Rx Importation May Face Hurdles From European, Canadian Regulations

April 29, 2005

As U.S. lawmakers push legislation to legalize the importation of pharmaceuticals, a potential stumbling block to implementing such a plan could come from the very countries proponents hope will provide the lower-cost drugs.

In the European Union (EU), for example, it now appears impossible to access medicines from EU-member countries as envisioned under current U.S. importation proposals, a European pharmaceutical industry source said.

"If you have a U.S. resident flying over to Europe, that would make the issue possible, but it's not possible on a commercial basis," said the source, who declined to be identified. In Europe, doctors may only prescribe drugs to patients they have physically examined, the source said. He suggested it might be possible to circumvent this regulation. "If you find one doctor not behaving properly, is that possible? I don't know." Another hurdle comes from the European Court of Justice, which has issued a ruling that prevents internet pharmacies in Europe from selling prescription drugs online, he added.

In Canada, also targeted as a key source of lower-cost drugs for the U.S., government health officials have criticized U.S. importation plans, and said Canada shouldn't become a "drug store" for its much larger southern neighbor. In early 2005, the government even considered a proposal to restrict sales by internet pharmacies. The plan called for the Canada Food & Drugs Act to be amended to prohibit doctors from prescribing medications to patients they haven't examined or patients who are not physically present in Canada.

The internet pharmacy proposal, however, was never acted upon. The Canadian government may be waiting for the U.S. -- including the Bush administration, the FDA and Congress -- to speak with one voice on the importation issue, said a Canadian pharmaceutical industry observer.