Policy Gain or Confidence Game? A workshop on pharmaceutical transparency across Europe, Canada and the United States

The Jean Monnet Health Law and Policy Network and the MacEachen Institute for Public Policy will be co-sponsoring a research workshop on Policy Gain or Confidence Game? A workshop on pharmaceutical transparency across Europe, Canada and the United States on July 3-4 2018 with

Sharon BATT
Andrew BOOZARY
Courtney DAVIS
Katherine FIERLBECK
Marc-André GAGNON
Janice GRAHAM
Matthew HERDER
Tom JEFFERSON
Trudo LEMMENS
Joel LEXCHIN
Nav PERSAUD
Joseph ROSS

For over a decade, regulatory jurisdictions have embraced the idea of pharmaceutical data transparency. Despite this aspirational rhetoric, however, real access to this data has remained limited, and meaningful progress toward greater transparency in the research and development of pharmaceutical drugs and biologics has, at best, been slow and uneven across jurisdictions. Laws requiring registration and results reporting of clinical trials have been in place for over a decade in the United States, but enforcement of those requirements has been non-existent; the European Medicines Agency has set the bar for public release of clinical trial data, but its efforts are being stymied by European Courts. And, although Canada enacted important changes in law, its regulator has thus far failed to implement them or, worse, created procedural obstacles to data openness.

This workshop seeks to understand this disjunction between rhetoric and achievement in greater comparative detail. Why have some jurisdictions been able to achieve more than others? Are the legal and political obstacles to greater transparency similar across regimes, or are they specific to each regulatory jurisdiction? Is the superficial embrace of transparency itself an impediment to more profound changes?

Recognizing the current fragility of pharmaceutical transparency, this workshop will bring together legal and political science scholars, clinician researchers, members of civil society, and policy makers in an effort to map out the varying levels of progress toward greater transparency across Europe, Canada, and the United States, unpack what lies behind that policy variation, and - more fundamentally - to ask: as one avenue of access to pharmaceutical data opens up, what others are at risk of closing down or being forgotten? Has the attempt to achieve greater transparency in pharmaceutical data been a success, or merely a shell game?