Canada’s public health department, Health Canada, is preparing to release its final guidance on the section of Vanessa’s Law designed to promote the transparency of information around pharmaceutical drugs. Vanessa’s Law is a 2014 Canadian law that grants the Minister of Health the power to disclose any data on drugs that it holds, including confidential business information. These data are critical for researchers who wish to independently evaluate a drug’s safety and efficacy.
However, the draft guidance, issued last March, creates many hoops for researchers to jump through in order to access this important information. These restrictions potentially undermine the law’s goal of helping to protect patient safety and public health through transparency. Some examples of the restrictions include the following:
- The requester must be a person who carries out functions relating to the protection or promotion of human health or the safety of the public, unlike the U.S. Freedom of Information Act (“FOIA”) under which anyone can request information.
- The requestor must indicate that he/she “has exhausted other sources of the information requested, including from the originator of the information.”
- The requestor must be prepared to complete a project and submit a project proposal describing how the data will be used and how the project relates to the protection or promotion of human health or safety of the public.
- The requestor must complete a Conflicts of Interest Declaration that provides information for Health Canada to assess whether or not the requestor’s financial interests and other affiliations may conflict with his/her use of the requested information.
- The requestor must sign a Confidentiality Agreement to maintain the confidentiality of and prohibit the reproduction of the disclosed data.
- Once the project is completed, if the researcher “has made a determination that the safety, efficacy or quality of a product(s) is changed as a result of the evaluation of the CBI [confidential business information] then the results should be submitted to Health Canada.”
- Finally, researchers must send copies of manuscripts to Health Canada upon submission for publication.
Some of these conditions impose larger burdens on researchers than others. Notably, the Confidentiality Agreement has been most heavily criticized, in part because it requires researchers to assemble research teams prior to being able to access the data and evaluate what skills might be needed on such a research team. The Confidentiality Agreement also prevents researchers from sharing the data used to complete a project, contrary to best research practices.
All of these conditions taken together create barriers for researchers wishing to independently evaluate a drug’s safety and efficacy. Health Canada’s final guidance hopefully will cut back on these restrictions in order to stay true to the law’s aim of promoting greater transparency around pharmaceutical drugs.
—Kathleen Choi ’18