Cablegate: Canadian Pharmaceutical Patents: Parliamentary

This record is a partial extract of the original cable. The full text of the original cable is not available.




E.O. 12958: N/A

1. Summary ) A Parliamentary committee has postponed a
decision to recommend changes to Canada,s drug patent rules
that cover the process for bringing generic drugs to the
market once the innovator,s patents expire. The Canadian
review mirrors the recent U.S. deliberations on the
Hatch-Waxman law that led to a June 12 decision by the FDA to
streamline the process for bringing generics to the market.
The committee,s decision to delay a recommendation for
possible regulatory change before the end of the current
Parliamentary session is seen as a temporary victory for the
brand-name pharmaceutical companies that oppose any
legislative changes. End Summary.

2. After four days of testimony, the House Industry and
Science committee postponed a decision to recommend reform of
Canada,s drug patent rules until Parliament reconvenes in
the fall. The committee reviewed the Patented Medicine
Notice of Compliance (NOC) Regulations, which are also known
as the &linkage regulations8 because these rules link the
regulatory approval of a generic drug to the patent status of
the drug it seeks to copy. A similar review of the
Hatch-Waxman law in the U.S. led to the recent FDA decision,
announced by President Bush on June 12, to institute new
regulations to streamline the process for bringing generic
drugs to the market.

3. The linkage regulations, which were last amended in 1998,
block Health Canada from approving a generic drug for up to
two years if there is any allegation of patent infringement.
Generic companies complained that by filing sequential
patents on minor improvements on a drug and then alleging
infringement on each, brand-name companies can "evergreen8
the market for a drug long after its original 20-year patent
expires. The generics proposed scrapping the automatic
24-month injunction altogether. The brand-name manufacturers
encouraged the committee to maintain the status quo, arguing
that the automatic injunction is necessary to prevent patent
infringement and encourage the development of new drugs.
Canada and the U.S. are the only countries that provide an
automatic injunction in cases of alleged patent infringement.

4. The recent high profile review of the Canadian health care
system by Roy Romanov, which was released last fall,
recommended that the GOC consider overhauling the Notice of
Compliance regulations. Health Canada, which administers the
regulations, generally agreed with this recommendation,
testifying to the committee that the growing complexity of
patents has made it difficult for them to administer the NOC
regulations. Industry Canada, on the other hand, argued
against changes to the regulations, noting that they are
necessary to protect and promote incremental innovation by
brand-name companies. The Parliamentary committee was evenly
divided on the issue and determined that they needed more
information before deciding on whether or not to amend the

5. Comment ) Failure to reach a decision is a victory for
the brand-name drug companies, who had hoped to avoid the
Parliamentary review of the regulations altogether. With the
upcoming Canadian elections it is not clear when or if the
committee will reconvene to make a final decision on whether
or not the regulations will be amended. Although Canada,s
patent regime is generally considered more pro-generic than
the U.S. system, even after the recent decision by the FDA,
the perception that the U.S. is taking action to &lower the
costs8 of prescription medications could motivate the
committee to recommend changes to the linkage regulations.

© Scoop Media

World Headlines


Myanmar: UN Condemns Escalating Violence In Deadliest Day Of Protests So Far

In response to the killing of at least 18 protesters demonstrating against Myanmar’s military coup, the UN human rights office (OHCHR) on Sunday together with the UN chief, strongly condemned the “escalating violence” and called for an immediate end to the use of force... More>>

Syria: Economic Decline, Rising Hunger And Surging Humanitarian Needs

Syria’s fragile economy has “suffered multiple shocks” over the past 18 months, with its currency plummeting and joblessness swelling as people struggle to cover their basic needs, the UN Emergency Relief Coordinator told the Security Council ... More>>

OECD: Final Quarter Of 2020 Shows Continued Recovery In G20 International Merchandise Trade

G20 international merchandise trade continued to rebound in the fourth quarter of 2020 ( exports up 7.2% and imports up 6.8%), following the sharp falls seen in the first half of 2020, as lockdown measures affected trade globally. Although growth ... More>>

Focus On: UN SDGs

UNFCCC: Greater Climate Ambition Urged As Initial NDC Synthesis Report Is Published

UN Climate Change today published the Initial NDC Synthesis Report, showing nations must redouble efforts and submit stronger, more ambitious national climate action plans in 2021 if they’re to achieve the Paris Agreement goal of limiting global temperature rise by 2°C—ideally 1.5°C—by the end of the century... More>>

2021: Critical Year To ‘reset Our Relationship With Nature’ – UN Chief

During this time of “crisis and fragility”, the UN chief told the United Nations Environment Assembly on Monday that human well-being and prosperity can be vastly improved by prioritizing nature-based solutions. Painting a picture of the turmoil ... More>>

Paris Agreement: UN Secretary-General António Guterres To Mark U.S. Reentry With Envoy For Climate John Kerry

Watch live at UN Secretary-General António Guterres will join U.S. Special Presidential Envoy for Climate John F. Kerry at an event marking the United States’ reentry into the Paris Agreement this Friday. The discussion with the Secretary-General ... More>>