Governance at Ipsen | Upholding Ethical Business Practices

Governance

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Our governance approach emphasizes integrity and responsibility, prioritizing what’s right over what’s easy. Through our dedication to collaboration and ethical management, we consistently fulfill our promise to enhance lives with innovative healthcare solutions.

François Garnier

EVP, General Counsel and Chief Business Ethics Officer

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Upholding ethical standards for patients and society

At Ipsen, we pride ourselves on our commitment to integrity, transparency and upholding the highest ethical standards. We are fostering responsible management while cultivating a strong ethical mindset that permeates every level of our organization.

  • Doing what is right, not what is easy - delivering our results in an ethical and compliant manner, upholding human rights and anti-corruption, and an environment of integrity.
  • Guided by our strategy: Focus. Together. For patients and society.  Strong corporate governance, Sustainable targets in compensation, and Generation Ipsen program.
  • Success delivered through responsible management – proactive risk management, and crisis management processes.  
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Ipsen’s Code of Conduct

Ipsen’s Code of Conduct is a dynamic blueprint that emphasizes ethical decision-making, transparency and accountability across our diverse operations. This robust framework fuels an unwavering commitment to revolutionizing patient care, cultivating an empowering corporate culture, and exceeding industry standards and regulations.

Combating corruption with ethics and transparency

At Ipsen, we proudly uphold ethical standards, integrity and transparency in all of our endeavors. Robust anti-corruption policies ensure strict adherence to all applicable national and international legislation, accurate financial recordkeeping, and stakeholder interactions based on integrity and merit.

Fight corruption is a pledge in our Code of Conduct, as Ipsen rejects any form of corruption that distorts fair trade, hinders economic development, and imposes multiple costs on society at large.

 

Ipsen’s commitment to conducting business with high standards of ethics is reflected through the Anti-Corruption Program, for a positive societal change under the Generation Ipsen. A dedicated cross-function operational committee works on meaningful anti-corruption initiatives and regularly reports to the Executive Leadership Team.

 

Ipsen has been certified since 2021 to the ISO 37001- International Anti-Corruption Standard for anti-corruption management systems, for the benefit of Patients, Society and Employees.

 

Click for Certification

Ipsen is a dynamic and growing global specialty-care biopharmaceutical group with a focus on transformative medicines in Oncology, Rare Disease and Neuroscience.

In line with our sustainability framework, Generation Ipsen, we recognize our role as a responsible taxpayer to pay our full share of taxes, including corporate income taxes, as part of our contribution to society.  Thus, Ipsen pays its fair share of taxes in all countries where it operates.

The aim of this document is to provide transparency to ensure a proper understanding of the way Ipsen approaches tax policy matters:

  • Our compliance
  • Our tax governance and risk management
  • Our attitude to tax planning
  • Our tax risks
  • Our engagement with Tax Authorities

Our Compliance

 

The tax affairs are managed in a manner that is consistent within Ipsen’s Code for Ethical conduct, to conduct business lawfully and ethically.

Ipsen is committed to observing all applicable laws, rules and regulations in meeting its tax compliance and reporting responsibilities in all jurisdictions where it operates, and to ensuring compliance with all relevant legal disclosure requirements.

 

Our tax governance and risk management

 

The fundamental objective of Ipsen’s tax governance is to guarantee strict compliance and transparency with the applicable tax regulations and ensure adequate supervision of the tax policy implemented by its subsidiaries in all the territories where it operates.

Ipsen applies diligent professional care and judgement, including ensuring that all decisions are taken at an appropriate level and are supported by consistent processes and guidelines and thorough documentation. The tax function is localized in France, UK and the US. The VP Group Tax department reports to the EVP CFO and our tax professionals are committed to the highest compliance standards in tax laws and regulations.

 

Our attitude to tax planning

 

Ipsen’s approach is to pay the correct and fair amount of tax to minimise the risk of uncertainty or disputes. Our tax positions are based on reasonable interpretation of applicable law and are aligned with the substance of the economic activity of our business locally.

We are committed to maintain and follow a transfer pricing policy that is based on OECD Transfer Pricing Guidelines notably the arm’s length standard and the goals of the OECD/G20 Base Erosion and Profit Shifting project (“BEPS”).

Ipsen has a zero-tolerance approach to tax evasion and the facilitation of tax evasion. Ipsen does not undertake aggressive tax planning or artificial tax arrangements. Where available, legitimate tax incentives (for example, R&D tax credits) or exemptions are implemented in the spirit in which they are intended and aligned with our commercial business activities and reputation.

 

Our tax risks

 

Ipsen seeks to comply fully with the tax regulations and actively manages its affairs to minimise the risk of non-compliance by ensuring that tax returns and payments are made on time with proper disclosure made to the tax authorities. We strive for full compliance and are continuously improving our processes, which are based on standardization, simplification and automation.

Areas of uncertainty and complexity of current international tax law are managed by the Tax Department and, in addition, we regularly seek advice from independent external tax advisors to minimize our tax risk.

 

Our engagement with the tax authorities

 

We seek to operate an honest and transparent relationship with all the tax authorities.

We file timely and accurate tax returns, and we respond openly and promptly to any questions that may be raised in relation to our tax returns. Like any multinational company, our tax returns are continuously under audit around the world. In the event a tax authority disagrees with our views on the appropriate tax treatment of a given item, we will work constructively to try to resolve the issue in a timely manner through appropriate methods of dispute resolution.

At Ipsen, we encourage employees to report potential non-compliant or unethical behaviors, fostering a speak-up culture and promoting transparency and accountability. Our Global Whistleblowing Policy is implemented since 2018.

We commit to fairly addressing concerns that come to us. Report any concerns through the Whispli designated Alert Platform or use the email address Ipsen.Ethics.Hotline@ipsen.com.

Ipsen continuously enhances its Business Ethics Program, backed by a robust infrastructure and governance system. By fostering a culture of ownership, accountability and mindful decision-making, we maintain a strong ethical foundation.

Ipsen is committed to ensuring a robust Opportunities and Risks Governance policy, with several strategic and operational committees actively working to identify, assess and address risks and opportunities.

Ipsen recognizes that its third parties play an important role in Ipsen’s success and commitments.  Accordingly, we strive to conduct business with organizations who share Ipsen’s commitment to ethical culture and operate in a socially and environmentally responsible manner.

 

The Ipsen Business Partner Code of Conduct  documents principles and expectations for establishing and maintaining a business relationship with our third parties.

  • Ipsen complies with international and national laws, regulations and codes that prohibit any form of corruption and avoids doing business with entities and/or individuals that are subject to official trade and economic sanctions. Following a risk-based approach, our Global Third Party Program ensures that we work with trusted and reputable third parties, that reasonably operate in a socially and environmentally responsible manner.
  • Ipsen also implemented a Supplier Risk Management process using a unified digital platform and engaging cross-functional risk experts to ensure potential suppliers meet our standards. This approach streamlines assessments and strengthens risk management throughout our organization.
  • Ipsen is committed to high financial compliance standards and has implemented a No PO No Pay approach for a wide majority of spend. This means third parties must have a valid purchase order before starting work and submitting an invoice for payment. Based on the country the third parties will be delivering services or goods to, the purchase order terms and conditions may slightly differ. Please click below for the applicable Purchase Order Terms & Conditions. Purchase Order Terms and Conditions 
  • We conduct supplier qualification and regular risk-based due diligence across our value chain, which involves ensuring that our expectations for human rights, among other topics such as anti-corruption and a sustainable environment, are addressed at the earliest stages of the third party engagement.

At Ipsen, we care about protecting the personal data of all our stakeholders. We ensure that we only use personal data as necessary, that our use of that data is lawful and fair, that we keep data secure, and that we inform individuals about how we use their data. We manage privacy compliance at Ipsen through policies, procedures and training, and by fostering a strong culture of respect for privacy.

We are committed to fostering transparency and trust in all of our collaborations with healthcare professionals (HCPs) and healthcare organizations (HCOs). By openly disclosing information on transfers of value, clinical trials, scientific publications and interest representation activities, we ensure integrity and promote a strong ethical foundation across our interactions.

 

Transparency rules and reports

 

Please follow the links to the countries to find the information about local Transparency rules and reports:

 

Austria

 

Belgium

 

Bulgaria

  • No transfer of value in 2018, 2019, 2021, 2022
  • 2020 EFPIA report in euro: Bulgarian
  • 2023 EFPIA report in lev: Bulgarian
  • Methodological note: English

 

Croatia

  • 2017 EFPIA report in euro: English
  • 2017 EFPIA report in kuna: English
  • No transfer of value in 2018, 2019, 2020, 2021, 2022, 2023
  • Methodological note: English

 

Cyprus 

  • No Transfer of value in 2018, 2020, 2021, 2022
  • 2019 EFPIA report in euro: English
  • 2023 EFPIA report in euro: English
  • Methodological note: English

 

Czech Republic

 

Denmark

 

Estonia

 

Finland

 

France

 

Germany

 

Greece

  • 2019 EFPIA report in euro: Greek
  • 2020 EFPIA report in euro: Greek
  • 2021 EFPIA report in euro: Greek
  • 2022 EFPIA report in euro: Greek
  • 2023 EFPIA report in euro: Greek
  • Methodological note: Greek

 

Hungary

 

Iceland

  • No Transfer of value in 2018, 2019, 2020, 2021, 2022, 2023

 

Ireland

 

Italy

 

Latvia

 

Lithuania

 

Luxembourg

  • 2019 EFPIA report in euro: English
  • No Transfer of value in 2020
  • 2021 EFPIA report in euro: English
  • 2022 EFPIA report in euro: English
  • 2023 EFPIA report in euro: English
  • Methodological note: English

 

Malta

  • No Transfer of value in 2018, 2019, 2020, 2021, 2022, 2023
  • Methodological note: English

 

Norway

 

Poland

 

Portugal

 

Romania

 

 

Russia

 

Serbia

  • No Transfer of value in 2018, 2019
  • 2020 EFPIA report in euro: English/ Serbian
  • 2021 EFPIA report in euro: English
  • 2022 EFPIA report in Serbian dinar: English
  • 2023 EFPIA report in Serbian dinar: English
  • Methodological note: English

 

Slovakia

  • Methodological note: Slovak

 

Slovenia

  • No transfer of value in 2018, 2019, 2020
  • 2021 EFPIA report in euro: English
  • 2022 EFPIA report in euro: English
  • 2023 EFPIA report in euro: English
  • Methodological note: English

 

Spain

 

Sweden

 

Switzerland

 

The Netherlands

 

Ukraine

United Kingdom 

 

Ipsen actively collaborates with patient organizations to better understand and support patients’ needs. Emphasizing transparency, we publicly disclose financial and non-financial support provided to these organizations in adherence to the EFPIA Code.

 

Based on our dedication to transparency and under the EFPIA Patient Organizations Code, we make a list of patient organizations to which we provide financial support (grants, sponsorships, donations, etc. etc..) or significant non-financial support publicly available for viewing.

 

Ipsen is committed to transparency in clinical research, providing readily accessible information to patients, healthcare professionals and researchers. Ipsen provides access to clinical data while ensuring patient anonymity and the protection of commercially confidential information. Our approach is aligned with the Pharmaceutical Research and Manufacturers of America (PhRMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) Principles for Responsible Clinical Trial Data Sharing (efpia.eu), which came into force in January 2014.

 

  • Study Registration: Ipsen discloses study information by registering studies and posting technical study results summaries on global and national public study registries in compliance with regulatory requirements and global industry standards.
  • Access to Clinical Data: Ipsen shares clinical data such as patient-level data and study documents with qualified scientific and medical researchers upon request. We publish anonymized clinical reports on agencies’ websites according to global and local legislations. We also collaborate with agencies and national competent authorities as necessary to allow access to documents containing information on our research.
  • Scientific Publication: Ipsen commits to submit for publication and/or present results of clinical trials, whatever the outcome, in biomedical journals, and/or at international congresses and at scientific meetings. Ipsen aims to provide open access to all Ipsen-affiliated research, ensuring free and unrestricted online availability of journal articles.
  • Lay/Plain Language Summaries: Ipsen publishes study summaries and journal publication summaries in easily understandable language.

Additional information on Ipsen Clinical Data Transparency is available when clicking on the below button.

Ipsen does not have internal animal research facilities. Although Ipsen outsources its animal testing, it has put in place an Animal Welfare governance body ensuring the appropriate treatment of animals. We are signatories of Gircor’s “French Charter for Transparency on the Use of Animals for Scientific and Regulatory Purposes,” and actively pursue the 3Rs: reduction, refinement and replacement of animal experimentation.

 

Patients and society are at the core of Ipsen’s mission to improve lives and health outcomes. Biological and medical research are critical to continuously increasing scientific knowledge and improving human health. While animal studies continue to play an important role in the medical research process and in the development of treatments improving the quality of life of millions of people, it is our priority to meet the highest possible standards of animal welfare. That’s why we are among the signatories of the “French Charter for Transparency on the Use of Animals for Scientific and Regulatory Purposes” developed by the GIRCOR.

 

Ipsen’s Cell-Based Assay is now fully implemented for its DYSPORT® products supplied to the U.S., Canada, E.U. and Switzerland.

Ipsen’s vision is to be a leading global biopharmaceutical company focused on innovation and Specialty Care and our mission is to improve patients’ lives through innovative new medicines

 

Ipsen commits to enable Early Access to patients to Ipsen medicines which are not yet approved by local Health Authorities, hence not yet available for prescription, when the Ipsen medicines is considered as eligible for Early Access.

 

What is “Early Access”:

Ipsen defines “Early Access”1 as access to:

  1. Unapproved medicine for the requested indication in the country where the request comes from
  2. For life-threatening or serious medical conditions
  3. Where there is no satisfactory alternative therapy available for the given medical condition
  4. Where there is no alternative option for the patient to participate in an ongoing clinical trial in the given indication
  5. Where the medicine has reasonable medical evidence of the positive balance of benefits/risks in the given indication and the medicinal product has started the regulatory process of approval in the US and/or the EU

Early Access can only take place if it is allowed within the local laws, rules and regulations or specifically approved in writing by local authorities.

 

The physician and the patient should discuss the expected benefits, known and potential unknown risks before seeking Early Access to a medicinal product.

 

In some cases, Ipsen may set up a program designed to provide Early Access to several patients in defined countries.

 

The list of Ipsen’s Early Access Programs in the United States is available on www.clinicaltrials.gov.

Request for Early Access to an Ipsen medicine:

 

Who can request Early Access?

Only qualified Physicians can make requests for Early Access to an Ipsen medicine once they have exhausted all other appropriate and available options to treat the medical condition of their patient, including enrollment in a clinical trial.

 

How can the Physician contact Ipsen and make a request?

Physicians can contact Ipsen and send a request for Early Access to: GlobalMedInfo@ipsen.com

 

What will happen to the request?

When the request is received by Ipsen, Ipsen will send an acknowledgement of receipt of the request within 48 business hours. The request will be assessed by Ipsen medical affairs fairly, as promptly as possible and after a thorough discussion with the Physician as necessary.

 

The decision will be based on at least the following criteria:

  1. The conditions for Early Access are met
  2. Patient’s individual medical conditions
  3. Ipsen medicine availability
  4. Regulatory and health system environment where the request has come from (e.g. to make sure a Pharmacovigilance structure is in place)

 

What will happen if the request is approved? 

If the request for Early Access is approved by Ipsen, the Physician must collect and complete all necessary documents to comply with appropriate rules and regulations – as quickly as possible. Once collected, Ipsen will send the Physician the requested Ipsen medicine for Early Access to treat their patient.

 

The physician must commit to the regulatory obligations including reporting of adverse events during the entirety of the Early Access.

 

What will happen if the request is not approved?

Ipsen is committed to Early Access but the company cannot guarantee approval and regrets that there are occasions where it is not appropriate for the company to provide Early Access to its medicine or where the request does not fall within the definition of Early Access. In these circumstances we commit to provide a timely response and clear rationale for the decision.

 

1Other terms commonly used: Compassionate Use, Early Access, Expanded Access Program, Managed Access Program, Patient Access Program, Special Access Program, Scheme Access Program, Temporary Use Authorization and Pre-approval access.