In every decision we make, we believe that our commitment to follow the highest bioethical standards and to act with integrity in all that we do ensures our continued ability to operate and innovate and to act as a responsible corporate citizen.

We consider bioethics as one of our core issues in the environmental, medical and animal spheres. 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.

Animal welfare, patenting, access to genetic resources and benefit sharing, and the safe application of gene technology, are among the issues with which we work. We recognise that bioethical issues are sometimes controversial. In our work, we try to apply the basic bioethical principles of not doing harm and doing good by demonstrating the benefits of respect and justice.

We work towards continuously improving our bioethical performance, by establishing and ensuring high ethical standards for experiments on living animals, clinical trials and the use of human material, and gene technology.

In addition, we set high ethical standards for our external partners, contract research organisations and suppliers and monitor their performance. We could not meet these goals if we did not engage in extensive dialogue and partnership with animal welfare organisations, patient organisations and other relevant stakeholders.

We wish to be proactive by ensuring active and positive compliance with the spirit, values, principles and content of relevant conventions, laws and requirements and by influencing new laws and regulations by setting new trends and standards.

In order to further disseminate our policies and strategies regarding bioethics, in 2002 we produced three Novo Nordisk Guides – for bioethics, for the ethical use of experimental animals, and the ethical use of human material.

Full list of types of animals purchased for experimentation (incl. transgenic animals).
(click to view list)

In the summer of 2002, Novo Nordisk decided to suspend the clinical studies of
our experimental diabetes drug, ragaglitazar (also known as NN622), following
observation of a tumour in a mouse. We felt that this finding, together with our earlier pre-clinical findings of tumours in rats, created concern that the drug might not be safe for chronic use. In February 2003 we have decided not to pursue further development of NN622 based on a renewed benefit/risk assessment of the compound.

The suspension of the NN622 clinical trial could well be seen as a test of our
Clinical Trial Policy. This policy, approved in 2001, codified the practices we had
been undertaking for many years. It describes the principles for conduct of Novo
Nordisk-sponsored clinical trials to ensure the safety, rights, integrity, confidentiality and well-being of trial subjects. The NN622 trial, which involved 2,500 people in 32 countries, was conducted in full compliance with all requirements for good clinical practice.

While the trial, and our decision to suspend it, was based on rigorous ethical guidelines, we regret that the decision created anxiety among some people who participated in the trials. Novo Nordisk immediately, simultaneously, and diligently informed the involved physicians, ethics committees, regulatory agencies and the stock exchange about the decision to suspend the clinical trials.

Unfortunately, and as a consequence of this, full and accurate information
about why a clinical trial is being suspended does not always reach trial participants
first through a reliable source, such as their physician. The participant may in fact read a media report of the decision to suspend the trial before he or she has a chance to meet with the physician. This media report may or may not present the full and accurate picture of the situation.

This presents a dilemma: while it is in our best interest that participants in our
clinical trials should get the best information as soon as possible from the best
source, pharmaceutical companies do not know who the trial participants are, and cannot contact them. Only the investigators conducting the trials are permitted to contact trial participants directly.

While these international guidelines are designed to ensure the independence of
the trial results and protect the integrity of the participants, it does mean that our desire to be open and transparent with all our stakeholders is limited in this instance by the prevailing system for conducting clinical trials.

As a company we cannot solve this dilemma; we must abide by the system. What we can do, as in this case, is to provide full information quickly to the trial investigators so that they can inform the trial participants about the decision and its consequences, if any, for their health.

Novo Nordisk’s aspiration is to defeat diabetes. Human stem cell research with the potential for cell transplantation is presently the most promising approach for curing type 1 diabetes, affecting approximately five million patients worldwide. We recognise, however, that it has prompted a passionate medical ethics debate – one in which we intend to take
a full and active part.

Stem cells are unspecialised cells that have a unique capacity to multiply indefinitely
and turn into several or all the different kinds of cells and tissues of the human body.

We see it as an obligation to pursue a potentially very promising treatment,
which might in due course improve the life of millions. Novo Nordisk also wants
to be prepared for these new therapies and thus maintain a successful and sustainable
business in diabetes care.

Yet we recognise that the source of some stem cells – the human embryo – is controversial. Some object to any research on these stem cells because of religious beliefs that human life has the status of a potential person from conception.

Others disagree. Proponents of stem cell research are convinced not only of the prospects of the therapy, but also because they perceive a fertilised human egg as gaining gradually in status, and thus rights, during its development.

Research performed on stem cells obtained from adults or umbilical cord blood has not evoked objections on ethical grounds. However, recognising that research on stem cells obtained from either foetuses or embryos poses moral and ethical issues for some people, we agree that scientific research in this field should be undertaken by adequately addressing both the ethical and legal issues.

Novo Nordisk is committed to contribute to an open dialogue and an ethical and political clarification regarding the use of human embryonic stem cells from surplus in vitro-fertilised embryos.

“Securing an unlimited supply of stem cells is one of the best hopes we have for curing diabetes. We believe it is appropriate and worthwhile to use spare embryos from in vitro fertilisation (IVF) clinics, which would otherwise be discarded, to try to treat children and others with diabetes,” says Dr Robert A. Goldstein, chief scientist, Juvenile Diabetes Research Foundation International.

• Roundtable on stem cells: During 2002, a number of activities have taken place. We hosted a roundtable in August that included several external stakeholders with expertise in bioethical issues, and held a meeting to inform employees about stem cell research as part of a regular series of informational meetings for employees on issues important to the company. It was attended by more than 800 employees in the Danish headquarters and shown live over the intranet.

• In support of proper regulation: We acknowledge that society’s elected representatives are the decision-makers on what applications are acceptable and what ethical limitations should be applied on the use of new technologies, eg the use of human embryonic stem cells. We urge all countries to enact legislation to ensure that such research is properly regulated and controlled.As in many other research areas, Novo Nordisk has long-time partners in national and international cooperative projects involving stem cells. Novo Nordisk’s activities have so far been restricted to the use of mouse embryonic stem cells.We want to work with human stem cell lines/cultures derived from spare embryos from IVF treatment that are obtained with informed consent and to direct these stem cells into mature insulin-producing beta cells, to be further developed for transplantation.  In Denmark, the legislation around the use of human embryonic stem cells for research is presently being revised. Novo Nordisk has encouraged Members of Parliament to vote for a change of legislation in favour of using human embryonic stem cells in a well-defined way.

In 2002, Novo Nordisk implemented a new policy of performing internal ethical
reviews of all present and future types of experiment on living animals. Two Ethical
Review Committees (ERCs), in development and in research, meet monthly to review
applications for animal experiments. No type of animal experiment at Novo Nordisk can be conducted without a review by the relevant ERC. Such review committees are not yet required by law in Denmark, but we feel this oversight is important to ensure high ethical standards.

Each committee is chaired by an experienced animal scientist and has members who are directly involved in animal experimentation and others who are not. The goal is to review current animal experiments in light of stress levels, housing conditions, how well the experiments meet the three Rs (reduce, refine and replace animal experiments wherever possible), and by cost-benefit analyses to determine whether the gain for humanity outweighs the possible suffering of the animals.

To date, the ERCs have functioned well, sharing information and advice that help those conducting animal experiments to place an even greater focus on the ethical aspects of the experiments.

• Progress on housing standards: We are making good progress towards our target
  of establishing and fully implementing new Novo Nordisk standards by 2005 for optimal housing in consideration of the needs of the animals we use. In 2002, the success of a prototype pen system for rabbits led us to erect 14 such pen systems, each capable of holding eight rabbits, and it is our goal that all our rabbits will live in pens, enhancing their welfare. We have added improvements to the two large outdoor enclosures for the exercise and socialisation of dogs and have extended our facility for housing pigs, allowing the animals to have contact, and built an outdoor area for exercise. All of these improvements were made as a result of our collaboration with the Danish Animal Welfare Society and valuable input from external animal behavioural experts.