There is still a chance to urge Canadian legislators to put clinical trial transparency on the agenda. Canada’s Bill C-17, or “Vanessa’s Law”, has cleared second reading in the House of Commons and will be considered by the Standing Committee on Health
this Thursday on Tuesday, 10th June. All parties support the Bill, which aims to reform Canada’s drug regulatory system. We and many others are calling for requirements for the registration and reporting of clinical trials to be added.
This means there is still time to write to MPs on the committee using our draft letter and ask that they include these important amendments. Use the letter below to write to MPs, asking them to include these important points.
Update: The Committee is set to finish hearings on the Bill on Thursday 12th June.
Dear members of the House of Commons Standing Committee on Health
I’m writing to you regarding Bill C-17, known as “Vanessa’s Law”. I am pleased that Parliament is considering a number of new measures such as the power to recall drugs that will significantly improve patient safety; however, I strongly believe the Bill needs key amendments to fully protect patient safety.
Specifically, I strongly believe the Bill needs key amendments to require all clinical trials and observational studies
- be publicly registered before they begin and
- have their full methods and results reported within one year of completion.
Results from around half of all clinical trials have never been published and many have never been registered. New laws in the United States and Europe require the registration and reporting of future clinical trials but in Canada there is no legal requirement to register or disclose the results. Information on what was done and what was found in these trials could be lost forever to doctors and researchers, leading to bad treatment decisions, missed opportunities for good medicine, and trials being repeated. Further, the regulator’s interpretation of the evidence must be publicly available when it approves, refuses or recalls a drug from the market.
I understand that Bill C-17, in its current form, lacks these transparency measures. Therefore I’m writing to you, in your capacity as a member of the Standing Committee, to urge you to consider amending Bill C-17 to make sure Canada’s drug regulatory system is transparent. This critical amendment would ensure that the evidence base behind a drug is open to scrutiny, physicians and other health care providers are adequately informed about a drug’s risks and benefits and patients are better protected from harm.
Other potential points for your email:
- Information about clinical trials and observational studies should not be considered confidential. The information is generated because people participate in trials in the hope of advancing knowledge. Treating the information as private property ignores the contribution that clinical trial participants make.
- Requiring the registration of clinical trials and observational studies alone is not enough to ensure transparency. Reporting results and providing independent access to clinical trial data are also essential.
- Ben Lobb, Chair firstname.lastname@example.org
- Libby Davies, Vice-Chair email@example.com
- Hedy Fry, Vice-Chair firstname.lastname@example.org
- Eve Adams Eve.Adams@parl.gc.ca
- Claude Gravelle email@example.com
- Wladyslaw Lizon Wladyslaw.Lizon@parl.gc.ca
- James Lunney firstname.lastname@example.org
- Dany Morin Dany.Morin@parl.gc.ca
- David Wilks David.Wilks@parl.gc.ca
- Terence Young email@example.com