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Overview of compliance program
Maureen Rogers, General Counsel and a member of the Novartis V&D Executive Committee, serves as the Chief Compliance Officer, and maintains overall responsibility for the global Novartis V&D Integrity and Compliance program. Ms. Rogers reports directly to Andrin Oswald, CEO of Novartis V&D.
Mark Dizon is the designated senior-level official serving as the Executive Director of Integrity and Compliance with daily responsibility for developing, operating and monitoring the Novartis V&D Integrity and Compliance Program.
Mr. Dizon reports directly to Ms. Rogers and either can be reached at nvd.integritycompliance@novartis.com
Mr. Dizon and Ms. Rogers have regular and direct access to present integrity and compliance issues to the Novartis V&D Executive Committee and CEO, and as such, have the ability to effectuate change within the organization as necessary and to exercise independent judgment.
Novartis V&D has established an Integrity and Compliance Department and uses various forums and a broader network of Compliance Officers and Liaisons to assist in the implementation and maintenance of the program.
Novartis V&D's code of conduct is an expression of the company's expected standards of behavior for everyone who conducts business on behalf of the Company. The Code establishes compliance responsibilities, supports applicable laws and regulations, and reinforces organizational policies and procedures. The Code articulates our fundamental principles, values and framework for action within our organization. Novartis V&D policies, together with business unit procedures, address potential areas of risk including, but not limited to, those identified in the HHS-OIG Guidance such as data integrity pertaining to government reimbursement practices, kickbacks, and other illegal remuneration.
We do not permit gifts, promotional materials, items or activities prohibited by the relevant marketing ethics codes (i.e. the IFPMA Code of Pharmaceutical Marketing Practices, EFPIA European Code of Practice on the Promotion of Medicines, PhRMA Code on Interactions with Healthcare Professionals, the AdvaMed Code of Ethics on Interactions with Healthcare Professionals, and the European Diagnostic Manufacturers Association Code of Ethics), U.S. state law requirements, or the HHS-OIG Guidance. For items and activities that are not prohibited, we have set a cumulative annual spending limit of $2500 per health care professional. These items and activities consist of:
- Occasional modest meals given in conjunction with informational educational presentations and discussions that provide educational and scientific value and,
- items that are for the education of patients and health care professionals as defined by applicable marketing ethics codes.
A critical element of our Integrity and Compliance Program is the education and training of our employees on their legal and ethical obligations under applicable health care program requirements. We are committed to taking necessary steps to effectively communicate our standards and procedures to all affected personnel. Moreover, we will regularly review and update our training programs, as well as identify additional areas of training on an "as needed" basis.
Novartis Vaccines and Diagnostics is committed to encouraging dialogue between management and employees. Our goal is that all employees, when seeking answers to questions or reporting potential instances of fraud and abuse, should know to whom to turn for a meaningful response and should be able to do so without fear of retribution. To that end, we have adopted principles regarding confidentiality and policies prohibiting retaliation as well as a helpline to which issues may be reported anonymously. Employees are expected to report suspected violations of company policy by calling the Novartis V&D Integrity Helpline or by contacting the Novartis Business Practices Officer by e-mail.
(866) 381-4321
We have instituted an Integrity and Compliance Program that includes efforts to monitor, audit, and evaluate adherence to the company's compliance activities. We note that in accordance with the HHS-OIG Guidance, the nature of our reviews as well as the extent and frequency of our compliance monitoring and auditing varies according to a variety of factors, including new regulatory requirements, changes in business practices, and other considerations.
Although, HHS-OIG recognizes that even an effective compliance program may not prevent all violations, our Integrity and Compliance Program strives to ensure that all violations of the law or company policy are identified and that proper corrective actions are taken to ensure that future incidences of non-compliance can be prevented. As such, our Integrity and Compliance Program requires the company to evaluate each case and respond promptly to potential violations of law or company policy, take appropriate disciplinary action, assess whether the violation is in part due to gaps in our policies, practices, or internal controls, and take action to prevent future violations. Moreover, continuous efforts are underway to create compliance systems that address evolving industry and regulatory standards and which aim at deterring unlawful and unethical behavior.
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