Sales & Marketing Practices
We know that health care providers and patients look to us to provide accurate and balanced information about our products and services.
We adhere to strict ethical sales and marketing practices in all our businesses, whether pharmaceuticals, vaccines or animal health.
One of the ways we provide product information is by maintaining 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, Our Values & Standards. We enforce these external and internal standards through our ethics and 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. To respond to increasing requests for on-demand information, in certain countries we offer resources and product information to health care providers on company websites and other digital platforms.
In some countries, where permitted by law, we may directly inform patients and other consumers about diseases and available treatments that they may wish to discuss with their doctors. We believe direct-to-consumer advertising contributes to greater awareness about conditions and diseases, which can benefit public health by increasing the number of patients appropriately diagnosed and treated.
We also recognize the importance of collaborating with health care providers and other customers and stakeholders to develop innovative services and solutions to improve the treatment and care of patients. We are committed to working with a wide range of stakeholders to help achieve our vision to make a difference in the lives of people globally through our innovative medicines, vaccines and animal health products.
Fostering ethical practices
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 and regulations and industry codes of conduct, and by our own global Code of Conduct, our corporate policies and procedures, and our ethics and compliance program.
Our ethics and compliance program seeks to address and prevent 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.
Our Guiding Principles for Ethical Business Practices Involving the Medical and Scientific Community include the following:
- We provide current, accurate and balanced information about our products; we share 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 give 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. Food and Drug Administration (FDA) regulations and the regulations of other countries in which the presentations or discussions are taking place.
- 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, we have several additional 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 through a rigorous approval process to ensure compliance with legal requirements and ethical considerations. In the U.S., we also submit new promotional materials to the FDA for new-product approvals and new indications 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.
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.
With the evolution of external data available to support our sales and marketing efforts, it is important to note that the company has a comprehensive global privacy program that manages our evolving risks and responsibilities pertaining to data, including data that we use to direct our commercial and marketing efforts.
The company is subject to a significant number of privacy and data protection laws and regulations globally, many of which place restrictions on our ability to collect, transfer, access and use personal data across the business. For more information on our privacy practices, please see the Privacy and Information Security section of this report.
Worldwide Review Guidelines
The review and approval of global promotional and educational materials for health care practitioners follow a comprehensive and strict process.
In the U.S. this is done through the Promotions Review Team process. Outside of the U.S., our employees follow the principles of the Worldwide Review Guidelines (WWRG) to define the concept of fairness and balance in the communication of scientific/educational information.
All such materials are reviewed and approved by medical personnel, captured in a global database, and assigned a unique identifying number and expiration date. All regional and country medical personnel involved in the review and approval of promotional/educational material receive comprehensive training on corporate policies, the WWRG, 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 repeat the training 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 are trained on anti-bribery and anticorruption laws such as the U.S. Foreign Corrupt Practices Act and the U.K. Bribery Act. Sales representatives in the U.S. are also 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.
After this initial training, we require periodic training aimed at recertifying employees on relevant policies and practices in accordance with local and functional requirements.
In addition to mandatory training on our Code of Conduct, employees receive training on other levels of business practice 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, the European Federation of Pharmaceutical Industries and Associations (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.
Among PhRMA’s Code on the Interactions with Healthcare Professionals (the Code) 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 complete PhRMA Code certification every year in compliance with the Code.
Other requirements of the Code have previously been incorporated into our already strong ethical business practices. For example, our company follows the standards for commercial support of continuing medical education established by the Accreditation Council for Continuing Medical Education, and our ethics and compliance program requires that company representatives be periodically assessed to make sure they comply with relevant company policies and standards of conduct.
We stress that if our employees are unsure about the appropriateness of the conduct that they ask for help. There are several places employees can turn for assistance. The first option is to talk their manager. If they do not feel comfortable with that course of action, the other resources they may contact are:
- Divisional Compliance Departments
- Office of Ethics
- Privacy Office
- Office of General Counsel
- Human Resources Department
|Sales & Marketing||2014||2015||2016||2017||2018|
|Number of warning letters or untitled letters from OPDP1 or APLB2 in the U.S.||0||0||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.