Long-Acting Reversible Contraceptive Device Regulations: Lessons for Canada
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2019-09-02
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Abstract
Unintended pregnancy rates in Canada have remained relatively stable over the past decade, even though contraceptive use has increased over the same time period. Given these statistics, it is possible that Canadians are using contraceptives inconsistently, or are using less effective contraceptive methods. For example, Long-Acting Reversible Contraceptives (LARC), such as intrauterine devices and subdermal implants, have the lowest failure rates of all currently developed reversible methods but are only used by less than five percent of female contraceptive users in Canada. Several researchers and health care professionals have suggested that increasing LARC use could have a significant impact on reducing the unintended pregnancy rate, given their high efficacy rates and minimal room for user error. However, Canadian women have limited choices when it comes to LARC products, which may influence LARC uptake. For example, no type of subdermal implant is currently available on the Canadian market, and several types of intrauterine devices are also unavailable. While there are many market factors that may affect product variety in Canada, some researchers have determined that unnecessary regulatory hurdles are largely responsible for Canada’s dearth of contraceptive products. The first step to increasing LARC uptake is to ensure that the Canadian regulatory system is properly equipped to attract and approve safe and effective LARC products. This paper examines the regulatory process in some of Canada’s peer countries—namely The United Kingdom, the United States, and Australia—in order to discover regulatory best practices for LARCs. This paper compares each country’s classification system for LARCs, the overall pathway to regulatory approval, clinical trial requirements, post-market surveillance activities, and the transparency of each country’s regulatory process. After a review of the literature, it is evident that there are many lessons to be learned from other countries’ experiences with LARC regulations. The overarching lesson is that it is imperative to include a number of voices in both the pre-market approvals process and in postmarket surveillance. Academic researchers, doctors, medical professionals, consumers, distributors, manufacturers, government officials, and international regulators all have an important role to play in upholding safety and efficacy standards. In an increasingly globalized pharmaceutical industry, Canada would do well to increase participation from each of these groups in order to reduce unnecessary regulatory hurdles for manufacturers while simultaneously protecting consumers from unsafe devices. The paper concludes with specific recommendations for Health Canada. If adopted, these recommendations will make Canada a more attractive market for LARC products while ensuring that the highest standards of safety and efficacy are upheld for Canadian contraceptive users. As a result, more LARC products will seek to enter the Canadian market, which will provide women with diverse needs and preferences with more options when it comes to selecting an effective contraceptive method.
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Sutton, B. (2019). Long-Acting Reversible Contraceptive Device Regulations: Lessons for Canada (Unpublished master's project). University of Calgary, Calgary, AB.