Canadian health officials are working "24/7" to review 23 new drug applications in a bid to help ease the national medicines shortage, federal Health Minister Leona Aglukkag has said.
The approval process for these drugs will take about one month instead of the usual six, she added, as officials struggle to deal with the shortages caused mainly by problems at the plant in Boucherville, Quebec, owned by Sandoz, which manufactures around 90% of Canada's injectable generic drugs.
In February, a fire broke out at the Boucherville plant, temporarily halting production, and the firm also announced that it would be cancelling production of some drugs and slowing the manufacture of others after the US Food and Drug Administration (FDA) found sanitation problems at the site and ordered it to improve its quality control procedures.
Members of the ruling Conservative party unanimously backed a motion proposed in the House of Commons last week by the opposition New Democratic Party calling on the government to adopt a concrete plan to manage the current shortage, adopt a National Drug Strategy to prevent this type of situation from happening again and expedite the review of regulatory submissions at Health Canada. The motion also includes demands from the provinces for a system that would require drugmakers to report any planned disruptions or discontinuations to Health Canada.
'Currently, drug manufacturers aren't required to inform authorities of potential supply problems. It's up to the Conservatives to change that. The government must act immediately to protect patients from avoidable drug shortages,” said NDP Health Critic Libby Davies, who tabled the motion.
Prime Minister Stephen Harper told the House that the shortage was due to a lack of planning by some provinces, which were reliant on a sole supplier for the drugs which are now hard to obtain.
However, Health Minister Aglukkag pointed out that that since neither the fire at the Sandoz plant nor the FDA's letter could have been predicted, a requirement that the firm should report planned disruptions would have had little effect on the current situation. She also said that the size and scope of the cutbacks at the Boucherville plant had not been fully disclosed until February. According to local reports, the firm had been aware that it would have to cut back production, as a result of the FDA letter, since last November.
A spokesman for Health Canada has also commented that the shortages are the unintended consequences of provinces seeking to save money through bulk purchasing. Because the drugs are made at a single factory, and there has been interruption of the supply line, the result is a national problem, said Dr Robert Cushman, director general of biologic and genetic therapies at the agency.
With such a small, concentrated market as Canada, companies leave the market because bulk purchasing arrangements mean that one firm will get "pretty much all the contracts for the country," he said.
Canada's research-based and generics industry associations have announced their support for the National Drug Strategy voted for by the House. In a joint statement, Canada's Research-Based Pharmaceutical Companies (Rx&D) and the Canadian Generic Pharmaceutical Association (CGPA) said the industry "looks forward to working with the federal government, provincial and territorial governments, and our partners in the health care sector, to develop a nationwide strategy to anticipate, identify and manage shortages of prescription medications."
The industry groups have also announced a joint plan which will: - permit inventory tracking, available publicly on one bilingual website; - develop a system to report anticipated shortages; and - recommend solutions when medications are not available.
Canada's current drug shortages date back to September 2010 and are expected to last for another year to 18 months, according to local reports.