The Applied Medical group of companies (“Applied” or “our organization”) is dedicated to upholding the highest ethical, quality and compliance standards as we fulfill our customers’ demand for surgical products that satisfy clinical and economic needs. Instead of aiming to merely meet minimum requirements, we have always been committed to exceeding the expectations set forth by applicable policies, standards and laws.
Our organization is guided by the belief that we can have a significant and sustainable impact on global healthcare by maintaining an unwavering commitment to transparent business practices. To this end, we conduct business in an open and honest manner and reject business practices that unnecessarily increase the cost of healthcare, compromise patient safety, or stifle innovation.
CORPORATE COMPLIANCE OVERVIEW
Applied has adopted a compliance program (“Compliance Program”) to apply to its operations globally.
In addition, Applied Medical’s relevant European entities have adopted the following initiatives that operate concurrently with the global compliance program:
With respect to Europe, we refer to all the above together as the Compliance Program.
The Compliance Program is intended to promote the prevention and resolution of actual or apparent conflicts of interest, appropriate disclosure in Company reports and public communications, compliance with applicable laws and regulations, accountability and prompt reporting of violations of corporate policies relating to the sale and marketing of Applied’s products to health care professionals (“HCPs”), and health care organizations (“HCOs”). It is Applied’s expectation that all team members, officers, directors, agents, representatives, consultants, and distributors shall comply with Company policies and procedures as well as all of the laws, rules and regulations of EEA Member States, Switzerland, the UK and other applicable jurisdictions globally.
COMPREHENSIVE COMPLIANCE PROGRAM SUMMARY
Fundamental elements of our Compliance Program are summarized below.
Risk Assessment: Applied has undertaken risk assessments of its operations to determine which of its activities, and which of its team members, are at greatest risk in relation to each relevant legal and ethical requirement (required by Italian and Spanish law but in substance applicable throughout Europe). We have focused our compliance efforts most strongly on mitigating the highest risks. Our risk assessment is updated as laws change, new compliance techniques emerge or Applied’s activities evolve.
Written Policies and Procedures: Applied has adopted the MedTech Europe Code of Ethical Business Practice (“MedTech Europe Code”) as the Company’s primary European statement of policies for assuring compliance with applicable laws, regulations and standards governing interactions with HCPs and HCOs. Applied has also adopted a Supplemental Code of Ethics concerning:
- participation and attendance by HCPs and team members at company conducted training courses;
- third-party organized educational events (also referred to as conferences or congresses);
- scholarships and educational grants;
- not purchasing gifts, meals or refreshments for HCPs
- not financially supporting local society or club dinners.
Compliance Leadership: The Chief Accounting Officer, has been designated as the Company’s Chief Compliance Officer (the “Compliance Officer”) reporting to the CFO. The Compliance Officer is empowered to exercise independent judgment and is responsible for developing, monitoring and otherwise administrating the Compliance Program. The Company also has appointed a Compliance Committee comprised of the Compliance Officer and members of the Company’s senior management to assist the Compliance Officer with review, revision and implementation of the Compliance Program to meet legal and regulatory requirements applicable to the Company.
Three non-executive Supervisory Directors have been appointed pursuant to Dutch law to oversees the activities of the executive directors and other senior leaders working within the European business.
An Italian Supervisory Board and a Spanish Supervisory Board each meet regularly to address compliance issues arising in their respective countries.
Where there is joint competence, each organ cross-notifies the others of relevant matters as appropriate to ensure that they are comprehensively addressed.
Education and Training: Applied routinely trains appropriate team members on their legal and ethical obligations and Applied's policies and procedures concerning all relevant laws. Applied regularly reviews and updates its training programs as needed. Compliance Leadership works with other team members to implement or update appropriate training programs, including specialized training as needed, as well as documenting and maintaining records of such training.
Communication: Applied encourages team members and external stakeholders to talk to managers, the Legal Department, the Compliance Leadership or other appropriate personnel about suspected illegal or unethical conduct or violations of Applied's policies. Applied has adopted open-door, confidentiality (to the extent possible) and non-retaliation policies in the event a Team Member or external stakeholder is concerned about a potential violation.
The global Compliance Committee can be contacted at: email@example.com.
The Italian Supervisory Board can be contacted at: firstname.lastname@example.org.
The Spanish Supervisory Board can be contacted at: email@example.com
Team members and external stakeholders may also use the Company’s anonymous “whistleblower” mechanism by completing a web-based form or calling a hotline. The country telephone number can be found by following the link and choosing the relevant country: https://secure.ethicspoint.eu/domain/media/en/gui/106646/index.html. These reporting mechanisms are intended only for reporting potential financial fraud, concerns regarding accounting controls or irregularities, auditing issues or illegal or unethical behavior in violation of Applied’s policies. For other workplace grievances, team members should contact their manager or the Personnel Department.
Auditing and Monitoring: The Compliance Officer, working in tandem with the Compliance Committee and other members of Applied’s senior staff, is responsible for auditing and monitoring compliance with Company policies and procedures. The Compliance Officer will work with other team members to audit and monitor compliance, as well as to document and maintain records of such audits.
Enforcement and Appropriate Disciplinary Action: All reported potential violations shall be forwarded to the appropriate members of Compliance Leadership. Receipt of the report will be confirmed to the individual making the report unless such report was made anonymously. Compliance Leadership or delegate also will investigate reports of suspected violations brought to the Company’s attention and will take appropriate action to address inappropriate conduct and deter future violations by team members or third parties with whom the Company does business. When a report impugns the conduct of an individual manager or group of managers, it may be necessary or appropriate to convene specific panels to conduct investigations, consider appeals and/or determine disciplinary sanctions. These steps will be taken promptly and the overall adequacy of the process and outcome will be reviewed by the relevant organ(s) of Compliance Leadership.
Corrective Action Procedures: As needed and on an ongoing basis, Compliance Leadership will assess the need to revise policies, procedures, training, communication or other elements of Applied’s Compliance Program to improve its content or address gaps, if any.
REPORTING OF VIOLATIONS; NO RETALIATION
Applied Medical has adopted an EU complaint whistleblowing mechanism. Both Applied Medical team members and external parties with whom we deal are encouraged to raise any compliance or ethical issues directly with the Applied Medical team member responsible for the function concerned. However, if an internal or external person is not comfortable to address the issue directly with our responsible team member, they can make a whistleblowing report (anonymous or otherwise; by telephone or online) on a broad range of issues in any of 12 major European languages. Visit https://secure.ethicspoint.eu/domain/media/en/gui/106646/index.html to report online and for details on how to report by telephone.
Last revised: 1 January 2022