Poor policy decisions, lack of funding, regulatory regimes, slow drug-listing processes and mediocre intellectual property protection partly to blame.Pamela Fralick, President, Innovative Medicines Canada
This article originally appeared in Policy Options on June 1, 2021.
Because of COVID-19, countries around the world have recognized the contribution that a strong life sciences sector makes to the health and well-being of their citizens and their economies. Canada is no different. Our country’s economic future will be driven by a robust life sciences sector with companies working at the forefront of knowledge and technology, and driving economic growth through significant investments in research and innovation. The life sciences sector includes all science and technology-based products and services applied to human health, as well as certain segments of the animal health industry. The major industry segments are pharmaceuticals, medical devices and laboratory instruments, health information technology, natural health products and healthcare services.
However, we have also learned another, harder truth here in Canada: the relationship between the federal government and the country’s innovative pharmaceutical industry is fractured. That poses a challenge to the life sciences in Canada and creates risks for our economy and our health.
This seems at odds with many other countries that have worked to foster robust domestic life science industries and partnered with industry. The U.K. and Israel, to name two, have strong histories of working with the pharmaceutical industry. Both countries were successful in building strong domestic capacity and when COVID-19 hit, were quickly able to mobilize and secure vaccine supply for their citizens.
I highlight this to illustrate an important point. The pharmaceutical industry is a global one and, as in many other international industries, companies make decisions about where to invest based on a range of factors, including the ability to access top talent, the regulatory environment and a host of other factors related to the ease of doing business.
In short, we are in a global competition for investment and today Canada is slipping further from the front of the pack.
Years of public policy decisions by governments of all stripes have made Canada less attractive to industry investment and commercial activity. This is not to say that there has been no investment, but rather that as a G7 nation we are capable of so much more.
Our regulatory regime, our slow and burdensome drug-listing processes, mediocre intellectual property protection, layers of duplicative regulatory red tape and decades of policy decisions have eroded the relationship between governments and the industry.
To be clear, the state of the relationship is not the responsibility of the government alone. Industry, too, has a role to play. We need to come to the table better-prepared, with real solutions that speak to protecting and advancing the sustainability of Canada’s healthcare systems.
As with any relationship, it takes a lot of work. But getting the newest and most innovative medicines to Canadians in a timely way is worth it. Attracting investment to Canada to foster innovation and contribute to a more robust domestic manufacturing capacity will also have lasting benefits.
To get there, we need to start with a commitment by both government and industry – a pledge to put collaboration at the centre of a comprehensive strategy to address critical issues like domestic biomanufacturing, regulatory complexity, patient access to new drugs for rare diseases and incentives for investment.
We are encouraged by the federal government’s recent commitment to consulting stakeholders on its approach to building our domestic manufacturing capacity. We are similarly hopeful to see action on longstanding federal commitments for a policy to address drugs for rare diseases. But we need to go further.
The government has consistently disregarded the industry’s calls for a more comprehensive and meaningful dialogue on damaging regulatory changes that will be implemented in a few short weeks, as all parties continue to focus on addressing the COVID-19 pandemic.
Canada’s innovative pharmaceutical companies are primed to join the government in an open dialogue and come to the table with concrete proposals to move collectively toward a world-class life sciences sector and a more self-sufficient Canada.
To do this, we propose four recommendations that would signal that Canada is determined to be a leader by leveraging our country’s strengths in research and development, encouraging domestic commercialization and manufacturing, enhancing international investment attractiveness and supporting health and economic resilience.
Establish a new and lasting partnership with stakeholders
While a commitment to collaboration is foundational, a structured partnership will ensure that stakeholders work together in a coordinated fashion. Regular and high-level interactions between governments and industry are a hallmark of leading life science countries such as the United Kingdom, Denmark, and Switzerland.
Full alignment between industry, government and other stakeholders may not always occur through interaction, but the meaningful dialogue and the principle of reasonable compromise should be the objective.
Support the uptake and adoption of innovation
Supporting and adopting innovative technologies will improve healthcare outcomes for Canadian patients and encourage greater industry investment.
For example, we can collectively shift our focus from a narrow view of the costs of new medicines to fully assess value to patients and the broader health system. The pandemic has further proven the critical need to get life-saving medicines and innovative products into the hands of those who need them the most. It is time we look at how we can better support Canadians and achieve earlier medicine adoption through a regulatory framework that prioritizes patient access as well as an ongoing study of how those medicines are performing in the real world.
Implement agile, efficient and predictable regulatory systems
Efficient and predictable regulatory systems improve patient outcomes by accelerating access to new treatments and medicines, providing the needed stability for industry investment.
The government should stop the changes to the Patented Medicine Prices Review Board (PMPRB) set for July 1, 2021, in the middle of a global health crisis. We wrote to federal Minister of Health Patty Hajdu about this in a May 4 letter. See it here. Canadians’ access to new innovative treatments will be at risk as the number of clinical trials happening in Canada will decline, and global investment in our life sciences sector will decrease.
Our international trade policies should support innovation at home and abroad. Canada can position itself as a reliable partner in a volatile global environment by supporting intellectual property protection within international organizations, promoting regulatory harmonization and countering protectionism and barriers to supply chains. We also need to highlight and promote our significant domestic strengths, including artificial intelligence and regenerative medicine, and leverage our extensive network of international trade agreements.
Canada’s innovative pharmaceutical industry is ready to collaborate on a path forward
Successfully implementing a balanced set of policy tools will take a great deal of time and effort by industry, governments and other stakeholders, but will result in health and economic benefits to Canada for decades to come.
Canada should take the opportunity to learn from this pandemic to create a more supportive regulatory environment. We can be better prepared when the next pandemic hits. We should acknowledge the life-saving regulatory efficiencies used to evaluate COVID-19 products and expand rolling reviews to other pharmaceutical approvals so that Canadians can access the treatments they need, sooner.
A stronger life sciences sector would meet the country’s domestic needs, drive research and development and enhance the health and well-being of Canadians. The time for a new deal is now. The pharmaceutical and vaccine industry is ready to work with the government of Canada to make it happen.