July 23, 2004
Karen Ash
Bureau of Policy, Therapeutic Products Directorate
1600 Scott St
Holland Cross, Tower B
2nd Fl, AL 3102C5
Ottawa ON K1A 0K9
Dear Ms. Ash:
Re: Canada Gazette, Part 1, May 11th, 2004. The proposal for
an amendment to the Food and Drug Regulations – Schedule 1272
(Deletion of levenorgestrel, when indicated for use as an emergency
contraceptive, from Schedule F
of the Food and Drug Regulations).
The Canadian Women’s Health Network (CWHN) strongly supports the
amendment to remove levonorgestrel when used as emergency contraceptive,
from Schedule F, that is, to non-prescription status. This will help
address an important public health issue for women—the risk of
unplanned pregnancy due to contraceptive failure or unprotected intercourse.
Thank you for undertaking this initiative.
Evidence demonstrates that levonorgestral is more effective and more
easily tolerated than the off label use of Ovral (a.k.a. the Yuzpe method).
The World Health Organization and professional organizations recognize
that ECP is medically safe, requires no physical assessment, and that
the dosage is the same for all women. Emergency contraception has been
available without a doctor’s prescription for many years in other
countries including England, Israel, Finland, and Norway.
We hope that the next stages of the regulatory process will be completed
as soon as possible.
As mentioned in our previous correspondence on this matter, non-prescription
status is just one small step in a comprehensive strategy for improving
access to ECP and improving the reproductive health of Canadian women.
Increasing awareness of ECP with health professionals and intermediaries
such as teachers and social workers, and the general public will be necessary.
Non-commercial health information materials will be needed. We remain
concerned the “behind the counter” status proposed by the
National Drug scheduling advisory committee will create unneeded barriers
as well.
It is especially critical that steps be taken to ensure access for low-income
women. Non-prescription drugs generally are not on provincial and private
formularies. Therefore this regulation change has the real possibility
of decreasing access for poor women and adolescents, since costs have
been seen as an impediment to use. It is important that, for example,
levenorgestrel as ECP be added to or remain on provincial formularies,
and be available through public health agencies and staff at no or reduced
costs.
We are aware that these matters are, with the exception of the First
Nations and Inuit Health Branch of Health Canada, primarily a provincial
responsibility. However, we do see a key leadership role for Health Canada
in developing a pan Canadian strategy to improve access to ECP.
We urge Health Canada, perhaps in partnership with Status of Women Canada,
to host a national workshop to address these issues. CWHN would be pleased
to participate in the planning of such an event should this request receive
a favourable response.
Sincerely,
Madeline Boscoe,
Executive Director
c.c. Women's Health Bureau, Health Canada
The Honourable Liza Frulla, Minister responsible for Status of Women
