Vol. 145, No. 8 — April 13, 2011

Registration

SOR/2011-93 March 25, 2011

FOOD AND DRUGS ACT

ARCHIVED — Regulations Amending the Food and Drug Regulations (1624 — Schedule F)

P.C. 2011-457 March 25, 2011

His Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to subsection 30(1) (see footnote a) of the Food and Drugs Act (see footnote b), hereby makes the annexed Regulations Amending the Food and Drug Regulations (1624 — Schedule F).

REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS (1624 — SCHEDULE F)

AMENDMENT

1. Part I of Schedule F to the Food and Drug Regulations (see footnote 1) is amended by adding the following in alphabetical order:

Eculizumab

Éculizumab

Olmesartan and its salts and derivatives

Olmésartan, ses sels et dérivés

Romiplostim

Romiplostim

Ustekinumab

Ustekinumab

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

These amendments add four medicinal ingredients to Part I of Schedule F to the Food and Drug Regulations.

Sections C.01.041 to C.01.049 of the Food and Drug Regulations control the sale of medicinal ingredients that are listed in Schedule F. Part I of Schedule F lists medicinal ingredients that require a prescription for human use and for veterinary use. Part II of Schedule F lists medicinal ingredients that require a prescription for human use, but do not require a prescription for veterinary use if so labelled or if in a form unsuitable for human use.

The degree of regulatory control afforded by Schedule F (prescription drug) status coincides with the risk factors associated with each medicinal ingredient. Oversight by a practitioner is necessary to ensure that appropriate risk/benefit information is considered before the drug containing the medicinal ingredient is administered and that the drug therapy is properly monitored.

Drugs can only be sold in Canada once Health Canada has assessed them for safety, efficacy and quality as required by the Food and Drugs Act and the Food and DrugRegulations. Final approval of the regulatory amendment adding a medicinal ingredient to Schedule F and its publication in the Canada Gazette, Part II, means that prescription status for the drug can be enforced under provisions of the Food and Drug Regulations.

Enforcement of prescription status is important as Health Canada has issued market authorization for the sale of drug products containing the medicinal ingredients described in these amendments.

Description and rationale

Health Canada’s Drug Schedule Status Committee recommends prescription status or exemption from prescription status for medicinal ingredients on the basis of an assessment of the medicinal ingredients against a set of established and publicly available factors. These factors include, but are not limited to, toxicity, pharmacological properties and therapeutic uses of the medicinal ingredients.

Description of the medicinal ingredients:

1. Eculizumab is used to treat patients with paroxysmal nocturnal hemoglobinuria, a rare disease characterized by episodes of red blood cell destruction and blood in the urine occurring primarily at night. Individualized instructions or direct supervision by a practitioner is required. The patient may also require routine laboratory monitoring. Eculizumab may cause undesirable or severe side effects at normal therapeutic dosage levels.
   
2. Olmesartan and its salts and derivatives are used to lower blood pressure in patients in whom the cause of high blood pressure is unknown. Individualized instructions or direct supervision by a practitioner is required. The patient may also require routine laboratory monitoring. Olmesartan and its salts and derivatives may cause undesirable or severe side effects at normal therapeutic dosage levels.
   
3. Romiplostim is a protein used to treat low blood platelet counts in patients with immune thrombocytopenic purpura, a disease in which the body’s immune system destroys platelets in the blood. Individualized instructions or direct supervision by a practitioner is required. The patient may also require routine laboratory monitoring. Romiplostim may cause undesirable or severe side effects at normal therapeutic dosage levels.
   
4. Ustekinumab is used to treat patients with moderate to severe chronic plaque psoriasis. Psoriasis is an autoimmune disease that causes scaly red patches called plaques on the skin. Individualized instructions or direct supervision by a practitioner is required. The patient may also require routine laboratory monitoring. Ustekinumab may cause undesirable or severe side effects at normal therapeutic dosage levels.

Prescription access to drug products containing these medicinal ingredients will benefit Canadians by decreasing the opportunities for improper use and by ensuring the guidance and care of a practitioner.

The provinces may incur costs to cover practitioners’ fees for services. However, the guidance and care provided by the practitioners would reduce the need for health care services that may result from improper use of drug products for human use that contain medicinal ingredients listed in Schedule F. The overall additional costs for health care services should therefore be minimal.

Drug products for human use containing medicinal ingredients listed in Schedule F may be covered by both provincial and private health care plans.

Consultation

The manufacturers affected by these amendments were made aware of the intent to recommend these medicinal ingredients for inclusion in Schedule F during the review of the drug submissions.

Direct notice of this regulatory proposal was provided to provincial and territorial Ministries of Health, medical and pharmacy licensing bodies, and industry, consumer and professional associations on January 11, 2010, with a 75-day comment period. This initiative was also posted on the Health Canada and Consulting With Canadians Web sites. No stakeholder comments were received expressing either support or concern during the comment period.

The process for this consultation with stakeholders is described in the Memorandum of Understanding (MOU) to streamline regulatory amendments to Schedule F. The MOU, signed by Health Canada, the Privy Council Office and the Department of International Trade on February 23, 2005, is posted on the Health Canada Web site.

Implementation, enforcement and service standards

These amendments come into force on the day on which they are registered.

These amendments do not alter existing compliance mechanisms under the provisions of the Food and Drugs Act and the Food and Drug Regulations enforced by the Health Products and Food Branch Inspectorate.

Contact

Refer to Project: 1624
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
C.R.C., c. 870