On December 10, 2019, the United States-Mexico-Canada Agreement (USMCA) was amended (see the amendments here). One of the major changes made relates to data protection for new biologic drugs.
A biologic is a drug that may contain a virus, toxin, antitoxin, vaccine, blood, allergenic product, or protein. In Canada, innovative drugs (including biologics) may be protected by an 8 year data protection term. Data protection protects innovative drugs from generic competition by protecting innovator data on safety and efficacy submitted to regulators by an innovator company in order to receive market approval.
The USMCA originally required parties to provide a 10 year term of data protection specifically for new biologic drugs (as previously reported in E-TIPS® here). This would have required an extension of the current 8 year term of data protection. The December 10, 2019 amendments remove the 10 year data protection requirement. As a result, the current 8 year term of data protection in Canada can be maintained for all innovative drugs.
Summary By: Vanessa Komarnicki
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E-TIPS is a registered trade-mark of Deeth Williams Wall LLP.