Committed to Transparency
At Sanofi US, we are focused on making a difference in patients’ lives. To ensure the availability of new medicines, we often seek to work and innovate with other individuals and organizations, including physicians, non-physician practitioners and teaching hospitals, with a common aim to improve patient health. We are fully committed to the financial transparency of these relationships; it is important to us to foster an understanding of these interactions and to prevent any real or perceived conflict of interest.
Under federal law and implementing regulations (now referred to as “Open Payments”), issued by the Centers for Medicare and Medicaid Services (CMS), any payment or other transfer of value we make to a physician, non-physician practitioner or teaching hospital is subject to collection and potential public reporting. Certain states have also enacted laws and regulations relating to transparency of interactions with healthcare professionals that often cover additional categories of healthcare professionals and are separate and in addition to the federal transparency reporting requirements. We are committed to complying with federal and applicable state laws and regulations today and in the future.
Value of Collaboration
Collaborating with healthcare professionals and healthcare organizations is an integral part of Sanofi’s efforts to develop new medicines and treatments. Working with physicians and non-physician practitioners leads to valuable feedback, improvements in patient care, developments in medical treatment, scientific advancements, and development of new medicines. We collaborate with healthcare professionals in a variety of ways, including: input on the design and running of clinical trials, interpretation of new scientific data, identification of unmet medical needs, publication of clinical trial results in medical journals, and presentation at medical conferences. We believe that when people understand the nature of these relationships, they are better able to understand the value and benefits of such collaboration.
Research & Development of New Medicines
Discovering and development of new medicines and treatments is a lengthy process that spans years and includes multiple clinical trials often involving hundreds or thousands of patients. These studies are required to show that a medicine is safe and effective to treat a particular disease or condition, and to meet the strict approval requirements of the US Food and Drug Administration (FDA) and other regulatory authorities. Conducting clinical studies would not be possible without the involvement of healthcare professionals, clinics, and hospitals. We work with these healthcare practitioners to design trial programs, recruit patients, monitor safety, and report study findings. Such collaboration is critical to make new and effective medicines that advance patient care.
Education of Healthcare Professionals about Health Conditions and Medicines
Healthcare professionals value the opportunity to learn from their peers who have real-life experience with our medicines. To help facilitate this learning, we work with physicians and non-physician practitioners to serve as educators and speakers. Patients and caregivers may also participate in educational sessions with healthcare professionals on the proper use of Sanofi US medicines. We also interact with healthcare professionals and their staff with presentations that may be given by Sanofi US representatives. Through these interactions, healthcare professionals may provide us with insights about patient care, and we share information about our medicines, including the benefits and risks, the diseases they treat, and the appropriate patients.
Sanofi US is committed to funding high-quality, independent educational activities in therapeutic areas of interest to the Company that have the potential to improve patient care and health outcomes. The purpose of an educational grant is to support an independent activity that encourages an educational interchange with respect to available scientific and medical information.
Corporate Giving and Support
Sanofi US supports patient organizations and professional associations in their efforts to advance medical care and improve patient outcomes. Sanofi US is committed to working together with national and community-based organizations to make a difference in patients’ lives. We support programs and initiatives of external, independent, not-for-profit organizations that align with the Sanofi US corporate vision and values. These organizations are generally healthcare-oriented and focus on one or more therapeutic areas in which Sanofi US is actively involved. We view our support through financial contributions as opportunities to establish meaningful collaboration with those whose values we share and whose actions truly drive change.
How Sanofi US Works with Healthcare Professionals
Sanofi US values its relationships with the healthcare professionals we work with and welcomes the opportunity to make a positive impact on patient health without jeopardizing healthcare professional independence or integrity. When consulting on patient treatments or conducting research for Sanofi, their efforts involve time commitments and draw on their professional expertise. Sanofi US compensates healthcare professionals consistent with fair market value and reimburses reasonable expenses incurred in connection with the services. For example, Sanofi US may enter into a collaboration with a healthcare professional for a variety of reasons, including but not limited to: study protocol development and conducting clinical trials, interpretation of new scientific data, identification of unmet medical needs, identification of a need for additional drug development in a particular disease state/condition, and sharing information on diseases and products with other healthcare professionals. Services other than consulting include healthcare professional presentations at disease awareness programs and meetings where an expert speaks to a healthcare professional or patient audience about a disease. When healthcare professionals are required to travel in conjunction with work on behalf of the company, Sanofi US covers reasonable travel expenses, including travel and lodging. When Sanofi US engages with healthcare professionals at in-office meetings during a meal break time, food and beverages may be provided.
Sanofi US has policies and procedures in place to guide the appropriate engagement of healthcare professionals in alignment with industry standards and government regulations.
How Patients Benefit
We believe the scientific exchange between healthcare manufacturers and healthcare professionals is essential to the advancement of medicine and the quality of patient care. Consultant meetings with healthcare professionals can help identify and address potential treatment gaps, as it allows providers and manufacturers to objectively discuss medical information. We also collaborate with thought-leading healthcare professionals on the development of new medicines and treatments. These activities may lead to important medical advances that improve patients’ lives.
Open Payments Reporting
The Patient Protection and Affordable Care Act (ACA) is a US federal statute that requires drug, biologic, device, and medical supply manufacturers to track direct and indirect payments and transfers of value to ‘covered recipients’ defined as US-licensed physicians, non-physician practitioners and teaching hospitals and report them to the federal government’s Centers for Medicare and Medicaid Services (CMS) for public disclosure. The intention of these regulations is to provide transparency in the relationships between the healthcare industry and healthcare professionals.
In addition to US federal laws, there are also several states with laws that impose additional restrictions or requirements on pharmaceutical manufacturers and may cover additional categories of healthcare professionals.
As part of our commitment to transparency and Open Payments regulations, Sanofi US implemented additional control processes for timely, accurate, and complete data collection and developed training programs to further educate employees on Open Payments requirements and policies and procedures.
Sanofi US is committed to reporting data to CMS “Open Payments” that is accurate, complete and timely. We will continue to work with covered recipients on questions they have pertaining to their data.
Reportable Payments and Transfers of Value
Direct (to the covered recipient) and indirect (made to any third party, entity, or non-covered recipient for, or at the request of the covered recipient) payments and other transfers of value provided by manufacturers to physicians, non-physician practitioners and teaching hospitals must be reported to CMS under Open Payments.
Applicable manufacturers are required to identify a nature of payment category for each transfer of value that they report. Similar to other pharmaceutical manufacturers, Sanofi US therefore has associated payments or transfers of value with what we believe to be an appropriate CMS nature of payment. In accordance with CMS guidance, Sanofi US has used the nature of payment category of 'gift' for transactions that do not meet the criteria of the other categories. Please visit the CMS website for additional Open Payments information including FAQs, definitions, and natures of payment categories.
Frequently Asked Questions
- How does Sanofi US ensure the data reported by CMS is accurate?
Sanofi US is committed to providing accurate, complete, and timely data to CMS as part of the Open Payments requirements. We have implemented control processes for data quality prior to submission to CMS. We followed the reporting requirements and procedures established by CMS for submitting data to their site at the time of submission. We work with covered recipients who question any aspect of the data.
- Why does Sanofi US invest so heavily in research?
Before medicines and medical technologies are approved by the US Food and Drug Administration (FDA) for use by patients, they must be tested extensively through clinical trials. This research examines how well potential drugs and treatments may work for patients. Healthcare professional participation is integral to the success of these trials. Physician and non-physician investigators conduct the research, track patient progress, and may participate in reporting the research in peer-reviewed journals. Sanofi US companies compensate investigators according to fair market value for the research being performed and reimburse expenses necessary to the research (e.g., investigator meeting travel).
- Do Sanofi US payments to healthcare professionals influence their prescribing habits?
Sanofi US does not work with or pay physicians or other healthcare professionals to induce or reward prescribing, recommending, or referring our product.
- Why are some payments and transfers of value not associated with a product?
Sanofi US may have discussions with healthcare professionals about general topics, such as a disease states, patient care, or other healthcare issues.
HCP & HCO (Covered Recipient) Q&A
- I am attending a Sanofi event at which food/beverage will be provided. Can I forego the food/beverage?
You can forego partaking in the food/beverage. To record your decision not to consume the Sanofi provided food/beverage, enter your name and signature on the Sanofi sign-in sheet and check the appropriate box in the column, “I will/will not consume the provided food/beverage.”
- I have a question regarding a Sanofi transaction on my Open Payments report. Who can I contact?
Please contact our Transparency team (US.Transparency@sanofi.com).
- I do not recognize a payment listed under my name. What can I do about it?
CMS requires reporting of a wide range of payments and other transfers of value, including some you may not immediately recognize. Examples include:
- You may have received the payment or transfer of value indirectly (made on behalf of Sanofi by a third party, entity, or non-covered recipient for, or at the request of the covered recipient). CMS requires companies to report payments and transfers of value that are received directly or indirectly through a third party.
- You may have received food or beverage at a meeting that our company sponsored. This would be an “in kind” transfer of value under the CMS regulations.
- My report as shown on the CMS website doesn’t match the tax documents I received from the Company. Why?
CMS Open Payments reporting requirements are entirely separate from IRS tax reporting requirements. The transfer of value date reported to CMS may align with the date that the activity took place or the payment date, depending on the nature or purpose of the activity. Please consult your tax advisor with any tax questions you have or our Transparency team with any transparency questions (US.Transparency@sanofi.com).
- I received a transfer of value at an industry event, but the date that is reflected for the reported value transfer does not match the date I received the value.
The dates reported for the value transfer may align with the date that the activity took place or the payment date, depending on the nature or purpose of the activity.
- Once data is published, can I dispute with CMS and can changes be made to CMS reporting?
Please visit the CMS Open Payments website for details related to the dispute process.
- How might I find additional information about Open Payments?
The best place to get the most up-to-date information about Open Payments is the CMS Open Payments website.