The results of the ongoing renegotiations of the North American Free Trade Agreement could have an impact on how much Canadians pay for their medications in the future, according to one expert.

In an article originally published by not-for-profit media outlet the Conversation, Joel Lexchin, an associate professor of family and community medicine at the University of Toronto, pointed out that the length of time that data protection is afforded to patented drugs is up for debate in the ongoing renegotiations.

Read: Assessing pharmacare’s impact on private drug plans

As a result, the cost of a national pharmacare plan could go up, possibly dramatically, he said. “This has to do with something called intellectual property rights. Usually when talk turns to IPRs, people think about patents. But there’s also something called data protection. The data that’s being protected is information about the effectiveness and safety of drugs that comes out of the clinical trials that brand name drug companies do when they want approval to market a new drug.” 

Data protection allows the makers of patented drugs to keep results of their clinical trials until the protection expires. This prevents generic replacements for these drugs from coming to market, since the data already exists, according to Lexchin. As such, generic drug makers can’t make cheaper alternatives available to Canadians until both a drug’s patent and data protection have expired.

The Canadian government currently affords patented drugs eight years of data exclusivity, with the potential for an extra six months if the medication is for children. Lexchin’s worry is that if these time periods were to increase, Canadians would feel the direct impact of price increases for many drugs.

Of particular concern is biologics, noted Lexchin, which accounted for seven of the top 10 patented drugs by spending in Canada, according to 2017 data by the Patented Medicine Prices Review Board. 

Read: Proposed PMPRB changes could limit Canada’s access to new drugs: report

Since biologics can be expensive, sometimes running into the thousands of dollars for a year’s treatment, access to cheaper, generic alternatives, known as subsequent entry biologics, has a direct effect on Canadians’ ability to afford their drugs, noted Lexchin.

In its NATFA renegotiations, Mexico agreed to an extension of data protection by between 1.5 and two years. “If we want a national pharmacare system, then we need to make sure that our negotiators don’t give in to any American demands about medical data protection,” said Lexchin.

Copyright © 2020 Transcontinental Media G.P. Originally published on

Join us on Twitter

Add a comment

Have your say on this topic! Comments that are thought to be disrespectful or offensive may be removed by our Benefits Canada admins. Thanks!

* These fields are required.
Field required
Field required
Field required