Transparency
Disclosures

Transparency
Disclosures

Our company aspires to being open and transparent about how we operate in order to earn and retain the trust and confidence of our customers, employees, shareholders, and other important stakeholders.

 

We do this by proactively providing nonproprietary information to stakeholders about our business and how we operate, which helps stakeholders make informed decisions about their interactions with the company and our products.

We disclose information through a variety of mechanisms, including our financial disclosures, our annual corporate responsibility report, and participation in voluntary efforts such as the CDP (formerly the Carbon Disclosure Project), as well as through the media and through one-on-one stakeholder discussions. As part of this commitment to increasing transparency, we also disclose information in this corporate responsibility report in the following areas:

CDP

CDP is an independent not-for-profit organization working to drive greenhouse gas (GHG) emissions reduction and sustainable water use by businesses and cities.

CDP works with investors globally to advance the investment opportunities and reduce the risks posed by climate change by asking almost 6,000 of the world’s largest companies to report on their climate strategies, GHG emissions and energy use in the standardized Investor CDP format. We have been disclosing climate information via the CDP for a number of years, and more recently have participated in both its Water and Supply Chain disclosures.

CLINICAL TRIALS

Our company is committed to the timely registration of clinical trial information and the disclosure of clinical trials — regardless of their outcomes.

Learn more about clinical trials.

Clinical Trial Disclosures
Since 2007, we have registered at trial initiation all clinical trials in patients in which treatment is assigned that our company sponsors and conducts worldwide on www.ClinicalTrials.gov. We also disclose results from registered clinical trials of marketed products—regardless of outcomes.

Clinical Trial Results
The clinical study results of our company and Schering-Plough, previously posted via the Pharmaceutical Research and Manufacturers of America (PhRMA) Clinical Study Results Database, have been available as of December 2011 on our corporate headquarters website.

Clinical Trial Data Sharing

We are committed to the PhRMA/EFPIA Principles for Responsible Clinical Trial Data Sharing.

Learn more about our policies and perspectives:

Scientific and medical researchers who wish to submit a proposal for access to our company’s data may send an inquiry by clicking here.

Clinical Research Protocols
Effective July 1, 2011, when we submit a manuscript on a study of an investigational or an approved medicine or vaccine to a biomedical journal, we will voluntarily include the protocol and statistical analysis plan. We previously supplied this material only upon request. Upon a journal’s acceptance of the manuscript for publication, we will provide the journal, at its own discretion, with the opportunity to post on its website the key sections of the protocol, including the objectives and hypotheses, patient inclusion and exclusion criteria, study design and procedures, efficacy and safety measures, and statistical analysis plan, and any amendments relating to those sections.

CORPORATE POLITICAL ADVOCACY AND CONTRIBUTIONS

Our company is committed to participating constructively and responsibly in the political process. To improve access to information about our advocacy activities, we disclose our costs associated with lobbying in the European Union and the United States.

Where permitted by law in the United States, Canada and Australia, the company provides corporate political contributions, primarily to the electoral campaigns of individual candidates.

To improve access to information about our corporate political and PAC contributions in the United States, our company semiannually posts our contributions, categorized by state, candidate and amount. We post our contributions in Canada and Australia annually.

We also disclose a list of industry and trade groups of which we are members, and our dues (dues that are greater than $25,000), to U.S. trade associations that are used for political purposes. We encourage all trade associations to which we belong to disclose publicly their political activities as well. Learn more.

EMPLOYEE DIVERSITY

We consider diversity and inclusion integral parts of the culture we seek to build. To learn more about our initiatives and performance, click here.

We were one of the first companies in the United States to begin disclosing our Equal Employment Opportunity data, and we continue to do so annually. To view our EEO-1 data, click here.

Grants to Medical, Scientific and Patient Organizations

We believe that providing support through grants or donation to third-party medical, scientific and patient organizations is an important way to advance our mutual objectives to improve health and advance patient care.

We disclose grants of more than $500 provided by the company’s Global Human Health division to U.S. organizations in support of independent, accredited educational programs for health care professionals, as well as grants to patient organizations and other medical education or scientific societies and organizations in the United States, Europe, the Middle East, Africa and Canada.

We have robust standards and policies in place to ensure that our grants are intended for, and provided in support of, improving patient care, and are not promotional or likely to be perceived as being promotional in nature, or provided to induce or reward prescription of our products. Furthermore, any grant or donation must also be permitted by and aligned with local country laws and regulations.

We update grants to medical, scientific and patient organizations quarterly in the United States, and annually in ex-U.S. jurisdictions.

The following three principles guide our approach to providing financial support to medical, scientific and patient organizations:

Independence: Our company respects the independence of medical, scientific and patient organizations and refrains from using our financial support to influence the policies of organizations or to promote specific medicines.

Transparency: Our company supports transparency of financial support provided to medical, scientific and patient organizations. We believe this is an important step in building public trust both in our company and in those to whom we provide support. Making our support public also enhances the visibility of our commitment to helping advance health and science.

Compliance with Local Laws: In providing financial support to medical, scientific and patient organizations, we comply with all relevant local laws and regulations.

As part of our commitment to these principles, we regularly review and update our Code of Conduct to reaffirm our mission and commitment to scientific excellence, ethics and integrity. These principles are also reflected in the company’s corporate policies, procedures and guidelines, which all employees are responsible for understanding and applying appropriately.

UNITED STATES

OUTSIDE THE UNITED STATES

Disclosure of grants to patient organizations has been mandatory in Europe since March 2009. However, in Europe, the Middle East and Africa, we voluntarily began disclosing financial support to patient organizations in 2008, and in Canada in 2009.

In October 2009, in Europe, the Middle East, Africa and Canada, our company also began to disclose grants to other third-party organizations such as medical societies and scientific organizations. The information disclosed includes the organizations, the amounts received, the dates of payment and the projects for which the money was used. Disclosures include all donations and charitable contributions, grants, and membership fees to professional societies or other medical or scientific organizations. We were a member of the working group to develop the European Federation of Pharmaceutical Industries and Associations (EFPIA) Code of Practice on Relationships between the Pharmaceutical Industry and Patient Organisations, which became effective on July 1, 2008.

2016 Grants Outside the U.S.

Payments to Health Care Professionals

We believe in broad disclosure of financial relationships between physicians and the pharmaceutical industry.

UNITED STATES

As an early supporter of the Physician Payments Sunshine Act (PPSA), we believe in broad disclosure of financial relationships between physicians and the pharmaceutical industry. In October 2009, our company began voluntarily disclosing all payments to U.S.-based health care professionals who speak on behalf of our company about our products and other health care issues.

We comply with the PPSA provisions of the U.S. Affordable Care Act, which require pharmaceutical manufacturers to annually disclose information on certain additional payments and other transfers of value furnished to U.S.-licensed physicians and U.S. teaching hospitals to the Department of Health and Human Services (HHS). In addition to submitting such information to HHS’s Center for Medicare & Medicaid Services each year, we post the information annually on this website.

We engage with health care professionals around the world to conduct company-sponsored clinical studies on the safety and effectiveness of our products. We conduct these studies, in accordance with strict regulatory requirements, with “real world” physicians and their patients in order to learn more about our products and bring new medicines and vaccines to patients who need them. Once a product is approved for marketing, we continue to conduct studies in order to monitor ongoing safety and effectiveness.

We also engage with health care professionals through our Investigator Studies Program, whose mission is to advance the delivery of quality health care by supporting investigator-initiated original research that will enhance the understanding of disease entities and their treatment. This program is open to all academic and community-based physicians and researchers worldwide who are interested in conducting their own research.

We are committed to the discovery and development of important new drugs and vaccines through collaboration with scientific leaders from academic and scientific organizations around the world. Advice in the form of consulting engagements with external medical and scientific experts results in meaningful scientific exchanges that bring real-world knowledge and perspectives to our company. These critical exchanges contribute to advancing science both at our company and in the broader scientific community, and ultimately help benefit human health.

We also engage physicians as speakers in the U.S. through our company’s Medical Forums, which are designed to deliver balanced medical and scientific information to health care professionals so that patients can have access to the medicines and vaccines they need and use these products correctly. These programs are structured to be consistent with the PhRMA Code on Interactions with Healthcare Professionals and are conducted in compliance with FDA regulations to help ensure that our product information is presented in an appropriately balanced manner, with respect to potential benefits and risks.

EUROPE

In 2016, we began disclosing payments to European-based health care professionals and health care organizations, in alignment with the disclosure code announced by the European Federation of Pharmaceutical Industries and Associations (EFPIA). Our company played a supportive role in the development and adoption of the code by the EFPIA board.

Philanthropic Grants and Contributions

We report philanthropic grants and charitable contributions, including contributions made through the Office of Corporate Responsibility, our company’s Foundation, U.S. Global Human Health, and the MSD for Mothers Program.

Post-Marketing Requirements

We recognize the importance of providing transparent information about the status of our marketing and development activities after a product has been approved by regulatory authorities.

This information can help ensure that health care providers and patients remain informed about our products.

To inform the public about post-marketing activities, we will, on a quarterly basis, post information on this website concerning post-marketing requirements (PMRs) for U.S.-marketed products intended for human use. Information will include the nature and status of the PMRs for the life cycle of a marketed product, in accordance with U.S. regulations. Information will also include reference to clinical, nonclinical or pharmacovigilance studies/trials that have been identified as PMRs. Additional background on post-marketing requirements is available at the FDA website.

HEADINGS, COLUMN HEADINGS & EXPLANATIONS

  • Registered Trade Name: [TRADE NAME (generic name)] Trade name registered in the U.S. market (active ingredient[s] in the drug).
  • NDA/BLA #: New Drug Application or Biologic License Application number.
  • Original Due Date: The date in the original FDA correspondence by which our company has agreed to complete the post-marketing requirement to the FDA.
  • Status: The status of the post-marketing requirement at the last quarterly update (Pending, Ongoing, Delayed, Terminated, Submitted, Fulfilled and Released – see definitions below).
  • Explanation of Status: An explanation is provided where appropriate. Any revisions to due date agreed upon with the FDA are reflected here.
  • PMR Description: The description of the post-marketing requirement.

U.S. POST-MARKETING REQUIREMENTS REPORT (2Q 2018)

Below are definitions of the status used for each final report submission. There may be differences between the status of the information posted to this website and that on the FDA Post-Marketing Commitments website, due primarily to the differences in timing of the updates and the fact that the Company only posts the status of the final report submission and not interim milestone statuses (such as final protocol, study/trial completion, etc). The due date reflected is the original due date agreed upon with FDA.  Any revisions to due date agreed upon with the FDA are reflected in Explanation of Status.

Pending: Commitment activity has not yet started.

Ongoing: Activity for the Commitment has begun. The commitment status should be changed from “Pending” to “Ongoing” when the first subject/patient is screened.

Delayed: The status is changed to “Delayed” once the original due date has passed or the due dates of any approved extensions have passed.

Terminated: The applicant ended the study before completion and has not yet submitted a final study report to the FDA.

Submitted: The applicant has concluded or terminated the study and has submitted a final study report to the FDA, but the FDA has not yet notified the applicant in writing that the study commitment has been fulfilled or that the commitment has been released.

Fulfilled: The applicant has submitted the final study report for the commitment, and upon review of the final study report, the FDA is satisfied that the applicant has met the terms of the commitment.

Released: The FDA has informed the applicant that it has been released from its obligation to conduct the post-marketing study because the study is either no longer feasible or would no longer provide useful information.

Pricing Practices in the United States

As part of our ongoing commitment to transparency about our business operations, and to help people better understand our pricing practices in the United States, in 2017 we began disclosing information about price increases for our medicines and vaccines.

This information includes the average annual list and net price increases across our product portfolio since 2010. The disclosure also includes the average discount rate for our medicines and vaccines each year.

These disclosures don’t tell the complete story about how we are responding to concerns about access and affordability. We have a long history of discovering medicines and vaccines and making them accessible and affordable to people who need them. Additional information about our activities can be found on our Access and Affordability page. We also recognize that more needs to be done, and we welcome opportunities to work with stakeholders to find long-term solutions.

Report on Pricing Practices in the U.S.

Pricing Action Transparency Report (2010-2017) Posted February 2018.

This is the corporate responsibility report of Merck & Co., Inc., Kenilworth, N.J., U.S.A., which is known as MSD outside the U.S. and Canada.