Mr. Speaker, I rise to support this bill, but to support sending it to committee. While this bill is a substantial improvement on the status quo, it has still taken the current government eight years, even though as Liberals we have pushed the government to change the way it regulates, the way it develops, and the way it looks at drug safety for Canadians.
However, the Conservatives have put the bill forward and there are some pieces of the bill that we like, but we think it falls short. There are other things we would like to see in this bill, and the minister herself has said in the House when she introduced the bill that she is open to amendments, so we are taking the minister at her word, and we are going to say we would like it to go to committee. We hope the minister will be true to her word and will look at our amendments then.
Here are some things we like about the bill.
We think that the minister getting the power to recall drugs is a very important piece that has been a long time coming. The minister has to be able to do so without first getting the manufacturer's approval. Before this, the minister had to get the manufacturer's approval to recall a drug or to say that a drug has severe side effects. The new language says that “If the Minister believes that a therapeutic product may present a serious risk of injury to human health...”. That is good language, and we support the minister getting those powers.
The minister used to have to overcome the reluctance of the companies to want to give that information. Now the minister would have the ability to compel industry to provide the information about the drugs that the minister wishes to either seek a notice of compliance on or that are actually out there in the public, and be able to recall them. This is all common sense, but it is crucial because nobody but the company itself knows the background of the clinical trials, of how the company formulated the drug and how that innovation occurred. Therefore it is important that the company is made to be forthcoming with some of that information.
What we also like about this bill is that the minister would compel health care providers and pharmacists to mandatorially report at-risk drug reactions. As a physician, I can say that was a difficult thing to do because it meant that physicians, after a whole busy day of seeing patients, at the end of the day then had to report all these things. It can take sometimes two hours out of their day. Now that the minister would provide an electronic means by which this could be easily done, it would make it much easier for physicians to comply with this.
The minister's ability to enforce conditions on market authorization and to compel changes to product labels is also very important, and the ability to move that forward would ensure patient safety. We think that is important, but we also want the minister not to do so in a hurry so that it would stop due diligence in terms of the ability to get the kind of information we need.
The fines of up to $5 million a day for the failure to remove a drug or the failure to obey the enforcement measures by the minister is also a very positive area.
Members will notice that we are saying that there are some very positive things about this bill. However, before this bill came about, I was writing a bill on this very same thing because we got a little tired of waiting for the government to do this after eight years; so I had some round-table meetings with experts on the issue. Here are some of the major elements that these experts feel are missing from the bill, which would make the bill stronger: better implementation of the ability to ensure patient safety, to ensure that there are appropriate regulations, and to ensure pre- and post-market surveillance of drugs.
This is about the precautionary principle, which should give the minister the power to ensure that the first and foremost thing she or he is concerned about, wherever possible, is being sure that on reasonable grounds, to prevent potential injury to a person or a citizen, the minister has that power to recall or remove a drug or not allow for notice of compliance. “Reasonable grounds” is sufficient. The minister should be protected for her ability to do this, using the term “reasonable grounds”. The minister's power should not just be limited to those who sell the drugs, because we know that in some areas the people who manufacture the drugs are not the people who sell the drugs.
They have different production arms and different distribution arms that distribute their drugs under different names. Therefore, it is important for the minister to look at the whole chain of distribution not merely at the manufacturer when recalling a drug.
Right now I think that the definitive issue of injury or harm is up for interpretation. For instance, let us look at the birth control drugs that did not work recently. No one felt that this was an important reason not to allow the drug a notice of compliance or to recall it, because they felt that if women became pregnant when using a contraceptive that did not work, it was not an adverse reaction and it did not cause severe injury or harm, because pregnancy is a lifestyle choice. I think that was a bending of the interpretation of what harm is. If women are taking a contraceptive, it is because they do not want to get pregnant. If they get pregnant, that is an adverse reaction. I think the ability to define what is injury or harm should be more clearly spelled out for two reasons: one, to protect the patient; and, two, to protect the minister from any kind of reaction from the company because it is clear what she means and what the legislation means by injury or harm. That should be clearly spelled out. It should be based not on subjective but on objective criteria that are in keeping with what we know about risks and harms pertaining to drugs. That would provide the minister protection and give her broader powers.
As well, we know that we cannot tell the adverse effects of a drug purely from the clinical trials. When a drug is undergoing clinical trials, it is done with a cohort of people who have been chosen, and out of that cohort it can be decided what the negative and adverse reactions are to the drug. However, when the drug goes out into the main community, into the citizenry at large and the general public, individual reactions to drugs can differ. While people may not have had reactions during the clinical trial, others in the main community may show adverse reactions. Therefore, the minister must have the ability to say that, although the government gave the drug a notice of compliance, due to the new reporting requirements for physicians and pharmacists it has noticed that after a year or six months there are adverse reactions that were not intended and did not show up in the clinical trials and that the drug will be recalled temporarily while we check on these. Then, ensuring that the precautionary principle is in place, the government can look at the drug and either put it back on the market if changes have been made or permanently recall it before it does any further harm.
To clearly define what we are doing is in the best interests of the minister. It would protect her from any kind of legal suit and so forth. That is an important piece we would like to see included.
The Auditor General has spoken on many an occasion about the lack of transparency in Health Canada's decision-making process. For instance, Health Canada publishes only very limited information on drugs and high-risk medical devices for which a notice of compliance is applied for. However, it does not tell us why it did not allow a drug a notice of compliance. It does not tell us what its opinions are about the drug, even though it may give it a notice of compliance and say that it is generally safe. There may be other clinicians who have said there are some concerns about the drug. Health Canada should put that out there to the public, so that pharmacists, prescribers, and patients would know that there could be some conditions under which the drug was allowed to go out there. There may be some potential negative effects with which the minister and the department are concerned, but they are releasing the drug anyway. That was in the bill when it was put forward as Bill . I noticed it has been removed. I wonder why, because it was a very good piece in that legislation that we agreed on and that the Auditor General wanted to happen. That enhances the transparency of Health Canada in terms of its regulations and looking at drug safety.
We cannot afford to use the fact that the manufacturer does not want us to give out trade secrets. We do not have to give out trade secrets when we are saying that we think there may or may not be a problem that we have in the back of our mind even though we have put the drug out there. It is an important thing to do. Europe is doing it. The European drug agency is putting out what the negative opinions are on a particular drug, even though it felt that the benefits outweighed the risks and that is why it put it forward.
There should be a legal requirement to register clinical trial data. This should be open to physicians, patients, and pharmacists so that they are able to know what clinical trial data shows. Now, I know that the government thinks that would let out trade secrets. However, the European drug agency is doing this.
The clinical data that is put out in terms of the clinical trial does not have to disclose proprietary issues regarding the drug itself or its trade secrets. It is about the ability to ensure patient safety, which is foremost in the mind of Health Canada, as it should be. Therefore, to release the full report of pre- and post-clinical trials and surveillance on an ongoing basis is an absolute necessity, but it is not in the bill. Not only is the European drug agency doing this, it is thinking of expanding it to bring in anonymous or non-nominal general patient responses to the drugs so that, again, there is full knowledge and full disclosure. Also, the FDA has just tabled its intention of doing the same thing.
Canada is way behind both Europe and the United States in terms of looking at patient safety, in terms of full disclosure, and in terms of acquiring full disclosure by the manufacturers, who do not seem to be worried about the proprietary issues of trade secrets because they know what to put in and what not to. Clinical information is not a proprietary trade secret. The formula of the drug and how the innovation occurred are proprietary trade secrets, but not clinical trials or data about them.
It is important for the minister to strengthen the bill by doing this and to do everything under the rubric of good independent research, and not just the companies' research. There should be an independent body that looks at those clinical trials, and not just Health Canada. Again, Europe is doing that, and the FDA has tabled its intention to do that. It has to be done in the name of public safety and good evidence-based information.
We would like to see more transparency from Health Canada on why it gives a drug a notice of compliance and why it does not. What are the reasons? Again, we need to know that about certain drugs. People read about drugs, and when they find out that other countries use certain drugs, they wonder why Canadians cannot get it. They want to know why they are not allowed access to drugs that could save their lives, et cetera.
Good information helps people understand why certain decisions are made. However, right now we do not know anything about why Health Canada approves a particular drug or not, why certain drugs are suspended, and why some drugs remain on the market in spite of adverse reactions in other countries. These are some things that we feel would strengthen the bill.
Disclosure in the name of public safety is always very good. We need to ensure that the first thing in the mind of Health Canada when it approves a drug, or not, is that people can trust Health Canada to make good decisions in their best interest, and be able to do so in an objective and clinical evidence-based response. I think that right now Health Canada faces a great deal of mistrust from the public and drug prescribers because it is not transparent in some of these things.
Why would the bill allow government and cabinet to impose stringent rules favouring data protection of manufacturers under the Food and Drugs Act? We do not think that should be able to stand alone.
We have seen issues where people have asked for drugs, but the government has said that the Food and Drugs Act is the reason it is not doing certain things. However, the Supreme Court of Canada has ruled very clearly that the issues of right to life, liberty, and the security of the person trump any piece of legislation, which is under section 7 of the charter. Patient safety should be foremost in anything that the bill would bring forward.
We oppose the amendment to the Food and Drugs Act in the bill to protect manufacturers' data. It should only be for proprietary data protection and not for anything else. The government should be protecting the patient, and Canadians.
The Liberal Party thinks that the bill is long overdue. There are some good points in Bill that move forward, with some steps we approve of, to enhance patient safety and knowledge of drugs for therapeutic prescribers.
The minister said that the bill should be open to amendments. We have, as I said just now, about five amendments we would like to see that would strengthen the bill. We approve of big chunks of the bill, and we would like to see the bill go to committee. We hope that the minister will be true to her word and allow for amendments to come forward so that the bill can go to the House and be accepted by all of us unanimously, because it is in the best interest of patient safety.
Mr. Speaker, I will be splitting my time with the member for .
I am pleased to speak today on Bill , which proposes to amend the Food and Drugs Act to better protect Canadians from potentially dangerous and unsafe drugs.
Over the past three years I have served on the Standing Joint Committee for the Scrutiny of Regulations and have come to appreciate first-hand the importance of regularly reviewing and carefully scrutinizing regulations in our legislation. Often the results can be quite surprising when reviewing regulations, and that is certainly apparent in the Food and Drugs Act. In my view, that is why the amendments proposed in Bill C-17 are extremely important to Canadians.
I would like to highlight this with an example. Under the current act, if a drug or medical device poses an unacceptable risk to patient health, only the drug and medical device manufacturers can initiate a recall, and that is only after they become aware that a risk exists. In other words, under our existing laws, it is up to the manufacturers to determine whether or not there is a health risk serious enough to warrant a recall. Health Canada plays a secondary role. The current law only requires a manufacturer to notify Health Canada of the manufacturer's decision to issue a recall after the fact.
However, it does not end there. Under our current laws, government cannot step in and order a manufacturer to recall a drug or medical device that is unsafe. Where our existing law becomes more bizarre is that if something like a candy bar is deemed unsafe to the public, the Minister of Health can issue a recall. To summarize, the Minister of Health can issue recalls for dangerous and unsafe foods, but not for dangerous and unsafe drugs. In my view, this situation is completely unacceptable.
Bill proposes to remedy this situation by ensuring that the Minister of Health has mandatory recall power to compel a manufacturer to recall a drug or medical device if it is determined that it presents a serious or imminent risk of injury to health. This authority provides government with the power to initiate a recall instead of leaving the decision to the manufacturer or requiring Health Canada to negotiate with industry when the health and safety of Canadians is at stake.
I should also add that under this recall provision, once a recall is ordered, anyone who sells a drug or medical device and is aware that the product has been subject to recall may be convicted of an offence. There is also a provision for an exemption to this penalty, an exemption that allows for Health Canada to have the flexibility to authorize the sale of a recalled product with our without condition. Why does that make sense? It is because it is conceivable that in some circumstances a patient may have unique medical needs for which no alternative to a recalled drug is available.
I should also point out that under the new recall measures there would be no changes that would limit a manufacturer's ability to issue a voluntary recall. However, if a manufacturer fails to act quickly and decisively, the Minister of Health would have new powers to better protect the health and safety of Canadians.
Recently I met with a constituent who shared with me the importance of quality control in diabetes testing strips. How much insulin to take is determined by these strips, and serious failure in these test strips could result in death. The need for increased protection for Canadians in this area, and many others, is important, and that is why I will be supporting the bill. The health and safety of Canadian families must absolutely come first, and serious risks at the manufacturing level have to be treated seriously.
While researching the bill late last evening, I was struck deeply when I came across the number of Canadian families that have suffered the loss of a loved one as a result of a dangerous drug. Indeed, a colleague of ours in this place knows all too well the serious need for Bill C-17. In fact, the more I researched this area, the more apparent it became of the need for Bill C-17 to become law.
In my view, this bill is long overdue. It is simply not acceptable that drugs that could pose a risk to patients remain on the market at the arbitrary discretion of the manufacturer.
To give some further perspective on how out of date these current regulations are, fines under the act are $5,000, while under Bill these fines can be increased to up to $5 million a day. Even jail time can be imposed under very serious circumstances. These are protections, I would argue, that Canadians need.
Before I close, here is some brief history I also believe is relevant and that I am sure many members of this House would appreciate hearing. Canada's Food and Drugs Act was first passed in 1920. Significant changes were made in 1947. Further changes were made in the 1960s, after a dangerous drug that was legal at the time resulted in the death and deformation of thousands of infant children.
I believe that Bill , which amends the Food and Drugs Act, is long overdue. Protecting Canadians from unsafe therapeutic products without delay or administrative red tape is a priority that I believe all members of this place should share.
I would also note that the has stated that she would be open to amendments to Bill if ideas are brought forward that would better protect Canadian patients.
From a regulatory perspective, the mandatory recall measures proposed in this bill are consistent with mandatory recall measures for therapeutic products in other countries, including the United States and the European Union.
I submit that it is time that Canada joined the list of countries with mandatory recall legislation, and I ask that all members of this House join me in supporting Bill . I thank all members for taking the time to hear my thoughts on this piece of legislation.
Mr. Speaker, it is an honour and a pleasure for me today to stand to support and talk to the House about Vanessa's law.
As my colleague from mentioned, this bill requires the reporting of serious adverse drug reactions to ensure that doctors and patients are aware of new risks, and introduces new tough fines for companies that put Canadians at risk. I encourage all members to support the bill's referral to committee so some progress can made on the important issue of drug safety and work toward better protections for Canadian patients.
I will focus my remarks on the importance of mandatory reporting of serious adverse drug reactions and also medical device incidents by health care institutions and how this would improve our ability to respond to safety issues that would help keep Canadians safe.
As members of the House can appreciate, drugs can not only have beneficial effects for patients, but can sometimes have unintended and unwanted side effects. These side effects, better known as adverse drug reactions, can sometimes represent very serious medical risks. What are termed serious adverse drug reactions in the bill are ones that require hospitalization and are often life threatening or result in permanent disability.
Adverse reactions to medications are estimated to amount up to 25% of emergency room visits and hospital admissions, an amazing number that would likely shock most of us. That is why I find it so appropriate that the bill has been entitled Vanessa's law, in memory of the member for 's late daughter, who tragically died of a heart attack while on prescription drugs that were later deemed not safe and then removed from the market.
The bill would make it a requirement for certain health care institutions to provide Health Canada with serious adverse drug reactions or medical device incidents. This information would allow Health Canada to take steps to prevent further harm related to these products. As I mentioned, although a significant number of Canadians are admitted to hospitals each year for serious drug reactions, again 25%, this important information about drugs and medical devices does not always reach Health Canada. This is a serious concern and one that legislators can actually help address.
Our country has one of the most rigorous drug approval systems in the world. Before a drug reaches the marketplace, the department reviews it for safety, quality and effectiveness. This review is generally based on scientific data that is attained through previous studies and observed in clinical testing.
Clinical testing is an important part in the development of drugs and medical devices, and we have every reason to have the confidence in the science. However, studying drugs before they are put on the market cannot tell us everything about these products. When a drug or medical device is introduced to the real world, it may produce different results from those that were observed in a controlled clinical trial setting. In fact, some serious issues may only become known after a medical device or drug is actually on the market.
It is therefore critical that we continue to monitor the use of drugs and medical devices in the marketplace and that information on serious adverse reactions are reported to Health Canada in a timely manner. Under current law, and this is interesting, only manufacturers and sponsors of clinical trials must report serious adverse reactions. However, they do not receive reports on some of the serious adverse reactions and cannot report incidents to the department if they do not know about them.
I will give credit where credit is due. Adverse drug reactions reported to Health Canada have been on the rise over the past five years. Unfortunately, despite these improvements, it is estimated that less than 10% of adverse drug reactions are actually reported. This underreporting of important safety information is a serious concern as it limits Health Canada's ability to identify at an early stage the potential safety issues with a product and to take timely action to prevent additional patient harm.
Some positive steps have already been taken to address underreporting by educating health care professionals on the value of reporting and how to properly report to Health Canada. Pre-emptive steps have also been taken to introduce new simplified forms and electronic forms to report. Devoting health care resources needlessly to an overly complex system creates a problem in itself and nipping this in the bud is simply good policy. In addition, Health Canada has worked with standard-setting bodies such as Accreditation Canada to assist health care institutions to standardize their process for reporting. Although this has helped, it is still not enough. We need to do better.
With Vanessa's Law, we will strengthen serious adverse drug reaction and medical device incident reporting, as well as provide the tools needed to respond to unsafe drugs.
Let me give a few examples to illustrate how this safety information can benefit patients and how the bill would support these measures.
When Health Canada receives important information about a certain medical device or drug, it will take the necessary steps to prevent future harm. Health Canada could alert health care professionals to any new harms and how they could be mitigated, or require the manufacturer to change the labelling to add a warning.
We know that many serious adverse drug reactions are preventable. Taking action to prevent these harms will free up valuable hospital resources, through addressing threats to health and safety before hospitalization is required.
As alluded to earlier, we are well aware of how busy health care institutions have become and we do not intend to impose any unnecessary burden on an already strained health care system. That is why we are strongly committed to further consultations with health care institutions, as well as with provincial and territorial governments.
There is a clear commitment in the bill to developing regulations that will set out what information is required, how it is reported and which health care institutions will be required to report.
Only those health care institutions that are best positioned to improve the quantity and quality of reporting would be required to report. Only useful safety information about a drug or medical device will be gathered in ways that are efficient and within time frames that are meaningful. Again, all with a view to ensure the least burdensome way to get the safety information that is needed.
Further, it is an expressed commitment in the bill that reported requirements will take into account existing information management systems with the view to not imposing any unnecessary administrative burden. This will lead to the development of a meaningful reporting system that is not only focused on increasing the quantity of data, but also in gathering quality data.
It is important for Health Canada to continue to monitor drugs and medical devices once they are on the market. The information that health care institutions will provide on serious adverse drug reactions will allow Health Canada to assess the balance between the benefits and the risks of a drug while it is on the market. More important, it will support timely identification of safety issues and early action to prevent future harm.
Our government's priority is the health and safety of Canadians families. Strengthening the reporting requirements for drugs and medical devices will better protect Canadians and their families from preventable harm.
These important measures need to be taken, and I hope Vanessa's Law will receive support from all parties so that all of us as a country can take action for better protection of Canadians.
I am thankful for the time allotted for me to speak to such an important bill and I look forward to questions.
Mr. Speaker, first of all, I would like to mention that I will be sharing my time with my colleague from .
I would also like to take the time to acknowledge the courage of my colleague from Oakville, with whom I had the opportunity to work in committee. To my mind, the fact that he took the time to share his experience is not only very moving, but also very important. Personal experience plays an important role in our efforts to make progress on such a file. It goes beyond politics.
As my colleagues said, the NDP will support the bill at second reading. We recognize that it is a step in the right direction. In fact, a number of my colleagues said so this morning. We also recognize that it is important to send this bill to committee in order to hear from certain witnesses who may not have been adequately consulted. I am thinking of the Canadian Nurses Association, among others, which says that the front-line workers who face medical challenges in communities were not sufficiently consulted. It will be a good opportunity for us to hear what these people have to say and perhaps to propose amendments.
It must be said, unfortunately, that we have been waiting for this for a very long time. The introduction of this bill has been delayed a bit. As I was saying earlier, when I asked my colleague a question in 2011, I was on the Standing Committee on Public Accounts. We were studying the Auditor General's report, which raised the problem of drug safety and the fact that the time between Health Canada receiving the information and sharing it with the public takes too long. In some cases it took two years, which is far too long.
I remember some of the testimony we heard. There did not seem to be a very clear commitment from the government at that time. Nonetheless, we have to look on the bright side. It is better late than never. The bill has been introduced and we believe it is a step in the right direction. We have to acknowledge that.
In this matter, we have to address a number of aspects having to do with drug safety. We will talk about it further. This is an extremely important issue. In the case of food safety, there were some explosive issues, such as the XL Foods recall, for example. This issue has a direct impact on the daily safety of thousands of people in Canada.
When it comes to food and drugs, we want to make sure that people can look after their health safely. People take drugs to feel better, not to end up with more problems. It is very important to ensure that companies can be required to recall their ineffective drugs. We must also ensure that information is shared. That is very important. What we noticed, and continue to notice, is that there is an issue with transparency and the sharing of information.
For example, one suggestion that the NDP made with regard to this issue and this bill relates to the public disclosure of the results of clinical trials. We know that information is not always being made public or shared with Canadians. I think that is a major problem, given that people often do not know anything about the drugs they are taking. They just go to the doctor and get a prescription. They rely on the doctor's expertise and the often very basic information they may have.
This is even more important today because, with all the information that is available on the Internet, many people may try to find the information themselves. If the government gave them information from reliable sources such as the department, it could be very reassuring for them. Canadians would know that the information provided by the government was reliable, accurate and complete. There is still a lot of work to be done in this regard.
Speaking of information and transparency, this also relates to food safety. I do not really like to make this comparison, since we are talking about two different issues, but they are similar in that the government and the minister need to take some responsibility. For example, with respect to the XL Foods recall, the Americans were the ones who discovered the problem. This bill contains an extremely important element in this regard: it ensures that the minister can issue a recall even when the negative effects of the drug are discovered outside Canada.
The information sent to the United States or Europe, for example, shows that many drugs are used throughout the world. We must not limit ourselves to our own experience. We must benefit from the knowledge of others.
Once again, this bill is a step in the right direction. It is becoming a recurring theme for the government to use information that was discovered, seen and recognized in other places to make important decisions regarding the safety of drugs in Canada.
The work of my colleague from also ties into this since she introduced Bill , which deals with drug shortages. At first glance, drug shortages do not seem to have a direct impact on drug safety, but I would venture to say that they do.
It has to do with transparency and the dissemination of information. It is problematic when the public—and not just patients, but doctors as well—does not have full information about drug shortages, a problem that my colleague's bill aimed to fix, because other drugs are used, including some lesser-known ones that could pose certain risks. These drugs are used in emergencies but the individuals involved do not necessarily understand all of the side effects that can sometimes be negative.
We need to understand why it is important to make this improvement. I know that a government member could tell me that the showed some openness on this issue last week when she claimed she was prepared to look into drug shortages. However, our team and one of our NDP colleagues made a meaningful suggestion, and this suggestion could significantly improve Canada's entire pharmaceutical system.
The provincial governments are obviously responsible for ensuring that the health care system runs smoothly. People have a lot of concerns about drugs. They need to have good information and we need to ensure that our prescription system helps take care of Canadians and does not cause harmful side effects. The public is very concerned about this, and we must take measures such as the ones in this bill to protect the public.
Although we have some concerns and this bill has some flaws, all parties can agree that it is still a step in the right direction to improve our health care system. After all, our public health care system is one of the cornerstones of our society. Any step in the right direction to improve this system must be supported.
Mr. Speaker, I am very pleased to rise in the House to speak on Bill , an act to amend the Food and Drugs Act.
As has been stated in the House, we in the NDP are supporting the bill at second reading. We believe that Bill C-17 would bring several key improvements to current drug safety laws.
The bill would allow the government to recall drugs or order a distributor to take corrective action to remedy a problem with a drug. The health minister could order a manufacturer or importer to modify the label of a drug to update the side effects or health risks associated with it. The health minister could order a review of a drug and require a copy of the review. The bill would require manufacturers to update Canadian information on the risks associated with a drug, even if the safety risks were discovered in another country.
We believe that this bill is a good first step in protecting Canadians' health and in improving the gaps in current drug safety legislation. Most importantly, it would give the health minister the long-needed power to recall unsafe drugs and to require that drugs undergo further testing if they appear to pose a health risk.
However, we believe that this proposed legislation does not go far enough. We want to see more comprehensive drug safety planning that goes beyond the measures in the bill.
As I have acknowledged, Canada needs a comprehensive drug safety plan so that Canadians can be assured that their medications are safe for use. Canadians need to have access to plain-language information about why their medications are safe, including on testing processes and on medication labelling.
To give some background, we know that 150,000 Canadians annually experience serious reactions from prescription drugs. In 2013 alone we saw several major drug safety incidents, such as diluted chemotherapy drugs given to over 1,200 patients in Ontario and New Brunswick.
France banned the product Diane-35 in January 2013 after four French deaths were linked to the drug, but Health Canada has remained quiet and has refused any follow-up action to ensure that Canadians are aware of the risks. Off-label use of acne medication Diane-35 is linked to nine adverse reactions causing death in Canada.
Another example is drug-maker Apotex, which was sanctioned by the FDA due to concerns raised about quality control and repeated deficiencies at two of its Toronto area manufacturing facilities. Health Canada was apparently not concerned about the warnings, even though it had not inspected the facilities since 2011.
Finally, I and many of my colleagues have raised a drug incident with the minister, and I know that many Canadians have been concerned about this, particularly Canadian women.
For example, there have been voluntary recalls of high-profile drugs used to treat heart problems, high blood pressure, infections, and mental illness. However, I want to point to a particular concern, as I said, for Canadian women, which is the birth control pill Alysena-28 and five other popular birth control pills that were voluntarily recalled or had serious safety warnings issued about them: Diane-35, Yaz, Yazmin, Esme-28, and Freya-28.
Despite warning signs and the fact that many Canadian women were sharing on social media and with the mainstream media information about the deficiencies they were noticing and hearing about, the Conservative government was slow to act in terms of recalls.
We know that most risks associated with prescription drugs are identified after they are introduced to consumers. Almost one-fifth of new active substances approved by Health Canada between 1995 and 2010 were later given serious safety warnings. Despite this, Health Canada still does not require post-market drug studies.
We know that seniors are five times more likely to be hospitalized for adverse drug reactions. A recent study showed that one in 200 seniors are hospitalized for an adverse drug reaction versus one in 1,000 for other Canadians.
We know that seniors are often on more medications, and this demonstrates the need for a better evaluation and monitoring system to prevent adverse reactions.
We also heard from the Auditor General, who in 2011 reported on Health Canada's regulation of pharmaceutical drugs. The Auditor General at that time stated:
The Department does not take timely action in its regulatory activities, with the exception of its review of two types of drug submissions. In particular, the Department is slow to assess potential safety issues. It can take more than two years to complete an assessment of potential safety issues and to provide Canadians with new safety information.
The Auditor General went on to raise various concerns when it comes to our regulation system.
When it comes to delays in terms of drugs that are necessary and have been proven to be very beneficial to people, I want to draw attention to the pill RU-486. Sadly, too many people have not familiarized themselves with the literature. It is an integral method in terms of reproductive choices, including medical abortion, that women have around the world in countries like the U.S. and 56 other countries. We know that Health Canada is taking too long in approving this pill. Despite the fact that it has been shown to be beneficial, we have yet to see an approval that would put Canada in the group of so many like-minded countries in making sure that women have access to medication they actually need.
We acknowledge that this is an important first step and a step in the right direction. However, we need the government to be far more proactive when it comes to drug safety and when it comes to recognizing the importance of making medication available to people.
I want to share one particular area where the federal government, sadly, is not showing leadership. It is in the cutbacks to medical coverage, including drug coverage, for first nations people. In fact, just yesterday, I met with the leaders from a first nation in Manitoba, Fisher River, and spoke with other first nations leaders who are very concerned about the cuts to non-insured health benefits, including drug coverage. It is a situation that is sadly putting more and more first nations people, including elders, in vulnerable situations, given that they are not able to access the kind of medical service and coverage they need to be the healthiest they can be. I am particularly concerned that this is affecting a population that we know lives disproportionately in poverty. They often have less access to medical services, such as the care of a doctor, or nurses, for that matter. I find it particularly troubling that the government, despite its commitment to moving forward when it comes to safe drug coverage, at the same time is cutting drug coverage for first nations people who would be covered under non-insured health benefits.
While we acknowledge that this is an important step, we also ask for leadership from the government when it comes to drug safety, drug coverage, and understanding that the federal government has a critical role to play in ensuring safety for the citizens of our country. Certainly we in the official opposition, the NDP, stand on the side of so many Canadians who are asking the federal government to finally take action.
Mr. Speaker, it is a pleasure to rise today to support Bill , an act that would protect patients and indeed all Canadians from drugs that are approved and used as prescribed and yet can result in patient deaths.
It is rare in this place to have such unanimity around a bill put forward by the government. This important legislation would amend the Food and Drugs Act. The government has taken a courageous step. The should have the right to recall an unsafe drug. That has been obvious since 1962, when Canada's Parliament discovered that it needed a special act of Parliament to pull thalidomide off the shelves. For half a century we have continued in the same circumstance. The Minister of Health has no power to recall a drug when that drug is recognized as dangerous. It is quite astonishing. It is not because parliamentarians and various ministers of health have not frequently wondered why they lacked those powers but it is because of one thing and that is the unholy, somewhat criminal power, that pharmaceutical lobbies hold over governments around the world.
I will be supporting Bill but I will be suggesting some areas where it could be strengthened.
I would like to pay tribute to two people. The first is the Canadian . Even though this legislation could be much stronger, it took courage to bring it this far.
I have to pay tribute, as everyone has mentioned, to the member of Parliament for whose own personal story is now well known. This is Vanessa's law. This legislation is named for his daughter. There really are no words to express the depth of my admiration and gratitude to this individual member of Parliament.
The member's situation and that of many others brings to light a really significant threat. I have been looking for the statistics for Canada but I will use those for the United States. In the U.S., roughly 100,000 people a year die from using prescription drugs as prescribed. There are a lot of risks to using prescription drugs. Pain relief drugs can create an addiction problem. People are using prescription drugs in ways that were not prescribed. Canadians use roughly the same drugs. The number of Canadians who die every year from using a drug prescribed by a doctor they trust, without any warning about side effects or possible death, must be in the thousands.
In the case of the hon. member for , his daughter Vanessa Charlotte Young took the drug Prepulsid as prescribed for a fairly minor health condition. Her parents went with her to every medical appointment. No one said anything about a side effect that might cause death. No parent would ever have allowed their child to take that drug had they known.
The hon. member for wrote a wonderful book called Death By Prescription. In the book he tells of going on Johnson & Johnson's website after his daughter's death to find out information on Prepulsid. He found other stories online and found that investigations had been done on this drug and that 80 deaths had been associated with it. The doctor did not know that when he prescribed the drug. The parents did not know that. Young Vanessa certainly did not know that.
Bill shines a light on a very large problem but it only begins to deal with the problem. When we think about the drug-pushing criminal element, we do not tend to think of white-collar crime. That is what this is. When a pharmaceutical executive decides not to warn the that there are problems with a drug, that some people might die, because the company's profit margins are high, then that kind of activity should be criminal. If that executive decides that any studies done on a drug are proprietary, are confidential, and should never be shared, that kind of activity should be criminal. This legislation proposes steps to criminalize it.
I think a lot of members will have read the book The Constant Gardener or saw the film. It always struck me that the most powerful part of that work of fiction by John le Carré was his comment in the legal disclaimer so that no drug company could sue him. He wrote:
...I can tell you this. As my journey through the pharmaceutical jungle progressed, I came to realize that, by comparison with reality, my story was as tame as a holiday postcard.
We are dealing with a seriously corrupt process. I am not talking about any individuals within it, but when the large pharmaceutical companies around the world have so much power over regulators that they can avoid having automatic recalls for drugs or having the drugs assessed properly before they are registered, we have a real problem.
One place we could look for solutions is a wonderful institution that operates out of the University of British Columbia called the Therapeutics Initiative. That institution does something that, unfortunately, is all too uncommon. It refuses to accept any favours, trips, or presents from drug companies. It operates on a very strict ethical code of conduct and reviews the data packages that it is allowed to see from the health department of British Columbia. It decides and advises the government whether pharmaceutical drugs being proposed for use in the B.C. health care system will do more benefit than harm. It has come to different conclusions than Health Canada on a number of occasions.
Where are the clauses of the bill that need to be beefed up? Some of my colleagues have mentioned this already. Briefly, we need to look at transparency. The Canadian Medical Association Journal, by the way, wrote an excellent review on this bill called, “Regulating prescription drugs for patient safety: Does Bill go far enough?” It was released May 13 of this year and I commend it to members. It provides some very good areas where the bill could be strengthened.
One thing it points to, and others have as well, is that there should be the registration of all drug trials and the results of those drug trials should be made public. A recommendation from the Canadian Medical Association Journal article is that we should also make sure that when Health Canada decides not to register a drug and concludes it might be unsafe, that information should also be made public. Health regulators should no longer tremble with fear about what the pharmaceutical industry might do to them if they warn the citizens of their country that a drug may have very significant side effects that pose a threat to life and health. Therefore, more transparency is required, and I hope that will be seen at committee.
The second area is clause 31.2 of the bill, that would increase the level of fines up to $5 million. It sounds like a lot until we look at the recent drug company settlements around the world. This is a list just in the last few years, since 2008. GlaxoSmithKline, for fraud and illegal promotion of Paxil, Wellbutrin, and Avandia, was fined $3 billion since 2012. The $5-million penalty in this bill puts it into a bit of perspective. Merck, for kickbacks to health care providers, paid $1.6 billion in settlements and fines since 2008. Eli Lilly, for the illegal promotion of Zyprexa, has paid $1.3 billion since 2009.
There is a very long list here of significant fines. For off-label promotion of Topamax, an epilepsy drug, Johnson & Johnson was fined $81 million. There were $600 million in fines for the off-label promotion of botox to Allergan. Novartis was fined $422.5 million for the off-label promotion of Trileptal in 2010. The list is longer than I have time for in my short speech. I hope it makes it clear to parliamentarians that while $5 million is a big number to us, it is small change to big pharma. We need to boost the penalties.
In my remaining time, I want to suggest that at the end of the question and comment period following my speech, we put to the House that since all members in all parties that have so far spoken to this bill today support its passage and would like to see it go to committee, we ask for unanimous consent to approve this quite excellent bill and work to make it better.
Mr. Speaker, I am pleased to be in the House today to debate Bill at second reading, which is an opportunity to talk about the bill in principle before it goes to committee.
Before I begin my remarks, I just want to note that although we give numbers to bills, this bill has been referred to as “Vanessa's law”. I want to pay tribute to our colleague on the other side of the House, the member for , for the incredible work he has done around drug safety, not only in his own constituency but also nationally, across the country. It is appropriate that the bill be named Vanessa's law and that it be a reminder to us all of what can happen when we do not have adequate legislation around drug safety in this country.
I am glad we are debating this bill. I have been told by some of my colleagues that a number of the government members are quizzing the opposition as to why this bill is not being rushed through. I want to begin with that point, because it is a familiar strain to hear.
The government introduced this bill back in December, I believe, but it did not come into the House for debate until March. When it came up for debate, it was a Friday afternoon, so it had maybe an hour of debate. This is the only opportunity that has come forward. Therefore, any suggestion that we have to rush this bill through or that somehow the opposition is holding this bill up is absurd and not based on reality, because it is the government itself that has dragged its feet on this bill.
We have said continually that we believe the bill should go to committee, but I am aware that some of my colleagues want to speak to this bill in principle at second reading, which is as it should be. I hope that it will go to committee soon so that the Standing Committee on Health can get into the bill, call witnesses, and examine it more closely.
I wanted to get that out of the way before we talk about the substance of the bill. It irks and irritates me that we so often hear this refrain that something has been slowed down or is not going fast enough when it is the government's own calendar and timetable that have pre-empted a bill being in the House.
We have had very minimal debate on this bill. Let us be clear about that. We do need to have debate at second reading. Second reading is here for a purpose. It is here for all members of Parliament to debate a bill in principle and get an overall understanding of it before it goes to committee and gets wedged into the clause-by-clause process.
Therefore, I am happy to be speaking today at second reading on Bill , which would amend the Food and Drugs Act.
For the record, a number of my colleagues who have spoken to the bill and I as the health critic for the NDP, the official opposition, have said that we think this bill is a good first step in protecting the health of Canadians and improving the gaps in the current drug safety legislation. The bill is long overdue. When I say “long overdue”, I mean decades.
I read an article in the Canadian Medical Association Journal a couple of months ago presented by Matthew Herder, Elaine Gibson, Janice Graham, Joel Lexchin, and Barbara Mintzes, who happens to be a researcher who lives in my community in east Vancouver. It was a good analysis of this bill and it was interesting to read their analysis.
It begins by pointing out something that people have probably forgotten, because it is one of those historical stories that happened long ago, but it had a profound effect on the lives of children, families, and Canadians overall. In their analysis, they begin by pointing out that Canada was the last developed country in the world to remove thalidomide from the market. To do that required an act of Parliament. That was in 1962. There are those of us here who remember hearing about the devastating consequences and catastrophic effects of that drug and what it did to children and families. Therefore, it is incredible that it required a specific act of Parliament to withdraw that particular drug. In fact, the two manufacturers voluntarily withdrew the drug from the market in March 1962.
However, that legislation stopped short of granting legal authority to the director at the health branch to unilaterally recall drugs, even though officials recognized that the co-operation of the manufacturer to recall a drug from the market could not be solely relied on.
Here we are, more than 50 years later, and we still have this gaping hole in Canada's Food and Drugs Act. We still have a huge issue around drug safety. Certainly, Health Canada is a regulator. It is meant to analyze new drugs that come on the market and approve them. Astoundingly, however, the federal government has never had the power to actually recall a drug. It has to negotiate around that.
There are many examples over the years where we have seen consequences from minor to serious to catastrophic to death because of this lack of oversight and based on the principles of caution and safety of Canadians. We are very glad to see that the bill would allow the minister to recall drugs. It would give fairly extensive powers, which is very important.
I want to give some broader oversight. A number of issues related to the bill are also very important.
I just quoted from an article in the Canadian Medical Association Journal. While they support Bill , they outline the need for at least six critical elements to be looked at and hopefully examined and added to the bill. All these people are experts. They are very involved in the issue of drug safety in Canada, and have done a lot of analysis not only on this bill, but on the reality of drug safety in Canada. I would like to spend a little time going over those elements.
By way of backdrop, we should be aware that even the Auditor General, in 2011, warned consumers, the government and all of us as legislators that consumers were not receiving proper safety warnings about pharmaceutical drugs fast enough because Health Canada was so slow to act on the potential issues that it identified. That was a pretty serious matter, and it took the Auditor General making a public report to flag the issue of drug safety. In that report, the time lag was characterized as very serious. It noted that it meant people sometimes had to wait more than two years before Health Canada completed a drug safety review of a product already on the market and provided updated information about the risks.
As the Interim auditor general noted at the time, “I think two years is too long”, and we certainly agree with that point.
That same 2011 audit also found there were gaps in the transparency about drug information. In fact, it is really keeping Canadians in the dark about Health Canada's drug safety work. There has been an issue about clinical trials and the lack of information that is being provided, which has been a long-standing issue.
We should note that in many other countries, information around clinical trials is provided so researchers, medical practitioners and consumers alike can make themselves aware, if they want to, about a product, particularly at the clinical trial level, and this is very important.
I know the minister recently made announcements about providing better information. Again, this is a good step, but it is very important to have this as part of a legislative package to ensure there is transparency in the work of Health Canada.
What do we have to hide? We should have nothing to hide. This information is critical to the health and safety of Canadians and to the medical community. It is also critical to health researchers who examine new products that are coming on to the market and the kind of testing and clinical trials that have been done.
We should always be on the side of transparency, of accountability and of advocating for much greater safety measures. If this means some of the procedures become more complicated for the manufacturers or they have to go through other steps, so be it. What is paramount and what is the first order of the day is patient and drug safety. Certainly the bill will help in this regard, but more needs to be done.
Here are some of the other issues that hopefully will be examined at committee. Although the bill calls for mandatory reporting measures for health care institutions, we really need to look at not so much the issue of adverse reactions, but the failure of Health Canada to follow up on them, which the bill does not do.
Again, there is a huge issue in safety, adverse reactions and what kind of process is in place to ensure this is properly followed up on by Health Canada so we have a continuum. There should be a seamless process that is clear and transparent for Canadians, for people who are interested in this issue to know they do not have to keep digging deeper and deeper to try to figure out a little information here and there, or if an adverse reaction is reported, will it be followed up. These things should be taking place as a matter of course. These things should be fundamentally inherent in the Health Canada process. Unfortunately, we have seen these gaps and so it becomes a bit of a patchwork approach that simply has failed. This system has not been a great model for drug safety for Canadians.
This is one element of the bill that needs to be looked at because it does not deal with the failure of Health Canada to follow up on adverse reactions. Nor does the bill deal with the issue regarding off-label prescriptions for drugs for adults and the risks this may pose.
The bill impacts prescribing off-label drugs to children, which is a step in the right direction. As we know, the practice of off-label prescriptions means a prescription is used for another use than originally intended, which is often totally legitimately. However, the need for oversight on the safety of off-label prescriptions is really important. This question requires some examination.
I have spoken about access to public information, about drug trials and the need for additional drug testing as to why medications are considered safe or not. These are some of the questions that need to be examined at committee. We have to go through the system step-by-step and really examine where there are gaps are holes. We will have to question the officials very closely on this. None of us are particularly expert on this, but we will have to try to navigate that process as best we can. Then we will have to look at the bill and layer it over that process and determine what holes still exist and what gaps, problems and issues have not been identified and dealt with in the bill. I have named a few.
Certainly another issue is the question of labelling. We are very concerned that there needs to be a much better communications system set up between doctors, pharmacists and patients for communicating and reporting on risks. If we have a good system in place, if an adverse report has been made and if we know there is a risk, how can we ensure there is a better communication of those risks, either through labelling or how the medical community addresses this?
In fact, this has been a big issue at the Standing Committee on Health in recent months. We looked at the whole question of prescription drugs and how they could be either misused, mis-prescribed or abused.
These drugs can save lives, help people heal and get better, but they can also kill if they are not used properly. We heard many stories and examples about prescription drugs and the lack of information, or a heavy-duty selling job by a pharmaceutical company or not enough transparency and information about safety concerns or adverse effects of it affecting people.
Unfortunately, there are too many tragedies. There are too many cases of people suffering from adverse effects of prescription drugs because of improper prescribing or, worst case, of a fatal overdose and death.
This is a very important. In fact, we need some sort of national database that effectively communicates between the different parts of the health system. We have a complex health system, but there is a federal role, which is to provide leadership and give overall oversight on patient and drug safety.
Health care is delivered at a provincial level, and many players involved. At the end of the day, there has to be some federal responsibility. While I am glad the has understood and been clear that this issue needs to be addressed, we have a long way to go, not only in drug safety but in oversight of our health care system and ensuring there is proper communication between different parts of our health care system.
Joel Lexchin of York University, a real expert on drug safety and someone who has been before the Standing Committee on Health since I have been there, said that Bill was a step forward for Canada's drug safety legislation. However, he also expressed concern that the legislation did not go far enough and that Canadians still needed to know about the evaluation process that determined whether medications were safe enough to be sold in Canada.
I look forward to this going to committee. We support the bill at second reading. It is an important first step, but more needs to be done. I hope that when the bill gets to committee, we can actually look at it in good faith and look at it on its merit to determine the elements of the bill that are in good order, approve them and sent them back to the House for approval. However, I hope we also look at the bill with a critical eye. Surely that is what we are here to do.
Unfortunately, over the last few years I have seen amendments shot down at committee just because they came from the opposition. I really hope that does not happen. I know there are colleagues who care deeply about the bill and I know that at the end of the day we want to see the best bill we can.
I appeal to the members that when we get to committee, we look at its merits and at what we can do to make the bill better, to answer some of the concerns. There is overall broad support, but there are issues and concerns. Let us address those. Let us look into that and work in good faith to ensure the bill is the best it can be. We will then have done a good job.
Mr. Speaker, I have the honour to rise today to speak to Bill , or Vanessa's law, as we call it in the House.
I will be sharing my time with the hon. member for .
By all accounts, this bill deserves our support, at least for further debate in committee. Even though the fundamental and necessary steps have been taken, there are some gaps. My colleague was clear about that.
Let us talk about the bill. Why would we need this bill? Something that happened recently in New Brunswick effectively illustrates the need for this bill. It happened in Ontario as well. Diluted chemotherapy drugs had been administered. If I recall correctly, more than 1,000 patients received these substandard diluted drugs. The patients involved deserved a lot more information than was available at the time.
There needs to be transparency. The more information that patients, citizens, pharmacists, and doctors have, the better. We need to have reliable information. I do not want Canada to become like the United States where drugs are marketed to be sold at a profit for the pharmaceutical company.
The goal is to put Canadians' health first. To have good health, there is nothing better than self-defence. The individual should have the choice. I think my colleagues on the government side might very well understand that, fundamentally, it is an individual choice to know what drugs might best protect us. That choice is made in co-operation with pharmacists, doctors, and the government, who have the information and should ensure transparency.
We are talking about co-operation between experts in the field and the individual who must choose what is best. There needs to be information. The problem now is a lack of transparency. The bill before us today raises a lot of questions, namely whether the transparency that will be there once this bill is passed will be adequate. People want to make informed decisions. Canadians have less and less confidence in their government. They are wondering whether the government is providing them with the necessary information.
There is talk of letting 28,000 federal public servants go. We know full well that this will have an impact on services. Many scientists have been fired, as have front-line employees who took phone calls from people looking for information. The government needs to be there to provide services to the public. Taxpayers have paid for this piece of legislation before us and they should benefit from it. When bills are introduced by the government without sufficient funding, and there are not enough people to study and enforce them, then there is not enough information to share with Canadians.
The fundamental problem I have with this government is that it does not understand the correlation between government resources and sharing information with Canadians or being transparent with them.
That is exactly why I feel this must go to committee. We need to look at the lack of resources. Federal resources are constantly being cut. Tax credits are constantly being increased for companies that do not need them, such as banks. Those companies are benefiting tremendously. I think that they are capable of paying their own experts.
When it comes to fundamental issues such as health, medication options, and choosing medical services they rely on, Canadians often lack the necessary information and have to do their own research.
We want to see better collaboration with pharmacists. They are open; they want to talk about products. Unfortunately, even after this bill is passed, pharmacists will not have enough information to properly explain the merits of each medication to their clients.
Clinical trials will be no more transparent than they were before. Pharmacists will not know the results of clinical trials conducted by the companies, which are often private. Pharmacists try to have confidence, but open and public transparency is the best way for companies to gain their trust.
Unfortunately, this bill does not do enough to ensure this transparency and collaboration that in a democracy are vital to making informed decisions. Should the bill be defeated for that reason? I believe it deserves to be sent to committee for further debate. That way, the people working in the field and patients who need services and who have something to say will be able to provide input that will improve the bill.
If the government were serious, it would have introduced this bill a long time ago. Members will recall that it finally introduced the bill in December as a result of pressure from the opposition. However, debate was very short, as the House spent less than one hour on it. Today, the government has finally brought it back. We understand that it wants to put it in place quickly. However, if it was in such a hurry, it could have introduced it a long time ago.
When people call on their government to provide a service, that government should listen instead of always passing harmful regulations and laws. For example, when the government amended the Navigable Waters Protection Act, the amendments were very detrimental for the fishing industry in my region. Instead of spending this time on bills that are detrimental to my constituents, we could have passed bills that everyone in the House could get behind, that warranted our attention, and that deserved being passed as quickly as possible.
For example, we could have addressed health issues. We absolutely must look after our constituents. They expect the House to do what it takes to ensure that they have all the services they deserve. We absolutely have to think of our constituents. When there is a possibility that some people will take medications that are diluted, improperly prescribed or that clearly do not comply with regulations, the best course of action is to inform people, pharmacists and doctors about the specific trials conducted, the reasons why the medications provided by pharmaceutical companies are on the market and their usefulness.
Canadians need to know that the drugs they are taking have been approved and that they are adapted to their needs. However, they do not have this information. Once this bill passes, someone would still have a hard time understanding why a drug is useful.
We want to have faith in our doctors, pharmacists, nurses and government. However, for that to happen, Canadians need to know that the government is giving them all the information available.
That is why it is so important for clinical trials to be transparent, and a number of witnesses called for that. They want more transparency.
Everyone would win if the government were more transparent, and being transparent in this bill would be a good start.
Mr. Speaker, today, we are talking about Bill . My first comment is that it is about time.
Finally, society will be able to better protect people. Finally, the government will have the power to order drug recalls. Finally, the government will have the power to order manufacturers to change the drug labels to include the side effects of a drug. Finally, the government will be able to order the assessment of drugs. Finally, the government will be able to require manufacturers to keep the available information up to date. It is about time.
When profit hangs in the balance, I do not believe in voluntary approaches. Earlier, my colleague talked about the Walkerton tragedy. We could also talk about the XL Foods recall. There are also heartbreaking examples related to the train derailment in Lac-Mégantic last year.
Good health is the most precious asset of every member of the House and everyone watching. We even wish people good health at the beginning of a new year. That is why I believe that this bill is a step in the right direction. I believe that we must move forward with this bill, but that we must also examine it carefully.
Basically, the bill explains that better coordination is needed when it comes to health administration. That is why this bill is a step in the right direction. We need a broad view of health and a comprehensive approach to pharmaceuticals to serve human beings. That is what we need.
In my riding, there is a company that tests drugs . Not to name names, but it is called inVentiv Health Clinics. I have had the pleasure of visiting this company, which conducts clinical research. I learned about the importance of the clinical trials conducted by pharmaceutical companies. In this era of globalization, clinical trials are conducted throughout the world, including in Canada. The unfortunate part is that the rigour of these tests varies from company to company and from country to country.
Legislation such as this, which requires manufacturers to take more responsibility, may ensure that clinical trials are more rigorous. It may also bring contracts that are currently being awarded to foreign companies back to Canada. This would be advantageous for Canadian companies and could be a positive effect of the bill. We would therefore be able to provide higher drug assessment standards for Canadians, including during the clinical phase.
We also have to talk about production quality and the distribution chain for drugs. We cannot remain silent about how drug shortages are managed. We also have to talk about transparency. A number of my colleagues have talked about transparency and how important it is. More and more, the world of pharmaceuticals is unbelievably complex. The pharmaceutical industry faces major challenges in coming up with new medications to improve our health, our children's health and our neighbours' health. Managing that complexity is increasingly difficult. That is why doctors and pharmacists, the people we trust when we have health problems, must have at hand all possible information about the products they are prescribing.
They want the best for us, we want the best for ourselves, and everyone wants to be healthy. Given the complex environment of medications today, increased transparency of course will help the specialists to make the best decisions possible, which is what each and every one of us wants. Clearly, to get an overall picture of medications, we have to look at both sides of the coin.
Very briefly, I would like to talk about experimental treatments. A young mother in my constituency suffers from ovarian cancer that no longer responds to traditional treatment. As much as we want to protect all Canadians from side effects and from frankly obscure studies through this bill, we also want to help this mother of two in my constituency who wants access to experimental drugs that have not gone through all the clinical trials and all the testing. I mention this because I feel it is important for us to understand the degree of complexity the world of medications has reached today.
That is why I am pleased that we are discussing this bill. That is also why I feel that we need to take the time to debate it properly and consider it as a first step towards better use of medication in our society. That is also why I am speaking about the importance of a comprehensive examination of the use of medication. I do not think we should be looking at one aspect at a time in order to fix a minor problem and then moving on to try and coordinate all the various aspects. That usually does not work very well.
I am therefore asking the House to continue studying this bill, but to do so in a comprehensive way so that we can avoid making this a technical process when it should be a holistic one.
We want to look at the complexity of the issue, but to do that we need an overall plan. We need to be able to inform our specialists, but Canadians also need to know what they are getting themselves into when they are taking medication. Taking something for a headache is fine. However, sometimes even taking too much of a certain medication for a headache can have severe side effects.
We need to be able to give people the tools so that they can have an intelligent conversation with their specialist. That specialist must have relevant information and be able to recognize how various medications interact with one another. That is especially important for seniors. The more medications someone is taking, the more important it is to know how those medications interact.
That is why we think this is a step in the right direction. In committee, we will propose amendments that call for more transparency. We also want to see a better communication system between the various stakeholders so that each one of us and every professional has the tools required to make the best decision possible.
Mr. Speaker, I take special interest in federal policies, legislation, and the regulations that govern the pharmaceutical sector. The western part of Montreal, a great part of which falls in the riding of Lac-Saint-Louis, includes many brand-name pharmaceutical companies and medical equipment suppliers that together employ a great many of my constituents. As a result, I am fortunate to be regularly kept apprised of issues impacting this industry. Constituents also contact me to share their concerns about matters like the cost of drugs and drug safety.
Liberals support sending Bill to the health committee for review and improvement. Whether the government agrees to important amendments at committee will signal whether it truly takes the safety of Canadians with respect to pharmaceutical products seriously.
Incidentally, I applaud the member for who has been relentless in pressing for enhanced drug safety in Canada. I have been witness to his interventions at health committee and can attest to his tenacity and expertise on the issue.
Bill however is a delayed response to an issue that has demanded our focused attention going back to the very beginning of the Conservative government's mandate.
A key pillar in the national pharmaceutical strategy launched in 2004 was “Strengthening evaluation of real-world drug safety and effectiveness” to strengthen surveillance of prescription drugs.
An earlier attempt to address the issue, Bill , languished on the order paper when the government, violating its own fixed date election law, triggered the 2008 election. That was six years ago. Canadians would like to know what has taken the government so long to address such a vital issue.
Let me get to the bill. What would Bill do? The bill applies to prescription and over-the-counter drugs, vaccines, gene therapies, and medical devices. The main features of Bill C-17 are as follows:
First, the bill would require mandatory reporting by health care institutions, presumably meaning hospitals, of adverse drug reactions in patients so that the government may know whether to re-evaluate a drug's safety.
Second, the bill would empower the government to order recalls of unsafe drugs without first entertaining representations from the manufacturer or being obliged to negotiate the recall with the manufacturer, provided the “believes that a therapeutic product presents a serious or imminent risk of injury to health...”. Astonishingly, the government does not already possess this authority when it comes to therapeutic products like drugs. On the other hand, the federal government currently has the power to recall bad toys, tools, cleaning supplies, clothing, and food, something it does with varying degrees of efficiency, but not unsafe drugs. Currently, drug recalls are at the discretion of the manufacturers and distributors. This is hard to believe but true.
Third, not only would Bill give the government the power to recall drugs, it would create stronger penalties for the marketing of unsafe pharmaceutical products, including jail time and new fines of up to $5 million per day instead of the current $5,000.
Fourth, the bill would authorize the to order a person to provide the minister with any information in the person's control regarding a therapeutic product that the minister believes “may present a serious risk of injury to human health” and that “the Minister believes is necessary to determine whether the product presents such a risk”.
Fifth, the bill would also authorize the to require label or packaging changes if the minister “believes that doing so is necessary to prevent injury to health...”.
Finally, the bill would allow the minister to order therapeutic authorization holders to conduct assessments and provide the results to the minister and in order to improve understanding about a product's effects on health and safety, compile information, conduct studies and tests, or monitor experience regarding a therapeutic product.
The bill is seen to have some important loopholes that compromise its ultimate effectiveness.
First, the definition of “therapeutic product” does not include a natural health product within the meaning of the National Health Products Regulations.
Furthermore, stakeholders are concerned about what constitutes a “prescribed health care institution” under the bill. Does this definition only mean hospitals or does it include clinics and doctors in family practice?
Also, the bill raises the real-life distinction between sellers of therapeutic products and holders of drug authorizations, underscoring the fact that in the complex modern marketplace, they may be different entities.
Incidentally, a therapeutic product authorization is:
....the authorization that permits the import, sale, advertisement, manufacture, preparation, preservation, packaging, labelling, storing and testing of a therapeutic product.
As an example of the distinction, and to quote an article in the Canadian Medical Association Journal:
...the company holding the market authorization may...license distribution to another company.
An historic example shows us why the distinction is significant and why there is a need for the bill to cover both sellers and those with authorization. When, in the 1960s, thalidomide was suspected of being harmful, manufacturers eventually withdrew the drug after some negotiation with Health Canada, the kind of negotiation this bill would presumably no longer require. However, free samples, the primary form of the drug's distribution, were still sitting in doctors' offices across the country. Health Canada did not have the legal authority to control or contain this problem.
The power the bill gives to the minister to recall or suspend drugs appears limited to sellers only. According to the CMA Journal, the :
...should be explicitly empowered to issue suspensions and recalls to both types of “persons”.
Another issue related to the question of the federal government's capacity to fully protect Canadians from unsafe drugs has to do with whether it has the financial and human resources to ensure that drugs important to Canada are manufactured under strict quality control standards, along with ensuring quality control in manufacturing facilities in Canada.
We know that the government has been cutting in areas related to environmental protection and health protection, whether at the Canadian Food Inspection Agency or Health Canada. For example, budget 2012 cut 275 positions from the health products division at Health Canada, the group responsible for monitoring the safety and efficacy of prescription drugs.
Constituents have spoken and written to me because they have been concerned about conditions abroad in plants that manufacture drugs, often generics. Their concerns have often followed news of recalls of drugs such as Ranbaxy's atorvastatin calcium, the generic version of Pfizer's Lipitor.
For example, a 20 milligram tablet was recently found in a sealed bottle marked for 10 milligram tablets of the drug, resulting in a 64,000 bottle recall. This situation followed another episode, where glass particles were found in other batches of this same generic Lipitor.
As a result of such incidents, the U.S. FDA has apparently increased its presence abroad with a view to auditing certain facilities. What is Health Canada doing? Does it have the resources, financial and human, to do anything? Is it working with the FDA?
Whether in the U.S. or Canada, we need drug monitoring systems that catch problems before unsafe products are in consumers' hands and bodies.
This bill is obviously a good step in the right direction, but we have to ensure that any loopholes that would compromise its efficacy are closed. This can be done at the health committee. We also have to ensure that the government, quite apart from this bill, commits the funding necessary to guarantee that we have a safe drug system in Canada. It obviously has to work with the FDA and other international partners in the process of doing so.
Again, I congratulate the member for for his assiduous efforts in this area. I look forward to seeing what happens to the bill in committee.
Mr. Speaker, I will be splitting my time with the member for .
It is a pleasure to rise today on behalf of my constituents of Surrey North to speak to Bill . Before I do, I would like to say that I had a chance to attend a graduation ceremony last night at Queen Elizabeth Secondary School where 310 young people graduated. I want to congratulate them and their parents for a job well done. It just so happens that Queen Elizabeth is my former school. I graduated from there many years ago. I took the red eye so I could speak to this important bill this afternoon.
Bill is a step in the right direction toward tackling a far-reaching problem. After years of pressure from the NDP, health care practitioners, and health care organizations, I am glad to see that the government is finally taking action to address many issues related to drug safety. However, while the bill is a definite step in the right direction, it does not go far enough in addressing some of the key gaps in Canadian drug safety legislation.
I am sure that all of my colleagues in the House would agree that all Canadians deserve to have the information they need to make informed decisions about their health care. Furthermore, I am sure we can all agree that all Canadians expect their health care providers to have all the information necessary to make the best decisions possible about the care they are providing, including information related to the medications they are prescribing. In reality, Canadians and their health care providers are being left in the dark when it comes to important decisions related to their health care. I can provide numerous examples for the House.
In 2011, the Auditor General warned that consumers were not receiving safety warnings about pharmaceutical drugs fast enough, because Health Canada is slow to act on potential issues it identifies. People sometimes have to wait more than two years before Health Canada completes a drug safety review of a product already on the market and before it provides updated information on the risks. This is a backwards process. Canadians deserve to have full information about pharmaceuticals before they make the choice to use them. One of the most basic principles we teach our children is to think before they act. The process Health Canada follows right now seems to encourage the exact opposite of that: use a pharmaceutical first and think about the potential consequences or side-effects later. This needs to change.
It is an unacceptable statistic that most risks associated with prescription drugs are identified after they are introduced to consumers. Almost one-fifth of new active substances approved by Health Canada between 1995 to 2010 were later given serious safety warnings. This further illustrates the backwards process currently being followed.
If that does not provide enough proof that drug safety legislation needs to be urgently strengthened, then let us look at the major drug safety incidents we witnessed in 2013.
How about the diluted chemotherapy drugs given to over 1,200 patients in Ontario and New Brunswick? How about the recall of the birth control pill Alysena 28? It took a full week before this recall was issued, and in the meantime, many Canadian women were exposed to unwanted pregnancies. If that is not enough, five other popular birth control pills were recalled and had serious safety warnings issued about them. The list goes on, but I think members are beginning to see a pattern here.
Canadians deserve better. They deserve to be presented with the full information they need to make informed decisions about their health. They should be able to trust that they will be protected from drugs that would put their well-being at risk.
It is for all these reasons that I, along with my colleagues, am glad to see this bill. Bill is a good step toward the comprehensive drug safety plan Canada so badly needs. Canadians should have assurance that their medications are safe for use, and they should have access to plain-language information on why their medications are safe.
Bill , in its current form, would allow the government to recall drugs or order the distributor to take corrective action to remedy a problem with a drug. It is a scary thought that up until now, Canada has not had mandatory recalls for drugs. This means that even if a drug posed serious health risks to Canadians, the government could not force the manufacturer to remove it from the Canadian market. This aspect of the bill would give the government the power to protect Canadians when drug safety issues arise.
Bill would also give the the power to order a manufacturer or importer to modify the label of a drug to update the side effects or health risks associated with it. It would also require manufacturers to update Canadian information about the risks associated with a drug, even if the safety risks were discovered in another country. These are all important steps on the road to ensuring that Canadians have as much information as possible about the drugs they are about to use.
However, while we on this side of the House support the legislation, there is still more that needs to be done to improve drug safety in our country. This legislation still leaves many gaps that must be addressed.
For example, although Bill would improve labeling, it would not set up better communications systems between doctors, pharmacists, and patients for communicating and reporting risks. Likewise it would not increase access to public information about drug trials, additional drug testing, and why medications are or are not considered safe. While it would include provisions regarding reporting adverse drug reactions, there is no mention of a follow-up by Health Canada to these reports.
There are more steps that need to be taken and more issues that need to be addressed to create the comprehensive drug safety plan that is needed in our country. Comprehensive drug safety legislation should include optimal prescribing practices to ensure that drugs are used only when medically necessary and for the correct reasons and that negative side effects and drug interactions are avoided as much as possible.
Canadians also deserve access to clinical trial results. The reporting of all trial results, both good and bad, would lead to better-informed health care decisions. Although since 2007 Health Canada has encouraged clinical trial sponsors to make their data available, it has no authority to compel this transparency, which is a vital component of a comprehensive approach to drug safety.
I am glad to see this critical step toward improving drug safety being taken. Bill has the potential to benefit all Canadians in a concrete way and to especially benefit vulnerable populations, such as children and seniors. The bill, in its current form, lays the groundwork for even more concrete measures to be taken to strengthen our drug safety legislation. It is my sincere hope that the government will carefully consider amendments that my colleagues will be proposing at committee that will strengthen the bill.
I would like to talk about that a little bit. We have seen over the last two or three years that the government has brought in legislation that has gone to committee stage. We have seen over and over that the opposition has made concrete, valid amendments. Unfortunately, the Conservatives do not seem to want to take any sort of advice, either from the opposition or from experts who have testified before the committees. I would urge the Conservatives to take into consideration amendments that will be offered at the committee stage to further improve this very important measure.
Mr. Speaker, I am very pleased to join my colleagues in the debate on this important bill, Bill .
The debate we are having in the House today is also very important. I have heard Liberal members questioning the fact that NDP members are rising in the House to take a stand on Bill and propose solutions. I have heard Conservative backbenchers yelling for us to send the bill to committee.
I think they have forgotten what has been happening in committee since the Conservatives won a majority. The Conservatives say publicly that they are open to amendments and discussions with the opposition parties to try to improve bills, but when it comes time in committee to actually consider amendments proposed by the opposition to try to improve the bills, the Conservatives insist on meeting in camera and systematically oppose any idea that comes from the opposition, even if that idea was shared time and time again by various subject matter experts, groups and Canadians who expressed their views to members from all parties.
The NDP believes it is important to take the time to publicly propose in the House the amendments we would like to see made to Bill in order to correct the flaws that still exist in this bill. No bill is perfect when it is sent to committee after second reading in the House. I have been here for three years and I have never seen a perfect bill come out of the House at second reading, and I am sure that other members who have been here longer have not either.
This is where we begin thinking about the bill and we take the time to debate it. Quite frankly, I find it unfortunate to hear my colleagues from the other parties saying that we are wasting our time, that we should send the bill to committee and that we should trust the committee members who will examine it. I would like to have such blind trust in the government, which holds a majority on every committee, but to date, I have seen virtually no evidence of its good faith.
Unfortunately for the Conservatives, it is our responsibility to take the time to discuss the bill in the House at second reading. it contains some good elements. We in the NDP know full well that we will not be able to come to a perfect result in the debates here at second reading. It will be very difficult to achieve that result in committee, but we still have some ideas to put forward that were raised on a number of occasions by experts whom we consulted and who provided their opinions on the matter.
As some of my colleagues have mentioned, Bill deals with a very important issue, namely drug safety. The changes that will be made to the current legislation are long-awaited, so this is a good first step in the right direction. The bill before us today would allow the government to require the recall of drugs or to order distributors to take corrective action in respect of their products. It would also allow the Minister of Health to order a manufacturer or importer to modify the label on a product in order to provide the most current information possible on side effects and health risks associated with the drug in question.
Bill would also allow the Minister of Health to order that a drug be tested and the results sent to the minister, and to require manufacturers to update the information available in Canada about any health risks associated with their products, even if those risks have been identified outside Canada.
While information is available in other countries, and while scientists have conducted research and there are documented cases of problems caused by taking certain drugs or by drug interactions, this literature is not distributed in Canada. Therefore, Canadians have to do their own research if they want to be informed. This appalling situation is frankly incomprehensible. This is one of the most important improvements that must be made to the bill as presented to us today.
We in the NDP are pleased to see that the government has finally listened to the pleas of doctors, health professionals, and representatives from the area and from the NDP. Our health critic, the hon. member for has been questioning the government for a very long time. She has been putting pressure on the government to finally take steps to correct the shortcomings in the current bill.
We are pleased to see a result, and we support the bill at second reading. We want the bill to go to committee so that it can be studied in greater detail and so that the necessary amendments can be made.
However, we believe that the bill still does not go far enough. There are still a lot of flaws. Every year, 150,000 Canadians suffer serious reactions after taking prescription drugs. That is a significant number, and these people still do not have access to all the information they need and do not have all the means they might have to protect themselves. Among these 150,000 Canadians, seniors are five times more likely than the rest of the population to be hospitalized as a result of an adverse drug reaction.
According to a 2013 study by the Canadian Institute for Health Information, one in 200 seniors was hospitalized as a result of an adverse drug reaction, compared to one in 1,000 for the rest of the Canadian population.
Before I became an MP, I spent some time as an information officer for the Régie de l'assurance maladie du Québec. I regularly answered questions from people, mainly over the phone. We had to explain how Quebec's public health insurance plan and public drug insurance plan worked. The NDP would like to see such a plan implemented Canada-wide. However, that is a topic for another debate.
I also regularly spoke to seniors who called in for information on the price of medications or on how the public drug insurance plan worked. They also had a lot of questions about the drugs they were taking. I did not have the ability to answer them, since I am not a pharmacist or health care professional. However, I could see that our seniors were distressed because, over the years, they had been prescribed more and more drugs for various reasons and they did not always have the information they needed. Furthermore, the information on labels is rather complex and not necessarily very clear. When someone is taking 6, 8 or 10 drugs at the same time for various health problems, it is very important for that person to have access to clear, accurate, up-to-date information, regardless of the source. Whether the information is from an international source or the research was conducted in Canada, it should be provided to Canadians. We hope to see that happen soon.
In my riding of Portneuf—Jacques-Cartier, the population is aging. I am concerned about how the lack of up-to-date information is affecting people at present. I am truly worried about how this could affect the health of the seniors I represent and the general population.
The NDP has called for various amendments that we would like to see made to Bill . First, we would like to ensure that best practices for prescribing drugs are adopted by physicians. We want to ensure that Canadians are prescribed the most appropriate drugs in appropriate quantities.
We are hearing more and more about overmedication, whether of our seniors or our veterans who need psychological or physical help and who are prescribed many drugs that are more or less effective. The vast majority of our population could benefit from major enhancements to drug safety.
The NDP would also like to see public disclosure of the results of clinical trials, which does not currently happen. This information will be held by Health Canada, but will not be available to the general public. Canadians do not have the right tools to determine the possible effects of different medications on themselves and on their health.
Unfortunately, I do not have enough time to speak about the various improvements that the NDP would like to make to Bill . I will simply mention once again that we are very proud to support the bill at second reading stage. However, we hope that the work in committee will be done in good faith and that we will truly be able to focus on Canadians' health and safety and enact the best possible bill to protect our citizens.
Mr. Speaker, we are having a wholesome debate today.
I want to reiterate what the bill is actually about. Bill would bring in the following measures. It would allow the government to recall drugs or order the distributor to take corrective actions to remedy the problem with the drugs. The government could order a manufacturer or importer to modify the label of a drug to update the side effects or health risks associated with it. The minister could order a review of the drug and to be reported back to the minister. People will be quite surprised by the fact that this cannot get done at this point. It would give the Governor in Council new powers to create regulations as needed for labelling and authorization criteria. It would require manufacturers to communicate risks associated with their drugs that have come up in other countries. It would impose new fines for keeping unsafe product on the market, up to $5 million per day, and could include jail time, with a stronger penalty if the manufacturer knowingly erred.
A lot of Canadians would be surprised to find out that these measures are not in place at this point in time. It is evident that we need a comprehensive drug plan so all Canadians can be assured their medications are safe for use and so they have access to plain language information about why their medications are safe, including the testing process and medication labelling.
We have heard over and over again at the health committee, when I sat on it a few years ago and today, whether it is GMO or anything else, that people want to see the labelling. They want to be informed, contrary to what the government sometimes thinks. Sometimes it thinks people are not paying attention to what is being said in the House. It thinks people are not paying attention to the bills. Canadians are paying attention.
While we support the legislation, more needs to be done to improve the drug safety measures. We will be proposing amendments to improve the bill. I understand the Liberals are also looking at proposing amendments as well. This is why we should not be rushing bills through. These issues date back many years. In 2011, the Auditor General warned that consumers were not receiving safety warnings about pharmaceutical drugs fast enough because Health Canada was slow to act on potential issues that it identified. That was one of the reasons the Auditor General brought forward.
Fast track now to 2014, three years later, and we are just getting this. If the government is saying that this was such a critical issue, why did it not bring it forward? If the Liberals are saying that this is such a critical issue, why did they not bring it forward when they had 13 years to do it?
I forgot to mention earlier, Mr. Speaker, that I will be splitting my time.
Certainly the NDP is looking at proposing amendments to improve the bill when it reaches committee. In the meantime, it is important to have a healthy debate in the House so we can get the ideas forward, so people can be more educated about what is going on and what the government is putting forward. It is a great bill. Why do we not want Canadians to know about it just by having the debate in the House and being able to hear from other witnesses as they may want to choose to have their words heard at committee, whether it is by writing a submission or being called as a witness?
Sometimes the government will put in place some type of advertising. This is basically what has happened here. It indicates it is taking care of the well-being of Canadians, but as we can see, the bill shows there was a big void. We know, for the most part, when we send something to committee, and my colleague spoke to this a little while ago, the Conservatives still have a majority on the committee and all too often they are just eager to pass legislation without proper amendments. Because the amendments are coming from the opposition, they sometimes think that they are not noteworthy.
Therefore, we want to ensure that people are aware of the proposition and of the changes and concerns we have with legislation. That is why we are having this debate today, so more people are aware of needed amendments and whether the government acts on those.
The Auditor General also found there were gaps in transparency that were keeping Canadians in the dark about Health Canada's drug safety work. Unlike many other countries, Health Canada also does not make information on clinical trials public.
I have a sister who was diagnosed with Alzheimer's at the age of 50. She was on a clinical trial. We would have liked to have known what those results were at the end of the day and more information about that.
If information on clinical trials are public, they would show the health risks and side effects associated with the drug during its testing phase. All Canadians should be made aware of what those are. I also think the scientific community is looking at this as well. It does not want to be kept in the dark. The information needs to be passed on in a public way.
When it comes to providing Canadians with the information they need, Health Canada has been slow to react as of late. It took a full week before the voluntary recall of Alysena 28 was communicated to Health Canada and made public. Guess what happened with that? Many women were exposed to unwanted pregnancies. Now there is a class action lawsuit against Apotex for the faulty birth control pills.
The United States stops these medications from going forward. In Canada, we hear about these medications being taken off the market, yet we continue administering them to Canadians. We need to react a little more swiftly and we need to pay attention to what is going on. While Canadians are Canadians and U.S. citizens are Americans, they are all people and it affects them the same way.
Currently drugs can be prescribed without knowing what effects they can have on children, seniors, or nursing women because Canada and other countries do not share the information they collect on the particular effects of drugs and they do not ask drug companies to share it. That is extremely important.
It is not just the NDP that is calling for amendments to the bill.
Dr. Joel Lexchin, who is the drug safety policy expert at York University, calls Bill a step forward for Canada's drug safety legislation. We basically have said the same thing.
Dr. Lexchin has also expressed concerns that the legislation would not go far enough and that Canadians would still not know enough about the evaluation process that determines whether medications would be safe enough to be sold in Canada.
Let us hear what else he has to say on what needs to be improved in the legislation. I hope the colleagues across are listening to what needs to be improved because these are some of the amendments that the NDP will be bringing forward at committee.
He says that the new drug safety law should require that when the minister makes a decision about a product needing additional testing or that a product should be withdrawn, that all of the documentation used in making that decision should be made public. All of the safety and efficacy effectiveness information about a product that was generated either in the testing phase or once the drug was on the market should be publicly available, including periodic safety update reports. How important is that? It is extremely important.
He also says that the minister should be able to make decisions without prior consultation with the company involved, and those are important to note. All too often we find that the big corporate entities have the government in their pockets. Therefore, this would certainly put that to rest. When a company is required to do additional testing, there should be an annual report about the status of that additional testing. Additionally, the complete results of those additional tests should be public.
He further says that if companies are required to do additional testing, then the companies should turn over the funding to do that testing to a neutral third party, for example, the Canadian Institutes of Health Research. The CIHR should be responsible for selecting the researchers to do the testing and the data should be analyzed completely independent from the company.
This is about the safety of patients and Canadians.
The government can go on and on about doing some advertising, but until it takes action such as some of the amendments that have been suggested here, we will not get that perfect bill that could provide more security to Canadians. We know over and over again when the government has done advertising. We can look at the economic action plan. We can look at Twitter feed amount it actually puts in. What really matters is to ensure we have proper legislation that will protect Canadians.