The discovery and development of new pharmaceuticals entails careful attention to a range of ethical considerations. Novo Nordisk upholds high standards in the areas of human ethics (clinical trial and stem cell research ethics), animal ethics (the reduction, refinement and replacement of animal experiments) and the use of gene technology in research and production. The same high ethical standards also apply to external partners such as contract research organisations and suppliers. On several occasions, the Novo Nordisk has been the driver behind new bioethical standards that gain wider adoption in the industry.
While a commitment to being a responsible company is the primary driver of Novo Nordisk’s high bioethical standards, Novo Nordisk also takes into account rising public expectations of greater accountability and transparency.
Although regulatory authorities monitor research to ensure it is conducted in accordance with relevant laws and universal principles, stakeholders also seek reassurance that companies consider any ethical concerns that may emerge. Through engagements with stakeholders Novo Nordisk seeks to achieve sustainable solutions to shared goals and draws valuable insights on stakeholder attitudes, wishes and needs. In particular, this is a matter of being respectful of the integrity of people participating in medical studies, animal welfare and culturally founded objections to certain types of research.
Bioethics performance rated by Dow Jones Sustainability Index
In 2008, Novo Nordisk received the highest possible score on the company’s performance in bioethics and animal experimentation by the Dow Jones Sustainability Index, a global index ranking companies on sustainability criteria. For the second consecutive year within bioethics, and the fourth year in a row within animal testing, Novo Nordisk’s rating was 100/100. The industry average currently stands at 41/100 and 50/100, respectively.
Bioethics Audit by PricewaterhouseCoopers
Bioethical issues in research and development play an increasingly significant role in the eyes of policy makers and the public. To assess the extent to which Novo Nordisk meets these stakeholders’ expectations, Novo Nordisk engaged an external party, PricewaterhouseCoopers, to perform a bioethics audit in 2008.
The audit focused on four main areas: animal welfare, clinical trials, stem cell research, and gene technology. The analysis was based on Novo Nordisk’s Bioethics strategy, SOPs and other internal documents, the corporate website, interviews and correspondence with company executives, and Novo Nordisk’s Annual Report.
The report concluded that “Novo Nordisk has an outstanding bioethics program and should be commended for its approach. The company’s emphasis on bioethical issues, development of specific policies, and its governance structure, designed to ensure that bioethics matters are incorporated into business decisions, make Novo Nordisk a leader in the pharmaceutical industry.”
Novo Nordisk was commended on many fronts, for example the company:
- only uses placebos during trials when it is scientifically and ethically justified.
- guarantees that patients in clinical trials will receive the best available and proven treatment after the trial ends.
- uses specific criteria, which must be met by a potential host country if Novo Nordisk is to perform a trial in that country.
- has improved housing and living conditions for animals used in experiments.
- ensures internal review of all animal experiments by Novo Nordisk Ethical Review Committee.
It was recommended that the company participate more actively in bioethical discussions at a global level. Novo Nordisk is currently selecting international initiatives aimed at high bioethical standards that it will support.
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Novo Nordisk’s approach
Novo Nordisk defines bioethics as all ethical issues related to the use of life science technologies for the development and production of biotechnological and pharmaceutical products. As a company committed to the Triple Bottom Line, a Bioethics Policy is included in the Novo Nordisk Way of Management – Novo Nordisk’s basic management principles. This policy, which provides operational guidelines within this area, is described below.
Novo Nordisk Bioethics Policy
In Novo Nordisk we will continuously improve our bioethical performance.
This means that we will:
- Promote bioethical awareness throughout the company
- Establish and ensure high ethical standards for:- Experiments on live animals- Clinical trials and use of human material- Gene technology- Our external partners, contract research organisations and suppliers, and monitor their performance
- Engage in stakeholder dialogue and partnerships, and report on our performance
- Live up to the spirit, values, principles and content of relevant conventions, laws and requirements.
Environment, Bioethics and Occupational Health & Safety Committee
The work in this field is governed by the Environment & Bioethics Committee, chaired by the executive vice president for Corporate Relations and chief of staffs. The committee, which is mandated by the Executive Management group, includes the chief science officer. Corporate principles for the use of animals and for clinical studies are part of the internal management systems and communicated to Novo Nordisk employees as well as to research partners.
For more information, please visit Novo Nordisk website on bioethics.