Scientific advances can spark controversy over bioethical issues. We want to responsibly bring to bear the growing potential of the life sciences to create maximum benefit for both humankind and other living beings. For us, it is important to clarify our own position on bioethical approaches.
Our approach to ethical business conduct
As a global company, it is crucial for us to identify and take up new bioethical trends and issues early on so that we can define our own position on such matters. Although we align all our operations with international and national laws, many discussions on bioethics pose questions that go 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 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 Merck Bioethics Advisory Panel (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 Merck Ethics Advisory Panel for Science and Technology (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 guide 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 bioethical 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 bioethical 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: 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.
Our Genome Editing Principle 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 by setting a clear framework for practices that reflect the most rigorous ethical standards. Our principles for disseminating information on the off-label use of our products are set out in corresponding policies that apply Group-wide.
Biological samples obtained from patients during clinical studies are indispensable to the development of new targeted treatments and advanced diagnostic methods. We have a guideline (our Fertility Principle) and standard operating procedures in place that define our approach to managing human biospecimens. 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 October 2021 and dealt with topics such as the animal welfare strategy we adopted in 2020 as well as our approach to vaccinating and testing employees for Covid-19. Panel members also addressed our ethical duty to go beyond the statutory requirements in terms of transparency on animal studies. In addition, the MEAP discussed our ethical responsibility with regard to the non-intended use of our products, especially those in our Life Science portfolio.
Merck Ethics Advisory Panel members
Biotechnology and genetic engineering
Throughout 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 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:
“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 in 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. 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.