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Biogen 

Comprehensive Compliance Program

 

(As required by the California Health & Safety Code section 11904) 

 

 

Biogen’s goal is to create advances in human healthcare through our pioneering research, 

development, manufacturing and commercial capabilities. Biogen is committed to meeting this 

goal while maintaining the highest level of integrity and ethical behavior in the conduct of our 

business. To this end, Biogen’s Code of Business Conduct is available to the public through its 

posting on this website.   

 

To conduct our business with integrity and ethically, Biogen has established and maintains a 

compliance program. This program has been developed in accordance with the laws applicable to 

our industry and the “Program Guidance for Pharmaceutical Manufacturers” published by the 

Office of the Inspector General of the U.S. Department of Health and Human Services (“OIG 

Guidance”). Moreover, the Pharmaceutical Research and Manufacturers of America, the 

pharmaceutical industry’s trade group, voluntarily adopted its own “Code on Interactions with 

Healthcare Professionals” known as the “PhRMA Code.” Biogen’s compliance program requires 

compliance with the PhRMA Code, which addresses topics such as informational presentations 

by the Company, third party continuing education and professional meetings, use of consultants 

and speakers, as well as restrictions on the provision of gifts and financial incentives to 

healthcare professionals.  

 

Consistent with the OIG Guidance, Biogen’s compliance program includes:  



 

Written standards of conduct, policies, and practices that verbalize the company’s 

commitment to compliance and set forth the ethical and compliance principles applicable 

to all employees.  



 

A compliance officer and compliance committees charged with the responsibility for 

operating and monitoring of the compliance program and with authority to report directly 

to the board of directors and the company’s president and chief executive officer.  



 

Regular education and training programs for all applicable employees.  

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

 

Line of communication between the compliance officer and all employees, including a 

process to receive complaints and ask questions (a hotline).  



 

Policies and practices to protect the anonymity of employees who make complaints and 

prohibit retaliation against complainants.  



 

Use of audits and other techniques to monitor compliance and identify and address of 

risk.  



 

Enforcement of compliance obligations through guidelines that include penalties for non-

compliance.  



 

Mechanisms to promptly and properly investigate and respond to reports of non-

compliance, including processes to initiate corrective measures and to report offenses to 

the relevant government authorities where appropriate.  



 

Written compliance materials that address specific areas of potential fraud and abuse, 

including risk areas relating to:  

o

 

The integrity of company-generated data that is used for government 

reimbursement purposes.  

o

 

Prohibition of kickbacks and illegal remuneration to persons or entities in a 

position to generate federal health care business for the company, either directly 

or indirectly.  

o

 

Compliance with laws regulating drug samples.  

 

In addition, Biogen has adopted policies and practices that govern the full arena of interactions 

with healthcare professionals. These policies prohibit illegal remuneration in violation of federal 

and state anti-kickback statutes and incorporate compliance with the PhRMA Code as a key 

element, including appropriate:  



 

Support for medical education, as well as the use of healthcare professionals to provide 

services to the Company as researchers, consultants and speakers.  



 

Provision of business courtesies.  



 

Making of grants and charitable contributions so that such funds are not conditioned, 

express or implied, on any agreement to prescribe, purchase, recommend, influence or 

provide favorable formulary status for any Biogen product.  



 

Promotion of Biogen products in compliance with the U.S. Food and Drug 

Administration’s regulatory framework regarding promotion of pharmaceutical products.  

 

As required by California Health & Safety Code section 119402, with specific reference to the 

provision of “gifts, promotional material, or items or activities” that a pharmaceutical company 

may provide to an individual medical or healthcare professional, the Company has established an 

aggregate dollar limit of $1,500.00 on applicable gifts, promotional material, or items or 

activities for each medical or healthcare professional in the State of California for the 12-month 

period beginning July 1, 2014. Drug samples intended for free distribution to patients, financial 

support for continuing medical education forums, financial support for health education 

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scholarships, and payments for professional services are exempt from this limit pursuant to 

section 119402. The dollar limit is a maximum only. 

  

To the best of our knowledge, as of July 1, 2015, Biogen is in material compliance with its 

Comprehensive Compliance Program and the requirements of the California Health & Safety 

Code section 119402.  

 

To obtain a copy of the certification please call the Compliance Helpline at 866-418-2859