Bioethics

Bioethics is concerned with fundamental questions that arise from how humans treat other creatures, both human and animal. These issues are the subject of often heated debate, in part because people's ethical positions are the reflection of their differing cultural, social, and religious backgrounds.

For Merck KGaA, Darmstadt, Germany, bioethical issues arise in the course of multiple activities; these include the use of stem cells, the use of genetically modified microorganisms, the research and application of infertility drugs, and the wide array of clinical research that we conduct.

Clinical trials

We want to alleviate human suffering by researching and developing innovative medicines. In doing so, we orient ourselves to corresponding statutory and regulatory requirements as well as industry standards. For clinical studies these standards include the Declaration of Helsinki , the clinical trial principles of the Pharmaceutical Research and Manufacturers of America (PhRMA) , and the Casebook on Ethical Issues in International Health Research  of the World Health Organization (WHO). These guidelines are rendered into internal standard operating procedures and detailed instructions that are communicated to all those involved; compliance with the guidelines is monitored. In order to give the public a clearer picture of our position, we publish our guidelines on conducting clinical trials.

Stem cell research

When clear statutory and regulatory requirements are lacking, Merck KGaA, Darmstadt, Germany collaborates closely with experts to develop appropriate guidelines. The requirements described in "Stem Cells and Human Cloning Principle" enable Merck KGaA, Darmstadt, Germany to conduct stem cell research within a strictly defined framework; they thus prevent us from violating applicable laws and regulations while enabling us to work within the framework of established ethical principles. Merck KGaA, Darmstadt, Germany is not involved in programs utilizing stem cells or human cloning for therapeutic purposes and does not pursue such approaches.

Infertility treatment research

In developing infertility treatments, Merck KGaA, Darmstadt, Germany avoids all invasive types of prenatal diagnostics. Within the framework of our "Fertility Research Policy", however, we are highly interested in improving the survival rate of fertilized embryos, thus improving the success rate for in-vitro fertilization.

Bioethics Advisory Panel

Bioethical issues are debated in a diverse social environment. Many of these questions are viewed very differently from country to country and are furthermore subject to general shifts in society. Being a global company, Merck KGaA, Darmstadt, Germany must therefore address these developments at an international level; we must detect the changes and incorporate them into our position on bioethical issues. In order to do so, Merck KGaA, Darmstadt, Germany instituted the Bioethics Advisory Panel (MBAP) in 2011, which convenes at least once a year and consists of renowned bioethics experts. Its members represent a range of pertinent disciplines such as law, theology and medical ethics.

In 2011, the panel addressed topics such as stem cell and fertility research, clinical trials and animal welfare. As a result of the discussions, our research guidelines for stem cell and fertility research as well as animal welfare have been revised and approved by the Executive Board of Merck KGaA, Darmstadt, Germany. In addition to this, the Stem Cell Research Oversight Committee was instituted at the suggestion of the Bioethics Advisory Panel.

Furthermore, the MBAP also discusses topics that prepare Merck KGaA, Darmstadt, Germany to engage in new, highly challenging projects in accordance with modern ethical standards. In 2012, clinical research in developing health care systems was therefore the focus of the panel's discussion, with the praziquantel project having received particular attention.

Within the scope of our Praziquantel Donation Program, Merck KGaA, Darmstadt, Germany is partnering with the World Health Organization (WHO) to combat the worm disease schistosomiasis in African school children. Praziquantel tablets in their current form are suitable for adults and children over the age of six; for children younger than six, it is currently not possible to properly treat the disease. Within the scope of a public-private partnership (PPP ), Merck KGaA, Darmstadt, Germany is researching a formulation of praziquantel for small children. This project makes it necessary to conduct clinical trials involving children in Africa. The children's parents and guardians must be informed of the risks of trial participation in an ethically responsible manner and give their consent. The Bioethics Advisory Panel discussed how to specifically accomplish this.

In 2013, the Bioethics Advisory Panel will discuss additional aspects of clinical research in developing health care systems and will furthermore address bioethical issues arising from developments in personalized medicine.