Our goal is to conduct research in an ethically responsible manner and to develop ethical frameworks that guide us in making forward-looking business decisions. Patient benefit and well-being are 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 positions when it comes to controversial topics.
Roles and responsibilities
Since 2010, our Ethics Advisory Panel for Science and Technology has been issuing clear recommendations on scientific and technology topics involving ethical questions as well as issues extending beyond pure bioethics, in line with our transformation into a science and technology company. Co-chaired by two of our leading scientific experts from our senior management team, the MEAP provides recommendations that guide our actions and business activities. In addition to renowned international experts from the fields of bioethics, medicine, philosophy, law, and the natural sciences, the panel also consists of technology and sustainability experts. The MEAP receives its mandate from the Executive Board.
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 recommendations issued by the MEAP. Our employees can also submit topics for discussion to the panel. In addition, they may report ethical concerns through our compliance hotline or by reaching out to our Bioethics team.
Our Stem Cell Oversight Committee (SCROC) was established on the recommendation of the MEAP back in 2013. This committee reviews and approves all planned in-house research activities involving the use of human stem cells, ensuring compliance with legal requirements as well as our ethical guidelines. This also includes joint projects with external partners. The committee consists of internal experts from our business sectors as well as external professionals from the fields of bioethics, medicine and law.
In 2022, we expanded the range of consulting services on ethics issues. Our goal is to also take ethics perspectives into account when making forward-looking business decisions. To this end, we launched the Ethics Foresight project, in which external experts and selected MEAP members support our employees from the business units on strategically relevant ethical issues.
Our commitment to policies and standards
Our Genome Editing Principle provides a mandatory ethical and operational framework for our employees. This is complemented by additional guidelines that define how we conduct research and business in an ethical manner. Our Stem Cell Principle sets the ethical boundaries for the use of human stem cells in our research. Our Fertility Principle regulates 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. 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 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 SCROC has reviewed the respective project and given approval. In 2022, review and approval were granted in one case. 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.