Bioethics are foundational to guiding how humans use the rapidly advancing power of life sciences and technology responsibly and ethically to the ultimate benefit of mankind, animals, plants and all living beings. In the course of our Healthcare and Life Science activities, we are faced with various bioethical issues, including stem cell use, animal testing, the use of genetically modified microorganisms, the potential impact of new gene editing techniques such as CRISPR/Cas, and our own clinical research. Beyond compliance with the relevant regulations and laws, we have a strong commitment to conducting research in an ethical manner, which is why we continuously evaluate all manner of positions on controversial topics in order to make informed decisions. In treating patients with our drugs and interacting with participants in our clinical studies, their wellbeing is always of utmost importance.
Our principles
Merck KGaA, Darmstadt, Germany Bioethics Advisory Panel
As a global company, it is important for us to promptly identify and address all international developments concerning bioethical issues. This approach is what enables us to define our own stance, as does the advice of external experts.
To this end, the Merck KGaA, Darmstadt, Germany Bioethics Advisory Panel (MBAP) convenes once a year to advise the company. Consisting of renowned international experts in the fields of bioethics, theology, science, and law, the MBAP is jointly headed by our Chief Medical Officer (CMO) and our Head of Global Health. The MBAP provides clear guidance on bioethical questions, which we take as a basis for our entrepreneurial conduct. For the benefit of our employees, we publish summaries from MBAP meetings on our Intranet.
Clinical studies
We discover and develop innovative medicines that meet patient needs. In doing so, we adhere to all relevant statutory and regulatory requirements, as well as scientific and ethical standards. For clinical studies, these standards particularly include the Declaration of Helsinki, in which the World Medical Association has formulated ethical principles for medical research involving human subjects, and the Good Clinical Practice (GCP) guidelines of the International Council for Harmonization (ICH). More details can be found under Clinical studies.
Stem cell research
We do not 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 do make use of stem cells in our research. In addition, we offer our customers several select stem cell lines. Our Stem Cells and Human Cloning Principles ensure compliance with our ethical approach. Furthermore, our Stem Cell Research Oversight Committee (SCROC), which was established in 2016, reviews our business strategies as well as all internal human stem cell research proposals to verify compliance with our ethical and legal guidelines. This also includes collaboration with external partners. The mandate of the SCROC is based on the recommendations of our Bioethics Advisory Panel.
Infertility treatment research
We develop treatments to improve the success rate of in vitro fertilization and are currently revising our Fertility Research Policy based on recommendations from the MBAP. You can find more information under Progress.
Biotechnology and genetic engineering
We utilize genetically modified organisms (GMOs) in our research and development work and have been manufacturing biotech products using GMOs since the 1980s. Without this technology, the major medical advances of past years would not have been possible.
Our most important research centers for medical biotechnology are in Darmstadt, Boston (MA, USA), Beijing (China), and Tokyo (Japan). Major biotech production sites are located in Aubonne and Corsier-sur-Vevey, Switzerland, the latter of which is one of the largest biopharmaceutical production facilities in Europe.
We manufacture our biotech products according to the highest standards. All our biotech activities are subject to strict statutory regulations worldwide. Compliance with these regulations is monitored by our biological safety officers. We continuously track regulatory changes pertaining to biotech products and adapt our processes accordingly, thus ensuring we adhere to all statutory requirements.
Off-label use
We endeavor to drive scientific and medical progress, often doing so in close collaboration with medical professionals. We regularly receive inquiries about the off-label use of our products, i.e. indications for which the drug was not originally approved. While each medicine is authorized for specific indications, cases do arise in which a physician wishes to prescribe a drug to treat a disease for which it is not approved. Such new applications can benefit patients. However, to use a drug in this way, solid evidence must exist showing that it can be effective in the treatment of the specific disease.
In 2016, we instituted a new Group-wide policy that sets out our principles for disseminating information regarding off-label use. In particular, we only market our medicines within the scope of the drug’s marketing approval. We never share information on off-label use for commercial ends and only provide such information upon direct request to healthcare professionals for medical purposes. The information must be backed by scientific evidence and factually balanced. Our employees are not permitted to make any sort of treatment recommendations for individual patients.
Progress
Merck KGaA, Darmstadt, Germany Bioethics Advisory Panel discussions
In 2015 and 2016, the MBAP discussed the following issues:
1. Selecting partnerships according to ethical standards
We collaborate with numerous partners in research and development, production, and marketing and sales. The MBAP has emphasized that it is crucial to form partnerships with organizations whose values align with ours. Our values are described in guidelines such as our Code of Conduct, our Human Rights Charter and the Merck KGaA, Darmstadt, Germany Responsible Sourcing Principles.
2. Biosampling & biobanking
A biobank is a repository that stores tissue samples and body fluids, as well as coded patient and specimen data. Although these are extremely important to our research, their storage and use for research require adherence to stringent ethical standards, not only in terms of specimen collection, including those for genetic analyses, but also for biobank operation. For this reason, we explain to all study participants the purposes for which we are using their samples. The participants then sign an informed consent form to confirm that they understand and that they authorize the use of their specimens.
Because we might want to use patient samples at a later date in other studies, the the MBAP has recommended that we include this possibility in the Informed Consent form for our study participants. Furthermore, in 2017 we will be adopting a policy on patient specimen handling and establishing a committee to advise our researchers on the use of these samples.
3. Fertility and the German Embryo Protection Act
Because we develop therapies to treat infertility, we are frequently confronted with various bioethical issues relating to such treatments. For instance, may embryos resulting from artificial insemination be screened for genetic disorders and then selected on this basis? The German Embryo Protection Act provides guidance on such questions. The MBAP has discussed the various issues thoroughly, and, based on these deliberations, we are currently revising our Fertility Research Policy.
4. Use of genome editing systems
We are a leading supplier of gene-editing technologies such as CRISPR/Cas9, which can be used to target and modify specific genes. 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”, the use of genetic editing techniques in plant cultivation. Statutes in different countries allow for a varying degree of latitude in applying this technique, which is why the MBAP has thoroughly discussed the possibilities and ethical boundaries of genome editing systems. The results of this discourse are being incorporated into our new Gene Editing Policy, which is under development. Moreover, in response to guidance from the MBAP, we are currently working to establish the Genome Editing Consortium, whose tasks shall include determining the responsibility and bioethical role of gene editing tool providers.