Vol. 148, No. 12 — June 4, 2014

Registration

SOR/2014-124 May 16, 2014

FOOD AND DRUGS ACT

Regulations Amending the Food and Drug Regulations (Data Protection — Miscellaneous Program)

P.C. 2014-580 May 15, 2014

His Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to section 30 (see footnote a) of the Food and Drugs Act (see footnote b), makes the annexed Regulations Amending the Food and Drug Regulations (Data Protection — Miscellaneous Program).

REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS (DATA PROTECTION — MISCELLANEOUS PROGRAM)

AMENDMENTS

1. (1) Subsection C.08.004.1(2) of the Food and Drug Regulations (see footnote 1) is replaced by the following:

(2) The purpose of this section is to implement Article 1711 of the North American Free Trade Agreement, as defined in the definition “Agreement” in subsection 2(1) of the North American Free Trade Agreement Implementation Act, and paragraph 3 of Article 39 of the Agreement on Trade-related Aspects of Intellectual Property Rights set out in Annex 1C to the Agreement Establishing the World Trade Organization, as defined in the definition “Agreement” in subsection 2(1) of the World Trade Organization Agreement Implementation Act.

(2) Subsections C.08.004.1(6) to (8) of the Regulations are replaced by the following:

(6) Paragraph (3)(a) does not apply to a manufacturer if the innovator consents to the filing of a new drug submission, a supplement to a new drug submission, an abbreviated new drug submission or a supplement to an abbreviated new drug submission by the manufacturer before the end of the period of six years specified in that paragraph.

(7) Paragraph (3)(a) does not apply to a manufacturer if the manufacturer files an application for authorization to sell its new drug under section C.07.003.

(8) Paragraph (3)(b) does not apply to a manufacturer if the innovator consents to the issuance of a notice of compliance to the manufacturer before the end of the period of eight years specified in that paragraph or of eight years and six months specified in subsection (4).

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.)

Issues

The Standing Joint Committee for the Scrutiny of Regulations has recommended that regulatory amendments are necessary in order to clarify and streamline the language of subsections C.08.004.1(2), (6), (7) and (8) of the Food and Drug Regulations, as follows:

Background

Data protection provisions were first introduced in 1995 to the Food and Drug Regulations under section C.08.004.1 to fulfil North American Free Trade Agreement obligations. In 2006, amendments to section C.08.004.1 were introduced in order to clarify and effectively implement Article 1711 of the North American Free Trade Agreement and Article 39 of the Agreement on Trade-related Aspects of Intellectual Property Rights.

The amendments provide innovative drugs with an internationally competitive, guaranteed minimum period of market exclusivity of eight years. An additional six-month period of exclusivity is available for innovative drugs that have been the subject of clinical trials designed and conducted for the purpose of increasing the knowledge of the use of the drug in pediatric populations. Collectively, these periods of market exclusivity are known as “data protection.”

The Standing Joint Committee for the Scrutiny of Regulations is a parliamentary committee that is responsible for reviewing and scrutinizing regulations and statutory instruments. In the course of review and correspondence with Health Canada, the Committee raised a number of points with a view to streamlining and improving the clarity of the regulatory language.

Health Canada is now introducing these amendments in order to address the Committee’s recommendations.

Objectives

The objective of these amendments is to streamline and clarify the language in subsections C.08.004.1(2), (6), (7) and (8) of the Food and Drug Regulations regarding data protection in order to address the recommendations of the Standing Joint Committee for the Scrutiny of Regulations.

Description

The Food and Drug Regulations are amended as follows:

“One-for-One” Rule

The “One-for-One” Rule does not apply, as the amendments are purely technical to address the recommendations of the Standing Joint Committee for the Scrutiny of Regulations, and have no administrative cost implications to industry.

Small business lens

The small business lens does not apply, as there are no costs for small businesses.

Consultation

Consultations were not conducted, as the amendments are purely technical to address the recommendations of the Standing Joint Committee for the Scrutiny of Regulations, and will not impact on stakeholder interests.

Rationale

The amendments streamline and clarify the regulatory language of the data protection provisions in section C.08.004.1 of the Food and Drug Regulations in response to recommendations from the Standing Joint Committee for the Scrutiny of Regulations. The amendments do not alter existing policy or administrative activities, and will not impact on stakeholder interests. They do not require the allocation of additional resources towards administering data protection in Canada.

Implementation, enforcement and service standards

These amendments are purely technical to address the recommendations of the Standing Joint Committee for the Scrutiny of Regulations, and do not alter existing implementation and enforcement activities or service standards.

Contact

Danielle Lozon
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Health Canada
Address locator: 3105A
Holland Cross, Tower B, 5th Floor
1600 Scott Street
Ottawa, Ontario
K1A 0K9
Fax: 613-941-7104
Email: LRM_MLR_consultations@hc-sc.gc.ca