We believe that ethical behavior when discovering and developing drugs touches particularly on these key areas for us in this point in our corporate development: preclinical and clinical testing, expanded access to drugs currently in development, and our codes of ethical conduct while doing business.
We are required by law to carry out preclinical testing of our product candidates. For preclinical development studies including those that help assess safety, pharmacology, toxicology, and absorption, distribution, metabolism and excretion of our product candidates, we strive to follow the “Three Rs” (3Rs) of Refinement, Reduction, and Replacement in our preclinical testing involving use of animals. For example, we plan to use more in silico (computer modelling) and in vitro (cellular testing) designs and approaches for assessing pharmacodynamics, for example, DEREK software and in vitro micronucleus assay for evaluating genotoxicity, in vitro hERG assay for evaluating cardiotoxicity. These examples show how we reduce and replace preclinical testing involving use of animals.
In addition, we follow Directive 2010/63/EU1Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals uses for scientific purposes, OJ L 276, 20 October 2010 in Europe with regards to preclinical 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 preclinical testing, and we monitor animal welfare in the European laboratories that we have engaged on a regular basis. We require compliance with local animal welfare regulations in laboratories outside of the European Union. In the United States, for example, we work only 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) and Good Pharmacovigilance Practice guidelines of the International Council for Harmonisation. Our adherence to these internationally recognized guidelines ensure 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, the EU Directive on Clinical Trials2Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use, OJ L 121, 1 May 2001, etc.
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 the trial subject will always supersede the interests of science, commerce, as well as those of society.
Our trials are only initiated if they are scientifically and medically justified and when they have external validation by clinical experts, and will always be reviewed by local health authorities and ethical committees before they are initiated. Trial participants (or the 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 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 taken.
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 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 or at relevant scientific meetings and congresses. As a publicly listed company we may also have obligations to communicate trial results by other means, such as via press releases.
Expanded access policy
In our pursuit of the development and commercialization of novel medicines that will improve people’s lives, we encourage patients to participate in clinical trials whenever possible. These clinical trials are critical to developing the information (or data) needed to evaluate investigational products and seek their approval by health authorities, such as the FDA and the EMA. In rare cases, patients are unable to participate in clinical trials and have exhausted all available treatment options. In these cases, Galapagos may consider providing an investigational product outside of a clinical trial, through a program called “expanded access.” Expanded access is also often referred to as “compassionate use.” A full copy of our Expanded Access Policy can be found on our website.
Our code of business conduct and ethics
We have established a code of business conduct and ethics (the code) to ensure that our directors, officers and employees are making ethical and legal decisions when conducting Galapagos’ business and performing their day-to-day duties. We expect our directors, officers and employees to conduct business with integrity, ethics and respect for human rights. We expect them to turn away from conflicts of interest, corruption and fraud. To this end, we give trainings on this code to our employees. The code is available at www.glpg.com/charters-and-codes.
Our suppliers are required to adhere to contractual terms that include anti-bribery and anti-corruption provisions. Our general terms and conditions of purchase also contain a specific clause on anti-bribery and anti-corruption.
Business ethics - actions 2018
- We completed an Animal Welfare Agency audit in Romainville. There were no citations recorded
- We formalized our clinical trials ethics policy
- We established a compassionate use policy, in compliance with the 21st Century Cures Act in the U.S.
- We trained 93% of all employees in our codes of conduct, including insider trading, and other policies required by Sarbanes-Oxley
- We were not informed of any breaches of our code of business conduct and ethics in 2018
- Promote the 3R’s further in preclinical testing
- Monitor and adjust training to ensure full compliance with our business ethics guidelines
1 Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals uses for scientific purposes, OJ L 276, 20 October 2010
2 Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use, OJ L 121, 1 May 2001