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Monday, June 8, 2020
Gene therapy appraisals may limit new drugs in Canada
Canada's separate environmental protection oversight unnecessarily delays development and approval
By Nigel Rawson
and Mackenzie Moir
The Fraser Institute
federal government plans to move ahead with major revisions in
regulations governing the tribunal that sets ceiling prices for new
prescription drugs in Canada.
countries with relatively higher drug prices with lower price countries
in the international price-comparison analysis';
·enforcing hard thresholds for cost per quality-adjusted life year;
·imposing a reduction in a drug’s price if its annual sales exceed a defined level;
·requiring pharmaceutical companies to divulge information on confidential rebates negotiated with payers in Canada.
Concerns raised in the latest consultation
on the revision indicate that clinical research will decrease in Canada
and manufacturers will delay bringing innovative new medicines to
Canada or not bring them here at all.
Furthermore, early evidence suggests that adjustments in research activities are already being made. New clinical trials registered
with Health Canada from Nov. 1, 2019, to March 15, 2020, fell by more
than 52 per cent compared with the same period in previous years,
whereas new trials in the United States decreased by only 21 per cent.
changes to the pricing controls are not the only deterrent to clinical
research in Canada, especially for novel genetic therapies that could be
game changers in the lives of patients with cancer and other diseases.
Cancer cellular immunotherapy trials increased from seven in 1995 to 1,579 in 2015, and the percentage of trials using genetically modified cells increased between 2006 and 2015 to a similar degree.
Most genetic therapies are delivered to their target cell by a viral vector.
Due to the potential ecological risk that cell and gene therapies may
pose, an application for a clinical trial or for marketing authorization
for these medicines requires an environmental risk assessment in most
appraisals are the international standard for these therapies and are
done not only in Canada but also in the U.S., the European Union and
in each of these jurisdictions, except Canada, the evaluation is
performed as part of a single review (the U.S. and the EU) or jointly
between ministries with regulatory overlap (Ministry of Labour, Health
and Welfare and Ministry of Environment in Japan).
on the other hand, uses a system that results in separate and
independent regulatory oversight that falls under environmental
protection laws for clinical research and marketing authorization.
In Canada, this regulatory arrangement originally added a potential delay of up to 120 days
for clinical trial applications for new biological substances that fell
under these regulations. This has recently been changed with an
informal commitment to shortening this review to 30 days.
the government may be receptive suggestions on how to address this
issue, a long-term solution remains potentially years away. In the
meantime, there’s concern that this regulatory overlap and the
completion of separate applications could cause delays, review
redundancies, and uncertainty. It’s possible that these impacts could
have a pernicious impact on innovation within this space.
many new medicines of this type on the horizon for testing in Canada,
it’s time for the federal government to take positive action to
harmonize environmental assessment requirements with other
jurisdictions. It must reduce the additional regulatory burden imposed
on Canadian academic investigators and drug developers, allowing them to
be more competitive internationally.
a time when the world is seeking answers to a pandemic, requiring
severe price reductions and the extra burden of a separate and
independent environmental assessment that disincentivizes the bringing
important, life-changing new medicines to Canada will make even less
sense when we eventually transition back into a more stable
Dr. Nigel Rawson is a senior fellow at the Fraser Institute, and Mackenzie Moir is a Fraser Institute analyst.