United Kingdom Added to Certificate of Supplementary Protection

Summary#

These are the final Regulations Amending the Certificate of Supplementary Protection Regulations (SOR/2020‑288). They add the United Kingdom to the list of countries used to judge whether a drug company filed its safety and effectiveness data in Canada quickly enough to get extra patent protection. The change took effect on December 21, 2020.

What it does#

• Adds the United Kingdom as a separate listed country in the Certificate of Supplementary Protection Regulations.
• Keeps the rule that an applicant must file its Health Canada submission within one year of filing in a listed country in order to qualify for a Certificate of Supplementary Protection (a period of extra protection for certain pharmaceuticals).
• Comes into force on the day the regulations were registered: December 21, 2020.

Who's affected#

• Drug companies and patent holders who apply for a Certificate of Supplementary Protection in Canada.
• Health Canada, which receives the regulatory submissions tied to these certificates.
• Patients and health-care providers indirectly, because the rule influences how quickly new drugs may appear in Canada.
• It is unclear if any other groups are affected; this is a technical change to maintain existing policy after the U.K. left the EU.

Why it matters#

• After Brexit, the United Kingdom stopped being an EU member. Without this change, U.K. filings might no longer count under the timing rule that helps companies secure extra protection for new drugs.
• By listing the U.K. separately, the government preserved the original intent: encourage early filing in Canada and help speed Canadians’ access to new medicines.
• The government says this is a technical update and imposes no new costs on businesses or on the government.