We strive for the highest standards of ethical conduct and are committed to establishing and sustaining an effective Compliance Program.
Spark Therapeutics is steadfast in its efforts to establish and maintain an effective 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). The purpose of our Compliance Program is to help prevent, detect and remediate violations of law and Company policies and promote a culture of ethical behavior within our organization. Our Compliance Program is reviewed and updated on a periodic basis to ensure it meets corporate objectives within the evolving legal and regulatory landscape.
To learn more about Spark Therapeutics' Compliance Program, click on the below topics:
Compliance Program Overview
The Head of Corporate Compliance has overall responsibility for the development and oversight of Spark Therapeutics' Compliance Program. Spark Therapeutics 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.
Spark Therapeutics has dedicated appropriate resources toward the ongoing establishment of corporate policies and training to address specific areas of risk potential regarding healthcare fraud and abuse. The Company's corporate policies and training will 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 upon implementation.
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 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.
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 Therapeutics to respond promptly to potential violations of law or Company policy; to investigate matters and assess whether there are gaps in policies, practices, or internal controls; and to implement corrective measures to prevent future violations.
California Compliance Declaration
Spark Therapeutics 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 Therapeutics 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 Therapeutics 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 Therapeutics also hereby declares that it is, in all material respects, in compliance with its Comprehensive Compliance Program as of July 1, 2016.
California Transparency in Supply Chains Act Disclosure
Spark Therapeutics is committed to ensuring that our supply chain reflects Spark Therapeutics' values and respect for human rights and the environment. Spark Therapeutics' 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 Therapeutics 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 Therapeutics' Code of Conduct and Business Ethics (“Code”) has been adopted by Spark Therapeutics' Board of Directors and applies to all Spark Therapeutics' employees, including officers, directors and contractors. Our Code of Conduct and Business Ethics is an articulation of Spark Therapeutics' 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 Therapeutics conducts business. In addition to exposing Spark Therapeutics 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 Therapeutics' 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 Therapeutics' 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 Therapeutics' employees are expected to report potentially corrupt behavior.
Ask a Question or Report a Concern
Spark Therapeutics 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 to ask a question and for reporting and handling concerns.
How to Ask a Question or Raise a Concern
Spark Therapeutics offers many channels for speaking up, asking questions and raising concerns.
These channels include:
In addition, Spark Therapeutics has established a Compliance and Business Ethics Helpline where reports can be made at any time by phone or online by anyone who has a question or would like to raise a concern. If you use the Compliance and Business Helpline, an external third party will ask for details about your question or concern and provide a reference number. Though not required, you may use that reference number to provide further information or check the status of an investigation by phone or online, regardless of how you originally used the hotline. You should note that investigations take time and our ability to share information may be limited.
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 Therapeutics 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 Therapeutics. Employees who engage in retaliation or intimidation will be subject to disciplinary actions as stated in our Code of Conduct and Business Ethics.