Health Governance and Pharmaceutical Product Development: Dilemmas in Exporting Clinical Research to Developing Countries.

Pharmaceutical product development and distribution is a costly and protracted process. The problem of drug access is particularly acute in developing countries where prohibitive costs delay or prevent universal access to essential medicines. The effect has been a disproportionate disease burden in countries that can ill-afford to treat entirely preventable diseases. As pharmaceutical companies increasingly export their clinical research trials to developing countries questions arise concerning the level of access such practices provide companies to subject populations. This is a particularly important issue given that evidence suggests that the ethical standards of such research are not as high as that conducted in Western countries, and that participants are more willing to participate in clinical trials than their western counterparts, due largely to illness and poverty and inferior access to treatment. Employing case studies and qualitative interview data, this paper will explore these issues, arguing that important national and global health governance and corporate regulatory issues must be addressed in order to thwart the development of a neo/post-colonial model of pharmaceutical product development. ..PAT.-Unpublished Manuscript [ABSTRACT FROM AUTHOR]