Annual Declaration of Compliance with California Health & Safety Code §119400-119402
Impel Pharmaceuticals’ (“Impel”) mission is to create life-changing therapies for a wide range of diseases with high unmet need. Our proprietary Precision Olfactory Delivery (“POD®”) technology is designed to deliver drugs deep into the vascular rich upper nasal space, an untapped gateway for administration of drugs. We are driven by a deep sense of purpose – to make everyday life better for the Patients we serve.
We act in accordance with Impel’s Code of Conduct, policies, procedures and applicable laws, regulations and industry codes including the California Health and Safety Code §119400-119402. This code requires pharmaceutical companies to adopt a Comprehensive Compliance Program consistent with the Office of Inspector General’s (OIG) publication “Compliance Program Guidance for Pharmaceutical Manufacturers” and the Pharmaceutical Research and Manufacturers of America (PhRMA) “Code on Interactions with Health Care Professionals”. Impel’s Compliance Program is constantly evolving and reviewed as compliance regulations from OIG and PhRMA change.
For a written copy of the Comprehensive Compliance Program description or this declaration, call 206-568-1466.
Impel’s Comprehensive Compliance Program
1. Leadership & Structure
Compliance Officer. Impel has assigned a Chief Compliance Officer (“CCO”) to serve as the manager of the overall Impel compliance, risk and governance program. Impel is committed to effectively managing risk and ensuring Impel operates with the highest level of integrity. Accordingly, it is the CCO’s responsibility to oversee the development, operation, and on-going effectiveness of Impel’s risk based Comprehensive Compliance Program. Further, the CCO, with support from the Corporate Compliance Committee and senior management, has the ability and authority to effect change within Impel and exercise independent judgment on behalf of the organization.
Corporate Compliance Committee. The Committee is the governing body of the Comprehensive Compliance Program which works closely with the CCO and Impel’s senior leaders to identify and address matters relating to compliance, risk and governance. The Committee is made up of senior leaders who have direct access to the CCO. Impel’s Board of Directors relies on the Committee to make sound, risk-based business decisions which are in the best interest of Impel’s constituents including employees, the healthcare community and the patients it serves.
2. Written Standards
Impel has established written policies, procedures, and guidance documents in compliance with the OIG Guidance and PhRMA Code to ensure employees are acting with the highest ethical standards.
The documents which have been established were developed under the Compliance Officer and Committee members. Impel’s Code of Conduct reemphasizes Impel’s commitment to compliance through its five (5) guiding principles. The Code and additional written standards are available and required for employees to read and adhere to.
3. Education & Training
All Impel employees are required to be trained on compliance concerns relevant to their job responsibilities. Impel utilizes a variety of training platforms to ensure employees have a strong understanding of Impel’s policies and the laws and regulations which govern the compliance program. Training is conducted during onboarding, with additional annual refreshers as well as on an needed basis.
4. Internal Lines of Communication
Impel urges all employees to speak up when they know, or suspect of, a violation to Impel’s Code, policies and procedures, or any laws, regulations, or industry codes with which Impel must comply. Impel has an open-door policy and encourages employees to report all known or suspected instances of non-compliance and any questions or concerns.
Impel does not tolerate retaliation against anyone who raises a concern in good faith. Employees may report compliance concerns or ask questions by contacting a manager, the human resources department, the compliance department, or Impel’s 24-hour hotline.
- Web intake site: http://impelnp.ethicspoint.com/
- Mobile intake site: http://impelnpmobile.ethicspoint.com/
- Hotline: 844-733-0093
5. Auditing & Monitoring
Impel has established a risk-based approach to auditing and monitoring. Annually, Impel will conduct a compliance risk assessment which will inform the volume and frequency of such monitoring and auditing activities. Activities which are monitored and audited include internal processes and departments as well as external vendor’s compliance to established business rules and best practices. Results on the auditing and monitoring effort will be communicated to Corporate Compliance Committee and senior leaders and will be utilized to effect any necessary change in current compliance policies and processes.
6. Responding to Potential Violations
Impel will evaluate all reports of non-compliance with Impel’s Code of Conduct, policies or procedures or any laws, regulations or industry codes with which Impel must comply in a timely manner and, if appropriate, conduct a prompt, unbiased investigation. The COO, or designee, will investigate all reported possible violations.
7. Corrective Action Procedures
Impel will take appropriate corrective action which might include coaching, training or discipline up to, in the case of employees, termination of employment to address violations of Impel’s Code of Conduct, policies or procedures or any laws, regulations or industry codes with which Impel must comply.
Although each case is different, Impel will ensure consistent and appropriate disciplinary actions are taken regardless of the employees role within the company. Impel has detailed an investigations process and progressive disciplinary action system to ensure standard enforcement.
Statement of Annual Aggregate Limit
The California Health & Safety Code §119400-119402 requires pharmaceutical companies to set an annual aggregate dollar limit on gifts, promotional materials, and expenditures provided to medical or healthcare professionals (“HCPs”). Impel has established an annual limit of $2,000 which represents a maximum cap to be spent per physician. The $2,000 annual limit does not include (1) drug samples, (2) financial support for continuing medical education events or health education sponsorships, or (3) bona fide service payments to HCPs. The limit may be revised due to the company’s changing size and volume of products. Additionally, the limit does not necessarily represent the average or spending goal which Impel is trying to match.
Declaration of Compliance
Impel declares, in good faith as of January 5, 2022 that the company is in compliance with a Comprehensive Compliance Program and the requirements of the California Health & Safety Code §119400-119402. This declaration is based on Impel’s review and understanding of the California Health & Safety Code §119400-119402 including the key components of a Comprehensive Compliance Program and the annual aggregate limit which was established. Impel will update this declaration on an annual basis.