Update Nov Dec 2013 - (Page 32)
Enforcement
80(1)(b) and 81(1)(a) of the Patent Act, the
patentees are required to submit pricing
information to the PMRPB. If a price is
found to be excessive, the PMPRB has
the authority to order a reduction and
repayment of excessive revenues under
s. 83(1) of the Patent Act.21 Secondly,
the PMPRB is responsible for reporting
trends in pharmaceutical sales and in
R&D spending by patentees.22
The Health Canada Special
Access Programme
Health Canada's Special Access Programme (SAP) permits the sale of unauthorized drugs to Canadian practitioners
for medical emergencies.23 Ordinarily,
a drug cannot be sold in Canada until
Health Canada issues a market authorization (i.e., notice of compliance)
having been satisfied of the drug's safety,
effectiveness and quality of manufacture.24 However, in rare circumstances a
drug may be made available to medical
practitioners through SAP prior to market authorization. These rare situations
are limited to "serious or life-threatening
conditions where conventional therapies
have failed, are unsuitable, or are unavailable either as marketed products or
through enrolment in clinical trials".25
In order to access an unauthorized
drug under SAP, practitioners must submit a request to Health Canada demonstrating that the use of the drug for the
proposed treatment is supported by credible research evidence. It is incumbent
on practitioners to inform patients of
the possible risks and benefits associated
with the use of any unauthorized drug.
Once the request is submitted, Health
Canada retains the discretion to authorize or deny the request. If the request is
granted, practitioners must report back
to Health Canada on use of the drug and
any adverse reactions observed. However, access under SAP does not suggest
32
Update
November/December 2013
the drug is safe or efficacious, nor does it
compel a manufacturer to sell the drug.26
The manufacturer is provided with complete discretion over whether it wishes to
make the unauthorized drug available
under the SAP and under what conditions, for example whether to charge for
the unauthorized drug or provide it for
free on compassionate grounds.
Celgene was a New Jersey-based
distributor of THALOMID. Until the
Canadian marketing authorization was
issued for THALOMID in 2010, Canadian healthcare professionals purchased
THALOMID from Celgene only under
the SAP. When Celgene obtained a Canadian patent for THALOMID in 2006,
the PMPRB requested drug pricing information. Celgene refused, arguing that
under commercial law principles THALOMID was not "sold in any market in
Canada". Rather, they argued the drug
was sold in New Jersey and remained
outside the PMPRB's jurisdiction.
Celgene Corp. v. Canada
On January 20, 2011, the Supreme
Court of Canada (SCC) rendered its first
decision on the PMPRB's jurisdiction,
since the Board's creation in 1987. The
SCC held that the PMPRB had jurisdiction to regulate the price of patented
medicines sold into Canada pursuant to
the SAP, despite the fact that such medicines do not have market authorizations
in Canada, and thus cannot be sold in
Canada outside of the SAP.
The SCC held that sales "in any market
in Canada" should be interpreted to "include sales of medicines that are regulated by the public laws of Canada".27 Since
THALOMID was sold through the SAP,
a public law of Canada, the PMPRB's jurisdiction included Celgene's sales of the
drug. The Court's finding was founded
on the legislative context and the Board's
consumer protection purpose outlined in
ss. 80(1)(b) and 83(1) of the Patent Act.28
It is the PMPRB's "responsibility for ensuring that the monopoly that accompanies the granting of a patent is not abused
to the financial detriment of Canadian
patients and their insurers".29
As a result of the Court's support
of the PMPRB's overarching consumer protection mandate, foreign drug
manufacturers, such as New Jersey-based
Celgene, are cautioned that they may be
subject to Canada's federal pricing review
board when making sales under the SAP
for serious or life-threatening conditions
prior to obtaining a marketing authorization in Canada.
Data Protection
Canada's Data Protection Regime
Pursuant to section C.08.004.1 of
Canada's Food and Drug Regulations,
an "innovative drug" is entitled to an
eight-year term of market exclusivity. An
eligible "innovative drug" must contain
a previously unapproved medicinal
ingredient, that is not a variation of a previously approved medicinal ingredient
such as a salt, ester, enantiomer, solvate
or polymorph. Other variations, such as
metabolites and prodrugs, are considered
on a case-by-case basis.
A six-month extension to the eightyear term is available where qualifying
pediatric studies are submitted within
the first five years of the term. Generic
drug manufacturers are prohibited from
filing abbreviated new drug submissions
during the first six of eight years and
cannot receive approval until the full
eight-year term has expired.
Given the relative infancy of Canada's
current data protection regime, which
has only been in effect since 2006, there
has been little jurisprudence interpreting
the data protection provisions to date. A
case involving THALOMID has been
www.fdli.org
http://www.fdli.org
Table of Contents for the Digital Edition of Update Nov Dec 2013
Update Nov Dec 2013
Update Nov Dec 2013 - (Page 1)
Update Nov Dec 2013 - (Page 2)
Update Nov Dec 2013 - (Page 3)
Update Nov Dec 2013 - (Page 4)
Update Nov Dec 2013 - (Page 5)
Update Nov Dec 2013 - (Page 6)
Update Nov Dec 2013 - (Page 7)
Update Nov Dec 2013 - (Page 8)
Update Nov Dec 2013 - (Page 9)
Update Nov Dec 2013 - (Page 10)
Update Nov Dec 2013 - (Page 11)
Update Nov Dec 2013 - (Page 12)
Update Nov Dec 2013 - (Page 13)
Update Nov Dec 2013 - (Page 14)
Update Nov Dec 2013 - (Page 15)
Update Nov Dec 2013 - (Page 16)
Update Nov Dec 2013 - (Page 17)
Update Nov Dec 2013 - (Page 18)
Update Nov Dec 2013 - (Page 19)
Update Nov Dec 2013 - (Page 20)
Update Nov Dec 2013 - (Page 21)
Update Nov Dec 2013 - (Page 22)
Update Nov Dec 2013 - (Page 23)
Update Nov Dec 2013 - (Page 24)
Update Nov Dec 2013 - (Page 25)
Update Nov Dec 2013 - (Page 26)
Update Nov Dec 2013 - (Page 27)
Update Nov Dec 2013 - (Page 28)
Update Nov Dec 2013 - (Page 29)
Update Nov Dec 2013 - (Page 30)
Update Nov Dec 2013 - (Page 31)
Update Nov Dec 2013 - (Page 32)
Update Nov Dec 2013 - (Page 33)
Update Nov Dec 2013 - (Page 34)
Update Nov Dec 2013 - (Page 35)
Update Nov Dec 2013 - (Page 36)
Update Nov Dec 2013 - (Page 37)
Update Nov Dec 2013 - (Page 38)
Update Nov Dec 2013 - (Page 39)
Update Nov Dec 2013 - (Page 40)
Update Nov Dec 2013 - (Page 41)
Update Nov Dec 2013 - (Page 42)
Update Nov Dec 2013 - (Page 43)
Update Nov Dec 2013 - (Page 44)
Update Nov Dec 2013 - (Page 45)
Update Nov Dec 2013 - (Page 46)
Update Nov Dec 2013 - (Page 47)
https://www.nxtbookmedia.com