The Tug of War Over Cross-Border Pharmaceutical Sales: What the US Wants, Canada May Not Deliver

Only days after the California State Assembly enacted a package of bills intended to contain rising prescription drug costs and make it easier for Californians to buy cheaper drugs from Canadian pharmacies, legislation has been introduced into the US Senate which, under certain conditions, would legalize drug imports from Canada. Previous state legislative efforts, such as the California initiative, had to contend with the federal law which permits drug imports only when and if the US Secretary of Human Health Services certifies that such importation is safe, and no such certification has been made in over a decade. The Senate bill (the Safe Importing of Medical Products and Prescription Therapies Act – Safe IMPORT Act) has these features:

• individuals will be allowed to import up to a 90-day supply of FDA-approved drugs purchased from licensed pharmacies in Canada (or any other permitted country)
• pharmacies, wholesalers and Internet importers will be allowed to import commercial quantities after meeting and maintaining strict requirements
• commercial importers will be obliged to register and maintain accurate supply chain records
• Internet pharmacy provisions will become effective when final regulations are issued, which the FDA must complete within one year

One of the California bills would require the state to set up a web site by July 1, 2005 that would help consumers safely buy drugs from Canada. The web site would include a price-charged comparison between California and Canada for 50 of the most commonly prescribed brand-name medicines. The web site would also list links to licensed Canadian pharmacies that meet California pharmacy standards and which only sell drugs approved by Health Canada's Therapeutic Products Directorate. For a number of reasons, US prices are often much higher than those in Canada. California is only one of several states and cities in the US to have attempted to facilitate entry of Canadian drugs into the US, usually via online pharmacies (see earlier issues of E-TIPSâ„¢: "The Internet Continues to be a Key Factor in the North American Prescription Drugs Market", Vol 2, No 19, March 3, 2004 and "Moves and Counter-Moves Affecting Canadian Internet Pharmacies", Vol 2, No 22, April 14, 2004). It has again been reported that Canada is considering implementing controls on Internet pharmacies that ship lower-cost US-made drugs to US patients. This was originally considered to be an issue only for the US Department of Commerce. However, US-based drug companies have warned Canadian pharmacies that they risk being cut off if they don't halt this practice and so concerns of domestic supply shortages have arisen, reportedly prompting Ottawa to consider interventions such as an export control list or export taxes. A Canadian Press report dated June 7, 2004, quoting official documents, revealed that the Canadian government has formulated a plan to monitor drug supplies and to act quickly if a shortage develops. For more information, see these news reports: http://makeashorterlink.com/?I52662088 http://makeashorterlink.com/?V26452088 http://www.bend.com/news/ar_view%5E3Far_id%5E3D15894.htm Summary by: Clare McCurley