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Date Posted: 21:54:29 11/15/03 Sat
Author: Scammer
Subject: Re: More on Canada
In reply to: Repost 's message, "More on Canada" on 08:27:30 11/12/03 Wed

Ban drug exports, say regulators
Selling to U.S. makes policing druggists impossible

Tom Blackwell
National Post


Saturday, November 15, 2003
ADVERTISEMENT


The bodies that regulate pharmacies across Canada are calling on the federal government to ban the cross-border sale of prescription drugs to the United States, arguing they cannot police druggists whose customers are in a different country.

Some of those customers have already lodged complaints against Canadian pharmacies, creating difficult challenges for the regulators, said the National Association of Pharmacy Regulatory Authorities.

The body is also concerned about possible shortages of drugs and pharmacists for the Canadian market as a result of the cross-border business.

Coming from a group of apolitical professional organizations, the association's call for a ban is the strongest assault yet in Canada against the burgeoning, but controversial, export industry.

"There are increasing questions and reports on drug shortages," said Barbara Wells, executive director of the umbrella group for provincial and territorial agencies.

"It just stands to reason that if we are going to be supplying the U.S. market, this is just the tip of the iceberg."

However, the groups believe the trade might eventually be viable if a system can be created to permit international regulation, Ms. Wells added.

The request that Health Canada shut down the business at least temporarily was endorsed yesterday by the U.S. Food and Drug Administration, which is strongly opposed to the importation of prescription drugs.

A ban is absolutely necessary, Tom McGinnis, the FDA's director of pharmacy affairs, said in an interview. "It's illegal."

Mark McLellan, the agency's commissioner, is scheduled to visit Health Canada officials in Ottawa on Tuesday to discuss the issue.

The pharmacy regulators' statement got a much different reception from the mail-order pharmacy business, which has grown within barely a year to sell as much as $1-billion of medication to the United States annually.

The declaration was a "ridiculous and rash, draconian step," said David Mackay of the Canadian International Pharmacy Association.

He noted the regulators in at least one province, Manitoba, have specifically agreed to oversee the international business, even drawing up special standards for it.

"To suggest all of a sudden that the regulatory authorities cannot stand by these agreements is an indictment of themselves," Mr. Mackay said. "It's saying their own system is incompetent."

In Manitoba, where the bulk of the mail-order pharmacies are located, fees from such businesses to the regulator, the Manitoba Pharmaceutical Association, total more than $700,000 a year, he said, allowing them to hire extra staff. Despite repeated inspections, no transgressions have been uncovered, Mr. Mackay said.

But there appears no immediate threat that Health Canada will take up the national regulatory association's suggestion.

"It is premature to consider banning export of prescription drugs because there is no evidence of drug shortages related to Internet pharmacy," said Krista Apse of Health Canada.

"Our bottom line is to ensure that Canadians continue to have access to affordable, safe drugs when they need them."

Still, the department will continue to monitor the situation closely, she said.

The regulatory association's members licence pharmacists, investigate complaints and mete out discipline when necessary. The Manitoban regulator has already received some complaints from the United States, although no more, proportionately, than it would normally get from Canadian pharmacy customers, she said.

But officials worry about their ability to subpoena witnesses from the United States, if necessary, or obtain confidential medical information from south of the border, which might be needed in an investigation of alleged wrongdoing, she said.

tblackwell@nationalpost.com

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  • Re: More on Canada -- More info, 21:55:40 11/15/03 Sat
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