Scientific advances can spark controversial debates over bioethical issues. We want to make responsible use of the growing potential of the life sciences to create maximum benefit for both humankind and other living beings. For us, it is important to adopt our own position on bioethical issues.
Our approach to ethical conduct
As a global company, it is critically important for us to identify and address emerging bioethical topics and issues early on so that we can define our own position. Although we do align all our operations with international and national laws, many discussions on bioethics pose questions that extend far beyond the framework set forth by current legislation. We therefore also seek advice from external experts.
In our work, we encounter various bioethical issues, including animal testing and clinical research, stem cell use, the use of genetically modified microorganisms, and the potential impact of new genome editing techniques such as CRISPR/Cas. 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 (MEAP) 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 2011. This committee reviews and approves all planned in-house research activities involving the use of human stem cells, and ensures to 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. In contrast to the MEAP, the experts will not develop concrete recommendations in the future but will determine the respective ethical risk for various scenarios and map several decision paths instead.
Our commitment: Guidelines and standards
Our Genome Editing Principle provides a mandatory ethical and operational framework for our employees. It sets clear boundaries for us both as a supplier of customized nucleases and genetically modified cell lines, and as a user of genome editing technologies for scientific research. This principle includes background information on the topic and explains our position on genome editing. Moreover, it specifically addresses the subject of human germline editing.
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. It sets a clear framework for practices that reflect the most rigorous ethical standards. Our principles on whether information on the off-label use of medicines may be passed on are based on Group-wide guidelines.
Biological samples obtained from patients during clinical studies are indispensable to the development of new targeted treatments and advanced diagnostic methods. We have defined our approach to managing human biospecimens in our Fertility Principle and in standard operating procedures. Accordingly, we handle these samples in a responsible and ethical manner; in doing so, we adhere to all regulatory requirements and abide by the consent given by patients for the use of their samples. This may include an optional consent that provides permission to use the biospecimens for further medical research beyond the clinical study.
Topics currently being discussed by the MEAP
The MEAP last convened in May 2022 and dealt with ethical issues surrounding cell culture media that could be used in the fertility sector. In addition, the panel completed the revisions of the Stem Cell Principle, the Genome Editing Principle and the Fertility Principle, thus harmonizing them with the Guidelines of the International Society for Stem Cell Research (ISSCR), which were updated in 2021. These address scientific advances and the related ethical, social and political changes since 2016. The basic tenets of our positions remain unchanged, with some details now adapted to the new guidelines. In addition, we marked the tenth anniversary of MEAP with a symposium in 2022. To mark this occasion, MEAP members produced a commemorative publication; the contributions contained therein discuss both past and future bioethical issues and their significance for science and practice.
MEAP members
Biotechnology and genetic engineering
Within 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 accordingly, thus ensuring compliance with all statutory requirements.
Using genome-editing techniques
We are a leading supplier of technologies such as CRISPR/Cas9, which can be used to target and modify specific genes, a process known as genome editing. 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.