Vol. 145, No. 5 — March 2, 2011

Registration

SOR/2011-42 February 10, 2011

FOOD AND DRUGS ACT

ARCHIVED — Regulations Amending the Medical Devices Regulations (1592 — Canada’s Access to Medicines Regime)

P.C. 2011-222 February 10, 2011

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), hereby makes the annexed Regulations Amending the Medical Devices Regulations (1592 — Canada’s Access to Medicines Regime).

REGULATIONS AMENDING THE MEDICAL DEVICES REGULATIONS (1592 — CANADA’S ACCESS TO MEDICINES REGIME)

AMENDMENT

1. Section 43.2 of the Medical Devices Regulations (see footnote 1) is replaced by the following:

43.2 Sections 43.3 to 43.6 apply, for the purposes of implementing the General Council Decision, to a medical device in respect of which a manufacturer has applied to the Commissioner of Patents for an authorization under section 21.04 of the Patent Act.

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.)

Issue and objectives

The amendment to section 43.2 of the Medical Devices Regulations serves to clarify that sections 43.3 to 43.6 are in place to enable the implementation of the General Council Decision, as requested by the Standing Joint Committee for the Scrutiny of Regulations.

Description and rationale

Currently, section 43.2 of the Medical Devices Regulations: Medical Devices to Be Sold for the Purposes of Implementing the General Council Decision — Application states:

“43.2 Sections 43.3 to 43.6 apply to a medical device in respect of which a manufacturer has applied to the Commissioner of Patents for an authorization under section 21.04 of the Patent Act for the purposes of implementing the General Council Decision.”

The provision concludes with “for the purposes of implementing the General Council Decision.” The structure of this provision does not provide the proper context since, as written, it appears to explain the requirements for an authorization application submitted by a manufacturer. However, the General Council Decision applies to regulatory states which are members of the World Trade Organization (WTO) and not to manufacturers in member states. In reality, member regulatory states implement General Council decisions through legislation. Then the manufacturer applies for authorization in order to comply with domestic law.

However, the phrase “for the purposes of implementing the General Council Decision” does serve to clarify that sections 43.3 to 43.6 are in place to enable the implementation of the General Council Decision. Therefore, it should be moved to provide the proper context, as follows:

“43.2 Sections 43.3 to 43.6 apply, for the purposes of implementing the General Council Decision, to a medical device in respect of which a manufacturer has applied to the Commissioner of Patents for an authorization under section 21.04 of the Patent Act.”

This is a low impact administrative change that will address the Standing Joint Committee for the Scrutiny of Regulations recommendation and will not have an impact on stakeholders.

Consultation

This amendment to section 43.2 of the Medical Devices Regulations is an administrative change that does not impact stakeholders; therefore, no consultation was conducted.

Implementation, and service standards

This amendment will be implemented by notifying the general public through publication in the Canada Gazette, Part II, and by notifying both internal and external stakeholders via email.

This amendment does not alter existing compliance mechanisms under the provisions of the Food and Drugs Act and Medical Devices Regulations enforced by the Health Products and Food Branch Inspectorate.

Contact

Refer to Project Number: 1592
Bureau of Policy, Science and International Programs
Therapeutic Products Directorate
Health Canada
Holland Cross
1600 Scott Street
Tower B, 2nd Floor
Address Locator: 3102C5
Ottawa, Ontario
K1A 0K9
Telephone: 613-948-4623
Fax: 613-941-6458
Email: regaff-affreg@hc-sc.gc.ca

Footnote a
S.C. 2005, c. 42, s. 2

Footnote b
R.S., c. F-27

Footnote 1
SOR/98-282