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. 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, the Merck 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.
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.
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. No Ethics Foresight projects were commissioned in 2023.
Our commitment to policies 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.
Using genome-editing techniques
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 and 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.