Material aspect 3: Conducting business ethically and responsibly

At Galapagos, our core business is the discovery and development of drugs with novel modes of action, and we prioritize ethical behavior in all its aspects.

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, efficacy and safety of these products before granting approval.

However, Galapagos explicitly forbids animal neglect or cruelty. We have implemented practices that demonstrate our commitment and responsibility to reduce and replace non-clinical testing involving use of animals to the extent possible, and we will continue to 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” strategy: Refinement, Reduction, and Replacement. The 3Rs 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 DEREK software, in vitro micronucleus assays to evaluate genotoxicity, and in vitro hERG assays to evaluate cardiotoxicity. Other improvements include the implementation of PCLS precision cut (liver /lung), imaging for longitudinal studies, the definition of humane endpoints, the review of procedures by the ethical committees and animal welfare committees. Our focus on animal welfare triggers a continuous improvement of, amongst others, the housing conditions of animals, accurate anesthesia or analgesia of animals, refinement of euthanasia methods, better enrichment of the animal environment (food, games, social activities), zootechnical registry reporting anomalies, and the use of statistical methods in order to reduce the number of animals.

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) and Croatia (Fidelta 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.

Outside of the European Union, we require compliance with local animal welfare regulations in laboratories. In the U.S., for example, we only work with laboratories that are accredited by the Association for Assessment and Accreditation of Laboratory Animal Care.

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 the 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. 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) also form the ethical foundation for our trial activities. We comply with laws and regulation 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, and we only conduct clinical trials in countries where we intend to market our drugs.

Overall, it is our policy that the interest, safety, and well-being of trial subjects 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 the 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.

Any adverse events are monitored and reported to authorities and ethical committees as needed, and appropriate actions are taken when needed.

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 patients, 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.

We publish our trials on the appropriate clinical trial registries (clinicaltrials.gov and the EudraCT Trial Registry) in a timely manner. 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’ board of directors is responsible for administering the Code. The board of directors 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: www.glpg.com/charters-and-codes.

Our suppliers are required to adhere to contractual terms that include anti-bribery and anti-corruption provisions. We have a purchase policy in place that includes selection criteria for the qualification of our suppliers in line with CSR aspects (and this ranges from, for example, no child labor to selecting coffee suppliers who work with respect for farmers and the environment). Our general terms and conditions of purchase also contain a specific clause on anti-bribery and anti-corruption, and we aim to implement a CSR questionnaire for hotels as part of our travel policy.