Government of Canada proposes access to "morning after pill" without a prescription
May 18, 2004

OTTAWA - Health Minister Pierre Pettigrew announced today that Health Canada is moving forward with allowing access to levonorgestrel -- popularly known as the "morning after pill" - without a doctor's prescription. The measure would mean more timely access to emergency contraceptives for women who need them.

"Women facing an emergency need timely access to this type of therapy," said Minister Pettigrew. "Making the drug available in pharmacies without a prescription will help women to prevent unwanted pregnancies. "

To be effective, levonorgestrel must be taken within the first 72 hours after unprotected intercourse or a contraceptive accident. Because a prescription is currently required for access to the drug, levonorgestrel is not always available within the recommended time period, especially during weekends and holidays.

Health Canada is proposing to amend the Food and Drug Regulations by removing levonogestrel from Schedule F when sold in a concentration of 0.75mg per oral dosage for use as an emergency contraceptive. Schedule F drugs are those which can only be made available by prescription. The move to amend Schedule F would allow the drug in the 0.75mg dosage to be available without a prescription from a physician.

Once a drug has been removed from Schedule F, the provincial and territorial pharmacy regulatory authorities decide on the conditions for its sale in consultation with the National Drug Scheduling Advisory Committee (NDSAC) of the National Association of Pharmacy Regulatory Authorities (NAPRA). NDSAC has recommended that provinces and territories adopt Schedule II status (behind-the-counter) for levonorgestrel 0.75mg, which would require professional intervention from the pharmacist at the point of sale.

"The fact that the drug would be available 'behind the counter' means that women would have timely access to the drug and receive professional health advice regarding its use," added the Minister.

The proposed amendment, to be published in the next issue of the Canada Gazette, Part I, expected on 22 May, would be the subject of a consultation period. Such consultations are a standard requirement for proposed regulatory amendments.

The department sent a Letter to Stakeholders on June 16, 2003 outlining this proposal, with a 30-day comment period. The letter and proposal were also posted on the Health Canada website.

The proposal to change the regulations responds to input received from women's groups and health professionals and has been made following an extensive review of the clinical evidence and safety data, and recommendations by pharmacists' associations.

Levonorgestrel has a long history of safe and effective use as an emergency contraceptive. The World Health Organization has determined that emergency contraceptives are appropriate for general use and do not present health risks because they are used for only short periods of time.