Proceedings of the Standing Senate Committee on
Social Affairs, Science and Technology
Issue 21 - Evidence - October 8, 2014
OTTAWA, Wednesday, October 8, 2014
The Standing Senate Committee on Social Affairs, Science and Technology met this day at 4:13 p.m. to continue its study of Bill C-17, An Act to amend the Food and Drugs Act.
Senator Kelvin Kenneth Ogilvie (Chair) in the chair.
[Translation]
The Chair: Welcome to the Standing Senate Committee on Social Affairs, Science and Technology.
[English]
I am Kelvin Ogilvie, from Nova Scotia, chair of the committee. I will invite my colleagues to introduce themselves.
Senator Eggleton: Art Eggleton, a senator from Toronto, deputy chair of the committee.
[Translation]
Senator Chaput: Maria Chaput, from the province of Manitoba.
[English]
Senator Nancy Ruth: Nancy Ruth, Ontario.
Senator Oh: Senator Oh, Ontario.
Senator Seth: Asha Seth, Ontario.
Senator Stewart Olsen: Carolyn Stewart Olsen, New Brunswick.
Senator Seidman: Judith Seidman from Montreal, Quebec.
The Chair: We're dealing today with a piece of legislation, Bill C-17, an act to amend the Food and Drugs Act, also known as Protecting Canadians from Unsafe Drugs Bill, or Vanessa's Law.
We are delighted to have with us today the Honourable Rona Ambrose, Minister of Health. With her, from Health Canada's Health Products and Food Branch, are Anne Lamar, Associate Assistant Deputy Minister; and David Lee, Director, Office of Legislative and Regulatory Modernization.
My understanding is that the minister has until about 5:15, but the officials will stay longer, as necessary. With that, minister, once again, I'm delighted to welcome you to the committee, and I invite you to speak to us.
Hon. Rona Ambrose, P.C., M.P., Minister of Health: Thank you so much, Mr. Chair. It's a pleasure to be here with all of you. Thank you for the invitation to speak to you about an issue I know has been researched very well by this committee, not just with this piece of legislation but for many years, from what I understand. I commend you for your efforts to deal with patient safety.
I am pleased to be joined by David Lee and Anne Lamar. You have already introduced them, so I won't do that.
As you said, this piece of legislation is an important one because we know it will make a difference in the health of many, many Canadians. It was very encouraging for me to see this legislation receive all-party support. Of course, it was very encouraging for Terence Young, MP, who has been the driving force behind this legislation as well. It was also heartening for those like David and Anne who worked on this piece of legislation. I thank you for seeing it through the upper house quickly, but obviously you are still doing a thorough job, so I commend you for that.
As you all know well, especially after the piece in the National Post today, which was a wonderful article, this bill is named after Vanessa Young, who tragically died of a heart attack while on a prescription drug that was later deemed to be not safe and then removed from the market. Vanessa's loss is obviously a terrible tragedy, and a story like hers reminds us all of the very serious consequences that pharmaceutical drugs can have and of the need for all governments to ensure that we have the strongest possible safety systems in place.
As I'm sure all senators would agree, it's critical for Canada's drug safety regulator to be doing as much as possible to ensure that we are preventing other families and patients from having to suffer such a terrible loss as the Young family.
I understand that this committee had the opportunity to hear from my colleague, Terence Young, Vanessa's father, and I would encourage senators to give his thoughts due and careful consideration. As you all know, he is a person who has devoted much of his life to this issue and is what I would call an expert in the area. I'm so pleased to have his support for this bill. Of course, he was instrumental during the House of Commons' Health Committee study as well. I thank you for inviting him to this committee.
Senators, what it really comes down to for me is this: Canadian families expect when they go to a pharmacy or hospital that the drugs that they receive are safe, of high quality and effective, which is of course very important in treating their condition.
The Food and Drugs Act has not been substantially updated in over 50 years. In that time, the world has changed significantly. The changes in this law are long overdue. Rapid advances in science, medicine and the ways in which information is both communicated and accessed were simply not anticipated half a century ago.
Because of shortcomings in our current laws, as Minister of Health — I say this often, and I think it shocks people — I have the authority to recall a bag of potato chips if evidence shows that it is unsafe, but I cannot right now require a pharmaceutical company to recall a drug. When there's a safety concern and a drug should not be on the market, Health Canada has few options other than to negotiate with the manufacturer in the hopes that they will voluntarily come to the right decision. While Health Canada does have tools available that can force companies to stop importing products or revoke a licence in order to stop operating within Canada, these powers are very blunt instruments that were not designed to provide the department with the flexible, modern tools that are required to keep Canadians safe.
That is why Vanessa's Law has been brought forward. It will provide Health Canada, as a regulator, with exactly the kind of precise authorities that are required to oversee Canada's modern drug system. For example, even if the department were to impose a stop sale order or an import ban on a supplying company, it currently has no authority to recall the products that already exist on pharmacy shelves. Similar to the recall of a car or other consumer products, a recall is used to remove a defective product from the marketplace or take action to correct the defect. For example, a certain lot may be found to be substandard and may not provide the desired effect or may cause harm. Normally we expect companies to act quickly to remedy those types of situations; but I'm sad to say that's not always the case.
Indeed, most Canadians would be surprised to know that their government does not currently have the authority to order a recall of a drug that could cause serious harm to patients. Vanessa's Law will enable Health Canada to order a manufacturer to take immediate action to recall a product if it poses a serious or imminent risk to human health. This means that unsafe products will no longer sit on any shelves at pharmacies while Health Canada attempts to negotiate a recall with a company that may be reluctant to comply.
With the support of all parties behind it, Vanessa's Law will deliver new powers to do just that. It will protect Canadians from unsafe drugs by enabling the government to recall unsafe products quickly, requiring health care institutions to report adverse drug reactions, imposing tough new penalties for unsafe products, compelling drug companies to revise labels, if needed, and very importantly compelling them to do further testing when issues are identified with a certain at-risk population, such as children, regarding a particular drug.
I was also pleased to see, since being introduced last December and after hearing from MPs of all parties and from various expert witnesses, that Vanessa's Law was further strengthened with transparency amendments advanced by Terrence Young and adopted by the Standing Committee on Health of the House of Commons. These amendments further enhance the patient safety elements included in this bill by making more information publicly available. This includes publicly disclosing safety decisions regarding companies' applications to sell medical products in Canada and the reasons behind those decisions, the disclosure of information related to clinical trials and greater clarity concerning the scope and disclosure of confidential business information. The transparency and openness of all regulatory authorities is of key importance in the 21st century. Canadians rightfully expect to be able to access detailed information about how and why Health Canada is making decisions that affect their health.
As I'm sure senators are aware, I have already begun to make some great strides to meet those expectations. In announcing the regulatory openness and transparency framework for Health Canada, I committed to making more information available regarding key safety decisions by the department and to continue making more information available each and every year. The amendments brought forward by Mr. Young are in the same spirit and will help to ensure that Canadians are better informed than ever about the important drug safety decisions that Health Canada is responsible for. While the transparency measures will be a great improvement in their own right, truly the most important thing about Vanessa's Law remains its new measures to strengthen safety oversight of therapeutic products throughout their life-cycles.
These measures are intended to improve Health Canada's ability to collect post-market safety information and to take appropriate action when a serious health risk is identified. Vanessa's Law will allow Health Canada to order drug or medical device companies to make changes to their labels or their packages. This will speed up the communication of important safety information to Canadians. Currently, when Health Canada becomes aware of a new safety issue that requires a new warning on the label, officials first have to contact the manufacturer and then spend sometimes countless hours persuading them to add a new warning to their label. This process can also become lengthy, as it is dependent upon the manufacturer agreeing with the department and taking action to update their own labels. In the meantime, potential harm to patients can continue to occur.
To increase the reporting of safety information that Health Canada uses to determine whether a label change or a recall is needed, Vanessa's Law also introduces stronger requirements for serious adverse drug reactions and medical device incident reporting by health care institutions. Currently, only drug companies must report serious side effects to Health Canada. This information is critical as it allows the department to take action to prevent them from happening to others. This is why Vanessa's Law will require health care institutions to report serious adverse drug reactions and medical incidents directly to Health Canada. Health Canada will also continue to encourage voluntary reporting of adverse drug reaction by health care professionals, patients and consumers.
Finally, and this promises to be one of the more visible instruments at Health Canada's disposal, Vanessa's Law introduces tougher measures for those who do not comply. The current fines and penalties simply do not reflect the severity and nature of offences that can occur. Previously, the fine was $5,000 a day. To put this in perspective, that's the same amount that a person can be fined for littering under some municipal bylaws. That will now change under Vanessa's Law to $5 million a day.
In closing, let me again state that our government has listened to the experts on this and, of course, to Mr. Young, whom I would also call an expert. We agree with health care professionals that we need a strengthened drug safety system. Drug safety is not an issue that should become the victim of rhetoric. I'm so pleased that the bill has proceeded to this stage with the support of all parties in the house. I know Canadians expect this issue to be taken seriously, as we all do, and so it is fitting to have a second parliamentary study undertaken by this committee, which has done so much work examining drug safety in our country.
I thank you for all of your work. We are happy to take any questions you may have.
The Chair: Thank you, minister. I will open the floor to questions from my colleagues. I will begin, by earlier agreement, with the sponsor of the bill in the Senate, Senator Seidman, to be followed by Senator Eggleton.
Senator Seidman: Thank you, minister, for being here. We have heard from many witnesses these last few weeks. Without exception all have praised this bill, which is long overdue. It brings important enhancements, as you have said, for the safety of Canadians as for prescription pharmaceuticals. Many thanks to you, minister, and to Terrence Young, who, as you said, has worked long and hard to bring this bill to fruition.
I would like to ask for clarification of some issues brought forward by witnesses during these hearings. Several witnesses have raised concerns with regard to the department's capacity to fulfill its new obligations under this proposed legislation. However, we have also heard about the amount of time that Health Canada currently spends negotiating safety issues with companies. Could you comment on how you think Vanessa's Law would impact the staff and resources currently being used to ensure drug safety?
Ms. Ambrose: I am happy to take that question. Health Canada officials work very hard to be as efficient as possible when making drug safety decisions. To that point, and you alluded to it in your question, Health Canada currently spends a significant amount of its time and resources negotiating with companies to resolve and address safety issues related to drugs and medical devices. I have been a part of that. I have seen how long it has taken at times for us to see movement from a company. Vanessa's Law will free up all the resources as it will give to officials the tools they need to act quickly, decisively and to move on. The key to it is that they will have the authority to take that kind of swift action.
I expect that the simple presence of these powers in the legislation will also improve the compliance of drug manufacturers. They know the lay of the land. They know that currently they have wiggle room and they use it. We know that. Even the fact that this bill has been discussed for the last couple of months, and some of them are not happy about it, they obviously know it will pass and they accept it. I'm sure they will comply with it. It has already sent a very strong message about what they should expect from the department. When the time comes to enforce these new powers, I know Health Canada will not hesitate to use them. They have wanted these authorities for a long time.
I hope that the increased level of fines and penalties will also serve as a deterrent, another compliance mechanism to have drug manufacturers act more responsibly and be more responsive to some of these patient safety issues. We always assess the capacity and resources for the department, but at this time the indication I'm getting is that this law will free up a great deal of resources and time that are currently spent negotiating.
An interesting fact is that approximately 1 in 10 label change submissions require more than 100 hours of review effort, often due to protracted negotiations with the manufacturer. People assume we ask them to do things and companies jump to it; but that is not the case. Imagine these valuable people spending 100 hours to have a label changed with the manufacturer.
I think it will make a big difference. On average, the review of a submission for a safety-related label change requires 37 hours of work by the department. So you can see why my understanding is that having this law come into effect will free up a lot of resources and time for these good people to focus on safety issues to the public as opposed to negotiating with companies. I hope that answers your question.
Senator Seidman: Yes, it certainly does.
The pharmaceutical industry expressed pretty significant concerns with some of the transparency amendments that were added to this bill during its study in the House of Commons. They claim that the new provisions will grant you too much authority to disclose confidential business information and suggest that the threshold for disclosing such information requires an ''imminent risk.''
Can you comment on whether you feel the transparency measures now in the bill will withstand possible challenges by the pharmaceutical industry?
Ms. Ambrose: I'm told they will and that we are on good ground. David might like to speak to that in a moment. I would say I'm familiar with the charge from the pharmaceutical companies that they're concerned there's an inconsistency with our international obligations in terms of current laws, but I have also heard they feel we should only release safety information where there is ''imminent risk.'' I know they have made these claims, but the information I have received is that we are in line with international obligations and appropriate laws, in terms of our WTO requirements, NAFTA requirements, as they relates to intellectual property.
We took great care in drafting this bill. David is the one who drafted it. I know they have a concern, but I don't think it is founded. I think it is important that we be able to use this information should it be required for a decision around public safety. David might like to follow up specifically on that clause.
David K. Lee, Director, Office of Legislative and Regulatory Modernization, Health Products and Food Branch, Health Canada: I can confirm, Mr. Chair, that the minister is exact in all of that description. I would add that when it comes to the word ''imminent,'' we would worry about that because if you have a safety issue — a Canadian is going to be harmed and you need to give confidential information that normally you wouldn't give out to competitors to mitigate that safety issue — it doesn't matter if that event is going to happen right away or they're going to have a stroke in six months. Imminent would be a very difficult word in that threshold.
Senator Eggleton: Thank you very much for introducing this legislation. I agree with Senator Seidman that most of the people that who here as witnesses agreed this legislation should be put through, and it is good legislation. Most people around this table — maybe all — think this is a step in the right direction.
Virtually everyone who appeared as a witness said they thought there could be some improvement, from one perspective or another, and of course the House of Commons committee did provide some improvements, so perhaps some further things will be considered by this committee.
One of the witnesses said, ''Well, what about the regulations?'' Because regulations are really what you need to get this all into force and effect. I have a couple of questions about the regulations. First, what is the timetable for them? Second, could this committee have a look at the proposed regulations before they're put into force and effect, just briefly, because I think we all want to see this done as quickly as possible. As one witness said, you know that old phrase ''the devil is in the details.'' If we could see the regulations prior to them being put into force and effect, that would be great.
Ms. Ambrose: The Prime Minister has said to me that we want to see these regulations as quickly as possible, for obvious reasons. Some of the authorities come into force immediately, others will have to come through regulation and some have been worked on already and are ready to go. Others are being worked on and will take a little more time, but I can turn to David — he's the drafter of all of this — if he wants to speak to that.
Senator Eggleton: Sure.
Mr. Lee: Mr. Chair, we will be very busy over the next few years, certainly. The minister is right. A lot of this does come into force right away and then we'll need to catch up with regulations to put them in place to support it. A lot of them will be procedural. We need to be transparent from the beginning. Will we give notice? Will we get right of representation? And then we will follow in with regulations so a lot of this can operate right away. We are looking at other contexts to draw down some of the key provisions in the bills, in our work on rare diseases, for example, and we have been working very hard on that framework.
So in terms of regulations coming in, they will come in in stages and there's quite a volume that will come in under the bill. You won't see them all at once. They'll likely come in different ways.
Senator Eggleton: Will we see substantive ones perhaps come here for our review? You can determine what is substantive and what's routine.
Mr. Lee: In terms of the operation of the regulations, again, if you look at the book, it is an incredibly thick book. We're talking about entire frameworks.
Senator Eggleton: All right.
Mr. Lee: It's not just drugs, it is also medical devices. That is a clear volume. Having said that, we have been very faithful to the Senate recommendations throughout. We have been studying very carefully, even in the design as we have been going along, both for the bill and the regulations. We will be very faithful to observations made here.
Senator Eggleton: I will try to slip in three questions very quickly, and put me down for a second round if we get one, because I have a few more.
Proposed new section 21.31 authorizes the minister to:
. . . order the holder of a therapeutic product authorization to conduct an assessment of the therapeutic product to which the authorization relates and provide the Minister with the results of the assessment.
Proposed new section 21.31(a) authorizes the minister to:
. . . compile information, conduct tests or studies or monitor experience in respect of the therapeutic product . . .
Well, yes, the industry does have a wealth of information, and we certainly want to help them. For them to conduct tests that you authorized them to do, as a result of some issue that arises, the concern is that the industry has a conflict of interest. So shouldn't we be having either a third party doing these tests or at least a third party monitoring the tests? Maybe the Drug Safety and Effectiveness Network or some alternative to it could be doing that.
My point here, minister, is we need to have some oversight of what the industry does, in terms of its study, to make sure that in fact it is accurate and fair. The safety of Canadians is what is at stake.
Ms. Ambrose: Sorry. Are you proposing a particular —
Senator Eggleton: I mentioned the Drug Safety and Effectiveness Network. They could do it, if you authorize. There needs to be an oversight. The industry has information. That's valuable. But they can't be the ones to completely do these studies without some oversight.
Ms. Ambrose: That is a good point. Anne wants to speak to that.
Anne Lamar, Associate Assistant Deputy Minister, Health Products and Food Branch, Health Canada: Thank you for that, minister. I have a couple of points. There are different ways we can obtain this information, whether it is working through the Drug Safety and Effectiveness Network, putting special committees in place or oversight to see some of this research done. As well, with our new authorities, we will be able to direct the type of research, the line of questioning that we may want to see. There would be some oversight from Health Canada. I will ask David if he wants to add to that.
Mr. Lee: These are going to be very carefully designed studies. If we see something wrong with the product — there's a big range in there — we may want a utilization study, who is on the drug? We can design exactly what we want the company to report back on. That's pretty precise. If we're looking for another event, let's say there's a harm that is happening and we need a confirmatory study, it has to be well-constructed. In those cases, we can often get experts in that can talk about clinical trial design, what is appropriate to look for and vet what we are putting in place to make sure that that's going to be a very sure-footed report from an evidence point of view and the science is good around it.
The intention with this power is you do put in studies that are going to answer very important questions and get you that answer. So it is in that design and the exercise of the power that you will see quite a bit of oversight.
Ms. Ambrose: To Anne's point, it doesn't preclude us from working with organizations like the one that you refer to, the Drug Safety and Effectiveness Network. There's that opportunity.
Senator Eggleton: You mentioned this article in the National Post today about Terrence Young and one of the quotes in here about the bill is:
The drug industry has given the bill cautious support, even though Mr. Young says it is ''doing its very best to undermine it.''
I think we've got to keep all of that in mind.
Finally, I'll ask you about financial resources. I realize Senator Seidman asked you about that, but a lot of people who came before the committee did express a concern about the capacity of the department to be able to do that. I must say that this committee, in its studies on pharmaceuticals, has been underwhelmed, to say the least, about some of the inactivity of the department. I noticed in some Toronto Star articles that you're taking some action on some of the issues that they raise, which are similar to issues that have been raised previously at this committee.
Look at the Auditor General's report. The Auditor General said that the department hadn't met its inspection targets of 2 per cent in clinical trials. This might have been the previous Auditor General. He or she points out that when inspections turned up a non-compliance issue, it took Health Canada between 56 and 142 days to notify the parties of the problem. They talked about the poor record of inspecting foreign drug manufacturing sites, doing very little compared to what the United States does. Of course this committee learned a lot about the Ranbaxy pharmaceuticals from India. On top of all that, the federal budget in 2012 cut 275 positions, I understand, from the health products division of Health Canada.
All of this would indicate that there is going to be a challenge. Notwithstanding what you're saying about less negotiation time, there's still an awful lot of time to-ing and fro-ing in the discussions before a decision about recall or suspension might be made. There is a lot of concern that the department needs more resources to be able to do this.
Ms. Ambrose: First of all, Anne just told me that there was nothing cut, so that's some misinformation. She can always elaborate on it off-line with you, if you'd like.
Health Canada officials are focused and committed to health and safety, but they do not have the necessary authorities to deal with some of these issues quickly, as I think Canadians would like us to do. Even though there are limitations to the actions Health Canada can take, we have tried, or I've tried in the last year, through our openness and transparency framework and other measures we've instituted at the department to bring in more robust measures so we can at least fill that gap and deal with some of these issues, as we did recently with Apotex and another company, as quickly as we possibly can.
Again, I go back to the fact that a great deal of time and energy is spent negotiating with companies, because we have very blunt instruments, whether it's to ban imports or do a stop sale order. If that's where we have to go but it's not actually necessary, that can create a ripple effect where it could impact the availability of drug supplies. We could end up with a drug shortage. It impacts the provinces. It impacts the patient. We may not need to recall a drug. There may not be a safety issue with a particular product but there may be a safety issue with the manufacturing. These are all complex issues. For that reason, the regulatory authority needs much more complex instruments and authorities. That's what this bill provides.
I really appreciate the work you're doing on this, and I hope we can pass this bill as quickly as possible so we don't have these kinds of issues arise. It concerns me that it affects the reputation or the confidence people may have in the work that these good people do. I know they're very committed, but they do need our support and they need this kind of support. I think we're moving in the right direction, and I hope, for all their background and education, and many of them are highly educated, that they don't have to spend 100 hours negotiating with a pharmaceutical company to change a label, which is frankly ridiculous.
On resources, as we move through this, we'll continue to assess whether or not we need further resources. At this time, the indication is that we're okay.
The Chair: Thank you, minister. Before I move to other colleagues, I'd like to follow up on the second question that Senator Eggleton asked you with regard to assurance that the follow-up studies would be clear and effective. Perhaps, minister, I could address my question to Mr. Lee, if that's okay with you.
Ms. Ambrose: I would be very comfortable with that.
The Chair: It's my understanding that the authority that is given here authorizes up to essentially a further clinical trial. We could call it essentially a clinical trial. Mr. Lee, normally is it not the case that even back when a company has a drug that they think they will bring to market, the company devises a clinical trial and interacts with the health authority to ensure that the outline of the trial is something that the authority would be willing to consider the evidence from? That's the first question I want to ask you. Is that assumption correct?
Mr. Lee: That's absolutely correct, Mr. Chair. In fact, in order to conduct that study, they have to bring all the information to Health Canada and get approval from our clinical trial regulations.
The Chair: Thank you very much. I'm assuming the same would be true with the follow-up authority that the minister would have.
Mr. Lee: That's correct.
The Chair: Thank you. So there is that involvement, and then Health Canada will evaluate the results of the study, as it does for the clinical trial.
Furthermore, under this legislation, is it not now the case that the results of all clinical trials will be transparent, which is the big issue with regard to the previous issue? In actual fact, does this bill not bring us to a point where the evidence will not only be available perhaps to, say, the Drug Safety and Effectiveness Network, but it will be available in a transparent fashion to the experts anywhere to look at the results of this; is that correct?
Mr. Lee: That's correct, Mr. Chair. The intention of the registration provision is really to make sure that, once a trial is entered into, it's posted, and then positive and negative results at the conclusion are put up, summaries are put up, in that register.
Senator Eggleton: This is post-approval?
Mr. Lee: That's even for Phase IV.
The Chair: Exactly. Essentially, it's a Phase IV, or it's the life cycle approach to looking at a drug. Anything authorized here will be part of the authority under this bill.
Mr. Lee: If I may clarify a little, Mr. Chair, not all studies will be of that kind of clinical trial-like study, but we think if it's that important to ask, then it's that important to bring back through the trial oversight and that transparency.
The Chair: Thank you. So we understand it will be transparent in that sense.
Mr. Lee: That's correct, Mr. Chair.
The Chair: Thank you very much.
Senator Seth: Thank you, minister, for being here. I'm so happy. I certainly support this bill. I know it is so important for drug safety, efficacy and transparency, which are important for the citizens. I understand this law is named after a child, Vanessa. Could you elaborate on how Bill C-17 will benefit children?
Ms. Ambrose: I think this bill will benefit everyone, because obviously all of us, many millions of Canadians, use pharmaceutical products. Of course, they're necessary, and most importantly we want them to be effective, but we want them also to be safe, and we want our regulator to be involved in the process every step of the way so that there is that level of oversight.
In terms of the safety of children, in particular, one of the things that the bill allows us to do is further studies. That's an issue that was raised to me by cancer researchers and those who are treating children with cancer. We included that in the bill. What they said to me was that there are products on the market that have never been tested on children for certain reasons. Sometimes it's difficult to run clinical trials with children. Having said that, drugs that have only ever really been used on adults are being used on children with sometimes quite harmful effects. Of course, physicians want to try what's out there, but it would be nice for them to have some sense if there's further information on how this could affect a child if they're treating them.
One of the things I thought was excellent to include in the bill is this notion that we could ask a pharmaceutical company that has a drug on the market to do further testing to show the safety of that particular product as it applies to children, because that hasn't been done with many drugs that are used on children today. This was in the context specifically of drugs for cancer treatment. I don't know if that answers your question, but that's one specific area that relates concretely to the bill as it applies to children.
Senator Seth: That's perfect. Thank you.
Senator Cordy: Thank you, minister, for being here. As Canadians, we owe a debt of gratitude to Terence Young for advocating over many years for changes to the Food and Drugs Act; and, Minister, you also deserve credit. I only met Mr. Young after he was elected in 2008, while you are the minister who has brought forward the changes. Congratulations.
Following up on Senator Eggleton's questions, we heard from a number of witnesses concerning the resources of Health Canada in order to deal with this bill. If we're all in favour of the bill, it would be a shame if we felt that the resources aren't there for it. Witnesses who appeared before us felt that they aren't there. I know you addressed it with Senator Eggleton, but we heard from Ms. Janet Currie, who said her concern was that Health Canada currently does not have the resources to support the bill. We heard from Dr. Joel Lexchin, who said that Health Canada needs more resources to encourage the monitoring of pharmaceuticals. We heard from others but those are two names that I happened to jot down.
Can you give us some reassurance that the resources are there so that we're not bringing forward a bill that has all-party approval only to find it in the never-never land of bureaucracy? How can we feel reassured that the resources are there?
Ms. Ambrose: First, just the very presence of the bill is helpful, in terms of compliance by the pharmaceutical companies, whether it's the elevated fines, jail time or the recall powers, and the fact that Health Canada has new authorities. That will make a difference.
Second, and I've mentioned it a few times, is the huge amount of time that is spent negotiating with companies often when we want to make changes to a label or to encourage a voluntary quarantine or a voluntary recall, because we can't do a mandatory recall now. There's a lot of back and forth with many lawyers and letter writing. You can ask Terence about when he was involved with this issue for his daughter. He has a stack of letters this high that the pharmaceutical company wrote back and forth to Health Canada at the time. They kept delaying and delaying the negotiations, hoping to keep their product on the shelf for another week. Those two things right off the bat will make a difference. The presence of the proposed legislation and, as David said, the powers and authorities will come into effect immediately after the bill receives Royal Assent.
A huge volume of regulations will move through the system. As we do that, by all means we will continue to assess the capacity. If there is need for further resources, we will address that. At this time, I've been told that we are okay. I have to take that advice from my deputy minister. As I said, we'll continue to assess it. The regulations will take a phased-in approach, and if further resources are needed, we'll look at it.
Senator Cordy: I'll do a two-for-one question so I can get them both in. We also heard that technology may not be there within the department. Mr. Theo suggested to us that there should be more funds for Canada Health Infoway for electronic technology in order to get everybody talking to one another. Witnesses before this committee have said that there are computers even within hospitals that don't talk to one another. How do we ensure that information gets quickly to the people who need it from Health Canada?
We also heard so many times in our study, and you referred to it earlier, about the lack of transparency in Health Canada and that people are going online to the Federal Drug Administration website to get information on pharmaceuticals. Some committee members tried to access that website but couldn't as the website was down. For those who did get on, the jargon was so heavy that an average Canadian could never work through the minefield of trying to find out whether a drug has a problem.
Since this bill is before us, and I know it's not part of the bill but certainly would make it more helpful to Canadians, the website for Health Canada could be clearer and the information more transparent so people don't need a doctoral degree to understand it. Also, the website should not be down for long periods of time, which was the case of our committee trying to access it.
Ms. Ambrose: I'm not aware of any outage of the website, but we've taken a number of steps in the last year to address transparency. It's an important principle for our government and for me. It's important, I believe, to build the necessary confidence in the department as a regulator. People need to have complete confidence that those who are looking at the safety of these products are doing so in a transparent way. As I said, many months ago, we introduced the openness and transparency framework for Health Canada. In fact, when it comes to drug safety reviews and summaries, we are now ahead of the FDA in terms of the amount of information we release; and we're ahead of the EU. I would say that we are making great progress. We're also starting to post inspections of plants done by our drug safety folks.
We will continue to add to the transparency framework and not just on drug safety summaries. We lead the world in terms of the amount of information we release publicly. We want to be world leaders in as many ways as we can. If there's something you think we should be doing more of, by all means let us know. We are striving to have the most transparent system that we can have.
In terms of adverse drug reactions, the provinces and territories were part of the consultation with regard to this bill. They understand their responsibilities in terms of reporting adverse drug reactions through hospitals to Health Canada directly. There isn't a great deal of advance technology needed to fill out a form and send it to Health Canada. By all means, we'll be assessing whether we have everything ready to receive all that information, because it's critically important that we can analyze it quickly and over time so we can make decisions about drug safety.
Was there anything else?
Senator Cordy: Technology.
Ms. Ambrose: Technology is a whole other debate; but I will say that Infoway, in particular, has completed most of its mandate in terms of projects across the country. Some Northern jurisdictions and Atlantic jurisdictions still have projects underway that are being implemented. They've done excellent work and they've withstood a serious audit. Their projects seem to be implemented very well. I know the provinces and territories really appreciate the support of the federal government through Infoway for the funding of technology. Absolutely, technology is key to making sure we're speaking to all jurisdictions. As you know, even within a city there are different platforms.
Senator Cordy: Even within a hospital?
Ms. Ambrose: Even within a hospital there are different platforms. Everyone is struggling with their next phase of IT strategy; but we don't foresee problems with hospitals being able to send us that information. In terms of the safety summaries and making them understandable for Canadians, some summaries are hundreds of pages long. They're available should somebody want to look at them, but we've tried hard to make them understandable, relevant and easy to read for someone who is just going onto the website, as you did, to get that quick information about the safety of a product.
By all means, this is new and we just started doing this in the last year. We're striving to do more and to be as transparent as we can.
The Chair: In this regard, I know the regulations will have a great deal to do with how effective the issue is with transparency of trial results. We're certainly hoping that those will fully support the intent of the bill.
Senator Oh: Minister, I would like to praise you for this wonderful bill, and Terence Young for raising this in C-17. I fully support this bill.
I just want to know, with any new drugs that have come onto the shelves, is the department monitoring any feedback on side effects, sickness, complaints, so that at any time you can recall the drugs off the shelf?
Ms. Ambrose: Well, right now we do have adverse drug reaction information that we collect from the manufacturer. It is not mandatory from health care institutions like hospitals. That's what is different and good about this bill, because if someone is going into the emergency room and there was an adverse drug reaction, we want to know about it. There will be forms to fill out, sent in to Health Canada directly, which we don't necessarily get now in a consistent way. The experts at Health Canada will be able to analyze that information to see if there's a trend, if there's potential harm that a drug is creating and then be able to either change a label or potentially recall that drug more quickly. That's a big change, and it's an important one.
Senator Oh: How long a period are you entitled to monitor the drug for? One year, two years?
Ms. Ambrose: How long would we monitor one for?
Senator Oh: A lifetime?
Ms. Ambrose: In perpetuity. As long as it is there we would continue to receive information about it should there be an adverse drug reaction. Many pharmaceutical products do not cause adverse drug reactions, but for those that do right now, we don't collect the information in a consistent way from those who are seeing it on the front lines.
Importantly, some people thought we should do this with doctors, not hospital institutions. That was my first reaction; we should have the doctors send in forms as well. But the experts advised us that it is at the hospital setting where you see the serious adverse drug reactions and that's where we want to collect the information, so that's what we have done.
Senator Oh: I think this bill will not only benefit Canadians, but you will be setting a precedent for many countries that look to Canada for this.
Ms. Ambrose: I hope so.
Senator Stewart Olsen: This is something that bears repeating. Questions that have come up all along are questioning whether Health Canada has the resources, et cetera. For me, I would think that this is the first change that's been made in 50 years. Perhaps you could reassure us one more time that the ongoing assessment is going to be very important. I would assume, if you are assessing on an ongoing basis, you would notice if you didn't have resources. You would notice if it wasn't working and would take steps to fix it, because I have great confidence that that's what is happening right now within the department.
Ms. Ambrose: Absolutely. This is a phased-in approach. As I said, resources will be freed up because of the huge amount of time that's wasted, to a certain extent, negotiating with companies for something as simple as a label change.
As I said, this is a phased-in approach with the amount of regulations that you will see coming through. As they come into force, which is when the department and officials will be dealing with these issues, by all means, we will continue to assess it as it rolls out. I'm sure I will hear from them if they need more resources.
Senator Seidman: I have one more question. Some questions have arisen here in witness testimony regarding the definition of a prescribed institution or a prescribed time when it comes to establishing the regulations around mandatory adverse drug reaction reporting.
As the department defines these terms in the regulatory phase, will it work with stakeholders and provincial and territorial governments to ensure that these regulations comply with international standards while also minimizing the additional administrative burden to be placed on the so-called prescribed institutions?
Ms. Ambrose: Yes. That issue did come up with the institutions themselves, their concern about this being a burden. At the end of the day everybody recognizes, whether or not it is another form to fill out, it is critically important. We did have the support of those in the province and at the institutional level to move forward.
In terms of the reporting, we have spoken to both the provinces and people at the institutional level. We committed to them that as we move forward through the regulations, we would continue to speak to them so that they understand what their obligations are. I feel confident that everyone is supportive and understands why this is necessary.
Let's hope that we can make it as simple as possible. Maybe we can have an app, something through technology that makes it simple for physicians working in the ER. We will explore those options and work with them. They're in a unique position to report these kinds of incidents. Without them, we can't do this. We will try to make it as easy for them as possible so they can get that information to us consistently and clearly, and I know they agree that this is incredibly important. By all means, they have been included in the discussions.
Senator Eggleton: In regard to counterfeit drugs, there haven't been any successful prosecutions of illegal online pharmacies by Health Canada. Some of these operations are selling falsified, dangerous and counterfeit drugs abroad, too, not only here. However, several Canadians have been successfully prosecuted, through the efforts of the FDA in the United States, for operating such websites and selling counterfeit drugs.
A few years ago, Bill C-51, a predecessor of the bill we have in front of us now in many respects, included a provision for dealing with counterfeit drugs. This one doesn't.
You may argue there's a new bill called C-8, which is the Combating Counterfeit Products Bill. I'm not clear how that's going to operate in this connection and whether it will result in something more significant being done. The RCMP, when they came here, indicated that there had been some referrals, they did some investigations, they gave us some statistics, but again no prosecution.
One of the things that both they and the Canadian Border Services Agency were concerned about was just who was in charge of all of this, and I think at the end of the day they concluded it is really Health Canada that should be in charge of it.
Is this going to get straightened out? Will we deal with these people who are engaged in alleged criminal activities, doing things that are a danger to the Canadian public? By the way, these are the kind of people who should be getting long-term jail sentences but the bill reduces the jail sentence from previously three years down to two years. Anyway, since there's no successful prosecution to date, then that doesn't really mean an awful lot.
What's going to happen in this case of counterfeit drugs, illegal online pharmacies?
Ms. Ambrose: That issue is addressed already in current law, both through the Copyright Act and through the Food and Drugs Act. There are prohibitions in place for us to deal with that.
When there is an incident of suspected counterfeit products, it is referred to the RCMP for investigation and we play a supporting role in those investigations. I can ask David, because I know he's involved in these issues, to give you a bit more information about how it works.
Mr. Lee: Counterfeiting is a serious issue. You are correct. It was introduced in Bill C-51 some time ago. Having said that, right now with counterfeiting, the minister is correct, there are prohibitions for selling drugs that are not approved. Counterfeit drugs are, first of all, not approved by Health Canada. We can effect seizures, to make sure the product doesn't go out into the market.
The other thing — and this is in regard to the terms — is that the Criminal Code is available to the Crown for counterfeiters, and they can go there and use the 14-year maximum sentences under that instrument for that kind of behaviour. It is lateral to the Food and Drugs Act, but it is available to them, especially if somebody is harmed and it is a very serious incident. The two are meant to work together, or can work together in those cases.
Senator Eggleton: You haven't successfully prosecuted anybody. Yet the United States has.
Ms. Ambrose: Did you press the RCMP?
Senator Eggleton: The RCMP says they're doing the best they can under the circumstances, same with the border services people, but they're pointing their fingers at Health Canada.
Mr. Lee: I would need to check for you on details because it was some time ago, forgive me, but in Hamilton some time ago a pharmacist was selling a hard drug that had talcum powder in it and there was a coroner's inquiry around that. My impression, and please take it as a memory, is that there was a discussion around using the code in that particular instance. So, first of all, we seize.
The important thing, from our perspective, is that's not going out and being consumed by Canadians. We are on guard on that point.
If you need to follow up with prosecution, go after people who are doing this. My impression is the Criminal Code is available.
Senator Eggleton: Well, no successful prosecutions. I hope you can catch up with the FDA.
Anyway, let me ask you about the fact that much of this bill uses the word ''may'' as opposed to the word ''shall.'' Actually, I had this conversation with Mr. Lee, so I would like the minister to respond to this.
People have indicated a concern about this, feeling that we need to have tighter language and not so much discretionary language in it. I think these same people are concerned that ultimately we have talked about openness and transparency, and a lot of people continue to indicate they're concerned about that.
I realize you said in answer to another question, minister, that, well, the department is doing its best to have this stuff made open and transparent, but a lot of people who came here as witnesses don't agree with that. They talked about the kind of things that Senator Cordy talked about, that it is confusing; it is hard to get; you have to dig down deep; or it is better to go to the FDA site or somebody else's site to get more information. They talked about the summary basis of decision documents, which, they said, ''That's all very nice that it's put forward as an improvement, but it fails to provide adequate information.''
It is not just information for the public in general, but it is also information for the professional people who badly need it.
Why aren't we making these powers mandatory? It is also one of the reasons I asked you about the regulations, because if they're not going to be mandatory here, they're going to be discretionary. Then we should be able to see the regulations to make sure that it ends up being the way that we want it to be and you want it to be — open and transparent.
Ms. Ambrose: Of course, the regulations go through the Gazette process. You will be more than welcome to look at them. They will be transparent, and, obviously, there's going to be a consultation process with the regulations, so people will be able to see them.
I know there's been a lot of discussion about certain sections of the bill in terms of wording around ''may release information'' to one of ''shall release information.'' I have been, right from the beginning, open to any expert advice and was willing and happy to amend the bill at the Health Committee to create more transparency.
I spoke with Terence Young about this and said, ''Are there any concerns around this criticism?'' and he said no. I have not heard it from other experts that I have asked for advice on.
When you look at the amount of information that is required to be shared, whether it is information, changing a label, safety assessments or forcing a recall, all of these are publicly disclosed. On these points, there's absolutely no discretion. Those are the points that the experts, at least, have advised that are the most important thing.
Of course, the legislation requires the public registration of all clinical trials, another thing that experts said they wanted to make sure was included, and we amended the bill for that reason.
When it comes to the areas that are worded as an authority for the minister to exercise, rather than an obligation for the department, I'm confident, after speaking to experts in the area, that these sections would dramatically improve transparency. The Health Committee gave these sections due consideration, and they have also been carefully vetted by the department to ensure that they are compliant with our trade obligations, which I know is one of the issues raised as well under NAFTA and the WTO.
In terms of that specific section, they're worded that way to provide the minister with as much authority as possible to disclose confidential business information, without creating unnecessary legal risks or operational burdens on the department.
I know David has already spoken to this issue, but operationally, if we change the ''shall,'' it would impose an ongoing duty to disclose all confidential information in respect to a product in question. This would operationally place a huge burden on Health Canada and would slow our ability to provide timely risk information to physicians and patients when a risk has been identified.
We have listened very clearly to this specific criticism, and I believe that we have addressed it. The department feels comfortable with it; Terence feels comfortable with it; other experts do. When it comes to the areas where there is a clear requirement, an obligation, it is in those areas we want to see action, which is changing labels, recalling a product, requiring further studies, and, of course, requiring the registration of clinical trials. I feel comfortable we have addressed that criticism.
The Chair: Minister, I realize we are at the time that you had available. I would like to ask my colleagues if they have further questions for the officials here today. They're prepared to stay longer if senators have questions. They don't have further questions.
In that case, minister, I want to express my satisfaction that our country is bringing forward this bill to bring the legislation some 50 years forward in this area. I am perhaps as aware as anybody of the nature of the issues over the last 50 years. That spans my career time in these areas, and I believe this is a very significant improvement and benefit to Canadians.
Clearly, we could all imagine more things to be added to the bill, and I'm hopeful that you will continue to monitor the issues and the issues that have been raised during the discussion of the bill, and, where necessary, not hesitate to bring forward further amendments that are essential to Canadians.
I have to say that in the past when I have been frustrated with some of the issues under the existing legislation, when I read it in detail, I saw nothing but an opportunity to frustrate the officials who would have to enforce the current legislation. We have seen an example of that in very recent times.
One of the things that this bill does is it gives the authority to move forward. I am also somewhat aware of how long it takes for a single letter to be drafted and approved within a bureaucracy. When Terence can show a thick file of letters back and forth, we can easily speculate on the amount of time that is there and to have the authority to move forward and deal with this.
Furthermore, your authorities under the recall now allow you to recall perhaps simply a batch, or, on the other hand, recall gives you the authority to recall all of it, where a suspension did not. You simply suspended, but you could not remove drugs from inventory and so on.
While there are those who have suggested other things that could be included, I do want to congratulate you and to express my appreciation for your leadership in bringing this bill forward to us. The committee will decide tomorrow how we will recommend on it, but I'm speaking in terms of bringing the bill forward to us and through the process to this stage. As a committee, we are very pleased this bill has come to us. We have spent some time looking into these areas, and for that, I'm very appreciative of my colleagues for the knowledge that they have in dealing with this.
With that, minister, Mr. Lee and Ms. Lamar, I want to thank you very much for being here with us today.
Ms. Ambrose: Thank you very much.
The Chair: I thank you on behalf of the committee. With that, I declare the meeting adjourned.
(The committee adjourned.)