alaine grande, chief legal counsel, astraZeneca canada inc.
In 2013, two areas of focus for AstraZeneca were the Comprehensive Economic Trade Agreement negotiations
between Canada and the European Union, and the modernization of the Food and Drug Act and Regulations
(Canada). On Oct. 18, 2013, the Canadian federal government announced an "agreement in principle" had been
reached in the CETA negotiations with the European Union. The life sciences intellectual property improvements
included in CETA are, 1) patent term restoration which offers research-based pharmaceutical companies the
opportunity to recover up to two years
of lost time on their patents as a result of
regulatory or product approval delays, and
2) a right of appeal, that allows research
based pharmaceutical companies to appeal
a decision under the Patented Medicines
(Notice of Compliance) Regulations; a
right that is currently only available to
generic pharmaceutical companies. We
SPECIALIZATION IN BUSINESS LAW
believe the improvements to intellectual
property protection in Canada brought
forth by CETA are very important to
our industry and to our country, as they
demonstrate support for innovation
and will help drive further research and
development investment into Canada.
The modernization of the Food and
Drug Act and Regulations (Canada)
continues to be an area of focus for
AstraZeneca in 2014, as the resulting
legislative and regulatory changes have an
important impact on our industry
and our business. Recent events include
Health Canada's continuing work on the
implementation of a new framework for
the authorization of orphan drugs, and the
federal government's introduction Dec. 6,
2013, of new patient safety legislation, Bill
C-17 entitled Protecting Canadians from
Unsafe Drugs Act (Vanessa's Law), which
aims to "improve Health Canada's ability to
collect post-market safety information and
the ability to take appropriate action when a
serious risk to health is identified." IH
Part-time, Executive LLM program
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Taught by U of T Faculty of
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to see the full interviews
from last year go to
canadianlawyermag.com
and click on
digital editions — February 2013
or click on canadian lawyer tv
to view video interviews.
TIME:
EVENT:
For more information, call 416-978-1400 or visit:
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Supported by the Association of Corporate Counsel
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canadianlawyermag.com/inhouse February 2014 29
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