Vol. 145, No. 6 — March 16, 2011
SOR/2011-58 March 3, 2011
FOOD AND DRUGS ACT
ARCHIVED — Regulations Amending the Food and Drug Regulations (1627 — Schedule F)
P.C. 2011-265 March 3, 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 (1627 — Schedule F).
REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS (1627 — SCHEDULE F)
1. Part I of Schedule F to the Food and Drug Regulations (see footnote 1) is amended by adding the following in alphabetical order:
Lapatinib and its salts
Lapatinib et ses sels
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 three 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 Drug Regulations. 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. Golimumab is a human monoclonal antibody that acts on the immune system and is used to treat adults with active forms of rheumatoid arthritis, psoriatic arthritis (inflammatory diseases of the joints), and ankylosing spondylitis (inflammatory disease of the spine). Direct supervision by a practitioner is required during treatment and routine laboratory monitoring is required. Golimumab may cause undesirable or severe side effects at normal therapeutic dosage levels.
2. Lapatinib and its salts are anti-cancer drugs that are used to treat patients with HER2+ (receptor positive) breast cancer that is advanced or has spread to other parts of the body. Direct supervision by a practitioner is required during treatment and routine laboratory monitoring is required. Lapatinib and its salts may cause undesirable or severe side effects at normal therapeutic dosage levels.
3. Vorinostat is an anti-cancer drug that is used to treat patients with advanced cutaneous T-cell lymphoma (a cancer of the immune system) in whom the disease has persisted, become worse or returned following treatment with other drugs. Individualized instructions and direct supervision by a practitioner are required during treatment and routine laboratory monitoring is required. Vorinostat 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.
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.
Refer to Project Number: 1627
Bureau of Policy, Science and International Programs
Therapeutic Products Directorate
1600 Scott Street
Tower B, 2nd Floor
Address Locator: 3102C5
S.C. 2005, c. 42, s. 2
R.S., c. F-27
C.R.C., c. 870