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Translated by Zoe Yarymowich
Please note that since the publication of this article, several elements (policies, clinical guidelines, etc.) have evolved. The information presented in this article is therefore not necessarily up to date.
Access to abortion has always been an issue close to my heart. I have always thought of access to this type of intervention as one taken for granted by society. It was my favourite subject to debate during class in high school, and it still is today. Recently, I have been researching Mifegymiso, the abortion pill, and the health policies surrounding it. I naively thought that the fruit of my research would result in a simple and straightforward argument. I was barking up the wrong tree.
The issues surrounding Mifegymiso are much more complex than what the media would lead us to believe. Legal vagueness is increasing, the institutions involved contradict each other, and concrete obstacles stand in the face of outdated although recent regulations. In short, I am under the impression that we are swimming in a sea of misinterpretations, uncertainties, and doubts about Mifegymiso. Although it is quite difficult to navigate right now, I believe it is important to (try to) set the record straight.
First of all, you should know that there are two types of abortions or voluntary termination of pregnancy (VTP): surgical and medical (INESSS, 2017). The pharmaceutical product Mifegymiso was authorized in Canada as a so-called medical or pharmacological abortion regimen in July 2015 (Heath Canada, 2016a). Mifegymiso consists of one tablet of mifepristone and four tablets of misoprostol, administered in two phases (INESSS, 2017). The product has three distinct actions that ultimately lead to the termination of pregnancy. First, mifepristone blocks the effect of progesterone on the endometrium and myometrium, which prevents the support of an embryo (Health Canada, 2016a). Second, it contributes to cervical dilation (Health Canada, 2016a). Finally, misoprostol leads to contractions of the uterine myometrium (Health Canada, 2016b). Health Canada has permitted the use of Mifegymiso up to seven weeks into pregnancy (Health Canada, 2016a).
Although the trade name Mifegymiso refers to the combination of mifepristone and misoprostol in Canada, the use of these two products is widespread elsewhere in the world (INESSS, 2017). Indeed, their use was approved as early as 1988 in France and China (Chan, 2016; Dunn & Cook, 2014; INESSS, 2017). Today, they are used in more than 60 countries around the world (CAPS, 2017) although they are named differently (Mifegyne, Mifeprex RU-486, etc.). The WHO even included them on the Model List of Essential Medicines (INESSS, 2017).
Prelude to Concerns
With just a few clicks, it is easy to find a multitude of testimonials from doctors and other medical experts claiming loud and clear that the current situation is unreasonable and that we should hasten the step to make Mifegymiso accessible as quickly as possible knowing that the efficacy and safety of the product has repeatedly been established (Mifeprex REMS Study Group, 2017). However, I heard it on the grapevine that some medical professionals feared the arrival of Mifegymiso in the Canadian market, arguing that while the product is safe and effective, it is less so compared to surgical abortion. This is not necessarily true, because each intervention has different complications and are therefore more difficult to compare (INESSS, 2017). Nevertheless, an article grouping together several studies was able to assess the risk of suffering from serious but treatable complications (i.e., hospitalization, blood transfusion, serious infection, etc.) from 0.01-0.7% and a mortality rate of 0.00063% (Mifeprex REMS Study Group, 2017). These are low risks, but they should not be overlooked. If we talk about intervention failure (the pregnancy continues to progress), the odds are estimated at 5%, a fairly high rate (Health Canada, 2016b).
Therefore, the problem is not necessarily in the safety of the product itself, but in the follow-up. The manufacturer Celopharma, the Food and Drug Administration (FDA), and Health Canada agree on this point: a follow-up (between 7 and 14 days following the initial intake of medication) is mandatory, necessary, and essential to ensure that the treatment has been successful, that there are no serious complications and that if there are any, the woman is quickly taken care of and transferred (if necessary) to a medical center with the appropriate resources (i.e.curettage) (INESSS, 2017; Health Canada, 2016a). The fear is that patients will not want to return a second (or sometimes third) time for their follow-up, especially if they have already had to travel several tens of kilometers for their initial appointment. In my opinion, this is a major issue. Yet, there is radio silence on this end.
Operation versus Medication: The War of Accessibility
On the other hand, it should not be forgotten that Mifegymiso offers an interesting alternative for women (Vogel et al., 2016). Having more than one option increases decision-making autonomy, an important concept in health (Beauchamp, 2006; Mifeprex REMS Study Group, 2017). For example, a woman with a high BMI may be offered an alternative that is more suited to the situation and therefore safer (INESSS, 2017). For women who do not have access to abortion services in Prince Edward Island, for example, (AbortionInCanada, n.d.) or in the Yukon where services are extremely limited (Cano & Foster, 2016), access to the abortion pill would make an enormous difference in terms of reproductive health (Cano & Foster, 2016). I must, however, impose a caveat because accessibility is only theoretical for the moment since Mifegymiso is not covered by the government (INESSS, 2017; Health Canada, 2016c). In my opinion, a real step in the direction of accessibility would be to cover Mifegymiso (Gomez et al., 2014; Vogel et al., 2016) to the same degree as surgical VTP (AbortionInCanada, n.d.), especially as according to predictions, medical VTP would turn out to be less expensive than surgical VTP (INESSS, 2017).
Gestational Age, a Time Constraint
Another critique that is often voiced concerns the maximum gestational age imposed by Health Canada, which are likely to be too restrictive. Several countries indeed allow medical VTP up to ten weeks into pregnancy. However, the further along into pregnancy, the less effective Mifegymiso is. Effectively, it goes from 95.5-97% efficacy at 49 days of gestational age to 90-95.5% efficacy between 64 and 70 days (CAPS, 2017). It can be inferred that this is why Celopharma, the company marketing Mifegymiso, has set the limit at seven weeks during its initial request to Health Canada (Health Canada, 2016c). In my opinion, it is therefore useless to want to be more permissive in terms of gestational age, given that the effectiveness drops significantly (CAPS, 2017) and that the likelihood of undesirable side effects (i.e. strong hemorrhage) increases with gestational age (INESSS, 2017). On the other hand, surgery remains an option in its own right for people who are more advanced in their pregnancy (depending on the location, the procedure can be done up to 23 weeks into pregnancy; FQPN, 2017). A person at ten weeks of pregnancy having to travel to receive a surgical VTP faces the same problem in terms of accessibility as a woman who must travel to undergo the same type of intervention because medical VTP at nine or ten weeks has failed. The accessibility argument chanted by the media when it comes to the gestational age limit is therefore not valid, in my opinion.
Swallowing the Pill...Before a Witness
Some also blame the obligation to ingest the first dose in front of a doctor. Except that this is undoubtedly a major misinterpretation. Health Canada has established that the administration of Mifegymiso must be done under medical supervision, which effectively means that a medical evaluation by a trained physician must be done (Health Canada, 2016c). Health Canada clearly states that the doctor does not need to watch the patient swallow the pill, although it is recommended (Health Canada, 2016c). Likewise, physicians are not required to stock Mifegymiso (Health Canada, 2016c). Doctors must, however, provide the product directly to patients (INESSS, 2017) and this is where I must express my reservations. If all the requirements imposed by Health Canada are met (i.e., there has been a medical assessment and examination, discussion of the decision and other options [CAPS, 2017], as well as possible risks and complications [INESSS, 2017], why wouldn’t pharmacists be allowed to deliver the product like they already do with thousands of others (Bannert & Iselin, 2015; Norman & Soon, 2016)? Regardless of what Health Canada says, the current situation undoubtedly imposes an unnecessary obstacle to the distribution of Mifegymiso (Cotescu et al., 2016), and the justifications offered as an explanation are insufficient. For example, to say that this model is inspired by other countries (Health Canada, 2016c) is not worth much because a host of other countries, comparable to Canada (e.g., Australia or the United States), allow pharmacists to dispense the product after medical evaluation (INESSS, 2017; Mifeprex REMS Study Group, 2017; Norman et al., 2016).
At a Pharmacy Near You...or Not!
The most popular criticism concerns the distribution of the abortion pill in Canada. Many people wonder why it is still not accessible if it was legalized almost two years ago. At the risk of repeating myself, the answer is not simple. First, health falls under provincial jurisdiction and each province and territory has several bodies involved (the College of Physicians, various professional orders, the Ministry of Health and Social Services, etc.), which, from the outset, makes the process more complicated just in terms of coordinating recommendations. Second, in the majority of provinces and territories, Mifegymiso has not yet been added to the formularies as the evaluation of the product by the Canadian Agency for Drugs and Technologies in Health has not yet been completed (ACMTS, 2016). Finally, certain restrictions implemented by Health Canada indeed limit the number of clinics that satisfy the conditions put in place (for example medical supervision and guaranteed access to emergency treatment if necessary) (Dressler et al., 2013) and therefore may request to obtain the product (Health Canada, 2016c).
Imbroglio for Mifegymiso
In this somewhat delicate matter, the media criticize the health authorities for the decisions made, accusing them of unnecessarily slowing down the marketing of Mifegymiso. However, not everything is so simple and in this present case, it is important to consider the other side of the coin, which the media does rarely or poorly. Reading newspapers from both the English and French Canadian point of view, I got the impression that too often the regulations put in place by Health Canada and other federal bodies are interpreted without having looked into the reasons behind the implementation of these regulations. Instead of guiding us through the confusion surrounding Mifegymiso, we are weighed down. Not everything is black or white and it is more difficult to position myself on this issue than I would have thought because of the complexity of the issues themselves, but also because of the administrative vagueness surrounding them.
Peroration with Precautions
There is obviously a long way to go for Mifegymiso, as much at the legal as commercial level. Although at first glance, the health agencies seem to want to put a spoke in the wheels in Mifegymiso, I believe they are only wary. The product’s legal, economic, social, and medical impact in the Canadian context has not yet been sufficiently studied to adequately justify a potential rush to market. Naturally, the circumstances would be quite different if Canada were in a more urgent situation where, for example, abortion was completely inaccessible, which fortunately is not the case.
I am not ruling out exercising an excess of caution vis-à-vis Mifegymiso, but in my opinion, it is too early to decide. Only time will tell whether Canada and its provinces and territories should have shown more flexibility in the advent of the abortion pill. Slowly but surely, the pill will go down!
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