Stem cell ethics

We join the majority of scientists within the field of stem cell research, in the belief that pluripotent stem cells are essential to gain basic knowledge about how cells grow and develop. This knowledge will allow us to confirm the possibility of using stem cells in cell replacement therapies.

Ethical implications of stem cell research

Research using stem cells that come from fertilised human eggs (known as “human embryonic stem cells”) has started an important ethical debate. There are large differences between countries in relation to the law and control of research on human embryonic stem cells.

We recognise and respect that research areas involving ethical issues need to be thoroughly discussed in society. We would like to continue to be part of an open discussion about understanding the ethical and legal issues in the use of human embryonic stem cells.

In 2001, we formed a focus group to explore the ethical issues of stem cell research. The focus group looked at the benefits to patients and society and balanced this against the possible threat of overlooking our values and ethical codes. Based on the group’s findings we decided to support stem cell research. We developed our position, held employee meetings and press conferences, and took part in public hearings and debates.

In 2003 the Danish Parliament passed a law which allows the use of human embryonic stem cells in the research and development of new medicines and cures for patients. We are keeping the focus on the ethical issues related to stem cell research and continues to follow the ethical debate around the world.

We urge all countries to establish legislation that will ensure that this field is adequately regulated and controlled.

Our position on stem cells

Vision to cure diabetes
We have a vision to find a cure for diabetes, and human stem cell research with the potential for cell transplantation, is currently the most promising approach to achieve this goal.

2 Investigation of use of stem cells
We are investigating the use of stem cells to treat other serious chronic diseases and the use of stem cells as a tool to increase disease understanding and accelerate the drug discovery process.

3 Human pluripotent stem cells
We have extended our research on mouse pluripotent stem cells to include human pluripotent stem cells, in order to move forward in our efforts to direct human stem cells to mature into insulin-producing beta cells which can be further developed for transplantation to patients.

4 Use of pluripotent stem cells
We are using pluripotent stem cells as it has not yet been demonstrated that the same scientific results can be obtained by the use of multipotent adult/tissue-specific stem cells when it comes to expansion potential and developmental capacity.

5 Human embryonic stem cells
We only work with human embryonic stem cells derived from surplus embryos from in vitro fertilisation (IVF) treatment that are donated with freely given informed consent. Such embryos are otherwise destined by law to be discarded. We do not support human egg donation for the creation of human embryos solely for research purposes.

6 Cloning of human beings
We believe cloning of human beings (reproductive cloning) unethical and does not engage in any activity in this area.

7 Patenting of stem cells
We support the position that human embryonic stem cells, as such, cannot be patented. However, the research-based protocols used to develop stem cells into therapeutic cells, as well as the mature cells and tissues developed by these specific protocols, should be patentable.

8 Protection of human embryo
We support a legislative framework around the use of human embryonic stem cells that adequately protects the human embryo and at the same time ensures that the knowledge obtained can be used to help patients with serious chronic diseases such as diabetes.

9 Stem cell therapies
We support stem cell therapies that are only made available after having been proven to be safe and efficacious in preclinical and controlled clinical trials.

For more information, please see our position on human biosamples.

 

Stem cell research raises questions

Stem cells could possibly cure very serious long‑term diseases. In diseases where particular cells die as the disease progresses - pluripotent stem cells may be used to grow into cells of the same type.

The newly made cells can then be transplanted to the patient to replace the lost cells. Several cell therapies based on mature cells made from pluripotent stem cells are currently being tested in patients.

Novo Nordisk wants to develop new stem cell-based therapies to help patients with serious long-term diseases that will allow us to continue to offer life-changing treatments in the future.

For example, Type I diabetes often affects very young people who then need to use insulin for the rest of their lives. An alternative treatment that would relieve these patients from the burden of the disease and its complications is very attractive.

Young patients and their families therefore have a strong belief in the possibilities of treatment with cell therapy using stem cells

The use of human embryonic stem cells raises ethical issues because the cells come from a fertilised human egg. Some consider it unethical to deal with human embryonic stem cells in a lab.

We make our decisions based on balancing the benefits to patients and society and the possible threat of overlooking our values and ethical codes. Importantly, we only use stem cells that come from eggs that would not otherwise be used and have been donated by people after giving their informed consent.

Once the stem cells have been extracted from the fertilised egg, these cells are kept in the lab and can be used to create new cells. This could possibly serve as an unlimited cell source.

Novo Nordisk recognises and respects that research areas involving ethical issues need to be thoroughly discussed in society. We would like to be part of an open discussion about understanding the ethical and legal issues in the use of human embryonic stem cells.

As a company, we find it important to share information on the issue to ensure a rational and informed debate rather than one based upon wrong assumptions.

Novo Nordisk is committed to do research to find a cure for diabetes and other serious long-term diseases. Stem cells present a unique opportunity that is important to be involved in.

Pluripotent stem cells have the potential to develop into the 220 to 240 different cell types that make up the human body but they cannot develop into a full human being.

The immature pluripotent stem cells may form benign tumours (known as “teratomas”), when they are injected or transplanted. If mature cells formed from pluripotent stem cells are to be given to patients, all relevant precautions must be in place to ensure patient safety.

In some countries you are allowed to create an embryo that is identical to the person who has donated cell material. This is a process called “therapeutic cloning” and it means you can create stem cells that are compatible with the original donor.

This method holds the potential for misuse - to clone a human being. Novo Nordisk is not involved in any research or development that involves therapeutic cloning.

In Denmark it has been legal to use embryonic stem cells since 2003 – meaning that it is possible to use unused fertilised eggs from patients undergoing fertility treatment (IVF) provided the donor gives their informed consent. Novo Nordisk was active in the debate prior to the 2003 law change.

The clinical testing of cell therapies based on human pluripotent stem cells needs to follow the strict safety protocols required by regulatory authorities.

Research in stem cells is constantly refined and new unexpected findings may evolve. Therefore, we need to follow the development closely and continue the ethical debate about the use of stem cells.

We will see situations where we need to make decisions even though the answers are not clear and scientists may not always agree on the risks and benefits. It may for example be argued that using embryonic stem cells is the same as organ donation.

We need to carefully evaluate the concerns raised around the use of embryonic stem cells and take these into consideration when we frame our position. New facts may be brought to light that would call for a change in our position, it is an active process.