Thank you. I apologize in advance. We were originally scheduled to be here until 9:45 and I'll have to leave shortly before 10:00, so I won't be here for the full two hours.
It's an embarrassment to our nation that Health Canada does not at present have the power to recall a pharmaceutical product from our market. I urge the committee members to rectify this omission by ensuring the passage of Bill C-17. You will thereby play an important role in helping to protect the safety of Canadians.
That said, there are a number of ways in which Bill C-17 can and should be enhanced. Others on this panel are speaking to the critical matter of transparency. I'm not going to address this. I'm going to outline three other measures that I urge you to embrace. These measures are simple, straightforward, and I hope, easy to comprehend. I'm happy to take questions after.
I'm even going to give you the suggested wording for the amendments that I propose. Despite how basic they are, these measures have the potential to dramatically improve patient safety, which is, as you know, the intended aim of the bill before you.
Here they are. First, expand the application of Bill C-17 to ensure that it applies to all holders of therapeutic product authorizations. Second, incorporate a greater range of adverse events. Third, exempt Health Canada from liability for measures taken in good faith.
I'll go through these one-by-one.
First, expanding the application of Bill C-17. The language at present generally refers to holders of therapeutic product authorizations. However, the specific provision on ability to recall refers only to sellers of products. The production and distribution of pharmaceuticals is complex and may involve several companies. Not all holders may be sellers.
For example, a company holding the authorization may license product sales to a different company and therefore not fall within the definition of seller. The recall provisions in the bill should be amended to capture all entities in the production chain and should specifically refer to the holders of therapeutic product authorizations.
Second, incorporate a greater range of adverse events. The language of the bill at present refers to injury and to harm. You may recall the incident last year regarding packaging of the birth control medication Alysena. Health Canada initially took the view that the problem with the packaging, potentially leading to numerous pregnancies in Canada and having resulted now in multiple claims of unwanted pregnancy and lawsuits, did not constitute a serious adverse health consequence.
They eventually accepted that if a particular woman should not get pregnant specifically for medical reasons, this would constitute such an adverse consequence, but not simply if she was opting not to get pregnant; i.e. taking the birth control pill for non-medical reasons.
In other words, pregnancy was and is, I assume in the interpretation of Health Canada, a lifestyle choice and not a serious adverse event.
The wording of Bill C-17 should be altered to incorporate language that envelopes situations of product mislabelling or mispackaging. Suggested wording is as follows, “For greater clarity, an adverse drug reaction includes but is not limited to circumstances in which the therapeutic product does not have its intended effect due to mislabelling or mispackaging of the product”.
An adverse drug reaction includes circumstances in which the drug does not have its intended effect due to mislabelling or mispackaging of the product.
Third, exempt Health Canada from liability for measures taken in good faith. Last and perhaps most importantly, the Minister of Health or her designate need to be able to exercise the powers outlined in Bill C-17 with impunity, provided that they act in good faith. Tort liability is in my view a marvellous mechanism for accountability and I would not usually be arguing for immunity on the part of government from its actions; however, consider this.
Pharmaceutical companies are among the most powerful corporations in the world. The total revenue of the Government of Canada for 2012-13 was $257 billion. The total revenue of the top 10 pharmaceutical corporations combined was over $400 billion in 2013. The total revenue of the top 50 pharmaceutical corporations was $610 billion in 2012. The incentive on the part of pharmaceutical corporations to commence lawsuits is high. In recent years they have engaged in illegal activities, and faced and absorbed fines for these illegal activities in the billions of dollars with barely a blink in their ability to continue functioning. It's not exactly David and Goliath, the Government of Canada versus pharmaceutical corporations, but you get the idea. To restate the basic facts I just outlined, Canada's total government revenue was $257 billion. The top 10 pharmaceutical companies' is over $400 billion.
I'm concerned that Health Canada will be impeded in its ability to execute the functions outlined in Bill C-17 for fear of lawsuits that could place a serious dent in our economy. Take the example of a precautionary recall of a product from the market in light of concerns followed by evidence accumulated by the corporation that the recall proved not to be necessary in the end. One can well imagine a lawsuit by the seller for sales lost during that period of recall. A primary means to ensure that Health Canada can vigorously pursue its mandate to protect Canadians is to amend Bill C-17 to incorporate a clear exemption from liability.
What would such an exemption look like? Here's some draft wording for example. The clerks have copies of this and you can get it after.
The government is not liable in respect of any loss or damage caused or resulting, directly or indirectly, by or from,
(a) the enactment of (specified sections of) this Act or a regulation or standard made under these sections of this Act, or
(b) anything done or omitted in the exercise or performance or purported exercise or performance of a power or duty conferred under this Act or regulations unless the person who brings the action proves that the person exercising or performing or purporting to exercise or perform the power or duty was not acting in good faith.
What is good faith? It's acting not with maleficent or evil aim, in other words, acting positively in a moral sense. Then if this measure is enacted, the government is immune from lawsuits for its actions in this regard.
In conclusion I urge you to promote the passage of Bill C-17 along with the specific enhancements that I'm recommending. The stated aim of the bill is to protect Canadians from unsafe drugs. These measures will ensure that the bill, once it becomes law, will live up to its lofty name. Members of this committee are uniquely poised to play a positive role in protecting Canadians and I encourage you to do so.