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

An Act to amend the Food and Drugs Act

This bill was last introduced in the 41st Parliament, 2nd Session, which ended in August 2015.

Sponsor

Rona Ambrose  Conservative

Status

This bill has received Royal Assent and is now law.

Summary

This is from the published bill. The Library of Parliament often publishes better independent summaries.

This enactment amends the Food and Drugs Act regarding therapeutic products in order to improve safety by introducing measures to, among other things,

(a) strengthen safety oversight of therapeutic products throughout their life cycle;

(b) improve reporting by certain health care institutions of serious adverse drug reactions and medical device incidents that involve therapeutic products; and

(c) promote greater confidence in the oversight of therapeutic products by increasing transparency.

Elsewhere

All sorts of information on this bill is available at LEGISinfo, provided by the Library of Parliament. You can also read the full text of the bill.

September 27th, 2018 / 10:15 a.m.
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President and Chief Executive Officer, Canadian Organization for Rare Disorders

Dr. Durhane Wong-Rieger

First of all, we want to make sure we do not have the barriers that the proposed reforms to the PMPRB would have, and that is to discourage countries from coming in.

I think we want to talk about having a national program that would allow us to bring in all of those patients. The numbers are small, so we're not going to be able to....

Most of these drugs have to come into specialty clinics, so we have a proposal for a rare disease strategy that would also include centres of excellence. They would include the ability to do what we call a life-cycle approach. We can bring in the drugs. We can identify early on, as we're bringing them in, which patients are going to be immediately eligible—like those with ALS—and which ones are not at all going to be eligible, set up a monitoring program for them to have access to it, and then over time, as we are learning from those patients who are on it....

In the old days, we would call it post-market monitoring. As Cathy talked about, under the new bill, Bill C-17, we can enforce those kinds of post-market monitoring programs that we can learn from.

We have a lot of tools at our disposal and, quite frankly, we do not necessarily need to invent them. We can look at some of the model programs we've put together. Canada knows how to do this. We already have these kinds of monitoring programs with very specific drugs, but we want to be able to make that the standard, make it so we can do it nationally, which we don't necessarily do well, and then not wait until we've gone through two more years of negotiations before we implement it.

We know how to do it. We just need to make sure we put that template in place and have the specialty clinics that are there also able to support the use of them, and, as she talked about, the administration of them, and the ongoing data collection to make sure they're used appropriately and, at the end of the day, price readjustment.

September 27th, 2018 / 9:30 a.m.
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Director General, Biologics and Genetic Therapies Directorate, Health Products and Food Branch, Department of Health

Catherine Parker

You are correct that in 2012 the Minister of Health announced that Canada was going to proceed with the development of an orphan drug framework for Canada. We advanced a significant amount of work under that project. Most notable was the enactment of Bill C-17, Vanessa's law, which gave the regulator under the Food and Drugs Act many more powers that would be useful, especially in the rare disease space.

At that time we also considered going forward with a specific set of regulations. We decided on a change of course in this respect. We had conversations and dialogue with our international regulatory partners on some of the challenges they face because they had specific legislation for orphan drugs. We ultimately decided not to proceed with specific regulations, but through a regulatory review of drugs and devices initiative, we incorporated new processes and new pathways that could be very valuable for the approval of orphan drugs and also for some other products.

May 30th, 2016 / 5:15 p.m.
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Conservative

Colin Carrie Conservative Oshawa, ON

Dr. Tamblyn, I think that's a great idea on the adverse drug events. I mentioned Vanessa's Law and the safety component. What kind of doctor uptake and buy-in are you getting with this adverse drug reaction reporting? Do you have an update on how things are going with Vanessa's Law?

Professor Herder, do you?

May 30th, 2016 / 5:15 p.m.
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President and Chief Executive Officer, Canadian Organization for Rare Disorders

Dr. Durhane Wong-Rieger

That means that a lot of these drugs come in with conditional approvals, and that's really important. I think the conditions, as you say, under Vanessa's Law, allow us to be able to hold companies accountable. But the other thing is to engage the patient community, because we get a lot of push-back that says, gee, what if we've started drugs, and we have stop criteria, and the patients don't want to come off them—

May 7th, 2015 / 5:10 p.m.
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Deputy Minister, Department of Health

Simon Kennedy

Yes, I can certainly assure the member that the Health Canada funding as regards water and safe water...and in the specific case of Health Canada our role is around testing. There are other elements that belong to Aboriginal Affairs, and so on, but certainly that funding continues and is not lapsing.

If I could just for a moment come back on Vanessa's Law, there is an injunction power under the legislation that would allow us to step in very quickly if there was an issue around advertising. I just wanted to close the loop on that.

May 7th, 2015 / 5:10 p.m.
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Deputy Minister, Department of Health

Simon Kennedy

Thank you very much for the question.

There's a variety of quite powerful provisions that have come into force under Vanessa's Law, and unfortunately I'm not able to cite the specific one with relation to advertising or how it applies, but I could come back to the committee.

For example, under the rules now we're able to have the courts impose penalties including jail time and fines of up to $5 million per day instead of the current $5,000 per day. Drug companies are compelled to revise labels to reflect new risk information, including updates for health warnings for children. Recalls on unsafe products require stronger surveillance. There's a very wide range. This is a law with very strong teeth.

My apologies, I'm trying to remember but I don't have at my fingertips the specific provisions on advertising. I think the general principle is that we're going to look at being a lot tougher on these kinds of violations in the future.

May 7th, 2015 / 5:05 p.m.
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Conservative

Terence Young Conservative Oakville, ON

Okay I'll be fast.

Mr. Kennedy, last year at the Toronto airport I came in one night and there were these advertisements, these big, high signs about eight feet high, in bright colours, you couldn't miss them, and they said, “Humira”. Now, I know disease awareness advertisements are allowed under the current law, but this isn't a disease awareness advertisement, this is a drug advertisement.

It has the name of a very expensive drug that costs about $22,000 a year for treating rheumatoid arthritis, juvenile arthritis, and Crohn's disease. The reason they're not supposed to advertise prescription drugs is that they all have dangers and a doctor should be deciding. No one should make a decision to take a prescription drug without consulting an expert first. The adverse effects from Humira are that it can cause cancer and it can cause tuberculosis. It's definitely not a decision that you want to make while you're walking by with your suitcase in an airport.

What can we do under Vanessa's Law, or what can you do or what do you intend to do to stop drug companies from planting seeds in people's heads to try to get around their doctors so that they decide to take a drug before they know anything about it?

May 7th, 2015 / 4:35 p.m.
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NDP

Murray Rankin NDP Victoria, BC

Thank you very much.

Thank you very much, officials, for being here. As I said earlier I appreciate it. I'd like to first talk about off-label use of drugs as an issue. That is the misleading advertising for unapproved uses of drugs. The International Journal of Risk and Safety examined how Health Canada regulates and enforces Canadian drug advertising. It reviewed complaints for a decade between 2000 and 2011, and it concluded that Health Canada was not doing enough.

The official opposition asked an order paper question that revealed Health Canada received 359 complaints about pharmaceutical advertising, but didn't levy a single fine in response. They wrote letters and Health Canada “worked with them to achieve compliance”. There are big fines under the amendments of Vanessa's Law to the Food and Drug Act, big fines of $500 million and so forth, but if you don't enforce them why would anybody take it seriously?

We appreciate your having to work with companies to achieve compliance, but if there are no teeth in the rules prohibiting it, why are they ever going to comply or ever going to do the right thing? If you just get a warning letter, what does it matter?

May 7th, 2015 / 4:20 p.m.
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Conservative

Terence Young Conservative Oakville, ON

—but Vanessa's Law gives a place for them to go where something will be acted on.

May 7th, 2015 / 4:15 p.m.
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Conservative

Terence Young Conservative Oakville, ON

Thank you, Minister, for joining us today, and to everyone else who came.

Before I ask my question, I would like to congratulate you and Health Canada on the anti-drug online and television ads, which we saw, which you commissioned. I thought they were very effective. Obviously, they would get the viewer's attention. It appeared as if they were slanted toward young people, which is very important, before they decide to try drugs, so they are aware that they would be very bad for their health. I thought they were excellent so I wanted to congratulate you on them.

As you know, Minister, drug safety issues have been a focus of my life for many years, so I was very pleased to have had the opportunity to take part in our review of Vanessa's Law. We ensured that the final wording of the bill addressed long-standing issues that drug safety experts have been raising for years about the lack of transparency by Health Canada.

When we're drafting legislation on issues as important as drug safety, it's absolutely essential that we listen to the experts and accept good advice when it is offered. Your openness to hearing that advice has strengthened the bill, and I believe it will serve to strengthen our drug safety system for years to come.

We have now had the law passed for some time. I know that a number of measures are undergoing consultation to ensure that the details are implemented effectively; in other words, we're going to get it right. Can you please provide some additional details to the committee about the continuous monitoring of the development of these powers that have been put in place?

May 7th, 2015 / 3:45 p.m.
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Simon Kennedy Deputy Minister, Department of Health

Thanks, Minister.

On this particular case, the original submission was made under the access to information rules. The ministry is obliged to apply the access law, which does require a number of exemptions for business information and so on.

With new authorities under Vanessa's Law, there is this other avenue we can use to make information available where there is a health or safety threat. We've spoken to the researcher in question, and we sent him a fairly detailed letter to explain the process to make an application under Vanessa's Law. That conversation is going on and our hope would be to be able to move through that avenue to deal with the issue.

May 7th, 2015 / 3:45 p.m.
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Conservative

Rona Ambrose Conservative Edmonton—Spruce Grove, AB

I sympathize with his experience.

Under Vanessa's Law, the intention is to make clinical trial information available, but still to some extent—and for legal reasons obviously—protect confidential business information. Our intention under Vanessa's Law—and it's my belief—is that we should be sharing as much as we possibly can.

On that specific one, I think that's still under way, but I know Simon is working on that.

May 7th, 2015 / 3:45 p.m.
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NDP

Murray Rankin NDP Victoria, BC

I appreciate that.

As you speak of transparency, that takes me to Vanessa's Law, to which you made reference earlier.

Toronto doctor, Nav Persaud, made an information request to Health Canada to get clinical trials on a pregnancy drug, an anti-nausea drug called Diclectin. He tried that three and a half years ago. He finally got 359 pages, 212 of which were completely redacted or censored.

In March, after Vanessa's Law came in, he resubmitted the request for all of the 359 pages, and so far has been given nothing. I got that as recently as two days ago in a letter. The clinical trial data was something that was to be made available, as I understood it, under Vanessa's Law. His experience has been entirely frustrating.

May 7th, 2015 / 3:40 p.m.
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Conservative

Rona Ambrose Conservative Edmonton—Spruce Grove, AB

First of all, let me say it's important that we remember this tragic event that happened in the 1960s, reflect upon the good work of this committee around Vanessa's Law, and remember why it's so important that we have strong drug safety laws in this country.

Our government has very deep sympathy for what happened. While this happened in the sixties, I offered our government's and all Canadians' public regret and apologies to those who were affected by thalidomide. We know we can never undo the pain and suffering that people have experienced.

I had an opportunity to meet a few times with Mercedes Benegbi, who is the head of the Thalidomide Victims Association of Canada. As you know, we did announce $180 million to be distributed among the survivors. I'm pleased to say that we've been able to get out the $125,000 tax-free lump sum immediately to survivors. The reason we worked very quickly is that it will take us some time to get the yearly pension set up with the other $168 million we have. Also, we have an extraordinary medical assistance fund. We're in the middle of working out the details of that.

May 7th, 2015 / 3:30 p.m.
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Edmonton—Spruce Grove Alberta

Conservative

Rona Ambrose ConservativeMinister of Health

Thank you very much, Mr. Chair, and thank you to the committee. I want to thank all of you for the work you do on the health committee. I know many of you are passionate about the issues of health, and I thank you for your commitment to that.

I'm joined by Simon Kennedy, Health Canada's new deputy minister; Krista Outhwaite, our newly appointed president of the Public Health Agency of Canada; and Dr. Gregory Taylor, whom you've met before, Canada's chief public health officer. I know he'll be here for the second half. You might want to ask him about his trip to Guinea and Sierra Leone to visit our troops and others who are working on the front dealing with Ebola. I'm sure he'll have some great things to share with you.

Michel Perron is here on behalf of the Canadian Institutes of Health Research. He's also new. Last time I know you met Dr. Alain Beaudet.

We also have Dr. Bruce Archibald, who's the president of the Canadian Food Inspection Agency. I think you've met Bruce as well.

Mr. Chair, I'd like to start by sharing an update on some of the key issues that we've been working on recently. I'll begin by talking about Canada's health care system, the pressures it's facing, and the opportunities for improvement through innovation. I will then highlight some recent activities on priority issues such as family violence and the safety of drugs in food.

According to the Canadian Institute for Health Information, Canada spent around $215 billion on health care just in 2014. Provinces and territories, which are responsible for the delivery of health care to Canadians, are working very hard to ensure their systems continue to meet the needs of Canadians, but with an aging population, chronic disease, and economic uncertainty, the job of financing and delivering quality care is not getting easier.

Our government continues to be a strong partner for the provinces and territories when it comes to record transfer dollars. Since 2006, federal health transfers have increased by almost 70% and are on track to increase from $34 billion this year to more than $40 billion annually by the end of the decade—an all-time high.

This ongoing federal investment in healthcare is providing provinces and territories with the financial predictability and flexibility they need to respond to the priorities and pressures within their jurisdictions.

In addition of course, federal support for health research through the CIHR as well as targeted investments in areas such as mental health, cancer prevention, and patient safety are helping to improve the accessibility and quality of health care for Canadians.

But to build on the record transfers and the targeted investments I just mentioned, we're also taking a number of other measures to improve the health of Canadians and reduce pressure on the health care system. To date we've leveraged over $27 million in private sector investments to advance healthy living partnerships. I'm very pleased with the momentum we've seen across Canada.

Last year we launched the play exchange, in collaboration with Canadian Tire, LIFT Philanthropy Partners, and the CBC, to find the best ideas that would encourage Canadians to live healthier and active lives. We announced the winning idea in January: the Canadian Cancer Society of Quebec and their idea called “trottibus”, which is a walking school bus. This is an innovative program that gives elementary schoolchildren a safe and fun way to get to school while being active. Trottibus is going to receive $1 million in funding from the federal government to launch their great idea across the country.

Other social innovation projects are encouraging all children to get active early in life so that we can make some real headway in terms of preventing chronic diseases, obesity, and other health issues. We're also supporting health care innovation through investments from the Canadian Institutes of Health Research. In fact our government now is the single-largest contributor to health research in Canada, investing roughly $1 billion every year.

Since its launch in 2011, the strategy for patient-oriented research has been working to bring improvements from the latest research straight to the bedsides of patients. I was pleased to see that budget 2015 provided additional funds so that we can build on this success, including an important partnership with the Canadian Foundation for Healthcare Improvement.

Canadians benefit from a health system that provides access to high-quality care and supports good health outcomes, but we can't afford to be complacent in the face of an aging society, changing technology, and new economic and fiscal realities. That is why we have been committed to supporting innovation that improves the quality and affordability of health care.

As you know, the advisory panel on health care innovation that I launched last June has spent the last 10 months exploring the top areas of innovation in Canada and abroad with the goal of identifying how the federal government can support those ideas that hold the greatest promise. The panel has now met with more than 500 individuals including patients, families, business leaders, economists, and researchers. As we speak, the panel is busy analyzing what they've heard, and I look forward to receiving their final report in June.

I'd also like to talk about another issue. It's one that does not receive the attention that it deserves as a pressing public health concern, and that's family violence. Family violence has undeniable impacts on the health of the women, children, and even men, who are victimized. There are also very significant impacts on our health care and justice systems.

Family violence can lead to chronic pain and disease, substance abuse, depression, anxiety, self-harm, and many other serious and lifelong afflictions for its victims. That's why this past winter I was pleased to announce a federal investment of $100 million over 10 years to help address family violence and support the health of victims of violence. This investment will support health professionals and community organizations in improving the physical and mental health of victims of violence, and help stop intergenerational cycles of violence.

In addition to our efforts to address family violence and support innovation to improve the sustainability of the health care system, we have made significant progress on a number of key drug safety issues. Canadians want and deserve to depend on and trust the care they receive. To that end, I'd like to thank the committee for its thoughtful study of our government's signature patient safety legislation, Vanessa's Law. Building on the consultations that we held with Canadians prior to its introduction, this committee's careful review of Vanessa's Law, including the helpful amendments that were brought forward by MP Young, served to strengthen the bill and will improve the transparency that Canadians expect.

Vanessa's Law, as you know, introduces the most significant improvements to drug safety in Canada in more than 50 years. It allows me, as minister, to recall unsafe drugs and to impose tough new penalties, including jail time and fines up to $5 million per day, instead of what is the current $5,000 a day. It also compels drug companies to do further testing and revise labels in plain language to clearly reflect health risk information, including updates for health warnings for children. It will also enhance surveillance by requiring mandatory adverse drug reaction reporting by health care institutions, and requires new transparency for Health Canada's regulatory decisions about drug approvals.

To ensure the new transparency powers are providing the kind of information that Canadian families and researchers are looking for, we've also just launched further consultations asking about the types of information that are most useful to improve drug safety. Beyond the improvements in Vanessa's Law, we're making great progress and increasing transparency through Health Canada's regulatory transparency and openness framework. In addition to posting summaries of drug safety reviews that patients and medical professionals can use to make informed decisions, we are now also publishing more detailed inspection information on companies and facilities that make drugs. This includes inspection dates, licence status, types of risks observed, and measures that are taken by Health Canada. Patients can also check Health Canada's clinical trials database to determine if a trial they are interested in has met regulatory requirements.

Another priority of mine is tackling the issue of drug abuse and addiction in Canada. There's no question that addiction to dangerous drugs has a devastating and widespread impact on Canadian families and communities. In line with recommendations from this committee, I am pleased that the marketing campaign launched last fall by Health Canada is helping parents talk with their teenagers about the dangers of smoking marijuana and prescription drug abuse. The campaign addresses both of those things, because too many of our young people are abusing drugs that are meant to heal them.

Our government also recognizes that those struggling with drug addictions need help to recover a drug-free life. From a federal perspective, of course, we provide assistance for prevention and treatment projects under our national anti-drug strategy. We've now committed over $44 million to expand the strategy to include prescription drug abuse and are continuing to work with the provinces to improve drug treatment.

I've now met and will continue to meet with physicians, pharmacists, first nations, law enforcement, addictions specialists, medical experts, and of course parents to discuss how we can collectively tackle prescription drug abuse.

Finally, our government continues to make very real investments to strengthen our food safety system. As only the latest example, I recently announced a five-year investment of more than $30 million in the CFIA's new food safety information network. Through this modern network, food safety experts will be better connected, and laboratories will be able to share urgently needed surveillance information and food safety data, using a secure web platform. This will put us in an even better position to protect Canadians from food safety risk by improving our ability to actually anticipate, detect, and then effectively deal with food safety issues. This investment will continue to build on the record levels of funding we've already provided, as well as the improved powers such as tougher penalties, enhanced controls on E. coli, new meat labelling requirements, and improved inspection oversight.

In conclusion, those are just some of the priorities that will be supported through the funding our government has allocated to the Health portfolio. This year's main estimates, notably, include investments for first nations health, for our ongoing contribution to the international response to the Ebola outbreak in West Africa, and the key research and food safety investments that I have already mentioned.

I'll leave it at that. If committee members have any questions, my officials and I would be very pleased to answer them. Thank you.