The notion of benefit

The first focus of the position paper centres around the benefit to the community in which certain drugs are tested. In fact, before selecting a region of the world or a population in which to conduct a clinical trial, there needs to be clear commitment on how this research will benefit the community. The use of vulnerable populations as ”guinea pigs“, testing treatments that will never be available to them is entirely unethical. This is made clear in the Helsinki Declaration (October 2000), one of the pillar document of ethics of research in human subjects: ”Medical research is only justified if there is a reasonable likelihood that the populations in which the research is carried out stand to benefit from the results of the research.“

Even more so, in article 8 of the research ethics guidelines elaborated by the Council of International Organisations of Medical Sciences (CIOMS), it is stated that: ”the sponsoring agency should ensure that, at the completion of successful testing, any product developed will be made reasonably available to the inhabitants of the underdeveloped community in which the research was carried out.“ In these guidelines it is also pointed out that any exception to this rule should be clearly agreed upon by both parties before the beginning of the trial. These agreements should be included in the dossier to be evaluated by ethical committees so that they can review the real ”potential benefit“ of the study for the local community.

Continuing on the same line, when pharmaceutical companies test drugs in developing countries they need to ensure the integrity of the study. For this to happen it is essential to guarantee that the area benefits from the necessary materials and equipments for the running of the study and follow-ups. If the current medical and scientific structure is not sufficient, sponsors are required to help their development through financial or in-kind assistance.