Legal and ethical aspects of global drug development from a human rights perspective

The development, registration, price and actual availability and accessibility of (new) medicines is increasingly complex and problematic. Throughout the entire ‘lifeline’ of medicines (development – registration – patient use), various multisectoral problems arise which raise multidisciplinary questions, including from a human rights perspective.

Issues raise such as: when is decision-making legitimate in the field of drug development? Is it problematic if scientific evidence underpinning regulatory decision-making includes (unknown) risks? How should one deal with both manifest and non-manifest conflicts between various sources of regulation influencing the entire pharma lifeline? But also, what is the responsibility of actors such as the Big Pharma and the Dutch Medicines Evaluation Board? And, what does it imply to regard patients as rights-holders?

The research is carried out in one year in collaboration with the Ethics Institute and Netherlands Institute of Human Rights of Utrecht University and is funded by the Dutch Medicines Evaluation Board. Contact: Dr. Marie Elske Gispen, m.e.c.gispen rug.nl