TOPIC/ISSUE
Health Canada’s approval on Linepharma’s abortion pill Mifepristone has taken more than 106 days longer compared to 40 other new medications approved in recent years; the longest of which took 644 days to be approved (Grant, 2014). This issue holds political significance for several reasons:
 Unequal Access to Abortion Services – Approval of Mifepristone will equalize access to these services in areas where they are scarce as women can obtain the service through their family doctor.
 Privacy – The approval of Mifepristone will allow family physicians to prescribe this medication so that abortion can happen within the confidentiality of the patient and their primary care physician.
 Medication Safety – The substitute abortion medication is Methotrexate, a chemotherapy medication that is inferior to Mifepristone as it requires more time to work, is less predictable, and is more likely to cause birth defects should the abortion fails.
 Political Issue – There are suspicions that the Harper Government is politically involved in the Mifepristone’s latest delay as it will conveniently postpone the decision until after the fall election.
 Canadian Women Rights – Since the medication has been approved and has been greatly beneficial to women in many other countries, Mifepristone’s delay has also been seen as an issue of women’s right to a medical treatment that is considered as the Gold Standard for medical abortion.
ANALYSIS – Policy Cycle, Key Interests, Institutional Factors, and Ideas
Stage of Policy Cycle:
 Health Canada reverted back to the Policy Formulation stage from the Decision Making stage as they requested Linepharma for more information regarding Mifepristone, consequently delaying the ruling on the drug even longer.
 The decision is being made at the Federal and Legislative level, which has nation-wide effects.
Key Interests:
 Elected Politicians – They have Structural power and are Dominant interests. As Executives, they have substantial amount of power to influence the policy making process. An example is Stephen Harper, who is interested in Canadians’ wellbeing and re-election.
 Bureaucracies – They also have Structural power and are Dominant interests but have less power than Elected Politicians. Health Canada falls under this class and its main interest is in ensuring approved drugs are safe for public use.
 Interest Groups – They have Professional and Countervailing powers. They are either Challenging or Dominant interests who are invested in pushing for or against the approval of Mifepristone or otherwise. Some examples are: National Abortion Federation, Society of Obstetricians and Gynecologists of Canada, Religious Groups, and Campaign Life Coalition.
 The Public – They have Countervailing source of power and are Repressed interests. Ironically speaking, this includes the Abortion Patients who are the users of the abortion services.
 Academia – These actors have Professional source of power and are Dominant interest. They are well respected and are considered as research advisors to the policy making process. Their interests are in studying and providing analysis of the current Health Canada drug approval process to influence change.
Key Institutional Factors:
 Lack of Policies for Safe Abortions – Systemic debates over abortion has continued since the early 1900 and yet there are still no policies in place which either promote or encourage capacity building for safe abortions within the health care system.
 A Closed-Door Approval Process – At both levels of drug screening, the process happens behind closed doors without public access to information. In contrast, the United States FDA has a much more transparent process; for example, drug registry, full review and committee transcripts are published online and the public is invited to submit input¬¬.
 Conflicting Funding Pressures – The 2004 User Fees Act requires that pharmaceutical companies fund the majority of the drug approval process. There are conflicting funding pressures exerted on the drug approval process as both government and business fund it.
Key Ideas:
 The drug approval process is founded on the principles of expert-driven, non-partisan decision-making that is threatened by all other interference.
 Patient privacy, patient-centered care and patient safety are all important considerations in this issue because the use of mifepristone would facilitate more discrete abortions.
 Since mifepristone can also increase access to abortions in rural areas where other options are not available, this policy affects equity of access.
FINDINGS AND IMPLICATIONS
Findings
 Despite the identified benefits and major interests in approving Mifepristone, Health Canada continues to delay its decision.
 Health Canada’s decision to revert back to the Policy Formulation Stage and its closed-door approval process only intensify the issue and erode Health Canada’s reputation as a neutral drug regulator interested in using facts and evidence to make clear and informed decisions that benefit the public.
Statement of Implications – All these combined suggests a biased/value-based decision making as opposed to what is meant to be an evidence/fact-based approval process, as well as media sensationalism. As a result, the abortion patients continue to be the repressed interests, despite being the very users of these services.