Evidence of meeting #34 for Health in the 41st Parliament, 2nd Session. (The original version is on Parliament’s site.) The winning word was clause.

A recording is available from Parliament.

On the agenda

MPs speaking

Also speaking

Jim Keon  President, Canadian Generic Pharmaceutical Association
Walter Robinson  Vice-President, Government Affairs, Canada's Research-Based Pharmaceutical Companies (Rx & D)
Nancy Abbey  Executive Director, Reuse of Single-Use Devices Task Force, MEDEC - Canada’s Medical Technology Companies
Keith McIntosh  Senior Director, Scientific and Regulatory Affairs, Canada's Research-Based Pharmaceutical Companies (Rx & D)
Linda Wilhelm  Chair, Operations Committee, Best Medicines Coalition
Jeff Morrison  Director, Government Relations and Public Affairs, Canadian Pharmacists Association
Helen Long  President, Canadian Health Food Association
Barry Power  Pharmacy Consultant, Canadian Pharmacists Association
David Lee  Director, Office of Legislative and Regulatory Modernization, Policy, Planning and International Affairs Directorate, Health Products and Food Branch, Department of Health
Supriya Sharma  Acting Associate Assistant Deputy Minister, Health Products and Food Branch, Department of Health
Philippe Méla  Procedural Clerk
David Edwards  Senior Counsel, Legal Services Unit--Health Canada, Department of Justice

9:30 a.m.

Conservative

The Chair Conservative Ben Lobb

Just give a brief response, and then we're over time.

9:35 a.m.

Senior Director, Scientific and Regulatory Affairs, Canada's Research-Based Pharmaceutical Companies (Rx & D)

Keith McIntosh

I think that point 8 font size is a very important question, and we have supported plain—

9:35 a.m.

Conservative

Terence Young Conservative Oakville, ON

It's on the label, but you know doctors don't read them.

9:35 a.m.

Conservative

The Chair Conservative Ben Lobb

Okay, thank you very much.

Next up is Mr. Morin.

You're ready to go, sir.

9:35 a.m.

NDP

Dany Morin NDP Chicoutimi—Le Fjord, QC

Thank you, Mr. Chair.

My first question goes to Mr. Robinson.

To what extent do pharmaceutical companies conduct safety trials once the medications have been approved for the market? In your opinion, do the new clauses in this bill encourage that kind of regular study after a medication is on the market?

9:35 a.m.

Vice-President, Government Affairs, Canada's Research-Based Pharmaceutical Companies (Rx & D)

Walter Robinson

There are trials during and after a drug's lifecycle. Before it is put on the market, during the clinical trials, there is a safety program. There is—

real world evidence that we collect,

Those are the requirements of regulatory bodies like Health Canada or the FDA. After the end of a drug's lifecycle, we have to keep providing information that it is not harmful for 25, 30 and even 50 years. We exchange all the details with Health Canada and other public bodies. It is important to mention that a drug's profile can change over time because of its use in clinical situations.

Mr. Lexchin did not criticize our industry, but he did mention a very important point. Let me give you one example. A product is approved by Health Canada and goes onto the market. It is well used clinically and works very well for the patients. However, as Mr. Young well knows, after five or six years, a new drug or natural product may appear on the market and is contraindicated because of its interactions with the drug already on the market. There can be adverse effects because of that contraindication. We have to keep providing all those details.

As we mentioned in our remarks, the dialogue with Health Canada and the manufacturers must be enhanced when a case of adverse effects is reported by a hospital or another clinical institution.

9:35 a.m.

NDP

Dany Morin NDP Chicoutimi—Le Fjord, QC

When a drug has been approved by Health Canada, when preauthorization trials have been done and it is being sold on the market, do pharmaceutical companies continue to conduct studies on the drug, or do they wait until adverse effects have been reported by the public before more investigation is done?

9:35 a.m.

Vice-President, Government Affairs, Canada's Research-Based Pharmaceutical Companies (Rx & D)

Walter Robinson

Yes. Both. Under the legislation, Canada's Medical Technology Companies and the Canadian Generic Pharmaceutical Association are required to do that.

Let me continue in English.

By law, we've always been required to report adverse events. We have safety studies in the clinical phase and in the regulatory approval phase. We follow good clinical practices and good research practices. Health Canada and the FDA have reciprocal abilities to do good manufacturing inspections of our facilities. Then, in a post-approval world, we have adverse event reporting, risk management plans that continue to be updated, post-market surveillance that either the manufacturers undertake on their accord or regulators order—they both work—and label updates and safety communication, which are some of the things we've already pointed to.

9:35 a.m.

NDP

Dany Morin NDP Chicoutimi—Le Fjord, QC

We have talked about the general situation in the pharmaceutical industry. However, in your opinion, are there pharmaceutical companies that neglect to conduct long-term studies after a product is on the market? If the answer is that, unfortunately, some companies do the bare minimum in that regard, do you believe that Health Canada's requirements should be a little higher as a result?

9:40 a.m.

Senior Director, Scientific and Regulatory Affairs, Canada's Research-Based Pharmaceutical Companies (Rx & D)

Keith McIntosh

I think the important point here is that, as I think you said, the standards do need to be high, and they need to be to the highest standard internationally. On good manufacturing processes, we've been working with Health Canada to make sure that documentation and inspections for products that come into Canada are of the highest quality and to make sure that their systems are effective to make sure that's the case.

Certainly we expect and we hope that...and we work with Health Canada to ensure that for the review mechanisms as well the highest standards are met.

9:40 a.m.

Conservative

The Chair Conservative Ben Lobb

Thank you very much.

Mr. Lunney, you have about four minutes.

June 12th, 2014 / 9:40 a.m.

Conservative

James Lunney Conservative Nanaimo—Alberni, BC

Thanks very much, Mr. Chair.

Mr. Robinson, we talked briefly about the situation with proton pump inhibitors, common acid-suppressing drugs, that have been clearly linked to a hospital infection called Clostridium difficile. The risk has increased on the order of 40% to 275%.

Now, that information wasn't available when these products were approved, but over 20 years research has been accumulating. It was at least 10 years ago, when the first evidence came out in Montreal, which was considered the epicentre for this new infection, that I started raising questions with then Minister of Health Ujjal Dosanjh.

In terms of the risk of infection, we now know, through further studies, that people on those medications have not only an increased risk of infection of 40% to 275%; among those infected, they also have an increased risk of the worst complications, about 300%. They also have an increased risk of death, about 500%.

When I asked that question of the Honourable Ujjal Dosanjh in 2005, Health Canada contacted your member companies, four of which produce PPIs, although there may be more by now. The response I got back was that they weren't aware of any connection between their products and hospital infections.

Can you provide any evidence, since I know you're aware of this issue, that any of your member companies actually did any research to establish, voluntarily, whether there was a connection between acid suppression and hospital-based infections? That's 1,400 deaths a year currently; so over 10 years, at least 14,000 Canadians have perished, with hundreds of millions of dollars expended in hospital costs.

9:40 a.m.

Vice-President, Government Affairs, Canada's Research-Based Pharmaceutical Companies (Rx & D)

Walter Robinson

Through you, Mr. Chair, to Dr. Lunney, as we had a conversation earlier, I won't speak to specific products, but the therapeutic class I know very well. I take two PPIs a day for a hiatus hernia, because they are avoiding an unnecessary and invasive surgical procedure that is 50% effective, not 100% effective.

In the context of coming back to my earlier testimony with respect to the changing safety profile of the medication, which is right at the heart of your question, I do not know of any studies that may or may not have been undertaken. Those questions would be best addressed to the member companies.

I do know as well, though, that C. difficile and MRSA, another of these hospital-borne and very antibiotic-resistant infections, are a key issue occupying health care institutions and health integration networks. Several of our member companies are pursuing vaccines.

Perhaps Keith could speak a little more to the science around that.

9:40 a.m.

Conservative

James Lunney Conservative Nanaimo—Alberni, BC

Before you do I would like to say that perhaps unlike you, who may be one of the 30% who should be taking them, there is compelling evidence that at least 60% to 70% of the patients taking them should not be taking them for just GERD, or esophageal reflux.

9:40 a.m.

Vice-President, Government Affairs, Canada's Research-Based Pharmaceutical Companies (Rx & D)

Walter Robinson

Many of those products are now in the generic realm and have lost their market exclusivity, which comes back to the point that I made earlier in my testimony. It is about how we're in a continuum here of health care of proper diagnosis, appropriate prescribing, optimal use, real-world surveillance, and measuring outcomes to move us back to a virtuous circle of medicine—which you know well as a physician—back to proper education and diagnosis. I think we all have a role to play there.

9:40 a.m.

Conservative

James Lunney Conservative Nanaimo—Alberni, BC

Thank you.

9:40 a.m.

Conservative

The Chair Conservative Ben Lobb

Thank you very much.

I want to thank all our guests here for our first hour.

We're going to suspend for a minute to bring on our next panel. We'll just keep moving right along.

Thank you very much for taking the time.

9:40 a.m.

Conservative

The Chair Conservative Ben Lobb

Welcome back, ladies and gentlemen.

We're in the second hour of our meeting here. We have Linda Wilhelm by video conference. We'll do a technology check here.

Can you hear us okay, Linda?

9:40 a.m.

Linda Wilhelm Chair, Operations Committee, Best Medicines Coalition

I can hear you. Wonderful.

9:40 a.m.

Conservative

The Chair Conservative Ben Lobb

We can hear you too. That's good.

9:40 a.m.

Chair, Operations Committee, Best Medicines Coalition

Linda Wilhelm

I can hear you just fine.

9:40 a.m.

Conservative

The Chair Conservative Ben Lobb

We'll get right into it. Seeing as how we always like to test our technology first, you're first up by default. You have 10 minutes to present. Go ahead, and welcome.

9:40 a.m.

Chair, Operations Committee, Best Medicines Coalition

Linda Wilhelm

I want to thank the committee for having me and for including patients in the review and discussion on this legislation. I'm representing the Best Medicines Coalition, which is a national alliance of patient organizations. We're very interested in health policy and involving patients in the development of health policy, and our focus has been primarily around pharmaceutical issues in Canada. We try to make sure the patient voice is heard and listened to. I am a member of our board and I'm also a past chair of the organization. I'm also president of the Canadian Arthritis Patient Alliance, which is a national organization of arthritis patients from across the country.

We've been working with Health Canada for a number of years on developing this legislation. We think it's very important for patients, and BMC and CAPA are very supportive of this legislation.

I've been living with rheumatoid arthritis for almost 40 years, and part of living with this disease day to day is taking medications. Throughout the years there have been issues around some of our medications, and we've always had discussions with Health Canada about the limitations they have right now when there is an issue with a drug. The biggest example I can think of is Vioxx and all the issues around that. Vioxx was a drug that many patients benefited from. When there were issues with it, it was withdrawn. As somebody living with inflammatory arthritis, I can tell you we take far more dangerous drugs than Vioxx on a daily basis. Patients lost access to this drug. Had Health Canada had the powers that this bill will give them, patients who knew the risks and benefits and the possible uncertainties around Vioxx would still have access to the drug, and those who shouldn't be taking it would not have access to it.

As I said, we've been closely involved with Health Canada for a number of years on the consultation end of this legislation and everything it entails. I'd like to give credit to them for including all the stakeholders in this and listening to everybody's perspective, which, at times, surely got messy. Again, the Best Medicines Coalition and the patients I represent support this legislation under which Health Canada can have a regulatory framework that's modernized, and not operate under the constraints of legislation that was developed almost 40 or 50 years ago. We need to have better post-market surveillance in Canada. Health Canada has made great strides in the last number of years with MedEffect and with some of its initiatives, but they need to be able to get information when they need it and not be under the constraints they are currently working under.

We really believe this legislation is long overdue and very important for patient safety going forward. It's very important to involve patients, as has been done with this, to hear the broader perspective that we can bring to the table as people who actually have to put these drugs into our bodies to be able to live a healthy life.

We look forward to continuing to work with Health Canada going forward. Again, this is very important in the future for patients and post-market surveillance.

That's really all I have to say.

9:50 a.m.

Conservative

The Chair Conservative Ben Lobb

Well, thank you very much. That's great.

Next up, from the Canadian Pharmacists Association, we have Jeff Morrison and Barry Power. Go ahead.

9:50 a.m.

Jeff Morrison Director, Government Relations and Public Affairs, Canadian Pharmacists Association

Thank you, Mr. Chair, and good morning to the committee. Thank you to the Standing Committee on Health for the invitation to appear this morning. My name is Jeff Morrison. I'm director of government relations and public affairs with the Canadian Pharmacists Association. With me—I'm very happy—is Barry Power, a pharmacy consultant with CPhA, an adjunct assistant professor at the school of pharmacy with the University of Waterloo, and a pharmacist himself.

As you know, CPhA is the national association representing the pharmacist profession in Canada.

Drug safety is a priority for the Canadian Pharmacists Association and for all pharmacists in Canada. Although it is not possible to completely eliminate all risks associated with the use of prescription drugs, pharmacists spend a lot of time counselling patients on the appropriate and safe use of the drugs they are taking. That is why the CPhA supported the general spirit and thrust of Bill C-17, Vanessa's Law, when it was introduced by the minister in December 2013.

In particular, the CPhA supports the bill's intent to increase penalties for unsafe products and to provide Health Canada with new powers to recall unsafe products and to compel companies to do further testing on a product when issues are identified with certain at-risk populations, as well as the requirement for drug companies to revise labels to clearly reflect health risk information, including potential updates for health warnings for children.

However, there are some concerns and outstanding questions we have with regard to the bill. Although these questions and concerns may be addressed during the regulatory development process, we still wish to raise them with the committee this morning.

First, the bill provides a blanket exemption for natural health products. As NHPs are medicinal products and have the ability to cause harm, and given that Health Canada and several provinces state that between 60% to 70% of therapeutic products consumed by Canadians are in fact NHPs, the CPhA feels that NHPs should be included within the scope of the bill.

Second, the bill mandates the need for adverse drug reporting by stating the following, which I'm sure you know:

A prescribed health care institution shall provide the Minister, within the prescribed time and in the prescribed manner, with prescribed information that is in its control about a serious adverse drug reaction that involves a therapeutic product or a medical device incident that involves a therapeutic product.

However, this clause raises several questions that frankly the bill doesn't clarify.

For example, what is a prescribed health care institution? Is a pharmacy a health care institution? Will the downtown community health centre, of which I was the president, be considered a health care institution?

It would be helpful to specify the definition of a prescribed health care institution that is required to provide information.

Also, what is a serious adverse drug reaction? How is that to be defined? For example, is it necessary to report a well-known but serious reaction? All health care professionals know of many of the serious adverse reactions caused by chemotherapy, for example, during cancer treatment. Would they be expected to report these? Where do we draw the line between what is to be reported and what is considered well-established fact? Again, clarification within the bill would be useful.

Also, what will happen with this information? Will it be analyzed? Will all the information that is reported be made publicly available? If so, how so? As pharmacists we believe that Health Canada should be transparent in the provision and aggregation of the information it receives from this mandatory reporting, but at present, the legislation as written is unclear on whether this information will be properly analyzed and shared with health practitioners and with Canadians.

The same issue regarding transparency can also be applied to the bill's requirement that the minister may order the manufacturer to conduct additional assessments and tests of a questionable product or drug in regard to health and safety. The legislation states that the results of these tests will be provided to the minister. However, there is no allowance currently in the bill for providing that information more publicly, including to pharmacists, other practitioners, and Canadians. As you can probably guess, we feel it should.

Last, the bill also states that this reporting requirement “shall take into account existing information management systems, with a view to not recommending the making of regulations that would impose unnecessary administrative burdens”. However, this clause would appear to be at odds with the reality of the situation on the ground.

By its inclusion in the bill, the requirement for prescribed health care institutions to report adverse drug reactions will impose additional administrative burdens. Although technological solutions can and should help, the fact remains that additional human resources will be required to collect and provide this data. If the definition of prescribed health care institution is broad in scope—as I mentioned earlier, we don't have that—then the administrative requirements will likely increase. As a result, we're uncertain about how the bill can reconcile what would appear to be two contradictory goals of, on the one hand, increasing reporting, but on the other hand, without imposing administrative burdens.

In short, Mr. Chair, the Canadian Pharmacists Association is very supportive of Bill C-17. Given pharmacists' preoccupation with safe and effective use of medications, the CPhA believes the legislation is a step in the right direction. However, as I've outlined, we feel that there are clauses within the bill that could benefit from greater clarity and certainty in terms of how they will be applied.

Thank you, Mr. Chair.

We are ready to answer the committee's questions.