A new law agreed in Canada yesterday says that information from clinical trials must be made public. Bill C-17 or “Vanessa’s Law” includes amendments that will require “clinical trial information be disclosed on a public registry.” This is great. This came after many of you wrote to MPs on the Health Committee during discussions on the Bill asking them to ensure that all clinical trials are registered and reported.
Rona Ambrose, Minister of Health said:
I will also personally ensure that Health Canada continues to find ways to be more open and more transparent with Canadians each and every year. I’ve made that commitment. We will be looking at further steps to ensure that crucial drug safety information is made available to Canadians.
The amendments were approved by Parliament yesterday and the Bill could become law in the next few weeks. The relevant section of the Bill states
21.71 The holder of a therapeutic product authorization…shall ensure that prescribed information concerning the clinical trial or investigational test is made public within the prescribed time and in the prescribed manner.
Regulations which set out what information must be made public, in what form and over what time span will be written by the Minister of Health and Health Canada after the Bill becomes law.
We now have a chance to influence those regulations. We will be writing to the Minister and Health Canada to ask them to hold an open public consultation on what should be included in the regulations. We will let you know how this goes.