On May 29, 2019, the federal government introduced Bill C‑100 to implement the new trilateral trade deal known as the Canada-United States-Mexico Agreement (CUSMA, also referred to as USMCA), making Canada the first of the three member countries to introduce legislation that would ratify the treaty.
CUSMA provides more protections for biologic and innovative pharmaceuticals under Canadian law. However, the treaty does not require the immediate adoption of these new protections and none of them are directly implemented by Bill C‑100.
As we reported, full implementation of CUSMA will require Canadian law to include:
- Extended data protection for biologics (Article 20.49). CUSMA requires ratifying states to provide a minimum of ten years’ data protection from the date of first marketing authorization for new biologics. This increases data protection available to new biologics in Canada from eight to ten years, but does not match the 12 years of protection provided in the U.S.
When will it come into force? Bill C-100 creates the authority to implement this obligation by making regulations under the Food and Drugs Act, paving the way for a specific regulatory proposal at a later date. Canada must fully implement this obligation no later than 5 years after the date of entry into force of CUSMA (Article 20.90).
- Patent term restoration (Article 20.44). CUSMA requires Canada to adopt a patent term restoration (PTR) system to recover time lost due to “unreasonable delays” in the issuance of a patent, at the request of the applicant. PTR will exist in addition to any certificate of supplementary protection (CSP) available for pharmaceutical patents under Canadian law.
When will it come into force? Bill C-100 does not include any amendments to the Patent Act. Canada must fully implement this obligation no later than 4.5 years after the date of entry into force of CUSMA (Article 20.90).
Bill C‑100 passed first reading in the House of Commons and will proceed to second reading. It is uncertain whether Bill C‑100 will pass before the current Parliament dissolves, with only three weeks remaining before summer recess and a federal election scheduled for October 21, 2019.
Nonetheless, the federal government has expressed confidence that Bill C‑100 will pass. Foreign Affairs Minister Chrystia Freeland was clear, stating, “I am confident we will be successful moving forward.” Trade Committee Chair Mark Eyking also suggested taking the unusual step of recalling Parliament for an extended summer sitting, if needed, to pass Bill C‑100.
Meanwhile, CUSMA itself will not come into force until the first day of the third month after it has been ratified by all three member countries. Due to a variety of intervening factors including ongoing disputes on tariffs, it remains unclear when this milestone will be reached.