A Message from the CEO
In keeping with our commitment in maintaining the highest level of integrity and ethical responsibility, we have developed the Medicure Corporate Compliance Program. Conducting our business within the boundaries of this Program will ensure the successes we realize are accomplished honestly, fairly, and with the utmost respect for healthcare providers, patients, and fellow employees.
The Program contains fundamental legal, regulatory, and ethical guidelines for conducting business at Medicure and its US subsidiary, Medicure Pharma. It summarizes our compliance infrastructure and policies and serves as a valuable resource for employees or others with compliance questions or concerns.
A culture of compliance cannot be realized without the commitment and recognition by each employee of their role in fulfilling our compliance mission. With your help, we can achieve our business objectives while maintaining our integrity and enhancing our reputation as an ethical leader in the pharmaceutical industry.
Albert Friesen, Ph.D.
The Medicure Corporate Compliance Program has been designed to ensure that Medicure and its US subsidiary, Medicure Pharma, conducts business with the highest level of awareness, training, commitment, and adherence to applicable laws and regulations. To do so, requires the implementation of policies and procedures that address potential compliance risk areas as well as identifiable mechanisms for reporting, investigating, monitoring, and correcting cases of suspected non-compliance.
The Medicure Corporate Compliance Program has been developed in accordance with the requirements and guidelines set forth in the Department of Health and Human Services (DHHS), Office of Inspector General (OIG) Compliance Guidance.
Further information and disclosures with respect to specific state compliance laws within the United States can be found in Appendix A. Medicure and its subsidiaries do not have any sales activity outside of the United States.
Medicure has developed a compliance infrastructure designed to ensure accountability for legal and ethical responsibilities across the Company. The compliance infrastructure is comprised of the Chief Compliance Officer, and other compliance representation from various functional areas within or as external consultants to the Company who all participate as members of the Compliance Committee (CC).
The Medicure Corporate Compliance Program operates under the direction of the Chief Compliance Officer. The Chief Compliance Officer serves as the chair of the Compliance Committee (CC) and has primary responsibility for implementation and oversight of the Corporate Compliance Program. The Chief Compliance Officer may enlist support from internal or external resources to assist him/her with the implementation of the Program. The Chief Compliance Officer provides annual or more frequent substantive compliance updates to the Board of Directors and the CEO. Other responsibilities of the Chief Compliance Officer or his or her designees include:
Making periodic revisions to the Corporate Compliance Program in light of any regulatory, legal, or organizational changes requiring such revisions;
Coordinating and ensuring employees undergo the essential compliance training;
Developing open communication channels to encourage employees to inquire about or report compliance issues without fear of retribution;
Overseeing internal investigations and any corresponding corrective actions;
Directing monitoring and auditing efforts to ensure compliance with laws, regulations and policies; and
Providing the necessary periodic declarations or certifications relative to applicable compliance requirements.
The CC has been established to advise and assist the Chief Compliance Officer and his/her designees in the implementation and oversight of the Corporate Compliance Program. The CC will convene on a quarterly basis to update and review compliance issues. The CC is composed of senior representatives from various functions and disciplines within or as consultants to the Company.
It is the responsibility of the Chief Compliance Officer and his or her designee(s), in conjunction with the CC, to create, revise, and communicate policies and procedures that address areas of potential compliance risk within the Company. These policies shall be reviewed periodically and updated as necessary to reflect regulatory, legal or organizational changes. These policy reviews, as well as the requisite training and education, either initially or as updated, shall be performed by the respective compliance function or discipline within the organization.
The Company has adopted core compliance policies that provide the prevailing principles to help ensure that we conduct our business affairs with honesty and integrity and in full compliance with all applicable laws, rules and regulations.
In addition, all employees are required to familiarize themselves with and adhere to all Company standards, policies and procedures that apply in the areas within the scope of their work responsibilities.
Hard copy versions of all policies or procedures falling under the Corporate Compliance Program are maintained within the respective compliance disciplines. Electronic versions of these policies will also be available to affected employees through an internal database.
An effective education and training program is an integral part of the Corporate Compliance Program. Employees will be required to participate in compliance-related training designated by the Chief Compliance Officer, or by another function or discipline within the organization. Our compliance education and training programs are designed with the following objectives:
To educate employees on their ethical and legal obligations in reference to applicable federal health care program requirements.
To encourage a culture of compliance within the organization and ensure that employees understand their role in the compliance process; and
To promote knowledge of and compliance with corporate policies and procedures and relevant federal, state, and local laws and regulations;
To communicate industry standards and governmental requirements while providing a means for the quick identification and resolution of compliance issues
To understand the consequences of failing to comply with the presented comprehensive compliance program
In addition, the Company regularly reviews and updates the training program where new updates are needed, as well as identifying additional areas that need to be addressed.
Situations which involve concerns about conflicts of interest, violations or suspected violations of laws, rules, policies, regulations, or this Corporate Compliance Program may not always be clear and may require complex judgment. A Compliance Help Line has been established for any employee to call with questions about compliance or to report a suspected violation of policy. The Help Line is a toll-free number that is available 24 hours a day, 7 days a week. The Help Line is administered on Medicure's behalf by an independent third party whose employees are specially trained at collecting pertinent information. The Help Line administrator will summarize the calls and send reports to the Chief Compliance Officer or his/her designee, within one business day. Individuals are also encouraged to be open and candid in discussing any compliance issues with their manager.
All employees are required to report any concerns about conflicts of interest, violations or suspected violations of laws, rules, policies, regulations, or this Corporate Compliance Program. You may report any such concerns to the Compliance Help Line at (800) 385-7429.
On calls made to the Compliance Help Line, employees have the option of providing their identification or making an anonymous report. It's important that employees have confidence and trust in the Company in knowing that all efforts will be made to conceal the identity of the caller and the report being made, to the extent possible when investigating the matter.
Every employee has the responsibility to report to the Company any suspected violation of law or policy by another employee or agent of the Company. Employees can report such violations without fear of retribution or retaliation. Employees, who threaten, retaliate against or harass any person who has reported a compliance concern shall be subject to disciplinary action up to and including termination.
An essential goal of the Corporate Compliance Program is to identify these unethical or unlawful policy violations and to take appropriate corrective actions in order to punish and further prevent these violations. We foster a culture in which problems and concerns relating to compliance are brought to light, investigated, and remediated.
We are committed to investigating and addressing any reports of suspected policy violations while seeking to ensure that all reported violations are handled in a uniform and evenhanded manner, and in a manner designed to promote compliance with Company policies.
A key aspect to the Corporate Compliance Program is periodic monitoring and auditing of employee compliance with policies and procedures to assess whether elements of the Corporate Compliance Program have been satisfied. For example, assessments may include whether, for a defined risk area, standards have been developed, dissemination and training around these standards have been conducted, a mechanism for determining adherence to these standards is in place, an investigation into alleged misconduct was commenced, and appropriate corrective action, if any, has been taken.
The monitoring and auditing plan is reasonably designed to detect violations by an organization's employees or agents. The monitoring and auditing plan will also maintain and enhance the effectiveness of internal controls by assessing changes to laws, regulations, or business activities affecting the Company.
Unless otherwise specified, records pertaining to the implementation and maintenance of the Corporate Compliance Program shall be maintained with the Chief Compliance Officer in the Corporate Compliance Program files. In some cases, training records and other compliance documents will be maintained within the specific compliance function or discipline.
State Compliance Laws
Medicure has developed its Corporate Compliance Program in accordance with the "Compliance Program Guidance for Pharmaceutical Manufacturers," published by the Office of Inspector General, U.S. Department of Health and Human Services ("OIG Guidance") and the California Health and Safety Code, Part 15, Division 104, § 119400-119402.
Medicure has adopted written policies and procedures to help ensure that we conduct our business affairs with honesty and integrity and in full compliance with all applicable laws, rules and regulations. To this end, Medicure has adopted the PhRMA Code as its Marketing Code of Conduct for our employees conducting business in the state of California. The specific annual dollar limit that Medicure has placed on items or activities provided to a healthcare professional in California is $1,500.00.
To the best of our knowledge, and based upon our good faith understanding of the statutory requirements of SB 1765, we are in compliance with the basic established elements of the OIG Compliance Guidance and with our Corporate Compliance Program as published on our public website at www.medicure.com/compliance. Copies of the Medicure Corporate Compliance Program can also be obtained by calling (800) 385-7429.
Medicure has adopted written policies and procedures to help ensure that we conduct our business affairs with honesty and integrity and in full compliance with all applicable laws, rules and regulations. To this end, Medicure has adopted the PhRMA Code as its Marketing Code of Conduct for any future employees we may have conducting business in the state of Nevada. Currently, Medicure does not have any employees conducting business in the state of Nevada.
Medicure does not currently employ or contract with a pharmaceutical or medical device manufacturer agent in the state of Massachusetts.