Stakeholder trust in Novo Nordisk is earned through our responsible approach to doing business and the transparency with which we approach the issues of concern to our stakeholders. This is particularly valuable when dealing with one of the dilemmas most associated with the pharmaceutical industry: bioethics.

Use of human material - Continuing the dialogue on stem cells - Go-ahead for research purposes - Clinical trials: a responsible approach - Informed consent 

The Hagedorn Research Institute is at the forefront of stem-cell research in diabetes. Mattias Hansson is member of the international research team. In the picture he cultivates embryonic stem cells from mice.

We rely on the public’s confidence that what we do to develop our business also serves the best interests of society. Life sciences offer many opportunities for developing therapies that can bring benefits to many people in need of better healthcare. However, we also recognise that the new biotechnologies pose a range of ethical dilemmas and raise questions to which no one yet knows the answers. We define bioethics as all ethical issues related to the use of life science technologies for the development and production of biotechnological and pharmaceutical products. This includes the ethical use of human materials, human volunteers and patients in clinical trials, and the use of experimental animals.

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Novo Nordisk uses human material in the discovery and development of new drugs. It is of key importance that we are able to test drug compounds in human cells and tissues at different stages of drug discovery in order to rapidly select viable compounds and to estimate the safety before testing the compounds in humans. The use of human material also helps to reduce the use of experimental animals, a goal we describe in the article ‘Treating animals with respect’. Human material is obtained from live donors or from deceased persons via donor banks or tissue biobanks, or from individuals participating in biomedical research projects via collaborating universities, hospitals and other non-profit organisations. We obtain our material from Denmark and several other countries. Public authorities and governments are now seeking to better regulate the use of biobanks and to address the transfer of human materials across borders, an area that is not yet well regulated. We support regulation of biobanks to protect donors, in particular
the requirement to practise informed consent for use of the material.

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There are several ethical issues related to medical development that are of interest, and sometimes of concern, to our stakeholders. These include the international debate on stem-cell research and the use of human embryos in research. Novo Nordisk currently sees human stem-cell research with the potential for cell transplantation as the most promising approach to finding a cure for type 1 diabetes. We recognise that the source of some stem cells – the human embryo – is controversial. That is why we maintain an open dialogue with stakeholders and have put forward our positions.

Novo Nordisk wants to extend its research on mouse embryonic stem cells to include human embryonic stem cells, in order to be able to move forward in its efforts to direct human embryonic stem cells into mature insulin-producing beta cells, which can be further developed for transplantation. We will only use human embryonic stem cells when it is not anticipated that the same scientific results can be obtained from the use of adult stem cells, and we will only work with human embryonic stem cells derived from spare embryos from IVF treatment that are obtained with freely given informed consent. Novo Nordisk does not support IVF treatment for women, or the creation of human embryos, solely for research purposes.

Elected politicians must be the ones to make decisions on what applications are acceptable and what ethical limitations should be applied to the use of new technologies, such as the use of human embryonic stem cells. However, great differences exist between European countries concerning the state of legislation and control of research into human stem cells, and this is a cause for concern. As a number of scientists are already investigating the properties of human stem cells, Novo Nordisk urges all countries to enact legislation to ensure that such research is properly regulated and controlled. Novo Nordisk finds cloning of human beings (reproductive cloning) unethical and supports initiatives aimed at a global ban.

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In 2002, the Danish Parliament investigated the need for an ethical and political clarification on legislation regarding the use of human embryonic stem cells from surplus in vitrofertilised embryos. Novo Nordisk supported the Parliament in examining the issue and offered our perspective to the discussion. In May 2003 the Parliament decided to allow research on
human embryonic stem cells with the aim of obtaining new knowledge that will improve the chances of curing diseases in human beings.

According to Danish law, any application to use human embryonic stem cells for such purposes must undergo an ethical evaluation. We support this decision, and Novo Nordisk fully complies with its constraints, respecting ethical concerns. Novo Nordisk also supports initiatives to regulate stem-cell research at the EU level and is following this process closely and providing input.

The Danish decision paves the way for researchers to reach their goal of finding a cure for type 1 diabetes. Novo Nordisk is currently investing DKK 17 million in stem-cell research at the Hagedorn Research Institute in Denmark, the research facility owned by the company. The Hagedorn Research Institute is at the forefront of stem-cell research in diabetes, working closely both with the US National Institutes of Health (as part of the NIH-supported Beta Cell Biology Consortium) and the Juvenile Diabetes Research Foundation (as part of the JDRF Center for Beta Cell Therapy in Europe).

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Novo Nordisk conducts clinical trials globally in order to test the safety and efficacy of new drugs before marketing. Furthermore, Novo Nordisk sponsors clinical trials after approval to market a drug has been granted in order to gain more clinical knowledge and experience of these products.

We conduct clinical trials in Europe, Asia, including Japan, North America, South America and certain African countries. About 15% of the trials take place in the developing world. We recognise that clinical trials held in developing countries have prompted media debate over the ethical conduct of these trials. For Novo Nordisk, there is no ethical conflict over the way we conduct clinical trials in the developing world as opposed to the developed world. All persons enrolled in our trials are protected by the same rights, high ethical standards and regulations irrespective of which country they are in.

The clinical trials we sponsor are conducted according to the World Health Organization’s Helsinki Declaration describing human rights for patients participating in clinical trials, the International Conference on Harmonisation (ICH) for current Good Clinical Practice (GCP), local regulatory guidelines and our own internal Standard Operating Procedures and Policy on Ethical Conduct of Clinical Trials. Trial activities only start after approval from an external local ethical committee, and no procedure involving a person undergoing clinical trials will take place before the person has given informed consent. Novo Nordisk personnel audit trial sites on a regular basis to ensure that these guidelines are met.

We conduct our trials globally because we need to test our products in the populations where the product is going to be marketed. Indeed, the countries’ regulatory authorities often require us to do this. Physicians in the developing countries also wish to be part of our trials from a desire to be involved in the front line of research. The not unlimited number of patients who are willing and suitable to be involved in clinical trials also requires us to expand our global recruitment base.

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We ensure that the people participating in the trials are given detailed information, both verbally and in written form, about the purpose of the trial, and the potential risks and benefits of participation. This information is always given to patients in their native language. The patient and the investigator need to sign the informed consent form to document that this has happened. We take care to make sure that literacy, poverty or cultural barriers do not prevent a person’s full understanding of the issues involved in participating in a clinical trial. A trial participant can withdraw at any time without providing a reason.

We also do not conduct a trial unless the investigator or physician has the necessary skills and competence to perform it. The investigators are paid to compen-sate for their time, and most often this money is paid into a research fund used for research purposes at the given hospital. GCP prohibits companies conducting clinical trials from paying patients directly for participation in a trial.

We will continue to adhere to the highest ethical standards regarding clinical trials, as well as the use of human material and the way in which we market and sell our products.