We know that doctors and patients look to us to provide accurate and balanced information about our products.
We adhere to strict ethical sales and marketing practices for all our businesses, whether pharmaceuticals, vaccines or animal health.
The best way to provide product information is for health care companies to maintain informative and ethical professional relationships with health care providers. Our interactions with providers, other customers and consumers are governed by laws and regulations, and by our long-standing global Code of Conduct. We enforce these external and internal standards through our Global Compliance Program.
We recognize that both our reputation for integrity and the trust that our stakeholders place in us are dependent on our ethical practices. Consequently, we want to make certain that the ways in which we market and sell our products to our customers—health care professionals, health insurers and governments—include accurate, balanced and useful information so that prescribers can make the best decisions for their patients. Our high ethical, sales and marketing standards require that scientific information is the predominant factor in prescribing decisions, reinforcing our reputation for providing high-quality products and for contributing to improvements in public health.
Our professional sales representatives and other employees inform our customers about our medicines and vaccines and their appropriate use. In some countries, where permitted by law, we may also directly inform patients and other consumers about diseases and available treatments that they may wish to discuss with their doctors.
We also market our products directly to consumers at times. We believe direct-to-consumer (DTC) advertising contributes to greater awareness about conditions and diseases, which can benefit public health by increasing the number of patients appropriately diagnosed and treated.
|Sales & Marketing Summary||2011||2012||2013||2014||2015|
|Number of warning letters or untitled letters from OPDP1 or APLB2 in the U.S.3||0||1||0||0||0|
|1 OPDP: Since September 2011, the Division of Drug Marketing, Advertising and Communication (DDMAC) is now the Office of Prescription Drug Promotion (OPDP).|
2 APLB: Advertising and Promotional Labeling Branch (APLB) of the FDA Center for Biologics Evaluation and Research.
3 As of 2014, data now incorporate information from our Animal Health business.
Ethical relationships with health care professionals are critical to our mission of helping patients be well.
An important part of achieving this mission is ensuring that health care professionals have balanced and accurate information about our products. All of our sales and marketing activities are conducted in accordance with our Guiding Principles for Ethical Business Practices involving the Medical and Scientific Community. These principles are aligned with national regulations and worldwide industry codes, including the International Federation of Pharmaceutical Manufacturers & Associations Code of Practice and the World Health Organization’s Ethical Criteria for Medicinal Drug Promotion.
The principles serve as a bridge between countries’ laws and regulations, industry guidelines, and our own Code of Conduct, enabling us to interact with the medical and scientific communities, to meet our ethical and legal obligations, and to contribute to improvements in human health.
We provide promotional information in several ways, including:
- Product discussions between our professional representatives and health care professionals
- Promotional and/or educational meetings sponsored and organized by our company
We also provide non-promotional information through educational and scientific activities, including:
- Scientific presentations at medical conferences
- Support of independent continuing medical education (CME)
- Articles and related scientific studies published in peer-reviewed scientific journals
- Web-based tools such as Univadis®
Our interactions and informational materials must provide truthful, balanced and non-misleading information to health care professionals. All of our interactions with health care professionals are highly regulated by government through laws such as the U.S. Anti-Kickback Statute; the Food, Drug & Cosmetic Act; the U.S. Foreign Corrupt Practices Act (FCPA); and anti-bribery laws in other countries.
Our company’s robust anti-bribery/anticorruption program and corporate policy give our employees the awareness and knowledge to comply with applicable laws and regulations, and to understand that the company will not tolerate any act of impropriety. Our activities must comply not only with company policies but with applicable laws, including the laws of the U.S. and other countries in which we do business.
Our program prohibits the offer, promise or giving of any payment or benefit at any time to an individual or entity for the purpose of improperly influencing decisions or actions with respect to our business. This policy applies to direct engagements (e.g., those driven by our company) as well as to indirect engagements (e.g., those managed through a third-party intermediary or partner).
We conduct anticorruption/anti-bribery training with relevant employees, which is supplemented with additional training for employees who engage with non-U.S. government officials. In many countries, health care professionals are considered government officials because of their employment by a government hospital, or are advisers or decision-makers for the government on matters that could affect our business.
Continuing Medical Education (CME) and Continuing Education (CE) Programs
Our CME/CE Grant Program supports independent educational programs whose purpose is to maintain, develop or enhance the knowledge, skills and/or professional performance that health care professionals rely on to provide services for patients, the public or the profession. We are committed to ensuring that our CME/CE programs are educational and not promotional. Through them, we seek to increase physicians’ knowledge about the latest scientific data and health care topics, thereby improving patient care.
The environment in which we sponsor or support educational programs worldwide is complex, governed by a multitude of laws, regulations, and medical or industry association guidelines. We are committed to honoring them all in the countries in which we operate.
CME programs that we support or sponsor are governed by an internal policy, and also must be aligned with appropriate standards such as the Accreditation Council for Continuing Medical Education (ACCME) standards for commercial support of CME in the U.S., the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) Code of Practice, and the standards of the European Federation of Pharmaceutical Industry Associations (EFPIA). These standards specify independence, financial disclosure and other requirements applicable to CME programs sponsored by commercial entities, including pharmaceutical manufacturers. Click here to view a list of grants of more than $500 made to U.S. organizations by our company’s Global Human Health division in support of independent, accredited educational programs for health care professionals.
U.S. Medical Forums
We deliver balanced medical and scientific information to health care professionals within the U.S. through our company’s Medical Forums, which are conducted by external speakers. Speakers are selected based on their expertise in the relevant subject matter. By attending one of our Medical Forums, health care professionals participate in interactive learning on therapeutic and health care industry topics. The goal of these interactions is to help attendees achieve improved medical results for their patients.
With our strict standards for conducting these Medical Forums, we comply with the PhRMA Code on Interactions with Health Care Professionals as well as with FDA regulations, which make sure that any product presentation is appropriately balanced with information regarding the product’s potential benefits and risks and is consistent with approved product labeling.
We disclose certain payments to U.S. medical and scientific professionals who speak on behalf of the company. For a list of these disclosures, click here.
Obtaining Services from External Healthcare Professionals
We engage the services of external health care professionals only when we do not have the specialized talent or expertise internally, or when an external viewpoint is critical. We ensure that compensation provided to external health care professionals is fair and reasonable, and is aligned with fair market value of the service in the home country of the health care professional providing the service.
Prescription Product Samples
Where sampling is permitted, our company has established country-specific guidance and policies on providing prescription product samples to health care professionals. This guidance specifies the appropriate distribution and use of samples to safeguard against the potential for misuse or abuse of our products, or the diversion of our products to inappropriate channels. In accordance with the law and ethical practices, we do not provide product samples to reduce or discount the price paid or reimbursed, or in exchange for prescribing, purchasing or contracting for our products or for recommending our products for formulary status.
Unapproved, or “Off-Label,” Use of Our Medicines and Vaccines
In accordance with laws, regulations, internal policies and ethical practices, our professional representatives and other members of our sales and marketing team are not permitted to promote product uses that are inconsistent with the approved product label, sometimes referred to as “off-label” promotion. We have policies and training in place to address violations, and we ensure that physicians are aware that we do not encourage off-label use.
We believe that direct-to-consumer (DTC) advertising can be an important and helpful way to inform patients about diseases that may be relevant to them and about therapeutic options they may want to discuss with their physicians.
We conduct such advertising only in countries where direct-to-consumer advertising is permitted. We try to help consumers achieve better health outcomes by delivering accurate, relevant and understandable information on disease prevention, identification and potential treatment. To remain true to this goal, we adhere to the letter and spirit of FDA regulations and guidelines governing DTC promotion, meet or exceed all Pharmaceutical Research and Manufacturers of America (PhRMA) guidelines on DTC advertising, and follow a comprehensive set of internal policies and practices when engaging in DTC advertising within the U.S.
Our company has a long-standing policy of voluntarily submitting new U.S.-based DTC advertising campaigns to the FDA for its review and comment before running them. Under our DTC policies and practices, the information provided in our DTC advertising must:
- Contain appropriate product benefit and risk information
- Be appropriately balanced, consistent with FDA regulations, and use appropriate “taste and tone”
- If on television, run at appropriate times of the day or night and during appropriate programs.
- Be approved by our company’s Promotion Review Team (PRT), a governing body consisting of a team of reviewers (including the job owner, an attorney, a physician, representatives from the Office of Promotion and Advertising Review [for U.S.], Regulatory and a product scientific specialist) who ensure that promotional material is clinically and scientifically accurate, compliant with applicable laws and regulations, and compliant with company policy. In addition, we include information on our Patient Assistance Programs, along with a toll-free phone number for more information, in all new U.S.-based DTC print and television advertisements.
We inform health care professionals about our products before we advertise them to consumers, and we do not launch DTC advertising in the U.S. until at least six months after a new product has been approved. We also implement comprehensive programs to educate physicians and other prescribers about a new product before starting product-specific DTC broadcast advertising in the U.S. These principles and our practices are reflected in the PhRMA Guiding Principles on Direct-to-Consumer Advertisements about Prescription Medicines.
We believe that our marketing, sales and advertising activities make an important contribution to medicine by informing our customers of treatment options based on the most recent scientific information and findings from rigorous clinical studies.
Our sales and marketing practices are governed by external laws, regulations and industry codes of conduct, and by our own global Code of Conduct, our corporate policies and procedures, and our Global Compliance Program. Our Compliance Program seeks to prevent and address inappropriate practices, and we evaluate our policies and practices as appropriate. Our practices are monitored and compliance is enforced to ensure that our interactions with customers and consumers help inform their decisions accurately and in a balanced manner. We believe that compliance with all policies governing scientific, business and promotion-related activities, in letter and spirit, is a corporate and individual responsibility of the highest order. Through our ethical behavior, we strive to ensure that scientific information predominates in prescribing decisions.
Mechanisms for Fostering Ethical Sales & Marketing Practices
The key principles of our Guiding Principles for Ethical Business Practices Involving the Medical and Scientific Community are as follows:
- We provide current, accurate and balanced information about our products; we transmit sound scientific and educational information; and we support medical research and education.
- Our employees are prohibited from offering health care professionals items of personal benefit, such as tickets to sporting events, support for office social events, or gift certificates for stores or golf outings. Where permitted, we may occasionally provide health care professionals with approved educational items that are not of substantial monetary value and that are intended primarily for educational purposes. Such materials may include medical textbooks, medical journals and anatomical models.
- Our employees and others speaking on behalf of the company may provide presentations specifically designed to provide the type of information that practicing health care professionals have indicated is needed and most useful in the treatment of their patients, in accordance with U.S. FDA regulations and the regulations of other countries in which the presentations or discussions are taking place. In connection with such presentations or discussions, occasional modest meals may be offered to attendees and must occur in a venue and manner conducive to informational communication.
- A company representative may offer occasional modest meals to health care professionals in connection with an informational presentation; however, such meals must be in accordance with local codes and regulations
Our sales representatives must provide truthful, non-misleading information in their interactions with the medical and scientific community. Our compliance program is consistent with applicable laws and regulations, and is aligned with the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) Code of Pharmaceutical Marketing Practices, as well as with regional and country industry codes, such as the Pharmaceutical Research and Manufacturers of America (PhRMA) Code and the Compliance Program Guidance for Pharmaceutical Manufacturers, published by the Office of the Inspector General, U.S. Department of Health and Human Services. In addition to our global Code of Conduct and Guiding Principles for Interactions with Health Care Professionals, we have several mechanisms in place to minimize noncompliance and foster ethical promotional practices:
Hiring people with the right values, and then reinforcing those values: We look for people who believe in a value system similar to ours. In our interview process, we try to ascertain how candidates make decisions. We are interested in people who will want to commercialize our medicines and vaccines based on the merits of our products and the applicable science.
Maintaining strict control over promotional materials: Every promotional claim we make throughout the world has to be approved by our medical and legal experts for accuracy and balance, in accordance with legal requirements and ethical considerations. In the U.S., we also submit new promotional materials for new-product approvals and new indications to the FDA prior to use.
Ensuring strong medical, legal and compliance oversight: Our medical, legal and compliance teams are active partners who foster ethical promotional practices, helping to achieve business goals by reducing risk and increasing compliance with the laws and guidelines in a highly regulated environment. Our medical, legal and compliance teams are also involved in ensuring that the sales force provides balanced information to physicians and health care decision makers.
Implementing a promotional approach that reflects customer input: Our sales and marketing teams actively seek input from health care professionals, consumers and payers to understand their needs regarding our common goal of improving patient outcomes. We incorporate their feedback into training efforts and promotional activities in order to build trustworthy partnerships with our customers and to achieve our common goal.
Enforcing a performance management system that rewards ethical behavior: Our companywide annual performance management system considers not only what an employee has achieved but also how he or she has done so, with a specific focus on ethical behavior.
Working to raise marketing standards industrywide: We are active on numerous industry association committees that address marketing standards.
Conducting continuous oversight, monitoring and risk assessment: We conduct ongoing oversight and monitoring of our key risk areas and of any activities that have been identified through our annual risk assessment process.
Review Guidelines for Global Promotional and Educational Content
The review of global promotional and educational content follows a comprehensive, strict process and standards that define the concept of fairness and balance in the communication of that content. All global promotional and educational content is reviewed and approved by the appropriate promotion review team, captured in a global database, and assigned a unique resource code and expiration date. All regional and country medical personnel involved in the review and approval of promotional and educational content receive comprehensive training on corporate policies, promotion standards and process, the medical reviewer role, and the required database functionalities.
As a condition of employment, all of our sales and marketing employees are required to be certified periodically on sales and marketing practices.
In the U.S., for example, employees who do not satisfactorily meet these training requirements may not conduct specific activities on their own and must complete the training again until they meet the requirements.
All new employees receive training and testing and must be certified on relevant policies and our company’s ethical operating standards. And although many of our employees who market and sell our medicines and vaccines have advanced scientific or medical degrees and backgrounds, all of our sales representatives must complete general sales and product training. Training is specific to the country where an employee is based and covers the scope of the employee’s responsibilities in ensuring compliance with applicable laws and regulations.
Sales representatives in the U.S. are required to understand, among other things, their responsibilities under the Anti-Kickback Statute, the U.S. Prescription Drug Marketing Act, and all applicable FDA promotional regulations. Sales representatives are trained on anti-bribery and anticorruption laws such as the U.S. Foreign Corrupt Practices Act (FCPA) and the U.K. Bribery Act.
After this initial training, we require periodic training aimed at recertifying employees on relevant policies and practices according to local and functional requirements. In addition to mandatory training on our Code of Conduct, employees receive training on other levels of business practices and compliance, according to their roles and responsibilities. We evaluate and update the content for all marketing and sales training periodically to ensure that it remains relevant and current.
Industry Codes of Conduct
The pharmaceutical industry as a whole recognized that more needed to be done to address concerns raised by public officials and stakeholders in the health care community. Self-regulating industry codes of conduct such as the IFPMA, EFPIA and PhRMA codes set the standards that govern the industry’s sales and marketing practices and ensure that companies have adequate policies and procedures in place to comply with the codes.
Key Components of the PhRMA Code
Among the PhRMA Code’s key components is an annual requirement for company CEOs and chief compliance officers to certify personally that they have processes in place that foster compliance with the Code. The Code also encourages companies to obtain third-party verification of their compliance policies and procedures. We have completed PhRMA Code certification in each of the last four years.
Other requirements of the Code have previously been incorporated into our already strong ethical business practices. For example, the company follows the standards for commercial support of continuing medical education established by the Accreditation Council for Continuing Medical Education (ACCME), and our Compliance Program requires that company representatives be periodically assessed to make sure they comply with relevant company policies and standards of conduct.