Health Committee on April 29th, 2008

[Patrick Brown, Conservative, Barrie, ON]

One thing I read is that it will be a challenge if we have expectations that regulations can change to require physicians to take a different approach.

What approaches are realistic? One thing I heard from the CMA when they were here previously was that real-time access to health warnings is an issue. If they are sent by fax or mail there is a real-time difference in the sense that information doesn't get to physicians as fast as it could. We've heard that in some areas, such as in New Zealand, they utilize mobile devices to provide information and databases directly to physicians in an immediate manner. What are your thoughts on that? What could we do to enable physicians more efficiently?

[Tom Brogan]

How do we communicate adverse events to the physician?

[Patrick Brown, Conservative, Barrie, ON]

That's one angle, but it is also about tying them to a database so they can see a patient's history.

[Tom Brogan]

Let me deal with informing doctors. It's quite possible to know which doctors are prescribing which medications, so Health Canada wouldn't be beyond the pale. This might fall under provincial jurisdiction, so I want to be careful here. If a doctor is prescribing a fair amount of a drug that is found to be causing a lot of adverse events, those doctors could be targeted with messages. I believe that Health Canada and some private companies actually do that. How effectively they do it, I don't know.

As for information coming in the other direction, I think Mr. Ménard said it quite well. The choice for a doctor is either treating the patient or reporting the adverse event. From talking to doctors, given the work they have to do, it's very difficult for me to see how we could encourage them to report more frequently. It takes time away from their very busy practices and away from the patients, and it's not crystal clear. There is a fairly good website, if I understand correctly. There's the telephone.

One way that might be more practical would be to have the provincial agency or Health Canada, whichever has jurisdiction, contact doctors who are writing a lot of prescriptions for drugs at risk. That would be a relatively inexpensive way to do it. Ask them if they're getting adverse reactions.

[Patrick Brown, Conservative, Barrie, ON]

Ms. Wasylycia-Leis was commenting before about the nature of your database. I think you said that it was pretty significant in size, bigger than the NPDUIS database. I think it was mentioned on your website that this was data collected from nine or ten provinces and over 17 major drug program administrators. Could you maybe tell us about the size of your database and whether it's based on Canadian data only, or does it have some foreign data incorporated into it as well?

[Tom Brogan]

Our data comes from Canadian sources only. There are multiple levels of data. We get expenditure data from every province except Prince Edward Island, so we know how much a province has paid for each drug under the public drug benefit plan. That data's fine for looking at trends and spending on each individual drug and so on, but that's not really where the power of the research is.

The next level is where you have an anonymized patient code. They scramble the patient codes so no one can identify who the patient is. Every time they send us data, which is usually daily or weekly, it has the same patient code on it, so we can track people over time. You can see the dosage people are taking, which drugs they are taking, whether they are on more than one medication, and whether they have quit taking a medication. We get the same kind of information from about 5,000 or 6,000 pharmacies in Canada. That's the difference in the data.

We get those data for our analysis from two provinces, one federal organization, and just about every insurer in the country, and that's what the reports have been built upon.

[Patrick Brown, Conservative, Barrie, ON]

Previously today we heard some comments from Gerald Dal Pan from the U.S. Food and Drug Administration, and my colleague Ms. Davidson,asked about the life-cycle approach.

This is a general question to you and Mr. Ménard. What are your comments on the life-cycle approach? Is that a step in the right direction?

[Tom Brogan]

I believe that is the right track, yes, very definitely.

[The Chair, Conservative, Joy Smith]

Thank you, Mr. Brogan.

We're now going to go into our second round of five minutes each. We are very close on time, so we will start off with Mr. Temelkovski.

[Lui Temelkovski, Liberal, Oak Ridges—Markham, ON]

Thank you very much, Madam Chair.

Mr. Ménard, you mention in your presentation that when drugs are introduced into the marketplace, the drugs should be accompanied by a pouch with a phone number so people can call in adverse reactions. Did I hear you right, first and foremost?

[Jean-Pierre Ménard]

Yes. There's a package insert with each drug. It contains a description of the drug, specifies the risks involved, and provides certain indications. It is clear that under the statute and regulations, the manufacturer should be obliged to indicate to the user where to report any adverse effect. This would allow users to provide greater feedback. Therefore, those who believed, rightly or wrongly, that they experienced adverse effects could draw the attention of public authorities to this problem.

[Lui Temelkovski, Liberal, Oak Ridges—Markham, ON]

This phone number where it should be reported, would you be in agreement to have it reported to Health Canada, or should it be reported to the manufacturer of the drug?

[Jean-Pierre Ménard]

I think it must be reported to public authorities. Currently, under-reporting is said to be prevalent. The problem regarding post-market regulation is that expectations concerning self-regulation by pharmaceutical companies are much too high. Yet, through experience, we know that this mechanism works to a certain extent, but is very limited. In order to gain public trust, and guarantee accountability within the process, a neutral public authority must be responsible for regulation.

[Lui Temelkovski, Liberal, Oak Ridges—Markham, ON]

We agree so far. Once it is reported then to the public authority--to Health Canada--how do we engage the shareholders, the doctors, the pharmacists, the health professionals? How do we engage them to increase the reporting, or is it not necessary as long as it is quality reporting rather than quantitative reporting?

[Jean-Pierre Ménard]

I believe that quantity is just as important. With respect to reporting adverse drug reactions, we could opt for a highly elaborate formula that only a professional would be able to understand easily, but it would be preferable to adopt a rather simple process. If we are serious about prevention, we absolutely need a critical mass. In other words, out of 10 adverse drug reaction reports, two or three will be significant. Nonetheless, we cannot focus exclusively on the good, the strongest and the best. I think we need to invite ordinary people, especially professionals, to get involved in the process. Among other things, we have to dedicate ourselves to educating the public and professionals.

Even if this matter falls under provincial jurisdiction, professional associations also have a role in educating their members. In my opinion, people are receptive if they know that there's a purpose, and that things will be studied and analyzed. It is much easier to convince people when that is the case.

As we speak, some doctors who have filled out and sent in their reports say that they do not have the slightest idea of what happened next. We must make sense out of all this. It would be important for the message to be conveyed by the relevant public authority.

[Lui Temelkovski, Liberal, Oak Ridges—Markham, ON]

Public reporting is done on a small number; we've heard about 10%. Should we look at public reporting in other jurisdictions, such as other countries, and do you think that pharmaceutical companies that have that data should be obliged to share that information--that international experience--with local authorities?

[Jean-Pierre Ménard]

We did not identify any countries where adverse reactions were reported 100% of the time. The number of reports varies according to country, but rates never reach 90% or 95%. Rates are always lower. There are two schools of thought. Some say that even if we make reports mandatory, if there are no sanctions or consequences, this will mean that nothing will happen and people will not comply. It is tantamount to legislation being enacted and nothing being done to make sure that it is respected. Conversely, if an obligation is built into the law, this means that the issue is considered important, and by extension makes people's responsibility just as important. The person who holds such information and does not report it...

[The Chair, Conservative, Joy Smith]

Could you just sum up, Mr. Ménard?

[Jean-Pierre Ménard]

I believe that a public message can be sent through making such reports mandatory.

[The Chair, Conservative, Joy Smith]

Thank you, Mr. Ménard.

We'll go to Mr. Tilson.

[David Tilson, Conservative, Dufferin—Caledon, ON]

Monsieur Ménard, there is no statutory obligation for a doctor to report an adverse reaction. From your experience as counsel, what does case law say? What are the courts saying? In other words, there are lots of malpractice actions. I would expect that if a patient comes to see the doctor and says that he or she has had a reaction, and the doctor thinks that maybe it is genetics or maybe the person didn't follow a prescription or maybe it's all kinds of things, then maybe it's malpractice. My question to you is whether the courts have said that the doctor should have reported this and that this is part of a malpractice action. In turn, would that cause doctors to report all cases of adverse reactions?

[Jean-Pierre Ménard]

Firstly, there are laws that oblige doctors to indicate other things. For example, we have a law on youth protection, as well as a law on mandatory reporting. In Quebec, under the Health and Social Services Act, there's an obligation to declare all accidents or incidents. They are broader, but they are obligations nonetheless.

Legally speaking, we have, indeed, yet to find a ruling in case law that sanctions a doctor for not having made a report. Why? Because in civil litigation, it must be proven that a doctor made a mistake and that this mistake was harmful to the patient. Yet, when patients consult their doctor because they believe that they are having a bad reaction to a drug, the act of reporting or not reporting this incident—even if that in itself could constitute a breach in civil law—is not the cause of the patient reacting adversely to a drug. Generally speaking, this is not the type of offence that would lead to a malpractice suit. This is why we do not have any case law of this nature.

The only way of making doctors more accountable for their actions is by broadening these obligations through professional ethical codes, or statutory law. Nonetheless, with respect to case law, the courts are not sanctioning this type of offence in civil litigation because the offence in and of itself did not result in the consequences suffered by a patient. It may have consequences on other patients if a report is not made however, there could consequences for other patients. Perhaps other patients who were aware of the fact that a doctor did not declare information that he or she held could take legal action. It is a rather long and arduous road.

[David Tilson, Conservative, Dufferin—Caledon, ON]

On the obligation to report by pharmaceutical companies, Mr. Brogan, can you tell me what that is? Do they have to tell Health Canada? Can they just say that it is a minor thing and that they are not going to report it?

[Tom Brogan]

This is a bit outside our area, and I don't know the answer.

[David Tilson, Conservative, Dufferin—Caledon, ON]

Okay, you'll pass on that.

Does anyone else have any knowledge about the obligation of the drug companies?