The Canadian government takes too long to lift its
automatic ban on new medicines and evidence shows that the policy
of automatically banning new medicines harms Canadians far more
than it helps them, according to
A Lethal Guardian: The Canadian Government's Ban on Prescription Drugs
, released today by The Fraser Institute.
"This automatic ban is harmful to Canadians' health and is
implicated in the deaths of hundreds of Canadians annually, while
many more Canadians suffer needlessly because the government
prevents them from getting the medicines they require," said John
R. Graham, author of the new study and an adjunct scholar at The
When any new drug is invented and ready for distribution in
Canada, the Canadian government responds by enforcing an
automatic ban on its use. This ban is removed for patients who
need the drug immediately only under extraordinary circumstances.
The general ban is only lifted after the manufacturer has paid a
user fee and waited for Health Canada to undertake a lengthy
review to certify the safety and efficacy of the medicine.
The time it takes Health Canada to lift its ban on new drugs is
very long and is, in fact, increasing as time goes on. Between
1997 and 2002, the median time to remove the ban grew from just
over 16 months to two years: a 50 percent increase in just five
Although other developed countries have similar regulatory
burdens, they take much less time to lift their bans on new
medicines. In 2001, the Canadian government took eight months
longer, at the median, than the United States to lift its
prohibitions. During the three years from 1999 through 2001,
Sweden lifted its bans seven months faster than Canada did, while
the United Kingdom acted almost six months faster and Australia
acted three months faster.
"Recent changes to address this failure, including the User Fees
Act that was designed to increase departmental accountability,
will not improve the situation because Canadians are still
forbidden from choosing medicines that the government does not
permit," Graham pointed out.
In fact, Health Canada has been charging user fees for about a
decade and its performance has, nevertheless, declined over that
time. It is unlikely that increased domestic user fees or taxes
will free Canadians from their government's dangerous delays in
approving new medicines.
Although Health Canada has more regulatory employees examining
each new drug application than the United Kingdom, Sweden, or
Australia, it nevertheless takes much longer to grant approvals
than those countries. Because Health Canada has a monopoly on
earning user fees for certifying the safety and effectiveness of
drugs used by Canadians, unlike regulators in the European Union,
it faces little incentive to provide timely approvals in a cost
effective manner without external pressure.
Graham advises that Parliament amend the Food and Drug Act to
allow Canadians to use new medicines once a regulator in a
comparable jurisdiction, such as the United States, the European
Union, or Australia, has removed its prohibition. Health Canada
would retain the right to compel manufacturers to label their
medicines with the warning that Health Canada had not approved
the safety or efficacy of the medicine.
"If Health Canada nevertheless wants to review the drug's safety
or efficacy, it will be able do so, using general government
revenue. If the manufacturer wants Health Canada to review the
medicine, with a view to removing its warning label, it would pay
a user fee to have Health Canada review it," said Graham.
The amended Act would require the Health Minister to make annual
reports to Parliament containing information about the new drugs
allowed in Canada due to this reciprocity, the number of new
prescriptions written as a result of patients exercising their
freedom, the application and removal of warning labels by Health
Canada, as well as reported negative and positive consequences to
Canadian patients' health associated with the faster use of new
After a period of five years, Parliament would review how
Canadians have responded to the faster availability of new
medicines due to these amendments, and could introduce further
regulatory reform based on that information.
"By giving Canadians the choice whether to adhere to Health
Canada's recommendations or not, the government will be able to
responsibly reduce the regulatory burden that prevents Canadians
from getting new medicines," concluded Graham.