Regulations Amending the Certificate of Supplementary Protection Regulations: SOR/2020-288
Canada Gazette, Part II, Volume 155, Number 1
SOR/2020-288 December 21, 2020
P.C. 2020-1133 December 20, 2020
Her Excellency the Governor General in Council, on the recommendation of the Minister of Industry, pursuant to section 134 footnote a of the Patent Act footnote b, makes the annexed Regulations Amending the Certificate of Supplementary Protection Regulations.
Regulations Amending the Certificate of Supplementary Protection Regulations
1 Paragraph 6(1)(a) of the Certificate of Supplementary Protection Regulations footnote 1 is amended by striking out “and” at the end of subparagraph (iv) and by adding the following after subparagraph (v):
- (vi) the United Kingdom; and
Coming into Force
2 These Regulations come into force on the day on which they are registered.
REGULATORY IMPACT ANALYSIS STATEMENT
(This statement is not part of the Regulations.)
On January 1, 2020, in what is commonly referred to as “Brexit,” the United Kingdom (U.K.) ceased to be a Member State of the European Union (EU). Since 2017, Canada has had a free trade agreement with the EU and its Member States, the Comprehensive and Economic Trade Agreement (CETA). As a result of Brexit, the U.K. will no longer qualify for preferential treatment under the CETA. Therefore, changes to certain domestic regulations are required bring them into conformity with Canadian international trade obligations by removing trade preferences to the U.K.
Under CETA, Canada provides an additional period of protection for pharmaceuticals. This obligation is implemented through the Certificate of Supplementary Protection (CSP) regime, which includes the Certificate of Supplementary Protection Regulations (the Regulations). Although originally established to meet CETA obligations, the scope of the CSP regime is not limited to applicants from EU member countries.
In order to qualify for a CSP, applicants must file their Health Canada regulatory submission no later than one year after they file an equivalent submission in a country listed in the Regulations, which include EU member countries, the United States, Australia, Japan, and Switzerland. This obligation ensures that in order to qualify for a CSP, a new drug submission is filed early in Canada, which is historically a country of second filing, and speeds up access for Canadians to new life-saving drugs. The U.K. is currently captured by the Regulations as a “country that is a member of the European Union.”
The objective of the amendment is to add the U.K. as a separate qualifying jurisdiction to maintain continuity of policy intent.
Description and rationale
The Regulations are amended to list the U.K. as a separate listed country. This technical amendment ensures that the timely submission requirement continues to operate consistently with its policy intent.
The amendment does not impose any costs on the Government or stakeholders.
One-for-one rule and small business lens
The one-for-one rule does not apply to these amendments, as there is no change in administrative costs or burden to business.
The small business lens does not apply to these amendments, as there are no costs to small business.
The Canada–European Union Comprehensive Economic and Trade Agreement Implementation Act (S.C. 2017, c. 6) received royal assent on May 16, 2017. Regulatory amendments to implement Canada’s commitment under the CETA were approved by the Governor in Council on August 31, 2017. These approvals were supported by a comprehensive consultation strategy.
Technical changes to these regulations to bring them into conformity with Canadian international trade obligations and to ensure that regulations continue to operate consistently with their policy intent did not require consultations.
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