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.

[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.

[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.

[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]

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?

Business of the House

[Peter Van Loan, Conservative, Leader of the Government in the House of Commons]

Mr. Speaker, I will start with the concept of the very strange proposition put forward by my friend. He uses this concept of shifts and believes there is some perverse obligation on the part of the government that, if the opposition wishes to filibuster the production of new laws and delay their production, we somehow have an obligation to match them step for step in extending that process. His comparison is with ordinary Canadians. He said that ordinary Canadians should not produce a product at the end of the day at work; they should take two, three, or four days to get the same thing made. That is his idea of getting things done. That is his idea of how ordinary Canadians can work. I think that says something about the culture of the NDP and the hon. member. I will let members guess what culture that is. It is a culture that does say we should take two or three times longer to get something done or to get to our destination than we possibly can.

We on this side are happy to make decisions to get things done for Canadians. In fact, that is exactly what we have been doing. Since I last rose in response to a Thursday question, the House has accomplished a lot, thanks to our government's plan to work a little overtime this spring.

I know the House leader of the official opposition boasts that the New Democrats are happy to work hard, but let us take a look at what his party's deputy leader had to say on CTV last night. The hon. member for Halifax was asked why the NDP agreed to work until midnight. She confessed, “We didn't agree to do it.” She then lamented, “We are going from topic to topic. We are doing votes. We are at committees. They are really intense days. We're sitting until midnight.”

On that part, I could not agree more with the deputy leader of the NDP, believe it or not, but with much more cheer in my voice when I say those words, because we think it is a good thing. These are intense days. We are actually getting things done. We are actually voting on things. We are actually getting things through committee. For once, we are going from topic to topic in the run of the day.

Let me review for the House just how many topics, votes, and committee accomplishments we have addressed since the government asked the House to roll up its sleeves.

Bill C-24, the strengthening Canadian citizenship act, was passed at second reading and has even been reported back from the citizenship committee.

Bill C-10, the tackling contraband tobacco act, was concurred in at report stage and later passed at third reading.

Bill C-31, the economic action plan 2014 act, no. 1, was reported back from the finance committee.

Bill C-27, the veterans hiring act, was passed at second reading.

Bill C-20, the Canada-Honduras economic growth and prosperity act, was concurred in at report stage.

On the private members' business front we saw:

Bill C-555, from the hon. members for West Nova in support of the seal hunt, was passed at second reading.

Bill C-483, from my hon. colleague, the member for Oxford, cracking down on prisoners' escorted temporary absences was passed at third reading.

Bill C-479, from the hon. member for Ancaster—Dundas—Flamborough—Westdale, on improving the place of victims in our justice system was passed at third reading last night.

Progress is not limited to Conservative initiatives. The Green Party leader's Bill C-442, respecting a Lyme disease strategy, was reported back from committee yesterday.

The hon. member for Timmins—James Bay saw a motion on palliative care pass.

We have also seen countless reports from committees reviewing the government's spending plans, as well as topics of importance to those committees.

This morning we even ratified the appointment of an officer of Parliament.

Finally, I do want to reflect on the accomplishment of Bill C-17, the protecting Canadians from unsafe drugs act (Vanessa's law), which members may recall me discussing in last week's Thursday statement. It finally passed at second reading. However, this did not happen until the NDP relented and changed its tune to allow the bill to go to committee. It was the first time ever that we had an expression from the New Democrats when we gave notice of intention to allocate time in which they said, “We don't need that time; we're actually prepared to allow a bill to advance to the next stage”. I think, by reflecting on the fact that those dozens of other times the NDP did not take that step, we could understand that they did not want to see a bill advance; they did not want to see progress made. That lets Canadians understand quite clearly why it is we need to use scheduling and time allocation as a device to get things done in the face of a group that thinks the objective is to fill up all possible time available with words rather than actual votes and getting things done.

It is clear that our approach is working. We are getting things done in the House of Commons and delivering results for Canadians.

Perhaps I might be overly inspired by the example of Vanessa’s Law, but I do want to draw the attention of the House to Bill C-32, the Victims Bill of Rights Act.

So far, we have seen three days of debate on second reading of the bill, but “debate” is actually not accurate. What we have witnessed is speech, after speech, after speech—most of them from New Democrats—offering platitudes of support for the idea of getting that bill to a committee where it could be studied. What I want to know is, why will they not just let it happen? Victims of crime want to see meaningful action, not just kind words.

Suffice it to say that I will need to schedule additional time for discussion of this bill. Perhaps the NDP will let it pass after a fourth day of talk.

This afternoon, we will continue with the report stage debate on Bill C-31, our budget implementation bill. When that concludes, we will turn to Bill C-20, to implement our free trade agreement with Honduras, at third reading. If time permits, we will continue the third reading debate on Bill C-3, the Safeguarding Canada's Seas and Skies Act.

Tomorrow morning, we will start the report stage debate on Bill C-24, which makes the first modernization of the Citizenship Act in 35 years. After question period, I will call Bill C-32, the Victims Bill of Rights Act, to see if the NDP is ready to deliver results, not talk.

Monday morning, we will continue the third reading debate on Bill C-20, if more time is needed, and then resume the second reading debate on Bill C-18, the Agricultural Growth Act. After question period, we will get back to the Strengthening Canadian Citizenship Act.

Tuesday shall be the eighth allotted day when the NDP will have a chance to talk, and talk, about a topic of their own choosing. At the end of the night, we will have a number of important votes on approving the funds required for government programs and services and pass two bills to that end.

On Wednesday, we will debate our budget bill at third reading, and then we will start the second reading debate on Bill C-36, the Protection of Communities and Exploited Persons Act, which my seatmate, the Minister of Justice, tabled yesterday.

We will continue the debates on Bill C-36 and Bill C-24, if extra time is needed, on Thursday. After those have finished, and on Friday, we will resume the uncompleted debates on Bill C-3, the Safeguarding Canada's Seas and Skies Act, at third reading; Bill C-6, the Prohibiting Cluster Munitions Act, at report stage; Bill C-8, the Combating Counterfeit Products Act, at third reading; Bill C-18, the Agricultural Growth Act, at second reading; Bill C-26, the Tougher Penalties for Child Predators Act, at second reading; Bill C-32, the Victims Bill of Rights Act, at second reading; and Bill C-35, the Justice for Animals in Service Act (Quanto's Law), at second reading.

To make a long story short, we have accomplished much in the House over the last week, but we still have much left to do, which inspires me to note that in the week ahead I have to take my automobile in for maintenance. At that time, when I take it to the dealership, I hope one person will work on it for an hour, get the job done, and then return it to me at a reasonable cost. I do hope I am not told, “There are still many more employees who have not had a chance to have a shift working on your car as well, so we are going to keep it here another three days and give everybody a turn to work on your car.” I hope the dealership will do as Conservatives do: get the job done and then deliver me the product.

Health

[Terence Young, Conservative, Oakville, ON]

Mr. Speaker, this morning I was pleased to take part in the beginning of the health committee study of Bill C-17, Vanessa's law.

I was pleased that we could get the study under way and would like to thank the NDP members for finally conceding to allow the bill to be referred for study after their initial attempts to slow its progress through this House.

To ensure that the official opposition remains mindful of the importance of this legislation, I would ask the Minister of Health to please inform the House, once again, about the important measures that it contains to protect the health and safety of Canadians.

[James Lunney, Conservative, Nanaimo—Alberni, BC]

Thank you, Minister and officials, for being with us today.

Minister, I think a lot of people would be surprised to learn from your earlier remarks that it's been nearly 50 years since patient safety legislation has been significantly updated. This seems to be a worldwide phenomenon that there are great gaps in the information on safety and effectiveness of drugs used in real-world settings. More information is needed on the safety and effectiveness of pharmaceuticals when used by the diverse patient populations, and outside the controlled, experimental environment of clinical trials.

I was wondering if you would be able to elaborate for the committee on how Health Canada currently undertakes post-market surveillance activities. What kind of improvements are here in Bill C-17, in Vanessa's law?

[Anne Lamar]

In reference to the AG report from 2011, obviously, Health Canada took those recommendations very seriously. We've completed, actually, the majority of the action items that were recommended. We can certainly provide more follow-up details to the committee on that.

I think that what is being proposed in Bill C-17 is actually completely in line with the OAG report. In fact, we have already started, as the minister alluded to, to move some of our priorities, change the way we are doing our business. I referred to some of the efficiencies that we find around electronic reporting, with large IT systems that help us to manage that information.

You also referenced a time lag in terms of information coming in and being able to provide a signal assessment. Again, that will be enabled and be even stronger with new systems. I think as well with the fact that we won't need to be negotiating on some of the authorities like recall, for example, where it does take more time for us to get information out to the public, we will see ourselves saving time in that regard. Our capacity to communicate, to take that information and communicate it externally to Canadians, to pharmacists, to practitioners who need it, I think will clearly be enabled.

[Rona Ambrose, Conservative, Edmonton—Spruce Grove, AB]

When Vanessa's law was introduced, I did have high hopes for its quick passage, given the support that it received by all parties in the Commons. I know you yourself said that it was a step in the right direction. I also received correspondence from several members, from all parties, who believe that this is a very important bill and urged me to secure passage of Bill C-17, which is Vanessa's law, as quickly as possible.

We did work in that direction. I will simply say that sometimes the work we do is caught up by.... The House leaders do the work that they do. I will just say at this point that, yes, there were exchanges between House leaders as to when this bill should move forward. I'll just leave it at the fact that I'm glad that we have now seen the bill unanimously supported by all parties to move to committee. I'm glad to see that happen.

[The Chair, Conservative, Ben Lobb]

Good morning, ladies and gentlemen. Welcome and thank you for coming to the committee meeting this morning.

We're studying Bill C-17. We have the minister and officials with us. The minister will be with us for the first hour and then we'll continue on with the officials. If we have 15 minutes for committee business at the end, we'll do that.

Welcome, Minister. Welcome, officials. We'll allow you to start. You have 10 minutes or thereabouts for your opening remarks and then we'll go into our rounds of questions.

Time Allocation for Vanessa's Law

[Peter Van Loan, Conservative, Leader of the Government in the House of Commons]

Mr. Speaker, I am rising in relation to the point of order raised by the hon. House leader of the official opposition made on Friday afternoon.

I was quite prepared to see the House advance Bill C-17. I was prepared to leave it at that and take the victory for what it was and move on. However, since the hon. member for Burnaby—New Westminster confirmed at that time that he wished to continue with his point of order, I do want to supplement my hon. friend's intervention on it.

First, I did want to make the point that the NDP House leader told the House that the hon. member for Oakville made comments in the House “with the government leader's full endorsement and encouragement”. I appreciate my counterpart's sense that my powers are all-seeing, all-knowing, and all-powerful. However, I can assure the House that in this case my hon. friend from Oakville proceeded entirely on his own initiative in the comments on Bill C-17 that he made, as every MP has the right to do.

That being said, I do wish to congratulate the hon. member for Oakville for his very successful efforts. I am proud of him as a colleague for having taken the initiative, even if I cannot share in any credit or blame for his having done so. His persistence last week in seeing the bill through to committee clearly paid off, given that the NDP did change its tune late on Friday afternoon on this matter.

Turning to the substance of his point of order, the opposition House leader claims that the time allocation notice, which I gave on Thursday evening in relation to Bill C-17, the protecting Canadians from unsafe drugs act, should be rescinded because he alleges there were no consultations on the bill.

As the deputy government whip said on Friday, our party does not reveal the content of the discussions of the House leaders' meetings.

It is common knowledge around here that the recognized parties' House leaders and whips and their deputies and staff gather every Tuesday afternoon to discuss upcoming parliamentary business, along with the Clerk or her representative in attendance. Some weeks, such as last week, the House leaders will even gather for a second meeting. That is on top of the innumerable exchanges that take place by email, informal meetings, and phone conversations among these various actors.

Last week's House leaders' meeting would have been held on the heels of the NDP's Tuesday filibuster of Bill C-17, when it has been the expectation and hope of all other parties that the second reading debate would wind up that morning.

Astute observers of the business of the House would conclude that it was not in isolation that I gave time allocation notices on Thursday evening for Bills C-17 and C-27. Indeed, I only gave those notices once it had become obvious that no agreement for a time allocation motion under Standing Orders 78(1) or 78(2), let alone any other firm agreement, could be reached among the required parties with respect to those two bills.

I can absolutely assure the Speaker and the entire House that both myself and my staff did put proposals on Bill C-17 to the NDP House leader and his staff, both verbally and in writing, last week. I have no difficulty whatsoever in assuring the Speaker that the requirement for consultations contemplated in the standing orders was fulfilled.

As to what that requirement is, I would refer the House leader of the official opposition to a ruling of the Deputy Speaker on March 6, 2014, at page 3598 of the Debates, in response to a point of order raised by the previous NDP House leader, where he opened by making reference to page 667 of House of Commons Procedure and Practice, second edition:

This is what is required when one of these notices is brought forward:The notice in question is to state that the agreement could not be reached under the other provisions of the rule and that the government therefore intends to propose a motion...The hon. government House leader, when he rose in the House yesterday, preceded his presentation of the motion with the following words:

Mr. Speaker, I would like to advise that agreements could not be reached under the provisions of Standing Orders 78(1) or 78(2)...That is all that is required by the Standing Orders. The nature of the consultation, the quality of the consultation, and the quantity of the consultation is not something that the Chair will involve himself in. That has been the tradition of this House for many years. What the Chair would have to do, in effect, is conduct an extensive investigative inquiry into the nature of the consultation. That is not our role, nor do the rules require it. Therefore, I am rejecting the request for the point of order.

In this case, while I might welcome such an investigations and Canadians, I can assure the House, would be most interested in its findings and I would be most satisfied for them to receive those, I do also understand the policy rationale for not conducting them. That is a policy rationale of encouraging full-ranging negotiations without a concern for potential investigations like that.

Finally, I would like to note the significance of the point of order raised by the opposition House leader. He has, however, inadvertently, given Canadians an insight into how the NDP approaches the business of managing the progress of legislation in the House of Commons.

The NDP members make a great deal of fuss every time the government makes use of time allocation to ensure MPs can get to vote on a bill. The NDP members keep track of how often it happens and make a big deal about that statistic. I have been heard to remark myself that often they seem to enjoy compelling us to run up that statistic.

Why does that happen? The NDP has now finally told Canadians why it happens. In raising this point of order it has asked that a notice of time allocation be rescinded or withdrawn on the basis that it is not necessary. The NDP is prepared to allow the bill to advance. This is the very first time the NDP has done that, the very first time it has told the House that it is prepared to advance a bill and thus that a time allocation motion need not be moved. Never before, since this Parliament began, some three years ago, has it taken this step. Never on any of those many occasions when New Democrats stood up to denounce the use of the scheduling device of time allocation have they pre-empted that step with a statement that they are willing to advance a bill. This, however unintended by the NDP, has given Canadians a valuable insight into the approach of the NDP and why, as a result, the government makes use of the standing orders provisions to bring some certainty to the scheduling of debates and votes.

I hope, however, that this marks the beginning of a new approach by the NDP and not merely an unusual exception to the rule, brought on by the very effective comments of the hon. member for Oakville on the matter of Bill C-17.

I hope that we will see many more occasions where the NDP makes it clear that it is prepared to see a bill advance and, as such, resorting to Standing Order 73 is not required. There are several such notices on the order paper. I invite the NDP to advise the House which of those bills it is prepared to see advanced. Such a gesture would be welcome, and I am prepared to assure the House leader of the opposition it will be received in a non-partisan and co-operative manner.

Either way, I wish to thank the opposition House leader for having done a service in revealing to Canadians how it is that the NDP approaches debate in the House. This revelation will, I am sure, help to inform the views of all those who follow the work we do.

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

[Colin Carrie, Conservative, Parliamentary Secretary to the Minister of the Environment]

Mr. Speaker, following the comments of the opposition House leader, I hope that we can get unanimous consent for the following:

I move:

That, notwithstanding any Standing Order or usual practices of this House, Bill C-17, An Act to amend the Food and Drugs Act, be deemed to have been read a second time and referred to the Standing Committee on Health.

(Bill C–17. On the Order: Government Orders:)

May 27—Second reading and reference to the Standing Committee on Health of Bill C-17, An Act to amend the Food and Drugs Act—Minister of Health