Despite the opposition from a board made up largely of pharmacists, plans to license Canadian pharmacies will proceed, the state's health director says.

01:00 AM EDT on Thursday, October 21, 2004

BY FELICE J. FREYER
Journal Medical Writer

A law that would make Rhode Island the first state in the nation to license Canadian pharmacies hit an expected bump in the road yesterday, when a state board rejected regulations to implement it.

But the new law appears likely to roll toward its January enactment anyway, as Rhode Island continues down its unique path in coping with a nationwide dilemma.

Responding to citizens' demands for lower-cost drugs from Canada, Illinois and Wisconsin are sponsoring efforts to help residents get Canadian drugs, and municipalities around the country are obtaining Canadian drugs for their employees.

In Rhode Island, the General Assembly this year passed a law that allows the state to license Canadian pharmacies in the same way it licenses mail-order pharmacies in the United States. The law conflicts with a federal ban on drug importation.

Yesterday, the state Board of Pharmacy unanimously rejected regulations drafted by the Health Department staff. The new rules merely insert the phrase "or province of Canada" in appropriate places throughout the existing regulations on mail-order pharmacies.

In an interview afterward, Health Director Patricia A. Nolan said that, while she would weigh the Pharmacy Board's concerns, its vote could not kill the regulations.

"It seems to me the statute's pretty clear that we need to go ahead and deal with the rules," Nolan said. The next step will be to schedule public hearings on them, she said.

The action in Rhode Island comes as the debate over Canadian drugs heats up in the presidential campaign. Drugs cost significantly less in Canada because of government price controls. But in the United States, the Medicare law enacted last year with the support of the Bush administration prohibits the U.S. government from negotiating better prices for Medicare beneficiaries.

Sen. John Kerry, the Democratic presidential candidate, has pledged to allow drug importation from Canada. In his last debate with Kerry, President Bush said he would support the idea "if there's a safe way to do it."

Meanwhile, the American Medical Association, which had pushed for the Medicare law, last week called on Congress to pass legislation empowering federal officials to negotiate with manufacturers of drugs that will be covered by Medicare. The Veterans Administration and Department of Defense have already been able to obtain substantial discounts through such negotiations.

On Monday, a coalition claiming to represent 10 million Canadians called on the Canadian government to ban drug exports, saying that Canadians are facing shortages as drugs stream over the border.

The U.S. Food and Drug Administration has acknowledged that it cannot enforce its ban on Canadian drug imports. Many Rhode Islanders are buying them by calling toll-free numbers, ordering through the Internet or visiting a storefront operation in Warwick.

Proponents of drug importation say that many of the drugs Americans are getting from Canada were originally made in the United States, and that Canada's safety standards are reliable.

Richard Bidwell of the Rhode Island Gray Panthers, an advocacy group for the elderly, said he was initially reluctant to order his medications from Canada, because of safety concerns. A few months ago, his worries about cost took precedence and he started ordering his medications from Canada through the Warwick store. "And I'm still walking around," he said.

Even though it's already easy to obtain the drugs, Bidwell has been pushing for the new Rhode Island law because he believes that state licensure would ease people's worries about imported drugs.

But it's exactly that responsibility that the Rhode Island Pharmacy Board believes it cannot meet.

The vote rejecting the regulations came after a brief discussion. Board member Stephen Kogut, a pharmacist, pointed to a section of the proposed regulations requiring out-of-state pharmacies to comply with the laws of "the state or province of Canada in which it is located."

"What do we know about the laws of the province of Canada?" he asked.

"We don't know anything about it," replied board chairwoman Susan DelMonico, a CVS pharmacist.

"So it has to comply with laws that we don't know anything about?" Kogut said.

"In Rhode Island, we do have the right to inspect and make sure a pharmacy is complying with the laws," DelMonico said. "In Canada, the Board of Pharmacy would not be able to ascertain that."

But Nolan, the health director, said later that the state is not quite so helpless in regulating Canadian drugs.

"Actually, we've had some discussion about whether to do that," she said. "I've talked to folks in Illinois who did go and do pharmacy inspections in Canada. We may decide that it's important to do that. If an application comes in, we can look at what the requirements are in that particular province."

After the vote, the board invited comments from a small audience. Jack Hutson, executive director of the Rhode Island Pharmacists Association, applauded the vote. "We understand that the Department of Health is in a difficult situation in that the General Assembly passed laws in direct violation of federal law," he said.

Putting the Health Department's imprimatur on imported drugs would represent a "dangerous precedent," Hutson asserted. He said there are not enough drugs in Canada to supply the U.S. population, and opening the borders would inevitably allow in drugs from less-well-regulated countries and from counterfeiters and organized crime.

But Irene Santos of the Senior Agenda Consortium talked about the toll of high drug prices. "You're killing us," she told the board, "and you're killing your own parents and grandparents and maybe even yourself because no one's getting any younger."

Bidwell, of the Gray Panthers, called safety concerns "a red herring" and said the conflict with federal law was unimportant because the federal law was not being enforced.

He also accused the pharmacists on the board of having a conflict of interest because they risk losing customers to Canadian pharmacies. On Tuesday, the Gray Panthers and Rhode Island Jobs for Justice went to CVS in Woonsocket to deliver a letter asking DelMonico, the pharmacy board chairwoman who works for CVS, to recuse herself from the vote.

Yesterday, DelMonico addressed that complaint, saying that board members do not represent a company but work for the best interests of their profession. "Every member of this board serves as a professional," she said.

The nine-member Pharmacy Board is made up of seven pharmacists and two people representing the public. Most professional licensing and regulatory boards in the Health Department are comprised chiefly of the professionals being regulated. The exception is the board regulating physicians, nearly half of whose members are not doctors.

Although DelMonico was criticized for her ties to CVS, the giant drugstore chain's chief, Tom Ryan, made headlines in May when he called on the federal government to legalize drug importation and establish a system to make it safe.