Dickson Michael
University of South Carolina College of Pharmacy, USA.
Manag Care. 2004 Mar;13(3 Suppl):3-6.
The following questions facilitate further thought on the issue of reimportation: POLICY ISSUES: Who should pay for drug development? Do NCEs provide value for money invested? What is the most efficient means of developing new drugs? What is the proper balance between societal benefit and intellectual property protection? REGULATORY QUESTIONS: If reimportation or importation is permitted, how can the provenance of a product be protected? How is reimportation defined? Can a product be transported from the United States to Europe to Canada and then be sent back to the United States? Or, is reimportation a single-step process (e.g., United States to Canada and vice versa)? If reimportation is limited to Canada, can we expect that other countries would want to be included (or excluded) from our reimportation policy? Will state pharmacy practice acts be applicable to reimportation? Does reimportation alter the balance between state and federal regulations? If legal action occurs because of alleged harm from a reimported product, who is liable? MARKET ISSUES: Will U.S. prices rise in protected markets to compensate for losses due to reimports? Will Canadians be allowed to import prescription drugs from the United States?
