If we are honest - those of us who have been following the Federal Ministry of Health, Policy Bureau Drugs Directorate consultations for the last two years - knew deep in our hearts that Levonorgestrel would be de-regulated. However, given the abysmal track record of this type of family planning in the United States and in the United Kingdom, when applied to children and youth - we hoped that common sense might have prevailed. Sadly this has not been the case. It began two years ago with the announcement that deregulation was being considered and comments were requested from invited groups. The pro-life voice was not sought but thanks to Lifesite we received word soon enough to submit our concerns and have submitted our response to the drugs directorate on two occasions. However on April 20th 2005 "...Health Minister Ujjal Dosanjh announced an amendment to the Food Drug Regulations permitting Levonorgestrel 0.75mg, also known as the morning after pill, to be sold without a prescription....Levonorgestrel 0.75mg is an emergency contraceptive that can help prevent pregnancy up to three days after unprotected sex and is most effective if taken within 24 hours.....Health Canada’s decision to exempt Plan B from being sold only by prescription was made following extensive review of clinical evidence and safety data on the product. Health Canada undertook extensive consultations that included publication in Canada Gazette Part 1 on May 22nd 2004...."1

"Levonorgestrel 0.75mg is an emergency contraceptive that can help prevent pregnancy" The government order allowing the behind the counter sales claims the drug can be used to "prevent pregnancy," yet the same document goes on to say that it does so by "preventing the fertilized egg from attaching to the wall of the uterus.."2 Pharmaceutical companies state clearly that the prevention of implantation is at the very least a back-up mechanism in their formulations of the pill, while some newer "contraceptives" are solely aimed at prevention of implantation, for example the contraceptive vaccine.3

Now just which is Levonorgestrel a contraceptive or an abortifacient or is it both? Let us consult groups who support abortion. Ontario Women’s Health Council "The primary mechanism by which ECPs prevent pregnancy is by delaying or inhibiting ovulation. They may also work by inhibiting tubal transport of the egg or sperm, interfering with fertilization, or altering the lining of the uterus." Toronto Public Health; "Sometimes it works by preventing the sperm and egg from meeting. Sometimes, if the sperm has already fertilized the egg, it may prevent the growing group of cells from implanting in the uterus..." Planned Parenthood Federation of Canada; "The way the pills work depends on where you are in your monthly cycle when you take them. They can work by stopping the egg from being released from your ovary, preventing fertilization of the egg or stopping the egg from becoming implanted in your uterus. This is similar to the way that regular birth control pills work." Pro Choice Action Network; "The Emergency Contraceptive Pill (ECP) can be used up to 72 hours after unprotected sex. There are various types of ECP; generally there will be two doses of pills 12 hours apart. The first dose must be taken within the 72-hour time limit. The pills work by preventing fertilization or implantation of a fertilized egg in the wall of the uterus." Society of Obstetricians and Gynecologists of Canada;"Multiple mechanisms have been proposed including induction of endometrial asynchrony, altered endometrial receptors, suppression or delay of the LH surge, and ovarian steroid changes through pituitary suppression with subsequent corpus luteum disruption. Most of these mechanisms are felt to either suppress ovulation or prevent fertilization. The mechanism may also be through blocking implantation. Women should be aware of the possible mechanisms of emergency contraception because for some women this may not be an ethically acceptable option." 1st-morning-after-pill-4-birth-control.com in answer to a question "Can you let me know PlanB’s mechanism of action. "The medication in PlanB which is Levonorgestrel is similar to the ingredients in most birth control tablets. It works by delaying ovulation and therefore delaying fertilization. It may also prevent implantation in the uterus, but that is speculative."

Our consultations with pro-life groups gave us the following Canadian Physicians for Life: "The morning after pill is a multiple dose of an oral contraceptive. The MAP may prevent ovulation, or if fertilization has occurred, it may ruin the implantation of a newly conceived human being. It is important that the potential for post fertilization effects be communicated to patients and health-care providers, as many consider human life to be present and valuable from the moment of fertilization. The common description of MAP as an emergency contraception fails to accurately describe its possible abortifacient action4 and is misleading the public."

The Society for the Protection of Unborn Children (UK) sought a judicial review on morning after pills, two of the witness statements in support of the drug company and the judge’s ruling acknowledged the fact that non-barrier birth control could affect the lining of the womb, which is where the early embryo needs to implant.5

Well it seems pretty clear that the morning after pill always retains the ability to prevent implantation of a new human being and therefore can accurately be called an abortifacient. What seems strange is why our Ministry of Health has allowed sale of the morning after pill behind the counter, when there is ample evidence that this practice just does not work. This evidence is even
present in the British Columbia study that apparently gave the impetus for deregulation as we shall note later.

"Experience in other countries shows that easier access does not lead to excessive use...Wider availability and use of Levonorgestrel 0.75mg as an EC could significantly reduce the number of unwanted pregnacies"6

So says the Regulatory Impact Analysis Statement that accompanied the Ministry of Health Press Release. Obviously our recommendation that the UK be studied was not followed up or the Ministry might have taken note of the information provided in an article by Bob Roberts in the Daily Mirror in 2001. Easy access to the morning after pill for young girls has failed to reduce teen pregnancies, MPs were told. Cases of sexually transmitted diseases among girls 16-19 have also skyrocketed by more than 55 per cent. The startling statistics - relating to the 90's came at a time when the Government has decided to hand out emergency contraception to teenage girls in school. Economist Dr David Paton, who compiled the figures, said "The Government’s policy does not seem to be working..it says there is evidence behind the policies, but it appears to disappear into thin air.." The number of under 16s attending family planning clinics in England rose 146.3 percent from 1992-2000, Dr Paton told a conference organized by the all party pro-life group.

Prescriptions of the morning after pill to the same age span increased by 284.8 per cent. But in the same period conception fell just 1.2 per cent. For 16-19s, morning after pill prescriptions rose by 321.5 per cent. But the conception rate increased by .73 per cent to 56.8 per 1,000. Dr Paton of Nottingham University, said sex disease cases for 16-19s soared 58.3 per cent between 1995-2000. He said, "The figures are quite stark. The morning after pill use has shot up for under 16s, but there is no evidence that this is reducing conception." Dr Paton said US evidence showed that when abortion is made more difficult, conceptions rates go down ….7

It is believed here in Canada that making the morning after pill(MAP) more easily accessible through pharmacists "has the potential to reduce the number of unwanted pregnancies and subsequent abortions.."8 This has not been the experience of other provinces. In Quebec, the morning after pill became available without prescription in January 2002. The number of abortions rose from 28,489 in 2001 to a record high of 29,240 in 2002 and 29,429 in 2003 as reported by the study, "La situation demographique du Quebec". These figures do not include the number of abortions performed in private clinics which were not covered by health care dollars. In 2001, 4415 Quebec women purchased the morning after pill compared to 7,151 women in 2002. As of mid-December 2003, a total of 8717 women had received refunds from the Quebec government for the purchase of these pills.9

Let us take a look at the study in British Columbia, a province which started to provide MAP behind the counter in December 2000. In the results of the study it was noted that, The number of EC prescriptions increased from a pre-policy mean of 8805..in the years 1996 to 2000 to a post policy total of 17,794...The frequency of EC was highest among women of 20-24 years across all study years, and all age groups demonstrated a post policy increase in use." We noted with alarm that in the age-related frequency of use of EC per 1000 in British Columbia the pre-policy statistic of .4 for 10-14years skyrocketed to 51.9 increase in the post policy period - with an equally chilling statistical increase of 17.4 pre policy to a 51.4 post policy for the 15-19 age group. The aim of the study was to determine if women would obtain EC from pharmacists instead of physicians and whether the overall EC prescription would increase - obviously it has.

Pharmacists were given a four hour training program and provided with a standardized pharmacist-patient interview consent form. It was estimated that 550 pregnancies had been prevented out of 13,217 prescriptions. There was also a public health promotion that encouraged women to "store [MAP] for future use".

One problem with the study results was noted in that the PharmaNet data base likely understated the EC use for two reasons - it was either mis-coded since it was prescribed in non-standard quantities or was provided through emergency departments, walk in and youth clinics where samples kept on site or a "delegation of function" protocol where a nurse would dispense the EC would not be included in the PharmaNet data base. The nurses are trained - not quite the same as the pharmacists and a physician signs off on their training. They are then able to dispense the EC without prescription but under the management of the physician.

This poses another huge problem as far as accurate numbers of ECs dispensed since there could literally be thousands of children or youth accessing EC through youth or family planning clinics and these figures have not been counted. It is also interesting to note that in the two year post-policy period of non-prescription EC access, abortions have increased from 14,070 in 2000 to 15,820 in 2001 and 16,076 in 2002 in British Columbia - so much for "reducing the number of unwanted pregnancies and subsequent abortions".

The Government and the Canadian Pharmacist’s Association consider that "..pharmacists are well positioned to play a major role in increasing women’s access to emergency contraception.." We continue to respectfully disagree and reiterate our concern that pharmacists do not have access to medical records and may not be able to gain an accurate medical history in other ways. How will they discern if the young woman is accessing the pill for herself or someone else? A person’s doctor will only be notified that the morning after pill has been supplied if the person agrees. In April 2003 during a debate at the Royal College of Nursing’s (UK) annual conference, nurses called for tighter regulation on the way the morning after pill was handed out by pharmacists. They feared that pharmacists were selling the emergency contraception to girls and women without proper medical check ups (not required in Canada under this change) - failing to ask enough questions - in some cases encouraging some women to use these drugs as an alternative form of contraception - failing to warn customers about potential side-effects - and failing to check if the medication was actually suitable for them.10

Dr David Paton statement in reference to the UK government initiative holds true for Canada. "The Government’s policy does not seem to be working..it says there is evidence behind the policies, but it appears to disappear into thin air.." It is my fervent hope that the Parliamentary Pro-Life Caucus, Canadian Physicians for Life, the entire pro-life movement and all people of good will should work together to get this atrocious and wrong headed policy changed as soon as possible.

Jakki Jeffs is the Executive Director of Alliance for Life Ontario and past president of LifeCanada.

1 Health Canada News Release April 20th 2005; Health Canada Media Inquiries Jirina Vlk 613 957 2988
2 Health Canada April 19th 2005 “Regulatory Impact Analysis Statement,” page 1
3 Pal R. “Absence of corpus luteum rescue by chorionic gonadotropin in women immunized with a contraceptive vaccine,” Fertility and Sterility 76 (2): 332-336, 2001.
4 Postfertilization Effect of Hormonal Emergency Contraception: The Annal of Pharmacology, p. 470, March 2002 Vol. 36; Chris Kahlenbon, Joseph B Stanford and Walter L. Larimore
5 International Journal of Cancer on Courier-Mail on news.com.au and Society for the Protection of Unborn Children, May 20th 2003. www.spuc.org.uk/news/archive/2003/
May/21
6 Health Canada April 19th 2005 “Regulatory Impact Analysis Statement,” page 3
7 Mirror.co.uk Teen Pill a “failure” Bob Roberts, May 2001 www.mirror.co.uk/printable_version.cfm?method=printable_version_mirror&objectives
8 “Effects of making emergency contraception available without a physician’s prescription: a population-based only study. Judith A. Soon, Marc Levine, Brenda L. Osmund, Mary H.H. Ensom, David W. Fielding, JMAC 29 Mars 2005; 172 (7)
9 Louise Leduc. “La Pilule du lendemain: les beaux jours sont encore à venitre …” La Presse, December 18, 2003.
10 “Nurses warn on morning after pill” Isabel Oakshott, Health Correspondent, Evening Standard (UK) 30th April 2003