Bioethics (Entity Specific)

Scientific progress can also pose ethical questions. We want to utilize the growing potential of life sciences in a responsible way in order to create the greatest possible benefit for humanity and other forms of life. In doing so, we believe it is important to take our own position on bioethical matters and drive our innovations responsibly.

Our material impact related to bioethics (SBM-3)

ESRS SBM-3 – Bioethics

Bioethics

Identifier

 

Entity-PI-01

Material impacts, risks and opportunities

 

Potential positive impact

Time horizon

 

Medium-term

Value chain step

 

Up-stream; own operations; down-stream

Description

 

Responsible action in bioethical issues:
Bioethics refers to the ethical implications of biological and medical research, practices, and technologies. It encompasses a wide range of issues, including the ethical treatment of human test subjects and laboratory animals, informed consent and privacy concerns. Respecting bioethical guidelines is especially important if no statutory regulations are yet in place. We focus on responsible behavior by proactively developing global corporate guidelines and positions for bioethical matters, thereby strengthening trust in our company. Bioethics support us when we are working in sensitive areas, for example in global health, in fertility medicine and when researching and using organoids. It helps us to promote responsible innovation, thereby contributing positively to societal well-being.

ESRS MDR-P – Genome Editing Principles

Genome Editing Principles

Connection to material impacts, risks and/or opportunities

 

Entity-PI-01

Material sustainability matter

 

Bioethics

Key contents

 

The policy is a clear, binding and operational framework for our research, clinical and commercial activities in the field of genome editing. It is based on the careful assessment of ethical issues and legal principles. The policy describes our position on genome editing and prohibits intervention in the human germline. It sets clear limits for our company: firstly, for using the corresponding technologies in our research, and secondly for our function as a supplier of bespoke CRISPR-Cas nucleases and genetically modified cell lines.
The Ethics Advisory Panel for Science and Technology of Merck KGaA, Darmstadt, Germany (MEAP) regularly advises us on important ethical issues and legal topics regarding genome editing. The policies are regularly reviewed and adapted if necessary.

Scope

 

The policy applies Group-wide for all employees who use genome editing technologies or otherwise work with them. The employees are responsible for understanding and complying with the basic principles on genome editing. Moreover, we also expect third parties to adhere to the rules and to stay up to date with the current discussions on the ethical aspects of genome editing.

Accountability

 

Executive Board.

Third-party standards/initiatives

 

The policy is based on the German Embryo Protection Act and is consistent with the guidelines of the International Society for Stem Cell Research (ISSCR).

Consideration of stakeholder interests

 

We developed and reviewed the policy with the involvement of internal stakeholders and in close collaboration with the MEAP.

Availability

 

The policy is available internally on the intranet and publicly on our website.

ESRS MDR-P – Human Stem Cell Principles

Human Stem Cell Principles

Connection to material impacts, risks and/or opportunities

 

Entity-PI-01

Material sustainability matter

 

Bioethics

Key contents

 

The policy defines ethical boundaries for the use of human stem cells in research. It describes our current position regarding their use and provides background information.
The aim of the policy is to create a clear and binding framework for the use of human stem cells in research, clinical and commercial activities. It is based on a careful assessment of ethical issues and legal principles. The Stem Cells, Organoids & Novel Modalities Research Oversight Committee (SCROC) helps to ensure compliance with the policy in accordance with the latest scientific, ethical and legal knowledge. In addition, the MEAP regularly advises on ethic issues and legal impacts in the field of stem cell research and application. The policies are regularly reviewed and adapted if necessary.

Scope

 

The policy applies Group-wide for all employees who use stem cells or otherwise work with them. The employees are responsible for understanding and complying with the basic principles for the use of stem cells. Moreover, we also expect third parties to adhere to the rules, to stay up to date with the current discussions on the ethical aspects of using stem cells and to make an informed decision on their own use of stem cells.

Accountability

 

Executive Board.

Third-party standards/initiatives

 

The policy is based on the guidelines of the ISSCR.

Consideration of stakeholder interests

 

We developed and reviewed the policy with the involvement of internal stakeholders and in close collaboration with external experts and the MEAP.

Availability

 

The policy is available internally on the intranet and publicly on our website.

ESRS MDR-P – Fertility Principles

Fertility Principles

Connection to material impacts, risks and/or opportunities

 

Entity-PI-01

Material sustainability matter

 

Bioethics

Key contents

 

The policy describes our current position regarding the research and application of drugs and technologies in fertility medicine and provides the corresponding background information.
The aim of the policy is to offer a clear and binding framework for our research, clinical and commercial activities for infertility treatment and in vitro fertilization, which is based on the careful assessment of ethical issues and legal principles.
The MEAP regularly provides advice on ethical issues relating to the topic of fertility. The policies are regularly reviewed and adapted if necessary.

Scope

 

The policy applies Group-wide for all employees who work in the field of fertility medicine. The employees are responsible for understanding and complying with the guidelines on fertility medicine. Moreover, we also expect third parties to adhere to the rules and to stay up to date with the current discussions on the ethical aspects of fertility medicine.

Accountability

 

Executive Board.

Third-party standards/initiatives

 

The policy is based on the German Embryo Protection Act and is consistent with the guidelines of the ISSCR.

Consideration of stakeholder interests

 

We developed and reviewed the policy with the involvement of internal stakeholders and in close collaboration with the MEAP.

Availability

 

The policy is available internally on the intranet and publicly on our website.

Panel for ethical issues

Since 2011, the MEAP has been making clear recommendations on ethical issues that arise from our research and in science and technology. These recommendations extend beyond the field of traditional bioethics, in line with the transformation of our company into a science and technology company. The panel’s recommendations guide our actions and business activities. The members of the MEAP are renowned external experts from the fields of bioethics, medicine, philosophy, law, and natural sciences. The MEAP is appointed by the Executive Board and is jointly led by two members from the management of the Life Science and Healthcare business sectors. The panel meets multiple times per year and can also be convened at short notice should urgent ethical issues arise. Summary minutes of the meetings and the recommendations made by the MEAP are available on our intranet. All employees can submit topics for the MEAP to our Bioethics team. If necessary, we consult further external experts. In addition, all employees may address their concerns to the Bioethics team via our Compliance Hotline and a dedicated e-mail address (accessible via the intranet).

Positions in reproductive and stem cell research

The latest progress in reproductive medicine is posing new ethical challenges and questions, while case law continues to develop. We have therefore agreed on a position on egg donation. In addition, we are currently working on a position on elective single embryo transfer (eSET). Previously defined positions of the MEAP were discussed and reviewed during 2025 in harmony with the German Embryo Protection Act and our guidelines for fertility medicine.

The SCROC decides on in-house research activities involving the use of pluripotent stem cells with the aim of ensuring compliance with legal requirements as well as our ethical guidelines. This also applies to joint projects with external partners. The SCROC consists of experts from our business sectors. Should complex issues occur that are not covered by the expertise available internally, we will continue to involve external experts in the decision-making process. Currently, we are not conducting any research projects that, according to the SCROC Charter, would require approval by SCROC or external expertise.

During 2025 we also set up an organoids group under the umbrella of the SCROC. This working group is made up of experts from all fields who are involved in activities relating to organoids and have an overview of ongoing research activities. It is to meet twice a year from now on. Organoids are complex collections of cells that are grown in a 3D culture medium and replicate many features of tissues or organs. During fiscal 2025, the group initially created an overview of projects on organoids based on induced pluripotent stem cells (iPSC) and presented it to the MEAP. iPSCs are created by reprogramming adult skin or blood cells and are capable of developing into other cell types of the human or animal body.

Our targets in relation to bioethics (MDR-T)

We want to lay the groundwork for generating an overview of our organoid projects in research and development. Although the MEAP believes that retrieving and cultivating specific cell types, tissue and organoids from human stem cells poses only a few ethical issues, some of them may nevertheless be highly significant, particularly as developments in this field are progressing rapidly. We plan to assess this overview of all organoid projects annually in the MEAP. Beyond these ambitions, we have not defined any targets related to bioethics.

Share this page: