In support of mandatory reporting of drug shortages

House of Commons


November 19, 2013

Ms. Libby Davies (Vancouver East, NDP):  

Mr. Speaker, I would like to congratulate my colleague, the member for Saint-Bruno—Saint-Hubert, for bringing forward Bill C-523. It is a straightforward bill and one that is really needed. Basically, it would amend the Department of Health Act to oblige drug suppliers to advise the Minister of Health of any interruption or cessation of the production, distribution, or importation of drugs and oblige the minister to prepare and implement an emergency response plan to address drug shortages. It is straightforward and necessary.

In debate tonight, we have heard how serious the issue of drug shortages has been. There are thousands of patients and families across Canada who have suffered terrible anxiety, pain, and stress because they suddenly have found out that the prescription they require as a pain control measure or for epilepsy or a special condition is not available. It has had a huge impact on the medical community, pharmacists, doctors, anesthesiologists, and hospitals. By and large, the biggest impact on Canadians and what is causing the greatest anxiety and suffering is that their health and well-being have been compromised as a result of these shortages.

I am proud of the fact that the NDP has been monitoring and pushing for accountability on drug shortages ever since it became visible that there was a huge issue that was not being addressed by the federal government. In March of 2012, we brought forward a motion in the House of Commons for the government to, in co-operation with the provinces, territories and industries, develop a nationwide strategy to anticipate, identify and manage shortages of essential medications, require drug manufacturers to report promptly to Health Canada, and so on. It was adopted unanimously. It clearly laid out a course of action that needed to be taken. It was interesting that the government supported the motion in May of 2012.

We also tried to call for a review of that motion a year later to find out what progress had been made. We heard something in that regard from the parliamentary secretary tonight. A multi-stakeholder steering committee was set up with the provinces and health care organizations on purchases and supplies. We had a briefing in October of this year from Health Canada to find out how that work was going, and we still have significant concerns about drug shortages in Canada. As a result of that briefing in October of this year, I wrote to the Minister of Health on October 29 outlining some of the concerns we had.

Our major concern is that although the government has set up this multi-stakeholder steering committee and does involve the key players, there is still no system in place for accountability and to ensure that suppliers live up to their obligations. As we heard tonight, the system that has been put in place is basically a voluntary one, so there is no accountability to ensure it is being followed. As a result, it is left to regional purchasers such as hospitals, health authorities, and the provinces to chase after the suppliers to find out what problems there are and what they need to do.

The second concern I identified to the minister was that accountability should also extend to how the shortages were reported. I pointed out that there was only a voluntary system in place for companies to report shortages, and no consequences if they did not immediately report them, even in delays that would compromise patient health. This particular point is very much at the heart of my colleague’s bill. We have been pressing for a required or mandatory reporting system. As we have heard, this is in place in the United States, New Zealand, and the European Union. It is a good practice and one we should be emulating.

The third issue that we have identified as a concern, as a result of hearing about the progress that has been made, is that there is no system in place that tracks systemic manufacturing violations. We know from Health Canada that it has identified approximately 46% of drug shortages are due to manufacturing issues, including safety violations, yet there has been no way to track which companies may be negligent in their production. In fact, Health Canada officials stated to us that they had not yet been able to address the root causes and the preventive measures that were required to address drug shortages. A system of accountability for manufacturing standards would also help in minimizing drug shortages.

Therefore, while I appreciate that the minister has taken some steps, frankly speaking, they are not adequate. They have not gone far enough. Out in the health community there is still an enormous amount of concern that we will face further shortages, that we will be scrambling as we did in 2012, that there will be yet another crisis. At the end of the day, it will be Canadians who are already in very difficult circumstances and who are already in many ways suffering, maybe in chronic pain, who will bear the brunt of a system that is not working properly.  

The last comment I want to make is that we have studied this issue quite carefully. In fact, the parliamentary health committee had a study on drug shortages. The report issued by the committee was okay, it was adequate, but we felt it did not go far enough. Therefore, in the minority report from the NDP we made a number of recommendations, which I would like to refer to.

We urged the Minister of Health and the federal government to review the appropriate federal agency to assume responsibility for drug shortages notification website and to work with its provincial and territorial counterparts to set up and provide an investment for a public mandatory reporting system whereby drug companies would be required by law to report supply disruptions.

We also urged the Minister of Health and the government to convene an expert committee to identify critical drugs and require that any company marketing these critical drugs would have to give Health Canada a minimum of six months’ warning of supply reductions.

Finally, there were other recommendations, but we also urged the Minister of Health and the federal government to convene a study to identify factors causing the drug shortages to determine if there were regulatory measures in addition to mandatory reporting that would identify and prevent drug shortages.

These are very extensive recommendations that we made.

I will finish with this. I was a bit aghast at the parliamentary secretary’s comments earlier. On the one hand, she said that they were not going to support the bill because it sought to expand the role of the federal government and sought to expand the bureaucracy. She kind of trashed it. Then in the next breath she said that they would support mandatory reporting if it was needed. It seems to me that there is a contradiction. Conservatives supported the motion last year that came through the House as a result of an emergency debate.

Let us focus on the issue. Let us ensure that there is a system in place as outlined in this very good bill. It is very straightforward. Let us learn from what has happened in other jurisdictions and let us do a better job in Canada. We are not convinced the multi-stakeholder process that is in place now will actually do the job that is required. We urge members of the House to consider the bill and to support it when it comes to a second reading vote.