Abstract

The case brings into focus gross ethical violations in the drug trials conducted by Switzerland-based pharmaceutical major F. Hoffmann-La Roche AG (Roche), in Egypt. Healthcare in Egypt was predominantly driven by private hospitals, owing to the precarious condition of the public healthcare infrastructure and the regulatory frameworks that had crippled the government healthcare system. The poor penetration of insurance coverage made it necessary for many Egyptians to pay out of their own pockets for healthcare. Economic deprivation and lack of insurance coverage left many patients in Egypt with no option but to agree to participate in drug trials, predominantly conducted by transnational companies like Roche. The nascent stage of the Egyptian laws around the clinical trials had largely failed in observing and ensuring adherence to the laws concerned with human trials. Pharma majors had found emerging economies like Egypt a soft target and had chosen them as ideal destinations to conduct drug trials, without strictly adhering to regulations. Roche was found to have grossly deviated from several ethical and legal norms, having used unapproved and expired drugs for the trials as well as for sale, not nominating the drugs used in the trial for the state subsidized program, and encouraging unethical distribution channels in contravention of the laws – to name just a few. Roche went deliberately in search of a treatment-naive population, who had not taken any prior medication, anticipating that it would get more reliable and consistent results then, though this contravened the guidelines of equal distribution of subjects. Other allegations against Roche included the study tests being conducted based on shallow and unscientific designs, ineffective post-trial access, poor ancillary care, and disproportional risk/benefit ratio to the trial participants. These observations called for a close scrutiny of the ethical stand of Roche as a global pharmaceutical major and its role in bending ethical and legal principles by denying risk-embracing trial participants in emerging economies their rights. This case takes a particular view of Egypt’s experience with Roche and the various ways in which the basic ethical aspects and some legal aspects were compromised.

Learning Objectives

The case is structured to achieve the following Learning Objectives:

• Evaluating and understanding the ethical issues and challenges prevailing in emerging economies, especially in the area of pharmaceutical drug trials on humans
• Appraising the role and responsibilities of the trial sponsors toward the patients, from an ethical point of view
• Appreciating the relationship between business and public and evaluating a collaborative stakeholder approach to safeguard the ethical essentials in business

Keywords

Roche; Pharma Research; clinical trials; ethics in business; Big Pharma; Ethical dilemma; Drug trials; healthcare; Outsourced clinical trials; ethical concerns; human subject protection