filing complaints. The Wall Street Journal also reported on the new code.
The Code continues to prohibit preapproval promotional activities for pharmaceutical products, company-sponsored entertainment at events, and providing or offering personal gifts to healthcare professionals. “The new Code provides a framework for the industry to act with integrity and build trust, as we work towards improving patient heath,” says IFPMA President and AstraZeneca CEO David Brennan. “This is not about doing the easy thing, but the right thing.”
Expansion of the Code and the requirement that all members adopt and implement it wherever they operate demonstrates the industry’s commitment. In the interest of patient care, IFPMA calls on physicians, nurses, and other companies to ensure adherence to equally high standards of practice throughout the healthcare sector.
“The expansion of this Code of Practice is welcome and necessary to bring greater clarity to the ethical standards that should be adhered to”, said Durhane Wong-Rieger, Chair, International Alliance of Patients’ Organizations (IAPO). “The public must have trust and confidence in all healthcare decision-making and IAPO welcomes IFPMA’s commitment to promote appropriate standards and will observe closely how well these are implemented and followed globally.”
"The revised IFPMA Code especially will strengthen international standards on clinical trials transparency and interactions with key stakeholders in the healthcare community," Matthew Bennett, senior vice president of PhRMA, said in the statement.
New Code of Practice
Since its initial adoption in 1981 as the foundation of a global self-regulatory approach, the Code has been regularly updated and strengthened to adapt to changing needs. The scope of the 2012 revision extends this already high standard of pharmaceutical industry practice beyond marketing practices to cover all interactions with healthcare professionals, medical institutions and patient organizations. It is a requirement of IFPMA membership that member associations accept the conditions of the IFPMA Code and, subject to local laws and regulations, adopt codes that meet local requirements but are consistent with, and as comprehensive as, the IFPMA Code.
Effective 1st September 2012, the IFPMA Code of Practice (Updated 2011) replaces the 2006 IFPMA Code of Pharmaceutical Marketing Practices. Member associations of IFPMA must incorporate this Code into existing national codes no later than 1st September 2012, subject to the guidance set out in Articles (iv) and (v) above.
The following Guiding Principles set out basic standards to inform the 2012 IFPMA Code of Practice which applies to the conduct of IFPMA Member Companies and their agents. This helps ensure that their interactions with stakeholders are appropriate.
- The healthcare and well-being of patients are the first priority for pharmaceutical companies.
- Pharmaceutical companies will conform to high standards of quality, safety and efficacy as determined by regulatory authorities.
- Pharmaceutical companies’ interactions with stakeholders must at all times be ethical, appropriate and professional. Nothing should be offered or provided by a company in a manner or on conditions that would have an inappropriate influence.
- Pharmaceutical companies are responsible for providing accurate, balanced, and scientifically valid data on products.
- Promotion must be ethical, accurate, balanced and must not be misleading. Information in promotional materials must support proper assessment of the risks and benefits of the product and its appropriate use.
- Pharmaceutical companies will respect the privacy and personal information of patients.
- All clinical trials and scientific research sponsored or supported by companies will be conducted with the intent to develop knowledge that will benefit patients and advance science and medicine. Pharmaceutical companies are committed to the transparency of industry sponsored clinical trials in patients.
- Pharmaceutical companies should adhere to both the spirit and the letter of applicable industry codes. To achieve this, pharmaceutical companies will ensure that all relevant personnel are appropriately trained.
Basis of Interactions
Interactions should be focused on informing healthcare professionals about medicines, providing scientific and educational information and supporting medical research and education. 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.
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.
Standards of Promotional Information
Promotion should not be inconsistent with locally approved product information. 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.
Printed Promotional Material
All printed promotional materials, other than a “reminder” advertisement, 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; and
- “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.
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” may be omitted.
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.
Interactions with Healthcare Professionals
Events and Meetings
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 inform healthcare professionals about products.
Events Involving Foreign Travel. No company may organize or sponsor an Event for healthcare professionals (including sponsoring individuals to attend such an Event) 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. The “home country” is where the professional practices medicine.
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) 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.
Appropriate Venue. All Events must 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.
Limits. 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.
Entertainment. No entertainment or other leisure or social activities should be provided or paid for by member companies.
Guidance from Member Associations. Member associations are encouraged to provide written guidance on the meaning of the terms “renowned” and “extravagant”, and the meaning of the terms “moderate” and “reasonable.” As a general rule, the hospitality provided must not exceed what participants would normally be prepared to pay for themselves.
Sponsorships
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
- 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.
Guests. Companies should not pay any costs associated with individuals accompanying invited healthcare professionals.
Fees for Services. Health care 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.
Prohibition of Cash and Personal Gifts. Payments in cash or cash equivalents (such as gift certificates) must not be provided or offered to healthcare professionals. Gifts for the personal benefit of healthcare professionals (such as sporting or entertainment tickets, electronics items, etc.) must not be provided or offered.
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.
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 patient care.
Guidance on Values. Member associations shall provide guidance using local currency, on the precise value for the following:
- “minimal value” for promotional aid items
- “modest value” for items of medical utility
Samples
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. 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.
Clinical Research and Transparency
Disclosure must maintain protection 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).
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.
Support for Continuing Medical Education
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.
Interactions with Patient Organizations
All interactions with patient organizations must be ethical. The independence of patient organizations must be respected. 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. 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.
Events. 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.
Company Procedures and Responsibilities
Companies should establish and maintain appropriate procedures to ensure compliance with relevant codes and applicable laws 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.
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.
Infringement, Complaints, and Enforcement
Genuine complaints relating to infringements of the IFPMA Code are encouraged. Detailed procedures for complaints and the handling of complaints (including the respective roles and jurisdiction of IFPMA and member associations) are set out in Appendix 1: IFPMA Code of Practice Operating Procedure.
Measures to Ensure and Enforce Compliance
Each member association should strongly encourage its member companies to adopt procedures to assure adherence to its national code. While strong local legal and regulatory mechanisms and vigorous government enforcement may obviate the need for compliance mechanisms in some countries, member associations are encouraged, where appropriate, to include provisions intended to assure compliance with their national codes. The IFPMA recognizes, however, that local laws and practices vary widely and will affect the types of compliance provisions, if any, that may be adopted.
FAQs
A public disease awareness campaign targeted at the public must not promote specific pharmaceutical products. Whilst not covered by the IFPMA Code, disease awareness campaigns must of course comply with local laws, regulations, and/or codes.
The IFPMA Code applies to the promotion of over-the-counter (OTC) products directed towards healthcare professionals. However, the promotion of OTC products to consumers falls outside the scope of this Code. The Code specifically does not seek to regulate the following activities:
- Promotion of prescription only pharmaceutical products directly to the general public (i.e. direct to consumer advertising);
- Promotion of self-medication products that are provided “over-the-counter” (OTC) directly to consumers without prescription;
- Pricing or other trade terms for the supply of pharmaceutical products, including promotion and marketing of pharmaceutical products to commercial customers;
- Certain types of non-promotional information or activities; and
- Promotion of medical devices.
Where a company finances or otherwise secures or arranges the publication of promotional material in journals, such promotional material must not resemble independent editorial matter.
Care should be taken to ensure that communications for a compassionate use program are not, in effect, advertisements for an unlicensed medicine or use.
Reprints of scientific and medical articles, when used as stand-alone documents, are not developed by pharmaceutical companies and as such cannot be considered as promotional materials. If, however, they are proactively presented to a healthcare professional together, with other, company-originated documents, they then become promotional materials. In all cases, where promotion refers to, includes, or is presented together with scientific or medical articles or studies, clear references should be provided. Any reprint of artwork (including graphs, illustrations, photographs or tables) taken from articles or studies and included or presented with promotional materials should clearly indicate the source of the artwork and be faithfully reproduced.
Quotations from medical and scientific literature or from personal communications should be faithfully reproduced (except where adaptation or modification is required in order to comply with any applicable codes, in which case it must be clearly stated that the quotation has been adapted and/or modified) and the precise sources identified. Quotations should not change or distort the intended meaning of the author or the significance of the underlying work or study.
Any comparison made between different pharmaceutical products should be based on relevant and comparable aspects of the products and be capable of substantiation. Comparative advertising should not be misleading.
Where possible and within the context of national requirements, companies should provide the same core product information (such as contraindications, warnings, precautions, side effects and dosage) as it provides in developed countries.
A company can only organize events involving travel if it is justified, i.e.: (a) A significant proportion of the invited healthcare professionals are from outside of the company’s home country, and it makes greater logistical or security sense to hold the event in another country; or (b) The relevant resource or expertise that is the object or subject matter of the event is located outside of the company’s home country.
When a company organizes a meeting, refreshments and or meals incidental to the main purpose of the event can be provided. It would not be appropriate for a company to fund attendance at a concert, purchase of entertainment tickets or pay for entertainment in any form. However, if there is background music or a local performance at the venue where the event is taking place, which is not paid for by a pharmaceutical company, this may be permitted.
A promotional aid is a non-monetary item given for a promotional purpose. Promotional aids must be related to the work of the recipient healthcare professionals and should be of minimal value and quantity. Possible examples include inexpensive pens and notepads. Promotional items intended for the personal benefit of the healthcare professional, such as music CDs, paintings or food baskets are not acceptable. Promotional literature such as detail aids, leave-behind pieces, booklets, etc. are not considered to be promotional aids.
Items might include an anatomical model for use in an examination room, or medical textbooks, as both primarily involve a patient benefit. A DVD or CD player however would not be permissible. Items should not be offered on more than an occasional basis, even if each individual item is appropriate.
Many patient organizations are supported by a number of pharmaceutical companies. There may, however, be situations where only one pharmaceutical company wishes to support a particular patient organization or one of its activities. It would be acceptable under the IFPMA Code for that pharmaceutical company to be the only pharmaceutical company providing funding as long as that company did not make its support conditional on it being the sole funder.
Discussion
Overall this is reflective of the PhRMA code adopted by US companies with an international flavor. Much of what is allowed ex US is no longer available to US based health care providers. The reasoning for this new code is based on several recently passed laws around physician industry interaction in the UK, France and China.