Abstract
On June 28, Health Minister Ujjal Dosanjh Made a Long-awaited announcement that “the Government of Canada will introduce measures to ensure Canadians continue to have access to an adequate supply of safe and affordable prescription drugs” — long awaited in that for over two years CPhA had been pushing Health Canada to act via a stream of meetings, position papers, and the media (where Internet pharmacies have garnered a lot of attention). In fact, while three health ministers had been in place over this period, the first to take any position was Minister Dosanjh in his November 2004 speech at Harvard, where he stated that Canada cannot be the drugstore of the United States.
There were a number of developments in the months following Dosanjh's speech. While CPhA kept up its criticism of the cross-border drug trade, often in collaboration with CMA and our respective regulatory bodies, the Internet pharmacy industry went into active lobbying mode in the media and with politicians. They have been especially successful in rallying Manitoba politicians (where, with the support of the provincial government, the majority of Internet pharmacies are based), using the cry that 4000 jobs — an unsubstantiated number — are at stake.
On the US front, the number of states taking part in state-sponsored Canadian drug importation programs grew (e.g., I-Save-Rx). On the national front, bills are before US Congress and Senate that would legalize both personal and bulk drug imports from Canada. It was the potential fallout from this last development that likely forced the government to finally act, however, the June announcement fell short of explicit closure of the industry. It appears that political pressure on the Minister has softened the approach Health Canada will take — at least for now.
From CPhA's perspective, each of the three initiatives announced by Mr. Dosanjh generates questions of feasibility or clarity. The first was to revise the Food & Drugs Act to allow the government to prohibit the bulk export of prescription drugs “when necessary to protect the health of Canadians.” When questioned, the Minister later clarified that an export ban might only be temporary and only used when a shortage of a particular drug is anticipated. The Internet pharmacy industry (and Manitoba politicians) hailed this announcement, realizing they would not be put out of business since the ban would only affect bulk drug exports, not personal importation by individual Americans.
While this is a good first step, we do not believe it goes far enough. The current level of personal drug importation has already had an impact on the supply and pricing of Canadian drugs. If legalized in the US, this side of the business would likely expand exponentially, with accompanying negative impacts. As well, creating a system where controls only kick in when a drug is judged to be in short supply is only a temporary solution and does not appear to put Canadians first.
Health Canada also proposed establishment of a drug supply network to provide more comprehensive data on our prescription drug supply. CPhA has long asked that a monitoring system be developed to identify and track shortages, so this was a welcome announcement. However, outstanding issues include criteria for defining a drug shortage, how data will be collected, data timeliness, and options for subsequent action.
The final proposal would amend regulations governing the sale of prescription drugs to require an established patient-practitioner relationship. The Minister did not provide a definition of patient-practitioner relationship, nor how pharmacists might be expected to ensure this relationship exists. Defining and enforcing these in regulatory terms could be a challenge and needs to be done by health care providers and their regulatory bodies, not by Health Canada.
The Minister has stated that the next step (yet to begin at time of writing) is consultation on these proposals with organizations such as CPhA, CMA, and the regulatory bodies. As it stands, the Minister will likely introduce legislative changes in the fall, and stakeholders on both sides, including CPhA, will be using the upcoming consultation process to strengthen their arguments for and against the cross-border drug trade.