Responsible Pharma Practices
- Organisation Info
- IFPMA Code of Practice
Representing the research-based pharmaceutical industry in Geneva
Founded in 1968, the IFPMA is a global, non-profit, nongovernmental organization. With members across the globe and a secretariat based in Geneva, Switzerland, the IFPMA represents the research-based pharmaceutical industry, including the biotechnology and vaccine sectors. Our members comprise leading international companies as well as national and regional industry pharmaceutical associations in both developing and developed countries. Our primary role is to improve global health by representing our members in dialogue with intergovernmental bodies, nongovernmental organizations, Geneva-based missions of national governments, civil society organizations and others. The IFPMA has several expert committees and working groups which leverage industry expertise to develop effective approaches to health issues. Its governing bodies are the IFPMA Council, a group of elected representatives from member companies and associations, and the IFPMA Assembly, which comprises the entire membership. The President of the IFPMA is elected by the Council for a two-year term and is chosen from among the Chief Executive Officers of member companies. The IFPMA has two Vice Presidents, also elected for a period of two years.
The IFPMA advocates policies that encourage discovery of and access to life-saving and life-enhancing medicines to improve the health of people everywhere.
To fulfil its mission, the IFPMA follows these guiding principles:
Encourage a global policy environment that is conducive to medicines innovation, both therapeutic and preventive, for the benefit of people around the world. Promote and support principles of ethical conduct and practices voluntarily agreed upon, as exemplified by the IFPMA Code of Practice. Promote and support the adoption of high standards of manufacturing practices and quality assurance for pharmaceutical products. Contribute industry expertise and foster collaborative relationships and partnerships with international organizations dedicated to the improvement of public health, especially in developing and emerging countries. Ensure regular contact and experience-sharing and coordinate efforts of members towards achieving these objectives.
The research-based pharmaceutical industry is the primary source of information about its own products and recognizes its responsibility for ensuring product information is accurate and does not mislead. Advertising and promotion are essential for informing healthcare professionals about new medicines and new uses for existing medicines. Self-regulation, via the IFPMA Code of Practice, supplemented by member association and company codes, sets standards for the ethical promotion of medicines.
Self-Regulation of Pharmaceutical Promotion
The international research-based pharmaceutical industry is committed to the improvement of the health of mankind through the research, development, production, marketing and safety surveillance of new medicines 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 about its products to healthcare providers in order to appropriately use prescription medicines.
Promotional activities (i.e. interactions and marketing practices) must be consistent with high ethical standards and information should be designed to help healthcare providers to provide the best care to patients. Information provided must be objective, truthful and in good taste. It must also conform to all relevant laws and regulations. Claims for therapeutic indications and conditions of use must be based on valid scientific evidence and must include clear statements with respect to side effects, contra-indications and precautions.
The same high standards of ethical behavior should apply to the promotion of pharmaceutical products in all countries, regardless of the level of development of their economic and health care systems.
These principles are embodied in the IFPMA Code Practice, first adopted as the foundation of a global approach self-regulation by the pharmaceutical industry in 1981 and updated frequently since then. Building on the experience of the 2006 Code and discussions with key stakeholders, the scope of the 2012 revision of the IFPMA Code has expanded beyond marketing practices to cover interactions with healthcare professionals, medical institutions and patient organizations. The IFPMA continues to support self-regulation as the most appropriate mechanism for ensuring ethical marketing and promotion of medicines by pharmaceutical companies it represents.
1. SCOPE AND DEFINITIONS
The IFPMA Code covers interactions with healthcare professionals, medical institutions and patient organizations, and the promotion of pharmaceutical products. Where direct promotion to the public is allowed, this is covered by local laws, regulations and/or relevant codes of practice. Member companies should, of course, comply with these local laws, regulations and/or codes.
For the purposes of the IFPMA 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 represents the interests and needs of patients, their families and 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 any company that is a member of IFPMA (direct member) or a member of any association that is a member of IFPMA (indirect member). “Company” can refer to national companies and/or the worldwide parent company.
- “member association” means any association that is a member of IFPMA.
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 medicines, 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 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 Article 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; 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.
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 Article 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 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 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.
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.
7.1.7 Guidance from Member Associations
Member associations are encouraged to provide written guidance on the meaning of the terms “renowned” and “extravagant” as used in Article 7.1.4 of this Code, and the meaning of the terms “moderate” and “reasonable”, as used in Article 7.1.5 of this Code. As a general rule, the hospitality provided must not exceed what participants 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
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.
7.5 Gifts and other Items
7.5.1 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.
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 patient care.
7.5.4 Guidance on Values
Member associations shall provide guidance using local currency, on the precise value for the following:
- “minimal value” for promotional aid items in Article 7.5.2 above;
- “modest value” for items of medical utility in Article 7.5.3 above
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.
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 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).
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 IFPMA Code where applicable.
11. Interaction with Patients Organisations
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 patien 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
12 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.
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 personne
13 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.
13.2 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.