California Compliance Disclosure
Baylis Medical Technologies Inc. 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 medical device companies adopt and make public Comprehensive Compliance Programs (“Compliance Programs”) that govern such companies’ marketing and promotional activities.
Baylis Medical Technologies Inc. (“Baylis”), headquartered in Mississauga, Ontario, Canada, is a global provider of medical technologies designed to improve the health and quality of people’s lives. Baylis’ 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 Baylis does business. The policies and procedures issued under the Compliance Program are appropriate to Baylis and are modeled on guidance set forth in the AdvaMed Code of Ethics on Interactions with Healthcare Professionals, the MedTech Canada Code of Conduct, the MedTech Europe Code of Ethical Business Practice, the UK Bribery Act, the Foreign Corrupt Practices Act, the Anti-Kickback Statute, the Sunshine Act, and various other statutory provisions and regulatory codes applicable to where Baylis does business.
The Compliance Program is designed to assist Baylis in maintaining its reputation of good corporate citizenship and the high levels of trust Baylis has established in the global marketplace. Baylis’ Compliance Program aids Baylis by giving Baylis personnel specific direction in preventing, detecting and resolving compliance challenges. Baylis is committed to ensuring that its personnel are trained comprehensively and understand their duties under the Compliance Program.
Baylis investigates and resolves all reported compliance concerns in a timely manner; reporting compliance concerns is each Baylis 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, Baylis 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 Baylis’ 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. Questions regarding Baylis’ Code of Ethics and/or this Compliance Disclosure may be addressed to the company’s Compliance Officer at firstname.lastname@example.org.
Element 1: Policies, Processes, and Procedures
Baylis’ written and unwritten policies, processes, and procedures – including the Code of Ethics and policies and procedures Baylis has put in place and published to its personnel – emphasize individual and corporate social responsibility for compliance with all applicable laws and regulations and adherence to the highest ethical standards. All Baylis personnel worldwide must understand and comply with these obligations, and Baylis trains its personnel to ensure that they do comply.
The Baylis Code of Ethics describes Baylis’ commitment to operate in accordance with accepted standards of business integrity, Baylis policies, and applicable laws and regulations. Baylis’ Compliance Officer ensures that the Code of Ethics is regularly reviewed, and that appropriate stakeholders are consulted when required.
The Code of Ethics and Baylis’ compliance policies provide explicit guidance aimed at ensuring the integrity of Baylis personnel’s relationships with customers and other Health Care Professionals (“HCPs”) across the globe. Baylis’ compliance policies and procedures closely model the standards set out by the AdvaMed Code of Ethics for Interactions with Health Care Professionals, the Medtech Canada Code of Conduct, and the Medtech Europe Code of Ethical Business Practice. Baylis’ policies also incorporate appropriate laws from each jurisdiction in which Baylis operates or does business (US federal and state laws governing medical device companies, and the UK Bribery Act 2010). Baylis ensures that legal and compliance-related developments relevant to Baylis’ 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, Baylis routinely updates its limits and guidelines for promotional materials, items and/or promotional activities provided to California licensed health care professionals, based on our evolving compliance needs. For information regarding our limits, please contact the Compliance Department at email@example.com.
Element 2: Leadership and Structure
The Baylis Compliance Program is designed to equip and empower the participation of Baylis personnel at all levels, as well as distributors. The Compliance Officer manages and oversees the day-to-day operations of the Compliance Program and reports to the President of Baylis Medical.
Employees in Baylis’ Legal Department are responsible for routinely reviewing the Compliance Program and advising the Compliance Officer regarding its operation. The Legal Department works with stakeholders such as the Sales and Marketing Departments to ensure the most effective implementation of the Compliance Program.
Element 3: Training and Education
As part of their general compliance training, Baylis personnel must 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 Baylis policies and procedures.
The Compliance Officer ensures that all Baylis personnel receive generalized compliance training wherever they are in the world, as well as specialized training relevant to their day-to-day activities. Additional training may be required for specific departments, new personnel, or to address significant changes in law or industry practices. The Compliance Officer also sends compliance updates to Baylis personnel as appropriate.
Element 4: Effective Lines of Communication
Baylis encourages candid and open communication between management and Baylis personnel regarding compliance concerns. Baylis 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. Baylis 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 Baylis.
Compliance concerns may be directed to numerous managers, supervisors and executives throughout the organization, and are ultimately reported to Baylis’ Compliance Officer. Baylis also offers an email account to receive, address, and respond to complaints. Anyone who has a compliance concern or suspects a potential violation of our policies may report their concern using these avenues. 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 Monitoring
The Legal Department 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 Baylis policies and procedures.
Element 6: Enforcement and Discipline
Baylis Compliance Program documents establish the standards to which personnel are expected to adhere, as well as publish the procedures Baylis follows in response to any reported or otherwise-suspected improper behavior. Baylis timely investigates such suspected and/or reported non-compliance and responds promptly using its Compliance Program Enforcement Protocol (CPEP), which involves corrective and preventative actions, in collaboration with other departments such as Human Resources. 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 Prevention
As noted above, Baylis 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 Baylis management to ensure that Baylis 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 Compliance Officer reports such investigation outcomes, corrective actions and prevention plans to the President.
Element 8: Risk Assessment
Baylis views compliance not as a periodic evaluation but rather, as an ongoing commitment to collaborate with various heads of departments to ensure that the company maintains its ethical and legal responsibilities. As such, we regularly ensure that the Legal Department coordinates with key staff to identify risk areas and challenges. Results are routinely presented to senior leadership so internal strategies can constantly adapt. Baylis continuously monitors the top risk mitigation plans and progress and updates are provided to leadership throughout the year.