In late December 2012, Health Canada published, for public consultation, a draft version of the new Prescription Drug List, the proposed amendments to the Food and Drug Regulations to implement the List, and the draft guidance document entitled Determining Prescription Status for Human and Veterinary Drugs.
As part of the Jobs, Growth and Long-term Prosperity Act (Bill C-38), which received Royal Assent on June 29, 2012, the Canadian Government amended the Food and Drugs Act so that the Minister of Health could establish a list of prescription drugs to replace the existing Schedule F to the Regulations. In addition to the creation of the List, the regulatory process to add a drug to, or remove a drug from, Schedule F will be replaced by an administrative process where drugs can be classified, or declassified, as prescription drugs in less time. Currently, a regulatory amendment (which requires approval from the Governor in Council) is needed to give a drug prescription status by adding it to Schedule F, or to switch its status from prescription to non-prescription by removing it from Schedule F. The objective of the proposed changes is to gain efficiencies for Health Canada by moving towards a less burdensome non-regulatory approach for maintaining the list of prescription drugs.
The List sets out drugs and classes of drugs that are divided based on medicinal ingredients for human and veterinary use. Of note, drugs that are currently listed in Schedule F will also be included in the List.
In addition to repealing Schedule F, the proposed regulatory amendments describe the process involved in determining whether to add a drug to, or remove a drug from, the List and specifically outlines the principles that Health Canada will consider in making these determinations, including whether:
(a) supervision by a practitioner is necessary
(i) for the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in respect of which the drug is recommended for use, or
(ii) to monitor a disease, disorder or abnormal physical state, or its symptoms, in respect of which the drug is recommended for use, or to monitor the use of the drug;
(b) the level of uncertainty respecting the drug, its use or its effects justifies supervision by a practitioner; or
(c) use of the drug can cause harm to human or animal health or a risk to public health and the harm or the risk can be mitigated by a practitioner's supervision.
If one or more of the above principles apply, the drug will typically be classified as a prescription drug. However, there may be cases where, in the interest of an individual, public or animal health, exceptions are made (e.g., flu vaccines are not prescription drugs so that large public vaccination campaigns can be undertaken in the interest of individual and public health).
The draft guidance document replaces Health Canada's policy on Factors for Listing Drugs in Schedule F and supports the proposed regulatory amendments by providing detailed explanations of the aforementioned principles.
Importantly, this new approach is not intended to impact the safety, quality and efficacy of drugs in Canada. Health Canada has indicated that all drug submissions will continue to be subject to the same scientific assessments prior to determining whether to classify a drug as a prescription drug. The changes are also not intended to affect the regulation of prescription drug sales, advertising, or importation in Canada.
The public consultation is open for comment until March 7, 2013.