Voluntary drug-shortage reporting adopted despite concerns
Health Canada bureaucrats worried of 'bad company behaviour' by drug makers
The federal health minister opted to let drug makers voluntarily alert doctors and pharmacists of medication shortages despite concerns from her own department that the approach could put Canada's drug supply at risk, documents show.
Records obtained by The Canadian Press indicate civil servants at Health Canada warned in February of last year that a voluntary notice system was "susceptible to bad company behaviour" and could see firms neglect to report every shortage.
An outline comparing voluntary versus mandatory approaches cautioned there would be no way to punish manufacturers who fail to report production gaps, which leaves health practitioners scrambling to get drugs to their patients.
Three weeks later Health Minister Leona Aglukkaq wrote to drug industry associations requesting they voluntarily release information on the increasingly common problem of medication shortages.
The letter to the Canadian Generic Pharmaceutical Association, Rx&D and BIOTECanada said that "regulatory alternatives" forcing notification would be considered only if it was not possible for the industry to develop a voluntary plan.
Opposition to voluntary reporting
Health Canada threw its support behind the resulting system — drawn up with input from health groups — in which drug makers pledged to post shortage information on a central website aimed at health professionals and patients. The site, drugshortages.ca, went live in April.
Voluntary reporting has been strongly opposed by the Canadian Cancer Society, the Canadian Anesthesiologists' Society and other health and patient groups. They insist the best way to ensure Canadians reliably get medications such as chemotherapy drugs and antibiotics is for Ottawa to require full disclosure from drug manufacturers on planned or unexpected gaps in production.
Aglukkaq's spokesman Steve Outhouse said a voluntary system was chosen because it would take too long for Health Canada to bring forward regulations mandating companies disclose production gaps.
"The website that tracks drug shortages is up and running now because of adopting a voluntary approach. Regulations can take years to pass, and would mean delays in getting this information to Canadians," Outhouse said in an email.
He added that a mandatory system will be considered if manufacturers do not voluntarily comply.
The issue of drug shortages came to the forefront in February when a Sandoz Canada plant providing 90 per cent of generic injectable anesthetics and other medications commonly used by hospitals cut production due to a facility upgrade and subsequent fire.
Cancer Society senior analyst Lauren Dobson-Hughes said the advocacy group regularly hears from patients struggling to hunt down therapeutic medications that do not pop up on the drug-shortage website.
"When cancer patients call they say, 'I cannot get my hands on this drug for love nor money.' And yet it is not listed short," she said.
"We know that drug shortages are increasing, but because nobody's tracking them systemically on a mandatory basis we still don't know where or how they're impacting patients," Dobson-Hughes added.
The Canadian Press obtained the internal Health Canada documents on drug shortages through the Access to Information Act.
Other records show a limited form of mandatory reporting was recommended in an exhaustive $25,000 report on drug shortages commissioned by Health Canada — one of several times the department has probed the issue of shortage notices.
The July 2011 report by Secor Group advised that Health Canada give manufacturers no choice but to provide an immediate alert on outages of drugs produced by one or a small number of manufacturers.
The report came months before Aglukkaq gave final approval to the industry's voluntary reporting plan.
Documents show recommendations in favour of a mandatory system date back to late 2010. During talks with industry and health groups, Health Canada floated a proposal for "a requirement for manufacturers to notify Health Canada of anticipated or occurring drug shortages when it has a public health impact."
Voluntary system ruled out
The idea was generally supported by participants, who ruled out a voluntary system, a subsequent memo indicates.
The document states that one of the "consistent themes" in feedback was that "notification of drug shortages should be mandatory (not in guidance or voluntary) and Health Canada must ensure timely communication of the information."
Drug makers advised the department that possible shortage regulations should be fairly wide-ranging and not limited to drugs made by a single manufacturer, according to the memo.
"The industry responses also suggested that the proposal should extend to multi-sourced products to better meet the policy objective and that it must be flexible to accommodate exceptional circumstances, if the trigger for notification includes a set time period (in advance of a planned shortfall)."
The Canadian Generic Pharmaceutical Association and BIOTECanada confirmed they were involved in the 2010 talks, but declined to say whether they supported the proposal.
An Rx&D spokeswoman said the group did not provide comment on mandatory reporting of shortages, but responded to other issues surrounding medication sourced from multiple suppliers.
All three groups said they are behind the current voluntary tracking system, which they created following Aglukkaq's request.