Bill C-17 (Historical)

Protecting Canadians from Unsafe Drugs Act (Vanessa's Law)

An Act to amend the Food and Drugs Act

This enactment amends the Food and Drugs Act regarding therapeutic products in order to improve safety by introducing measures to, among other things,
(a) strengthen safety oversight of therapeutic products throughout their life cycle;
(b) improve reporting by certain health care institutions of serious adverse drug reactions and medical device incidents that involve therapeutic products; and
(c) promote greater confidence in the oversight of therapeutic products by increasing transparency.

[Prof. Matthew Herder]

Absolutely. Bill C-17 is strong as it stands. It could be made really strong if the amendments are included.

[Prof. Matthew Herder]

Perhaps I can speak first.

I think the point Professor Gibson was making was around restrictive interpretation of harm or injury. Her point was that without clear guidance, harm or injury encompassed products that had been mislabelled or mispackaged and that therefore wouldn't work as a result, as was the case in a contraceptive pill, which they may not include in the definition of “harm”.

With the definitions that are in Bill C-17 and with the additional wording that she proposed for circumstances in which they may not work because of mislabelling or mispackaging, the bill would capture other things as well as adverse drug reactions—the more traditional kinds of harm.

I'm not sure that I have squarely addressed your question, but I think we're there in terms of what has been offered.

[Dany Morin, NDP, Chicoutimi—Le Fjord, QC]

I am very happy about that.

Thank you for giving me the opportunity to speak my native language.

My first question is for Mr. Lexchin and Mr. Herder. Other witnesses may also make comments on this.

Earlier, we spoke about a contraceptive pill which, according to the old definition which is not included in Bill C-17, meant that a pregnancy was considered to be the consequence of a life choice. So, according to the new definition we find in the bill before us, are there other concrete examples of medications which were mistakenly classified?

In other words, will the new definition solve other situations we may have seen in Canada, aside from the contraceptive pill which was used as an example previously?

[Terence Young, Conservative, Oakville, ON]

Mr. Chair, I have a point of order.

Professor Gibson made a really brief remark on natural health products, and I could tell she wanted to say more. I wonder if we could ask the clerk to write to Professor Gibson to ask her if she wouldn't mind submitting further remarks in addition to her brief comments on the record about natural health products and Bill C-17.

[Prof. Janice E. Graham]

Thank you. It's a very good question, Mr. Wilks. Thank you for asking it.

I was researching at Health Canada when the natural health products directorate was brought into being. At that point in time, Canada was a world leader, and it remains a world leader in having a natural health products directorate. Unfortunately, and I will say it here, they caved to industry pressure—and I'm talking about the natural health products industry—and removed issues of efficacy from approvals. So unlike biologics and pharmaceuticals, NHPs or natural health products don't actually need to have the stamp of showing that they are an efficacious agent.

Mostly people were worried about safety, and I share all of my colleagues' concern that many of the natural health products aren't all that safe. This is something that is recognized everywhere in the world.

I was in West Africa last month and watched a little boy writhing on the ground after he had to have a terrible abscess removed without painkillers, because the nurse in this tiny clinic without electricity recognized that these kids were coming in and.... People first go to what in Canada is the medicine cabinet or to what anywhere else is the local herbalist and pick up whatever they have. When they finally go as a last effort to the emergency ward, the emergency people can't treat them, because they don't know what they've taken.

I think the issue of natural health products would very easily derail all of our interests in getting the amended Bill C-17 forward, but I would like to leave it off for now, because we want to see Bill C-17 amended and approved.

[Dr. Joel Lexchin]

I certainly think we need more information about natural health products. I work in an emergency department. When people come in and they say they're taking various natural health products, I really have no idea of, one, the inherent risks associated with those products, and two, how those products interact with any prescription drugs that those people may be taking.

I'm not alone. I think most of my colleagues are in the same position. We definitely need more information about the safety of these products. But I think one of the things that killed Bill C-51 was the opposition from the natural health products community. I would hate to see Bill C-17 killed because of that same kind of opposition. I think we need to move forward with better regulation of natural health products. But I agree that I think it can be done at a later date.

[Sylvia Hyland]

I'm not sure the risks are lower. Our position is the understanding that the inclusion of natural health products in the more complex bills cause them not to move forward and be enacted. Bringing that into this bill might actually slow down the great work that's already been started. So maybe the natural health products do need to be dealt with, but in the future...to take Bill C-17 and take this first step forward. So I do think they will need to be looked at, but I'm not sure we need to bring them in right now to Bill C-17.

Does that help?

[David Wilks, Conservative, Kootenay—Columbia, BC]

Thank you.

Thank you, Mr. Morin.

I wanted to touch upon a couple things, and unfortunately, one of our witnesses left. One of the things that was brought up was the natural health products that were not included in Bill C-17 due to their low risk profile and the fact that they're already adequately regulated.

Ms. Hyland, do you agree with the approach, given the inherent low risk of natural health products? Perhaps I could listen to Professor Herder and Dr. Lexchin, and Janice Graham, who is online as well.

We'll start with Ms. Hyland.

[Terence Young, Conservative, Oakville, ON]

That's a terrific example.

Can you please comment on drug disasters? I wanted to ask you, if Bill C-17 had been law throughout the 1990s and clinical data had been published throughout the 1990s, how many or what drug disasters could have been avoided?

[Francis Scarpaleggia, Liberal, Lac-Saint-Louis, QC]

If we passed Bill C-17 without the amendments, without strong amendments that have been suggested, would we be laggards? What I guess I'm getting at is whether this bill is simply a placebo, or is it going to make substantial progress anyway? Would we still be behind the United States and Europe, in terms of transparency, if we passed the bill without the amendments that you and others are suggesting?

[Dr. Joel Lexchin]

If you compare us with the United States and the EU, right now we're a distant third in terms of transparency. With the passage of Bill C-17, with the amendments that have been suggested, I think Canada would be leading both the U.S. and the EU. Right now, though, we're not doing very well in terms of transparency, disclosure of information.

[Prof. Matthew Herder]

I'll speak to the specific issue, if I may, of that provision on trade agreements.

The current wording of the statute is that it's a power to make regulations in respect of the trade agreements and the opening language of the clause is, “without limiting the powers conferred elsewhere in this act”, or something essentially to that effect, so that you can create regulations to deal with these trade commitments, but they don't undermine or shape the powers that are already in the statute outside of that set of regulations.

Under the proposed amendment, in Bill C-17, the language is, “Without limiting the power conferred” in this section, so that means, by implication, that implementing those trade agreements or commitments around those trade agreements around intellectual property, could shape powers elsewhere in the legislation. That's my interpretation of the effect of that wording. That's very subtle. It does not necessarily shape those powers. It just creates the possibility of doing that in the name of trade and respecting particular articles in NAFTA and the TRIPS agreement around intellectual property.

I hope that clarifies it. The first time I read the bill, I didn't catch it. It's very subtle language, but I think it's important and it opens the door to sort of fettering responsibilities or powers that are in the legislation around recalls, things in the name of patient safety or transparency. It could, in theory, certainly be tempered by virtue of that new wording.

[Sylvia Hyland, Vice President and Chief Operating Officer, Institute for Safe Medication Practices Canada]

Mr. Chair, members of the committee, and staff, thank you for giving me the opportunity to be here on behalf of ISMP Canada.

I would like to state our strong support for Bill C-17,, the protecting Canadians from unsafe drugs act, also known as Vanessa's law.

ISMP Canada is an independent, not-for-profit organization established in 2000 to analyze incidents of preventable harm from medications, to identify system improvements, and to work collaboratively to advance medication safety.

One of the key elements in Bill C-17 is a stronger requirement for reporting by health care institutions of serious adverse drug reactions and medical device incidents that involve drugs. We believe that this will better identify drug-related risks.

Repeated research has shown that harm from medications happens more frequently than practitioners and the public realize. A study in 2008 found that more than one in nine emergency department visits are due to drug-related adverse events, of which 68% were thought to be preventable. The research, along with experience, has shown that in many cases harm can be prevented and patients can be protected, but only if we as health care providers and administrators are aware of the problems.

One of the ways we become aware of the problems is through a robust reporting system. The value of improved reporting will be more information to better evaluate a drug's benefit-to-risk ratio. With adverse event or adverse reaction reporting, anyone can make a report. One report can make a difference and ultimately impact on the way that health care is provided.

Our organization works closely with hospitals, and we know that reporting is taking place on a voluntary basis. There is a growing culture of safety and a growing awareness of the value of reporting. We also know that the reporting of harm from medications is variable. The bill provides impetus to build on existing infrastructure, create more consistency, and adopt standardized approaches so that the quality of data collected can improve.

A readiness for this bill exists. It is our experience that when there is recognized value, additional work on the part of practitioners or organizations will not be a barrier to implementation. There is a level of awareness that, if enacted, this legislation will not only promote reporting but will spark more collaboration at the provincial and national levels.

With this bill we have an opportunity to identify best practices for reporting and for coordinating existing systems to provide adverse drug reaction data to Health Canada. There will be opportunity to link this work through such advancing technologies as the electronic health record and thereby continuously improve data capture on the use and safety of medications.

As well, analysis and interpretation of data will improve. One of the limitations of the current system for voluntary reporting by practitioners in hospitals is that it is not possible to infer or project the probability of specific harms. This can be improved with mandatory reporting. In other words, voluntary reports of severe and unexpected cases of harm from medications help to detect new risks and can provide early warning. However, increasing the number of reports through a mandatory process in hospitals will also help to identify trends and will better support continuous evaluation of a drug's benefit-to-risk balance.

Our organization works closely with consumers and patients, and it is our experience that most consumers and patients are under the impression that mandatory reporting already exists. This bill helps us to live up to their expectations. Ultimately, this bill will help ensure that practitioners, together with patients, have enough information to make an educated decision about drug treatment.

A second key component of the bill is strengthening safety oversight by providing Health Canada with increased authorities.

Health Canada's life-cycle approach to drug safety oversight recognizes the need for continuous evaluation of the use of a drug and its benefit-to-risk balance in the real world experience. The bill empowers Health Canada to require licence holders to conduct assessments, compile information on product use, conduct tests or monitor experience, take preventative measures, and monitor the effectiveness of such measures.

Pharmacovigilance activities are now being viewed more broadly as relating to not only adverse reactions that inform the inherent benefit-to-risk ratio of the drug molecule itself but also the preventable adverse events that inform health care system improvements, practice improvements, and label improvements.

For example, following analysis of medication errors, which by their nature are preventable harms from medication, we have worked with manufacturers and Health Canada to improve package label design, so that critical information is the most prominent information, rather than, for example, emphasis placed on branding or marketing. In this way, we can increase the probability that important information will stand out and also reduce the risk for error.

The authorities provided in the bill will allow greater influence on the unique considerations for the package and its label, the product monograph, the package insert, and the patient information provided. With the evolution of medication safety, we now know much more about designing labels for safety, designing labels and packages with the end user in mind, and utilizing human factors expertise to help ensure optimal representation of information and reduce risk of error.

There is a tension between the safety science and the many efforts to market, brand, and sell a product. The two can be at odds. It is important that Health Canada be positioned to assert safety over marketing, safety over branding, and safety over sales. We need to have Health Canada in a position to demand quick action when the safety of Canadians is at risk.

I acknowledge that there have been pharmacovigilance advances and successful safety initiatives accomplished within the limitations and constraints of the current Food and Drugs Act.

Many manufacturers have moved quickly to improve product problems when compelling information for change has come forward, but not always. By enabling a prompt response to identified risks, such as requiring a label change or to make new safety information available, or ordering a product recall, we believe that the safety of patients is enhanced.

Again, as we work with consumers and patients, we often find that they are under the impression that Health Canada already has the authorities outlined in the bill. The bill helps us live up to their expectations.

In summary, the components of Vanessa's law encourage collaboration and system improvement for reporting of serious adverse drug reactions. The bill aligns Health Canada authority with expected accountability and responsibility.

The bill has undergone extensive study and consultation, and it meets the test of reasonableness. We are grateful for this chance to encourage the standing committee to move forward with Bill C-17.

Thank you again, Mr. Chair, and members of the committee, for this opportunity. I look forward to our discussions and the next steps.

[Professor Matthew Herder, Assistant Professor, Faculties of Medicine and Law, Health Law Institute, Dalhousie University, As an Individual]

Thank you, Chair.

Thank you for the privilege of appearing before you today. l'm a legal scholar with expertise in intellectual property law. Given time constraints, l'm going to focus solely on the issue of transparency, which Bill C-17 does not address. l have two themes, each with a few specific points that l want to touch upon. I'll conclude by reading five key provisions that l think should be added to the bill.

My first theme is to make evidence and regulatory work transparent.

First, amend Bill C-17 to make registration of all clinical trials, from phase one to phase four, as well as other investigational studies and the reporting of all such study results, mandatory for all new drugs and new indications for existing drugs that are submitted for regulatory approval, whether those submissions are successful or not.

Second, empower the Minister of Health to disclose clinical study reports. Access to clinical study reports and the data they contain can be critical to understanding the quality of the evidence behind a given drug.

A study published just last week in the British Medical Journal comparing clinical study reports with published information regarding duloxetine, a commonly prescribed treatment for major depressive disorder in Canada, concluded, “Clinical study reports contained extensive data on major harms that were unavailable” from other sources.

The optimal procedures for sharing clinical study reports are the subject of live debate. For that reason, defining the procedures by which clinical study reports should be made available by way of regulations is appropriate. But vesting the minister with the authority to make them available is critical.

Third, require the minister to publicly report all decisions, including product approvals, refusals, suspensions, and recalls, and the reasons behind those decisions. Patients, physicians, researchers, indeed drug manufacturers and other regulators would benefit from knowing how the regulator is interpreting the evidence. In time, this will improve the quality of the regulator's decision-making and Canadians' confidence in it.

Fourth, attach real penalties to non-compliance with transparency requirements. Despite clear penalties backed by the force of law, in the United States compliance has been less than adequate. According to one study, 78% of trials registered on ClinicalTrials.gov failed to provide results within the statutory one-year timeframe.

I therefore suggest a modified enforcement strategy. As is done in the U.S., Bill C-17 should make failure to comply with registration and results reporting subject to monetary fines. However, Bill C-17 should also tie results reporting to market approval.

Bill C-17 already includes an amendment to the Food and Drugs Act that would require manufacturers to comply with any terms or conditions attached to the market approval. This power should not be used only on occasion. Rather, that new power should be used in every single drug approval where results reporting is, at the time of market authorization, still incomplete. Where the regulator rejects a drug or a new indication for an existing drug, and the results reporting requirement has not been fulfilled—it has to be within six months—manufacturers should incur an additional monetary fine.

The second theme is to make it absolutely clear that transparency trumps commercial claims.

Here's my first point. Subclause 6(6) of Bill C-17 proposes a modification to subsection 30(3) of the current Food and Drugs Act. The proposed change opens the door to limiting the powers contained in the act in order to implement trade agreement articles relating to intellectual property. This proposed amendment should be deleted from the bill. The federal government's responsibility to protect the welfare of Canadians should not be reduced by trade objectives.

On my second point, and this is my last point, claims by manufacturers that certain information is proprietary—that is, confidential business information or trade secrets—has long been the central barrier to transparency. However, consistent with its international obligations, Canada's food and drug regulations already protect data against unfair commercial use, providing eight years of data exclusivity to innovative drugs on top of any available patent protection. Nevertheless, it is received wisdom within Health Canada that information about drug safety and effectiveness cannot be disclosed. Consequently, Bill C-17 must make it plain that the regulator has the power to disclose that information.

People have given up their bodies and taken on serious, even life-threatening, risks to help generate that information. It is not for the companies to own in secret, and the regulator has to be free to disclose it.

To conclude, here are five provisions that should be added to Bill C-17, in light of the foregoing.

First, all clinical trials and other investigational studies involving a therapeutic product shall be registered on a publicly accessible, searchable database before participant recruitment begins, in accordance with the regulations. As well, the minister shall not issue a market authorization in respect of a therapeutic product unless any clinical trials and other investigational studies involving said therapeutic product were registered in accordance with this provision, whether or not those trials and other investigational studies were carried out in Canada.

Second, all clinical trials and other investigational studies involving a therapeutic product shall report the results thereof on a publicly accessible, searchable database within one year of the completion of the trial or study, in accordance with the regulations. As well, where the results of one or more completed trials or investigational studies associated with the therapeutic product have not been reported in accordance with this provision prior to market authorization, the minister shall require as a condition of market authorization that such results be reported in accordance with this provision within six months of the date of market authorization. Finally, in the event that a therapeutic product is not granted a market authorization by the minister, the manufacturer shall report the results of all clinical trials and investigational studies in accordance with this provision within six months of the date of the minister's decision not to grant market authorization.

Third, the minister may publicly disclose clinical study reports in accordance with the regulations.

Fourth, the minister shall disclose in a publicly accessible, searchable database, information about therapeutic product authorizations, including any terms or conditions associated with a therapeutic product authorization, indication changes, refusals, suspensions, and recalls, and the reasons for each such decision.

Fifth, the minister, in fulfilling the foregoing provisions, shall publicly disclose information regarding the safety and effectiveness of a therapeutic product, including adverse drug reactions, which it receives from manufacturers, health-care institutions, and other persons. As well, information referred to in this provision shall not be used by a manufacturer for unfair commercial purposes as described by the regulations.

Those are the provisions I suggest are essential to add in their entirety to the bill for it to achieve its full promise.

Thank you.

[Professor Elaine Gibson, Associate Professor, Health Law Institute, Dalhousie Schulich School of Law, As an Individual]

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.