Within Novo Nordisk's "Values in Action" initiative, Bioethics was identified as one of three fields of ethical issues with which the company has to deal, the other two being Human and Social issues, and Business/Finance ethics. Building on the substantial work already undertaken internally, in March 1998 we were commissioned to undertake an independent, external bioethics review of the company. The overall objective was to review Novo Nordisk's attitudes to and management of bioethical issues from both a strategic and an operational point of view, and to provide recommendations on how these might be addressed in the future. The project, which was completed by the end of 1998, provided an analysis of Novo Nordisk's policies and statements, mapped out the key issues for the company, assessed the adequacy and appropriateness of the management of bioethical issues, and surveyed the status of bioethics activities outside the company. A number of workshops were held internally to discuss the findings and their implications.

In 1998, Vernon Jennings, Director of SustainAbility Ltd., and Svend Andersen, Professor at the Centre for Bioethics at Aarhus University in Denmark, conducted an external review of Novo Nordisk’s attitudes to and handling of bioethical issues. One of the recommendations was that we need to further engage stakeholders in the development of our bioethical thinking.

Ethics can be a controversial issue, particularly in industrialized pluralistic societies, but it is possible to single out some features of ethics that could find widespread agreement. We recommended that Novo Nordisk consider bioethics not only in the Human sphere but also in two other spheres - Animal and Environmental. In pursuing its business goals, the company needs to understand the (bio)ethical arguments, be familiar with them, and develop methodologies for dealing with them in a consistent way.

The statement of purpose in "Novo Nordisk Vision 21" clearly expresses ethical values such as the satisfaction of "real needs"; "improving the way people live and work"; "fight[ing] the burdens of disease"; and "provid[ing] sustainable biological solutions". Against the background of the overall concept of ethics, we defined bioethics as "the ethics of biological research and the development and application of biotechnology, both within and beyond the human sphere".

Not surprisingly, one of the conclusions from our review was that inside Novo Nordisk bioethical issues are seen to be important in maintaining the company's "right-to-operate" and equally importantly the "right-to-innovate". These are especially significant for Novo Nordisk, given that the company is dependent on new technologies and the pace of change in the development and application of bio-technology is very rapid. Our review confirmed Novo Nordisk's commitment to the principles of transparency and proactive public discussion, and it is widely recognized internally that the company needs to be able to discuss bioethics with its stakeholders in a more meaningful and consistent way. However, the level of technical understanding of biotechnology in society is low, and a suitable, shared vocabulary for addressing bioethical issues, both in society and within Novo Nordisk, is needed. This is one of the main difficulties - communication on bioethics using a common language is limited.

Novo Nordisk faces many complex bioethical issues and the challenges are how to make ethical considerations fully operational and how to develop common methods of ethical assessment. Bioethical assessment methodologies should help the company to understand the issues better and make judicious decisions on how to deal with them. We recommended that goals and targets be set for all major bioethical issues, so that, as in other aspects of management, performance and progress can be measured and monitored.

However, we concluded that in many cases the necessary structures are in place for Novo Nordisk to keep abreast of new developments, but expertise and education and training in bioethics emerged as key issues for the company. Those people who make decisions in the company and those confronted by bioethical issues in their daily work should be the key targets. In line with practice in other areas, we recommended that all major research and development proposals should be subject to formal bioethical analysis.

How Novo Nordisk should manage the international aspects of bioethical issues emerged as a key question for the review. In our view, further integration, closer cooperation and more contact and exchange between Novo Nordisk's operations would be beneficial.

We also concluded that, with regard to bioethics, there could be greater clarity in the decision-making processes within the company; that roles and responsibilities should be more clearly defined; and the current decision-making bodies further rationalized and coordinated. Whilst the review recommended that the Corporate Environment and Bioethics Committee should continue to be the primary body dealing with bioethical issues, it also recommended that Novo Nordisk should continue with both a "top-down" and "bottom-up" approach.

Novo Nordisk needs to continue to engage stakeholders in the development of its bioethical thinking and its research and development programmes. We recommended that an external point of reference for its bioethical work would help provide the appropriate context, and we recommended that the scope of the reporting and communication of bioethical issues, for example in the annual reports, should be expanded.

In carrying out a bioethics review, Novo Nordisk has once again taken the lead in the biotechnology and life sciences industries. The development of a more systematic approach to the management of bioethical issues will undoubtedly help the company fulfil its mission and respond to concerns within society at large.

Dr. Vernon Jennings, Director, SustainAbility
Professor Svend Andersen, Centre for Bioethics,
University of Aarhus