Health official anticipates holdup in Canadian pharmacy licensing

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A senior official at the state Department of Health said Wednesday it is “highly unlikely” the department will be able to license Canadian pharmacies to sell prescription drugs in Rhode Island by the Jan. 15 deadline set by the General Assembly.

Donald Williams, associate director for health services regulation at the health department, said he expects that the law adopted by the General Assembly permitting the state to license Canadian pharmacies will end up in court because it is opposed by several powerful constituencies, including the pharmaceutical industry and pharmacists in Rhode Island.

"There’s so much on the table, so many dollars ... that someone’s going to take us to court,” Williams said at a hearing on proposed revisions to regulations drafted by the department on the licensing law.

The General Assembly in June passed the law allowing Canadian pharmacies to receive Rhode Island licenses. It instructed the Health Department to develop regulations by Jan. 15 for how Canadian pharmacies would be licensed in Rhode Island. Rhode Island is considered the first state to enact such a law.

The federal Food and Drug Administration opposes importing prescription drugs, saying it cannot guarantee the safety of medicines sold through foreign pharmacies. But the FDA has not stopped states from setting up Internet sites to help consumers buy drugs through Canadian pharmacies. Rhode Island has such a guide on its secretary of state’s Web site.

Williams, who’s been at the health department for 28 years, said the Rhode Island law has placed the state at odds with federal statutes.

“And the (Rhode Island) legislature knew that,” he said.  “We’re trying to effect what the legislature wants, and I hope someone stops us.”

Rhode Island Attorney General Patrick Lynch wrote to the health department in August saying licensing of Canadian pharmacies raises “serious legal issues,” the most important being the conflict with federal law.

“The costs of prescription drugs are a burden to many Rhode Islanders and the need to obtain affordable prescription drugs is essential. Unfortunately, enabling an entity to violate federal laws and regulations is not good law enforcement policy, and it does not solve the real challenge of access to affordable prescription medications,” the attorney general wrote.

Lynch said he’s joined other states to ask the federal government to expedite the creation of a system in prescription medicine can be legally and safely imported from Canada.

The debate over prescription drug imports has intensified since the General Assembly responded to residents’ concern over soaring drug prices by passing the licensing law. Several municipalities are considering buying prescription drugs from Canada.

Even before the law was passed, scores of Rhode Islanders made bus trips across the border to buy their medicines in Canada, where they are often significantly cheaper because of government price controls. Congress has considered legalizing the importation of prescription drugs but has met strong opposition from the White House and the pharmaceutical industry.

Opponents to the licensing law, and the regulations, reiterated at the hearing that imported prescription medicines may come from unknown origins, which means their safety can’t be guaranteed. They also argue licensing would rupture patients’ relationships with their pharmacists and could hurt production by domestic drug manufacturers.

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