Material aspect 3: Conducting business ethically and responsibly
We believe that ethical behavior is particularly important and inherent to our business: preclinical and clinical testing, access to our investigational medicines through our clinical trials, expanded access to drugs currently in development for patients who are not eligible to enroll in clinical trials, and our codes of ethical conduct.
To ensure our business is compliant with regulatory and corporate policies, and that we conduct business in an ethical way, we have developed a Compliance and Ethics Program that is available on our company intranet.
Animal welfare in drug development
It is not possible to examine the complex interactions in a living organism solely by use of modeling and in vitro studies. In vivo studies remain essential in discovery, development and production of new medicines. Moreover, regulatory authorities worldwide require that new products have been evaluated in both animals and humans in order to ensure the quality, safety and efficacy of these products before granting approval. Without animal testing, no new medicines would be approved.
Galapagos explicitly forbids the unethical treatment of animals, such as animal neglect or cruelty, and strives to offer the animals a high quality of life, while constantly seeking ways to make improvements. We have implemented practices that demonstrate our commitment and responsibility to refine, reduce and replace non-clinical testing involving use of animals to the greatest extent possible, and we will continue to research, promote, and further implement alternative methods. For non-clinical development studies, including those that assess efficacy and safety of our product candidates, we firmly stand behind the “Three Rs” principle: Refinement, Reduction, and Replacement. The Three Rs principle is based on the premise that animals should be used only if a scientist’s best efforts to find a non-animal alternative have failed, and that when animals are needed, only the most humane methods should be used on the smallest number of animals required to obtain valid information.
To illustrate this point, we make more frequent use of in silico (computer modelling) and in vitro (cellular testing) designs and approaches. Examples are the implementation of in silico software, and in vitro assays to allow for the early assessment of potential safety issues. Other improvements include the implementation of new pharmacological models reducing animal-based development or the review of procedures by the ethical and animal welfare committees. We recently published an article on a novel in silico approach,1Bercu J et al. A cross-industry collaboration to assess if acute oral toxicity (Q)SAR models are fit-for-purpose for GHS classification and labelling. Regulatory Toxicology and Pharmacology 120 (2021) 104843 which was awarded by the Society of Toxicology. We are engaged in a number of partnerships, including the Virtual Human Platform, an organization that aims to accelerate the transition to animal-free safety assessments through innovation in data science, human tissue culture models and transition management.
Our focus on animal welfare triggers a continuous improvement of, amongst others, the housing conditions of animals, better enrichment of the animal environment (food, games, social activities), reviewing any anomalies, and the commitment to immediate action. We expect the same ethos from third parties we work with such as Contract Research Organizations (CROs) and academia. We performed a thorough assessment of all third parties and have regular interactions with them on, for example, the culture of care, enrichment best practices, group housing vs single housing, and the size of cages.
In addition, we follow Directive 2010/63/EU in Europe with regards to animal testing. The requirement to be compliant with Directive 2010/63/EU forms part of the pre-assessment and selection process of the European laboratories that we use for non-clinical testing, and we monitor animal welfare in the European laboratories we engage with on a regular basis.
We also follow the national regulations defining high standards for animal welfare for our internal studies in France (GLPG internal facility). We systematically submit our projects to the National Authorities for ethical approval, and are regularly inspected in order to maintain the highest accreditations. We subcontract our preclinical safety studies to CROs that are committed to the highest standards in animal welfare and that are regularly inspected by their respective National Authorities. We demand the same level of diligence and compliance from all our suppliers, and perform regular audits.
Outside of the European Union, we require compliance with local animal welfare regulations in laboratories. In the U.S., for example, we work only with laboratories that are accredited by the Association for Assessment and Accreditation of Laboratory Animal Care.
We are proud that the Animal Welfare Committee we implemented in 2019 continues to put a framework in place for future discussions, to enforce animal welfare best standards and to ascertain that our ethical values are well understood. The Animal Welfare Committee reports directly to the Development Management Committee and CEO of Galapagos, and in addition to its advisory role, the Committee will regularly organize audits to assess animal study practices. Its mission's to conduct gap analyses on Galapagos’ expectations and to ensure compliance in all our partnering animal facilities, to exchange and agree on best practices across all sites, to develop key policies and SOPs, to define KPIs and monitor the effort and progress, and to communicate on our ethical values, both internally and externally.
Our clinical trials ethics
Galapagos sponsors and conducts clinical trials in accordance with the applicable international standards. The fundamental guidelines are the Declaration of Helsinki (and its amendments) and Good Clinical Practice (including amendments), as well as Good Pharmacovigilance Practice guidelines of the International Council for Harmonisation. Our adherence to these internationally recognized guidelines ensures the rights, safety and well-being of participants in our clinical trials. In addition, other international guidelines like The Belmont Report, Council for Coordination of International Medical Congresses guidelines, The Nuremberg Code, United National Educational, Scientific and Cultural Organization’s (Declaration on Bioethics and Human Rights) form the ethical foundation for our trial activities. We comply with laws and regulations in the countries/regions in which we are conducting our trials, including the U.S. Code of Federal Regulations and the EU Directive on Clinical Trials.
Furthermore, we uphold our own internal procedures and standards for clinical trials, irrespective of the country in which the trial is conducted.
Overall, it is our policy that the interest, safety, and well-being of trial participants and patients will always supersede those of science, commerce, as well as those of society.
Our trials are only initiated if they are scientifically and medically justified and when they are externally validated by clinical experts. Moreover, they will always be reviewed by local health authorities and ethical committees before initiation. Trial participants (or their legally authorized representative) must give written consent after being properly informed of the trial, including of its risks and potential benefits. Participants are duly informed that they are able to withdraw from the trial at any time, without any explanation, and then will receive appropriate standard care.
We or our representatives conduct regular site monitoring visits to ensure that clinical trials are conducted in accordance with the applicable approved study protocol.
Adverse events are monitored and reported to authorities and ethical committees as needed, and appropriate actions are taken when needed. Our Safety Monitoring Committee enables timely evaluation of accumulating safety data of ongoing studies, and adapts risk-management strategies to support safe and ethical conduct of Galapagos studies. An Independent Data Monitoring Committee (IDMC) may be installed to act as an advisor to Galapagos on whether to continue, modify, or terminate a trial based on periodic assessment of trial data. The IDMCs remain independent from Galapagos and are composed of members with no relevant conflicts of interest.
Our trials ensure proper indemnification of participants in case a product candidate or trial procedure causes bodily harm.
We favor transparency and make results from our clinical trials conducted in patients available independent of the outcome – to physicians, and researchers, with full consideration for protection of patient data privacy and commercial confidentiality. We report the outcome in accordance with the CONSORT Statement, or Consolidated Standards of Reporting Trials, designed to improve transparency around clinical trials.
Clinical trials and summary results are registered on Clinicaltrials.gov and/or the EU Clinical Trials Register. Starting 1 January 2021, we commited to registering Galapagos-sponsored Phase 1 to 4 clinical trials conducted in any geographical territory. We commit to making a summary of the results of these Galapagos-sponsored Phase 2 to 4 clinical trials publicly available within 6 months of completion for pediatric studies and 12 months for adult studies. We attempt to publish results in peer-reviewed journals, in accordance with Good Publication Practice and the International Committee of Medical Journal Editor’s Uniform Requirements for Manuscripts Submitted to Biomedical Journals, and at relevant scientific meetings and congresses. As a publicly listed company, we also have the obligation to communicate trial results by other means to the investor community, such as via press releases.
Our code of business conduct and ethics
We have established a Code of Business Conduct and Ethics (the "Code”) that outlines the binding principles of business conduct and ethical behavior that is expected from all our staff and third parties working on behalf of Galapagos.
Galapagos’ supervisory board is responsible for administering the Code. The supervisory board has delegated day-to-day responsibility for administering and interpreting the Code to our General Counsel who has been appointed as our Compliance Officer under this Code.
We expect our directors, officers and employees to exercise reasonable judgment when conducting our business. We encourage our directors, officers and employees to refer to this Code frequently to ensure that they are acting within both the letter and the spirit of this Code.
We expect our employees and third-party suppliers to conduct business with integrity, ethics and respect for human rights. We expect them to turn away from conflicts of interest, corruption, and fraud. Our Code of Business Conduct and Ethics is a mandatory training and is available on our website.
Our suppliers are required to adhere to contractual terms that include anti-bribery and anti-corruption provisions. We consider CSR criteria in our vendor selection process as appropriate for the type of vendor with which we are working. Our general terms and conditions of purchase also contain a specific clause on anti-bribery and anti-corruption.
Actions in 2020
- With regard to animal welfare, in 2020, we implemented our Animal Welfare Committee, and agreed on KPIs. Its mission is to further exchange and agree on best animal welfare practices across all sites, to develop key policies and SOPs, to define KPIs and monitor the effort and progress, and to communicate on our ethical values, internally and externally
- The Animal Welfare Committee is composed of a diverse team of scientists and non-scientists, and reports directly to the Development Management Committee and CEO of Galapagos. In addition to its advisory role, the committee will regularly organize audits to assess the animal study practices
- The Animal Welfare Committee took more than 20 major “R” initiatives and made decisions that supported our “Three Rs” philosophy, and included this in our selection process for non-clinical partners
- In aiming to create value for patients around our clinical trial activities, several new roles were created in 2020 to engage with patients and patient organizations
- 93.5% of our employees completed the training on our Code of Business Conduct and Ethics
- During the onboarding process of new employees, we emphasize the importance of our Compliance & Ethics Program, our Code of Business Conduct and Ethics and all channels available for them to raise questions and concerns
- We will continue to evaluate our internal processes and KPIs with regard to animal welfare in the Galapagos Animal Welfare Committee, for all our internal and external facilities
- We will monitor the progress made and report it yearly
- We will continue to maintain and expand our focus on patients, amongst others by co-creating our Patient Partnership Charter with patient representatives, and by obtaining patient insights, for example when designing new trials
- We will explore innovative tools and processes to reduce clinical trial burden on patients and sites
- We will share easy to understand study results with patients, per EU Clinical Trial Directive No 536/2014
- We will further strengthen the Galapagos Compliance & Ethics Program to meet the changing needs of our organization through:
- Developing and rolling out a new Code of Conduct - titled "Making It Happen The Right Way" to reflect the ongoing changes that are relevant to Galapagos
- Promoting our culture of speaking up both internally and with external stakeholders
- Refining our third-party oversight through an enhanced risk assessment framework and due diligence as we enter new geographies
1 Bercu J et al. A cross-industry collaboration to assess if acute oral toxicity (Q)SAR models are fit-for-purpose for GHS classification and labelling. Regulatory Toxicology and Pharmacology 120 (2021) 104843