Federal and State Disclosure Requirements
Spectranetics closely monitors evolving federal and state laws and regulations governing disclosure requirements surrounding our relationships with health care professionals.
California Annual Declaration of Compliance
As part of Spectranetics’ continuing commitment to corporate compliance, Spectranetics declares that, to the best of its knowledge, and based on a good faith understanding of the statutory requirements of California Health and Safety Code sections 119400 and 119402, it has adopted a Comprehensive Compliance Program as mandated by this California law. As of the date of this declaration, Spectranetics believes it is in compliance with its Commercial and Development Comprehensive Compliance Program in all material respects.
Consistent with Spectranetics’ understanding of the California statute, this declaration is limited to those activities undertaken by Spectranetics that are directed to California. Spectranetics makes this declaration, in good faith, in the absence of clarifying regulations or guidance from the State of California. This declaration reflects our consideration of the May 2003 Compliance Program Guidance for Pharmaceutical Manufacturers issued by the United States Department of Health and Human Services Office of Inspector General. This Guidance advances the seven elements of an effective compliance program, now widely recognized throughout the industry, however affords broad discretion to manufacturers in the definition of scope as well as development and design of manufacturer administered compliance programs.
California Transparency in Supply Chain Act of 2010
On Jan. 1, 2012, the California Transparency in Supply Chains Act of 2010 went into effect, requiring retailers and manufactures doing business in California to disclose their efforts in finding and eliminating slavery and human trafficking in their supply chains. This disclosure is intended to provide information to consumers, allowing them to make more informed choices about the products they buy and the companies they support.
We are committed to the performance of our supply chain and the quality of the material and services they convey. As part of that commitment, there are a variety of actions that we undertake to select and monitor the suppliers that partner with us.
Spectranetics utilizes a variety of contracting and administrative instruments to manage our business with others. Manufacturing agreements, quality agreements and purchase order terms and conditions are used to specify not only the physicality of the material we get, but that that it is produced in a manner that meets our values and our Code of Conduct and Ethics policy.
Spectranetics utilizes a thorough Supplier Selection and Evaluation process to ensure we have the right partner for the job. In addition to the right technical, financial, and process capabilities, these suppliers must support our values and may be audited as part of this process.
Spectranetics regularly monitors our suppliers for continuous adherence to quality and process controls. This process also includes audits and on-site inspection by Spectranetics teammates and/or third party auditors as warranted
Spectranetics requires the acceptance of our Terms and Conditions as a prerequisite to send materials and goods to us. This requires the supplier to comply with the laws in the countries in which they do business. Failure to comply is a breach of this contract and will be acted on by Spectranetics.
All Spectranetics agents (including suppliers) must agree to follow the Spectranetics Corporate Code of Conduct and Ethics in order to do business with us. This includes following all local labor laws and rules, including those with respect to wage and hour laws. We do not permit or tolerate child or forced labor in the manufacture of any part of our products.
Spectranetics employs a training system that ensures all Teammates are trained to the specific procedures that apply to their function. All Teammates are required to abide by our Code of Conduct and Ethics. The company’s Corporate Compliance Officer oversees our performance to this procedure and uses tools such as our compliance hot line and periodic audits to ensure we count on each other to maintain and reinforce our Code’s values and standards.