Matthew Herder shares a template letter that physicians, researchers, civil society groups, investigative journalists, and others can use to gain access to unpublished pharmaceutical safety and effectiveness data.
This is a call to action—a call that physicians, biomedical researchers, civil society, journalists, and others have long made concerning the need to improve the level of transparency in pharmaceutical research and regulation. It’s important to echo that call now, not only because it’s right—transparency is vital to evidence-based medicine and patient safety—but because a new mechanism in Canadian law has the potential to open up a great deal of hidden information about pharmaceutical interventions.
Only one physician researcher appears to have taken advantage of this mechanism since Canada passed Vanessa’s Law in 2014. That has to change. It’s not enough for governments to enact laws and policies that require greater pharmaceutical transparency. Real people and institutions—physicians, other health care providers, biomedical researchers, civil society organizations, investigative journalists, and others—have to enact transparency too.
To aid in this process, I have developed a tool—a template letter—that is free to download and use as a means of gaining access to unpublished pharmaceutical safety and effectiveness data. The tool and the terms it contains are based upon best research practices, research ethics norms, and the European Medicines Agency policy on publication clinical data.
Who can use this letter?
Any “person who carries out functions relating to the protection or promotion of human health or the safety of the public” can use this letter.
The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.