How Does the Health Canada Approval Process Work?
The Health Canada approval process begins after a drug has been tested in preclinical and clinical trials. Through a variety of laboratory and animal testing, pre-clinical trials are designed to determine if the drug will produce the intended result. The preclinical data must support the notion that the drug is non-toxic and safe. Then, an application is submitted to the Therapeutic Products Directorate (TPD) of Health Canada. Once this application is approved, the drug is then clinically tested on humans.
After preclinical testing, clinical testing and with supporting data collection, the sponsor may file a “New Drug Submission” with the TPD. Information and data on the drug are attached to the submission. The information and data outline the safety, effectiveness and quality of the drug as well as the production details, packaging and labeling details, information regarding therapeutic claims, its side effects and results of both the preclinical and clinical testing. The TPD’s review is an assessment to determine if the benefits outweigh the risks. If the conclusion is “yes” then the drug is issued a Notice of Compliance and a Drug Identification Number which allows the sponsor to market the drug in Canada.
Where is RU-486 at in the Approval Process?
RU-486 has been in the approval process since 2001. Clinical studies were conducted, halted and then re-started. In December 2012, Health Canada received an application to consider RU-486 for marketing.
It is unclear where the application now sits in the process. Up until January of this year Health Canada refused to acknowledge the existence of an application to approve RU-486.
On the government level, it still remains that no Canadian law has been passed to regulate abortions since the law was struck down by the Supreme Court of Canada in the 1988 R. v. Morgentaler decision. In that case, the Supreme Court of Canada noted that the existing law put women at risk because of the law’s uneven application based on geographic location; and, that Parliament had the jurisdiction to enact legislation to limit or prohibit abortion. Prime Minister Harper has stated that abortion is not on the agenda for discussion.
The Health Canada process stands officially independent from the government that funds it.
Is RU-486 a Pro-Woman Drug?
RU-486 is not a pro-woman drug.
Considering this drug from several perspectives yields the same result. While RU-486 would provide greater access to abortion for women in Canada, that access would come with a cost.
The cost of RU-486 is measured by Health Canada in terms of gains vs. losses. If the gains or “benefits” of RU-486 outweigh the losses or “risks” then it is deemed as a “success” in the drug approval process. Consequently the same method is being used to measure the value of the life of a woman or a child in the womb. Measuring the well-being of a woman or child on such a scale does not advocate on their behalf or bring justice.
Information on RU-486 and its long term effects is scarce and much may be unreported. However, RU-486 and induced abortion can have long term effects such as: maternal or fetal death; uterine hyperstimulation; risk of hysterectomy; uterine rupture or perforation; later risk of premature births; risk of preterm delivery; chronic pelvic pain as a result of a pelvic infection, pelvic inflammatory disease, infertility, and possible deformation of the child in the womb are all possible side effects.
RU-486 doesn’t just impact women medically. It takes a toll psychologically and emotionally. Any woman choosing to take RU-486 experiences a painful process that takes at least two weeks. This painful process is accompanied by the “passing” of the aborted baby. When the first pill is taken the baby is starved of the nutrients needed to sustain life, which means a deceased child may be carried in the womb for up to a week before being able to take the second pill to expel the baby. Because RU-486 can be taken up to about two months into the pregnancy, the baby may already have formed a discernable head and limbs. Women have found this both psychologically and emotionally taxing.
There is much more to consider than temporary side effects, choice or giving a woman a sense of control over her abortion.
A woman must live with this choice forever. What happens when the relief of her choice wears off, or “control” over the abortion leaves her feeling the opposite? For some women, once the finality of the personal choice sets in, there is an overwhelming sense of responsibility for the death of a child. In one report, a U.S. woman was hospitalized after trying to commit suicide subsequent to just such a chemical abortion. A New Zealand study noted that young women who undergo abortions are more likely to display suicidal behaviour, depression, substance abuse, anxiety, PTSD, and other mental disorders. Other studies conducted by Dr. David Reardon describe a correlation between abortion and mental health issues such as sleep disorders and child abuse. The psychological and emotional scars from RU-486 are real and permanent. It is much more than just taking a few pills and waiting.