TORONTO, March 15 /CNW/ - Canadian patients are waiting longer than
Americans and Europeans for access to new medicines due to slow government
approval processes, according to a new study by independent research
organization The Fraser Institute.
"The approval process at Health Canada is inefficient compared to other
countries," said Brett Skinner, the Institute's Director of Health,
Pharmaceutical and Insurance Policy Research and author of Access Delayed,
Skinner notes that Health Canada has followed the American approach to
drug approval, yet it has far fewer resources and less than 10 per cent of the
staff of the U.S. Food and Drug Administration. On the other hand, drug
approval agencies in European countries have fewer resources than Canada yet
manage to consistently review and approve drugs in a timeframe similar to the
"Canadians are waiting an extra two to three years for new medicines when
you add up the total time it takes for the various federal and provincial
government agencies to make up their minds on approving and paying for a new
drug," he said.
Skinner's report shows how delays at three separate stages of the
approval process are contributing to the problem: Health Canada, which must
certify a drug is safe and effective for public use; the Common Drug Review, a
national agency, makes recommendations on whether a drug should be eligible
for reimbursement from public drug plans; and provincial governments, which
finally decide if a drug will be covered by public health plans.
He calculates that in 2005 Health Canada took an average of 397 days to
approve a new pharmaceutical and 633 days to approve a new biological
medicine. The Common Drug Review adds another 257 days for pharmaceuticals and
186 days for biological drugs, with final provincial approval adding 201 days
for pharmaceuticals and 187 days for biologicals.
"The result is that even after waiting too long for Health Canada to
approve a new drug as safe and effective, the process is further delayed by
provincial governments that increasingly refuse to pay for new drugs or take
too long in deciding whether a new drug should be eligible for provincial
reimbursement," Skinner said.
In Access Delayed, Access Denied, Skinner spells out four specific policy
changes to improve the process in Canada and speed up access to new medicines.
Harmonization-cooperation with other jurisdictions
Take advantage of regulatory knowledge and capacity of other
jurisdictions, rather than attempting to duplicate the American process.
Health Canada should consolidate resources through sharing data, workload, and
processes. If Canada established agreements of "mutual recognition" with other
countries, new medications approved in those countries could be introduced to
the Canadian market far more rapidly.
Ensure that Health Canada must meet strictly enforced and appropriate
targets before receiving any user fees from drug companies wishing to have
their products reviewed. This has reduced delays in the United States.
Canada should compete with international regulators for the user fees
charged to drug makers, on the basis of the time it takes to issue regulatory
approval. This has been successful in the European Union where regulators in
all participating countries must lift bans on the marketing of the new
medicines that are approved by any one regulator.
Private health insurance
Provincial Medicare does not cover drugs delivered outside of hospitals
and separate federal/provincial/territorial drug programs cover only about
one-third of the population. This non-comprehensive, non-universal system of
coverage is inefficient. Coverage under private drug plans is better than the
coverage offered under public drug plans.
Unlike public drug programs, private insurance plans do not normally
restrict the specific kinds of drugs eligible for reimbursement - so consumer
choice is preserved. Instead of rationing, private drug plans rely on premiums
and small user charges to successfully control costs. In almost all private
plans, every drug that is deemed safe and effective by Health Canada is
eligible for reimbursement immediately. Fewer new drugs are covered under
public programs and when they are covered, patients wait more than a year
longer than people covered under private plans to get access to them.
As an alternative to our current health and drug programs, Canada should
introduce a competitive market system of universal compulsory private health
insurance that comprehensively covers all types of health treatments -
including drugs. Under such a system, public subsidies would guarantee that
low-income people could afford to share the superior benefits of private
health insurance plans. Countries like Switzerland achieve universal health
insurance coverage for their people more efficiently with similar approaches.
"Drugs are a prime example of a medical technology that is often more
efficient than other health treatments such as surgery," Skinner said. "But as
a result of excessive bureaucracy, government duplication, and a lack of
comprehensive insurance coverage, patients are either blocked from obtaining
new medicines or the costs are made prohibitive. The end result is that
Canadians are either forced or encouraged to opt for treatments that can be
less efficient at treating their health conditions. And in the long run, this
could end up costing everyone more."
The Fraser Institute is an independent research and educational
organization based in Canada. Its mission is to measure, study, and
communicate the impact of competitive markets and government intervention on
the welfare of individuals. To protect the Institute's independence, it does
not accept grants from governments or contracts for research. Visit
For further information:
For further information: MEDIA CONTACT: Brett Skinner, Director, Health,
Pharmaceutical and Insurance Policy Research, The Fraser Institute, Tel: (416)
363-6575, ext. 224, Email: firstname.lastname@example.org; Dean Pelkey, Associate
Director of Communications, The Fraser Institute, Tel: (604) 714-4582, Email