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Prescription drug plan would ban bulk exports


OTTAWA—Canadian health officials would have the power to ban bulk exports of prescription drugs from Canada under a recently proposed amendment to Canada's Food and Drugs Act.

The proposal is a direct response to a recently passed U.S. law that essentially prohibits federal officials from preventing U.S. citizens from importing prescription drugs from Canada for their personal use, Canadian officials say.

Bill C-378, proposed in the House of Commons of Canada on Oct. 31, would amend the Food and Drugs Act to give the minister of health the authority to ban bulk exports of prescription drugs and would establish penalties for individuals who violate the ban. The bill would also amend food and drug regulations to specify that prescription drugs can be exported only under certain conditions and by certain parties, such as the manufacturer of the drug.

"Canada needs to protect itself from dramatic expansion of importation by the U.S. of drugs intended for our patients," said Dr. Carolyn Bennett, a member of the Canadian Parliament who proposed the bill. "The prospect of the U.S. legalizing large-scale purchases from our domestic supplies is real."

Introducing the bill became more urgent after President George Bush on Oct. 4 signed a Department of Homeland Security funding law that essentially bars federal customs and border officials from interfering with the reimportation of most prescription drugs by prohibiting federal funds from being used for such purposes, Dr. Bennett said. A provision of the law-known as H.R. 5441-applies to reimportation by individuals transporting a 90-day or less supply of prescription drugs for their personal use and includes all approved prescription drugs except for controlled substances or biological products. Canadian officials say this law is the first step toward the full legalization of drug imports from Canada, which they believe could be enacted by a newly elected U.S. Congress.

While the Canadian Pharmacists Assn. praised C-378 as a critical step forward, the Ottawa-based organization said the legislation also should ban personal drug exports due to concerns about the U.S. law.

Under the U.S. Food, Drug and Cosmetic Act, it is illegal for anyone other than the original manufacturer to reimport prescription drugs into the United States. But several state and local governments have defied the law by creating programs or Web sites to facilitate the reimportation of drugs from Canada and other countries. In the past, U.S. customs officials instituted a lax enforcement policy that allowed individuals to reimport prescription drugs for personal use, but they began enforcing the ban at U.S. borders in the last year by intercepting drug shipments.