Against vaccine assay secrecy

Abstract

Increasing the transparency of the evidence base behind health interventions such as pharmaceuticals, biologics, and medical devices, has become a major point of critique, conflict, and policy focus in recent years. Yet the lack of publicly available information regarding the immunogenicity assays upon which many important, widely used vaccines are based has received no attention to date. In this paper we draw attention to this critical public health problem by reporting on our efforts to secure vaccine assay information in respect of 10 vaccines through Canada's access to information law. We argue, under Canadian law, that the public health interest in having access to the methods for these laboratory procedures should override claims by vaccine manufacturers and regulators that this information is proprietary; and, we call upon several actors to take steps to ensure greater transparency with respect to vaccine assays, including regulators, private firms, researchers, research institutions, research funders, and journal editors.

Keywords: access to information law; intellectual property; transparency; vaccine assays.

Figure 1.

Number of access to information requests processed and partially or fully denied by Health Canada, and number of exemptions relied upon to partially or fully deny such requests, 1991-2012. *Figure 1 was compiled using information contained in Health Canada's annual reports regarding access to information requests, which are publicly available. Data for fiscal years 1992-1993, 1996-1997, 1997-1998, and 1998-1999 is not publicly available, and only some data is available for fiscal years 2007-2008, 2009-2010, and 2011-2012).