Audrey Chapman
Access to sexual and reproductive health care is a fundamental right that all states must respect, protect, and fulfil, and is articulated in regional and international treaties including the International Covenant on Economic, Social and Cultural Rights (ICESCR), the Convention on the Elimination of All Forms of Discrimination Against Women (CEDAW), and the Convention on the Rights of the Child (CRC).
But one year on from the US Supreme Court ruling in Dobbs v. Jackson Women’s Health Organization which overturned the constitutional right to abortion–established in 1973 by Roe v. Wade–abortions (an essential element of sexual and reproductive health care) are now unavailable in nearly a third of US states and restricted in 11 others.[1]
While the US Supreme Court rarely engages international human rights law and the US has not ratified the ICESCR, CEDAW or CRC, it is time for human rights treaty bodies to explicitly recognize a right to abortion in international human rights law to provide advocates and lawmakers around the world with international legal guidance and clarity.
State level bans and restrictions in the United States over the past year have not satisfied abortion opponents who have further sought to restrict access to abortion through the revocation of the US Food and Drug Authority’s (FDA) approval of the widely used abortion pill mifepristone. The FDA approved the use of mifepristone 23 years ago, initially for the termination of pregnancies up to 7 weeks, extended to 10 weeks in 2016 with additional evidence of its safety. At this time, it also loosened dispensing restrictions making it available via telehealth, through the mail, and from permitted registered pharmacies. Currently about 53% of abortions in the United States utilize medication rather than surgical procedures.
Mifepristone, which is on the World Health Organization’s list of essential drugs, is approved for use in ending pregnancy in more than 90 countries, and has never before had its approval rescinded.[2] When used as part of a two-pill regime, mifepristone with misoprostol, it successfully terminates 99% of pregnancies with a very low risk of major complications and mortality.[3]
Mifepristone court rulings
Ending access to mifepristone has become the target of lawsuits filed by opponents of abortion, with supporters of abortion then filing countersuits to preserve its availability. In November 2022, the Alliance for Hippocratic Medicine (AHM) and several other anti-abortion groups filed a lawsuit in the US District Court for the Northern District of Texas arguing that the FDA’s approval of mifepristone for pregnancy termination in 2000 was impermissible under the Federal Food, Drug, and Cosmetic Act and asking that the court order the FDA to immediately suspend or withdraw that approval. The plaintiffs also contended that the 1873 anti-obscenity law, the Comstock Act, which was no longer being enforced, prohibits the mailing of medication used for abortion.[4] The litigants carefully chose this jurisdiction as the US District Court for the Northern District of Texas has a single judge appointed by former President Trump, who is a known abortion opponent. On April 7, 2023 this judge, Matthew Kacsmaryk, handed down a decision ordering the FDA to suspend approval of mifepristone within seven days. Although he does not have scientific training, his decision was based on his own assessment that mifepristone is a dangerous drug, that medication abortion scars women, and that the FDA did not use the appropriate procedure when approving the drug. This was the first time that the judiciary overruled the FDA’s scientific panels and expertise.[5]
Realizing that this decision sets a dangerous precedent for court interference in other FDA evidence-based decisions, medical associations, patient groups, and executives from pharmaceutical and biotech industries have taken issue with Kacsmaryk’s ruling.[6] Medical associations expressed concern that it “introduces the extraordinary, unprecedented danger of courts upending longstanding drug regulatory decisions.”[7] More than 400 leaders of drug and biotechnology companies issued a statement condemning the Texas decision: “Judicial activism needs to stop here. If courts can overturn drug approval without regard to science or evidence, or for the complexity required to fully vet the safety and effectiveness of new drugs, any medicine is at risk for the same outcome as mifepristone.”[8]
The attorneys general of 17 states and the District of Columbia, all supporters of abortion rights, filed a lawsuit in the Eastern District of Washington State countering the claims made by the Alliance for Hippocratic Medicine. On April 7, 2023, less than an hour after the Texas decision was issued, Judge Thomas Rice, an Obama appointee, issued a contradictory ruling that the FDA should not limit access to mifepristone in those jurisdictions that had filed the lawsuit.[9]
In addition, the US Federal Department of Justice acting on behalf of the FDA and Danco Laboratories, the manufacturer of mifepristone, appealed the Texas federal court decision to the US Court of Appeals for the Fifth Circuit in New Orleans, a conservative court whose jurisdiction includes Texas. A three-judge panel of the Court of Appeals issued a mixed decision staying the most sweeping aspects of the Texas District Court decision so that mifepristone could remain available while the case goes through the courts.
The Department of Justice, acting on behalf of the FDA and Danco Laboratories, filed an emergency application to the US Supreme Court asking it to pause the parts of the Appeal Court’s ruling that limited the availability of mifepristone. According to their brief, “If allowed to take effect the lower court’s order would upend the regulatory regime for mifepristone, with sweeping consequences for the pharmaceutical industry, women who need access to the drug, and the FDA’s ability to implement its statutory authority.”[10] On April 21, 2023 the US Supreme Court blocked the District Court’s ruling in a 7-2 decision, sending the case back to the US Court of Appeals for the Fifth Circuit. Access to mifepristone will not change while this litigation continues.
Aftermath of the litigation
These legal battles have had the positive consequence of doubling awareness of mifepristone since January 2023, with a recent poll finding about two-thirds of adults have now heard of the drug, up from 30% in January, and 66% of American adults support mifepristone staying on the market and most are aware that medication abortion is safe.[11] Since knowledge about reproductive rights and the means to implement them is a basic human right this increased awareness is a positive trend.
Whatever the final impact of the litigation or the status of abortion in any particular state it will not completely stop access to mifepristone. There is now an expanding global supply of abortion pills including overseas manufacturers and domestic distribution networks which can circumvent bans and restrictions. It is estimated that overseas suppliers have provided abortion pills to around 100,000 people in the United States since the Dobbs decision.[12]
Seven states where abortion is still legal have also passed shield laws to try to protect both abortion providers who treat residents in states with abortion restrictions, and the patients from these states who seek care.[13] It is possible that the to-date untested shield laws would also protect physicians and pharmacists who are prescribing and mailing abortion pills to women in states with abortion restrictions.
But many women likely remain unaware of their options and it is probable that economically disadvantaged women in states with very restrictive laws will be the ones least able to obtain mifepristone. Moreover, having to rely on unregulated networks and for-profit suppliers is not ideal medically, financially, or legally.
Reflections
The Dobbs Supreme Court decision and the subsequent legal tangles over access to mifepristone underscore the potential fragility of abortion rights and the need for vigilant advocates. Abortion rights, and more broadly reproductive rights, are controversial in many jurisdictions in the world with conservative individuals, groups, and governments reluctant to grant reproductive autonomy to women.
If there were strong, explicit, and robust international human rights standards to protect and promote the right to abortion, they could be extremely influential in matters of domestic law, even when states have not ratified all relevant UN conventions. However, currently the right to abortion is not directly enshrined in any of the key international human rights instruments. It is only recently that the right to abortion has been mentioned in a general comment, and even so, the text is not written in affirmative terms that women’s rights to health, bodily autonomy, and to reproductive rights vest women with the right to a safe abortion and post-abortion care. Instead in the two general comments where abortion is discussed it is placed primarily in the context of preventing unsafe abortions, which is a worthy goal, but an inadequate rationale for the right to abortion. For example, in General Comment No. 22 (2016) of the Committee on Economic, Social and Cultural Rights on sexual and reproductive rights, paragraph 28: “Preventing unintended pregnancies and unsafe abortions requires States to adopt legal and policy measures to guarantee all individuals access to affordable, safe and effective contraceptives and comprehensive sexuality education, including for adolescents; to liberalize restrictive abortion laws, to guarantee women and girls access to safe abortion services and quality post-abortion care, including by training health-care providers, and to respect the rights of women to make autonomous decisions about their sexual and reproductive health.”[14]
The UN Human Rights Committee reiterates the same points in its 2018 General Comment 36 on the Right to Life and also prohibits any restrictions that might lead to an unsafe abortion or risk of death from an unsafe abortion. It calls on states to reform their laws so as to not apply criminal sanctions either against women and girls choosing to undergo abortions or medical service providers offering them. Its most assertive statement is that “states parties must provide safe, legal and effective access to abortion where the life and health of a pregnant woman or girl is at stake and where carrying a pregnancy to term would cause the pregnant woman or girl substantial pain or suffering, most notably where the pregnancy is the result of rape or incest or is not viable.”[15]
What is lacking in both general comments is the more affirmative grounding that women’s rights to health, health care, bodily autonomy, and even to life, require that states recognize and provide the means to fulfill the fundamental right to abortion. This must not just be a corollary to prevent unsafe abortions, as important as that objective is. The global human rights community needs to affirm the right to abortion as a fundamental right enabling women to protect and promote their health and wellbeing preferably in the form of a joint resolution or general comment on the right to abortion by several UN human rights committees.
Audrey R. Chapman, PhD, is Healey Professor of Medical Ethics and Humanities at the University of Connecticut School of Medicine, and an adjunct professor at the University of Connecticut Law School, United States.
References
[1] Dobbs v. Jackson Women’s Health Organization, 142 Supreme Court 2228, 2242-43 (2022); M. Felix, L. Sobel, and A. Salganicoff, “A Review of Exceptions in State Abortion Bans: Implications for the Provision of Abortion Services,” KFF, 2023, https://www.kff.org/womens-health-policy/issue-brief/a-review-of-ex…
[2] M. Berger and M. Klimentov, “Abortion pill at heart of Supreme Court Ruling is approved in over 90 countries,” The Washington Post, May 17, 2023, www.washingtonpost.com/world/2023/04/19/abortion-pill-mifepristone-g…
[3] L. O. Gostin and R. Reingold, “The Mifepristone Battle: The Supreme Court Steps in,” The Health Docket, Med Page Today, April 17, 2023, https:/www.medpagetodat.com/opinion/the-health-docket/104061
[4] Alliance for Hippocratic Medicine v. FDA, CV-002223-Z (U.S. District CT., 5th Circuit, Northern District of Texas).
[5] see note 3.
[6] E. J. MacKenzie and J. Rosen, “Judicial overreach is an immediate hazard to already precarious public health,” STAT, April 20, 2023, https://www.statnews.com/2023/04/20/mifepristone-aca-court-rulin…
[7] Ibid.
[8] Ibid.
[9] see note 3.
[10] L. Sobel, A. Salganicoff, and M. Felix, “Update on the Status of Alliance Hippocratic Medicine v. the Food and Drug Administration, et. al.” KFF, April 21, 2023, https://www.kff.org/policy-watch/update-on-status-alliance-hippocr…
[11] A. Kearney, G. Sparks, A. Kirzinger, et al., “KFF Health Tracking Poll May 2023: Health Care in the 2024 Election and in the Courts,” 5/26/2023, https://www.kff.org/womens-health-policy/poll-finding/kff-tracking-p
[12] A. McCann, “World Becomes Remedy to Abortion Pill Limits,” The New York Times, April 19, 2023, pp. A1 and A14.
[13] J. E. Parker, “How abortion access changed in the first year after Roe v Wade,” STAT, June 24, 2023, https://www.statnews.co,/2023/06/24/abortion-roe-v-wade-anniversary/?utm-campaign+morning-rounds&utm_medium=email/
[14] United Nations Committee on Economic, Social and Cultural Rights, General Comment 22 (2016) on the Right to sexual and reproductive health (article 12 of the International Covenant on Economic, Social and Cultural Rights), E/6.12/GC/22, paragraph 28.
[15] United Nations Human Rights Committee, General Comment No. 36 (2018) on article 6 of the International Covenant on Civil and Political Rights on the right to life, CCPR/C/GC/36 -2018, paragraph 8.