Madam Chair, members of the committee, we thank you for providing the Ordre des pharmaciens du Québec with the opportunity to discuss disruptions in the drug supply and, especially, potential solutions for preventing those shortages and limiting their impact on the health of Canadians. Joining me today is Manon Lambert, Director General and Secretary of the Ordre des pharmaciens du Québec. She can also answer your questions.
Stability in the supply of pharmaceutical products was a key concern for the order well before the media began reporting on the crisis we are witnessing today. In March 2011, we established a multipartite committee to study the causes of the shortages and prioritize recommendations for possible solutions. We will present the results of that work in mid-April in collaboration with the Collège des médecins du Québec, Quebec's college of physicians; the Association des pharmaciens des établissements de santé, the association of health-care institution pharmacists; and the Association québécoise des pharmaciens propriétaires, Quebec's association of owner-pharmacists.
At the beginning of this process, our findings were cause for concern: the number of supply disruptions between 2006 and 2010 had quadrupled, and the disruptions would last several months. What is worse, it appears that the shortages entail major clinical risks, as exemplified by some 15 related deaths in as many months in the United States and, closer to home, 65 surgeries that were recently postponed in the Outaouais owing to a shortage of injectable medications. Some groups, particularly people living with cancer, are especially vulnerable to these shortages and are often their first victims.
The Ordre des pharmaciens du Québec and its partners view the drug supply problem today as a public health issue that calls for immediate and concerted action by the various players involved. At the federal level, our recommendations address three complementary and overlapping elements.
First, Health Canada must assume leadership in dealing with this major issue. To do so, it must create a monitoring unit. The role of this unit would be to monitor disruptions internationally and nationally, as well as to support the provinces in their efforts to prevent shortages. In addition, this monitoring unit will have to develop reciprocal relationships with other regulatory authorities, such as the FDA.
Second, the federal government must implement a legislative framework that requires companies to give notice of the following two situations: one year for any halt in production, and six months for any expected disruption in the drug supply.
Last, a Canadian list of essential drugs must be compiled in order to prioritize efforts to mitigate clinical risks and provide particularly proactive monitoring. I will expand on those three recommendations.
In the first recommendation, we are working from the premise that a drug, given its life-saving capacity, is an exceptional consumer product that, as such, deserves a customized legislative and organizational framework. We feel that the stability of the drug supply today should be the focus of a national vision, and our first recommendation is to establish a hub for monitoring and concerted action across Canada.
In the United States, the FDA monitors the global situation in order to eliminate the problem of drug shortages at the root. We believe that, in Canada, an independent national organization should be responsible for identifying risks that could affect the supply, and for encouraging information-sharing among the country's regulatory bodies. Beyond this simple observer role, the organization should also have mechanisms that would enable it to react quickly and prevent shortages, or at least reduce their impact on the health of Canadians.
We feel that Health Canada should take the initiative in creating this monitoring unit—in association with the provinces—by making it a priority on the agenda for the next conference of federal-provincial-territorial health ministers, to be held in Halifax on September 27 and 28. I will now discuss the second recommendation.
That being said, a unit like this will not have the means to carry out its mission unless it receives relevant information in time to implement mitigating measures. The entirely volunteer process the pharmaceutical industry currently uses to report production problems or changes that might affect a drug's availability seems to us to be clearly inadequate.
For example, manufacturers in France are required to inform regulatory bodies of any factors that could influence a drug's availability one year in advance. In some instances, such as single-source essential products, a manufacturer that wants to cut back or stop production may even be legally required to keep producing until an alternative can be put into place. Canada must enact a similar measure.
We also believe that Health Canada must impose a legislative framework for manufacturers, requiring them to report any significant changes in the production chain that could limit access to one or more drugs a minimum of six months in advance, or as soon as they know about it. A non-binding resolution would not provide the safeguards needed to protect Canadians.
Under a coercive system like this, Sandoz would have been required to inform the authorities, back in 2009, that the FDA had issued it a notice of non-compliance. In this specific instance, as in many others, the voluntary system appears to have shown its limits.
Lastly, as is done in a great many countries, we hope Health Canada will coordinate the compilation of a list of the essential “single-source” drugs used in the different provinces.
These so-called single-source drugs, manufactured by a single company, obviously present a greater risk for shortages, since no other supplier can step in to resolve a reduction or stoppage in production. In these cases, not only is the health of Canadians jeopardized should production difficulties arise, but the manufacturer's monopoly position also limits the negotiating power of regulatory bodies in the event of a crisis.
Once again, the recent example of disruptions at Sandoz, the sole manufacturer of many drugs, has made all the players in our health care system aware of the vulnerability that comes with dependence on a single supplier.
An interruption in the supply of essential drugs creates major problems of a medical, ethical and human nature. The disruption involving CaelyxTM, a drug used to treat ovarian cancer, is a recent dramatic example. Faced with shortages, some Quebec hospitals were forced to give priority to those patients who had already begun treatment, thereby delaying administration of the first dose for other patients. We believe that no patient should have such crucial treatment suspended or delayed.
We are convinced that, by ensuring minimum stockpiles of essential drugs, Health Canada would increase the network's ability to adapt and thus limit the risk of out-of-stock products.
There is an urgent need for action. Such measures have already been adopted in other countries and must be introduced here as quickly as possible.
In the meantime, we hope Health Canada will adapt the special access program to the new reality of supply disruptions. We find it inconceivable that this program, which is the main recourse for hospitals for access to international stock, is currently not more effective in the fight against stock disruptions. The program should also be available to the patients of community pharmacists.
Our three recommendations represent a major paradigm shift that places the supply issue in the context of national public health and, above all, proposes a proactive and collaborative approach to replace the reactive mode that typifies current federal and provincial actions.
Therefore, our efforts are aimed at prevention and action, rather than at enduring situations that are unfortunately bound to recur. We want to reiterate that the measures we are proposing have but one aim: to protect the health of all Canadians.
Thank you for your attention.