New research into the 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.

When is decisionmaking legitimate in the field of drug development, if scientific evidence underpinning regulatory decisionmaking includes (unknown) risks as well? How would you 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 Dutch Medicines Evaluation Board and what does it imply to regard patients as rights-holders?

Dr Marie Elske Gispen has received a one-year grant of the Dutch Medicines Evaluation Board to conceptualise together with a junior researcher the most pressing legal and ethical aspects of global drug development from a human rights perspective. She received the grant together with the Ethics Institute and Netherlands Institute of Human Rights of Utrecht University.

Dr Marie Elske Gispen is postdoc researcher at the Department of International Law and affiliated to the Global Health Law Groningen Research Centre, and works together with Prof. Brigit Toebes on children’s rights and tobacco control in a 3-year research project funded by the Dutch Cancer Society.

This article was published by the Faculty of Law.

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