The Shire Corporate Integrity Agreement (CIA) is a contract between Shire Pharmaceuticals and the US government that was signed in 2014. The agreement was put in place to ensure that Shire operates in compliance with all federal laws and regulations, especially those governing the marketing and promotion of pharmaceutical products.
The CIA is an important tool for monitoring and regulating the behavior of pharmaceutical companies, which have been known to engage in illegal and unethical practices in the past. The agreement requires Shire to implement a comprehensive compliance program, including training for employees and monitoring of compliance efforts.
One of the key provisions of the CIA is the requirement for Shire to establish a hotline for reporting potential violations of the law or the company`s code of conduct. This hotline is available to employees, vendors, and anyone else who has concerns about Shire`s behavior. The company is also required to report any suspected violations to the government within 30 days.
In addition, the CIA requires Shire to disclose its financial relationships with healthcare providers. This includes payments made to doctors, hospitals, and other healthcare organizations for research, consulting, and other services. The goal is to ensure that these relationships are transparent and not influenced by improper financial incentives.
The Shire CIA is an important step in promoting transparency and ethical behavior in the pharmaceutical industry. By requiring companies to operate in compliance with federal regulations, the agreement helps to protect consumers and maintain the integrity of the healthcare system. In addition, it provides a framework for monitoring and enforcing compliance, which can help to prevent future violations and misconduct.
Overall, the Shire Corporate Integrity Agreement is an important tool for promoting corporate responsibility and transparency in the pharmaceutical industry. It provides a framework for monitoring and enforcing compliance, while also promoting ethical behavior and accountability. By complying with the terms of the agreement, Shire is helping to maintain the trust and confidence of its customers, shareholders, and the public at large.