california compliance

A. Introduction

Bluebird Bio, Inc. (“Bluebird”) is pursuing gene therapies to give patients and their families more bluebird days. With a dedicated focus on severe genetic diseases including but not limited to sickle cell disease, β-thalassemia and cerebral adrenoleukodystrophy, we custom design each of our therapies to address the underlying cause of disease and have developed in-depth and effective analytical methods to understand the safety of our lentiviral vector technologies and drive the field of gene therapy forward.

Bluebird’s Code of Business Conduct and Ethics (“Code”) reflects our commitment to conducting business with high standards of ethical behavior. The Code is applicable to all Bluebird employees, directors, and officers.

Bluebird is committed to establishing and maintaining an effective compliance and ethics program that promotes conducting business with integrity and complying with the laws applicable to Bluebird and its operations. Our compliance and ethics program is based on the elements described in the "Compliance Program Guidance for Pharmaceutical Manufacturers" issued by the Office of Inspector General of the U.S. Department of Health and Human Services (the "OIG Guidance") and the "Code of Ethics on Interactions with Healthcare Professionals" issued by the Pharmaceutical Research and Manufacturers of America (“PhRMA Code”).

Bluebird’s compliance and ethics program is designed, implemented and operated with the goal of preventing, detecting and responding to potential or actual instances of non-compliance. All Bluebird employees are required to comply with the Code of Conduct, company policies, and applicable laws. However, as acknowledged by the OIG Guidance, the implementation of a comprehensive compliance program does not guarantee that there will be no misconduct. If Bluebird becomes aware of potential violations of law, the Code of Conduct or company policy, the matters are investigated. As appropriate, disciplinary and corrective actions are implemented to prevent future violations. Additionally, Bluebird continuously assesses the effectiveness of its compliance program to enable it to implement necessary adjustments or refinements to the program.

Following is an overview of Bluebird’s comprehensive compliance and ethics program which is reviewed and updated periodically to meet changing regulatory, legal and compliance requirements.

Leadership and Oversight

Bluebird has a Chief Compliance Officer who is responsible for developing, operating, and monitoring the compliance and ethics program. The Compliance Officer reports directly to the Chief Legal Officer. Bluebird’s Compliance Officer has the ability to effectuate change within the organization and to exercise independent judgment.

Bluebird has established a Compliance Committee designed to provide leadership and support for the company’s compliance and ethics program, assist Bluebird’s leadership team in managing the compliance and ethics program, and to provide assistance and guidance in assessing and verifying the effectiveness of the compliance and ethics program to promote our ethical business culture and compliant operating environment. The members of the Compliance Committee are senior leaders from multiple business functions. The Compliance Committee meets on a regular basis to monitor Bluebird’s comprehensive compliance and ethics program.

Written Standards

In addition to the Code, Bluebird has developed and implemented compliance policies and procedures to help ensure compliance with applicable laws and to support ethical decision-making. These policies and procedures have been developed under the direction and supervision of the Chief Compliance Officer and Compliance Committee. Bluebird’s written standards address the key areas of potential risk for medical device manufacturers identified in the OIG Guidance. All Bluebird employees, officers, and directors are required to adhere to the company’s policies and procedures.

Bluebird’s relationships with healthcare professionals are intended to benefit patients. Informational presentations and discussions by employees or those speaking on behalf of Bluebird provide valuable scientific and educational benefits. In connection with such presentations or discussions, Bluebird may offer occasional meals in accordance with the PhRMA Code.

With respect to business activities in California, Bluebird has established "a specific annual dollar limit on educational items and promotional activities Bluebird may give or otherwise provide to an individual medical or healthcare professional." Bluebird has established an annual maximum dollar limit of $1,500, effective as of January 1, 2022. Bluebird will evaluate this limit on an annual basis and make any necessary adjustments consistent with any operational or practical issues related to compliance with the statute. The annual limit does not include expenditures for the following:

Financial support for continuing medical education programs
Financial support for health educational scholarships
Payments for legitimate professional services, and any meals or expenses associated with the provision of such services
Patient educational materials provided to patients by their physician with the purpose of educating the patient or enhancing the patient’s understanding or management of the condition

Education and Training

All Bluebird commercial employees receive appropriate compliance training which includes education on the OIG Guidance, the PhRMA Code, anti-kickback laws and anti-corruption, the federal False Claims Act, and requirements related to product promotion, privacy, conflicts of interest, and other applicable federal, state, and industry rules and guidelines. Bluebird regularly reviews and revises its compliance training and seeks to identify new areas of training that may be needed to educate employees on compliance matters and the laws and requirements applicable to Bluebird.

Internal Lines of Communication

Bluebird encourages open communication and maintains an open reporting environment. The company has adopted and reinforces its policy against retaliation. Bluebird’s Code and policies require employees to report any actual or suspected violations of the Code, company policies or applicable law. Each reported matter is appropriately investigated and addressed. Employees can raise concerns or report potential misconduct in a number of ways including managers and business leaders; the Compliance, Legal or People and Culture teams; or the third-party operated hotline. Employees may raise concerns without fear of retaliation. In addition, Bluebird’s Compliance compliance-related policies, guidance and information can be found on the Company’s internal website which all employees have access to.

Auditing and Monitoring

Bluebird’s compliance and ethics program includes auditing and monitoring activities to assess whether policies and procedures which address compliance risk areas have been implemented, communicated and are followed. The areas for monitoring and auditing are reviewed and updated to reflect evolving compliance concerns, new regulatory requirements, changes in business practices, and other considerations. The results of auditing and monitoring activities are considered in adapting and improving existing compliance policies, procedures and training.

Responding to Potential Violations

Employees are required to adhere to the Code and company policies. Any violations can subject an employee to serious disciplinary measures, including possible termination of employment. Although the disciplinary and corrective actions for each situation are determined on a case-by-case basis, Bluebird seeks to ensure consistent and appropriate disciplinary and corrective actions are taken in response to violations.

Corrective Action

Bluebird conducts investigations of potential violations of the Code and company policies in accordance with its written investigations and corrective action protocol to ensure timely, complete, and objective investigations. In accordance with the OIG Guidance, the exact nature and level or thoroughness of the internal investigation will vary according to the circumstances. Once an internal investigation is completed, corrective action and preventative measures are determined and implemented as appropriate.

This description is effective as of January 1, 2024. Bluebird will assess its compliance program at least annually, for the purpose of declaring compliance with California Health and Safety Codes §§ 119400-119402.

California Declaration of Compliance

Bluebird Bio, Inc. (“Bluebird”) is committed to establishing and maintaining an effective compliance and ethics program that promotes conducting business with integrity and complying with the laws applicable to Bluebird and its operations. Based on a good faith understanding of the requirements of Section 119402 of the California Health & Safety Code, Bluebird hereby declares that, to the best of its knowledge, as of January 1, 2024, Bluebird is in material compliance with its comprehensive compliance and ethics program and the requirements of the California Health & Safety Code §§ 119400-119402. It is Bluebird’s expectation that all employees and representatives comply with its compliance and ethics program and all policies that support this program. Bluebird is committed to assessing ongoing compliance with its compliance program, which is designed to prevent, detect and respond to potential or actual instances of non-compliance.

A copy of this Declaration may be obtained by contacting Bluebird at 1-833-999-6378.