Compliance Program Overview
1. Leadership and Structure
The Head of Corporate Compliance has overall responsibility for the development and oversight of Spark’s Compliance Program. Spark is committed to ensuring that the Head of Corporate Compliance has the ability to exercise independent judgment and effectuate change within the organization as necessary. In this capacity, the Head of Corporate Compliance may report matters directly to the CEO and provide documented reports of Compliance Program operations to the Board of Directors.
2. Written Standards
Spark has dedicated appropriate resources toward the establishment of corporate policies to address specific areas of risk potential regarding healthcare fraud and abuse. The Company’s corporate policies reflect the principles set forth in the “Code on Interactions with Healthcare Professionals,” published by the Pharmaceutical Research and Manufacturers of America (PhRMA Code). All employees are expected to comply with these standards.
Annual Spending Limit
As required by California Health and Safety Code 119402, Spark has also established a maximum annual aggregate dollar limit of $2,000 for gifts, promotional materials or activities provided to California health care professionals. This dollar limit represents a spending cap, not a goal or average, and typically the amount spent per health care professional is anticipated to be substantially less than this maximum amount.
Consistent with California law, this annual dollar limit does not include items as drug samples given to medical or health care professionals intended for free distribution to patients, financial support for continuing medical education forums, financial support for health educational scholarships, and payments made at fair market value for legitimate professional services provided by health care professionals.
3. Education and Training
We are committed to education and training of corporate compliance policies, and timely communication of our directives and guidance. New personnel receive training as part of their initial training and existing personnel receive compliance training on at least an annual basis. We review and update training programs periodically, as well as identify additional areas of training on a continual basis.
4. Internal Lines of Communication
Dialogue is encouraged between management and employees. In addition, all employees, when seeking answers to questions or reporting potential instances of fraud and abuse, should know to whom to turn for a meaningful response and be able to do so without concern of retribution. To that end, we have implemented policies regarding confidentiality and prohibition of retaliation, as well as established a Compliance Hotline so that issues may be reported anonymously. This Hotline is available 24 hours a day, 7 days a week. Corporate Compliance staff are accountable for ensuring appropriate review and follow-up with respect to issues raised via the Compliance Hotline or through other means.
5. Auditing and Monitoring
It is the role of the Head of Corporate Compliance to develop a plan for auditing and monitoring compliance with Spark’s Compliance Program. These audits are intended to identify potential or existing risk areas and to take corrective measures in an effort to prevent the occurrence or recurrence of non-compliance.
6. Responding to Potential Violations and Corrective Action Procedures
The objective of our Compliance Program is to ensure that the consequences of violating the law or Company policy are clearly understood and that appropriate, consistent disciplinary action is enforced. However, the U.S. Department of Health and Human Services in 2003 (HHS-OIG) recognizes that even an effective Compliance Program may not prevent all violations. As such, our Compliance Program requires Spark to respond promptly to potential violations of law or Company policy. When deemed necessary, the Head of Corporate Compliance, or a designee, will conduct an investigation into potentially non-compliant activity to determine whether a violation has occurred. Corrective measures take into account the findings of reviews of non-compliance, assessing whether enhancements should be made to our policies, practices, training, or internal controls, and taking action to prevent future violations.
California Compliance Declaration
Spark is committed to complying with all applicable laws, regulations and industry standards. The Company has developed a Comprehensive 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 in 2003 (HHS-OIG Guidance) which includes policies consistent with the Pharmaceutical Research and Manufacturers of America Code on Interactions with Health Care Professionals (PhRMA Code). Our Compliance Program includes numerous policies and procedures and is continually assessed and evaluated to ensure consistency with additional laws and guidance. It is designed to prevent, detect and remediate violations of law, regulations and Company policies, as well as to promote an ethical culture that will, among other things, guide our interactions with healthcare professionals and healthcare entities. In the event that Spark becomes aware of any potential or actual violations of policy or law, an investigation will be triggered and, if necessary, followed by appropriate remedial or corrective actions in accordance our Compliance Program.
Based on a good faith understanding of the requirements of Sections 119400 and 119402 of the California Health & Safety Code, Spark hereby declares that, to the best of its knowledge, its Comprehensive Compliance Program addresses the California statutory requirements for inclusion of policies addressing the HHS-OIG Guidance and PhRMA Code and limits on gifts and incentives to health professionals. Subject to the above, Spark also hereby declares that it is, in all material respects, in compliance with its Comprehensive Compliance Program as of July 1, 2021.
Copies of this declaration and the Compliance Program Overview may be obtained by calling 1-855-SPARKTX / 1-855-772-7589.
California Transparency in Supply Chains Act Disclosure
Spark is committed to ensuring that our supply chain reflects Spark’s values and respect for human rights and the environment. Spark’s relationships with suppliers are based on lawful and fair practices. We expect our suppliers to obey the laws that require them to treat workers fairly, provide a safe and healthy work environment and protect environmental quality. In furtherance of this policy, Spark obligates its suppliers by contract to comply with all applicable laws and regulations, including those relating to slavery and human trafficking of the country or countries in which they are doing business.
Code of Conduct and Business Ethics
Spark’s Code of Conduct and Business Ethics has been adopted by Spark’s Board of Directors and applies to all Spark’s employees, including officers, directors and contractors. Our Code is an articulation of Spark’s compliance principles and the expectation that our employees act with integrity and the high standards of ethical behavior. The Code establishes expectations for standards of behavior when conducting business on behalf of the Company and presents a framework for compliance with applicable laws and Company policies.
Anti-bribery and Corruption
Bribery is considered illegal in all countries in which Spark conducts business. In addition to exposing Spark to severe sanctions, any employee, officer, director or other person acting on behalf of the Company who engages in such conduct can also face substantial fines and/or imprisonment.
Spark’s employees are advised not to offer or accept money, gifts or anything else of value as a bribe or inducement to make, or as a reward for making (or not making) any decision that favors Spark’s interests or to otherwise seek to gain an unfair business advantage or enhanced product sales. This includes providing benefits to government officials (including those in local and national governments and those serving public interests) and other organizations, healthcare professionals, patients, suppliers, charities or advocacy groups. Spark’s employees are expected to report potentially corrupt behavior.
Reporting a Concern
Spark is committed to conducting business in an ethical and compliant manner. If standards are not met or an issue is identified, we have established procedures for reporting and handling concerns.
How to Raise a Concern
Spark offers many channels for speaking up, asking questions and raising concerns.
These channels include:
- Human Resources
- Corporate Compliance
- Legal Department
In addition, Spark has a Confidential Hotline managed by an external third party http://compliance.sparktx.com (1-844-826-8149) where reports can be made at any time by phone or online by anyone who has a concern about a suspected violation.
Anonymity and Confidentiality
Where permitted by local laws, the Confidential Hotline may be used to anonymously report known or suspected issues or ask a question. Your report will be shared only with those who need to know it to answer your question or investigate the matter. Should you identify yourself, Spark will make every reasonable effort to keep your identity confidential while conducting a fair and thorough investigation. In some instances, the Company may be required by law to reveal your identity.
Spark Therapeutics Non-Retaliation Policy
No form of retaliation or intimidation against an individual who makes a good-faith report of a suspected violation will be tolerated by Spark. Employees who engage in retaliation or intimidation will be subject to disciplinary actions as stated in our Code of Conduct and Business Ethics.