Commitment

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.

Our Compliance Program

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:

  • A Group Compliance Officer (“GCO”) and Business Ethics Board (”BEB”) charged with the responsibility for operating and monitoring the compliance program. Written standards of conduct, policies, and practices that detail the company’s commitment to compliance and set forth the ethical and compliance principles applicable to all employees
  • A Corporate Compliance Working Committee (“CCWC”) assisting the GCO to set up, operate and maintain the Compliance Program; a ​group of ​people within a ​company or ​organization whose ​job is to make ​certain that all ​laws and ​rules ​relating to its ​activities are obeyed
  • Written compliance materials that address handling specific risk areas
  • Ad hoc regular education and training programs for all employees
  • Lines of communication between the GCO and all employees, including a process to receive complaints and ask questions
  • Confidential external line, called the Helsinn Compline for reporting issues. Policies and practices to protect the anonymity, where appropriate, of employees who make complaints and to prohibit retaliation against complainants are applied
  • Use of audits and routine monitoring activities to monitor compliance and identify and address risk
  • Enforcement of compliance obligations through policies that include penalties for non-compliance
  • Mechanisms to promptly and properly investigate and respond to reports of non-compliance, including processes to initiate corrective measures and to report offenses to the relevant government authorities where appropriate

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:

    Helsinn Therapeutics (U.S.) Inc., Comprehensive Compliance Program

    Helsinn Therapeutics (U.S.) Inc., California Declaration 2017

Compliance Program Pillars

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:

  • Prevent compliance violations through creation of new policies and procedures, Compliance Helpdesk and trainings
  • Respond to these compliance violations - disciplinary actions and consequences for misconduct - including monitoring for compliance effectiveness and continuous improvement
  • Respond to these compliance violations - disciplinary actions and consequences for misconduct - including monitoring for compliance effectiveness and continuous improvement
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Integrity Alliances

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.

Maintaining business integrity allows us to cultivate our reputation

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.

TOP LEADERSHIP

  • Board of Directors
  • Business Ethics Board
  • Group Compliance Officer
  • Working Compliance Committee

REGIONAL LEADERSHIP

  • Regional General Management
  • Regional Compliance Officer
  • Compliance Ambassador

PARTNERS RESOURCES

  • Human Resources
  • Corporate Communication
  • Sustainability
  • Quality and Supply Chain Operations
  • Legal Department
  • Finance and Internal Control
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Anti Corruption Policy

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 personnel shall not pay, offer, authorize, or promise to pay -indirectly or directly- anything of value for the purpose of inducing or influencing a person or entity to, in any way, assist Helsinn in obtaining or retaining business or securing any improper advantage
  • Helsinn also prohibits facilitation payments, small payments or gifts of nominal value to Government Officials that are made to expedite or obtain the performance of routine, non-discretionary governmental actions which are ordinarily or commonly performed by a Government Official
  • Helsinn personnel must not give or accept gifts, payments, discounts, favours or personal services to or from third parties where these would, or might appear to improperly influence them in connection with their work
  • Helsinn personnel may give or accept meals and other entertainment to or from business related contacts only if reasonable, appropriate and infrequent

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.

Helsinn enforces a zero tolerance policies against corruption

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Compliance Team

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.