Mallinckrodt Pharmaceuticals ("Mallinckrodt" or “Company”) is committed to establishing and maintaining an effective Compliance Program in accordance with the applicable laws, regulations, and Codes of the countries within which it operates. Our global Compliance Program is one of the key components of our commitment to the highest standards of corporate conduct.
The purpose of our Compliance Program is to prevent and detect violations of law or Company policy. It is Mallinckrodt's expectation that employees and contractors will comply with Mallinckrodt's Guide to Business Conduct, policies, relevant laws, regulations, and Codes.
In the event that Mallinckrodt becomes aware of violations of law or Company policy, we will investigate the matter and, where appropriate, take disciplinary action and implement corrective measures to prevent future violations. Described below are the fundamental elements of Mallinckrodt's Compliance Program. We have tailored our Compliance Program to fit the unique environment of our industry. This dynamic landscape causes us to regularly review and enhance our Compliance Program to meet our evolving compliance needs.
Our Chief Compliance Officer is responsible for overseeing the administration and implementation of the Compliance Program and reports quarterly on compliance related matters to the Company’s Compliance Committees. The Chief Compliance Officer has the ability to effectuate change within the organization as necessary and to exercise independent judgment. The Committees have oversight responsibilities for the Mallinckrodt Compliance Program and provide advice, counsel, and support to the Chief Compliance Officer as needed.
As part of our commitment to the highest standards of ethical conduct, Mallinckrodt has implemented policies and procedures that are consistent with the applicable country laws and regulations. These policies and procedures are reviewed regularly to ensure relevancy to Mallinckrodt’s operations and the evolving healthcare regulatory environment.
A critical element of our Compliance Program is the education and training of our employees and contractors on their legal and ethical obligations under applicable polices, laws, and regulations. Mallinckrodt is committed to taking necessary steps to effectively communicate our standards and procedures to all affected personnel. Mallinckrodt will regularly review and update its training programs, as well as identify additional areas of training on an "as needed" basis.
Mallinckrodt is committed to encouraging dialogue between management and employees. Our goal is that all employees, when seeking answers to questions or reporting potential instances of policy violations, should know to whom to turn for a meaningful response and should be able to do so without fear of retribution. To that end, we have adopted principles regarding confidentiality and the prohibition of retaliation as outlined in the Mallinckrodt Guide to Business Conduct. Employees are expected to report suspected violations of Company policy by contacting their Manager, Legal Department, Human Resources, the Compliance Department, or via the Compliance Integrity Hotline.
General questions or concerns can always be directed to the Compliance inbox at Compliance.Dept@mnk.com
Mallinckrodt's Compliance Program includes monitoring, auditing, and evaluating adherence to the Company's compliance activities. The nature and frequency of our reviews vary according to a number of factors, including new regulatory requirements, changes in business practices, and other considerations.
Mallinckrodt's Compliance Program strives to ensure that the consequences of violating the law or Company policy are clearly understood and the appropriate, consistent disciplinary action is enforced. As such, our Compliance Program requires the Company to evaluate each case and reasonably respond to potential violations of law or Company policy, take appropriate disciplinary action, assess whether the violation is in part due to gaps in our policies, practices, or internal controls, and take action to prevent future violations.
Mallinckrodt's Guide to Business Conduct is an expression of the Company's expected standards of behavior for everyone who conducts business on behalf of the Company. The Guide establishes compliance responsibilities, supports applicable laws and regulations, and reinforces corporate policies and procedures. The Guide articulates our fundamental principles, values and framework for ethical conduct.
The Modern Slavery Act 2015 (“the Act”) came into effect on 29 October 2015 and requires those entities carrying on a business or part of a business in the UK, supplying goods or services, and having annual turnover of £36 million or more to disclose information regarding the steps they have taken to eradicate slavery and human trafficking from their supply chain as well as within their own organization during the previous financial year. This statement has been prepared by Mallinckrodt plc and its consolidated subsidiaries(“Mallinckrodt” or “we”) in order to comply with Section 54 of the Act and covers the fiscal year ended December 28, 2018. Mallinckrodt plc is incorporated in Ireland and its principal executive offices are located at 3 Lotus Park, The Causeway, Staines-Upon-Thames, Surrey, United Kingdom. The subsidiary entities that are covered by this report include the following: Mallinckrodt ARD Holdings Limited; Mallinckrodt Chemical Holdings (U.K.) Ltd.; Mallinckrodt Chemical Limited; Mallinckrodt Enterprises UK Limited; Mallinckrodt Equinox Limited; Mallinckrodt Medical Holdings (UK) Limited; Mallinckrodt Pharmaceuticals Limited; Mallinckrodt UK Ltd.; Mallinckrodt UK Finance LLP; MKG Medical UK Ltd; MUSHI UK Holdings Limited; and Therakos (UK), Ltd.
We are a global business that develops, manufactures, markets and distributes specialty pharmaceutical products and therapies. Areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, nephrology, pulmonology and ophthalmology; immunotherapy and neonatal respiratory critical care therapies; analgesics and gastrointestinal products.
People throughout the world count on Mallinckrodt products every day to help them lead healthier lives, and we believe that all human life should be held in the highest regard. While we believe the risk of modern slavery and human trafficking is relatively low in the highly regulated pharmaceutical industry, as a global company we recognize that our responsibility to ensure that modern slavery and human trafficking are not taking place extends to our business relationships as well. To support these efforts, we have joined the Pharmaceutical Supply Chain Initiative (PSCI), a consortium of pharmaceutical and healthcare companies that share a vision of better social, environmental and economic outcomes within the supply chain (https://pscinitiative.org/home).
We have taken several steps to mitigate the risks associated with modern slavery in our business and supply chain. In particular, we support the human rights of our workers and the treatment of all people with dignity and respect through two core policy documents: the Mallinckrodt Supplier Code of Conduct and the Mallinckrodt Pharmaceuticals Guide to Business Conduct.
The Mallinckrodt Supplier Code of Conduct outlines the expectations for the ethical behavior of our suppliers and prohibits child and compulsory labor, human trafficking and slavery, unsafe and hazardous working conditions and environments, and any behavior that does not maintain human dignity and respect. These standards apply to all suppliers of goods and services to any Mallinckrodt business or supplier, regardless of location.
All of our employees are required to be trained on the Mallinckrodt Pharmaceuticals Guide to Business Conduct and to certify annually both to their understanding and compliance. The Guide reflects our aims for good global citizenship and worldwide social responsibility. It provides that we must provide clean and safe working environments and conditions free of human rights violations, and forbids forced or child labor at Mallinckrodt and at the companies with which we work, with no exceptions. The Guide also prohibits human trafficking or slavery, unsafe or hazardous conditions or environments, or any behavior that does not maintain human dignity and respect. It further states that Mallinckrodt must not engage in activities that fail to protect individual dignity and respect, even if permissible under local law, and must pay a fair wage.
We may take disciplinary action against anyone found to have violated the Mallinckrodt Pharmaceuticals Guide to Business Conduct or the Mallinckrodt Supplier Code of Conduct, which can include termination of employment or supply agreements.
Mallinckrodt incorporates language related to compliance with the Act into certain of its contracts with suppliers and other service providers, and will continue to assess appropriate incorporation of such language as business needs evolve. In addition, as a contractor to the U.S. government, we have specific obligations with regard to human trafficking pursuant to Federal Acquisition Regulation clause 52.222-50, Combating Trafficking in Persons, and Defense Federal Acquisition Regulation Supplement 252.222-7007, Representation Regarding Combating Trafficking in Persons. In 2017, we instituted a Human Trafficking Policy that applies to all Mallinckrodt employees, subcontractors, suppliers and other partners that assist in our performance of all U.S. government contracts and subcontracts, and expressly prohibits Mallinckrodt from engaging in human trafficking while performing under such contracts.
Mallinckrodt encourages reporting of any unethical conduct up through supervisors and the leadership chain of command, or through the Mallinckrodt Pharmaceuticals Integrity Hotline. The Integrity Hotline is a simple way for employees, suppliers and customers to express concerns regarding any potential unethical situation. The Integrity Hotline is available seven days a week, 24 hours a day. Additional information may be found at https://www.mallinckrodt.com/contact‐us, Compliance & Business Integrity.
Although we do not have a formal process for verifying our supply chains or obtaining certification of compliance from suppliers, all suppliers are subject to audit. Mallinckrodt conducts audits of its suppliers based on an internal assessment of business and environmental health and safety risk, and measures against recognized industry standards. We do not use a third party to verify supply chains or perform unannounced audits.
This statement has been approved by our Board of Directors on 15 May 2019.
Mark C. Trudeau
President, Chief Executive Officer and Director
Statement regarding compliance with California Health & Safety Code § 119402
California Health & Safety Code, Sections 119400 – 119402, (“California Code”) requires pharmaceutical companies to adopt a compliance program in accordance with the April 2003 publication “Compliance Program Guidance for Pharmaceutical Manufacturers” (“OIG Compliance Guidance”) developed by the United States Department of Health and Human Services Office of Inspector General (“OIG”) and policies for compliance with the Pharmaceutical Research and Manufacturers of America (“PhRMA”) “Code on Interactions with Health Care Professionals” (“PhRMA Code”) within six months of any update or revision of the PhRMA Code.
Mallinckrodt Pharmaceuticals (“Mallinckrodt” or “Company”) has established a Compliance Program in accordance with the OIG Compliance Guidance and has policies in place to foster compliance with the PhRMA Code. For purposes of compliance with the requirements of the California Code and as part of the Compliance Program, Mallinckrodt has established a specific annual aggregate dollar limit of $2000 on gifts, promotional materials, or items or activities that Mallinckrodt may give or otherwise provide to an individual medical or healthcare professional in California on an annual basis from January 1 to December 31. Such items or activities primarily include: medical educational items such as textbooks or clinical reprints, intended to enhance patient care; modest meals associated with a substantive discussion of a Company product or a disease state; and other items or activities permitted under the PhRMA Code, the AdvaMed Code of Ethics for Interactions with Healthcare Professionals and/or the OIG Compliance Guidance. These items and activities are primarily directed to the dissemination or communication of medical and scientific information as a resource for healthcare professionals to assist in making clinical or other medical judgments. This limit may be revised from time to time, in which case the revised limit will be published in this section of the Company website. This limit represents a spending cap, not a goal or average; in many cases, the amount spent per prescriber is substantially less than the cap amount.
In accordance with the California Code, the annual limits do not include the following:
Annual Declaration of Compliance
Mallinckrodt’s Compliance Program was developed with consideration given both to the goals of sections 119400- 119402 of the California Health and Safety Code and to the operations, size, and organization of the Company. Based upon our good faith understanding of these statutory requirements, we believe we are in compliance in all material respects with our Compliance Program and the requirements of the California Health and Safety Code.
Where available and permitted by law, Mallinckrodt’s Compliance Integrity Hotline allows colleagues or partners to report a concern or to get information or advice anonymously. Where available, the Compliance Hotline can be reached by phone or online via the web–reporting tool. The toll-free Compliance Hotline is available seven days a week, 24 hours a day. The Compliance Hotline is operated by specially trained third–party representatives in the United States.
For individuals in the European Union, please note that Mallinckrodt’s Compliance Hotline phone and web services only allow the reporting of certain issues, depending on local law (generally: financial, accounting and auditing matters). Other matters may be reported by contacting the Mallinckrodt Compliance Department directly at Compliance.Dept@mnk.com
For questions or comments regarding Mallinckrodt's Compliance Program email us at Compliance.Dept@mnk.com
For all other questions or comments that do not pertain to Compliance, please go to our Contact Us page to find the appropriate department.
You may contact Global Pharmacovigilance to report any side effect / adverse drug experience related to a medicinal product. Full details on contacting Pharmacovigilance can be found here.
You may contact Product Monitoring to report any quality complaint or medical device report. Full details on contacting Product Monitoring globally can be found here.