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Results: 46 - 60 of 666
View Marcus Powlowski Profile
Lib. (ON)
Have they told Cystic Fibrosis Canada that the reason they weren't asking for approval from Health Canada was a result of the proposed changes to PMPRB, and that unless those changes were withdrawn, they wouldn't submit the drug for approval?
Kelly Grover
View Kelly Grover Profile
Kelly Grover
2021-06-04 14:33
They didn't tell us that, but it was said publicly.
View Don Davies Profile
NDP (BC)
Thank you.
When we undertook the study, the analysts from the Library of Parliament told us this about the PMPRB:
...an independent quasi-judicial body whose mandate is to regulate the prices of patented prescription and non-prescription medicines to ensure that the prices are not “excessive“ during [the] period of market exclusivity. It does not have a mandate to set the prices of patented medecines [sic] sold in Canada.
Dr. Batt, in a joint written submission to the committee, you said:
When independent stakeholders and industry representatives hold “divergent and even diametrically opposing points of view,” the PMPRB’s responsibility is not to strike a “balance” between the demands of industry and policies that serve the public interest. The PMPRB’s role is to come down firmly on the side of the public. It is not to protect the payers... and it is definitely not to make concessions to an industry that is far too powerful.
I wonder if you can expand on what you think the role of the PMPRB should be.
Sharon Batt
View Sharon Batt Profile
Sharon Batt
2021-06-04 14:42
I see the PMPRB as a consumer protection organization. I have worked for a consumer protection organization in Quebec, where I was one of the editors of their consumer protection magazine. The concept of a consumer protection organization is that industry is very powerful and that individual citizens are not particularly powerful, and they need the government to step in and take their side when there is a contest between a powerful industry and the public interest.
Pamela Fralick
View Pamela Fralick Profile
Pamela Fralick
2021-06-04 14:46
Mr. Chair and honourable members, thank you for the opportunity to present today. I'm joined, as you've just heard, by Declan Hamill, our vice-president for policy, regulatory and legal affairs.
We are here on behalf of Innovative Medicines Canada, which represents 47 member companies from the innovative medicines and life sciences sectors. The pandemic continues to underscore the importance of innovative medicines to the health of Canadians. Most importantly, it is demonstrating why timely access to innovative treatments and vaccines is so critical.
It's also one of the reasons we are calling on the government to suspend for the duration of the pandemic the implementation of the Patented Medicine Prices Review Board's regulatory changes, which are set to come into force on July 1.
The government has previously cited COVID-19 as a primary reason for delaying the implementation of the PMPRB's regulatory changes. I think we can all agree that the same rationale applies today. More importantly, delaying these regulatory changes will also ensure that we all have the time needed to re-evaluate the desired policy outcomes, the effectiveness of the consultation process and the premise on which the PMPRB's new regulations were developed.
Since the changes were first proposed, there has been a strong consensus among industry representatives and many stakeholders that the consultation activities were not intended to inform decision-making. From initial steps, which included a 2018-19 steering committee and working group, through to later stages, many points of concern were raised and disregarded.
The lack of meaningful engagement led industry to undertake serious actions, including two Federal Court legal proceedings and a constitutional challenge in Quebec. Most recently, in its submission to the Quebec Court of Appeal, the Attorney General of Quebec submitted that the proposed PMPRB changes infringe on provincial jurisdiction and that therefore all the regulatory changes should be disallowed.
Providing the appropriate time and process to consider any PMPRB regulatory changes will also ensure that any decisions are based on accurate understanding of where Canada stands regarding the price of medications compared to those in other key countries. Contrary to PMPRB's assertions, Canadian drug prices are in the middle of the current list of those of comparative countries, not at the top.
Overall, median international prices were 16% higher than Canadian prices. Increases in the annual Canadian price of patented medicines have been on average less than the rate of inflation as measured by the consumer price index.
Further review will also demonstrate that the price of innovative medicines is not the primary cost driver for Canadian public and private drug plans as PMPRB claims. Rather, increased drug use by Canada's aging population and the related growth in chronic diseases are the primary cost drivers, not the price of medicines. Although the need for Canadians to have access to the most innovative medicines and vaccines is clear, the PMPRB regulatory changes will impact the market incentives that encourage early access availability in Canada.
Information obtained through an access to information request shows that PMPRB's analysis concludes that prices for certain medicines will drop between 90% and 99%. There is a point at which price reductions make it not commercially reasonable for companies to introduce drugs for approval in Canada or alternatively that they will be introduced significantly later. This is already an issue in Canada.
Independent data sources show that Canadians have access to only 48% of all new medicines launched globally, which means we are behind countries like the U.K., Germany, Japan, and France. This gap in access will increase if the proposed PMPRB changes proceed.
Additional time to consider PMPRB regulatory changes will also provide an opportunity to reflect on the true breadth of the Canadian biopharmaceutical sector's economic contributions. According to a recent report from Statistics Canada, the sector generates almost $15 billion in economic activity and $2 billion annually in R and D spending. Calculations based on this data put the industry's ratio of R and D to sales ratio at 8.8%, which is more than twice that reported by PMPRB, which uses a 1987 definition of research and development.
To be clear, our industry is not opposed to modernizing PMPRB, but we believe it can be done in a way that maintains patient access to new treatments and medications, builds on Canada's talent and expertise, and attracts international investment.
A vibrant life sciences sector in Canada starts with clear and balanced policy objectives. We believe a whole-of-government approach involving Health Canada, Innovation Science and Economic Development, Finance and International Trade is essential. It also includes fair and accurate reporting on patented medicine pricing, on understanding the real cost drivers to the system and prioritizing the value of saving lives.
IMC and our international counterparts remain committed to working with the federal government and all stakeholders. Our global CEOs have reached out to the Prime Minister on several occasions over the past three years, hoping to engage in collegial and collaborative dialogue, and to this day remain keen to develop a productive working relationship.
Thank you for this opportunity to speak with you today. I respectfully request that the committee recommend that the government delay the implementation of the PMPRB’s regulatory changes.
We look forward to answering your questions.
View Marcus Powlowski Profile
Lib. (ON)
What would you suggest in response to Ms. Little's point about the price that the drug company is asking for the treatment of her daughter's cystinosis? The system would seem to have failed if they're asking for $100,000 and there's nothing we can do about it.
If, for example, Vertex is not bringing the drug to market, does that not suggest to you that the present system is failing?
Christopher McCabe
View Christopher McCabe Profile
Christopher McCabe
2021-06-04 15:16
I would say that both of those are credible examples of the system failing, and the government should take seriously its responsibilities to its citizens and certainly entertain the use of it.
The U.K. government did entertain the use of its rights around a very expensive breast cancer drug, which helped to trigger a negotiation that otherwise might well not have happened. These tools are there for a reason and are used sparingly but effectively, and I wouldn't criticize anyone who used them in both of the cases you identified.
View Luc Thériault Profile
BQ (QC)
View Luc Thériault Profile
2021-06-04 15:20
Thank you, Mr. Chair.
We have a situation where people are claiming that we need to implement the reforms as they stand and that the pharmaceutical companies are indeed bluffing. They believe that the drug companies are not going to leave, that clinical trials are going to continue and that patients will face no consequences, even though we have no innovation strategy, even though we separate health from innovation and from research and development, and even though we have no really effective rare disease strategy in place. Some people feel that there will be no impact. Some people feel there are risks.
Ms. Fralick, I'd like to know what Canada represents in the global market. We can always target Vertex, but if it simply didn't start clinical trials here, we would have access to those drugs six to eight years down the road, right?
No one is going to be able to single out anyone, because it's a global free market. Am I mistaken?
View Luc Thériault Profile
BQ (QC)
View Luc Thériault Profile
2021-06-04 15:22
Mr. Chair, can we start over? I will quickly repeat my question.
What weight does Canada carry on the global market?
Can we really believe that companies are bluffing when they say there will be fewer clinical trials?
Pamela Fralick
View Pamela Fralick Profile
Pamela Fralick
2021-06-04 15:23
There are many elements to your question. We already lag behind our international peers in terms of the numbers of new products launched. This would be my first point. It's critical that the PMPRB does not further erode Canada's status in that global market.
At the moment, Canadians only have access to 48% of all new medicines launched globally. That compares with 64% in Germany and 60% in the U.K. We've talked about that before and there is, of course, more in the U.S. Only 25% of all medicines are available in Canada within the first year of international launch compared with a higher percentage in Germany, the U.K. and the U.S.
There is also a time lag that has been referred to. I'll include that in my comments because you're asking about the international status of Canada. Canadians wait an average of 17 months from the first international launch, whereas medicines are available far sooner in other countries—for example, 11 months in Germany, 12 months in the U.K. and four months in the U.S., so we're already at a disadvantage.
You asked specifically about clinical trials, but if there's time, I'll add a bit more. The industry, first of all, is extremely important to Canada in its support of clinical trials. Between 65% and 75% of clinical trials initiated in Canada in every quarter since 2015 have sponsored by industry.
According to the data we have been collecting, there's been a decrease of about 20%, compared with the previous three years, in clinical trials being launched in this country. Some of that might be due to COVID. I know that someone raised that point, but we're looking at data across quite a period of time.
I have other data points on impact, but I will stop there in deference to your question.
View Don Davies Profile
NDP (BC)
Thank you.
Ms. Little, first of all, thank you for sharing your very personal experience, and best wishes to your daughter.
You made reference to the fact that the molecules involved in the medicine that helps your daughter were discovered in the 1950s, and if I understand correctly, all that changes is that a pharmaceutical company takes the same molecule, changes the delivery system and charges, if I may say, an outrageously expanded amount of money for it.
Can you explain that in detail to us?
Erin Little
View Erin Little Profile
Erin Little
2021-06-04 15:28
Yes.
The active ingredient, cysteamine, is in all four of the products that I previously talked about. With cysteamine, the hardest part of almost any treatment, if you ask any patient, is the side effects. The side effects of cysteamine are from all drugs. When they took Cystagon and turned it into Procysbi.... Cystagon has to be given every four hours and Procysbi has to be given every two hours.
I wholeheartedly support this drug being here in Canada and Canadians having access to it. If Olivia were a 26-year-old woman managing a relationship and career, of course I would want her to have a drug that makes compliance easier. The problem is that all of the side effects are still the same: gastro upset, making patients smell, loss of or poor appetite, gas, bloating...just horrendous things that nobody wants to deal with.
The difference between Cystagon and the Procysbi was that they enteric-coated the latter, so it releases differently. Is it worth that? That's not for me to decide, but a drug—an active ingredient—that's been around for decades and was first introduced as a treatment in 1994 for patients...I find it unjustifiable and with the—
View Don Davies Profile
NDP (BC)
Erin Little
View Erin Little Profile
Erin Little
2021-06-04 15:29
The drug is based on weight, I just have to point out. There is the two-year-old who takes Procysbi for $56,000 a year versus Olivia who takes Cystagon at $18,000 a year. If Olivia were on Procysbi, she would have to take a higher dose, which would result in more money.
The compounded eye drops that have been safe, effective and on the market for years are $3,000 a year. The new drops are $120,000 a year. Again, they do offer easier compliance, but the drug is the same.
View Don Davies Profile
NDP (BC)
No, that's good.
I'm going to spend a bit of time on the last one, because I think Trikafta is a very interesting example of this. I think every single Parliamentarian wants every single Canadian who needs Trikafta to get access to it, and that's not happening today.
Here's a brief history of it. We know that it was a research team at the Hospital for Sick Children at the University of Toronto that discovered a CF gene in the 1980s. It was the Canadian Cystic Fibrosis Foundation and clinics that identified almost all of the research subjects from families in Canada. They donated blood samples. The Canadian Cystic Fibrosis Foundation and the Canadian Institutes of Health Research supported the research. CFF gave $150 million to Vertex in 2000 to do the research.
When the company finally launched the precursor to that, Kalydeco, they priced it at $294,000 annually for two pills a day. Twenty-nine researchers contacted them; they wrote Vertex's CEO to express their dismay and disappointment that this successful drug was diminished by this “unconscionable price”, in their words.
Aidan Hollis, whom you reference, studied Vertex's pricing for Kalydeco and Orkami—a precursor as well to Trikafta—estimates that the company's profits from the two drugs will be $21.1 billion. He concludes that the high prices are not justified by costs or the need to support the innovation. The price seems more designed to reward shareholders.
My question is, what can we do to get Trikafta into the hands of Canadians? Is it time that the Canadian government used compulsory licensing? If this company won't apply to Health Canada to make this drug available, should we exercise our right to compulsory license that drug? Finally, how many times has the Canadian government used compulsory licensing?
Results: 46 - 60 of 666 | Page: 4 of 45

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