Material aspect 3: Conducting business ethically and responsibly

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: in preclinical and clinical trials, expanded access to medicines currently in development for patients who are not eligible to enroll in clinical trials, clear and adequate information to patients, clinical trials that are tailored to the needs of patients and investigational site staff 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, available on our company intranet.

Animal welfare in drug development

Regulatory authorities worldwide require that new medicines are evaluated in both animals and humans to ensure the quality, safety and efficacy of these products before granting approval. Without animal testing, no new medicines would be approved.

We created the Galapagos Animal Welfare Committee in 2019 to oversee animal welfare activities and to support the scientists in charge of animal testing. The Animal Welfare Committee put a framework in place to enforce animal welfare best standards (policy, KPI, laboratory evaluations and audits, recommendations, mitigation and corrective actions, regulatory and legal actions) and to ascertain that our ethical values are well understood by our partners. The Animal Welfare Committee reports directly to the Development and Research Management Committees and CEO of Galapagos, and in addition to its advisory role, the Committee will regularly evaluate animal study practices.

Galapagos explicitly forbids the unethical treatment of animals, such as neglect or cruelty, and strives to provide animals with a good quality of life, while constantly seeking ways to make improvements.

For non-clinical 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.

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 implement alternative methods. We make more frequent use of in silico (computer modelling) and in vitro (cellular testing) study designs and approaches. Examples are the implementation of new modelling and simulation approaches for supporting the toxicity assessment of our compounds as well as the use of in vitro cardiomyocyte assays to allow for the early assessment of potential cardiotoxicity 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 are engaged in several 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 (group vs single housing, size of cages), enrichment of the animal environment (food, games, social activities), reviewing any irregularities, 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 carry out a thorough assessment of all third parties and release an animal welfare policy that clarifies our expectations.

In Europe, compliance 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 laboratories we engage with on a regular basis. Outside the European Union, we require compliance in laboratories with local animal welfare regulations. 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. We also follow the national regulations defining high standards for animal welfare for our internal studies in France. We systematically submit our projects to the National Authorities for ethical approval and are regularly inspected in order to maintain the highest accreditations.

Our clinical trials ethics

Galapagos sponsors and conducts clinical trials in accordance with 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 Harmonization. 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 such as The Belmont Report, Council for Coordination of International Medical Congresses guidelines, The Nuremberg Code, United National Educational, Scientific and Cultural Organization’s (UNESCO) 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, the EU Directive on Clinical Trials and the EU Clinical Trial Regulation (when applicable). 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 and commerce.

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 the risks and potential benefits. Participants are duly informed that they can withdraw from the trial at any time, without any explanation, and then will receive appropriate 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 adopts risk-management strategies to support safe and ethical conduct of Galapagos studies.

An Independent Data Monitoring Committee (IDMC) may be introduced 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 are independent from Galapagos and are composed of members with no 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 therefore, independent of the outcome, make patient study results available 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 committed 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 Galapagos-sponsored Phase 2 to 4 clinical trials publicly available within 6 months of completion for pediatric studies, and 12 months for adult studies. As discussed above in Material aspect 1, we provide publicly available open access to our publications in peer-reviewed journals free of charge. 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.

In some rare cases, patients are unable to participate in clinical trials and have exhausted all available treatment options. Here, Galapagos has a policy in place to assess whether the investigational product can be offered to a patient outside of a clinical trial, through a program called 'expanded access’, also often referred to as 'compassionate use’. A full copy of our Expanded Access Policy can be found on our website.

Patient safety for our first marketed product

We currently have one product, Jyseleca, on the market in the European Union, and Great Britain. Adverse events and other information relevant to assess the benefit/risk profile of Jyseleca are collected and evaluated by Galapagos in the frame of its pharmacovigilance system. Individual and aggregated reports are submitted to the authorities as required. When needed, appropriate actions are taken to ensure a positive benefit/risk balance for our patients. The Safety Management Team, overseen by the Safety Board, enables timely evaluation of accumulating safety data and adopts risk-management strategies to support the marketed product. Galapagos has a Qualified Person for Pharmacovigilance who ensures the function of the pharmacovigilance system and continuous monitoring of the benefit/risk profile of Galapagos’ marketed products.

Our Code of Conduct

In 2021, we refined our Code of Conduct to fully reflect what it means to ‘Make it Happen the Right Way’ at Galapagos.

Like a compass, our Code is there to navigate and steer us in the right direction, enabling us to feel confident and proud of the choices we make, however hard they may be.

The new Code includes specific guidance to ensure that we live by the principles that are important to us, as members of the Galapagos team:

• Putting patients first
• Acting ethically and with integrity
• Being thoughtful and considered in our actions
• Speaking up for what is right
• Maintaining individuality and diversity
• Holding ourselves accountable for our actions

Galapagos’ supervisory board is responsible for administering the Code. Our Compliance & Ethics function is responsible to for designing and implementing the code through our Compliance & Ethics Program and this is done in close collaboration with our General Counsel.

We expect our supervisory board members, management board members, and employees to exercise reasonable judgment when conducting our business and encourage them 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 ethically, with integrity and respect for human rights. We expect them to turn away from conflicts of interest, corruption, and fraud. All Galapagos employees and officers are required to read and absorb the Code which is also available on our company 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 that we are working with. Our general terms and conditions of purchase also contain a specific clause on anti-bribery and anti-corruption.

Making it Happen the Right Way - The Making Of…

Time for Change: the Why…

As an organization, we are coming through some significant changes not least having recently been joined by our colleagues from Gilead. So now, more than ever, it is of key importance that we take the time to think about our culture and what it means to be a member of the Galapagos team; No better time for us to launch our new Code.

Like a compass, our Code is there to navigate us and steer us in the right direction, enabling us to feel confident and proud of the choices we make, however hard they may be.

Meet our Compliance & Ethics Team: the Who…

The project to revamp our new Code of Conduct was led by our Compliance & Ethics team, headed by Stephanie Wingrove, our Head of Compliance & Ethics. We asked her and the team what inspired them to create this new Code;

Q: The new Code looks and feels dramatically different to our old Code, and to those of the majority of our peers. What inspired you?

A: Our team was really keen to create something that was unique to Galapagos. As a team, we are interested in how we can use the principles of behavioral science to influence behavior within our organization and this was at the forefront of our minds when we were creating the Code.

Q: Could you give us an example of how you did this?

A: Yes, we have a few! For example, it was really important that the language, tone and imagery we used was likely to trigger an emotional response in our readers. This is important because by doing this, the document is far more likely to resonate with our people and to stick in their minds. People are far more likely to “sign up” to a Code that has made them feel something and which aligns with their own personal values.

Q: The Code incorporates quotes from employees across our organization- why did you choose to include these?

A: This was about more than just including the quotes in our Code. For us, it was key that our employees were engaged in the process of building the code and that their contributions played a part in the final product- this is so important to ensure buy-in. As you can imagine, we received a high number of quotes, and unfortunately not all could be included in the Code itself. But they weren’t wasted; we incorporated these into our communications campaign for the new Code so that everyone who participated saw the value of their contribution.

Q: This all sounds great. So, what next for the Code and the Compliance & Ethics team?

A: Well, Chapter 4 of our Code states that at Galapagos, we Speak Up for what is right. Cultivating an environment in which every member of our team feels safe and empowered to use their voice is a key part of building a strong culture. So, we will be rolling our Speak Up/ Listen Up campaign over the course of 2022. We’d love to come back next year to tell you all about it!

Not your average Code of Conduct: the How…

We raised the Bar

By creating a Code that stands out from anyone else’s. A Code that others will want to emulate

• We chose a title that reflects and connects with who we are
• Aligned with our corporate vales and therefore meaningful to every member of our organization
• Custom-made and unique to Galapagos- not something that could be copied and pasted into any other organization. Resonates uniquely with Galapagos team members

We Made it Happen

By creating a Code that helps every member of the Galapagos team to make it happen the right way

We must not only imagine a better future for patients; we must work consistently: make it happen to make a difference and do it the right way to harvest meaningful and lasting results. We must prioritize humanity and quality above all.

Alessandra Oortwijn

Senior Medical Director

• Every member of the Galapagos team was asked to provide their thoughts on what “Making it Happen the Right Way” meant to them
• Our Code was built with these thoughts as our foundation and throughout the Code, are quotes provided by members of our team
• Our Code was built by Galapagos people, for Galapagos people