Critical issued of the appropriateness of conducting clinical trials in emerging countries has arisen over years. Being a leading company in biopharmaceutical industry, Novo Nordisk faces the critiques of whether it is justice to offshoring their clinical trials in developing economies. With the consistency of ethical principles brought up by Novo Nordisk, the company would be able to move their trials into emerging economies with the best interest for stakeholders.
I will also propose ideas to Mr, Dejgaard for possible approach to media as well as the practices that Novo Nordisk could have changed over time at the end. Conducting Clinical Trials in Emerging Economies With Utilitarian approach, every party has different perspectives in the outcome of an action. In this case, we have shareholders, employees, customers, supply chain, government and local communities, with secondary stakeholders of media, special interest groups and NGOs.
For customers, government and local communities, they emphasize more on the proof of efficacy and safety of medical products. While shareholders, employees, supply chain care more of the profitability as a whole in general. As a result, Novo Nordisk will be better off maximizing its profits while holding their ethical justice for conducting clinical trials in emerging countries. Economic Aspect
As the Nobel prize winner, Milton Friedman pointed out that making profit will be the first priority for business to fulfill social responsibility, Novo Nordisk has every right to maximize its best interest for its stakeholders include shareholders, employees, customers, suppliers, governments and local communities. From financial performance stand point, conducting clinical trials in emerging economies benefits Novo Nordisk from saving costs, accessing to larger demographic participant, obeying less strict rules applied, and establishing efficacy in different environmental onditions. Ethical Aspect On the other hand, firms should consider the corporate social responsibility brought by the society. Firms definitely need to incorporate their highest moral standards to build trust and reputation for themselves in order to better off in long run. Novo Nordisk always follows the regulation from Helsinki Declaration with other international ethical guidelines. They made sure that the interest and well-being of the trial subject should always transcend over the interest of science, society and commerce. Decision Principles
Even though I think conducting clinical trials in emerging economies is beneficial to the firm, Novo Nordisk should still follow below guidelines for this major decision to protect its own reputation and serve the best interest for every stakeholder: • Execute clinical trials when the internal organization is well established and external environment is proper regulated in emerging countries. • Conduct placebo clinical trials when they are scientifically and ethically justified. • Ensure the human rights of the participants in emerging countries associated with the predictable risks
Responses to The Media I understand that Mr. Dejaard holds a high ethical stands, and is not interested in misleading the public or ethical dissembling in the response. It is also important to clear up the actions Novo Nordisk has taken for the past years and give public a clear picture of how the firm is operating. If a journalist is inviting for an interview, Mr. Dejaard should present himself into the public and response to the inquiry people have, otherwise, absence will only show irresponsible image that he might try to escape from the issue. Medical Ethics I will suggest Mr.
Dejaard to pull out historical data indicating that the random checks investigated from Food and Drug Administration (FDA), the American and European authorities have never identified ethical problems in clinical trials in emerging economies. Second, assert the ethic codes from their company will help the publics to receive the image of Novo Nordisk has complied with the Helsinki Declaration of the World Medical Association. Ethical Business Media might inquiry the fairness of conducting placebo experiment in emerging countries by Novo Nordisk based on the industry trends in recent time.
Mr. Dejaard could response to them that Novo Nordisk usually stay away from placebo trials, and only used in phase 1 trials which only healthy volunteers participated. Also, Novo Nordisk framed new business ethics policy in 2005 with generally accepted high standards while training managers and employees attending workshops and offering e-learning policy. To better respond to the media, Mr. Dejaard could also indicate that Novo Nordisk will try to implement some new action plan that could benefit stakeholders as a whole in order to minimize ethical conflicts.
I suggest the following action plan for Novo Nordisk to benefit them in long run. Action Plan Enhance Auditing System To build trust for the stakeholder for Novo Nordisk, I believe the firm should develop a more solid auditing system. Instead auditing 10% of all trials, Novo Nordisk should increase the rate up to 50% or more. From a public view, 10% of investigating in all trials is not sufficient enough to prove that the trials are ethical conducted. With the increasing number of trials being audited and investigated, the quality of the clinical trials could be better controlled.
Build up Placebo Experiment Standard In the “Clinical Trials: Novo Nordisk’s Position,” it pointed out that placebo will only be used as comparator when scientifically and ethical justified. It is quite unclear for public to know what would be an appropriate placebo experiment for Novo Nordisk to conduct while proven therapy is available. It is important to insiders to identify whether or not conducting placebo experiment under certain circumstances will have any additional risk and irreversible harm.