Blueprint Medicines’ Comprehensive Compliance Program
Our Program includes the following elements designed to prevent, detect and remediate violations of law, regulations and company policies.
Oversight and Governance
Blueprint Medicines has a Chief Compliance Officer who has overall responsibility for the Program. The Chief Compliance Officer has direct access to our Chief Executive Officer and makes reports to the Board of Directors concerning our Program. We have also appointed a Compliance Committee to advise and assist our Chief Compliance Officer with oversight of our Program.
Written Policies, Procedures and Standards of Conduct
Blueprint Medicines has written and communicated policies and procedures to, among other things, address potential risk areas for pharmaceutical manufacturers including those identified in the Compliance Program Guidance for Pharmaceutical Manufacturers issued in 2003 by the Office of the Inspector General of the Department of Health and Human Services (“OIG Guidance”). We have a Code of Business Conduct and Ethics (“Code”) that guides us in making ethical and legal decisions when conducting Blueprint Medicines business and performing day-to-day duties. The Code has been made available to all employees via our internal website and upon arrival to the company.
Education and Training
Education and training are essential to effectively communicate our standards and requirements to all employees and enable their performance in accordance with them. All Blueprint personnel, agents and contractors acting on Blueprint Medicines’ behalf (collectively “Blueprint Medicines Personnel”) are provided training on compliance policies, procedures and guidelines applicable to their job functions.
Open and Effective Lines of Communication
Blueprint Medicines is committed to fostering an environment where employees feel comfortable and encouraged to speak up and raise compliance-related concerns or questions. Additionally, Blueprint Medicines Personnel can contact the Compliance and Ethics Hotline anonymously, 24 hours a day, 7 days a week at Blueprintmedicines.ethicspoint.com or 844-857-5642. Employees are provided information regarding the hotline during new hire training, ongoing compliance training and via our intranet. Our Code expressly prohibits retaliation against any employee who makes a good faith report of based suspected misconduct.
Auditing, Monitoring and Responding to Potential Violations
The Program includes activities designed to monitor and audit compliance with our policies and procedures. We review our compliance-related monitoring and auditing activities on a regular basis to help ensure that significant compliance-related risks are appropriately addressed. We believe that our Program increases the likelihood of preventing or identifying unlawful and unethical behavior. We recognize, however, that even an effective compliance program will not prevent all violations. Our Program, therefore, requires the company to investigate and respond promptly to potential violations of law or policy, take appropriate disciplinary action as warranted, assess whether the potential violation may be due to gaps in our policies, practices or internal controls, and, if so, take appropriate corrective action to prevent or limit future violations.
State of California Compliance Program Declaration
In accordance with the requirements of California Health & Safety Code §§ 119400-119402, we have established an annual dollar limit of $3,000 for certain spending on individual medical or healthcare professionals licensed in California. We include in this dollar limit the value of educational items and meals provided to healthcare professionals in connection with business and educational discussions with those individuals. The annual spending limit set forth in this declaration does not include grants for medical education or research, sponsorships or fair market value payments for professional services.
This dollar limit represents a spending maximum and not an average or goal. We reserve the right to change this limit at any time.
We also adhere to global transparency laws and regulations, including Section 6002 of the Patient Protection and Affordable Care Act, which requires us to report payments and transfers of value made to certain healthcare professionals and teaching hospitals.
To the best of our knowledge and based on our good faith understanding of the statutory requirements, we declare that we are in compliance with our Program and the requirements of California Health & Safety Code §§ 119400-119402 in all material respects.
This declaration is not intended and should not be construed to imply that we have not identified any instances in which Blueprint Medicines Personnel has or may have violated one or more provisions of our Program. In such situations, we take reasonable and appropriate remedial or corrective actions in a manner consistent with our Program.
Copies of this declaration and a description of our Program may be obtained by contacting our Compliance Department at Compliance@blueprintmedicines.com or by calling Blueprint Medicines’ compliance hotline, operated by a third-party provider, at 844-857-5642. Please state that you are requesting a printed copy of Blueprint Medicines’ Annual Declaration of Compliance and provide your contact information, including your first name and last name, your email address or home address, and your phone number.
Updated as of July 1, 2023Download as PDF