Bioethics are foundational in guiding how we use the rapidly advancing power of life sciences and technology 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, with controversy surrounding certain bioethical issues arising from the explosive progress in science and particularly molecular biology. In light of this situation, we believe it necessary to clearly state our position on these issues.

Our approach to ethical business conduct

In the course of our activities, we encounter various bioethical issues, including use, animal testing, the use of genetically modified microorganisms, the potential impact of new genome editing techniques such as , and our own clinical research. We are strongly committed to conducting research in an ethical manner. In treating patients with our drugs and supplying academic researchers and the biopharma industry with our products, patient benefit and wellbeing are always of utmost importance. When faced with controversial topics, we carefully evaluate all relevant positions to ensure we make informed decisions in line with the highest ethical standards.

How we assess bioethical issues

Our Bioethics Advisory Panel (MBAP) of Merck KGaA, Darmstadt, Germany convenes once a year and also provides support when urgent bioethical issues arise. Co-chaired by our Global Chief Medical Officer (CMO) and the head of our Global Health Institute, 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.

In 2017, we adapted the organizational structure of the MBAP to reflect the current requirements of bioethical issues so that it now advises on bioethical questions pertaining to all three of our business sectors. Moreover, by appointing external experts from Africa and Asia to the panel, we have also integrated the views of these regions more strongly in bioethical discussions. Our Dedicated Guidance Panels for Genome Editing and Stem Cell topics are also now operating under the overarching MBAP. These panels are responsible in particular for the operational implementation of our positions and are empowered to make decisions regarding specific questions on individual projects. Formed in 2011, the Stem Cell Research Oversight Committee (SCROC) verifies in advance all internal research proposals employing human stem cells, with our ethical guidelines, and legal requirements pertaining to research. This also includes collaboration with external partners. The SCROC works under the guidance of the MBAP.

Our commitment: Identifying issues early on

As a global company, it is crucial for us to promptly identify and address new developments concerning bioethical 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 purview of legislators, which is why we also seek the advice of external experts.

Bioethics Advisory Panel discussions

In 2017, in addition to organizational changes, the MBAP discussed the establishment of our new Global Health Institute, as well as fertility research, stem cell research and genome editing. We have submitted the panel's advice and scientific recommendations for publication in a peer-reviewed journal.

Our Global Health Institute aims to improve access to healthcare, particularly in developing countries. Its focus areas are addressing the unmet needs of women and children, as well as infectious diseases and antimicrobial resistance. The panel has suggested developing a guideline for the Global Health Institute that would define aspects such as collaboration with partner organizations and research priorities.

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 hubs for medical biotechnology are Darmstadt, Boston (MA, USA), Beijing (China), and Tokyo (Japan). Major biotech production sites are located in Martillac 9France), as well as Aubonne and Corsier-sur-Vevey, Switzerland, the latter of which is one of the largest biopharmaceutical production facilities in Europe.

Across our Group, we manufacture our biotech products according to the highest standards , and 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.

Using genome-editing applications

We are a leading supplier of technologies such as , 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”, the use of genome editing techniques in plant cultivation. Statutes in different countries allow for a varying degree of latitude in applying this technique, which is why in 2017 the MBAP once more thoroughly discussed the current possibilities and ethical boundaries of genome editing systems. The results of this discourse have been incorporated into our new Genome Editing Technology Principle, which took effect at the end of October 2017. This principle provides our employees with background information and explains our current stance on such technology. It thus defines a mandatory ethical and operational framework – firstly for us as a supplier of custom targeted and genetically modified cell lines, and secondly as a user of genome editing technologies for scientific research.

Stem cell research

At present, 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 do make use of stem cells in our research. In addition, we offer our customers several select stem cell lines. Our updated Stem Cells Principle, which was discussed by the Stem Cell Research Oversight Committee in 2017 and took effect in October 2017, ensures compliance with our ethical approach. The panel further recommended a new Informed Consent form for the use of induced pluripotent stem cells (iPSCs), which are identical to embryonic cells and can generate every type of cell in the human body.

Fertility research

Because we develop treatments for infertility and seek to improve the success rate of fertilization, 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? In such questions, the German Embryo Protection Act is our legislative point of reference. Developed based on guidance from the MBAP, our new Fertility Principle came into force at the end of October 2017. Further discussion topics on the MBAP’s 2017 agenda included various issues pertaining to medical technology and products for fertility research. We have the support of the panel in establishing a data pool of clinical evidence regarding fertility technologies.

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.

When conducting clinical studies in which biological samples are collected, we inform study participants upfront about the purposes for which we use their samples. On this basis participants may consent to the use of their specimens, thereby enabling us to learn more about the study drug, the disease, or other medical questions. Participants can withdraw their consent at any time.

In addition, study participants are given the opportunity to authorize the use of their biosamples for further medical research beyond the clinical study. This way they help to address future scientific questions and ultimately support medical progress. In 2017 we implemented a policy and a standard operating procedure defining the principles and processes of human biosample management during and after clinical studies.

Biological samples, including tissue samples and body fluids, are permanently stored in biobanks together with the corresponding encrypted patient and specimen data. While these are extremely important to our research, their storage and use for research purposes requires us to adhere to stringent ethical standards. In 2017 we implemented new rules governing biobank operation and the use of stored samples.

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 of the International Council for Harmonisation (). More details can be found under Clinical studies.

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 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.

Our principles for disseminating information regarding the off-label use of our products are set out in corresponding globally applicable policies. 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 provide such information to healthcare professionals only for medical purposes and only upon direct, unsolicited request. 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.

Stem cells
Undifferentiated cells with the potential to develop into many different cell types that carry out different functions.
CRISPR/Cas
A biomolecular method for targeting, cutting and editing the DNA of an organism (genome editing). Experts think this technique has great potential for curing diseases or generating plants and animals with new traits.
Compliance
Adherence to laws and regulations as well as to voluntary codices that are internal to Merck KGaA, Darmstadt, Germany. Compliance is a component of diligent corporate governance.
Stem cells
Undifferentiated cells with the potential to develop into many different cell types that carry out different functions.
CRISPR/Cas
A biomolecular method for targeting, cutting and editing the DNA of an organism (genome editing). Experts think this technique has great potential for curing diseases or generating plants and animals with new traits.
Nucleases
Nucleases are a group of enzymes whose primary function is to partially or fully degrade nucleic acids.
In vitro
Procedures involving components of an organism that have been isolated from their usual biological surroundings (e.g. test tube experiments).
Good clinical practice (GCP)
An international quality standard that enforces tight guidelines on ethical aspects of clinical studies.
ICH
The aim of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is to promote uniform assessment criteria for product registration in Europe, the United States and Japan. The ICH makes recommendations toward achieving greater harmonization in the interpretation and application of technical guidelines and requirements for pharmaceutical product registration.

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