Bayer Inc. commends Health Canada for regulatory amendments to allow public communication of preventative claims



    - New Regulatory Amendments Increase Canadians' Awareness of the Benefits
    of Self-Care Products -

    TORONTO, Jan. 31 /CNW/ - Bayer Inc., one of Canada's leading healthcare
companies, commends Health Canada on new regulatory amendments affecting
Schedule A of the Food and Drugs Act (FDA). These amendments will allow the
communication of Health Canada approved preventative claims regarding Schedule
A diseases to the public in the Food and Drug Regulations (FDR). Under the new
amendments published recently in Canada Gazette Part II, the manufacturers of
non-prescription drugs and Natural Health Products (NHPs) will now be
permitted to advertise and label their products with preventative treatment
claims to the general public. These regulatory amendments are the culmination
of more than a decade of efforts by Health Canada, NDMAC, and companies such
as Bayer Inc., and will ensure Canadians have the information they need to
make informed health choices.
    "Today, we wish to commend Health Canada, and express our full support
for these regulatory amendments which will respond to Canadians' right to
information about these products, and allow them to take a more active role in
their health," said Philip Blake, President and Chief Executive Officer, Bayer
Inc. "Some non-prescription products and NHPs have long had the scientific
evidence that supports the safe and effective use to help prevent, or reduce
the risk of, a Schedule A disease. The new regulatory amendments will provide
Canadians with the information they need to make an informed choice or speak
with their doctor about the preventative benefits of these products."
    Schedule A of the FDA contains a list of diseases, disorders or abnormal
physical states including cancer, obesity and diabetes. When Schedule A
restrictions were initially introduced in 1934, there were no treatments for
many of these diseases, no prescription system for drugs, and no universal
medicare in Canada. To address the healthcare environment at that time,
Schedule A restrictions were added to help prevent fraud; prohibit
advertisements to the public in respect to treatments for conditions where no
treatments existed; prohibit the advertisement of treatments where self
treatment was not considered safe; and to encourage people to seek medical
attention for serious conditions.(1)
    Today, many of the diseases listed in Schedule A can be prevented. In
addition, Canadians now have access to a healthcare system, are better
educated regarding their health, and want to make their own health-related
choices. According to a recent survey, Canadians are increasingly turning to
non-prescription drugs and NHP self-care products to manage their health.(2)
    The Schedule A amendments apply only to non-prescription drugs and NHPs,
and do not include changes to current regulations regarding foods or medical
devices.(3) The amendments also maintain Health Canada's long-held position
that direct-to-consumer advertising should not be allowed for prescription
drugs.(4) The regulations take effect on June 1, 2008.

    About Bayer Inc.

    Bayer Inc. (Bayer) is a Canadian subsidiary of Bayer AG, an international
research-based group with core businesses in healthcare, crop science, and
innovative materials.
    Headquartered in Toronto, Ontario, Bayer Inc. operates the Bayer Group's
HealthCare and MaterialScience businesses in Canada. Bayer CropScience Inc.,
headquartered in Calgary, Alberta operates as a separate legal entity in
Canada. Together, the companies play a vital role in improving the quality of
life for Canadians - producing products that fight diseases, protecting crops
and animals, and developing high-performance materials for applications in
numerous areas of daily life.
    Canadian Bayer facilities include the Toronto headquarters and offices in
Ottawa and Calgary. Bayer Inc. has approximately 1,000 employees across Canada
and had sales of over $910 million CDN in 2006. Globally, the Bayer Group had
sales of over 28 billion Euro in 2006.
    Bayer Inc. invested approximately $47 million CDN in research and
development in 2006. Worldwide, the Bayer Group spends the equivalent of over
2 billion Euro in 2006 in R&D.
    For more information about Schedule A of the Food and Drugs Act please
visit: http://canadagazette.gc.ca/partII/2007/20071226/html/sor288-e.html
(Posted December 26, 2007)

    REFERENCES
    ---------------------------------
    (1)Health Canada. Why were Section 3 and Schedule A Established?
    Available at: http://www.hc-sc.gc.ca/ahc-asc/public-
    consult/consultations/col/sec_a/sched-ann_a_background-
    contexte_e.htmlNo.sched_a.
    (2) Ipsos-Reid, Public Views on Self-Care. (February 2005).
    (3)Government of Canada. Canada Gazette. Regulations Amending Certain
    Regulations Made under the Food and Drugs Act (Project 1539) Vol. 141,
    No. 26 - December 26, 2007. Available at:
    http://canadagazette.gc.ca/partII/2007/20071226/html/sor288-e.html.
    (4)Government of Canada. Canada Gazette. Regulations Amending Certain
    Regulations Made under the Food and Drugs Act (Project 1539) Vol. 141,
    No. 26 - December 26, 2007. Available at:
    http://canadagazette.gc.ca/partII/2007/20071226/html/sor288-e.html.





For further information:

For further information: Rachel Manna, Manning Selvage & Lee (MS&L),
(416) 847-1320; Alison Bing, Bayer Inc., (416) 240-5298

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