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, and 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 C-51. 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 C-17 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.