Regulations Amending the Use of Patented Products for International Humanitarian Purposes Regulations (Miscellaneous Program): SOR/2018-141

Canada Gazette, Part II, Volume 152, Number 14

Registration

June 25, 2018

PATENT ACT

P.C. 2018-873 June 22, 2018

Her Excellency the Governor General in Council, on the recommendation of the Minister of Industry, pursuant to subsection 12(1)^{footnote a} of the Patent Act^{footnote b}, makes the annexed Regulations Amending the Use of Patented Products for International Humanitarian Purposes Regulations (Miscellaneous Program).

Regulations Amending the Use of Patented Products for International Humanitarian Purposes Regulations (Miscellaneous Program)

Amendments

1 Section 3 of the Use of Patented Products for International Humanitarian Purposes Regulations^{footnote 1} is repealed.

2 Section 11 of the Regulations is replaced by the following:

11 For the purpose of paragraph (b) of the definition average price in subsection 21.17(6) of the Act, the publications reporting the prices in Canada of pharmaceutical products sold by or with the consent of the patentee that are equivalent to the pharmaceutical product to which an authorization under section 21.04 of the Act relates are the following:

• (a) the Ontario Drug Benefit Formulary/Comparative Drug Index published by the Ministry of Health and Long-Term Care of Ontario;
• (b) the list of insured medications set out in Schedule 1 to the Regulation respecting the List of medications covered by the basic prescription drug insurance plan, CQLR, c. A-29.01, r. 3, as is published under the title “List of Medications” on the website of the Régie de l’assurance maladie du Québec; and
• (c) the PPS Buyers Guide published by ProActive Pharma Solutions (PPS) or the parts of its website known as PPS Centrus where those prices are set out.

3 The portion of Form 9 of the schedule to the French version of the Regulations after section 3 is replaced by the following:

Octroyée à ________, le ____________________

_______________________________________
Signature du commissaire aux brevets

4 Paragraph 3(a) of Form 10 of the schedule to the English version of the Regulations is replaced by the following:

• (a) the quantities of the pharmaceutical product that were authorized under authorization number ________ to be manufactured and sold for export under section 21.04 of the Act were not or will not have been exported before the authorization ceases to be valid; and

Coming into Force

5 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.)

Issues

The Standing Joint Committee for the Scrutiny of Regulations (SJCSR) has identified a few language and grammatical inconsistencies in the English and French versions of the Use of Patented Products for International Humanitarian Purposes Regulations, SOR/2005-143 (the Regulations) that require the attention of Innovation, Science and Economic Development Canada.

While reviewing the matters raised by the SJCSR, two additional technical changes were found to be necessary to align with recent changes in the Patent Act^{footnote 2} and to update the descriptions and titles of referenced publications.

Background

The Regulations prescribe the forms and other supplementary administrative rules to complement Canada’s Access to Medicine Regime (CAMR).

CAMR, in force since 2005, implements the August 30, 2003, decision of the General Council of the World Trade Organization (WTO) which waived two provisions of the Agreement on Trade-Related Aspects of Intellectual Property Rights thought to be a barrier to developing and least-developed countries’ access to lower-cost medicines. The implementing legislation amended the Patent Act to enable a Canadian pharmaceutical manufacturer to apply to the Commissioner of Patents for a compulsory licence to export a lower cost, generic version of a patented pharmaceutical product to a developing or least-developed country unable to manufacture its own.

Both the August 30, 2003, decision and CAMR anticipate that the procedure for applying for an export licence is to be initiated internationally by an eligible importer posting a notice on a dedicated WTO website. That notice must identify the name and quantity of the required product. The products that are eligible for export under CAMR are listed on Schedule 1 of the Patent Act. CAMR also contains safeguards to guard against inappropriate or illicit use of the regime, to ensure the interests of patent holders are taken into account, and to ensure the safety of drugs exported under the regime.

Objectives

The objectives of these regulatory amendments are to correct the inconsistencies noted by the SJCSR by

• ensuring consistency between the English and French versions of the text; and
• amending language where more appropriate and/or more precise language was deemed necessary by the SJCSR.

Description

The regulatory proposal will achieve the following results:

• repeal section 3 in both the English and French versions of the Regulations;
• remove the words “as amended from time to time” in paragraphs 11(a), (b), and (c) of the English version of the Regulations, and the words “avec leurs modifications successives” in section 11 of the French version of the Regulations as the appropriate date is fixed by the Act;
• in both the English and French versions, update the referenced publications in paragraph 11(a), (b) and (c);
• amend the portion after section 3 of Form 9 of the schedule to the French version to align with the English version by adding a place to state the location at which the authorization was granted; and
• amend Form 10, paragraph 3(a), of the English version to align the verb tense with the French version by replacing “will not be exported” by “will not have been exported”.

“One-for-One” Rule

The One-for-One Rule does not apply to this proposal, as the changes are housekeeping in nature and would not lead to increased administrative costs for stakeholders.

Small business lens

The small business lens does not apply to this proposal, as there are no costs on small business.

Consultation

Consultations on the amendments to the Regulations were not required as the changes are grammatical in nature and not substantive. In addition, the changes will have no impact on public policy and would present no cost to the Government of Canada or to the private sector. In light of the SJCSR’s interest in these amendments, Innovation, Science and Economic Development Canada has kept the Committee apprised of its progress on the amendments.

Rationale

The amendments to CAMR’s Regulations would respond to the recommendations of the SJCSR by making a variety of housekeeping changes to the Regulations.

These amendments would ensure consistency between the French and English versions of the Regulations, and improve the clarity and precision of the regulatory text for the regulated community.

Overall, given the housekeeping nature of the amendments, there are expected to be minimal impacts and no measurable costs or benefits for stakeholders.

Contact

Mark Schaan
Director General
Marketplace Framework Policy Branch
Innovation, Science and Economic Development Canada
235 Queen Street
Ottawa, Ontario
K1A 0H5
Telephone: 343-291-3700
Fax: 613-952-1980
Email: mark.schaan@canada.ca