California Compliance Disclosure – USA
Updated November 1, 2024
California Compliance Disclosure
This California Compliance Disclosure (“Compliance Disclosure”) is provided pursuant to the requirements of CAL. HEALTH & SAFETY CODE §§ 119400 – 119402, which requires that certain pharmaceutical and medical device companies adopt and make public Comprehensive Compliance Programs (“Compliance Programs”) that govern such companies’ marketing and promotional activities.
Teleflex, Inc. (“Teleflex”), headquartered in Wayne, PA, is a global provider of medical technologies designed to improve the health and quality of people’s lives. Teleflex’s Compliance Program is global in scope and incorporates the highest standards of ethical and legal conduct as expressed in laws, rules and regulations applicable to the many territories in which Teleflex does business. The Compliance Program is primarily structured to follow Office of the Inspector General of the US Department of Health and Human Services (“OIG”) Compliance Program Guidance documents, as well as the Federal Sentencing Guidelines’ Eight Elements of an Effective Compliance Program (endorsed by the OIG and set forth in the sections below). The policies and procedures issued under the Compliance Program are appropriate to Teleflex and are modeled on, and often stricter than, guidance set forth in the AdvaMed Code of Ethics on Interactions with Healthcare Professionals, the MedTech Europe Code of Ethical Business Practice, and various other self-regulatory codes applicable to where Teleflex does business.
The Compliance Program is designed to assist Teleflex in maintaining its reputation of good corporate citizenship and the high levels of trust Teleflex has established in the global marketplace. Teleflex’s Compliance Program aids Teleflex by giving Teleflex personnel specific direction in preventing, detecting and resolving compliance challenges. Teleflex is committed to ensuring that its personnel are trained comprehensively and understand their duties under the Compliance Program.
Teleflex investigates and resolves all reported compliance concerns in a timely manner; reporting compliance concerns is each Teleflex employee’s obligation, and non-compliance with this or any other Compliance Program obligations may result in disciplinary action up to and including termination of employment or contract.
As of the date of this Compliance Disclosure, Teleflex believes that its operations follow its Compliance Program and the provisions of CAL. HEALTH & SAFETY CODE §§ 119400 – 119402.
This Compliance Disclosure is made solely for the purpose of complying with the California law cited above and should not be read in isolation from Teleflex’s other discussions of its compliance related activities and information currently disclosed or disclosed in the future in its public statements, press releases, securities filings, and elsewhere. To see a copy of Teleflex’s Code of Ethics, please click here. Questions regarding Teleflex’s Code of Ethics and/or this Compliance Disclosure may be addressed to Howard Cyr, Corporate Vice President, Chief Compliance Officer at howard.cyr@teleflex.com.
Element 1: Written Policies and ProceduresTeleflex’s written policies and procedures – including the Code of Ethics and policies and procedures Teleflex has put in place and published to its personnel – emphasize individual and corporate responsibility for compliance with all applicable laws and regulations and adherence to the highest ethical standards. All Teleflex personnel worldwide must understand and comply with these obligations, and Teleflex trains its personnel to ensure that they do comply.
The Teleflex Code of Ethics describes Teleflex’s commitment to operate in accordance with accepted standards of business integrity, Teleflex policies, and applicable laws and regulations. Teleflex’s Chief Compliance Officer ensures that the Code of Ethics is regularly reviewed and offers revisions to an ethics and compliance committee composed of the CEO and other senior business leaders responsible for compliance operations.
The Code of Ethics and Teleflex’s compliance policies provide explicit guidance aimed at ensuring the integrity of Teleflex personnel’s relationships with customers and other Health Care Professionals (“HCPs”) across the globe. Teleflex’s compliance policies and procedures closely model the AdvaMed Code of Ethics for Interactions with Health Care Professionals and incorporate appropriate laws and standards of conduct from each jurisdiction in which Teleflex operates or does business (e.g., MedTech Europe, US state laws governing medical device companies, and the UK Bribery Act 2010). Teleflex ensures that legal and compliance-related developments relevant to Teleflex’s business are captured in the policies and procedures and that those foundational documents are revised, published and trained on, as necessary, to maintain compliance with applicable laws.
Consistent with CAL. HEALTH & SAFETY CODE § 119402, Teleflex has established a written $2,500-per-calendar-year limit for promotional spending related to California Health Care Professionals, including meals and educational items. The spending limit, consistent with California statute, excludes the following:
The Teleflex Compliance Program is designed to equip and empower the participation of Teleflex personnel at all levels – from the Board of Directors and Teleflex Leadership to Sales Representatives, Distributors, accountants, engineers, and administrative personnel. Teleflex has also established the executive position, the Chief Compliance Officer, with global responsibility over the Compliance Program. The Chief Compliance Officer manages and oversees the day-to-day operations of the Compliance Program and reports directly to the CEO and Audit Committee of the Teleflex Board of Directors.
Teleflex has also established a Business Ethics and Compliance Committee (“BECC”) that meets once per quarter to review the Compliance Program and advise the Chief Compliance Officer regarding its operation. The Compliance Committee is made up of the CEO, Chief Compliance Officer and leaders of key operational functions within Teleflex, including Legal, Finance, Accounting, Internal Audit, Clinical and Medical Affairs, and Human Resources.
Element 3: Training and EducationAs part of their general compliance training, Teleflex personnel must annually acknowledge and document that they have reviewed the Code of Ethics and the compliance policies and procedures and acknowledge their obligation to carry out their responsibilities in accordance with applicable law and Teleflex policies and procedures.
The Chief Compliance Officer ensures that all Teleflex personnel receive generalized compliance training wherever they are in the world, as well as specialized training relevant to their day-to-day activities. Such training occurs at least annually, with additional training events as necessary for new personnel or to address significant changes in law or industry practices. The Chief Compliance Officer also sends compliance updates to Teleflex personnel as appropriate.
Element 4: Effective Lines of CommunicationTeleflex encourages candid and open communication between management and Teleflex personnel regarding compliance concerns. Teleflex has established (and communicated to personnel) multiple reporting channels, all of which are confidential, which offer personnel the means to report compliance concerns without fear of retaliation. Teleflex not only encourages its personnel to report possible violations of the Code of Ethics, its policies and procedures, U.S. law, or anti-corruption laws, it requires such reporting: Failure to report suspected non-compliance may result in disciplinary action up to and including termination of employment or contract with Teleflex.
Compliance concerns may be directed to numerous managers, supervisors and executives throughout the organization, and are ultimately reported to Teleflex’s Chief Compliance Officer. Teleflex also offers an Ethics Line, which is hosted by an independent third party and is available 24/7. Anyone who has a compliance concern or suspects a potential violation of our policies may report their concern using the Ethics Line phone number provided on internal company resources (i.e. intranet; posters, etc.…) or they may report on-line at http://www.teleflexethicsline.com. Callers may choose to remain anonymous and will be treated as confidential. We maintain and communicate a strict policy of non-retaliation to ensure that no action is taken against anyone who reports, in good faith, actual or suspected misconduct.
Element 5: Auditing and MonitoringThe Chief Compliance Officer ensures audits occur – both formal and informal – to address areas of risk. Based on these potential areas of risk, an annual monitoring and auditing plan is created to include efforts to monitor, audit, and evaluate compliance with the Compliance Program and Teleflex policies and procedures.
Element 6: Enforcement and DisciplineTeleflex Compliance Program documents establish the standards to which personnel are expected to adhere, as well as publish the procedures Teleflex follows in response to any reported or otherwise-suspected improper behavior. Teleflex timely investigates such suspected and/or reported non-compliance and responds promptly with corrective action as appropriate and required, and consistent with Teleflex’s Compliance Program policies and procedures. We track all corrective actions taken in an effort to maintain a consistent approach globally as well as to attempt to identify patterns of behavior.
Element 7: Response and PreventionAs noted above, Teleflex timely investigates suspected and/or reported non-compliance and responds promptly with corrective and preventive actions tailored to address improper actions or prevent potential violations.
Actions in response to detected violations of the Compliance Program or applicable laws, rules or regulations can include, but are not limited to, corrective actions, prevention plans, disciplinary action (up to and including dismissal), revision of Compliance Program documents, and re-training. The Compliance Department works with Teleflex management to ensure that Teleflex personnel who remain with the company successfully complete any corrective action or prevention plans and takes the lead on re-drafting documents and conducting follow-up training, as necessary.
The Chief Compliance Officer reports such investigation outcomes, corrective actions and prevention plans to the CEO and Compliance Committee. Certain matters are also reported to the Teleflex Board of Directors’ Audit Committee, as appropriate.
Element 8: Risk AssessmentTeleflex performs an annual risk assessment that incorporates interviews with key staff to identify risks areas and challenges. Results are presented to senior leadership and the board with a strategy developed to determine internal controls and accountability. Teleflex continuously monitors the top risk mitigation plans and progress and updates are provided to leadership throughout the year.