Scientific advances can spark controversial debates over ethical questions. We want to make responsible use of the growing potential of the life sciences to maximize benefit for both humankind and other living beings. In this context, it is important to us that we adopt our own position on bioethical questions.
Our approach to ethical business conduct
As a science and technology company with a broad spectrum of research activities, it is critically important for us to identify and address emerging bioethical topics and questions early on so that we can define our own position. Although we align all our operations with international and national laws, many technological developments raise new ethical questions that extend far beyond the framework set forth by current legislation. Our goal is to conduct research in a responsible manner, which is why we develop ethical guidelines – also in close collaboration with external experts – in order to make well-founded decisions for responsible research.
In our work, we encounter various topics of ethical relevance such as animal testing, clinical research, stem cell use, the use of genetically modified microorganisms, and the potential impact of new genome editing techniques such as CRISPR/Cas. Moreover, we discuss in our committees the ethical aspects of providing products such as organoids for both academic research purposes and the biopharmaceutical industry.
We carefully evaluate our position when it comes to controversial topics. We always prioritize the well-being of and benefit for various groups of patients, whether in clinical studies or during treatment with our medicines.
Roles and responsibilities
Since 2010, our Ethics Advisory Panel for Science and Technology (MEAP) has been making clear recommendations on ethical questions in science and technology as well as on questions extending beyond the field of traditional bioethics, in line with our transformation into a science and technology company. The recommendations of the MEAP guide our actions and business activities.
The members of the MEAP are renowned international experts from the fields of bioethics, medicine, philosophy, law, and the natural sciences as well as technology and sustainability. The MEAP has its mandate from the Executive Board and is chaired jointly by the two members of the Executive Board with responsibility for the Healthcare and Life Science business sectors.
The MEAP meets multiple times a year and can also be convened on an ad-hoc basis in response to emerging urgent ethical questions. The meeting minutes can be accessed on our intranet, along with the recommendations given by the MEAP. Our employees can submit topics for the MEAP to the Bioethics team. If necessary, we involve further external experts. In addition, all employees may address their concerns to the Bioethics team via our compliance hotline and a dedicated e-mail address (accessible via the intranet).
A further board, the Stem Cell Oversight Committee (SCROC), reviews and decides on all planned in-house research activities involving the use of human embryonal or pluripotent stem cells, ensuring compliance with legal requirements as well as our ethical guidelines. This also applies to joint projects with external partners. Up until the end of 2022, the SCROC consisted of internal experts from our business sectors as well as external advisors from the fields of bioethics, medicine, and law. In 2023 and in line with a resolution by the MEAP, we transformed the SCROC into a primarily internal board. The reason for this is that research plans that call for separate committee approval pursuant to the SCROC charter are currently not being carried out within the company. However, we will continue to involve external experts in the decision-making process should especially complex issues call for this.
Furthermore, for ethical questions arising for instance in the context of forward-looking business decisions, targeted Ethics Foresight projects can be initiated. We specifically engage external experts to work on these projects. In contrast to the MEAP, no specific recommendations result from Ethics Foresight projects, but the respective ethical risk for various scenarios is determined and several decision paths are mapped instead. In addition, the projects map potential consequences of various decisions. No Ethics Foresight projects were commissioned in 2023.
Our commitment: Guidelines and standards
Our Genome Editing Principle provides a binding ethical and operational framework for our employees. Apart from our position on genome editing, it includes information on human germline editing. It sets clear boundaries for us both as a supplier of customized CRISPR/Cas nucleases and genetically modified cell lines and as a company that uses genome editing technologies in our research.
This is complemented by further guidelines that form the ethical framework of our research and business activities. Our Stem Cell Principle sets the ethical boundaries for the use of human stem cells in our research. Our Fertility Principle regulates our fertility treatment and in-vitro fertilization research activities.
Biological samples are indispensable to the development of new targeted treatments and advanced diagnostic methods. We have defined our principles and processes for managing human biospecimens in standard operating procedures. Accordingly, we handle these samples in a responsible and ethical manner; in doing so, we adhere to relevant regulatory requirements and abide by the consent given to us by donors for the use of their samples.
Topics currently being discussed by the MEAP
In 2023, the MEAP met in May and October and discussed ethical questions of organoids, among other things. These are organ-like microstructures that can be produced artificially in the laboratory, for example from induced pluripotent stem cells.
The use of organoids is increasingly opening up the possibility of partially replacing and fundamentally reducing animal testing. This is in line with our commitment to animal welfare (see Animal welfare). In addition, it is becoming apparent in research and practical application that organoids could offer scientific advantages over animal models – one of the reasons why the use of organoids is currently increasing rapidly. This growth raises urgent bioethical questions, for example with regard to cell donation. The MEAP recommended that future donors should be more fully informed about the use of their cells, including any commercial uses. We want to review and further develop the design of consent forms in this regard.
The MEAP also addressed the legal and ethical classification of human embryo-like models recently created for the first time, as documented in the scientific literature. This discussion placed particular emphasis on the context of the German Embryo Protection Act and its possible implications for our work.
The MEAP also recommended examining how ethical standards can best be upheld for global health issues. This concerns mass drug administration (MDA), where participants must be informed and informed consent obtained. One focus was on MDA projects that are carried out with local partners or international organizations; the aim is to implement such actions effectively within the agreed areas of responsibility.
MEAP members
Biotechnology and genetic engineering
Throughout the Group, we manufacture our biotech products in accordance with rigorous standards at all sites. All these activities are subject to strict statutory regulations worldwide and compliance with these regulations is monitored by our biological safety officers. We continuously track local regulatory changes that relate to biotech products and adapt our processes if necessary. This helps us to ensure that all legal requirements are known and complied with.
Using genome-editing techniques
We are a leading supplier of technologies such as CRISPR/Cas, which can be used to target and modify specific genes, a process known as genome editing. CRISPR/Cas opens up new possibilities in genetic engineering research that could bring about major advances in the treatment of serious diseases. Laws in different countries allow for a varying degree of latitude in applying this technique. Bioethical positions on germline editing have been evolving for years through academic and social discourse. Our position on human germline editing is as follows:
“In accordance with the German Embryo Protection Act, we do not support the use of genome editing in human embryos or clinical applications of germline interventions in humans. We recognize that there may be value in responsibly conducted related research.”
Stem cell research
We neither participate in clinical programs that utilize human embryonic stem cells or cloned human cells for the treatment of diseases, nor do we pursue such approaches ourselves. However, we use human embryonic stem cells in our research and offer our customers several select stem cell lines. In both applications, we allow the use of human embryonic stem cells only if clearly defined conditions have been met. For instance, we only utilize stem cells for research purposes if our SCROC has reviewed the respective project and given approval. In fiscal 2023, no projects required the approval of the SCROC (2022: one project). We exclusively make use of cell lines that have been approved by the United States National Institutes of Health (NIH) and are allowed under the German Embryo Protection Act as well as the German Stem Cell Law.