At Helsinn, our vision is to help people with cancer get the most out of every day. As one of the world's leading cancer care companies, our goal is to make everything we do, from the products we choose to license, to the exacting standards we apply, to manufacturing, count towards improving the lives of people with cancer. Helsinn is committed to meeting this goal while maintaining the highest level of integrity and ethical behavior in the conduct of our business.
To conduct our business with ethics and integrity, Helsinn has established and maintains a compliance program. This program has been developed in accordance with the laws, regulations, Helsinn Policies and Codes applicable to our industry. Helsinn’s compliance program requires compliance with the pharma industry codes wherever we do business.
Helsinn’s compliance program includes:
Our compliance program has been composed by the widely recognized elements of an effective Compliance Program. The main elements are:
The creation of appropriate standards, policies and procedures, and guidelines establishes a framework of behavior for the company to follow. These standards are based on organizational risks and laws, codes and policies of the countries in which the business activity takes place.
A high level management committee often works with the GCO on operational issues and interfaces with the Board on oversight matters. As such, appropriate authority has been given to the GCO and BEB to make decisions and oversee the compliance program.
Initial and ongoing training for employees is essential to a compliance program to help ensure that they know how to be compliant and to set Helsinn’s expectations of them. Documentation of training such as: when it occurred, who attended, and the content or agenda is important to both measure the effectiveness of the program, and to reference should an incident occur that requires employee disciplinary action. Ongoing education and communications are necessary to reinforce training topics and inform relevant audiences about other compliance issues and information.
Ongoing monitoring and auditing can help identify areas of risk where further attention is needed such as policy development or corrective action. Monitoring and auditing can also spot trends that may indicate a need for stronger controls such as further education and training.
A helpline is available for employees to report incidents or concerns and serves as a venue to ask questions. All allegations are promptly investigated.
Fair, equitable and consistent methods to manage employees involved in compliance incidents serve as an important part of an effective compliance program and also illustrate the company’s commitment to compliance and ethics. Coordination among the Legal, Human Resources and the Compliance Office can help ensure the proper disciplinary steps are taken based on the specifics of the incident.
If misconduct or a gap in the program has been discovered, appropriate action on behalf of the company should follow. This step shows the company’s resolve to correct the issue once the company becomes aware of it and that the company does not continue to let issues arise in the future. It is very important, once the company is informed of an issue, to address it promptly. This may often include consultation among the Legal, Human Resources and the Compliance Department.
Helsinn Therapeutics (U.S.) Inc. has established a comprehensive Compliance Program in accordance with the April 2003 “Compliance Program Guidance for Pharmaceutical Manufacturers” (“OIG Guidance”) and the “Pharmaceutical Research and Manufacturers of America (PhRMA) Code.” To learn more about Helsinn Therapeutics (U.S.) Inc. Compliance Program or to access our annual declaration of compliance with the California Health & Safety Code please click on the following links:
Integrity is a fundamental part of the Helsinn strategy and must be practiced at all levels of the Group and by employees. A robust compliance program and a strong culture of integrity can have a positive impact on the long-term success and sustainability of our Group.
The Compliance program has been created and implemented based on Prevent-Detect-Respond pillars in order to:
Helsinn conducts operations and activities with the highest level of integrity and maintains an organizational culture that encourages ethical conduct and a commitment to compliance with the law.
The integrity of Helsinn, the respect to its collaborators and personnel and its commitment to quality are Helsinn key values. These are values that we must protect. The work we do carries heavy responsibility to patients. No business opportunity should ever be allowed to take precedence over our ethics or integrity.
With support from top leadership, regional leadership and partner resources, we are able to minimize risk, protect the company’s reputation and foster a culture of high performance with integrity.
Helsinn adheres to all applicable laws, rules, regulations, directives and guidance against corruption.
Our Group Anti-Corruption policy has been endorsed by the Helsinn Board of Directors and applies globally to its personnel and third parties in any Helsinn operation. Helsinn personnel are required to strictly comply with anticorruption laws and regulations in the countries in which they work for Helsinn. Helsinn employees must ensure that their actions and conduct comply with applicable local laws and specific contractual obligations entered into by Helsinn in relation to the work they are completing.
In Helsinn we comply with the following standards:
Helsinn zero tolerance policies against corruption covers interactions with third parties and in the context, Third Parties refer to any individual or organization Helsinn meets and works with. It refers to actual and potential customers, suppliers, distributors, contractors, business partners, agents, advisers/consultants, and government and public bodies – this includes their advisors, representatives and officials, politicians, and public parties.
The Compliance program – led by the Group Compliance Officer based in Helsinn Headquarter in Lugano (CH) – is supported by compliance resources at headquarters and around the world.
Full dedicated teams consisting of Regional Compliance Officers or Ambassadors covering all countries in which we are based are a fundamental part of our Compliance team.