Key Ethical Issues for Merck and the Pharmaceutical Industry

As one of the leading global pharmaceutical firms, over and above general ethical issues related to working practices, Merck faces the same set of ethical issues that have brought a growing amount of scrutiny to this industry: pricing of and access to medicines, appropriate promotion practices and interactions with policymakers, deciding what products to develop, assessing the benefits and risks of products, and the conduct of clinical trials and publication of results.

Medicine Pricing, Intellectual Property Rights, and Access:

Some critics of the pharmaceutical industry claim that the price of medicines and intellectual property rights contribute to inadequate global access to medicines and vaccines. Merck believes strong national systems to protect intellectual property are essential to the discovery and development of innovative medicines, and in turn, innovation is a key driver of growth and competitiveness for national economies. We believe the larger ethical issue that needs to be addressed is the lack of infrastructure and investment in health that exists in many parts of the world. For more information on how we improve access to medicines and vaccines worldwide, please click here.

Appropriate Sales & Marketing Practices:

In order to help provide the best possible care to their patients, doctors rely on pharmaceutical companies to provide accurate and balanced information about their medicines and vaccines. We believe the best way to accomplish this goal is to maintain informative, ethical and professional relationships between health care professionals and pharmaceutical companies. Relationships with health care professionals are governed by laws, regulations, industry codes of practice as well as internal corporate policies - and Merck employees are trained to comply with these measures. Merck recognizes that the pharmaceutical industry has been criticized for inappropriate promotional activities that have occurred in the past and has actively supported the strengthening of industry standards — including enhancements to the Pharmaceutical Research and Manufacturers of America (PhRMA) Code on Interactions with Healthcare Professionals that were approved in July 2008 — as well as taken steps to strengthen our own policies and practices. Merck strives to provide accurate and balanced information and minimize the potential for inappropriate activities. We believe that high ethical standards will help us maintain our reputation and that the quality of our products and the provision of accurate and balanced scientific information alone should be the basis for prescribing decisions. For more information on our sales & marketing practices, please click here.

Direct-to-Consumer Advertising:

Since the FDA released draft guidelines in 1997 on the use of broadcast direct-to-consumer (DTC) advertising for prescription drugs, the growth of DTC advertising has increased significantly in the United States. Some stakeholder groups have called for additional restrictions on DTC ads. Merck believes that DTC advertising contributes to greater public awareness about health conditions and diseases, as well as available treatments and preventive vaccines. We also believe DTC advertising can help increase the number of patients who are appropriately diagnosed and treated, which could have enormous public health benefits. Merck strives to enable consumers to achieve better health outcomes by delivering accurate, relevant information on disease prevention, identification, and treatment in an understandable manner. All of our DTC ads are designed to help consumers more confidently engage in dialogue with their health care provider about treatment options. Merck has a long-standing policy to voluntarily submit new DTC advertising campaigns to FDA for pre-review. We wait until a response from FDA is received prior to running the advertising campaign, and modify the advertising to address written comments received from FDA. For more information about our approach to DTC advertising, please click here.

Interactions with Policymakers:

As society and technology evolve, so must laws, policies and related processes. Merck believes in engaging with policymakers and other stakeholders to explain our views, provide analyses of the issues at stake, and share information that can help clarify complex topics and dispel misperceptions in ways that will benefit patients and promote social and economic development. We monitor policy developments and contribute to debates on a broad set of issues at the local, national, regional and global levels. Merck is committed to following the highest ethical standards in our interactions with policymakers, always seeking to remain consistent and transparent in advocating for policies, while also recognizing the complexity and sophistication of a policy landscape that often does not lend itself to simple explanations. For further information please click here.

Conduct of Clinical Trials and Publication of Study Results:

We conduct our studies in an ethical and rigorously scientific manner, collaborating with leading experts in the field, to clearly demonstrate the benefits, risks and value of our medicines and vaccines to physicians and to the patients who need to take them. We are committed to publishing results of all of our clinical trials in patients in a timely, objective, accurate and balanced manner, regardless of the outcome of the trial. For more information on how we conduct clinical trials and publish the results, please click here.

Ensuring Confidence in the Safety and Quality of Our Products:

The health of patients is our mission. We dedicate extensive efforts to studying our medicines and vaccines before seeking regulatory approval to market them and continue this work after the products are approved. This means working with independent physicians and experts to characterize the efficacy and safety profiles of our products. We make extensive information about our products available, enabling doctors to evaluate the risks as well as the benefits of any treatment and discuss them with their patients. This approach is what led us in September 30, 2004, to announce a voluntary worldwide withdrawal of VIOXX^® (rofecoxib), our arthritis and acute pain medication. Merck took this action because we believed it best served the interests of patients. Although we believed it would have been possible to continue to market VIOXX with labeling that would incorporate the new data, given the availability of alternative therapies and the questions raised by the data, we concluded that a voluntary withdrawal was the responsible course to take. The Company has a dedicated VIOXX Information Center that contains major Company communications on the matter and other resources. For further information on how we ensure our products are as safe as possible, please click here.

Financial Support of Activities with Independent Third-Party Groups, Including Health Care Professionals and Patient Groups:

We strongly believe that our relationships with the medical community are vital to the advancement of science, medicine and the well-being of patients. Discovering, developing and bringing innovative vaccines and medicines to the market is our first responsibility. That mission cannot be accomplished without sustained relationships with a wide range of external organizations and health care professionals. In October 2008, Merck began reporting grants over $500 made by its Global Human Health division to U.S. organizations for independent professional education initiatives, including accredited continuing medical education (CME). Over the course of 2009, we plan to expand our reporting to include other grants/payments to U.S. organizations.

While disclosure of supported patient organizations became mandatory in Europe in March 2009, Merck has voluntarily disclosed support to patient organization in Europe, Middle East and Africa made by Merck offices in those regions since 2008.  In addition, in the second half of 2009, Merck plans to begin reporting payments made to patient organization by Merck operations in Canada from 2009 onward.  Also in 2009, Merck operations in Europe, Middle East, Africa and Canada plan to begin disclosing grants to other third-party institutions made beginning in January 2009.

In June 2008, Merck implemented Guiding Principles for Business Practices Involving the Medical and Scientific Community. These principles serve as a bridge between country laws, regulations, industry guidelines, and the Company's Values and Standards, which are articulated in Company policies, guidelines, and procedures. The principles are intended to enable interactions with the medical and scientific community that comply with our ethical and legal obligations and improve human health.

In 2008, Merck endorsed the Physicians Payment Sunshine Act, mandating disclosure of these financial relationships. In the absence of a legislative requirement, we plan to voluntarily disclose in the fourth quarter of 2009 all payments to US-based health care professionals who speak on behalf of Merck or our products. For more information on our financial interactions with independent third-party groups, please click here.

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.