HESA Committee Report

Submitted by the Hon. Hedy Fry, P.C., M.P., LPC, Vancouver Centre

In March 2012, the House of Commons Standing Committee on Health undertook a short study on the federal role in drug supply. Three meetings on this subject were held, although it was quite clear that more meetings were needed to adequately deal with a topic of such complexity and to hear from all witnesses who wanted to appear before the committee.

The Liberal Party of Canada flagged the serious issue of drug shortages to the House of Commons and the Committee in September 2011 in the form of a motion calling on the Committee for an urgent study of the issue and its deleterious impact on patient health.

Drug shortages have become more critical in the last ten years. In a Canadian Pharmacists Association survey, published in December 2010, 80% of respondents indicated they could not fill a prescription that day and 94% reported they could not fill a prescription in the previous week. These numbers are up from 63% and 80% respectively from a 2004 survey.

Recently, Canada’s Research-Based Pharmaceutical Companies and the Canadian Generic Pharmaceutical Association agreed to work together to voluntarily post information about current and potential drug shortages. While the Liberal Party welcomes this collaboration, we know that posting information about drug shortages does nothing to resolve the actual cause of the shortage nor find an available source of the drug itself. Indeed, the global nature of these shortages may result in stockpiling in many countries. Given Canada's dependence on other nations with strong pharmaceutical industrial sectors this can present a real and critical problem of supply management.

In fact, this problem was highlighted in the testimony of witnesses appearing at the Committee. Unfortunately that testimony is absent from this report.

The Liberal Party decided that this report does not adequately represent what the Committee heard from expert witnesses. We are therefore presenting this dissenting report.

In order to understand the true nature and complexity of the Drug Shortage problem and proposed solutions; it would be preferable for readers to read online the evidence heard by the Committee on March 27, March 29, and April 3, 2012. Limitation on space allocation for this dissenting report does not allow us to give the full testimony.

While the report highlights the complexity of the drug supply process and the jurisdictional responsibilities, there are three key pieces missing in the committee report, that were identified by witnesses, as critical to ensuring that drug shortages do not recur.

As noted in the report, concerns were raised on the accuracy of a drug’s status of “active” or “discontinued” in the Drug Product Database (DPD). This can negatively affect the ability of health providers to identify alternative therapeutic options. A review is needed of the DPD.

Witnesses also called for modernisation of Health Canada’s Special Access Program, which allows health providers to access drugs and medical devices that are not approved for sale in Canada.

Several witnesses identified serious flaws in the current pharmaceutical industry's drug shortage website. They noted that voluntary reporting is not reliable and drugs that are in short supply are not always listed.

Concern was also raised regarding the twenty day warning of a drug shortage, since it does not allow enough time to find and adapt alternative therapies for individual patient needs.

In many cases, alternative therapies are not available. Witnesses suggested that reporting be mandatory and that the time frame for drug-shortage warning to be expanded to six-month minimum.

The Committee heard that there is a pro-active role for Health Canada in ensuring a supply of medically necessary drugs. As Liberals had suggested in November 2011, Health Canada should begin a strategy to anticipate, identify and manage drug shortages using the existing U.S. Food and Drug Administration (FDA) model. In response to the drug shortage crisis, the U.S. FDA established an eleven person team to work exclusively on preventing and managing drug shortages. Witnesses suggested that Health Canada implement a similar team to work with local and global drug industry partners to identify early shortages and ensure a continued supply of medically necessary drugs.

As a result of the inadequate representation of witness testimony in the Committee report; recommendations do not reflect the solutions that were presented.

So the Liberal Party of Canada, in keeping with witness presentations, recommends the following:

1.    That Health Canada undertake an immediate review of the Drug Product Database (DPD) and the Special Access Program (SAP), including an assessment of the resources allocated to those programs, and to optimise them, as part of a pan-Canadian Drug Shortage strategy;

2.    That the Minister of Health mandate manufacturers to report within a minimum of six months, early evidence of a potential drug shortage to Health Canada and other stakeholders;

3.    That the Minister of Health establish an expert team, within Health Canada, exclusively, to anticipate, identify, and manage drug shortages, (similar to the United States of America’s Food and Drug Administration team); and

4.    That Health Canada report, within six months, to the House of Commons Standing Committee on Health, on the establishment of a nationwide strategy to anticipate, identify, and manage shortages of medically required drugs.