Bioethics and biotechnology

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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, not least 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 many areas; 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. Beyond compliance with regulations and laws, we have a strong commitment to conducting research in an ethical manner, to ensure patients’ wellbeing and to evaluate different positions on controversial topics (e.g. stem cell research) in order to make informed decisions.

Our Bioethics Advisory Panel

Bioethical issues are debated in a diverse social environment. Many of these questions are perceived very differently from country to country, and how people view them is furthermore subject to changes in society. As a global company, we must address developments concerning bioethical issues at an international level; we must identify the changes and incorporate them into our position on bioethics. To this end, we have established the Bioethics Advisory Panel (MBAP), which convenes at least once a year to advise the company. It is headed by our Chief Medical Officer (CMO) and consists of globally renowned bioethics experts from a range of pertinent disciplines such as law, theology and medical ethics. The MBAP provides clear recommendations on the issues discussed, which we then integrate into our guidelines and internalize in our conduct. In order to educate our employees on bioethical considerations, we publish high-level summaries from the MBAP meetings on our intranet.

In 2013, the MBAP met to discuss clinical trial data transparency and principles on data sharing. At the end of 2013, the company introduced its policy on clinical trial data sharing and published a summary of our responsible data sharing principles on our data request website . They are in line with the respective principles of the European Federation of Pharmaceutical Industries and Associations (EFPIA), as well as the Pharmaceutical Research and Manufacturers of America (PhRMA).

Other discussion topics included biobanking and genetic testing, as well as pharmacogenomics and targeted therapies in pharmaceutical development. A biobank is a repository that stores tissue samples, along with coded patient data and sample data. Biobanks have great potential for future research in areas such as oncology. They require, however, adherence to high ethical standards both in terms of collecting specimens and genetic data, as well as how the databases are operated. These aspects are described in the Informed Consent form, a document in which study participants must confirm that they have been informed, that they understand, and that they authorize the use of their specimens. This includes consent to anonymize samples, store them and eventually destroy them. The MBAP emphasized that biobanking can only be considered viable if the intended uses of the biobank are made transparently clear, and if bioethical standards are conscientiously applied. With regard to pharmacogenomics and targeted therapies, the company is taking various approaches into consideration, including the use of tumor characteristics such as certain mutations. These approaches are important for the design of future clinical trials.

In 2014, the MBAP discussed several topics, including post-clinical trial access to study drugs and issues arising from the development of praziquantel for small children, as well as the opportunities and bioethical implications of biosimilars.

Access to study drugs post trial is a commitment laid out in several ethical guidance documents, such as the Declaration of Helsinki . These state that if a study drug has shown itself to be beneficial, safe and in line with local requirements, it should continue to be available to trial participants after the clinical trial, which is what the MBAP has recommended. If the drug is commercially available, the patient will be switched to the marketed drug. If the drug is not yet approved, a single/named patient, compassionate use or early access program may be considered in order to continue treatment.

Within the scope of our Praziquantel Donation Program, we are researching a formulation of praziquantel for small children. This project requires clinical trials involving children in low-resource areas such as Africa. The children's parents and guardians must be informed of the risks of trial participation in an ethically responsible manner and then be asked to give their consent. The MBAP discussed the proposal for Phase I testing of the pediatric praziquantel formulation and concluded that the overall aim of the pediatric praziquantel clinical development program is ethically appropriate.

In addition to this, the MBAP discussed ethical considerations regarding biosimilars. To promote worldwide access to high-quality biologics, the company established a biosimilars unit  in 2012. We strongly advocate that the same standards of high quality, safety, efficacy, and scientific need be consistently applied to all medicines and across all geographies, regardless of whether the drug in question is patented or a biosimilar.

Clinical trials

We aim to alleviate human suffering by researching and developing innovative medicines. To achieve this, we adhere to all relevant statutory and regulatory requirements, as well as industry standards. For clinical studies, these standards include the Declaration of Helsinki and the Good Clinical Practice (GCP) guidelines of the International Conference on Harmonization (ICH). More details can be found under Clinical Trials.

Stem cell research

When clear statutory and regulatory requirements are lacking, the company collaborates closely with experts to develop appropriate guidelines. The requirements described in the "Stem Cells and Human Cloning Principle" enable us to conduct stem cell research within a strictly defined legal framework. They prevent us from violating applicable laws and regulations while enabling us to work within the framework of established ethical principles. Our Stem Cell Research Oversight Committee reviews internal stem cell research proposals and commercial strategies for compliance with our ethical and legal guidelines.

The company is not involved in clinical programs utilizing stem cells or human cloning for therapeutic purposes and does not pursue such approaches.

Infertility treatment research

In developing treatments for infertility, the company avoids all invasive types of prenatal diagnostics. Within the framework of our "Fertility Research Policy", however, we are focusing on improving the success rate for in vitro fertilization.

Our Embryo Viability Assessment Test (Eeva) is designed to improve in vitro fertilization (IVF) outcomes by providing clinicians and embryologists with objective information that will enable them to predict embryo viability with a new level of accuracy. Eeva uses intelligent computer vision software to measure key scientifically and clinically validated cell division parameters from video image.

Biotechnology and genetic engineering

Merck KGaA, Darmstadt, Germany utilizes genetically modified organisms in research and development and has been manufacturing biotech products that are produced using genetically modified organisms (GMOs) since the 1980s. Without this technology, the major medical advances of the last several years would not have been possible.

Our major research centers for medical biotechnology are located in Darmstadt (Germany), Boston (United States), Beijing (China), and Tokyo (Japan). Important production sites for this are Aubonne and Corsier-sur-Vevey in Switzerland.

The biotech facility in Corsier-sur-Vevey remains one of the largest biotech production facilities in Europe. We are a leader in this field. We produce our highly valuable biotech products utilizing the highest standards. All our biotechnological activities are subject to strict legal regulations worldwide; compliance with these regulations is monitored by biological safety officers. The company continually tracks regulatory changes pertaining to biotech products and adapts its processes accordingly, thus ensuring compliance with all statutory requirements.

DISCLAIMER

Publication of Merck KGaA, Darmstadt, Germany.

In the United States and Canada the subsidiaries of Merck KGaA, Darmstadt, Germany operate under the umbrella brand EMD.

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