The Federal Court of Canada has recently held that a drug
previously approved in Canada, but withdrawn for safety reasons,
could later qualify as an "innovative drug". In
Celgene Inc. v. the Minister of Health1, the
Court found that thalidomide satisfied the definition of
"innovative drug" under the Food and Drug
Regulations (the "Regulations") such that
it would now be entitled to data protection. While it may be
possible that new uses of previously approved drugs could be
considered "innovative" where the supporting data was
gathered at considerable cost and not otherwise publicly available,
the Federal Court cautioned that in each instance the determination
of "innovative" should be considered on a case-by-case
In the early 1960s, after initially receiving approval in Canada
for use in sleeplessness, minor ailments and morning sickness in
pregnancy, thalidomide was permanently withdrawn from the Canadian
market due to its association with foetal malformation.
In 1995, thalidomide was made available again through Health
Canada's Special Access Programme2 in response to
requests for use in leprosy, immune related conditions, and certain
forms of cancer. In mid-2009, Celgene filed a New Drug Submission
with the Minister of Health seeking market authorization for
thalidomide in Canada for use in the treatment of a form of cancer.
While market authorization was granted, Celgene was advised that
the drug would not be eligible for data protection under the
Regulations because thalidomide was not an innovative drug
since it had been previously approved in Canada.
Under the Regulations, an "innovative drug"
is provided with a data exclusivity period of eight years, commonly
referred to as data protection, during which time no drug
submission that makes a "direct or indirect" comparison
to the innovative drug can be approved.
Celgene sought judicial review of the Minister's
Thalidomide Entitled To Data Protection
According to the Federal Court, the data protection provisions
of the Regulations were implemented in the
Regulations to comply with Canada's international
treaty obligations -- to encourage and reward innovation by
protecting data that innovators generate to obtain drug approval.
The provisions require that a drug not be "previously
approved" in order for it to be eligible for data protection
to ensure a manufacturer is not granted protection for something
that has been previously used and for which no innovation was
The Court noted in its decision that it would be
"inconsistent with these treaties to refuse data protection
when a drug is put to an entirely new use, on the basis of
extensive and genuinely new data ensuring its effectiveness and
safety." Justice de Montigny stated that new uses of
previously approved drugs must be considered on a case-by-case
basis in order to determine how innovative they are and whether the
data supporting them was "gathered at considerable cost which
is not otherwise publicly available in that assembled form."
In the Court's view, safety and effectiveness are main
considerations with respect to drug approval and that when a
drug's approval has been withdrawn for safety reasons, the drug
should not be considered as previously approved.
The Court found that "Celgene's innovation was to take
something that was banned as dangerous and which had not been found
to be safe and efficacious and to show it to be a useful,
lifesaving drug." Celgene could not, however, rely on old
data; instead it had to produce new data in order to obtain drug
Effective September 1, 2016, the Disposition of Surplus Real Property Regulation to the Ontario Education Act was amended with the intention to reduce barriers to the formation of health and community hubs in Ontario.
Health Canada is proposing to change the way that it regulates non-prescription drugs, natural health products and cosmetics in Canada, which will now be referred to collectively as "self-care products."
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