Shire is a specialty pharmaceutical company with a mission to research, develop, and market treatments of rare diseases and a strategic focus to meet the needs of the specialist physician and his or her patients. Shire and its employees are committed to adopting the highest ethical standards in all of its dealings. Shire’s corporate plan to promote these values is detailed in this Comprehensive Compliance Plan (“CCP”).
Shire has appointed a Chief Compliance Officer (“CCO”), who is charged with overseeing the CCP. The CCO is a Senior Vice President of Shire who has direct access and reporting responsibilities to the CEO. The CCO is charged with developing the standards of conduct issued as part of the CCP, directing auditing and monitoring activities, as appropriate, and implementing corrective measures, as necessary.
Comprehensive Compliance Plan
The goal of Shire’s CCP is to prevent, detect, and correct practices or incidents that do not comply with the law or with Shire’s policies. The United States Office of Inspector General’s (“OIG”) voluntary Guidance for Pharmaceutical Manufacturers (“the OIG Guidance”) has been reviewed and will serve as the basis of Shire’s CCP on an on-going basis. The CCP will be designed to address areas of potential problems or high risk, as determined by the CCO.
Shire has created a corporate Code of Ethics. The Code of Ethics has been adopted by Shire’s Board of Directors and applies to all Shire employees, including officers and directors. While Shire is not a member of the Pharmaceutical and Research Manufacturers of America (“PhRMA”), Shire has implemented the PhRMA Code on Interactions with Healthcare Professionals. Shire and its CCO have developed and implemented written policies based on the OIG Guidance, as appropriate. All of Shire’s personnel are expected to comply with the code of Ethics, the PhRMA code, and all compliance policies, as they might be applicable to their activities.
Shire is committed to developing and providing effective compliance training for all of its employees, not only on the elements of the compliance plan, but also on the pertinent federal and state standards. Shire will periodically conduct internal auditing and monitoring to evaluate compliance with company policies.
Shire has established internal lines of communications, and encourages all employees to promptly report any concerns that they may have regarding violations of the Code of Ethics or the CCP. Concerns may be reported anonymously through the Compliance Helpline +1 866 747 4473, or directly to the CCO, any manager, the HR Department, a member of the Executive Committee, or the Group General Counsel and Company Secretary.
Shire, and the CCO will evaluate and investigate all reports, as appropriate. When appropriate, corrective disciplinary action will be imposed, without regard to the employee’s level within the organization.
Shire may revise and amend the CCP at any time.
SB 1765 Declaration
California law SB 1765, codified at California Business and Professions Code, Sections 119400 to 119402 (“the California law”), requires all pharmaceutical companies to adopt a comprehensive compliance plan based upon the OIG Guidance and the PhRMA Code. Under the California law, a pharmaceutical company must also annually declare that it is in compliance with its own comprehensive compliance plan and the requirements of the Sections 119400 to 119402. A pharmaceutical company must make its comprehensive compliance plan and its annual declaration of compliance available to the public on its website and through a toll-free number. We understand the California statute only imposes obligations for activities directed to California.
Shire declares that to the best of our knowledge, and based on a good faith understanding of the California statute, as of this date, Shire is in compliance with the Compliance Program described above. Ensuring ethical and legal conduct is an ongoing company commitment. The Compliance Program is intended to be a dynamic program to meet the company’s evolving compliance needs and expectations. Therefore, Shire will continue to develop and refine its Compliance Program.
Annual Spending Limit
The California law requires pharmaceutical companies to voluntarily adopt a specific annual dollar limit on gifts, promotional materials, or items or activities that the pharmaceutical company and its employees and representatives may give or otherwise provide to an individual medical or health care professional in California. The limit does not include amounts attributable to drug samples, financial support for continuing medical education, or payment for legitimate professional services. Shire has adopted an annual spending limit.
Shire’s annual spending limit shall be $2000. This limit is neither an average spending limit, nor a targeted spending limit, and Shire believes that its actual spending will fall short of this limit. The annual limit may be revised from time to time.