Our goal is to conduct this research in an ethical manner. We develop frameworks that guide us in making informed decisions to meet the most rigorous ethical standards. Patient benefit and well-being is always our top priority, whether in clinical studies, treatment with our medicines, or the distribution of our products to academic researchers and the biopharmaceutical industry. We carefully evaluate our position when it comes to controversial topics.
Roles and responsibilities
For around ten years, the Bioethics Advisory Panel of Merck KGaA, Darmstadt, Germany (MBAP), appointed by the Executive Board, provided guidance on bioethical questions. To tackle a broader array of topics going forward, in May 2021 we transformed this body into the Ethics Advisory Panel for Science and Technology of Merck KGaA, Darmstadt, Germany (MEAP). The new committee provides clear recommendations on science and technology topics and issues that go beyond pure bioethics. Co-chaired by two of our leading scientific experts, the MEAP provides recommendations that steer our actions and business activities. In addition to renowned international specialists from the fields of bioethics, theology, law, and science, the panel also features technology and sustainability experts.
The MEAP meets multiple times a year and can also be convened on an ad-hoc basis in response to emerging urgent ethical issues. The meeting minutes can be accessed on our intranet, along with the guidance resulting from each meeting. Our employees can submit topics for the MEAP to discuss and can furthermore report ethical concerns through our compliance hotline or by reaching out to our Bioethics team.
Our dedicated committees on genome editing and stem cell research operate under the overarching MEAP. Using our internal guidelines as a basis, they make recommendations on issues relating to specific topics. Our Stem Cell Research Oversight Committee (SCROC) verifies all internal research proposals that employ human stem cells, ensuring compliance with legal requirements as well as our ethical guidelines. This also includes joint projects with external partners.
Our commitment to policies and standards
Our Genome Editing Principle provides a mandatory ethical and operational framework for our employees. It is complemented by additional guidelines that shape our approach to ethically conducted research and business. Our Stem Cell Principle sets the ethical boundaries for the use of human stem cells in our research. Our Fertility Principle guides our research in fertility treatment and in-vitro-fertilization.
Use of genome-editing technologies
CRISPR/Cas9 opens up new possibilities in genetic engineering research that could bring about major advances in the treatment of serious diseases or in “green genetic engineering”, which is the use of genome editing techniques in plant cultivation. Laws in different countries allow for a varying degree of latitude in applying this technique. Bioethical views 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, the Group does 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 research in this area.”
Stem cell research
At the present time, 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 only allow the use of human embryonic stem cells if clearly defined conditions have been met. For instance, we only utilize stem cells for research purposes if our Stem Cell Research Oversight Committee (SCROC) has reviewed the respective project and given approval. 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. At its October 2021 meeting, the SCROC revised our Stem Cell Principle to align it with the new guidelines published by the International Society for Stem Cell Research (ISSCR) in 2021.