The offices of Health Minister Marjorie Michel, shown in Ottawa in June, and Industry Minister Mélanie Joly said the government will carefully consider the task force's recommendations.Adrian Wyld/The Canadian Press
Ottawa’s pharmaceutical-industry task force is urging Health Canada to rely more on the review work of foreign regulators and invest more in health data infrastructure, as part of a suite of recommendations that aim to help Canada navigate geopolitical pressures on the pharmaceutical sector.
The task force, whose more than two dozen members are made up mainly of the Canadian heads of patented drug companies, was formed in March to advise the federal government on how to support the industry and ensure access to medication in the midst of developments such as U.S.-Mexico-Canada trade talks.
The task force published its final report on Friday. Its 39 recommendations run the gamut from streamlining regulatory reviews, to harmonizing national research-ethics standards as a way to encourage spending on clinical trials, to supporting the development of artificial-intelligence applications in health care.
“The current geopolitical context is creating an urgent need to re-evaluate Canada’s industrial and market strategy in the innovative pharmaceuticals and life sciences industry as well as a unique opportunity for Canada to become a global leader in the innovative life sciences industry,” the report says.
The offices of Health Minister Marjorie Michel and Industry Minister Mélanie Joly said the government will carefully consider the recommendations.
Innovative Medicines Canada, the main lobby group for patented drug makers, said the report must translate into urgent action.
“The task force’s 39 recommendations reflect the breadth of this work, but to turn them into real progress for patients, the federal government must prioritize what matters most: structural reform, an open market that allows both domestic and global companies to flourish, and enhanced federal investment in innovative medicines,” Bettina Hamelin, IMC’s chief executive officer, said in a statement.
Michael Law, a pharmaceutical policy researcher and academic director of the Centre for Health Policy at the University of Calgary, said the regulatory streamlining makes sense, as Canada has among the most complicated and time-consuming drug-approval pathways in the world.
However, a lot of the suggestions in the task force’s report are in areas the federal and provincial governments are already working on.
“There’s a lot of movement in the system already,” he said.
For example, the first recommendation in the report is that Health Canada should expand and accelerate the adoption of a framework for relying on the work of trusted foreign regulators.
Health Canada already proposed such a framework in January and, earlier this month, proposed the first drug classes and foreign regulators to be used in the program. The initial focus will be on veterinary drugs and pediatric medication, with the list of regulators including the U.S. Food and Drug Administration, the European Medicines Agency and Australia’s Therapeutic Goods Administration.
The task force report suggests more drugs should be included, such as those treating cancer and vaccines. It suggests the first such reviews should start by the end of the year.
On the AI investments, the federal government announced in June it would invest up to $100-million in an Ontario-based health data initiative called Vital, based at St. Michael’s Hospital in Toronto, and expand it to the rest of Canada.
The task force report recommends Ottawa build on the investment in Vital and the Canadian Institute for Health Information “to deliver a sovereign pan-Canadian data infrastructure enabling real-time interoperable data use and scale, including federated models enabling cross-jurisdictional analysis, integrated data across the full patient journey, and government frameworks allowing responsible private sector participation.”
Among the other recommendations are for Ottawa to establish a late-stage scale-up capital vehicle for life sciences, attract more investment from pension funds and insurers in the sector and create a biotechnology index of publicly-traded companies.
The report suggests Ottawa address the recommendations about government bodies within the next three months and work on the industrial and investment policies within nine months.