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Pamela Fralick, President, Innovative Medicines Canada (IMC)

Pamela Fralick, President, Innovative Medicines Canada (IMC)

22 March 2023

Canada presently accounts for roughly 1-2% of the global pharma R&D investment. What makes the country attractive for companies in this sector?

It’s worth clarifying that 1-2% actually puts us amongst the top 10 countries in the world in terms of the overall innovative pharmaceutical market. That makes Canada a key destination for the innovative pharmaceutical industry. We have an extremely high reputation, firstly due to the quality of our universal health system – it’s not perfect of course, but no Canadian will go bankrupt to access the physician and hospital services they need. Our research institutions are world-recognized, as is the quality of our researchers. We have a bit of a challenge, in fact, because other countries want to hire our talent, so we have to make sure we continue with brain gain, rather than brain drain. 

One differentiator that isn’t mentioned as frequently is our diverse population - Canada is a nation of settlers, along with our Indigenous populations. As a result, we’re able to conduct clinical trials on a broad, diverse population, especially in larger cities like Montreal, Toronto, and Vancouver, which is extremely attractive for the innovative pharmaceutical industry. 

You represent the voices of some of the most innovative pharma companies in the world. What are the main topics that you currently have on your agenda?

The driving force behind our work is ensuring that Canadians have safe and fast access to the most innovative medicines in the world. Everything we do contributes to this particular vision.

 

That being said, one of the challenges we are facing presently is that of the 460 new medicines that came to the market globally between 2012 and 2021 (based on IQVIA data) only 18% are available in Canada through government drug plans, and only roughly 44% are launched in Canada through other plans.

 

We have to unpack these statistics and better understand why that is. 

Another concern is the amount of time it takes to get approved new products to patients, as we do have a complex and rather cumbersome system. We want products to be safe in every respect, however, it is such a lengthy process compared to similar countries. We come in last among the G7 from this perspective, and 19th out of 20 peer OECD countries in the time it takes for patients to access approved new medicines. These two pieces really drive us in all of our work. 

Regarding the long timelines to make innovative medicines available to Canadians, what are some ways in which the process can be improved? Have you identified any particular steps that do not add value? 

When new medicines are introduced, they go to Health Canada which assesses the safety and efficacy of the product. CADTH (The Canadian Agency for Drugs and Technologies in Health) then evaluates the medicines to provide reimbursement recommendations and advice to payers. Following the CADTH recommendation, the pCPA (pan-Canadian Pharmaceutical Alliance), which is made up of Canadian public drug plans, combines their bargaining power to negotiate purchasing arrangements. Finally, and even after these prolonged processes have been completed, companies must still work with individual public drug plans to ensure that drugs are listed and reimbursed. There is no one-stop-shop over here, and each one of these pieces has its own complexities and delays. 

We are in a process to unpack the data and understand how the timelines can be reduced.  However, I would strongly emphasize that nobody in this industry wishes to compromise safety - we want to cut time to patient access to new medicines, not corners. 

We are also looking at some of the lessons learnt during the pandemic. If we were in fact able to change our processes during the pandemic with no risk to safety, could we not apply those lessons to day-to-day work? The federal government recently released a package of regulatory amendments that are intended to implement pandemic drug approval policy efficiencies on a permanent basis. While we are still analyzing the proposed changes, we support the underlying policy objective to make our regulatory process faster and more agile. 

IMC recently called for a suspension of the PMPRB (Patented Medicine Prices Review Board) revised Draft Guidelines. What is the reason behind that?

The PMPRB is a body unique to Canada, whose role is to ensure that the maximum prices of patented medicines are not excessive relative to designated international comparators. The most recent Guidelines proposals are the latest step in a multiyear process that has created significant concerns and uncertainty for industry, patients, and the life sciences community. We are committed to working with the Government and other stakeholders to see if we can get a balanced system consistent with PMPRB’s mandate without negatively impacting access to new medicines or the life sciences sector’s future viability. 

Is there a final message that you would like to leave our audience with?

We are excited to see the Canadian industry growing once again. Recently, we have seen a number of promising developments, including the creation of new vaccine facilities, the expansion of existing manufacturing centers, and new partnerships between global pharma companies and Canadian life sciences start-ups. We want to see this continuing. Ultimately, patients are at the center of everything we do, and the real common ground between governments and our industry.