Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law)

Elizabeth May: Mr. Speaker, I appreciate the member’s remarks and the fact that the official opposition will be voting in support of the bill, as will I. I certainly hope it will pass before we rise this summer, as the hon. member for Oakville has indicated he would like to see.

Would the hon. member for Churchill agree that perhaps at the close of our second reading debate today, we might be able to move for unanimous consent that the bill go straight to committee?

Niki Aston: Mr. Speaker, as we have indicated, we are very much in support of the bill and have been from the beginning. I think it is important for us to be able to share our position and, certainly, our hopes for further steps that need to be taken in this same vein. I think that is an absolutely critical role that we have as parliamentarians. Certainly, I expect that many of us will share our support and share further steps as this debate goes forward. We certainly hope that we can bring this bill into law sooner rather than later.

Elizabeth May: Mr. Speaker, it is a pleasure to rise today to support Bill C-17, 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 Minister of Health 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 C-17 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 Minister of Health. 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 Oakville 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 Oakville, 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 Oakville 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 C-17 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 health minister 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 C-17 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.

Terence Young: Mr. Speaker, I thank the member for Saanich—Gulf Islands from the bottom of my heart for a heartfelt and highly accurate speech. I certainly agree that the Therapeutics Initiative is one of the best institutes in Canada for identifying safety risks around prescription drugs, and has been for some time. Her call for amendments to be bill, from my viewpoint, are more than welcome, and the Minister of Health has said she is willing to consider amendments. In my view, this is democracy at its best. It is a non-partisan issue and the minister is taking a non-partisan approach, so I am very pleased about that.

The member talked about fines of $5 million a day. The bill also includes the provision that when there is criminal negligence and a court saw that it needed to be addressed with a major fine, there could be unlimited fines. A judge could conceivably fine a big pharma company that committed criminal negligence the full amount of their sales for the period of time the drug was on the market.

We need Bill C-17 now, as soon as possible. We need it approved now at second reading to get it to the health committee, if the House approves. We can talk about those issues and hopefully get the bill passed by the end of June. We need to get it approved now. I am hoping that today, at the end of the hour, the parties will agree to send it to committee so that we can reduce the damage and the adverse drug reactions that patients might otherwise experience if we drag out this process.

Elizabeth May: Mr. Speaker, I am humbled by the very kind words of the member for Oakville. He knows this file better than anybody, at a personal cost that none of us should have to pay. We are in his debt.

I am certainly heartened that it is possible for the fines to be increased if the courts find criminal negligence causing death, but I think the minister should have the ability to raise the fines, rather than just having the ability for a judge down the road, at the judge’s discretion, to apply the kinds of fines that will make big pharma recognize that Canada is not a country where they can play fast and loose with our health.

Charlie Angus: Mr. Speaker, I listened with great interest to my hon. colleague and I was very interested in the litany of fines that have been paid out by big pharma.

There was a real eye-opener for me one night when I was at a restaurant that a friend owned. The friend was putting on a dinner for doctors. It was a private function. Someone showed up at the door of the restaurant with an envelope containing $500 cash. The restaurant owner asked him what he was doing there, and he said he was paying for the booze. It was a salesman from a drug company.

The restaurant owner said, “I am sorry; this is not something I am supporting. You can leave if you are going to pay money to anybody to promote your drugs. If you want to promote your drugs, do it outside my premises”.

I was very shocked by that. I had no idea whether this was a common practice or not, but it certainly struck me.

I ask my hon. colleague if she could drill down a bit more for people listening to this debate about the kinds of fines that have been paid by these companies, because these fines really raise questions about basic standards of putting public interest ahead of the very large profit margins that may be at stake.

Elizabeth May: Mr. Speaker, I wish the story of the hon. member for Timmins—James Bay about someone showing up with an envelope full of cash was unusual in this business. I was shocked to hear from experts in the Therapeutics Initiative, and this is a stunning statistic, that for every doctor in Canada, there are three drug salesmen. There are conferences. A seminar on a new drug happens to be held in Hawaii.

In his book, the hon. member for Oakville tells a story that I found at page 253. In referring to his time as a member of the provincial legislature in Ontario, he writes:

The Big Pharma lobbyists are nice people. They have a job to do. And in most cases it includes spreading around a lot of money. They do it subtly. There is no quid pro quo. “Hey, if I buy you dinner…will you speak up to help get our drug approved…?” But before you finish the last bit of your beef tenderloin, you will have heard the marvellous story of how their drug keeps patients out of the hospital and saves the taxpayers hundreds of millions.

There is the pressure from the pharmaceutical lobby and the quite inappropriate distribution of gifts. As the hon. member for Timmins—James Bay said, the fact is that there is a litany. I did not mention Abbott, which blocked 23 states from obtaining a cheaper alternative to their cholesterol drug. They were fined $22.5 million in 2010 for blocking jurisdictions in the U.S. from accessing a cheaper version of the drug that works just as well.

Let us pull back the blinds on the pharmaceutical industry, which spends more money to find a cure for baldness than it does to deal with malaria. Let us look at the profit motive, which is insidious, and find more ways to get generics out there. Let us look very closely at trade agreements like CETA and the trans-Pacific trade partnership and see what that is doing to advance the profits of pharmaceutical companies at the expense of the people they are supposed to be curing.

Carol Hughes: Mr. Speaker, I really appreciate my colleague’s comments. The member for Timmins—James Bay also emphasized prevention.

Every year, 150,000 Canadians experience serious reactions to prescription drugs. We have been waiting for this bill for a long time. The Liberals were in power for 13 years, and they did nothing to ensure that drugs in Canada are safe.

Given that 19.8% of the new active ingredients approved by Health Canada between 1995 and 2010 later became the subject of serious warnings, does my colleague think that this bill will address all of our concerns? Is there any way this bill can be improved?

Elizabeth May: Mr. Speaker, I would like to thank my colleague from Algoma—Manitoulin—Kapuskasing.

I completely agree with her. There is no doubt that Bill C-17 is very important. This is a brave step forward in the interest of everyone’s well-being.

However, we have to improve it, and I hope we can do that quickly. I believe everyone here agrees on that. The minister herself even said that she is ready to accept amendments.

We have to take decisive action against dangerous drugs. We have a once-in-a-generation chance to make sure this bill is as strong as possible.

Carol Hughes: Mr. Speaker, this is really an important piece of legislation. As we said, it has been a long time coming. The Liberals certainly did not act on this issue. Given that we see a government that is going in the right direction but that sometimes thinks that what it has put forward is the be-all and end-all, it is again important to indicate that there needs to be oversight with respect to the amendments that will be put forward. Certainly our party is willing to put amendments forward once it goes to committee, but we should not be rushing legislation in the House just so it can get to committee for discussion and have the government members not even look at those amendments. Those are extremely important.

I know that my colleague is well aware of the Auditor General’s report in 2011 on this issue, but I am asking if she thinks the bill is comprehensive enough. I am sure her answer will be “Of course not, because we have talked about amendments”, but maybe she can elaborate a bit on some of the other safety aspects that we should be putting in place.

Elizabeth May: Mr. Speaker, in terms of the comprehensiveness of the bill, it certainly addresses a lot of the right areas, and a lot will remain to be done by regulation.

We want to see the transparency that I referred to around all trials. All drug trials should be registered and their results made public. We want to see transparency around Health Canada’s decisions on whether it is going to allow a drug or not, around the area of fines, and around drug recalls. We need to have much better information on the side effects of prescription drugs. As well, the labelling should be as clear as possible so that anyone with a prescription drug is able to see, without having to search out secondary materials, whether there are significant side effect risks with this drug.

Those pieces are coming in subsequent regulations, but when we go to committee, we will study it more closely. We are in somewhat of a hurry, because the sooner we act, the more Canadians can be protected from drugs that they never would have used if they had known of their health risks.