Mr. Chair, members of the committee, thank you for inviting me to contribute to this important study on Canada's pharmaceutical sovereignty.
My name is Stéphane Lévesque, and I am the general manager of Groupement provincial de l'industrie du médicament, or GPIM, an association that has been active for more than 40 years and represents small and medium-sized businesses and emerging pharmaceutical companies, primarily in the generic drug sector.
At the outset, we must recognize a fundamental reality: Pharmaceutical sovereignty is a complex and difficult objective to achieve. We must be realistic: Canadian pharmaceutical sovereignty will never be absolute. We must also recognize that it depends as much on provincial governments as on the federal government. Better collaboration among all levels of government will be essential if we truly want to make progress.
That said, we can certainly do better.
First, let's talk about Canadian ownership versus simply being established in Canada.
It is essential to distinguish between a pharmaceutical company merely operating in Canada and one that is Canadian-owned. Foreign companies established here play an important role, but Canadian-owned companies should occupy a more strategic place in our pharmaceutical autonomy. The pandemic demonstrated the limits of excessive dependence on foreign interests. Some countries prioritized their own populations by redirecting medicines, vaccines and medical equipment. Canada must therefore implement targeted financial, regulatory and commercial measures to better support Canadian-owned pharmaceutical companies.
Second, let's look at Health Canada delays.
In 2018, the modernization of regulatory fees was intended to improve regulatory performance. Today, however, we are witnessing the opposite. Review timelines for drug submissions continue to grow longer. Delays are now measured in months, sometimes years, even though the established target for a generic drug review is 180 days. Meanwhile, other jurisdictions, particularly the United States, are improving their efficiency. Without regulatory predictability, investments become significantly riskier.
Recently, to improve performance, Health Canada proposed an order allowing reliance on decisions or documents from foreign regulatory authorities for certain drugs. GPIM was the first organization to raise concerns that this measure could produce the opposite effect of what is intended. It could further overwhelm Health Canada's already limited internal resources due to an increasing number of submissions from foreign companies and could even lead to a form of regulatory dumping, to the detriment of Canadian-owned businesses. This is not encouraging for Canadian pharmaceutical sovereignty.
Third, let's consider the lowest-price policy for generic drugs.
Provincial reimbursement policies based almost exclusively on the lowest price represent a major obstacle to pharmaceutical sovereignty. Twenty or thirty years ago, a much larger share of medicines were manufactured in Canada. However, the combination of lowest-price policies and the absence of annual indexation pushes manufacturers toward lower-cost countries such as India and China. Without policy changes, this offshoring trend will continue.
Fourth, let's turn to buying Canadian.
GPIM supports a buy Canadian policy that includes pharmaceuticals. A portion of hospital procurement contracts and strategic stockpiles of essential medicines should be reserved for Canadian-owned companies.
Fifth, let's consider active pharmaceutical ingredient, or API, manufacturing.
We can have all the manufacturing capacity in the world in Canada, but without access to active molecules, we are heading in the wrong direction. We must support innovative and less-polluting API manufacturing. At Université de Montréal, Professor André Charette is working on continuous flow manufacturing, with the support of Médicament Québec. The project is an excellent example of this but has been slow to materialize due to insufficient government support.
Sixth, let's look at strategic alliances.
We must develop agreements with reliable and trusted countries in order to share certain production capacities. A chosen and strategic interdependence is preferable to a dependence imposed upon us.
In conclusion, pharmaceutical sovereignty will require consistent political choices, targeted investments and better coordination among governments. Above all, it will require a long-term vision aimed at protecting the health and economic security of Canadians.
Thank you.