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 Global Compliance Program. Our 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.
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 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. 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 our 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 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.
INTERNATIONAL MEDICAL MEDIA STANDARDS
The review and approval of global promotional and educational materials for health care practitioners follow a comprehensive and strict process, as outlined in the International Medical Media Standards (IMMS) guidance document. The IMMS principles are followed by our employees on a worldwide basis, and define the concept of fairness and balance in the communication of scientific/educational information. All such materials are reviewed and approved by medical and legal 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 IMMS, 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 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 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, 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.