Health Canada plan could give you more information about prescription drugs

Health Canada plan could give you more information about prescription drugs

A Toronto doctor says a plan by Health Canada to consider releasing confidential data about clinical trials of prescription drugs and medical devices is long overdue.

Dr. Nav Persaud, a staff physician at St. Michael's Hospital, said Wednesday that the move could change the way certain medications are used and would give doctors more detailed information when prescribing drugs. 

"This could be a huge step forward," Persaud told Metro Morning.

"We are talking about detailed information about the effects of medications, whether they are beneficial, the side effects. And right now, this information is treated as confidential by Health Canada. So you can't access it, your doctor can't access it, researchers can't access it.

"And that information can sometimes change our conclusions about whether medications are effective or safe."

Health Canada announced the plan in a document released last Friday.

Currently, only Health Canada and pharmaceutical companies have access to confidential information about clinical trials of drugs and devices. More transparency is good news for patients, many of whom want more details about whether drugs are effective or harmful, he said.

"This information is generated by people volunteering to be in research studies, and they are accepting some risk to do that," he said.

"They accept that risk, thinking that they are going to benefit the health of others, that other people will be able to make more informed decisions after the information from these clinical trials is made public. It's outrageous that this information is kept confidential."

Persaud, also an assistant professor at the University of Toronto, said he has been trying to get information about a popular morning sickness drug for more than five years.

He received one document about the drug that was titled "Adverse Events," which means side effects, but the information below the title was redacted, or blacked out. He continues to request information under two separate laws.

"I'm at the current point where I have access to some information, but because of a confidentiality agreement, I am not able to share it all," he said.

"In the future, there should be a new process where doctors, or researchers, or patients just make requests for this information and you receive it, totally open, not redacted."

New draft rules coming later this year

In an emailed statement, Health Canada said it is soliciting opinions about its plan until May 26, then it will introduce draft regulations later this year. It plans to consult researchers, industry representatives, health practitioners and patient groups over the coming months. 

Once the regulations are in force, it will create a "new channel for public access" to enable the public to obtain clinical information. That channel could be a web portal, it said.

"Health Canada has long recognized that opening up access to clinical data can have widespread benefits throughout the health care system and considerable effort has been put into this work for a number of years," it said.

Health Canada said its plan, once implemented, will bring the federal department more in line with "forward-thinking international regulators" including the European Medicines Agency and the U.S. Food and Drug Administration.