Bioethics guides us in how to use the rapidly advancing power of life science and the resulting technologies responsibly and ethically to the ultimate benefit of society, humans and other living beings. However, factors such as diverse cultural backgrounds have led to heated debates on divisive bioethical topics and issues arising from the explosive progress in science. In light of this situation, we feel the need to clarify our own position on bioethical approaches.
Our approach to ethical business conduct
In our work, we encounter various bioethical and digital ethics topics and issues, including animal testing and clinical research, stem cell use, the use of genetically modified microorganisms, use of health data, and the potential impact of new genome editing techniques such as CRISPR/Cas. We are strongly committed to conducting this research in an ethical manner. Patient well-being and benefit is always our number one priority. This applies to clinical studies as well as to treatment with our drugs and distribution of our products to academic researchers and the biopharmaceutical industry. We carefully evaluate our position on controversial topics so that we can develop frameworks and make informed decisions that meet rigorous ethical standards.
How we assess bioethics and digital ethics
The Bioethics Advisory Panel of Merck KGaA, Darmstadt, Germany (MBAP), co-chaired by two of our senior executive scientific experts, gives clear guidance on bioethical topics and issues, which steers our actions and entrepreneurial conduct. The MBAP consists of renowned external international experts in the fields of bioethics, theology, science, and law. The panel’s composition reflects the fact that the evaluation and assessment of bioethics are strongly contingent on cultural and regional factors. The bioethical assessment of topics must be viewed holistically. The MBAP meets once per year but can also be convened on an ad-hoc basis, if required, in response to emerging urgent bioethical issues. We publish a summary of the discussions and resulting guidance from each meeting on our intranet. Our employees can ask MBAP members for advice and are able to report concerns on bioethical issues through channels such as our SpeakUp Line or by reaching out to the Bioethics Office.
Our dedicated guidance panels for genome editing and stem cell matters operate under the overarching MBAP. Using our internal guidelines as a basis, they make recommendations on issues relating to specific topics and are informed by the operational teams about the progress made with respect to implementation. Our Stem Cell Research Oversight Committee (SCROC) performs tasks such as verifying all internal research proposals that employ human stem cells and ensuring compliance with our ethical guidelines and any legal requirements. This also includes collaboration with external partners.
Our Digital Ethics Advisory Panel (DEAP) guides our new digital business models with an initial focus on digital health. The DEAP consists of world-leading experts in digital health business models as well as experts in ethics and medicine. It plays a pivotal role in ensuring that we develop new digital technologies responsibly and address potential digital ethics issues arising from the usage of digital technologies and data-driven business models at an early stage.
Our commitment: Identifying topics and issues early on
As a global company, it is crucial for us to promptly identify and address new developments concerning bioethical topics and issues in order to define our own stance. Although we align all our business activities with international and national legislation, many bioethical discussions raise questions that far exceed the current scope of legislators, which is why we also seek the advice of external experts.
The birth of the first babies from genome-edited embryos in China significantly challenged the field of bioethics in 2019. This breach of law, ethics and academic self-regulation led to marked global criticism. Subsequent discussions emphasized the need for profound bioethical debate and meaningful governance of genome-editing research in the human germline. Statements and positions were issued by the National Academy of Sciences, the Royal Society and the German Ethics Council. This led to the creation of the World Health Organization (WHO) expert advisory committee on Developing Global Standards for Governance and Oversight of Human Genome Editing. Regulation in this research field is expected to emerge in the following years.
Our Genome Editing Principle provides a mandatory ethical and operational framework for our employees. It sets clear operational boundaries for us both as a supplier of custom targeted nucleases and genetically modified cell lines, and as a user of genome editing technologies for scientific research. The principle includes background information on the topic and explains our position on genome editing. It furthermore specifically addresses the subject of human germline editing.
The Genome Editing Principle is complemented by additional principles 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 by setting a clear framework for practices aligned with highest ethical standards. Our principles for disseminating information regarding the off-label use of our products are set out in corresponding policies that apply Group-wide.
Topics currently being addressed by our Bioethics Advisory Panel
The Bioethics Advisory Panel of Merck KGaA, Darmstadt, Germany (MBAP) convened in October 2020 to discuss important topics such as the use of genome editing tools in agriculture. We sought the MBAP’s input in light of the heterogeneity of regulatory frameworks across regions along with calls to reform from the scientific community and the ongoing public controversy around genetically modified foods. The panel also addressed the sourcing of human biosamples: The need in pre-clinical development for this material is growing and requires a framework on donor consent as well as an understanding of ethical implications of its usage. Further topics of discussion included the off-label use of products and how we can provide appropriate information and obtain authorization for the treatment of children in large-scale public health programs such as our Praziquantel Donation Program (informed consent).
Digital Ethics Advisory Panel
Our ethics horizon extends beyond bioethical questions. We also strive to be the “digital ethics company”, adhering to rigorous ethical standards in critical areas such as health data handling. In 2019, we therefore created the Digital Ethics Advisory Panel (DEAP) to deal with all ethical questions resulting from our Digital (Health) Businesses, especially from the joint venture Syntropy with Palantir. It held four sessions in 2020. Together with the DEAP and additional academic partners, we currently develop a Code of Digital Ethics (CoDE). The CoDE is to serve as a guideline for our digital business models, a tool for analyzing ethical challenges, and a basis for practical DEAP guidance.
Biotechnology and genetic engineering
Across our Group, we manufacture our biotech products in accordance with the highest standards. All related activities are subject to strict statutory regulations worldwide. 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 we adhere to 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 or in “green genetic engineering”, which is the use of genome editing techniques in plant cultivation. Statutes in different countries allow for a varying degree of latitude in applying this technique. Bioethical views on germline editing have been evolving for years in academic and societal discussions. Our statement on human germline editing is as follows:
“Merck KGaA, Darmstadt, Germany does not support the use of genome editing in human embryos and clinical applications of germline interventions in humans in accordance with the German Embryo Protection Act. Our company recognizes that there may be value of responsibly conducted related research.”
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. We do, however, use human embryonic stem cells in our research and offer our customers several selected stem cell lines. Thus, our Stem Cell Principle ensures compliance with our ethical approach. All projects are reviewed and approved by the SCROC before any stem cells are used for research purposes. We only use cell lines approved by the United States National Institute of Health (NIH) and allowed under the German Embryo Protection Act and the German Stem Cell Law. The SCROC did not hold any meetings in 2020 as no pressing matters had to be discussed.
We develop treatments for infertility and seek to improve the success rate of in vitro fertilization. As a result, we are frequently confronted with various related bioethical issues. Our legislative point of reference for these issues is the German Embryo Protection Act, and we are guided by our Fertility Principle, which was developed based on input from the MBAP.
Biosampling and biobanking
Biological samples obtained from patients within clinical studies are indispensable to the development of new precision treatments and advanced diagnostic methods. We handle these samples in a responsible and ethical manner, in compliance with all regulatory requirements and according to the consent given by patients for the use of their samples. This may include the permission to use biospecimens for further medical research beyond the clinical study through an optional consent. Since 2017, we have had a policy and standard operating procedures in place that define our principles and processes for human biosample management during and after clinical studies.