4 - Benefit for the whole population

As stated by the revised Helsinki Declaration (October 2000) ‘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».

THE CIOMS article 8 states that ”As a general rule, 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: exceptions to this general requirement should be justified to by all concerned parties before the research bas begun“

Although the meaning of ”reasonably available“ is not clearly specified, the wording of the guidelines clearly implies that there is an obligation for the sponsor to ensure the availability of the product. Hence, the mechanism for ensuring such availability should be specifically set forth in an agreement before the study begins. The principle of justice requires that a vulnerable population should not be the focus of research unless the potential benefits of the research are extended to that group after the trial.

An agreement should be negotiated

Prior to the beginning of any research studies in vulnerable populations and/or countries, agreements should be negotiated between the relevant parties to make the effective intervention or other research benefits available to the host country after the study is completed.

In the particular case of a pharmaceutical company conducting trials on a new drug in developing countries, the company should commit to make this drug available at a locally affordable price after the completion of the drug development process.

The nature of any pre-research negotiations between sponsors, host country officials, patients’ advocates, and other appropriate parties should be included in the drug dossier evaluated by local ethics committees. In cases in which it is not foreseeable that successful interventions will become available in the host country, the ethics committees should be supplied with a detailed explanation of the reasons that render the research justifiable in the context of the single country and/or community, and a reasonable risk/benefit ratio presented.