The approval of Mifegymiso has exposed the legal and practical limitations of Health Canada’s adoption of Risk Management Plans for drugs.
Two developments at Health Canada recently came crashing together in an illuminating way: the adoption of Risk Management Plans in the drug approval process and the approval of Mifegymiso, commonly referred to as the abortion pill.
Health Canada began using Risk Management Plans (RMPs) in February 2009 as part of its efforts to modernize the drug review process by moving to a “life cycle” approach, in which drugs are evaluated both before and after they are approved. A manufacturer seeking Health Canada’s approval for a new drug is often told that it should submit an RMP. An RMP describes the steps taken to “identify, characterize, prevent or minimize risks related to drug products,” and assesses the effectiveness of these steps. The plans may include, for example, a lab tests or the distribution of educational materials. Revisions to an RMP may be made at the instigation of the manufacturer or at the request of Health Canada throughout the regulatory life cycle of the drug.
Regulators in other countries adopted similar programs during the early 2000s. For example, the US Food and Drug Administration (FDA) requires that a Risk Evaluation and Mitigation Strategies (REMS) accompany certain applications for drug approval or be introduced after approval if unforeseen safety issues arise.
Unfortunately, the legal force and effect of RMPs in Canada is unclear. Unlike REMS, which the FDA is legally empowered to enforce, RMPs are not anchored in any authority under the Food and Drugs Act or the Food and Drug Regulations. This raises the question of whether Health Canada’s use of RMPs, like some other components of the life cycle policy, may be beyond its jurisdiction. Further, regulatory force and effect are clearly attached to the drug’s “label” – the product monograph and information in and on the package. While physicians are legally permitted to prescribe “off label” (i.e. in a manner inconsistent with the monograph), in doing so they assume liability for such use of the drug.
We requested a copy of the RMP for Mifegymiso but were told it could not be given to us without the permission of the maker — which was not granted.
RMPs are also not part of the “label” for the purposes of the Food and Drugs Act. Any legal force and effect that attaches to the “label” therefore does not attach to RMPs. According to Health Canada, RMPs are not binding on the regulatory colleges for the health professionals who prescribe and dispense drugs (physicians, nurse practitioners and pharmacists). However, whether they create potential liability for individual health care professionals who do not follow them is unknown. Finally, Health Canada considers RMPs to be confidential documents, so they are not posted on its Drug Product Database (we requested a copy of the RMP for Mifegymiso but were told it could not be given to us without the permission of the maker — which was not granted). In contrast, the FDA publishes the REMS in an online database.
In July 2015, Mifegymiso was approved by Health Canada. As is required for all drugs, the manufacturers produced a Product Monograph approved by Health Canada, setting out the drug’s indications, methods of administration and risks at the time of Mifegymiso’s approval. In keeping with Health Canada’s practice of explaining some of its decisions, a Summary Basis of Decision was also subsequently published. Still, Mifegymiso’s introduction was unusually rocky. Women’s health advocates raised concerns immediately about restrictions on distribution and administration that they feared would create barriers to access to abortion and compromise safety. For example, they objected to the requirement that a physician observe the patient taking the first dose and the requirement that the physician hand the drug directly to the patient (as opposed to the usual process of a pharmacist dispensing a drug directly to the patient).
To its credit, Health Canada later removed the requirement to observe ingestion from the revised Product Monograph (the Summary Basis of Decision reflected that change) and posted a “Myths vs. Facts” document online in an effort to alleviate some of the confusion and controversy.
But no changes were made about who can dispense directly to patients. The Product Monograph is silent on this point, the “Myths vs. Facts” document indicates physician-only dispensing, and although we don’t know exactly what the RMP says, we can assume it includes the dispensing restriction, because the “Myths vs. Facts” document says “the risk management approach for Mifegymiso includes physician-only dispensing.”
However, following communication with Health Canada, regulatory colleges for physicians and pharmacists in two provinces issued guidelines for their members indicating that it is permissible for pharmacists to dispense directly to patients. In British Columbia, the College of Physicians and Surgeons and the College of Pharmacists appear to have grounded their permission in the view that direct-to-patient dispensing by pharmacists is “off-label” use (which is permitted). Ontario’s colleges don’t use the “off-label” justification; instead, while acknowledging that Health Canada restricts direct-to-patient dispensing to physicians, they ground their permission in provincial legislation regulating the practice of pharmacists.
This is all quite confusing. On the BC approach, we would say that direct-to-patient dispensing by pharmacists cannot be considered “off-label” use because the “label” is actually silent on dispensing. On the Ontario approach, an important question is unanswered: What is the relationship between the RMP’s legal force and effect, especially in regard to potential liability, and provincial legislation regulating the practice of pharmacy?
At least four problems with the RMP process surfaced dramatically through the introduction of Mifegymiso.
First, with RMPs being inaccessible to all but Health Canada and the manufacturer, and being of uncertain legal force and effect, health care professionals cannot know how to practise without violating their legal duties. This barrier violates the rule-of-law principle that the law must be knowable.
Second, because regulatory colleges cannot access RMPs, they cannot know what advice to give their members about their legal duties. They are thus being hampered in the exercise of their own statutory duties — which include, notably, to protect the public interest.
Third, elements of RMPs can be inconsistent with the existing provincial/territorial regulatory framework for the practice of medicine, nursing and pharmacy. For example, the requirement that physicians dispense Mifegymiso conflicts directly with British Columbia’s prohibition on physicians dispensing drugs and with the significant discouragement of it in other provinces.
When Health Canada directs how and by whom drugs are to be dispensed, it may be exceeding federal jurisdiction.
Fourth, RMPs can step directly onto provincial/territorial territory. The regulation of health professionals is a role of the provinces and territories, not the federal government. When Health Canada directs how and by whom drugs are to be dispensed, it may be exceeding federal jurisdiction. But because RMPs are kept confidential, provinces and territories would not know about the breaches of their jurisdiction and so would not know to challenge it.
Fortunately, there are solutions to three of these problems (but not to the potential jurisdictional overreaching).
First, the RMPs should be posted online with the Product Monograph and other authorization documents. This way providers and their regulators can know their rights and responsibilities and act accordingly. This change would also fit with Health Canada’s recent commitments to increase transparency in drug regulation.
Second, Health Canada should get and share a legal opinion on the legal force and effect of RMPs on health professionals.
Third, Health Canada and companies applying for approval should consult with regulators of health care professionals who prescribe and dispense drugs in advance of completing the RMPs. This way they can ensure that they are not including provisions in the RMP that conflict with existing standards that apply to physicians, nurse practitioners and pharmacists.
With these measures, Health Canada could achieve a central policy objective of using RMPs: to “support Canadians’ timely access to safe, efficacious and high quality drugs.”
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