Health Committee on June 10th, 2014

[The Chair, Conservative, Ben Lobb]

Good morning, ladies and gentlemen. We're continuing our study on Bill C-17. We have a number of witnesses today, so we might as well get right at it.

First of off, we'll start with our guest who's on teleconference this morning.

Ms. Graham, can you hear us okay?

[Professor Janice E. Graham, Professor of Pediatrics, Faculty of Medicine, Dalhousie University, As an Individual]

Yes, I can.

Can you hear me?

[The Chair, Conservative, Ben Lobb]

We can hear you loud and clear.

We're going to have you go first. We'll have four or five presentations—you'll be first—and then after the conclusion, we'll be open for questions. So can you stay on the line, if that's okay?

You have around 10 minutes for your presentation. Go ahead, if you like.

[Prof. Janice E. Graham]

Thank you very much for this opportunity to contribute to your study of Bill C-17

I'm going to focus today on why I think amendments to the bill are needed to address openness and transparency of clinical trials data and the decisions surrounding the approval of drugs by Health Canada.

I became interested in the transparency of safety and efficacy data almost 20 years ago while working as a research fellow on a phase four clinical trial. The manufacturer who sponsored our study selected the positive results from our database, ignoring the not-so-positive cases in order to argue for inclusion of that drug into the provincial formulary. I was appalled at the manipulation and wondered how mediocre drugs get approved in the first place given their cost to our health care system.

Between 2001 and 2006, I conducted extensive anthropological research at Health Canada's regulatory authorities. I was observing drug evaluations, regulatory activities, and decision-making. Also, I participated in progressive licensing consultations with Health Canada and I chaired their expert advisory committee on the special access program.

Concerns and recommendations that our committee made in 2008 about the role and fit of regulatory modernization were never made public and several apply to the recommendations for Bill C-17.

In 2004, Health Canada received the Code of Silence award from the Canadian Association of Journalists as the most secretive government department for denying access to drug databases that could harm or kill Canadians. The CAJ charged that commercial interests trumped Canadians' health. Regulatory capture, a term that gets used by all sides to accuse a regulatory authority of favouring the interests of one stakeholder over another, can happen in any sector. It's non-partisan.

The ability of Health Canada's regulatory evaluators and independent reviewers to do their job is challenged when assessing partial and incomplete data. I do not wish to criticize the dedicated work carried on by Health Canada's regulators. They work under considerable structural and financial constraints. Hiring just a few more evaluators in 2004 and 2005—while I was doing my research there—enabled the directorates to move out of years of backlog.

Improvements in recent years have made Health Canada's activities and reports more readily accessible. But these still remain weak instruments, lacking important details about the research design and methodologies, data, critical appraisal, and the assessment that would ensure unbiased results and analyses. While Health Canada's reviewers use many mechanisms to arrive at their decisions, including bilateral consultations with the sponsor and ongoing clarification of their questioning during reviews, I suggested there remains an essential role for independent appraisal that requires open access to the clinical trial data and to Health Canada's decision-making.

As a case in point, Health Canada's assessment of the stem cell therapy Prochymal left more questions than answers. In 2012, Canada became the first country to conditionally approve Prochymal for the treatment of acute graft-versus-host disease in children. Approval was based on very encouraging data showing clinically meaningful responses provided by the sponsor. The U.S. FDA wasn't convinced though and denied approval of that drug. The manufacturer, Osiris, planned to use Prochymal for the treatment of many other diseases, opening the door to multiple off-licence indications.

The fact that the panel recommended a warning for the product monograph to say, “The long term effects of Prochymal® in growing children are unknown“ would, I hope, have alerted the marketed health products directorate to a ticking time bomb.

Based on limited and unpublished clinical trial data, Canada's decision to approve Prochymal was lauded as a huge achievement by the financial and drug development communities. Canada was seen to be signaling a shift, that they were open to industry for faster access, more than for the safe drugs that Canadians need as promised in the 2003 throne speech.

Health Canada's summary basis of decision-making for Prochymal presented a confused picture of the criteria and proceedings that allowed its approval. Data from two unpublished studies were used to arrive at the decision, and one didn't even meet statistical significance for the critical end point. I quote from the summary basis of decision-making:

To date, only preliminary evidence exists to indicate a potential therapeutic value for Prochymal; however, so far, Prochymal has not exhibited worrisome toxicity and has shown a relatively benign safety profile.

I submit to you that so does a placebo and the evidence was that this trial was based on only 28 days of clinical research.

HPFB's own consultations say that the summary basis of decision documents do “not contain enough detailed information about clinical trials including study participants, results and harms to truly allow consumers and health care providers to make informed choices.”

In a business article titled “How to Tell When a Drug Company Fibs About Clinical Trial Results”, Adam Feuerstein wrote:

Osiris Therapeutics “disappeared” important data when the company announced results...from a mid-stage study of its stem cell therapy Prochymal in heart attack patients.

Regulation works well when it takes nothing for granted and has multiple, iterative mechanisms to control for potential gaps. The good regulator wears both a belt and suspenders. I don't think any of us wants Canadian regulators caught with their pants down. I cannot afford a ticking time bomb—none of us can. Bill C-17 does not go far enough in ensuring independent, systematic review of all clinical trial data. Steps to ensure access to clarifications and consultations between industry sponsors and regulators, and the details in rationale for drug approval, approval with conditions, refusal, and suspended or recalled drugs, are not included in the present draft of Bill C-17. Neither is budgetary commitment to provide the resources for the enhanced regulatory activities that modernization will need to meet obligations to Canadians for the safety and efficacy of therapeutic health products. Without budgetary commitment to carry out these extra activities, provisions in the act will be futile.

Regulatory modernization has swept across nations. It's intended to keep pace with our political neighbours in terms of policy, economy, and science and technology, but it can also be an opportunity for clinical trialists and regulators to adopt new, more robust methodologies. While Bill C-17 will enhance the recall powers of the health minister, it puts no emphasis on enhancing the capacity and capability of Health Canada with the precautionary buffer of independent review and access to decision-making.

Instead, regulatory modernization has pushed for post-market surveillance and follow-up for conditionally approved drugs, many of which should be stopped at the gate. With quicker access to these drugs, Canadians risk becoming phase four clinical trial guinea pigs who are not protected by the careful controls in traditional phase one, two, and three clinical trials.

Without the benefits of independent, open and transparent access to clinical trial results, the authorization and approval of the use of medications remain an ethically unjustifiable black box. Bill C-17 will serve all Canadians better if it can address this gap. As the journal Nature points out:

Greater openness about clinical-trial data should help to speed up drug development, provide independent assessments of drug safety and efficacy and increase trust in industry science.

It's a win-win for us all.

Thank you.

[The Chair, Conservative, Ben Lobb]

Thank you very much.

Next up by video conference, we have...is it Joel Lexchin?

[Dr. Joel Lexchin, Professor, School of Health Policy and Management, York University, As an Individual]

It's Lexchin, like you're going to have in two days.

[The Chair, Conservative, Ben Lobb]

Like an election.... Well, all right. Welcome, Mr. Lexchin.

You have 10 minutes, so go ahead, sir.

[Dr. Joel Lexchin]

I want to thank the standing committee for the opportunity to appear today.

I teach health policy at York University and work as an emergency physician at the University Health Network in Toronto. I've been analyzing, talking about, and writing about pharmaceutical policy for over 30 years, and I'm the author or co-author of about 140 peer-reviewed articles on these topics.

My testimony is going to focus on three issues: first, the need to ensure that any post-market studies are carried out in a timely manner; second, the problems with clinical trials conducted by companies making the products being tested; and finally, the need to improve on the amount of information that Health Canada discloses after it has approved a new drug.

In discussing the first issue, I'll examine the situation regarding the notice of compliance with conditions policy. For the second, I will use the results of a recent systematic review that looks at the results and conclusions of trials funded by drug companies, and those trials that receive funding from other sources. And for the third issue, I'll draw on a study that I and a graduate student recently published, that looked at the quantity and quality of information that's disclosed in the summary basis of decision documents that Health Canada releases after it approves a new drug.

With regard to the notice of compliance with conditions, this is a policy that was adopted back in 1998, and the goal was—and here's a quote from Health Canada—to provide patients suffering from “serious, life-threatening or severely debilitating diseases or conditions” with earlier access to promising new drugs. This is where surrogate markers have suggested that these products offer “effective treatment, prevention, or diagnosis of a disease or condition for which no drug is presently marketed in Canada”, or significantly improve efficacy or significantly diminish risk over existing therapies.

One example of a surrogate marker would be that a drug shrinks the size of a cancer tumour. In return for getting a notice of compliance with conditions, companies have to commit, in writing, to undertake confirmatory studies—that is, studies that definitively establish efficacy—and then submit these results to the therapeutic products directorate at Health Canada. If these post-marketing trials do not provide sufficient evidence of clinical benefit, the notice of compliance with conditions could be revoked and products removed from the market. Health Canada will also issue a notice of compliance with conditions for a new indication for an existing product.

Since this policy was adopted in 1998, Health Canada has issued a total of 60 notices of compliance with conditions for either new active substances—these are molecules that have never before been marketed in Canada—or new indications for existing drugs. Out of these 60, seven were either revoked, suspended, not fulfilled, or removed, which leaves 53. Out of those 53, 28 have been fulfilled and 25 have yet to be fulfilled.

A table that I've provided in this brief shows that it took six years for four or more of these 28 to be fulfilled, and of the 25 that have yet to be fulfilled, 15 have been on the market for more than six years. Some have been on the market for as long as 12 years, which means that these drugs are being prescribed by doctors, being taken by patients, and nobody really knows either how well they work, or if they work at all.

Health Canada provides no information that's publicly available as to the status of the clinical trials that are supposed to be undertaken to fulfill the conditions for which these products were licensed.

The second topic is trials funded by drug companies. About 80% of all clinical trials are funded by pharmaceutical companies.

I recently participated in a Cochrane Collaboration review that looked at the results and conclusions of trials funded by drug companies and those that received their funding from other sources. Just as a brief bit of background, the Cochrane Collaboration is an independent, non-profit, non-governmental organization consisting of about 31,000 volunteers in more than 20 countries. It was formed to organize medical research information in a systematic way to facilitate the choices that health professionals, patients, policy-makers, and others face in health interventions according to the principles of evidence-based medicine.

Our review, which was published two years ago, found that studies that were sponsored by drug and device companies more often had favourable results and conclusions than those that were sponsored by any other source. The findings were consistent across a wide range of diseases and treatments. Specifically, we found that if a study was sponsored by a company, the results were 2.15 times more likely to be positive and the conclusions 2.67 times more likely to be positive than if any other source—charities, hospitals, universities, CIHR—had funded the trials. This indicates that the mere fact that drug companies are sponsors of the trials creates a bias that they're likely to be positive. If the committee wants a copy of this review, I'd be happy to provide an electronic copy.

Finally, with regard to the summary basis of decision documents, this is an initiative that Health Canada started as of January 1, 2005. This is a document that's issued after a new drug or medical device is approved, and it explains the scientific and benefit-risk information that was considered prior to approving the product. Of particular interest to people like me, who are health care professionals, is the section of the summary basis of decision document that contains a description of the pre-market clinical trials that were examined by Health Canada and a summary of the final risk-benefit assessment of the product. Health Canada's position is that as a result of the summary basis of decision documents, Canadian health care professionals and patients will have more information at their disposal to support informed treatment choices.

Recently a graduate student of mine and I examined all 161 summary basis of decision documents that looked at a total of 456 clinical trials that Health Canada had examined between January 1, 2005, and the end of April 2012. We looked particularly at the information that was disclosed about the safety and efficacy of the drugs. We were interested in information about the characteristics of the patients who participated in the trials and about the risks and benefits of the drugs.

For the characteristics of the patients, we looked at information about age, sex, whether the patients were in hospital or were outpatients, and how the patients were chosen for inclusion in the trial.

For the risks and benefits of the drugs, we looked at information about how long the study ran, the statistical significance of the results, whether the drug was compared to a placebo or another drug, what percentage of patients withdrew from the trial, and if there was any difference between the withdrawal rates for people who were taking the new drug and the withdrawal rates for people who were taking either the placebo or the comparator drug.

Here are some of the results we found. The number of summary basis of decision documents that fully reported on the sex of the patient was 32 out of 161. The number of documents that fully reported on the age of the patients was 53 out of 161.

The number of documents that reported on how long the trials ran was 90 out of 161. The number of documents that reported on how many people withdrew from the trials was four out of 157. Four of the documents couldn't be analyzed for this issue. The number of documents that fully reported on differences between withdrawal rates for people taking the new drug and people who were taking either the placebo or the comparator drug was one out of 154.

Our conclusions were:

Overall, clinical trial information in SBDs is presented in a haphazard manner, with no apparent method to its presentation....at least one-third of the potential information about patient trial characteristics and the benefits and risks of tested treatments is missing.

I would be happy to provide an electronic copy of this study to the committee.

Based on the foregoing information, I have two recommendations for changes in Bill C-17.

First, if Health Canada requires post-market trials for drugs, then it has to report on a regular basis, probably annually, on the status of those trials. For instance, are they delayed, and if so why? When are they expected to start? Are they in progress, and when are they expected to be completed? If they are completed, what were the results?

Second, Health Canada should ensure that all of the results of clinical trials dealing with the safety and efficacy of a new drug are made publicly available within one year of completion of the trial, after they have redacted any information that might identify any individual patients.

Finally, I think that Health Canada needs to institute a mechanism of separating the funding of any post-market study from the conduct of the trial. What I'm suggesting is that the company that has committed to undertake the trial give the money to do that trial to CIHR. CIHR would then select the researchers, who would design and undertake the trial; those researchers would analyze the results of the trial independent of the company, and the results of the trials would be made public.

Thank you very much for listening to me.

[The Chair, Conservative, Ben Lobb]

Thank you very much, Doctor.

Next up we have as an individual Elaine Gibson.

Go ahead, for 10 minutes.

[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.

[The Chair, Conservative, Ben Lobb]

Thank you, very much. Thank you.

Next up, we have Mr. Herder.

Go ahead, sir, for 10 minutes.

[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.

[The Chair, Conservative, Ben Lobb]

Thank you very much.

The final presentation for the morning is from Ms. Hyland. Go ahead. You have 10 minutes.

[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.

[The Chair, Conservative, Ben Lobb]

Ms. Gibson, you indicated that you have to leave at 20 to, or a quarter to. Is that right?

[Prof. Elaine Gibson]

I'll probably leave at five to 10:00.

[The Chair, Conservative, Ben Lobb]

I say that, so that if anybody has specific questions for you, they direct them to you before you go. I'm not trying to tell anybody who to ask questions to though.

Ms. Davies, you have seven minutes.

[Libby Davies, NDP, Vancouver East, BC]

Thank you very much, Chairperson, and thank you to all of the witnesses for being here today. You're clearly experts in the field and it's much appreciated that you've been so specific today.

I think that there's strong support for this bill from all parties. It's very unfortunate, though, that it's being jammed through at the last minute. We've had something like 45 witnesses who have been asked to appear. Last Thursday, we heard from the government officials. Today, we're hearing from the five of you. We'll hear from some more witnesses on Thursday and then we're into clause-by-clause on Monday. I think what is important is that we get this bill right. We take a good proposition and we try to make it the best that we can make it. You've given us some very specific suggestions. I think it's very unfortunate that we won't get to hear most of the witnesses who want to be heard on this bill.

The bill sat around for six months because the government didn't call it. Now, at the eleventh hour, there's a crisis and it has to be rushed through. I want to get that on the public record because I think it's very disturbing.

In terms of the testimony that you've given I want to clarify a couple of things.

Janice, you made a number of points and you mentioned that the independent appraisal of all clinical trial data was important and that it should be independent.

Joel, you also suggested that the pharmaceutical companies should pay for the independent trials so as to separate the money from whoever does the trial. I want to understand whether the two of you are talking about the same thing or whether you're actually talking about separate things. Could you address that?

Matthew, you made some specific recommendations that were very helpful. One that hasn't received a lot of attention is the issue of deleting—I forget the clause number—the clause that deals with the trade agreements overriding this bill. I'd like you to spell that out a bit more. As I understand it, from what you're saying, if we have transparency in this bill and if it came down to a trade agreement that had privacy over the intellectual property rights with some of these drugs, then the trade agreement would overtake this bill and the transparency wouldn't exist. I want you to clarify what you're saying.

Would any of you care to address whether or not you think this bill should be broadened to include natural health products? We've received a whack of emails from people who think that should be the case. We did talk to the Minister about it and she said that natural health products are considered to be a much lower risk. In terms of what we're dealing with in this bill I think that seems to be a reasonable assumption. I would like to get your take on it because you are experts on drug safety. Do you think, at this point, we should contemplate whether or not natural health products should be included?

I know there are a lot of points. I'd appreciate it if Joel, Matthew, and Elaine would comment.

[Dr. Joel Lexchin]

I can start with the points about independent evaluation.

First of all, there are my suggestions about who does the trials, who analyzes them, and whether or not these are the trials that would be required. The second point about independent analysis is that, even with all of the best intentions, people make mistakes when they're analyzing trials. Health Canada does. Independent researchers do. I think you need full disclosure, as was said, of the clinical trial reports. Once a drug is on the market, people can go back to that kind of information, look at it, and see whether or not they think that the right decisions were made. Perhaps they could analyze that information in different ways and point out things that weren't apparent to the people who initially did the analysis.

I think these two things are complementary.

[Prof. Janice E. Graham]

I can speak to this, if I may. Yes, I agree with Joel that they're complementary. In what I presented, I was really focusing on independent appraisal by people not involved at all in the clinical trial and people who weren't necessarily government regulators. At the same time, I would absolutely reinforce and agree with what Joel is suggesting.

I am on the record as saying this for about 10 years. In Canada, everywhere, it would be ideal if industry would give over the money they're spending on trials—which they partially give to academic researchers—and instead give that money to a completely independent source, like perhaps CIHR, who could then determine who could do these trials, so that the clinical researchers are not going cap in hand to industry to conduct the trials for them.

[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.

[Prof. Elaine Gibson]

I will address your last question on natural health products.

[The Chair, Conservative, Ben Lobb]

Can you put it in about 20 seconds? We're way over time.

[Prof. Elaine Gibson]

No, don't include natural health products.

[The Chair, Conservative, Ben Lobb]

Okay.