Ethical Promotion of our products is critical to our mission of providing products and information for the benefit of patients. Our promotional efforts are focused on informing healthcare providers about the benefits and proper use of our products, providing scientific and educational information, and supporting medical research and education.
Ferring’s Compliance Program
Ferring has a well-structured corporate compliance program designed to support legal and ethical actions throughout the Company. It is principally composed of the Chief Compliance Officer and the Corporate Compliance Risk Committee. Ferring’s Effective Compliance Program is as follows:
Elements of the Compliance Program
1. Leadership and Structure
Chief Compliance Officer
The Chief Compliance Officer is responsible for overseeing Ferring’s corporate compliance program, including the monitoring and self-evaluation programs relating to the legal and regulatory obligations of the Company. The Chief Compliance Officer also has responsibility for documenting, researching, investigating and managing all reported activities of alleged non-compliance. The Chief Compliance Officer ensures that there is consistent interpretation of our standards throughout the Company. In addition to investigating matters and promoting compliance with our standards of conduct, the Chief Compliance Officer engages in a number of proactive efforts to strengthen Ferring’s culture of performance with integrity, including the execution of risk assessments, deployment of targeted training, and the delivery of ongoing communications and compliance education initiatives. The Chief Compliance Officer chairs the Corporate Compliance Risk Committee and the Corporate Compliance Oversight Committee. The Chief Compliance Officer reports to the General Counsel of Ferring Group and the President of Ferring Pharmaceuticals U.S.
Your central resource for compliance information and contacts is the compliance section of the Ferring USA website, https://ferringusa.com. The website contains helpful information and other resources about the laws, policies, and procedures summarized in The Guide. On this website, you also can find the name and contact information for the Chief Compliance Officer.
Compliance with Laws and Regulations
We are committed to complying with all laws, rules and regulations relating to Ferring’s business and all Ferring policies, procedures and guidelines. Many aspects of our business are governed by laws and regulations, including the research, development, manufacturing and marketing of pharmaceutical products, and dealings with government agencies or regulatory authorities. Each employee must understand and follow the legal and regulatory requirements, as well as Company requirements, that apply to his or her responsibilities.
2. Written Policies and Procedures
Ferring ensures employees are trained through internal SOPs, Code of Conduct and training curriculum that focuses on addressing risk areas identified in the HHS-OIG Guidance and the requirements of the PhRMA and AdvaMed Codes on Interactions with Healthcare Professionals. Our Code of Conduct specifically focuses on Ferring’s principles with Integrity, our standards and thoroughly outlines Ferring’s Compliance Program. All Ferring employees are provided with literature for Conducting Business with Integrity outlining the responsibilities of the Corporate Compliance Group and colleagues. Additionally, Ferring has adopted policies and procedures to address the specific risk areas addressed in the OIG Guidance and to incorporate the principles of the revised PhRMA code and the revised AdvaMed Code.
3. Effective Training and Education
Ferring provides employees with Compliance training to assist them in meeting the responsibility of conducting Ferring business in an ethical and compliant manner. Each employee is required to certify that he/she has completed this training program. Employees receive annual training that covers Ferring policies and procedures and the laws and regulations that underpin them, including, but not limited to, arrangements with healthcare providers (e.g. consulting agreements, speaker programs).
4. Effective Lines of Communication
Ferring maintains an “AlertLine” to enable employees with a confidential call number to make anonymous complaints regarding accounting or auditing misconduct or violations of the company’s Code of Conduct and to promote a positive work environment. Ferring is committed to a confidential, to the extent allowed by law, and non-retaliatory disclosure process.
5. Internal Auditing and Monitoring
Ferring Pharmaceutical’s Compliance program includes activities to monitor, audit, and evaluate compliance with the Company’s policies and procedures.
In accordance to the OIG’s Compliance Program Guidance, Ferring conducts a targeted approach based on identified and then prioritized risk areas.
6. Disciplinary Guidelines
Ferring Alert Line
The Ferring Alert Line is a toll-free phone number (1-800-446-1494) that you can call to report your concerns about unethical or non-compliant behavior if you are not comfortable discussing them face-to-face. The Ferring Alert Line is available 24 hours a day, 7 days a week. It never uses call tracing or recording devices, and if you wish, you may remain completely anonymous.
The Alert Line representatives will listen to concerns, ask questions, and review the information provided. They will then forward matters to Ferring’s Global Ethics Officer, who will take appropriate action. Callers can also arrange to receive information about the Company’s response to the call.
Violations of Ferring’s compliance policies and procedures subject employees to disciplinary action. Employees who fail to comply with these policies and procedures, or who negligently or willfully fail to detect and report violations of these policies and procedures, will be subject to investigation which could include, up to and including termination.
7. Corrective Action
Ferring’s compliance program is enforced to prevent and detect unlawful and unethical behavior. However, as recognized in the OIG Guidance, no compliance program can completely eliminate the possibility that an individual employee or employees may engage in conduct that would be considered improper. As part of Ferring’s compliance program, internal investigation and corrective action processes have been established to undertake corrective action and preventive measures, which are implemented as appropriate.
Ferring’s reputation and the trust and confidence of those with whom we do business are among our most vital corporate resources. Our company is committed to conducting its affairs in a uniformly ethical manner and pursuant to a standard of fundamental honesty and fair dealing. This standard requires adherence to all laws, regulations, and normal ethical practices that apply to the company’s business activities. Ferring adheres to the PhRMA Code when interacting with its customers and how it approaches its business. A copy of the PhRMA Code can be found on Ferring’s external website www.ferringusa.com by pulling down the “Values” tab and then the “Compliance Policies & Procedures” tab.
Performance with Integrity – A Shared Responsibility
What does it mean to perform with integrity?
Performing with integrity means setting the right priorities and delivering on our commitments while adhering to Ferring’s values and the standards set forth in this guidebook. We do this by:
- integrating integrity into all that we do;
- holding ourselves personally accountable to high ethical standards;
- demonstrating leadership by fostering an environment focused on performance with integrity and accountability.
At Ferring, performance with integrity is not only what we do, it’s who we are.
Prohibition Against Retaliation and Protection of Anonymity
A crucial and all-important value at Ferring is maintaining an environment where people in all parts of the organization feel safe raising concerns and reporting suspected violations of applicable ethical and business standards or laws, rules, regulations or Ferring policies. Ferring prohibits any form of retaliation against any individual, who, in good faith, reports actual or suspected violations of applicable regulations, laws, guidance, or Ferring policy. Ferring personnel who retaliate against individuals who have reported an alleged violation will be subject to disciplinary action, up to and including termination. Ferring’s Compliance Officer, in coordination with the Human Resources Department, will investigate and track any and all reported instances of retaliation against Ferring personnel. In action, Ferring will protect the confidentiality of anyone reporting non-compliance information within the boundaries of the law.
State Compliance Obligations
Marketing with Integrity
Beyond adhering to pharmaceutical industry regulations and standards, Ferring is committed to fair competition as a matter of corporate conduct. We abide by all laws that apply to our marketing activities. Under these laws, it is illegal to use unfair methods of competition or unfair or deceptive acts or practices in commerce.
Examples include, but are not limited to:
- false or misleading advertising, or any other form of misrepresentation made in connection with sales
- bribery of competitors’ or customers’ employees;
- unfair comments about competitors’ products.
Promotional Activities and Interactions with Healthcare Professionals
Regulation of advertising and product promotion directly affects our customer relationships. All colleagues should understand the basic rules Ferring follows to ensure compliance with the laws and regulations regarding promotional activities and interactions with healthcare professionals.
Ferring’s policy, pursuant to applicable law and regulations, is that all promotional materials and communications must be:
- accurate and not misleading;
- balanced, substantiated, and scientifically rigorous; and
- compliant with U.S. medical, legal, and regulatory standards.
Strict regulations govern our relationships with healthcare professionals, including our interactions with physicians, nurses, pharmacists, and others who administer, prescribe, purchase, or recommend prescription medicines. These interactions are not limited to promotional activities; our educational and commercial relationships with healthcare professionals are also strictly regulated.
All interactions with healthcare professionals should be guided by:
- Compliance Code for US-based employees of Ferring Pharmaceuticals, provided in orientation materials;
- Marketing & Sales policies;
- Field Guide on Healthcare Law Compliance;
- PhRMA Code on Interaction with healthcare professionals;
- Advamed Code on Interaction with healthcare professionals;
- Applicable national and regional industry association codes; and
- Applicable laws, regulations, and other industry standards.
Colleagues in sales, marketing, medical, and regulatory functions must also be familiar with Ferring policies and procedures on labeling, promotional programs, product samples, and other relevant policies and procedures.
Monitoring the Safety, Performance, and Quality of Our Products
At Ferring, patient safety is a key priority. Therefore, we must work diligently to understand the safety and tolerability of our products so that we can provide high-quality information regarding their relative risks and benefits to medical professionals, patients, and regulatory authorities.
Understanding a product’s safety profile, as well as its quality and performance characteristics, is essential. These components are extensively monitored during clinical studies. However, it is only after a product has been marketed and used in real-world conditions that its safety profile and performance characteristics become more completely known.
Product Experience Disclosure
Ferring’s robust medical governance process ensures vigilant maintenance of the benefit and risk profile of its products. It also ensures timely communication of all new product information to patients, healthcare professionals, and regulators. Worldwide these stakeholders are fully informed of the uses, safety, contraindications, and side effects of our products and where appropriate, their operational requirements and characteristics. We provide this information using: package inserts;
- mailings to physicians and other healthcare professionals;
- educational and/or promotional materials;
- presentations by our field representatives;
- disclosure of clinical trial results; and
- disclosure of regulatory post-marketing commitments and their status.
The information provided must be consistent with the worldwide body of scientific knowledge pertaining to the relevant products. It must also comply with requirements of Good Clinical Practice and government regulation.
Certain research and business activities may involve the review of patient medical records or the collection of personal medical information. Patient information must be kept strictly confidential, and must only be used or disclosed in accordance with applicable laws and regulations or with the patient’s consent. All employees, contractors and companies working with Ferring must protect and ensure the privacy and security of the health information entrusted to us by patients, consumers, and others.
Communicating Honesty: It is in Everyone’s Best Interest
Integrity is a significant part of our business. Medical professionals trust our research and results. Consumers trust the quality of our products. That is why honest communication about product experience is absolutely essential.
Bribery and Corruption
Ferring has a longstanding corporate policy that prohibits employees or anyone acting on our behalf from providing any payment or benefit to any person or entity in order to improperly influence a government official or to gain an unfair business advantage.
In the U.S., business laws forbid making, offering, or promising any payment or anything of value (directly or indirectly) to a government official when the payment is intended to influence an official act or decision to award or retain business. In our business, we must be particularly sensitive to bribery and corruption issues because governments are often both the regulator of our products and a major customer. We also use the services of healthcare professionals and scientists, many of whom are employees of public institutions and may be considered government officials. For this reason no employee should ever make a payment or provide a benefit that is intended to improperly influence or even appears to improperly influence a government official’s actions.
Ferring also prohibits “commercial bribery,” which is illegal in many countries. Commercial bribery is giving something of value to an intermediary (e.g., an employee of a customer) without his or her supervisor’s knowledge, with the intent to influence the supervisor’s commercial conduct. Ferring prohibits any employee, consultant, middleman, or other agent from directly or indirectly engaging in commercial bribery.
Trade association meetings and other industry gatherings serve legitimate and worthwhile purposes. However, these meetings pose certain risks, as they bring together competitors who might discuss matters of mutual concern and potentially cross the line of non-compliance with competition law obligations. Even joking about inappropriate topics, such as marketing or pricing strategies, could be misinterpreted and misreported. If the conversation turns to any kind of anti-competitive discussion, you should refuse to discuss the matter and leave the conversation immediately.
U.S. Antitrust Laws
The U.S. Antitrust laws are designed to protect competition and the free market. Ferring supports the antitrust laws as a cornerstone of competition. There are severe civil and criminal penalties for violations of the antitrust laws. Ferring employees must comply with the antitrust laws. If an employee has any questions regarding the U.S. antitrust laws, the employee should seek guidance from U.S. counsel.
It is unlawful for competitors to agree on market allocation, prices, discounts, rebates or other terms and conditions of sale of competing products. The agreement does not need to be in writing or even be explicit to be in violation. Antitrust violations have been found based on evidence that representatives of competing companies were present at a meeting where pricing was discussed, and they subsequently adjusted their prices to be substantially the same. No Ferring employee may have discussions with employees of a competitor on any topic without first clearing the discussion with the U.S. Counsel and obtaining antitrust guidance.
Resale Price Maintenance
Some restrictions on which our customers may sell products to their customers may be unlawful. All contracts with customers must be approved by the U.S. Counsel.
It is unlawful to take any action that has the effect of foreclosing the market to any competitor. Actions that have been found to be in violation include pricing below cost and exclusive dealing or tying arrangements. All agreements with customers and all pricing regimens must be approved by the U.S. Counsel.
It is unlawful to give one customer in a given class of trade (e.g., wholesalers) a discount that is not available to other customers in the same class of trade. All agreements with customers and all pricing regimens must be approved by the U.S. Counsel.
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