TAG overview

Bioethics guide us in how to 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 on divisive bioethical issues arising from the explosive progress in science and particularly molecular biology. In light of this situation, we feel the need to clarify our own position on these issues.

Our approach to ethical business conduct

In our work we encounter various bioethical issues, including animal testing and clinical research, use, the use of genetically modified microorganisms, and the potential impact of new genome editing techniques such as . We are strongly committed to conducting this research in an ethical manner. Patient wellbeing and benefit is always our number one priority, both during treatment with our drugs and when our products are distributed to academic researchers and the biopharma industry. We carefully evaluate our position on controversial topics so that we can make informed decisions that meet the highest ethical standards.

How we assess bioethical issues

The Bioethics Advisory Panel of Merck KGaA, Darmstadt, Germany (MBAP), co-chaired by a senior executive biomedical expert of our companyand the Head of our Global Health Institute, gives clear guidance on bioethical issues, which steers our behavior and entrepreneurial conduct. It consists of renowned international experts in the fields of bioethics, theology, science, and law. The MBAP meets once a year and also spontaneously, if required, in response to emerging urgent bioethical issues. We publish a summary of the discussions from each meeting on our internal electronic collaboration platform. Our employees can ask MBAP members for advice and are able to report concerns on ethical issues.

We continuously adapt the organizational structure of the MBAP to reflect the current requirements of bioethical issues in all three of our business sectors. In 2018, two experts from Africa and Asia became standing members, having previously had guest status. This has enabled us to further integrate the important views of these regions in our bioethical discussions.

Our dedicated guidance panels for genome editing and stem cell topics continue to operate under the overarching MBAP. These panels are responsible for the operational implementation of our stance and are empowered to make decisions about specific questions on individual projects. Since it was formed in 2011, the Stem Cell Research Oversight Committee (SCROC), for example, has been verifying all internal research proposals that employ human stem cells and ensuring with our ethical guidelines and any legal requirements. This also includes collaboration with external partners.

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 scope of legislators, which is why we also seek the advice of external experts.

Bioethics Advisory Panel discussions

In 2018, the MBAP addressed, for the first time, the topic of Artificial Intelligence (AI) and related ethical issues. The recommendation was to develop a supervisory board that includes roles and responsibilities for the highly sensitive data that is used in clinical and other applications of AI.

Other topics included new developments in stem cell research, genome editing and animal welfare.

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 (Germany), Boston (MA, United States), Beijing (China) and Tokyo (Japan). Major biotech production sites are located in Martillac (France) and Aubonne, as well as Corsier-sur-Vevey (both in Switzerland), 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 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.

Our Genome Editing Technology Principle provides a mandatory ethical and operational framework for our employees, setting clear operational boundaries for us both as a supplier of custom targeted 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 current stance on the technology.

In 2018, the MBAP re-examined the current possibilities and ethical boundaries of genome editing systems and agreed that our Principle did not need to be updated. It was determined to understand more fully the advances in genome editing in agriculture, as well as , and the associated ethical and country-specific legal implications. A number of MBAP members and scientists of our company pooled their insights to co-author a paper entitled, “Ethical Considerations in the Manufacture, Sale, and Distribution of Genome Editing Technologies”, which was published in the American Journal of Bioethics. The paper shows that we have become a thought leader in the scientific discussion on genome editing innovations and that we are committed to fostering a broader dialogue in a bid to create lasting buy-in and acceptance for this promising technology.

Stem cell research

We currently neither participate in clinical programs that utilize human embryonic 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 select . Thereby, 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 that are allowed under the German Embryo Protection Act and the German Stem Cell Law.

During 2018, the SCROC continued discussions on a new Informed Consent Form for the use of induced pluripotent stem cells (iPSCs), which is expected to be finalized in 2019. iPSCs are identical to embryonic cells and can generate every type of cell in the human body. They are used in many research projects, but, in most cases, do not require specific approval by the SCROC. The SCROC also decided to support the generation of derived from adult stem cells under the precondition that stem cells derived from fetal tissue should be avoided.

So far, we do not support research aimed at producing artificial gametes. Any support on our part would have to comply with the German Embryo Protection Act and our Fertility Principle.

The topic of producing artificial gametes will be revisited by the SCROC in order to follow up on ongoing developments.

Fertility research

We develop treatments for infertility and seek to improve the success rate of fertilization, and so 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 steered by our Fertility Principle, which was developed based on guidance from the MBAP and came into force in October 2017.

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, a policy and standard operating procedures have defined our principles and processes of human biosample management during and after clinical studies.

Biological samples, including tissue and body fluids, are stored in biorepositories 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 and all current legislation.

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 2018, we included a statement regarding requests on off-label use in the new compliance policy concerning interactions with patients. We only market our medicines within the scope of the drug’s marketing approval and we never share information on off-label use for commercial ends but 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 (gene 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 a company. Compliance is a component of diligent corporate governance.
Nucleases
Nucleases are a group of enzymes whose primary function is to partially or fully degrade nucleic acids.
Gene drive technologies
Gene drive technologies refer to methods for accelerating the spread of genes in populations. In general, the technique can employ adding, deleting, disrupting, or modifying genes. These can be used, for example, on mosquitoes that transmit malaria, dengue, and zika pathogens in order to stop their spread.
Stem cells
Undifferentiated cells with the potential to develop into many different cell types that carry out different functions.
Stem cell lines
Stem cell lines are groups of stem cells derived from animal or human tissue. They can be cultivated in vitro and multiply indefinitely.
Organoid
An organoid is a miniaturized and simplified version of an organ produced in vitro in three dimensions by means of a cell culture. It shows realistic micro-anatomy similar to an organ. Organoids are derived from one or a few tissue cells, embryonic stem cells or induced pluripotent stem cells, which can self-organize in a three-dimensional culture, owing to their self-renewal and differentiation capacities. Organoids are, among others, used as model systems in the investigation of diseases and the development of drugs.
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 develops guidelines for the evaluation of the quality, effectiveness and safety of medicinal products.

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