Statement - Patient safety paramount in approval process for subsequent entry biologic therapies: says Rx&D

    OTTAWA, April 14 /CNW Telbec/ - The following is a statement by Russell
Williams, President of Canada's Research-Based Pharmaceutical Companies (Rx&D)
reacting to the recent release by Health Canada of a draft guidance document
regarding Subsequent Entry Biologics (SEBs).
    "We are pleased that Health Canada is moving forward with this
consultation process by releasing a draft guidance document for Subsequent
Entry Biologics (SEBs). As the industry that develops medicines and vaccines
that improve and save lives, we believe that Health Canada's approach should
respect the following fundamental principles:
    "The first is patient safety. Biologic medicines and treatments are
created from living cells using leading-edge science. They are extremely
complex and cannot be copied in the same way as traditional pharmaceutical
medicines. The framework must give patients the confidence that the approval
process is sufficiently rigorous to ensure SEBs, which may be similar but not
the same as first generation biologics, are safe and effective for patients.
    "This regime must also respect Canada's support for internationally
competitive intellectual property safeguards that are the catalyst for
innovation. This includes protection for innovators' clinical trial data and
patents. Biologics represent major advances in many therapeutic areas and have
provided new hope and treatments for those suffering from a wide range of
diseases from cancer to osteoporosis, just to name a few. Safeguarding and
strengthening intellectual property rights gives innovators the incentive to
do research in Canadian labs to develop the next generation of innovative
treatments and cures.
    "The approval process for SEBs must be both clear and predictable and we
believe that regulatory amendments are the best way to accomplish this. Health
Canada should also examine and build on best practices in other developed
jurisdictions such as the European Union.
    "Due to the importance of this issue in the future treatment of Canadian
patients, the participation of stakeholders including patients, health
providers, academics and industry is crucial to the success of the
consultation process. As a partner in the health care system, we intend to be
fully engaged in this ongoing process working collaboratively to improve the
health and prosperity of Canadians".

    About Rx&D

    Rx&D is an association of leading research-based biopharmaceutical
companies dedicated to improving the health of all Canadians through the
discovery and development of new medicines and vaccines. Our community
represents 20,000 men and women working for 50 member companies and invests
more than $1 billion in research and development each year to fuel Canada's
knowledge-based economy. Guided by our Code of Ethical Practices, our
membership is committed to working in partnership with governments, healthcare
professionals and stakeholders in a highly ethical manner.

For further information:

For further information: François Lessard, Communications, (613)

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Canada's Research-Based Pharmaceutical Companies (Rx&D)

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