Ethical Sales and Marketing Practices

Ensuring Ethical Sales and Marketing Practices

Our sales and marketing practices are governed by laws and regulations, and by our global Code of Conduct, business practices and compliance guidance. These practices are monitored and enforced to ensure that our interactions with customers and consumers help inform their decisions accurately and in a balanced manner. We believe that compliance, in letter and spirit, with all policies governing scientific, business and promotion-related activity is a corporate and individual responsibility of the highest order. Our ethical behavior will ensure that scientific information predominates in prescribing decisions.

Recently Revised PhRMA Code

Inappropriate promotional activities have been criticized as having an unduly influential impact on physician prescribing....
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Merck’s Global Code of Conduct and Guidance for Interactions with Health Care Professionals

The key principles of the Merck Code of Conduct and business practices guidance for involving the medical and scientific community are:

We provide current, accurate and balanced information about Merck products, we transmit sound scientific and educational information, and we support medical research and education.
Merck employees are prohibited from offering health care professionals items of personal benefit, such as tickets to sporting events, support for office social events, gift certificates to stores or golf outings. We occasionally may provide health care professionals with approved educational items that are not of substantial monetary value. These materials are intended primarily to educate health care professionals and may include items such as medical textbooks, medical journals or anatomical models.
Merck employees and others speaking on Merck’s behalf may provide presentations and discussions specifically designed to provide the type of information that practicing medical and health care professionals have indicated to Merck that they need and find most useful in the treatment of their patients, in accordance with FDA and other country regulations. In connection with such presentations or discussions, occasional modest meals may be offered to attendees and should occur in a venue and manner conducive to informational communication.
Occasional modest meals may be offered to health care professionals by a Merck representative in connection with an informational presentation, however, such meals must be in accordance with local codes and regulations.

Enforcing Our Code

Our sales representatives seek to ensure that their interactions with the medical and scientific community are based on providing truthful, non-misleading information. Our Business Practices and Compliance Program (Program) is governed by applicable laws and regulations and aligned with the International Federation of Pharmaceutical Manufacturers Associations (IFPMA) Code of Marketing Practices as well as regional and local 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 Inspector General, U.S. Department of Health and Human Services. To ensure the Program responds to evolving business and compliance needs and risks, we regularly assess and adjust it.

For further details on the Merck code and its enforcement, please click here

Training our Employees who Interact with Health Care Professionals

As a condition of their continued employment, all of our sales and marketing employees are required to be certified on sales and marketing practices periodically. The training process is overseen by training departments and other groups. In the United States, for example, employees who do not satisfactorily meet the training requirements may not conduct specific activities without direct supervision, and must complete the training again until they do meet the requirements.

New employees receive testing and certification on related policies and Merck's ethical operating standards. In addition, although many of our employees who market and sell our medicines and vaccines have advanced scientific or medical degrees and backgrounds, our sales representatives must complete general sales and product training. This includes training specific to the country where the employee is based, and covers the employee's responsibilities to ensure compliance with local laws and regulations that relate to pharmaceutical sales and marketing. For example, our sales representatives in the United States are required to understand their responsibilities under the Anti-Kickback Statute, the U.S. Prescription Drug Marketing Act and U.S. FDA drug promotion regulations.

After this initial training, there is periodic training aimed at re-certifying employees on relevant policies and practices according to local and functional requirements. In addition to mandatory training on our Code of Conduct, there are other levels of business practices and compliance training, mandated based on employees' roles and responsibilities. We evaluate and update the content for all marketing and sales training periodically to ensure it remains relevant and current.

Channels for Escalation, Investigation, Remediation and Recognition of Concerns and Violations

Our employees worldwide understand and are aware that they should bring to the attention of management workplace issues of any type, including potential violations of law, Company policy or the Company's Code of Conduct. Merck strives to provide a work environment that encourages employees to communicate openly with management, without fear of retaliation or retribution. In 2008, we established comprehensive, corporate guidelines for escalation, investigation, remediation and recognition of non-compliance events, which we are in the process of implementing across our different divisions and regions. Through these guidelines, we will ensure that events are escalated to the appropriate place within the Company, and properly and thoroughly investigated. This approach also will ensure the appropriate disciplinary action is taken, up to and including dismissal, when necessary.

In addition to these channels to address potential violations, there are a variety of resources for employees to raise concerns in a confidential manner without fear of retaliation. As a first step, employees can seek out an immediate supervisor or manager to discuss suspected violations. If the matter is not successfully resolved, or if concerns remain, employees are encouraged to pursue the issue with his or her next level of management, Human Resources or legal counsel.

Additional confidential mechanisms managed by the Chief Ethics and Corporate Compliance Officer include:

The Merck AdviceLine, a telephone line available to employees around the world 24 hours a day, seven days a week, staffed by an independent organization that allows employees to remain anonymous in accordance with applicable legal standards for operation of whistleblowing hotlines.
The Merck Ombudsman Program, which offers a "safe haven" for U.S. employees to express work-related issues without fear of retaliation. This program confidentially addresses employees' concerns about conduct that may be inconsistent with Merck's policies, practices, values and standards.
The Merck Office of Ethics, which actively supports Merck's commitment to the highest standards of ethics and integrity in all of our business practices, with Ethics Officers available to answer questions, provide guidance and respond to concerns in a confidential environment.

For more information on the Office of Ethics, please click here.

Other Mechanisms for Fostering Ethical Marketing and Selling Practices

In addition to our global code of conduct for interactions with health care professionals, to minimize non-compliance and foster ethical promotional practices, Merck has several mechanisms in place:

Merck Resolves Federal and State Investigations

As previously reported, in February 2008, Merck reached civil settlements with federal and state authorities to resolve longstanding investigations related to disputes over the proper calculation of Medicaid rebates as well as certain past sales and marketing activities that ended in 2001. The settlements do not constitute an admission by Merck of any liability or wrongdoing. Merck believes our pricing and sales and marketing policies and practices were consistent with all applicable regulations and contracts during the relevant time. As a result of the agreements, lawsuits against Merck will be dismissed by federal courts in Philadelphia, New Orleans and Nevada. Nearly all of the states acknowledged in their agreements that Merck voluntarily began to put in place substantial compliance initiatives in 2001, prior to Merck being contacted by the government concerning an investigation. As required by the CIA, Merck has retained an Independent Review Organization ("IRO") to conduct a systems review of its promotional policies and procedures and to conduct, on a sample basis, transactional reviews of Merck's promotional programs and certain Medicaid pricing calculations. Merck is also required to provide regular reports and certifications to the HHS-OIG regarding its compliance with the CIA. On May 15, 2009, Merck submitted its first Annual Report to the U.S. Department of Health and Human Services Office of Inspector General (HHS-OIG) consistent with the requirements of the agreement. For additional details, please see our Form 10-K for the years ended December 31, 2007 and December 31, 2008.

2007 Form 10-K(PDF*)
2008 Form 10-K(PDF*)

Hiring people with the right values and then reinforcing them: We look for people who we believe have a similar value system. In our interview process we try to ascertain how they make decisions. We want people who will want to commercialize our medicines and vaccines based on the merits of our products and the science.
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 United States, we also submit new promotional materials for new product approvals and new indications to FDA prior to use.
Strong medical and legal oversight: Merck’s medical and legal teams are active partners to help 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 and legal teams are also involved in training the sales force about providing balanced information to physicians and health care decision makers.
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 for our common goal of improving patient outcomes. We incorporate their feedback into training efforts and promotional activities to build trusting partnerships with our customers and achieve our common goal.
Performance management system that rewards ethical behavior: Our Company-wide annual performance management system considers not only what an employee has achieved but also how they have done so, with a specific focus on ethical behaviors.
Working to raise marketing standards industrywide: Merck is active in numerous industry association committees that address marketing standards.
Global risk assessment tool: We have developed a process to assess risks associated with sales and marketing-related business practices and processes, benchmarked to industry best practices. It has been implemented so far in 29 countries around the world. By the end of 2009 it will cover all major country operations.

The review and approval of global promotional and educational materials for health care practitioners follows a comprehensive and strict process as enunciated in the "International Medical Media Standards" (IMMS) guidance document. The IMMS principles are followed on a worldwide basis and define the concept of "fairness and balance" in the communication of scientific/educational information. At Merck all such materials are reviewed and approved by medical and legal personnel, captured in a global data base (Protrack), and assigned a unique identifying number and expiration date. In 2008, Merck developed two new training programs and all regional and country medical personnel involved in the review and approval of promotional/educational material receives comprehensive training that focuses on Corporate policies, IMMS, medical reviewer role, and the required database functionalities.

Merck is committed to the highest ethical sales and marketing standards wherever it operates.

The content on this page was last modified on September 15, 2009.

Merck & Co., Inc., Whitehouse Station, NJ, USA, and Schering-Plough Corporation, Kenilworth, NJ, USA, are now one company. We have combined our global operations under the name Merck & Co., Inc. We are working to update our corporate responsibility Web site to reflect our new, combined, global organization.