Evidence of meeting #24 for Health in the 45th Parliament, 1st session. (The original version is on Parliament’s site, as are the minutes.) The winning word was companies.
A recording is available from Parliament.
Conservative
Matt Strauss Conservative Kitchener South—Hespeler, ON
Okay, thank you.
Dr. Somers, I was excited that you came to speak to us today. You said a number of very interesting things. The first thing I'll ask you is whether I got your comments correct when I put them to Mr. Watson that, to your knowledge, Canada is a bit peculiar and that the reporting requirements for opioid manufacturers are different than in other jurisdictions.
Full Professor, As an Individual
The key point I made was not related to volumes of drugs and that tracking, but rather the fact that providing funding, direct funding to universities, to clinicians, to researchers is disclosed only on a voluntary basis, and so a fraction of the money that is allocated by pharmaceutical companies in Canada for those purposes—
Conservative
Matt Strauss Conservative Kitchener South—Hespeler, ON
I'm sorry if I misrepresented your comments, and I'll just put those back to Mr. Watson.
Does Apotex give money to universities for research in the way that Dr. Somers is describing, and is that not tracked or declared?
President and Chief Executive Officer, Apotex Inc.
Once again, we're a generic pharmaceutical company. We don't fund research. Whether we have any relationships related to a generic portfolio, I'm not aware of that, but we are not....
Conservative
Matt Strauss Conservative Kitchener South—Hespeler, ON
Dr. Somers, I read in the news about your being ordered to destroy your research data by the B.C. government. Is that true, and is that even legal for them to ask you to do that?
Full Professor, As an Individual
It's an extraordinary step, and yes, that was correct. We had some over 20 years of research data collected over pharmaceutical trials, randomized trials, other studies involving addiction drug treatment court, a whole variety of interventions designed with collaborators around the world. One week after the B.C. government learned that we had those data and were mobilizing to evaluate their current drug policies, we received a letter ordering us to destroy everything, effectively undermining our ability to do that work that had already been funded and approved.
Full Professor, As an Individual
Can I shoehorn a clarification in?
I had to think about this term “sovereignty” before appearing here today. My understanding is that the committee's interest is both in the meaning of sovereignty as it relates to internal autonomy and agency, as well as security of freedom from external actors and threats and that meaning of sovereignty. From my perspective, knowing that Canada is—
Conservative
The Vice-Chair Conservative Dan Mazier
Sorry, but we do have time limitations here.
If you want to submit a paper on that, please by all means submit that to the committee and we'll take those comments under consideration.
Liberal
Sonia Sidhu Liberal Brampton South, ON
Thank you, Mr. Chair.
Thank you, witnesses.
My question is for Mr. Watson.
If the federal government were to adopt a national strategy of pharmaceutical sovereignty, what three priorities do you believe should be at the centre of ensuring Canadians have reliable, affordable access to essential medicine? You already talked about sustainable pricing, but give three priorities, if you can speak to that.
President and Chief Executive Officer, Apotex Inc.
First of all, we do have a backlog of products waiting for approval, and I would say bringing new products to market sooner is one. By the way, a couple of years ago, three years ago maybe, I think Health Canada was leading the way on time to market and approvals to the point where you had regulators like the FDA trying to understand what were some of the key processes that Health Canada was using. This is something that the country definitely knows how to do and has done. I think there's unleashing that backlog, which would once again continue to bring more innovation from the generic side into the market and all of a sudden continue to offer more affordable medicines out to the marketplace.
The second thing would be to prioritize Canadian local manufacturers and find ways to incentivize local manufacturers to continue to invest in Canada, continue to bring products here in Canada and manufacture in Canada and be given credit for domestic manufacturing for those products.
Liberal
Sonia Sidhu Liberal Brampton South, ON
To follow up on that, from an industry perspective, what types of tax incentives, such as tax credits or regulatory reforms or direct investments, would most effectively encourage companies to expand pharmaceutical manufacture in Canada?
President and Chief Executive Officer, Apotex Inc.
I would defer to Terry, but I'd be happy to comment after Terry from a company perspective.
President, Canadian Pharmaceutical Manufacturers and Exporters Alliance
We've looked at this quite closely, and we have developed a list of tax incentives and depreciation incentives that we have submitted to the Department of Finance as part of our budget submission, which I think you will be receiving as part of this deliberation. These are things like a refundable tax credit for the manufacturing of medicines in Canada.
The premise here is we are suggesting that pharmaceutical production be treated as a critical industry similar to other critical industries that receive tax and favourable economic support from the federal government as part of a broader strategy. It's something that's desirable in Canada. We should support it.
We have also recommended that the depreciation allowance for equipment be increased. We have recommended that the tax deductibility for investments not be capped.
There was, in the past, a tax credit given to drug companies for donating medicines for charitable purposes. That tax credit was removed a few years ago. We think that should be restored.
Liberal
Sonia Sidhu Liberal Brampton South, ON
I just want a clarification.
I'm hearing here that Health Canada's approval of any drug is done in 180 days. I think there are major delays in approvals after that, after Health Canada's approval. I think there is more procedure on that, but Health Canada's record for the approval of any new drug is 180 days.
President, Canadian Pharmaceutical Manufacturers and Exporters Alliance
That is the target, but it's rarely met. I think that's what my colleague, Jim, was referring to in particular. Although there are targets and a process in place that are covered by the user fees that drug companies submit to Health Canada, there is a mechanism that enables Health Canada to send it back on the 179th day. That's the concern we have, that they are not reaching their own milestones.
President, Canadian Generic Pharmaceutical Association
I think their failure to reach their milestones costs Canadians and the health care system substantially. Generic medicines come on the market at much lower pricing, so when they're delayed, the programs have to pay the higher brand prices for longer.
The other thing it does is.... A company invests in developing the product. It does the formulations, the studies and the clinical trials. It submits it to Health Canada. The company is waiting to get an approval. It's trying to plan its production processes, etc. Health Canada now is unable in many, many cases to tell a company when it might get a final decision. This does affect investment and the ability to produce these products in Canada and make them available to Canadians.
I've talked quite a bit today about Health Canada. It is critical that they have good resources, expert resources, and that they review products and give good decisions on time.
Conservative
Conservative
Burton Bailey Conservative Red Deer, AB
Thank you, Mr. Chair.
My question is for Ms. Hamelin.
Earlier, we talked a little bit about the approval process. I don't want to hear it from start to finish, but could you outline some of the things you haven't heard that you think would be beneficial in this process, things that we need to improve so that Canadians can get access to treatments more quickly and reliably?
President and Chief Executive Officer, Innovative Medicines Canada
That is an excellent question, Mr. Chair.
There are numerous duplicative processes that are applied in Canada between the submission of a new innovative medicine to Health Canada and that medicine actually coming onto a public formulary so that Canadians have access to it. On average, that time frame—between the beginning of the regulatory review and the formulary listing—is three and a half years after a medicine is launched, for example, in the U.S. or in Canada.
The process starts with regulatory review at Health Canada. That is followed by what is called a health technology assessment by Canada's Drug Agency, followed by lengthy negotiations around pricing with the pan-Canadian Pharmaceutical Alliance. That is followed by negotiations with each of the provinces and territories. Many of the processes are duplicative, and they are not happening in parallel. They are sequential, and that adds a tremendous amount of time. For a patient with cancer who is waiting for this new cancer medicine, it can be a question of life or death.
That really needs to be addressed. It becomes a much more pivotal issue in the context of the U.S. highlighting the pricing in Canada. Canada is one of the eight countries with most favoured nation pricing, and the U.S. is really putting that in the limelight. That puts a great amount of risk on medicines being launched here because we don't have this clear, predictable, supportive policy environment that is needed to actually launch medicines here.
We actually have some numbers from our membership which suggest that already at least 10 medicines have not been launched in Canada in the past few months because of the uncertainty that is created by the most favoured nation pricing policy that's triggered by the U.S. That is significant for Canada. It involves mostly cancer medicines.
Conservative
Burton Bailey Conservative Red Deer, AB
You mentioned price reform. How can we be assured that the pharmaceutical companies are engaging in transparent communication with Canadian-based innovation, so that we are getting the best prices for Canadians?
It will have to be a very short answer.