Canadian Senator proposes process to expedite export of low-cost drugs for HIV, other diseases

Canadian Sen. Yoine Goldstein earlier this week proposed a bill that would reform Canada's Access to Medicines Regime by expediting the process of exporting generic drugs for diseases such as HIV to developing countries, the Ottawa Citizen reports.

The bill would address provisions in the Patent Act, which in 2004 was amended to create exemptions to intellectual property rules, thereby allowing generic drug manufacturers to produce low-cost drugs for diseases in developing countries.

Since 2004, only one shipment of drugs has been exported by the generic drug manufacturer Apotex. At the time of shipment, Apotex reported the process was too cumbersome and costly and that it did not plan to use CAMR again, the Citizen reports. "The red tape that is built into the legislation inhibits people from doing it -- they just don't want to be bothered," Goldstein said, adding, "The truth is this (reform) should have been done a long time ago." The law currently requires generic pharmaceutical companies to qualify for each individual shipment of drugs exported. Goldstein's proposal would allow generic drug companies to send multiple shipments of a drug to several countries without having to re-qualify for each shipment. Under the bill, nongovernmental organizations also would be able to buy and distribute generic medications through CAMR, which currently is restricted to governments.

Richard Elliott, executive director of the Canadian HIV/AIDS Legal Network, said "The need is enormous, but (CAMR) just isn't user-friendly in its current form." RX&D -- which represents brand-name pharmaceutical companies in Canada -- argued there is no need to amend the Patent Act. RX&D President Russell Williams said, "Parliament has reviewed it and come to the conclusion that it doesn't need changing. The bill is fair, functional and efficient." He added that "targeting CAMR is a problem." Apotex has expressed its support for the bill, the Citizen reports. "It was sheer effort on our part to get that first shipment out," Apotex Vice President for Regulatory Affairs Bruce Clark said, adding, "The brands say it's fair, fast and functional, but by whose definition? Would the patients in Africa say it's functional?" The bill likely will receive a second reading in the Senate next month (Taylor, Ottawa Citizen, 4/2).