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Novo Nordisk and Clinical Trials in Emerging Economies

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Question 1: Considering both economic and ethical aspects, is it appropriate for companies like Novo Nordisk to conduct clinical trials in, for example, India, and if so under what conditions? What exactly are the principles that should guide such a decision?
1. Ethical aspect.
Nordisk’s implementation of clinical trials in India is appropriate. The appropriateness is expressed through the following guidelines:
• Novo Nordisk’s trials seriously comply with medical ethics (Hippocrates’s oath) through its particular attention to individual patients joining any of its trials.
• Novo Nordisk has applied all the guidelines and global recommendations from specialized agencies and has adopted its policies on clinical trials. Accordingly: o Clinical trials sponsored by the company always comply with Helsinki Declaration, listing the rights of patients enrolled in clinical trials, and the global ethical principles like Nuremberd rules, and Belmont report, CIOMMS and the principles of the International Conference of Harmonization on Current Clinical Practice (CGCP) o Countries where Novo Nordisk conducts trials will be ensured to have a proper internal organization and proper legal environment. o No testing activities are conducted before permitted by the ethics review board and the health authorities. o The safety information of Novo Nordisk’s trials will be continuously monitored and appropriate actions will be taken if risks of the tried medicine outweigh the benefits it brings. o No procedure involving human subjects is carried out before approved by the subjects who have already been informed of potential risks taking the trials. A patient can at any time withdraw from the trial without making clear of their reason. o The products used in trials of Novo Nordisk will be mass produced and controlled based on international and local laws.
2. Economic aspect:

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