Procedures and Standards of Conduct for Employees
At Shire, integrity is central to everything we do. We earn and maintain the trust of patients, customers and the healthcare community by demonstrating ethics in our daily decision making. In Shire’s pursuit for excellence on behalf of patients, caregivers and healthcare professionals, Shire colleagues must achieve results the right way, doing business in compliance with our policies, procedures and legal requirements. As such, we adopted the fundamental principles from the U.S. Department of Health and Human Services Office of Inspector General (HHS-OIG) Compliance Program Guidance. In addition to the HHS-OIG Guidance, we also comply with the European Federation of Pharmaceutical Industries and Associations (EFPIA) Code of practice on relationships between pharma and patient organisations.
While Shire is not a member of the Pharmaceutical and Research Manufacturers of America (“PhRMA”), Shire complies with the principles of the PhRMA Code in its interactions with healthcare professionals and its guidelines on advertising and promotion. Shire also abides by U.S. state laws that require adoption of a state-developed code of conduct that applies to interactions with certain healthcare professionals and institutions in a particular state.
As required by California Health & Safety Code §§ 119400 et seq. ("California Law") also known as CA S.B. 1765, Shire has established an annual limit of $2000 for certain expenditures to licensed healthcare professionals in California.
Shire hereby declares that it is in substantial compliance with both its own compliance program as well as CA SB 1765. Since compliance is best achieved through ongoing efforts, Shire continues to develop, review and periodically enhance its many ongoing compliance programs. A copy of this document and/or Shire's written declaration of compliance can be obtained by sending an email to ShireGlobalCompliance@shire.com
All Shire colleagues must adhere to the company's written policies and procedures, including the Shire Code of Ethics and a global policy related to interactions with the healthcare community and government officials. This interactions policy establishes the requirements for providing grants to support medical/scientific research and medical education, engaging consultants for services and making charitable donations and/or corporate sponsorships to customers and non-customers alike. Shire’s commitment to doing business with integrity extends to its contractors, agents and suppliers as described in the Shire Code of Ethics.
Shire colleagues are responsible for the integrity of their own work. Upon hire, and annually thereafter, each colleague must acknowledge receipt of our Code of Ethics and confirm that they understand and will comply with these standards. Our Code of Ethics emphasizes the importance of applying the company’s ethical principles and commitment to compliance in its employees’ decision-making process, and ultimately behavior. It also provides a channel for colleagues to raise questions and resolve issues.
Since Shire’s Code of Ethics and the supporting policies and procedures may change from time to time, Shire colleagues are responsible for knowing and complying with the current laws, rules, regulations, standards, policies and procedures that govern their work. Shire colleagues are also individually responsible for reporting wrongdoing. If a law or company policy has been broken, employees are required to report it promptly. If a Shire colleague fails to comply with applicable laws, rules, regulations, standards, policies and procedures, he or she risks being disciplined or terminated. If a Shire colleague breaks the law, he or she may also be personally liable.
Shire managers are responsible for maintaining an ethical climate.
Every Shire manager must:
- Explain to their employees why it's important to comply with our Code of Ethics.
- Encourage discussion of the Code and situations in which it applies in day-to-day activities.
- Respond promptly and properly to concerns raised by employees.
- Protect employees against reprisals when they report, in good faith, actions they feel violate the law or Shire’s values, standards or policies.
- Ensure that significant ethics and compliance issues are shared with Shire’s investigations team.
Education and Training
Shire’s Code of Ethics requires compliance with laws, regulations and internal policies that govern how the company works. In order to reinforce the company's standards and help employees understand the policies and regulations, Shire offers compliance training for colleagues across a variety of topics and in various formats.
Compliance training enables our colleagues to perform with integrity by helping colleagues understand the legal and regulatory implications of their actions. Shire provides risk-specific training to appropriate colleagues, reinforced with guidance from the compliance team and other resource guides to facilitate compliance.
Shire maintains e-learning programs discussing preventing discrimination, federal government ethics, global privacy principles, healthcare fraud and abuse, data integrity, electronic media use, and Foreign Corrupt Practices Act, among others. Making courses available electronically, in multiple languages, makes them more accessible to more employees, improves productivity and fosters consistency across the company. E-learning enables appropriate compliance training across the world to meet the ever-changing requirements of legislative and regulatory bodies.
E-learning complements training efforts in other areas such as good manufacturing practices, environment, health and safety, and quality. The goal is to give Shire employees the understanding and tools needed to comply with all necessary laws and regulations wherever they are based and wherever Shire does business. The training content is evaluated and updated periodically to ensure it remains relevant and current.
Communications and Reporting
Shire strives to develop a culture that produces conscientious and ethically-minded employees who are committed to integrity, honesty, openness and fairness. Shire encourages colleagues to raise issues and open communications about any concern. To support these concepts, Shire has established the following resources.
The Compliance Decision Guide – 4P Test – helps colleagues think through situations to decide on the most appropriate course of action, consistent with Shire’s Code of Ethics, values and expected behaviors. The questions within the 4P Test about policy, purpose, process and perception will guide colleagues on whether or not actions are appropriate.
Shire has a number of resources available for those who are seeking information about, or guidance on, the company's Code of Ethics or, who wish to report a potential violation of the standards. This process encourages colleagues, as a first step, to seek out local management or other resources for assistance in handling their inquiry. Alternative contacts are available to employees, including Regional Compliance Officers, the Global Compliance team or Corporate Responsibility Office resources.
Shire’s EthicsPoint Helpline, a telephone and web resource, is available to colleagues, their families, suppliers and customers as another channel to report or seek guidance on issues. This Helpline has the ability to connect counselors 24-hours a day, seven days a week in almost any language.
Employees, customers, suppliers and other Shire constituencies may use the Helpline to seek guidance, discuss concerns or report issues relative to Shire's Code of Ethics. Persons calling the Helpline may choose to remain anonymous.
No Retaliation Policy
Shire colleagues may never punish nor retaliate against anyone for raising a good-faith question or concern about compliance with policy or legal requirements. Shire enforces a non-retaliatory environment, making it safe for employees and other stakeholders to raise ethics and compliance concerns in good faith. Shire’s non-retaliation policy is actively supported by Shire’s senior management and is strictly enforced.
Upon receipt of reasonable indications of suspected noncompliance, the Compliance Assurance team, along with other Shire colleagues, as appropriate, will investigate the allegations to determine whether a material violation of the applicable laws, regulations or policies has occurred, and advise as to the appropriate steps to correct the problem.
Monitoring and Auditing
Shire’s Compliance team is responsible for prioritizing, commissioning and conducting compliance assessments and audits to evaluate Shire compliance programs and assist in ensuring compliance with applicable legal, regulatory, and industry requirements, Shire policies, control and process requirements and ethical standards. These are conducted with the assistance of internal resources, such as Internal Audit, and external resources, such as outside counsel and external auditors.
The Compliance team is also responsible for the design and implementation of the company’s compliance monitoring program which includes some ongoing compliance testing performed by business and country management.
Enforcing Standards/ Hiring and Disciplinary Action
Shire is committed to hiring a workforce whose actions reflect a high degree of integrity and ethics. Accordingly, Shire conducts background checks on potential employees and is developing other measures to ensure that it does not employ or do business with persons or organizations that have been excluded, debarred, suspended or are otherwise ineligible to participate in Federal healthcare programs. Shire has committed significant resources in hiring highly qualified and skilled individuals. Additionally, Shire requires all new hires to receive and sign its Code of Ethics.
If, after all investigations of potential wrongdoing are completed, any employee who is in intentional and material violation of applicable laws, rules, regulations or corporate policies will be subject to appropriate disciplinary corrective action up to and including termination. Although each situation is evaluated on a case-by-case basis, Shire consistently undertakes appropriate disciplinary action to address inappropriate conduct and deter future violations.
Correction and Preventative Action
Shire is committed to preventing and detecting violations of law or internal policies and procedures and taking appropriate corrective actions as necessary. Shire's ethics and compliance program is designed to ensure that potential violations of law or company policy are responded to promptly, appropriate disciplinary action is taken, and evaluation is given to prevent future violations.